Linezolid Pfizer 600 mg filmomhulde tabletten

Země: Nizozemsko

Jazyk: nizozemština

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

Aktivní složka:

LINEZOLID

Dostupné s:

Pfizer B.V.

ATC kód:

J01XX08

INN (Mezinárodní Name):

LINEZOLID

Léková forma:

Filmomhulde tablet

Složení:

CARNAUBAWAS (E 903) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; NATRIUMZETMEELGLYCOLAAT (E468) ; TITAANDIOXIDE (E 171),

Podání:

Oraal gebruik

Terapeutické oblasti:

Linezolid

Přehled produktů:

Hulpstoffen: CARNAUBAWAS (E 903); CELLULOSE, MICROKRISTALLIJN (E 460); HYPROLOSE (E 463); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; NATRIUMZETMEELGLYCOLAAT (E468); TITAANDIOXIDE (E 171);

Datum autorizace:

2015-02-12

Informace pro uživatele

LINE PF 600FCT 014 EN PIL 29Aug2016
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LINEZOLID PFIZER 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Linezolid is and what it is used for
2.
What you need to know before you take Linezolid
3.
How to take Linezolid
4.
Possible side effects
5.
How to store Linezolid
6.
Contents of the pack and other information
1.
WHAT LINEZOLID PFIZER IS AND WHAT IT IS USED FOR
Linezolid 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 Linezolid is suitable
to treat your infection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LINEZOLID PFIZER
DO NOT TAKE LINEZOLID PFIZER:

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 medications may be used to treat depression or Parkinson’s
disease.

if you are breast-feeding. This is because Linezolid passes into
breast milk and could affect the
baby.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Linezolid.
Linezolid may not be suitable for you if you answer YES to any of the
following questions. In this cas

Charakteristika produktu

LINE PF 600FCT 014 EN SmPC 15Feb2016
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Linezolid Pfizer 600 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 600 mg linezolid.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, ovaloid tablet of 7.22 mm in length, 3.75 mm in width, 2.5 mm
thick debossed with
“LZD” on one side and “600” on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nosocomial pneumonia
Community acquired pneumonia
Linezolid 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 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 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