APPLE- apple injection, solution
APRICOT- apricot injection, solution
AVOCADO- avocado injection, solution
BANANA- banana injection, solution
BLACKBERRY- blackberry injection, solution
BLUEBERRY- blue ridge blueberry injection, solution
CANTALOUPE- cantaloupe injection, solution
CHERRY FOOD- cherry injection, solution
CRANBERRY- cranberry injection, solution
DATE- date injection, solution
BASIL- basil injection, solution
GRAPEFRUIT- grapefruit injection, solution
BLACK BASS- largemouth bass injection, solution
LEMON- lemon injection, solution
LIME- lime, citrus injection, solution
ORANGE FOOD- orange injection, solution
PEACH- peach injection, solution
PEAR- pear injection, solution
PINEAPPLE- pineapple injection, solution
PINTO BEAN- kidney bean injection, solution
BEEF- beef injection, solution
STRAWBERRY- strawberry injection, solution
CATFISH- catfish injection, solution
WATERMELON- watermelon injection, solution
CHICKEN FOOD- chicken injection, solution
CLAM- quahog injection, solution
RED KIDNEY BEAN- kidney bean injection, solution
LIMA BEAN- lima bean injection, solution
NAVY BEAN- kidney bean injection, solution
GREEN STRING BEAN- string bean injection, solution
CODFISH- cod injection, solution
BROCCOLI- broccoli injection, solution
CRAB MEAT- blue crab injection, solution
BRUSSEL SPROUTS- brussels sprout injection, solution
CABBAGE- cabbage injection, solution
CARROT- carrot injection, solution
CAULIFLOWER- cauliflower injection, solution
CELERY- celery injection, solution
EGG WHITE- egg white injection, solution
CUCUMBER- cucumber injection, solution
WHOLE EGG- egg injection, solution
GREEN PEPPER- green bell pepper injection, solution
EGG YOLK- egg yolk injection, solution
LETTUCE- lettuce injection, solution
MUSHROOM FOOD- cultivated mushroom injection, solution
FLOUNDER- flounder injection, solution
GREEN OLIVE- green olive injection, solution
ONION- onion injection, solution
PARSLEY- parsley injection, solution
GREEN PEA- pea injection, solution
SWEET POTATO- sweet potato injection, solution
WHITE POTATO- potato injection, solution
GRAPE- concord grape injection, solution
RADISH- radish injection, solution
RHUBARB- rhubarb injection, solution
SOYBEAN- soybean injection, solution
SPINACH- spinach injection, solution
YELLOW SQUASH- squash injection, solution
TOMATO- tomato injection, solution
HADDOCK- haddock injection, solution
HALIBUT- pacific halibut injection, solution
COW MILK- cow milk injection, solution
CASHEW NUT- cashew injection, solution
COCONUT- coconut injection, solution
ENGLISH WALNUT FOOD- english walnut injection, solution
BLACK PEPPER- black pepper injection, solution
PEANUT FOOD- peanut injection, solution
PECAN FOOD- pecan injection, solution
PERCH- perch injection, solution
BARLEY FOOD- barley injection, solution
BUCKWHEAT- buckwheat injection, solution
OATS FOOD- oat injection, solution
RICE FOOD- rice injection, solution
RYE FOOD- rye injection, solution
WHOLE WHEAT FOOD- wheat injection, solution
PIMENTO- red bell pepper injection, solution
PORK- pork injection, solution
PACIFIC SALMON- pink salmon injection, solution
PAPAYA- papaya injection, solution
SCALLOP- scallop injection, solution
SHRIMP- shrimp injection, solution
SUNFLOWER SEED- sunflower seed injection, solution
BLACKEYED PEA- black-eyed pea injection, solution
CORN FOOD- corn injection, solution
CACAO BEAN- cocoa injection, solution
COFFEE FOR DIAGNOSTIC USE ONLY- coffee bean injection, solution
BARLEY MALT- barley malt injection, solution
CINNAMON- cinnamon injection, solution
DILL SEED- dill injection, solution
GARLIC- garlic injection, solution
GINGER- ginger injection, solution
HORSERADISH- horseradish injection, solution
MUSTARD SEED- mustard seed injection, solution
OREGANO- oregano injection, solution
PEPPERMINT- peppermint injection, solution
POPPY SEED- poppy seed injection, solution
SAGE FOOD- sage injection, solution
SESAME SEED- sesame seed injection, solution
SPEARMINT- spearmint injection, solution
THYME- thyme injection, solution
VANILLA- vanilla injection, solution
ALMOND- almond injection, solution
ACACIA POLLEN- acacia injection, solution
RED ALDER POLLEN- alnus rubra pollen injection, solution
SMOOTH ALDER POLLEN- alnus incana subsp. rugosa pollen injection, solution
ARIZONA ASH POLLEN- fraxinus velutina pollen injection, solution
GREEN RED ASH POLLEN- fraxinus pennsylvanica pollen injection, solution
WHITE ASH POLLEN- fraxinus americana pollen injection, solution
ASH MIX, GREEN/WHITE POLLEN- fraxinus americana pollen and fraxinus pennsylvanica pollen injection, solution
QUAKING ASPEN POLLEN- populus tremuloides pollen injection, solution
BAYBERRY POLLEN- morella cerifera pollen injection, solution
AMERICAN BEECH POLLEN- fagus grandifolia pollen injection, solution
BOX ELDER POLLEN- acer negundo pollen injection, solution
MOUNTAIN CEDAR POLLEN- juniperus ashei pollen injection, solution
