The instruction for medical use
of Klion® medicine – D 100
International unlicensed name
Are not present
the Dosage form
of the Tablet vaginal
One tablet contains
active agents: metronidazole of 100 mg, Miconazolum nitrate of 100 mg, excipients: sodium lauryl sulfate, silicon dioxide colloidal anhydrous, magnesium stearate, povidone, Natrii hydrocarbonas, tartaric acid, sodium carboxymethylstarch (type A), krospovidon, gipromelloza, lactoses monohydrate.
of the Tablet of almost white color, with a biconvex surface, an oval form with the pointed end, about 24 x 14 mm in size, with an engraving 100 on one party.
of Antiseptics and antimicrobial drugs for treatment of gynecologic diseases. Antiseptic agents and antimicrobial drugs for treatment of gynecologic diseases (excepting combinations with corticosteroids). Imidazole derivatives. An imidazole of derivatives a combination
the ATX G01AF20 Code
Pharmacokinetics At properties topical administration of metronidazole and Miconazolum of nitrate is noted their insignificant absorption through mucous membranes. Neither metronidazole, nor Miconazolum nitrate are not soaked up in quantities which could be registered. It corresponds to values below of 0.2 mkg/ml and 0.3 mkg/ml, respectively.
Metronidazole at oral administration is usually well soaked up, and peak plasma concentration is reached between the first and third hours. At single oral administration of 250 mg the peak plasma concentration of 5 mkg/ml determined by method of gas chromatography is reached. The bioavailability of drug at oral administration is nearly 100%.
According to data of the researches conducted with participation of healthy volunteers and patients, metronidazole quickly gets into cerebrospinal liquid and reaches therapeutic concentration in abscesses of a brain and in abscesses of lungs. It has the considerable volume of distribution, and less than 20% of the circulating metronidazole contact proteins of plasma. Drug comes to biliary tract where the concentration comparable with plasma are reached. Average elimination half-life of metronidazole at healthy volunteers makes 8 hours. The main way of removal of metronidazole and its metabolites is urine (60-80% of a dose), 6-15% of a dose are excreted with excrements.
Metronidazole is drug for treatment of trichomoniasis for topical and oral administration. Miconazolum nitrate is antifungal drug which is used for treatment of the infections caused by dermatophytes and Candida, besides, at topical administration it possesses the significant bacteriostatic action concerning a number of gram-positive bacteria. The purpose of topical administration of this combined drug is topical treatment of trichomoniasis and also prevention of vaginal mycosis which is often shown after treatment by metronidazole.
Also drug can be used in the vaginal mycoses which are not connected with treatment by metronidazole.
– topical treatment of trichomoniasis and/or fungal infections of urinogenital ways at women
the Route of administration and doses
In trichomoniasis: along with intake of metronidazole inside, 1 vaginal tablet Клион®-ä 100, previously having slightly moistened, it is necessary to enter deeply into a vagina once a day (in the evening before going to bed) within 10 days.
During these 10 days it is necessary to take daily 2 pill of metronidazole (250 mg x 2 times) inside (one tablet in the morning and one evening) in time or after a meal, without chewing.
The absolute recovery can be reached only if the sexual partner at the same time also receives medical treatment for metronidazole (tablets for intake).
In case of inefficiency of treatment: the 10-day course of treatment can be repeated.
In candidiasis: 1 vaginal tablet Клион®-ä 100, previously having slightly moistened, it is necessary to enter deeply into a vagina once a day (in the evening before going to bed) within 10 days.
Very often (˃1/10)
– a headache
Often (ot1/100 to & lt, 1/10)
– an abdominal pain, intestinal gripes, diarrhea
Infrequently (from ˃1/1000 to & lt, 1/100)
– peripheral neuropathy (hypesthesia), dizziness, spasms, lacks of coordination, drowsiness
– a loss of appetite, a dysgeusia (metal taste in a mouth), vomiting, a language oblozhennost
– a Quincke’s disease, a skin itching, rash, a small tortoiseshell
– irritation in the injection site, fervescence
Is rare (from ˃1/10000 to & lt, 1/1000)
– fungal superinfection (for example, candidiasis)
– confusion of consciousness
– urine discoloration (darkening of urine is caused by a metabolite of metronidazole and has no clinical value)
is Very rare (& lt, 1/10000)
– a neutropenia (leukopenia), thrombocytopenia
– anaphylactic reactions
– a cholestasia, jaundice
– a multiformny erythema
– increase in activity of hepatic enzymes
of the Contraindication
– hypersensitivity to active ingredients or to any of drug excipients
– pregnancy and the period of a lactation
– patients with rare congenital forms of a lactose intolerance, a lactose intolerance of Lapp, glyukozo-galaktozny malabsorption
the interactions of metronidazole and Miconazolum of nitrate Given relatively at vaginal use are unknown so far.
