FLAGYSTATIN Vaginal ovules (2018)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
Name of the medicinal product
FLAGYSTATIN (500 mg metronidazole and 100,000 IU nystatin).
Indications and clinical use
Mixed vaginal infection due to Trichomonas vaginalis and Candida albicans. FLAGYSTATIN has antibacterial and antifungal properties. To reduce the development of drug-resistant bacteria/fungi and maintain ...
Contraindications
Hypersensitivity to FLAGYSTATIN (metronidazole and nystatin); or any of its constituents, or to imidazoles. Combined treatment with oral metronidazole should be avoided in cases of active neurological ...
Warnings and precautions
Warnings General Metronidazole has been shown to be carcinogenic in mice and rats (see TOXICOLOGY section). Unnecessary use of the drug should be avoided and prolonged treatment duration should be carefully ...
Adverse reactions
They are infrequent and minor: vaginal burning and granular sensation. Bitter taste, nausea and vomiting, already known to occur with metronidazole, were mainly seen when oral metronidazole was administered ...
Drug interactions
Precautions must be borne in mind, as it is possible that drug interactions usually associated with oral administration of metronidazole or nystatin may occur following the vaginal administration of FLAGYSTATIN. ...
Dosage and administration
One vaginal ovule daily, inserted deep into the vagina, for 10 consecutive days. If after 10 days of treatment a cure has not been achieved, a second 10-day course of treatment should be given. If Trichomonas ...
Overdosage
Symptoms No case of accidental massive ingestion of FLAGYSTATIN has been reported yet. However, single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. ...
Action and clinical pharmacology
Metronidazole is bactericidal against anaerobic bacteria; it exerts trichomonacidal activity and is also active against Giardia lamblia and Entamoeba histolytica. Its exact mechanism of action has not ...
Storage and stability
Store the vaginal ovules at room temperature between 15-25ºC and protect from light.
Dosage forms, composition and packaging
Vaginal ovules containing 500 mg metronidazole and 100,000 IU nystatin; boxes of 10 ovules with applicator. Non-medicinal ingredient: glycerides of saturated fatty acid (hard fat).
Pharmaceutical information
FLAGYSTATIN is a preparation delivering 500 mg of metronidazole a) and 100,000 units of nystatin b) per vaginal application. Structural Formula a) Metronidazole b) Nystatin. Nystatin is a substance, or ...
Detailed pharmacology
Metronidazole shows little or no effect on the cardiovascular, respiratory or autonomic nervous systems of dogs, rats and mice. In vitro, activity was studied using decreasing concentrations of metronidazole ...
Toxicology
Local Tolerance FLAGYSTATIN vaginal inserts were administered daily to six female Rhesus monkeys for thirty days. As compared with a control group given a placebo insert, no significant compound-related ...
Marketing authorization holder
Sanofi-aventis Canada Inc., 2905 Place Louis R.-Renaud, Laval, Quebec H7V 0A3
Submission control number
217062
Date of revision
August 16, 2018
References
1. Cosar, C., Ganter, P., and Julou, L. Étude expérimentale du métronidazole (8823 R.P.). Activités trichomonacide et amoebicide. Toxicité et propriétés pharmacologiques générales. Presse Méd., 69, 1069, ...
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