Monural 3g 1's granules for oral solution

The instruction for medical use


of MONURAL medicine

the Trade name
Monural

Mezhdunarodnoye the unlicensed


name Fosfomitsin Lekarstvennaya
the Granule form for preparation of solution for intake, 3 g

Structure
contains 1 bag:
active agent - a fosfomitsina of a trometamol of 5.631 g (3.0 g of a fosfomitsin are equivalent),
excipients: sucrose, saccharin, fragrance tangerine, fragrance orange

the Description
the Granulated powder of white color with a characteristic smell of tangerine fragrance

Pharmacotherapeutic group
Antibacterial drugs other. Fosfomitsin.
The ATX J01XX01 code

the Pharmacological

Fosfomitsin's Pharmacokinetics properties trometamol is quickly soaked up from digestive tract at intake. In an organism dissociates on fosfomitsin and trometamol. Trometamol has no antibacterial properties. The bioavailability of a single dose is from 34 to 65%. The maximum concentration in plasma is observed in 2-2.5 hours (tmax) after reception and makes 22-32 mkg/ml (Cmax). Plasma elimination half-life is equal to 4 hours.
Fosfomitsina trometamol does not contact proteins of plasma, is not metabolized, mainly collects in urine. At Monural's reception in urine high concentration (from 1053 to 4415 mg/l) for 99% bactericidal for the majority of ordinary causative agents of infections of urinary tract is reached. The minimum inhibiting concentration of a fosfomitsin for these activators makes 128 mg/l. It is maintained in urine for 24-48 hours that assumes an odnodozny course of treatment.
Fosfomitsin is brought by kidneys in not changed view with creation of high concentrations in urine to 90%. About 10% of the accepted dose are excreted with a stake in not changed look. At patients with moderate decrease in renal function (clearance of creatinine & gt, 80 ml/min.), including its physiological decrease at elderly people, elimination half-life of a fosfomitsin is a little extended, but concentration in urine remains at the therapeutic level.
A pharmacodynamics
Active Monurala ingredient – a fosfomitsina trometamol – an antibiotic of a wide range, derivative phosphonic acid.
Monural possesses bactericidal action. The mechanism of action is connected with suppression of the first stage of synthesis of a cell wall of bacteria. Being a structural analog of phosphoenol of pyruvate, enters competitive interaction with enzyme N - acetyl - glyukozamino - 3 - about-enolpiruvil-transferase therefore there is specific, selective and irreversible inhibition of this enzyme that provides lack of cross resistance with other classes of antibiotics and a possibility of synergism with other antibiotics (in vitro note synergism with amoxicillin, cefalexin, pipemidinovy acid). The antibacterial range of action of a fosfomitsin of a trometamol of in vitro includes the majority usual gram-positive (Enterococcus spp., Enterococcus faecalis, Staphylococcus aureus, Staphylococcus saprophyt., Staphylococcus spp.) and gram-negative (E. coli, Citrobacter spp., Enterobacter spp., Klebsiella spp., Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Pseudomonas spp., Serratia spp.) activators. In vitro of a fosfomitsin trometamol reduces adhesion of a number of bacteria on an epithelium of urinary tract.

Indications
Monural is applied to treatment of the following of an infection caused by the pathogenic microorganisms sensitive to a fosfomitsin:
- acute and uncomplicated infections of urinary tract
- an asymptomatic bacteriuria
- prevention of an infection of urinary tract when performing surgical interventions and diagnostic a research on lower parts of urinary tract (for example, the TOUR)


the Adult appoint the Route of administration and doses on 1 bag (3 g) once a day.
Granules dissolve in a glass of water or other nonalcoholic liquid and use at once after preparation. Monural accept in 1 times a day on an empty stomach in 2 hours prior to or after a meal, preferably before going to bed, previously having emptied a bladder.
The course of treatment makes 1 day. In more hard cases (the elderly patients recuring infections) accept 1 more bag in 24 hours.
For the purpose of prevention of infection of urinary tract at surgical intervention and transurethral diagnostic procedures accept Monural on 1 bag in 3 hours prior to and in 24 hours after intervention.

Side effects
Often (& gt, 1/100 to & lt, 1/10)
- a vulvovaginitis
- a headache, dizziness
- diarrhea, nausea, dyspepsia
Seldom (& gt, 1/1000 to & lt, 1/100)
- tachycardia
- paresthesias
- an abdominal pain, vomiting
- rash, urticaria, an itching
- an asthenia
does not know
- an acute anaphylaxis, allergic reactions
- hypotonia
- asthma
- a Quincke's edema
- pseudomembranous colitis

of the Contraindication
- hypersensitivity to any component of drug
- a heavy renal failure (clearance of creatinine & lt, 10 ml/min.)
- a hemodialysis

Medicinal interactions
Simultaneous use of Metoclopramidum, antacids or salts of calcium causes considerable decrease therapeutic in effective concentration of a fosfomitsin in plasma and urine. As a result, these drugs have to be used at an interval of time (about 2 - 3 hours). Other drugs increasing gastrointestinal motility can cause similar effects.

Special instructions
the Concomitant use of food slows down Monural's absorption, drug needs to be used in 2 hours prior to or after a meal.
At use of drug it is necessary to be guided by official recommendations about appropriate use of antibacterial drugs, in particular for prevention of development of resistance to antibiotics.
The beginning of heavy and ultimate diarrhea in time or after treatment by antibiotics can be a symptom of the antibiotiko-associated colitis. Its most serious form is pseudomembranous colitis which treatment has to be begun immediately. In certain cases purpose of adequate therapy is required. Use of antiperistaltic drugs is a contraindication at this clinical picture.
Monural contains sucrose. Patients with hereditary intolerance of fructose, glyukozo-galaktozny malabsorption or sakharozo-izomaltazny insufficiency should not use this medicine.
Children
As experience of use of the drug Monural for children is limited because of its high dosage not suitable for children and teenagers with body weight less than 50 kg, Monural should not be applied in this age group.
Pregnancy and the period of a lactation
This limited number of the studied pregnancies do not show undesirable impacts on pregnancy, a fruit or on health of the newborn.
In need of prescribing of drug in the period of a lactation it is necessary to stop breastfeeding for the period of treatment.
Features of influence of medicine on ability to run motor transport and potentially dangerous mechanisms
Considering side effects of medicine, it is necessary to be careful at control of motor transport and other potentially dangerous mechanisms

Overdose
Symptoms: vestibular dysfunction, hearing disorder, metal smack and general change of flavoring feelings.
Treatment: intake of liquid inside for the purpose of increase in a diuresis. Symptomatic therapy.

The form of release and packing
of 8 g of drug place in the four-layer laminated bags.
On 1 bag together with the instruction for medical use in the state and Russian languages put

Storage conditions in a cardboard pack
to Store at a temperature not above 30 °C.
To store out of children's reach!


3 years
not to apply a period of storage after the expiration date specified on packing

Prescription status
According to the prescription


the Producer Zambon Svittserland of Ltd.,
Via Industria 13, Kadempino's SN-6814, Switzerland

the Owner of the registration certificate
S.P.A. Zambon., Italy

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
of VIVA FARM LLP,
2nd Ostroumova St., 33, 050030, Almaty, Republic of Kazakhstan
ph.: +7 727 383 74 63, fax: +7 727 383 74 56, e-mail: pv@vivapharm.kz