ORDINE morphine hydrochloride trihydrate 2mg/mL oral solution

Country: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

morphine hydrochloride trihydrate, Quantity: 2 mg/mL

Доступно од:

Arrotex Pharmaceuticals Pty Ltd

INN (Међународно име):

morphine hydrochloride trihydrate

Фармацеутски облик:

Oral Liquid, solution

Састав:

Excipient Ingredients: sodium methyl hydroxybenzoate; glycerol; sodium citrate dihydrate; water for injections; disodium edetate; citric acid

Пут администрације:

Oral

Јединице у пакету:

1 x 200mL

Тип рецептора:

(S8) Controlled Drug

Терапеутске индикације:

ORDINE oral solution is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

Резиме производа:

Visual Identification: Clear, colourless to pale yellow aqueous solution; Container Type: Bottle; Container Material: Polyethylene Terephthalate; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Статус ауторизације:

Licence status A

Датум одобрења:

2008-08-26

Информативни летак

ORDINE® oral solution
1
ORDINE
®
oral solution
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1. Why am I using ORDINE?
ORDINE contains the active ingredient morphine hydrochloride
trihydrate. ORDINE is used for the short-term relief of severe pain
for which other treatment options have failed, or otherwise unsuitable
to provide sufficient management of pain.
For more information, see Section 1. Why am I using ORDINE? in the
full CMI.
2. What should I know before I use ORDINE?
Do not use if you have ever had an allergic reaction to morphine or
any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become
pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use
ORDINE? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with ORDINE and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4. How do I use ORDINE?

Your doctor will tell you exactly how much to take.

Measure the dose accurately with a medicine measure.

Follow the instructions given to you by your doctor or your
pharmacist.

You must only take ORDINE by mouth.
More instructions can be found in Section 4. How do I use ORDINE? in
the full CMI.
5. What should I know while using ORDINE?
Things you
should do

Remind any doctor or dentist you visit that you are using ORDINE.

Tell your doctor or pharmacist if you are taking any other medicines
that you use to help you relax,
anything that contains alcohol (like cough syrup) or other medicines
that treat pain.
Things you
should not do

Do not stop using this medicine suddenly.

Do not take

Карактеристике производа

ORDINE
®
ORAL SOLUTION
Page 1 of 17
AUSTRALIAN PRODUCT INFORMATION – ORDINE
®
(MORPHINE
HYDROCHLORIDE TRIHYDRATE) ORAL SOLUTION
WARNINGS
Limitations of use
Because of the risks associated with the use of opioids, ORDINE oral
solution should only be
used in patients for whom other treatment options, including
non-opioid analgesics, are
ineffective, not tolerated or otherwise inadequate to provide
appropriate management of pain
(see Section 4.4 Special warnings and precautions for use).
Hazardous and harmful use
ORDINE oral solution poses risks of hazardous and harmful use which
can lead to overdose and
death. Assess the patient’s risk of hazardous and harmful use before
prescribing and monitor
the patient regularly during treatment (see Section 4.4. Special
warnings and precautions for
use).
Life threatening respiratory depression
Serious, life-threatening or fatal respiratory depression may occur
with the use of ORDINE oral
solution. Be aware of situations which increase the risk of
respiratory depression, modify
dosing in patients at risk and monitor patients closely, especially on
initiation or following a
dose increase (see Section 4.4 Special warnings and precautions for
use).
Concomitant use of benzodiazepines and other central nervous system
(CNS) depressants,
including alcohol
Concomitant use of opioids with benzodiazepines, gabapentinoids,
antihistamines, tricyclic
antidepressants, antipsychotics, cannabis or other central nervous
system (CNS) depressants,
including alcohol, may result in profound sedation, respiratory
depression, coma, and death.
Limit dosages and durations to the minimum required; and monitor
patients for signs and
symptoms of respiratory depression and sedation. Caution patients not
to drink alcohol while
taking ORDINE oral solution.
1
NAME OF THE MEDICINE
Morphine hydrochloride trihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ORDINE oral solution (1 mg/mL) contains morphine hydrochloride
trihydrate 1 mg/mL. *
ORDINE oral solution (2 mg/mL) contains morphine hydrochloride
tr