Standardized Bermuda Grass Pollen
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Questions & Answers
Side Effects & Adverse Reactions
See WARNINGS box at the beginning of the instruction sheet.
Extracts standardized using the Bioequivalent Allergy Unit may be more or less potent than extracts based on AU/ml, weight to volume, or PNU methods of expressing potency. See Adverse Reactions section in this insert for a description of the possible local reactions and systemic reactions. Comparative skin tests can be performed to determine the relative potency before initial use of new extracts. DO NOT GIVE ALLERGY INJECTIONS INTRAVENOUSLY. Subcutaneous injections are recommended. Injections may produce large local reactions that may be painful to the patient. DO NOT GIVE FULL-STRENGTH INJECTIONS UNTIL COMPARATIVE SKIN TESTING IS PERFORMED. After inserting the needle, but before injecting extract, withdraw the plunger slightly. If blood appears in the syringe re-insert the needle at another site. Careful selection of dose and injection should prevent most systemic reactions.
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FDA Labeling Changes
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Uses
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 LABELED 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 grass pollen extracts for immunotherapy are available for previously treated patients to facilitate dose selection for safe switching from non-standardized to standardized extracts. Patients being treated with grass pollen extracts for the first time can be initially immunized with dilutions prepared from the 10,000 BAU/ml extract (see Dosage and Administration). 100,000 BAU/ml grass pollen extract can be administered if the patient tolerates the 10,000 BAU/ml extract.
Grass pollen immunotherapy is intended for patients whose grass allergic symptoms cannot be satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. (5)
History
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Other Information
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 recommended route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. Do not inject intravenously. The extract is sterile and contains 50% (v/v) glycerin as a preservative. Standardized grass pollen extracts are available in both 10,000 BAU/ml and 100,000 BAU/ml potencies, except for Bermuda which is only available in 10,000 BAU/ml. The source material of the standardized grass extracts are the grass pollens. The 100,000 BAU/ml grass pollen extracts are prepared by extracting pollen at a 1:10 w/v ratio then diluting if necessary to the appropriate range for 100,000 BAU/ml. The 10,000 BAU/ml grass pollen extracts are prepared by dilution of the 100,000 BAU/ml grass pollen extracts. The 10,000 BAU/ml Bermuda grass pollen extract is prepared by extracting Bermuda grass pollen at a 1:10 w/v ratio then diluting if necessary to the appropriate range for 10,000 BAU/ml.
The potency (in Bioequivalent Allergy Units per ml or BAU/ml) of standardized grass pollen extracts is determined by an in-vitro ELISA Competition assay (1) against CBER reference extracts and CBER reference serum pools distributed by the Center for Biologics Evaluation and Research, U S Food and Drug Administration. Potency based on Bioequivalent Allergy Units (BAU/ml) is printed on the label. FDA reference grass pollen extracts were assigned potency designations based on quantitative skin testing (2). The FDA reference extracts which can be diluted 1:500,000 fold intradermally to produce a sum of erythema diameter response of 50mm in highly puncture reactive subjects have been assigned 10,000 BAU/ml. References which can be diluted 1:5,000,000 fold intraderrnally to produce a sum of erythema diameter response of 50mm have been assigned 100,000 BAU/ml.
Sources
Standardized Bermuda Grass Pollen Manufacturers
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Allergy Laboratories, Inc.
![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.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Standardized Bermuda Grass Pollen | Allergy Laboratories, Inc.
DIAGNOSTIC SKIN TESTING: These products are used to determine a patient's sensitivity to specific antigens and aid in the diagnosis and treatment of atopic diseases. After a thorough history, a decision can be made as to which allergens will be appropriate to use for testing. The recommended procedure is to initially perform puncture tests, then follow with intradermal tests. For enhanced safety, scratch or puncture test with 10,000 BAU/ml before testing with 100,000 BAU/ml. See recommended dosage below:
* See Table B for information regarding range of BAU/ml that elicits a 50mm response for highly reactive patients.
The negative intradermal control used for the 100 BAU/ml concentration should contain 0.5% (v/v) glycerin. SCRATCH OR PUNCTURE TEST: Concentration BAU/ml Dosage Bermuda Grass 1 drop 10,000 Other Grasses 10,000 1 drop 100,000 1 drop INTRADERMAL TEST: Concentration BAU/ml Dosage ml When scratch or puncture test is negative: 100 0.02 When scratch or puncture test is positive: * 0.02 FREQUENCY OF ADMINISTRATION:The number of skin tests applied at one time will depend on the particular patient and their allergic history. These tests should be performed and observed in 15 to 20 minutes. Additional tests may be applied in sequence. Perform tests on the anterolateral aspect of the upper arm on an area that permits the effective application of a tourniquet proximal to the site of the test. The skin at the site of injection should be disinfected with rubbing alcohol before testing.
