国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Gentamicin sulfate
Amdipharm Limited
J01GB; J01GB03
Gentamicin sulfate
80 mg/2ml
Solution for injection
Product subject to prescription which may not be renewed (A)
Other aminoglycosides; gentamicin
Marketed
1995-04-20
Package leaflet: Information for the patient GENTICIN ® 80MG/2ML SOLUTION FOR INJECTION Gentamicin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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, pharmacist or nurse. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. The name of your medicine is Genticin 80mg/2ml Solution for Injection it will be called Genticin Injection for ease here after. WHAT IS IN THIS LEAFLET 1. WHAT GENTICIN INJECTION IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN GENTICIN INJECTION 3. HOW YOU WILL BE GIVEN GENTICIN INJECTION 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE GENTICIN INJECTION 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT GENTICIN INJECTION IS AND WHAT IS IT USED FOR The name of your medicine is Genticin Injection. This medicine contains the active ingredient gentamicin which belongs to a group of medicines called antibiotics. Genticin Injection is used in adults and children to treat bacterial infections such as severe chest infections, urinary tract infections and septicaemia. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN GENTICIN INJECTION YOU SHOULD NOT BE GIVEN GENTICIN INJECTION: if you are allergic to gentamicin or to a similar medicine containing an aminoglycoside antibiotic or any of the other ingredients of this medicine (listed in section 6) if you suffer from MYASTHENIA GRAVIS (a disease causing muscle weakness). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before you are given Genticin Injection: if you have any problems with your kidney or liver if you have any problems with your hearing if you have any infections or a fever if you have low blood pressure or low blood volume if you are considered to be significantly overweight if you have Parki 完全なドキュメントを読む
Health Products Regulatory Authority 31 August 2021 CRN00CGQZ Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Genticin 80mg/2ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2 ml ampoule contains gentamicin sulfate equivalent to 80 mg gentamicin base. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Each ampoule contains a sterile, clear colourless to pale yellow solution. The solution is preservative free. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Genticin Solution for Injection is indicated in adolescents, children and adults for the following: The treatment of systemic infections due to susceptible bacteria such as, bacteraemia, septicaemia, urinary-tract infections and severe chest infections. Consideration should be given to official local guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The daily dose recommended in children, adolescents and adults with normal renal function, is 3-6 mg/kg body weight per day as 1 (preferred) up to 2 single doses. _Paediatric population (newborns and infants)_ The daily dose in newborns is 4.0- 7.0 mg/kg body weight per day. Due to the longer half-life, newborns are given the required daily dose in 1 single dose. The daily dose in infants after the first month of life is 4.5-7.5 mg/kg body weight per day as 1 (preferred) up to 2 single doses. In children and in neonates, it can be expected that serum levels will be lower than those found in adults at equivalent dosage per kg body weight. _Elderly population_ Adjust dosage according to weight and renal function. Older people may require lower maintenance doses than younger adults because of impaired renal function. _Serious infections_ In life-threatening infections the frequency of dosage may need to be increased to 6-hourly and the quantity of each dose may also be increased at the discretion of the clinician up to a total dosage of 6 mg/kg in 24 hours. In 完全なドキュメントを読む