DBL™ Glyceryl Trinitrate

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Glyceryl trinitrate 5 mg/mL

Available from:

Pfizer New Zealand Limited

INN (International Name):

Glyceryl trinitrate 5 mg/mL

Dosage:

50 mg/10mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Glyceryl trinitrate 5 mg/mL Excipient: Ethanol Propylene glycol Water for injection

Units in package:

Ampoule, glass, 5x10mL, 50 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Dynamit Nobel GmbH

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, 5x10mL - 50 mL - 36 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

1985-09-12

Summary of Product characteristics

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Supersedes: pfdglyci10219
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NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
_ _
DBL™ Glyceryl Trinitrate, Solution for injection, 50 mg/10 mL
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each millilitre of DBL Glyceryl Trinitrate for Injection contains 5
milligrams of glyceryl
trinitrate, absolute ethanol and propylene glycol in Water for
Injections. DBL Glyceryl
Trinitrate for Injection is available in ampoules in 50 mg glyceryl
trinitrate/10 mL.
EXCIPIENT(S) WITH KNOWN EFFECT
•
Ethanol
•
Propylene glycol
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection for intravenous infusion.
4.
CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS
DBL Glyceryl Trinitrate for Injection for intravenous infusion, are
indicated as follows:
1.
Acute myocardial infarction with or without left ventricular failure.
2.
Left heart failure associated with subacute and acute pulmonary
oedema.
3.
To reduce ventricular ectopic activity following myocardial
infarction.
4.
To reverse symptomatic coronary artery spasm following provocative
testing in the
diagnosis of variant angina.
5.
Control
of
hypertension
during
surgical
cardiovascular
procedures
and
in
the
production of controlled hypotension during such procedures.
6.
Treatment of angina pectoris in patients who have not responded to
recommended doses
of organic nitrates and/or a beta blocker.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Dosage is affected by the type of infusion set used (see below).
Dosage recommendations
represented as microgram glyceryl trinitrate per minute can only be
offered as a starting
infusion rate. The correct dose for individual patients will be
determined by the response to
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Supersedes: pfdglyci10219
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therapy. All patients should be on continuous cardiovascular
monitoring during infusion
therapy.
When non-absorbing tubing is used the dosage for DBL Glyceryl
Trinitrate for Injection
infusion solution should be initially 5 microgram/minute delivered
thr