Label: DAISY- leucanthemum vulgare solution
DANDELION- taraxacum officinale solution
SUNFLOWER- helianthus annuus solution

  • NDC Code(s): 22840-1500-2, 22840-1500-4, 22840-1501-1, 22840-1502-1, view more
    22840-1503-2, 22840-1503-4, 22840-1504-2, 22840-1505-1, 22840-1506-1, 22840-1569-2, 22840-1570-2, 22840-1570-4, 22840-1571-2, 22840-1571-4, 22840-1572-2, 22840-1573-2, 22840-1573-4, 22840-5500-2, 22840-5500-5, 22840-5501-2, 22840-5501-4, 22840-5501-5, 22840-5502-2, 22840-5502-4, 22840-5502-5
  • Packager: Greer Laboratories, Inc.
  • Category: NON-STANDARDIZED ALLERGENIC LABEL
  • DEA Schedule: None
  • Marketing Status: Biologic Licensing Application

Drug Label Information

Updated November 20, 2023

If you are a consumer or patient please visit this version.

  • HIGHLIGHTS OF PRESCRIBING INFORMATION

    HIGHLIGHTS OF PRESCRIBING INFORMATION

    These highlights do not include all the information needed to use Non-Standardized Allergenic Extracts (Pollens, Molds, Epidermals, Insects, Foods and Miscellaneous Inhalants) safely and effectively. See full prescribing information for Non-Standardized Allergenic Extracts.

    Non-Standardized Allergenic Extracts (Pollens, Molds, Epidermals, Insects, Foods, and Miscellaneous Inhalants)

    Solutions for percutaneous, intradermal or subcutaneous administration.

    Initial U.S. Approval: 1968

    WARNING: SEVERE ALLERGIC REACTIONS

    See full prescribing information for complete boxed warning.

    • Non-Standardized Allergenic Extracts can cause severe life-threatening systemic reactions, including anaphylaxis. (5.1)
    • Do not administer these products to patients with severe, unstable or uncontrolled asthma. (4)
    • Observe patients in the office for at least 30 minutes following treatment.Emergency measures and personnel trained in their use must be available immediately in the event of a life-threatening reaction. (5.1)
    • Patients with extreme sensitivity to these products, on an accelerated immunotherapy build-up, switching to another lot, receiving high doses of these products, and patients exposed to similar allergens may be at increased risk of a severe allergic reaction. (5.1)
    • These products may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a systemic allergic reaction, and for patients receiving medications such as beta-blockers that may make them unresponsive to epinephrine or inhaled bronchodilators. (5.1, 5.2)

    RECENT MAJOR CHANGES
    Warning and Precautions, Anaphylaxis Following False Negative Food Allergen Skin Test Results (5.3) 01/2023

    INDICATIONS AND USAGE

    Non-Standardized Allergenic Extracts are indicated for:

    • Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific allergens. (1)
    • Immunotherapy for reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or in vitro testing for allergen-specific IgE antibodies. (1)

    Food extracts have not been proven safe or effective in allergen immunotherapy.

    DOSAGE AND ADMINISTRATION

    For percutaneous, intradermal or subcutaneous use only.

    The extracts are diluted with sterile diluents when used for intradermal testing or subcutaneous immunotherapy. For percutaneous testing, the extracts are diluted with sterile diluents in patients expected to be at greater risk for systemic allergic reaction. Dosages vary by mode of administration and by individual response. See full prescribing information for instructions on preparation, administration, and adjustments of dose. (2.1)

    DOSAGE FORMS AND STRENGTHS

    Non-Standardized Allergenic Extracts are labeled in weight/volume and/or protein nitrogen units (PNU)/milliliter (a measure of total protein), and are supplied as sterile aqueous stock concentrates at up to 1:10 weight/volume or 40,000 PNU/milliliter, or 50% glycerin stock concentrates at up to 1:20 weight/volume. (3)

    CONTRAINDICATIONS

    • Severe, unstable or uncontrolled asthma. (4)
    • History of any severe systemic or local allergic reaction to an allergen extract. (4)

    WARNINGS AND PRECAUTIONS

    Severe allergic reactions have occurred following the administration of other allergenic extracts and may occur in individuals following the administration of Non-Standardized Allergenic Extracts in the following situations:

    • Extreme sensitivity to Non-Standardized Allergenic Extracts, receipt of high doses of Non-Standardized Allergenic Extracts, or concomitant exposure to similar environmental allergens. (5.1)
    • Receiving an accelerated immunotherapy build-up schedule (e.g., “rush” immunotherapy), or changing from one allergenic lot to another. (5.1)

    ADVERSE REACTIONS

    The most common adverse reactions, occurring in 26 to 82% of all patients who receive subcutaneous immunotherapy, are local adverse reactions at the injection site (e.g., erythema, itching, swelling, tenderness, pain). (6)

    Systemic adverse reactions, occurring in ≤ 7% of patients who receive subcutaneous immunotherapy, include generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema, and hypotension. These can be fatal. (6)

    To report SUSPECTED ADVERSE REACTIONS, contact GREER Laboratories, Inc. at 1-855-274-1322 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    DRUG INTERACTIONS

    • Antihistamines and other medications that suppress histamine, including topical corticosteroids, topical anesthetics and tricyclic antidepressants can interfere with skin test results. (7)

    See 17 for PATIENT COUNSELING INFORMATION

  • FULL PRESCRIBING INFORMATION: CONTENTS*

    WARNING: SEVERE ALLERGIC REACTIONS
    1 INDICATIONS AND USAGE
    2 DOSAGE AND ADMINISTRATION

    2.1 Preparation for Administration
    2.2 Diagnostic Testing
    2.3 Immunotherapy
    3 DOSAGE FORMS AND STRENGTHS
    4 CONTRAINDICATIONS

    5 WARNINGS AND PRECAUTIONS
    5.1 Serious Systemic Adverse Reactions
    5.2 Epinephrine
    5.3 Anaphylaxis Following False Negative Food Allergen Skin Test Results
    5.4 Cross-Reactions and Dose Sensitivity
    6 ADVERSE REACTIONS
    7 DRUG INTERACTIONS

    7.1 Antihistamines
    7.2 Topical Corticosteroids and Topical Anesthetics
    7.3 Tricyclic Antidepressants
    8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy
    8.2 Lactation
    8.4 Pediatric Use
    8.5 Geriatric Use
    11 DESCRIPTION
    12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action
    14 CLINICAL STUDIES
    15 REFERENCES
    16 HOW SUPPLIED/STORAGE AND HANDLING

    16.1 How Supplied
    16.2 Storage and Handling
    17 PATIENT COUNSELING INFORMATION
    *Sections or subsections omitted from the Full Prescribing Information are not listed.

  • BOXED WARNING (What is this?)

    FULL PRESCRIBING INFORMATION

    WARNING: SEVERE ALLERGIC REACTIONS

    • Non-Standardized Allergenic Extracts can cause severe life-threatening systemic reactions, including anaphylaxis. (5.1)
    • Do not administer these products to patients with severe, unstable, or uncontrolled asthma. (4)
    • Observe patients in the office for at least 30 minutes following treatment. Emergency measures and personnel trained in their use must be available immediately in the event of a life-threatening reaction. (5.1)
    • Patients with extreme sensitivity to these products, those on an accelerated immunotherapy build-up schedule, those switching to another allergenic lot, those receiving high doses of Non-Standardized Allergenic Extracts, or those also exposed to similar allergens may be at increased risk of a severe allergic reaction. (5.1)
    • These products may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction. (5.1)
    • These products may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers. (5.2)
  • 1 INDICATIONS AND USAGE

    Non-Standardized Allergenic Extracts are indicated for:

    • Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens.
    • Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies.

