STANDARDIZED MITE MIX, DERMATOPHAGOIDES PTERONYSSINUS AND DERMATOPHAGOIDES FARINAE, 10000 AU PER ML- standardized mite mix, dermatophagoides pteronyssinus and dermatophagoides farinae, 10000 au per ml injection, solution
STANDARDIZED MITE MIX, DERMATOPHAGOIDES PTERONYSSINUS AND DERMATOPHAGOIDES FARINAE, 30000 AU PER ML- standardized mite mix, dermatophagoides pteronyssinus and dermatophagoides farinae, 30000 au per ml injection, solution
STANDARDIZED MITE, DERMATOPHAGOIDES PTERONYSSINUS, INTRADERMAL, 30 AU PER ML- standardized mite, dermatophagoides pteronyssinus, intradermal, 30 au per ml injection, solution
STANDARDIZED MITE, DERMATOPHAGOIDES PTERONYSSINUS, INTRADERMAL, 300 AU PER ML- standardized mite, dermatophagoides pteronyssinus, intradermal, 300 au per ml injection, solution
STANDARDIZED MITE, DERMATOPHAGOIDES PTERONYSSINUS, BULK, 10000 AU PER ML- standardized mite, dermatophagoides pteronyssinus, bulk, 10000 au per ml injection, solution
STANDARDIZED MITE, DERMATOPHAGOIDES PTERONYSSINUS, SCRATCH OR BULK, 30000 AU PER ML- standardized mite, dermatophagoides pteronyssinus, scratch or bulk, 30000 au per ml injection, solution
STANDARDIZED MITE, DERMATOPHAGOIDES FARINAE, INTRADERMAL, 30 AU PER ML- standardized mite, dermatophagoides farinae, intradermal, 30 au per ml injection, solution
STANDARDIZED MITE, DERMATOPHAGOIDES FARINAE, INTRADERMAL, 300 AU PER ML- standardized mite, dermatophagoides farinae, intradermal, 300 au per ml injection, solution
STANDARDIZED MITE, DERMATOPHAGOIDES FARINAE, BULK, 10000 AU PER ML- standardized mite, dermatophagoides farinae, bulk, 10000 au per ml injection, solution
STANDARDIZED MITE, DERMATOPHAGOIDES FARINAE, SCRATCH OR BULK, 30000 AU PER ML- standardized mite, dermatophagoides farinae, scratch or bulk, 30000 au per ml injection, solution
Jubilant HollisterStier LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
STANDARDIZED MITE EXTRACT (Dermatophagoides farinae), STANDARDIZED MITE EXTRACT (Dermatophagoides pteronyssinus), and STANDARDIZED MITE MIXTURE EXTRACT (Dermatophagoides farinae and Dermatophagoides pteronyssinus) safely and effectively. See full prescribing information for STANDARDIZED MITE EXTRACT (Dermatophagoides farinae), STANDARDIZED MITE EXTRACT (Dermatophagoides pteronyssinus), and STANDARDIZED MITE MIXTURE EXTRACT (Dermatophagoides farinae and Dermatophagoides pteronyssinus). STANDARDIZED MITE EXTRACT (Dermatophagoides farinae) STANDARDIZED MITE EXTRACT (Dermatophagoides pteronyssinus) STANDARDIZED MITE MIXTURE EXTRACT (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Injection, for percutaneous, intradermal, or subcutaneous use.Initial U.S. Approval: 1988 August 2024 345014-H08 WARNING: ANAPHYLAXISSee full prescribing information for complete boxed warning.
