VOLTFAST Powder for oral solution Ref.[49860] Active ingredients: Diclofenac

Source: Health Products Regulatory Authority (IE)  Revision Year: 2020  Publisher: Wisdom Pharmaceutical Technology Co Limited, Wilton Park House, Wilton Place, Dublin 2, Ireland

Product name and form

Voltfast Sachets 50mg Powder for Oral Solution.

Pharmaceutical Form

Powder for oral solution.

White to light yellow powder for oral solution.

Qualitative and quantitative composition

The active ingredient is potassium [o-[(2,6-dichlorophenyl)-amino]-phenyl-acetate (diclofenac potassium).

One sachet contains 50 mg of diclofenac potassium.

One sachet also contains 50mg aspartame (E951).

For a full list of excipients, see section 6.1.

Active Ingredient Description
Diclofenac

Diclofenac is a non-steroidal anti-inflammatory drug. The mechanism of action of diclofenac in AK may be related to the inhibition of the cycloxygenase pathway leading to reduced prostaglandin E2 (PGE2) synthesis. In addition, immunohistochemistry (IHC) from skin biopsies ac revealed that the clinical effects of diclofenac in AK are primarily due to anti-inflammatory, anti-angiogenic and possibly anti-proliferative effects and apoptosis-inducing mechanisms.
List of Excipients

Potassium hydrogen carbonate
Mannitol
Aspartame
Saccharin sodium
Glyceryl dibehenate
Mint flavour
Anise flavour

Pack sizes and marketing

Sachet consisting of coupled paper/aluminium/polyethylene, hermetically sealed in four directions. Three sachets are packaged in one carton.

Marketing authorization holder

Wisdom Pharmaceutical Technology Co Limited, Wilton Park House, Wilton Place, Dublin 2, Ireland

Marketing authorization dates and numbers

PA2308/001/001

Date of first authorisation: 14 July 2006
Date of last renweal: 25 July 2008

Drugs

Drug Countries
VOLTFAST Ireland, Italy, Malta, Nigeria, New Zealand, Singapore
 
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