STANDARDIZED BERMUDA GRASS POLLEN- cynodon dactylon pollen injection, solution STANDARDIZED KENTUCKY BLUEGRASS POLLEN- poa prat

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10)

Dostopno od:

Allergy Laboratories, Inc.

INN (mednarodno ime):

CYNODON DACTYLON POLLEN

Sestava:

CYNODON DACTYLON POLLEN 10000 [BAU] in 1 mL

Pot uporabe:

PERCUTANEOUS

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

      Standardized grass pollen extracts are used for the diagnosis and treatment of allergic disease to grass pollen. The standardized (Bioequivalent Allergy Unit) extract in these vials is designed primarily for the physician equipped to prepare dilutions and mixtures as required. STANDARDIZED GRASS POLLEN EXTRACTS L A BELED IN BAU/ml ARE NOT INTERCHANGEABLE WITH GRASS POLLEN EXTRACTS LABELED IN AU/ml OR WITH NON-STANDARDIZED (WEIGHT/VOLUME) GRASS POLLEN EXTRACTS. Patients being switched from other types of extracts to Allergy Laboratories should have their dose adjusted. Diagnosis of allergic disease to these grasses is made through a combined medical history sufficiently complete to identify allergic symptoms to grass pollen and identification of grass allergy by diagnostic skin testing. It is recommended that diagnostic skin testing (scratch or puncture) be performed with 10,000 BAU/ml grass pollen extracts before testing with 100,000 BAU/ml grass pollen extracts. 10,000 BAU/mL and 100,000 BAU/ml gras

Povzetek izdelek:

      Bulk extract (stock concentrate) in 50% (v/v) glycerin containing 10,000 BAU/ml or 100,000 BAU/ml is supplied in 10ml, 30ml, and 50ml vials. Bermuda Grass bulk extract is available in 10,000 BAU/ml only. Scratch testing for Bermuda Grass in 50% (v/v) glycerin containing 10,000 BAU/ml is supplied in 2ml dropper vials. Scratch testing for the other grasses in 50% (v/v) glycerin containing 10,000 BAU/ml or 100,000 BAU/ml is supplied in 2ml dropper vials. Intradermal testing (aqueous) for all standardized grasses containing 100 BAU/ml is supplied in 5ml vials.

Status dovoljenje:

Biologic Licensing Application

Lastnosti izdelka

STANDARDIZED BERMUDA GRASS POLLEN- CYNODON DACTYLON POLLEN INJECTION,
SOLUTION
STANDARDIZED KENTUCKY BLUEGRASS POLLEN- POA PRATENSIS POLLEN
INJECTION,
SOLUTION
STANDARDIZED MEADOW FESCUE GRASS POLLEN- FESTUCA ELATIOR POLLEN
INJECTION,
SOLUTION
STANDARDIZED ORCHARD GRASS POLLEN- DACTYLIS GLOMERATA POLLEN
INJECTION, SOLUTION
STANDARDIZED REDTOP GRASS POLLEN- AGROSTIS ALBA POLLEN INJECTION,
SOLUTION
STANDARDIZED PERENNIAL RYEGRASS GRASS POLLEN- LOLIUM PERENNE POLLEN
INJECTION,
SOLUTION
STANDARDIZED SWEET VERNAL GRASS POLLEN- ANTHOXANTHUM ODORATUM
POLLEN INJECTION, SOLUTION
STANDARDIZED TIMOTHY GRASS POLLEN- PHLEUM PRATENSE POLLEN INJECTION,
SOLUTION
ALLERGY LABORATORIES, INC.
----------
STANDARDIZED GRASSES
ALLERGY LABORATORIES, INC.
Oklahoma City OK 73109
INSTRUCTIONS AND DOSAGE SCHEDULE FOR
STANDARDIZED ALLERGENIC EXTRACTS
BERMUDA GRASS POLLEN _(Cynodon dactylon)_
KENTUCKY BLUE GRASS POLLEN _(Poa pratensis)_
MEADOW FESCUE POLLEN _(Festuca elatior)_
ORCHARD GRASS POLLEN _(Dactylis glomerata)_
REDTOP GRASS POLLEN _(Agrostis alba)_
PERENNIAL RYE GRASS POLLEN _(Lolium perenne)_
SWEET VERNAL GRASS POLLEN _(Anthoxanthum odoratum)_
TIMOTHY GRASS POLLEN _(Phleum pratense)_
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.
STANDARDIZED GRASS POLLEN EXTRACTS LABELED IN BAU/ML ARE NOT
INTERCHANGEABLE WITH GRASS POLLEN EXTRACTS LABELED IN AU/ML OR
WITH NON-STANDARDIZED (WEIGHT/VOLUME) GRASS POLLEN EXTRACTS. For
guidance in selecting dose, refer to Table A in the Clinical
Pharmacology section that describes
the potency of non-standardized grass pollen extracts. Comparative
skin tests can be performed to
determine the relative potency before initial use of new extracts. For
previously untreated patents,
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