ANIMAL ALLERGENS, AP HORSE HAIR AND DANDER
-
equus caballus hair and
equus caballus dander injection, solution
ANIMAL ALLERGENS, AP CATTLE HAIR AND DANDER
-
bos taurus hair and
bos taurus dander injection, solution
ANIMAL ALLERGENS, FEATHER MIX
-
gallus gallus feather,
anas platyrhynchos feather and
anser anser feather injection, solution
AP HOUSE DUST MIX
-
house dust injection, solution
DUST, HOUSE MIXTURE
-
house dust injection, solution
INSECTS (WHOLE BODY) COCKROACH MIX
-
periplaneta americana and
blatella germanica injection, solution
INSECTS (WHOLE BODY), FIRE ANT MIX
-
solenopsis richteri and
solenopsis invicta injection, solution
MOLDS - MOLD MIX 10
-
alternaria alternata,
aspergillus fumigatus,
emericella nidulans,
aspergillus niger var. niger,
aspergillus terreus,
fusarium oxysporum vasinfectum,
dendryphiella vinosa,
cladosporium cladosporioides,
mucor racemosus,
penicillium digitatum,
penicillium expansum,
penicillium expansum,
penicillium chrysogenum var. chrysogenum,
clonostachys rosea f. rosea,
phoma exigua var. exigua,
aureobasidium pullulans var. pullutans and
rhizopus stolonifer injection, solution
MOLDS - MOLD MIX 4
-
alternaria alternata,
aspergillus fumigatus,
emericella nidulans,
aspergillus niger var. niger,
aspergillus terreus,
cladosporium cladosporioides,
penicillium digitatum,
penicillium expansum,
penicillium expansum,
penicillium chrysogenum var. chrysogenum and
clonostachys rosea f. rosea injection, solution
MOLDS - TRICHOPHYTON MIX
-
trichophyton tonsurans,
trichophyton rubrum and
trichophyton mentagrophytes injection, solution
MOLDS, PENICILLIUM MIX
-
penicillium digitatum,
penicillium expansum,
penicillium expansum,
penicillium chrysogenum var. chrysogenum and
clonostachys rosea f. rosea injection, solution
MOLDS, RUSTS AND SMUTS, ALTERNARIA TENUIS
-
alternaria alternata injection, solution
MOLDS, RUSTS AND SMUTS, ASPERGILLUS FUMIGATUS
-
aspergillus fumigatus injection, solution
MOLDS, RUSTS AND SMUTS, CANDIDA ALBICANS
-
candida albicans injection, solution
MOLDS, RUSTS AND SMUTS, CEPHALOSPORIUM ACREMONIUM
-
acremonium strictum injection, solution
MOLDS, RUSTS AND SMUTS, CURVULARIA SPICIFERA
-
cochliobolus spicifer injection, solution
MOLDS, RUSTS AND SMUTS, EPICOCCUM NIGRUM
-
epicoccum nigrum injection, solution
MOLDS, RUSTS AND SMUTS, FUSARIUM VASINFECTUM
-
fusarium oxysporum vasinfectum injection, solution
MOLDS, RUSTS AND SMUTS, HELMINTHOSPORIUM INTERSEMINATUM
-
dendryphiella vinosa injection, solution
MOLDS, RUSTS AND SMUTS, HORMODENDRUM CLADOSPORIOIDES
-
cladosporium cladosporioides injection, solution
MOLDS, RUSTS AND SMUTS, MUCOR RACEMOSUS
-
mucor racemosus injection, solution
MOLDS, RUSTS AND SMUTS, PENICILLIUM NOTATUM
-
penicillium chrysogenum var. chrysogenum injection, solution
MOLDS, RUSTS AND SMUTS, PHOMA HERBARUM
-
phoma exigua var. exigua injection, solution
MOLDS, RUSTS AND SMUTS, PULLULARIA PULLULANS
-
aureobasidium pullulans var. pullutans injection, solution
MOLDS, RUSTS AND SMUTS, RHIZOPUS NIGRICANS
-
rhizopus stolonifer injection, solution
MOLDS, RUSTS AND SMUTS, STEMPHYLIUM BOTRYOSUM
-
pleospora tarda injection, solution
POLLENS - GRASSES, BAHIA GRASS PASPALUM NOTATUM
-
paspalum notatum pollen injection, solution
POLLENS - GRASSES, JOHNSON GRASS SORGHUM HALEPENSE
-
sorghum halepense pollen injection, solution
POLLENS - TREES, ACACIA ACACIA LONGIFOLIA
-
acacia longifolia pollen injection, solution
POLLENS - TREES, ALDER, RED ALNUS RUBRA
-
alnus rubra pollen injection, solution
POLLENS - TREES, ASH, WHITE FRAXINUS AMERICANA
-
fraxinus americana pollen injection, solution
POLLENS - TREES, BIRCH MIX
-
betula papyrifera pollen,
betula pendula pollen and
betula nigra pollen injection, solution
POLLENS - TREES, BOXELDER/MAPLE MIX
-
acer negundo pollen,
acer saccharum pollen and
acer rubrum pollen injection, solution
POLLENS - TREES, CEDAR, MOUNTAIN JUNIPERUS ASHEI
-
juniperus ashei pollen injection, solution
POLLENS - TREES, CEDAR, RED JUNIPERUS VIRGINIANA
-
juniperus virginiana pollen injection, solution
POLLENS - TREES, COTTONWOOD, COMMON POPULUS DELTOIDES
-
populus deltoides pollen injection, solution
POLLENS - TREES, ELM, AMERICAN ULMUS AMERICANA
-
ulmus americana pollen injection, solution
POLLENS - TREES, ELM, CHINESE ULMUS PARVIFOLIA
