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The description Fluomizinis an automatic translation from the original language.
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Fluomizin 10 mg vaginal tablets
The description Fluomizinis an automatic translation from the original language.
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Each vaginal tablet contains 10 mg dequalinium chloride.
The description Fluomizinis an automatic translation from the original language.
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The description Fluomizinis an automatic translation from the original language.
In no case do you use this information for any medical appointments or manipulations.
Be sure to read the original instructions of the medicine from the package.
This description may contain numerous errors due to automatic translation!
Keep this in mind and don't use this description!
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The description Fluomizinis an automatic translation from the original language.
In no case do you use this information for any medical appointments or manipulations.
Be sure to read the original instructions of the medicine from the package.
This description may contain numerous errors due to automatic translation!
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Contraindications
The description Contraindications Fluomizinis an automatic translation from the original language.
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Special warnings and precautions for use
The description Special warnings and precautions for use Fluomizinis an automatic translation from the original language.
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To minimize exposure of the newborn to dequalinium chloride, vaginal tablets should not be used within 12 hours before birth.
There are no efficacy and safety data available on the re-treatment of patients who did not respond to or relapsed immediately after initial therapy with Fluomizin. Patients should be advised to consult their physician if the symptoms persist at the end of the treatment or in case of recurrence.
Using a higher daily dose or increasing the recommended treatment duration might increase the risk of vaginal ulcerations.
No efficacy and safety data on the treatment of bacterial vaginosis in women aged less than 18 years or more than 55 years are available.
Interaction with other medicinal products and other forms of interaction
The description Interaction with other medicinal products and other forms of interaction Fluomizinis an automatic translation from the original language.
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Anionic substances such as soaps, detergents and surfactants can reduce the antimicrobial activity of dequalinium chloride. Thus, concomitant intravaginal use of soaps, spermicides or vaginal douches (vaginal washes) is not recommended.
Fluomizin 10 mg vaginal tablets do not impair the functionality of latex condoms. There are no data on the interaction with non-latex condoms and other intravaginal devices such as diaphragms. Thus, concomitant use of non-latex condoms and other intravaginal devices is not recommended for at least 12 hours following the treatment.
Fertility, pregnancy and lactation
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Effects on ability to drive and use machines
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No studies on the effects on the ability to drive and use machines have been performed.
Undesirable effects
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Overdose
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Pharmacodynamic properties
The description Pharmacodynamic properties Fluomizinis an automatic translation from the original language.
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Pharmacokinetic properties
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Pharmacotherapeutic group
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Preclinical safety data
The description Preclinical safety data Fluomizinis an automatic translation from the original language.
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Systemic toxic effects of Fluomizin are unlikely on the basis of the negligible systemic exposure of dequalinium chloride administered intravaginally.
In vivo and in vitro studies with dequalinium chloride did not yield any indication of a potential to cause mutagenicity.
No reproduction toxicity studies have been conducted with dequalinium chloride.
A study in rabbits showed the good vaginal tolerance of Fluomizin.
List of excipients
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Lactose monohydrate
Cellulose, microcrystalline
Magnesium stearate
Incompatibilities
The description Incompatibilities Fluomizinis an automatic translation from the original language.
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Shelf life
The description Shelf life Fluomizinis an automatic translation from the original language.
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3 years.
Special precautions for storage
The description Special precautions for storage Fluomizinis an automatic translation from the original language.
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3 года.
Nature and contents of container
The description Nature and contents of container Fluomizinis an automatic translation from the original language.
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Special precautions for disposal and other handling
The description Special precautions for disposal and other handling Fluomizinis an automatic translation from the original language.
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No special requirements.
Marketing authorisation holder
The description Marketing authorisation holder Fluomizinis an automatic translation from the original language.
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Kora Corporation Ltd t/a Kora Healthcare
Swords Business Park, Swords, Co. Dublin, Ireland
Marketing authorisation number(s)
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PL 39972/0004
Date of first authorisation/renewal of the authorisation
The description Date of first authorisation/renewal of the authorisation Fluomizinis an automatic translation from the original language.
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30/06/2015
Date of revision of the text
The description Date of revision of the text Fluomizinis an automatic translation from the original language.
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11/04/2017
Pharmacy sales terms
The description Pharmacy sales terms Fluomizinis an automatic translation from the original language.
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Special instructions
The description Special instructions Fluomizinis an automatic translation from the original language.
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ATC - Anatomical and therapeutic chemical classification
The description ATC - Anatomical and therapeutic chemical classification Fluomizinis an automatic translation from the original language.
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Nosological classification (ICD-10)
The description Nosological classification (ICD-10) Fluomizinis an automatic translation from the original language.
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