    Food extracts have not been proven safe or effective in allergen immunotherapy.

  • 2 DOSAGE AND ADMINISTRATION

    For percutaneous, intradermal or subcutaneous use only.

    The extracts are diluted with sterile diluents when used for intradermal testing or subcutaneous immunotherapy. For percutaneous testing, the extracts are diluted with sterile diluents in patients expected to be at greater risk for systemic allergic reaction. Dosages vary by mode of administration and by individual response.

    2.1 Preparation for Administration

    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard solution if either of these conditions exist.

    The extracts are diluted with sterile diluents when used for percutaneous and intradermal testing, or for subcutaneous immunotherapy.

    Extracts labeled “For Diagnostic Use Only” are intended for percutaneous and intradermal testing only. These extracts have not been shown by adequate data to be safe and effective for therapeutic use. The extracts labeled For Diagnostic Use Only are the foods Barley, Coffee, Oat, Pineapple, Rye, Spinach, Wheat, the insects Flea, House Fly, Mosquito, and the plant and plant parts Cottonseed and Flax.

    Undiluted 50% glycerin stock concentrate is used for percutaneous testing. To prepare 10-fold dilutions for percutaneous testing in patients suspected to be at greater risk for systemic allergic reaction, start with the stock concentrate. Proceed as shown in Table 1. The 10-fold dilution series uses 0.5 milliliters of concentrate added to 4.5 milliliters of sterile 50% glycerin diluent. Subsequent dilutions are made in a similar manner.

    To prepare 10-fold dilutions for intradermal testing and immunotherapy, start with a 1:10 weight/volume, 1:20 weight/volume, or up to a 40,000 PNU/milliliter stock concentrate. Proceed as shown in Table 1. The 10-fold dilution series uses 0.5 milliliter of concentrate added to 4.5 milliliters of sterile diluent (glycerin-free diluents for intradermal testing, glycerin-free or 10% glycerin-saline diluents for immunotherapy). Subsequent dilutions are made in a similar manner.

    Table 1: 10-fold Dilution Series*
    Dilution Extract Milliliters of DiluentDilution Strength (w/v)Dilution Strength (w/v)Dilution Strength (PNU/milliliter)
    0Concentrate1:101:2020,000
    10.5 mL Concentrate4.51:1001:2002,000
    20.5 mL Dilution 14.51:1,0001:2,000200
    30.5 mL Dilution 24.51:10,0001:20,00020
    40.5 mL Dilution 34.51:100,0001:200,0002
    50.5 mL Dilution 44.51:1,000,0001:2,000,0000.2
    60.5 mL Dilution 54.51:10,000,0001:20,000,0000.02

    *There is no direct potency correlation across the table between PNU/milliliter and w/v.

    Undiluted 50% glycerin stock concentrate is used for percutaneous testing. To prepare 5-fold dilutions for percutaneous testing in patients suspected to be at greater risk for systemic allergic reaction, start with the stock concentrate. Proceed as shown in Table 2. The 5-fold dilution series uses 1 milliliter of concentrate added to 4 milliliters of sterile 50% glycerin diluent. Subsequent dilutions are made in a similar manner.

    To prepare 5-fold dilutions for intradermal testing or immunotherapy, start with a 1:10 weight/volume, 1:20 weight/volume, or up to a 40,000 PNU/milliliter stock concentrate. Proceed as shown in Table 2. The 5-fold dilution series uses 1 milliliter of concentrate added to 4 milliliters of sterile diluent (glycerin-free diluents for intradermal testing, glycerin-free or 10% glycerin-saline diluents for immunotherapy). Subsequent dilutions are made in a similar manner.

    Table 2: 5-fold Dilution Series*
    DilutionExtractMilliliters of DiluentDilution Strength (w/v)Dilution Strength (w/v)Dilution Strength (PNU/milliliter)
    0Concentrate1:101:2020,000
    11 mL Concentrate41:501:1004,000
    21 mL Dilution 141:2501:500800
    31 mL Dilution 241:1,2501:2,500160
    41 mL Dilution 341:6,2501:12,50032
    51 mL Dilution 441:31,2501:62,5006.4
    61 mL Dilution 541:156,2501:312,5001.28

    *There is no direct potency correlation across the table between PNU/milliliter and w/v.

    2.2 Diagnostic Testing

    Diagnostic testing can be performed via percutaneous or intradermal administration of the Non-Standardized Allergenic Extracts. A positive skin test reaction should be interpreted in relation to the patient’s history and known exposure to the specific allergen(s).

    Percutaneous Skin Testing

    Preparation and Dose

    For percutaneous testing (prick or puncture), use glycerinated extract; use the extracts at the highest available stock concentration. In patients suspected to be at greater risk for systemic allergic reaction, use 10-fold or 5-fold dilutions of the concentrate.

    Prick test: Place one drop of extract with appropriate controls on the skin and with a skin test device, pierce through the drop into the skin with a slight lifting motion. Alternatively, use skin test devices loaded with the extract from the storage trays in a similar manner or in accordance with the device manufacturer’s recommendations.

    Puncture test: Place one drop of extract or control on the skin and pierce the skin through the drop with a skin test device perpendicular to the skin. Alternatively, use skin test devices loaded with the extract from the storage trays in a similar manner or in accordance with the device manufacturer’s recommendations.

    Interpreting Results

    When using percutaneous skin test devices, follow the directions provided with the test devices. A glycerinated histamine control solution (6 milligrams/milliliter or 1 milligram/milliliter histamine base) may be used as the positive control. A 50% glycerin-saline solution may be used as the negative control.

    Read and record skin test responses 15 to 20 minutes after exposure. Individual patient reactivity can vary with time, allergen potency, and/or immunotherapy, as well as testing technique. The most reliable method of recording a skin test reaction is to measure the largest diameter of both wheal and erythema. While some correlation exists between the size of the skin test reaction and the degree of sensitivity, other factors should be considered in the diagnosis of allergy to specific allergens (see Figure 1 below).

    Figure 1: Measurement of Wheal and Flare

    Use a paper or plastic millimeter skin reaction guide as shown below.

    Figure_1

    Fifteen minutes after application of the skin test, measure the length and midpoint orthogonal width of each flare and wheal from the inner edge of the reaction.

    Length_and_Midpoint_Orthogonal_Width

    The length of the skin test is defined as the largest diameter and the width of the skin test is defined as the diameter perpendicular to the length at its midpoint. Consider the wheal and flare as separate entities. First, measure the flare and then independently measure the wheal.

    Measuring the Flare

    Measure_the_Flare

    Measuring the Wheal

    Measuring_the_Wheal

    The average diameter measurement in the example above of the flare is (26 mm + 36 mm)/ 2 = 31 mm and the average diameter of the wheal is (10 mm + 16 mm)/2 = 13 mm.

    Responses to positive controls should be at least 3 millimeters larger than responses to the negative controls.

    Negative controls should elicit no reaction or only reactions of small diameter (less than 2 millimeters wheal, less than 5 millimeters erythema).

    If either the positive or negative control response does not meet the above criteria, results for the allergenic extracts tested at the same time should be considered invalid and be repeated.

    Intradermal Skin Testing

    Preparation and Dose

    For intradermal testing, dilute stock concentrate to 1:100 to 1:1000 volume to volume of Non-Standardized Allergenic Extracts stock concentrate solution. Dilute the stock concentrate solution with sterile diluent [see Dosage and Administration (2.1)]. Use normal or buffered saline or normal saline with human serum albumin (HSA) diluent. If the result from the initial test dose is negative, subsequent intradermal tests using increasingly stronger doses may be performed up to the maximum recommended strength of 1:25 volume to volume dilution of the extract concentrate solution.

