البلد: ماليزيا
اللغة: الإنجليزية
المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
GLYCERYL TRINITRATE
Vitamode Sdn.bhd
GLYCERYL TRINITRATE
1 (100 actuations) Units; 1 (200 actuations) Units
Beximco Pharmaceuticals Ltd.
Please refer to section E12 اقرأ الوثيقة كاملة
NITROSOL ® Sublingual Aerosol Spray 400 mcg/actuation VASODILATOR Each Actuation Delivers: GLYCERYL TRINITRATE BP 400 MCG PRODUCT DESCRIPTION It is a clear solution of Glyceryl Trinitrate which is filled into aluminium can fitted onto a valve. The propellant 1, 1, 1, 2- Tetrafluoroethane (HFA 134a) is then filled into the can through valve. The can fitted with valve is then again fitted with an actuator, collar and safety hood. This is then packed inside an inner carton with leaflet inside. PHARMACODYNAMICS Glyceryl trinitrate relieves angina pectoris by reduction of cardiac work and dilation of the coronary arteries. In this way, not only is there a lessening in arterial oxygen requirement but the amount of oxygenated blood reaching the ischaemic heart is increased. PHARMACOKINETICS The pharmacokinetics of glyceryl trinitrate are complex; venous plasma levels of the drug show wide and variable fluctuations and are not predictive of clinical effect. In a human pharmacodynamic study, pharmacological activity had commenced one minute after dosing and was obvious by two minutes. INDICATION For the treatment and prophylaxis of angina pectoris and the treatment of variant angina. RECOMMENDED DOSE At the onset of an attack, one or two metered sprays should be administered on or under the tongue. A spray may be repeated approximately every 5 minutes as needed. No more than 3 metered sprays are recommended within a 15 minute period. If chest pain persists after a total of 3 sprays, prompt medical attention is recommended. Nitrosol ® may be used prophylactically 5 to 10 minutes before engaging in activities that might precipitate an acute attack. MODE OF ADMINISTRATION _SUBLINGUAL_ During use the patient should rest, ideally in the sitting position. The container should be held vertically with the valve head uppermost and the spray orifice as close to the mouth as possible. The dose should preferably be sprayed into the mouth on or under the tongue by pressing the button firmly and the mouth should be closed immediately اقرأ الوثيقة كاملة