LACTOJINAL - instructions for use, dose, side effects, contraindications

Auxiliary substancesVa: potato starch ~ 139.810 mg, lactose monohydrate ~ 74.676 mg, sodium glutamate ~ 15.345 mg, sodium thiosulphate ~ 91.388 mg, magnesium stearate 3.410 mg;

Shell: gelatin.

Description:Transparent gelatin capsules of size "0", filled with light yellow powder with a brownish hue.

Pharmacotherapeutic group:Eubiotic

ATX: & nbsp

Lactobacilli

Pharmacodynamics:

Characteristics of the preparation

Lactobacillus casei is a type of Gram-positive rod-shaped anaerobic non-spore-forming bacteria.

Lactobacillus casei is a normal obligate flora of the oral cavity, intestine, vulva and vagina of a person.

Pharmacological properties

Lactobacillus casei, along with other species of lactobacilli (L. acidophilus, L. fermentum, L. cellobiosum, etc.), are present in the normal flora of the vulva and vagina of a woman. Colonization of the vagina with live chopsticks L. casei rhamnosus Doderleini creates a similar to the physiological environment in the vagina. Strain L. casei rhamnosus Doderleini in the formulation Laktozhinal^® has antagonistic activity against a wide range of pathogenic and conditionally pathogenic bacteria (including Staphylococcus spp., Proteus spp., enteropathogenic Escherichia coli), improves local metabolic processes and promotes restoration of natural local immunity.

Pharmacokinetics:

When the capsule of the drug Laktozhinal^® In the vagina, the gelatinous capsule shell dissolves with the release of a lyophilized culture of live lactobacilli. In vitro it was shown that L. casei rhamnosus Doderleini the pH is lowered for several hours. Specified property L. casei rhamnosus Doderleini when the drug is introduced into the vagina, it helps restore its natural microflora.

Deficiency of lactobacilli is one of the important factors in the development of candidiasis vulvovaginitis.Lactobacilli are physiological antagonists of yeast-like fungi of the genus Candida due to the secretion of antifungal substances and competition for receptors on the vaginal epitheliocytes (suppress the attachment of Candida to the vaginal epitheliocytes, inhibit their growth and reproduction).

The results of the clinical study showed the efficacy of Laktozhinal® in restoring normal vaginal microflora and preventing recurrent candidiasis vulvovaginitis when it is used after the end of antifungal therapy.

Indications:

Restoration of normal vaginal microflora after antibacterial therapy of bacterial vaginosis; when preparing for routine gynecological operations; prenatal preparation of pregnant women at risk for bacterial vaginosis.

Prevention of recurrences of vulvovaginal candidiasis (including exacerbations of recurrent vulvovaginal candidiasis) after local and / or systemic therapy with antifungal agents.

Contraindications:

· Hypersensitivity to the drug components

· Vulvovaginal candidiasis (thrush)

· Children under 18 years of age (efficacy and safety not established).

Pregnancy and lactation:

Laktogynal^® can be used during pregnancy and during breastfeeding.

Dosing and Administration:

The route of administration is intravaginal.

Insert the capsule deep into the vagina, moistening it in a small amount of water to accelerate the dissolution of the drug.

Restoration of normal vaginal microflora after antibacterial therapy of bacterial vaginosis: one capsule in the morning and in the evening for 7 days or one capsule daily for 14 days.

In preparation for routine gynecological operations, prenatal preparation of pregnant women at risk for bacterial vaginosis: one capsule in the morning and in the evening for 7 days or one capsule daily for 14 days - as part of complex therapy.

The dosage regimen should be adjusted depending on the severity of the clinical effect.

Prevention of recurrences of vulvovaginal candidiasis (including exacerbations of recurrent vulvovaginal candidiasis) after local and / or systemic therapy with antifungal agents: 1 capsule at night.The duration of therapy with the drug is determined by the doctor. The course of treatment should not exceed more than 21 days. The question of conducting repeated courses is decided individually.

Side effects:Allergic reactions (including itching, burning, redness in the genital area, increased mucosal discharge from the vagina).

Overdose:No cases of overdose have been reported.

Interaction:

It is not recommended to use the drug together with spermicide.

Possible simultaneous use with antibacterial, antiviral and immunomodulating medications.

Clinically significant cases of interaction have not been reported.

Special instructions:

After administration, the capsule dissolves, leaving no stains on the laundry or odor.

The drug is intended for use in women over 18 years of age.

Effect on the ability to drive transp. cf. and fur:Application of the drug Laktozhinal^® does not affect the ability to drive vehicles and mechanisms.

Form release / dosage:Vaginal capsules.

Packaging:

For 14 capsules in a colorless transparent glass bottle,corked with a plug of chlorobutyl elastomer; The neck of the bottle with the stopper is covered with a protective transparent shrink film made of PVC. The bottle together with the instruction for use is placed in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:3 years. Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-001340

Date of registration:09.12.2011 / 20.12.2016

Expiration Date:Unlimited

The owner of the registration certificate:Bezen Helskea SABezen Helskea SA Belgium

Manufacturer: & nbsp

BIOSE INDUSTRIE France

Representation: & nbspBEZEN HELSKEA ENG LLCBEZEN HELSKEA ENG LLCRussia

Information update date: & nbsp30.10.2017

Illustrated instructions

Instructions

LACTOJINAL® (LACTOGINAL®)