-
ulmus parvifolia pollen injection, solution
POLLENS - TREES, HACKBERRY CELTIS OCCIDENTALIS
-
celtis occidentalis pollen injection, solution
POLLENS - TREES, MAPLE, HARD ACER SACCHARUM
-
acer saccharum pollen injection, solution
POLLENS - TREES, MESQUITE, PROSOPIS JULIFLORA
-
prosopis juliflora pollen injection, solution
POLLENS - TREES, MULBERRY MIX
-
morus alba pollen and
morus rubra pollen injection, solution
POLLENS - TREES, OAK MIX
-
quercus rubra pollen,
quercus virginiana pollen and
quercus alba pollen injection, solution
POLLENS - TREES, OAK, RED QUERCUS RUBRA
-
quercus rubra pollen injection, solution
POLLENS - TREES, OLIVE OLEA EUROPAEA
-
olea europaea pollen injection, solution
POLLENS - TREES, PECAN CARYA CARYA ILLINOENSIS
-
carya illinoinensis pollen injection, solution
POLLENS - TREES, RUSSIAN OLIVE ELAEAGNUS ANGUSTIFOLIA
-
elaeagnus angustifolia pollen injection, solution
POLLENS - TREES, SYCAMORE, AMERICAN (EASTERN) PLATANUS OCCIDENTALLIS
-
platanus occidentalis pollen injection, solution
POLLENS - TREES, TREE MIX 11
-
fraxinus americana pollen,
fagus grandifolia pollen,
betula nigra pollen,
juglans nigra pollen,
populus deltoides pollen,
ulmus americana pollen,
carya ovata pollen,
acer saccharum pollen,
quercus rubra pollen,
platanus occidentalis pollen and
salix nigra pollen injection, solution
POLLENS - TREES, TREE MIX 5
-
carya illinoinensis pollen,
acer saccharum pollen,
acer negundo pollen,
acer rubrum pollen,
quercus rubra pollen,
quercus virginiana pollen,
quercus alba pollen,
platanus occidentalis pollen and
salix nigra pollen injection, solution
POLLENS - TREES, TREE MIX 6
-
fraxinus americana pollen,
fagus grandifolia pollen,
betula papyrifera pollen,
betula nigra pollen,
betula pendula pollen,
juglans nigra pollen,
populus deltoides pollen and
ulmus americana pollen injection, solution
POLLENS - TREES, WALNUT, BLACK JUGLANS NIGRA
-
juglans nigra pollen injection, solution
POLLENS - TREES, WILLOW, BLACK SALIX NIGRA
-
salix nigra pollen injection, solution
POLLENS - WEEDS AND GARDEN PLANTS, COCKLEBUR XANTHIUM STRUMARIUM
-
xanthium strumarium pollen injection, solution
POLLENS - WEEDS AND GARDEN PLANTS, GOLDENROD SOLIDAGO CANADENSIS
-
solidago canadensis pollen injection, solution
POLLENS - WEEDS AND GARDEN PLANTS, LAMB QUARTERS CHENOPODIUM ALBUM
-
chenopodium album pollen injection, solution
POLLENS - WEEDS AND GARDEN PLANTS, PIGWEED, ROUGH REDROOT AMARANTHUS RETROFLEXUS
-
amaranthus retroflexus pollen injection, solution
POLLENS - WEEDS AND GARDEN PLANTS, PLANTAIN, ENGLISH PLANTAGO LANCEOLATA
-
plantago lanceolata pollen injection, solution
POLLENS - WEEDS AND GARDEN PLANTS, RAGWEED, GIANT AMBROSIA TRIFIDA
-
ambrosia trifida pollen injection, solution
POLLENS - WEEDS AND GARDEN PLANTS, RAGWEED. WESTERN AMBROSIA PSILOSTACHYA
-
ambrosia psilostachya pollen injection, solution
POLLENS - WEEDS AND GARDEN PLANTS, RUSSIAN THISTLE SALSOLA KALI
-
salsola kali pollen injection, solution
POLLENS - WEEDS AND GARDEN PLANTS, SAGEBRUSH, MUGWORT ARTEMISIA VULGARIS
-
artemisia vulgaris pollen injection, solution
POLLENS - WEEDS AND GARDEN PLANTS, SCALE, WING (SHAD) ATRIPLEX CANESCENS
-
atriplex canescens pollen injection, solution
POLLENS - WEEDS, CARELESS/PIGWEED MIX
-
amaranthus palmeri pollen and
amaranthus retroflexus pollen injection, solution
POLLENS - WEEDS, DOCK/SORREL MIX
-
rumex crispus pollen and
rumex acetosella pollen injection, solution
POLLENS - WEEDS, GIANT, SHORT, WESTERN RAGWEED MIX
-
ambrosia trifida pollen,
ambrosia artemisiifolia pollen and
ambrosia psilostachya pollen injection, solution
POLLENS - WEEDS, KOCHIA SCOPARIA
-
kochia scoparia pollen injection, solution
POLLENS - WEEDS, MARSHELDER/POVERTY MIX
-
iva axillaris pollen,
iva annua var. annua pollen and
iva xanthifolia pollen injection, solution
POLLENS - WEEDS, WEED MIX 2630
-
xanthium strumarium pollen,
chenopodium album pollen,
amaranthus retroflexus pollen,
rumex crispus pollen and
rumex acetosella pollen injection, solution
Hollister Stier Laboratories LLC
----------
INSTRUCTIONS ALLERGENIC EXTRACTS FOR INTRADERMAL TESTING
WARNINGS
This product is intended for use only by physicians who are experienced in the use of allergenic extracts, or for use under the guidance of an allergist.
