GLYCERYL TRINITRATE MEDSURGE glyceryl trinitrate 50 mg/50 mL concentrated solution for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

glyceryl trinitrate, Quantity: 50 mg

Available from:

Medsurge Pharma Pty Ltd

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: glucose; glucose monohydrate; propylene glycol; water for injections

Administration route:

Intravenous

Units in package:

1 x 50 mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

GLYCERYL TRINITRATE MEDSURGE is indicated for:,? Control of blood pressure in perioperative hypertension, i.e. 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, free from visible particles; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2019-05-07

Patient Information leaflet

GLYCERYL TRINITRATE WOCKHARDT
Version 1
1
GLYCERYL TRINITRATE WOCKHARDT_ _
GLYCERYL TRINITRATE (_GLIS-ER-ILE TRI-NITE-RATE_)_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
GLYCERYL TRINITRATE
WOCKHARDT (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 taking
this medicine 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 GLYCERYL
TRINITRATE
WOCKHARDT 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 GLYCERYL
TRINITRATE
WOCKHARDT
_WHEN YOU MUST NOT BE _
_GIVEN IT _
YOU SHOULD NOT BE GIVEN
GLYCERYL TRINITRATE
WOCKHARDT IF YOU HAVE AN
ALLERGY TO GLYCERYL TRINITRATE OR
ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET.
Some of the symptoms of an
allergic reaction may include:
•
shortness of breath
•
wheezing or difficulty
breathing
•
swelling of the face, lips,
tongue or other parts of the
body
•
rash, itching or hives on the
skin
You should not be given
glyceryl trinitrate if you have
any of the following conditions:
•
low blood pressure
•
a rece

Summary of Product characteristics

GLYCERYL TRINITRATE WOCKHARDT
Version 2 6 September 2021
1
AUSTRALIAN PRODUCT INFORMATION – GLYCERYL TRINITRATE
WOCKHARDT (GLYCERYL TRINITRATE) CONCENTRATED
SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Glyceryl trinitrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains glyceryl trinitrate 50 mg in 50 mL.
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.
Contains glucose (2.53 g/50 mL vial). For the full list of excipients,
see
SECTION 6.1 LIST OF
EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Concentrated solution for injection
GLYCERYL TRINITRATE WOCKHARDT is a clear, colourless solution, free
from visible
particles.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
GLYCERYL TRINITRATE WOCKHARDT is indicated for:
•
Control of blood pressure in perioperative hypertension, i.e.
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.
GLYCERYL TRINITRATE WOCKHARDT
Version 2 6 September 2021
2
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 more cautious as partial response is seen. Initial
titration should be in
5 micrograms/min increments, wi