Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
BLUEFISH (UNII: 79U8P8X3Q5) (BLUEFISH - UNII:79U8P8X3Q5)
Nelco Laboratories, Inc.
INTRADERMAL
PRESCRIPTION DRUG
Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again. Allergenic extracts should not be used if the patient has asthma, cardiovascular disease, emphysema, diabetes, bleeding diathesis or pregnancy, unless a specific diagnosis of t
Allergenic extracts are supplied with units listed as: Weight/volume (W/V), Protein Nitrogen Units (PNU/ml), Allergy Units (AU/ml) or Bioequivalent Allergy Units (BAU/ml). Sizes: Diagnostic Scratch: 5 ml dropper application vials Diagnostic Intradermal: 5 ml or 10 ml vials. Therapeutic Allergens: 5 ml, 10 ml, 50 ml multiple dose vials.
Biologic Licensing Application
BLUEFISH - BLUEFISH INJECTION, SOLUTION NELCO LABORATORIES, INC. ---------- ALLERGENIC EXTRACT WARNING Diagnostic and therapeutic allergenic extracts are intended to be administered by a physician who is an allergy specialist and experienced in allergenic diagnostic testing and immunotherapy and the emergency care of anaphylaxis. This product should not be injected intravenously. Deep subcutaneous routes have been safe. Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and/or death. (SEE ADVERSE REACTIONS) Serious adverse reactions should be reported to Nelco Laboratories immediately and a report filed to: MEDWATCH, THE FDA MEDICAL PRODUCT PROBLEM REPORTING PROGRAM, AT 5600 FISHERS LANE, ROCKVILLE, MD. 20852-9787, CALL 1-800-FDA-1088. Extreme caution should be taken when using allergenic extracts for patients who are taking beta- blocker medications. In the event of a serious adverse reaction associated with the use of allergenic extracts, patients receiving beta-blockers may not be responsive to epinephrine or inhaled brochodialators. (SEE PRECAUTIONS) Allergenic extracts should be used with caution for patients with unstable or steroid-dependent asthma or underlying cardiovascular disease. (SEE CONTRAINDICATIONS) DESCRIPTION Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). _(See product insert for standardized extracts)_ For diagnostic purposes, allergenic extracts are Lees het volledige document