Parenteral fluid and/or plasma expanders may be utilized for treatment of shock.
4, p. 52, edited by Middleton et al. Injections should never be given intravenously. Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and/or death. 19, pp 419-436, 1988. 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. A positive reaction is approximately 10-15 mm erythema with 2.5 mm wheal. 49288-0272-1, 9-20. Studies indicate allergic individuals produce immunoglobulins of the IgE class in response to exposure to allergens. 49288-0154-2, HEW, NIH Publication No. 49288-0285-5, 79-387, Chapter 4, pp. A negative control (50% glycerine for prick-puncture testing) would exclude false-positive reactions due to ingredients in diluent or patients who have dermatographism. 17. 49288-0285-2, See the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and OVERDOSAGE sections. The usual duration of treatment has not been established. Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. 49288-0343-3, Intracutaneously inject 0.01 to 0.02 ml of the test allergen to form a 4 mm diameter superficial skin wheal. 1, Chap. Repeat dose in 5-10 minutes if necessary. Possible adverse reactions include unusual swelling and/or tenderness at injection site, rhinorrhea, sneezing, coughing, wheezing, shortness of breath, nausea, dizziness, or faintness. It is important that a new, sterile, disposable syringe and needle be used for each extract tested. Labels, All Index
49288-0154-3, 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. 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. Long acting antihistamines (e.g., astemizole) may inhibit the wheal and flare for up to forty days.1, 2, Imipramines, phenothiazines, and tranquilizers. Larger local reactions are not only uncomfortable, but indicate the possibility of a severe systemic reaction if dosage is increased. 3. 84-86. Refer to WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections for signs and symptoms of an overdose. is this? 49288-0403-4, may be prepared either by dilution from a more concentrated stock or by direct extraction. Bullock, J., Frick, O.: Mite Sensitivity in House Dust Allergic Children, Am. If you are a consumer or patient please visit J. Dis. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). 57, August 1986. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. A 5/8 inch, 25 gauge needle on a sterile syringe will allow deep subcutaneous injection. 6, p. 511, December 1980. 63, No. This fabric has clothed millions of people and has furnished blankets and pillowcases for the comfort of sleepers. Is Linen or Cotton Better in Hot Weather. 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. 49288-0582-4, florentina root allergenic extract 1 GM per 20 ML Injectable Solution, Iris germanica var. Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Large, persistent local reactions or minor exacerbations of the patients allergic symptoms may be treated by local cold applications and/or use of oral antihistamines. The epinephrine HCL 1:1000 dose for infants to 2 years is 0.05 to 0.1 ml; for children 2 to 6 years it is 0.15 ml; for children 6 to 12 years it is 0.2 ml. : Inhalant Allergy Immunotherapy with Standardized and Nonstandardized Allergenic Extracts, American Academy of Otolaryngology-Head and Neck Surgery: Instructional Courses, Vol. 49288-0583-5. Some people are allergic to cotton plant tissues. Therefore, it is imperative that physicians administering allergenic extracts understand and prepare for treatment of severe reactions. The dermatitis may be atopic, which means that it can occur on parts of the body not in direct contact with the allergen. PRICK-PUNCTURE TESTING: To identify highly sensitive individuals and as a safety precaution, it is recommended that a prick-puncture test using a drop of the extract concentrate be performed prior to initiating very dilute intradermal testing. Discontinue use of the tourniquet after hour. All source materials are inspected by Antigen Laboratories technical personnel in accordance with 21 CFR 680.1 (b) (1). 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. Patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodilators. If loss of potency is suspected, potency can be checked using side by side skin testing with freshly prepared dilutions of equal concentration on individuals with known sensitivity to the allergen. 49288-0344-5, A systemic reaction to allergenic extract could cause uterine contractions leading to spontaneous abortion or premature labor. 49288-0581-3, I and II, pp 135-163, 1988. 