Package Insert and Label Information: Animal Allergens, AP Horse Hair and Dander
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, AP DOG HAIR AND DANDER CANIS SPP — canis lupus familiaris hair and canis lupus familiaris dander injection, solution
ANIMAL ALLERGENS, DOG HAIR AND DANDER CANIS SPP. — canis lupus familiaris hair and canis lupus familiaris dander injection, solution
ANIMAL ALLERGENS, FEATHER MIX — gallus gallus feather, anas platyrhynchos feather and anser anser feather injection, solution
ANIMAL ALLERGENS, GUINEA PIG HAIR AND DANDER — cavia porcellus hair and cavia porcellus dander injection, solution
AP HOUSE DUST MIX — house dust injection, solution
DUST, HOUSE MIXTURE — house dust injection, solution
FOOD — ANIMAL PRODUCTS AND POULTRY PRODUCTS, BEEF BOVINE SPP. — beef injection, solution
FOOD — ANIMAL PRODUCTS AND POULTRY PRODUCTS, CHICKEN MEAT GALLUS SP. — poultry injection, solution
FOOD — ANIMAL PRODUCTS AND POULTRY PRODUCTS, EGG, WHITE GALLUS SP. — egg white injection, solution
FOOD — ANIMAL PRODUCTS AND POULTRY PRODUCTS, EGG, YOLK GALLUS SP. — egg yolk injection, solution
FOOD — ANIMAL PRODUCTS AND POULTRY PRODUCTS, PORK SUS SP. — pork injection, solution
FOOD — DAIRY PRODUCTS, CASEIN, COW MILK — casein injection, solution
FOOD — DAIRY PRODUCTS, MILK, WHOLE COW — cow milk injection, solution
FOOD — FISH AND SHELLFISH, CLAM — quahog, unspecified injection, solution
FOOD — FISH AND SHELLFISH, CODFISH GADUS CALLARIAS — cod, unspecified injection, solution
FOOD — FISH AND SHELLFISH, CRAB XIPHOSURUS SOWERBYI — crab leg, unspecified injection, solution
FOOD — FISH AND SHELLFISH, LOBSTER HOMARUS AMERICANUS — lobster, unspecified injection, solution
FOOD — FISH AND SHELLFISH, SALMON SALMO SALAR — salmon, unspecified injection, solution
FOOD — FISH AND SHELLFISH, SHRIMP CRAGO SP. — shrimp, unspecified injection, solution
FOOD — FISH AND SHELLFISH, TUNA THUNNUS SP. — tuna, unspecified injection, solution
FOOD — PLANT SOURCE, ALMOND PRUNUS AMYGDALUS — almond injection, solution
FOOD — PLANT SOURCE, APPLE MALUS SP. — apple injection, solution
FOOD — PLANT SOURCE, BANANA MUSA SAPIENTUM — banana injection, solution
FOOD — PLANT SOURCE, BRAZIL NUT BERTHOLLETIA EXCELSA — brazil nut injection, solution
FOOD — PLANT SOURCE, CARROT DAUCUS CAROTA — carrot injection, solution
FOOD — PLANT SOURCE, CASHEW NUT ANACARDIUM OCCIDENTALIE — cashew injection, solution
FOOD — PLANT SOURCE, CELERY APIUM GRAVEOLENS — celery injection, solution
FOOD — PLANT SOURCE, CORN ZEA MAYS — corn injection, solution
FOOD — PLANT SOURCE, HAZELNUT (FILBERT) CORYLUS SPP. — hazelnut, unspecified injection, solution
FOOD — PLANT SOURCE, MELON, CANTALOUPE CUCUMIS MELO — cantaloupe injection, solution
FOOD — PLANT SOURCE, ORANGE CITRUS SINENSIS — orange injection, solution
FOOD — PLANT SOURCE, PEA, GREEN OR ENGLISH PISUM SATIVUM — pea injection, solution
FOOD — PLANT SOURCE, PEACH PRUNUS PERSICA — peach injection, solution
FOOD — PLANT SOURCE, PEANUT ARACHIS HYPOGAEA — peanut injection, solution
FOOD — PLANT SOURCE, PECAN CARYA ILLINOENSIS — pecan injection, solution
FOOD — PLANT SOURCE, POTATO, WHITE SOLANUM TUBEROSUM — potato injection, solution
FOOD — PLANT SOURCE, RICE, WHOLE GRAIN — rice injection, solution
FOOD — PLANT SOURCE, RYE GRAIN — rye injection, solution
FOOD — PLANT SOURCE, SOYBEAN GLYCINE SOJA — soybean injection, solution
FOOD — PLANT SOURCE, STRAWBERRY FRAGARIA CHILOENSIS — strawberry injection, solution
FOOD — PLANT SOURCE, STRING BEAN MIX — string bean injection, solution
FOOD — PLANT SOURCE, TOMATO NICOTIANA SPP. — tomato injection, solution
FOOD — PLANT SOURCE, WALNUT, BLACK JUGLANS NIGRA — black walnut injection, solution
FOOD — PLANT SOURCE, YEAST, BAKER SACCHAROMYCES CEREVISIAE — yeast injection, solution
