Cyclimorph 10 solution for injection

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

CYCLIZINE TARTRATE; Morphine tartrate

Saadav alates:

Amdipharm Limited

ATC kood:

N02AA; N02AA51

INN (Rahvusvaheline Nimetus):

CYCLIZINE TARTRATE; Morphine tartrate

Annus:

10 mg/ml + 50 milligram(s)/millilitre

Ravimvorm:

Solution for injection

Retsepti tüüp:

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

Terapeutiline ala:

Natural opium alkaloids; morphine, combinations

Volitamisolek:

Not marketed

Loa andmise kuupäev:

1978-04-01

Infovoldik

PACKAGE LEAFLET: INFORMATION FOR THE USER
CYCLIMORPH
®
10 SOLUTION FOR INJECTION AND CYCLIMORPH
®
15 SOLUTION FOR INJECTION
morphine tartrate and cyclizine tartrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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, pharmacist or
nurse.
-
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 Cyclimorph Injection is and what it is used for
2.
What you need to know before you are given Cyclimorph Injection
3.
How Cyclimorph Injection will be given to you
4.
Possible side effects
5.
How to store Cyclimorph Injection
6.
Contents of the pack and other information
1.
WHAT CYCLIMORPH INJECTION IS AND WHAT IT IS USED FOR
The name of your medicine is Cyclimorph 10 mg Solution for Injection
or Cyclimorph 15 mg Solution for
Injection (called Cyclimorph Injection in this leaflet). It contains
morphine tartrate which belongs to a group
of drugs called opioids. Cyclimorph Injection also contains cyclizine
tartrate which is an anti-histamine with
activity against feeling sick (nausea) and being sick (vomiting).
Cyclimorph Injection is used in adults and
children for the relief of moderate to severe pain in which reduction
of nausea and vomiting associated with
morphine is required.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CYCLIMORPH INJECTION
YOU SHOULD NOT BE GIVEN THIS MEDICINE :
-
if you are allergic to morphine tartrate, cyclizine tartrate or any of
the other ingredients of this
medicine (listed in section 6)
-
if you are suffering from breathing problems or excessive phlegm (such
as asthma or bronchitis)
-
if you have been told your heart is not working properly (heart
failure)
-
if you are suffering from a head injury
-
if you have raised pressure around the brain
-
if you are suffering from stomach problems such

Toote omadused

Health Products Regulatory Authority
21 December 2023
CRN00DWC1
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cyclimorph 10 solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Cyclimorph 10 Injection contains morphine tartrate 10 mg and cyclizine
tartrate 50 mg (equivalent to 39.01 mg cyclizine) in
each 1 ml ampoule.
Excipient with known effect:
Sodium metabisulphite (E223) (1 mg /1 ml ampoule).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection (Injection)
A clear very slightly coloured solution. pH 4.3 - 5.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cyclimorph Injection is indicated in adults and children for the
relief of moderate to severe pain in all suitable medical and
surgical conditions (see section 4.3 and 4.4) in which reduction of
the nausea and vomiting associated with the administration
of morphine is required.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and children over 12 years _
The usual dose is 10-20 mg morphine tartrate, given subcutaneously,
intramuscularly or intravenously. Additional doses may
not be given more frequently than 4-hourly.
Not more than 3 doses (representing 150 mg cyclizine tartrate: i.e. 3
ml of Cyclimorph 10
Injection) should be given in any
24-hour period.
_Elderly_
Morphine doses should be reduced in elderly patients and titrated to
provide optimal pain relief with minimal side effects since:

Increased duration of pain relief from a standard dose of morphine has
been reported in elderly patients.

A review of pharmacokinetic studies has suggested that morphine
clearance decreases and half-life increases in
older patients.

The elderly may be particularly sensitive to the adverse effects of
morphine.
_Paediatric population_
_Children 6‑12 years:_ 5‑10 mg morphine tartrate as a maximum
single dose.
_Children 1‑5 years: _ 2.5‑5 mg morphine tartrate as a maximum
single dose.
Health Products Regulatory Authority
21 December 2023
CRN00DWC1
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