PINCHOT CEDAR POLLEN- juniperus pinchotii pollen injection, solution
RED CEDAR POLLEN- juniperus virginiana pollen injection, solution
EASTERN COTTONWOOD POLLEN- populus deltoides pollen injection, solution
WESTERN COTTONWOOD POLLEN- populus deltoides subsp. monilifera pollen injection, solution
COTTONWOOD MIX, EASTERN/WESTERN POLLEN- populus deltoides subsp. monilifera pollen and populus deltoides pollen injection, solution
ARIZONA CYPRESS POLLEN- cupressus arizonica pollen injection, solution
BALD CYPRESS POLLEN- taxodium distichum pollen injection, solution
AMERICAN ELM POLLEN- ulmus americana pollen injection, solution
CEDAR FALL BLOOMING ELM POLLEN- ulmus crassifolia pollen injection, solution
CHINESE SIBERIAN ELM POLLEN- ulmus pumila pollen injection, solution
ELM MIX, AMERICAN/CHINESE/SLIPPERY POLLEN- ulmus pumila pollen and ulmus americana pollen and ulmus rubra pollen injection, solution
EUCALYPTUS BLUE GUM POLLEN- eucalyptus globulus pollen injection, solution
DOUGLAS FIR POLLEN- pseudotsuga menziesii pollen injection, solution
SWEETGUM POLLEN- liquidambar styraciflua pollen injection, solution
HACKBERRY POLLEN- celtis occidentalis pollen injection, solution
SHAGBARK HICKORY POLLEN- carya ovata pollen injection, solution
WHITE HICKORY POLLEN- carya tomentosa pollen injection, solution
HICKORY MIX, PIGNUT/SHAGBARK/SHELLBARK/WHITE POLLEN- carya tomentosa pollen and carya laciniosa pollen and carya ovata pollen and carya glabra pollen injection, solution
ONE SEED JUNIPER POLLEN- juniperus monosperma pollen injection, solution
ROCKY MOUNTAIN JUNIPER POLLEN- juniperus scopulorum pollen injection, solution
RIVER BIRCH POLLEN- betula nigra pollen injection, solution
BIRCH MIX, RIVER/PAPER/SWEET/WHITE POLLEN- betula nigra pollen and betula papyrifera pollen and betula lenta pollen and betula populifolia pollen injection, solution
WHITE GRAY BIRCH POLLEN- betula populifolia pollen injection, solution
SUGAR HARD MAPLE POLLEN- acer saccharum pollen injection, solution
MAPLE MIX, RED/SILVER/SUGAR POLLEN- acer saccharum pollen and acer saccharinum pollen and acer rubrum pollen injection, solution
MESQUITE POLLEN- prosopis juliflora pollen injection, solution
PAPER MULBERRY POLLEN- broussonetia papyrifera pollen injection, solution
RED MULBERRY POLLEN- morus rubra pollen injection, solution
WHITE MULBERRY POLLEN- morus alba pollen injection, solution
BLACK OAK POLLEN- quercus velutina pollen injection, solution
BLACKJACK OAK POLLEN- quercus nigra pollen injection, solution
BUR OAK POLLEN- quercus macrocarpa pollen injection, solution
LIVE OAK POLLEN- quercus virginiana pollen injection, solution
2-OAK MIX, RED/WHITE POLLEN- quercus rubra pollen and quercus alba pollen injection, solution
5-OAK MIX, BLACKJACK/BUR/POST/RED/WHITE POLLEN- quercus nigra pollen and quercus macrocarpa pollen and quercus stellata pollen and quercus rubra pollen and quercus alba pollen injection, solution
3-OAK MIX, BLACK/BLACKJACK/POST POLLEN- quercus velutina pollen and quercus nigra pollen and quercus stellata pollen injection, solution
POST OAK POLLEN- quercus stellata pollen injection, solution
QUEEN PALM POLLEN- syagrus romanzoffiana pollen injection, solution
EUROPEAN OLIVE POLLEN- olea europaea pollen injection, solution
DATE PALM POLLEN- phoenix dactylifera pollen injection, solution
PECAN POLLEN- carya illinoinensis pollen injection, solution
WHITE PINE POLLEN- pinus strobus pollen injection, solution
4-PINE MIX, AUSTRIAN/LOBLOLLY/SCOTCH/WHITE POLLEN- pinus strobus pollen and pinus sylvestris pollen and pinus taeda pollen and pinus nigra pollen injection, solution
LOMBARDY POPLAR POLLEN- populus nigra pollen injection, solution
WHITE POPLAR POLLEN- populus alba pollen injection, solution
PRIVET POLLEN- ligustrum vulgare pollen injection, solution
BLUE SPRUCE POLLEN- picea pungens pollen injection, solution
UPLAND SUMAC POLLEN- rhus glabra pollen injection, solution
SYCAMORE POLLEN- platanus occidentalis pollen injection, solution
TREE OF HEAVEN POLLEN- ailanthus altissima pollen injection, solution
BLACK WALNUT POLLEN- juglans nigra pollen injection, solution
BLACK WILLOW POLLEN- salix nigra pollen injection, solution
PUSSY WILLOW POLLEN- salix discolor pollen injection, solution
BLACK LOCUST POLLEN- robinia pseudoacacia pollen injection, solution
WHITE OAK POLLEN- quercus alba pollen injection, solution
BAHIA GRASS POLLEN- paspalum notatum pollen injection, solution
CULTIVATED BARLEY POLLEN- hordeum vulgare pollen injection, solution
CREEPING BENT GRASS POLLEN- agrostis stolonifera pollen injection, solution
ANNUAL BLUEGRASS POLLEN- poa annua pollen injection, solution
HUNGARIAN SMOOTH BROME POLLEN- bromus inermis pollen injection, solution
CANARY GRASS POLLEN- phalaris minor pollen injection, solution
SOUTHERN CHEAT CHESS POLLEN- bromus secalinus pollen injection, solution
CULTIVATED CORN POLLEN- zea mays pollen injection, solution
