OXYNORM oxycodone hydrochloride 50 mg/1 mL solution for injection ampoule

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

oxycodone hydrochloride, Quantity: 50 mg/mL

Tersedia dari:

Mundipharma Pty Ltd

INN (Nama Internasional):

oxycodone hydrochloride

Bentuk farmasi:

Injection, solution

Komposisi:

Excipient Ingredients: citric acid monohydrate; sodium citrate dihydrate; water for injections; sodium hydroxide; sodium chloride; hydrochloric acid

Rute administrasi :

Intravenous, Subcutaneous

Unit dalam paket:

1 mL x 5 ampoules

Jenis Resep:

(S8) Controlled Drug

Indikasi Terapi:

OxyNorm solution for infusion 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.

Ringkasan produk:

Visual Identification: clear, colourless to pale yellow solution, practically free from particulates; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius

Status otorisasi:

Registered

Tanggal Otorisasi:

2010-05-12

Selebaran informasi

OXYNORM
® SOLUTION FOR
INJECTION OR INFUSION
_Oxycodone hydrochloride (ox-ee-code-own hi-dro-klor-ide)_
CONSUMER MEDICINE INFORMATION
WARNING:
LIMITATIONS OF USE
OxyNorm should only be used when your doctor decides that other
treatment options are not able to effectively manage your
pain or you cannot tolerate them.
HAZARDOUS AND HARMFUL USE
OxyNorm poses risks of abuse, misuse and addiction which can lead to
overdose and death. Your doctor will monitor you
regularly during treatment.
LIFE THREATENING RESPIRATORY DEPRESSION
OxyNorm can cause life-threatening or fatal breathing problems (slow,
shallow, unusual or no breathing) even when used as
recommended. These problems can occur at any time during use, but the
risk is higher when first starting OxyNorm and
after a dose increase, if you are older, or have an existing problem
with your lungs. Your doctor will monitor you and change
the dose as appropriate.
USE OF OTHER MEDICINES WHILE USING OXYNORM
Using OxyNorm with other medicines that can make you feel drowsy such
as sleeping tablets (e.g. benzodiazepines), other
pain relievers, antihistamines, antidepressants, antipsychotics,
gabapentinoids (e.g. gabapentin and pregabalin), cannabis and
alcohol may result in severe drowsiness, decreased awareness,
breathing problems, coma and death. Your doctor will mini-
mise the dose and duration of use; and monitor you for signs and
symptoms of breathing difficulties and sedation. You must
not drink alcohol while using OxyNorm.
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about OxyNorm solution
for injection or infusion ("injection or
infusion").
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 this
medicine against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, TALK TO
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET IN A SAFE PLACE.
You

Karakteristik produk

OxyNorm
®
solution for injection or infusion
Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION – OXYNORM
® (OXYCODONE
HYDROCHLORIDE) SOLUTION FOR INJECTION OR INFUSION
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, OxyNorm
solution for injection or
infusion 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 _
OxyNorm solution for injection or infusion 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 OxyNorm
solution for injection or infusion. 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 OxyNorm solution for injection or
infusion.
1
NAME OF THE MEDICINE
Oxycodone hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSI