Šalis: Izraelis
kalba: anglų
Šaltinis: Ministry of Health
CLINDAMYCIN PHOSPHATE
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
G01AA10
CREAM
CLINDAMYCIN PHOSPHATE 2 %W/W
VAGINAL
Required
PHARMACIA & UPJOHN COMPANY , USA
CLINDAMYCIN
CLINDAMYCIN
Treatment of bacterial vaginosis only if bacteria susceptible to clindamycin were found.
2014-05-31
Dalacin 2% Vaginal Cream PIL CC 230323 Technical change 2023-0084860 1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor's prescription only DALACIN ® 2% VAGINAL CREAM CLINDAMYCIN PHOSPHATE 2% Inactive ingredients and allergens: see section 2 under ‘Important information about some of this medicine’s ingredients’ and section 6 ‘Further information’. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? The medicine is intended for treatment of bacterial vaginal infections, if bacteria susceptible to clindamycin have been identified. THERAPEUTIC GROUP: Lincosamide antibiotics. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: you are sensitive (allergic) to the active ingredient clindamycin or to lincomycin or to any of the other ingredients in this medicine (see section 6). you suffer or have previously suffered from inflammatory bowel disease or antibiotic-associated colitis (inflammation of the colon). SPECIAL WARNINGS REGARDING USE OF THE MEDICINE Tell your doctor before using this medicine if you have diarrhoea or usually get diarrhoea when you take antibiotics. If you develop severe, prolonged or bloody diarrhoea during or after using Dalacin 2% Vaginal Cream, contact your doctor immediately since it may be necessary to stop the treatment. This may be a sign of bowel inflammation (pseudomembranous colitis) which can occur following treatment with antibiotics. As with all vaginal infections, sexual intercourse during treatment with Dalacin 2% Vaginal Cream is not recommended. Dalacin 2% Vaginal Cream may decrease the effectiveness of condoms or diaphragms. Do not rely Perskaitykite visą dokumentą
Dalacin 2% Vaginal Cream LPD CC 301122 Page 1 of 7 DALACIN ® 2% VAGINAL CREAM 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. Each applicator full of 5 grams of vaginal cream contains approximately 100 mg of clindamycin phosphate. Excipients of known effect Dalacin Cream contains 160.5 mg cetostearyl alcohol in each 5 g applicator which is equivalent to 32.1 mg/g. Dalacin Cream contains 250 mg propylene glycol in each 5 g applicator which is equivalent to 50 mg/g. Dalacin Cream contains 50 mg benzyl alcohol in each 5 g applicator which is equivalent to 10 mg/g For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Vaginal Cream White, semi-solid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of bacterial vaginosis only if bacteria susceptible to clindamycin were found. DALACIN ® 2% Vaginal Cream can be used to treat non-pregnant women and pregnant women during their second and third trimesters. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The recommended dose is one applicatorful of clindamycin vaginal cream 2% intravaginally, preferably at bedtime, for three or seven consecutive days. Paediatric population Safety and efficacy in paediatric patients have not been established (see section 4.4). Elderly No clinical studies have been conducted in populations older than 60. _ _ 4.3 CONTRAINDICATIONS Dalacin ® 2% Vaginal Cream is contra-indicated in patients with a history of hypersensitivity to clindamycin, lincomycin, or to any of the excipients listed in section 6.1. Dalacin ® 2% Vaginal Cream is also contraindicated in individuals with a history of inflammatory bowel disease or a history of antibiotic-associated colitis. Dalacin 2% Vaginal Cream LPD CC 301122 Page 2 of 7 2014-0004758 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Before or after initiation of therapy with clindamycin, other infections including Trichomonas vaginalis, Perskaitykite visą dokumentą