国: カナダ
言語: 英語
ソース: Health Canada
NITROGLYCERIN
OMEGA LABORATORIES LIMITED
C01DA02
GLYCERYL TRINITRATE
10MG
SOLUTION
NITROGLYCERIN 10MG
INTRAVENOUS
10ML
Ethical
NITRATES AND NITRITES
Active ingredient group (AIG) number: 0103615004; AHFS:
CANCELLED POST MARKET
2022-06-20
PRODUCT MONOGRAPH NITROJECT® (Nitroglycerin for Injection,USP) Sterile For Intravenous Infusion 10 mg/10 mL (1 mg/mL) & 50 mg/10 mL (5 mg/mL) VASODILATOR Omega Laboratories, Ltd. 11 177, Hamon Montreal, Canada H3M 3E4 Control Number: 153511 Date of Revision: June 26, 2012 2 NITROJECT® (NITROGLYCERIN FOR INJECTION, USP) STERILE FOR INTRAVENOUS INFUSION 1 MG/ML (10 MG/10 ML) & 5 MG/ML (50 MG/10 ML) CAUTION: SEVERAL PREPARATIONS OF NITROGLYCERIN FOR INJECTION ARE AVAILABLE. THEY DIFFER IN CONCENTRATION AND/OR VOLUME PER VIAL. WHEN SWITCHING FROM ONE PRODUCT TO ANOTHER ATTENTION MUST BE PAID TO DILUTION AND TO THE DOSAGE AND ADMINISTRATION INSTRUCTIONS. THERAPEUTIC CLASSIFICATION VASODILATOR ACTIONS AND CLINICAL PHARMACOLOGY The principal pharmacological action of NITROJECT® (Nitroglycerin for Injection, USP) is the relaxation of vascular smooth muscle. Nitrates probably act primarily by reducing oxygen demand rather than increasing myocardial oxygen supply. Although venous effects predominate, nitroglycerin produces, in a dose-related manner, dilatation of both arterial and venous beds. Dilation of the postcapillary vessels, including large veins, promotes peripheral pooling of blood and decreases venous return to the heart, reducing left ventricular end-diastolic pressure (preload). Arteriolar relaxation reduces systemic vascular resistance and arterial pressure (afterload). Left ventricular end diastolic pressure and volume are decreased, resulting in reduction of ventricular wall tension results in a net decrease in myocardial oxygen consumption (as measured by the pressure-rate product, tension time index and stroke work index). A favorable net balance between myocardial oxygen supply and demand is achieved. Elevated central venous and pulmonary capillary wedge pressures, pulmonary vascular resistance and systemic vascular resistance are also reduced by nitroglycerin therapy. Therapeutic doses of intravenous nitroglycerin reduce systolic, diastolic and mean arterial blood pressure. Effective coronary perfusio 完全なドキュメントを読む