METRONIDAZOLE

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

METRONIDAZOLE

Available from:

LAPIDOT MEDICAL IMPORT AND MARKETING LTD

ATC code:

J01XD01

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

METRONIDAZOLE 500 MG / 100 ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

B.BRAUN MELSUNGEN AG, GERMANY

Therapeutic group:

METRONIDAZOLE

Therapeutic area:

METRONIDAZOLE

Therapeutic indications:

Treatment and prophylaxis of infection which are or may be due to anerobic bacteria,especially Bacteriodes species,including Bacteriodes fragilis, Fusobacterium,Eurobacterium and Clostridium species.

Authorization date:

2020-10-31

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Metronidazole B.Braun 500 MG / 100 ML
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of solution contains 5 mg of metronidazole
100 ml of solution contain 500 mg of metronidazole
_EXCIPIENT 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
This medicinal product contains 14 mmol (or 322 mg) sodium per 100 ml.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for infusion
Clear, colourless up to faintly, straw- coloured solution, practically
free from
particles
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment and prophylaxis of infection which are or may be due to
anerobic
bacteria,especially Bacteriodes species,including Bacteriodes
fragilis,
Fusobacterium,Eurobacterium and Clostridium species
.
The treatment is effective in cases of:
•
Infections of the C.N.S (e.g. brain abscess, meningitis),
•
Infections of the lung and pleura (e.g. necrotizing pneumonia,
aspiration
pneumonia, lung abscess),
•
Endocarditis,
•
After operations (e.g. recto-colonic surgery) and infections of the
G.I. tract,
•
Suppurating diseases in the abdominal and pelvic area (peritonitis,
liver
abscess, endometritis),
•
Gynaecologic infections (e.g. hysterectomy, caesarian section,
childbed
fever, septic abortus),
•
Osteomyelitis,
•
Septicaemia in thrombophlebitis,
•
Severe form of intestinal and hepatic amoebiasis.
A prophylactic use is always indicated in operations with a high risk
of anaerobic
infections (gynaecologic and intra-abdominal operations).
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Unless otherwise directed the following dosage guidelines are
recommended:
ADULTS AND CHILDREN OVER 12 YEARS:
Maintenance dose:
Approximately 7.5 mg Metronidazole/kg body weight over one hour every
8 hours,
corresponding to 100 ml
(500 mg) Metronidazole injection for a 70 Kg adult.
L