контрактне виробництво
свічки контактне виробництво
виробництво торгова марка
KANDIKLIN
Release form
Pessaries.
For children
Not used
For pregnant women
Not specified
For nursing mothers
Not specified
For drivers
Does not affect
Storage temperature
to 25 °C
INSTRUCTION
storage
active substance: sertaconazole; 1 pessary contains sertaconazole nitrate 300 mg; excipients: colloidal anhydrous silicon dioxide, solid fat.
Medicinal form
Pessaries. Main physical and chemical properties: oval pessaries of white or almost white color.
Pharmacotherapeutic group
Antimicrobial and antiseptic agents used in gynecology. Imidazole derivatives. Code ATX G01 AF.
Pharmacological properties
Pharmacodynamics. Sertaconazole is an antifungal drug, an imidazole derivative, which has high fungicidal activity and is intended for local use in gynecology. The mechanism of action consists in inhibiting the synthesis of ergosterol and increasing the permeability of the cell membrane, which leads to the destruction of pathogens. Effective against pathogenic yeast fungi (Candida albicans, Candida spp. and Malassezia furfur), dermatophytes (Trichophyton, Epidermophyton and Microsporium spp.) and pathogens that cause infectious diseases of the skin and mucous membranes, including gram-positive strains (Staphylococcus, Streptococcus) . Pharmacokinetics. There is no systemic absorption. When used vaginally, the concentration of the active substance in blood plasma did not reach the detection limit. After vaginal use of radiolabeled sertaconazole, no radioactivity was detected in plasma.
Indication
Local treatment of vaginal candidiasis.
Contraindication
Known hypersensitivity to antifungal agents, imidazole derivatives, or to any excipients of the medicinal product. Simultaneous use of the drug with latex condoms or a pessary (diaphragm).
Interaction with other medicinal products and other forms of interaction
With the simultaneous use of pessaries with local contraceptives, their spermicidal effect may decrease. Simultaneous use with latex condoms or a pessary is contraindicated due to the risk of their damage.
Features of use
If the diagnosis of candidiasis is confirmed, factors (hygienic or lifestyle) that contribute to the development and manifestations of a fungal infection should be identified and eliminated. During treatment, to avoid relapses, it is not recommended to use soap with an acidic pH and to douching. You should use mainly cotton underwear. It is also advisable to apply an antifungal cream containing sertaconazole to the vulva and perineum. When using the drug, it is recommended to refrain from sexual intercourse. It is recommended to consider the possibility of simultaneous treatment of a sexual partner. Treatment can be carried out during menstruation. It is also recommended to treat other pathogenic microorganisms that can be associated with candidiasis. Treatment should be stopped if a local allergic reaction occurs. In the absence of characteristic clinical signs of vaginal candidiasis, a positive microbiological test result in itself is not an indication for treatment. Use during pregnancy or breastfeeding. There are no data on the presence of embryotoxicity and teratogenic effect of sertaconazole. Taking into account the method of application (one-time treatment dose) and the lack of systemic absorption of the drug, the use of sertaconazole by pregnant women is possible, provided that the expected benefit for the woman outweighs the potential risk for the fetus. There are no data on the penetration of sertaconazole into breast milk. During breastfeeding, the drug should not be used, except in cases where, in the opinion of the doctor, the expected benefit to the mother outweighs the potential risk to the child. The ability to influence the speed of reaction when driving vehicles or other mechanisms. Does not affect.
Methods of application
For adults, 1 pessary should be inserted deep into the vagina, preferably in a supine position, once a day in the evening before going to bed. If the clinical signs of the disease do not disappear, repeated use of the drug is possible after 7 days. Children. Sertaconazole is not used in children.
Overdose
After vaginal use, overdose was practically not noted.
Side effects
Disorders of the immune system: sometimes transient local irritation (burning and itching) is possible. This may be a consequence of the action of cell fragments upon the death of pathogens, so such a reaction may be a sign of successful therapy. Allergic reactions often appear. Reporting of suspected adverse reactions Reporting of suspected adverse reactions after registration of a medicinal product is important. This makes it possible to constantly monitor the benefit/risk ratio of the use of the medicinal product.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not higher than 25 °C. Keep out of the reach of children.
Packaging
1 pessary in a strip of polyvinyl chloride film. 1 strip in a pack.
Leave category
By prescription.
Producer
Monfarm PJSC, Ukraine.
Address
Ukraine, 19161, Cherkasy region, Uman district, village Avramivka, str. Zavodska, 8