CENTER-AL - DACTYLIS GLOMERATA POLLEN- dactylis glomerata pollen injection, suspension CENTER-AL - CARYA ILLINOINENSIS POLLEN-

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DACTYLIS GLOMERATA POLLEN (UNII: 83N78IDA7P) (DACTYLIS GLOMERATA POLLEN - UNII:83N78IDA7P)

Available from:

ALK-Abello, Inc.

INN (International Name):

DACTYLIS GLOMERATA POLLEN

Composition:

DACTYLIS GLOMERATA POLLEN 20000 [PNU] in 1 mL

Administration route:

SUBCUTANEOUS

Therapeutic indications:

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

Product summary:

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.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

CENTER-AL - DACTYLIS GLOMERATA POLLEN- DACTYLIS GLOMERATA
POLLEN INJECTION, SUSPENSION
CENTER-AL - CARYA ILLINOINENSIS POLLEN- CARYA ILLINOINENSIS
POLLEN INJECTION, SUSPENSION
CENTER-AL - AMARANTHUS RETROFLEXUS POLLEN- AMARANTHUS RETROFLEXUS
POLLEN INJECTION, SUSPENSION
CENTER-AL - PLANTAGO LANCEOLATA POLLEN- PLANTAGO LANCEOLATA
POLLEN INJECTION, SUSPENSION
CENTER-AL - POPULUS ALBA POLLEN- POPULUS ALBA POLLEN INJECTION,
SUSPENSION
CENTER-AL - AMBROSIA ACANTHICARPA POLLEN- AMBROSIA ACANTHICARPA
POLLEN INJECTION, SUSPENSION
CENTER-AL - AMBROSIA ARTEMISIIFOLIA POLLEN- AMBROSIA ARTEMISIIFOLIA
POLLEN INJECTION, SUSPENSION
CENTER-AL - AMBROSIA TRIFIDA POLLEN- AMBROSIA TRIFIDA POLLEN
INJECTION,
SUSPENSION
CENTER-AL - AMBROSIA PSILOSTACHYA POLLEN- AMBROSIA PSILOSTACHYA
POLLEN INJECTION, SUSPENSION
ALK-ABELLO, INC.
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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