Glyceryl trinitrate 50mg/50ml solution for infusion vials

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Glyceryl trinitrate

Tilgjengelig fra:

hameln pharma Ltd

ATC-kode:

C01DA02

INN (International Name):

Glyceryl trinitrate

Dosering :

1mg/1ml

Legemiddelform:

Solution for infusion

Administreringsrute:

Intravenous

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 02060100; GTIN: 5016386003226

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GLYCERYL TRINITRATE 1 MG/ML SOLUTION FOR INFUSION
WHAT IS IN THIS LEAFLET:
1. What Glyceryl Trinitrate is and what it is used for
2. What you need to know before you receive Glyceryl Trinitrate
3. How to use Glyceryl Trinitrate
4. Possible side effects
5. How to store Glyceryl Trinitrate
6. Contents of the pack and other information
1.
WHAT GLYCERYL TRINITRATE IS AND WHAT IT IS
USED FOR
Glyceryl Trinitrate belongs to a group of drugs called nitrates. This
medicine is used to prevent and relieve the pain or discomfort of
an angina attack (chest pain). It relaxes the muscle around blood
vessels and makes the heart’s work easier.
This solution is only used in hospitals and is given to you by a
doctor or nurse. It is used in the following conditions:
•
heart failure and acute myocardial infarction (heart attack)
•
angina attack
•
to lower blood pressure during surgery
•
to control blood pressure during and after cardiac surgery
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE
GLYCERYL TRINITRATE
DO NOT USE GLYCERYL TRINITRATE:
•
IF YOU ARE ALLERGIC (hypersensitive) to nitrate medicines or to
any of the other ingredients in Glyceryl Trinitrate (See section
6).
•
IF YOU ARE TAKING a medicine for the treatment of erectile
dysfunction (e.g. sildenafil vardenafil, tadalafil). If you take
Glyceryl Trinitrate concomitantly with such medicines a severe
and possibly dangerous fall in blood pressure can occur. This
would result in collapse, unconsciousness and could be fatal.
You should not take such medicines whilst on Glyceryl Trinitrate
treatment.
•
if you are in shock (a life-threatening medical condition where
insufficient blood flow reaches the body tissues)
•
if you have severe anaemia (lack of red blood cells)
•
if you have low blood pressure
•
if you have low blood volume
•
if you have low blood oxygen (this can make you feel fatigued
and short of breath) and angina caused by a heart disease
where the muscle mass of the left heart ventricle is enlarged
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Preparatomtale

OBJECT 1
GLYCERYL TRINITRATE 1MG/ML SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 30-Sep-2016 | hameln
pharmaceuticals ltd
1. Name of the medicinal product
Glyceryl Trinitrate 1 mg/ml solution for infusion
2. Qualitative and quantitative composition
1 ml solution contains 1 mg glyceryl trinitrate.
Amount of active substance per pack size:
TOTAL VOLUME
TOTAL GTN CONTENT
CONTAINER
5ml
5mg
ampoule
10ml
10mg
ampoule
25ml
25mg
ampoule
50ml
50mg
vial
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for infusion
The product is a clear and colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
The following indications exist for Glyceryl Trinitrate:
• Unresponsive congestive heart failure, including that secondary to
acute myocardial infarction; acute
left-sided heart failure and acute myocardial infarction,
• Refractory unstable angina pectoris and coronary insufficiency,
including Prinzmetal's angina,
• Control of hypertensive episodes and/or myocardial ischaemia
during and after cardiac surgery,
• Induction of controlled hypotension for surgery.
4.2 Posology and method of administration
For intravenous use. Glyceryl Trinitrate should be administered by
means of a micro-drip set infusion
pump or similar device which permits maintenance of constant infusion
rate.
Recommendations on the dilution of the product are presented in this
section. For further instructions on
dilution of the product before administration, see section 6.6.
_Adults_
The dose of Glyceryl Trinitrate 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.
_Paediatric population_
The safety and efficacy of Glyceryl Trinitrate has not yet been
established in children.
_Elderly population_
There is no evidence that a posology adjustment is required in the
elderly
USE IN SURGERY
A starting dose of 25 mcg/min is recommended for the control of
hypertens