    Inject 0.02 milliliters of the extract solution intradermally according to the algorithms shown in Figure 2.

    Figure 2: Algorithm for Dilution of Stock Concentrate Solution of Non-Standardized Allergenic Extracts for Intradermal Skin Testing

    Figure_2

    1 Corresponds to 1:10,000 - 1:15,625 volume to volume dilution of 1:20 weight/volume glycerinated extract concentrates

    2 Corresponds to 1:100 - 1:125 volume to volume dilution of 1:20 weight/volume glycerinated extract concentrates

    3 Corresponds to 1:50 - 1:100 volume to volume dilution of 1:20 weight/volume glycerinated extract concentrates

    4 Corresponds to 1:25 - 1:100 volume to volume dilution of 1:20 weight/volume glycerinated extract concentrates

    2.3 Immunotherapy

    For subcutaneous administration only.

    Preparation and Dose

    Stock concentrates of Non-Standardized Allergenic Extracts are available in aqueous (up to 1:10 weight/volume or 40,000 PNU/milliliter) and 50% glycerin (up to 1:20 weight/volume) strengths for immunotherapy. Stock concentrates are diluted in normal saline, buffered saline, HSA-saline, or 10% glycerin-saline, depending on the patient’s reactivity to the diluent. See Table 1 and Table 2 for dilution preparation.

    Administration of Immunotherapy

    Administer immunotherapy by subcutaneous injection in the lateral aspect of the upper arm or thigh. Avoid injection directly into any blood vessel.

    The optimal interval between doses of allergenic extract varies among individuals. Injections are usually given 1 to 2 times per week until the maintenance dose is reached, at which time the injection interval is increased to 2, then 3, and finally 4 weeks. Dosages vary by mode of administration, and by clinical response and tolerance. The minimum course of treatment may be three to five years, depending on the clinical response.

    Guidelines for Immunotherapy

    The initial dose of the extract should be based on the skin test reactivity. In patients suspected to be at greater risk for systemic allergic reaction by history and skin test, the initial dose of the extract should be 0.05 milliliter of a 1:20,000,000 to 1:2,000,000 weight/volume extract dilution. Patients not suspected to be at greater risk for systemic allergic reaction may be started at 0.1 milliliter of a 1:200,000 to 1:20,000 weight/volume extract dilution.

    The dose of allergenic extract is increased at each injection by no more than 50% of the previous dose, and the next increment is governed by the response to the last injection.

    Select the maximum tolerated maintenance dose based on the patient’s clinical response and tolerance. Doses larger than 0.2 milliliter of the stock concentrate are rarely administered because an extract in 50% glycerin diluent can cause discomfort upon injection.

    Dosage Modification Guidelines for Immunotherapy

    The following conditions may indicate a need to withhold or reduce the dosage of immunotherapy.

    • Symptoms of rhinitis and/or asthma
    • Infection accompanied by fever
    • Exposure to excessive amounts of clinically relevant environmental allergen prior to a scheduled injection
    • Large local reactions that persist for longer than 24 hours can be an indication for repeating the previous dose or reducing the dose at the next administration

    Any evidence of a systemic reaction is an indication for a significant reduction (at least 75%) in the subsequent dose. Repeated systemic adverse reactions are sufficient reason for the cessation of further attempts to increase the dose.

    Local adverse reactions require a decrease in the next dose by at least 50%. Proceed cautiously in subsequent dosing. In situations prompting dose reduction, once the reduced dose is tolerated, a cautious increase in dosage can be attempted.

    Changing extract to a different lot or from a different manufacturer: When switching to a different lot of extract, or from another manufacturer’s extract, decrease the starting dose. Because manufacturing processes and sources of raw materials differ among manufacturers, the interchangeability of extracts from different manufacturers cannot be assured. In general, a dose reduction of 50 to 75% of the previous dose should be adequate, but each situation must be evaluated separately, considering the patient’s history of sensitivity, tolerance of previous injections, and other factors. Dose intervals should not exceed one week when rebuilding the dose.

    Unscheduled gaps between treatments: Patients can lose tolerance to allergen injections during prolonged periods between doses, which increases their risk for an adverse reaction. The duration of tolerance between injections varies from patient to patient.

    During the build-up phase, when patients receive injections 1 to 2 times per week, repeat or reduce the extract dosage if there has been a substantial time interval between injections. This depends on: 1) the concentration of allergen immunotherapy extract that is to be administered; 2) a previous history of systemic reactions; and 3) the degree of variation from the prescribed interval of time, with longer intervals since the last injection leading to greater reductions in the dose to be administered.

    This suggested approach to dose modification, due to unscheduled gaps between treatments during the build-up phase, is not based on published evidence. The individual physician should use this or a similar protocol for the specific clinical setting.

    Similarly, if unscheduled gaps occur during maintenance therapy, it may be necessary to reduce the dosage and bring the patient up to maintenance dosing using an established build-up protocol.

    Changing from non-stabilized to human serum albumin (HSA) stabilized diluents: Allergenic extracts prepared with diluents containing HSA and 0.4% phenol are more stable than those prepared with diluents that do not contain stabilizers. When switching from a non-stabilized to an HSA-stabilized diluent, consider lowering the dose for immunotherapy.

  • 3 DOSAGE FORMS AND STRENGTHS

    Non-Standardized Allergenic Extracts are labeled in weight/volume and/or protein nitrogen units (PNU)/milliliter (a measure of total protein), and are supplied as sterile aqueous stock concentrates at up to 1:10 weight/volume or 40,000 PNU/milliliter, or 50% glycerin stock concentrates at up to 1:20 weight/volume.

  • 4 CONTRAINDICATIONS

    Non-Standardized Allergenic Extracts are contraindicated in patients with:

    • Severe, unstable or uncontrolled asthma
    • History of any severe systemic or local allergic reaction to an allergen extract
  • 5 WARNINGS AND PRECAUTIONS

    5.1 Serious Systemic Adverse Reactions

    Serious systemic adverse reactions have occurred following the administration of other allergenic extracts and may occur in individuals following the administration of Non-Standardized Allergenic Extracts in the following situations:

    • Extreme sensitivity to the specific allergen(s)
    • Receipt of an accelerated immunotherapy build-up schedule (e.g., “rush” immunotherapy)
    • Receipt of high doses of allergenic extracts or concomitant exposure to similar environmental allergens
    • Change from one allergenic extract lot to another allergenic extract lot

    High-risk patients have had fatal reactions. Consider using more dilute preparations in patients suspected to be at greater risk of systemic allergic reaction [see Dosage and Administration (2.1)].

    Administer Non-Standardized Allergenic Extracts in a healthcare setting under the supervision of a physician prepared to manage a severe systemic or a severe local allergic reaction.Observe patients in the office for at least 30 minutes following administration. 1

    5.2 Epinephrine

    Non-Standardized Allergenic Extracts may not be suitable for patients with certain medical conditions that may reduce the ability to survive a serious allergic reaction or increase the risk of adverse reactions after epinephrine administration. Examples of these medical conditions include but are not limited to: markedly compromised lung function (either chronic or acute), unstable angina, recent myocardial infarction, significant arrhythmia, and uncontrolled hypertension.

