METRONIDAZOLE INTRAVENOUS INFUSION 500 mg100 ml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

METRONIDAZOLE

Available from:

B. BRAUN SINGAPORE PTE LTD

ATC code:

J01XD01

Dosage:

500 mg/100 ml

Pharmaceutical form:

INJECTION

Composition:

METRONIDAZOLE 5.000g/1000ml

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

B BRAUN MEDICAL INDUSTRIES SDN BHD

Authorization status:

ACTIVE

Authorization date:

1988-05-14

Summary of Product characteristics

013112.0FT1120C16
DIRECTIONS FOR USE
READ CAREFULLY!
1.
NAME OF THE MEDICINAL PRODUCT
Metronidazole Intravenous Infusion 500 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains 5 mg of metronidazole
100 ml of solution contain 500 mg of metronidazole
_Excipients with known effect: _
1 ml solution contains
Sodium chloride
7.4 mg
Disodium phosphate dodecahydrate
1.5 mg
_Electrolyte content (per 100 ml): _
Sodium
14 mmol
Chloride
13 mmol
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for infusion;
A clear and slightly yellow solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment and prophylaxis of infections caused by metronidazole
susceptible microorganisms (mainly anaer-
obic bacteria).
Metronidazole is indicated in adults and children for the following
indications:
●
infections of the central nervous system (e. g. brain abscess,
meningitis)
●
infections of lung and pleura (e. g. necrotising pneumonia, aspiration
pneumonia, lung abscess)
●
endocarditis
●
infections in the gastrointestinal tract and the abdominal area (e.g.
peritonitis, liver abscess, postopera-
tive infections after colonic and rectal surgery, purulent diseases in
the abdominal and pelvic cavities)
●
gynaecologic infections (e. g. endometritis, after hysterectomy or
caesarean section, childbed fever, sep-
tic abortion)
●
infections in the ear-nose-throat region (e. g. P
LAUT
-V
INCENT
-angina)
●
bone and joint infections (e. g. osteomyelitis)
●
gas gangrene
●
septicaemia with thrombophlebitis.
In a mixed aerobic and anaerobic infection, antibiotics appropriate
for the treatment of the aerobic infection
should be used in addition to Metronidazole Intravenous Infusion 500
mg.
A prophylactic use is always indicated prior to operations with a high
risk of anaerobic infections (gynaeco-
logic and intra-abdominal operations)
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
013112.0FT1120C16
4.2
POSOLOGY AND METHOD OF