TRAUMON Gel Ref.[51169] Active ingredients: Etofenamate

Source: Medicines Authority (MT)  Revision Year: 2022  Publisher: Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

Product name and form

Traumon Gel 10%.

Pharmaceutical Form

Traumon Gel 10%: Gel.

Clear to slightly opalescent, colourless to slightly yellowish gel.

Qualitative and quantitative composition

Traumon Gel 10%: 1 g of gel contains 100 mg Etofenamate.

Other components with known effects: Propylene glycol (E1520): This medicine contains 51-99 mg propylene glycol in a 5-10 cm long gel line, which corresponds to 30 mg propylene glycol per 1 g Traumon Gel 10%.

For a complete list of other components, see section 6.1.

Active Ingredient Description
Etofenamate

Etofenamate is a flufenamic acid derivative, which is readily transported through the skin and concentrated in inflamed tissue, where it exerts anti-inflammatory and analgesic effects by inhibiting the release of histamine, lysosomal enzymes and prostaglandin.

List of Excipients

Traumon Gel 10%:

ฮฑ-Hexadecyl/(Z)-octadec-9-en-1-yl]-ฯ‰-hydroxypoly(oxyethylene)-8
Macrogol 400
Sodium hydroxide
Carbomer (average viscosity 50000 mPaยทs)
Isopropyl alcohol
Propylene glycol
Purified water

Pack sizes and marketing

Traumon Gel 10%:

Original packaging of 50 g gel.

Original packaging of 100 g gel.

Packaging for hospitals.

Not all package sizes may be marketed.

Marketing authorization holder

Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

Marketing authorization dates and numbers

MA1507/02301

18th January 2008/30th November 2012

Drugs

Drug Countries
TRAUMON Austria, Germany, Malta, Poland

ยฉ All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.