INDICATIONS AND USAGEStandardized Mite Extract (Dermatophagoides farinae), and Standardized Mite Extract (Dermatophagoides pteronyssinus) are skin tests indicated for: (1)
Standardized Mite Extract (Dermatophagoides farinae), Standardized Mite Extract (Dermatophagoides pteronyssinus), Standardized Mite Mixture Extract (Dermatophagoides farinae and Dermatophagoides pteronyssinus) (standardized mite extracts) are immunotherapies indicated for: (1)
DOSAGE AND ADMINISTRATIONFor percutaneous, intradermal, or subcutaneous use only. Administration:
See full prescribing information for details on dosing and dilution preparation. (2) DOSAGE FORMS AND STRENGTHSInjection. Standardized mite extracts are labeled in Allergenic Units per milliliter (AU/mL). (11) Refer to the vial label for the product concentration. (16)
CONTRAINDICATIONSWARNINGS AND PRECAUTIONSThe risk of anaphylaxis may be increased in the following situations: (5)
ADVERSE REACTIONSCommon adverse reactions reported for standardized mite extracts are:
To report SUSPECTED ADVERSE REACTIONS, contact Jubilant HollisterStier at 1-800-495-7437 or Adverse.Reactions@jubl.com; or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONSSee 17 for PATIENT COUNSELING INFORMATION. Revised: 12/2024 |
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: ANAPHYLAXIS
|
Standardized Mite Extract (Dermatophagoides farinae), and Standardized Mite Extract (Dermatophagoides pteronyssinus) are skin tests indicated for:
Standardized Mite Extract (Dermatophagoides farinae), Standardized Mite Extract (Dermatophagoides pteronyssinus), Standardized Mite Mixture Extract (Dermatophagoides farinae and Dermatophagoides pteronyssinus) are immunotherapies indicated for:
2.1 Preparation for Administration
Appearance is clear to slightly opalescent. Standardized mite extracts should be a yellowish to light brown solution. 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.
Standardized mite extracts diluted with Albumin Saline with Phenol (0.4 %) (stabilized diluent) may be more potent than standardized mite extracts diluted with diluents that do not contain albumin. When switching from non-stabilized to stabilized diluent, consider less concentrated initial dilutions for both intradermal testing and immunotherapy.
Different formulations, preparations, or new lots of standardized mite extracts are not interchangeable. Dosage should be adjusted appropriately when formulations, preparations, or lots of standardized mite extracts are changed [see Immunotherapy (2.3) and Dosage Forms and Strengths (3)].
Standardized mite extracts may be prepared for intradermal (diagnosis) or subcutaneous (immunotherapy) administration by diluting stock concentrates.
To prepare dilutions for intradermal testing and immunotherapy, start with a stock concentrate, and prepare a ten-fold (1:10) dilution by adding 0.5 mL of concentrate to 4.5 mL of sterile aqueous diluent. Prepare subsequent dilutions in a similar manner (see Table 1).
Table 1: 10-fold Dilution Series for Standardized Mite Extracts Labeled 10,000 AU*/mL and 30,000 AU*/mL
Dilution** |
Extract |
Milliliters of Diluent |
Dilution Strength AU/mL |
Dilution Strength AU/mL |
0 |
Concentrate |
0 |
10,000 |
30,000 |
1 |
0.5mL Concentrate |
4.5 |
1,000 |
3,000 |
2 |
0.5mL Dilution 1 |
4.5 |
100 |
300 |
3 |
0.5mL Dilution 2 |
4.5 |
10 |
30 |
4 |
0.5mL Dilution 3 |
4.5 |
1 |
3 |
5 |
0.5mL Dilution 4 |
4.5 |
0.1 |
0.3 |
6 |
0.5mL Dilution 5 |
4.5 |
0.01 |
0.03 |
7 |
0.5mL Dilution 6 |
4.5 |
0.001 |
0.003 |
* Allergy Units
** Store extract dilutions at 2 °C to 8 °C (36 °F to 46 °F).
2.2 Diagnostic Testing
For percutaneous and intradermal use only.
Use Standardized Mite Extract (Dermatophagoides farinae) or Standardized Mite Extract (Dermatophagoides pteronyssinus) to identify patients who exhibit an allergic response to either species of dust mite (D. farinae or D. pteronyssinus). False positive reactions may occur. A positive skin test reaction must be interpreted in the context of the individual’s clinical history and known exposure to the allergen.
Percutaneous Skin Testing
Dose
Unless an individual is suspected to be at greater risk for anaphylaxis, the initial starting dose is 1 drop (approximately 0.05 mL) of concentrated standardized mite extract (30,000 AU/mL). For individuals suspected to be at greater risk for anaphylaxis (for example, as indicated by a history of allergen-induced anaphylaxis), initiate percutaneous testing with 1 drop of a diluted standardized mite extract, if negative retest with the next higher concentration(s). Doses should be administered 15‑20 minutes apart [see Preparation for Administration (2.1)].
Administration
Place one drop (approximately 0.05 mL) of standardized mite extract on the skin and using a skin test device, such as a sterile needle, lancet, or bifurcated needle, pierce through the drop into the skin with a slight lifting motion.
