Glyceryl Trinitrate 5 mg/ml Sterile Concentrate

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Glyceryl trinitrate

Inapatikana kutoka:

Pfizer Healthcare Ireland

ATC kanuni:

C01DA; C01DA02

INN (Jina la Kimataifa):

Glyceryl trinitrate

Kipimo:

5 milligram(s)/millilitre

Dawa fomu:

Concentrate for solution for infusion

Dawa ya aina:

Product subject to prescription which may not be renewed (A)

Eneo la matibabu:

Organic nitrates; glyceryl trinitrate

Idhini hali ya:

Marketed

Idhini ya tarehe:

1987-10-01

Taarifa za kipeperushi

Page 1 of 8
2018-0042593
PACKAGE LEAFLET: INFORMATION FOR THE USER
GLYCERYL TRINITRATE 5MG/ML STERILE CONCENTRATE
glyceryl trinitrate
READ ALL OF THIS LEAFLET CAREFULLY, BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or
nurse.

If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Glyceryl Trinitrate 5mg/ml Sterile Concentrate is and what it is
used for
2.
What you need to know before you use Glyceryl Trinitrate 5mg/ml
Sterile Concentrate
3.
How to use Glyceryl Trinitrate 5mg/ml Sterile Concentrate
4.
Possible side effects
5.
How to store Glyceryl Trinitrate 5mg/ml Sterile Concentrate
6.
Contents of the pack and other information
1. WHAT GLYCERYL TRINITRATE 5MG/ML STERILE CONCENTRATE IS AND WHAT IT
IS USED FOR
Glyceryl Trinitrate 5mg/ml Sterile Concentrate contains glyceryl
trinitrate which is a
vasodilator (a medicine that widens the blood vessels).
Glyceryl trinitrate is used for the control of blood pressure during
operations or to improve
blood flow during and after heart operations. It can also be given to
you after
you have had a heart attack or to control angina attacks (sudden pains
in the chest)
when other medicines have not worked.
You must talk to a doctor if you do not feel better or if you feel
worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE GLYCERYL TRINITRATE 5MG/ML
STERILE
CONCENTRATE
DO NOT USE GLYCERYL TRINITRATE 5MG/ML STERILE CONCENTRATE:

if you are allergic to glyceryl trinitrate or medicines of the same
group (organic
nitrates) or any of the other ingredients of this medicine (listed in
section 6)

if you have low blood pressure or a low volume of blood in your
circulation (e.g. if
you have had severe blood loss)

if you suffer from increased intracranial pressure (high pressure
within the skull)
�

Tabia za bidhaa

Health Products Regulatory Authority
29 April 2022
CRN00CKJD
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Glyceryl Trinitrate 5 mg/ml Sterile Concentrate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains 5 mg glyceryl trinitrate. Each 5 ml and 10
ml ampoules contains 25 mg and 50 mg glyceryl trinitrate
respectively.
Excipients with known effect:
Each 5 ml ampoule contains 2639.2 mg ethanol and 223.6 mg propylene
glycol.
Each 10 ml ampoule contains 5278.4 mg ethanol and 447.2 mg propylene
glycol.
Each ampoule contains 527.84 mg/ml of ethanol (52.78% w/v) and 44.72
mg/ml of propylene glycol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion (Sterile Concentrate).
Clear, practically colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
SURGERY: Glyceryl trinitrate is indicated for the prompt control of
hypertension during cardiac surgery.
It may also be used for the production and maintenance of controlled
hypotension during surgical procedures.
Glyceryl trinitrate may be given for the control of myocardial
ischaemia both during and following cardiovascular surgery.
UNRESPONSIVE CONGESTIVE CARDIAC FAILURE SECONDARY TO ACUTE MYOCARDIAL
INFARCTION:
Glyceryl trinitrate may be used in patients presenting with
unresponsive congestive heart failure secondary to acute myocardial
infarction.
UNSTABLE ANGINA: Glyceryl trinitrate infusion may be used to reduce
myocardial oxygen demand in proportion to the reduction
in pre- and after-load. It may be indicated for the control of anginal
episodes in patients with unstable angina who do not
respond to standard treatment and/or beta-blockers.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The posology of glyceryl trinitrate i.v. should be adjusted to achieve
the desired clinical response.
_Adults_
The recommended dose range is 10-200 microgram/min, although larger
doses than this have been used. During some
surgical procedures, doses of up to 400 m