    These products may not be suitable for patients who are taking medications that can potentiate or inhibit the effect of epinephrine. These medications include:

    Βeta-adrenergic blockers: Patients taking beta-adrenergic blockers may be unresponsive to the usual doses of epinephrine used to treat serious systemic reactions, including anaphylaxis. Specifically, beta-adrenergic blockers antagonize the cardiostimulating and bronchodilating effects of epinephrine.

    Alpha-adrenergic blockers, ergot alkaloids: Patients taking alpha-adrenergic blockers may be unresponsive to the usual doses of epinephrine used to treat serious systemic reactions, including anaphylaxis. Specifically, alpha-adrenergic blockers antagonize the vasoconstricting and hypertensive effects of epinephrine. Similarly, ergot alkaloids may reverse the pressor effects of epinephrine.

    Tricyclic antidepressants, levothyroxine sodium, monoamine oxidase inhibitors, and certain antihistamines: The adverse effects of epinephrine may be potentiated in patients taking tricyclic antidepressants, levothyroxine sodium, monoamine oxidase inhibitors, and the antihistamines chlorpheniramine, and diphenhydramine.

    Cardiac glycosides, diuretics: Patients who receive epinephrine while taking cardiac glycosides or diuretics should be observed carefully for the development of cardiac arrhythmias.

    5.3 Anaphylaxis Following False Negative Food Allergen Skin Test Results
    False negative skin test results associated with anaphylaxis from subsequent exposure to the allergen have been reported during postmarketing diagnostic use of some food allergenic extracts. Based on the patient’s clinical history and index of suspicion, healthcare providers should consider confirming negative skin testing with serologic testing by measuring specific serum IgE or with a medically-supervised oral food challenge.

    5.4 Cross-Reactions and Dose Sensitivity

    When determining the final dose of an allergen mixture for immunotherapy, consider cross-reactivity among component extracts.

    Determine the initial dilution of allergenic extract, starting dose, and progression of dosage based on the patient’s history and results of skin tests 2 [see Dosage and Administration (2.1)]. Strongly positive skin tests can be indicators for potential adverse reactions.

  • 6 ADVERSE REACTIONS

    The most common adverse reactions, occurring in 26 to 82% of all patients who receive subcutaneous immunotherapy are local adverse reactions at the injection site (e.g., erythema, itching, swelling, tenderness, pain). 1 Systemic adverse reactions, occurring in < 7% of patients who receive subcutaneous immunotherapy, 3 include generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema, and hypotension. These adverse reactions can be fatal. 1

    The allergenic extracts labeled “For Diagnostic Use Only” that contain sodium formaldehyde sulfoxylate (SFS) can cause slight discoloration of the skin at the site of administration. This discoloration can remain for extended amounts of time.

  • 7 DRUG INTERACTIONS

    7.1 Antihistamines

    Do not perform skin testing with allergenic extracts within 3 to 10 days of use of first-generation H 1-histamine receptor blockers (e.g., clemastine, diphenhydramine) and second-generation antihistamines (e.g., loratadine, cetirizine). These products suppress histamine skin test reactions and could mask a positive response. 2

    7.2 Topical Corticosteroids and Topical Anesthetics

    Topical corticosteroids can suppress skin reactivity; therefore, discontinue use at the skin test site for 2 to 3 weeks before skin testing. Avoid use of topical local anesthetics at skin test sites as they can suppress flare responses. 2

    7.3 Tricyclic Antidepressants

    Tricyclic antidepressants can have potent antihistamine effects that can affect skin testing. If tricyclic medication has been recently discontinued, allow 7 to 14 days before initiating skin testing. 2

  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    Risk Summary

    All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. There are no human or animal data to establish the presence or absence of Non-Standardized Allergenic Extracts-associated risks during pregnancy.

    8.2 Lactation

    Risk Summary

    It is not known whether Non-Standardized Allergenic Extracts are present in human milk. Data are not available to assess the effects of these extracts on the breastfed child or on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Non-Standardized Allergenic Extracts and any potential adverse effects on the breastfed child from the extracts or from the underlying maternal condition.

    8.4 Pediatric Use

    For use of these products in children younger than 5 years of age, consideration should be given to the patient’s ability to comply and cooperate with allergen immunotherapy and the potential for difficulty in communicating with the child regarding systemic reactions. 1

    8.5 Geriatric Use

    Data are not available to determine if subjects 65 years of age and older respond differently to allergen immunotherapy than younger subjects.

  • 11 DESCRIPTION

    Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9.

    Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant.

    Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures.

    Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter.

    Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter.

  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    The skin test reaction results from interaction of the introduced allergen and allergen-specific IgE antibodies bound to mast cells, leading to mast cell degranulation and release of histamine, tryptase and other mediators, which results in the formation of the wheal and flare.

    The precise mechanisms of action of allergen immunotherapy are not known. Immunologic responses to immunotherapy include changes in allergen-specific IgE levels, allergen-specific IgG levels, and regulatory T cell responses. 1

  • 14 CLINICAL STUDIES

    Specific immunotherapy with allergenic extracts is helpful in reducing symptoms associated with exposure to the offending allergens. A summary of effectiveness by the Panel on Review of Allergenic Extracts, an advisory committee to the U.S. Food and Drug Administration, has been published. 4

  • 15 REFERENCES

    1. Cox LJ, Nelson H, Lockey R.Allergen immunotherapy: A practice parameter third update. J Allergy Clin Immunol. 2011;127:(1)S1-55.
    2. Bernstein IL, Li JT, Bernstein DI, et al.Allergy diagnostic testing: an updated practice parameter. Ann Allergy Asthma Immunol. 2008;100:S1-148.
    3. Greenberg MA, Kaufman CR, Gonzalez GE, et al. Late and immediate systemic-allergic reactions to inhalant allergen immunotherapy. J Allergy Clin Immunol. 1986;77:865-870.
    4. Federal Register Proposed Rule: Biological Products: Implementation of Efficacy Review, Allergenic Extracts, Federal Register 1985;50: 3082-3288.
  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    16.1 How Supplied

    Non-Standardized Allergenic Extracts and mixes may be supplied as aqueous stock concentrates of up to 1:10 weight/volume or 40,000 PNU/milliliter for intradermal and subcutaneous testing. The extracts may also be supplied as 50% glycerin stock concentrates of up to 1:20 weight/volume for use in percutaneous skin testing and subcutaneous immunotherapy. Non-Standardized Allergenic Extracts are labeled in weight/volume and/or PNU/milliliter and may be provided in 5, 10, and 50 milliliter vials. Glycerinated extracts are also supplied in 5 milliliter dropper vials for prick or puncture testing.

