Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
METRONIDAZOLE
May & Baker Limited
1 g Grams
Suppositories
1977-09-30
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 Soma hati kamili