Pajjiż: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
Ceftriaxone sodium
Hospira Pty Limited
Medicine Registered
Product Information - Australia Version 1.0 Page 1 of 11 HOSPIRA™ CEFTRIAXONE SODIUM POWDER FOR INJECTION NAME OF THE MEDICINE Ceftriaxone sodium N S NH 2 O N H N OMe N S COONa S N N N O ONa Me H H O 3.5 H 2 O DESCRIPTION Hospira™ Ceftriaxone Sodium Powder for Injection is a sterile, semisynthetic, broad spectrum cephalosporin antibiotic for intravenous or intramuscular administration. Ceftriaxone sodium is Disodium (6R,7R)-7-[[(2Z)-(2-aminothiazol-4-yl)(methoxyimino)acetyl]amino]-3- [[(2-methyl-6-oxido-5-oxo-2,5-dihydro-1,2,4-triazin-3-yl)sulphanyl]methyl]-8-oxo-5-thia-1- azabicyclo[4.2.0]oct-2-ene-2-carboxylate 3.5 hydrate. . The chemical formula of ceftriaxone sodium is C 18 H 16 N 8 Na 2 O 7 S 3 3 ½H 2 O. It has a calculated molecular weight of 661.59 (CAS registry number: 104376-79-6). Ceftriaxone sodium is a white or yellowish crystalline powder which is very soluble in water, sparingly soluble in methanol and very slightly soluble in ethanol. The pH of a 5% aqueous solution is approximately 6 to 8. Ceftriaxone sodium solutions may be light yellow to amber coloured in colour. Hospira™ Ceftriaxone Sodium Powder for Injection contains approximately 83 mg (3.6 mEq) of sodium per gram of ceftriaxone activity. PHARMACOLOGY PHARMACOKINETICS Ceftriaxone is absorbed poorly from the gastrointestinal tract. Average plasma concentrations of ceftriaxone following a single 30 minute intravenous (IV) infusion of a 0.5, 1 or 2 g dose and intramuscular (IM) administration of a single 0.5 or 1 g dose in healthy subjects are presented in Table 1. Product Information - Australia Version 1.0 Page 2 of 11 TABLE 1 AVERAGE CEFTRIAXONE PLASMA CONCENTRATIONS AFTER SINGLE DOSE ADMINISTRATION. DOSE/ ROUTE AVERAGE PLASMA CONCENTRATIONS (MICROGRAMS/ML) (TIME FORM END OF ADMINISTRATION) 0.5 hour 1 hour 2 hour Aqra d-dokument sħiħ