FLAGYL

Country: Ինդոնեզիա

language: ինդոնեզերեն

source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

active_ingredient:

METRONIDAZOLE

MAH:

AVENTIS PHARMA - Indonesia

INN:

METRONIDAZOLE

dosage:

500 MG

pharmaceutical_form:

INFUS

units_in_package:

DUS, 40 KANTONG PLASTIK @ 100 ML

manufactured_by:

BAXTER HEALTHCARE S.A. - Ireland

authorization_date:

2020-12-03

SPC

FLAGYL
®
METRONIDAZOLE
COMPOSITION
FLAGYL
®
lnfus : contains 500 mg metronidazole/100
ml infusion
PHARMACOLOGICAL PROPERTIES
Trichomoniacide, anaerobicide.
Disposition of
metronidazole given orally or by
intravenous
injection
remains
constant,
with
average elimination time of 8 hours in healthy man.
Metronidazole was detected in cerebrospinal fluid,
saliva and breast milk in same concentration as in
plasma. Metronidazole was also detected in the pus
of hepatic abscess.
INDICATIONS
-
Urethritis and vaginitis due to _Trichomonas vagina/is_
-
Amoebiasis _(Intestinal and hepatic amoebiasis)_
-
Prevention of post-operative anaerobic infections
-
Giardiasis due to _Giardia lambliasis_
DOSAGE AND ADMINISTRATION
Intravenous infusion at the rate of 5 ml per minute
has to be replaced soon with oral administration.
Treatment of infections in which bacteria have
been identified:
In patient whom oral medication is not possible.
Adult and children< 12 years.
Adult: 500 mg by i.v. infusion every 8 hours.
Children: 7.5 mg/kg body-weight every 8 hours.
Prevention
of
post
operative
abdominal
infections ( especia I
ly colorecta I), gynaecology.
Adult: 500 mg by i.v. infusion before operation,
followed by 500 mg oral medication every 8
hours as soon as this becomes feasible.
Children:
7.5
mg/kg
body-weight (1.5 ml/kg
body-weight) every 8 hours.
WARNINGS AND PRECAUTIONS
-
Used
with
caution
in
nursing
mothers
as
metronidazole is excreted in breast milk, during
SOOMG/100ML
....
SANOFI �
first and second trimesters of
pregnancy as
metronidazole crosses the placental barrier.
-
Used
with
caution
in
patients
with
central
nervous system diseases. Disturbances of central
nervous system has been reported in some cases
but disappeared if therapy is discontinued or
dose decreased.
-
Taking alcohol during metronidazole therapy
may cause abdominal cramps, nausea, vomiting,
headache, flushing.
-
In prolonged metronidazole administration, it is
recommended to perform hematological tests.
-
Dosage should be reduced and administered
with caution