Standardized Orchard Grass Pollen
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Questions & Answers
Side Effects & Adverse Reactions
Concentrated extracts must be diluted with sterile diluent prior to first use on a patient for treatment or intradermal testing.
DO NOT INJECT INTRAVENOUSLY.
All concentrates of allergenic extracts have the ability to cause serious local and systemic reactions including death in sensitive patients.(3)(See Adverse Reactions)
Standardized Pollen extracts should be used with caution when treating patients who exhibit hypersensitivity to standardized pollen extracts as confirmed by diagnostic testing.
An allergenic extract should be temporarily withheld from patients or the dose of the extract adjusted downward if any of the following conditions exist: (1) Severe symptoms of rhinitis and/or asthma (2) Infections or flu accompanied by fever and (3) Exposure to excessive amounts of clinically relevant allergen prior to a scheduled injection.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Standardized Pollen Extract is intended for use in the diagnosis and therapy of pollen allergic patients as established by allergy history and skin test reactivity. 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 10,000 BAU/mL dose form is indicated for percutaneous testing. If negative, 100,000 BAU/mL dose form can be used for percutaneous testing. For immunotherapy, availability of 10,000 and 100,000 BAU/mL dosages facilitates safe switching. (See Dosage & Administration)
The use of standardized grass pollen extracts is indicated for hyposensitization treatment and may be used as part of the over-all management of the allergic patient. Treatment of grass sensitive patients consists of using specific standardized grass products of up to and including doses of 100,000 BAU/mL (up to 10,000 BAU/mL for Bermuda grass) or stock mixtures of standardized grass products. Stock mixtures of standardized grass extracts are particularly useful in hyposensitization treatment when multiple allergies to grasses are diagnosed. For previously untreated patients, the 10,000 BAU/mL concentrates can be used to formulate dosages. If tolerated, the concentrates can be inceased to 100,000 BAU/mL dose formulation.
History
There is currently no drug history available for this drug.
Other Information
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% Na2HPO4, 0.036% KH2PO4, 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.
Sources
Standardized Orchard Grass Pollen Manufacturers
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Nelco Laboratories, Inc.
![Standardized Orchard Grass Pollen Injection, Solution Standardized Perennial Rye Grass Pollen Injection, Solution Standardized Timothy Grass Pollen Injection, Solution Standardized Redtop Grass Pollen Injection, Solution Standardized Kentucky (June) Bluegrass Pollen Injection, Solution Standardized Meadow Fescue Grass Pollen Injection, Solution Standardized Sweet Vernal Grass Pollen Injection, Solution Standardized Bermuda Grass Pollen Injection, Solution [Nelco Laboratories, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Standardized Orchard Grass Pollen | Nelco Laboratories, Inc.
It is imperative that the physician determine a safe initial dose. Patients being switched from one lot of Standardized Pollen to another lot of Standardized Pollen (from the same or different manufacturers) should have the initial dose from the new lot reduced by 75%. For patients being switched from non-standardized extract to a standardized extract, the selection of dose needs to be based on the dose of the extract currently administered and the relative potency with regards to the standardized extract. (See Clinical Pharmacology Table C for a comparison of standardized and non-standardized pollen extracts). Side by side comparison of wheal and erythema by skin testing of standardized and non-standardized extract can be carried out to determine comparability of doses selected.
For safe and effective use of allergenic extracts, sterile solutions, vials, syringes, etc. should be used and aseptic precautions followed when making dilution's and giving injections. The usual precautions to be observed in administering extracts are necessary. A sterile tuberculin syringe graduated in 0.1mL units to measure each dose for the prescribed dilution should be used.
After therapeutic injections patients should always be observed for at least 30 minutes. If adverse reactions appear, the next therapeutic injection of extract should be reduced to the dose which does not elicit a reaction and subsequent doses increased more slowly.
Recommended dosage and range: (Scratch or Prick tests)
The general method of making a scratch test is to first scarify the skin and then apply a drop of extract to the scratch. Make scarifications at least 2.5 cm apart. Hold the scarifier between thumb and index finger, press the sharp edge of the instrument against the skin and twirl instrument rapidly. The scratch should disrupt the outer layers of epidermis but should not produce immediate oozing of blood. One drop (0.05mL) of extract is rubbed or applied into each scratch. Always apply a control scratch with each test set. Sterile Diluent (for a negative control) is used in exactly the same way as an active test extract. Histamine may be used as a positive control. Scratch or prick test sites should be examined at 15 and 30 minutes. To prevent excessive absorption, wipe off antigens producing large reactions as soon as the wheal appears. Record the size of the reaction.
The concentration of Standardized Pollen extract for Scratch or Prick-puncture testing is prepared using 10,000 BAU/mL. If negative, 100,000 BAU/mL can be used to determine sensitivity of the patient.
Recommended dosage and range: (Intradermal tests)
Patients with a negative scratch or prick-puncture test:
Patients who do not react to a valid scratch or prick- puncture test should be tested intradermally with 0.05mL of a 50 BAU/mL extract solution. If this test is negative, a second intradermal test may be performed using a 100 BAU/mL extract dilution. The negative puncture test control must be diluted appropriately for intradermal use.