Allergenic extracts may potentially elicit a severe life-threatening systemic reaction, rarely resulting in death.7 Therefore, emergency measures and personnel trained in their use should be available immediately in the event of such a reaction. Patients should be instructed to recognize adverse reaction symptoms and cautioned to contact the physician's office if symptoms occur.
Scratch, prick or puncture test first. Test intradermally only to those antigens giving negative or questionable reactions on scratch, prick or puncture testing.
This product should never be injected intravenously.
Patients on non-selective beta blockers may be more reactive to allergens given for testing or treatment and may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.6
Refer also to the WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS Sections below for further discussion.
DESCRIPTION
Extracts for intradermal testing are supplied in sterile multi-dose vials containing, in addition to the extract allergens and antigens, 0.5% sodium chloride, 0.275% sodium bicarbonate, up to 2% glycerin, 2.5% glycerin for AP™ products; and, as preservative, 0.4% phenol. The strength of these extracts may be expressed in terms of
1. Weight to Volume (w/v)
2. Protein Nitrogen Units/mL (PNU/mL)
3. Allergy Units/mL (AU/mL)
4. Bioequivalent Allergy Units/mL (BAU/mL)
5. Concentrate
-
Weight to volume (w/v). For regular extracts this describes the extraction ratio, i.e., the amount of crude allergen added to the extracting fluid. A 1:10 extract, therefore, indicates that the solution contains the extracted material from one gram of raw material added to each 10 mL of extracting fluid. The amount and composition of extracted material will vary with the kind of antigen, the extracting fluid, duration of extraction, pH, temperature, and other variables. In contrast to this, APTM (acetone precipitated) extracts, if present, are prepared by reconstituting dry allergenically active concentrates produced by a precipitation process from extracts of raw materials. For those AP™ extracts labeled on a weight per volume (w/v) basis, the strength designation indicates the dry weight of finished (acetone) precipitate per volume of reconstituting fluid. For example, 1:50 (w/v) means that each gram of dry precipitate obtained from the original extract is reconstituted in 50 mL of solution.
-
Protein Nitrogen Units per mL (PNU/mL). One protein nitrogen unit represents 0.00001 mg phosphotungstic acid-precipitable protein nitrogen dissolved in one mL of antigen extract. The PNU content of extracts of the same antigen may vary according to the method of measuring the PNU. Thus, PNU contents of extracts from different manufacturers are not comparable unless the PNU method is known to be the same and reproducible from lot to lot. Also, the amount of protein nitrogen extracted from an antigen is influenced by the same variables as the weight to volume extract. Allergenic materials make up a variable proportion of the total protein of an extract.
-
Allergy Units per mL (AU/mL). The potency of standardized APTM and regular extracts labeled in Allergy Units (AU)/mL is determined by in vitro comparison to the reference standard established by the Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration.
-
Bioequivalent Allergy Units per mL(BAU/mL). When originally licensed, the Reference Preparations for standardized extracts were arbitrarily assigned 100,000 Allergy Units (AU)/mL. Subsequently, quantitative skin testing by the ID50EAL method14 was used to determine that some Reference Preparations should be assigned 10,000 AU/mL, and others 100,000 AU/mL. To avoid possible confusion about this change in the method of allergy unit assignment, the nomenclature changed for standardized extracts whose allergy units are assigned based on quantitative skin testing, and are labeled in Bioequivalent Allergy Units (BAU)/mL. References labeled 10,000 BAU/mL can be diluted one to a half million fold, and references labeled 100,000 BAU/mL can be diluted one to 5 million fold and produce a sum of erythema diameter of 50 mm when Intradermal testing highly reactive subjects.
-
Concentrate. Concentrate label terminology applies to allergenic extract mixtures, where the individual allergens being combined vary in strength or the designation of strength.
CLINICAL PHARMACOLOGY
Allergenic extracts for intradermal testing used according to the DOSAGE AND ADMINISTRATION Section, produce erythema or erythema and wheal reactions in patients with significant IgE-mediated sensitivity to the relevant allergen. This allergic inflammatory response, although not completely understood, is thought to begin with the reaction of antigen with IgE on the surface of basophils, or mast cells, which initiates a series of biochemical events resulting in the production of histamine, slow-reacting substance of anaphylaxis and other mediators. These, in turn, produce the immediate-type wheal and flare skin reaction.
INDICATIONS AND USAGE
Certain diagnostics carry labeling which states Allergenic Extract for Diagnostic Use Only. Data to support the therapeutic use of products labeled with this statement have not been established.15
In addition to a carefully taken history, the use of intradermal testing extracts is an accepted method in the diagnosis of allergenic conditions.1, 2, 3 When scratch, prick or puncture reactions are small, or if the patient gives a history of allergic symptoms to a substance but scratch, prick or puncture tests are inconclusive, intradermal tests may be indicated. However, ANTIGENS PRODUCING LARGE 3 TO 4+ SCRATCH, PRICK OR PUNCTURE TESTS SHOULD NOT BE TESTED INTRADERMALLY.
