Morphine Juno

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Morphine hydrochloride trihydrate 10 mg/mL equivalent to morphine base 7.58 mg/mL

Available from:

Juno Pharmaceuticals NZ Limited

INN (International Name):

Morphine hydrochloride trihydrate 10 mg/mL (equivalent to morphine base 7.58 mg/mL)

Dosage:

10 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Morphine hydrochloride trihydrate 10 mg/mL equivalent to morphine base 7.58 mg/mL Excipient: Hydrochloric acid Water for injection

Prescription type:

Class B1 Controlled Drug

Manufactured by:

S.A.L.A.R.S SpA

Therapeutic indications:

Morphine hydrochloride is indicated for: - the relief of moderate to severe pain not responsive to non-opioid analgesics - symptomatic relief of severe and intractable pains of various categories, in terminal cancer patients - use as a pre-operative medication and as an analgesic adjunct in general anaesthesia

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, Type I - 5 dose units - 24 months from date of manufacture stored at or below 25°C protect from light - Ampoule, glass, Type I - 10 dose units - 24 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

2015-07-06

Patient Information leaflet

Page 1
MORPHINE JUNO
Morphine hydrochloride injection
_(MOR-feen)_
_ _
_ _
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 Morphine Juno
morphine hydrochloride 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 Juno
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 JUNO 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 anesthetic 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 JUNO
_ _
_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 of an allergic reaction to morphine may include:
•
shortness of breath, wheezing or difficulty breathing
•
swelling of the face, lips, tongue or other parts of the body
•
rash, itching or hives on the skin.
YOU SHOULD NOT BE GIVE

Summary of Product characteristics

Datasheet – New Zealand
MORPHINE JUNO
_(MORPHINE HYDROCHLORIDE INJECTION) _
DATA SHEET
1. PRODUCT NAME
The name of the medicine is Morphine Juno as morphine hydrochloride
trihydrate, (10mg /mL,
20mg /mL, 50mg /5mL, 100mg/5mL) Solution for injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
morphine hydrochloride trihydrate 10mg/mL, 20mg/mL, 50mg /5mL,
100mg/5mL
For full list of excipients, see section 6.1
3. PHARMACEUTICALS FORM
Morphine Juno injection is a clear, colourless to almost colourless,
sterile solution for
injection.
The pH of the solution ranges between 3.0 and 5.0.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
MORPHINE JUNO IS INDICATED FOR
•
the relief of moderate to severe pain not responsive to non-opioid
analgesics
•
symptomatic relief of severe and intractable pains of various
categories, in terminal
cancer patients
•
use as a pre-operative medication and as an analgesic adjunct in
general anaesthesia.
4.2 DOSE AND METHOD OF ADMINISTRATION
NOTE
:
1
. Opioid antagonists and facilities for administration of oxygen and
control of
respiration
should
be
available
during,
and
immediately
after
parenteral
administration of morphine.
2
Morphine hydrochloride contains almost an equivalent amount of
morphine base
per milligram as morphine sulphate and morphine tartrate. Therefore,
the two
preparations may be used interchangeably.
Datasheet – New Zealand
Morphine Juno should be administered by subcutaneous, intramuscular or
slow intravenous
injection.
ADULTS
:
The usual adult dose is 5 to 20 milligrams. Doses may be repeated
every 4 to 6 hours.
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.
ELDERLY PATIENTS
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