To prepare a 50 BAU/mL dilution from Nelco's
10,000 BAU/mL vial:
Take 5.0 mL of the 10,000 BAU/mL + 5.0mL of diluent
equals Vial A at 5,000 BAU/mL.
Take 1.0 mL of Vial A + 9.0 mL diluent equals
Vial B at 500 BAU/mL.
Take 1.0 mL of Vial B + 9.0 mL diluent equals
Vial C at 50 BAU/mL.
Patients tested only by the intradermal method: (See table B) Patients being suspected of being highly allergic should be tested with 0.05 mL of a 0.1 BAU/mL dilution. A negative test should be followed by repeat tests using progressively stronger concentrations until the maximal recommended strength of 100 BAU/mL is reached. The negative puncture test control must be diluted appropriately for intradermal use. To prepare this dilution follow the tenfold dilution series chart for therapeutic allergens.
Skin tests are graded in terms of the wheal and erythema response noted at 10 to 20 minutes. Wheal and erythema size may be recorded by actual measurement as compared with positive and negative controls.
Preparation Instructions: To prepare a dilution for intradermal and therapeutic use, one starts with 10,000 BAU/mL stock concentrate and makes a 1:10 dilution by adding 1.0 mL of the concentrate to 9.0mL of sterile diluent. Subsequent dilutions are made in similar manner.
TEN-FOLD DILUTION SERIES Dilution Extract Diluent mL BAU/mL 0 Concentrate 0 10,000 1 1 mL concentrate 9 1,000 2 1 mL dilution #1 9 100 3 1 mL dilution #2 9 10 4 1 mL dilution #3 9 1 5 1 mL dilution #4 9 0.1 6 1 mL dilution #5 9 0.01Recommended dosage and range: (Therapeutic)
Dosage of allergenic extracts is a highly individualized matter and varies according to the degree of sensitivity of the patient, the clinical response and tolerance to the extract administered during the injection regimen. The dosage of allergenic extract does not vary significantly with the respiratory allergic disease under treatment. In patients who appear to be highly sensitive by history and skin test, the initial dose of the extract should be 0.05mL of 5 BAU/mL which results in a dosage of 0.25 BAU. Patients with lesser sensitivity may be started using 1 BAU/mL. The amount of allergenic extract is increased at each injection by not more than 50%-100% of the previous amount, and the next increment is governed by the response to the last injection. Any evidence of systemic reaction is an indication for a significant reduction (at least 50%) in the subsequent dose. Any evidence of a local or generalized reaction requires a reduction in dosage. After therapeutic injections, patients should always be observed for at least 20 minutes. If adverse reactions appear, the next therapeutic injection of extract should be reduced to the dose which dose not elicit a reaction and subsequent doses increased more slowly. The upper limits of dosage have not been established. Doses larger than 0.2 mL of 10,000 BAU/mL may be painful due to glycerin content. Dosage use of up to 100,000 BAU/mL is determined by patient response and administered at the discretion of the physician.
Suggested Dosage Charts *(Note Disclaimer)
*This is a suggested dose chart only. Dose regimen has not been subjected to adequate and well controlled studies to determine safety and efficacy.
Please read entire instructions before commencing immunotherapy. Observe patients for 30 minutes after an injection. Note: Certain individuals may not tolerate this suggested schedule. The physician may need to adjust both the dosage and interval accordingly.
Suggested Treatment Schedule Vial # Injection # Volume (mL) 1 (5 BAU/mL) 1 0.05 1 2 0.10 1 3 0.15 1 4 0.20 1 5 0.30 1 6 0.40 1 7 0.50 2 (50 BAU/mL) 8 0.05 2 9 0.10 2 10 0.15 2 11 0.20 2 12 0.30 2 13 0.40 2 14 0.50 3 (500 BAU/mL) 15 0.05 3 16 0.10 3 17 0.15 3 18 0.20 3 19 0.30 3 20 0.40 3 21 0.50 4 (5,000 BAU/mL) 22 0.05 4 23 0.07 4 24 0.10 4 25 0.15 4 26 0.20 4 27 0.25 4 28+++ 0.25Note: Maintenance dose is that dose which provides symptomatic relief or the strongest dose that can be tolerated by the patient. Therefore, a physician must determine each patient's maintenance dose.
Intervals between doses: The optimal interval between doses of allergenic extract has not been definitely established. However, as it is customary practiced, injections are given once or twice per week until the maintenance dose of extract is reached. At this time, the injection interval may be increased to 2 weeks, then 3 weeks and finally to 4 weeks. If the patient does not return for 6-8 weeks after the last injection, the dose should be reduced to 25% of the last dose. If longer than 8 weeks, a dose reduction of 1,2, or 3 dilutions may be made depending on a consideration of the components and the patient's sensitivity.(3) The dosage and the interval between injections may need to be modified according to the clinical response of the patient. When switching patients to a new extract the initial dose should be reduced 3/4 so that 25% of previous dose is administered.
Duration of Treatment: 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.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
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