MONURIL Granules for oral solution (2016)
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Περιεχόμενα
Name of the medicinal product
Monuril 3 g granules for oral solution.
Qualitative and quantitative composition
One sachet contains 5.631 g of fosfomycin trometamol equivalent to 3.0 g fosfomycin. Excipient(s) with known effect: One sachet contains 2.213 g of sucrose, see section 4.4. For the full list of excipients, ...
Pharmaceutical form
Granules for oral solution.
Therapeutic indications
Monuril is indicated in the treatment of acute lower uncomplicated urinary tract infections, caused by pathogens sensitive to fosfomycin in adult and adolescent females. Monuril is also indicated for prophylaxis ...
Posology and method of administration
Posology Acute lower uncomplicated urinary tract infections <u>Adults and adolescent females (>12 years of age):</u> 1 sachet (3 g) once. Prophylaxis of urinary tract infections for surgery and diagnostic ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with severe renal insufficiency (creatinine clearance <10 ml/min). Patients undergoing haemodialysis. ...
Special warnings and precautions for use
Hypersensitivity reactions, including anaphylaxis and anaphylactic shock, may occur during fosfomycin treatment and may be life-threatening (see section 4.8). If such reaction occurs, fosfomycin should ...
Interaction with other medicinal products and other forms of interaction
Concomitant administration of metoclopramide has been shown to lower serum and urinary concentrations of fosfomycin and should be avoided. Other drugs that increase gastrointestinal motility may produce ...
Fertility, pregnancy and lactation
Pregnancy At the present time, single-dose antibacterial treatments are not suitable to treat urinary tract infections in pregnant women. However, for fosfomycin trometamol, animal studies do not indicate ...
Effects on ability to drive and use machines
No specific studies have been performed but patients should be informed that dizziness has been reported. This may influence some patients' ability to drive and use machines.
Undesirable effects
The most common adverse reactions following the single-dose administration of fosfomycin trometamol involve the gastrointestinal tract, mainly diarrhoea. These events are usually self-limited in duration ...
Overdose
Experience regarding the overdose of oral fosfomycin is limited. However cases of hypotonia, somnolence, electrolytes disturbances, thrombocytopenia and hypoprothrombinemia have been reported with parenteral ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antibacterials for systemic use – other antibacterials ATC code: J01XX01 Mode of action Fosfomycin acts on at the first stage of bacterial wall synthesis. It inhibits the phosphoenolpyruvate ...
Pharmacokinetic properties
Absorption After single-dose oral administration, fosfomycin trometamol has an absolute bioavailability of about 34-41%. Rate and extent of absorption are reduced by food. Distribution Fosfomycin is distributed ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity or toxicity to reproduction. No carcinogenicity data are ...
List of excipients
Mandarin flavour Orange flavour Saccharin Sucrose
Incompatibilities
Not applicable.
Shelf life
Three years. After reconstitution in water, the solution is stable at room temperature for 24 hours.
Special precautions for storage
Store away from direct sunlight.
Nature and contents of container
Sachets are a four layer laminate: paper, polyethylene, aluminium, polyethylene. Sachets are supplied in cardboard outer containing 1 sachet, 2 sachets or 5 sachets. Not all pack sizes may be marketed. ...
Special precautions for disposal and other handling
The dose must be dissolved in a glass of water and administered soon after dissolving. Any unused product or waste material should be disposed in accordance with local requirements.
Marketing authorization holder
ZAMBON S.p.A., Via Lillo Del Duca, 10, 20091 Bresso (Milan) – Italy, Tel: +39 02 665 241, Fax: +39 02 665 01 492
Marketing authorization number(s)
PL 31654/0006
Date of first authorization / renewal of the authorization
18/03/1994 / 19/09/2008
Date of revision of the text
20/01/2016
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