DERMATRANS Transdermal patch Ref.[49857] Active ingredients: Glyceryl trinitrate

Source: Health Products Regulatory Authority (IE)  Revision Year: 2017  Publisher: Rottapharm Ltd, Damastown Industrial Park, Mulhuddart, Dublin 15

Product name and form

DERMATRANS 5 mg/24 h transdermal patch.

Pharmaceutical Form

Transdermal patch.

Each patch is circular, light yellow and transparent with printed identification code (NR5), covered by a square both sides aluminised and both sides siliconised protective liner.

Qualitative and quantitative composition

One transdermal patch contains 15.70 mg of glyceryl trinitrate/6.38 cm² delivering 5 mg of glyceryl trinitrate in 24 hours (0.2 mg/hour).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Glyceryl trinitrate

Glyceryl trinitrate is a vasodilator and is used for angina of effort. Vasodilation is achieved by the releasing of free redical nitric oxide which activates guanylate cyclase and increases synthesis of guanosine 3′ and 5′-monophosphate with resultant effects on the phosphorylation of proteins in smooth muscle. If taken in excess, its vasodilatory effect can cause headache.

List of Excipients

Acrylate-vinylacetate copolymer (Durotak 387-2516)
Hydroabietyl phthalate (Cellolyn 21 E)
Butyltitanate polymer
Lacquered polypropylene foil

Pack sizes and marketing

Immediate packaging:

The adhesive side of the patch is covered by a square both side aluminised and siliconised protective liner that is removed before use; each patch is sealed in a sachet consisting of Surlyn, heat sealable material, aluminium foil, polyethylene and paper.

Secondary packaging:

Cardboard box.

Each cardboard box contains 15 or 30 patches.

Not all pack sizes may be marketed.

Marketing authorization holder

Rottapharm Ltd, Damastown Industrial Park, Mulhuddart, Dublin 15

Marketing authorization dates and numbers

PA0868/006/001

Date of first authorisation: 14 April 2000
Date of last renewal: 14 April 2010

Drugs

Drug Countries
DERMATRANS Spain, Ireland, Italy

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