Страна: Нидерландия
Език: нидерландски
Източник: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
TOBRAMYCINE 60 mg/ml
Aristo Pharma GmbH Wallenroder Strasse 8-10 13435 BERLIJN (DUITSLAND)
J01GB01
TOBRAMYCINE 60 mg/ml
Verneveloplossing
NATRIUMCHLORIDE ; NATRIUMHYDROXIDE (E 524) ; STIKSTOF (HEAD SPACE) (E 941) ; WATER VOOR INJECTIE ; ZWAVELZUUR (E 513)
Inhalatie
Tobramycin
1900-01-01
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TOBRAMYCINE ARISTO 300 MG/ 5 ML VERNEVELOPLOSSING tobramycin 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 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 Tobramycine Aristo is and what it is used for 2. What you need to know before you use Tobramycine Aristo 3. How to use Tobramycine Aristo 4. Possible side effects 5. How to store Tobramycine Aristo 6. Contents of the pack and other information 1. WHAT TOBRAMYCINE ARISTO IS AND WHAT IT IS USED FOR Tobramycine Aristo contains a medicine called tobramycin. This is an aminoglycoside antibiotic. Tobramycine Aristo is used in patients aged six years and older who have cystic fibrosis to treat chest infections caused by a bacteria called _Pseudomonas aeruginosa_ . Tobramycine Aristo fights the infection caused by _Pseudomonas_ bacteria in your lungs, and helps to improve your breathing. When you inhale Tobramycine Aristo, the antibiotic can get directly into your lungs to fight against the bacteria causing the infection. For the best results of this medicine, use it as this leaflet instructs you. WHAT IS _PSEUDOMONAS AERUGINOSA_? This is a very common bacteria that infects nearly everyone with cystic fibrosis at some time during their lives. Some people do not get this infection until later on in their lives, while others get it very young. This is one of the most damaging bacteria for people with cystic fibrosis. If the infection is not properly controlled, it will continue to damage your lungs causing further problems to your breathing. Tobramycine Прочетете целия документ
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Tobramycine Aristo 300mg/ 5ml verneveloplossing 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ampoule of 5 ml contains tobramycin 300 mg as a single dose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Nebuliser solution Clear, slightly yellow solution free 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tobramycine Aristo is indicated in cystic fibrosis (CF) patients aged 6 years and older for long-term management of chronic pulmonary infection due to _Pseudomonas aeruginosa_ . Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Tobramycine Aristo is supplied for use via inhalation and is not for parenteral use. Posology The recommended dose for adults and children is one ampoule twice daily for 28 days. The dose interval should be as close as possible to 12 hours and not less than 6 hours. After 28 days of therapy, patients should stop Tobramycine Aristo therapy for the next 28 days. A cycle of 28 days of active therapy and 28 days of rest from treatment should be maintained. Dosage is not adjusted for weight. All patients should receive one ampoule of Tobramycine Aristo (300 mg of tobramycin) twice daily. Controlled clinical studies, conducted for a period of 6 months using the following tobramycin dosage regimen, have shown that improvement in lung function was maintained above baseline during the 28 day rest periods. Tobramycin Dosing Regimen in Controlled Clinical Studies Cycle 1 Cycle 2 Cycle 3 28 Days 28 Days 28 Days 28 Days 28 Days 28 Days Tobramycin 300 mg twice daily plus standard care standard care Tobramycin 300 mg twice daily plus standard care standard care Tobramycin 300 mg twice daily plus standard care standard care Safety and efficacy for long-term management of chronic pulmonary infection due to _Pseudomonas _ _aeruginosa_ have been assessed in controlled and open label studies for up to 96 weeks (12 cycle Прочетете целия документ