STANDARDIZED CAT HAIR injection, solution

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

FELIS CATUS HAIR (UNII: 1564HD0N96) (FELIS CATUS HAIR - UNII:1564HD0N96)

제공처:

Antigen Laboratories, Inc.

INN (International Name):

FELIS CATUS HAIR

구성:

FELIS CATUS HAIR 10000 [BAU] in 1 mL

관리 경로:

SUBCUTANEOUS

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

INDICATIONS AND USAGE     Allergenic extract is indicated for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to cat allergen, they experience allergic symptoms.  Confirmation is determined by skin testing.  An orderly approach to the diagnostic use of allergenic extracts usually begins with direct skin testing. CONTRAINDICATIONS     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 disease, possibly due to routine immunization.  Patients who have experienced a recent myocardial infarction may not be tolerant of immunotherapy.  Children with nephrotic syndrome probably should not receive injections due to a variety of seemingly unrelated events, such as immunization causing exacerbation of their nephrotic disease.     This product is not intended for the treatment of patients who do not experience allerg

제품 요약:

HOW SUPPLIED     Standardized Cat allergenic extract is expressed in BAU/ml.  It is supplied in 10,000 BAU/ml, 5,000 BAU/ml and 1,000 BAU/ml in 5, 10, 30 and 50 ml containers.  Extracts in 5 ml dropper bottles are available for prick-puncture testing.  To insure maximum potency for the entire dating period, all stock concentrates contain 50% v/v glycerine.

승인 상태:

Biologic Licensing Application

제품 특성 요약

STANDARDIZED CAT HAIR - STANDARDIZED CAT HAIR INJECTION, SOLUTION
ANTIGEN LABORATORIES, INC.
----------
ALLERGENIC EXTRACT
WARNINGS
STANDARDIZED CAT HAIR AND CAT PELT EXTRACTS LABELED IN BIOEQUIVALENT
ALLERGY UNITS (BAU/ML)
ARE NOT INTERCHANGEABLE WITH EACH OTHER AND ARE NOT INTERCHANGEABLE
WITH CAT EXTRACTS
LABELED IN ALLERGY UNITS (AU/ML). STANDARDIZED CAT ALLERGENIC EXTRACT
IS INTENDED FOR USE BY
PHYSICIANS WHO ARE EXPERIENCED IN THE ADMINISTRATION OF ALLERGENIC
EXTRACTS FOR DIAGNOSIS,
IMMUNOTHERAPY AND THE EMERGENCY CARE OF ANAPHYLAXIS, OR FOR USE UNDER
THE GUIDANCE OF AN
ALLERGY SPECIALIST. THIS EXTRACT IS NOT DIRECTLY INTERCHANGEABLE WITH
OTHER ALLERGENIC EXTRACTS.
PATIENTS BEING SWITCHED FROM OTHER TYPES OF EXTRACT TO ANTIGEN
LABORATORIES’ ALLERGENIC
EXTRACTS SHOULD BE STARTED AS THOUGH THEY WERE COMING UNDER TREATMENT
FOR THE FIRST TIME.
SEE “WARNINGS” SECTION. AS WITH ALL ALLERGENIC EXTRACTS, SEVERE
SYSTEMIC REACTIONS MAY
OCCUR. IN CERTAIN INDIVIDUALS, THESE LIFE-THREATENING REACTIONS MAY
RESULT IN DEATH. PATIENTS
SHOULD BE OBSERVED FOR AT LEAST 20 MINUTES FOLLOWING ALLERGENIC
EXTRACT INJECTIONS.
TREATMENT AND EMERGENCY MEASURES, AS WELL AS PERSONNEL TRAINED IN
THEIR USE, SHOULD BE
IMMEDIATELY AVAILABLE IN THE EVENT OF A LIFE-THREATENING REACTION.
SENSITIVE PATIENTS MAY
EXPERIENCE SEVERE ANAPHYLACTIC REACTIONS RESULTING IN RESPIRATORY
OBSTRUCTION, SHOCK, COMA
AND/OR DEATH. PATIENTS BEING SWITCHED FROM ONE LOT OF EXTRACT TO
ANOTHER FROM THE SAME
MANUFACTURER SHOULD HAVE THE DOSE REDUCED BY 75%.
THIS PRODUCT SHOULD NOT BE INJECTED INTRAVENOUSLY. DEEP SUBCUTANEOUS
ROUTES HAVE PROVEN
TO BE SAFE, SEE “WARNINGS”, “PRECAUTIONS”, “ADVERSE
REACTIONS” AND
“OVERDOSAGE” SECTIONS.
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