Puncture testing: Apply one drop of extract to the skin. Pierce the drop of extract and skin using a sterile hypodermic needle or vaccinating needle. Maintain the needle perpendicular to the skin surface and rock the needle back and forth to produce a small hole without bleeding. Do not rotate or gouge the needle. Remove needle from skin and wipe excess extract from skin surface.
Scratch testing: Using a scarifier or needle, make a scratch 1/16 inch long on the epidermis penetrating the outer cornified area but being careful not to draw blood. Apply one drop of extract to the scratch.
Intradermal testing: Use a separate sterile syringe (tuberculin type equipped with a 27 gauge by 3/8 inch needle with intradermal bevel) for each antigen. The tests are made by injecting 0.02ml of allergen into the epidermis. If the test has been performed properly, the solution should raise a bleb 2 to 3mm in diameter. If the bleb does not appear, the injection was made too deeply.
A negative control consisting of the same solution that the extract was prepared in, should be applied to one of the sites in the same manner as the tests being performed. For example, the negative intradermal control should contain 0.5% (v/v) glycerin, if a 100 BAU/ml concentration grass is used for intradermal testing. Histamine phosphate should be used as a positive control for evaluation of skin testing. Histamine phosphate is available from other manufacturers. See their directions for use, for recommended dosage and interpretation of results.
A positive reaction usually develops in 15 to 20 minutes. The positive response is a wheal and flare reaction that is larger than the negative control and judged on the size of the reaction. Scratch or puncture tests may not elicit as large and well defined reaction as the intradermal. (5)
The following grading system for intradermal testing is recommended (9):
Reaction Erythema Wheal 0 <5mm <5mm +/- 5-10mm 5-10mm 1+ 11-20mm 5-10mm 2+ 21-30mm 5-10mm 3+ 31-40mm 10-15mm or with pseudopods 4+ >40mm >15mm or with many pseudopodsIMMUNOTHERAPY:
The following are two methods of injection therapy:
1. Pre-seasonal in which treatment is begun three months before seasonal difficulty begins and brought to maintenance dose by injections 4 to 7 days apart and discontinued after that season ends.
2. Perennial treatment is the recommended mode of therapy in which the patient is, by injection therapy, brought up to tolerated maintenance dose and remains at that dose until amelioration of allergic symptoms occurs. Injections may be given at intervals of 4 to 7 days.
Allergenic extracts must be diluted before use. Normally immunotherapy can be started with a 1 BAU/ml dilution. If a patient appears to be extremely sensitive, based on skin testing results, dilutions of the extract can further be made before injections are started. See Table B for additional information. The following are suggested procedures for making a proper dilution series. Recommended diluents contain 0.9% sodium chloride and 0.4% phenol as a preservative. Dlluents with HSA (Human Serum Albumin) as a stabilizer can also be used. Allergenic extracts should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
TEN FOLD DILUTION SERIES: EXTRACT
VOLUME EXTRACT
CONCENTRATION BAU/ml DILUENT
VOLUME DILUTION
CONCENTRATION BAU/ml 1 part 100,000 + 9 parts = 10,000 1 part 10,000 + 9 parts = 1,000 1 part 1,000 + 9 parts = 100 1 part 100 + 9 parts = 10 1 part 10 + 9 parts = 1Perennial treatment may be started using the following dosage and dilution schedule. (Modified from Reference 10) This schedule is only illustrative and may not be applicable to all patients, since the degree of sensitivity to grass allergens differs among individuals. The dose administered must be adjusted based on the patient's sensitivity and tolerance. Initial dose can be based on end point titration using a dose that elicits a 1-2+ reaction. Maintenance dose is based on patient tolerance.
Dose # Dose Volume (ml) Concentration 1 0.05 1 BAU/ml 2 0.10 3 0.20 4 0.30 5 0.40 6 0.50 7 0.05 10 BAU/ml 8 0.10 9 0.20 10 0.30 11 0.40 12 0.50 13 0.05 100 BAU/ml 14 0.10 15 0.20 16 0.30 17 0.40 18 0.50 19 0.05 1,000 BAU/ml 20 0.10 21 0.20 22 0.30 23 0.40 24 0.50 25 0.05 10,000 BAU/ml 26 0.10 27 0.20 28 0.30 29 0.40 30 0.50 31 0.05 100,000 BAU/ml 32 0.10 33 0.20 34 0.30 35 0.40Gradually increase the dose as outlined in the schedule. If you give a dose that causes a mild local reaction (manifested by warmth or redness) repeat the same dose. If the reaction is severe or systemic (manifested as hives, asthma, or hay fever) drop back a dose in schedule and build again. If a severe local reaction or a systemic reaction is again encountered, this should be considered more than the maximum tolerance for this patient. The maintenance dose is the largest dose that relieves symptoms without producing local reactions. The size and interval of doses will vary and can be adjusted as necessary. The normal interval between doses is 4 to 7 days. The usual duration of treatment has not been established. A period of two or three years of injection therapy constitutes an average minimum course of treatment.
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