wake-up call [5:<5 mm> <10 mm 5-10 mm 5-10 mm 10-20 mm 1+ 5-10 mm 11-20 mm 20-40 mm 2+ 5-10 mm 21-30 mm 40-60 mm 3+ 10-15 mm a 31-40 mm 60-80 mm 4+> 15 mm b >40 mm >80 mm a. or with pseudopods b. or with many pseudopods 3. Immunotherapy Allergen extracts should be administered using a sterile syringe with 0.01 mL gradations and a 25-27 gauge x 1/2" to 5/8" needle. The injections are given subcutaneously. The most common sites of injection are the lateral aspect of the upper arm or thigh. Intracutaneous or intramuscular injections may produce large local reactions which may be very painful. Dosage of allergenic extracts is a highly individualized matter and varies according to the degree of sensitivity of the patient, his clinical response, and tolerance to the extract administered during the early phases of an injection regimen. The starting dose should be based on skin tests of the extract to be used for immunotherapy. To prepare dilutions for intradermal and therapeutic use, make a 1:10 dilution by adding 1.0 mL of the concentrate to 9.0 mL of sterile aqueous diluent. Subsequent serial dilutions are made in a similar manner. (See Table I.) To determine the starting dose, begin intradermal testing with the most dilute extract preparation. Inject 0.02 mL and read the reaction after 15 minutes. Intradermal testing is continued with increasing concentrations of the extract until a reaction of 10-20 mm erythema ( E 20-40 mm) and/or a 5 mm wheal occurs. This concentration at a dose of 0.03 mL then can serve as a starting dose for immunotherapy and be increased by 0.03 mL to as high as 0.12 mL increments each time until 0.3 mL is reached, at which time a dilution 10 times as strong can be used, starting with 0.03 mL. Proceed in this way until a tolerance dose is reached or symptoms are controlled. Suggested maintenance dose is 0.2 mL of the concentrate. Occasionally, higher doses are necessary to relieve symptoms. Special caution is required in administering doses greater than 0.2 mL. The interval between doses normally is 3 to 7 days. This is offered as a suggested schedule for average patients and will be satisfactory in most cases. However, the degree of sensitivity varies in many patients. The size of the dose should be adjusted and should be regulated by the patient s tolerance and reaction. The size of the dose should be decreased if the previous injection resulted in marked local or the slightest general reaction. Another dose should never be given until all local reactions resulting from the previous dose have disappeared. In some patients, the dosage may be increased more rapidly than called for in the schedule. In seasonal allergies, treatment should be started and the interval between doses regulated so that at least the first 20 doses will have been administered by the time symptoms are expected. Thus, the shorter the interval between the start of immunotherapy and the expected onset of symptoms, the shorter the interval between each dose. Some patients may even tolerate daily doses. A maintenance dose, the largest dose tolerated by the patient that relieves symptoms without producing undesirable local or general reactions is recommended for most patients. The upper limits of dosage have not been established; however, doses larger than 0.2 mL of the glycerinated concentrate may be painful due to the glycerin content. The dosage of allergenic extract does not vary significantly with the respiratory allergic disease under treatment. The size of this dose and the interval between doses will vary and can be adjusted as necessary. Should symptoms develop before the next injection is scheduled, the interval between doses should be decreased. Should allergic symptoms or local reactions develop shortly after the dose is administered, the size of the dose should be decreased. In seasonal allergies, it is often advisable to decrease the dose to one-half or one-quarter of the maximum dose previously attained if the patient has any seasonal symptoms. The interval between maintenance doses can be increased gradually from one week to 10 days, to two weeks, to three weeks, or even to four weeks if tolerated. Repeat the doses at a given interval three or four times to check for untoward reactions before further increasing the interval. Protection is lost rapidly if the interval