Krajina: Holandsko
Jazyk: holandčina
Zdroj: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
LINEZOLID 600 mg/stuk
Pharmaceutical Works Polpharma S.A. 19, Pelplinska Street 83-200 STAROGARD GDANSKI (POLEN)
J01XX08
LINEZOLID 600 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; HYPROMELLOSE (E 464) ; MACROGOLSTEARAAT, TYPE I ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMDIWATERSTOFCITRAAT (E 331) ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE (E 464) ; MACROGOLSTEARAAT, TYPE I ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMDIWATERSTOFCITRAAT (E 331) ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE (E 464) ; MACROGOLSTEARAAT, TYPE I ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMDIWATERSTOFCITRAAT (E 331) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Linezolid
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); HYPROMELLOSE (E 464); MACROGOLSTEARAAT, TYPE I; MAGNESIUMSTEARAAT (E 470b); NATRIUMDIWATERSTOFCITRAAT (E 331); NATRIUMZETMEELGLYCOLAAT (E468); POVIDON K 30 (E 1201); TITAANDIOXIDE (E 171);
1900-01-01
PACKAGE LEAFLET: INFORMATION FOR THE USER LINEZOLID POLPHARMA 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 Linezolid Polpharma tablets is and what it is used for 2. What you need to know before you take Linezolid Polpharma tablets 3. How to take Linezolid Polpharma tablets 4. Possible side effects 5. How to store Linezolid Polpharma tablets 6. Contents of the pack and other information 1. WHAT LINEZOLID POLPHARMA TABLETS IS AND WHAT IT IS USED FOR Linezolid Polpharma tablets 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 in adults. Your doctor will have decided if this medicine is suitable to treat your infection. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LINEZOLID POLPHARMA TABLETS DO NOT TAKE LINEZOLID POLPHARMA TABLETS: • 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 may be used to treat depression in Parksinson’s disease • if you are breastfeeding. This is because linezolid passes into breast milk and could affect the baby. WARNINGS AND PRECAUTIONS Linezolid Polpharma tablets may not be suitable for you if you answer YES to any of the follow Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Linezolid Polpharma 600 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 600 mg of linezolid For the full list of excipients see section 6.1 3. PHARMACEUTICAL FORM Film-coated tablet Off-white, oblong, biconvex film-coated tablets, approx. 19.5 mm by 9 mm 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Nosocomial pneumonia - Community acquired pneumonia Linezolid XXX tablets 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 XXX tablets 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 XXX tablets 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 disease Prečítajte si celý dokument