COW MILK injection, solution GOAT MILK injection, solution CHICKEN injection, solution DUCK MEAT injection, solution LAMB in

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

COW MILK (UNII: 917J3173FT) (COW MILK - UNII:917J3173FT)

Dostupné z:

Antigen Laboratories, Inc.

INN (Medzinárodný Name):

COW MILK

Zloženie:

COW MILK 0.05 g in 1 mL

Spôsob podávania:

SUBCUTANEOUS

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing. 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 immunization causing exacerbation of nephrotic disease.

Prehľad produktov:

Stock concentrates are available in concentrations of 2-10% or weight/volume (w/v) of 1:50, 1:33, 1:20 or 1:10. Some juicy or liquid foods are available at 1:1 volume/volume (v/v) extraction ratio. Fresh egg white extract is available at 1:9 v/v extraction ratio. Antigen E content of ragweed mixtures ranges from 46-166 U/ml for Ragweed Mixture (Short/Giant/Western/Southern Ragweed), 47-239 U/ml for Short/Giant/Western Ragweed Mixture, and 106-256 U/ml for Short/Giant Ragweed Mixture. Refer to container label for actual Antigen E content. Extract (stock concentrate) is supplied in 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% glycerine v/v.

Stav Autorizácia:

Biologic Licensing Application

Súhrn charakteristických

COW MILK - COW MILK INJECTION, SOLUTION
GOAT MILK - GOAT MILK INJECTION, SOLUTION
CHICKEN - CHICKEN INJECTION, SOLUTION
DUCK MEAT - DUCK MEAT INJECTION, SOLUTION
LAMB - LAMB INJECTION, SOLUTION
RABBIT MEAT - RABBIT MEAT INJECTION, SOLUTION
TURKEY - TURKEY INJECTION, SOLUTION
BEEF - BEEF INJECTION, SOLUTION
EGG WHITE - EGG WHITE INJECTION, SOLUTION
WHOLE EGG - WHOLE EGG INJECTION, SOLUTION
GOOSE MEAT - GOOSE MEAT INJECTION, SOLUTION
PORK - PORK INJECTION, SOLUTION
VENISON - VENISON INJECTION, SOLUTION
ANTIGEN LABORATORIES, INC.
----------
ALLERGENIC EXTRACT
WARNINGS
ALLERGENIC EXTRACT IS INTENDED FOR USE BY, OR UNDER THE GUIDANCE OF,
PHYSICIANS WHO ARE
EXPERIENCED IN THE ADMINISTRATION OF ALLERGENIC EXTRACTS FOR DIAGNOSIS
AND/OR
IMMUNOTHERAPY AND THE EMERGENCY CARE OF ANAPHYLAXIS. THIS EXTRACT IS
NOT DIRECTLY
INTERCHANGEABLE WITH OTHER ALLERGENIC EXTRACTS. THE INITIAL DOSE MUST
BE BASED ON SKIN
TESTING AS DESCRIBED IN THE “DOSAGE AND ADMINISTRATION” SECTION OF
THIS INSERT.
PATIENTS SWITCHING FROM OTHER TYPES OF EXTRACTS TO ANTIGEN
LABORATORIES’ ALLERGENIC EXTRACTS
SHOULD BE STARTED AS IF THEY WERE UNDERGOING TREATMENT FOR THE FIRST
TIME. PATIENTS BEING
SWITCHED FROM ONE LOT OF EXTRACT TO ANOTHER FROM THE SAME MANUFACTURER
SHOULD HAVE THE
DOSE REDUCED BY 75%.
SEVERE SYSTEMIC REACTIONS MAY OCCUR WITH ALL ALLERGENIC EXTRACTS. 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 ALLERGENIC
EXTRACT INJECTIONS. TREATMENT AND EMERGENCY MEASURES, AS WELL AS
PERSONNEL TRAINED IN
THEIR USE, MUST BE 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. REPORT SERIOUS ADVERSE EVENTS TO MEDWATCH, 5600 FISHERS
LANE, ROCKVILLE,
MD 20852-9787, PHONE 1-800-FDA-1088.
THIS PRODUCT SHOULD NOT BE INJECTED INTRAVENOUSLY. DEEP SUBCUTANEOUS
ROUTES HAVE PROVEN
TO BE SA