Bermuda Grass
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Questions & Answers
Side Effects & Adverse Reactions
See warnings at the beginning of this package insert. Standardized extracts may be more, less, or equivalently potent compared to non-standardized extracts (See table I).
Conversion from non-standardized to standardized Grass Pollen Extracts:
There is no one specific formula to convert immunotherapy patients from non-standardized to standardized extracts. However, you may wish to consider the following as part of your overall plan:
A. Time your conversion outside of the height of the grass pollen season.
B. Table I describing potency of non-standardized extracts in CLINICAL PHARMOCOLOGY section can be used as a guide in selection dose.
CAUTION: By the very nature of non-standardized extracts individual lots may vary more than 10-fold from the average value expressed in these tables. Further, you must consider the rapid decline in potency of non-glycerinated concentrates or aqueous dilutions of glycerinated concentrates of grass pollen extract. The BAU/mL expressed in the tables, therefore, may be overstated when compared to actual patient treatment extracts.
1. Refer to the table in the CLINICAL PHARMACOLOGY section and based on the current w/v or PNU determine an approximate BAU concentration that would be about 1/10 the non-standardized dose that the patient is currently receiving. To compare dose selection by puncture and intradermal testing, compare their wheal and erythema responses. If the reaction to the standardized is equal to or less than the non-standardized, proceed with immunotherapy beginning with 0.05 mL of the standardized extract concentration tested, and proceed to maintenance as described in the DOSAGE AND ADMINISTRATION Section.
2. If the intradermal reaction to the standardized extract is greater than the non-standardized dose, dilute 10 fold and repeat until skin response to standardized is equal to or less than non-standardized, then proceed with immunotherapy.
C. From alum precipitated or modified extracts to standardized extracts: It is recommended that therapy be initiated as if the patient were not previously treated.
Patients should always be observed for at least 20 - 30 minutes after any injection. In the event of a marked systemic reaction (for a description of systemic reactions see Adverse Reaction Section), application of a tourniquet above the injection site and intramuscular administration of 0.2 mL to 1.0 mL (0.01 mg/kg) of Epinephrine Injection (1:1000) is recommended. This dose can be repeated after 15 minutes, as needed. Maximal recommended dose for children between 2 and 12 years of age is 0.5 mL. The tourniquet is then gradually released at 15 minute intervals. Patients under treatment with beta-blockers may be refractory to the usual dose of epinephrine. DO NOT GIVE ALLERGENIC EXTRACTS INTRAVENOUSLY.
Volume expanders and vasopressor agents may be required to reverse hypotension. Inhalation bronchodilators and parenteral aminophylline may be required to reverse bronchospasm. In cases of respiratory obstruction, oxygen and intubation may be necessary. Life-threatening reactions unresponsive to the above may require cardiopulmonary resuscitation.
Withhold allergenic extracts temporarily or reduce the dose in patients with any one of the following conditions:
- Severe rhinitis or asthma symptoms;
- Infection or flu accompanied by fever;
- Exposure to excessive amounts of clinically relevant allergen prior to therapy.
Patients with unstable asthma or steroid dependent asthmatics and patients with underlying cardiovascular disease are at greater risk to a fatal outcome from a systemic allergic reaction12.
See also PRECAUTIONS and ADVERSE REACTIONS.
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Uses
Indicated use of allergenic extracts is for the diagnosis and treatment (hyposensitization therapy) of patients who experience allergic symptoms due to exposure to grass pollen and who exhibit type I skin sensitivity when tested to those specific allergens.
Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants in situations where the offending allergen cannot be avoided.
For previously untreated patients, prior to the initiation of therapy, clinical sensitivity to the standardized grass pollen extract should be established by careful evaluation of the patient's history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided.
Standardized grass pollen extracts labeled in BAU/mL are not interchangeable with grass pollen extracts labeled in AU/mL or non-standardized grass pollen extracts.
10,000 BAU/mL extracts are indicated for percutaneous testing. If negative, the 100,000 BAU/mL dose may be used. Availability of 10,000 and 100,000 BAU/mL dosages facilitate safe switching. Patients who tolerate dilutions prepared from the 10,000 BAU/mL dosage and require a higher dose may be treated with dilutions prepared from the 100,000 BAU/mL dosage.
100,000 BAU/mL concentrations may be especially useful when patients are hyposensitized to numerous allergens. Mixing of allergenic extracts dilutes the potency of each constituent. Using higher concentrations such as 100,000 BAU/mL allows for dilution with other extracts without sacrificing immunizing properties. CAUTION: The final potency of each individual component in a patient mixture should never exceed 10,000 BAU/mL. See also, DOSAGE AND ADMINISTRATION section for discussion of mixture labeling.
