देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
Gentamicin sulfate
Pharmexon Consulting s.r.o
J01GB; J01GB03
Gentamicin sulfate
40 milligram(s)/millilitre
Solution for injection/infusion
Other aminoglycosides; gentamicin
2020-03-20
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT GENTAMICIN PHARMEXON 40 MG/ML, SOLUTION FOR INJECTION/INFUSION Gentamicin sulfate 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. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Gentamicin Pharmexon is and what it is used for 2. What you need to know before you use Gentamicin Pharmexon 3. How to use Gentamicin Pharmexon 4. Possible side effects 5. How to store Gentamicin Pharmexon 6. Contents of the pack and other information. 1. WHAT GENTAMICIN PHARMEXON IS AND WHAT IT IS USED FOR Gentamicin Pharmexon 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. Gentamicin Pharmexon should only be used in combination with other antibiotics except for complicated infections of the kidneys, urinary tract and bladder. You may receive Gentamicin Pharmexon to treat the following diseases: • Complicated infections of the urinary tract • Infections and inflammation within the belly • Infections of lungs and airways occurring during hospital treatment • Infections of lungs from cystic fibrosis • Inflammation of the inner lining of the heart (to treat infections) • Infections of the skin related to severe burns • Serious infections with bacteria in the blood 2. WHAT YOU NEED TO KNOW BEFORE YOU USE GENTAMICIN PHARMEXON DO NOT USE GENTAMICIN PHARMEXON: • if you are allergic to gentamicin or any of the other ingredients of this medicine (listed in section 6); WARNINGS AND PRECAUTIONS Talk to your doctor bef पूरा दस्तावेज़ पढ़ें
Health Products Regulatory Authority 20 March 2020 CRN008K6L Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gentamicin Pharmexon 40 mg/ml solution for injection/infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 40 mg of gentamicin (corresponding to 67.8 mg gentamicin sulfate). Each ampoule of 2 mL contains 80 mg of gentamicin (corresponding to 135.6 mg gentamicin sulfate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection/infusion. A clear colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Gentamicin Pharmexon is indicated for the treatment of the following infections in adults and children from birth when less toxic antimicrobial agents are not effective (see sections 4.4 and 5.1) Under these conditions, Gentamicin Pharmexon is indicated in the treatment of the following infections: - Complicated urinary tract infection (cUTI), including acute pyelonephritis - Complicated intra-abdominal infection (cIAI) - Hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP) - Broncho-pulmonary infections in patients with cystic fibrosis - Infective endocarditis - Burn wound infections - Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Gentamicin Pharmexon 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). Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION CAUTION: In the absence of data, administration of Gentamicin solution for injection/infusion via inhalation is not recommended (see section 4.4) Posology The dose depends on the severity of the clinical picture, the setting, the patient's renal function पूरा दस्तावेज़ पढ़ें