Linezolid Pfizer 2 mg/ml oplossing voor infusie

Riik: Holland

keel: hollandi

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

Toimeaine:

LINEZOLID

Saadav alates:

Pfizer B.V.

ATC kood:

J01XX08

INN (Rahvusvaheline Nimetus):

LINEZOLID

Ravimvorm:

Oplossing voor infusie

Koostis:

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

Manustamisviis:

Intraveneus gebruik

Terapeutiline ala:

Linezolid

Toote kokkuvõte:

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

Loa andmise kuupäev:

2015-02-12

Infovoldik

LINE PF 2INF 013 EN PIL 29Aug2016
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LINEZOLID PFIZER 2 MG/ML OPLOSSING VOOR INFUSIE
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.
-
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 ARE TREATED WITH 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 case
tell your doctor as he/she will need to check your general health and
your blood pressure before and
during your treatment or may decide

Toote omadused

LINE PF 2INF 013 EN SmPC 15Feb2016
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Linezolid Pfizer 2 mg/ml oplossing voor infusie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for infusion contains 2 mg linezolid. 300 ml infusion
bags contain 600 mg
linezolid.
Excipients with known effect
Each 300 ml also contains 13.7 g glucose and 114 mg sodium.
_ _
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Isotonic, clear, colourless to yellow solution with pH range of
4.4-5.2.
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.
LINE PF 2