FOOD — PLANT SOURCE, YEAST, BREWER SACCHAROMYCES CEREVISIAE — yeast injection, solution
INSECTS (WHOLE BODY) COCKROACH MIX — periplaneta americana and blatella germanica injection, solution
INSECTS (WHOLE BODY), ANT, FIRE SOLENOPSIS INVICTA — solenopsis invicta injection, solution
INSECTS (WHOLE BODY), ANT, FIRE SOLENOPSIS RICHTERI — solenopsis richteri injection, solution
INSECTS (WHOLE BODY), FIRE ANT MIX — solenopsis richteri and solenopsis invicta injection, solution
MOLDS — ALTERNARIA/HORMODENDRUM MIX — alternaria alternata and cladosporium cladosporioides injection, solution
MOLDS — MOLD MIX 10 — alternaria alternata, aspergillus fumigatus, aspergillus nidulans, aspergillus niger var. niger, aspergillus terreus, fusarium oxysporum vasinfectum, dendryphiella vinosa, cladosporium cladosporioides, mucor racemosus, penicillium digitatum, 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, aspergillus nidulans, aspergillus niger var. niger, aspergillus terreus, cladosporium cladosporioides, penicillium digitatum, 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 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, ASPERGILLUS NIGER — aspergillus niger var. niger injection, solution
MOLDS, RUSTS AND SMUTS, BOTRYTIS CINEREA — botrytis cinerea 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, EPIDERMOPHYTON FLOCCOSUM — epidermophyton floccosum 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, BROME, SMOOTH BROMUS INERMIS — bromus inermis pollen injection, solution
POLLENS — GRASSES, CORN, CULTIVATED ZEA MAYS — zea mays pollen injection, solution
POLLENS — GRASSES, JOHNSON GRASS SORGHUM HALEPENSE — sorghum halepense pollen injection, solution
POLLENS — GRASSES, OATS, COMMON, CULTIVATED AVENA SATIVA — avena sativa pollen injection, solution
POLLENS — GRASSES, SOUTHERN GRASS MIX — poa pratensis pollen, dactylis glomerata pollen, agrostis gigantea pollen, phleum pratense pollen, anthoxanthum odoratum pollen, sorghum halepense pollen and cynodon dactylon pollen injection, solution
POLLENS — GRASSES, SOUTHERN GRASS MIX 10TH OF CONCENTRATE — poa pratensis pollen, dactylis glomerata pollen, agrostis gigantea pollen, phleum pratense pollen, anthoxanthum odoratum pollen, sorghum halepense pollen and cynodon dactylon 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, BEECH, AMERICAN FAGUS GRANDIFOLIA — fagus grandifolia pollen injection, solution
POLLENS — TREES, BIRCH MIX — betula papyrifera pollen, betula pendula pollen and betula nigra pollen injection, solution
POLLENS — TREES, BOTTLEBRUSH, CALLISTEMON SPP. — callistemon citrinus 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, CYPRESS, ARIZONA CUPRESSUS ARIZONICA — cupressus arizonica pollen injection, solution
POLLENS — TREES, CYPRESS, BALD TAXODIUM DISTICHUM — taxodium distichum 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, EUCALYPTUS (BLUE GUM) EUCALYPTUS GLOBULUS — eucalyptus globulus pollen injection, solution
POLLENS — TREES, GUM, SWEET LIQUIDAMBAR STYRACIFLUA — liquidambar styraciflua pollen injection, solution
POLLENS — TREES, HACKBERRY CELTIS OCCIDENTALIS — celtis occidentalis pollen injection, solution
POLLENS — TREES, HICKORY, SHAGBARK CARYA OVATA — carya ovata pollen injection, solution
POLLENS — TREES, LINDEN (BASSWOOD) TILIA AMERICANA — tilia americana pollen injection, solution
POLLENS — TREES, MAPLE, HARD ACER SACCHARUM — acer saccharum pollen injection, solution
POLLENS — TREES, MELALEUCA (PUNK TREE) MELALEUCA QUINQUENERVIA — melaleuca quinquenervia 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, OLIVE, RUSSIAN ELAEAGNUS ANGUSTIFOLIA — elaeagnus angustifolia pollen injection, solution
POLLENS — TREES, PALM, QUEEN COCOS PLUMOSA — syagrus romanzoffiana pollen injection, solution
