STANDARDIZED MITE, MIXED- dermatophagoides farinae and dermatophagoides pteronyssinus injection, solution

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

DERMATOPHAGOIDES FARINAE (UNII: PR9U2YPF3Q) (DERMATOPHAGOIDES FARINAE - UNII:PR9U2YPF3Q), DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K) (DERMATOPHAGOIDES PTERONYSSINUS - UNII:57L1Z5378K)

Доступно од:

ALK-Abello, Inc.

INN (Међународно име):

DERMATOPHAGOIDES FARINAE

Састав:

DERMATOPHAGOIDES FARINAE 5000 [AU] in 1 mL

Пут администрације:

PERCUTANEOUS

Терапеутске индикације:

This product is indicated for the diagnosis and treatment of hypersensitivity in patients with symptoms compatible with dust mite allergy. Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants, in situations where the offending allergen cannot be avoided. Mixtures of standardized mite (D. farinae and D. pteronyssinus) should be considered for treatment of patients who are sensitive to both species. Prior to the initiation of therapy, clinical sensitivity should be established by careful evaluation of the patient's history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can be easily avoided. There are no known absolute contraindications to immunotherapy. However, a patient should not be immunized with preparations of allergens to which the patient has not demonstrated symptoms and positive skin tests. In most case

Резиме производа:

For percutaneous testing, 5 mL vial, 10,000 AU/mL in glycerin 50% (V/V). For immunotherapy, 10 mL, 30 mL and 50 mL vials of bulk concentrate, 10,000 AU/mL in glycerin 50% (V/V). STORAGE: To maintain stability of allergenic extracts, proper storage conditions are essential. Bulk concentrates and diluted extracts are to be stored at 2o to 8o C even during use. Bulk or diluted extracts are not to be frozen. Do not use after the expiration date shown on the vial label.

Статус ауторизације:

Biologic Licensing Application

Карактеристике производа

STANDARDIZED MITE, MIXED- DERMATOPHAGOIDES FARINAE AND
DERMATOPHAGOIDES
PTERONYSSINUS INJECTION, SOLUTION
ALK-ABELLO, INC.
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STANDARDIZED MIXED MITE 5ML
ALLERGENIC EXTRACT
STANDARDIZED MITE
(DERMATOPHAGOIDES FARINAE AND DERMATOPHAGOIDES PTERONYSSINUS)
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
allergenic extracts of the
same labeled potency from different manufacturers. The patient must be
re-evaluated with the
newly selected extract. 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
standardized allergenic extracts 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 reaction symptoms occur. As with
all allergenic extracts,
severe systemic reactions may occur. Patients with unstable asthma or
steroid dependent
asthmatics and patients with underlying cardiovascular disease are at
greater risk. In certain
individuals, these life-threatening reactions may result in death.
Patients should be observed for
20 to 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. Deep subcutaneous
routes have proven to be
safe. See the warnings, precautions, adverse reactions and over-dosage
sections below.
Sensitive patients may experience severe anaphylactic reactions
resulting in respiratory
obstruction, shock, coma and/or death.
Patients receiving beta-blockers may not be responsive to ep