For self-loading devices refer to the manufacturer’s product instructions.
Include a positive histamine skin test control to identify patients whose recent use of drugs with antihistamine activity may result in a false negative skin test. [see Drug Interactions (7.1)].
Include a negative control to detect false positive responses, which can occur when the patient has a non-specific reaction to the diluent or due to dermographism. A 50% glycerin solution may be used as the negative control.
Interpreting Results
Measure and record skin test responses 15-20 minutes after exposure.22 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).
Figure 1: Measurement of Wheal and Flare
Use a paper or plastic millimeter skin reaction guide as shown below.
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.
The wheal is a smooth, slightly elevated area which is redder or paler than the surrounding skin. The flare is the red outermost zone of the skin test reaction.
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 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.
Intradermal (Intracutaneous) Skin Testing
Always perform percutaneous tests prior to intradermal skin tests.22
Dose
For patients with negative or equivocal percutaneous testing for whom there is a high index of suspicion of dust mite allergy, intradermal testing may be performed with 0.02 to 0.05 mL of a 30 AU/mL extract solution. [see Preparation for Administration (2.1)]. If this test is negative, a second intradermal test may be performed with 0.02 to 0.05 mL of a 300 AU/mL extract solution.
Administration
Intradermally inject the dose of the diluted allergenic extract using a 1 mL syringe.
Include a positive histamine control at intradermal strength to identify patients whose recent use of drugs with antihistamine activity may result in a false negative skin test. [see Drug Interactions (7.1)].
Include an aqueous buffer negative control (Sterile Albumin Saline with Phenol, Sterile Buffered Saline with Phenol) to detect false positive responses, which can occur when the patient has a non-specific reaction to the diluent or due to dermographism.
Interpreting Results
Measure wheal responses for the histamine positive control test and allergen tests at 15‑20 minutes after injection. Refer to Figure 1 for the measurement of wheal and flare.
2.3 Immunotherapy
For subcutaneous use only.
Subcutaneous injections for immunotherapy should be prepared by dilution of stock concentrate. See Table 1 for dilution preparation.
Administration
Administer immunotherapy by subcutaneous injection in the lateral aspect of the arm or thigh. Do not inject directly into any blood vessels.
Most adverse reactions occur within 30 minutes after injection. Therefore, observe patients for at least 30 minutes.23
Dose Build-up
Dosing of standardized mite extracts for allergen immunotherapy is highly individualized. The initial dose should be based on the patient’s percutaneous skin test reactivity and clinical history. The initial dose is typically 0.05 mL of a 0.01 to 0.03 AU/mL dilution. In patients who appear to be exquisitely sensitive by skin test and history, consider a lower initial dose such as 0.05 mL of a 0.001 to 0.003 AU/mL dilution. The dose 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. Dosing is increased in increments until 0.5 mL is reached, following which 0.05 mL is administered from the next most concentrated allergen extract or allergen mixture vial in the dilution series. Injections are typically given one or two times per week until the maintenance dose is reached.
Maintenance Dose Selection and Intervals
Select a maintenance dose based on the patient's clinical response and tolerance.
Dosage Modification for Immunotherapy
Withhold immunotherapy and/or reduce dosage, if any of the following conditions exist:
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.
In situations prompting dose reduction, a cautious increase in dose can be attempted once the reduced dose is tolerated. The dose should be reduced to the last level not causing the reaction and maintained at this level for two or three treatments before cautiously increasing again.
Prolonged period has elapsed since the last injection: Patients may lose tolerance for allergen injections during prolonged intervals (> 4 weeks) between doses. The duration of tolerance is an individual characteristic and varies from patient to patient. In general, the longer the lapse in the injection schedule, the greater dose reduction required.
Changing to a different lot of standardized extract: All extracts can lose allergenic activity over time and extracts vary in allergenic activity. Two different lots of extract could differ substantially in allergenic activity, even if they are the same formula and concentration. The volume of the first dose from the new vial should not exceed 50% of the previous dose. Do not use extracts beyond their expiry date.
Changing to an extract from a different manufacturer:Since manufacturing processes and sources of raw materials differ among manufacturers, the interchangeability of extracts from different manufacturers cannot be assured. Decrease the starting dose of the new extract when the extract is the same formula and dilution as the one previously used. In general, a volume dose reduction to 50% of the previous product dose is adequate, but each situation must be evaluated separately considering the patient's history of sensitivity, tolerance of previous injections, and other factors. If the patient tolerates the 50% decrease, then raise the next dose to the previous tolerated dose amount. To re‑establish the maintenance dose the starting interval between doses should not be greater than one week.