BLUE GRAMA GRASS- bouteloua gracilis pollen injection, solution
JOHNSON GRASS POLLEN- sorghum halepense pollen injection, solution
TALL OAT GRASS POLLEN- arrhenatherum elatius pollen injection, solution
CULTIVATED OATS POLLEN- avena sativa pollen injection, solution
QUACK GRASS POLLEN- elymus repens pollen injection, solution
ITALIAN RYEGRASS POLLEN- lolium perenne subsp. multiflorum pollen injection, solution
GRAIN SORGHUM POLLEN- sorghum bicolor subsp. bicolor pollen injection, solution
SUDAN GRASS POLLEN- sorghum bicolor subsp. drummondii pollen injection, solution
CULTIVATED WHEAT POLLEN- triticum aestivum pollen injection, solution
WESTERN WHEAT POLLEN- pascopyrum smithii pollen injection, solution
ALFALFA POLLEN- medicago sativa pollen injection, solution
SWEET CLOVER POLLEN- melilotus albus pollen injection, solution
SUGAR BEET POLLEN- beta vulgaris pollen injection, solution
WESTERN JUNE GRASS POLLEN- koeleria macrantha pollen injection, solution
BROOMWEED POLLEN- amphiachyris dracunculoides pollen injection, solution
CARELESS WEED POLLEN- amaranthus palmeri pollen injection, solution
COCKLEBUR POLLEN- xanthium strumarium pollen injection, solution
YELLOW CURLY DOCK POLLEN- rumex crispus pollen injection, solution
FIREBUSH KOCHIA POLLEN- kochia scoparia pollen injection, solution
GOLDENROD POLLEN- solidago canadensis pollen injection, solution
GREASEWOOD POLLEN- sarcobatus vermiculatus pollen injection, solution
GROUNDSEL TREE POLLEN- baccharis halimifolia pollen injection, solution
NETTLE POLLEN- urtica dioica pollen injection, solution
LAMBS QUARTERS POLLEN- chenopodium album pollen injection, solution
BURWEED MARSHELDER POLLEN- iva xanthifolia pollen injection, solution
NARROWLEAF MARSHELDER POLLEN- iva angustifolia pollen injection, solution
COMMON MUGWORT POLLEN- artemisia vulgaris pollen injection, solution
ROUGH MARSHELDER POLLEN- iva annua var. annua pollen injection, solution
SPINY PIGWEED POLLEN- amaranthus spinosus pollen injection, solution
ROUGH REDROOT PIGWEED POLLEN- amaranthus retroflexus pollen injection, solution
PIGWEED MIX, ROUGH/SPINY POLLEN- amaranthus retroflexus pollen and amaranthus spinosus pollen injection, solution
ENGLISH PLANTAIN POLLEN- plantago lanceolata pollen injection, solution
FALSE BUR RAGWEED POLLEN- ambrosia acanthicarpa pollen injection, solution
GIANT RAGWEED POLLEN- ambrosia trifida pollen injection, solution
STANDARDIZED SHORT RAGWEED POLLEN- ambrosia artemisiifolia pollen injection, solution
WESTERN RAGWEED POLLEN- ambrosia psilostachya pollen injection, solution
3-RAGWEED MIX, GIANT/SHORT/WESTERN POLLEN- ambrosia psilostachya pollen and ambrosia trifida pollen and ambrosia artemisiifolia pollen injection, solution
RUSSIAN THISTLE POLLEN- salsola kali pollen injection, solution
COMMON BIG SAGEBRUSH POLLEN- artemisia tridentata pollen injection, solution
SAGE MIX, COMMON/DARK-LEAVED/DRAGON/PASTURE POLLEN- artemisia ludoviciana pollen and artemisia tridentata pollen and artemisia dracunculus pollen and artemisia frigida pollen injection, solution
PRAIRIE SAGE POLLEN- artemisia frigida pollen injection, solution
ANNUAL SALTBUSH POLLEN- atriplex wrightii pollen injection, solution
SHADSCALE POLLEN- atriplex confertifolia pollen injection, solution
SOUR DOCK SHEEP SORREL POLLEN- rumex acetosella pollen injection, solution
WATER HEMP POLLEN- amaranthus tuberculatus pollen injection, solution
WINGSCALE POLLEN- atriplex canescens pollen injection, solution
ANNUAL WORMWOOD POLLEN- artemisia annua pollen injection, solution
COMMON WORMWOOD POLLEN- artemisia absinthium pollen injection, solution
MEXICAN TEA POLLEN- chenopodium ambrosioides pollen injection, solution
DOCK MIX, SOUR SHEEP SORREL/YELLOW POLLEN- rumex acetosella pollen and rumex crispus pollen injection, solution
STANDARDIZED RAGWEED MIX, GIANT/SHORT- ambrosia trifida pollen and ambrosia artemisiifolia pollen injection, solution
DANDELION POLLEN- taraxacum officinale pollen injection, solution
SUNFLOWER POLLEN- helianthus annuus pollen injection, solution
ALTERNARIA TENUIS ALTERNATA- alternaria alternata injection, solution
ASPERGILLUS FUMIGATUS- aspergillus fumigatus injection, solution
ASPERGILLUS GLAUCUS- eurotium herbariorum injection, solution
ASPERGILLUS NIGER- aspergillus niger var. niger injection, solution
ASPERGILLUS TERREUS- aspergillus terreus injection, solution
PULLULARIA PULLULANS- aureobasidium pullulans var. pullutans injection, solution
BOTRYTIS CINEREA- botrytis cinerea injection, solution
CANDIDA MONILA ALBICANS- candida albicans injection, solution
CEPHALOSPORIUM ACREMONIUM- acremonium strictum injection, solution
CEPHALOTHECIUM ROSEUM- trichothecium roseum injection, solution
CHAETOMIUM GLOBOSUM- chaetomium globosum injection, solution
CLADOSPORIUM FULVUM- passalora fulva injection, solution
CURVULARIA SPICIFERA- cochliobolus spicifer injection, solution
EPICOCCUM NIGRUM- epicoccum nigrum injection, solution
