For interpretation of skin reactions, refer to chart below. 1, pp. View NDC Code(s)NEW! Discomfort is minimized by dividing the dose in half and administering injection at two different sites.16, 17, Antihistamines. When harvested and processed, they make a fine textile called cotton. To insure maximum potency for the entire dating period, all stock concentrates contain 50% glycerine v/v. 76-113, 1985. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). It is not known whether allergenic extracts cause fetal harm during pregnancy or affect reproductive capacity. Children can receive the same dose as adults. Child., pp. Small amounts of erythema and swelling at the site of injection are common. PubMed, Immunotherapy must be given under physicians supervision. This fabric has clothed millions of people and has furnished blankets and pillowcases for the comfort of sleepers. A decreased skin test reactivity has been observed in patients undergoing specific immunotherapy with pollen extracts, grass pollen allergoids, mites, hymenoptera venoms, or in professional beekeepers who are spontaneously desensitized. If after 20 minutes no skin reaction is observed, continue testing using increasing increments of the concentration until a reaction of 5-10 mm wheal and 11-30 mm erythema is obtained, or a concentration of 5-2 or 10-1 has been tested. Individuals with autoimmune disease may be at risk of exacerbating symptoms of the underlying disease, possibly due to routine immunization. Adverse reactions to allergenic extracts are usually apparent within 20-30 minutes following injection of immunotherapy. Studies indicate allergic individuals produce immunoglobulins of the IgE class in response to exposure to allergens. 6. Refer to container label for actual Antigen E content. When a sequence of five-fold or ten-fold dilutions of an allergen are injected, the endpoint is determined by noting the dilution that first produces a wheal and erythema (15 minutes after injection) that is 2 mm larger than wheals with erythema produced by weaker, non-reacting dilutions (5 mm negative wheal). 63, No. 6, p. 511, December 1980. Dilutions of the allergenic extracts containing less than 50% glycerine are less stable. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Some people are allergic to cotton fibers. Prolonged pain or pain radiating up arm is usually the result of intramuscular injection, making this injection route undesirable. Alternatively, some people who think that they are allergic to cotton may actually react to dyes applied to cotton textiles. Citations, Report Adverse This product should not be injected intravenously. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. This cross-linking results in stimulation of mast cell which leads to release and generation of pharmacologically active substances that produce immediate hypersensitivity reaction.3, The mode of action of immunotherapy with allergenic extracts is still under investigation. 49288-0272-5, Store all stock concentrates and dilutions at 2-8 C. Keep at this temperature during office use. Refer to STORAGE section for proper storage condition for allergenic extract. Loosen tourniquet briefly at 5 minute intervals to prevent circulatory impairment. Patients switching from other types of extracts to Antigen Laboratories allergenic extracts should be started as if they were undergoing treatment for the first time. Children with nephrotic syndrome probably should not receive injections due to immunization causing exacerbation of nephrotic disease. A 5/8 inch, 25 gauge needle on a sterile syringe allows deep subcutaneous injection. : Inhalant Allergy Immunotherapy with Standardized and Nonstandardized Allergenic Extracts, American Academy of Otolaryngology-Head and Neck Surgery: Instructional Courses, Vol. Chemicals that are beta-blockers and may be components of other drugs: Acebutolol, Atenolol, Esmolol, Metoprolol, Nadolol, Penbutolol, Pindolol, Propanolol, Timolol, Labetalol, Carteolol.1, Beta-adrenergic agents. 1365-1376, 1988.
