HOUSE DUST MITE, DERMATOPHAGOIDES FARINAE injection HOUSE DUST MITE, DERMATOPHAGOIDES PTERONYSSINUS injection

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

DERMATOPHAGOIDES FARINAE (UNII: PR9U2YPF3Q) (DERMATOPHAGOIDES FARINAE - UNII:PR9U2YPF3Q)

Beszerezhető a:

Allermed Laboratories, Inc.

INN (nemzetközi neve):

DERMATOPHAGOIDES FARINAE

Összetétel:

DERMATOPHAGOIDES FARINAE 10000 [AU] in 1 mL

Az alkalmazás módja:

CUTANEOUS

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Standardized mite extract is indicated for use in the diagnosis of patients with a history of allergy to mites or house dust and for the treatment of patients with a history of mite allergy who have established sensitivity to mites by diagnostic skin testing. The use of mite extract for the above purposes should be made only by physicians with special familiarity and knowledge of allergy as described in a standard allergy textbook 10 . Injections of mite extract should not be administered in the presence of diseases characterized by a bleeding diathesis. Immunotherapy should not be started in patients until a specific diagnosis of Type I allergy to mite is made by a physician based on skin testing with this product. Other contraindications include: EXTREME SENSITIVITY TO MITE: Determined from previous anaphylaxis following skin testing, immunotherapy, or natural exposure. AUTOIMMUNE DISEASE: Individuals with autoimmune disease maybe at risk, due to the possibility of routine immunizations e

Termék összefoglaló:

Extract of D. farinae and D. pteronyssinus containing 5,000 and 10,000 Allergy Units per mL is supplied in 50% glycerol v/v in 10 mL, 30 mL and 50 mL vials. Extract containing 10,000 Allergy Units per mL is supplied in 50% glycerol v/v in dropper vials for scratch or prick-puncture testing. An equal v/v mixture of the two mites is offered in 10, 30 and 50 mL vial sizes at a concentration of 2,500 AU/mL or 5,000 AU/mL for each mite. See DESCRIPTION above for the complete list of the active and inactive ingredients of this product. Extract of D. farinae and D. pteronyssinus may be diluted in sterile buffered saline containing 0.4% phenol or in sterile buffered saline containing human serum albumin and 0.4% phenol.

Engedélyezési státusz:

Biologic Licensing Application

Termékjellemzők

HOUSE DUST MITE, DERMATOPHAGOIDES FARINAE- HOUSE DUST MITE,
DERMATOPHAGOIDES FARINAE INJECTION
HOUSE DUST MITE, DERMATOPHAGOIDES PTERONYSSINUS- HOUSE DUST MITE,
DERMATOPHAGOIDES PTERONYSSINUS INJECTION
ALLERMED LABORATORIES, INC.
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ALLERGENIC EXTRACT STANDARDIZED MITE _DERMATOPHAGOIDES FARINAE _AND
_DERMATOPHAGOIDES_
_PTERONYSSINUS_
WARNINGS
This product is intended for use by physicians who are experienced in
the administration of
allergens extracts or for use under the guidance of an allergy
specialist. The initial dose must be
based on skin testing as described in the dosage and administration
section of this insert. Patients
being switched from alum-absorbed or other types of precipitated
extracts or non-standardized
extracts to this extract should be started as though they were coming
under treatment for the first
time. Patients should be instructed to recognize adverse reaction
symptoms and cautioned to
contact the physician's office if symptoms occur. As with all
allergenic extracts, severe systemic
reactions may occur and in certain individuals these reactions may be
life-threatening or cause
death. Patients should be observed for at least 20 minutes following
treatment. Emergency
measures as well as personnel trained in their use should be
immediately available in the event of
a life-threatening reaction. Patients being switched from one lot of
extract to another from the
same manufacturer should have the dose reduced to 25 percent. Patients
receiving beta-blocking
drugs may be refractive to the usual dose of epinephrine, in the event
that epinephrine is required
to control an adverse allergic reaction to this product. This product
should never be injected
intravenously. See also the WARNINGS, and ADVERSE REACTIONS Sections
below.
DESCRIPTION
Mite extract is a sterile solution containing the extractables of mite
whole bodies in 0.25% sodium
chloride, 0.125% sodium bicarbonate, 50% glycerol by volume and 0.4%
phenol as a preservative. The
mites are grown on a medium of yeast and pork and are hand