Cat Pelt Standardized

Warnings This product is intended for use only by physicians who are experienced in the administration of high dose allergy injection therapy, or for use under the guidance of an allergist.
Allergenic extracts may potentially elicit a severe life-threatening systemic reaction, rarely resulting in death.1 Therefore, emergency measures and personnel trained in their use must be available immediately in the event of such a reaction. Patients should be instructed to recognize adverse reaction symptoms and cautioned to contact the physician’s office if symptoms occur.
This standardized extract may be more potent than regular extracts and therefore is not directly interchangeable with our non-standardized extracts, or other manufacturers’ products. Standardized pelt and hair extracts are manufactured from different source materials and are not interchangeable. Standardized cat extracts labeled in AU/mL are not interchangeable with extracts labeled in BAU/mL. See DESCRIPTION Section.
This product should never be injected intravenously.
Patients on non-selective beta blockers may be more reactive to allergens given for testing or treatment and may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.5 Refer also the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and OVERDOSE Sections for further discussion.

Allergenic extracts for subcutaneous injection and prick or puncture for diagnosis are sterile solutions containing the extractables of the source material and components of the extraction fluid. Standardized Cat Pelt is available as an extract from acetone precipitated source material in two different extraction fluids described below.

Source Material:
Cat Pelt source material consists of hair and whole epidermis which have undergone an acetone precipitation process. AP™ Acetone Precipitated Cat Pelt is derived from precipitate formed when acetone is added to an aqueous extract.

Extracting Fluids:
Glycero-Coca’s: Contains 0.5% sodium chloride, 0.275% sodium bicarbonate, and 50% glycerin (v/v) as a preservative.
Albumin Saline with Phenol: Contains 0.9% sodium chloride, 0.03% Albumin (Human), and 0.4% phenol as a preservative.

Product Concentration:
1. Bioequivalent Allergy Units. When originally licensed, standardized cat extracts containing 10 to 20 Fel d I units/mL were arbitrarily assigned 100,000 Allergy Units (AU)/mL. Subsequently, quantitative skin testing by the ID50EAL method 23 was used to determine that standardized cat extracts containing 10 to 19.9 Fel d I units/mL should be assigned 10,000 AU/mL rather than 100,000 AU/mL. To avoid possible confusion about this change in allergy unit assignment, the nomenclature changed for cat extracts, and such products are labeled in Bioequivalent Allergy Units (BAU/mL).
Each lot of Standardized Cat Pelt extract is standardized by quantitating the Fel d I content based on standards on file with the Center for Biologics Evaluation and Research (CBER) of the U.S.
Food and Drug Administration. Test extracts are diffused in agar containing standard anti-serum to Fel d I and compared to the diffusion of a reference cat allergen preparation.2 The potency of the extract is expressed as units of Fel d I per mL, and extracts containing 10-19.9 Fel d I units per mL are labeled at 10,000 BAU/mL.
It has been recognized that there are differences in the levels of non Fel d I allergens among standardized cat extracts which utilize different source materials. Isoelectric focusing (IEF) patterns have been shown to be predictive of the presence of non Fel d I allergens. Therefore, each lot of Standardized Cat Pelt is compared by IEF to a Cat Pelt Extract Reference and a Cat Hair Extract Reference on file with the CBER. The labeled name of the cat extract (i.e., Cat Hair Extract or Cat Pelt Extract) must be supported by matching the IEF profile of the corresponding reference.

2. Concentrate. Concentrate label terminology applies to allergenic extract mixtures where the individual allergens being combined vary in strength or the designation of strength.

e.g.	Concentrate
50%	Short Ragweed 1:20 w/v
25%	Std. Cat Pelt 10,000 BAU/mL
25%	Std. Mite D. farinae 10,000 AU/mL

Should the physician choose to calculate the actual strength of each component in the “Concentrate” mixture, the following formulation may be used:

Actual Allergen Strength in concentrate Mixture

=

Allergen Manufacturing Strength

x

% Allergen in Formulation (by volume or parts)

Ingredients:
Active ingredients are the allergen(s) noted on the vial label. Preservative is 50% (v/v) glycerin or 0.4% phenol, as indicated on the vial label. Glycerinated extracts contain 0.5% sodium chloride, 0.275% sodium bicarbonate and 50% glycerin (v/v) as a preservative. Albumin Saline extracts contain 0.9% sodium chloride, 0.03% Albumin (Human), and 0.4% Phenol as a preservative.