Morphine sulfate 10mg/1ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Morphine sulfate

Available from:

hameln pharma Ltd

ATC code:

N02AA01

INN (International Name):

Morphine sulfate

Dosage:

10mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intramuscular; Subcutaneous; Intravenous

Class:

Schedule 2 (CD)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070200; GTIN: 5016386222634

Patient Information leaflet

MORPHINE SULFATE INJECTION 10 MG PER ML
morphine sulfate
1. WHAT MORPHINE INJECTION IS AND WHAT IT
IS USED FOR
Morphine
Injection
belongs
to
a
group
of
medicines
known
as
PAINKILLERS
(opiate
analgesics). Morphine Injection is used to relieve
severe or very severe pain.
2. WHAT YOU NEED TO KNOW BEFORE YOU
USE MORPHINE INJECTION
DO NOT USE MORPHINE INJECTION:
• if you are
SENSITIVE
or
ALLERGIC
to morphine
or any of the other ingredients of this medicine
(listed in section 6)
• if you have a breathing disorder
• if you have a head injury or raised pressure
around your brain.
• if you have a convulsive disorder (epilepsy) or
suffer from
FITS
(seizures).
• if you have acute alcohol poisoning (intoxication).
• if you suffer from liver or kidney failure.
• if you have a narrowing of the tubes leading to
your bladder.
• if you have inflammation of your pancreas
• if you have impaired function of your gallbladder.
• if you have an inflammation of your bowel or a
bowel obstruction.
• if you have low blood pressure with a lack of
adequate circulatory filling.
• if you suffer from an enlarged prostate gland.
• if you have a
THYROID
problem.
• if you have
PHAEOCHROMOCYTOMA
- a tumour
of the adrenal gland.
• if you are
TAKING
any of the antidepressant
medicines known as
MONOAMINE OXIDASE
INHIBITORS
(MAOIs) or have taken them during
the
LAST TWO WEEKS.
• if you are unconscious (coma).
WARNINGS AND PRECAUTIONS:
Tell your doctor or nurse before using Morphine
Injection:
• if you have low blood pressure
• if you have an under-active thyroid gland
• if you have asthma or other breathing difficulties
• if you have kidney or liver disorders
CHILDREN:
This medicine is
NOT RECOMMENDED
for use in
children under 12 years of age. If you have any
concerns ask your doctor or pharmacist.
OTHER MEDICINES AND MORPHINE INJECTION:
Tell your doctor or nurse if you are using or
have
recently
used
or
might
use
any
other
medicines, including medicines obtained without a
prescription. This is especially importa

Summary of Product characteristics

OBJECT 1
MORPHINE SULFATE INJECTION 10 MG PER ML
Summary of Product Characteristics Updated 28-Sep-2015 | hameln
pharmaceuticals ltd
1. Name of the medicinal product
Morphine Sulfate Injection 10 mg per ml
2. Qualitative and quantitative composition
Each ml of sterile solution for injection contains 10 mg Morphine
Sulfate
For excipients see 6.1
3. Pharmaceutical form
Solution for injection
4. Clinical particulars
4.1 Therapeutic indications
Analgesic for severe and very severe pain.
4.2 Posology and method of administration
Morphine injection may be administered subcutaneously, intramuscularly
or intravenously. Dosage
should be adjusted according to the severity of the pain and the
response of the patient.
Appropriate starting doses are as follows:
Administration
Adults and adolescents over 12
years
Intravenously
2.5-10mg
Subcutaneously,
intramuscularly
5 - 20 mg
Individuals might require considerably higher doses for sufficient
relief of pain. In general, the minimum
effective dose should be administered.
For intravenous administration it is important to inject morphine
slowly over a period of 4 to 5 minutes
with the patient in the recumbent position.
For continuous intravenous infusion of morphine, appropriate starting
doses are 1-2 mg per hour in adults
and adolescents over 12 years. Daily doses will not usually exceed 100
mg per day in adults and
adolescents over 12 years, however, in cancer patients chronic
administration of higher doses up to 4 g
per day may occasionally be required.
Children under 12 years
This formulation is not recommended for use in children under 12
years.
In the Elderly
The dose of morphine should be reduced in elderly patients and
titrated to provide optimal pain relief with
minimal side effects. Morphine clearance decreases and half-life
increase in older patients.
In patients with disturbed Renal Function
Caution should be exercised in the use of Morphine in patients with
renal dysfunction i.e. renal failure,
because such patients can show signs of overdose following
conservative d