Nchi: Nyuzilandi
Lugha: Kiingereza
Chanzo: Medsafe (Medicines Safety Authority)
Cefepime dihydrochloride monohydrate 1 g
Pfizer New Zealand Limited
Cefepime dihydrochloride monohydrate 1 g
1 g
Powder for injection
Active: Cefepime dihydrochloride monohydrate 1 g Excipient: Arginine
Vial, glass, single dose, Type I clear glass 20 mL vial with a grey bromobutyl rubber closure and Al flip-off green seal, 1 g
Prescription
Prescription
Orchid Chemicals and Pharmaceuticals Limited
Indicated for the treatment of lower respiratory tract infections, including pneumonia and bronchitis, when caused by susceptible bacteria.
Package - Contents - Shelf Life: Vial, glass, single dose, Type I clear glass 20 mL vial with a grey bromobutyl rubber closure and Al flip-off green seal - 1 g - 24 months from date of manufacture stored at or below 25°C protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light
2011-08-22
Data Sheet – New Zealand Hospira 3.0 Page 1 of 12 DBL TM CEFEPIME POWDER FOR INJECTION NAME OF THE MEDICINE Cefepime (as hydrochloride monohydrate) powder for solution for injection PRESENTATIONS Cefepime hydrochloride is a semi-synthetic broad spectrum cephalosporin antibiotic for parenteral administration. The chemical name is: Pyrrolidinium, 1-[[7-[[2-amino-4- thiazolyl)(methoxyimino)acetyl]-amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en- 3-yl]methyl]-1-methyl-,chloride, monohydrochloride, monohydrate, [6R- [6 , 7 (Z)]]. Cefepime hydrochloride is a white to pale yellow powder. It is highly soluble in water. It has a pH of between 4.0 and 6.0. DBL TM Cefepime Powder for Injection is a sterile lyophilised powder for injection containing the inactive ingredient L-arginine to control the pH of the reconstituted solution at 4.0 to 6.0. Following reconstitution with Water for Injection as directed in labelling, it results in a pale yellow to amber coloured, clear solution. Each 20 mL vial contains either 1.914 g or 3.828 g of sterile cefepime – L-arginine powder, which is equivalent to 1 g or 2 g of cefepime and approximately 725 mg of arginine per gram of cefepime. It contains no antimicrobial preservative and is for use in one patient only. USES _ACTIONS_ Cephalosporins act by interfering with bacterial cell-wall synthesis, leading to lysis of the infectious organism. _PHARMACOKINETICS_ _In Adults_ Average plasma concentrations of cefepime observed in normal adult males at various times following single 30-minute infusions of 1 g and 2 g are summarised in Table 1. Following intramuscular (IM) administration, cefepime is completely absorbed. The average plasma concentrations of cefepime at various times following a single IM injection are summarised in Table 1. TABLE 1: MEAN PLASMA CONCENTRATIONS OF CEFEPIME (MICROGRAM/ML) CEFEPIME DOSES 0.5 HR 1 HR 2 HR 4 HR 8 HR 12 HR 1 g IV 66.9 41.8 25.3 11.0 2.8 0.8 2 g IV 127.6 81.7 45.4 20.1 4.6 1.2 1 g IM 14.8 25.9 26.3 16.0 4.5 1.4 2 g IM 36.1 49.9 5 Soma hati kamili