Changes made in the extract concentrate formula: Changes other than those listed above such as a difference in extracting fluid (e.g., change from non-glycerin extracts to 50% glycerin extracts), combining two or more stock concentrates, or any other change can affect a patient’s tolerance of the treatment. Extra dilutions are recommended whenever starting a revised formula. The greater the change, the greater the number of dilutions required.23
Duration of Treatment
The duration of treatment for immunotherapy has not been established. A period of three to five years of injection therapy constitutes an average minimum course of treatment. Evaluate patients for treatment response at least every 6 to 12 months while they receive immunotherapy. The decision to continue or stop immunotherapy must be individualized.23
Injection. Standardized mite extracts are labeled in Allergenic Units per milliliter (AU/mL) [see Description (11)]. Refer to the vial label for the product concentration [see How Supplied/Storage and Handling (16)].
Standardized mite extracts are contraindicated in individuals with the following conditions:
5.1 Anaphylaxis
Anaphylaxis, which may lead to death, can occur in individuals following the administration of standardized mite extracts, particularly in the following situations [see Adverse Reactions (6)]: 18, 19, 20, 21
Standardized mite extracts may not be suitable for individuals who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta‑blockers.
Medications to treat systemic reactions, as well as emergency equipment should be available for immediate use. Administer standardized mite extracts in a healthcare setting under the supervision of a healthcare provider prepared to manage anaphylaxis. Individuals should remain in the provider’s office for a minimum of 30 minutes after receiving an injection of standardized mite extracts, so that any adverse reaction can be observed and appropriately managed.
Common adverse reactions reported for standardized mite extracts are:
No clinical trials of standardized mite extracts have been conducted.
Published studies of allergenic extracts report systemic reactions occurring in fewer than 1 % in patients receiving conventional immunotherapy and greater than 36 % in patients receiving rush immunotherapy.1, 14, 26, 27 Most systemic reactions occurred within 30 minutes of injection. However, systemic reactions have been reported to occur up to 2 hours after the final injection with rush schedules. Some reactions have occurred up to 6 hours after skin tests or immunotherapy.23, 24, 28
7.1 Antihistamines
Do not perform skin testing with standardized mite extracts within 3 to 10 days of first-generation H1‑histamine receptor blockers (e.g., clemastine, diphenhydramine) and second-generation antihistamines (e.g., loratadine, fexofenadine) being used. These products suppress histamine skin test reactions and could mask a positive response.2, 22, 23
7.2 Topical Corticosteroids and Topical Anesthetics
Topical corticosteroids may suppress skin reactivity; therefore, discontinue use at the skin test site for at least 2 to 3 weeks before skin testing.2, 3 Avoid use of topical local anesthetics at skin test sites because they can suppress flare responses.4, 22, 23
7.3 Tricyclic Antidepressants
Tricyclic antidepressants, such as doxepin, can have potent antihistamine effects and may alter skin test results. Allow 7 to 14 days after discontinuation of tricyclic medication prior to skin testing.17, 22, 23
See 17 for PATIENT COUNSELING INFORMATION.
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 standardized mite extracts associated risks during pregnancy.16
Risk Summary
It is not known whether standardized mite 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 standardized mite extracts and any potential adverse effects on the breastfed child from the extracts or from the underlying maternal condition.
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 receipt of the product and the potential for difficulty in communicating with the child regarding systemic reactions.13, 23
The volume of a dose for immunotherapy may need to be divided for pediatric patients [see Immunotherapy (2.3)].
Standardized mite extracts are injections for percutaneous, intradermal, or subcutaneous use labeled in Allergy Units per milliliter (AU/mL).5 Standardized Mite Extract (Dermatophagoides farinae), Standardized Mite Extract (Dermatophagoides pteronyssinus), and Standardized Mite Mixture Extract (Dermatophagoides farinae and Dermatophagoides pteronyssinus) are sterile solutions containing the extractables of D. farinae and/or D. pteronyssinus, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Source material for the extracts is the whole bodies of the mites. The mites are each grown on a medium of brine shrimp eggs and wheat germ, and are handled and cleaned in a manner such that the maximum carryover of the medium components is less than 1%. The medium contains no material of human origin.
