Vilprafen Soljutab 1000 mg 10s dispersing tablets

The instruction for medical use









of Vilprafen Solyutab Torgovoye medicine a name

Vilprafen Solyutab



Mezhdunarodnoye the unlicensed





name Dzhozamitsin Lekarstvennaya

the Tablet form the dispersed 1000 mg



Structure

One tablet contains

active agent dzhozamitsin 1000.0 mg, is equivalent to a dzhozamitsin to propionate 1067. 66 mg,

excipients: cellulose microcrystalline, hypro rod (L.M.), sodium docusate, aspartame, silicon dioxide colloidal anhydrous, fragrance strawberry 052311 ARE 0551, magnesium stearate.



The description

White or white with a yellowish shade, oblong shape of a tablet, sweet, with a smell of strawberry, c the inscription IOSA and risky on one party and inscription 1000 - on another.



Pharmacotherapeutic group

Antibacterial drugs for system use. Macroleads, linkozamida and streptogramina. Macroleads. Dzhozamitsin.

The ATX J01FA07 code



the Pharmacological



Pharmacokinetics Later properties of intake dzhozamitsin is quickly and completely soaked up from digestive tract, meal does not affect bioavailability. The maximum concentration of a dzhozamitsin in serum is reached in 1-2 h after reception. About 15% of a dzhozamitsin contact proteins of plasma. Especially high concentrations of substance are found in lungs, tonsils, saliva, sweat and plaintive liquid. Concentration in a phlegm exceeds concentration in plasma by 8-9 times. Collects in a bone tissue. There passes the placental barrier, cosecretes in breast milk. Dzhozamitsin is metabolized in a liver to less active metabolites and excreted, mainly, with bile. Excretion of drug with urine less than 20%.

The pharmacodynamics

Vilprafen Solyutab is applied to treatment of bacterial infections, its bacteriostatic activity is caused by inhibition of synthesis of protein of bacteria. During creation in the center of inflammation of high concentrations has bactericidal effect.

Drug is highly active concerning intracellular microorganisms (Chlamydia trachomatis and Chlamydia pneumoniae, Mycoplasma pneumoniae, Mycoplasma hominis, Ureaplasma urealyticum, Legionella pneumophila), gram-positive bacteria (Staphylococcus aureus, Streptococcus pyogenes and Streptococcus pneumoniae (pneumococcus), Corynebacterium diphteriae), gram-negative bacteria (Neisseria meningitidis, Neisseria gonorrhoeae, Haemophilus influenzae, Bordetella pertussis) and also against some anaerobic bacteria (Peptococcus, Peptostreptococcus, Clostridium perfringens). Slightly influences enterobakteriya therefore changes natural bacterial flora of digestive tract a little. It is effective at resistance to erythromycin. The resistance to Vilprafen Solyutab develops less than to other antibiotics from group of macroleads.



Indications

the Acute and persistent infections caused by microorganisms, sensitive to drug:

- tonsillitis, pharyngitis, a peritonsillitis, laryngitis, average otitis, sinusitis

- diphtheria (in addition to treatment by diphtheritic anti-toxic serum)

- scarlet fever, in case of hypersensitivity to penicillin

- an acute bronchitis, exacerbation of chronic bronchitis

- pneumonia (including caused by atypical activators)

- an ornithosis

- an ulitis and diseases of the parodont

- blepharitis, a dacryocystitis

- a pyoderma, a furunculosis, anthrax, an ugly face (at hypersensitivity to penicillin)

- eels, a lymphangitis, lymphadenitis, an inguinal lymphogranuloma

- prostatitis, an urethritis, gonorrhea, syphilis (at hypersensitivity to penicillin)

- chlamydial, mycoplasmal (including ureaplazmenny) both multi-infections



the Route of administration and doses

the Dispersed pill Vilprafen Solyutab can be taken in two various ways: they can be swallowed entirely, washing down with water or previously, before reception, to dissolve in water. Tablets should be dissolved at least in 20 ml of water. Before reception it is necessary to mix carefully formed suspension.

The recommended daily dose for adults and teenagers is aged more senior than 14 years makes from 1 g to 2 g of drug. In case of need the dose can be increased up to 3 g a day. The daily dose has to be divided into 2-3 receptions.

The daily dose for children from 5 to 14 years is appointed calculated on the basis of 40 50 mg/kg of body weight daily, divided into 2-3 receptions.

In case of ordinary and spherical eels Vilprafen Solyutab in a dose is recommended to appoint 500 mg twice a day within the first 2-4 weeks, further - 500 mg of drug as the supporting treatment within 8 weeks once a day.

Duration of treatment is defined by the doctor. According to the recommendations of World Health Organization about use of antibiotics duration of treatment of streptococcal infections has to be not less than 10 days.


