Linezolid Hetero 2 mg/ml, oplossing voor infusie

Pajjiż: Olanda

Lingwa: Olandiż

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

Ingredjent attiv:

LINEZOLID

Disponibbli minn:

Hetero Europe S.L. Viladecans Business Park, Edificio Brasil, Catalunya 83-85 08840 VILADECANS (SPANJE)

Kodiċi ATC:

J01XX08

INN (Isem Internazzjonali):

LINEZOLID

Għamla farmaċewtika:

Oplossing voor infusie

Kompożizzjoni:

CITROENZUUR 0-WATER (E 330) ; GLUCOSE 1-WATER ; NATRIUMHYDROXIDE (E 524) ; STIKSTOF (HEAD SPACE) (E 941) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; WATER VOOR INJECTIE ; ZOUTZUUR (E 507),

Rotta amministrattiva:

Intraveneus gebruik

Żona terapewtika:

Linezolid

Sommarju tal-prodott:

Hulpstoffen: CITROENZUUR 0-WATER (E 330); GLUCOSE 1-WATER; NATRIUMHYDROXIDE (E 524); STIKSTOF (HEAD SPACE) (E 941); TRINATRIUMCITRAAT 2-WATER (E 331); WATER VOOR INJECTIE; ZOUTZUUR (E 507);

Data ta 'l-awtorizzazzjoni:

2017-04-24

Fuljett ta 'informazzjoni

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LINEZOLID HETERO 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 or pharmacist.
- 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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Linezolid Hetero is and what it is used for
2. What you need to know before you take Linezolid Hetero
3. How to take Linezolid Hetero
4. Possible side effects
5. How to store Linezolid Hetero
6. Contents of the pack and other information
1.
WHAT LINEZOLID HETERO IS AND WHAT IT IS USED FOR
Linezolid Hetero 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 Hetero is
suitable to treat your infection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LINEZOLID HETERO
DO NOT TAKE LINEZOLID HETERO:
• 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 Hetero passes
into breast milk and could
affect the baby.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Linezolid Hetero.
Linezolid Hetero may not be
suitable for you if you answer yes to any of the following questions.
I

Karatteristiċi tal-prodott

1
SAMENVATTING VAN DE PRODUCTKENMERKEN
1.
NAME OF THE MEDICINAL PRODUCT
Linezolid Hetero 2 mg/ml, oplossing voor infusie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 2 mg linezolid. 300 ml infusion bags contain 600 mg
linezolid.
Excipients: each 300 ml also contains 13.7 g glucose and 115 mg
sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Isotonic solution, clear, colourless to yellow solution.
pH = 4.4 - 5.0
Osmolarity = 280 - 330 mOsmol/kg
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nosocomial pneumonia
Community acquired pneumonia
Linezolid Hetero 2mg/ml Oplossing voor infusie 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 Hetero 2mg/ml
Oplossing voor infusie 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 Hetero 2mg/ml Oplossing voor infusie 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 again