STANDARDIZED GRASS POLLEN, GRASS MIX 4 injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Jubilant HollisterStier LLC

INN (International Name):

POA PRATENSIS POLLEN

Composition:

POA PRATENSIS POLLEN 2500 [BAU] in 1 mL

Administration route:

PERCUTANEOUS

Therapeutic indications:

16, 17, 18, 20 Standardized glycerinated allergenic extracts in potencies of 10,000 BAU/mL and 100,000 BAU/mL are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific grass pollens. Concentrated extracts must be diluted prior to use in intradermal testing and immunotherapy. The selection of allergenic extracts to be used should be based on a thorough and carefully taken history of hypersensitivity, and confirmed by skin testing. 27, 28 10,000 BAU/mL dose form should be used initially for percutaneous testing. If negative, the 100,000 BAU/mL dose can be used. The use of mixed or unrelated antigens for skin testing is not recommended since, in the case of a positive reaction, it does not indicate which component of the mix is responsible for the reaction, while, in the case of a negative reaction, it fails to indicate whether the individual antigens at full concentration would give a positive reaction. Utilization of such mixes for

Product summary:

Standardized allergenic extracts of grass pollens are supplied for diagnostic and therapeutic use: Diagnostics: Extracts: Pollens* Prick/puncture tests, 10,000 BAU/mL and 100,000 BAU/mL [50% glycerin (v/v)] in 5 mL dropper vial. Intradermal Tests [Aqueous] of 100 BAU/mL in 5 mL vial, and 1,000 BAU/mL in 5 mL vial. (Intradermal test solutions may contain up to 5% glycerin.) *Bermuda grass, 10,000 BAU/mL is highest concentration. Bulk Therapeutics [50% glycerin (v/v)] in multiple dose vials: Extracts: Pollens* 10 mL vial, in strengths of 100,000 BAU/mL and 10,000 BAU/mL 30 mL vial, in strengths of 100,000 BAU/mL and 10,000 BAU/mL 50 mL vial, in strengths of 100,000 BAU/mL and 10,000 BAU/mL *Bermuda grass, 10,000 BAU/mL only.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

STANDARDIZED GRASS POLLEN, GRASS MIX 4- STANDARDIZED GRASS POLLEN,
GRASS MIX 4 INJECTION, SOLUTION
JUBILANT HOLLISTERSTIER LLC
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ALLERGENIC EXTRACTS STANDARDIZED GRASS POLLEN (GLYCERINATED)
WARNINGS
This product is intended for use only by licensed medical personnel
experienced in
administering allergenic extracts and trained to provide immediate
emergency
treatment in the event of a life-threatening reaction.
Allergenic extracts may potentially elicit a severe life-threatening
systemic reaction,
rarely resulting in death 1. Therefore, emergency measures and
personnel trained
in their use must be available immediately in the event of such a
reaction. Patients
should be instructed to recognize adverse reaction symptoms and
cautioned to
contact the physician's office if symptoms occur. See ADVERSE
REACTION, Section
3, of this insert for information regarding adverse event reporting.
Standardized glycerinated extracts may differ in potency from regular
extracts and
therefore, are not directly interchangeable with non-standardized
extracts, or other
manufacturers' products.
Note: BAU/mL Standardized grass pollens are not interchangeable with
any other
grass pollen products. This product should never be injected
intravenously.
Patients with cardiovascular diseases or pulmonary diseases such as
symptomatic
unstable, steroid-dependent asthma, and/or those who are receiving
cardiovascular drugs such as beta blockers, may be at higher risk for
severe
adverse reactions. These patients may also be more refractory to the
normal
allergy treatment regimen. Patients should be treated only if the
benefit of
treatment outweighs the risks.1
Refer also to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE
REACTIONS and OVERDOSE Sections for further discussion.
DESCRIPTION
The grass pollens available in standardized form are: Bermuda Grass
(_Cynodon_
_dactylon_), Orchard Grass (_Dactylis glomerata_), Perennial Ryegrass
(_Lolium perenne_),
Timothy Grass (_Phleum pratense_), Redtop Grass (_Agrostis alba_),
Kentucky Bluegra