Ülke: Malta
Dil: İngilizce
Kaynak: Medicines Authority
Viatris Healthcare Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN , Ireland
J01GB01
TOBRAMYCIN 300 ml/5ml
NEBULISER SOLUTION
TOBRAMYCIN 300 ml/5ml
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Authorised
2018-11-27
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER TOBI® 300 MG/5 ML NEBULISER SOLUTION Tobramycin 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 Tobi is and what it is used for 2. What you need to know before you use Tobi 3. How to use Tobi 4. Possible side effects 5. How to store Tobi 6. Contents of the pack and other information 1. WHAT TOBI IS AND WHAT IT IS USED FOR WHAT IS TOBI FOR? Tobi contains a medicine called tobramycin. This is an aminoglycoside antibiotic. Tobi is used in patients aged six years and older who have cystic fibrosis to treat chest infections caused by a bacteria called Pseudomonas aeruginosa Tobi fights the infection caused by Pseudomonas bacteria _ _ in your lungs, and helps to improve your breathing. When you inhale Tobi, the antibiotic can get directly into your lungs to fight against the bacteria causing the infection. For the best results of this medicine, take 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. Tobi kills the bacteria that cause infections in the lungs. The infection can be controlled successfully if the p Belgenin tamamını okuyun
Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 13 1. NAME OF THE MEDICINAL PRODUCT TOBI ® 300 mg/5 mL Nebuliser Solution Tobramycin 300 mg/5 ml Nebuliser Solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ampoule of 5mL contains tobramycin 300mg as a single dose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Nebuliser solution. Clear, slightly yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TOBI 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 TOBI 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 TOBI 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 TOBI (300 mg of tobramycin) twice daily. Controlled clinical studies, conducted for a period of 6 months using the following TOBI dosage regimen, have shown that improvement in lung function was maintained above baseline during the 28 day rest periods. TOBI Dosing Regimen in Controlled Clinical Studies Cycle 1 Cycle 2 Cycle 3 28 Days ys ys ys ys ys 300 mg twice plus rd care rd 300 mg daily plus rd care rd 300 mg daily plus rd care rd 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 cycles), but have not been studied in patients under the age of 6 years, patients with forced expiratory volume in 1 Page 3 of 13 second (FEV 1 ) <2 Belgenin tamamını okuyun