between doses is more than four weeks. (See WARNINGS Section.) The usual duration of treatment has not been established. A period of two or three years of injection therapy constitutes an average minimum course of treatment. TABLE 1 TEN-FOLD DILUTION SERIES Standardized Extracts Labeled 10,000 BAU/mL Dilution Extract + Diluent = BAU/mL Concentration 0 Concentrate +0 mL = 10,000 1 1 mL concentrate +9 mL = 1,000 2 1 mL dilution #1 +9 mL = 100 3 1 mL dilution #2 +9 mL = 10 4 1 mL dilution #3 +9 mL = 1 5 1 mL dilution #4 +9 mL = 0.1 6 1 mL dilution #5 +9 mL = 0.01 7 1 mL dilution #6 +9 mL = 0.001 (4) PEDIATRIC USE The dose for the pediatric population is the same as for adults. (See PRECAUTIONS .) (5) GERIATRIC USE The dose for elderly patients is the same as for adults patients under 65. 28 How is Cat Pelt Standardized Supplied Standardized Cat Pelt allergenic extract is supplied for diagnostic and therapeutic use: Diagnostics: Prick or puncture testing, 10,000 BAU/mL [50% glycerin (v/v)] in 5 mL dropper vial. Bulk Therapeutics, multiple dose vials in either Glycero-Coca s or Albumin Saline with Phenol (0.4%) extracting fluid. 10 mL vial, 10,000 BAU/mL 30 mL vial, 10,000 BAU/mL 50 mL vial, 10,000 BAU/mL STORAGE The expiration date of the Standardized Cat Pelt extract containing 10,000 BAU/mL is listed on the container label. The extract should be stored at 2 - 8 C. Dilutions of the BAU/mL concentrates are less stable and, if loss of potency is suspected, should be checked by skin testing with equal bioequivalent allergy units of a freshly prepared dilution on known cat allergic individuals. LIMITED WARRANTY A number of factors beyond our control could reduce the efficacy of this product or even result in an ill effect following its use. These include storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use. No warranty, express or implied, including any warranty of merchantability or fitness, is made. Representatives of the Company are not authorized to vary the terms or the contents of any printed labeling, including the package insert, for this product except by printed notice from the Company s headquarters. The prescriber and user of this product must accept the terms hereof. REFERENCES 1. Lockey, Richard F., Linda M. Benedict, Paul C. Turkeltaub, Samuel C. Bukantz. Fatalities from immunotherapy (IT) and skin testing (ST). J. Allergy Clin. Immunol, 79 (4): 660-677, April 1987. 2. Assay for Cat Allergen I, Manual of Methods, Laboratory of Allergenic Products, Center for Biologics Evaluation and Research, Oct. 1993. 3. Patterson, Roy, et al. Allergy Principles and Practice, 2nd ed. E. Middleton, Jr., C.E. Reed, E.F. Ellis, Ed., C.V. Mosby Co., St. Louis, MO, 1983, Chapter 52. 4. Levy, D.A., L.M. Lichtenstein, E.O. Goldstein, and K. Ishizaka. Immunologic and cellular changes accompanying the therapy of pollen allergy. J. Clinical Investigation, 50:360, 1971. 5. Jacobs, R.L., G.W. Rake, Jr., et al. Potentiated anaphylaxis in patients with drug-induced beta-adrenergic blockade. J. Allergy and Clin. Immunol., 68 (2): 125-127, August 1981. 6. Lowell, F.C., W. Franklin. A double-blind study of treatment with aqueous allergenic extracts in cases of allergic rhinitis. J. Allergy, 34 (2): 165-182, 1983. 7. Lowell, F.C., W. Franklin. A double-blind study of the effectiveness and specificity of injection therapy in ragweed hay fever. N. Eng. J. Med., 273 (13): 675-679, 1965. 8. Zavazal, V., A. Stajner. Immunologic changes during specific treatment of the atopic state. II. Acta. Allergol., 25 (1): 11-17, 1970. 9. Reisman, R.E., J.I. Wypych, E.E. Arbesman. Relationships of immunotherapy, seasonal pollen exposure and clinical response to serum concentrations of total IgE and ragweed-specific IgE. Int. Arch. Allergy Appl. Immunol., 48 (6): 721-730, 1975. 10. Ohman, J.L., S.R. Findlay, K. Leiterman. Immunotherapy in cat-induced asthma: double-blind trial with evaluation of in vivo and vitro responses. J. Allergy Clin. Immunol. 74:230, 1984. 11. Sundin, B., G. Lilja, V. Graff-Lonnevig, G. Hedlin, H. Heilborn, K. Norrlind, K-O Pegelow, and H. Lowenstein. Immunotherapy with partially purified and standardized animal dander extracts. I Clinical results from a double-blind study on patients with animal dander asthma. J. Allergy Clin. Immunol. 77:478, 1986. 