Krajina: Nový Zéland
Jazyk: angličtina
Zdroj: Medsafe (Medicines Safety Authority)
Tobramycin 300mg
Boucher & Muir (New Zealand) Limited t/a BNM Group
300 mg/5mL
Solution for inhalation
Active: Tobramycin 300mg Excipient: Sodium chloride Sodium hydroxide Sulfuric acid Water for injection
Prescription
Tobramycin BNM is indicated for the management of cystic fibrosis patients with P. aeruginosa infections. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with FEV1 <25% or >75% predicted, or patients colonised with Burkholderia cepacia.
Package - Contents - Shelf Life: Ampoule, plastic, LDPE ampoule, 5 mL - 56 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 28 days opened stored at or below 25°C protect from light
2018-09-25
1 TOBRAMYCIN BNM Consumer Medicine Information TOBRAMYCIN BNM _TOBRAMYCIN _ Solution for inhalation 300 mg/5 ml WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using Tobramycin BNM. This leaflet answers some common questions about Tobramycin BNM. It does not contain all the available information. The most up-to-date Consumer Medicine Information can be downloaded from www.medsafe.govt.nz. Those updates may contain important information about the medicine and its use of which you should be aware. Reading this leaflet does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using Tobramycin BNM against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again. WHAT TOBRAMYCIN BNM IS USED FOR Tobramycin BNM contains an antibacterial agent, tobramycin, which is active against a common lung infection that occurs in patients with cystic fibrosis (CF). Tobramycin belongs to a class of antibiotics called aminoglycosides. It works by killing or stopping the growth of the bacteria that cause the infection. The bacterium that commonly infects the lungs of most cystic fibrosis patients at some stage of their lives is _Pseudomonas aeruginosa_. It is one of the most damaging bacteria for people with CF. Some people do not get this infection until later on in their lives, while others get it very young. If the infection is not properly fought, it will continue to damage your lungs, causing further problems with your breathing. Tobramycin BNM solution is for administration by inhalation via a nebuliser and compressor. When you inhale Tobramycin BNM, the antibiotic can get straight into your lungs to fight against the infection and to improve your breathing. 2 TOBRAMYCIN BNM FOR BEST RESULTS, PLEASE USE TOBRAMYCIN BNM AS THIS LEAFLET INSTRUCTS YOU. Although Tobramycin BN Prečítajte si celý dokument
1 TOBRAMYCIN BNM TOBRAMYCIN SOLUTION FOR INHALATION 300 MG/5 ML NEW ZEALAND DATA SHEET 1 TOBRAMYCIN BNM TOBRAMYCIN BNM 300 mg/5 mL solution for inhalation 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 mL ampoule contains 300 mg tobramycin. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Tobramycin BNM is a solution for inhalation. It is a sterile, clear, slightly yellow solution free from visible particles. It has a pH of 4.0 to 5.0 and an osmolality of 150 to 200 mOsm/kg. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tobramycin BNM is indicated for the management of cystic fibrosis patients with _P. aeruginosa_ infections. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with FEV 1 <25% or >75% predicted, or patients colonised with _Burkholderia_ _cepacia _ (see Section 5.1 Pharmacodynamic properties: Clinical trials). 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE _ADULTS AND PAEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER _ The recommended dosage for both adults and paediatric patients 6 years of age and older is one single-use ampoule (300 mg) administered twice daily for 28 days. Dosage is not adjusted by weight. All patients should be administered 300 mg twice daily. The doses should be taken as close to 12 hours apart as possible; they should not be taken less than six hours apart. 2 TOBRAMYCIN BNM TOBRAMYCIN SOLUTION FOR INHALATION 300 MG/5 ML Tobramycin BNM is inhaled while the patient is sitting or standing upright and breathing normally through the mouthpiece of the nebuliser. Nose clips may help the patient breathe through the mouth. Tobramycin BNM is administered twice daily in alternating periods of 28 days. After 28 days of therapy, patients should stop Tobramycin BNM therapy for the next 28 days, then resume therapy for the next 28 days on/28 days off cycle. METHOD OF ADMINISTRATION Tobramycin BNM is for oral inhalation only and must not be administered by any other route. The contents of one ampoule should b Prečítajte si celý dokument