Standardized Orchard Grass Pollen

STANDARDIZED ORCHARD GRASS POLLEN — dactylis glomerata pollen injection, solution
STANDARDIZED PERENNIAL RYE GRASS POLLEN — lolium perenne pollen injection, solution
STANDARDIZED TIMOTHY GRASS POLLEN — phleum pratense pollen injection, solution
STANDARDIZED REDTOP GRASS POLLEN — agrostis gigantea pollen injection, solution
STANDARDIZED KENTUCKY (JUNE) BLUEGRASS POLLEN — poa pratensis pollen injection, solution
STANDARDIZED MEADOW FESCUE GRASS POLLEN — festuca pratensis pollen injection, solution
STANDARDIZED SWEET VERNAL GRASS POLLEN — anthoxanthum odoratum pollen injection, solution
STANDARDIZED BERMUDA GRASS POLLEN — cynodon dactylon pollen injection, solution
Nelco Laboratories, Inc.

WARNINGS

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. For previously untreated patients, the initial dose must be based on skin testing as described in the dosage and administration section of this insert. Standardized Grass Pollen extract is NOT directly interchangeable with Grass Pollen extracts labeled in AU/mL, or with non-standardized Grass Pollen extracts.

This product should not be injected intravenously. Deep subcutaneous routes have proven to be safe. Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and/or death. (See Adverse Reactions)

Serious adverse reactions should be reported to Nelco Laboratories immediately and a report filed to: MedWatch, The FDA Medical Product Problem Reporting Program, at 5600 Fishers Lane, Rockville, Md. 20852-9787, call 1-800-FDA-1088.

Extreme caution should be taken when using allergenic extracts for patients who are taking beta-blocker medications. In the event of a serious adverse reaction associated with the use of allergenic extracts, patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodialators.(1) (See Precautions)

Allergenic extracts should be used with caution in patients with unstable or steroid-dependent asthma or with underlying cardiovascular disease. (See Contraindications)

DESCRIPTION

Standardized Grass Pollen Extracts include: Orchard (Dactylis glomerata) , Perennial Rye (Lolium perenne) , Timothy (Phleum pratense) , Redtop (Agrostis alba) , Kentucky (June) Bluegrass (Poa pratensis) , Bermuda (Cynodon dactylon) , Meadow Fescue (Festuca elatior) , Sweet Vernal (Anthoxanthum odoratum). The standardized grass pollen extract is prepared by extracting raw pollen material at a ratio of either 1:5 w/v, 1:6.66 w/v or 1:10 w/v in Cocas fluid containing 0.5% NaCl, 0.275% NaHCO3 , WFI and 0.4% phenol as preservative. Following extraction, a calculated amount of glycerin is added to make a 50%(v/v) glycerinated solution. Standardized Grass Pollen extracts have potency designations of 10,000 BAU/mL and 100,000 BAU/mL except Bermuda Grass (10,000 BAU/mL only). Extracts with a potency of 10,000 BAU/mL are diluted from the 100,000 BAU/mL lots with Glycerol Saline 50%(v/v). The Glycerol Saline 50%(v/v) solution consists of Glycerin and Salts and Buffered Diluent whose ingredients are 0.5% NaCl, 0.08% Na2 HPO4 , 0.036% KH2 PO4 , WFI and 0.4% phenol as a preservative. All extracts are aseptically filled in sterile containers. Standardized pollen extracts are intended for administration by prick-puncture or intradermal routes when used for diagnostic purposes and administered subcutaneously when used for immunotherapy injection.

Standardized grass pollen extracts labeled in BAU/mL are not interchangeable with grass pollen extracts labeled in AU/mL or with non-standardized grass pollen extracts. The Bioequivalent Allergy Unit (BAU), the potency unit used for all Standardized Pollen Extracts, replaces the previous unitage for these products. Bioequivalent Allergy Units were assigned to the FDA, Center for Biologics Evaluation and Research (CBER) reference extracts, based on quantitative intradermal skin test results. BAU’s are intended to assure that the labeled unitage of different allergenic extracts will correspond to the expected clinical response in sensitive patients. References labeled 10,000 BAU/mL can be diluted one half million fold to produce an intradermal sum of erythema diameter response of 50mm in highly puncture reactive subjects. 100,000 BAU/mL can be diluted 1:5 million fold to yield the same intradermal response.(2) The assignment of BAU/mL to standardized grass pollen extracts, is accomplished by an ELISA assay comparing the extract to the CBER reference.

