SAROCLADIUM STRICTUM injection, solution ALTERNARIA ALTERNATA injection, solution ASPERGILLUS FUMIGATUS injection, solution A

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

SAROCLADIUM STRICTUM (UNII: 3F36V0451W) (SAROCLADIUM STRICTUM - UNII:3F36V0451W)

から入手可能:

ALK-Abello, Inc.

INN（国際名）:

SAROCLADIUM STRICTUM

構図:

SAROCLADIUM STRICTUM 0.05 g in 1 mL

投与経路:

PERCUTANEOUS

適応症:

Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust, molds, animal danders, various other inhalants, and in situations where the offending allergen cannot be avoided. Prior to initiation of therapy, the 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 easily be avoided. A patient should not be immunized with preparations of allergens to which the patient has not demonstrated symptoms, IgE antibodies, positive skin tests, or properly controlled challenge testing. In most cases, immunotherapy is not indicated for those allergens that can be eliminated or minimized by environmental control. Patients on beta-blockers are not candidates for immunotherapy, as they can be non-responsive to beta-agonists that may be required to reverse a systemic reaction (also see WARNINGS AND ADVERSE

製品概要:

10 mL and 50 mL, single antigens or specified mixtures, potency expressed in PNU/mL (up to and including 100,000 PNU/mL) or W/V (up to and including 1:10 W/V), aqueous or in 50% glycerin, to be diluted prior to use. 1:10 w/v short ragweed extracts contain ≥ 300 units/mL of AgE. STORAGE: To maintain stability of allergenic extracts, proper storage conditions are essential. Bulk concentrates and diluted extracts are to be stored at 2° to 8° 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.

認証ステータス:

Biologic Licensing Application

製品の特徴

SAROCLADIUM STRICTUM- SAROCLADIUM STRICTUM INJECTION, SOLUTION
ALTERNARIA ALTERNATA- ALTERNARIA ALTERNATA INJECTION, SOLUTION
ASPERGILLUS FUMIGATUS- ASPERGILLUS FUMIGATUS INJECTION, SOLUTION
AUREOBASIDIUM PULLULANS- AUREOBASIDIUM PULLULANS VAR. PULLUTANS
INJECTION, SOLUTION
BIPOLARIS SOROKINIANA- COCHLIOBOLUS SATIVUS INJECTION, SOLUTION
BOTRYTIS CINEREA- BOTRYTIS CINEREA INJECTION, SOLUTION
CANDIDA ALBICANS- CANDIDA ALBICANS INJECTION, SOLUTION
CLADOSPORIUM CLADOSPORIOIDES- CLADOSPORIUM CLADOSPORIOIDES INJECTION,
SOLUTION
EPICOCCUM NIGRUM- EPICOCCUM NIGRUM INJECTION, SOLUTION
GIBBERELLA PULICARIS- GIBBERELLA ZEAE INJECTION, SOLUTION
MUCOR PLUMBEUS- MUCOR PLUMBEUS INJECTION, SOLUTION
PENICILLIUM NOTATUM- PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM
INJECTION, SOLUTION
RHODOTORULA MUCILAGINOSA- RHODOTORULA MUCILAGINOSA INJECTION, SOLUTION
SACCHAROMYCES CEREVISIAE- SACCHAROMYCES CEREVISIAE INJECTION, SOLUTION
TRICHOPHYTON MENTAGROPHYTES- TRICHOPHYTON MENTAGROPHYTES INJECTION,
SOLUTION
ALK-ABELLO, INC.
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GLYCERINATED THERAPEUTIC MOLD
DIRECTIONS FOR USE OF
THERAPEUTIC ALLERGENIC EXTRACTS
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.
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. In certain individuals, these reactions may
rarely 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. Patients with unstable asthma or steroid dependent
asthmatics and patients with
underlying cardiovascular disease are at greater risk. Adverse events
are to be reported to Med
Watch (1-800-FDA-1088), Adverse Event Reporting , Food