POLLENS — TREES, PALO VERDE CERCIDIUM FLORIDUM — parkinsonia florida pollen injection, solution
POLLENS — TREES, PECAN CARYA CARYA ILLINOENSIS — carya illinoinensis pollen injection, solution
POLLENS — TREES, PEPPER TREE, CALIFORNIA SCHINUS MOLLE — schinus molle pollen injection, solution
POLLENS — TREES, PINE MIX — pinus contorta pollen and pinus ponderosa pollen injection, solution
POLLENS — TREES, PRIVET LIGUSTRUM VULGARE — ligustrum vulgare 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, TREE OF HEAVEN AILANTHUS ALTISSIMA — ailanthus altissima 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, DOG FENNEL EUPATORIUM CAPILLIFOLIUM — eupatorium capillifolium 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, NETTLE URTICA DIOICA — urtica dioica 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 AND GARDEN PLANTS, SCOTCH BROOM CYTISUS SCOPARIUS — cytisus scoparius flowering top injection, solution
POLLENS — WEEDS AND GARDEN PLANTS, SORREL, SHEEP RUMEX ACETOSELLA — rumex acetosella pollen injection, solution
POLLENS — WEEDS, CARELESS WEED AMARANTHUS PALMERI — amaranthus palmeri 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 — bassia scoparia pollen injection, solution
POLLENS — WEEDS, MARSHELDER/POVERTY MIX — iva axillaris pollen, iva annua pollen and cyclachaena 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
Jubilant HollisterStier LLC
WARNINGS
This product is intended for use only by licensed medical personnel experienced in administering allergenic extracts and trained to provide immediate emergency treatment in the event of a life-threatening reaction. 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 must be available immediately in the event of such a reaction. Patients should be instructed to recognize adverse reaction s ymptoms and cautioned to contact the physician’s office if symptoms occur. 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. This product should never be injected intravenously. Refer also to the WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS Sections for further discussion.
DESCRIPTION
Sterile extracts for scratch, prick or puncture testing are supplied in dropper vials containing, in addition to the extract allergens and antigens, 50% (v/v) glycerin as preservative, 0.5% sodium chloride and 0.275% sodium bicarbonate. The strength of these extracts may be expressed in terms of
- Weight to Volume (w/v)
- Protein Nitrogen Units/mL (PNU/mL)
- Allergy Units/mL (AU/mL)
- Bioequivalent Allergy Units/mL (BAU/mL)
- Concentrate
1. 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 materials will vary with the kind of antigen, the extracting fluid, duration of extraction, pH, temperature, and other variables. AP™ (acetone precipitated) extracts, if present, are prepared by reconstituting dry, allergenically active concentrates produced by 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.
2. 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, the PNU content of extracts from different manufacturers is 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.
3. Allergy Units per mL (AU/mL).
The potency of extracts labeled in Allergy Units per mL (AU/mL) is determined by in vitro comparison to a reference standard established by the Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA).
4. 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 ID50 EAL method 13 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 such products 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.
5. Concentrate.
Concentrate label terminology applies to allergenic extract mixtures, where the individual allergens being combined vary in strength or the designation of strength.
