FLAGYL 1 g Grams Suppositories

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

METRONIDAZOLE

Inapatikana kutoka:

May & Baker Limited

INN (Jina la Kimataifa):

METRONIDAZOLE

Kipimo:

1 g Grams

Dawa fomu:

Suppositories

Idhini hali ya:

Withdrawn

Idhini ya tarehe:

2006-11-27

Tabia za bidhaa

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flagyl Suppositories 1g.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 1g of Metronidazole.
For excipients, see 6.1
3 PHARMACEUTICAL FORM
Suppository
Cream-coloured, torpedo-shaped suppositories.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
In the prevention and treatment of infections due to
anaerobic bacteria; particularly species of _Bacteroides_,
anaerobic 
_Streptococci_, _Fusobacteria_, _Clostridia_, etc.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
Rectal.
Recommended Dosage:
Adults:
1g 8 hourly. Substitute oral medication as early
as possible. If rectal administration prolonged beyond 3
days reduce 
dose to 1g 12 hourly for remainder of course.
Children:
7.5mg/kg 8 hourly.
Prophylaxis against anaerobic infection-chiefly in
the context of abdominal (especially colorectal) and
gynaecological 
surgery:
Adults: 
1g 8 hourly.
Children one half or a quarter of a 500mg suppository 8 hourly.
4.3 CONTRAINDICATIONS
Metronidazole should be used with caution in patients with
active or chronic severe peripheral and central nervous 
system disease due to the risk of neurological aggravation.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Issued 06/09/2005_
_CRN 2014467_
_page number: 1_
Use in patients known to be hypersensitive to metronidazole.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
1. If prolonged therapy is required, the physician should bear in
mind the possibility of peripheral neuropathy or 
leucopenia. Both effects are usually reversible. High
dosage regimes have been associated with transient 
epileptiform seizures. Caution is required in patients with
active disease of the central nervous system except for 
brain abscess.
2. Metronidazole and a metabolite have b