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Instructions for medical use of
Bepanthen® Plus
Trade name
Bepanthen® Plus
International nonproprietary name
No
Dosage form
Cream for external use
Composition
1g of cream includes:
active substance: dexpanthenol 50 mg; chlorhexidine dihydrochloride 5 mg
adjuvants: DL- pantolactone, cetyl alcohol, stearyl alcohol, white soft paraffin, liquid paraffin, lanolin, macrogol stearate, purified water.
Description
Homogeneous, non-transparent cream, almost white color with faint odor.
Pharmacotherapeutic group
Antiseptic and disinfecting drugs. Biguanides and amidines.
Chlorhexidine in combination with other drugs.
ATХ Код: D08AC52
Pharmacological properties
Pharmacokinetics
Dexpanthenol is quickly absorbed by skin. Dexpanthenol transforms in pantothenic acid (Vitamine B5) and joints to endogenous part of this Vitamine. In blood pantothenic acid binds to plasma proteins(b-globulins and albumen); is excreted in unchanged form – 60-70% with urine, the remained part through gastrointestinal system.
In case of application on skin chlorhexidine is practically not absorbed. In case of oral use, chlorhexidine is almost completely extracted with faeces.
Pharmacodynamics
Dexpanthenol is active component of Bepanthen® Plus, quickly transforms in cells into pantothenic acid (Vitamin B5). Pantothenic acid is a component of essential coenzyme A. In form of acetyl coenzyme A it takes an important part in cell metabolism and improves regeneration of cell and mucous membrane. Dexpanthenol is easily distributed in case of local use.
Chlorhexidine hydrochloride is one of the most active and good tolerated topical anti-infective agent with bactericidal activity in relation of gram-positive bacteria, especially sensible strains of Staphylococcus aureus and microorganism referred to skin infections. In a less degree it shows activity in relation of gram-negative pathogens, some typesPseudomonas and Proteus resistant to it, not effective against viruses.
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.
Adverse reaction
The listed adverse reactions are specified on the basis of spontaneous notifications, it is not possible to define accurate frequency of occurrence of each of them.
Immune system, diseases of skin and areolar tissue: allergic reactions including skin allergic reactions including skin allergic reactions: contact dermatitis, allergic dermatitis, irritation, erythema, rash, nettle rash, irritation of skin;
Hypersensitivity,anaphylactic reaction and acute anaphylaxis (potentially life threatening) with corresponding laboratory and clinic cases of bronchial allergy, including syndrome of weak and average reactions, potentially influencing on skin, respiratory tract, gastrointestinal system and heart-vascular system, including such symptoms like rash, nettle rash, edema, irritation and cardio respiratory distress.
Contraindications
- increased individual sensitivity to drug components
- in case of damage of extensive parts of skin
- in case of eardrum perforation
Drug interaction
Chlorhexidine is incompatible with soap and other anionic compounds. As a precaution of possible interaction (antagonism or inactivation), Bepanthen Plus is not recommended to apply at the same time with other antiseptics.
Special indications
Avoid contact with eye, ears and mucous membranes.
Do not apply the drug on extended parts of skin.
Dexpanthenol together with chlorhexidine (Bepanthen® Plus) shall not applied during treatment of skin irrigation, possibility of infection of which is minimal (for example, sun burns). In such situation it is recommended to use creams or lotion with dexpanthenol.
Pregnancy and breast-feeding
The cream can be used during pregnancy and breast-feeding (before nursing it is required to wash off the drug).
Do not apply in case damage of large skin area during pregnancy and breast-feeding.
Effects on ability to drive and use potentially dangerous machines
Not effect.
Overdosage
Bepanten Plus is well tolerated even in large dosages, there is no indications of its toxicity in literature. Hypervitaminosis is not known. In case of accidental eye contact, rinse by water or physiological solution. Often repeated application of the drug on the same damaged area, can lead to skin irrigation.
Treatment. Stop using the drug. Symptomatic treatment.
Form of output and packing
30 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.
Name and country of the organization-manufacturer
GP Grenzach Produktions GmbH, Germany
Name and country of the organization-packager
GP Grenzach Produktions GmbH, Germany
Name and country of the Registration Certificate holder
Bayer Consumer Care AG, Switzerland
Name and country of the Registration Certificate holder
Bayer Consumer Care AG, 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
