Western Water Hemp

WESTERN WATER HEMP — amaranthus tuberculatus pollen injection, solution
CARELESS WEED — amaranthus palmeri pollen injection, solution
WINGSCALE — atriplex canescens pollen injection, solution
SHADSCALE — atriplex confertifolia pollen injection, solution
LENSCALE — atriplex lentiformis pollen injection, solution
ALLSCALE — atriplex polycarpa pollen injection, solution
ALFALFA POLLEN — medicago sativa pollen injection, solution
LAMBS QUARTERS — chenopodium album pollen injection, solution
COCKLEBUR — xanthium strumarium pollen injection, solution
MEXICAN TEA — chenopodium ambrosioides pollen injection, solution
YELLOW SWEET CLOVER — melilotus officinalis pollen injection, solution
JERUSALEM OAK — chenopodium botrys pollen injection, solution
DANDELION — taraxacum officinale pollen injection, solution
TALL DOCK — rumex altissimus pollen injection, solution
BITTER DOCK — rumex obtusifolius pollen injection, solution
YELLOW DOCK — rumex crispus pollen injection, solution
WHITE (MEXICAN) DOCK — rumex salicifolius var. mexicanus pollen injection, solution
SHEEP SORREL — rumex acetosella pollen injection, solution
FALSE RAGWEED — ambrosia acanthicarpa pollen injection, solution
RABBIT BUSH — ambrosia deltoidea pollen injection, solution
DOG FENNEL — eupatorium capillifolium pollen injection, solution
GOLDENROD — solidago canadensis pollen injection, solution
BURWEED MARSH ELDER — iva xanthifolia pollen injection, solution
ROUGH MARSH ELDER — iva annua var. annua pollen injection, solution
KOCHIA — kochia scoparia pollen injection, solution
NETTLE POLLEN — urtica dioica pollen injection, solution
ENGLISH PLANTAIN — plantago lanceolata pollen injection, solution
ROUGH (REDROOT) PIGWEED — amaranthus retroflexus pollen injection, solution
SPINY PIGWEED — amaranthus spinosus pollen injection, solution
POVERTY WEED — iva axillaris pollen injection, solution
RUSSIAN THISTLE — salsola kali pollen injection, solution
SLENDER RAGWEED — ambrosia confertiflora pollen injection, solution
GIANT RAGWEED — ambrosia trifida pollen injection, solution
SOUTHERN RAGWEED — ambrosia bidentata pollen injection, solution
WESTERN RAGWEED — ambrosia psilostachya pollen injection, solution
DESERT RAGWEED — ambrosia dumosa pollen injection, solution
ANNUAL SALTBUSH — atriplex wrightii pollen injection, solution
COASTAL SAGE — artemisia californica pollen injection, solution
SUNFLOWER POLLEN — helianthus annuus pollen injection, solution
COMMON MUGWORT SAGE — artemisia vulgaris pollen injection, solution
DESERT SAGE — artemisia tridentata pollen injection, solution
COMMON WORMWOOD SAGE — artemisia absinthium pollen injection, solution
WESTERN MUGWORT SAGE — artemisia ludoviciana pollen injection, solution
PRAIRIE SAGE — artemisia frigida pollen injection, solution
INDIAN WORMWOOD SAGE — artemisia dracunculus pollen injection, solution
ATRIPLEX MIXTURE — atriplex polycarpa pollen, atriplex wrightii pollen, atriplex lentiformis pollen and atriplex canescens pollen injection, solution
CHENOPODIUM MIXTURE — chenopodium botrys pollen, chenopodium album pollen and chenopodium ambrosioides pollen injection, solution
DOCK/SORREL MIXTURE — rumex crispus pollen and rumex acetosella pollen injection, solution
FRANSERIA MIXTURE — ambrosia dumosa pollen, ambrosia acanthicarpa pollen, ambrosia deltoidea pollen and ambrosia confertiflora pollen injection, solution
MARSH ELDER MIXTURE — iva xanthifolia pollen and iva annua var. annua pollen injection, solution
PIGWEED MIXTURE — amaranthus palmeri pollen, amaranthus retroflexus pollen, amaranthus spinosus pollen and amaranthus tuberculatus pollen injection, solution
RAGWEED MIXTURE — ambrosia trifida pollen, ambrosia bidentata pollen, ambrosia artemisiifolia pollen and ambrosia psilostachya pollen injection, solution
SHORT/GIANT RAGWEED MIXTURE — ambrosia trifida pollen and ambrosia artemisiifolia pollen injection, solution
SHORT/GIANT/WESTERN RAGWEED MIXTURE — ambrosia trifida pollen, ambrosia artemisiifolia pollen and ambrosia psilostachya pollen injection, solution
SAGE MIXTURE — artemisia vulgaris pollen, artemisia absinthium pollen, artemisia tridentata pollen and artemisia ludoviciana pollen injection, solution
SORREL MIXTURE — rumex obtusifolius pollen, rumex acetosella pollen, rumex altissimus pollen, rumex salicifolius var. mexicanus pollen and rumex crispus pollen injection, solution
NUMBER TWO WEED MIXTURE — xanthium strumarium pollen, chenopodium album pollen, amaranthus retroflexus pollen, rumex acetosella pollen and rumex crispus pollen injection, solution
NUMBER FOUR WEED MIXTURE — artemisia californica pollen, xanthium strumarium pollen, artemisia vulgaris pollen, artemisia tridentata pollen, artemisia dracunculus pollen, kochia scoparia pollen, chenopodium album pollen, iva axillaris pollen, artemisia frigida pollen, amaranthus retroflexus pollen, salsola kali pollen, rumex acetosella pollen, amaranthus tuberculatus pollen and rumex crispus pollen injection, solution
WASHINGTON/OREGON COASTAL WEED MIXTURE — xanthium strumarium pollen, artemisia vulgaris pollen, plantago lanceolata pollen, chenopodium album pollen, amaranthus retroflexus pollen, rumex acetosella pollen and rumex crispus pollen injection, solution
WASHINGTON/OREGON INLAND WEED MIXTURE — iva xanthifolia pollen, artemisia vulgaris pollen, artemisia tridentata pollen, ambrosia acanthicarpa pollen, ambrosia trifida pollen, chenopodium album pollen, amaranthus retroflexus pollen, salsola kali pollen, ambrosia artemisiifolia pollen, ambrosia psilostachya pollen and atriplex canescens pollen injection, solution
NUMBER THREE WEED MIXTURE — kochia scoparia pollen, chenopodium album pollen, amaranthus retroflexus pollen and rumex acetosella pollen injection, solution
LAMBS QUARTERS- chenopodium album pollen 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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