History
There is currently no drug history available for this drug.
Other Information
Standardized allergenic extract of grass pollens from Timothy (Phleum pratense), Orchard (Dactylis glomerata), June (Poa pratensis), Red Top (Agrostis alba), Sweet Vernal (Anthoxanthum odoratum), Meadow Fescue (Festuca elatior), Perennial Rye (Lolium perenne), Bermuda Grass (Cynodon dactylon), in the accompanying vial are sterile, and contain glycerin 50% v/v and phenol 0.4% (preservative). Inert ingredients may include sodium chloride for isotonicity and sodium bicarbonate buffer.
Glycerinated pollen extracts, for subcutaneous injection for immunotherapy and/or percutaneous or intracutaneous testing (see Dosage and Administration section), are prepared from defatted dried pollen extracted in glycerinated Coca’s Fluid, filtered aseptically, and dispensed into multiple dose vials. These are subsequently tested for sterility, safety, and potency.
Standardized grass pollen extracts labeled in BAU/mL are not interchangeable with grass pollen extracts labeled in AU/mL or non-standardized grass pollen extracts.
For ease in use and for lot-to-lot consistency, the potency is expressed in Bioequivalent Allergy Units (BAUs) per milliliter. A value of 10,000 BAU/mL is assigned to the CBER reference standard that can be diluted 1:0.5 million to produce intradermal ƩE (sum of Erythema) of 50 mm in highly puncture reactive subjects1. A value of 100,000 BAU/mL is assigned to the CBER reference standard that can be diluted 1:5 million to produce intradermal ƩE (sum of Erythema) of 50 mm in highly puncture reactive subjects. The relative potency of each lot of standardized extract has been compared to the official CBER reference standard by an acceptable assay such as ELISA Inhibition.2 When the potency is equivalent by ELISA Inhibition to the reference, the product is assigned 10,000 BAU/mL or 100,000 BAU/mL. Standardized grass pollen extracts, except for Bermuda, have potency designations of either 10,000 BAU/mL or 100,000 BAU/mL. Bermuda grass pollen extract is only available with a 10,000 BAU/mL potency designation.
In the ELISA Inhibition assay, a competitive binding assay, the wells of microtiter plates are coated using a characterized allergenic extract. Allergic sera is added to each well. The binding of IgE specific for the coating allergen is inhibited by concentrations of a test sample of an extract of the same allergen. The amount of IgE bound to the solid phase allergen (and subsequently the degree of inhibition) is determined using enzyme-labeled anti-human IgE antibodies and the appropriate substrate. The potency relative to a reference is determined using a parallel line bioassay method.
Sources
Bermuda Grass Manufacturers
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Alk-abello, Inc.
![Bermuda Grass, Standardized Injection, Solution Bermuda Grass, Standardized Solution Kentucky Bluegrass (June), Standardized Injection, Solution Meadow Fescue Grass, Standardized Injection, Solution Orchard Grass, Standardized Injection, Solution Redtop Grass, Standardized Injection, Solution Rye Grass, Perennial Standardized Injection, Solution Sweet Vernal Grass, Standardized Injection, Solution Timothy, Standardized Injection, Solution [Alk-abello, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Bermuda Grass | Alk-abello, Inc.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
When diluting bulk extracts, use of Sterile Diluent for Allergenic Extracts or Sterile Diluent for Allergenic Extracts Normal Saline with HSA are recommended. Dilutions should be made with sterile disposable syringes using aseptic technique. Commonly 10 fold dilutions are used to achieve a desired concentration for intradermal testing or initiation and continuation of immunotherapy. For example transferring 0.5 mL of a 10,000 BAU/mL extract into 4.5 mL of diluent will yield 5 mL of extract @ 1,000 BAU/mL. Prepare as many additional serial dilutions as necessary to reach the appropriate concentration.
Stock mixtures of grass pollen extracts are compounded from individual grass pollen extracts. The total potency per milliliter (mL) of these mixtures is described on the container label, where space permits. The contribution each individual component is expressed in the supplemental labeling accompanying the vial.
Diagnosis –In diagnosing the sensitive individual, the symptom history must be associated with exposure to the allergen. Skin testing is used in conjunction with a definitive history for diagnosing individual sensitivities.
An excellent method of recording results is to cover the skin reaction with transparent tape, outline the erythema first then the wheal with an indelible pen, then remove the tape and transfer it to the patient's permanent record. For preferred results, it is recommended that the actual measurement of the extent of both responses be recorded. This can be accomplished by measuring the longest erythema diameter, then selecting the mid-point of that line and measuring at a 90o angle to that line to determine the orthogonal diameter. The sum of these two measurements is the sum of erythema (ƩE); the sum of wheal diameters is determined in a similar manner.