EPIDERMOPHYTON FLOCCOSUM- epidermophyton floccosum injection, solution
FUSARIUM VASINFECTUM OXYSPORUM- fusarium oxysporum vasinfectum injection, solution
FUSARIUM SOLANI- haematonectria haematococca injection, solution
GEOTRICHUM CANDIDUM- geotrichum candidum injection, solution
HELMINTHOSPORIUM SATIVUM- cochliobolus sativus injection, solution
HORMODENDRUM CLADOSPORIUM CLADOSPORIOIDES- cladosporium cladosporioides injection, solution
MUCOR PLUMBEUS- mucor plumbeus injection, solution
MUCOR RACEMOSUS- mucor racemosus injection, solution
NEUROSPORA SITOPHILA- neurospora sitophila injection, solution
NIGROSPORA SPHAERICA- khuskia oryzae injection, solution
PENICILLIUM NOTATUM CHRYSOGENUM- penicillium chrysogenum var. chrysogenum injection, solution
PHOMA DESTRUCTIVA- phoma destructiva injection, solution
RHIZOPUS NIGRICANS- rhizopus stolonifer injection, solution
RHODOTORULA MUCILAGINOSA- rhodotorula mucilaginosa injection, solution
SPONDYLOCLADIUM ATROVIRENS- helminthosporium solani injection, solution
STEMPHYLIUM SARCINIFORME- stemphylium sarciniforme injection, solution
TRICHODERMA LIGNORUM- trichoderma viride injection, solution
TRICHOPHYTON MENTAGROPHYTES- trichophyton mentagrophytes injection, solution
TRICHOPHYTON RUBRUM- trichophyton rubrum injection, solution
TRICHOPHYTON TONSURANS- trichophyton tonsurans injection, solution
VERTICILLIUM ALBO ATRUM- verticillium albo-atrum injection, solution
BERMUDA GRASS SMUT- ustilago cynodontis injection, solution
CORN SMUT- ustilago maydis injection, solution
JOHNSON GRASS SMUT- sporisorium cruentum injection, solution
WHEAT RUST- puccinia graminis injection, solution
COTTON SEED FOR DIAGNOSTIC USE ONLY- cotton seed injection, solution
FLAX SEED FOR DIAGNOSTIC USE ONLY- flax seed injection, solution
HOUSE DUST- house dust injection, solution
KAPOK- ceiba pentandra fiber injection, solution
ORRIS ROOT- iris germanica var. florentina root injection, solution
PYRETHRUM- tanacetum cinerariifolium flower injection, solution
SILK- bombyx mori fiber injection, solution
COTTON LINTERS- cotton fiber injection, solution
CATTLE HAIR AND EPITHELIA- bos taurus hair and bos taurus skin injection, solution
DOG HAIR AND EPITHELIA- canis lupus familiaris hair and canis lupus familiaris skin injection, solution
CHICKEN FEATHERS- gallus gallus feather injection, solution
DUCK FEATHERS- anas platyrhynchos feather injection, solution
GOOSE FEATHERS- anser anser feather injection, solution
FEATHER MIX, CHICKEN/DUCK/GOOSE- gallus gallus feather and anas platyrhynchos feather and anser anser feather injection, solution
GUINEA PIG HAIR AND EPITHELIA- cavia porcellus hair and cavia porcellus skin injection, solution
HAMSTER HAIR AND EPITHELIA- mesocricetus auratus skin injection, solution
HOG HAIR AND EPITHELIA- sus scrofa hair and sus scrofa skin injection, solution
HORSE HAIR AND DANDER- equus caballus hair and equus caballus skin injection, solution
MOUSE HAIR AND EPITHELIA- mus musculus skin injection, solution
RABBIT HAIR AND EPITHELIA- oryctolagus cuniculus hair and oryctolagus cuniculus skin injection, solution
FIRE ANT- solenopsis invicta injection, solution
AMERICAN COCKROACH- periplaneta americana injection, solution
GERMAN COCKROACH- blatella germanica injection, solution
HOUSEFLY FOR DIAGNOSTIC USE ONLY- musca domestica injection, solution
MOSQUITO FOR DIAGNOSTIC USE ONLY- aedes taeniorhynchus injection, solution
RINKEL MOLD MIX A- aspergillus fumigatus and botrytis cinerea and chaetomium globosum and epicoccum nigrum and fusarium oxysporum vasinfectum and cochliobolus sativus and neurospora sitophila and mucor plumbeus and phoma exigua var. exigua and penicillium chrysogenum var. chrysogenum and aureobasidium pullulans var. pullutans and rhizopus stolonifer and rhodotorula mucilaginosa and saccharomyces cerevisiae and geotrichum candidum injection, solution
RINKEL MOLD MIX B- trichothecium roseum and passalora fulva and cochliobolus spicifer and myrothecium verrucaria and trichophyton schoenleinii and mycogone nigra and neurospora crassa and khuskia oryzae and paecilomyces variotii and microascus brevicaulis and helminthosporium solani and pleospora tarda and streptomyces griseus and trichoderma viride injection, solution
RINKEL MOLD MIX C- absidia capillata and acrothecium robustum and microsporum audouinii and microsporum canis and apiospora montagnei and phycomyces blakesleeanus and sporotrichum pruinosum and stachybotrys chartarum and syncephalastrum racemosum and tetracoccosporium paxianum and verticillium albo-atrum and thermomyces lanuginosus and trichosporon cutaneum injection, solution
OSAGE ORANGE VAR BOIS DARC POLLEN- maclura pomifera pollen injection, solution
LAKE TROUT- trout injection, solution
TUNA- tuna injection, solution
TURKEY FOOD- turkey injection, solution
BLACK WALNUT FOOD- black walnut injection, solution
Allergy Laboratories, Inc.
