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starting stage [.001),:< 0.01 between empiric and withhold strategies. Primary outcome Endotracheal intubation (%) 3 (2.2) 1 (0.94) 7 (6.25) 0 (0) Secondary outcomes Days intubated Avg. (SD) 5.67 (2.89) 24 (N/A) 8 (6.22) 0 (0) ICU admission (%) * 97 (72.39) 49 (46.23) 90 (80.36) 9 (25.71) ICU LOS Avg.(SD) 1.5 (1.18) 1.73 (3.28) 2.25 (3.35) 1.3 (0.5) Total LOS Avg.(SD) 1.58 (1.56) 1.17 (2.94) 2.47 (3.68) 0.94 (0.85) Antivenom ADR (%) * 26 (19.4) 0 (0) 20 (17.86) 0 (0) Outcome code % * No Effect 4.76 29.29 0 0 Minor 71.43 56.57 34.23 63.64 Moderate 20.63 13.13 54.05 36.36 Major 3.17 1.01 11.71 0 Adverse reactions associated with North American Coral Snake Antivenin (Equine) administration were documented in 46 (18.25%) cases. The most common adverse reactions were hives, rash and/or welts (12%); itching (9%); shortness of breath (8%); hypotension (2%) and angioedema (1%). Antihistamines were administered to 46 patients, corticosteroids to 40, and epinephrine to 10 cases to treat these adverse reactions. REFERENCES Bowden, C and Krenzelok, E: Clinical applications of commonly used contemporary antidotes, a US perspective. Drug Safety 1997; 16(1):9-47. Sasaki, J et al: Coral snake bites and envenomation in children, A case series. Ped Emerg Care 2014; 30(4):262-5. Wood A, Schauben J, Thundiyil J, et al. Review of Eastern coral snake (Micrurus fulvius fulvius) exposures managed by the Florida Poison Information Center Network: 1998-2010. Clin Toxicol 2013; 51(8):783-8. How Supplied/Storage and Handling North American Coral Snake Antivenin (Equine) is supplied as a sterile lyophilized powder in single use vial (NDC 0008-0423-01) in a carton (NDC 0008-0423-03). Store vials between 2 and 8 C (36 and 46 F). Do not freeze. Use the reconstituted and diluted product within 4 hours. Patient Counseling Information Advise patients to contact the physician or emergency department immediately if they experience any signs and symptoms of delayed allergic reactions or serum sickness up to 14 days following hospital discharge. Symptoms include rash, pruritus, joint pain, arthralgia, fever, lymphadenopathy, and malaise. U.S. Govt. License No. 3 LAB-0726-6.0 PRINCIPAL DISPLAY PANEL - 10 mL Vial Label NDC 0008-0423-01 Antivenin Micrurus fulvius equine origin North American Coral Snake Antivenin 10 mL Rx only PRINCIPAL DISPLAY PANEL - 10 mL Vial Carton NDC 0008-0423-03 Contains 1 of NDC 0008-0423-01 Antivenin Micrurus fulvius equine origin North American Coral Snake Antivenin 10 mL This package contains one vial of lyophilized Antivenin (Micrurus fulvius) with 0.25% phenol as a preservative (before lyophilization). Sealed under partial vacuum. Pfizer Injectables Rx only NORTH AMERICAN CORAL SNAKE ANTIVENIN (EQUINE) coral snake (micrurus fulvius) immune globulin antivenin (equine) injection, powder, for solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0008-0423 Route of Administration INTRAVENOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CORAL SNAKE (MICRURUS FULVIUS) IMMUNE GLOBULIN ANTIVENIN (EQUINE) (CORAL SNAKE (MICRURUS FULVIUS) IMMUNE GLOBULIN ANTIVENIN (EQUINE)) CORAL SNAKE (MICRURUS FULVIUS) IMMUNE GLOBULIN ANTIVENIN (EQUINE) 250 [arb'U] in 10 mL Inactive Ingredients Ingredient Name Strength PHENOL THIMEROSAL Packaging # Item Code Package Description 1 NDC:0008-0423-03 1 VIAL in 1 CARTON 1 NDC:0008-0423-01 10 mL in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101099 10/12/2016 Labeler - Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. (828831441) Establishment Name Address ID/FEI Operations Pharmacia and Upjohn Company LLC 618054084 ANALYSIS(0008-0423), API MANUFACTURE(0008-0423), LABEL(0008-0423), MANUFACTURE(0008-0423), PACK(0008-0423) Revised: 09/2017 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer 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 frequently


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