Extracts of all allergens do not produce equivalent results in intradermal testing. The intensity of the skin reaction produced will be determined by two factors: the degree of sensitivity of the patient and the nature of the antigenic extract applied. In general, pollen extracts produce whealing reactions, whereas other inhalants produce erythematous reactions with wheals less often. Skin tests to foods seldom produce whealing reactions except for infrequent instances of severe sensitivity to fish, nuts or spices, and rarely other foods.
CONTRAINDICATIONS
There are no known absolute contraindications to allergy skin testing. Patients with cardiovascular diseases or pulmonary diseases such as symptomatic asthma, and/or who are receiving cardiovascular drugs such as beta blockers, may be at higher risk for severe adverse reactions. These patients may also be more refractory to the normal anaphylaxis treatment regime.
WARNINGS
Scratch, prick or puncture test first. Test intradermally only to those antigens giving negative or questionable reactions on scratch, prick or puncture testing. Excessively large local reactions or systemic reactions are more likely to occur if the patient is skin tested shortly after exposure to large amounts of antigen to which he or she is sensitive. Therefore, use caution when applying pollen tests to patients during their active pollen season, or after an exposure to inhalant allergens that produce symptoms. Refer to boxed WARNINGS Section.
PRECAUTIONS
1. General
It
is recommended that disposable syringes and needles are used for
intradermal tests to prevent the possibility of accidental transfer of
serum hepatitis and other infectious agents from one person to another.
Always have injectable epinephrine and a tourniquet available when
tests are being made. (See
ADVERSE REACTION Section.) Patients should
be observed in the office for 30 to 45 minutes after each set of
intradermal tests and instructed to return to the office promptly if
symptoms of an allergic reaction or shock occur. In order to avoid
darkening and possible precipitation, do not dilute the following
extracts with solutions containing phenol: Privet pollen and food
extracts of White Potato, Corn, Oat, Rye, and Wheat. Injections of such
extracts discolored by reaction with phenol may produce lasting
tattoo-like discoloration of the skin.
2. Information for Patients
Patients should be instructed in the recognition of adverse reactions to diagnostic testing. Patients should be made to understand the importance of a 30 to 45 minute observation period and be warned to return to the office promptly if symptoms occur after leaving.
3. Carcinogenesis, Mutagensis, Impairment of Fertility
Long-term
studies in animals have not been conducted with allergenic extracts to
determine their potential for carcinogenicity, mutagenicity or
impairment of fertility.
4. Pregnancy
4,5 Pregnancy Category C. Animal reproduction studies have not been conducted with
allergenic extracts. It is also not known whether allergenic extracts
can cause fetal harm when administered to a pregnant woman or can
affect reproduction capacity. Allergenic extracts should be given to a
pregnant woman only if clearly needed.
5. Nursing Mothers
There
are no current studies on secretion of the allergenic extract
components in human milk or effect on the nursing infant. Because many
drugs are excreted in human milk, caution should be exercised when
allergenic extracts are administered to a nursing woman.
6. Drug Interactions
Patients
on non-selective beta blockers may be more reactive to allergens given
for testing or treatment and may be unresponsive to the usual doses of
epinephrine used to treat allergic reactions.6
Certain
medications may lessen the skin test wheal and erythema responses
elicited by allergens and histamine for varying time periods.
Conventional antihistamines should be discontinued at least 5 days
before skin testing. Long acting antihistamines should be discontinued
for at least 3 weeks prior to skin testing.10Topical steroids should be discontinued at the skin test site for at least 2-3 weeks before skin testing. 10, 11 Tricyclic antidepressants such as Doxepin should be withheld for at least 7 days before skin testing.12Topical local anesthetics may suppress the flare responses and should be avoided in skin test sites. 13
7. Geriatric Use
Skin
test wheal size decreases with age. The decrease in allergeninduced
skin test reaction parallels that to histamine; therefore, appropriate
positive skin test controls should always be performed.1
8. Pediatric Use
Wheal sizes in response to allergen skin testing can be smaller in infants than in adults. The skin response to histamine parallels that for allergens; therefore, appropriate postitive control skin tests should always be performed.1
ADVERSE REACTIONS
1. Local Reactions
Large, persistent local reactions or minor exacerbations of the patient's allergic symptoms may be treated by local cold applications and/or the use of oral antihistamines, but they should be considered a warning of possible severe systemic reactions.
2. Systemic Reactions
With careful attention to dosage and administration, such reactions occur infrequently, but it must be remembered that allergenic extracts are highly potent in sensitive individuals and OVERDOSE could result in anaphylactic symptoms. Therefore, it is imperative that physicians administering allergenic extracts understand and be prepared for the treatment of severe reactions. Adverse reaction frequency data for allergenic extract administration for testing and treatment show that risk is low.7, 8 It cannot be overemphasized that, under certain unpredictable combinations of circumstances, anaphylactic shock is a possibility. Other possible systemic reaction symptoms, in varying degrees of severity, are fainting, pallor, bradycardia, hypotension, angioedema, cough, wheezing, conjunctivitis, rhinitis and urticaria. If a systemic or anaphylactic reaction does occur, apply a tourniquet above the site of injection, if tests are performed on the arms, and inject the 1:1000 epinephrine-hydrochloride intramuscularly or subcutaneously into the opposite arm. Loosen the tourniquet at least every 10 minutes. Do not obstruct arterial blood flow with the tourniquet.
EPINEPHRINE:
ADULT DOSAGE: 0.3 to 0.5 mL should be injected. Repeat in 5 to 10 minutes if necessary.
