The instruction for use
of medicine of experts
of ZALAIN® (ZALAIN®)
the Trade name
Mezhdunarodnoye the unlicensed
name Sertakonazol Lekarstvennaya a form
Cream for external use of 2% 20 mg
of 1 g of cream contains
active agent – a sertakonazol nitrate of 20 mg,
excipients: ethylene glycol and polyethyleneglycol palmitostearat, poliglikolizirovanny saturated glycerides, glycerin isostearate, paraffin oil, methylhydroxybenzoate, sorbic acid, purified water.
White soft cream, flavourless or with a slight smell of fat.
Antifungal drugs for external use. Derivative imidazole.
The code of automatic telephone exchange D01AC14
Pharmacokinetics Therapeutic Concentration properties of a sertakonazol in the keratosic layer of skin after putting drug is reached within 30 minutes and more than 48 hours remain. There are no data indicating absorption and system effects of a sertakonazol when drawing on skin. At daily use of cream within 14 days in the increasing quantities sertakonazol it is not found in blood and urine.
Sertakonazol is derivative an imidazole and petrolthiophene with a broad spectrum of activity concerning a pathogenic fungi of the sort Candida (C. albicans, C. tropicalis, C. spp.), other pathogenic fungi (Pityrosporum orbiculare, Malassezia spp.), dermatophytes (Trichophyton and Microsporum) and also the gram-positive pathogenic stafilokokk and streptococci causing infections of skin and mucous membranes. In therapeutic doses renders fungicidal and fungistasis. The mechanism of action of a sertakonazol consists in suppression of synthesis of ergosterol, the main component of membranes of fungal cells and in competitive antagonism with other component of a cell wall – tryptophane. It leads to disorganization and increase in permeability of a cellular membrane, destruction and extermination of a pathogenic microorganism.
Superficial mycoses of skin:
– a dermatophytosis
– mycoses of shins, feet and brushes
– trunk mycoses
– beard mycosis
– multi-colored (scaly) deprive
– seborrheal dermatitis
the Route of administration and doses
For external use.
Cream is applied with evenly thin layer on affected areas of skin, taking about 1 cm of adjacent sites of healthy skin. Cream is recommended to put daily 1-2 times a day (in the evening, or in the morning and in the evening). Duration of treatment depends on an etiology of the activator and localization of an infection. As a rule, clinical laboratory treatment of a disease is observed within 2–4 weeks. The recommended treatment duration to an absolute clinical recovery and prevention of a recurrence is 4 weeks.
Drug is well transferred when drawing, as to the affected skin, and intact.
– quickly taking place local erythematic reaction which is not demanding drug withdrawal.
– hypersensitivity to a sertakonazol, derivatives of an imidazole or other components of drug.
Interaction with other medicines is not revealed.
Zalain cream in ophthalmologic practice is not recommended to use special instructions.
Use of acid detergents is not recommended (acidic environment promotes reproduction of mushrooms of the sort Candida).
Data on use of Zalain cream for children are absent.
In a simultaneous infection of vulvar lips and adjacent sites of skin (candidosis vulvitis) the Zalain drug treatment vaginal suppositories can be complemented with prescribing of the drug Zalain cream on area of external genitals and perianal area.
Pregnancy and the period of a lactation
Sertakonazol is not found in blood serum after topical administration of cream in high doses, and existence of possible risk for pregnant women and newborns is not proved. Use of drug during pregnancy is possible if the expected advantage of therapy for mother exceeds possible risk for a fruit and the child.
In the period of a lactation cream cannot be applied on mammary glands. There are no data on use of drug in the period of a lactation. In need of use of drug it is necessary to resolve an issue of the breastfeeding termination.
Influence on ability of control of vehicles and works with mechanisms
does not influence.
At external use overdose is improbable. At accidental use of drug inside to carry out symptomatic treatment.
A form of release and packing
Cream in aluminum tubas on 20 g, with a plastic cap together with the instruction for use is packed into a cardboard box.
not to use an expiration date after the expiry date specified on packing.
To Store storage conditions at a temperature below +25 °C!
To store out of children’s reach!
the Producer Ferrer INTERNASIONAL A.O., Barcelona, Spain, for
JSC EGIS PHARMATSEVTICHESKY PLANT
1106 Budapest, Keresturi St., 30-38 HUNGARY
Phone number: (36-1) 265-5555, fax: (36-1) 265-5529