Country: Armenia
Bahasa: Inggeris
Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
fosfomycin (fosfomycin trometamol)
ADIPHARM EAD
J01XX01
fosfomycin (fosfomycin trometamol)
3000mg
granules for oral solution
(1) sachet
Prescription
Registered
2020-07-23
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FOSFOSEPTIC 3 G GRANULES FOR ORAL SOLUTION Fosfomycin trometamol 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. - 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What FOSFOSEPTIC is and what it is used for 2. What you need to know before you use FOSFOSEPTIC 3. How to use FOSFOSEPTIC 4. Possible side effects 5. How to store FOSFOSEPTIC 6. Contents of the pack and other information 1. WHAT FOSFOSEPTIC IS AND WHAT IT IS USED FOR Your medicine contains the active substance fosfomycin trometamol. FOSFOSEPTIC is an antibiotic used for the treatment of acute, uncomplicated lower urinary tract infections (UTI) caused by pathogens sensitive to fosfomycin in women and girls over the age of 12 years. Fosfomycin is used for prophylaxis of urinary tract infections in diagnostic and surgical procedures involving the lower urinary tract in adult men and women. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FOSFOSEPTIC _ _ DO NOT TAKE FOSFOSEPTIC: - if you are allergic to fosfomycin trometamol or any of the other ingredients of this medicine (listed in section 6); - If you have severe renal insufficiency (creatinine clearance < 10ml/min); - If you are on hemodialysis. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking FOSFOSEPTIC. In association with the use of almost all broad-spectrum antibacterial agents, including fosfomycin trometamol, there have been reports of antibiotic-associated diarrhea. It is important to consider this in patients developing severe diarrhea during or after fosfomycin tromet Baca dokumen lengkap
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT FOSFOSEPTIC 3 G GRANULES FOR ORAL SOLUTION 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance in one sachet: Fosfomycin trometamol 5,631 g Excipients with known effect: Each sachet contains 2,153 g sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Granules for oral solution Almost white granules with citrus flavour 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS FOSFOSEPTIC 3 g granules for oral solution is indicated for the treatment of acute, uncomplicated lower urinary tract infections (UTI) caused by pathogens sensitive to fosfomycin in women and girls above 12 years. Prophylaxis of urinary tract infections in diagnostic and surgical procedures involving the lower urinary tract in adult men and women. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology FOSFOSEPTIC 3 g granules for oral solution The recommended dose for the treatment of uncomplicated lower urinary tract infections in women and girls over the age of 12 years is a single dose FOSFOSEPTIC 3 g sachet. The recommended dose for prophylaxis of urinary tract infections in diagnostic and surgical procedures involving the lower urinary tract in adult men and women is two doses of FOSFOSEPTIC 3 g sachet; the first dose of FOSFOSEPTIC 3 g sachet should be taken 3 hours before the surgical procedure, and one dose Fosfomycin 3 g sachet should be taken 24 hours after surgery Method of administration FOSFOSEPTIC is for oral administration and should be taken on an empty stomach, preferably before bedtime, after emptying the bladder. The contents of one sachet should be dissolved in a glass of water and taken immediately after that. 2 4.3 CONTRAINDICATIONS - Hypersensitivity to fosfomycin trometamol or to any of the excipients listed in section 6.1. - Patients with severe renal insufficiency (creatinine clearance < 10 ml/min). - Patients undergoing haemodialysis. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Hypersensitivity reactions including ana Baca dokumen lengkap