92, No. IMMUNOTHERAPY: If the first injection of the initial dilution of extract is tolerated without significant local reaction, increasing doses by 5-20% increments of that dilution may be administered. & Articles, All INTRADERMAL TESTING-SKIN ENDPOINT TITRATION: The allergenic extracts to which the patient is sensitive, the patients degree of sensitivity and the dose of allergen to be used in immunotherapy can be determined through the use of intracutaneous skin tests involving progressive five-fold dilutions of allergenic extracts. Willoughby, J.W. Injections should never be given intravenously. Patients who have been taking beta-blockers may be unresponsive to epinephrine. florentina root allergenic extract 0.05 GM/ML Injectable Solution, Iris germanica var. 1, pp. Small amounts of erythema and swelling at the site of injection are common. Ten-fold dilution to 10-6 of a 1:10 w/v (10%) extract would be a safe starting dilution. Sterile solutions, vials, syringes, etc. Physicians undertaking immunotherapy should be concerned with patients degree of sensitivity. Report Adverse The following are commonly prescribed beta-blockers: Levatol, Lopressor, Propanolol Intersol, Propanolol HCL, Blocadren, Propanolol, Inderal-LA, Visken, Corgard, Ipran, Tenormin, Timoptic. 49288-0272-5, 11. 4. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. Wasserman, S., Marquart, D.: Anaphylaxis, Third Edition, Allergy Principles and Practice, C.V. Mosby Co., Vol. 49288-0344-4, If a systemic or anaphylactic reaction does occur, apply tourniquet above the site of allergenic extract injection and inject intramuscularly or subcutaneously 0.3 to 0.5 ml of 1:1000 Epinephrine-hydrochloride into the opposite arm or gluteal area. Long-term corticosteroid therapy modifies the skin texture and makes the interpretation of immediate skin tests more difficult.1, Theophylline.
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.
49288-0583-4, Children can receive the same dose as adults. Dilutions of the allergenic extracts containing less than 50% glycerine are less stable. (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. 49288-0344-1, Detergents used to wash cotton fabrics may also contain allergens. A mild burning immediately after injection is expected; this usually subsides in 10-20 seconds. 49288-0583-2, Some people are allergic to cotton fibers. 16. Immunotherapy must be given under physicians supervision. I, Chap. It cannot be overemphasized that, under certain unpredictable combinations of circumstances, anaphylactic shock is always a possibility. Adverse reactions to allergenic extracts are usually apparent within 20-30 minutes following injection of immunotherapy. 49288-0403-3, Biochemical Data Summary. 13. Report serious adverse events to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787, phone 1-800-FDA-1088. 8. Loosen tourniquet briefly at 5 minute intervals to prevent circulatory impairment. Antibodies protect against diseases, but they may also provoke allergic 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. Tranquilizers and antiemetic agents of the phenothiazine class have H1 antihistaminic activity and can block skin tests.1, Corticosteroids. 49288-0343-1,
Perelmutter, L.: IgE Regulation During Immunotherapy of Allergic Diseases. to volume. Do not administer in the presence of diseases characterized by bleeding diathesis. Ishizaka, K.: Control of IgE Synthesis, Third Edition, Allergy Principles and Practices, Vol. Stock concentrates are available in concentrations of 2-10% or weight/volume (w/v) of 1:50, 1:33, 1:20 or 1:10. Dosages progressively increase according to the tolerance of the patient at intervals of one to seven days until, (1) the patient achieves relief from symptoms, (2) induration at the site of injection is no larger than 50 mm in 36 to 48 hours, (3) a maintenance dose is reached (the largest dose tolerated by the patient that relieves symptoms without undesirable local or systemic reactions). Proper measurement of dose and caution in making injection will minimize reactions. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Child., pp. 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. Epinephrine 1:1000 should be available. 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. : Skin test suppression by antihistamines and the development of subsensitivity, J. Refer to OVERDOSAGE section. 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. 1, Chapter 15, C.V. Mosby Co., St. Louis, Missouri, September 1988. Diagnostic use of allergenic extracts usually begins with direct skin testing. 49288-0582-1, Refer to WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections below. (2) A volume of 0.02-0.05 ml should be injected slowly into the superficial skin layers making a small bleb (superficial wheal). The usual precautions in administering allergenic extracts are necessary, refer to boxed WARNINGS and WARNINGS section. Aseptic technique must be observed in making dilutions from stock concentrates. Precaution is necessary when using extract mixture for skin testing. Adverse reactions include, but are not limited to urticaria; itching; edema of extremities; respiratory wheezing or asthma; dyspnea; cyanosis; tachycardia; lacrimation; marked perspiration; flushing of face, neck or upper chest; mild persistent clearing of throat; hacking cough or persistent sneezing. 