Morphine sulfate 15 mg/ml solution for injection

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MORPHINE SULFATE

Available from:

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

ATC code:

N02AA01

INN (International Name):

MORPHINE SULFATE 15 mg

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

MORPHINE SULFATE 15 mg

Prescription type:

POM

Therapeutic area:

ANALGESICS

Authorization status:

Authorised

Authorization date:

2018-09-28

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

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Morphine sulfate 10 mg/ml solution for injection
Morphine sulfate 15 mg/ml solution for injection
Morphine sulfate 30 mg/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.
1 ml of solution contains 15 mg of morphine sulfate.
Excipient with known effect: Also contains 2.89 mg of sodium per ml.
1 ml of solution contains 30 mg of morphine sulfate.
Excipient with known effect: Also contains 2.24 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.
Method of administration
The injectio