    Non-Standardized Allergenic Extracts available are as follows:

    Pollens ‑ Grasses
    Bahia Grass, Paspalum notatum
    Brome, Smooth, Bromus inermis
    Canarygrass, Reed, Phalaris arundinacea
    Johnson Grass, Sorghum halepense
    Quack (Couch) Grass, Elymus repens
    Ryegrass, Giant Wild, Leymus condensatus
    Ryegrass, Italian, Lolium multiflorum
    Velvetgrass, Holcus lanatus
    Wheatgrass, Western, Pascopyrum smithii
    Pollens - Trees
    Acacia, Acacia dealbata
    Alder, Hazel, Alnus serrulata
    Alder, Red, Alnus rubra
    Alder, White, Alnus rhombifolia
    Ash, Arizona (Velvet), Fraxinus velutina
    Ash, Green, Fraxinus pennsylvanica
    Ash Mix (Equal parts Fraxinus pennsylvanica, Fraxinus americana)
    Ash, Oregon, Fraxinus latifolia
    Ash, White, Fraxinus americana
    Aspen, Populus tremuloides
    Beech, American, Fagus grandifolia
    Birch, Black-Sweet, Betula lenta
    Birch, Mix (Equal parts Betula lenta, Betula nigra, Betula populifolia)
    Birch, River, Betula nigra
    Birch, Spring, Betula occidentalis
    Birch, White, Betula populifolia
    Box Elder, Acer negundo
    Cedar, Mountain, Juniperus ashei
    Cedar, Red, Juniperus virginiana
    Cedar, Salt (Tamarisk), Tamarix gallica
    Central/Eastern 4 Tree Mix (Equal parts Ulmus americana, Acer negundo, Carya illinoinensis, Quercus virginiana)
    Cottonwood, Arizona (Fremont), Populus fremontii
    Cottonwood, Black, Populus trichocarpa
    Cottonwood, Eastern, Populus deltoides
    Cottonwood, Western, Populus deltoides ssp. monilifera
    Cypress, Arizona, Callitropsis arizonica
    Cypress, Bald, Taxodium distichum
    Eastern Oak Mix (Equal parts Quercus velutina, Quercus rubra, Quercus alba)
    Eastern 6 Tree Mix (Equal parts Fagus grandifolia, Populus deltoides, Quercus rubra, Betula nigra, Carya ovata, Fraxinus americana)
    Eastern 7 Tree Mix (Equal parts Ulmus americana, Fagus grandifolia, Populus deltoides, Quercus rubra, Betula nigra, Carya ovata, Fraxinus americana)
    Eastern 8 Tree Mix (Equal parts Ulmus americana, Fagus grandifolia, Populus deltoides, Quercus rubra, Betula nigra, Carya ovata, Fraxinus americana, Acer saccharum)
    Eastern 10 Tree Mix (Equal parts Platanus occidentalis, Ulmus americana, Fagus grandifolia, Populus deltoides, Quercus rubra, Betula nigra, Carya ovata, Fraxinus americana, Acer saccharum, Liquidambar styraciflua)
    Elm, American, Ulmus americana
    Elm, Cedar, Ulmus crassifolia
    Elm Mix (Equal parts Ulmus americana, Ulmus pumila)
    Elm, Siberian, Ulmus pumila
    Eucalyptus, Bluegum, Eucalyptus globulus
    Hackberry, Celtis occidentalis
    Hazelnut, American, Corylus americana
    Hickory Mix (Equal parts Carya glabra, Carya ovata, Carya laciniosa, Carya tomentosa)
    Hickory-Pecan Mix (Equal parts Carya illinoinensis, Carya ovata)
    Hickory, Shagbark, Carya ovata
    Hickory, Shellbark, Carya laciniosa
    Hickory, White, Carya tomentosa
    Juniper Mix (Equal parts Juniperus monosperma, Juniperus scopulorum)
    Juniper, Oneseed, Juniperus monosperma
    Juniper, Pinchot, Juniperus pinchotii
    Juniper, Rocky Mountain, Juniperus scopulorum
    Juniper, Utah, Juniperus osteosperma
    Juniper, Western, Juniperus occidentalis
    Locust Blossom, Black, Robinia pseudoacacia
    Mango Blossom, Mangifera indica
    Maple-Box Elder Mix (Equal parts Acer saccharum, Acer negundo)
    2 Maple Mix (Equal parts Acer rubrum, Acer saccharum)
    3 Maple Mix (Equal parts Acer rubrum, Acer saccharinum, Acer saccharum)
    Maple, Red, Acer rubrum
    Maple, Silver/Soft, Acer saccharinum
    Maple, Sugar/Hard, Acer saccharum
    Melaleuca, Melaleuca quinquenervia
    Mesquite, Velvet, Prosopis velutina
    Mulberry, Paper, Broussonetia papyrifera
    Mulberry, Red, Morus rubra
    Mulberry, White, Morus alba
    Oak, Arizona (Gambel), Quercus gambelii
    Oak, Black, Quercus velutina
    Oak, Bur, Quercus macrocarpa
    Oak, California Black, Quercus kelloggii
    Oak, California Live, Quercus agrifolia
    Oak, California White, Quercus lobata
    Oak, Post, Quercus stellata
    Oak, Red, Quercus rubra
    Oak, Virginia Live, Quercus virginiana
    Oak, Water, Quercus nigra
    Oak, Western White, Quercus garryana
    Oak, White, Quercus alba
    Olive, Olea europaea
    Olive, Russian, Elaeagnus angustifolia
    Orange Pollen, Citrus X sinensis
    Palm, Queen, Syagrus romanzoffiana
    Pecan, Carya illinoinensis
    Peppertree Mix (Equal parts Schinus molle, Schinus terebinthifolius)
    Pine, Australian (Beefwood), Casuarina equisetifolia
    Pine, Loblolly, Pinus taeda
    Pine, Longleaf, Pinus palustris
    Pine Mix (Equal parts Pinus taeda, Pinus strobus, Pinus echinata)
    Pine, Ponderosa, Pinus ponderosa
    Pine, Virginia Scrub, Pinus virginiana
    Pine, White (Eastern), Pinus strobus
    Pine, White (Western), Pinus monticola
    Pine, Yellow, Pinus echinata
    Poplar, Lombardy’s, Populus nigra
    Poplar, White, Populus alba
    Privet, Ligustrum vulgare
    Sweetgum, Liquidambar styraciflua
    Sycamore, American, Platanus occidentalis
    Sycamore, California (Western), Platanus racemosa
    11 Tree Mix (Equal parts Fagus grandifolia, Platanus occidentalis, Ulmus americana, Juglans nigra, Salix nigra, Populus deltoides, Quercus rubra, Betula nigra, Carya ovata, Acer saccharum, Fraxinus americana)
    Walnut, Black, Juglans nigra
    Walnut, California Black, Juglans californica
    Walnut, English, Juglans regia
    Wax Myrtle, Morella cerifera
    Western Oak Mix (Equal parts Quercus kelloggii, Quercus agrifolia, Quercus garryana)
    Western 3 Tree Mix (Equal parts Olea europaea, Ulmus pumila, Platanus racemosa)
    Western 10 Tree Mix (Equal parts Acacia dealbata, Acer negundo, Populus fremontii, Olea europaea, Ulmus pumila, Betula occidentalis, Juniperus occidentalis, Platanus racemosa, Quercus garryana, Morus alba)
