Linezolid Sandoz 600 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

LINEZOLID 600 mg/stuk

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

J01XX08

INN (Algemene Internationale Benaming):

LINEZOLID 600 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Linezolid

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); HYPROLOSE (E 463); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Autorisatie datum:

1900-01-01

Bijsluiter

Sandoz B.V.
Page 1/8
Linezolid Sandoz 600 mg, filmomhulde tabletten
RVG 113824
1311-v4c
1.3.1.3 Bijsluiter
Februari 2024
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LINEZOLID SANDOZ 600 MG FILM-COATED
TABLETS
linezolid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What [nationally completed name] is and what it is used for
2.
What you need to know before you take [nationally completed name]
3.
How to take [nationally completed name]
4.
Possible side effects
5.
How to store [nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[nationally completed name] is an antibiotic of the oxazolidinones
group that works by stopping the
growth of certain bacteria (germs) that cause infections.
It is used to treat pneumonia and some infections in the skin or under
the skin. Your doctor will have
decided if [nationally completed name] is suitable to treat your
infection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME]
DO NOT TAKE [NATIONALLY COMPLETED NAME] IF YOU ARE
•
allergic to linezolid or any of the other ingredients of this medicine
(listed in section 6)
•
taking or have taken within the last 2 weeks any medicines known as
monoamine oxidase
inhibitors (MAOIs for example phenelzine, isocarboxazid, selegiline,
moclobemide).
These may be used to treat depression or Parkinson’s disease.
•
breast-feeding
This is because it passes into breast milk and could affect the baby.
Sandoz B.V.
Page 2/

Productkenmerken

Sandoz B.V.
Page 1/20
Linezolid Sandoz 600 mg, filmomhulde tabletten
RVG 113824
1311-v6b
1.3.1.1 Samenvatting van de Productkenmerken
Januari 2024
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Linezolid Sandoz 600 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg of linezolid.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White to off white colored biconvex oval shaped film-coated tablet,
18.8 mm long, 9.9 mm wide and
6.4 mm thick with “LZ600” debossed on one side and plain on the
other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Nosocomial pneumonia
-
Community acquired pneumonia
[Nationally completed name] is indicated for the treatment of
community acquired pneumonia
and nosocomial pneumonia when known or suspected to be caused by
susceptible Gram-
positive bacteria. In determining whether linezolid is an appropriate
treatment, the results of
microbiological tests or information on the prevalence of resistance
to antibacterial agents
among Gram-positive bacteria should be taken into consideration (see
section 5.1 for the
appropriate organisms).
Linezolid is not active against infections caused by Gram-negative
pathogens. Specific therapy
against Gram-negative organisms must be initiated concomitantly if a
Gram-negative pathogen
is documented or suspected.
-
Complicated skin and soft tissue infections (see section 4.4)
Sandoz B.V.
Page 2/20
Linezolid Sandoz 600 mg, filmomhulde tabletten
RVG 113824
1311-v6b
1.3.1.1 Samenvatting van de Productkenmerken
Januari 2024
[Nationally completed name] is indicated for the treatment of
complicated skin and soft tissue
infections only when microbiological testing has established that the
infection is known to be
caused by susceptible Gram-positive bacteria.
Linezolid is not active against infections caused by Gram-negative
pathogens. Linezolid should
only be used in patients with complicated skin and soft tissue
infections with kn