Side effects

Seldom

- loss of appetite, nausea, heartburn, vomiting, dysbacteriosis, a meteorism, diarrhea, pseudomembranous colitis

Very seldom

- skin allergic reactions

- the tranzitorny increase in activity of liver enzymes in blood plasma in rare instances accompanied with disturbance of outflow of bile and jaundice, cholestatic hepatitis

- a dose-dependent passing hearing disorder

- candidiasis

-



Contraindication hypovitaminosis

- hypersensitivity to antibiotics to macroleads and other components of drug

- heavy abnormal liver functions



Medicinal interactions

Vilprafen Solyutab in insignificant degree influences the system of P450 cytochrome, suppressing metabolism and increasing concentration in blood plasma of indirect antikogulyant, carbamazepine, valproic acid, Disopyramidum.



Vilprafen Solyutab / other antibiotics

As bacteriostatic antibiotics can reduce bactericidal effect of other antibiotics, such as penicillin and cephalosporins, it is necessary to avoid joint prescribing of drug with these types of antibiotics. It is not necessary to appoint together with lincomycin as perhaps mutual decrease in their efficiency.

Vilprafen Solyutab/ksantina

Some representatives of antibiotics - macroleads slow down elimination of xanthines (theophylline) that can lead to possible intoxication. Kliniko-pilot studies indicate that Vilprafen Solyutab has less impact on theophylline discharge, than other antibiotics - macroleads.

Vilprafen Solyutab / antihistaminic drugs

After the joint prescribing of drug and drugs containing terfenadin and astemizol can be marked out delay of removal of a terfenadin or astemizol that in turn can lead ment of the life-threatening cardiac arrhythmias caused by lengthening of an interval of QT.

Vilprafen Solyutab/agonista serotoninovy 5-HT 4 - receptors

Joint prescribing of the drug Vilprafen Solyutab and the drugs containing tsizaprid can be noted delay of removal of a tsizaprid that in turn can lead ment of the life-threatening cardiac arrhythmias caused by lengthening of an interval of QT.

Vilprafen Solyutab/alkaloida of an ergot

there Are individual messages about strengthening of vasoconstriction after joint prescribing of alkaloids of an ergot and antibiotics of macroleads. Therefore the accompanying Vilprafen Solyutab's use and ergotamine has to be followed by the corresponding control of patients.

Vilprafen Solyutab/tsiklosporin

Joint prescribing of the drug Vilprafen Solyutab and cyclosporine can cause increase in level of cyclosporine in blood plasma and creation of nephrotoxic concentration of cyclosporine in blood. It is regularly necessary to control concentration of cyclosporine in plasma.

Vilprafen Solyutab/digoksin

At joint appointment of Vilprafen Solyutab and digoxin the increase in level of the last in blood plasma is possible.

Vilprafen Solyutab / hormonal contraceptives

In rare instances contraceptive effect of hormonal contraceptives can be insufficient during treatment macroleads. In this case it is recommended to use non-hormonal contraceptives in addition.

Antacids reduce absorption in a GIT of a dzhozamitsin a little.



Special instructions

At patients with a renal failure treatment should be carried out taking into account results of the corresponding laboratory tests.

It is necessary to consider a possibility of cross resistance to various antibiotics to macroleads.

In case of persistent heavy diarrhea it must be kept in mind a possibility of development against the background of antibiotics of life-threatening pseudomembranous colitis.

Pregnancy and a lactation

use at pregnancy and during breastfeeding according to indications Is authorized. The European department of WHO recommends dzhozamitsin as choice drug at treatment of a chlamydial infection at pregnant women.

Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms

Drug does not affect ability to run motor transport and potentially dangerous mechanisms.



Overdose

Symptoms: strengthening of side effects.

Treatment: the supporting and symptomatic therapy. Ensuring sufficient intake of liquid in an organism.



The form of release and packing

On 5 tablets place in blister strip packaging from a film of polyvinylchloride/polyvinyldichloride and aluminum foil.

On 2 blister strip packagings together with the instruction for medical use in the state and Russian languages place in a pack cardboard.





To Store storage conditions in the dry, protected from light place, at a temperature not over 25C.

To store out of children's reach!





2 years

not to use a period of storage after an expiration date!



Prescription status

According to the prescription





the Producer Famar Lyon, 29 Avenue Charles de Gaulle, 69230 Saint-Zhenya-Laval, France



the Owner of the registration certificate

Astellas of Pharm B.V. Europe,

Netherlands Silviusveg 62, 2333 VE Leiden, Netherlands



the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods):

Representation Astellas of Pharm B.V. Europe in RK

Almaty, 050559, Al-Farabi Ave. 15, Nurla Tau's Centre Party of Finland, zd 4B,

office No. 20 Phone number (727) 311-13-89 Fax (727) 311-13-90

www.astellas.ru,







e-mail of astellas@com.kz