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fee [5mm:<5mm +/- 5-10mm 5-10mm 1+ 11-20mm 5-10mm 2+ 21-30mm 5-10mm 3+ 31-40mm 10-15mm or with pseudopods 4+> 40mm >15mm or with many pseudopods IMMUNOTHERAPY: The following are two methods of injection therapy: Pre-seasonal in which treatment is begun three months before seasonal difficulty begins and brought to maintenance dose by injections four to seven days apart and discontinued after that season ends. Perennial treatment is the recommended mode of therapy in which the patient is, by injection therapy, brought up to tolerated maintenance dose and remains at that dose until amelioration of allergic symptoms occurs. Injections may be given at intervals of 4 to 7 days. Allergenic extracts must be diluted before use. Normally immunotherapy can be started with a 1 BAU/ml dilution. If a patient appears to be extremely sensitive, dilutions of the antigen can further be made before injections are started. The following are suggested procedures for making a proper dilution series. Recommended diluents contain 0.9% sodium chloride and 0.4% phenol as a preservative. TEN FOLD DILUTION SERIES: EXTRACT VOLUME EXTRACT C ONCENTRATION BAU/ml DILUENT VOLUME DILUTION CONCENTRATION BAU/ml 1 part 10,000 + 9 parts = 1,000 1 part 1,000 + 9 parts = 100 1 part 100 + 9 parts = 10 1 part 10 + 9 parts = 1 1 part 1 + 9 parts = 0.1 1 part 0.1 + 9 parts = 0.01 Perennial treatment may be started using the following dosage and dilution schedule. THIS SCHEDULE IS ONLY ILLUSTRATIVE AND HAS NOT BEEN SUBJECTED TO ADEQUATE OR WELL-CONTROLLED TRIALS TO DETERMINE EITHER ITS SAFETY OR EFFICACY. Dose # Dose Volume (ml) Concentration 1 0.05 1 BAU/ml 2 0.10 3 0.20 4 0.30 5 0.40 6 0.50 7 0.05 10 BAU/ml 8 0.10 9 0.20 10 0.30 11 0.40 12 0.50 13 0.05 100 BAU/ml 14 0.10 15 0.20 16 0.30 17 0.40 18 0.50 19 0.05 1,000 BAU/ml 20 0.10 21 0.20 22 0.30 23 0.40 24 0.50 25 0.05 10,000 BAU/ml 26 0.10 27 0.20 28 0.30 29 0.40 30 0.50 Gradually increase the dose as outlined in the schedule. If you give a dose that causes a mild local reaction manifested by warmth or redness, repeat the same dose. If the reaction is severe or systemic (manifested as hives, asthma, or hay fever), drop back a dose in schedule and build again. If a severe local reaction or a systemic reaction is again encountered, this should be considered more than the maximum tolerance for this patient. The maintenance dose is the largest dose that relieves symptoms without producing local reactions. The size and interval of doses will vary and can be adjusted as necessary. The normal interval between doses is 4 to 7 days. HOW SUPPLIED Bulk extract (stock concentrate) in 50% (v/v) glycerin containing 10,000 BAU/ml is supplied in 10ml, 30ml, and 50ml vials. Scratch testing in 50% (v/v) glycerin containing 10,000 BAU/ml is supplied in 2ml dropper vials. Intradermal testing (aqueous) containing 100 BAU/ml is supplied in 5ml vials. STORAGE These extracts should be stored at 2 to 8 degrees Celsius. Excessive heating (above room temperature) and repeated freeze-thawing should be avoided. The dating period (expiration date) is shown on the vial label. Once extracts are diluted the shelf life decreases. Extracts should be re-ordered when out of date. Please allow a minimum of three (3) weeks for delivery due to the holding period for sterility testing. REFERENCES Anderson, M.C., Baer, H.: Methodology for Assay of Cat Allergen, 1 May 1986, In Methods of the Laboratory of Allergenic Products, Division of Bacterial Products, Food and Drug Administration. Turkeltaub, P.C., Rastogi, S.C., Baer, H .: Assignment of Allergy Units to Reference Preparations using the ID 50 EAL Method, May 1986, In Methods of the Laboratory of Allergenic Products, Division of Bacterial Products, Food and Drug Administration. Wasserman, S.I.: Biochemical mediators of allergic reactions. In Patterson, R. (ed): Allergic diseases: diagnosis and management, p. 86. Philadelphia, J.B. Lippincott Co. 1985. Grammer, L.C.: Principle of immunologic management of allergic diseases due to extrinsic antigens. In Patterson, R. (ed): Allergic diseases: diagnosis and management, p. 358. Philadelphia, J.B. Lippincott Co. 1985. Booth, B.H.: Diagnosis of Immediate Hypersensitivity. In Patterson, R. (ed): Allergic diseases: diagnosis and management, p. 102. Philadelphia, J.B. Lippincott Co. 1985. Metzger, W.J., et al.: The safety of immunotherapy during pregnancy. J. Allergy Clin. Immunol., 64 (4): 268-272, 1978. Patterson, R. et al.: Immunotherapy. In Middleton, E. Jr., Reed, C.E. and Ellis, E.F. (ed): Allergy; Principles and Practice, (Vol. 2) p. 1119, St. Louis, The C.V. Mosby Co. 1983. Norman, P.S.: In vivo methods of study of allergy: Skin and Mucosal tests, techniques and interpretation. In Middleton, E. Jr., Reed, C.E. and Ellis, E.F. (ed): Allergy Principles and Practice, (Vol 1), p. 258. St. Louis, The C.V. Mosby Co. 1978. ALLERGY LABORATORIES, INC. Oklahoma City, OK 73109 U.S. License #103 (405) 235-1451 (800) 654-3971 Revised 09/23/92 STANDARDIZED CAT HAIR felis domesticus hair injection, solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:54575-288 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FELIS CATUS HAIR (FELIS CATUS HAIR) FELIS CATUS HAIR 10000 [BAU] in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN 50 mL in 100 mL SODIUM CHLORIDE 0.166 g in 100 mL SODIUM BICARBONATE 0.091 g in 100 mL WATER Packaging # Item Code Package Description 1 NDC:54575-288-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-288-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-288-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-288-50 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103324 10/30/1992 Labeler - Allergy Laboratories, Inc. (007191810) Establishment Name Address ID/FEI Operations Allergy Laboratories, Inc. 007191810 MANUFACTURE Revised: 03/2010 Allergy Laboratories, Inc. 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... Ozempic Ozempic (semaglutide) is a glucagon-like peptide-1 (GLP-1) analog administered once-weekly for the... Ogivri Ogivri (trastuzumab-dkst) is a HER2 / neu receptor antagonist biosimilar to Herceptin indicated for... Sublocade Sublocade (buprenorphine) is a once-monthly injectable partial opioid agonist formulation for the... More most appropriate


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