12. Chapman, M.D., T.A.E. Platts-Mills, M. Gabriel, H.K. Ng, W.G.L. Allen, L.E. Hill, A.J. Nunn. Antibody response following prolonged hyposensitization with Dermatophagoides pteronyssinus extract. Int. Arch. Allergy Appl. Immunol., 61: 431-440, 1980. 13. Norman, P.S. Postgraduate Course Presentation. An overview of immunotherapy, implications for the future. J. Allergy Clin. Immunol, 65 (2): 87-96, 1980. 14. Norman, P.S., W.L. Winkenwerder. Maintenance immunotherapy in ragweed hay fever. J. Allergy, 74: 273-282, 1971. 15. Norman, P.S., W.L. Winkenwerder, L.M. Lichtenstein. Immunotherapy of hay fever with ragweed Antigen E; comparisons with whole pollen extract and placebos. J. Allergy, 42: 93-108, 1968. 16. Sheldon, J.M., R.G. Lovell, K.P. Matthews. A Manual of Clinical Allergy. Second Edition. W.B. Saunders, Philadelphia, pp. 107-112, 1967. 17. Sherman, W.B. Hypersensitivity Mechanism and Management. W.B. Sanders, Philadelphia, pp. 169-172, 1968. 18. Swineford, O. Asthma and Hay Fever. Charles C. Thomas, Springfield, IL, pp. 148-155, 1971. 19. Pauli, G., J.C. Bessot, R. Thierry, and A. Lamensons. Correlation between skin tests, inhalation tests and specific IgE in a study of 120 subjects to house dust and D. pteronyssinus. Clin. Allergy, :337, 1977. 20. Murray, A.B., A.C. Ferguson and B.J. Morrison. Diagnosis of house dust mite allergy in asthmatic children: What constitutes positive history? J. Allergy Clin. Immunol. 71:21, 1983. 21. Turkeltaub, Paul C., MD, and Peter J. Gergen, MD. The risk of adverse reactions from percutaneous prick-puncture allergen skin testing, venipuncture, and body measurements: Data from the second National Health and Nutrition Examination Survey 1976-80 (NHANES II). J. Allergy Clin. Immunol. 84 (6): 886-890, Dec. 1989. 22. DuBuske, L.M., C.J. Ling and A.L. Sheffer. Special problems regarding allergen immunotherapy. Immunol. Allergy Clin. North Am. (USA). 12(1): 145-175, 1992. 23. Turkeltaub, Paul C., MD, Suresh Rastogi, and Harold Baer. Skin test method for evaluation of subject sensitivity to standardized allergenic extracts and for assignment of Allergy Units to reference preparations using the ID 50 EAL Method. Manual of Methods, Center for Biologics Evaluation and Research. May 1986. 24. Pipkorn, Ulf. Pharmacological influence of anti-allergic medication on In Vivo allergen testing. Allergy. 43: 81-86, 1988. 25. Andersson, M. and U. Pipkorn. Inhibition of the dermal immediate allergic reaction through prolonged treatment with topical glucocorticosteroids. Journal Allergy Clinical Immunology. 79 (2): 345-349. February 1987. 26. Rao, Kamineni S., et al. Duration of suppressive effect of tricyclic anti-depressants on histamine induced wheal and flare reactions on human skin. Journal Allergy Clinical Immunology. 82: 752-757, November 1988. 27. Pipkorn, Ulf, and M. Andersson. Topical dermal anesthesia inhibits the flare but not the wheal response to allergen and histamine in the skin prick test. Clinical Allergy. 17: 307-311, 1987. 28. Peebles, Ray Stokes, Jr., B. Bochner, Howard J. Zeitz, ed. Anaphylaxis in the elderly. Immunology and Allergy Clinics of North America. 13 (3): 627-646, August 1993. STANDARDIZED CAT PELT standardized cat pelt injection, solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-4810 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FELIS CATUS DANDER (FELIS CATUS DANDER) FELIS CATUS DANDER 10000 [BAU] in 1 mL Inactive Ingredients Ingredient Name Strength glycerin sodium bicarbonate sodium chloride Packaging # Item Code Package Description 1 NDC:65044-4810-1 5 mL in 1 VIAL 2 NDC:65044-4810-2 10 mL in 1 VIAL 3 NDC:65044-4810-3 30 mL in 1 VIAL 4 NDC:65044-4810-4 50 mL in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103890 10/20/1992 Labeler - Hollister-Stier Laboratories LLC (069263643) Registrant - Hollister-Stier Laboratories LLC (069263643) Establishment Name Address ID/FEI Operations Hollister-Stier Laboratories LLC 069263643 manufacture Revised: 12/2009 Hollister-Stier Laboratories LLC Print this page ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Recently Approved Lonhala Magnair Lonhala Magnair (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator for... 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the whole thing Cat Pelt Standardized to flamable
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