Cat Pelt

Cat Pelt

Cat Pelt Recall

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Questions & Answers

Side Effects & Adverse Reactions

See warnings at beginning of this package insert. Standardized allergenic extracts may be more potent than non-standardized extracts. This cat extract may be compositionally different than unstandardized and standardized extracts from other suppliers.

This cat extract is prepared from cat pelt and should not be interchanged with Standardized Cat Hair Extract or Standardized Cat Pelt Extract from other sources. This product has been assigned a bioequivalent allergy unit (BAU) designation based on both in vivo and in vitro potency measures. The physician should perform skin tests to determine the initial starting dose for standardized extracts.

From standardized aqueous extracts from other manufacturers to ALK-Abello standardized aqueous extracts: The physician should establish the potency relationship, perhaps by comparative skin testing at equal concentration, prior to injecting the first standardized dose.

Patients should always be observed for at least 20 to 30 minutes after any injection. In the event of a marked systemic reaction, application of a tourniquet above the injection site and administration of 0.2 mL to 1.0 mL (0.01 mg/kg) of Epinephrine Injection (1:1,000) is recommended. Maximal recommended dose for children between 2 and 12 years of age is 0.5 mL. The tourniquet is then gradually released at 15 minute intervals. Patients under treatment with beta-blockers may be refractory to the usual dose of epinephrine.

Volume expanders and vasopressor agents may be required to reverse hypotension. Inhalation bronchodilators and parenteral aminophylline may be required to reverse bronchospasm. In cases of respiratory obstruction, oxygen and intubation may be necessary. Life-threatening reactions unresponsive to the above may require cardiopulmonary resuscitation.

PRODUCT SHOULD NOT BE GIVEN INTRAVENOUSLY.

In the presence of active symptoms such as rhinitis, wheezing, dyspnea, etc., the indications of immunotherapy must be weighed carefully against the risk of temporarily aggravating the symptoms by the injection itself. If the protective action of allergenic extract injections is considered essential for the patient's welfare, appropriate symptomatic therapy with antihistaminic, adrenergic or other drugs might be needed either prior to or in conjunction with the allergenic extract injections.

Withhold allergenic extracts temporarily or reduce the dose in patients with any one of the following conditions:

      - Severe rhinitis or asthma symptoms;

      - Infection or flu accompanied by fever;

      - Exposure to excessive amounts of clinically relevant allergen prior to therapy.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

This product is indicated for the diagnosis and treatment (hyposensitization therapy) of patients who experience allergic symptoms due to exposure to cats and who exhibit type I skin sensitivity when tested to those specific allergens.

Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants, in situations where the offending allergen cannot be avoided.

Prior to the initiation of therapy, clinical sensitivity should be established by careful evaluation of the patient's history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can be easily avoided.

History

There is currently no drug history available for this drug.

Other Information

Standardized Allergenic Extract in the accompanying vial is a sterile solution and contains glycerin 50% v/v and phenol 0.4% (preservative). Inert ingredients include sodium chloride. It is intended for percutaneous testing, intradermal testing and subcutaneous injection.

Glycerinated cat pelt extracts are prepared from defatted & dried cat pelts extracted in phenol saline, concentrated, dialyzed, glycerinated, filtered aseptically, and dispensed in multidose vials. These are subsequently tested for sterility, safety and potency.

This is a Standardized Cat Pelt Extract and is not interchangeable with Standardized Cat Hair Extract from this or other manufacturers (See Warnings) Standardized Cat Pelt extract contains Cat allergens in addition to Fel d I (Cat I). Biologic potency with this product has been assessed by quantitative intradermal skin testing.1 For ease in use and for lot to lot consistency, the potency of each standardized Cat Pelt lot is expressed relative to an FDA reference in Bioequivalent Allergy Units (BAU's) per milliliter. BAU's are assigned to standardized cat preparations based on major allergen content, Fel d I (Cat I), using official FDA methods and reagents.2 BAU's have been shown by FDA to correlate with clinical allergenicity. (See table below)

Table: Major Allergen Content /BAU
Fel d I (u/mL) BAU/mL
10-19.9 10,000
5-9.9 5,000

                 

        

Cat Pelt Manufacturers


  • Alk-abello, Inc.
    Cat Pelt, Standardized Injection, Solution Cat Pelt, Standardized Solution [Alk-abello, Inc.]

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