49288-0403-1, Respiratory obstruction not responding to parenteral or inhaled bronchodilators may require theophylline, oxygen, intubation and the use of life support systems. Allergenic extract is intended for use by, or under the guidance of, physicians who are experienced in the administration of allergenic extracts for diagnosis and/or immunotherapy and the emergency care of anaphylaxis. Report Adverse 92, No. 49288-0343-4, Carcinogenesis, Mutagenesis, Impairment of Fertility: Long term studies in animals have not been conducted with allergenic extract to determine their potential for carcinogenicity, mutagenicity or impairment of fertility. Seebohm, P.M., et al: Panel on Review of Allergenic Extracts, Final Report, Food and Drug Administration, March 13, 1981, pp. The most satisfactory sites on the back for skin testing are from the posterior axillary fold to 2.5 cm from the spinal column, and from the top of the scapula to the lower rib margins. Patients should be observed for at least 20 minutes following allergenic extract injections. This dilution can be prepared by diluting 1:20 to 1:50 w/v (2% - 5%) extracts to 5-6 or 1:10 w/v (10%) extracts to 5-7 (five-fold dilutions). Report serious adverse events to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787, phone 1-800-FDA-1088. Sterile syringe and needle must be used for each individual patient to prevent transmission of serum hepatitis, Human Immunodeficiency Virus (HIV) and other infectious agents. A negative control (50% glycerine for prick-puncture testing) would exclude false-positive reactions due to ingredients in diluent or patients who have dermatographism. Epinephrine or beta-adrenergic drugs (Alupent) may be ineffective. Extract should be temporarily withheld or dosage reduced in case of any of the following conditions: 1) flu or other infection with fever; 2) exposure to excessive amounts of allergen prior to injection; 3) rhinitis and/or asthma exhibiting severe symptoms; 4) adverse reaction to previous injection until cause of reaction has been evaluated by physician supervising patients immunotherapy program. INTRADERMAL TESTING-SKIN ENDPOINT TITRATION: physician must proceed cautiously in the treatment of the highly sensitive patient who develops large local or systemic reactions, SERIAL DILUTION TITRATION TEST DILUTIONS APPROXIMATE ALLERGENIC EXTRACT CONCENTRATION RESULTING FROM 1:5 DILUTION, All Drug For this reason, cotton factory workers may develop an allergy to cotton fibers. 8. Edited by J. Pepys & A.M. Edwards, Proceedings of an International Symposium, Davos, Switzerland, Pitman Medical Publishing Co., 1979, pp. Dust mites are another possible cause of an allergic reaction wrongly attributed to cotton. 49288-0343-5, Antihistamines, H2 antagonist, bronchodilators, steroids and theophylline may be used as indicated after providing adequate epinephrine and circulatory support.4. 1213-1219. These fibers grow on cotton seeds inside the cotton boll, or the fruit of the cotton plant. Prick-puncture testing is performed by placing a drop of extract concentrate on the skin and puncturing the skin through the drop with a small needle such as a bifurcated vaccinating needle. 14. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label. may be prepared either by dilution from a more concentrated stock or by direct extraction. A period of two or three years on immunotherapy constitutes an average minimum course of treatment. A systemic reaction to allergenic extract could cause uterine contractions leading to spontaneous abortion or premature labor. 2. Files, All Mapping Needless to say, the physician must proceed cautiously in the treatment of the highly sensitive patient who develops large local or systemic reactions.6, Some patients may tolerate larger doses of the allergenic extract depending on patient response.7 Because diluted extract tends to lose activity in storage, the first dose from a more concentrated vial should be the same, or less than, the previous dose.8, 12. 11. The diluting effect of individual components within a mixture may cause false negative reactions. An endpoint dose of 0.15 ml is a safe initial dose to be followed by escalation to the optimal maximum tolerated dose for each individual. Matthews, K., et al: Rhinitis, Asthma and Other Allergic Diseases. