STANDARDIZED SHORT RAGWEED POLLEN injection, solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3)

Disponible depuis:

Antigen Laboratories, Inc.

DCI (Dénomination commune internationale):

AMBROSIA ARTEMISIIFOLIA POLLEN

Composition:

AMBROSIA ARTEMISIIFOLIA POLLEN 100000 [AU] in 1 mL

Mode d'administration:

SUBCUTANEOUS

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

INDICATIONS AND USAGE     Allergenic extract is indicated for diagnostic testing and treatment (immunotherapy) of patients whose histories indicate allergic symptoms upon natural exposure to short ragweed pollen.  Confirmation is determined by 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.  Recent myocardial infarction patients may not tolerate immunotherapy.  Children with nephrotic syndrome probably should not receive injections due to a possibility of immunization causing exacerbation of their nephrotic disease.     Standardized Short Ragweed extract is not intended for the treatment of patients who do not experience allergic symptoms upon natural exposure to the allergen.     Allergenic extracts are not intended for diagnosing patients whose skin does not manifest immediate hypersensitiv

Descriptif du produit:

HOW SUPPLIED     Standardized Short Ragweed allergenic extract concentration is expressed in AU/ml.  Standardized Short Ragweed (100,000 AU/ml) 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% v/v glycerine.

Statut de autorisation:

Biologic Licensing Application

Résumé des caractéristiques du produit

STANDARDIZED SHORT RAGWEED POLLEN - STANDARDIZED SHORT RAGWEED POLLEN
INJECTION,
SOLUTION
ANTIGEN LABORATORIES, INC.
----------
ALLERGENIC EXTRACT
WARNINGS
STANDARDIZED SHORT RAGWEED 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.
_ Patients being_
_switched from other manufacturers’ extracts to Antigen
Laboratories' allergenic extracts should be_
_started as though they were receiving treatment for the first
time.(See “WARNINGS” section below.)_
SEVERE SYSTEMIC REACTIONS MAY OCCUR WITH ALL ALLERGENIC EXTRACTS. 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, 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. PATIENTS BEING
SWITCHED FROM ONE LOT OF
EXTRACT TO ANOTHER LOT FROM THE SAME MANUFACTURER SHOULD HAVE THE DOSE
REDUCED BY 75%. REPORT SERIOUS ADVERSE EVENTS TO MEDWATCH, 5600 FISHERS LANE,
ROCKVILLE, MD 20852-
9787, PHONE 1-800-FDA-1088.
ALLERGENIC EXTRACTS SHOULD NOT BE INJECTED INTRAVENOUSLY. DEEP
SUBCUTANEOUS ROUTES HAVE
PROVEN TO BE SAFE. SEE THE “WARNINGS”, “PRECAUTIONS”,
“ADVERSE REACTIONS”
AND “OVERDOSAGE” SECTIONS. PATIENTS RECEIVING BETA-BLOCKERS MAY NOT BE RESPONSIVE TO EPINEPHRINE
OR INHALED
BRONCHODILATORS. PATIENTS WITH RESPIRATORY OBSTRUCTION NOT RESPONDING
TO PARENTERAL OR
INHALED BRONCHODILATORS MAY REQUIRE THEOPHYLLINE, OXYGEN, INTUBATION
AND 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
“ADVERSE REACTIONS” SECTION.
DESCRIPTION
A