ZYVOX TABLET 600 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

LINEZOLID

Available from:

PFIZER PRIVATE LIMITED

ATC code:

J01XX08

Dosage:

600 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

LINEZOLID 600 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Viatris Pharmaceuticals LLC (Vega Baja)

Authorization status:

ACTIVE

Authorization date:

2000-10-19

Patient Information leaflet

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

Summary of Product characteristics

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