Linezolid Polpharma 600 mg, filmomhulde tabletten

Land: Nederland

Språk: nederlandsk

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

Aktiv ingrediens:

LINEZOLID 600 mg/stuk

Tilgjengelig fra:

Pharmaceutical Works Polpharma S.A. 19, Pelplinska Street 83-200 STAROGARD GDANSKI (POLEN)

ATC-kode:

J01XX08

INN (International Name):

LINEZOLID 600 mg/stuk

Legemiddelform:

Filmomhulde tablet

Sammensetning:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; HYPROMELLOSE (E 464) ; MACROGOLSTEARAAT, TYPE I ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMDIWATERSTOFCITRAAT (E 331) ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE (E 464) ; MACROGOLSTEARAAT, TYPE I ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMDIWATERSTOFCITRAAT (E 331) ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE (E 464) ; MACROGOLSTEARAAT, TYPE I ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMDIWATERSTOFCITRAAT (E 331) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171),

Administreringsrute:

Oraal gebruik

Terapeutisk område:

Linezolid

Produkt oppsummering:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); HYPROMELLOSE (E 464); MACROGOLSTEARAAT, TYPE I; MAGNESIUMSTEARAAT (E 470b); NATRIUMDIWATERSTOFCITRAAT (E 331); NATRIUMZETMEELGLYCOLAAT (E468); POVIDON K 30 (E 1201); TITAANDIOXIDE (E 171);

Autorisasjon dato:

1900-01-01

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
LINEZOLID POLPHARMA 600 MG, FILMOMHULDE TABLETTEN
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 Linezolid Polpharma tablets is and what it is used for
2.
What you need to know before you take Linezolid Polpharma tablets
3.
How to take Linezolid Polpharma tablets
4.
Possible side effects
5.
How to store Linezolid Polpharma tablets
6.
Contents of the pack and other information
1.
WHAT LINEZOLID POLPHARMA TABLETS IS AND WHAT IT IS USED FOR
Linezolid Polpharma tablets 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 in adults. Your doctor will have decided if this
medicine is suitable to treat your infection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LINEZOLID POLPHARMA TABLETS
DO NOT TAKE LINEZOLID POLPHARMA TABLETS:
•
if you are allergic to linezolid or any of the other ingredients of
this medicine (listed in section 6).
•
if you are 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 in Parksinson’s disease
•
if you are breastfeeding. This is because linezolid passes into breast
milk and could affect the baby.
WARNINGS AND PRECAUTIONS
Linezolid Polpharma tablets may not be suitable for you if you answer
YES to any of the follow

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Linezolid Polpharma 600 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 600 mg of linezolid
For the full list of excipients see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet
Off-white, oblong, biconvex film-coated tablets, approx. 19.5 mm by 9
mm
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
- Nosocomial pneumonia
- Community acquired pneumonia
Linezolid XXX tablets is indicated in adults 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 XXX tablets 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)
Linezolid XXX tablets is indicated in adults 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 known or possible co-
infection with Gram negative organisms if there are no alternative
treatment options available (see
section 4.4). In these circumstances treatment against Gram negative
organisms must be initiated
concomitantly.
Linezolid should only be initiated in a hospital environment and after
consultation with a relevant
specialist such as a microbiologist or infectious disease