    Western Walnut Mix (Equal parts Juglans californica, Juglans regia)
    Willow, Arroyo, Salix lasiolepis
    Willow, Black, Salix nigra
    Pollens - Weeds and Garden Plants
    Allscale, Atriplex polycarpa
    Amaranth, Green, Amaranthus hybridus
    Baccharis Mix (Equal parts Baccharis sarothroides, Baccharis halimifolia)
    Burningbush (Kochia), Kochia scoparia spp. scoparia
    Burrobrush, Ambrosia salsola
    Central/Western Weed Mix (Equal parts Kochia scoparia ssp. scoparia, Chenopodium album, Salsola kali)
    Cocklebur, Xanthium strumarium
    Common Weed Mix (Equal parts Xanthium strumarium, Plantago lanceolata, Chenopodium album, Amaranthus retroflexus, Salsola kali)
    Dock-Sorrel Mix (Equal parts Rumex acetosella, Rumex crispus)
    Dock, Yellow (Curly), Rumex crispus
    Dogfennel, Eupatorium capillifolium
    Goldenrod, Solidago canadensis
    Iodinebush, Allenrolfea occidentalis
    Lamb's Quarters, Chenopodium album
    Lenscale (Quailbrush), Atriplex lentiformis
    Marsh Elder, True (Rough), Iva annua
    Marshelder, Burweed (Giant Poverty), Cyclachaena xanthiifolia
    Mixed Amaranths (Equal parts Amaranthus hybridus, Amaranthus palmeri, Amaranthus retroflexus)
    Mugwort, Common, Artemisia vulgaris
    National Weed Mix (Equal parts Xanthium strumarium, Ambrosia trifida, Chenopodium album, Amaranthus retroflexus, Ambrosia artemisiifolia)
    Nettle, Urtica dioica
    Palmer's Amaranth, Amaranthus palmeri
    Pigweed, Rough Redroot, Amaranthus retroflexus
    Pigweed, Spiny, Amaranthus spinosus
    Plantain, English, Plantago lanceolata
    Plantain-Sorrel Mix (Equal parts Plantago lanceolata, Rumex acetosella)
    Rabbit Bush, Ambrosia deltoidea
    Ragweed, Desert, Ambrosia dumosa
    Ragweed, False, Ambrosia acanthicarpa
    Ragweed, Giant (Tall), Ambrosia trifida
    Ragweed, Lanceleaf, Ambrosia bidentata
    Ragweed, Slender, Ambrosia confertiflora
    Ragweed, Western, Ambrosia psilostachya
    Russian Thistle, Salsola kali
    Sagebrush, Common, Artemisia tridentata
    Sage Mix (Equal parts Artemisia tridentata, Artemisia ludoviciana)
    Sage, Prairie, Artemisia ludoviciana
    Saltbush, Annual, Atriplex wrightii
    Scale/Atriplex Mix (Equal parts Atriplex polycarpa, Atriplex lentiformis, Atriplex canescens)
    Sorrel, Sheep (Red), Rumex acetosella
    Waterhemp, Tall, Amaranthus tuberculatus
    3 Weed Mix (Equal parts Xanthium strumarium, Chenopodium album, Amaranthus retroflexus)
    Western Ragweed Mix (Equal parts Ambrosia acanthicarpa, Ambrosia psilostachya)
    Wingscale, Atriplex canescens
    Plants and Plant Parts
    Cotton Linters, Gossypium hirsutum
    Cottonseed, Gossypium hirsutum (For Diagnostic Use Only)
    Flax, Linum usitatissimum (For Diagnostic Use Only)
    Gum, Arabic, Acacia senegal
    Gum, Karaya, Sterculia urens
    Gum, Tragacanth, Astragalus gummifer
    Kapok, Ceiba pentandra
    Orris Root, Iris germanica
    Pyrethrum, Chrysanthemum cinerariifolium
    Tobacco, Cultivated, Leaf, Nicotiana tabacum
    Pollens - Cultivated Farm Plants
    Alfalfa, Medicago sativa
    Beet, Sugar, Beta vulgaris
    Corn, Cultivated, Zea mays
    Oat, Cultivated, Avena sativa
    Rape (Mustard), Brassica napus
    Red Clover, Trifolium pratense
    Rye, Cultivated, Secale cereale
    Wheat, Cultivated, Triticum aestivum
    Pollens - Flowers
    Daisy, Leucanthemum vulgare
    Dandelion, Taraxacum officinale
    Sunflower, Helianthus annuus
    Molds, Rusts and Smuts
    AHH Mold Mix (Equal parts Alternaria alternata, Bipolaris sorokiniana, Cladosporium sphaerospermum)
    Alternaria alternata
    Alternaria/Hormodendrum Mix (Equal parts Alternaria alternata, Cladosporium sphaerospermum)
    Aspergillus amstelodami
    Aspergillus flavus
    Aspergillus fumigatus
    Aspergillus Mix (Equal parts Aspergillus amstelodami, Aspergillus flavus, Aspergillus fumigatus, Aspergillus nidulans, Aspergillus niger)
    Aspergillus nidulans
    Aspergillus niger
    Aureobasidium pullulans
    Bermuda Grass Smut, Ustilago cynodontis
    Bipolaris sorokiniana
    Botrytis cinerea
    Candida albicans
    Chaetomium globosum
    Cladosporium herbarum
    Cladosporium sphaerospermum
    Corn Smut, Ustilago maydis
    Curvularia spicifera
    Dematiaceae Mix (Equal parts Alternaria alternata, Aureobasidium pullulans, Bipolaris sorokiniana, Cladosporium herbarum, Curvularia spicifera, Helminthosporium solani)
    Epicoccum nigrum
    Epidermophyton floccosum
    Fusarium Mix (Equal parts Gibberella fujikuroi, Fusarium solani)
    Fusarium solani
    Geotrichum candidum
    Gibberella fujikuroi
    Gliocladium viride
    Grain Smut Mix (Equal parts Ustilago maydis, Ustilago tritici, Ustilago nuda, Ustilago avenae)
    Grass Smut Mix (Equal parts Ustilago cynodontis, Sporisorium cruentum)
    Helminthosporium solani
    Hypomyces perniciousus
    Loose Kernel Smut, Sporisorium cruentum
    Loose Smut, Wheat, Ustilago tritici
    Microsporum canis
    Mold Mix #1 (Equal parts Alternaria alternata, Aspergillus niger, Bipolaris sorokiniana, Cladosporium sphaerospermum, Penicillium chrysogenum var. chrysogenum)
    Mold Mix #2 (Equal parts Aureobasidium pullulans, Curvularia spicifera, Gibberella fujikuroi, Mucor plumbeus, Rhizopus stolonifer)
    Mold Mix #3 (Equal parts Alternaria alternata, Aspergillus niger, Cladosporium sphaerospermum, Penicillium chrysogenum var. chrysogenum)
    Monilia Mix (Equal parts Candida albicans, Neurospora intermedia)
    Mucor circinelloides f. circinelloides
    Mucor circinelloides f. lusitanicus
    Mucor Mix (Equal parts Mucor circinelloides f. lusitanicus, Mucor plumbeus)
    Mucor plumbeus
    Neurospora intermedia
    New Stock Fungi Mix (Equal parts Sarocladium strictum, Alternaria alternata, Aspergillus niger, Aureobasidium pullulans, Bipolaris sorokiniana, Botrytis cinerea, Candida albicans, Chaetomium globosum, Cladosporium sphaerospermum, Epicoccum nigrum, Gibberella fujikuroi, Mucor plumbeus, Penicillium chrysogenum var. chrysogenum, Phoma betae, Rhizopus stolonifer, Trichophyton mentagrophytes)
