VANILLA- vanilla bean injection, solution ENGLISH WALNUT injection, solution GRAPE injection, solution WATERMELON injection,

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

VANILLA BEAN (UNII: Q74T35078H) (VANILLA BEAN - UNII:Q74T35078H)

Available from:

ALK-Abello, Inc.

INN (International Name):

VANILLA

Composition:

VANILLA 0.1 mg in 1 mL

Administration route:

PERCUTANEOUS

Therapeutic indications:

These products are for diagnostic use only. Diagnostic allergenic extracts are indicated for use in skin testing to establish the clinical relevance of specific allergens to which the patient has been exposed. By measuring skin test response the physician may assess the degree of sensitivity that patients have to the allergens. For extracts standardized in AU and BAU, see individual directions for use. Allergenic extracts for diagnostic use only of coffee, mosquito, cottonseed, and flaxseed have not been shown by adequate data to be safe and effective for therapeutic use. Patients on beta blockers can be non-responsive to beta agonists that may be required to reverse a systemic reaction (also, see boxed WARNING statement and ADVERSE REACTIONS ). The physician should carefully weigh the benefit derived from skin testing vs. the risk to the patient should a systemic reaction arise. Patients with unstable asthma or steroid dependent asthmatics and patients with underlying cardiovascular disease are at greater r

Product summary:

For scratch and prick testing: 5 mL dropper applicator vials in 50% v/v glycerin or 10mL stoppered vial in 50% v/v glycerin. Available individually and in a complete set of the most common allergens. Available in either Protein Nitrogen Units (PNU/mL) or weight to volume (w/v). For intracutaneous testing: 5 mL sterile vials, aqueous based, individually and in a complete set of the most common allergens. Available in either Protein Nitrogen Units (PNU/mL) or weight to volume (w/v). Histatrol ® Positive skin test control - histamine. 1 mg/mL and 0.1 mg/mL histamine base. See Product Catalog for specific diagnostic concentrations available.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

VANILLA- VANILLA BEAN INJECTION, SOLUTION
ENGLISH WALNUT- ENGLISH WALNUT INJECTION, SOLUTION
GRAPE- GRAPE INJECTION, SOLUTION
WATERMELON- WATERMELON INJECTION, SOLUTION
WHEAT- WHEAT INJECTION, SOLUTION
ALK-ABELLO, INC.
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FOOD ALLERGENIC EXTRACTS
ALLERGENIC EXTRACTS,
FOR DIAGNOSTIC USE ONLY
DIRECTIONS FOR USE
WARNING
This product is intended for use by physicians who are experienced in
the administration of
allergenic extracts and the emergency care of anaphylaxis, or for use
under the guidance of an
allergy specialist.
As with all allergenic extracts, severe systemic reactions may occur.
In certain individuals these
life-threatening reactions may result in death. Fatalities associated
with skin testing have been
reported. Patients should be observed for at least 20 - 30 minutes
following testing. Emergency
measures and adequately trained personnel should be immediately
available in the event of a life-
threatening reaction.
Patients with unstable asthma or steroid dependent asthmatics and
patients with underlying
cardiovascular disease are at greater risk to a fatal outcome from a
systemic allergic reaction.
Sensitive patients may experience severe anaphlactic reactions
resulting in respiratory
obstruction, shock, coma and/or death. Adverse events are to be
reported to MedWatch (1-800-
FDA-1088), Adverse Event Reporting, Food and Drug Administration, 5600
Fishers Lane,
Rockville, MD 20852-9787. This product should not be injected
intravenously. Patients receiving
beta blockers may not be responsive to epinephrine or inhaled
bronchodilators. Respiratory
obstruction not responding to parenteral or inhaled bronchodilators
may require theophylline,
oxygen, intubation and the use of life support systems. Parenteral
fluid and/or plasma expanders
may be utilized for the treatment of shock. Adrenocorticosteroids may
be administered
parenterally or intravenously. Refer to WARNINGS, PRECAUTIONS, and
ADVERSE
REACTIONS sections below.
Port Washington, NY 11050
U.S. Government License No. 1256
DESCRIPTION
Sterile dia