Ország: Egyesült Királyság
Nyelv: angol
Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)
Gentamicin sulfate
Zentiva Pharma UK Ltd
J01GB03
Gentamicin sulfate
5mg/1ml
Solution for injection
Intracerebroventricular; Intrathecal
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010400; GTIN: 5013011006485
Approved 25/06/15 PATIENT INFORMATION LEAFLET GENTAMICIN INTRATHECAL 5MG/ML SOLUTION FOR INJECTION 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 further questions, please 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. Your doctor may have given you this medicine before from another company. It may have looked slightly different. However, either brand will have the same effect. IN THIS LEAFLET: 1. What gentamicin is and what it is used for 2. Before you have gentamicin 3. How to have gentamicin 4. Possible side effects 5. How to store gentamicin 6. Further information 1. WHAT GENTAMICIN IS AND WHAT IT IS USED FOR The name of this medicine is Gentamicin Intrathecal 5mg/ml solution for injection (called gentamicin 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 of the: Brain - including meningitis Spinal cord 2. BEFORE YOU HAVE GENTAMICIN DO NOT HAVE THIS MEDICINE IF: You have Myasthenia Gravis or a related condition. This is a disease that causes muscle weakness. You are allergic (hypersensitive) to gentamicin sulphate, any other aminoglycosides (such as streptomycin) or to any of the other ingredients of this medicine (see Section 6: Further Information). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat and tongue. Do not have this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before having gentamicin. TAKE SPECIAL CARE WITH GENTAMICIN AND CHE Olvassa el a teljes dokumentumot
OBJECT 1 GENTAMICIN INTRATHECAL 5MG/ML Summary of Product Characteristics Updated 10-Jul-2015 | Zentiva 1. Name of the medicinal product Gentamicin Intrathecal 5mg/ml Solution for Injection. 2. Qualitative and quantitative composition Each ampoule (1ml) contains Gentamicin Sulphate Ph Eur equivalent to 5mg Gentamicin base. 3. Pharmaceutical form Injection. 4. Clinical particulars 4.1 Therapeutic indications Gentamicin is an aminoglycoside antibiotic with broad-spectrum bactericidal activity. It is usually active against most strains of the following organisms: Escherichia coli, Klebsiella spp., Proteus spp. (indole positive and indole negative), Pseudomonas aeruginosa, Staphylococci, Enterobacter spp., Citrobacter spp. and Providencia spp. Gentamicin Intrathecal Injection is indicated as a supplement to systemic therapy in bacterial meningitis, ventriculitis and other bacterial infections of the central nervous system. 4.2 Posology and method of administration Bacterial meningitis and ventriculitis: The starting dose of Gentamicin Intrathecal Injection for both children and adults is 1mg daily, intrathecally or intraventricularly, together with 1mg/kg every eight hours intramuscularly. The MIC of the infecting organism in the C.S.F. should be assessed and, if necessary, the intrathecal/intraventricular dose increased to 5mg daily, whilst keeping the intramuscular dose at 1mg/kg eight-hourly. Treatment should be continued for at least 7 days but longer if necessary. Periodic serum and C.S.F. gentamicin assays should be carried out to ensure that adequate antibiotic levels are maintained and that serum and C.S.F. levels do not exceed 10mg/l. ROUTE OF ADMINISTRATION Intrathecal or intraventricular. 4.3 Contraindications Gentamicin is contra-indicated in patients with a known allergy to it and other aminoglycosides. Evidence exists that gentamicin may cause neuromuscular blockade and is therefore contra-indicated in myasthenia gravis and related conditions. 4.4 Special warnings and precautions for use Ototoxicity has Olvassa el a teljes dokumentumot