Diamorphine 5mg powder for solution for injection ampoules

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Vedd Meg Most

Letöltés Betegtájékoztató (PIL)
15-06-2018
Letöltés Termékjellemzők (SPC)
15-06-2018

Aktív összetevők:

Diamorphine hydrochloride

Beszerezhető a:

Accord-UK Ltd

ATC-kód:

N07BC06

INN (nemzetközi neve):

Diamorphine hydrochloride

Adagolás:

5mg

Gyógyszerészeti forma:

Powder for solution for injection

Osztály:

Schedule 2 (CD)

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: 04070200; GTIN: 5012617018588

Betegtájékoztató

                                * Please note that ONLY Artwork Studio is permitted to make changes to
the above artwork.
No changes are permitted by any 3rd party other than added notes and
mark ups for required changes.
approved for print/date
PROOF ROUND
UK-Eire-Artwork-Support@Actavis.com
Technical
Approval
NON PRINTING COLOURS
COLOURS
DATE SENT:
DATE RECEIVED:
Item no:
ORIGINATOR:
ORIGINATION DATE:
REVISION DATE:
REVISED BY:
DIMENSIONS:
MIN BODY TEXT SIZE:
SUPPLIER:
1.
2.
3.
4.
5.
6.
1.
2.
3.
DIAMORPHINE HCI 5 10 AND 30MG PIL UK
Black
BBBA1712
C.Grant
23/01/18
30/01/18
C.Grant
296 x 129 mm
8.5pt
IL/IDT Biologika GmbH
23/01/18
30/01/18
02
READ ALL OF THIS LEAFLET CAREFULLY,
BEFORE YOU ARE GIVEN THIS INJECTION.
•
Keep this leaflet. You may need to
read it again.
•
If you have any other questions,
please ask your doctor.
•
If any of the side effects gets
serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor.
Before being used, the powder in the
ampoules will be mixed with a
liquid to make a solution which will
be given to you by injection. This is
called Diamorphine Hydrochloride
BP Injection in this leaflet.
1.
WHAT DIAMORPHINE
HYDROCHLORIDE BP INJECTION IS
AND WHAT IT IS USED FOR
2. BEFORE YOU ARE GIVEN THE
INJECTION
3. HOW THE INJECTION IS GIVEN
4. POSSIBLE SIDE EFFECTS
5. STORING THE INJECTION
6. FURTHER INFORMATION
1.
WHAT DIAMORPHINE
HYDROCHLORIDE BP
INJECTION IS AND WHAT IT IS
USED FOR
Diamorphine hydrochloride belongs
to a class of medicines known as
opioid analgesics. They help to
relieve pain.
Diamorphine Hydrochloride BP
Injection can be used to
•
relieve severe pain associated with
surgery, a heart attack or a
terminal illness, or
•
relieve breathlessness caused by
fluid in the lungs.
2. BEFORE DIAMORPHINE
HYDROCHLORIDE BP
INJECTION IS GIVEN TO YOU
DIAMORPHINE HYDROCHLORIDE BP
INJECTION IS NOT SUITABLE FOR
EVERYONE. TELL THE DOCTOR OR NURSE
THAT YOU MUST NOT HAVE THE
INJECTION IF:
•
you are aware that you are allergic
to diamorphine or any other opioid
analgesic such as codeine

                                
                                Olvassa el a teljes dokumentumot
                                
                            

Termékjellemzők

                                OBJECT 1
DIAMORPHINE HYDROCHLORIDE BP 5 MG
LYOPHILISATE FOR SOLUTION FOR INJECTION.
Summary of Product Characteristics Updated 01-Aug-2017 | Accord-UK Ltd
1. Name of the medicinal product
Diamorphine Hydrochloride BP 5 mg Lyophilisate for Solution for
Injection.
2. Qualitative and quantitative composition
Each ampoule contains 5 mg of Diamorphine Hydrochloride BP
3. Pharmaceutical form
Lyophilisate for solution for injection.
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_, 5 mg repeated every four hours if necessary (up to 10 mg
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_, 5-10 mg regularly every four hours by subcutaneous or
intramuscular injection. The dose
may be increased according to individual needs.
_Myocardial infarction_, 5 mg by slow intravenous injection (1
mg/minute) followed by a further 2.5 mg to
5 mg if necessary.
_Acute pulmonary oedema_, 2.5 mg to 5 mg by slow intravenous injection
(1mg/minute).
If breakthrough pain occurs give a subcutaneous (preferable) or
intramuscular injection of diamorphine
equivalent to one-sixth of the total 24-hour subcutaneous infusion
dose. It is kinder to give an intermittent
bolus injection _s
                                
                                Olvassa el a teljes dokumentumot
                                
                            

A termékkel kapcsolatos riasztások keresése