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Description

The instruction for medical use

of KLOVINAL medicine

the Trade name
Klovinal

Mezhdunarodnoye the unlicensed name
is not present

the Dosage form
Pessaries vaginal

Structure
One pessary contains
active agents: metronidazole of 500.0 mg, Clotrimazolum of 100.0 mg, lactobacillus of 150 million
excipients: polyethyleneglycol 1500, methylparahydroxybenzoate, propilparagidroksibenzoat, bottled hydroxytoluene.

The description
Pessaries of white or almost white color of the extended form

Pharmacotherapeutic group
of Antiseptics and antimicrobial drugs for treatment of gynecologic diseases
Derivatives of an imidazole
of the Imidazole of derivatives a combination
ATH G01AF20 Code

the Pharmacological

Pharmacokinetics Evenly properties is distributed on a mucous membrane of a vagina, having local fungicide effect. Practically it is not soaked up from a vagina cover mucosal surface.

The pharmacodynamics
Metronidazole possesses anti-protozoan and antibacterial, antifungal action at topical administration in gynecology. It is active concerning Entamoebahistolyticai Giardialambliai anaerobic bacteria.
Clotrimazolum has the broad antifungal spectrum of action which includes dermatophytes, yeast, a mold, etc. Effect of Clotrimazolum fungistatic or fungicidal, depending on concentration of Clotrimazolum in the place of an infection.

Indications
For topical treatment of the infectious and inflammatory, gynecologic diseases caused by sensitive microorganisms:
– nonspecific vaginita
– fungal vaginita
– the mixed vaginita
– a vulvovaginitis
– tservikovaginita.

The route of administration and doses
On one pessary enter deeply into a vagina in the evening, before going to bed. A course of treatment – 6 days.

Side effects
seldom:
– spasms in a stomach, vomiting, diarrhea, flavoring disorders, loss of appetite, pancreatitis
– allergic reactions, erubescence, irritation, an itching, rash, urticaria, temperature increase and a Quincke’s edema
– nausea and vomiting, a diarrhea
– a headache, dizziness, peripheral touch neuropathy, spasms, an ataxy, mental disorders, hallucinations
– the passing disorders of vision (diplopia, short-sightedness)
it is very rare:
– an agranulocytosis, a neutropenia and thrombocytopenia
– irregular and abnormal vaginal bleedings, discharges from a vagina with an unpleasant smell, pains in the bottom of a stomach, a dysuria
– an acute anaphylaxis, pustulous rashes

the Contraindication abnormal liver function
– hypersensitivity to drug components.
– children’s and teenage age up to 18 years
– pregnancy (I trimester) and the lactation period

Medicinal interactions
At simultaneous use with indirect anticoagulants the potentiation of their action (increase in a prothrombin time) is possible.
At simultaneous use of metronidazole with Disulfiramum disturbances from central nervous system (consciousness oppression, development of psychotic disorders) can be observed.
At simultaneous use with Cimetidinum the metronidazole level in blood can increase.
Metronidazole slows down metabolism of warfarin and exponentiates anticoagulating effect.
At combined use with alcohol, there are symptoms similar to Disulfiramum use – spasms in a stomach, nausea, vomiting, headaches, thus, it is necessary to avoid alcohol intake within 24 hours after drug use.
Cimetidinum prolongs plasma clearance by inhibition of metabolic enzymes, drugs which induce liver enzymes (for example Phenobarbital) can increase metronidazole elimination.
Clotrimazolum can reduce action of barrier contraceptives as at simultaneous use, drug can cause damage of latex of contraceptives.
At simultaneous treatment with takrolimusy increase in a takrolimus in blood plasma is possible. In these cases it is necessary, to watch closely emergence of symptoms of overdose of a takrolimus, and if necessary to determine its level in blood plasma.

Special instructions
It is appointed with care to women 60 years are more senior, it is not appointed in the presence at patients in the anamnesis of hypersensitivity and or an allergy to drug components.
Terms of use of drug have to be limited for the purpose of prevention of forming of resistance to it of separate causative agents of diseases and risk of reinfection.
Pregnancy and a lactation
In ІІ and ІІІ pregnancy trimesters drug can be used only under observation of the doctor and only in cases if the expected advantage for mother exceeds potential risk for a fruit.
Metronidazole is emitted with milk therefore during breastfeeding it is necessary to stop administration of drug.
Features of influence of medicine on ability to run the vehicle and potentially dangerous mechanisms.
In therapeutic doses Klovinal does not influence ability to run the vehicle and performance of work, the demanding concentration of attention and speed of psychomotor reactions.

Overdose
Due to the low absorption of drug the overdose cases at observance of the recommended doses were not noted.

A form of release and packing
On 6 pessaries in blister strip packaging from a film polyvinylchloride.
On 1 planimetric packing together with the instruction for medical use in the state and Russian languages put in a pack from cardboard.

Storage conditions
In the dry, protected from light place at a temperature not above 25 °C.
To store out of children’s reach!

Period of storage
2 years.
Not to apply after expiry date

Prescription status
According to the prescription

BLISSGVSPHARMALTD Producer, India.
10 DewanUdyogNagar, Aliyali, Palghar,
Maharashtra – 401,404, India

the Owner of the registration certificate
of BLISSGVSPHARMALTD, India.
102, Hyde Park, Saki Vihar Road,
Andheri (E) Mumbai – 400,072, India

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of KazEvroFarm LLP Almaty, Kurmangaza St. 48 and, office 9 the 050000 Phone number Index (727) 2729871, 2615141 Fax number (727) 2614466 E-mail address of info@kazeuropharm.com

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