M0BCore Safety Profile

Transcription

1 M0BCore Safety Profile Active substance: Clindamycin Pharmaceutical form(s)/strength: 300mg/2 ml Ampulle, 600 mg/4 ml Ampulle, 900 mg/6 ml Ampulle, 75 mg/5 ml Granulat für orale Lösung, 150 mg Kapselnn, 300 mg Kapseln, Lösung zur äußerlichen Anwendung, Lotion. Vaginalcreme P-RMS: AT/H/PSUR/0035/001 Date of FAR:

2 EU Core Safety Profile Active Substance: Clindamycin Phosphate or hydrochloride or palmitate (Oral/Injectable Preparations) Brand Names: CELOCIN, DALACIN, DALACIN C, SOBELIN, DALACINE Pharmaceutical form(s)/strength: 150mg/ml, 300mg/2ml, 600mg/4ml and 900mg/6ml Solution For Injection IM/IV, 150mg/ml Solution For Injection Parenteral IM/IV, 75mg, 150mg and 200mg Hard Capsule, Oral, 15mg/ml and 75mg/ml Granules For Solution, Oral P-RMS: Austria Date: 13 December 2012 Supersedes: 4.3 Contraindications Clindamycin is contraindicated in patients previously found be sensitive Clindamycin, lincomycin, any component of the formulation, or any excipient listed in Section 6.1 (List of excipients). Clindamycin phosphate solution for injection must not be given premature babies or neonates because of the benzyl alcohol content (see Section 4.6). 4.4 Special warnings and precautions for use The clindamycin phosphate injectable formulation contains benzyl alcohol (9.45 mg/ml). Benzyl alcohol has been reported be associated with a fatal "Gasping Syndrome" in premature infants. Benzyl alcohol may cause xic reactions and anaphylacid reactions in infants and children up 3 years old. The amount of benzyl alcohol at which xicity may occur is not known. Treatment with antibacterial agents alters the normal flora of the colon leading overgrowth of Clostridium difficile. This has been reported with use of nearly all antibacterial agents, including clindamycin. Clostridium difficile produces xins A and B which contribute the development of Clostridium difficile associated diarrhea (CDAD) and is a primary cause of antibiotic-associated colitis. It is important consider the diagnosis of CDAD in patients who present with diarrhea subsequent the administration of antibacterial agents. This may progress colitis, including pseudomembranous colitis (see Section 4.8), which

3 may range from mild fatal colitis. If antibiotic-associated diarrhoea or antibiotic-associated colitis is suspected or confirmed, ongoing treatment with antibacterial agents, including clindamycin, should be discontinued and adequate therapeutic measures should be initiated immediately. Drugs inhibiting peristalsis are contraindicated in this situation. Since clindamycin does not diffuse adequately in cerebrospinal fluid, the drug should not be used in the treatment of meningitis. If therapy is prolonged, liver and kidney function tests should be performed. The use of clindamycin phosphate may result in overgrowth of non-susceptible organisms, particularly yeasts. Clindamycin phosphate should not be injected intravenously undiluted as a bolus, but should be infused over at least minutes as directed in. 4.5 Interaction with other medicinal products and other forms of interaction Clindamycin administered by injection has been shown have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. 4.6 Fertility, pregnancy and lactation Pregnancy Oral and subcutaneous reproductive xicity studies in rats and rabbits revealed no evidence of impaired fertility or harm the fetus due clindamycin, except at doses that caused maternal xicity. Animal reproduction studies are not always predictive of human response. Clindamycin crosses the placenta in humans. After multiple doses, amniotic fluid concentrations were approximately 30% of maternal blood concentrations. Benzyl alcohol can cross the placenta. (see Section 4.3). In clinical trials with pregnant women, the systemic administration of clindamycin during the second and third trimesters has not been associated with an increased frequency of congenital abnormalities. There are no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy.