Directions for Use
This product is intended for use by physicians who are experienced in the administration of allergenic extracts and the emergency care of anaphylaxis, or for use under the guidance of an allergy specialist.
Patients should be instructed to recognize adverse reaction symptoms and cautioned to contact physicians’ office if reaction symptoms occur. As with all allergenic extracts, severe systemic reactions may occur. In certain individuals these life threatening reactions may be fatal. Patients should be observed for at least 20 to 30 minutes following treatment and emergency measures as well as personnel trained in their use should be immediately available in the event of a life threatening reaction. Serious adverse reactions can be reported to the US Food and Drug Administration MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787, (800) FDA-1088, or www.fda/gov/medwatch.
This product should not be injected intravenously. Patients who are taking non-selective beta blockers may be more reactive to allergens given for testing and may be unresponsive to the usual doses of epinephrine used to treat allergic reactions. Refer to the Warnings, Precautions, Adverse Reactions and Dosage sections below.
Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract.
|Therapeutic and Scratch extracts: ||Intradermal 1:500 v/v (foods)
||Intradermal 1:1,000 v/v (pollens, molds, epidermals, inhalants)
|Glycerin, USP, 50% v/v||Glycerin, USP, 0.1% v/v||Glycerin, USP, 0.05% v/v
|Sodium chloride, USP, 0.166% w/v||Sodium chloride, USP, 0.9% w/v||Sodium chloride, USP, 0.9% w/v
|Sodium bicarbonate, USP, 0.091% w/v||Sodium bicarbonate, USP, 0.000182% w/v||Sodium bicarbonate, USP, 0.000091% w/v
|Phenol, USP, 0.4%
w/v||Phenol, USP, 0.4% w/v
|Sterile Diluent for Allergenic Extract: ||
|Normal Saline with Phenol: ||Human Serum Albumin: ||Glycerin, USP, 50% w/v
|Sodium chloride, USP 0.9% w/v||Sodium chloride, USP 0.9% w/v||Sodium bicarbonate, USP 0.091% w/v
|Phenol, USP 0.4% w/v
||Phenol, USP 0.4% w/v||Sodium chloride, USP 0.166% w/v
|Water for Injection, USP q.s.||Normal Serum Albumin (Human), 0.03% w/v||Water for Injection, USP, q.s.
|Air replaced with Nitrogen, NF||Water for Injection, USP q.s.||
|Air replaced with Nitrogen, NF||
The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:
The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens.
Allergenic extracts for diagnostic testing 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 basofils, or mast cells, which initiates a series of biochemical events resulting in the production of histamine and other mediators. These, in turn, produce the immediate-type “wheal and flare” skin reaction. The more mediator released, the larger the reaction. Because of a variety of factors, including the types of allergen extracts, delayed skin reactions can occur and usually disappear within a couple of days. The type of extract, size of the reaction and timing of the reaction are all factors used in determining a patient’s sensitivity to an allergen.
Allergen immunotherapy (also known as desensitization, hyposensitization, allergy vaccination, or allergy shots) involves treating a patient with increasing dosage of the allergens to which he is allergic, eventually reaching a dose plateau whereas the patient experiences an increased tolerance upon re-exposure to the allergens. The patient may or may not need to receive continued treatment to demonstrate the desensitization. The exact mechanisms of reaction of desensitization with allergens, which involve the allergen, IgE and IgG antibodies, mast cells and basophils and possibly other mediators, are not completely understood. However, efficacy has been shown in numerous well-controlled studies using specific common allergens.
The goals of allergen immunotherapy are to decrease the production of IgE antibodies, initiate the production of IgG antibodies and stabilize mast cells and basophils. Overproduction of IgE in response to an allergen can induce other cells, particularly mast cells and basophils, to initiate a complex chain reaction that results in allergy symptoms. Numerous IgE receptor sites are located on mast cells as well as basophil cells. These cells are among the first cells to be encountered by the antigen. They contain potent chemical mediators (histamine and leukotriene, for example) of inflammation that are released when IgE and a specific allergen cross-link on the cell surface. The release of the chemical mediators results in inflammation and allergy symptoms. As a response to immunotherapy, the production of IgG is believed to work by blocking IgE from binding to mast cells and basophils. Thus IgG, the blocking antibody, may prevent the release of chemical mediators that produce allergy symptoms.
