Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
PASPALUM NOTATUM POLLEN (UNII: V003SHB7VK) (PASPALUM NOTATUM POLLEN - UNII:V003SHB7VK)
Nelco Laboratories, Inc.
PASPALUM NOTATUM POLLEN
PASPALUM NOTATUM POLLEN 10000 [PNU] in 1 mL
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
BAHIA GRASS - BAHIA GRASS INJECTION, SOLUTION ANNUAL BLUE GRASS - ANNUAL BLUE GRASS INJECTION, SOLUTION CANADIAN BLUE GRASS - CANADIAN BLUE GRASS INJECTION, SOLUTION BROME GRASS - BROME GRASS INJECTION, SOLUTION CANARY GRASS - CANARY GRASS INJECTION, SOLUTION CORN GRASS - CORN GRASS INJECTION, SOLUTION COUCH QUACK GRASS - COUCH QUACK GRASS INJECTION, SOLUTION GRAMA GRASS - GRAMA GRASS INJECTION, SOLUTION JOHNSON GRASS - JOHNSON GRASS INJECTION, SOLUTION CULTIVATED OAT - CULTIVATED OAT INJECTION, SOLUTION CULTIVATED RYE - CULTIVATED RYE INJECTION, SOLUTION GIANT WILD RYE - GIANT WILD RYE INJECTION, SOLUTION ITALIAN RYE GRASS - ITALIAN RYE GRASS INJECTION, SOLUTION SALT GRASS - SALT GRASS INJECTION, SOLUTION VELVET GRASS - VELVET GRASS INJECTION, SOLUTION CULTIVATED WHEAT - CULTIVATED WHEAT INJECTION, SOLUTION WEST WHEAT GRASS - WEST WHEAT GRASS INJECTION, SOLUTION SOFT CHEAT BROME - SOFT CHEAT BROME INJECTION, SOLUTION SMOOTH BROME - SMOOTH BROME 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 brochodia Izlasiet visu dokumentu