    Oat Smut, Ustilago avenae
    Paecilomyces variotii
    Penicillium chrysogenum var. chrysogenum
    Penicillium digitatum
    Penicillium Mix (Equal parts Penicillium camemberti, Penicillium chrysogenum, Penicillium digitatum, Penicillium chrysogenum var. chrysogenum, Penicillium roqueforti)
    Phoma betae
    Phycomycetes Mix (Equal parts Mucor circinelloides f. lusitanicus, Rhizopus stolonifer)
    Rhizopus arrhizus
    Rhizopus Mix (Equal parts Rhizopus stolonifer, Rhizopus arrhizus)
    Rhizopus stolonifer
    Rhodotorula mucilaginosa
    Saccharomyces cerevisiae
    Sarocladium strictum
    Stemphylium solani
    Trichoderma harzianum
    Trichophyton mentagrophytes
    Trichophyton rubrum
    Trichothecium roseum
    Animal Allergens
    Canary Feathers, Serinus canaria
    Cattle Epithelia, Bos taurus
    Chicken Feathers, Gallus gallus
    Dog Epithelia, Canis lupus familiaris
    Duck Feathers, Anas platyrhynchos
    Gerbil Epithelia, Meriones unguiculatus
    Goat Epithelia, Capra hircus
    Goose Feathers, Anser anser
    Guinea Pig Epithelia, Cavia porcellus
    Hamster Epithelia, Mesocricetus auratus
    Hog Epithelia, Sus scrofa
    Horse Epithelia, Equus caballus
    Mixed Feathers (Equal parts Gallus gallus, Anas platyrhynchos, Anser anser)
    Mouse Epithelia, Mus musculus
    Parakeet Feathers, Melopsittacus undulatus
    Rabbit Epithelia, Oryctolagus cuniculus
    Rat Epithelia, Rattus norvegicus
    Silk Worm Cocoon, Bombyx mori
    Insects (Whole Body)
    Ant, Black Carpenter, Camponotus pennsylvanicus
    Ant, Fire, Solenopsis invicta
    Ant, Fire, Solenopsis richteri
    Cockroach, American, Periplaneta americana
    Cockroach, German, Blattella germanica
    2 Cockroach Mix (Equal parts Periplaneta americana, Blattella germanica)
    Deer Fly, Chrysops vittatus
    Flea, Ctenocephalis felis (For Dagnostic Use Only)
    House Fly, Musca domestica (For Dagnostic Use Only)
    Mosquito, Aedes taeniorhynchus (For Diagnostic Use Only)
    Food - Animal Products and Poultry Products
    Beef, Bos taurus
    Chicken Meat, Gallus gallus
    Egg, White, Chicken, Gallus gallus
    Egg, Whole, Chicken, Gallus gallus
    Egg, Yolk, Chicken, Gallus gallus
    Lamb, Ovis aries
    Pork, Sus scrofa
    Turkey Meat, Meleagris gallopavo
    Food - Dairy Products
    Milk, Cow, Bos taurus
    Food - Fish and Shellfish
    Bass, Black, Centropristis striata
    Catfish, Channel, Ictalurus punctatus
    Clam, Northern Quahog, Mercenaria mercenaria
    Cod, Atlantic, Gadus morhua
    Crab, Blue, Callinectes sapidus
    Fish Mix (Equal parts Gadus morhua, Paralichthys lethostigma, Hippoglossus hippoglossus, Scomber scombrus, Thunnus albacares)
    Flounder, Southern, Paralichthys lethostigma
    Lobster, American, Homarus americanus
    Mackerel, King/Atlantic, Scomber scombrus
    Oyster, Atlantic/Eastern, Crassostrea virginica
    Perch, Ocean, Sebastes alutus
    Salmon, Atlantic, Salmo salar
    Scallops, Sea, Placopecten magellanicus
    Shellfish Mix (Equal parts Mercenaria mercenaria, Callinectes sapidus, Crassostrea virginica, Placopecten magellanicus, Farfantepenaeus aztecus)
    Shrimp, Brown, Farfantepenaeus aztecus
    Trout, Rainbow, Oncorhynchus mykiss
    Tuna, Yellowfin, Thunnus albacares
    Food - Plant Source
    Almond, Prunus dulcis
    Apple, Malus pumila
    Apricot, Prunus armeniaca
    Banana, Musa acuminata
    Barley, Whole Grain, Hordeum vulgare (For Diagnostic Use Only, Contains SFS*)
    Bean, Lima, Phaseolus lunatus
    Bean, Navy, Phaseolus vulgaris
    Bean, String Green, Phaseolus vulgaris
    Blueberry, Velvetleaf, Vaccinium myrtilloides
    Brazil Nut, Bertholletia excelsa
    Broccoli, Brassica oleracea var. botrytis
    Buckwheat, Fagopyrum esculentum
    Cabbage, Brassica oleracea var. capitata
    Cacao Bean, Theobroma cacao
    Cantaloupe, Cucumis melo
    Carrot, Daucus carota
    Cashew Nut, Anacardium occidentale
    Cauliflower, Brassica oleracea var. botrytis
    Celery, Apium graveolens var. dulce
    Cherry, Sweet, Prunus avium
    Cinnamon, Cinnamomum verum
    Coconut, Cocos nucifera
    Coffee, Coffea arabica (For Diagnostic Use Only)
    Corn, Zea mays
    Cranberry, Vaccinium macrocarpon
    Cucumber, Cucumis sativus
    Garlic, Allium sativum
    Ginger, Zingiber officinale
    Grape, White Seedless, Vitis vinifera
    Grapefruit, Citrus X paradisi
    Hazelnut (Filbert), Corylus americana
    Hops, Humulus lupulus
    Lemon, Citrus X limon
    Lettuce, Lactuca sativa
    Malt (Barley), Hordeum vulgare
    Mushroom, Agaricus campestris
    Mustard Seed, Sinapis alba
    Nutmeg, Myristica fragrans
    Oat, Avena sativa (For Diagnostic Use Only, Contains SFS*)
    Olive, Green, Olea europaea
    Onion, Allium cepa
    Orange, Citrus X sinensis
    Pea, Green or English, Pisum sativum
    Peach, Prunus persica
    Peanut, Arachis hypogaea
    Pear, Pyrus communis
    Pecan, Carya illinoinensis
    Pepper, Black, Piper nigrum
    Pepper, Green, Capsicum annuum
    Pineapple, Ananas comosus (For Diagnostic Use Only, Contains SFS*)
    Potato, Sweet, Ipomoea batatas
    Potato, White, Solanum tuberosum
    Raspberry, Red, Rubus idaeus
    Rice, Oryza sativa
    Rye, Secale cereale (For Diagnostic Use Only, Contains SFS*)
    Sesame Seed, Sesamum indicum
    Soybean, Glycine max
    Spinach, Spinacia oleracea (For Diagnostic Use Only, Contains SFS*)
    Squash, Yellow Summer, Cucurbita pepo var. ovifera
    Strawberry, Fragaria X ananassa
    Tomato, Solanum lycopersicum
    Vanilla, Vanilla planifolia
    Walnut, Black, Juglans nigra
    Walnut, English, Juglans regia
    Watermelon, Citrullus lanatus
    Wheat, Whole, Triticum aestivum (For Diagnostic Use Only, Contains SFS*)

