SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Clindamycin Kabi 150 mg/ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution for injection contains 150 mg clindamycin (as phosphate). Each ampoule with 2 ml contains 300 mg clindamycin. Each ampoule with 4 ml contains 600 mg clindamycin. Each ampoule with 6 ml contains 900 mg clindamycin. Excipients with known effect: Each ampoule with 2 ml contains 18 mg benzyl alcohol and 16.9 mg sodium. Each ampoule with 4 ml contains 36 mg benzyl alcohol and 33.9 mg sodium. Each ampoule with 6 ml contains 54 mg benzyl alcohol and 50.9 mg sodium. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for injection. The medicinal product is a clear and colourless to slightly yellow coloured solution. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Clindamycin Kabi is indicated for the treatment of the following severe infections caused by clindamycin susceptible micro-organisms (see section 5.1). In case of aerobic infections clindamycin constitutes an alternative treatment in case other antibacterial agents are inactive or contra-indicated (e.g. in case of allergy to penicillins). In case of anaerobic infections a treatment with clindamycin as first choice agent can be envisaged. - Staphylococcal bone and joint infections such as osteomyelitis and septic arthritis - Chronic sinusitis caused by anaerobic micro-organisms - Infections of the lower respiratory tract such as: . aspiration pneumonia, pulmonary abscess, necrotising pneumonia and empyema In case of suspected polymicrobial pulmonary infections, an agent with adequate activity against gram-negative bacteria should also be given in combination to cover possible gram-negative bacteria. - Intra-abdominal infections such as peritonitis and abdominal abscess where the treatment of choice is clindamycin associated with an antibiotic with good activity against aerobic gram- negative bacteria. - Pelvic and female genital infections such as PID, endometritis, perivaginal infections, tubo- ovarian abscesses, salpingitis, pelvic cellulites when simultaneously another antibiotic with good activity against aerobic gram-negative bacteria is administered. - Skin and soft tissue infections Consideration should be given to official guidance on the appropriate use of antibacterial agents. kipdips142,788.doc 1 4.2 Posology and method of administration Posology Adults and adolescents older than 12 years - for the treatment of severe infections (such as intra-abdominal infections, female pelvic infections or other severe infections): 12 to 18 ml Clindamycin Kabi daily (corresponding to 1800 to 2700 mg clindamycin) in 2 - 4 equal doses, generally in combination with an antibiotic with good activity against aerobic gram-negative bacteria. - for the treatment of less complicated infections: 8 to 12 ml Clindamycin Kabi daily (corresponding to 1200 to 1800 mg clindamycin) administered in three or four equal doses. Normaly the maximum daily dose for adults and adolescents older than 12 years is18 ml Clindamycin Kabi (corresponding to 2700 mg clindamycin) in 2 to 4 equal doses. In life-threatening infections doses up to 4800 mg/day have been given. Single IM injections of greater than 600 mg are not recommended nor is administration of more than 1.2 g in a single one-hour infusion. Alternatively, the drug may be administered in the form of a single rapid infusion of the first dose followed by continuous IV Infusion. Paediatric Population Children (over 1 month of age up to 12 years): Serious infections: 15-25 mg/kg/day in three or four equal doses. More severe infections: 25-40 mg/kg/day in three or four equal doses. In severe infections it is recommended that children be given no less than 300 mg/day regardless of body weight. Older people: The half-life, volume of distribution and clearance, and extent of absorption after administration of clindamycin phosphate are not altered by increased age. Analysis of data from clinical studies has not revealed any age-related increase in toxicity. Dosage requirements in older people should not be influenced, therefore, by age alone. See section 4.4 for other factors which should be taken into consideration. Patients with hepatic impairment In patients with liver disease of moderate to severe degree, elimination half-life of clindamycin is prolonged. A reduction in dosage is generally not necessary if Clindamycin Kabi is administered every 8 hours. However, the plasma concentration of clindamycin should be monitored in patients with severe hepatic insufficiency. Depending on the results, this measure can make a reduction in dosage or an increase in the dose intervals necessary. Patients with renal impairment: In the presence of kidney diseases, elimination