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Medically reviewed by Oliinyk Elizabeth Ivanovna, PharmD. Last updated on 03.04.2022
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The description Fluomizinis an automatic translation from the original language.
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more...Fluomizin 10 mg vaginal tablets
The description Fluomizinis an automatic translation from the original language.
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more...Each vaginal tablet contains 10 mg dequalinium chloride.
The description Fluomizinis an automatic translation from the original language.
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more...The description Fluomizinis an automatic translation from the original language.
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more...The description Fluomizinis an automatic translation from the original language.
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Contraindications
The description Contraindications Fluomizinis an automatic translation from the original language.
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more...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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more...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
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more...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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more...Effects on ability to drive and use machines
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more...No studies on the effects on the ability to drive and use machines have been performed.
Undesirable effects
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more...Overdose
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more...Pharmacodynamic properties
The description Pharmacodynamic properties Fluomizinis an automatic translation from the original language.
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Pharmacokinetic properties
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more...Pharmacotherapeutic group
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more...Preclinical safety data
The description Preclinical safety data Fluomizinis an automatic translation from the original language.
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more...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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more...Lactose monohydrate
Cellulose, microcrystalline
Magnesium stearate
Incompatibilities
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Shelf life
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more...3 years.
Special precautions for storage
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more...3 года.
Nature and contents of container
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Special precautions for disposal and other handling
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more...No special requirements.
Marketing authorisation holder
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more...Kora Corporation Ltd t/a Kora Healthcare
Swords Business Park, Swords, Co. Dublin, Ireland
Marketing authorisation number(s)
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more...PL 39972/0004
Date of first authorisation/renewal of the authorisation
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more...30/06/2015
Date of revision of the text
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more...11/04/2017
Pharmacy sales terms
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more...Special instructions
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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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more...Nosological classification (ICD-10)
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more...References:
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