Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
Gentamicin
B. Braun Melsungen AG
J01GB; J01GB03
Gentamicin
1 milligram(s)/millilitre
Solution for infusion
Product subject to prescription which may not be renewed (A)
Other aminoglycosides; gentamicin
Marketed
2009-03-06
PACKAGE LEAFLET: INFORMATION FOR THE USER GENTAMICIN 1 MG/ML SOLUTION FOR INFUSION GENTAMICIN 3 MG/ML SOLUTION FOR INFUSION Gentamicin 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. – If you get any side effects talk to your doctor. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. What Gentamicin 1 mg/ml or Gentamicin 3 mg/ml is and what it is used for 2. What you need to know before you are given Gentamicin 1 mg/ml or Gentamicin 3 mg/ml 3. How Gentamicin 1 mg/ml or Gentamicin 3 mg/ml is given to you 4. Possible side effects 5 How to store Gentamicin 1 mg/ml and Gentamicin 3 mg/ml 6. Contents of the pack and other information 1. WHAT GENTAMICIN 1 MG/ML OR GENTAMICIN 3 MG/ML IS AND WHAT IT IS USED FOR Gentamicin 1 mg/ml or Gentamicin 3 mg/ml belongs to a group of medicines called antibiotics, that is, they are used to treat severe infections with bacteria that can be killed by the active substance gentamicin. For the treatment of the diseases listed below, except for complicated infections of kidneys, urinary ducts and bladder, Gentamicin 1 mg/ml or Gentamicin 3 mg/ml should only be used in combination with other antibiotics. You may receive Gentamicin 1 mg/ml or Gentamicin 3 mg/ml to treat the following diseases: – Complicated and recurrent infections of kidneys, urinary ducts and bladder – Infections of lungs and airways occurring during in-patient treatment – Infections within the belly, including inflammation of the peritoneum – Infections of skin and soft tissues, including severe burns – Sepsis (an infection of the entire body), bacteria in the blood – Inflammation of the inner lining of the heart (to treat infections) – To treat infections after operations 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN GENTAMICIN 1 MG/ML OR GENTAMICIN 3 MG/ML THIS MEDICINE MUST NO Đọc toàn bộ tài liệu
Health Products Regulatory Authority 15 March 2021 CRN00C17T Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gentamicin 1 mg/ml solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 mg/ml solution for infusion: 1 ml of solution for infusion contains gentamicin sulphate equivalent to 1 mg gentamicin. 1 bottle of 80 ml contains 80 mg of gentamicin. _ _ Excipient with known effect: 283 mg (12 mmol) of sodium (as chloride) per 80 ml bottle For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. A clear colourless aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of severe infections due to bacteria susceptible to gentamicin when less toxic antimicrobial agents are not effective. Gentamicin 1 mg/ml solution for infusion should for all indications, except complicated urinary tract infections, only be used in combination with other relevant antibiotics (predominantly together with a beta-lactam antibiotic or with an antibiotic effective against anaerobic bacteria). Under these conditions, Gentamicin 1 mg/ml solution for infusion may be used in: • Complicated and recurrent urinary tract infections • Nosocomial lower respiratory tract infections including severe pneumonia • Intraabdominal infections including peritonitis • Skin and soft tissue infections including severe burns • Septicaemia including bacteraemia • Treatment of bacterial endocarditis • Treatment of surgical infections Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY DOSAGE IN PATIENTS WITH NORMAL RENAL FUNCTION _Adultsand adolescents_ Treatment of bacterial infections The daily dose recommended in adolescents and adults with normal renal function, is 3 – 6 mg/kg body weight per day as 1 (preferred) up to 2 single doses. A maximum daily dose of 6 mg/kg may be needed for the treatment of serious infections and when the susce Đọc toàn bộ tài liệu