Χώρα: Ευρωπαϊκή Ένωση
Γλώσσα: Αγγλικά
Πηγή: EMA (European Medicines Agency)
Tobramycin
Pari Pharma GmbH
J01GB01
tobramycin
Antibacterials for systemic use,
Respiratory Tract Infections; Cystic Fibrosis
Vantobra is indicated for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis (CF).Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Revision: 5
Authorised
2019-02-18
24 B. PACKAGE LEAFLET 25 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VANTOBRA 170 MG NEBULISER SOLUTION 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 Vantobra is and what it is used for 2. What you need to know before you use Vantobra 3. How to use Vantobra 4. Possible side effects 5. How to store Vantobra 6. Contents of the pack and other information 1. WHAT VANTOBRA IS AND WHAT IT IS USED FOR WHAT VANTOBRA IS Vantobra contains an antibiotic medicine called tobramycin. It belongs to a class of antibiotic medicines called aminoglycosides. WHAT VANTOBRA IS USED FOR Vantobra is used in patients with cystic fibrosis aged 6 years and older to treat lung infections caused by bacteria named _Pseudomonas aeruginosa_ . _Pseudomonas aeruginosa_ is a bacterium that frequently infects the lungs of cystic fibrosis patients at some time during their lives. If the infection is not properly treated, it continues to damage the lungs, causing further problems with breathing. HOW VANTOBRA WORKS When you inhale Vantobra, the antibiotic can enter directly into your lungs to fight the bacteria causing the infection. It works by disrupting the production of proteins that the bacteria need to build their cell walls. This damages the bacteria and eventually kills them. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE VANTOBRA _ _ DO NOT USE VANTOBRA: • if you are allergic (hypersensitive) to tobramycin, to any type of aminoglycoside antibiotics, or to any of the other ingredients of Vantobra (listed in section Διαβάστε το πλήρες έγγραφο
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Vantobra 170 mg nebuliser solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each single-dose ampoule of 1.7 ml contains 170 mg tobramycin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Nebuliser solution. A clear to slightly yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vantobra is indicated for the management of chronic pulmonary infection due to _Pseudomonas aeruginosa_ in patients aged 6 years and older with cystic fibrosis (CF). _ _ 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 Vantobra is the same for all patients within the approved age range, regardless of age or weight. The recommended dose is one ampoule (170 mg/1.7 ml) administered twice daily (i.e. total daily dose is 2 ampoules) for 28 days. The dose interval should be as close as possible to 12 hours and not less than 6 hours. Vantobra is taken in alternating cycles of 28 days. A cycle of 28 days of active therapy (on-treatment period) and 28 days of rest from treatment (off-treatment period) should be maintained. _Missed doses _ In case of a missed dose with at least 6 hours remaining until the next dose, the patient should inhale _ _ the dose as soon as possible. If less than 6 hours remain to the next planned dose, the patient should wait for the next dose and not inhale more to make up for the missed dose. _Duration of treatment _ Treatment should be continued on a cyclical basis for as long as the physician considers the patient is gaining clinical benefit from the treatment taking into account that long-term safety data are not available for Vantobra. If clinical deterioration of pulmonary status is evident, additional or alternative anti-pseudomonal therapy should be considered. See also information on clinical benefit and tolerability in sections 4.4, 4.8 and 5.1. Special populations _Elderly patie Διαβάστε το πλήρες έγγραφο