Allergenic Extract

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PASPALUM NOTATUM POLLEN (UNII: V003SHB7VK) (PASPALUM NOTATUM POLLEN - UNII:V003SHB7VK)

Available from:

Nelco Laboratories, Inc.

INN (International Name):

PASPALUM NOTATUM POLLEN

Composition:

PASPALUM NOTATUM POLLEN 10000 [PNU] in 1 mL

Administration route:

INTRADERMAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

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