Previously, the potency / concentration of grass mixtures was designated based on the manufacturing strength, e.g. 1:10 w/v or 1:20 w/v, or in PNU’s/mL. For grass mixtures containing standardized extracts, the potency will reflect the contribution of each individual component in the mixture, i.e., the actual potency of each component will be listed on a per mL basis. In addition, because the individual components may be cross-reactive, an additional caution statement, “due to cross reactivity, total potency may be 100,000 BAU/mL,” will be added to the label.

CLINICAL PHARMACOLOGY

The mode of action of allergenic extracts is still under investigation. The pharmacological action of allergenic extracts used diagnostically is based on the liberation of histamine and other substances when the allergen reacts with IgE antibodies attached to the mast cells. When allergenic extracts are used for therapeutic immunotherapy, the effect is an increase in immunoglobulin G (IgG) and an increased T suppresser lymphocyte which interferes with the allergic response.(3) Although immunotherapy may be considered as immunosuppression, in which the production of allergen-specific antibody is inhibited, the mechanism of the clinical effectiveness of immunotherapy remains under investigation. Assignment of BAU/mL potency designation was determined based on Puncture and Intradermal Data with CBER Grass References.(2)

Puncture & Intradermal Data with CBER Grass References

A. Puncture Data with 10,000 BAU/mL Grass Extracts (bifurcated needle)

Reference Pollen FDA Lot # N P Σ E (mm) Mean P Σ E (mm) Range P Σ W (mm) Mean P Σ W (mm) Range
Bermuda E4-Ber 15 90.3 43-123 15.7 7-31
June E3-Jkb 15 77.3 47-107 15.9 6-28
Meadow Fescue E4-Mf 15 81.1 57-115 11.9 7-22
Orchard E4-Or 15 84.3 57-111 14.1 9-19
Perennial Rye E10-Rye 15 92.3 73-135 17.5 6-36
Redtop E4-Rt 15 77.1 42-98 14.1 8-19
Sweet Vernal E4-Sv 15 81.2 28-123 15.7 8-30
Timothy E6-Ti 15 88.3 51-109 16.9 8-40

B. Intradermal Dose (BAU50 ) of CBER Grass References for 50 mm Sum of Erythema

Reference Pollen FDA Lot # BAU50 /mL Mean BAU50 /mL Range
Bermuda E4-Ber 0.02 0.4-0.0003
June E3-Jkb 0.02 0.1-0.004
Meadow Fescue E4-Mf 0.02 0.9-0.002
Orchard E4-Or 0.02 1.9-0.002
Perennial Rye E10-Rye 0.02 0.7-0.002
Redtop E4-Rt 0.02 0.8-0.004
Sweet Vernal E4-Sv 0.02 1.0-0.002
Timothy E6-Ti 0.02 0.6-0.002

C. Potency of Selected Glycerinated Non-Standardized Grasses distributed by Nelco Laboratories, Inc.

Extract Weight/ Volume # of Lots Range (BAU/mL)

* Note: These extracts were previously distributed.

Orchard 1:10 3 144,200-155,300
Bermuda 1:20; 1:10 3 7,800-12,560
Sweet Vernal 1:10 3 180,600-236-200
Timothy 1:10 2 99,100-110,200
Perennial Rye 1:20; 1:10 2 77,900-162,100
June 1:20; 1:10 3 79,000-111,500
Redtop 1:20; 1:10 3 179,900-300,500
Meadow Fescue 1:20 2 128,800-294,800

The potency of the glycerinated non-standardized grass extracts are equivalent to or exceed the potency for standardized grass pollen extract (Range for equivalence to CBER reference labeled 100,000 BAU/mL is 67,300 to 148,600, and range for equivalence to CBER reference labeled 10,000 BAU/mL is 6,730 to 14,860).

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