STANDARDIZED MITE D FARINAE- dermatophagoides farinae injection, solution STANDARDIZED MITE D PTERONYSSINUS- dermatophagoides p

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Nyelv: angol

Forrás: NLM (National Library of Medicine)

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Letöltés Termékjellemzők (SPC)
10-08-2017

Aktív összetevők:

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

Beszerezhető a:

Allergy Laboratories, Inc.

INN (nemzetközi neve):

DERMATOPHAGOIDES FARINAE

Összetétel:

DERMATOPHAGOIDES FARINAE 10000 [AU] in 1 mL

Az alkalmazás módja:

PERCUTANEOUS

Terápiás javallatok:

Standardized mite extract is used for the diagnosis and treatment of allergic disease to mite. Diagnosis of allergic disease to mite is made through a combined medical history sufficiently complete to identify allergic symptoms to mite and identification of mite allergy by diagnostic skin testing. Hyposensitization therapy to mite is treatment for patients exhibiting allergic reactions to mite. Immunotherapy is intended for patients whose symptoms cannot be satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. (5) There are no known absolute contraindications to hyposensitization therapy. See precautions section for pregnancy risks. A patient should not be treated with allergens unless a history of symptoms and a positive skin test reaction have been demonstrated. Allergenic extracts should only be administered to patients that show symptoms of allergy or asthma. The physician must determine if the benefits outweigh the risks in using these products for tre

Engedélyezési státusz:

Biologic Licensing Application

Termékjellemzők

                                STANDARDIZED MITE D FARINAE- DERMATOPHAGOIDES FARINAE INJECTION,
SOLUTION
STANDARDIZED MITE D PTERONYSSINUS- DERMATOPHAGOIDES PTERONYSSINUS
INJECTION,
SOLUTION
ALLERGY LABORATORIES, INC.
----------
STANDARDIZED MITES
Oklahoma City, OK 73109
INSTRUCTIONS AND DOSAGE SCHEDULE FOR
STANDARDIZED ALLERGENIC
EXTRACTS MITE EXTRACT
_(Dermatophagoides farinae) (Dermatophagoides pteronyssinus)_
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.
Extracts standardized using the Allergy Unit may be more potent than
extracts based on the weight
to volume or PNU methods of expressing potency. Allergy Laboratories
extract is not directly
interchangeable with other allergenic extracts. The initial dose must
be based on skin testing as
described in the dosage and administration section of this insert.
Patients being switched from
other types of extracts to Allergy Laboratories 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 physicians office if reaction
symptoms occur. As with all
allergenic extracts, severe systemic reactions may occur. In certain
individuals these life
threatening reactions may be fatal. Patients should be observed for at
least 30 minutes
following treatment and emergency measures as well as personnel
trained in their use should be
immediately available in the event of a life threatening reaction.
This product should not be injected intravenously. Subcutaneous
injections are recommended.
Patients who are taking non-selective beta blockers may be more
reactive to allergens given for
testing or treatment and may be unresponsive to the usual doses of
epinephrine used to treat
allergic reactions.
Refer also to the warnings, precautions, adverse reactions and dosage
sections below.
DESCRIPTION
The standardized mite extract contains t
                                
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