At use of vaginal tablets Клион®-ä 100 in a combination with metronidazole tablets for intake there can be following types of medicinal interactions:
– metronidazole can exponentiate anti-coagulative effect of oral anticoagulants that can lead to lengthening of a prothrombin time therefore, it is necessary to correct their dose
– inductors of enzymes (for example, Phenytoinum, phenobarbital) can promote metronidazole metabolism acceleration that can lead to decrease in plasma levels and increase in plasma clearance of Phenytoinum
– inhibitors of enzymes (for example, Cimetidinum) can extend elimination half-life and reduce plasma clearance of metronidazole
– consumption of alcoholic beverages during intake of metronidazole can cause disulfiramopodobny side effects (intestinal colic, nausea, vomiting, a headache and face reddening)
– metronidazole and Disulfiramum should not be accepted in common (can arise: the additive effect, psychotic reactions, confusion of consciousness)
– intake of metronidazole can promote increase in content of lithium in blood plasma in this connection it is necessary to reduce a dose or to cancel lithium drug prior to therapy by metronidazole
– in cases of simultaneous use of cyclosporine and metronidazole concentration of cyclosporine can increase in blood plasma. If combination therapy by these drugs is necessary, it is recommended to control concentration of cyclosporine in blood plasma
– metronidazole promotes reduction of clearance of a 5-ftoruratsil and increase in its toxicity
– metronidazole can affect results of assessment of certain biochemical indicators of blood serum, such as aspartate aminotransferase (nuclear heating plant), alaninaminotranspherase (ALT), lactate dehydrogenase (LDG), triglycerides and glyukozohexokinaza
during a course of treatment drug Клион®-ä 100 and also, at least, within one day after its end, is forbidden consumption of alcoholic beverages.
During Клион®-ä 100 drug treatment, vaginal tablets, it is necessary to avoid sexual contacts.
In case of inefficiency of treatment the replacement by other system trikhomonatsidny and/or antifungal drug is recommended.
In case of hypersensitivity, irritation of mucous membranes, treatment by this drug should be stopped.
Pregnancy and a lactation
Drug is contraindicated at pregnancy.
Metronidazole at oral administration gets through a placental barrier and quickly gets to a fruit blood stream.
Now there are no adequate and controlled researches at pregnant women. On the basis of meta-analysis of the researches conducted in the first trimester of pregnancy the conclusion was drawn that increase in fetotoksichesky action was not observed.
Metronidazole at intake is excreted in breast milk in the concentration similar to plasma. It can give to breast milk bitter smack.
For protection of the baby against drug influence, it is necessary to stop intake of metronidazole, or to stop breastfeeding during intake of metronidazole and also within 1 or 2 days after completion of therapy, in view of need of therapy for mother.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Drug does not affect ability to control of vehicles and work with mechanisms.
Symptoms: nausea, vomiting and ataxy.
Treatment: symptomatic, gastric lavage, activated carbon, hemodialysis. Specific antidote is absent. Metronidazole and its metabolites are well removed at dialysis. Drug is intended only for intravaginalny use. In case of inadvertent intake of a large amount of drug it is necessary to wash out a stomach.
A form of release and packing
On 10 tablets in planimetric bezjyacheykovy packing from the soft aluminum foil covered with a polyethylene layer.
On 1 planimetric packing together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
In the dry and protected from light place at a temperature from 15 of 0C up to 30 0C.
To store out of children’s reach!
Drug not to use a period of storage of 5 years After expiry date.
According to the prescription
the Name and the country
of the JSC Gideon Richter manufacturing organization,
1103 Budapest, Dyomryoi St., 19-21, Hungary
the Name and the country of the owner of the registration certificate
of JSC Gideon Richter, Hungary
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products:
Representative office of JSC Gideon Richter in RK
Phone number: 8-(727) – 258-26-22, 8-(727) – 258-26-23