4 Clindamycin should be used in pregnancy only if clearly needed. Lactation Orally and parenterally administered clindamycin has been reported appear in human breast milk in ranges from μg/mL. Because of the potential for serious adverse reactions in nursing infants, clindamycin should not be taken by nursing mothers. Fertility Fertility studies in rats treated orally with clindamycin revealed no effects on fertility or mating ability. 4.7 Effects on ability drive and use machines Clindamycin has no or negligible influence on the ability drive and use machines. 4.8 Undesirable effects System Organ The table below lists the adverse reactions identified through clinical trial experience and post-marketing surveillance by system organ class and frequency. Adverse reactions identified from post-marketing experience are included in italics. The frequency grouping is defined using the following convention: common ( 1/10); ( <1/10); Uncommon ( 1/1,000 ); ( 1/10,000 <1/1,000); (< 1/10,000); and Not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Infections and infestations Blood and Lymphatic System Immune System Clindamycin Capsules 1/10 Uncommon < 1/ (cannot be estimated from available data) Vaginal infection Agranulocysis Leukopenia Neutropenia Thrombocypenia Eosinophilia Anaphylacid reaction Drug reaction with eosinophilia and systemic sympm (DRESS)

5 System Organ 1/10 Uncommon < 1/ (cannot be estimated from available data) Nervous System Dysgeusia Gastrointestinal Hepabiliary Abdominal pain Diarrhoea Pseudomemb ranous colitis (see section 4.4) Liver function test abnormal Nausea Vomiting Oesophageal ulcer Oesophagitis Jaundice Skin and Subcutaneous Tissue System Organ Infections and infestations Blood and Lymphatic System Immune System Rash maculopapular Urticaria Clindamycin Granules for oral solution Com mon 1/10 Eosinophilia Uncommo n < 1/ Toxic epidermal necrolysis Stevens-Johnson syndrome Acute generalised exanthemaus pustulosis (AGEP) Erythema multiforme Dermatitis exfoliative Dermatitis bullous Rash morbilliform Pruritus (cannot be estimated from available data) Vaginal infection Agranulocysis Neutropenia Thrombocypenia Leukopenia Anaphylacid reaction Drug reaction with eosinophilia and systemic sympm (DRESS) Nervous System Dysgeusia Gastrointestinal Diarrhoea Abdomina Oesophageal ulcer

6 Hepabiliary Pseudomembra nous colitis (see section 4.4) Liver function test abnormal l pain Vomiting Oesophagitis Nausea Jaundice Skin and Subcutaneous Tissue Rash maculopapular Toxic epidermal necrolysis Stevens-Johnson syndrome Acute generalised exanthemaus pustulosis (AGEP) Erythema multiforme Dermatitis exfoliative Dermatitis bullous Rash morbilliform Urticaria Pruritus System Organ Infections and infestations Blood and Lymphatic System Immune System Clindamycin solution for injection 1/10 Uncommon < 1/ (cannot be estimated from available data) Vaginal infection Agranulocysis Leukopenia Neutropenia Thrombocypenia Eosinophilia Anaphylacid reaction Drug reaction with eosinophilia and systemic sympm (DRESS) Nervous System Dysgeusia

7 Cardiac Cardiorespirary arrest Hypotension Vascular Thrombophlebitis Gastrointestina l Pseudomembrano us colitis (see section 4.4) Diarrhoea Nausea Abdominal pain Vomiting Hepabiliary Liver function test abnormal Jaundice Skin and Subcutaneous Tissue Rash maculopapular Erythema multiforme Pruritus Urticaria Toxic epidermal necrolysis Stevens-Johnson syndrome Acute generalised exanthemaus pustulosis (AGEP) Dermatitis exfoliative General and Administrative Conditions 4.9 Overdose Pain Abscess Dermatitis bullous Rash morbilliform Injection site irritation Hemodialysis and perineal dialysis are not effective in removing clindamycin from the serum.