INDICATIONS AND USAGE
Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.
There are no known absolute contraindications to diagnostic testing or hyposensitization with allergen immunotherapy.
Patients with cardiovascular disease or pulmonary disease 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 regimen.
Immunotherapy is not generally indicated when the offending allergen(s) can be effectively eliminated or minimized by environmental control. There are differences of opinion on the possibility of routine immunizations exacerbating autoimmune diseases. The evidence has been inconclusive. Therefore, caution should be exercised in administering immunotherapy to patients with other immunologic diseases and only administered if the risk from exposure to the allergen is greater than the risk of exacerbating the underlying disorder. Injections should be avoided in patients with a bleeding tendency.
See boxed WARNINGS at the beginning of this information sheet.
Do not administer allergenic extract injections intravenously. Patients should always be observed for at least 20 to 30 minutes after any skin test or injection. Concentrated allergenic extracts should be diluted with Sterile Diluent for Allergenic Extract prior to use for intradermal testing and for immunotherapy preparation. Systemic reactions may occur infrequently and may range from mild exaggeration of the patient’s allergic symptoms to urticaria, rhinitis, conjunctivitis, angioedema, cough, wheezing, fainting, pallor, bradycardia, hypotension, or even, in extremely sensitive individuals, to anaphylactic shock and death. Have epinephrine 1:1,000 readily available in case of a reaction. Emergency measures and personnel trained for medical emergencies should be immediately available in the event of a life-threatening reaction. Patients with unstable asthma or steroid dependent asthmatics and patients with underlying cardiovascular disease are at greater risk. Patients taking beta-blocker medication may not respond to the usual dose of epinephrine.
Diagnostic testing as well as immunotherapy should be temporarily withheld from patients or the dose reduced until cause of reaction is evaluated by prescribing physician if any of the following conditions exist: (1) severe symptoms of rhinitis and/or asthma, (2) infection or flu accompanied by fever, (3) exposure to excessive amounts of clinically relevant allergen prior to a scheduled injection, and (4) systemic reaction to previous injection.
The presence of asthmatic signs and symptoms may be an indicator of severe reaction following allergen injections. Any evidence of a local or generalized reaction requires a dose reduction during the initial stages of immunotherapy, as well as during maintenance therapy. Patient reactions to previous injections should be reviewed before each new injection and a conservative dosage schedule should be followed until a pattern of local responses is established which can be used to monitor increases in dosage. Patients should be observed in the office for at least 20 to 30 minutes after each treatment injection and instructed to seek medical attention if symptoms of a systemic reaction occur. Most severe reactions will occur within this time period, and rapid treatment measures should be initiated (see ADVERSE REACTIONS). In rare circumstances, a patient may have systemic reactions to minute doses of antigen and does not demonstrate increasing tolerance to injections after several months of treatment. If systemic reactions or excessive local responses occur persistently at very small doses, efforts at immunotherapy should be stopped.
When changing lots of extracts, even though the formulation may be the same, the first dose should not exceed 50% of the previous dose as the extract may have lost potency over time and a fresh extract could have an effective potency that is substantially greater than that of the old extract. Aseptic technique should always be used when injections of allergenic extracts are administered.
(2) INFORMATION FOR PATIENTS
Patients should be instructed to remain in the office for 20 to 30 minutes after each injection to monitor for adverse reactions. Patients should be instructed to describe any active allergic symptoms such as rhinitis, wheezing, dyspnea, etc. prior to injection including any late reactions from previous administration.
(3) DRUG INTERACTIONS
Beta-Blockers: Patients who are taking non-selective beta blockers may be more reactive to allergens given for testing and may be unresponsive to the usual doses of epinephrine used to treat allergic reactions. Patients with cardiovascular diseases and/or pulmonary diseases such as symptomatic unstable, steroid-dependent asthma, and/or those who are receiving cardiovascular drugs such as beta-blockers, may be at higher risk for severe adverse reactions.
Antihistamines can significantly inhibit the immediate skin test reactions. If long acting antihistamines have been taken recently, it is recommended that they should be stopped for the following minimum intervals before skin testing is performed: 1 week for hydroxyzine or cetirizine; 4 to 7 days for loratadine; 3 to 4 days for fexofenadine; and 24 to 48 hours for other sustained release antihistamines.
(4) CARCINOGENISIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
Long term studies with allergenic extracts have not been conducted in animals to determine their potential for carcinogenesis, mutagenesis, or impairment of fertility.
(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 if they can affect reproduction capacity. The physician must weigh the benefits of immunotherapy against the risk of anaphylactic reactions that could result in harm to the mother and/or fetus. Hyposensitization should be used during pregnancy only if clearly necessary and administered cautiously.
(6) NURSING MOTHERS
It is not known if allergenic extracts appear in human milk. Because many drugs are excreted in human milk, caution should be exercised when allergenic extracts are administered to a nursing woman.
(7) PEDIATRIC USE
Extracts have not been studied in children, so the safety in children has not been established. Doses of allergenic extracts for children are generally the same as those for adults. In the case of large doses, the amount of extract given to a child may be modified so that the discomfort of the injection is minimized.
(1) Local Reactions - A mild burning immediately after the injection is to be expected; this usually subsides in 10 to 20 seconds. Reactions at the site of injection (erythema, swelling, pruritus) may be immediate or delayed. Immediate wheal and erythema reactions are ordinarily of little consequence; but if very large, may be the first manifestation of a systemic reaction. Delayed reactions start several hours after injection with local edema, erythema, itching or pain. The reactions are most apparent 24 hours after injection and usually require no treatment. Antihistamines may be administered orally if necessary. Large local reactions may be treated by local applications of cold, wet dressings and/or the use of oral antihistamines. These reactions should be considered a warning of possible severe systemic reaction and need for temporarily reduced dosage. In such cases the next therapeutic dose should be reduced to the last dose which did not elicit a reaction and subsequent doses increased more slowly.
