Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CLINDAMYCIN PHOSPHATE
Pharmacia Limited
100 Milligram
Pessary
1998-12-21
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dalacin 100 mg Vaginal Ovule 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Clindamycin phosphate equivalent to 100mg clindamycin. ‘For excipients see 6.1”. 3 PHARMACEUTICAL FORM Pessary. Semisolid, white to off-white pessaries. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dalacin Vaginal Ovule is indicated for the treatment of bacterial vaginosis (formerly referred to as _Haemophilus_ vaginitis, _Gardnerella _vaginitis, nonspecific vaginitis, _Corynebacterium _vaginitis, or anaerobic vaginosis). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The recommended dose is one ovule intravaginally at bedtime for three consecutive days. (For instructions for use see Section 6.6) USE IN PAEDIATRIC PATIENTS: The use of Dalacin Vaginal Ovule has not been studied in patients under 16 years of age. USE IN ELDERLY PATIENTS: The use of Dalacin Vaginal Ovule has not been studied in patients over 65 years of age. USE IN PATIENTS WITH RENAL IMPAIRMENT: The use of Dalacin Vaginal Ovule has not been studied in patients with impaired renal function. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.3 CONTRAINDICATIONS Dalacin Vaginal Ovules are contraindicated in patients with a history of hypersensitivity to clindamycin, lincomycin or the hard fat (a suppository base consisting of a mixture of glycerides of saturated fatty acid). Dalacin Vaginal Ovules are also contraindicated in individuals with a history of antibiotic-associated colitis. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Before or after initiation of therapy with Dalacin Vaginal Ovule, other infections including Trichomonas vaginalis, Candida albicans, Chlamydia trachomatis and gonococcal infections may need to be investigated Read the complete document