213-217, May 1979. Updated These fibers grow on cotton seeds inside the cotton boll, or the fruit of the cotton plant. 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. ), More about getting RSS News & Updates from DailyMed, 2 Presence in Breast Milk, Medline Plus, Antihistamines, H2 antagonist, bronchodilators, steroids and theophylline may be used as indicated after providing adequate epinephrine and circulatory support.4. They also cause the production of antibodies, according to the "British Journal of Industrial Medicine. 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. Allergenic extracts should be used during pregnancy only if potential benefit justifies potential risk to fetus.11. 49288-0272-2, When harvested and processed, they make a fine textile called cotton. In some cases, they have a true cotton allergy. Extracts in 5 ml dropper bottles are available for prick-puncture testing. 49288-0285-1, 49288-0581-1, Strongly positive skin tests may be risk factors for systemic reactions. Finally, it was shown that specific immunotherapy in patients treated with ragweed pollen extract induced a decreased late-phase reaction.1. In certain individuals, especially in steroid-dependent/unstable asthmatics, these life-threatening reactions may result in death. Immediate medical attention must be sought for reactions that occur during or after leaving physicians office. Dust mites are another possible cause of an allergic reaction wrongly attributed to cotton. Copy the URL below and paste it into your RSS Reader application. 1986, "British Journal of Industrial Medicine"; An Investigation of Allergy in; V. Popa, et al; Apr. Adrenocorticosteroids may be administered parenterally or intravenously. Tricyclic antidepressants exert a potent and sustained decrease of skin reactions to histamine. 49288-0154-4, 49288-0154-5, 49288-0403-5,
49288-0582-3, 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. 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. Allergy Clin. However, they may be reacting to allergens introduced into the fabric during its manufacture, such as formaldehyde. For this reason, cotton factory workers may develop an allergy to cotton fibers. 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. Certain plants of the genus Gossypium have soft fibers that cling to the seeds. Survey of Fatalities from Skin Testing and Immunotherapy 1985-1989, Journal of Allergy and Clinical Immunology, Vol. 49288-0272-4, Refer to OVERDOSAGE section for description of treatment for anaphylactic reactions. 6-15, 1993. Some of these may be allergenic, according to "Environmental Health Perspectives.". Treatment and emergency measures, as well as personnel trained in their use, must be available in the event of a life-threatening reaction. 49288-0581-5, RxNorm, 49288-0285-3, Patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodilators. Store all stock concentrates and dilutions at 2-8 C. Keep at this temperature during office use. 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. 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.
49288-0582-2, ", Some of the allergens in cotton fibers persist during the processing of cotton. A Web Experience brought to you by LEAFtv, "Environmental Health Perspectives"; Immunologic Responses to; John Salvaggio; Apr. Smaller, less conclusive reactions may be considered positive in conjunction with a definitive history of symptoms on exposure to the allergen. 76-113, 1985. The expiration date of the allergenic extracts is listed on the container label. Antihistamines inhibit the wheal and flare reaction. Some people experience allergic reactions when they wear cotton clothing or when they sleep on cotton pillowcases. Less aggressive immunotherapy schedules may be indicated for such patients. Discomfort is minimized by dividing the dose in half and administering injection at two different sites.16, 17, Antihistamines. Because many drugs are excreted in human milk, caution should be exercised when allergenic extracts are administered to a nursing woman. Animal reproduction studies have not been conducted with allergenic extracts. They sometimes produce positive responses in skin tests for allergens. Patients extremely sensitive to a common allergen in several components of a mixture may be more likely to experience a systemic reaction than when skin tested individually for each component.9. Reactions should not be considered significant unless they persist for at least 24 hours or exceed 50 mm in diameter. Events, (What Boxed Warnings,
