Morphine Sulfate 30mg/ml, Solution for injection

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Morphine sulfate

Dostupné s:

Ethypharm

ATC kód:

N02AA; N02AA01

INN (Mezinárodní Name):

Morphine sulfate

Dávkování:

30 milligram(s)/millilitre

Léková forma:

Solution for injection

Terapeutické oblasti:

Natural opium alkaloids; morphine

Stav Autorizace:

Marketed

Datum autorizace:

2006-06-02

Informace pro uživatele

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MORPHINE SULFATE 10MG/ML AND 30MG/ML SOLUTION FOR INJECTION
Morphine Sulfate
(Referred to as Morphine Sulfate Injection in this leaflet)
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, or pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Morphine Sulfate Injection is and what it is used for
2. What you need to know before you are given Morphine Sulfate
Injection
3. How Morphine Sulfate Injection will be given
4. Possible side effects
5. How to store Morphine Sulfate Injection
6. Contents of the pack and other information
1.
WHAT MORPHINE SULFATE INJECTION IS AND WHAT IT IS USED FOR
Morphine is an opioid analgesic with powerful pain relieving
properties. This medicine is used for the
relief of moderate to severe pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN MORPHINE SULFATE INJECTION
YOU SHOULD NOT BE GIVEN MORPHINE SULFATE INJECTION IF:
-
you are allergic to Morphine Sulfate or any of the other ingredients
of this medicine listed in section
6.
-
you are currently taking drugs used to treat depression
-
known as monoamine oxidase inhibitors (MAOIs) or have taken them in
the last 2 weeks
-
you usually suffer from breathing difficulties (such as chronic
obstructive airways disease) or you
are currently
having an asthma attack or difficulty breathing
-
you are suffering from severe headaches or you have suffered a head
injury
-
you suffer from alcoholism
-
you suffer from heart problems as a result of long term
lung disease
-
you are suffering from stomach pains or you have
recently had abdominal surgery
-
you are suffering from a tumour of the adrenal gland
known as phaeochromocytoma
-
you suffer from a condition causing bluish discolo

Charakteristika produktu

Health Products Regulatory Authority
01 November 2023
CRN00DWH9
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Morphine Sulfate 30mg/ml, Solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml of solution for injection contains 30mg Morphine Sulfate.
metabisulfite
Excipients with known effect:
Total sodium content is 2.23 mg per ml, including 1.1mg of sodium
metabisulfite (E223).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection
A clear colourless or almost colourless, particle free solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Morphine Sulfate injection is indicated in adults & children for the
management of moderate to severe pain
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
The usual dose by subcutaneous or intramuscular injection is 10 to
15mg repeated every four hours if required.
The dosage should be adjusted according to the severity of the pain
and the response of the patient. In cases of terminal pain,
higher doses may be required.
Slow intravenous injection:
For intravenous use, 4 to 10mg, diluted in 4 to 5ml of Water for
Injections should be administered slowly over four to five
minutes
The Elderly and debilitated patients:
Caution is advised. A reduction in dose is advisable because of the
depressant effect on respiration.
Paediatric population:
Children from age one year: 0.1 to 0.2 mg/kg body weight by
subcutaneous or intramuscular injection every four hours as
required, not to exceed 15mg per dose.
Hepatic impairment:
A reduction in dosage should be considered in hepatic impairment.
Renal impairment:
The dosage should be reduced in moderate to severe renal impairment.
For concomitant illnesses/conditions where dose reduction may be
appropriate see Section 4.4
Discontinuation of therapy
Health Products Regulatory Authority
01 November 2023
CRN00DWH9
Page 2 of 8
An abstinence syndrome may be precipitated if opioid administration is
suddenly discontinued. Therefore, the dose should