Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
CLINDAMYCIN PHOSPHATE
Pharmacia Ireland
2 Base %w/w
Vaginal Cream
2001-05-22
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dalacin 2 % Vaginal Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of cream contains clindamycin phosphate equivalent to 20 mg or 2.0 % w/w clindamycin. Excipients: For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Vaginal cream. White, semi-solid cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Antibiotic for use in the management of bacterial vaginosis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION One applicator full (approximately 5 grams) intravaginally preferably at bedtime for 7 consecutive days. In patients in whom a shorter treatment course is desirable, a 3 day regimen has been shown to be effective. _Children and the elderly: _No clinical studies have been conducted in populations younger than 15 years or older than 60 years. Dalacin Cream is not recommended for use in these age groups. 4.3 CONTRAINDICATIONS Dalacin Cream is contra-indicated in patients previously found to be hypersensitive to preparations containing clindamycin or any of the components of the cream base (see section 6.1 List of excipients). Although cross- sensitisation to lincomycin has not been demonstrated, it is recommended that Dalacin Cream should not be used in patients who have demonstrated lincomycin sensitivity. Dalacin Cream 2% is also contraindicated individuals with a history of inflammatory bowl disease or a history of antibiotic-associated colitis. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE As there are no data available on the use of Dalacin Cream in patients younger than 15 years of age or older than 60 years of age, it should not be used in these populations. The use of Dalacin Vaginal Cream may result in the overgrowth of non-susceptible organisms, particularly yeasts. O Прочитать полный документ