देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
Gentamicin
Noridem Enterprises Limited
J01GB03
Gentamicin
20 milligram(s)/millilitre
Solution for injection/infusion
gentamicin
Not marketed
2021-11-12
_ _ PACKAGE LEAFLET: INFORMATION FOR THE USER GENTAMICIN_ _20 MG / ML SOLUTION FOR INJECTION / INFUSION GENTAMICIN_ _40 MG / ML SOLUTION FOR INJECTION / INFUSION GENTAMICIN_ _80 MG / ML SOLUTION FOR INJECTION / INFUSION 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. WHAT IS IN THIS LEAFLET 1. What Gentamicin _ _ is and what it is used for 2. What you need to know before you are given Gentamicin _ _ 3. How Gentamicin _ _ is given 4. Possible side effects 5. How to store Gentamicin _ _ 6. Contents of the pack and other information 1. WHAT GENTAMICIN_ _IS AND WHAT IT IS USED FOR Gentamicin _ _ contains the active substance gentamicin. It belongs to a group of antibiotics called aminoglycosides. This medicine is used to treat severe infections caused by bacteria. This includes: • infections of the urinary tract (including kidneys or bladder) • infections in the chest (including lungs), such as hospital-acquired and ventilator-associated pneumonia (HAP and VAP) • bacterial inflammation of the heart lining (endocarditis) • infections of the abdomen • infections of the brain and spinal cord (meningitis caused by bacterial) • infections of the bones and joints (osteomyelitis and bacterial arthritis) • management of neutropenic patients with fever that is suspected to be due to a bacterial infection • infections of the whole body due to the presence of _Listeria monocytogenes_ in the blood • severe infection in newborn babies. • infections of the blood (bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above) Note: Combination treatment is mainly indicated together with a beta-la पूरा दस्तावेज़ पढ़ें
Health Products Regulatory Authority 10 November 2022 CRN00CXP0 Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gentamicin 20 mg/mL Solution for injection/infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of solution contains 20 mg gentamicin (as gentamicin sulfate). Each ampoule of 2 mL solution contains 40 mg gentamicin. Excipient with known effect Each mL of solution contains 1.60 mg sodium metabisulfite. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection / infusion Clear and colourless solution. pH 3.00-5.50 Osmolality: 80 – 90 mOsm/kg 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Gentamicin is an aminoglycoside antibiotic with broad-spectrum bactericidal activity. It is indicated in adults and children including neonates. Gentamicin is indicated for the treatment of severe infections caused by pathogens susceptible to gentamicin. Under these conditions, gentamicin can be used for: - urinary tract infections - bacterial endocarditis - intra-abdominal infections - meningitis caused by Gram-negative pathogens - osteomyelitis and bacterial arthritis - management of neutropenic patients with fever that is suspected to be due to a bacterial infection - Hospital-acquired and Ventilator-associated Pneumonia (HAP and VAP) - listeriosis - severe neonatal infections. Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. _ _ Note: Combination treatment is mainly indicated together with a beta-lactam antibiotic or with an antibiotic effective against anaerobic bacteria for life-threatening infections with an unknown pathogen, for mixed anaerobic/aerobic infections, for bacterial endocarditis, for systemic Pseudomonas infections and in neutropenic patients with fever that is suspected to be due to a bacterial infection. _ _ Consideration should be given to official guidance on the appropriate use of antibacterial agents. Health Products Re पूरा दस्तावेज़ पढ़ें