FLAXSEED injection, solution COFFEE injection, solution COTTONSEED injection, solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

FLAX SEED (UNII: 4110YT348C) (FLAX SEED - UNII:4110YT348C)

Saatavilla:

Antigen Laboratories, Inc.

INN (Kansainvälinen yleisnimi):

FLAX SEED

Koostumus:

FLAX SEED 0.05 g in 1 mL

Antoreitti:

INTRADERMAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. The following allergenic extracts are "For Diagnostic Use Only": Coffee (Coffea arabic ), Cottonseed (Gossypium spp. ), Flaxseed (Linum usitatissimum ), Leafhopper (Cicadellidae), Miller Moth (Night Flying Lepidoptera), Cricket (Gryllidae) and Moth (Frenatae). These extracts are intended for diagnostic testing of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by 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 condition, possibly due to routine immunization. Children with nephrotic syndrome should not receive injections due to immunization exacerbating nephrotic diseases. Allergenic

Tuoteyhteenveto:

The stock concentrate of allergenic extract is expressed in weight/volume, at 1:50 w/v (2%) or 1:20 w/v (5%). It is supplied in 10, 30 and 50 ml containers. Extracts in 5 ml sterile 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.

Valtuutuksen tilan:

Biologic Licensing Application

Valmisteyhteenveto

FLAXSEED - FLAXSEED INJECTION, SOLUTION
COFFEE - COFFEE INJECTION, SOLUTION
COTTONSEED - COTTONSEED INJECTION, SOLUTION
ANTIGEN LABORATORIES, INC.
----------
ALLERGENIC EXTRACT “FOR DIAGNOSTIC USE ONLY”
WARNINGS
ALLERGENIC EXTRACT IS INTENDED FOR USE BY PHYSICIANS OR UNDER THE
GUIDANCE OF PHYSICIANS
WHO ARE EXPERIENCED IN THE ADMINISTRATION OF ALLERGENIC EXTRACTS FOR
DIAGNOSIS AND THE
EMERGENCY CARE OF ANAPHYLAXIS. THIS EXTRACT IS NOT DIRECTLY
INTERCHANGEABLE WITH OTHER
ALLERGENIC EXTRACTS. 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._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 TESTING.
EMERGENCY MEASURES, AS WELL
AS TRAINED PERSONNEL, SHOULD BE IMMEDIATELY AVAILABLE IN THE EVENT OF
A LIFE-THREATENING
REACTION.
THIS PRODUCT SHOULD NOT BE INJECTED INTRAVENOUSLY. SEE THE "WARNINGS",
"PRECAUTIONS", "ADVERSE REACTIONS" AND "OVERDOSAGE" SECTIONS.
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.
_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
TREATMENT OF SHOCK.
ADRENOCORTICOSTEROIDS MAY BE ADMINISTERED PARENTERALLY OR
INTRAVENOUSLY. REFER TO
''WARNINGS", "PRECAUTIONS" AND "ADVERSE REACTIONS" SECTIONS BELOW.
DESCRIPTION
Antigen Laboratories' allergenic extracts are manufactured from source
material listed on the vial label.
The extract is a st