NITROJECT INJ 1MG/ML SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

NITROGLYCERIN

Dostopno od:

OMEGA LABORATORIES LIMITED

Koda artikla:

C01DA02

INN (mednarodno ime):

GLYCERYL TRINITRATE

Odmerek:

10MG

Farmacevtska oblika:

SOLUTION

Sestava:

NITROGLYCERIN 10MG

Pot uporabe:

INTRAVENOUS

Enote v paketu:

10ML

Tip zastaranja:

Ethical

Terapevtsko območje:

NITRATES AND NITRITES

Povzetek izdelek:

Active ingredient group (AIG) number: 0103615004; AHFS:

Status dovoljenje:

CANCELLED POST MARKET

Datum dovoljenje:

2022-06-20

Lastnosti izdelka

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