ONION injection, solution ORANGE injection, solution OYSTER- eastern oyster injection, solution GREEN PEA- pea injection, sol

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)

Dostępny od:

ALK-Abello, Inc.

INN (International Nazwa):

ONION

Skład:

ONION 0.1 mg in 1 mL

Droga podania:

PERCUTANEOUS

Wskazania:

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

Podsumowanie produktu:

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.

Status autoryzacji:

Biologic Licensing Application

Charakterystyka produktu

ONION- ONION INJECTION, SOLUTION
ORANGE- ORANGE INJECTION, SOLUTION
OYSTER- EASTERN OYSTER INJECTION, SOLUTION
GREEN PEA- PEA INJECTION, SOLUTION
PEACH- PEACH INJECTION, SOLUTION
PEANUT- PEANUT INJECTION, SOLUTION
PEAR- PEAR INJECTION, SOLUTION
PECAN NUT- PECAN INJECTION, SOLUTION
BELL PEPPER- GREEN BELL PEPPER INJECTION, SOLUTION
BLACK PEPPER- BLACK PEPPER INJECTION, SOLUTION
PINEAPPLE- PINEAPPLE INJECTION, SOLUTION
PISTACHIO NUT- PISTACHIO INJECTION, SOLUTION
PLUM- PLUM INJECTION, SOLUTION
PORK- PORK INJECTION, SOLUTION
SWEET POTATO- SWEET POTATO INJECTION, SOLUTION
ALK-ABELLO, INC.
----------
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 theophy