البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
GLYCERYL TRINITRATE
NOVARTIS ISRAEL LTD
C01DA02
PATCHES
GLYCERYL TRINITRATE 50 MG/PATCH
TRANSDERMAL
Required
NOVARTIS PHARMA STEIN AG, SWITZERLAND
GLYCERYL TRINITRATE
GLYCERYL TRINITRATE
Prophylaxis of angina pectoris.
2015-04-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only NITRODERM TTS 5 Transdermal Patch ACTIVE INGREDIENT: Each patch contains 25 mg nitroglycerin. NITRODERM TTS 10 Transdermal Patch ACTIVE INGREDIENT: Each patch contains 50 mg nitroglycerin. INACTIVE INGREDIENTS: See section 6 “Further information”. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them, even if it seems to you that their ailment is similar. This medicine is not intended for children. If an angina attack has already started, you should use fast-acting nitrate preparations (sublingual tablets or spray) instead of Nitroderm TTS patches. 1. WHAT IS THE MEDICINE INTENDED FOR? This medicine is used to prevent or reduce the frequency of angina pectoris attacks. THERAPEUTIC GROUP: A vasodilator belonging to a group of medicines called nitrates. Nitroderm TTS is an adhesive patch containing the active substance nitroglycerin, which is delivered through the skin into the bloodstream. Nitroglycerin widens the blood vessels, which makes it easier for the heart to do its work. 2. BEFORE USING THE MEDICINE X DO NOT USE THIS PREPARATION IF: you are sensitive (allergic) to the active ingredient or any of the additional ingredients contained in the medicine, listed in section 6 “Further information” or to nitrates or nitrites. you suffer from a breakdown of the blood circulation, with very low blood pressure, such as in a state of shock. you suffer from increased intracranial pressure (a condition that your doctor will recognize and inform you about). you suffer from a disease of the valves of the heart or an inflammatory disease of the heart. you are currently taking a medicine to treat erectile اقرأ الوثيقة كاملة
NIT API JUN21 V4.1 Page 1 of 11 NITRODERM ® TTS (nitroglycerin) 25 mg or 50 mg transdermal patch PRESCRIBING INFORMATION 1 TRADE NAME NITRODERM ® TTS 5 NITRODERM ® TTS 10 2 DESCRIPTION AND COMPOSITION ACTIVE SUBSTANCE Nitroderm TTS contains Nitroglycerin (25mg or 50mg) in a transdermal therapeutic system (TTS). LIST OF EXCIPIENTS Lactose monohydrate, Dimeticone / Dimethicone, Silica, colloidal anhydrous / Colloidal silicon dioxide / Light Anhydrous Silicic Acid. 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 two systems are available: TABLE 2-1 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 during normal use. After 12 hours, for example, each system has delivered 10% of its original nitroglycerin content. 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. NIT API JUN21 V4.1 Page 2 of 11 3 INDICATIONS Prophylaxis of angina pectoris 4 DOSAGE AND ADMINISTRATION GENERAL RULES Nitroderm TTS is not intended for the immediate relief of acute at اقرأ الوثيقة كاملة