FLAGYL INJECTION FOR INTRAVENOUS INFUSION 0.5% wv

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

METRONIDAZOLE

Available from:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC code:

J01XD01

Dosage:

0.5% w/v

Pharmaceutical form:

INJECTION

Composition:

METRONIDAZOLE 0.5% w/v

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

BAXTER HEALTHCARE SA

Authorization status:

ACTIVE

Authorization date:

1988-03-21

Patient Information leaflet

Flagyl 
®                                      

                            [sanofi Logo]

_Metronidazole  _
INJECTION 

PROTECT FROM LIGHT 
DO NOT STORE ABOVE 25°C 

INDICATIONS 
FLAGYL Injection is indicated in the prophylaxis and treatment of
infections in which anaerobic 
bacteria have been identified or are suspected to be cause. 

FLAGYL is active against a wide range of pathogenic micro-organisms
notably species of 
bacteroides, fusobacteria, clostridia, eubacteria and anaerobic
cocci.  

It is indicated in: 
1. The prevention of post-operative infections due
to anaerobic bacteria, particularly species of 
bacteroides and anaerobic streptococci. 
2. The treatment of septicaemia, bacteraemia, peritonitis, brain
abscess, necrotising pneumonia, 
osteomyelitis, puerperal sepsis, pelvic abscess, pelvic
cellulitis and post-operative wound infections 
from which susceptible pathogenic anaerobes have been isolated. 

KINETICS 
Metronidazole is widely distributed in body tissues after
injection. At least half the dose is excreted 
in the urine as metronidazole and its metabolites including
an acid oxidation product, an hydroxy 
derivative and a glucuronide. Ten per cent of the dose is bound
in plasma. The elimination half-life 
of metronidazole is 8.5 ± 2.9 hours. 

Metronidazole diffuses across the placenta and is found in the
breast milk of nursing mothers in 
concentrations equivalent to those in the serum. 

ADMINISTRATION AND DOSAGE 
FLAGYL Injection should be infused intravenously at an approximate
rate of 5 ml/minute. Oral 
administration should be substituted as soon as feasible. 

Only those substances specifically listed under
“Pharmaceutical Precautions” should be mixed with 
FLAGYL Injection. 

FLAGYL Injection may be diluted with appropriate volumes of diluents
listed under “Pharmaceutical 

Summary of Product characteristics

Flagyl
® [sanof i Logo ]
_Metronidazole _
INJECTION
PROTECT FROM LIGHT
DO NOT STORE ABOVE 25° C
INDICATIONS
FLAGYL Injection is indicated in the prophylaxis and treatment of
infections in which anaerobic
bacteria have been identified or are suspected to be cause.
FLAGYL
is
active
against
a
wide
range
of
pathogenic
micro-organisms
notably
species
of
bacteroides, fusobacteria, clostridia, eubacteria and anaerobic cocci.
It is indicated in:
1. The prevention of post-operative infections due to anaerobic
bacteria, particularly species of
bacteroides and anaerobic streptococci.
2. The treatment of septicaemia, bacteraemia, peritonitis, brain
abscess, necrotising pneumonia,
osteomyelitis, puerperal sepsis, pelvic abscess, pelvic cellulitis and
post-operative wound infections
from which susceptible pathogenic anaerobes have been isolated.
KINETICS
Metronidazole is widely distributed in body tissues after injection.
At least half the dose is excreted
in the urine as metronidazole and its metabolites including an acid
oxidation product, an hydroxy
derivative and a glucuronide. Ten per cent of the dose is bound in
plasma. The elimination half-life
of metronidazole is 8.5 ± 2.9 hours.
Metronidazole diffuses across the placenta and is found in the breast
milk of nursing mothers in
concentrations equivalent to those in the serum.
ADMINISTRATION AND DOSAGE
FLAGYL Injection should be infused intravenously at an approximate
rate of 5 ml/minute. Oral
administration should be substituted as soon as feasible.
Only those substances specifically listed under “Pharmaceutical
Precautions” should be mixed with
FLAGYL Injection.
FLAGYL Injection may be diluted with appropriate volumes of diluents
listed under “Pharmaceutical
Precautions”.
On no account should any other substances be administered concurrently
by the same i.v. route
except for those specifically listed under “Pharmaceutical
Precautions”.
_Anaerobic Infections _
Treatment for 7 days should be satisfactory for most patients but,
depending on clinical and
bacte