DBL GLYCERYL TRINITRATE 50mg/10mL Injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

glyceryl trinitrate, Quantity: 50 mg

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: ethanol absolute; propylene glycol; water for injections

Administration route:

Intravenous

Units in package:

5x50mg/10mL(E), 5x50mg/10mL

Prescription type:

Not scheduled. Not considered by committee, (S4) Prescription Only Medicine

Therapeutic indications:

Glyceryl Trinitrate Concentrate Injection is indicated for: Control of blood pressure in perioperative hypertension associated with surgical procedures, especially cardiovascular procedures, such as the hypertension seen during intratracheal intubation, anaesthesia, skin incision, sternotomy, cardiac bypass and in the immediate post-surgical period. Congestive heart failure associated with acute myocardial infarction. Treatment of angina pectoris in patients who have not responded to recommended doses of organic nitrates and/or a beta blocker. Production of controlled hypotension during neurosurgical and orthopaedic surgical procedures.

Product summary:

Visual Identification: Clear colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

1991-10-08

Patient Information leaflet

DBL™ Glyceryl Trinitrate for Injection CMI
Page 1
DBL™ GLYCERYL TRINITRATE FOR
INJECTION
Glyceryl Trinitrate _ (GLIS-er-ile tri-NITE-rate)_
CONSUMER MEDICINE INFORMATION
_Date of Dispensing_
_ _
_Consumer Name _
_Pharmacist Name _
_Consumer Address _
_Pharmacist Address _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about DBL™
Glyceryl Trinitrate for Injection
(Glyceryl trinitrate).
It does not contain all the
available information.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given
glyceryl trinitrate against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET
IN A SAFE PLACE.
You may need to read it again.
WHAT DBL™ GLYCERYL
TRINITRATE FOR INJECTION
IS USED FOR
Glyceryl trinitrate belongs to a
group of medicines called nitrates
or vasodilators. It relaxes the
muscles surrounding blood
vessels (arteries and veins) and
so helps more blood and oxygen
reach the heart. It is also used to
control or lower the blood
pressure during some surgical
procedures.
Your doctor may have prescribed
glyceryl trinitrate for another
reason. Ask your doctor if you
have any questions about why
glyceryl trinitrate has been
prescribed for you.
Glyceryl trinitrate is not addictive.
This medicine is available only
with a doctor’s prescription.
Glyceryl trinitrate is not
recommended for use in children,
as there is not enough information
on its effects in children.
BEFORE YOU ARE GIVEN
DBL™ GLYCERYL
TRINITRATE FOR INJECTION
_WHEN YOU MUST NOT BE _
_GIVEN IT _
YOU SHOULD NOT BE GIVEN DBL™
GLYCERYL TRINITRATE FOR INJECTION
IF YOU HAVE AN ALLERGY TO
GLYCERYL TRINITRATE OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
Symptoms of an allergic reaction
to glyceryl trinitrate may include:
•
shortness of breath, wheezing
or difficulty breathing
•
swelling of the face, lips,
tongue or oth

Summary of Product characteristics

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Page 1 of 11
AUSTRALIAN
PRODUCT
INFORMATION
–
DBL™
GLYCERYL
TRINITRATE
CONCENTRATE
INJECTION
(GLYCERYL
TRINITRATE)
1.
NAME OF THE MEDICINE
Glyceryl trinitrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each millilitre of DBL™ Glyceryl Trinitrate Concentrate Injection
contains 5 milligrams of
glyceryl trinitrate, absolute ethanol and propylene glycol in Water
for Injections.
EXCIPIENT WITH KNOWN EFFECT
Ethanol absolute
For the full list of excipients, see
SECTION 6.1
LIST OF EXCIPIENTS
.
3.
PHARMACEUTICAL FORM
Glyceryl trinitrate is a white to pale yellow, thick, flammable,
explosive liquid. It is slightly
soluble
in
water,
and
soluble
in
acetone,
alcohol,
carbon
disulphide,
chloroform,
dichloromethane, ether, ethyl acetate, glacial acetic acid and
methanol.
DBL™ Glyceryl Trinitrate Concentrate Injection is a sterile, clear,
practically colourless
solution for intravenous infusion after dilution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DBL™ Glyceryl Trinitrate Concentrate Injection is indicated for:
•
Control of blood pressure in perioperative hypertension, ie
hypertension associated with
surgical procedures, especially cardiovascular procedures, such as the
hypertension seen
during intratracheal intubation, anaesthesia, skin incision,
sternotomy, cardiac bypass and
in the immediate post-surgical period.
•
Congestive heart failure associated with acute myocardial infarction.
•
Treatment of angina pectoris in patients who have not responded to
recommended doses of
organic nitrates and/or a beta blocker.
•
Production of controlled hypotension during neurosurgical and
orthopaedic surgical
procedures.
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Page 2 of 11
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
The initial dosage of glyceryl trinitrate when non-absorbing tubing is
used should be 5
micrograms/min, delivered through an infusion pump capable of exact
and constant delivery
of the drug. Subsequent titration must be adjusted to the clinical
situation, with dose increments
becoming
mor