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Instructions for medical use of
BEPANTHEN®
Trade name:
Bepanthen®
International nonproprietary name
Dexpanthenol
Dosage form
Cream for outward application 5%
Composition
1g of cream includes:
active substance: dexpanthenol 50 mg;
adjuvants: DL- pantolactone, phenoxyethanol, amphizol K, cetyl alcohol, stearyl alcohol, lanolin, isopropyl myristate, propylene glycol, purified water.
Description
Soft, elastic, homogeneous, blind cream from white to light yeallow-white color with faint specific odor.
Pharmacotherapeutic group
Other drugs for treatment of hyper cicatrization. Dexpanthenol.
CodeАТХ D03AX03
Pharmacological properties
Pharmacokinetics
Dexpanthenol is quickly absorbed by skin. Dexpanthenol transforms in pantothenic acid and add endogenous reserve of the Vitamine. In blood pantothenic acid binds to plasma proteins; 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. Pantothenic acid is a component of essential coenzyme A. In form of acetyl coenzyme it takes an important part in cell metabolism and improves regeneration of cell and mucous membrane.
Dosage and methods of use
Cream shall be applied by thin coating once or several times per day, as and when necessary on preliminary cleaned wound or irrigated skin and slightly embrocated. If necessary, use bandage.
Period of treatment depends on indications and effectiveness of therapy.
During breast-feeding apply cream on nipple after each breast-feeding procedure.
During treatment of damage of mucous of uterine cervix apply once or several times per day according to doctor prescription.
Adverse reaction
- 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.
Special indications
Avoid eye contact with cream.
Pregnancy and breast-feeding
In case of pregnancy, the drug shall be used on doctor’s order.
During treatment of cracked nipples during breast-feeding period, it is necessary to wash off drugs prior to breast-feeding.
Effects on ability to drive and use potentially dangerous machines
Bepanthen does not influence on ability to drive and use othermachines.
Overdosage
Cases of overdosage are not registered.
Form of output and packing
30 g of drug are 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.
Name and country of the organization-manufacturer
GP Grenzach Produktions GmbH, Germany
Name and country of the Registration Certificate holder
Bayer Consumer Care AG, Switzerland
Address of the organization receiving claims from consumers regarding the quality of products (goods) on the territory of the Republic of Kazakhstan and responsible for post-registration supervision over the drug safety:
«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: +7 727 244 70 01
e-mail: kz.claims@bayer.com