PEDIATRIC DOSAGE: The usual initial dose is 0.01 mg (mL) per kg body weight or 0.3 mg (mL) per square meter of body surface area. Suggested dosage for infants to 2 years of age is 0.05 mL to 0.1 mL; for children 2 to 6 years, 0.15 mL; and children 6 to 12 years, 0.2 mL. Single pediatric doses should not exceed 0.3 mg (mL). Doses may be repeated as frequently as every 20 minutes, depending on the severity of the condition and the response of the patient. After administration of epinephrine, profound shock or vasomotor collapse should be treated with intravenous fluids, and possibly vasoactive drugs. Oxygen should be given by mask. Intravenous antihistamine, theophylline or adrenal corticosteroids may be used if necessary after adequate epinephrine and circulatory support have been given. Emergency resuscitation measures and personnel trained in their use should be available immediately in the event of a serious systemic or anaphylactic reaction not responsive to the above measures. [
Ref. J. Allergy Clin. Immunol. 77 (2): 271-273, 1986]. Rarely are all of the above measures necessary; the tourniquet and epinephrine usually produce prompt responses. However, the physician should be prepared in advance for all contingencies. Promptness in beginning emergency treatment measures is of utmost importance.
OVERDOSE SECTION
See
ADVERSE REACTIONS Section.
DOSAGE AND ADMINISTRATION
1. General
Parenteral Drug Products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
2. Intradermal Testing Methods
Cleanse the rubber stopper of the vial with liquid antiseptic before withdrawing extract. A sterile tuberculin syringe with 26-gauge, short-bevel needle should be used for the injection. The anterior surface of the upper and lower arm is preferable for testing. Cleanse the skin with soap and water or wash with alcohol or other antiseptic. Introduce the needle between the superficial layers of the skin and inject 0.02 mL of the extract. Test sites should be at least 2.5 cm apart, and no more than 10 to 20 antigens should be introduced at one time. This group can be followed with additional groups of 10, providing the reactions are not numerous or strong. The same amount of extract should be injected in each site for proper comparison. It is advisable to avoid testing with more than one allergen in the same group in each series, i.e., nuts, fish, epidermals, etc. A site should be injected with 0.02 mL of the control solution. All skin tests should be validated by appropriate positive control tests (e.g., histamine) and negative control tests [e.g., Glycerin, Albumin Saline with Phenol (0.4%), or Buffered Saline with Phenol (0.4%)]. The negative control test should be the same material as is used as a diluting fluid in the tested extracts. Diluting fluid is used in the same way as an active test extract. False positive reactions are sometimes encountered in intradermal testing, and the possibility of irritation reactions should always be taken into consideration. In cases where the patient is known to be quite sensitive, screen testing by scratch, prick or puncture method is recommended, and intradermal testing should be done with caution. The intradermal strength supplied is usually safe for testing patients presenting negative scratch, prick or puncture test reactions. It is recommended that a 1:10 dilution of the stock intradermal strength be used in preliminary testing of patients not previously screened by scratch, prick or puncture tests.
3. Use of Antigen Mixes
The use of complicated mixes of unrelated pollens for testing is not recommended since in the case of a positive reaction it does not indicate which pollen(s) are responsible, and in the case of a negative reaction, it fails to indicate whether the individual pollens at full concentration would give a positive reaction.
4. Reading Skin Test Reactions
A positive reaction consists of an urticarial wheal with surrounding erythema (resembling somewhat a mosquito bite reaction) larger than the control site. The smallest reaction considered positive is erythema with a central papule at least 5 mm in diameter. In some instances with no reaction at the control site, erythema may be considered an indication of sensitivity. In general, the size of wheal and erythema response correlates directly with the patient's sensitivity to that allergen.
Standardized Products
(a)
Mites: The skin test concentrations of 30 AU/mL and 300 AU/mL in multiple dose vials are used for intradermal testing.
Intradermal skin test results in selected highly sensitive subjects are presented for reference purposes:
AU/mL that Elicited ∑E = 50 mm |
Allergen
| Number of Persons
| Mean
| 2 Std. Dev. Range
|
D. farinae
| 12
| 0.0609
| 0.0015-2.6016
|
D. pteronyssinus
| 12
| 0.333
| 0.0003-4.0077
|
Intradermal extracts should be used as follows:
(1)
Patients with a negative scratch, prick or puncture test: Patients who do not react to a valid scratch, prick or puncture test should be tested intradermally with 0.02 to 0.05 mL of a 30 AU/mL extract solution. If this test is negative, a second intradermal test may be performed using a 300 AU/mL extract solution. The negative control used with this latter dilution should contain 0.5% glycerin.
(2)
Patients tested only by the intradermal method: Patients suspected of being highly allergic should be tested with 0.02 to 0.05 mL of a solution containing 0.03 AU/mL. A negative test should be followed by repeat tests using progressively stronger concentrations until the maximum recommended strength of 300 AU/mL is reached. The negative control used with this latter dilution should contain 0.5% glycerin.
(b)
Cat Hair and Cat Pelt: Intradermal endpoint titration (IET) tests were completed with Cat Pelt extract using 15 subjects to determine the mean concentration required to produce a ∑E of 50 (D
50) mm.That concentration contained 0.042 BAU/mL (range 0.002 to 0.890 BAU/mL).
IET tests were completed with Cat Hair extract using 15 subjects to determine the mean concentration required to produce a ∑E of 50 mm (D
50). That concentration contained 0.049 BAU/mL (range 0.006 to 0.661 BAU/mL).
