Active substanceNyfaratelNyfaratel
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    Polikem Sr.L.     Italy
  • Dosage form: & nbspcoated tablets
    Composition:One tablet contains:

    Active substance: nifuratel 200.00 mg;

    Excipients (core): corn starch 60.00 mg, starch rice 5.00 mg, macrogol-6000 (polyethylene glycol-6000) 15.00 mg, talc 30.00 mg, magnesium stearate 2.50 mg, gelatin 2.30 mg, acacia gum (gum arabic) 2.30 mg;

    Auxiliary substances (shell): sucrose 150.00 mg, magnesium carbonate 33.00 mg, titanium dioxide 0.90 mg, wax 0.30 mg.

    Description:Round biconvex tablets, coated with a white coating.
    Pharmacotherapeutic group:Antimicrobial and antiprotozoal drug - nitrofuran
    ATX: & nbsp

    G.01.A.X.05   Nyfaratel

    Pharmacodynamics:

    Nifuratel is an antimicrobial agent from the group of nitrofurans; has antiprotozoal, antifungal and antibacterial action.

    Nifuratel has high efficiency and low toxicity, which causes a wide range of its clinical applications.

    Highly effective against Papilobacter and Helicobacter pylori, gram-positive and gram-negative microorganisms.

    The spectrum of action includes: Enterococcus faecalis, Enterococcus faecium, Staphylococcus aureus, Bacillus subtilis, Escherichia coli, Shigella flexneri 2a, Shigella flexneri 6, Shigella sonnei, Salmonella typhi, Salmonella typhimurium, Salmonella enteridis, Klebsiella spp., Enterobacter sph., Serratia spp., Citrobacter spp. , Morganella spp., Rettgerella spp., Pragia fontium, Budvicia aquatica, Rachnella aquatilis and Acinetobacter spp., other atypical enterobacteria, as well as protozoa (Trichomonas, amoeba, lamblia); is less active with respect to Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa.

    It is the drug of choice for the therapy of salmonellosis, shigellosis and other acute intestinal bacterial infections.

    Active with respect to Trichomonas vaginalis, highly active against fungi of the genus Candida.

    Especially effective against strains Helicobacter pylori, resistant to metronidazole.
    Pharmacokinetics:When ingested quickly absorbed from the gastrointestinal tract. Penetrates through the blood-brain and hematoplacental barrier, excreted in breast milk. Metabolised in the liver and muscle tissue. Completely removed from the body by the kidneys (30-50% unchanged), having a strong antibacterial effect in the urinary tract.
    Indications:

    - Vulvovaginal infections caused by susceptible pathogens (pathogens, Candida fungi, Trichomonas, bacteria, chlamydia).

    - Pyelonephritis, urethritis, cystitis, pyelitis and other diseases of the urinary system.

    - Intestinal amebiasis and giardiasis.

    - Chronic inflammatory diseases of the upper gastrointestinal pathways associated with infection Helicobacter pilory.

    Contraindications:

    - Hypersensitivity to the active substance or any component of the drug.

    - Deficiency of sucrose / isomaltose, intolerance to fructose, glucose-galactose malabsorption.

    Pregnancy and lactation:

    Nifuratel penetrates the hematoplacental barrier, so the use of the drug is possible only on strict indications, if the expected effect of therapy exceeds potential risk to the fetus.

    Nifuratel is excreted into breast milk, therefore, if it is necessary to prescribe the drug during lactation, the question of stopping breastfeeding should be resolved.

    Dosing and Administration:

    The drug is taken orally following the recommendations.

    Vaginal infections:

    Adults: 1 tablet 3 times a day after meals for 7 days (take the drug should both sex partners).

    Children: the recommended dose of 10 mg / kg body weight daily for 10 days.

    The recommended dose should be taken in two divided doses.

    Urinary tract infections:

    Adults: depending on the severity of the disease 1-2 tablets 3 times a day for 7-14 days.

    Children: the recommended dose is 30-60 mg / kg body weight. The recommended dose should be taken in two steps.

    On the recommendation of a doctor, the course of treatment of urinary tract infections can be prolonged or repeated.

    Intestinal amebiasis:

    Adults: 2 tablets 2-3 times a day for 10 days.

    Children: the recommended dose of 10 mg / kg body weight 3 times a day.

    Giardiasis:

    Adults: 2 tablets 2-3 times a day for 7 days.

    Children: the recommended dose of 15 mg / kg body weight 2 times a day for 7 days.

    Inflammatory diseases of the upper gastrointestinal tract associated with Helicobacter pylori:

    Adults: 2 tablets 2-3 times a day for 7 days.

    Children: the recommended dose of 15 mg / kg body weight 2 times a day for 7 days.

    Side effects:

    Dyspeptic disorders: nausea, vomiting, bitterness in the mouth, diarrhea, heartburn.

    Allergic reactions: skin rash, itching.

    Overdose:There have been no cases of overdose.
    Interaction:

    Strengthens the antifungal action of nystatin.

    Special instructions:

    When treating vaginal infections only by oral Macromore, it is recommended to increase the daily dosage of the drug to 4-6 tablets.

    During the treatment period, you should refrain from having sexual intercourse.

    Effect on the ability to drive transp. cf. and fur:

    The drug does not affect the ability to drive vehicles and engage in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:

    The tablets covered with a cover of 200 mg.

    Packaging:

    For 10 tablets in a blister of PVC / aluminum foil.

    2 blisters with instructions for use are placed in a cardboard box.

    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children!

    Shelf life:

    5 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N015307 / 01
    Date of registration:31.08.2009 / 22.07.2014
    Expiration Date:Unlimited
    The owner of the registration certificate:Polikem Sr.L.Polikem Sr.L. Italy
    Manufacturer: & nbsp
    Representation: & nbspCBS CJSC LTDCBS CJSC LTDItaly
    Information update date: & nbsp25.03.2018
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