ANIMAL ALLERGENS, AP CATTLE HAIR AND DANDER- cattle hair and dander injection, solution ANIMAL ALLERGENS, AP DOG HAIR AND DANDE

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BOS TAURUS HAIR (UNII: TOQ97Z8644) (BOS TAURUS HAIR - UNII:TOQ97Z8644), BOS TAURUS DANDER (UNII: C8VYS726O8) (BOS TAURUS DANDER - UNII:C8VYS726O8)

Available from:

Jubilant HollisterStier LLC

INN (International Name):

EQUUS CABALLUS HAIR

Composition:

EQUUS CABALLUS HAIR 0.01 g in 1 mL

Administration route:

PERCUTANEOUS

Therapeutic indications:

NON-STANDARDIZED ALLERGENIC EXTRACTS are indicated for: - Skin test diagnosis of individuals with a clinical history of allergy to the specific corresponding allergens. NON-STANDARDIZED ALLERGENIC EXTRACTS are indicated for: - Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for allergen specific IgE antibodies for the specific corresponding allergens. Non-standardized allergenic extracts are contraindicated in individuals with the following conditions: - Severe, unstable or uncontrolled asthma. - History of any severe systemic reaction to the allergen extract when administered for diagnosis or treatment. - Medical conditions that reduce the ability to survive anaphylaxis. 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%, respecti

Product summary:

Non-standardized allergenic extracts and mixes are supplied as 50% glycerin stock concentrates labeled in weight/volume and provided in 10 milliliter, 30 milliliter and 50 milliliter vials for use in percutaneous 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 POLLEN – GRASS ALLERGENS Bahia Grass,Paspalum notatum Brome, SmoothBromus inermis Corn, CultivatedZea mays Grass Mix 8-100,000 BAU/mL each ofP. pratensis; A. gigantean; P. pretense; 10,000 BAU/mL ofC. dactylon ; 1:20w/v ofS. halepense Johnson Grass,Sorghum halepense Oats, Common Cultivated,Avena sativa POLLEN – TREE ALLERGENS Acacia, Golden,Acacia longifolia Alder, Red,Alnus rubra Ash, White,Fraxinus americana Beech, American,Fagus grandifolia Birch Mix (PRW)-B. papyrifera, B. pendula, B. nigra Bottlebrush,Melaleuca citrina Boxelder/Maple Mix (BHR)-A. negundo, A. saccharum, A. rubrum Cedar, Mountain,Juniperus ashei Cedar, Red,Juniperus virginiana Cottonwood, Common,Populus deltoides Cyprus, Arizona,Cupressus arizonica Cyprus, Bald,Taxodium distichum Elm, American,Ulmus americana Elm, Chinese,Ulmus parvifolia Gum, Sweet,Liquidambar styraciflua Hackberry,Celtis occidentalis Hickory, Shagbark,Carya ovata Maple, Hard/Sugar,Acer saccharum Melaleuca,Melaleuca quinquenervia Mesquite,Prosopis glandulosa Mulberry Mix (RW)-M. rubra, M. alba Oak Mix (RVW)-Q. rubra, Q. virginiana, Q. alba Oak, Red,Quercus Rubra Olive Tree,Olea europaea Palm, Queen,Syagrus romanzoffiana Pecan Tree,Carya illinoinensis Pine Mix (LY)-P. contorta, P. ponderosa Privet, Common,Ligustrum vilgare Russian Olive,Elaeagnus angustifolia Sycamore, American,Platanus occidentalis Tree Mix 5-20% each ofF. Americana; J. nigra; P. deltoides; U. Americana; 6.7% each ofB. papyrifera; B. nigra; B. pendula Tree Mix 6- Tree Mix 6-20% each ofF. Americana; J. nigra; P. deltoides; U. Americana; 6.7% each ofB. papyrifera; B. nigra; B. pendula Tree Mix 11-10% each ofF. americana; B. nigra; J. nigra; P. deltoides; U. americana; C. ovata; A. saccharum; Q. rubra; P. occidentalis; S. nigra Walnut, Black,Juglans nigra Willow, Black,Salix nigra POLLEN – WEED AND GARDEN PLANT ALLERGENS Careless Weed,Amaranthus palmeri Careless/Pigweed Mix (CR)-A. palmeri, A. retroflexus Cocklebur, Common,Xanthium strumarium Dock/Sorrel Mix (DS)-R. crispus, R. acetosella Dog Fennel, Eastern,Eupatorium capillifolium Goldenrod,Solidago canadensis Kochia,Kochia scoparia Lamb’s Quarters,Chenopodium album Marshelder/Poverty Mix (BPT)-C. xanthifolia, I. annua, I. axillaris Nettle,Urtica dioica Pigweed, Rough Redroot,Amaranthus retroflexus Plantain, English,Plantago lanceolata Ragweed, Giant,Ambrosia trifida Ragweed Mix (GSW)-A. trifida, A. artemisiifolia, A. psilostachya Ragweed, Western,Ambrosia psilostachya Russian Thistle,Salcola kali Sagebrush, Mugwort,Artemisia vulgaris Scale, Wing,Atriplex canescens Sorrel, Sheep,Rumex acetosella Weed Mix 2630-25% each ofX. strumarium; C. album; A. retroflexus; 12.5% each ofR. crispus; R. acetosella MOLDS Alternaria/Hormodendrum Mix-A. tenuis, H. cladosporioides Alternaria tenuis (Alternariaalternata) Aspergillus fumigatus Aspergillus niger var. niger Botrytis cinerea Candida albicans Cephalosporium acremonium (Sarocladiumstrictum) Curvularia spicifera (Cochliobolusspicifer) Epicoccum nigrum Epidermophyton floccosum Fusarium vasinfectum (Fusariumoxysporumvasinfectum) Heliminthosporium interseminatum (Dendryphiellavinosa) Hormodendrum cladosporioides (Cladosporium cladosporioides) Mold Mix 4-25% each ofA. alternata; C. cladosporioides; 6.2% each ofA. fumigatus; A. nidulans; A. nigervar. niger; A. terreus; P. digitatum; P. expansum; P. chrysogenumvar. chrysogenum; C. rosea f. rosea Mold Mix 10-2.5% each ofA. fumigatus; A. nidulans; A. nigervar. niger; A. terreus; P. digitatum; P. expansum; P. chrysogenumvar. chrysogenum; C. roseaf. rosea; 10% each ofA. alternata; F. oxysporumvasinfectum; D. vinosa; C. cladosporioides; M. racemosus; P. exiguavar. exigua; A. pullulansvar. pullutans; R. stolonifer Mucor racemosus Penicillium Mix-P. expansum, P. digitatum, P. chrysogenum, C. rosea Penicillium notatum (Penicilliumchrysogenumvar. chrysogenum) Phoma herbarum (Phomaexiguavar. exigua) Pullularia pullulans (Aerobasidiumpullulansvar. pullulans) Rhizopus nigricans (Rhizopusstolonifer) Stemphylium botryosum (Pleosporatarda) Trichophyton Mix-T. tonsurans, T. rubrum , T. mentagrophytes EPIDERMALS AP Horse Hair and Dander,Equuscaballus AP Cattle Hair and Dander,Bostaurus AP Dog Hair and Dander,Canislupusfamiliaris Dog Hair and Dander,Canislupusfamiliaris UF Dog Hair and Dander,Canislupusfamiliaris Feather Mix-G. gallus, A. platyrhynchos, A. anser Guinea Pig Hair and Dander,Caviaporcellus INSECTS Cockroach, American,Periplanetaamericana Cockroach, German,Blatellagermanica Cockroach Mix-P. americana, B. germanica Fire Ant,Solenopsisinvicta Store extracts at 2°C to 8°C (36°F to 46°F).

