Nazione: Paesi Bassi
Lingua: olandese
Fonte: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
LINEZOLID
Hetero Europe S.L. Viladecans Business Park, Edificio Brasil, Catalunya 83-85 08840 VILADECANS (SPANJE)
J01XX08
LINEZOLID
Oplossing voor infusie
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),
Intraveneus gebruik
Linezolid
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);
2017-04-24
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 Leggi il documento completo
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 Leggi il documento completo