Țară: Singapore
Limbă: engleză
Sursă: HSA (Health Sciences Authority)
ERTAPENEM SODIUM EQV ERTAPENEM
FRESENIUS KABI (SINGAPORE) PTE LTD
J01DH03
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
ERTAPENEM SODIUM EQV ERTAPENEM 1G/VIAL
INTRAVENOUS DRIP
Prescription Only
ACS DOBFAR S.p.A - Milano site (Drug Product Intermediate)
ACTIVE
2020-10-16
discontinuation of therapy, the level of ertapenem was undetectable in the breast milk of four women and was detected at trace levels (< 0.13 μg/mL) in one woman. _In vitro_ studies indicate that ertapenem does not inhibit P-glycoprotein- mediated transport of digoxin or vinblastine and that ertapenem is not a substrate for P-glycoprotein-mediated transport (see _INTERACTIONS WITH _ _OTHER MEDICINES_). METABOLISM In healthy young adults, after IV infusion of radiolabelled 1g ertapenem, the plasma radioactivity consists predominantly (94%) of ertapenem. The major metabolite of ertapenem is the ring-opened derivative formed by hydrolysis of the beta-lactam ring. _In vitro_ studies in human liver microsomes indicate that ertapenem does not inhibit metabolism mediated by any of the six major cytochrome p450 (CYP) isoforms: 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (see INTERACTIONS WITH OTHER MEDICINES). EXCRETION Ertapenem is eliminated primarily by the kidneys. The mean plasma half-life in healthy young adults and patients 13–17 years of age is approximately 4 hours and approximately 2.5 hours in paediatric patients 3 months to 12 years of age. Following administration of a 1 g radiolabelled IV dose of ertapenem to healthy young adults, approximately 80% is recovered in urine and 10% in faeces. Of the 80% recovered in urine, approximately 38% is excreted as unchanged drug and approximately 37% as the ring-opened metabolite. In healthy young adults given a 1 g IV dose, average concentrations of ertapenem in urine exceed 984 μg/mL during the period 0–2 hours post-dose and exceed 52 μg/mL during the period 12–24 hours post-dose. PHARMACOKINETICS IN SPECIAL POPULATIONS _Gender _ Following administration of a 1 g IV dose over 30 minutes, the plasma concentrations (AUC) of ertapenem, both total and unbound, were similar in healthy male and female subjects (total drug AUC was 570.0 .g.hr/mL for men vs 566.8 .g.hr/mL for women). _Elderly _ Following a 1 g IV dose of ertapenem, AUC increases by approximately 39% LQ HOGHUO\ Citiți documentul complet