DBL MORPHINE TARTRATE 400mg/5mL Injection

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

morphine tartrate

Disponible des:

Pfizer Australia Pty Ltd

Estat d'Autorització:

Registered

Informació per a l'usuari

DBL™
Morphine Sulfate Injection and DBL™
Morphine Tartrate Injection CMI
Page 1
DBL™
MORPHINE SULFATE INJECTION
Morphine Sulfate Pentahydrate_ (_
_MOR-feen SUL-fate Pent-a-hy-drate) _
DBL™
MORPHINE TARTRATE INJECTION_ _
Morphine Tartrate_ _
_(MOR-feen TAR-trate) _
_ _
CONSUMER MEDICINE INFORMATION
_Date of Dispensing _
_Consumer Name _
_Pharmacist Name _
_Consumer Address _
_Pharmacist Address _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about DBL
Morphine Sulfate Injection and
DBL™
Morphine Tartrate Injection
(Morphine).
It does not contain all the available
information.
It does not take the place of talking
to your doctor or pharmacist.
All medicines have risks and
benefits
.
Your doctor has weighed
the risks of you being given
Morphine Injection against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET IN A SAFE PLACE
You may need to read it again.
WHAT MORPHINE
INJECTION IS USED FOR
Morphine is a pain reliever that
belongs to a group of medicines
called opioid analgesics. Morphine
acts in the brain and spinal cord.
It is used most commonly for relief
of severe pain. It may also be
used just before or during an
operation to help the anaesthetic
work better.
Your doctor may have prescribed
morphine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY MORPHINE
HAS BEEN PRESCRIBED FOR YOU.
Morphine may produce physical
dependency if used for a long time
(ie more than two weeks). Physical
dependency means you may
experience unpleasant feelings if
you stop morphine suddenly.
However, it is also important to
keep your pain under control. Your
doctor can advise you on how to
manage this.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU ARE GIVEN
MORPHINE INJECTION
_WHEN YOU MUST NOT BE _
_GIVEN IT _
YOU SHOULD NOT BE GIVEN
MORPHINE IF
YOU HAVE AN ALLERGY
TO MORPHINE, OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
Symptoms o

Fitxa tècnica

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Page 1 of 18
AUSTRALIAN
PRODUCT
INFORMATION
–
DBL™
MORPHINE
TARTRATE
(MORPHINE
TARTRATE)
1.
NAME OF THE MEDICINE
Morphine tartrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL™
Morphine
Tartrate
Injection
is
a
sterile
solution
containing
morphine
tartrate
trihydrate
80
milligrams/mL
[equivalent
to
morphine
sulphate
pentahydrate
78
milligrams/mL] and sodium metabisulphite 1 milligram/mL in water for
injections. The pH
of the solution ranges between 4.0 and 5.0.
Morphine tartrate is a crystalline powder, which is soluble in 11
parts of water, slightly
soluble in alcohol, and practically insoluble in chloroform, ether and
carbon disulfide.
Excipient(s) with known effect
Sodium metabisulfate
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
DBL™
Morphine
Tartrate
Injection
is
a
clear,
colourless
to
almost
colourless,
sterile
solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Morphine tartrate is indicated for the symptomatic relief of severe
and intractable pains of
various categories, in terminal cancer patients.
4.2
DOSE AND METHOD OF ADMINISTRATION
NOTE:
Opioid
antagonists
and
facilities
for
administration
of
oxygen
and
control
of
respiration should be available during, and immediately after
parenteral
administration of
morphine.
DOSAGE
ADULTS
The usual adult dose by intramuscular or subcutaneous injection is 5
to 20 milligrams. Doses
may be repeated every 4 to 6 hours.
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Morphine may be administered intravenously when a rapid onset of
action is desired. The
usual adult dose is 2.5 to 15 milligrams diluted in 4 to 5 mL of water
for injections given
slowly over 4 to 5 minutes.
The dose should be reduced in elderly patients, those with respiratory
impairment and in
patients receiving other CNS depressant medication. In severe or
chronic pain, the dose may
need to be adjusted according to the response and tolerance of the
patient.
Dosage reduction may b