STANDARDIZED MITE DERMATOPHAGOIDES FARINAE injection, solution STANDARDIZED MITE DERMATOPHAGOIDES PTERONYSSINUS injection, solu

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Nelco Laboratories, Inc.

INN (Међународно име):

DERMATOPHAGOIDES FARINAE

Састав:

DERMATOPHAGOIDES FARINAE 10000 [AU] in 1 mL

Пут администрације:

SUBCUTANEOUS

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Standardized mite allergenic extracts are intended for use in the diagnosis and therapy of D.farinae and D.pteronyssinus mite allergy, as established by allergy history and skin test reactivity (6,10) . Standardized Mite extracts are not interchangeable with non standardized mite extracts. To select patients for a confirmation of allergic disease diagnosis and/or treatment with allergen extracts, screening tests should be done using in vivo identification testing methods (i.e. scratch or intradermal testing).(13) Standardized mite extract containing equal parts of D.farinae and D.pteronyssinus is intended for therapy only. The use of standardized mites extract is indicated for hypersensitization treatment and may be used as part of the over-all management of the allergic patient. This treatment is particularly to be recommended when a patient's sensitivity to mite has been determined initially by scratch or intradermal skin tests. This product should not be used if the patient has asthma, cardiovascular disea

Резиме производа:

Diagnostic Allergens- Scratch or Prick test: 10,000 AU/mL, 50% glycerin in 5 mL dropper vials. Intradermal test- 100 AU/mL in 5 mL or 10 mL sterile multiple dose vials. Therapeutic allergens - In 5 mL, 10 mL, 50 mL multiple dose vials as individual allergens, stock mixture containing 5000 AU/mL of D. farinae plus 5000 AU/mL of D. pteronyssinus, or mixture prescribed by physician. Dilution's of concentrate can be made with either buffered diluent with 0.4% phenol or 50% glycerin (v/v) with salts.

Статус ауторизације:

Biologic Licensing Application

Карактеристике производа

STANDARDIZED MITE DERMATOPHAGOIDES FARINAE - STANDARDIZED MITE
DERMATOPHAGOIDES FARINAE INJECTION, SOLUTION
STANDARDIZED MITE DERMATOPHAGOIDES PTERONYSSINUS - STANDARDIZED MITE
DERMATOPHAGOIDES PTERONYSSINUS INJECTION, SOLUTION
NELCO LABORATORIES, INC.
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ALLERGENIC EXTRACT
WARNINGS
Standardized Allergenic Extract is intended for use by physicians who
are experienced in the
administration of standardized (AU/mL) allergenic extracts for
immunotherapy and the emergency
care of anaphylaxis, or for use under the guidance of an allergy
specialist. Standardized
allergenic extracts are 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 extract to
standardized allergenic extracts
should be started as though they were coming under treatment for the
first time. Standardized Mite
extract is NOT directly interchangeable with non-standardized Mite
extract.
This product should not be injected intravenously. Deep subcutaneous
routes have proven to be
safe. Sensitive patients may experience severe anaphylactic reactions
resulting in respiratory
obstruction, shock, coma and/or death.
Patients should be observed for at least 30 minutes
following treatment and emergency measures and personnel trained in
their use should be
immediately available in the event of a life threatening reaction.
(SEE PRECAUTIONS)
Allergenic extracts may be used with caution for patients with
unstable or steroid-dependent
asthma or with underlying cardiovascular disease. (CONTRAINDICATIONS)
Extreme caution should be taken when using allergenic extracts for
patients who are taking beta-
blocker medications. In the event of a serious adverse reaction
associated with the use of
allergenic extracts, patients receiving beta-blockers may not be
responsive to epinephrine or
inhaled bronchodialators.
Serious adverse reactions should be reported to Nelco Laboratories
immediately and a repo