Standardized Mite Extract (Dermatophagoides farinae) and Standardized Mite Extract (Dermatophagoides pteronyssinus) concentrates (stock concentrates) containing 30,000 AU/mL are supplied in dropper vials for percutaneous testing. Stock concentrates are also available in multiple-dose vials containing 10,000 AU/mL and 30,000 AU/mL to be diluted for intradermal testing and immunotherapy.
Standardized Mite Mixture Extract (Dermatophagoides farinae and Dermatophagoides pteronyssinus), is a mixture of the two mite species, in equal parts, resulting in D. pteronyssinus at 15,000 AU/mL and D. farinae at 15,000 AU/mL is available for therapeutic use. A mixture of the two species is also available at 5,000 AU/mL each species.
The potency of each lot of standardized mite extract is determined by comparison to the US reference preparation (10,000 AU/mL) provided by the Center for Biologics Evaluation and Research of the FDA. The relative potency of each extract is determined by ELISA inhibition and labeled in AU/mL.
Clinical studies that address the efficacy of immunotherapy are available.6, 7 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.25
16.1 How Supplied
Standardized mite extracts are supplied as 50 % glycerin stock concentrates labeled in Allergenic Units per Milliliter (AU/mL) and provided in 10 milliliter, 30 milliliter and 50 milliliter vials for use in percutaneous and intradermal skin testing and subcutaneous immunotherapy. These extracts may also be supplied in 5 milliliter dropper vials for percutaneous testing only. These products are supplied as listed in Table 2.
Table 2: Available Products
Available Products Name Allergenic Extracts |
NDC |
Vial Size |
Standardized Mite, Dermatophagoides farinae 10,000 AU/mL |
65044-6723-2 |
10 mL |
Standardized Mite, Dermatophagoides farinae 10,000 AU/mL |
65044-6723-4 |
50 mL |
Standardized Mite, Dermatophagoides farinae 30,000 AU/mL |
65044-6720-1 |
5 mL |
Standardized Mite, Dermatophagoides farinae 30,000 AU/mL |
65044-6720-2 |
10 mL |
Standardized Mite, Dermatophagoides farinae 30,000 AU/mL |
65044-6720-3 |
30 mL |
Standardized Mite, Dermatophagoides pteronyssinus 10,000 AU/mL |
65044-6695-2 |
10 mL |
Standardized Mite, Dermatophagoides pteronyssinus 10,000 AU/mL |
65044-6695-4 |
50 mL |
Standardized Mite, Dermatophagoides pteronyssinus 30,000 AU/mL |
65044-6692-1 |
5 mL |
Standardized Mite, Dermatophagoides pteronyssinus 30,000 AU/mL |
65044-6692-2 |
10 mL |
Standardized Mite, Dermatophagoides pteronyssinus 30,000 AU/mL |
65044-6692-3 |
30 mL |
Standardized Mite Mix, Dermatophagoides farinae and Dermatophagoides pteronyssinus 5,000 AU/mL (each species) |
65044-6691-2 |
10 mL |
Standardized Mite Mix, Dermatophagoides farinae and Dermatophagoides pteronyssinus 5,000 AU/mL (each species) |
65044-6691-4 |
50 mL |
Standardized Mite Mix, Dermatophagoides farinae and Dermatophagoides pteronyssinus 15,000 AU/mL (each species) |
65044-6690-2 |
10 mL |
Standardized Mite Mix, Dermatophagoides farinae and Dermatophagoides pteronyssinus 15,000 AU/mL (each species) |
65044-6690-3 |
30 mL |
16.2 Storage and Handling
Store extracts at 2 °C to 8 °C (36 °F to 46 °F).
Instruct patients to remain in the office under observation for a minimum of 30 minutes after an injection or longer, if deemed necessary for the individual.
Inform patients that reactions may occur more than 30 minutes after skin testing or an injection.
Instruct patients to recognize the following symptoms as systemic adverse reactions and seek emergency medical care right away if any of these occur:
Manufacturer:
Jubilant HollisterStier LLC
Spokane, WA 99207 U.S.A.
