Pays: Pays-Bas
Langue: néerlandais
Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
LINEZOLID
Pfizer B.V.
J01XX08
LINEZOLID
Oplossing voor infusie
CITROENZUUR 0-WATER (E 330) ; GLUCOSE 1-WATER ; NATRIUMHYDROXIDE (E 524) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; WATER VOOR INJECTIE ; ZOUTZUUR (E 507),
Intraveneus gebruik
Linezolid
Hulpstoffen: CITROENZUUR 0-WATER (E 330); GLUCOSE 1-WATER; NATRIUMHYDROXIDE (E 524); TRINATRIUMCITRAAT 2-WATER (E 331); WATER VOOR INJECTIE; ZOUTZUUR (E 507);
2015-02-12
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 Lire le document complet
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 Lire le document complet