(2) Systemic Reactions - Most severe systemic reactions occur within 30 minutes of injection but may occur at anytime subsequent to treatment. Symptoms may range from mild to life-threatening (due to anaphylaxis). Systemic reactions are characterized by one or more of the following symptoms: sneezing, mild to severe generalized urticaria, itching other than at the injection site, extensive or generalized edema, wheezing, asthma, dyspnea, cyanosis, tachycardia, lacrimation, marked perspiration, cough, hypotension, syncope and upper airway obstruction. Symptoms may progress to anaphylactic shock and death.
If a systemic or anaphylactic reaction does occur, apply a tourniquet above the site of injection and inject 1:1,000 epinephrine-hydrochloride intramuscularly into the opposite arm or gluteal area. Loosen the tourniquet at least every 10 minutes. Do not obstruct arterial blood flow with the tourniquet.
1:1,000 EPHEDRINE DOSAGE:
ADULT: 0.3 mL to 0.5 mL should be injected intramuscularly or subcutaneously. Repeat in 5 to 10 minutes if necessary.
PEDIATRIC: 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.
Doses may be repeated 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 vasoactive drugs if necessary. An open airway should be insured. Give oxygen by mask. Intravenous antihistamine, inhaled bronchodilators, theophyllin and/or adrenal corticosteroids may be used if necessary after adequate epinephrine and circulatory support has been given. Emergency resuscitation measures and personnel trained in their use must be available immediately in the event of a serious systemic or anaphylactic reaction not responsive to the above measures.
If the patient is continued on immunotherapy, a decrease of at least 50% in the next dose should follow serious systemic reactions. Increases in dose should be made cautiously. Repeated systemic reactions are sufficient reason for discontinuation of increased dosages.
(3) To report suspected ADVERSE REACTIONS, contact Allergy Laboratories, Inc. 800-654-3971 or FDA 800-FDA-1088 or www.fda/gov/medwatch.
Signs and symptoms of overdose are typically local and systemic reactions. For a description and management of overdose reactions, see ADVERSE REACTIONS.
DOSAGE AND ADMINISTRATION
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Allergenic extracts may be administered for diagnostic testing or therapeutic purposes. The dosage will depend on the particular use of the extract.
General: When used for diagnostic testing to determine a patient’s sensitivity to specific antigens and aid in the diagnosis and treatment of atopic disease, the recommended procedure is to initially perform puncture tests, then follow with intradermal tests. The number of skin tests applied at one time will depend on the particular patient and their allergic history. These tests should be performed and observed in 15 to 20 minutes. Additional tests may be applied in sequence. Perform tests on the anterolateral aspect of the upper arm on an area that permits the effective application of a tourniquet proximal to the site of the test. The skin at the site of injection should be disinfected with rubbing alcohol before testing. A positive reaction usually develops in 15 to 20 minutes. The positive response is a wheal and flare reaction that is larger than the negative control and evaluated based on the size of the reaction.
Controls: A negative control containing the same solution that the extract was prepared in should be applied to a test site in the same manner as the tests being performed. Histamine phosphate should be used as a positive control for evaluation of skin testing. Refer to manufacturers directions provided with Histamine phosphate for recommended dosage and administration.
Percutaneous testing: In general, skin is scratched, punctured or pricked just before the allergen is applied or through a drop of test allergen which is placed on the skin. There are several devices available for this technique. Refer to the device manufacturers instructions for proper use. Test areas should be no closer than 4-5 cm apart to avoid the interference of multiple reactions. Clean test areas with alcohol and air dry. Place the allergen on the volar surface of the patient’s forearm, upper arm, or back.
1. For puncture tests, apply one drop of extract to the skin. Pierce the drop of extract and skin using a sterile hypodermic needle or vaccinating needle. Maintain the needle perpendicular to the skin surface and rock the needle back and forth to produce a small hole without bleeding. Do not rotate or gouge the needle. Remove needle from skin and wipe excess extract from skin surface.
2. For scratch tests using a scarifier or needle: make a scratch 1/16 inch long on the epidermis penetrating the outer cornified area but being careful not to draw blood. Apply one drop of allergen to the scratch or puncture.
Intracutaneous (Intradermal) testing: If puncture test is negative, proceed with intradermal test. Intradermal tests should not be performed if puncture test is positive. Use a separate sterile syringe (tuberculin type equipped with a 27 gauge by 3/8 inch needle with intradermal bevel) for each antigen. To administer the test, inject 0.02 mL of allergen into the epidermis using dilutions of the concentrated extract; a 1:500 v/v dilution for foods and 1:1,000 v/v dilution for other extracts. If the test has been performed properly, the solution should raise a bleb 2 to 3 mm in diameter. If the bleb does not appear, the injection was made too deeply. To prepare intradermal testing strengths using 1:20 w/v bulk concentrates, use the following example: Add 1 mL of 1:20 w/v to 4 mL diluent to make a 1:100 v/v dilution. Add 1 mL of 1:100 v/v to 4 mL diluent to make a 1:500 v/v dilution. Add 0.5 mL of 1:100 v/v dilution to 4.5 mL diluent to make a 1:1,000 v/v dilution.
