Diamorphine Hydrochloride 5mg for injection

Šalis: Malta

kalba: anglų

Šaltinis: Medicines Authority

Veiklioji medžiaga:

DIAMORPHINE HYDROCHLORIDE

Prieinama:

Pinewood Laboratories Limited Ballymacarbry, Clonmel, Co. Tipperary, Ireland

ATC kodas:

N07BC06

INN (Tarptautinis Pavadinimas):

DIAMORPHINE HYDROCHLORIDE 5 mg

Vaisto forma:

POWDER FOR INJECTION

Sudėtis:

DIAMORPHINE HYDROCHLORIDE 5 mg

Recepto tipas:

POM

Gydymo sritis:

OTHER NERVOUS SYSTEM DRUGS

Autorizacija statusas:

Withdrawn

Leidimo data:

2019-03-26

Pakuotės lapelis

Page
1
of
14
PACKAGE LEAFLET: INFORMATION FOR THE USER
DIAMORPHINE HYDROCHLORIDE 5MG, 10MG, 30MG, 100MG, 250MG AND 500MG
FOR INJECTION
THIS MEDICINE CONTAINS DIAMORPHINE HYDROCHLORIDE WHICH IS AN OPIOID,
WHICH CAN CAUSE
ADDICTION. YOU CAN GET WITHDRAWAL SYMPTOMS IF YOU STOP TAKING IT
SUDDENLY.
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, nurse or
pharmacist.
- If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Diamorphine Injection is and what it is used for
2.
What you need to know before you are given Diamorphine Injection
3.
How Diamorphine Injection should be given
4.
Possible side effects
5.
How to store Diamorphine Injection
6.
Contents of the pack and other information
1.
WHAT DIAMORPHINE INJECTION IS AND WHAT IT IS USED FOR
This medicine had been prescribed for you to relieve moderate to
severe pain. Diamorphine is used
for the relief of severe pain associated with surgical procedures,
heart attack and pain in terminally
ill patients. It is also used to treat breathlessness caused by fluid
in the lungs.
It contains diamorphine hydrochloride which belongs to a class of
medicines called opioids, which
are ‘pain relievers’.
This medicine has been prescribed to you and should not be given to
anyone else.
Opioids can cause addiction and you may get withdrawal symptoms if you
stop taking it suddenly.
Your prescriber should have explained how long you will be taking it
for and when it is appropriate
to stop, how to do this safely.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DIAMORPHINE INJECTION
DIAMORPHINE INJECTION SHOULD NOT BE GIVEN IF YOU:
•
have ever had a reaction to or been told that you are allergic to
diamorphine or morphine
•
have
been
told
you
have
a
tumour
of
the
adrenal
gland

Prekės savybės

Page
1
of
6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diamorphine Hydrochloride 5mg for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
DIAMORPHINE HYDROCHLORIDE 5MG FOR INJECTION
- Each ampoule contains 5mg of Diamorphine Hydrochloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
A white to off-white, sterile, freeze-dried powder of Diamorphine
Hydrochloride for reconstitution for injection.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Diamorphine may be used in the treatment of severe pain associated
with surgical procedures, myocardial infarction or
pain in the terminally ill and for the relief of dyspnoea in acute
pulmonary oedema.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
Diamorphine may be given by the intramuscular, intravenous or
subcutaneous routes. Glucose intravenous infusion is
the preferred diluent, particularly when the drug is administered by a
continuous infusion pump over 24 to 48 hours,
although it is also compatible with sodium chloride intravenous
infusion.
The dose should be suited to the individual patient.
Posology
ADULTS:
ACUTE PAIN:
5mg repeated every four hours if necessary (up to 10mg for heavier,
well muscled patients) by
subcutaneous or intramuscular injection. By slow intravenous
injection, one quarter to one half the corresponding
intramuscular dose.
CHRONIC PAIN:
5-10mg regularly every four hours by subcutaneous or intramuscular
injection. The dose may be
increased according to individual needs.
MYOCARDIAL INFARCTION:
5mg by slow intravenous injection (1mg/minute) followed by a further
2.5mg to 5mg if
necessary.
ACUTE PULMONARY OEDEMA:
2.5mg to 5mg by slow intravenous injection (1mg/minute).
CHILDREN AND ELDERLY:
As diamorphine has a respiratory depressant effect, care should be
taken when giving the drug to the very young and the
elderly and a lower starting dose than normal is recommended.
HEPATIC IMPAIRMENT:
A reduction in dosage should be considered in hepatic impairment.
RENAL IMPAIRMENT:
Th