Patient's response is graded on the basis of the size of erythema and/or wheal.
Percutaneous (prick/scratch/puncture) test:Prick, scratch, or puncture skin tests should be performed initially using a glycerinated extract at 10,000 BAU/mL.
What follows are general guidelines for percutaneous testing14. Different devices and/or techniques influence the size of the reaction, therefore it is important to refer to the device manufacturer's or distributor's instructions when grading reactions. As a negative control the diluent should be tested and included in the interpretation in the skin test reactions. Use of a positive control such as histamine base at 1 mg/mL should be used to assess skin test reactivity.
0 No reaction or less than control + Erythema greater than control, smaller than a nickel (21 mm diameter) ++ Erythema greater than a nickel in diameter, no wheal +++ Wheal and erythema without pseudopods ++++ Wheal and erythema with pseudopods Intradermal test:Intradermal testing should start with a dilute solution, usually in the range of 0.1 BAU/mL or less.
Glycerinated extracts diluted for intradermal testing may be diluted at least 25-fold to less than 2% glycerin (by volume) as glycerin above this level can cause false positive intradermal skin tests. Use a negative control skin test with glycerin content equal to the glycerin content of the allergen dose used for intradermal testing. Use of a positive control such as histamine base at 0.1 mg/mL or 0.01 mg/mL should be used to test reactivity.
On the forearm or upper outer aspect of the arm, using a 26 - 27 gauge, short bevel needle, inject intradermally 0.05 mL of the intradermal test solution. Skin whealing responses should be observed 10 - 20 minutes after administering the test.
A negative skin test is one where the sum of erythema was 0 or equal to the sum of the wheal. As a negative control, the diluent should be tested and included in the interpretation of the skin reactions. What follows are general guidelines intradermal testing 14.
0 No reaction or less than negative control + 3-4 mm wheal with erythema, or erythema alone larger than a nickel (21 mm diameter) ++ 4-8 mm wheal and erythema without pseudopods +++ Over 8 mm wheal and erythema without pseudopods ++++ Wheal and erythema with pseudopods Immunotherapy -Starting dose for immunotherapy is related directly to a patient's sensitivity as determined by carefully executed skin testing. Degree of sensitivity can be established by determination of D50 (the intradermal dose, base three, that produces a ƩE = 50 mm).1
A general rule is to begin at 1/10 of the dose that produces sum of erythema of 50 mm (approximately a 2+ positive skin test reaction). For example, if a patient exhibits a 2+ intradermal reaction to 1 BAU/mL, the first dose should be no higher than 0.05 mL of 0.1 BAU/mL. Dosage may be increased by 0.05 mL each time until 0.5 mL is reached, at which time the next 10-fold more concentrated dilution can be used, beginning with 0.05 mL, if no untoward reaction is observed.
If a tolerated dose of allergenic extract has been established, the initial dose from the new extract should be reduced to 25% of the previously well tolerated dose (see also Precautions).
Interval between doses in the early stages of immunotherapy is no more than once to twice a week, and may gradually be increased to once every two weeks. Generally, maintenance injections may be given as infrequently as once every two weeks to once a month.
Injections are given subcutaneously preferably in the arm. It is advantageous to give injections in alternate arms and routinely in the same area. In some patients, a local tolerance to the allergen may develop thus preventing a possible severe local reaction.
After inserting the needle, but before injecting the dose, pull plunger of the syringe slightly. If blood returns in the syringe, discard the syringe and contents and repeat injection at another site.
Bulk concentrated extracts must be diluted for initial therapy and intradermal skin testing. For recommended diluent, refer to DOSAGE AND ADMINISTRATION section.
Allergenic extracts slowly become less potent with age. During the course of treatment, it may be necessary to continue therapy with a vial of extract bearing a later expiration date. The initial dose of the extract bearing the later expiration date should be lowered to a safe non-reaction-eliciting level. When switching one standardized extract with another, at least 75% reduction in dose is suggested.
Use standard aseptic precautions when making dilutions. The first dose of the new extract should be reduced at least 75% of the amount of the dosage from the previous extract.
Stability studies for diluted and undiluted forms of this product are not complete. Indications are the undiluted product will retain its potency under recommended storage conditions at least until the expiration date on the vial label is reached. It is recommended that minimal amounts of the concentrate be diluted so that the diluted product is used up within a relatively short period of time; i.e., preferably not more than four weeks.
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