Maracex 20mg/ml Solution for Inj/Inf (5ml vial)

Nazione: Malta

Lingua: inglese

Fonte: Malta Medicines Authority

Principio attivo:

MORPHINE HYDROCHLORIDE

Commercializzato da:

AS KALCEKS Krustpils iela 71E, Riga, LV-1057,, Latvia

Codice ATC:

N02AA01

INN (Nome Internazionale):

MORPHINE HYDROCHLORIDE 100 mg

Forma farmaceutica:

SOLUTION FOR INFUSION OR INJECTION

Composizione:

MORPHINE HYDROCHLORIDE 100 mg

Tipo di ricetta:

POM

Area terapeutica:

ANALGESICS

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2018-03-02

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE USER
MARACEX 20 MG/ML SOLUTION FOR INJECTION/INFUSION
Morphine hydrochloride
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.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, nurse or pharmacist.
This includes any
possible side effects not listed in this leaflet. See section 4.
IN THIS LEAFLET:
1.
What Maracex is and what it is used for
2.
What you need to know before you use Maracex
3.
How to use Maracex
4.
Possible side effects
5.
How to store Maracex
6.
Contents of the pack and other information
1.
WHAT MARACEX IS AND WHAT IT IS USED FOR
1 ml of solution contains 20 mg of morphine hydrochloride (hereafter
– morphine). The
active substance morphine belongs to a group of medicines called
natural opium alkaloids.
This medicine is indicated in severe pain conditions which can be
adequately managed only
with opioid analgesics.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MARACEX
DO NOT USE MARACEX:
-
if you are allergic to morphine hydrochloride or any of the other
ingredients of this
medicine (listed in section 6),
-
in conditions with a lot of mucus in the airways,
-
in impaired breathing function,
-
in acute liver disease,
-
in anxiety conditions in patients affected by alcohol or sleeping
medicines.
WARNINGS AND PRECAUTIONS
Talk to your doctor, nurse or pharmacist before using Maracex:
-
if your lung function is impaired (emphysema, cor pulmonale,
hypercapnia, hypoxia,
significant obesity); in such cases, it is especially important to pay
attention to
morphine’s depressive effect on breathing,
-
if you have recently suffered a head injury. The danger of a
significant increase in
intracranial pressure and of hypoventilation in h

Scheda tecnica

Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Maracex 20 mg/ml solution for injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains 20 mg of morphine hydrochloride equivalent
to 15.2 mg morphine.
One ampoule (1 ml) contains 20 mg of morphine hydrochloride equivalent
to 15.2 mg morphine.
One ampoule (5 ml) contains 100 mg of morphine hydrochloride
equivalent to 76 mg morphine.
One ampoule (10 ml) contains 200 mg of morphine hydrochloride
equivalent to 152 mg morphine.
Excipient with known effect: each ml contains 2.4 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection/infusion.
Clear colourless or yellowish solution free from visible particles.
pH of solution is 3.0-5.0 and osmolality is 280-310 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Severe pain conditions which can be adequately managed only with
opioid analgesics.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Because the duration of the effects of morphine and the intensity,
reason and duration of pain vary
greatly and because morphine is used in connection with e.g. very
different surgical procedures,
posology is individualised.
_ADULTS _
_Subcutaneous or intramuscular _
Adults: 5 – 20 mg, usual dose is 10 mg, if necessary repeat every 4
hours.
Elderly: 5 – 10 mg per dose.
The subcutaneous route is not suitable for oedematous patients.
_Intravenous _
Adults: 2.5 – 15 mg (if necessary, dilute in 0.9% saline),
administered in 4 to 5 minutes.
Page 2 of 13
_Epidural administration _
The usual initial dose is 2-4 mg, generally diluted in 0.9% saline
solution. After the analgesic effect
has ended, usually after 6-24 hours, a new dose of 1-2 mg may be
administered if needed. For long-
term pain management for cancer patients, larger doses and continuous
epidural infusion are usually
needed.
The daily dose usually does not exceed 100 mg per day in adults, but
in some individual cases it is
necessary to use a high