Edited by J. Pepys & A.M. Edwards, Proceedings of an International Symposium, Davos, Switzerland, Pitman Medical Publishing Co., 1979, pp. It may be necessary to adjust the progression of dosage downward to avoid local and constitutional reactions. It is not known whether allergenic extracts are excreted in human milk. 49288-0343-4, IN THESE CASES THE POTENCY FOR SKIN TESTS AND THE ESCALATION OF THE TREATMENT DOSE MUST BE ADJUSTED TO THE PATIENTS SENSITIVITY AND TOLERANCE. Seebohm, P.M., et al: Panel on Review of Allergenic Extracts, Final Report, Food and Drug Administration, March 13, 1981, pp. 6. Patient should remain under observation of a nurse, physician, or personnel trained in emergency measures for at least 20 minutes following immunotherapy injection. The route of administration for immunotherapy is subcutaneous. In such cases dosage should be reduced to the last level not causing reaction and maintained for two or three treatments before cautiously increasing. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. Short-term (less than 1 week) administration of corticosteroids at the therapeutic doses used in asthmatic patients does not modify the cutaneous reactivity to histamine, compound 48/80, or allergen. Antigen E content of ragweed mixtures ranges from 46-166 U/ml for Ragweed Mixture (Short/Giant/Western/Southern Ragweed), 47-239 U/ml for Short/Giant/Western Ragweed Mixture, and 106-256 U/ml for Short/Giant Ragweed Mixture. Confirmation is determined by skin testing. However, some allergic reactions in cotton factory workers are not caused by the cotton fibers themselves, but by allergens added to the fibers while the cotton is being processed. The best areas on the arms are the volar surfaces from the axilla to 2.5 or 5 cm above the wrist, skipping the anticubital space. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. FDA Safety Recalls, Subcutaneous injections of increasing doses of allergenic extract into patients with allergic disease have been shown to result in both humoral and cellular changes including the production of allergen-specific IgG antibodies, the suppression of histamine release from target cells, decrease in circulating levels of antigen specific IgE antibody over long periods of time and suppression of peripheral blood T-lymphocyte cell responses to antigen.10, 14, 15. SINGLE DILUTION INTRADERMAL TESTING: The surface of the upper and lower arm is the usual location for skin testing. Patients being switched from one lot of extract to another from the same manufacturer should have the dose reduced by 75%. (current), tobacco leaf allergenic extract 100 MG/mL Injectable Solution, tobacco leaf allergenic extract 100 MG/ML Injectable Solution, Nicotiana tabacum leaf extract 0.1 GM/ML Injectable Solution, Nicotiana tabacum leaf extract 100 MG/ML Injectable Solution, orris root allergenic extract 100 MG/ML Injectable Solution, Iris germanica var. For patients demonstrating a positive prick-puncture skin test, an initial screening dilution of 1:312,500 w/v is safe. Matthews, K., et al: Rhinitis, Asthma and Other Allergic Diseases. Hence, the importance of a good patient history. 49288-0343-2,
Extract (stock concentrate) is supplied in 10, 30 and 50 ml containers. Monitor airways for obstruction. A cotton allergy may also express itself in respiratory problems, such as asthma and rhinitis, or inflammation of the nasal mucous membranes. November 13, 2009. However, it causes discomfort to individuals who are allergic to cotton. 14. This extract is not directly interchangeable with other allergenic extracts. 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). Fatalities are rare but can occur.5 Other possible systemic reaction symptoms are fainting, pallor, bradycardia, hypotension, angioedema, cough, wheezing, conjunctivitis, rhinitis,and urticaria.13, 14. Annals of Allergy, Vol. Children with nephrotic syndrome probably should not receive injections due to immunization causing exacerbation of nephrotic disease. 417-425, June 1979. 1969, "Dermatology Online Journal: Common Misconceptions in; Rajani Katta; 2008, N.C. Department of Labor; A Guide for; Cherie Berry, et al. The inhibitory effect of conventional antihistamines varies from 1 day up to 10 days, according to the drug and patients sensitivity. Allergenic extracts are highly potent to sensitive individuals and OVERDOSE could result in anaphylactic symptoms. 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. Patient must be instructed to report any adverse reactions that occur within 24 hours after injection. 1365-1376, 1988. Immunol., pp. Files, All Mapping Long, W.F., Taylor, R.J., Wagner, C.J., et al. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Refer to container label for actual Antigen E content. Intracutaneous test dilutions, five-fold or ten-fold, may be prepared from stock concentrate using physiologic saline as a diluent. 1213-1219. View NDC Code(s)NEW! The flowers of the cotton plant rest on a structure called a receptacle. These detergent allergens may adhere to the cotton fabric, where they may provoke an allergic reaction in a sensitized individual. Epinephrine or beta-adrenergic drugs (Alupent) may be ineffective. 49288-0272-3, Files, Presentations Fresh egg white extract is available at 1:9 v/v extraction ratio. 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.
