Diamorphine 30mg powder for solution for injection ampoules

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Diamorphine hydrochloride

Disponible depuis:

Wockhardt UK Ltd

Code ATC:

N07BC06

DCI (Dénomination commune internationale):

Diamorphine hydrochloride

Dosage:

30mg

forme pharmaceutique:

Powder for solution for injection

Mode d'administration:

Intravenous; Subcutaneous; Intramuscular

classe:

Schedule 2 (CD)

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 04070200; GTIN: 5012727900698

Notice patient

MEASURE BAR SHOULD BE 150MM AT 100% SCALE
Customer
Description
Item Code
Profile
Size
Min. Point Size
Market
Language
Proof By
Proof No.
Date
Artwork No.
Pharma
Code
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Wockhardt UK Limited
Diamorphine Amp Common Flat WUK leaflet
103917/4
W-LFT001
460 X 150mm
tom.robertson
1
17/08/2015
589280
242
Process Black
Text free area (non-printing)
Keyline (non-printing)
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UK
English
7.5pt
PACKAGE LEAFLET: INFORMATION FOR THE USER
DIAMORPHINE HYDROCHLORIDE 5MG, 10MG, 30MG,
100MG, 250MG AND 500MG FOR INJECTION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING
THIS MEDICINE.
- Keep this leaflet. You may need to read it again.
-
If you have further questions, please ask your doctor,
nurse or pharmacist.
-
This medicine has been prescribed for you personally
and you should not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor, nurse or pharmacist.
In this leaflet:
1. What Diamorphine Injection is and what it is used for
2. Before you are given Diamorphine Injection
3. How Diamorphine Injection should be given
4. Possible side effects
5. How to store Diamorphine Injection
6. Further information
1. WHAT DIAMORPHINE INJECTION IS AND WHAT
IT IS USED FOR
Diamorphine is one of a group of medicines called
opioid analgesics which are used 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 lun

Résumé des caractéristiques du produit

OBJECT 1
DIAMORPHINE HYDROCHLORIDE 30MG FOR INJECTION
Summary of Product Characteristics Updated 14-Dec-2015 | Wockhardt UK
Ltd
1. Name of the medicinal product
Diamorphine Hydrochloride 30mg for Injection
2. Qualitative and quantitative composition
Each ampoule contains 30mg of diamorphine hydrochloride
For full list of excipients, see section 6.1.
3. Pharmaceutical form
A white to off-white, sterile, freeze-dried powder of Diamorphine
Hydrochloride BP 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
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.
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.
_Re