Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
FOSFOMYCIN SODIUM
InfectoPharm Arzneimittel und Consilium GmbH
J01XX; J01XX01
FOSFOMYCIN SODIUM
40 milligram(s)/millilitre
Powder for solution for infusion
Product subject to prescription which may not be renewed (A)
Other antibacterials; fosfomycin
Marketed
2015-07-31
1 PACKAGE LEAFLET: INFORMATION FOR THE USER Fomicyt 40 mg/ml Powder for solution for infusion Fosfomycin _ _ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, or pharmacist or nurse. 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, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Fomicyt is and what it is used for 2. What you need to know before you use Fomicyt 3. How to use Fomicyt 4. Possible side effects 5. How to store Fomicyt 6. Contents of the pack and other information 1. WHAT FOMICYT IS AND WHAT IT IS USED FOR Fomicyt contains the active substance fosfomycin. It belongs to a group of medicines called antibiotics. It works by killing certain types of germs (bacteria) that cause serious infectious diseases. Your doctor has decided to treat you with Fomicyt to help your body fight an infection. It is important that you receive effective treatment for this condition. Fomicyt is used in adults, adolescents and children to treat bacterial infections of: the urinary tract the heart - sometimes called ‘endocarditis’ the bones and joints the lungs called "pneumonia" the skin and tissues below the skin the central nervous system the abdomen the blood, when caused by any of the conditions listed above 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FOMICYT DO NOT USE FOMICYT: if you are allergic to fosfomycin or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS: 2 Talk to your doctor, pharmacist or nurse before using Fomicyt if you suffer from one of the following disorders: heart problems (cardiac insufficiency) Läs hela dokumentet
Health Products Regulatory Authority 20 April 2021 CRN00C5T9 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fomicyt 40mg/ml Powder for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of solution for infusion contains 40 mg fosfomycin. Each bottle with 2.69 g of powder contains 2.64 g disodium fosfomycin, corresponding to 2 g fosfomycin and 0.64 g sodium, for solution in 50 ml of solvent. Each bottle with 5.38 g of powder contains 5.28 g disodium fosfomycin, corresponding to 4 g fosfomycin and 1.28 g sodium, for solution in 100 ml of solvent. Each bottle with 10.76 g of powder contains 10.56 g disodium fosfomycin, corresponding to 8 g fosfomycin and 2.56 g sodium, for solution in 200 ml of solvent. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for infusion. White to cream-coloured powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fomicyt is indicated in all age groups for the treatment of the following infections when it is considered inappropriate to use antibacterial agents that are commonly recommended for their initial treatment (see sections 4.2, 4.4 and 5.1): - complicated urinary tract infections - infective endocarditis - bone and joint infections - hospital-acquired pneumonia, including ventilator-associated pneumonia - complicated skin and soft tissue infection - bacterial meningitis - complicated intra-abdominal infections - bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The daily dose of fosfomycin is determined based on the indication, severity and site of the infection, susceptibility of the pathogen(s) to fosfomycin and the renal function. In children, it is also determined by age and body weight. _Adults and adolescents (≥ 12 years of age) (≥ 40 kg):_ The general dosage guidelin Läs hela dokumentet