Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Tobramycin
Chiesi Limited
J01GB; J01GB01
Tobramycin
300/4 milligram(s)/millilitre
Nebuliser solution
Product subject to prescription which may not be renewed (A)
Other aminoglycosides; tobramycin
Marketed
2007-06-01
CHIESI ITEM PACKAGE LEAFLET: INFORMATION FOR THE USER BRAMITOB 300MG/4ML NEBULISER SOLUTION Tobramycin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CON- TAINS 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 BRAMITOB IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BRAMITOB 3. HOW TO USE BRAMITOB 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE BRAMITOB 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT BRAMITOB IS AND WHAT IT IS USED FOR Bramitob contains tobramycin which is an antibiotic belonging to a family called the aminoglycosides. It fights infections caused by Pseudomonas aeruginosa. Bramitob is used for treating chronic chest infections in patients with cystic fibrosis caused by Pseudomonas bacteria. It kills the bacteria and helps to improve your breathing. Pseudomonas is a very common bacterium that infects nearly all patients 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. If infection is not properly controlled it will continue to damage the lungs causing further problems. As Bramitob is breathed-in the antibiotic, tobramycin, can get straight into your lungs to work against the bacteria causing the infection. Bramitob is indicated only for patients aged 6 years and older. To achieve the best results please make every effort to use your medicine as instructed. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BRAMITOB DO NOT USE BRAMITOB: • If you are allergic (hypersensitive) to tobramycin, any of the other ingredients of thi Pročitajte cijeli dokument
Health Products Regulatory Authority 09 April 2019 CRN008JR8 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bramitob 300mg/4ml Nebuliser Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 4 ml single-dose container contains tobramycin 300 mg. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Nebuliser solution. Clear, yellowish solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Management of chronic pulmonary infection due to _Pseudomonas aeruginosa_ in patients with cystic fibrosis aged 6 years and older. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Bramitob is intended for inhalation only and not for parenteral use. Consideration should be given to official guidance on the appropriate use of antibacterial agents. Therapy should be initiated by a physician experienced in the management of cystic fibrosis. The recommended dose for adults and children above 6 years is one single-dose container (300mg) twice daily (morning and evening) for 28 days. The dose interval should be as close as possible to 12 hours. After 28 days of therapy with Bramitob, patients should stop treatment for the next 28 days. Alternate cycles of 28-days of active therapy followed by 28 days without treatment should be maintained (a cycle of 28 days with therapy and 28 days without treatment). CHILDREN UNDER 6 YEARS OLD The efficacy and safety of Bramitob have not been demonstrated in patients less than 6 years of age. ELDERLY PATIENTS Tobramycin should be used with caution in elderly patients who may have reduced renal function (see section 4.4). PATIENTS WITH RENAL IMPAIRMENT Tobramycin should be used with caution in patients with known or suspected renal, dysfunction. Bramitob should be discontinued in the case of nephrotoxicity until serum concentration of tobramycin fall below 2 µg/mL (see section 4.4). PATIENTS WITH HEPATIC INSUFFICIENCY No changes in Bramitob dose are required in hepatic insufficiency. Dosage is not adjusted for body weight. All patients should be admin Pročitajte cijeli dokument