Страна: Малайзия
Език: английски
Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Nitroglycerin, diluted
SANDOZ PRODUCTS MALAYSIA SDN. BHD.
Nitroglycerin, diluted
30 Pieces
LTS Lohmann Therapie-Systeme AG
_Consumer Medication Information Leaflet (RiMUP) _ NITRODERM ® TTS TRANSDERMAL PATCH Nitroglycerin Transdermal Patch (25 mg, 50 mg) 1 WHAT IS IN THIS LEAFLET 1. What Nitroderm TTS is used for 2. How Nitroderm TTS works 3. Before you use Nitroderm TTS 4. How to use Nitroderm TTS 5. While you are using Nitroderm TTS 6. Side effects 7. Storage and Disposal of Nitroderm TTS 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT NITRODERM TTS IS USED FOR Nitroderm TTS belongs to a group of medicines called nitrates which widen the blood vessels. This medicine is used to prevent or reduce the frequency of angina attacks (chest pain or discomfort). HOW NITRODERM TTS WORKS Nitroderm TTS works by widening the blood vessels, which makes it easier for the heart to do its work. It may also be used for other conditions as determined by your doctor. If an angina attack has already started, you should use a fast- acting nitrate (sublingual tablets or spray) instead of Nitroderm TTS patches. BEFORE YOU USE NITRODERM TTS Follow all the doctor’s instructions carefully. They may differ from the general information contained in this leaflet. _When you must not use it _ If you are allergic (hypersensitive) to nitroglycerin, to any excipient of Nitroderm TTS, or to nitrates or nitrites. If you suffer from a breakdown of the blood circulation with very low blood pressure, such as in shock. If you have increased intracranial pressure (an increase of pressure in the brain). If you suffer from a disease of the valves of the heart or an inflammatory disease of the heart. If you are currently taking a medicine to treat erectile dysfunction from the group of so-called phosphodiesterase type 5 inhibitors (e.g. sildenafil). If any of these apply to you, tell your doctor without taking Nitroderm TTS. _ _ _PREGNANCY AND BREAST-FEEDING _ There is little experience with the use of Nitroderm TTS in pregnant women. You should tell your doctor if you are pregnant, or i Прочетете целия документ
Novartis Page 1 Malaysian Package Leaflet 15 Nov 2017 Nitroderm TTS® NITRODERM TTS TRANSDERMAL PATCH Vasodilator used in cardiac diseases DESCRIPTION AND COMPOSITION ACTIVE SUBSTANCE Nitroderm TTS contains Nitroglycerin( 25 mg, or 50 mg) in a transdermal therapeutic system (TTS). LIST OF EXCIPIENTS Silica, colloidal anhydrous and dimethicone. PHARMACEUTICAL FORM Transdermal patch Flat multilayer system designed to deliver nitroglycerin continuously through a release membrane following application to the skin. The release membrane limits delivery through hyperpermeable skin. The active substance penetrates the skin and thus becomes directly bioavailable to the systemic circulation at relatively constant concentrations during the recommended application period. The following three systems are available: TABLE 1 NITRODERM TTS PHARMACEUTICAL FORMS Nitroderm TTS 5 Nitroderm TTS 10 Nitroglycerin content 25 mg 50 mg Drug-releasing area 10 cm 2 20 cm 2 Imprint (backing side) CG CG DOD DPD Colour of the release liner off-white to yellowish The numeric components of the product designations TTS 5 and TTS 10 denote the nominal amount of nitroglycerin in mg delivered by the system per 24 hours. The remainder of the nitroglycerin in each system serves as a reserve and is not delivered in normal use. After 12 hours, for example, each system has delivered 10% of its original content of nitroglycerin. Since nitroglycerin is released from Nitroderm TTS at a constant rate per cm , the dose administered is related to the size of the drug-releasing area. The nominal rate of nitroglycerin release in vivo is approximately 20-25 microgram/cm .h. The following cross-sectional diagram shows the composition of Nitroderm TTS. Novartis Page 2 Malaysian Package Leaflet 15 Nov 2017 Nitroderm TTS® DESCRIPTION Nitroderm TTS 5: Flat, foil patch, sealed at the edges, with white paste-like filling, one side with a greyish- orange backing film with imprint “CG DOD”, the other side with an off-white protective liner. Shape: oblong, Прочетете целия документ