Šalis: Naujoji Zelandija
kalba: anglų
Šaltinis: Medsafe (Medicines Safety Authority)
Tobramycin 300mg
Maple Healthcare Limited
300 mg/5mL
Solution for inhalation
Active: Tobramycin 300mg Excipient: Sodium chloride Sodium hydroxide Sulfuric acid Water for injection
Prescription
Tobramycin Wockhardt 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, 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
2019-01-17
New Zealand Consumer Medicine Information TOBRAMYCIN WOCKHARDT Tobramycin 300 mg/ 5 mL, Solution for Inhalation WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using Tobramycin Wockhardt. This leaflet answers some common questions about Tobramycin Wockhardt. It does not contain all the available information. It 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 Wockhardt against the benefits they expect it will 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 need to read it again. WHAT TOBRAMYCIN WOCKHARDT IS USED FOR TOBRAMYCIN WOCKHARDT 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 lung 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 Wockhardt solution has been specially formulated for administration by inhalation via a nebuliser and compressor. When you inhale Tobramycin Wockhardt, NZ CMI Tobramycin Wockhardt V1.0 May 2019 the antibiotic can get straight into your lungs to fight against the infection and to improve your breathing. FOR BEST RESULTS, PLEASE USE TOBRAMYCIN WOCKHARDT AS THIS LEAFLET INSTRUCTS YOU. Although Tobramycin Wockhardt does not cure your condition, it does help control it. Tobramycin Wockhardt is not recommended for use in children younger th Perskaitykite visą dokumentą
Version 1.0 11 Dec 2018 Page 1 NEW ZEALAND DATA SHEET 1 PRODUCT NAME TOBRAMYCIN WOCKHARDT Tobramycin 300 mg/5 mL, Solution for inhalation. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 mL ampoule contains a sterile solution of tobramycin 300 mg For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS . 3 PHARMACEUTICAL FORM Solution for inhalation. TOBRAMYCIN WOCKHARDT is a sterile, clear slightly yellow, non-pyrogenic, aqueous solution with the pH and salinity adjusted specifically for administration by a compressed air driven reusable nebuliser. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TOBRAMYCIN WOCKHARDT injection 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 <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 DOSAGE 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. tobramycin 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 is administered twice daily in alternating periods of 28 days. After 28 days of therapy, patients should stop tobramycin therapy for the next 28 days, and then resume therapy for the next 28 days on/28 days off cycle. METHOD OF ADMINISTRATION TOBRAMYCIN WOCKHARDT is supplied as a single-use ampoule and is administered by inhalation, over a 10 to 15 minute period, using a hand-help PARI Perskaitykite visą dokumentą