BLUEFISH injection, solution

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

BLUEFISH (UNII: 79U8P8X3Q5) (BLUEFISH - UNII:79U8P8X3Q5)

から入手可能:

Nelco Laboratories, Inc.

投与経路:

INTRADERMAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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

製品概要:

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.

認証ステータス:

Biologic Licensing Application

製品の特徴

BLUEFISH - BLUEFISH INJECTION, SOLUTION
NELCO LABORATORIES, INC.
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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