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X. Copy the URL below and paste it into your RSS Reader application. This schedule is intended only as a guide and must be modified according to the reactivity of the individual patient. They also cause the production of antibodies, according to the "British Journal of Industrial Medicine. Ophthalmic beta-blockers: Betaxolol, Levobunolol, Timolol, Timoptic. Annals of Allergy, Vol. 5. J. Dis. 49288-0403-5, Patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodilators. Diagnostic use of allergenic extracts usually begins with direct skin testing. SINGLE DILUTION INTRADERMAL TESTING: The surface of the upper and lower arm is the usual location for skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing. Moreover, the cotton dust to which cotton factory workers are exposed contains other components besides cotton, such as inorganic matter, bacteria, molds, and pesticide residue. Subsequent exposure to the allergen results in a combination of allergen with IgE antibody fixed on mast cells or basophil membranes. florentina root extract 0.1 GM/ML Injectable Solution, orris root extract 0.1 GM/ML Injectable Solution, orris root extract 100 MG/ML Injectable Solution, tobacco leaf allergenic extract 50 MG/mL Injectable Solution, tobacco leaf allergenic extract 50 MG/ML Injectable Solution, Nicotiana tabacum leaf extract 0.05 GM/ML Injectable Solution, Nicotiana tabacum leaf extract 50 MG/ML Injectable Solution, kapok tree fiber allergenic extract 50 MG/mL Injectable Solution, kapok tree fiber allergenic extract 50 MG/ML Injectable Solution, Ceiba pentandra fiber allergenic extract 0.05 GM/ML Injectable Solution, kapok tree fiber extract 5 MG/ML Injectable Solution, cotton fiber allergenic extract 50 MG/ML Injectable Solution, cotton fiber allergenic extract 0.05 GM/ML Injectable Solution, cotton fiber extract 50 MG/ML Injectable Solution, Pyrethrum cinerariifolium allergenic extract 50 MG/ML Injectable Solution, Pyrethrum cinerariifolium extract 0.05 GM/ML Injectable Solution, Tanacetum cinerariifolium extract 0.05 GM/ML Injectable Solution, Tanacetum cinerariifolium extract 50 MG/ML Injectable Solution, tobacco leaf allergenic extract 20 MG/mL Injectable Solution, tobacco leaf allergenic extract 20 MG/ML Injectable Solution, Nicotiana tabacum leaf extract 0.02 GM/ML Injectable Solution, Nicotiana tabacum leaf extract 20 MG/ML Injectable Solution, jute fiber allergenic extract 50 MG/mL Injectable Solution, jute fiber allergenic extract 50 MG/ML Injectable Solution, Corcorus capsularis fiber extract 0.05 GM/ML Injectable Solution, Corcorus capsularis fiber extract 50 MG/ML Injectable Solution, orris root allergenic extract 50 MG/ML Injectable Solution, Iris germanica var. It appears that theophylline need not be stopped prior to skin testing.1, Beta-Blockers. Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. In certain individuals, especially in steroid-dependent/unstable asthmatics, these life-threatening reactions may result in death. Antibodies protect against diseases, but they may also provoke allergic reactions. 49288-0285-5, 58, pp. Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels. Long, W.F., Taylor, R.J., Wagner, C.J., et al. Stevens, E.: Cutaneous Tests, Regulatory Control and Standardization of Allergenic Extracts, First International Paul-Ehrlich Seminar, May 20-22, 1979, Frankfurt, Germany, pp. A cotton allergy may express itself in dermatitis, an inflammation of the skin characterized by such phenomena as rashes. 417-425, June 1979. The following are commonly prescribed beta-blockers: Levatol, Lopressor, Propanolol Intersol, Propanolol HCL, Blocadren, Propanolol, Inderal-LA, Visken, Corgard, Ipran, Tenormin, Timoptic. Allergenic extracts should be used during pregnancy only if potential benefit justifies potential risk to fetus.11. 49288-0343-1, 49288-0154-2, Wasserman, S.: The Mast Cell and the Inflammatory Response. 49288-0343-2, Allergy Clin. Injections should never be given intravenously. Bousquet, Jean: In vivo methods for study of allergy: Skin tests Third Edition, Allergy Principles and Practice, C.V. Mosby Co., Vol. The initial dilution of allergenic extract, starting dose, and progression of dosage must be carefully determined on the basis of the patients history and results of skin tests. I, Chap. This extract is not directly interchangeable with other allergenic extracts. 49288-0581-3, DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Oxygen should be given by mask if indicated. Benefit versus risk needs to be evaluated in steroid dependent asthmatics, patients with unstable asthma or patients with underlying cardiovascular disease. Events, (What Allergenic extracts have been used routinely in children, and no special safety problems or specific hazards have been found. Is Linen or Cotton Better in Hot Weather. Holgate, S.T., Robinson, C., Church, Mike: Mediators of Immediate Hypersensitivity, Third Edition, Allergy Principles and Practice, C.V. Mosby Co., Vol. (See Serial Dilution Titration Test Dilutions chart below.) 