Dandelion

DANDELION — taraxacum officinale pollen injection, solution
ALLSCALE — atriplex polycarpa pollen injection, solution
GROUNDSEL — baccharis halimifolia pollen injection, solution
BURROBRUSH — hymenoclea salsola pollen injection, solution
COCKLEBUR — xanthium strumarium pollen injection, solution
YELLOW DOCK — rumex crispus pollen injection, solution
DOG FENNEL — eupatorium capillifolium pollen injection, solution
FIREBUSH/BURNING BUSH — kochia scoparia pollen injection, solution
GOLDENROD — solidago canadensis pollen injection, solution
WESTERN WATER HEMP — amaranthus tuberculatus pollen injection, solution
IODINE BUSH — allenrolfea occidentalis pollen injection, solution
LAMB QUARTERS — chenopodium album pollen injection, solution
LENSCALE QUAILBRUSH — atriplex lentiformis pollen injection, solution
BURWEED MARSH ELDER — iva xanthifolia pollen injection, solution
ROUGH MARSH ELDER — iva annua var. annua pollen injection, solution
MEXICAN TEA POLLEN — chenopodium ambrosioides pollen injection, solution
MUGWORT — artemisia vulgaris pollen injection, solution
DARKLEAVES MUGWORT — artemisia ludoviciana pollen injection, solution
NETTLE — urtica dioica pollen injection, solution
PALMERS AMARANTH — amaranthus palmeri pollen injection, solution
ROUGH PIGWEED — amaranthus retroflexus pollen injection, solution
SPINY PIGWEED — amaranthus spinosus pollen injection, solution
ENGLISH PLANTAIN — plantago lanceolata pollen injection, solution
POVERTY WEED — iva axillaris pollen injection, solution
RABBITBUSH — ambrosia deltoidea pollen injection, solution
HACKBERRY — celtis occidentalis pollen injection, solution
AILANTHUS — ailanthus altissima pollen injection, solution
FALSE RAGWEED — ambrosia acanthicarpa pollen injection, solution
GREASEWOOD — sarcobatus vermiculatus pollen injection, solution
TALL RAGWEED — ambrosia trifida pollen injection, solution
RUSSIAN THISTLE — salsola kali pollen injection, solution
COMMON SAGEBRUSH — artemisia tridentata pollen injection, solution
SALTBUSH — atriplex wrightii pollen injection, solution
SHEEP SORREL — rumex acetosella pollen injection, solution
WESTERN RAGWEED — ambrosia psilostachya pollen injection, solution
WINGSCALE — atriplex canescens pollen injection, solution
WORMWOOD — artemisia absinthium pollen injection, solution
CARELESSWEED — amaranthus palmeri pollen injection, solution
CURLY DOCK — rumex crispus pollen injection, solution
Nelco Laboratories, Inc.

WARNING

Diagnostic and therapeutic allergenic extracts are intended to be administered by a physician who is an allergy specialist and experienced in allergenic diagnostic testing and immunotherapy and the emergency care of anaphylaxis.

This product should not be injected intravenously. Deep subcutaneous routes have been safe. Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and/or death. (See Adverse Reactions)

Serious adverse reactions should be reported to Nelco Laboratories immediately and a report filed to: MedWatch, The FDA Medical Product Problem Reporting Program, at 5600 Fishers Lane, Rockville, Md. 20852-9787, call 1-800-FDA-1088.

Extreme caution should be taken when using allergenic extracts for patients who are taking beta-blocker medications. In the event of a serious adverse reaction associated with the use of allergenic extracts, patients receiving beta-blockers may not be responsive to epinephrine or inhaled brochodialators.(1) (See Precautions)

Allergenic extracts should be used with caution for patients with unstable or steroid-dependent asthma or underlying cardiovascular disease. (See Contraindications)

DESCRIPTION

Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts)

For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.

CLINICAL PHARMACOLOGY

The pharmacological action of allergenic extracts used diagnostically is based on the liberation of histamine and other substances when the allergen reacts with IgE antibodies attached to the mast cells. When allergenic extracts are used for immunotherapy, the effect is an increase in immunoglobulin G (IgG) and an increased T suppresser lymphocyte which interferes with the allergic response.(2) With repeated administration of allergenic extracts changes develop in regards to IgG and IgE production and mediator-releasing cells. The histamine release response is reduced in some patients.

INDICATIONS AND USAGE

Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity.

Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.

CONTRAINDICATIONS

Allergenic extracts should not be used if the patient has asthma, cardiovascular disease, emphysema, diabetes, bleeding diathesis or pregnancy, unless a specific diagnosis of type 1 allergic disease is made based on skin testing and the benefits of treatment outweigh the risks of an adverse reaction during testing or treatment. Allergenic extracts are not indicated for use in patients who are not clinically allergic or who are not skin reactive to an allergen. Allergenic extracts should be discontinued or the concentration of potency substantially reduced in patients who experience unacceptable adverse reactions.

WARNINGS

DO NOT INJECT INTRAVENOUSLY.

Epinephrine 1:1000 should be available.

Concentrated extracts must be diluted with sterile diluent prior to first use on a patient for treatment or intradermal testing. All concentrates of glycerinated allergenic extracts have the ability to cause serious local and systemic reactions including death in sensitive patients. Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and /or death.(4) (See Adverse Reactions) An allergenic extract should be temporarily withheld from patients or the dose of the extract adjusted downward if any of the following conditions exist: (1) Severe symptoms of rhinitis and/or asthma (2) Infections or flu accompanied by fever and (3) Exposure to excessive amounts of clinically relevant allergen prior to a scheduled injection. When switching patients to a new lot of the same extract the initial dose should be reduced 3/4 so that 25% of previous dose is administered.

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