Страна: Сингапур
Язык: английский
Источник: HSA (Health Sciences Authority)
TEICOPLANIN
SANOFI-AVENTIS SINGAPORE PTE. LTD.
J01XA02
200 mg/vial
INJECTION, POWDER, FOR SOLUTION
TEICOPLANIN 200 mg/vial
INTRAVENOUS, INTRAMUSCULAR
Prescription Only
SANOFI S.P.A
ACTIVE
1990-09-29
TARGOCID 200MG Each vial provides 200mg teicoplanin presented as a lyophilisate for reconstitution. Each pack contains an ampoule of diluent. (Water for Injections Ph.Eur). TARGOCID 400MG Each vial provides 400 mg teicoplanin presented as a lyophilisate for reconstitution. Each pack contains an ampoule of diluent. (Water for Injections Ph.Eur). The vials do not contain any preservative. USES PROPERTIES Teicoplanin is a bactericidal, glycopeptide antibiotic, produced by fermentation of _Actinoplanes teicomyceticus_. It is active against both aerobic and anaerobic Gram-positive bacteria. SPECIES USUALLY SENSITIVE _Staphylococcus aureus _and coagulase negative staphylococci (sensitive or resistant to methicillin), streptococci, enterococci, _Listeria monocytogenes_, micrococci, , group _JK_ _corynebacteria _and Gram-positive anaerobes including _Clostriduim difficile_, and peptococci. SPECIES USUALLY RESISTANT _Nocardia asteroides_, lactobacillus sp, leuconostoc and all Gram-negative bacteria. Bactericidal synergy has been demonstrated _in vitro _with aminoglycosides against group D streptococci and staphylococci. _In vitro _combinations of teicoplanin with rifampicin or fluorinated quinolones show primarily additive effects and sometimes synergy. One step resistance to teicoplanin could not be obtained _in_ _vitro _and multi-step resistance was only reached _in vitro_ after 11-14 passages. Teicoplanin does not show cross-resistance with other classes of antibiotics. SUSCEPTIBILITY TESTING Sensidiscs are charged with 30 micrograms of teicoplanin. Strains showing an inhibition zone diameter of 14 mm or more are susceptible, and those of 10mm or less are resistant. INDICATIONS Targocid is indicated in potentially serious Gram-positive infections including those which cannot be treated with other antimicrobial drugs, eg penicillins and cephalosporins. Targocid is useful in the therapy of serious staphylococcal infections in patients who cannot receive or who have failed to respond Прочитать полный документ
TARGOCID ® INJECTION TEICOPLANIN [sanofi logo] NAME OF THE MEDICINAL PRODUCT Targocid 200mg powder for solution for injection/infusion or oral solution PHARMACEUTICAL FORM Powder for solution for injection/infusion or oral solution Powder for solution for injection/infusion or oral solution: spongy ivory coloured homogeneous mass CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Targocid is indicated in adults and in children from birth for the parenteral treatment of the following infections: - Infective endocarditis - bacteraemia that occurs in association with any of the indications listed, sepsis/ septicaemia - joint and bone infections - lower respiratory tract infections (pneumonia) - Skin and soft tissue infections - Complicated urinary tract infections (urosepsis) - peritonitis related to continuous ambulatory peritoneal dialysis (CAPD) Targocid is also indicated in adults as an alternative oral treatment for _Clostridium difficile_ infection associated diarrhoea and colitis (CDAD). Where appropriate, teicoplanin should be administered in combination with other antibacterial agents. Consideration should be given to official guidance on the appropriate use of antibacterial agents. POSOLOGY AND METHOD OF ADMINISTRATION (PARENTERAL USE) Posology The dose and duration of treatment should be adjusted according to the underlying type and severity of infection and clinical response of the patient, and patient factors such as age and renal function. Measurement of serum concentrations Teicoplanin trough serum concentrations should be monitored at steady state after completion of the loading dose regimen in order to ensure that a minimum trough serum concentration has been reached: For most Gram-positive infections, teicoplanin trough levels of at least 10 mg/L when measured by High Performance Liquid Chromatography (HPLC), or at least 15 mg/L when measured by Fluorescence Polarization Immunoassay (FPIA) method. For endocarditis and other severe infections, teicoplanin trough levels of >15 mg/L when measured b Прочитать полный документ