Allergenic Extract, Flaxseed,Coffee,Cottonseed

Allergenic extract is intended for use by physicians or under the guidance of physicians who are experienced in the administration of allergenic extracts for diagnosis and the emergency care of anaphylaxis. This extract is not directly interchangeable with other allergenic extracts. Patients should be instructed to recognize adverse reaction symptoms and cautioned to contact the physician's office if reaction symptoms occur. As with all allergenic extracts, severe systemic reactions may occur.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 testing. Emergency measures, as well as trained personnel, should be immediately available in the event of a life-threatening reaction.

This product should not be injected intravenously. See the "WARNINGS", "PRECAUTIONS", "ADVERSE REACTIONS" and "OVERDOSAGE" sections.

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.

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.

Antigen Laboratories' allergenic extracts are manufactured from source material listed on the vial label. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms. All source materials are inspected by Antigen Laboratories' technical personnel in accordance with 21 CFR 680.1 (b) (I).

The following "For Diagnostic Use Only" allergenic extracts are extracted at a 1:20 w/v or 1:50 w/v ratio of source material to extracting fluid:

The source material for Coffee is prepared by grinding the seed of the coffee plant (Coffea arabic).

The source material for Cottonseed is prepared by grinding the seed of the cotton plant (Gossypium spp.).

The source material for Flaxseed is prepared by grinding the seed of the flax plant (Linum usitatissimum).

Leafhopper source material is pulverized whole bodies of Leafhoppers (Cicadellidae).

Miller Moth source material is pulverized whole bodies of night flying moths (Lepidoptera).

Cricket source material is pulverized whole bodies of crickets (Gryllidae).

Moth source material is pulverized whole bodies of moths of the order Frenatae.

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%

USP 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.

Do not administer in the presence of diseases characterized by bleeding diathesis. Individuals with autoimmune disease may be at risk of exacerbating symptoms of the underlying condition, possibly due to routine immunization. Children with nephrotic syndrome should not receive injections due to immunization exacerbating nephrotic diseases.

Allergenic extracts are not intended for diagnosing patients who do not manifest immediate hypersensitivity reactions to the allergenic extract when skin tested.

Refer to “WARNINGS," "PRECAUTIONS" and "ADVERSE REACTIONS" sections for signs and symptoms of an overdose.

If a systemic or anaphylactic reaction does occur, the first treatment should be injection intramuscularly or subcutaneously 0.3 to 0.5 ml of 1:1000 epinephrine-hydrochloride into the opposite arm or gluteal area. Apply tourniquet above site of allergenic extract injection and loosen briefly at 5 minute intervals to prevent circulatory impairment. If oxygen is indicated, it may be administered by nasal cannula or ambu bag.

The epinephrine HCL 1:1000 dose for infants to 2 years is 0.05 to 0.1 ml; for children 2 to 6 years it is 0.15 ml; for children 6 to 12 years it is 0.2 ml.

Symptoms of progressive anaphylaxis include airway obstruction and/or vascular collapse.

After administration of epinephrine, profound shock and vasomotor collapse should be treated with intravenous fluids and possibly vasoactive drugs. Monitor airways for obstruction. Oxygen should be given by mask if indicated.

Antihistamines, H2 antagonist, bronchodilators, steroids and theophylline may be used as indicated after giving adequate epinephrine and circulatory support.6

Patients who have been taking a beta-blocker may be unresponsive to epinephrine. Epinephrine or beta-adrenergic drugs (Alupent) may be ineffective. These drugs should be administered even though a beta-blocker may have been taken. The following treatment will be effective whether or not patient is taking a beta-blocker: Aminophylline IV, slow push or drip, Atrovent (Ipratropium bromide) Inhaler, 3 inhalations repeated, Atropine, 0.4 mg/ml, 0.75 to 1.5 ml IM or IV, Solu-Cortef, 100-200 mg IM or IV, Solu-Medrol, 125 mg IM or IV, Glucagon, 0.5-1 mg IM or IV, Benadryl, 50 mg IM or IV, Cimetidine, 300 mg IM or IV, Oxygen via ambu bag.

The stock concentrate of allergenic extract is expressed in weight/volume, at 1:50 w/v (2%) or 1:20 w/v (5%). It is supplied in 10, 30 and 50 ml containers. Extracts in 5 ml sterile dropper bottles are available for prick-puncture testing. To insure maximum potency for the entire dating period, all stock concentrates contain 50% glycerine v/v.

Store all stock concentrates and dilutions at 2-8 degrees C and keep at this temperature during office use. The expiration date of the allergenic extract is listed on the container label. Dilutions of the allergenic extract concentration containing less then 50% glycerine are less stable. If loss of potency is suspected, potency can be checked using side by side skin testing with freshly prepared dilutions of equal concentration on individuals with known sensitivity to the allergen.