देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
PHYTONADIONE (UNII: A034SE7857) (PHYTONADIONE - UNII:A034SE7857)
Teligent Pharma, Inc.
PHYTONADIONE
PHYTONADIONE 2 mg in 1 mL
PRESCRIPTION DRUG
New Drug Application
AQUAMEPHYTON - PHYTONADIONE INJECTION, EMULSION TELIGENT PHARMA, INC. ---------- AQUAMEPHYTON® (PHYTONADIONE) AQUEOUS COLLOIDAL SOLUTION OF VITAMIN K WARNING — INTRAVENOUS AND INTRAMUSCULAR USE Severe reactions, including fatalities, have occurred during and immediately after INTRAVENOUS injection of AquaMEPHYTON (Phytonadione), even when precautions have been taken to dilute the AquaMEPHYTON and to avoid rapid infusion. Severe reactions, including fatalities, have also been reported following INTRAMUSCULAR administration. Typically these severe reactions have resembled hypersensitivity or anaphylaxis, including shock and cardiac and/or respiratory arrest. Some patients have exhibited these severe reactions on receiving AquaMEPHYTON for the first time. Therefore the INTRAVENOUS and INTRAMUSCULAR routes should be restricted to those situations where the subcutaneous route is not feasible and the serious risk involved is considered justified. DESCRIPTION Phytonadione is a vitamin, which is a clear, yellow to amber, viscous, odorless or nearly odorless liquid. It is insoluble in water, soluble in chloroform and slightly soluble in ethanol. It has a molecular weight of 450.70. Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its empirical formula is C H O and its structural formula is: AquaMEPHYTON injection is a yellow, sterile, aqueous colloidal solution of vitamin K , with a pH of 5.0 to 7.0, available for injection by the intravenous, intramuscular, and subcutaneous routes. Each milliliter contains: Phytonadione 2 mg or 10 mg Inactive ingredients: Polyoxyethylated fatty acid derivative 70 mg Dextrose 37.5 mg Water for injection, q.s. 1 mL Added as preservative: Benzyl alcohol 9 mg 1 31 46 2 1 CLINICAL PHARMACOLOGY AquaMEPHYTON aqueous colloidal solution of vitamin K for parenteral injection, possesses the same type and degree of activity as does naturally-occurring vitamin K, which is necessary for the production via the liver of active prothrombin (factor II), proconvertin (factor VII), plasma thrombopl पूरा दस्तावेज़ पढ़ें