País: Israel
Idioma: inglés
Fuente: Ministry of Health
TIGECYCLINE
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
J01AA12
POWDER FOR SOLUTION FOR INFUSION
TIGECYCLINE 50 MG/DOSE
I.V
Required
WYETH LEDERLE S.R.L, ITALY
TIGECYCLINE
TYGACIL is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below for patients 18 years of age and older:Complicated Skin and Skin Structure Infections:Complicated skin and skin structure infections caused by Escherichia coli, Enterococcus faecalis (vancomycin-susceptible isolates ), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus agalactiae, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Streptococcus pyogenes, Enterobacter cloacae, Klebsiella pneumoniae, and Bacteroides fragilis .Complicated Intra-abdominal Infections:Complicated intra-abdominal infections caused by Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Enterococcus faecalis (vancomycin-susceptible isolates), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus anginosus grp. (includes S. angino
2018-04-20
Tygacil LPD WC 141221 1 2021-0074639 TYGACIL ® FULL PRESCRIBING INFORMATION TIGECYCLINE 50 mg POWDER FOR SOLUTION FOR I.V. INFUSION WARNING: ALL-CAUSE MORTALITY AN INCREASE IN ALL-CAUSE MORTALITY HAS BEEN OBSERVED IN A META-ANALYSIS OF PHASE 3 AND 4 CLINICAL TRIALS IN TYGACIL-TREATED PATIENTS VERSUS COMPARATOR. THE CAUSE OF THIS MORTALITY RISK DIFFERENCE OF 0.6% (95% CI 0.1, 1.2) HAS NOT BEEN ESTABLISHED. TYGACIL SHOULD BE RESERVED FOR USE IN SITUATIONS WHEN ALTERNATIVE TREATMENTS ARE NOT SUITABLE _[SEE INDICATIONS AND USAGE (1.4), WARNINGS AND PRECAUTIONS (5.1, _ _5.2) AND ADVERSE REACTIONS (6.1)]. _ 1 INDICATIONS AND USAGE TYGACIL is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below for patients 18 years of age and older: _1.1 COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS _ _ _ Complicated skin and skin structure infections caused by _Escherichia coli, Enterococcus faecalis_ (vancomycin-susceptible isolates), _Staphylococcus aureus_ (methicillin-susceptible and -resistant isolates), _Streptococcus agalactiae_ , _Streptococcus anginosus_ grp. (includes _S. anginosus, S. intermedius,_ and _S. _ _constellatus_ ), _Streptococcus pyogenes_ , _Enterobacter cloacae_ , _Klebsiella pneumoniae_ , and _Bacteroides _ _fragilis_ . _1.2 COMPLICATED INTRA-ABDOMINAL INFECTIONS _ Complicated intra-abdominal infections caused by _Citrobacter freundii_ , _Enterobacter cloacae_ , _Escherichia _ _coli_ , _Klebsiella oxytoca_ , _Klebsiella pneumoniae_ , _Enterococcus faecalis_ (vancomycin-susceptible isolates), _Staphylococcus aureus_ (methicillin-susceptible and -resistant isolates), _Streptococcus anginosus_ grp. (includes _S. anginosus, S. intermedius,_ and _S. constellatus_ ), _Bacteroides fragilis, Bacteroides _ _thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Clostridium perfringens,_ and _Peptostreptococcus micros_ . _1.3 COMMUNITY-ACQUIRED BACTERIAL PNEUMONIA _ Community-acquired bacterial pneumonia caused by _Streptococcus Leer el documento completo