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STANDARDIZED BERMUDA GRASS POLLEN

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Overview

What is STANDARDIZED BERMUDA GRASS POLLEN?

      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  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.



What does STANDARDIZED BERMUDA GRASS POLLEN look like?



What are the available doses of STANDARDIZED BERMUDA GRASS POLLEN?

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What should I talk to my health care provider before I take STANDARDIZED BERMUDA GRASS POLLEN?

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How should I use STANDARDIZED BERMUDA GRASS POLLEN?

      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. IN BAU/ml 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)

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:


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What are the side effects of STANDARDIZED BERMUDA GRASS POLLEN?

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What should I look out for while using STANDARDIZED BERMUDA GRASS POLLEN?

      There are no known absolute contraindications to hyposensitization therapy. See precautions section for pregnancy risks.

      A patient without a history of grass pollen allergy symptoms and a positive skin test reaction to grass pollen should not be treated. The physician must determine if the benefits outweigh the risks in using these products for treating patients. The benefit to risk ratio should be carefully weighed especially where risks of immunotherapy are higher than usual. This includes severe unstable asthma, highly allergic patients who have had previous severe or unusual problems with injections, pregnancy, or any fragile general medical condition. This also includes patients where potential benefits are limited due to coexisting non-allergic disease such as: non-specific vasomotor rhinitis, nasal septal deviation, nasal polyps, COPD (chronic obstructive pulmonary disease), cardiovascular or other non-allergic respiratory disease.

See 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.


What might happen if I take too much STANDARDIZED BERMUDA GRASS POLLEN?

Refer to section above.


How should I store and handle STANDARDIZED BERMUDA GRASS POLLEN?

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.       Bulk extract (stock concentrate) in 50% (v/v) glycerin containing 10,000 BAU/ml or 100,000 BAU/ml is supplied in 10ml, 30ml, and 50ml vials. Bermuda Grass bulk extract is available in 10,000 BAU/ml only. Scratch testing for Bermuda Grass in 50% (v/v) glycerin containing 10,000 BAU/ml is supplied in 2ml dropper vials. Scratch testing for the other grasses in 50% (v/v) glycerin containing 10,000 BAU/ml or 100,000 BAU/ml is supplied in 2ml dropper vials. Intradermal testing (aqueous) for all standardized grasses containing 100 BAU/ml is supplied in 5ml vials.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

The allergic state is initiated by an immune response inducing B cells to produce IgE antibodies to specific allergens. IgE antibodies bind to surface receptors on mast cells and basophils. When antigens gain access to the immune system they react with the bound IgE. The reacting antigen to the surface bound IgE stimulates a number of chemical mediators to be released from the mast cells and basophils. These include histamine, Eosinophil Chemotactic Factor (ECF-A) and leukotrienes. These chemical mediators are pharmacologically active at low concentrations and are partially responsible for the biological manifestations of the allergic response. (3) 

The mechanism by which immunotherapy achieves hyposensitization is not completely understood. There is an increase in "blocking antibody" (lgG) titer and in some patients a decrease in specific IgE, a decrease in histamine release to specific allergen and an increase in suppressor celI population to specific allergen. These changes may occur only after prolonged therapy. (4)

Clinical data from the Center for Biologics Evaluation and Research is shown in the following tables

Non-Clinical Toxicology
      There are no known absolute contraindications to hyposensitization therapy. See precautions section for pregnancy risks.

      A patient without a history of grass pollen allergy symptoms and a positive skin test reaction to grass pollen should not be treated. The physician must determine if the benefits outweigh the risks in using these products for treating patients. The benefit to risk ratio should be carefully weighed especially where risks of immunotherapy are higher than usual. This includes severe unstable asthma, highly allergic patients who have had previous severe or unusual problems with injections, pregnancy, or any fragile general medical condition. This also includes patients where potential benefits are limited due to coexisting non-allergic disease such as: non-specific vasomotor rhinitis, nasal septal deviation, nasal polyps, COPD (chronic obstructive pulmonary disease), cardiovascular or other non-allergic respiratory disease.

See 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.

      Patients who are taking non-selective beta blockers may be more reactive to skin tests and may be unresponsive to the usual doses of epinephrine used to treat allergic reactions. Antihistamines can significantly inhibit the immediate skin test reactions. If long acting antihistamines have been taken recently, it is recommended that they should be stopped for the following minimum intervals before skin testing is performed: at least 1 month for astemizole; 1 week for hydroxyzine or cetirizine; 4 to 7 days for Ioratadine; 3 to 4 days for terfenadine or fexofenadine; and 24 to 48 hours for other sustained release antihistamines. (6)

      The dosage should be reduced 50-75% from the previous dose when starting a patient on a new lot of standardized grass extract from the same manufacturer or from a different manufacturer. Table A in the Clinical Pharmacology section of this insert can be used for guidance when changing from a non-standardized grass extract to a standardized grass extract. The table shows the similarity in potency of two Iots of the non-standardized grass extracts with respect to the 10,000 BAU/ml standardized extracts. Comparative skin testing can be used to determine the dose.

      A separate sterile tuberculin type syringe should be used with each patient to prevent cross contamination of extracts. This will also prevent transmission of disease such as hepatitis, AIDS and other infectious diseases. Aseptic technique should always be used when injections of allergenic extracts are administered.

(1) Local Reactions:

      Some swelling and redness at the site of injection is not unusual. Mild burning that occurs immediately after the injection is normal; this usually subsides in 10 to 20 seconds. If the swelling and redness persist for a period of 24 hours or longer this should be a sign to proceed with caution in increasing the dosage. With the next injection the dosage should remain the same or be decreased. Large local reactions may indicate that a systemicreaction could occur with the next injection if the dosage was increased. If a patient continues to have reactions at the maintenance dose, the patient is considered to have exceeded the maximum tolerated dosage.

(2) Systemic Reactions:

      Systemic reactions occur infrequently but must be looked for in all patients, especially highly sensitive patients. Anaphylactic shock and death are always possible, therefore, physicians must beprepared for the treatment of these reactions. Systemic reactions can also be characterized by one or more of the following symptoms: angioedema, tachycardia, conjunctivitis, cough, fainting, hypotension, pallor, rhinitis, urticaria and wheezing.

      Systemic reaction can be treated by the immediate application of a tourniquet above the site of injection and the administration of 0.3 to 0.5ml of 1:1000 Epinephrine-Hydrochloride subcutaneously or intramuscularly in the opposite arm. The dosage may be repeated two times at 15 minute intervals. Loosen the tourniquet at least every 10 minutes.

      The pediatric dosage for 1:1000 Epinephrine-Hydrochloride is 0.05 to 0.1 ml for infants to 2 years of age; 0.15ml, for children 2 to 6 years; and 0.2ml, for children 6 to 12 years.

      Patients should always be observed for at least 30 minutes after any injection. Hypotension can be reversed by using vasopressor agents and volume expanders. Parenteral aminophylline and inhalation bronchodilators may be required for bronchospasm. Oxygen may also be needed. Maintenance of an open airwayis critical if upper airway obstruction is present. Adrenal corticosteroids and intravenous antihistamine can be given after adequate epinephrine and circulatory support has been administered. Physicians must be familiar with these systemic reactions and have all the equipment and drugs necessary for proper treatment. (8)

      Serious adverse reactions can be reported to the US Food and Drug Administration MedWatch Program. The MedWatch forms can be obtained by calling 1-800-FDA-1088. The address is: MedWatch, 5600 Fishers Lane, Rockville, MD, 20852-9787.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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