Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Tobramycin
Pfizer Healthcare Ireland
J01GB; J01GB01
Tobramycin
40 milligram(s)/millilitre
Solution for injection
Product subject to prescription which may not be renewed (A)
Other aminoglycosides; tobramycin
Marketed
1993-07-14
Page 1 of 6 2021-0073397 PACKAGE LEAFLET: INFORMATION FOR THE USER TOBRAMYCIN 40 MG/ML SOLUTION FOR INJECTION 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 nurse. • If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Tobramycin is and what it is used for 2. What you need to know before you use Tobramycin 3. How to use Tobramycin 4. Possible side effects 5. How to store Tobramycin 6. Contents of the pack and other information 1. WHAT TOBRAMYCIN IS AND WHAT IT IS USED FOR Tobramycin is an antibiotic medicine (used to fight infections caused by bacteria). Tobramycin can be used to treat: • infections of the brain and spinal cord, e.g. meningitis • infections of the stomach or intestines • infections of the bladder or kidney (urinary tract infection) • infections of the lungs, e.g. pneumonia • infections of the bone, skin or soft tissue including burns 2. WHAT YOU NEED TO KNOW BEFORE YOU USE TOBRAMYCIN TOBRAMYCIN MUST NEVER BE INJECTED INTRATHECALLY (INTO THE SPINE). DO NOT USE TOBRAMYCIN: • if you are allergic to tobramycin or any of the other ingredients of this medicine (listed in section 6), or similar medicines (called aminoglycosides) • if you are pregnant or breast feeding • if you are taking potent diuretics (water tablets) such as frusemide or ethacrynic acid Tell your doctor if the above applies to you before this medicine is used. WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR OR NURSE BEFORE USING TOBRAMYCIN: • if you or your family members have a mitochondrial mutation disease (condition caused by variants in the genome of mitochondria, the parts of your cells which help make energy) or loss of hearing due to antibiotic medicines; certain mitochondrial mutations may in Přečtěte si celý dokument
Health Products Regulatory Authority 18 August 2022 CRN00C8ZV Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tobramycin 40 mg/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 40 mg tobramycin. Excipient with known effect Each vial contains 2.4mg sodium metabisulphite (E223) per ml. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection (injection). Clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tobramycin Solution for injection is indicated in the treatment of the following serious infections caused by susceptible micro-organisms: The treatment of central nervous system infections including meningitis, septicaemia and neonatal sepsis; The treatment of gastro-intestinal infections including peritonitis; The treatment of complicated and recurrent urinary tract infections such as pyelonephritis and cystitis; The treatment of lower respiratory tract infections, including pneumonia, bronchopneumonia and acute bronchitis; The treatment of skin, bone and soft tissue infections including burns. Tobramycin may also be considered in serious staphylococcal infections for which penicillin or other less potentially toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgement indicate its use. Tobramycin Solution for injection (single dose regimen) is indicated in the treatment of the following serious infections caused by susceptible micro-organisms: The treatment of lower respiratory tract infections, including pneumonia, bronchopneumonia and acute bronchitis in adults with normal renal function. (see section 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Tobramycin Solution for Injection may be given intramuscularly or intravenously and the dosage is the same for either route of administration. To calculate the correct dosage, the patient's pre-treatment bodyweight should be obtained. To ensure the corre Přečtěte si celý dokument