4, p. 52, edited by Middleton et al. Injections should never be given intravenously. Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and/or death. 19, pp 419-436, 1988. 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. A positive reaction is approximately 10-15 mm erythema with 2.5 mm wheal. 49288-0272-1, 9-20. Studies indicate allergic individuals produce immunoglobulins of the IgE class in response to exposure to allergens. 49288-0154-2, HEW, NIH Publication No. 49288-0285-5, 79-387, Chapter 4, pp. A negative control (50% glycerine for prick-puncture testing) would exclude false-positive reactions due to ingredients in diluent or patients who have dermatographism. 17. 49288-0285-2, See the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and OVERDOSAGE sections. The usual duration of treatment has not been established. Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. 49288-0343-3, Intracutaneously inject 0.01 to 0.02 ml of the test allergen to form a 4 mm diameter superficial skin wheal. 1, Chap. Repeat dose in 5-10 minutes if necessary. Possible adverse reactions include unusual swelling and/or tenderness at injection site, rhinorrhea, sneezing, coughing, wheezing, shortness of breath, nausea, dizziness, or faintness. It is important that a new, sterile, disposable syringe and needle be used for each extract tested. Labels, All Index
49288-0154-3, 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. 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. Long acting antihistamines (e.g., astemizole) may inhibit the wheal and flare for up to forty days.1, 2, Imipramines, phenothiazines, and tranquilizers. Larger local reactions are not only uncomfortable, but indicate the possibility of a severe systemic reaction if dosage is increased. 3. 84-86. Refer to WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections for signs and symptoms of an overdose. is this? 49288-0403-4, may be prepared either by dilution from a more concentrated stock or by direct extraction. Bullock, J., Frick, O.: Mite Sensitivity in House Dust Allergic Children, Am. If you are a consumer or patient please visit J. Dis. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). 57, August 1986. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. A 5/8 inch, 25 gauge needle on a sterile syringe will allow deep subcutaneous injection. 6, p. 511, December 1980. 63, No. This fabric has clothed millions of people and has furnished blankets and pillowcases for the comfort of sleepers. Is Linen or Cotton Better in Hot Weather. 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. 49288-0582-4, florentina root allergenic extract 1 GM per 20 ML Injectable Solution, Iris germanica var. Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Large, persistent local reactions or minor exacerbations of the patients allergic symptoms may be treated by local cold applications and/or use of oral antihistamines. The epinephrine HCL 1:1000 dose for infants to 2 years is 0.05 to 0.1 ml; for children 2 to 6 years it is 0.15 ml; for children 6 to 12 years it is 0.2 ml. : Inhalant Allergy Immunotherapy with Standardized and Nonstandardized Allergenic Extracts, American Academy of Otolaryngology-Head and Neck Surgery: Instructional Courses, Vol. 49288-0583-5. Some people are allergic to cotton plant tissues. Therefore, it is imperative that physicians administering allergenic extracts understand and prepare for treatment of severe reactions. The dermatitis may be atopic, which means that it can occur on parts of the body not in direct contact with the allergen. PRICK-PUNCTURE TESTING: To identify highly sensitive individuals and as a safety precaution, it is recommended that a prick-puncture test using a drop of the extract concentrate be performed prior to initiating very dilute intradermal testing. Discontinue use of the tourniquet after hour. All source materials are inspected by Antigen Laboratories technical personnel in accordance with 21 CFR 680.1 (b) (1). 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. Patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodilators. If loss of potency is suspected, potency can be checked using side by side skin testing with freshly prepared dilutions of equal concentration on individuals with known sensitivity to the allergen. 49288-0344-5, A systemic reaction to allergenic extract could cause uterine contractions leading to spontaneous abortion or premature labor. 49288-0581-3, I and II, pp 135-163, 1988. 