Lactagel^® (Gel) Instructions for Use

Marketing Authorization Holder

Orion Pharma, LLC (Russia)

Manufactured By

Rolf Kullgren, AB (Sweden)

Contact Information

ORION CORPORATION ORION PHARMA (Finland)

Dosage Form

Lactagel^®

Vaginal gel 225 mg/5 ml: 5 ml tubes 7 pcs.

Dosage Form, Packaging, and Product Composition

Vaginal gel	1 tube
Lactic acid	225 mg

Excipients: glycogen, propylene glycol, hydroxypropyl methylcellulose, sodium lactate, water.
PH 3.8

5 ml – single-use tubes (7) – packages.

Therapeutic Category

Medical device for restoring the normal vaginal microflora

Properties

Gel containing lactic acid and glycogen.

Lactic acid helps to reduce vaginal pH (i.e., create a more acidic environment).

Glycogen is a nutrient medium necessary for the reproduction of lactobacilli.

By normalizing pH values and creating appropriate conditions for the reproduction of lactobacilli, Lactagel^® restores the natural environment in the vagina and eliminates symptoms (profuse discharge, discomfort and unpleasant odor).

Scope of Application

Of the Lactagel^® product

Relief of symptoms of bacterial vaginosis;
Maintenance of normal vaginal flora and prevention of symptoms of bacterial vaginosis.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
N76	Other inflammatory diseases of vagina and vulva
N89.8	Other noninflammatory disorders of vagina

ICD-11 code	Indication
GA00	Vulvitis
GA02.Z	Unspecified vaginitis
GA0Z	Inflammatory diseases of female genital tract, unspecified
GC42.1	Painful intercourse
MF3A	Vaginal discharge
GA1Z	Unspecified noninflammatory disorders of female genital tract
XA1LK7	Vagina

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

For effective relief of symptoms of bacterial vaginosis
Elimination of symptoms of bacterial vaginosis – profuse discharge, unpleasant odor, vaginal discomfort	Apply 1 tube daily for 7 days
Maintenance of normal vaginal flora and prevention of symptoms of bacterial vaginosis
Maintenance of natural vaginal pH values and prevention of the appearance of symptoms of bacterial vaginosis	Apply 1 tube every 3 days for 3 months
Maintenance of natural vaginal pH values during a course of antibiotic therapy and/or treatment with antifungal drugs	Apply 1 tube daily at the end of the course for 4-5 days
Elimination of symptoms of bacterial vaginosis during menstruation	After the end of menstruation, apply 1 tube per day for 1-2 days.

Method of application

Lactagel^® is available in single-use tubes.

To open the tube, turn the cap and remove it.
It is necessary to fully insert the tip of the tube into the vagina.
Squeeze the walls of the tube; without stopping the squeezing, remove the tube.
After that, the tube can be discarded.

It is best to use Lactagel^® before going to bed, as some of the gel may leak out. The use of hygienic panty liners is recommended.

Use during pregnancy and breastfeeding

Lactagel^® can be used during pregnancy, however, if a vaginal infection is suspected during pregnancy, it is recommended to consult a doctor.

Special instructions

The use of Lactagel should be avoided during attempts to conceive, as low vaginal pH values negatively affect sperm motility.

Lactagel^® should not be used as a contraceptive.

Do not use the tube if its integrity is compromised.

Storage Conditions

Lactagel^® should be stored out of the reach of children at room temperature.

Shelf Life

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

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer