Nchi: Uholanzi
Lugha: Kiholanzi
Chanzo: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
LINEZOLID 2 mg/ml
Alvogen IPCo S.ar.l 5, rue Heienhaff 1736 SENNINGERBERG (LUXEMBURG)
J01XX08
LINEZOLID 2 mg/ml
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);
1900-01-01
1.3.1 Package leaflet PACKAGE LEAFLET: INFORMATION FOR THE USER PNEUMOLID 2 MG/ML, OPLOSSING VOOR INFUSIE Linezolid READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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. WHAT IS IN THIS LEAFLET: 1. What [product name] is and what it is used for 2. What you need to know before you use [product name] 3. How to use [product name] 4. Possible side effects 5. How to store [product name] 6. Contents of the pack and other information 1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR [Product name] contains the active substance linezolid. 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 USE [PRODUCT NAME] DO NOT USE [PRODUCT NAME] - If you are allergic (hypersensitive) 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 may be used to treat depression or Parkinson’s disease; - If you are breastfeeding. This is because it passes into breast milk and could affect the baby. 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 Soma hati kamili
1.3.1 SUMMARY OF PRODUCT CHARACTERISTICS - CORE 1 NAME OF THE MEDICINAL PRODUCT Pneumolid 2 mg/ml, oplossing voor infusie 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 2 mg linezolid. Each 300 ml infusion bag contains 600 mg linezolid. Excipient(s) with known effect: this medicinal product contains 14.4 g glucose and 114 mg sodium per bag (300 ml). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. Isotonic, clear, colourless to yellow solution. The pH of the solution is 4.5 - 5.0. Osmolality is 270 – 330 mosmol/kg 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nosocomial pneumonia Community acquired pneumonia Linezolid is indicated 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 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. Linezoli Soma hati kamili