Morphine-hameln 10 mgml Injection

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

MORPHINE 7.52 mg/mL EQV MORPHINE SULPHATE PENTAHYDRATE

Available from:

ZYFAS PHARMA PTE LTD

ATC code:

N02AA01

Dosage:

10mg

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

MORPHINE 7.52 mg/mL EQV MORPHINE SULPHATE PENTAHYDRATE 10mg

Administration route:

INTRAVENOUS, SUBCUTANEOUS, INTRAMUSCULAR

Prescription type:

Prescription Only

Manufactured by:

Siegfried Hameln GmbH

Authorization status:

ACTIVE

Authorization date:

2009-02-09

Summary of Product characteristics

MORPHINE-HAMELN 10 MG/ML INJECTION
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Morphine-hameln 10 mg/ml Injection
Active substance: Morphine sulfate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injection contains:
Morphine sulfate 5 H
2
O 10.00 mg, equivalent to morphine 7.52 mg
3.
PHARMACEUTICAL FORM
Solution for injection
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Morphine sulfate is indicated for the relief of moderate to severe
pain not re-
sponsive to non-opioid analgesics. It may also be used as a
pre-operative med-
ication and as an analgesic adjunct in general anaesthesia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Subcutaneous, intramuscular and slow intravenous administration
_Adults_
Morphine sulfate is usually administered by intramuscular or
subcutaneous
injection, in the range of 5 to 20 mg, depending on the cause of pain
and the
patient response. Doses may be repeated every 4 to 6 hours.
Morphine sulfate may also be given intravenously when a rapid onset of
action
is desired. The dose is usually in the range of 2.5 to 15 mg diluted
in 4 to 5 ml of
water for injections given slowly over 4 to 5 minutes.
_Children_
Morphine sulfate is given by intramuscular or subcutaneous injection
in doses of
0.1 to 0.2 mg/kg bodyweight to a maximum of 15 mg. Injection may be
repeated
every 4 to 6 hours.
When a rapid onset of action is desirable, in a closely monitored
environment,
morphine may be titrated intravenously with caution, in a dose of 0.05
to 0.1
mg/kg, incrementally over 5 to 15 minutes. Repeat intravenous dosing
is unsub-
stantiated as a method of analgesia in children.
Morphine sulfate is not usually given pre-operatively in children
under 1 year,
and it should be given with extreme care to neonates. It should not be
given to
premature infants _(_see_ Contraindications)_.
Continuous intravenous infusion
The dosage of morphine should be titrated according to the patient‘s
analgesic
requirements and previous opiate experience. For the management of
acut