ERTAPENEM KABI POWDER FOR INJECTION 1GVIAL

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

ERTAPENEM SODIUM EQV ERTAPENEM

Available from:

FRESENIUS KABI (SINGAPORE) PTE LTD

ATC code:

J01DH03

Pharmaceutical form:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Composition:

ERTAPENEM SODIUM EQV ERTAPENEM 1G/VIAL

Administration route:

INTRAVENOUS DRIP

Prescription type:

Prescription Only

Manufactured by:

ACS DOBFAR S.p.A - Milano site (Drug Product Intermediate)

Authorization status:

ACTIVE

Authorization date:

2020-10-16

Summary of Product characteristics

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\