Morphine sulfate 100mg/50ml solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Morphine sulfate

Available from:

Torbay Pharmaceuticals

ATC code:

N02AA01

INN (International Name):

Morphine sulfate

Dosage:

2mg/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous

Class:

Schedule 2 (CD)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070200; GTIN: 05060131261904

Patient Information leaflet

PATIENT INFORMATION LEAFLET
MORPHINE SULFATE 2MG IN 1ML SOLUTION FOR INJECTION
•
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
KEEP THIS LEAFLET IN A SAFE PLACE, YOU MAY WISH TO READ IT AGAIN.
•
IF YOU HAVE ANY QUESTIONS OR ARE NOT SURE ABOUT ANYTHING, ASK YOUR
DOCTOR OR PHARMACIST.
•
IF ANY SIDE EFFECT GETS SERIOUS, OR IF YOU NOTICE ANY SIDE EFFECTS
NOT LISTED IN THIS LEAFLET, PLEASE TELL YOUR DOCTOR OR PHARMACIST.
IN THIS LEAFLET:
1. WHAT MORPHINE SULFATE SOLUTION FOR INJECTION IS AND WHAT IT IS USED
FOR
2. BEFORE YOU ARE GIVEN MORPHINE SULFATE SOLUTION FOR INJECTION
3. HOW MORPHINE SULFATE SOLUTION FOR INJECTION IS USED
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE MORPHINE SULFATE SOLUTION FOR INJECTION
6. FURTHER INFORMATION
1. WHAT MORPHINE SULFATE SOLUTION FOR INJECTION IS AND WHAT IT IS USED
FOR
Morphine Sulfate, the active ingredient, belongs to a group of strong
painkilling medicines called
opioids which must be used only under a doctor’s instruction.
This medicine is a solution for injection that has been prepared in
water so that it can be used
with specially designed pumps which provide a continuous injection
into the body. It is used in the
long term relief of moderate to severe pain, such as the pain caused
by surgery, heart attacks and
cancer. This medicine also helps to reduce the anxiety and
sleeplessness which may be caused
by the pain.
2. BEFORE YOU ARE GIVEN MORPHINE SULFATE SOLUTION FOR INJECTION
THIS MEDICINE SHOULD NOT BE USED IF YOU:
• Are allergic to Morphine Sulfate or any other strong painkilling
drugs
• Have a history of alcohol abuse
• Suffer from malfunctioning of the adrenal gland
(phaeochromocytoma)
• Have suffered a head injury
• Are at risk of a paralytic ileus (reduced gut motility)
• Have acute respiratory depression (breathlessness)
• Have raised pressure inside your skull
Check with your doctor if you are concerned about any of the above.
BEFORE USING THIS MEDICINE PLEASE TELL YOUR DOCTOR IF YOU:
• Are pregnant or breast feed

Summary of Product characteristics

OBJECT 1
MORPHINE SULFATE 2MG IN 1ML SOLUTION FOR
INJECTION
Summary of Product Characteristics Updated 14-Jul-2017 | Torbay &
South Devon NHS Foundation
Trust
1. Name of the medicinal product
Morphine Sulfate 2mg in 1mL Solution for Injection
2. Qualitative and quantitative composition
Each mL of sterile solution for injection contains 2mg Morphine
Sulfate.
For excipients, see 6.1
3. Pharmaceutical form
Solution for injection.
The solution is clear, colourless and visibly free from particles.
4. Clinical particulars
4.1 Therapeutic indications
Morphine Sulfate Solution for Injection is indicated for the relief of
moderate to severe pain. Morphine is
used especially in pain associated with cancer, myocardial infarction
and surgery. Morphine also helps to
relieve the anxiety and insomnia which may be associated with severe
pain.
4.2 Posology and method of administration
_Adults and children over 12 years:_
Morphine Sulfate Solution for Injection is formulated for use by the
intravenous route in Patient
Controlled Analgesia (PCA) systems. PCA, which permits adjustment of
dosage according to the patient's
individual needs, must only be carried out in departments and by staff
who are trained and have
experience of the system. Patient selection for the use of PCA must
ensure that the patient is capable of
understanding and following the instructions of the medical/nursing
staff. The specific department or unit
protocols must be covered to ensure aseptic transfer of the contents
of the vial to the PCA system.
There is a considerable variation in analgesic requirements among
patients and therefore individualised
treatment strategies are required. Dosage should be based on the
severity of the pain and the response and
opiate tolerance of the patient.
Loading Dose
Loading doses of typically between 1mg and 10mg (maximum 15mg) of
morphine sulfate may be given
by intravenous infusion over four or five minutes. The loading dose
used will depend upon the patient's
diagnosis and conditions.
PCA demand dose
An initial demand dos