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Cat Pelt Standardized
  • Professionals
  • FDA PI

Cat Pelt Standardized

Dosage form: injection, solution

ALLERGENIC EXTRACT

STANDARDIZED CAT PELT

(Felis domesticus)

Warnings

Standardized allergenic extract is intended for use by physicians who are experienced in the administration of allergenic extracts for immunotherapy and the emergency care of anaphylaxis, or for use under the guidance of an allergy specialist. Standardized Cat Pelt extract is not interchangeable with standardized Cat Hair extract or with any non-standardized Cat extracts. Standardized allergenic extracts are not directly interchangeable with allergenic extracts of the same-labeled potency from different manufacturers. The patient must be re-evaluated with the newly selected extract. The initial dose must be based on skin testing as described in the dosage and administration section of this insert. Patients being switched from other types of extracts standardized or unstandardized cat extracts from other suppliers, to this standardized allergenic extract should be started as though they were coming under treatment for the first time. 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. Patients with unstable asthma or steroid dependent asthmatics and patients with underlying cardiovascular disease are at greater risk. In certain individuals, these life-threatening reactions may rarely result in death. Patients should be observed for 20 to 30 minutes following treatment, and emergency measures, as well as personnel trained in their use, should be immediately available in the event of a life-threatening reaction.

This product should not be injected intravenously. Deep subcutaneous routes have proven to be safe. See the warnings, precautions, adverse reactions and overdosage sections below.

Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and/or death.

Adverse events are to be reported to MedWatch (1-800-FDA-1088), Adverse Experience Reporting, HFM-210 Center for Biologics Evaluation & Research, Food & Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448.

Patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodilators. Respiratory obstruction not responding to paren...