CENTER-AL - BROMUS INERMIS POLLEN- bromus inermis pollen injection, suspension

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

BROMUS INERMIS POLLEN (UNII: 766QT72BK6) (BROMUS INERMIS POLLEN - UNII:766QT72BK6)

Tillgänglig från:

ALK-Abello, Inc.

INN (International namn):

BROMUS INERMIS POLLEN

Sammansättning:

BROMUS INERMIS POLLEN 10000 [PNU] in 1 mL

Administreringssätt:

SUBCUTANEOUS

Terapeutiska indikationer:

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. 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. A patient should not be immunized against a substance which the patient has not demonstrated symptoms and/or tissue-fixed IgE antibodies as demonstrated by skin testing. Immunotherapy should not be attempted in patients with active asthma, severe respiratory obstruction, or cardiovascular disease. There is some evidence, although inconclusive, that routine immunizations may exacerbate autoimmune diseases. Hyposensitization should be given cautiously to patients with this predisposition. The physician must w

Produktsammanfattning:

Therapeutic Center-Al  Allergenic Extracts, Alum Precipitated, are supplied in 10 mL and 30 mL vials, in concentrations of 10,000 PNU/mL and 20,000 PNU/mL. Prescription treatment sets for individual patients are also available. Center-Al  must be stored continuously at 2° to 8°C. DO NOT FREEZE. Diluent: Sterile Diluent for allergenic extracts (Phenol-Saline) is provided in vials of 4.5 mL, 9.0 mL, and 30 mL.  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.

Bemyndigande status:

Biologic Licensing Application

Produktens egenskaper

CENTER-AL - BROMUS INERMIS POLLEN- BROMUS INERMIS POLLEN INJECTION,
SUSPENSION
ALK-ABELLO, INC.
----------
ALUM PRECIPITATED EXTRACTS
DIRECTIONS FOR USE OF CENTER - AL® THERAPEUTIC
ALLERGENIC EXTRACTS ALUM PRECIPITATED
OF
POLLENS, MOLDS,
INHALANTS AND EPIDERMALS
DOSAGE BASED ON
PROTEIN NITROGEN CONTENT
WARNING
This allergenic extract is intended for use by physicians who are
experienced in the
administration of allergenic extracts for immunotherapy and the
emergency care of anaphylaxis, or
for use under the guidance of an allergy specialist. These 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. Patients being
switched from other types of extracts such as aqueous extracts,
glycerinated extracts, or alum
precipitated extracts from other suppliers to this allergenic 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 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 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.
Sensitive patients may experience severe anaphylactic reactions
resulting in respiratory
obstruction, shock, coma and/or death. Patients with unstable asthma
or steroid dependent
asthmatics and patients with underlying cardiovascular disease are at
greater risk to a fatal
outcome from a systemic allergic reaction. If treated, these high risk
patients should be started at
lower (more conservative) doses and be progressed more slowly to a
maintenance dose. Usually
this is a lower dose than for those patients without these
pr