Land: Israel
Sprog: engelsk
Kilde: Ministry of Health
CLINDAMYCIN PHOSPHATE
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
J01FF01
SOLUTION FOR INJECTION
CLINDAMYCIN PHOSPHATE 150 MG/ML
I.V, I.M
Required
PFIZER INC, USA
CLINDAMYCIN
CLINDAMYCIN
For the treatment of infections caused by susceptible anaerobic bacteria.
2022-04-30
SUMMARY OF PRODUCT CHARACTERISTICS (SPC) WARNING _Clostridium difficile_ associated diarrhoea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin phosphate and may range in severity from mild diarrhoea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of _C. difficile_. Because clindamycin phosphate therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate, as described in the INDICATIONS section. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections. _C. difficile_ produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of _C. difficile_ cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhoea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against _C. difficile_ may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of _C. difficile_, and surgical evaluation should be instituted as clinically indicated. 1. TRADE NAME OF THE MEDICINAL PRODUCT Dalacin C 150 mg/ml 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains clindamycin phosphate equivalent to 150 mg clindamycin. For excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for Injection Clear, colourless, sterile solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dalacin C (clindamycin phosphate) is indicated for the treatment of infections caused by susceptible anaerobic bacteria. Clindamycin does not penetrate the blood Læs hele dokumentet
Dalacin C 150mg/ml LPD CC 280222 Page 1 of 11 2019-0057284, 2020-0061979, 2020-0061721 DALACIN ® C 150 MG/ML SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Dalacin ® C 150 mg/ml 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains clindamycin phosphate equivalent to 150 mg clindamycin. Excipients with known effect: Each ml of solution contains 9 mg of benzyl alcohol . For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for Injection Clear, colourless, sterile solution for intramuscular or intravenous use. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dalacin® C (clindamycin phosphate) is indicated for the treatment of infections caused by susceptible anaerobic bacteria. Clindamycin does not penetrate the blood/brain barrier in therapeutically effective quantities 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Parenteral (IM or IV administration). Dalacin ® C (clindamycin phosphate) MUST be diluted prior to IV administration and should be infused over at least 10-60 minutes. _Adults_ : Serious infections: 600 mg - 1.2 g/day in two, three or four equal doses. More severe infections: 1.2-2.7 g/day in two, three or four equal doses. 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. Dalacin C 150mg/ml LPD CC 280222 Page 2 of 11 2019-0057284, 2020-0061979, 2020-0061721 For more serious infections, these doses may have to be increased. In life-threatening situations, doses as high as 4.8 g daily have been given intravenously to adults. 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)_ : Serious infections: 15-25 mg/kg/day in three or four equal doses. Clindamycin should be dosed based on total body weight regardless of obesity. More severe infections: 25-40 mg/kg/day in three or four equal doses. In severe inf Læs hele dokumentet