92, No. IMMUNOTHERAPY: If the first injection of the initial dilution of extract is tolerated without significant local reaction, increasing doses by 5-20% increments of that dilution may be administered. & Articles, All INTRADERMAL TESTING-SKIN ENDPOINT TITRATION: The allergenic extracts to which the patient is sensitive, the patients degree of sensitivity and the dose of allergen to be used in immunotherapy can be determined through the use of intracutaneous skin tests involving progressive five-fold dilutions of allergenic extracts. Willoughby, J.W. Injections should never be given intravenously. Patients who have been taking beta-blockers may be unresponsive to epinephrine. florentina root allergenic extract 0.05 GM/ML Injectable Solution, Iris germanica var. 1, pp. Small amounts of erythema and swelling at the site of injection are common. Ten-fold dilution to 10-6 of a 1:10 w/v (10%) extract would be a safe starting dilution. Sterile solutions, vials, syringes, etc. Physicians undertaking immunotherapy should be concerned with patients degree of sensitivity. Report Adverse The following are commonly prescribed beta-blockers: Levatol, Lopressor, Propanolol Intersol, Propanolol HCL, Blocadren, Propanolol, Inderal-LA, Visken, Corgard, Ipran, Tenormin, Timoptic. 49288-0272-5, 11. 4. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. Wasserman, S., Marquart, D.: Anaphylaxis, Third Edition, Allergy Principles and Practice, C.V. Mosby Co., Vol. 49288-0344-4, If a systemic or anaphylactic reaction does occur, apply tourniquet above the site of allergenic extract injection and inject intramuscularly or subcutaneously 0.3 to 0.5 ml of 1:1000 Epinephrine-hydrochloride into the opposite arm or gluteal area. Long-term corticosteroid therapy modifies the skin texture and makes the interpretation of immediate skin tests more difficult.1, Theophylline.
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.
49288-0583-4, Children can receive the same dose as adults. Dilutions of the allergenic extracts containing less than 50% glycerine are less stable. (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. 49288-0344-1, Detergents used to wash cotton fabrics may also contain allergens. A mild burning immediately after injection is expected; this usually subsides in 10-20 seconds. 49288-0583-2, Some people are allergic to cotton fibers. 16. Immunotherapy must be given under physicians supervision. I, Chap. It cannot be overemphasized that, under certain unpredictable combinations of circumstances, anaphylactic shock is always a possibility. Adverse reactions to allergenic extracts are usually apparent within 20-30 minutes following injection of immunotherapy. 49288-0403-3, Biochemical Data Summary. 13. Report serious adverse events to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787, phone 1-800-FDA-1088. 8. Loosen tourniquet briefly at 5 minute intervals to prevent circulatory impairment. Antibodies protect against diseases, but they may also provoke allergic 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. Tranquilizers and antiemetic agents of the phenothiazine class have H1 antihistaminic activity and can block skin tests.1, Corticosteroids. 49288-0343-1,
Perelmutter, L.: IgE Regulation During Immunotherapy of Allergic Diseases. to volume. Do not administer in the presence of diseases characterized by bleeding diathesis. Ishizaka, K.: Control of IgE Synthesis, Third Edition, Allergy Principles and Practices, Vol. Stock concentrates are available in concentrations of 2-10% or weight/volume (w/v) of 1:50, 1:33, 1:20 or 1:10. Dosages progressively increase according to the tolerance of the patient at intervals of one to seven days until, (1) the patient achieves relief from symptoms, (2) induration at the site of injection is no larger than 50 mm in 36 to 48 hours, (3) a maintenance dose is reached (the largest dose tolerated by the patient that relieves symptoms without undesirable local or systemic reactions). Proper measurement of dose and caution in making injection will minimize reactions. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Child., pp. 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. Epinephrine 1:1000 should be available. 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. : Skin test suppression by antihistamines and the development of subsensitivity, J. Refer to OVERDOSAGE section. 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. 1, Chapter 15, C.V. Mosby Co., St. Louis, Missouri, September 1988. Diagnostic use of allergenic extracts usually begins with direct skin testing. 49288-0582-1, Refer to WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections below. (2) A volume of 0.02-0.05 ml should be injected slowly into the superficial skin layers making a small bleb (superficial wheal). The usual precautions in administering allergenic extracts are necessary, refer to boxed WARNINGS and WARNINGS section. Aseptic technique must be observed in making dilutions from stock concentrates. Precaution is necessary when using extract mixture for skin testing. Adverse reactions include, but are not limited to urticaria; itching; edema of extremities; respiratory wheezing or asthma; dyspnea; cyanosis; tachycardia; lacrimation; marked perspiration; flushing of face, neck or upper chest; mild persistent clearing of throat; hacking cough or persistent sneezing. 