Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
Gentamicin sulfate
Sanofi-Aventis Ireland Limited T/A SANOFI
J01GB; J01GB03
Gentamicin sulfate
20 mg/2ml
Solution for injection
Product subject to prescription which may not be renewed (A)
Other aminoglycosides; gentamicin
Marketed
1977-03-09
10/04/2019 17:58 - VISTAlink folder 3296792 - Page 1/3 11504760-03 PACKAGE LEAFLET: INFORMATION FOR THE USER CIDOMYCIN PAEDIATRIC 20MG/2ML SOLUTION FOR INJECTION Gentamicin IS THIS LEAFLET HARD TO SEE OR READ? PHONE 01 403 5600 FOR HELP READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • Keep this leaflet. You may need to read it again • If you have any further questions, ask your doctor or pharmacist • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist IN THIS LEAFLET: 1. What Cidomycin Paediatric is and what it is used for 2. Before you use Cidomycin Paediatric 3. How to have Cidomycin Paediatric 4. Possible side effects 5. How to store Cidomycin Paediatric 6. Further information 1. WHAT CIDOMYCIN PAEDIATRIC IS AND WHAT IT IS USED FOR The name of this medicine is Cidomycin Paediatric 20mg/2ml Solution for Injection (called Cidomycin in this leaflet). It contains a medicine called gentamicin sulphate. This belongs to a group of antibiotics called ‘aminoglycosides’. Gentamicin is used to treat infections caused by bacteria. This includes infections in: • Your urinary tract (including your kidneys or bladder) • Your chest (including your lungs) • Your blood – this is sometimes called ‘bacteraemia’ or ‘septicaemia’ 2. BEFORE YOU USE CIDOMYCIN PAEDIATRIC DO NOT HAVE THIS MEDICINE IF: • You have Myasthenia Gravis. This is a disease that causes muscle weakness. • You are allergic (hypersensitive) to Cidomycin or to any of the other ingredients of this medicine (see Section 6: Further Information). Signs of an allergic reaction include: a rash (hives), itching, swallowing or breathing problems, swelling of your lips, face, throat or tongue. Cidomycin must not be given by injection to the brain (Intraventricular administration) to infants (un Belgenin tamamını okuyun
Health Products Regulatory Authority 10 June 2021 CRN00CCNW Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cidomycin Paediatric 20mg/2ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2ml vial contains Gentamicin Sulphate equivalent to 20mg Gentamicin base (10mg/ml). Each 2ml vial also contains less than 1mmol sodium (<23mg). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for Injection. Clear colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Gentamicin is indicated for the treatment of serious systemic infections including those of the central nervous system due to organisms sensitive to this anti-infective. Such infections include urinary tract infections, chest infections, bacteraemia, septicaemia, severe neonatal infections and other systemic infections due to sensitive organisms. Gentamicin is usually active against most strains of the following organisms; _Eschericha coli_, _Klebsiella_ spp., _Proteus_ spp. (indole positive and indole negative) _Pseudomonas aeruginosa_, _Staphylococci_, _Enterobacter_ spp., _Citrobacter_ spp. and _Providencia_ spp. Consideration should be given to official local guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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. 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. The daily dose in newborns is 4-7 mg/kg body weight per day. Due to the longer half-life, newborns are given the required daily dose in 1 single dose. In impaired renal function, the recommended daily dose has to be decreased and adjusted to the renal function. Renal impairment: Gentamicin is excreted by simple glomerular filtration and, therefore, reduced dosage is necessary where renal function is impaired. Nomograms are Belgenin tamamını okuyun