Linezolid Pfizer 100 mg/5 ml granulaat voor orale suspensie

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

LINEZOLID

Beschikbaar vanaf:

Pfizer B.V.

ATC-code:

J01XX08

INN (Algemene Internationale Benaming):

LINEZOLID

farmaceutische vorm:

Granulaat voor orale suspensie

Samenstelling:

AMMONIUMGLYCYRRHIZAAT ; ASPARTAAM (E 951) ; CARMELLOSE NATRIUM (E 466) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; ETHANOL ; FRUCTOSE (D-) ; GLYCYRRHIZINEZUUR ; MALTODEXTRINE ; MANNITOL (D-) (E 421) ; NATRIUMBENZOAAT (E 211) ; NATRIUMCHLORIDE ; NATURLIJK EN KUNSTMATIG VANILLESMAAKSTOF S.D. ; NATUURLIJK EN KUNSTMATIG PEPERMUNTSMAAKSTOF S.D. F93125 ; NATUURLIJK EN KUNSTMATIG SINAASAPPELCREMESMAAKSTOF, Nor-Cap ; NATUURLIJK EN KUNSTMATIG SINAASAPPELSMAAKSTOF, Nor-Cap ; PEPERMUNTOLIE ; PEPERMUNTSMAAKSTOF ; PROPYLEENGLYCOL (E 1520) ; SACCHAROSE ; SILICIUMDIOXIDE (E 551) ; SINAASAPPEL TANGERINE SMAAKSTOF 10888-56 ; SINAASAPPEL-CREME SMAAKSTOF ; SINAASAPPELOLIE ; SINAASAPPELSMAAKSTOF ; SORBITOL (D-)(E 420) ; TOCOFEROL, DL-ALFA (E 307) ; TRINATRIUMCITRAAT 0-WATER (E 331) ; VANILLESMAAKSTOF ; XANTHAANGOM (E 415) ; ZETMEEL, GEMODIFICEERD (MODIFICATIE ONBEKEND) ; ZOETHOUTEXTRACT, MAGNASWEET No 135 ; ZOETHOUTSMAAKSTOF ; ZOETSTOFFEN POEDER No 918.005,

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Linezolid

Product samenvatting:

Hulpstoffen: AMMONIUMGLYCYRRHIZAAT; ASPARTAAM (E 951); CARMELLOSE NATRIUM (E 466); CELLULOSE, MICROKRISTALLIJN (E 460); ETHANOL; FRUCTOSE (D-); GLYCYRRHIZINEZUUR; MALTODEXTRINE; MANNITOL (D-) (E 421); NATRIUMBENZOAAT (E 211); NATRIUMCHLORIDE; NATURLIJK EN KUNSTMATIG VANILLESMAAKSTOF S.D.; NATUURLIJK EN KUNSTMATIG PEPERMUNTSMAAKSTOF S.D. F93125; NATUURLIJK EN KUNSTMATIG SINAASAPPELCREMESMAAKSTOF, Nor-Cap; NATUURLIJK EN KUNSTMATIG SINAASAPPELSMAAKSTOF, Nor-Cap; PEPERMUNTOLIE; PEPERMUNTSMAAKSTOF; PROPYLEENGLYCOL (E 1520); SACCHAROSE; SILICIUMDIOXIDE (E 551); SINAASAPPEL TANGERINE SMAAKSTOF 10888-56; SINAASAPPEL-CREME SMAAKSTOF; SINAASAPPELOLIE; SINAASAPPELSMAAKSTOF; SORBITOL (D-)(E 420); TOCOFEROL, DL-ALFA (E 307); TRINATRIUMCITRAAT 0-WATER (E 331); VANILLESMAAKSTOF; XANTHAANGOM (E 415); ZETMEEL, GEMODIFICEERD (MODIFICATIE ONBEKEND); ZOETHOUTEXTRACT, MAGNASWEET No 135; ZOETHOUTSMAAKSTOF; ZOETSTOFFEN POEDER No 918.005;

Autorisatie datum:

2015-02-12

Bijsluiter

LINE PF 100GOS 015 EN PIL 29Aug2016
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LINEZOLID PFIZER 100 MG/5 ML GRANULAAT VOOR ORALE SUSPENSIE
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 question

Productkenmerken

LINE PF 100GOS 015 EN SmPC 29Aug2016
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Linezolid Pfizer 100 mg/5 ml granulaat voor orale suspensie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Following reconstitution with 123 ml water, each 5 ml contains 100 mg
linezolid.
Excipients with known effect
Each 5 ml also contains 1052.9 mg sucrose, 500 mg mannitol (E421),
35.0 mg aspartame
(E951), 8.5 mg sodium, 12 mg fructose, 36 mg sorbitol (E420), ethanol
(alcohol), less than
100 mg._ _
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Granules for oral suspension.
White to light-yellow, orange flavoured granules.
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 t