Intradermal extract should be used as follows:
Intradermal Tests should be done only on patients with a negative prick or puncture test. Patients who do not react to a valid prick or puncture test should be tested intradermally with 0.02 to 0.05 mL of a 100 BAU/mL extract solution. If this test is negative, a second intradermal test may be performed using a 1,000 BAU/mL extract solution. If the intradermal dilutions were prepared from glycerinated concentrate, the negative control used with this latter dilution should contain 5% glycerin.
Standardized Cat Hair and Cat Pelt products are not interchangeable with each other or any other cat products including those labeled AU/mL.
(c)
Ragweed pollen (Short Ragweed or Giant and Short Ragweed Mixture) Antigen E Assayed: The intradermal strength for Short Ragweed extract is usually 500 PNU, which by calculation contains approximately 0.7 to 3 units of Antigen E/mL. For Giant and Short Ragweed mix the suggested intradermal strength is 500 PNU, which by calculation contains 0.4 to 1.5 units of Antigen E/mL. These strengths are usually safe for testing patients previously having negative scratch, prick or puncture test reactions. A 1:10 dilution of the stock intradermal strength should be used in preliminary testing of patients not previously screened by scratch, prick, or puncture tests. A study of ragweed sensitive patients9 indicates that intradermal tests, using 0.05 mL of extract, produce positive reactions (1+ to 2+) at Antigen E concentrations of from 2.7x10 -1 to 2.7x10 -6 units per mL. The equivalent PNU range was 100 to 0.001 PNU per mL. Skin tests are graded in terms of the wheal and erythema response noted at 15 minutes. Wheal and erythema size may be recorded by actual measurement of the extent of both responses.
5. Geriatric Use
The dose is the same in patients of all age groups. Because the wheal size in response to allergen skin testing decreases with age, appropriate histamine positive control skin tests must be performed.1
6. Pediatric Use
The dose is the same in patients of all age groups. Wheal size in response to allergen skin testing can be smaller in infants than in adults. Appropriate histamine positive control skin tests must be performed.1
Refer to the following table to determine the skin test sensitivity grade. The corresponding ∑E (sum of the longest diameter and the mid-point orthogonal diameters of erythema) is also presented.
Grade
| Erythema mm
| Papule or Wheal mm
| Coresponding mm ∑E
|
0
| <5
| <5
| <10
|
±
| 5-10
| 5-10
| 10-20
|
1+
| 11-20
| 5-10
| 20-40
|
2+
| 21-30
| 5-10
| 40-60
|
3+
| 31-40
| 10-15 (a)
| 60-80
|
4+
| >40
| >15 (b)
| > 80
|
a or with pseudopods
b or with many pseudopods
A positive skin reaction to any allergen must be interpreted in light of the patient’s history of symptoms, time of year, known exposures, and eating habits.
THE SKIN TESTS ARE IN NO WAY A SUBSTITUTE FOR A CAREFUL ALLERGENIC HISTORY; RATHER, THEY SERVE AS ADDITIONAL INFORMATION TO AID IN IDENTIFYING CAUSATIVE ALLERGENS IN PATIENTS WITH ALLERGIC DISORDERS.
HOW SUPPLIED
Most allergens are available in multiple dose 5 mL vials at PNU, w/v, some mixes as Concentrate, Standardized Mite products at AU/mL (30 AU/mL and 300 AU/mL each species), or Standardized Grass products at BAU/mL [100 BAU/mL and 1,000 BAU/mL (Bermuda 100 BAU/mL only)]. Product labels state vials are for intradermal testing and list strengths.
STORAGE
The expiration date of the diagnostic extracts is listed on the container label. The extract should be stored at 2° to 8°C, and kept at this temperature range during office use.
LIMITED WARRANTY
A number of factors beyond our control could reduce the efficacy of this product or even result in an ill effect following its use. These include storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration and biological differences in individual patients. Because of these factors, it is important that this product be stored properly, and that the directions be followed carefully during use. No warranty, express or implied, including any warranty of merchantability or fitness, is made. Representatives of the Company are not authorized to vary the terms or the contents of any printed labeling, including the package insert, for this product except by printed notice from the Company’s headquarters. The prescriber and user of this product must accept the terms hereof.
REFERENCES
1. Middleton, Elliott, Jr., C. E. Reed and E. F. Ellis (Eds.) Allergy Principles and Practice. Vol. 1, C. V. Mosby, 1978.
2. Sheldon, J. M., R. C. Lovell, and K. P. Mathews. A Manual of Clinical Allergy. W. B. Saunders, 1967.
3. Tuft, L. and H. L. Mueller, Allergy in Children. W. B. Saunders, 1979.
4. DuBuske, L.M., C.J. Ling and A.L. Sheffer. Special problems regarding allergen immunotherapy. Immunol. Allergy. Clin. North Am. (USA). 12(1): 145-175, 1992.
5. Weinstein, A. M., D. B. Dubin, W. K. Podleski, L. L. Spector and R. S. Farr. Asthma and pregnancy. JAMA 134(11): 1161-1165, 1979.
6. Jacobs, Robert L., Goeffrey W. Rake, Jr., et al. Potentiated anaphylaxis in patients with drug-induced beta-adrenergic blockade. J. Allergy Clin. Immunol. 68(2): 125-127, August 1981.
7. Lockey, Richard F., Linda M. Benedict, Paul C. Turkeltaub, Samuel C. Bukantz. Fatalities from immunotherapy (IT) and skin testing (ST). J. Allergy Clin. Immunol. 79(4): 660-677, 1987.