|Interpretation of results:||
|Percutaneous tests||Intradermal tests 1
|1+ Erythema with 5mm wheal||0 <5mm Erythema with a <5mm wheal
|2+ Erythema with a 5-10mm wheal
||+/- 5-10mm Erythema with a 5-10mm wheal
|3+ Erythema with a 10-15mm wheal||1+ 11-20mm Erythema with a 5-10mm wheal
|4+ Erythema with a wheal 15mm or larger with pseudopodia ||2+ 21-30mm Erythema with a 5-10mm wheal
|3+ 31-40mm Erythema with a 10-15mm wheal or with pseudopodia
|4+ >40mm Erythema with >15mm wheal or with pseudopodia
(1) General: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Injections are given subcutaneously; preferably in the arm. It is advantageous to give injections in alternate arms. Use sterile precautions and a tuberculin syringe when administering each dose. Allergen immunotherapy is typically initiated with a diluted formulation of allergens prescribed by a physician for administration to a patient. Doses are gradually increased over time and ultimately reach a maintenance dose where the patient is maintained for as long as the physician or patient feels is necessary. The formulation and dosage schedule is determined by the physician and is based on diagnostic testing and patient history. Patients with very high sensitivities should be initiated with lower concentrations (higher dilutions) and may need a very relaxed progression to maintenance doses. Pre-seasonal therapy may be initiated three months before seasonal difficulty begins and brought to maintenance dose and discontinued after that season ends. Perennial therapy (recommended) brings the patient up to tolerated maintenance dose where they remain until improvement of allergic symptoms occurs. Injections may be given at intervals of 4 to 7 days with either therapy.
(2) Suggested dilution series: Concentrated Allergenic Extracts must be diluted with Sterile Diluent for Allergenic Extract before using for immunotherapy. A 1:100,000 v/v dilution of concentrate is usually satisfactory to start treatment. To prepare a 10-fold dilution series from concentrated bulk extract, the following is suggested: Add 1 mL of 1:20 w/v extract to 4 mL diluent to make a 1:100 v/v dilution. Add 0.5 mL of the 1:100 dilution to 4.5 mL of diluent to make a 1:1,000 v/v dilution. Add 0.5 mL of the 1:1,1000 dilution to 4.5 mL diluent to make a 1:10,000 v/v dilution. Add 0.5 mL of the 1:10,000 dilution to 4.5 mL of diluent to make a 1:100,000 v/v dilution. The series may be extended to 1:1,000,000 v/v by preparing one more similar dilution as a precaution for sensitive patients.
(3) Maintenance: The maintenance level is the largest dose tolerated by the patient that relieves symptoms without producing undesirable local or general reactions. After immunotherapy has been established, a maintenance dose should be given at weekly intervals. The interval between maintenance doses can be increased gradually from one week to 10 days, to 2 weeks, 3 weeks, or even 4 weeks as allergy symptoms allow. Repeat maintenance doses at a given interval three or four times to check for continued allergy symptom relief before increasing the interval further. If large local (or systemic) reactions occur at one interval, do not increase the interval. Protection is lost rapidly if the interval between doses is more than 4 weeks. It may not be possible for all patients to reach the maximum dose indicated on the suggested dosage schedule.
(4) Suggested dosage schedule: Because the degree of sensitivity varies in many individuals, the dose and interval may need adjustment and should reflect the patient’s tolerance and response. A dose should never be given until all reactions resulting from a previous dose have entirely disappeared. After a period on immunotherapy, better tolerance may permit a longer interval between injections, or a larger maintenance dose, or both.
|1:100,000 v/v||1:10,000 v/v||1:1,000 v/v
|Dose ||Vol. (mL) ||Dose ||Vol. (mL) ||Dose ||Vol. (mL) ||Dose ||Vol. (mL)||Maintenance
|2||0.04||9||0.05||14||0.05||20||0.05||Continue 0.25 mL of 1:100 v/v weekly.
(5) Dose adjustments: Since the individual components of the extract are those to which the patient is allergic and to which he will be exposed, typical allergic symptoms may follow shortly after the injection, particularly those experienced by the patient during exposure when the antigen from the environment plus the injected antigen exceeds the patient’s tolerance to the antigen. In such cases, decrease the size of the next scheduled dose by at least one-half of the previous dose.
(6) Administration: Use aseptic precautions when diluting and/or preparing an injection. To avoid cross-contamination, do not use the same needle to withdraw materials from multiple vials. Use a sterile tuberculin syringe (26 or 27 gauge) with a needle at least 5/8” long and graduated in 0.01 mL units to measure each dose.
Bulk extract (stock concentrate) in 50% v/v glycerin is supplied in 10 mL, 30 mL, and 50 mL multiple dose vials as well as 2 mL scratch (dropper) vials. Intradermal tests are supplied in 5 mL vials at 1:500 v/v for food extracts and at 1:1,000 v/v for other extracts.
To insure the maximum potency of bulk extract and extract dilutions, it is recommended that they be maintained at a temperature of 2 to 8 degrees Celsius. Do not freeze. Do not use after the expiration date shown on the vial label.
- Norman, P.S.: In vivo methods of study of allergy: Skin and Mucosal tests, techniques, and interpretation. In Middleton, E. Jr., Reed, C. E. and Ellis, E.F. (ed): Allergy Principles and Practice, (Vol. 1), p. 258. St. Louis, The C.V. Mosby Co. 1978.
ALLERGY LABORATORIES, INC.
U.S. License # 103
Oklahoma City, OK 73109
(800) 654-3971, (405) 235-1451
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL