Green Pea

GREEN PEA — pea injection, solution
BLACK-EYED PEA — black-eyed pea injection, solution
PEAR — pear injection, solution
PARSLEY — parsley injection, solution
PEACH — peach injection, solution
PEANUT — peanut injection, solution
SWEET POTATO — sweet potato injection, solution
PUMPKIN — pumpkin injection, solution
PIMENTO — red bell pepper injection, solution
BLACK PEPPER — black pepper injection, solution
RED PEPPER — red bell pepper injection, solution
GREEN BELL PEPPER — green bell pepper injection, solution
MUSHROOM — cultivated mushroom injection, solution
MUSTARD SEED — mustard seed injection, solution
MUSTARD GREENS — mustard greens injection, solution
HONEYDEW MELON — honeydew melon injection, solution
MILLET — millet seed injection, solution
MINT — spearmint injection, solution
NUTMEG — nutmeg injection, solution
OLIVE — green olive injection, solution
POTATO — potato injection, solution
PAPRIKA — paprika injection, solution
ORANGE — orange injection, solution
WHOLE GRAIN OAT — oat injection, solution
ONION — onion injection, solution
PINEAPPLE — pineapple injection, solution
THYME — garden thyme injection, solution
VANILLA BEAN — vanilla injection, solution
WHOLE WHEAT — wheat injection, solution
TOMATO — tomato injection, solution
TAPIOCA — starch, tapioca injection, solution
TURNIP — turnip injection, solution
ENGLISH WALNUT MEAT — english walnut injection, solution
GRAPEFRUIT — grapefruit injection, solution
PLUM — plum injection, solution
RASPBERRY — raspberry injection, solution
BLACK WALNUT MEAT — black walnut injection, solution
WATERMELON — watermelon injection, solution
BREWERS YEAST — saccharomyces cerevisiae injection, solution
RICE — rice injection, solution
RYE — rye injection, solution
BAKERS YEAST — saccharomyces cerevisiae injection, solution
RADISH — raphanus sativus injection, solution
SAFFLOWER SEED — safflower injection, solution
SUGAR BEET — beet injection, solution
SUNFLOWER SEED — sunflower seed injection, solution
SAGE — salvia officinalis injection, solution
SESAME SEED — sesame seed injection, solution
SPINACH — spinach injection, solution
STRAWBERRY — strawberry injection, solution
MALT — malt extract, barley injection, solution
BUCKWHEAT — buckwheat injection, solution
BRAZIL NUT MEAT — brazil nut injection, solution
SOYBEAN — soybean injection, solution
BROCCOLI — broccoli injection, solution
BRUSSELS SPROUT — brussels sprout injection, solution
BLACKBERRY — blackberry injection, solution
CORN — corn injection, solution
CABBAGE — cabbage injection, solution
CANTALOUPE — cantaloupe injection, solution
BLUEBERRY — blueberry injection, solution
KIDNEY BEAN — kidney bean injection, solution
BAY LEAF — laurus nobilis injection, solution
ASPARAGUS — asparagus injection, solution
AVOCADO — avocado injection, solution
BANANA — banana injection, solution
ALMOND — almond injection, solution
APPLE — apple injection, solution
APRICOT — apricot injection, solution
BASIL — basil injection, solution
NAVY BEAN — kidney bean injection, solution
PINTO BEAN — kidney bean injection, solution
GREEN (STING) BEAN — string bean injection, solution
WHOLE GRAIN BARLEY — barley injection, solution
LIMA BEAN — lima bean injection, solution
MUNG BEAN — mung bean injection, solution
CARROT — carrot injection, solution
GARLIC — garlic injection, solution
GINGER — ginger injection, solution
CONCORD GRAPE — concord grape injection, solution
DILL SEED — dill injection, solution
EGGPLANT — eggplant injection, solution
FILBERT NUT MEAT — hazelnut injection, solution
LEMON — lemon injection, solution
LIME — lime (citrus) injection, solution
LENTIL — lentil injection, solution
WHITE GRAPE — wine grape injection, solution
HOPS — hops injection, solution
LETTUCE — lettuce injection, solution
CHERRY — sweet cherry injection, solution
CLOVE — clove injection, solution
CINNAMON — cinnamon injection, solution
CASHEW NUT MEAT — cashew injection, solution
CAULIFLOWER — cauliflower injection, solution
CELERY — celery injection, solution
WHOLE BEAN CACAO — cocoa bean injection, solution
CARAWAY SEED — caraway injection, solution
CUMIN — cumin injection, solution
DATE — date injection, solution
CRANBERRY — cranberry injection, solution
CUCUMBER — cucumber injection, solution
COCONUT — coconut injection, solution
PECAN NUT MEAT — pecan injection, solution
Antigen Laboratories, Inc.

WARNINGS

Allergenic extract is intended for use by, or under the guidance of, physicians who are experienced in the administration of allergenic extracts for diagnosis and/or immunotherapy and the emergency care of anaphylaxis. This extract is not directly interchangeable with other allergenic extracts. The initial dose must be based on skin testing as described in the “DOSAGE AND ADMINISTRATION” section of this insert. Patients switching from other types of extracts to Antigen Laboratories’ allergenic extracts should be started as if they were undergoing treatment for the first time. Patients being switched from one lot of extract to another from the same manufacturer should have the dose reduced by 75%.

Severe systemic reactions may occur with all allergenic extracts. In certain individuals, especially in steroid-dependent/unstable asthmatics, these life-threatening reactions may result in death. Patients should be observed for at least 20 minutes following allergenic extract injections. Treatment and emergency measures, as well as personnel trained in their use, must be available in the event of a life-threatening reaction. Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and/or death. Report serious adverse events to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787, phone 1-800-FDA-1088.

This product should not be injected intravenously. Deep subcutaneous routes have proven to be safe. See the “WARNINGS”, “PRECAUTIONS”, “ADVERSE REACTIONS” and “OVERDOSAGE” sections.

Patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodilators. Respiratory obstruction not responding to parenteral or inhaled bronchodilators may require theophylline, oxygen, intubation and the use of life support systems. Parenteral fluid and/or plasma expanders may be utilized for treatment of shock. Adrenocorticosteroids may be administered parenterally or intravenously. Refer to “WARNINGS”, “PRECAUTIONS” and “ADVERSE REACTIONS” sections below.

DESCRIPTION

Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin.

FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER:

INACTIVE INGREDIENTS:

Sodium chloride…………………………………………………………….0.95%

Sodium bicarbonate………………………………………………………..0.24%

Glycerine…………………………………………………………………50% (v/v)

Water for Injection…………………………………………………q.s. to volume

Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular.

Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v).

Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.

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