Nazione: Singapore
Lingua: inglese
Fonte: HSA (Health Sciences Authority)
LINEZOLID
PFIZER PRIVATE LIMITED
J01XX08
20 mg/ml
GRANULE, FOR SUSPENSION
LINEZOLID 20 mg/ml
ORAL
Prescription Only
Neolpharma, Inc.
ACTIVE
2000-10-19
ZYVOX™ Linezolid 1. NAME OF THE MEDICINAL PRODUCT ZYVOX™ Tablet 600 mg ZYVOX™ Solution for Infusion 2 mg/ml ZYVOX™ Granules for Oral Suspension 20 mg/ml 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Film coated tablets : Each tablet contains 600 mg of linezolid. Solution for infusion : Each ml contains 2 mg of linezolid. Powder for oral suspension : Following constitution, each 5 ml contains 100 mg of linezolid. For excipients, see section 6.1 3. PHARMACEUTICAL FORM Film-coated tablets, solution for infusion, powder for oral suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Linezolid is indicated for the treatment of ADULTS (12 YEARS AND OLDER) AND PEDIATRIC PATIENTS (BIRTH THROUGH 11 YEARS OF AGE) with the following infections caused by the susceptible strains of the designated Gram-positive bacteria only. Linezolid is not indicated for the treatment of Gram- negative infections. Specifi c Gram-negative therapy is required if a concomitant Gram-negative pathogen is documented or suspected (See sections 4.4 and 5.1) Community-acquired pneumonia caused by _Streptococcus pneumoniae_ (penicillin-sensitive strain only), including cases with concurrent bacteraemia, or _Staphylococcus aureus_ (methicillin- sensitive strain only). Nosocomial pneumonia caused by _Staphylococcus aureus_ (methicillin-sensitive and methicillin- resistant strains) or _Streptococcus pneumoniae_ (penicillin-sensitive strains only). Uncomplicated skin and skin structure infections caused by _Staphylococcus aureus_ (methicillin- sensitive strains only) or _Streptococcus pyogenes_. Complicated skin and skin structure infections, caused by _Staphylococcus aureus_ (methicillin- sensitive and methicillin resistant strains), _Streptococcus pyogenes_ or _Streptococcus agalactiae_. Vancomycin-resistant Enterococcus faecium including cases with concurrent bacteraemia. Linezolid should not be initiated as a fi rst line ther Leggi il documento completo
ZYVOX ® Linezolid 1. NAME OF THE MEDICINAL PRODUCT ZYVOX Tablet 600 mg ZYVOX Solution for Infusion 2 mg/ml ZYVOX Granules for Oral Suspension 20 mg/ml 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Film-coated tablets : Each tablet contains 600 mg of linezolid. Solution for infusion : Each ml contains 2 mg of linezolid. Powder for oral suspension : Following constitution, each 5 ml contains 100 mg of linezolid. For excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Film-coated tablets, solution for infusion, powder for oral suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Linezolid is indicated for the treatment of ADULTS AND ADOLESCENTS (12 YEARS AND OLDER) AND PEDIATRIC PATIENTS (BIRTH THROUGH 11 YEARS OF AGE) with the following infections caused by susceptible strains of Gram-positive bacteria only. Linezolid is not indicated for the treatment of Gram-negative infections. Specific Gram-negative therapy is required if a concomitant Gram-negative pathogen is documented or suspected (see sections 4.4 Special warnings and precautions for use and 5.1 Pharmacodynamic properties). Community-acquired pneumonia caused by _Streptococcus pneumoniae_ (penicillin-sensitive strains only), including cases with concurrent bacteremia, or _Staphylococcus _ _aureus_ (methicillin-sensitive strains only). Nosocomial pneumonia caused by _Staphylococcus _ _aureus _ (methicillin-sensitive and methicillin-resistant strains) or _Streptococcus pneumoniae_ (penicillin-sensitive strains only). Uncomplicated skin and soft tissue infections caused by _Staphylococcus aureus_ (methicillin- sensitive strains only) or _Streptococcus pyogenes_ . Complicated skin and soft tissue infections, caused by _Staphylococcus aureus_ (methicillin- sensitive and methicillin-resistant strains), _Streptococcus _ _pyogenes_ or _Streptococcus _ _agalactiae_ . Vancomycin-resistant _Enterococcus _ _faecium_ infections including cases with concurrent bacteremia. Linezolid should not be initiated as a first line therapy for communit Leggi il documento completo