U.S. Lic. No. 1272
Version Date: 08/2024
345014-H08
Mix of Standardized Mite 10 mL, 10k Carton Label
Mix of Standardized Mite 10 mL, 10k Vial Label
Mix of Standardized Mite 10 mL, 30k Carton Label
Mix of Standardized Mite 10 mL, 30k Vial Label
Mix of Standardized Mite 30 mL, 30k Carton Label
Mix of Standardized Mite 30 mL, 30k Vial Label
Mix of Standardized Mite 50 mL, 10k Vial Label
Mix of Standardized Mite 50 mL, 10k Carton Label
Standardized Mite, D. farinae 10 mL, 10k Carton Label
Standardized Mite, D. farinae 10 mL, 10k Vial Label
Standardized Mite, D. farinae 10 mL, 30k Carton Label
Standardized Mite, D. farinae 10 mL, 30k Vial Label
Standardized Mite, D. farinae 30 mL, 30k Carton Label
Standardized Mite, D. farinae 30 mL, 30k Vial Label
Standardized Mite, D. farinae 5 mL, 30k Carton Label
Standardized Mite, D. farinae 5 mL, 30k Vial Label
Standardized Mite, D. farinae 50 mL, 10k Vial Label
Standardized Mite, D. farinae 50 mL, 10k Carton Label
Standardized Mite, D. pter 10 mL, 10k Carton Label
Standardized Mite, D. pter 10 mL, 10k Vial Label
Standardized Mite, D. pter 10 mL, 30k Carton Label
Standardized Mite, D. pter 10 mL, 30k Vial Label
Standardized Mite, D. pter 30 mL, 30k Carton Label
Standardized Mite, D. pter 30 mL, 30k Vial Label
Standardized Mite, D. pter 5 mL, 30k Carton Label
Standardized Mite, D. pter 5 mL, 30k Vial Label
Standardized Mite, D. pter 50 mL, 10k Vial Label
Standardized Mite, D. pter 50 mL, 10k Carton Label
STANDARDIZED MITE MIX, DERMATOPHAGOIDES PTERONYSSINUS AND DERMATOPHAGOIDES FARINAE, 10000 AU PER ML
standardized mite mix, dermatophagoides pteronyssinus and dermatophagoides farinae, 10000 au per ml injection, solution |
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STANDARDIZED MITE MIX, DERMATOPHAGOIDES PTERONYSSINUS AND DERMATOPHAGOIDES FARINAE, 30000 AU PER ML
standardized mite mix, dermatophagoides pteronyssinus and dermatophagoides farinae, 30000 au per ml injection, solution |
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STANDARDIZED MITE, DERMATOPHAGOIDES PTERONYSSINUS, INTRADERMAL, 30 AU PER ML
standardized mite, dermatophagoides pteronyssinus, intradermal, 30 au per ml injection, solution |
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STANDARDIZED MITE, DERMATOPHAGOIDES PTERONYSSINUS, INTRADERMAL, 300 AU PER ML
standardized mite, dermatophagoides pteronyssinus, intradermal, 300 au per ml injection, solution |
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STANDARDIZED MITE, DERMATOPHAGOIDES PTERONYSSINUS, BULK, 10000 AU PER ML
standardized mite, dermatophagoides pteronyssinus, bulk, 10000 au per ml injection, solution |
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STANDARDIZED MITE, DERMATOPHAGOIDES PTERONYSSINUS, SCRATCH OR BULK, 30000 AU PER ML
standardized mite, dermatophagoides pteronyssinus, scratch or bulk, 30000 au per ml injection, solution |
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STANDARDIZED MITE, DERMATOPHAGOIDES FARINAE, INTRADERMAL, 30 AU PER ML
standardized mite, dermatophagoides farinae, intradermal, 30 au per ml injection, solution |
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STANDARDIZED MITE, DERMATOPHAGOIDES FARINAE, INTRADERMAL, 300 AU PER ML
standardized mite, dermatophagoides farinae, intradermal, 300 au per ml injection, solution |
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STANDARDIZED MITE, DERMATOPHAGOIDES FARINAE, BULK, 10000 AU PER ML
standardized mite, dermatophagoides farinae, bulk, 10000 au per ml injection, solution |
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STANDARDIZED MITE, DERMATOPHAGOIDES FARINAE, SCRATCH OR BULK, 30000 AU PER ML
standardized mite, dermatophagoides farinae, scratch or bulk, 30000 au per ml injection, solution |
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Labeler - Jubilant HollisterStier LLC (069263643) |
Registrant - Jubilant HollisterStier LLC - HollisterStier Allergy (119241112) |