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

ANIMAL ALLERGENS, AP CATTLE HAIR AND DANDER- CATTLE HAIR AND
DANDER INJECTION, SOLUTION
ANIMAL ALLERGENS, AP DOG HAIR AND DANDER CANIS SPP- ANIMAL ALLERGENS,
DOG DANDER CANIS SPP INJECTION, SOLUTION
ANIMAL ALLERGENS, DOG HAIR AND DANDER CANIS SPP.- DOG HAIR CANIS
SPP. INJECTION, SOLUTION
ANIMAL ALLERGENS, AP HORSE HAIR AND DANDER- AP HORSE HAIR AND
DANDER INJECTION, SOLUTION
ANIMAL ALLERGENS, FEATHER MIX- FEATHER MIX INJECTION, SOLUTION
ANIMAL ALLERGENS, GUINEA PIG HAIR AND DANDER- GUINEA PIG HAIR AND
DANDER INJECTION, SOLUTION
FOOD - ANIMAL PRODUCTS AND POULTRY PRODUCTS, BEEF BOVINE SPP.-
BEEF BOVINE SPP. INJECTION, SOLUTION
FOOD - ANIMAL PRODUCTS AND POULTRY PRODUCTS, CHICKEN MEAT
GALLUS SP.- CHICKEN MEAT GALLUS SP. INJECTION, SOLUTION
POLLENS - TREES, OLIVE OLEA EUROPAEA- OLIVE OLEA EUROPAEA INJECTION,
SOLUTION
POLLENS - TREES, PALM, QUEEN COCOS PLUMOSA- PALM, QUEEN COCOS
PLUMOSA INJECTION, SOLUTION
POLLENS - TREES, PALO VERDE CERCIDIUM FLORIDUM- PALO VERDE CERCIDIUM
FLORIDUM INJECTION, SOLUTION
POLLENS - TREES, PECAN CARYA CARYA ILLINOENSIS- PECAN CARYA CARYA
ILLINOENSIS INJECTION, SOLUTION
POLLENS - TREES, PEPPER TREE, CALIFORNIA SCHINUS MOLLE- PEPPER TREE,
CALIFORNIA SCHINUS MOLLE INJECTION, SOLUTION
POLLENS - TREES, PINE MIX- PINE MIX INJECTION, SOLUTION
POLLENS - TREES, PRIVET LIGUSTRUM VULGARE- PRIVET LIGUSTRUM
VULGARE INJECTION, SOLUTION
POLLENS - TREES, RUSSIAN OLIVE ELAEAGNUS ANGUSTIFOLIA- RUSSIAN OLIVE
ELAEAGNUS ANGUSTIFOLIA INJECTION, SOLUTION
POLLENS - TREES, SYCAMORE, AMERICAN EASTERN PLATANUS
OCCIDENTALLIS- SYCAMORE, AMERICAN EASTERN PLATANUS OCCIDENTALLIS
INJECTION,
SOLUTION
POLLENS - TREES, TREE MIX 11- TREE MIX 11 INJECTION, SOLUTION
POLLENS - TREES, TREE MIX 5- TREE MIX 5 INJECTION, SOLUTION
POLLENS - TREES, TREE MIX 6- TREE MIX 6 INJECTION, SOLUTION
POLLENS - TREES, TREE OF HEAVEN AILANTHUS ALTISSIMA- TREE OF HEAVEN
AILANTHUS ALTISSIMA INJECTION, SOLUTION
POLLENS - TREES, WALNUT, BLACK JUGLANS NIGRA- WALNUT, BLACK JUGLANS
NIGRA INJECTION, SOLUTION
POLLENS - TREES, WILLOW, BLACK SALIX NIGRA-