213-217, May 1979. Updated These fibers grow on cotton seeds inside the cotton boll, or the fruit of the cotton plant. 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. ), More about getting RSS News & Updates from DailyMed, 2 Presence in Breast Milk, Medline Plus, Antihistamines, H2 antagonist, bronchodilators, steroids and theophylline may be used as indicated after providing adequate epinephrine and circulatory support.4. They also cause the production of antibodies, according to the "British Journal of Industrial Medicine. 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. Allergenic extracts should be used during pregnancy only if potential benefit justifies potential risk to fetus.11. 49288-0272-2, When harvested and processed, they make a fine textile called cotton. In some cases, they have a true cotton allergy. Extracts in 5 ml dropper bottles are available for prick-puncture testing. 49288-0285-1, 49288-0581-1, Strongly positive skin tests may be risk factors for systemic reactions. Finally, it was shown that specific immunotherapy in patients treated with ragweed pollen extract induced a decreased late-phase reaction.1. In certain individuals, especially in steroid-dependent/unstable asthmatics, these life-threatening reactions may result in death. Immediate medical attention must be sought for reactions that occur during or after leaving physicians office. Dust mites are another possible cause of an allergic reaction wrongly attributed to cotton. Copy the URL below and paste it into your RSS Reader application. 1986, "British Journal of Industrial Medicine"; An Investigation of Allergy in; V. Popa, et al; Apr. Adrenocorticosteroids may be administered parenterally or intravenously. Tricyclic antidepressants exert a potent and sustained decrease of skin reactions to histamine. 49288-0154-4, 49288-0154-5, 49288-0403-5,
49288-0582-3, 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. 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. Allergy Clin. However, they may be reacting to allergens introduced into the fabric during its manufacture, such as formaldehyde. For this reason, cotton factory workers may develop an allergy to cotton fibers. 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. Certain plants of the genus Gossypium have soft fibers that cling to the seeds. Survey of Fatalities from Skin Testing and Immunotherapy 1985-1989, Journal of Allergy and Clinical Immunology, Vol. 49288-0272-4, Refer to OVERDOSAGE section for description of treatment for anaphylactic reactions. 6-15, 1993. Some of these may be allergenic, according to "Environmental Health Perspectives.". Treatment and emergency measures, as well as personnel trained in their use, must be available in the event of a life-threatening reaction. 49288-0581-5, RxNorm, 49288-0285-3, Patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodilators. Store all stock concentrates and dilutions at 2-8 C. Keep at this temperature during office use. 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. 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.
49288-0582-2, ", Some of the allergens in cotton fibers persist during the processing of cotton. A Web Experience brought to you by LEAFtv, "Environmental Health Perspectives"; Immunologic Responses to; John Salvaggio; Apr. Smaller, less conclusive reactions may be considered positive in conjunction with a definitive history of symptoms on exposure to the allergen. 76-113, 1985. The expiration date of the allergenic extracts is listed on the container label. Antihistamines inhibit the wheal and flare reaction. Some people experience allergic reactions when they wear cotton clothing or when they sleep on cotton pillowcases. Less aggressive immunotherapy schedules may be indicated for such patients. Discomfort is minimized by dividing the dose in half and administering injection at two different sites.16, 17, Antihistamines. Because many drugs are excreted in human milk, caution should be exercised when allergenic extracts are administered to a nursing woman. Animal reproduction studies have not been conducted with allergenic extracts. They sometimes produce positive responses in skin tests for allergens. Patients extremely sensitive to a common allergen in several components of a mixture may be more likely to experience a systemic reaction than when skin tested individually for each component.9. Reactions should not be considered significant unless they persist for at least 24 hours or exceed 50 mm in diameter. Events, (What Boxed Warnings,
