Pneumolid 2 mg/ml, oplossing voor infusie

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

LINEZOLID 2 mg/ml

Beschikbaar vanaf:

Alvogen IPCo S.ar.l 5, rue Heienhaff 1736 SENNINGERBERG (LUXEMBURG)

ATC-code:

J01XX08

INN (Algemene Internationale Benaming):

LINEZOLID 2 mg/ml

farmaceutische vorm:

Oplossing voor infusie

Samenstelling:

CITROENZUUR 0-WATER (E 330) ; GLUCOSE 1-WATER ; NATRIUMHYDROXIDE (E 524) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; WATER VOOR INJECTIE ; ZOUTZUUR (E 507),

Toedieningsweg:

Intraveneus gebruik

Therapeutisch gebied:

Linezolid

Product samenvatting:

Hulpstoffen: CITROENZUUR 0-WATER (E 330); GLUCOSE 1-WATER; NATRIUMHYDROXIDE (E 524); TRINATRIUMCITRAAT 2-WATER (E 331); WATER VOOR INJECTIE; ZOUTZUUR (E 507);

Autorisatie datum:

2014-03-05

Bijsluiter

1.3.1 Package leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
PNEUMOLID 2 MG/ML, OPLOSSING VOOR INFUSIE
Linezolid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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.
WHAT IS IN THIS LEAFLET:
1.
What [product name] is and what it is used for
2.
What you need to know before you use [product name]
3.
How to use [product name]
4.
Possible side effects
5.
How to store [product name]
6.
Contents of the pack and other information
1.
WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
[Product name] contains the active substance linezolid. 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 USE [PRODUCT NAME]
DO NOT USE [PRODUCT NAME]
-
If you are allergic (hypersensitive) 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 or Parkinson’s disease;
-
If you are breastfeeding. This is because it passes into breast milk
and could affect the baby.
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

1.3.1 SUMMARY OF PRODUCT CHARACTERISTICS - CORE
1 NAME OF THE MEDICINAL PRODUCT
Pneumolid 2 mg/ml, oplossing voor infusie
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 2 mg linezolid. Each 300 ml infusion bag contains 600 mg
linezolid.
Excipient(s) with known effect: this medicinal product contains 14.4 g
glucose and 114 mg sodium
per bag (300 ml).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Isotonic, clear, colourless to yellow solution.
The pH of the solution is 4.5 - 5.0.
Osmolality is 270 – 330 mosmol/kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Nosocomial pneumonia
Community acquired pneumonia
Linezolid 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)
Linezolid 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 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.
Linezoli