Nitrocine 1 mg/ml solution for infusion, ampoule

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Glyceryl trinitrate

Available from:

Merus Labs Luxco II S.à.R.L.

ATC code:

C01DA; C01DA02

INN (International Name):

Glyceryl trinitrate

Dosage:

1 milligram(s)/millilitre

Pharmaceutical form:

Solution for infusion

Prescription type:

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

Therapeutic area:

Organic nitrates; glyceryl trinitrate

Authorization status:

Not marketed

Authorization date:

1983-05-23

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NITROCINE
® 1 MG/ML SOLUTION FOR INFUSION
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 further questions, please ask your doctor or pharmacist

This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours

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 Nitrocine is and what it is used for
2. What you need to know before you are given Nitrocine
3. How you will be given Nitrocine
4. Possible side effects
5. How to store Nitrocine
6. Contents of the pack and other information.
1. WHAT NITROCINE IS AND WHAT IT IS USED FOR
Nitrocine belongs to a group of medicines called ‘nitrates’. These
are used to widen your
blood vessels and reduce the workload of your heart.
NITROCINE IS USUALLY USED IN EMERGENCY SITUATIONS TO:

Rapidly control high blood pressure during surgery, especially heart
surgery

Treat unstable angina. (Angina attacks feel like a tight pain in your
chest, neck or arm
and are a sign that your heart is not getting enough oxygen for the
amount of work it
is doing)

Treat heart failure following a heart attack. It is very important
that your doctor treats
these conditions as quickly and effectively as possible, as left
untreated the
consequences could be fatal.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN NITROCINE
DO NOT USE NITROCINE:

If you are allergic to glyceryl trinitrate or any of the other
ingredients of this
medicine (listed in section 6)

If you are allergic to any other nitrates

If you are taking medicines for failure to achieve an erection such as
Viagra. Using
Nitrocine with these medicines could cause a severe drop in blood
pressure and c

Summary of Product characteristics

Health Products Regulatory Authority
12 January 2021
CRN00C3GS
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nitrocine 1 mg/ml solution for infusion, ampoule
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ampoules containing 10 mg glyceryl trinitrate in 10 ml (1 mg/ml).
For a full list of excipients see Section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
Clear colourless and odourless isotonic sterile solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Surgery_
Nitrocine is indicated for:
1.
The rapid control of hypertension during cardiac surgery.
2.
Reducing blood pressure and maintaining controlled hypotension during
surgical procedures.
3.
Controlling myocardial ischaemia during and after cardiovascular
surgery.
_Unresponsive congestive heart failure:_
Nitrocine may be used to treat unresponsive congestive heart failure
secondary to acute myocardial infarction.
_Unstable angina:_
Nitrocine may be used to treat unstable angina which is refractory to
treatment with beta blockers and sublingual nitrates.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
The dose of Nitrocine should be adjusted to meet the individual needs
of the patient.
The recommended dosage range is 10 - 200 mcg/min but up to 400 mcg/min
may be necessary during some surgical
procedures.
_Elderly_
There is no evidence that a posology adjustment is required in the
elderly.
_Paediatric population_
The safety and efficacy of Nitrocine has not yet been established in
children.
_Surgery_:
A starting dose of 25 mcg/min is recommended for the control of
hypertension, or to produce hypotension during surgery.
This may be increased by increments of 25 mcg/min at 5 minute
intervals until the blood pressure is stabilized. Doses between
10 - 200 mcg/min are usually sufficient during surgery, although doses
of up to 400 mcg/min have been required in some
cases.
The treatment of perioperative myocardial ischaemia may be started
with a dose of 15 - 20 mcg/min, with subsequent
increments of 10 - 15 mcg/m