Edited by J. Pepys & A.M. Edwards, Proceedings of an International Symposium, Davos, Switzerland, Pitman Medical Publishing Co., 1979, pp. It may be necessary to adjust the progression of dosage downward to avoid local and constitutional reactions. It is not known whether allergenic extracts are excreted in human milk. 49288-0343-4, IN THESE CASES THE POTENCY FOR SKIN TESTS AND THE ESCALATION OF THE TREATMENT DOSE MUST BE ADJUSTED TO THE PATIENTS SENSITIVITY AND TOLERANCE. Seebohm, P.M., et al: Panel on Review of Allergenic Extracts, Final Report, Food and Drug Administration, March 13, 1981, pp. 6. Patient should remain under observation of a nurse, physician, or personnel trained in emergency measures for at least 20 minutes following immunotherapy injection. The route of administration for immunotherapy is subcutaneous. In such cases dosage should be reduced to the last level not causing reaction and maintained for two or three treatments before cautiously increasing. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. Short-term (less than 1 week) administration of corticosteroids at the therapeutic doses used in asthmatic patients does not modify the cutaneous reactivity to histamine, compound 48/80, or allergen. Antigen E content of ragweed mixtures ranges from 46-166 U/ml for Ragweed Mixture (Short/Giant/Western/Southern Ragweed), 47-239 U/ml for Short/Giant/Western Ragweed Mixture, and 106-256 U/ml for Short/Giant Ragweed Mixture. Confirmation is determined by skin testing. However, some allergic reactions in cotton factory workers are not caused by the cotton fibers themselves, but by allergens added to the fibers while the cotton is being processed. The best areas on the arms are the volar surfaces from the axilla to 2.5 or 5 cm above the wrist, skipping the anticubital space. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. FDA Safety Recalls, Subcutaneous injections of increasing doses of allergenic extract into patients with allergic disease have been shown to result in both humoral and cellular changes including the production of allergen-specific IgG antibodies, the suppression of histamine release from target cells, decrease in circulating levels of antigen specific IgE antibody over long periods of time and suppression of peripheral blood T-lymphocyte cell responses to antigen.10, 14, 15. SINGLE DILUTION INTRADERMAL TESTING: The surface of the upper and lower arm is the usual location for skin testing. Patients being switched from one lot of extract to another from the same manufacturer should have the dose reduced by 75%. (current), tobacco leaf allergenic extract 100 MG/mL Injectable Solution, tobacco leaf allergenic extract 100 MG/ML Injectable Solution, Nicotiana tabacum leaf extract 0.1 GM/ML Injectable Solution, Nicotiana tabacum leaf extract 100 MG/ML Injectable Solution, orris root allergenic extract 100 MG/ML Injectable Solution, Iris germanica var. For patients demonstrating a positive prick-puncture skin test, an initial screening dilution of 1:312,500 w/v is safe. Matthews, K., et al: Rhinitis, Asthma and Other Allergic Diseases. Hence, the importance of a good patient history. 49288-0343-2,
Extract (stock concentrate) is supplied in 10, 30 and 50 ml containers. Monitor airways for obstruction. A cotton allergy may also express itself in respiratory problems, such as asthma and rhinitis, or inflammation of the nasal mucous membranes. November 13, 2009. However, it causes discomfort to individuals who are allergic to cotton. 14. This extract is not directly interchangeable with other allergenic extracts. 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). Fatalities are rare but can occur.5 Other possible systemic reaction symptoms are fainting, pallor, bradycardia, hypotension, angioedema, cough, wheezing, conjunctivitis, rhinitis,and urticaria.13, 14. Annals of Allergy, Vol. Children with nephrotic syndrome probably should not receive injections due to immunization causing exacerbation of nephrotic disease. 417-425, June 1979. 1969, "Dermatology Online Journal: Common Misconceptions in; Rajani Katta; 2008, N.C. Department of Labor; A Guide for; Cherie Berry, et al. The inhibitory effect of conventional antihistamines varies from 1 day up to 10 days, according to the drug and patients sensitivity. Allergenic extracts are highly potent to sensitive individuals and OVERDOSE could result in anaphylactic symptoms. 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. Patient must be instructed to report any adverse reactions that occur within 24 hours after injection. 1365-1376, 1988. Immunol., pp. Files, All Mapping Long, W.F., Taylor, R.J., Wagner, C.J., et al. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Refer to container label for actual Antigen E content. Intracutaneous test dilutions, five-fold or ten-fold, may be prepared from stock concentrate using physiologic saline as a diluent. 1213-1219. View NDC Code(s)NEW! The flowers of the cotton plant rest on a structure called a receptacle. These detergent allergens may adhere to the cotton fabric, where they may provoke an allergic reaction in a sensitized individual. Epinephrine or beta-adrenergic drugs (Alupent) may be ineffective. 49288-0272-3, Files, Presentations Fresh egg white extract is available at 1:9 v/v extraction ratio. 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.