Morphine sulfate 10mg/ml Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Morphine sulphate

Available from:

AS Kalceks

ATC code:

N02AA01

INN (International Name):

Morphine sulphate

Dosage:

10 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

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

Therapeutic area:

morphine

Authorization status:

Marketed

Authorization date:

2018-11-30

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
MORPHINE SULFATE 10 MG/ML, 15 MG/ML AND 30 MG/ML SOLUTION FOR
INJECTION
Morphine sulfate
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 or nurse.
-
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 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 is and what it is used for
2.
What you need to know before you are given Morphine sulfate
3.
How Morphine sulfate will be given to you
4.
Possible side effects
5.
How to store Morphine sulfate
6.
Contents of the pack and other information
1.
WHAT MORPHINE SULFATE IS AND WHAT IT IS USED FOR
Morphine is one of a group of medicines called opioid analgesics,
which are used to relieve
moderate to severe pain.
Morphine is used for the relief of severe pain and it is also used to
treat breathlessness caused by
fluid in the lungs and as a pre-medication before operations in
adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN MORPHINE SULFATE
DO NOT USE MORPHINE SULFATE IF YOU:
-
are allergic to active substance or any of the other ingredients of
this medicine (listed in
section 6);
-
have conditions that make breathing difficult, such as obstructive
airways disease or your
breathing is weak;
-
are taking, or have recently taken (in the past two weeks) any drugs
for depression known
as monoamine oxidase inhibitors (MAOIs);
-
have head injuries, headaches or have increased pressure in the skull
(raised intracranial
pressure);
-
have problems related to fluid on the brain (cerebral oedema);
-
suffer from convulsions (fits);
-
have severe stomach cramps caused by a condition known as biliary
colic;
-
are suffering from acut

Summary of Product characteristics

Health Products Regulatory Authority
26 May 2023
CRN00DC8J
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Morphine sulfate 10mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains 10 mg of morphine sulfate.
Excipient with known effect: Also contains 3.11 mg of sodium per ml.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection (injection).
Clear colourless or almost colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Morphine is used for the symptomatic relief of severe pain; relief of
dyspnoea of left ventricular failure and pulmonary oedema
of cardiogenic origin; pre-operative use in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The dosage should be based on the severity of the pain and the
response and tolerance of the patient. The usual adult
subcutaneous or intramuscular dose is 10 mg every 4 hours, if
necessary, but may range from 5 mg to 20 mg.
The usual adult intravenous dose is 2.5 mg to 15 mg not more than
4-hourly, where necessary, but dosage and dosing interval
must be titrated against the patient's response and adjustments made
until analgesia is achieved.
_Elderly_
Because of the depressant effect on respiration, caution is necessary
when giving morphine to the elderly and reduced doses
may be required.
_Paediatric population_
Use in children is not recommended.
_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
An abstinence syndrome may be precipitated if opioid administration is
suddenly discontinued. Therefore the dose should be
gradually reduced prior to discontinuation.
Method of administration
The injection may be given by the intravenous, intramuscular or
subcutaneous route.
The subcutaneous rou