MIX OF 5 STANDARD GRASS POLLEN- agrostis gigantea pollen, anthoxanthum odoratum pollen, dactylis glomerata pollen, phleum praten

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG) (PHLEUM PRATENSE POLLEN - UNII:65M88RW2EG), DACTYLIS GLOMERATA POLLEN (UNII: 83N78IDA7P) (DACTYLIS GLOMERATA POLLEN - UNII:83N78IDA7P), POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (POA PRATENSIS POLLEN - UNII:SCB8J7LS3T), AGROSTIS GIGANTEA POLLEN (UNII: HU8V6E7HOA) (AGROSTIS GIGANTEA POLLEN - UNII:HU8V6E7HOA), ANTHOXANTHUM ODORATUM POLLEN (UNII: 2KIK19R45Y) (ANTHOXANTHUM ODORATUM POLLEN - UNII:2KIK19R45Y)

Tilgængelig fra:

ALK-Abello, Inc.

INN (International Name):

PHLEUM PRATENSE POLLEN

Sammensætning:

PHLEUM PRATENSE POLLEN 20000 [BAU] in 1 mL

Indgivelsesvej:

PERCUTANEOUS

Terapeutiske indikationer:

Indicated use of allergenic extracts is for the diagnosis and treatment (hyposensitization therapy) of patients who experience allergic symptoms due to exposure to grass pollen and who exhibit type I skin sensitivity when tested to those specific allergens. 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. For previously untreated patients, prior to the initiation of therapy, clinical sensitivity to the standardized grass pollen extract 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. 10,000 BAU/mL extracts are indicated for percutaneous testing. If negative, the 100,000 BAU/mL dose may be used. Availability of 10,000 and 100,000 BAU/mL dosages facilitate safe

Produkt oversigt:

For percutaneous testing, 5 mL vial, 10,000 BAU/mL and 100,000 BAU/mL (except Bermuda grass 10,000 BAU/mL only) in glycerin 50% (v/v). For immunotherapy, 10 mL, 30 mL, and 50 mL vials 10,000 BAU/mL in glycerin 50% (v/v), or 10 mL, 30 mL and 50 mL vials 100,000 BAU/mL in glycerin 50% (v/v). Bermuda is available only at 10,000 BAU/mL. 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.

Autorisation status:

Biologic Licensing Application

Produktets egenskaber

MIX OF 5 STANDARD GRASS POLLEN- AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM
ODORATUM
POLLEN, DACTYLIS GLOMERATA POLLEN, PHLEUM PRATENSE POLLEN AND POA
PRATENSIS POLLEN INJECTION,
SOLUTION
MIX OF 6 STANDARD GRASS POLLEN- AGROSTIS GIGANTEA POLLEN, DACTYLIS
GLOMERATA POLLEN,
FESTUCA PRATENSIS POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE
POLLEN AND POA PRATENSIS
POLLEN INJECTION, SOLUTION
MIX OF 7 STANDARD GRASS POLLEN- AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM
ODORATUM
POLLEN, DACTYLIS GLOMERATA POLLEN, FESTUCA PRATENSIS POLLEN, LOLIUM
PERENNE POLLEN, PHLEUM
PRATENSE POLLEN AND POA PRATENSIS POLLEN INJECTION, SOLUTION
GRASS MIX 4-S- AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM POLLEN,
DACTYLIS GLOMERATA
POLLEN, FESTUCA PRATENSIS POLLEN, LOLIUM PERENNE POLLEN, PHLEUM
PRATENSE POLLEN AND POA PRATENSIS
POLLEN INJECTION, SOLUTION
ALK-ABELLO, INC.
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STANDARDIZED GRASS 5ML
DIRECTIONS FOR USE OF ALLERGENIC EXTRACTS
STANDARDIZED GRASS POLLENS
WARNING
Standardized allergenic extract is intended for use by physicians who
are experienced in the
administration of standardized (BAU/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 initial dose of standardized extract
must be based on skin testing as
described in the warnings, dosage and administration section of this
insert.
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 at least 20 - 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