half-life is prolonged; however, a dosage reduction is not necessary in the event of mild to moderate impairment of renal function. Nevertheless, the plasma concentration should be monitored in patients with severe renal insufficiency or anuria. Depending on the results, this measure can make a reduction in dosage or an increase in the dose interval of 8 or even 12 hours necessary. Dosage in the event of haemodialysis Clindamycin cannot be removed by haemodialysis. Therefore, no additional dose is necessary before or after haemodialysis. Method of administration kipdips142,788.doc 2 Clindamycin Kabi is administered by intramuscular injection (I.M) or intravenous infusion (I.V). Clindamycin Kabi must be diluted prior IV administration and should be infused over at least 10-40 minutes. The concentration should not exceed 12 mg clindamycin per ml solution For instructions on dilution of the medicinal product before administration, see section 6.6. The medicinal product is to be visually inspected prior to use and also after dilution. Do not use Clindamycin Kabi if you notice any particles or strong coloration of the solution. Only clear solutions free of visible particles should be used. 4.3 Contraindications Hypersensitivity to clindamycin or lincomycin (parallel allergy exists) or to any of the excipients listed in section 6.1. Clindamycin Kabi contains benzyl alcohol in the following amounts: 18 mg in 2 ml, 36 mg in 4 ml and 54 mg in 6 ml product solution. Therefore it must not be given to premature babies and neonates. 4.4 Special warnings and precautions for use Clindamycin Kabi should only be used in the treatment of serious infections. In considering the use of Clindamycin Kabi, the practitioner should bear in mind the type of infection and the potential hazard of the diarrhoea which may develop, since cases of colitis have been reported during, or even two or three weeks following, the administration of Clindamycin Kabi. The disease is likely to follow a more severe course in older patients or patients who are debilitated. Caution should be exercised in patients with - impaired hepatic and renal function (see section 4.2), - disturbances in neuromuscular transmission (myasthenia gravis, Parkinson’s disease, etc.) as well as - a history of gastrointestinal disorders (e.g. earlier inflammations of the colon). - atopic diseases. Regular monitoring of liver function, renal function and haematology should be carried out during prolonged use of the drug, and in infants under the age of one year. Severe allergic reactions can occur even after the first application. In this event treatment with Clindamycin Kabi must be discontinued immediately and the standard emergency measures should be implemented. Rapid intravenous injection may have a serious effect on the heart (see section 4.8) and must be avoided. In long-term therapy (treatment for more than 3 weeks), the haemogram as well as hepatic and renal function should be checked at regular intervals. Long-term and repeated application of Clindamycin Kabi can lead to a superinfection and/or colonisation with resistant pathogens or yeasts on the skin and mucous membranes. Under certain circumstances, clindamycin therapy may be an alternative form of treatment in patients with a penicillin allergy (penicillin hypersensitivity). There have been no reports of a cross-allergy between clindamycin and penicillin and, based on the structural differences between the substances, this is not to be expected. However, in individual cases, information does exist on anaphylaxis (hypersensitivity) towards clindamycin in persons with an already existing penicillin allergy. This should be taken into consideration in a course of clindamycin treatment in patients with a penicillin allergy. kipdips142,788.doc 3 Colitis: Clindamycin therapy has been associated with a pseudomembranous colitis during and until 2 to 3 weeks after the treatment with clindamycin which may be fatal and which is associated with severe and persistent diarrhoea. Care should be taken when prescribing Clindamycin Kabi to a patient who has a tendency towards gastrointestinal illnesses, in particular colitis. Drugs which cause intestinal congestion and anti-motility drugs should be avoided. If severe diarrhoea occurs during therapy, Clindamycin Kabi should be discontinued immediately and appropriate diagnostic and therapeutic measures should be instituted. Clindamycin Kabi should not be used in case of acute infections of the respiratory tract, if these are caused by viruses. Clindamycin Kabi is not suitable for the treatment of meningitis, for the concentration of antibiotic obtained in the liquor cerebrospinalis is too little. Paediatric population This medicinal product contains