SORREL/DOCK MIX- rumex acetosella pollen and rumex crispus pollen injection, solution MIXED MOLDS- alternaria alternata, asperg

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW), RUMEX CRISPUS POLLEN (UNII: V825XJG64G) (RUMEX CRISPUS POLLEN - UNII:V825XJG64G)

Tilgjengelig fra:

ALK-Abello, Inc.

INN (International Name):

ALTERNARIA ALTERNATA

Sammensetning:

ALTERNARIA ALTERNATA 0.1 g in 1 mL

Administreringsrute:

PERCUTANEOUS

Indikasjoner:

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

Produkt oppsummering:

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.

Autorisasjon status:

Biologic Licensing Application

Preparatomtale

SORREL/DOCK MIX- RUMEX ACETOSELLA POLLEN AND RUMEX CRISPUS
POLLEN INJECTION, SOLUTION
MIXED MOLDS- ALTERNARIA ALTERNATA, ASPERGILLUS FLAVUS VAR. ORYZAE,
ASPERGILLUS
NIGER VAR. NIGER, ASPERGILLUS REPENS, ASPERGILLUS TERREUS,
CLADOSPORIUM
SPHAEROSPERMUM AND PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM INJECTION,
SOLUTION
MIXED PENICILLIUM- PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM INJECTION,
SOLUTION
MIXED RAGWEED- AMBROSIA ARTEMISIIFOLIA AND AMBROSIA TRIFIDA POLLEN
INJECTION,
SOLUTION
MOLD MIX 2- AUREOBASIDIUM PULLULANS VAR. PULLUTANS, CURVULARIA
INAEQUALIS,
GIBBERELLA ZEAE, MUCOR PLUMBEUS AND RHIZOPUS ARRHIZUS INJECTION,
SOLUTION
ALK-ABELLO, INC.
----------
SCRATCH NONSTANDARDIZED PRODUCTS
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
respond