OXYCODONE WOCKHARDT oxycodone hydrochloride 20 mg/2 mL solution for injection or infusion, glass ampoules

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

oxycodone hydrochloride, Quantity: 10 mg/mL

Prieinama:

Wockhardt Bio Pty Ltd

INN (Tarptautinis Pavadinimas):

oxycodone hydrochloride

Vaisto forma:

Injection, solution

Sudėtis:

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

Vartojimo būdas:

Subcutaneous, Intravenous

Vienetai pakuotėje:

5 x 2mL Ampoules

Recepto tipas:

(S8) Controlled Drug

Terapinės indikacijos:

OXYCODONE Wockhardt 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.

Produkto santrauka:

Visual Identification: A clear colourless sterile solution of Oxycodone Hydrochloride in water for injection.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorizacija statusas:

Licence status A

Leidimo data:

2017-09-14

Pakuotės lapelis

OXYCODONE Wockhardt V3.0 Oct 2020
1
OXYCODONE WOCKHARDT
_(Oxycodone hydrochloride) _
_ _
CONSUMER MEDICINE INFORMATION
WARNING:
LIMITATIONS OF USE
Oxycodone Wockhardt 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
Oxycodone Wockhardt 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
Oxycodone Wockhardt 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 Oxycodone Wockhardt 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 OXYCODONE W
ockhardt
Using Oxycodone Wockhardt 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 minimise 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 Oxycodone Wockhardt.
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Oxycodone Wockhardt solution
for 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 benefits and
risks. Your doctor has weighed
the risks of using Oxycodone
Wockhardt 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 P

Prekės savybės

AUSTRALIAN PRODUCT INFORMATION – OXYCODONE WOCKHARDT
(OXYCODONE HYDROCHLORIDE) SOLUTION FOR INJECTION OR INFUSION
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, OXYCODONE
WOCKHARDT 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 _
OXYCODONE WOCKHARDT 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 OXYCODONE
WOCKHARDT]. 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 OXYCODONE WOCKHARDT.
OXYCODONE WOCKHARDT PI-V 4.1
Page
2 of 16
1
NAME OF THE MEDICINE
Oxycodone hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
OXYCODONE WOCKHARDT 10 mg in 1 mL; 20 mg in 2 mL Solution for
injection or infusion contains
10mg/ml of oxycodone