Nchi: Israeli
Lugha: Kiingereza
Chanzo: Ministry of Health
GLYCERYL TRINITRATE
NOVARTIS ISRAEL LTD
C01DA02
PATCHES
GLYCERYL TRINITRATE 25 MG/PATCH
TRANSDERMAL
Required
NOVARTIS PHARMA STEIN AG, SWITZERLAND
GLYCERYL TRINITRATE
Prophylaxis of angina pectoris.
2015-04-30
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 Soma hati kamili