    *SFS – Sodium Formadehyde Sulfoxylate

    16.2 Storage and Handling

    Maintain at 2 to 8°C (36 to 46°F) during storage and use.

    Dilutions of concentrated extracts that result in a glycerin content of less than 50% can reduce extract stability. Extract dilutions at 1:100 volume to volume should be kept no longer than a month, and more dilute solutions no more than a week. The potency of a dilution can be checked by skin test comparison to a fresh dilution of the extract on a known allergic patient.

  • 17 PATIENT COUNSELING INFORMATION

    Instruct patient to remain under observation in the office for 30 minutes or longer after an injection.

    Caution patient that reactions can occur more than 30 minutes after skin testing or an injection.

    Instruct patient to recognize the following symptoms as adverse reactions and to immediately return to the office or immediately seek other medical attention if any of these symptoms occur following skin testing or an injection:

    • Unusual swelling and/or tenderness at the injection site
    • Hives or itching of the skin
    • Swelling of the face and/or mouth
    • Sneezing, coughing or wheezing
    • Shortness of breath
    • Nausea
    • Dizziness or faintness

    Manufacturer:

    U.S. License No. 308

    Greer Laboratories, Inc.

    Lenoir, NC 28645 U.S.A

  • PRINCIPAL DISPLAY PANEL

    5500-5_Daisy_20-wv

    1502-1_Dandelion_1000-wv

    5502-4_Sunflower_20-wv

    1504-2_Sunflower_40000-pnu

  • INGREDIENTS AND APPEARANCE
    DAISY 
    leucanthemum vulgare solution
    Product Information
    Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-1570
    Route of AdministrationINTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEUCANTHEMUM VULGARE POLLEN (UNII: H9E0IX4MOX) (LEUCANTHEMUM VULGARE POLLEN - UNII:H9E0IX4MOX) LEUCANTHEMUM VULGARE POLLEN0.1 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    PHENOL (UNII: 339NCG44TV)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22840-1570-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
    2NDC:22840-1570-450 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10183309/15/1981
    DANDELION 
    taraxacum officinale solution
    Product Information
    Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-1502
    Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TARAXACUM OFFICINALE POLLEN (UNII: WQ3S5294XY) (TARAXACUM OFFICINALE POLLEN - UNII:WQ3S5294XY) TARAXACUM OFFICINALE POLLEN0.001 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PHENOL (UNII: 339NCG44TV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22840-1502-15 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10183309/15/1981
    DANDELION 
    taraxacum officinale solution
    Product Information
    Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-1501
    Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TARAXACUM OFFICINALE POLLEN (UNII: WQ3S5294XY) (TARAXACUM OFFICINALE POLLEN - UNII:WQ3S5294XY) TARAXACUM OFFICINALE POLLEN1000 [PNU]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PHENOL (UNII: 339NCG44TV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22840-1501-15 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10183309/15/1981
    DANDELION 
    taraxacum officinale solution
    Product Information
    Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-1572
    Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TARAXACUM OFFICINALE POLLEN (UNII: WQ3S5294XY) (TARAXACUM OFFICINALE POLLEN - UNII:WQ3S5294XY) TARAXACUM OFFICINALE POLLEN20000 [PNU]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PHENOL (UNII: 339NCG44TV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22840-1572-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10183309/15/1981
    DAISY 
    leucanthemum vulgare solution
    Product Information
    Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-1569
    Route of AdministrationINTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEUCANTHEMUM VULGARE POLLEN (UNII: H9E0IX4MOX) (LEUCANTHEMUM VULGARE POLLEN - UNII:H9E0IX4MOX) LEUCANTHEMUM VULGARE POLLEN40000 [PNU]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    PHENOL (UNII: 339NCG44TV)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22840-1569-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10183309/15/1981
    SUNFLOWER 
    helianthus annuus solution
    Product Information
    Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-1503
    Route of AdministrationINTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HELIANTHUS ANNUUS POLLEN (UNII: 28D6K7E9IP) (HELIANTHUS ANNUUS POLLEN - UNII:28D6K7E9IP) HELIANTHUS ANNUUS POLLEN0.1 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    PHENOL (UNII: 339NCG44TV)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22840-1503-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
    2NDC:22840-1503-450 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10183309/15/1981
    DANDELION 
    taraxacum officinale solution
    Product Information
    Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5501
    Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TARAXACUM OFFICINALE POLLEN (UNII: WQ3S5294XY) (TARAXACUM OFFICINALE POLLEN - UNII:WQ3S5294XY) TARAXACUM OFFICINALE POLLEN0.05 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PHENOL (UNII: 339NCG44TV)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22840-5501-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:22840-5501-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
    3NDC:22840-5501-450 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10183309/15/1981
    DANDELION 
    taraxacum officinale solution
    Product Information
    Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-1571
    Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TARAXACUM OFFICINALE POLLEN (UNII: WQ3S5294XY) (TARAXACUM OFFICINALE POLLEN - UNII:WQ3S5294XY) TARAXACUM OFFICINALE POLLEN0.05 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PHENOL (UNII: 339NCG44TV)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22840-1571-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
    2NDC:22840-1571-450 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10183309/15/1981
    SUNFLOWER 
    helianthus annuus solution
    Product Information
    Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-1506
    Route of AdministrationINTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HELIANTHUS ANNUUS POLLEN (UNII: 28D6K7E9IP) (HELIANTHUS ANNUUS POLLEN - UNII:28D6K7E9IP) HELIANTHUS ANNUUS POLLEN0.001 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    PHENOL (UNII: 339NCG44TV)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22840-1506-15 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10183309/15/1981
    DANDELION 
    taraxacum officinale solution
    Product Information
    Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-1573
    Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TARAXACUM OFFICINALE POLLEN (UNII: WQ3S5294XY) (TARAXACUM OFFICINALE POLLEN - UNII:WQ3S5294XY) TARAXACUM OFFICINALE POLLEN40000 [PNU]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PHENOL (UNII: 339NCG44TV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22840-1573-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
    2NDC:22840-1573-450 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10183309/15/1981
    SUNFLOWER 
    helianthus annuus solution
    Product Information
    Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-1504
    Route of AdministrationINTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HELIANTHUS ANNUUS POLLEN (UNII: 28D6K7E9IP) (HELIANTHUS ANNUUS POLLEN - UNII:28D6K7E9IP) HELIANTHUS ANNUUS POLLEN40000 [PNU]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    PHENOL (UNII: 339NCG44TV)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22840-1504-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10183309/15/1981
    SUNFLOWER 
    helianthus annuus solution
    Product Information
    Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5502
    Route of AdministrationINTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HELIANTHUS ANNUUS POLLEN (UNII: 28D6K7E9IP) (HELIANTHUS ANNUUS POLLEN - UNII:28D6K7E9IP) HELIANTHUS ANNUUS POLLEN0.05 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    PHENOL (UNII: 339NCG44TV)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22840-5502-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
    2NDC:22840-5502-450 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
    3NDC:22840-5502-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10183309/15/1981
    DAISY 
    leucanthemum vulgare solution
    Product Information
    Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5500
    Route of AdministrationINTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEUCANTHEMUM VULGARE POLLEN (UNII: H9E0IX4MOX) (LEUCANTHEMUM VULGARE POLLEN - UNII:H9E0IX4MOX) LEUCANTHEMUM VULGARE POLLEN0.05 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    PHENOL (UNII: 339NCG44TV)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22840-5500-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
    2NDC:22840-5500-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10183309/15/1981
    DANDELION 
    taraxacum officinale solution
    Product Information
    Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-1500
    Route of AdministrationSUBCUTANEOUS, PERCUTANEOUS, INTRADERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TARAXACUM OFFICINALE POLLEN (UNII: WQ3S5294XY) (TARAXACUM OFFICINALE POLLEN - UNII:WQ3S5294XY) TARAXACUM OFFICINALE POLLEN0.1 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PHENOL (UNII: 339NCG44TV)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22840-1500-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
    2NDC:22840-1500-450 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10183309/15/1981
    SUNFLOWER 
    helianthus annuus solution
    Product Information
    Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-1505
    Route of AdministrationINTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HELIANTHUS ANNUUS POLLEN (UNII: 28D6K7E9IP) (HELIANTHUS ANNUUS POLLEN - UNII:28D6K7E9IP) HELIANTHUS ANNUUS POLLEN1000 [PNU]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    PHENOL (UNII: 339NCG44TV)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22840-1505-15 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10183309/15/1981
    Labeler - Greer Laboratories, Inc. (024671414)
    Registrant - Greer Laboratories, Inc. (024671414)
    Establishment
    NameAddressID/FEIBusiness Operations
    Greer Laboratories, Inc.024671414manufacture(22840-1569, 22840-1570, 22840-5500, 22840-1500, 22840-1502, 22840-1571, 22840-1572, 22840-1573, 22840-5501, 22840-1503, 22840-1504, 22840-1506, 22840-5502, 22840-1501, 22840-1505)