देश: नीदरलैंड
भाषा: डच
स्रोत: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
LINEZOLID 600 mg/stuk
Synthon B.V. Microweg 22 6545 CM NIJMEGEN
J01XX08
LINEZOLID 600 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Linezolid
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); HYPROLOSE (E 463); HYPROMELLOSE (E 464); MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);
1900-01-01
M1.3.1_03.LII.tab.001.04.NL.3013.01 PACKAGE LEAFLET: INFORMATION FOR THE USER GRAMPOLID 600 MG, FILMOMHULDE TABLETTEN 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 Grampolid is and what it is used for 2. What you need to know before you take Grampolid 3. How to take Grampolid 4. Possible side effects 5. How to store Grampolid 6. Contents of the pack and other information 1. WHAT GRAMPOLID IS AND WHAT IT IS USED FOR Grampolid is a medicine containing an active substance called linezolid. Grampolid 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 Grampolid is suitable to treat your infection. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GRAMPOLID DO NOT TAKE GRAMPOLID • 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. WARNINGS AND PRECAUTIONS 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 wi पूरा दस्तावेज़ पढ़ें
M1.3.1_01.LII.tab.002.01.NL.3013.02 1 NAME OF THE MEDICINAL PRODUCT Grampolid 600 mg, filmomhulde tabletten 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 600 mg linezolid. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White to off-white, oblong (approximately 18 mm x 6 mm), biconvex film coated tablets debossed with “L9II 600” on one side. 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. Linezolid should only be initiated in a hospital environment and after consultation with a relevant specialist such as a microbiologist or infectious diseas पूरा दस्तावेज़ पढ़ें