Quốc gia: Israel
Ngôn ngữ: Tiếng Anh
Nguồn: Ministry of Health
TIGECYCLINE
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
J01AA12
POWDER FOR SOLUTION FOR INFUSION
TIGECYCLINE 50 MG/DOSE
I.V
Required
PFIZER INC, USA
TIGECYCLINE
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. anginosus, S. intermedius, and S. constellatus), Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Clostridium perfringens, and Peptostreptococcus micros.Community-Acquired Bacterial Pneumonia:Community-acquired bacterial pneumonia caused by Streptococcus pneumoniae (penicillin susceptible isolates), including cases with concurrent bacteremia, Haemophilus influenzae (beta-lactamase negative isolates), and Legionella pneumophila.
2022-02-28
לע העדוה לע העדוה לע העדוה ( הרמחה ( הרמחה ( הרמחה עדימ עדימ עדימ ל ןולעב )תוחיטב ל ןולעב )תוחיטב ל ןולעב )תוחיטב אפור אפור אפור ןכדועמ( ןכדועמ( ןכדועמ( .102.50 .102.50 .102.50 ) ) ) רשוא – 61 . 61 ךיראת 10.61.0161 תילגנאב רישכת םש םושירה רפסמו TYGACIL 136.43.31352.01 םושירה לעב םש רזייפ יא ףא יפ מ"עב לארשי הקיטבצמרפ הז ספוט טרפמ ה דבלב תורמחה ! תושקובמה תורמחהה ןולעב קרפ ונ טסקט יחכ שדח טסקט ADVERSE REACTIONS … The following adverse reactions were reported (<2%) in patients receiving TYGACIL in clinical studies: _ _ … _Hemic and Lymphatic System_: partial thromboplastin time (aPTT), prolonged prothrombin time (PT), eosinophilia, increased international normalized ratio (INR), thrombocytopenia …. The following adverse reactions were reported (<2%) in patients receiving TYGACIL in clinical studies: _ _ … _Hemic and Lymphatic System_: prolonged activated partial thromboplastin time (aPTT), prolonged prothrombin time (PT), eosinophilia, increased international normalized ratio (INR), thrombocytopenia USE IN SPECIFIC POPULATIONS 8.1 PREGNANCY TERATOGENIC EFFECTS— PREGNANCY CATEGORY D _[SEE _ _WARNINGS AND PRECAUTIONS (5.6)] _ Tigecycline was not teratogenic in the rat or rabbit. In preclinical safety studies, 14 C-labeled tigecycline crossed the placenta and was found in fetal tissues, including fetal bony structures. The administration of tigecycline was associated with slight reductions in fetal weights and an increased incidence of minor skeletal anomalies (delays in bone ossification) at exposures of 5 times and 1 times the human daily dose based on AUC in rats and rabbits, respectively (28 mcg·hr/mL and 6 mcg·hr/mL at 12 and 4 mg/kg/day). 8.1 PREGNANCY TERATOGENIC EFFECTS— PREGNANCY CATEGORY D _[SEE _ _WARNINGS AND PRECAUTIONS (5.6)] _ Tigecycline was no Đọc toàn bộ tài liệu
Tygacil LPD CC 0923 3 1 1 2021-0067888 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 pneumoniae (penicillin-susceptible isolates), including cases with concurrent bacteremi Đọc toàn bộ tài liệu