BETESIL Plaster Ref.[27917] Active ingredients: Betamethasone

Revision Year: 2019  Publisher: IBSA Farmaceutici Italia S.r.l., Via Martiri di Cefalonia 2, 26900, Lodi

Product name and form

BETESIL 2.250 mg medicated plaster.

Pharmaceutical Form

Medicated plaster.

Colourless plaster.

Qualitative and quantitative composition

Each 7.5 cm x 10 cm medicated plaster contains: 2.250 mg of betamethasone valerate (corresponding to 1.845 mg of betamethasone).

Excipients with known effect: methyl parahydroxybenzoate (2.250 mg), propyl parahydroxybenzoate (1.125 mg).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Betamethasone

Betamethasone is a glucocorticoid which is about eight to ten times as active as prednisolone on a weight-for-weight basis. Betamethasone has anti-inflammatory, antipruritic, and vasoconstrictive properties.

List of Excipients

Plaster: unwoven cloth (polypropylene/polyethylene and rayon fibres) laminated with an ethylenemethyl methacrylate copolymer film.

Adhesive layer: sodium hyaluronate, 1,3-butylene glycol, glycerol, disodium edetate, tartaric acid, aluminium glycinate, polyacrylic acid, sodium polyacrylate, hydroxypropylcellulose, carmellose sodium, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), purified water.

Protective film: polyethylene terephthalate film.

Pack sizes and marketing

Boxes: 4 medicated plasters / 8 medicated plasters / 16 medicated plasters

Each medicated plaster is packed individually in a paper/polyethylene/aluminium/ethylenemethacrylic acid copolymer sachet.

Each box includes adhesive strips for securing dressings (medical device).

Not all pack sizes may be marketed.

Marketing authorization holder

IBSA Farmaceutici Italia S.r.l., Via Martiri di Cefalonia 2, 26900, Lodi

Marketing authorization dates and numbers

PL 21039/0009

Date of first authorization: 12/03/2007
Date of latest renewal: 09/10/2011

Drugs

Drug Countries
BETESIL Austria, France, United Kingdom

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