Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Tobramycin
Viatris Healthcare Limited
J01GB01
tobramycin
Antibacterials for systemic use,
Cystic Fibrosis; Respiratory Tract Infections
Tobi Podhaler is indicated for the suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with cystic fibrosis. See sections 4.4 and 5.1 regarding data in different age groups.Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Revision: 21
Authorised
2011-07-20
34 B. PACKAGE LEAFLET 35 PACKAGE LEAFLET: INFORMATION FOR THE USER TOBI PODHALER 28 MG INHALATION POWDER, HARD CAPSULES 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 Podhaler is and what it is used for 2. What you need to know before you take TOBI Podhaler 3. How to take TOBI Podhaler 4. Possible side effects 5. How to store TOBI Podhaler 6. Contents of the pack and other information Instructions for use with the Podhaler device ( _overleaf_ ) 1. WHAT TOBI PODHALER IS AND WHAT IT IS USED FOR WHAT TOBI PODHALER IS TOBI Podhaler contains a medicine called tobramycin which is an antibiotic. This antibiotic belongs to a class called aminoglycosides. WHAT TOBI PODHALER IS USED FOR TOBI Podhaler is used in patients aged 6 years and older who have cystic fibrosis to treat lung infections caused by bacteria called _Pseudomonas aeruginosa._ For the best results from this medicine, please use it as this leaflet instructs you. HOW TOBI PODHALER WORKS TOBI Podhaler is a powder for inhalation that is filled into capsules. When you inhale TOBI Podhaler, the antibiotic can enter directly into your lungs to fight against the bacteria causing the infection and to improve your breathing. WHAT IS _PSEUDOMONAS AERUGINOSA_ It is a very common bacterium that infects the lungs of 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. It is one of the most damaging bacteria for p Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT TOBI Podhaler 28 mg inhalation powder, hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 28 mg tobramycin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder, hard capsule Clear colourless capsules containing a white to almost white powder, with “MYL TPH” printed in blue on one part of the capsule and Mylan logo printed in blue on the other part of the capsule. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TOBI Podhaler is indicated for the suppressive therapy of chronic pulmonary infection due to _Pseudomonas aeruginosa_ in adults and children aged 6 years and older with cystic fibrosis. See sections 4.4 and 5.1 regarding data in different age groups. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose of TOBI Podhaler is the same for all patients within the approved age range, regardless of age or weight. The recommended dose is 112 mg tobramycin (4 x 28 mg capsules), administered twice daily for 28 days. TOBI Podhaler is taken in alternating cycles of 28 days on treatment followed by 28 days off treatment. The two doses (of 4 capsules each) should be inhaled as close as possible to 12 hours apart and not less than 6 hours apart. _ _ _Missed doses _ In case of missed dose with at least 6 hours until the next dose, the patient should take the dose as soon as possible. Otherwise, the patient should wait for the next dose and not inhale more capsules to make up for the missed dose. _Duration of treatment _ Treatment with TOBI Podhaler should be continued on a cyclical basis for as long as the physician considers the patient is gaining clinical benefit from the treatment with TOBI Podhaler. If clinical deterioration of pulmonary status is evident, additional or alternative anti-pseudomonal therapy should be considered. See also information on clini Прочетете целия документ