49288-0403-3, florentina root allergenic extract 1 GM per 20 ML Injectable Solution, Iris germanica var. Detergents used to wash cotton fabrics may also contain allergens. The usual duration of treatment has not been established. Antihistamines inhibit the wheal and flare reaction. A negative control, 50% glycerine diluted with diluent to 5-2 (1:25) or 10-1 (1:10) dilution and a positive control of histamine phosphate, should be tested and included in interpretation of skin reactions.1, 13. A mild burning immediately after injection is expected; this usually subsides in 10-20 seconds. Possible adverse reactions include unusual swelling and/or tenderness at injection site, rhinorrhea, sneezing, coughing, wheezing, shortness of breath, nausea, dizziness, or faintness. 49288-0582-3, Events, IN THESE CASES THE POTENCY FOR SKIN TESTS AND THE ESCALATION OF THE TREATMENT DOSE MUST BE ADJUSTED TO THE PATIENTS SENSITIVITY AND TOLERANCE. Cromolyn inhaled or injected prior to skin tests with allergens or degranulating agents does not alter skin whealing response.1, Other drugs. 49288-0582-5, Inhaled beta2 agonists in the usual doses used for the treatment of asthma do not usually inhibit allergen-induced skin tests. : The Effect of Preservatives and Dilution on the Deterioration of Russian Thistle (Salsola pestifer), a pollen extract. The Journal of Allergy and Clinical Immunology, Vol. Some people experience allergic reactions when they wear cotton clothing or when they sleep on cotton pillowcases. Smaller, less conclusive reactions may be considered positive in conjunction with a definitive history of symptoms on exposure to the allergen. For patients demonstrating a positive prick-puncture skin test, an initial screening dilution of 1:312,500 w/v is safe. Fresh egg white extract is available at 1:9 v/v extraction ratio. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. 9-20. Dilute 1:10 w/v (10%) extracts to 10-3 if using ten-fold dilutions. (1) Start testing with the most dilute allergenic extract concentration. 49288-0583-2, The rate of increase in dosage in the early stages of treatment with highly diluted extracts is usually more rapid than the rate of increase possible with more concentrated extracts. Reactions should not be considered significant unless they persist for at least 24 hours or exceed 50 mm in diameter. It cannot be overemphasized that, under certain unpredictable combinations of circumstances, anaphylactic shock is always a possibility. 49288-0272-4, IN THESE CASES THE POTENCY FOR SKIN TESTS AND THE ESCALATION OF THE TREATMENT DOSE MUST BE ADJUSTED TO THE PATIENTS SENSITIVITY AND TOLERANCE. Refer to WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections for signs and symptoms of an overdose. These detergent allergens may adhere to the cotton fabric, where they may provoke an allergic reaction in a sensitized individual. Reid, Michael J., Lockey, Richard F., Turkeltaub M.D., Paul C., Platts-Mills, Thomas. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. Presence in Breast Milk, Medline Plus, The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. All source materials are inspected by Antigen Laboratories technical personnel in accordance with 21 CFR 680.1 (b) (1). 12. Stock concentrates are available in concentrations of 2-10% or weight/volume (w/v) of 1:50, 1:33, 1:20 or 1:10. 49288-0344-4, florentina root extract 50 MG/ML Injectable Solution. Biochemical Data Summary. Some juicy or liquid foods are available at 1:1 volume/volume (v/v) extraction ratio. Boxed Warnings, 133-138. In such cases dosage should be reduced to the last level not causing reaction and maintained for two or three treatments before cautiously increasing. Updated
Systemic reactions range from mild exaggeration of patients allergic symptoms to anaphylactic reactions.14 Very sensitive patients may show a rapid response. Seebohm, P.M., et al: Panel on Review of Allergenic Extracts, Final Report, Food and Drug Administration, March 13, 1981, pp 9-48. This initial dilution can be prepared by diluting 1:20 to 1:50 w/v (2%-5%) extracts five-fold to 5-4 or 1:10 w/v (10%) extracts to 5-5. Imipramines, phenothiazines, and tranquilizers. Van Metre, T., Adkinson, N., Amodio, F., Lichtenstein, L., Mardinay, M., Norman, P., Rosenberg, G., Sobotka, A., Valentine, M.: A Comparative Study of the Effectiveness of the Rinkel Method and the Current Standard Method of Immunology for Ragweed Pollen Hay Fever, The Journal of Clinical Allergy and Immunology, Vol. 49288-0583-3, 213-217, May 1979. The Mast Cell-its role in Health and disease. Lower concentrations (e.g. to volume. Severe systemic reactions may occur with all allergenic extracts. (3) For patients without a history of extreme sensitivity, or a negative or weakly reactive prick-puncture test, the initial dilution for skin testing should be a dilution at least 1:12,500 w/v. RxNorm, Precaution is necessary when using extract mixture for skin testing. 4, p. 52, edited by Middleton et al.
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