Бепантен 5% д/наруж применения 100 гр мазь

Description

Instructions for medical use of

BEPANTHEN®

Trade name:

BEPANTHEN^®

International nonproprietary name

Dexpanthenol

Dosage form

Ointment for outward application, 5%

Composition

1 g of ointment includes:

active substance: dexpanthenol 50 mg;

adjuvants: Protegin X, cetyl alcohol, stearyl alcohol, lanolin, white bees wax, white soft paraffin, almond oil, liquid paraffin, purified water.

Description

Soft, elastic, homogeneous ointment of creany-white color with specific odor of lanolin.

Pharmacotherapeutic group

Dermatology. Drugs for treatment of wounds and ulcer. Wound-healthing drugs. Wound-healthing drugs, other. Dexpanthenol.

Code АТХ D03AX03

Pharmacological properties

Pharmacokinetics

Dexpanthenol is quickly absorbed by skin. Dexpanthenol transforms in pantothenic acid and add endogenous reserve of the Vitamine B. In blood pantothenic acid binds to plasma proteins (especially with β-globulin and albumen); is excreted in unchanged form – 60-70% with urine, the remained part through gastrointestinal system.

Pharmacodynamics

Dexpanthenol is active component of Bepanthene, quickly transforms in cells into pantothenic acid and Vitamin of B complex, that allows to have the same activity as the Vitamin. However Dexpanthenol has advantage, it is easier reabsorbable during local application. Pantothenic acid is component essential coenzyme A. In form of acetyl coenzyme A, coenzyme A takes an important part in cell metabolism. Correspondingly, pantothenic acid is necessary for formation and regeneration of skin and mucous membranes of body.

Indications

• prophylaxis and treatment of diaper rash of breast-feeding infants
• care after glandula mammaria during breast-feeding:treatment of dry and cracked nipples
• for improvement (activation) of skin healing in case of small damages, chapped skin, scratch , skin irrigations, erythemas due to diaper, easy burn,chronic ulcer, bedsores, skin transplantation, anal fissure and cervical erosion
• preventative measures and treatment of dry skin in case of damage of integrity of its cover including during use ofcorticosteroid drugs.

Dosage and methods of use

Outward application. Ointment shall be applied on damaged or irrigated skin once or several times per day as and when necessary.

Care after nursing infant: ointment shall be applied during each replacement of diaper (napkin).

Care after glandula mammaria of nursing mothers: ointment is applied on nipple after each breast-feeding proced. Prior to the next bearst-feeding it is reuired to remove remains of ointment by napkin or soft tissue.

Period of treatment depends on indications and effectiveness of therapy.

Adverse reaction

Very rear:

- allergic dermatitis

- contact dermatitis, irritation, redness

- eczema, rash, nettle rash

- skin irritation and pomphus

Contraindications

- increased individual sensitivity to drug components

Drug interaction

Cases of interaction with other drugs are not registered.

Other interaction

During treatment in genital or anal region excipients included in the ointment lead to decrease of reliability and damage of latex condoms decreasing their safety.

Special indications

Avoid eye contact with ointment.

Lanolin, stearyl and cetyl alcohols can lead to skin irrigation (for example, contact dermatitis)

Pregnancy and breast-feeding

The ointment can be used during pregnancy and breast-feeding period.

Effects on ability to drive and use potentially dangerous machines

No effects.

Overdosage

Cases of overdosage is not registered, even after use of high dosages of the ointment.

Form of output and packing

3.5 g, 30 g or 100 g of drug is placed in an aluminum tube. 1 tube with medical instruction in Kazakh and Russian is placed in cardboard package.

Storage conditions

Do not store above 25 °C.

Keep out of the reach of children!

Shelf life

3 years.

Do not use after the expiration date indicated on the package.

Conditions for drug supply

Over the counter.

Manufacturer/ Packer

GP Grenzach Produktions GmbH, Emil-Barell-Strasse 7, D-79639 Grenzach-Wyhlen, Germany

Name and country of the Registration Certificate holder

Bayer Consumer Care AG, Peter Merian-Strasse 84, Basel , Switzerland

Address of the organization receiving claims (offers) from consumers regarding the quality of products on the territory of the Republic of Kazakhstan:

«Bayer KAZ» LLP.

Timiryazev Street, 42, “Expo City” Business Center, Pav. 15

050057 Almaty, Republic of Kazakhstan

tel.: +7 727 258 80 40, fax: +7 727 258 80 39

e-mail: kz.claims@bayer.com

Address of the organization responsible for post-registration supervision over the drug safety on the territory of the Republic of Kazakhstan:

«Bayer KAZ» LLP.

Timiryazev Street, 42, “Expo City” Business Center, Pav. 15

050057 Almaty, Republic of Kazakhstan

Tel: +7 701 715 78 46 – round the clock

Tel.: +7 727 258 80 40 (106) – during working hours

Fax: +7 727 258 80 39

e-mail: pv.centralasia@bayer.com

Availability in pharmacies