8. Turkeltaub, Paul C., MD, and Peter J. Gergen, MD. The risk of adverse reactions from percutaneous prick-puncture allergen skin testing, venipuncture, and body measurements: Data from the second National Health and Nutrition Examination Survey 1976-80 (NHANES II). J. Allergy Clin. Immunol. 84(6): 886-890, Dec. 1989.
9. Norman, P. S., L. M. Lichtenstein, and K. Ishizaka. Diagnostic tests in ragweed hay fever. J. Allergy Clin. Immunol. 52(4): 212-224, 1973.
10. Pipkorn, Ulf. Pharmacological influence of anti-allergic medication on In Vivo allergen testing. Allergy. 43: 81-86, 1988.
11. Andersson, M. and U. Pipkorn. Inhibition of the dermal immediate allergic reaction through prolonged treatment with topical glucocorticosteroids. J. Allergy Clin. Immunol. 79(2): 345-349, February 1987.
12. Rao, Kamineni S., et al. Duration of suppressive effect of tricyclic anti-depressants on histamine induced wheal and flare reactions on human skin. J. Allergy Clin. Immunol. 82: 752-757, November 1988.
13. Pipkorn, Ulf, and M. Andersson. Topical dermal anesthesia inhibits the flare but not the wheal response to allergen and histamine in the skin prick test. Clinical Allergy. 17: 307-311, 1987.
14. Turkeltaub, Paul C., C. Rastogi Suresh, Harold Baer. Office of Biologics Research and Review skin test method for evaluation of subject sensitivity to standardized allergenic extracts and for assignment of allergy units to reference preparations using the ID50EAL method (Intradermal Dilution for 50 mm Sum of Erythema Determines the Allergy Unit). Methods of the Allergenic Products Branch Office of Biologics Research and Review, FDA, Bethesda, MD 20892. Revised May 9, 1986.
15. Food and Drug Administration. Bilogical products; Allergenic extracts classified in Category IIIB; Final order; Revocation of licenses. Federal Register. 59(220):59228ff, November 16, 1994.
ANIMAL ALLERGENS, AP HORSE HAIR AND DANDER
ap horse hair and dander
injection, solution |
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ANIMAL ALLERGENS, AP CATTLE HAIR AND DANDER
cattle hair and dander
injection, solution |
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ANIMAL ALLERGENS, FEATHER MIX
feather mix
injection, solution |
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AP HOUSE DUST MIX
ap house dust mix
injection, solution |
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DUST, HOUSE MIXTURE
dust, house mixture
injection, solution |
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INSECTS (WHOLE BODY) COCKROACH MIX
insects (whole body) cockroach mix
injection, solution |
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INSECTS (WHOLE BODY), FIRE ANT MIX
insects (whole body), fire ant mix
injection, solution |
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MOLDS - MOLD MIX 10
molds - mold mix 10
injection, solution |
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MOLDS - MOLD MIX 4
molds - mold mix 4
injection, solution |
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MOLDS - TRICHOPHYTON MIX
molds - trichophyton mix
injection, solution |
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MOLDS, PENICILLIUM MIX
molds, penicillium mix
injection, solution |
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MOLDS, RUSTS AND SMUTS, ALTERNARIA TENUIS
alternaria tenuis
injection, solution |
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MOLDS, RUSTS AND SMUTS, ASPERGILLUS FUMIGATUS
aspergillus fumigatus
injection, solution |
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MOLDS, RUSTS AND SMUTS, CANDIDA ALBICANS
candida albicans
injection, solution |
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MOLDS, RUSTS AND SMUTS, CEPHALOSPORIUM ACREMONIUM
cephalosporium acremonium
injection, solution |
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MOLDS, RUSTS AND SMUTS, CURVULARIA SPICIFERA
curvularia spicifera
injection, solution |
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MOLDS, RUSTS AND SMUTS, EPICOCCUM NIGRUM
epicoccum nigrum
injection, solution |
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MOLDS, RUSTS AND SMUTS, FUSARIUM VASINFECTUM
fusarium vasinfectum
injection, solution |
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MOLDS, RUSTS AND SMUTS, HELMINTHOSPORIUM INTERSEMINATUM
helminthosporium interseminatum
injection, solution |
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MOLDS, RUSTS AND SMUTS, HORMODENDRUM CLADOSPORIOIDES
hormodendrum cladosporioides
injection, solution |
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MOLDS, RUSTS AND SMUTS, MUCOR RACEMOSUS
mucor racemosus
injection, solution |
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MOLDS, RUSTS AND SMUTS, PENICILLIUM NOTATUM
penicillium notatum
injection, solution |
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MOLDS, RUSTS AND SMUTS, PHOMA HERBARUM
phoma herbarum
injection, solution |
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MOLDS, RUSTS AND SMUTS, PULLULARIA PULLULANS
pullularia pullulans
injection, solution |
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MOLDS, RUSTS AND SMUTS, RHIZOPUS NIGRICANS
rhizopus nigricans
injection, solution |
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MOLDS, RUSTS AND SMUTS, STEMPHYLIUM BOTRYOSUM
stemphylium botryosum
injection, solution |
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POLLENS - GRASSES, BAHIA GRASS PASPALUM NOTATUM
bahia grass paspalum notatum
injection, solution |
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POLLENS - GRASSES, JOHNSON GRASS SORGHUM HALEPENSE
johnson grass sorghum halepense
injection, solution |
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POLLENS - TREES, ACACIA ACACIA LONGIFOLIA
acacia longifolia
injection, solution |
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POLLENS - TREES, ALDER, RED ALNUS RUBRA
alder, red alnus rubra
injection, solution |
