Linezolid Hetero 600 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

LINEZOLID

Beschikbaar vanaf:

Hetero Europe S.L.

ATC-code:

J01XX08

INN (Algemene Internationale Benaming):

LINEZOLID

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CARNAUBAWAS (E 903) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; POLACRILINE KALIUM ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Linezolid

Product samenvatting:

Hulpstoffen: CARNAUBAWAS (E 903); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); LACTOSE 1-WATER; MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); POLACRILINE KALIUM; SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Autorisatie datum:

2013-09-12

Bijsluiter

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
LINEZOLID 600MG 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
WHAT LINEZOLID 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.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LINEZOLID
DO NOT TAKE LINEZOLID
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 case tell your
doctor as he/she will need to check your general health and

Productkenmerken

_SUMMARY OF PRODUCT CHARACTERISTICS _
1
NAME OF THE MEDICINAL PRODUCT
Linezolid Hetero 600 mg filmomhulde tabletten
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Linezolid 600 mg Film-Coated Tablets
Excipient(s) with known effect: each Linezolid film-coated tablet
contains 222 mg of
lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Linezolid 600 mg Film-Coated Tablets
Film-coated tablet.
White to off white, oval shaped, approx 18.4 mm in length and 9.6 mm
in width film-
coated tablet with “I” on one side and “22” on the other side,
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 initi