Страна: Нидерланды
Язык: голландский
Источник: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
LINEZOLID
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
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);
2014-03-05
Sandoz B.V. Page 1/23 Linezolid Sandoz 600 mg/ 300 ml, oplossing voor infusie RVG 113204 1313-V7 1.3.1.3 Bijsluiter April 2022 PACKAGE LEAFLET: INFORMATION FOR THE USER LINEZOLID SANDOZ 600 MG/ 300 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. - 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 [nationally completed name] is and what it is used for 2. What you need to know before you use [nationally completed name] 3. How to use [nationally completed name] 4. Possible side effects 5. How to store [nationally completed name] 6. Contents of the pack and other information 1. WHAT [NATIONALLY COMPLETED NAME] 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 [nationally completed name] is suitable to treat your infection. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME] DO NOT USE [NATIONALLY COMPLETED NAME] - 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 medicines may be used to treat depression or Parkinson’s disease; - If you are breast-feeding. This is because [nationally completed name] passes into breast milk and could affect the baby. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before taking [nationally completed name]. [Nation Прочитать полный документ
Sandoz B.V. Page 1/21 Linezolid Sandoz 600 mg/ 300 ml, oplossing voor infusie RVG 113204 1311-V4 1.3.1.1 Samenvatting van de Productkenmerken April 2022 1.3.1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Linezolid Sandoz 600 mg/ 300 ml, oplossing voor infusie 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution for infusion contains 2 mg of linezolid. Each 300 ml infusion bag contains 600 mg of linezolid. Excipient(s) with known effect Each ml of solution for infusion contains 0.38 mg of sodium. Each 300 ml bag of solution for infusion contains 114 mg of sodium. Each ml of solution for infusion contains 48 mg glucose monohydrate. Each 300 ml bag of solution for infusion contains 14.4 g glucose monohydrate. 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 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). Sandoz B.V. Page 2/21 Linezolid Sandoz 600 mg/ 300 ml, oplossing voor infusie RVG 113204 1311-V4 1.3.1.1 Samenvatting van de Productkenmerken April 2022 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 Прочитать полный документ