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POLLENS - TREES, ASH, WHITE FRAXINUS AMERICANA
ash, white fraxinus americana
injection, solution |
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POLLENS - TREES, BIRCH MIX
birch mix
injection, solution |
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POLLENS - TREES, BOXELDER/MAPLE MIX
boxelder/maple mix
injection, solution |
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POLLENS - TREES, CEDAR, MOUNTAIN JUNIPERUS ASHEI
cedar, mountain juniperus ashei
injection, solution |
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POLLENS - TREES, CEDAR, RED JUNIPERUS VIRGINIANA
cedar, red juniperus virginiana
injection, solution |
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POLLENS - TREES, COTTONWOOD, COMMON POPULUS DELTOIDES
cottonwood, common populus deltoides
injection, solution |
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POLLENS - TREES, ELM, AMERICAN ULMUS AMERICANA
elm, american ulmus americana
injection, solution |
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POLLENS - TREES, ELM, CHINESE ULMUS PARVIFOLIA
elm, chinese ulmus parvifolia
injection, solution |
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POLLENS - TREES, HACKBERRY CELTIS OCCIDENTALIS
hackberry celtis occidentalis
injection, solution |
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POLLENS - TREES, MAPLE, HARD ACER SACCHARUM
maple, hard acer saccharum
injection, solution |
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POLLENS - TREES, MESQUITE, PROSOPIS JULIFLORA
mesquite, prosopis juliflora
injection, solution |
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POLLENS - TREES, MULBERRY MIX
mulberry mix
injection, solution |
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POLLENS - TREES, OAK MIX
oak mix
injection, solution |
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POLLENS - TREES, OAK, RED QUERCUS RUBRA
oak, red quercus rubra
injection, solution |
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POLLENS - TREES, OLIVE OLEA EUROPAEA
olive olea europaea
injection, solution |
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POLLENS - TREES, PECAN CARYA CARYA ILLINOENSIS
pecan carya carya illinoensis
injection, solution |
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POLLENS - TREES, RUSSIAN OLIVE ELAEAGNUS ANGUSTIFOLIA
russian olive elaeagnus angustifolia
injection, solution |
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POLLENS - TREES, SYCAMORE, AMERICAN (EASTERN) PLATANUS OCCIDENTALLIS
sycamore, american (eastern) platanus occidentallis
injection, solution |
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POLLENS - TREES, TREE MIX 11
tree mix 11
injection, solution |
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POLLENS - TREES, TREE MIX 5
tree mix 5
injection, solution |
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POLLENS - TREES, TREE MIX 6
tree mix 6
injection, solution |
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POLLENS - TREES, WALNUT, BLACK JUGLANS NIGRA
walnut, black juglans nigra
injection, solution |
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POLLENS - TREES, WILLOW, BLACK SALIX NIGRA
willow, black salix nigra
injection, solution |
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POLLENS - WEEDS AND GARDEN PLANTS, COCKLEBUR XANTHIUM STRUMARIUM
cocklebur xanthium strumarium
injection, solution |
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POLLENS - WEEDS AND GARDEN PLANTS, GOLDENROD SOLIDAGO CANADENSIS
goldenrod solidago canadensis
injection, solution |
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POLLENS - WEEDS AND GARDEN PLANTS, LAMB QUARTERS CHENOPODIUM ALBUM
lamb quarters chenopodium album
injection, solution |
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POLLENS - WEEDS AND GARDEN PLANTS, PIGWEED, ROUGH REDROOT AMARANTHUS RETROFLEXUS
pigweed, rough redroot amaranthus retroflexus
injection, solution |
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POLLENS - WEEDS AND GARDEN PLANTS, PLANTAIN, ENGLISH PLANTAGO LANCEOLATA
plantain, english plantago lanceolata
injection, solution |
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POLLENS - WEEDS AND GARDEN PLANTS, RAGWEED, GIANT AMBROSIA TRIFIDA
ragweed, giant ambrosia trifida
injection, solution |
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POLLENS - WEEDS AND GARDEN PLANTS, RAGWEED. WESTERN AMBROSIA PSILOSTACHYA
ragweed. western ambrosia psilostachya
injection, solution |
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POLLENS - WEEDS AND GARDEN PLANTS, RUSSIAN THISTLE SALSOLA KALI
russian thistle salsola kali
injection, solution |
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POLLENS - WEEDS AND GARDEN PLANTS, SAGEBRUSH, MUGWORT ARTEMISIA VULGARIS
sagebrush, mugwort artemisia vulgaris
injection, solution |
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POLLENS - WEEDS AND GARDEN PLANTS, SCALE, WING (SHAD) ATRIPLEX CANESCENS
scale, wing (shad) atriplex canescens
injection, solution |
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POLLENS - WEEDS, CARELESS/PIGWEED MIX
careless/pigweed mix
injection, solution |
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POLLENS - WEEDS, DOCK/SORREL MIX
pollens - weeds, dock/sorrel mix
injection, solution |
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POLLENS - WEEDS, GIANT, SHORT, WESTERN RAGWEED MIX
giant, short, western ragweed mix
injection, solution |
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POLLENS - WEEDS, KOCHIA SCOPARIA
kochia scoparia
injection, solution |
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POLLENS - WEEDS, MARSHELDER/POVERTY MIX
pollens - weeds, marshelder/poverty mix
injection, solution |
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POLLENS - WEEDS, WEED MIX 2630
weed mix 2630
injection, solution |
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Revised: 12/2009Hollister Stier Laboratories LLC