Country: Israel
Language: English
Source: Ministry of Health
FOSFOMYCIN AS TROMETAMOL
RAFA LABORATORIES LTD
J01XX01
POWDER FOR ORAL SOLUTION
FOSFOMYCIN AS TROMETAMOL 3 G/SACHET
PER OS
Required
ZAMBON SWITZERLAND LTD., SWITZERLAND
FOSFOMYCIN
FOSFOMYCIN
A single-dose treatment for acute, uncomplicated urinary tract infection and as prophylaxis in diagnostic and surgical transurethral procedures.
2022-11-30
1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 This medicine is sold with a doctor's prescription only MONUROL POWDER FOR ORAL SOLUTION SACHET ACTIVE INGREDIENT: Each sachet contains: Fosfomycin (as trometamol) 3 g For the list of the additional ingredients, see section 6. See also 'Important information about some of the medicine's ingredients’ in section 2. READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for the treatment of your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. 1. WHAT IS THE MEDICINE INTENDED FOR? • For single-dose treatment of acute uncomplicated urinary tract infection . • For preventive treatment of infections subsequent to surgical or diagnostic procedures of the lower urinary tract. THERAPEUTIC GROUP: antibiotic medicine. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • You are sensitive (allergic) to the active ingredient or to any of the additional ingredients the medicine contains (for the list of the additional ingredients, see section 6). • You suffer from severe kidney failure (creatinine clearance of less than 10 ml/min). • • You are a dialysis patient. SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE: BEFORE TREATMENT WITH MONUROL TELL THE DOCTOR IF: • You suffer from persistent bladder infections. • You previously suffered from diarrhea after taking any antibiotic medicine. • You suffer or have suffered in the past from impaired kidney function. ADDITIONAL WARNINGS: Conditions you need to pay attention to: The medicine may cause serious side effects. These effects include allergic reactions and inflammation of the large intestine. You must pay attention to symptoms while you are taking the medicine, to reduce the risk of any problems. See 'Serious side effects' i Read the complete document
MONUROL-DL-Nov 2022-02 1. NAME OF THE MEDICINAL PRODUCT Monurol 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One sachet contains 5.631 gram of fosfomycin trometamol equivalent to 3 gram fosfomycin Excipient(s) with known effect: One sachet contains 2.213 g of sucrose, see section 4.4. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for oral solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A single-dose treatment for acute, uncomplicated urinary tract infection and as prophylaxis in diagnostic and surgical transurethral procedures. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose for the treatment of acute uncomplicated lower urinary tract infections is a single 3 g sachet in adults. The recommended regimen for the prophylaxis of urinary tract infections in surgery and diagnostic procedure involving lower urinary tract in adult males and females is one Monurol 3 g sachet 3 hours before surgery and one 3 g sachet 24 hours after surgery. Children and young people weighing less than 50 kg and/ or below 12 years old (see Special warnings and precautions for use). Method of administration Monurol is for oral administration. It should be taken on an empty stomach, about 2-3 hours before or after eating, preferably before bedtime, after emptying the bladder. The dose should be dissolved into a glass of water and taken immediately after its preparation. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with severe renal failure (creatinine clearance < 10mL/min). Patients undergoing haemodialysis. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Hypersensitivity reactions Serious and occasionally fatal hypersensitivity reactions, including anaphylaxis and anaphylactic shock, may occur during fosfomycin treatment (see sections 4.3 and 4.8). If such reactions occur, treatment with fosfomycin must be discontinued immediately and adequate emergency measures must be initiated. _Clostridioides d Read the complete document