NITRODERM TTS Transdermal patch Ref.[28290] Active ingredients: Glyceryl trinitrate

Source: Υπουργείο Υγείας (CY)  Revision Year: 2019  Publisher: Novartis Ireland Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland LOCAL REPRESENTATIVE: Novartis Pharma Services Inc., Methonis Tower, 73 Archibishop Makarios III Avenue, 1070 Nicosia ...

Product name and form

NITRODERM TTS 5.

Pharmaceutical Form

Transdermal patch.

Qualitative and quantitative composition

Nitroglycerin on lactose 250mg equivalent to nitroglycerin 25mg.

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

The active ingredient is Nitroglycerin 10% w/w on lactose.

Other excipients are: lactose monohydrate, dimeticone, silica, colloidal andhydrous, colloidal silicon dioxide, light anhydrous sillicic acid.

Pack sizes and marketing

Individual patches in a sealed pouch (made of paper/PE/AL/surlyn*). 10, 28 or 30 sealed patches in each cardboard container.

  • Aluminium 12µm ± 10%, polyethylene 16G/m² ± 20%, surlyn 20G/m² ± 15%.

Not all pack sizes may be marketed.

Marketing authorization holder

Novartis Ireland Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

LOCAL REPRESENTATIVE: Novartis Pharma Services Inc., Methonis Tower, 73 Archibishop Makarios III Avenue, 1070 Nicosia

Marketing authorization dates and numbers

Nitroderm TTS 5: 18485

Date of first authorisation: 28 September 1999
Date of latest renewal: 19 September 2011

Drugs

Drug Countries
NITRODERM TTS Austria, Cyprus, Germany, Ecuador, Spain, Hong Kong, Israel, Japan, Mexico, New Zealand, Turkey

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