ASPEN FENTANYL fentanyl (as citrate) 500 microgram/10 mL solution for injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fentanyl citrate, Quantity: 785 microgram (Equivalent: fentanyl, Qty 500 microgram)

Available from:

Aspen Pharmacare Australia Pty Ltd

INN (International Name):

Fentanyl citrate

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium chloride; water for injections

Administration route:

Intramuscular, Intravenous

Units in package:

5's and 10's

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

Short duration analgesia during premedication, induction and maintenance of anaesthesia, and in the immediate postoperative period. Opioid analgesic supplement to general and regional anaesthesia. Combination with a neuroleptic as an anaesthetic premedication for the induction of anaesthesia, and as an adjunct in the maintanance of general and regional anaesthesia.

Product summary:

Visual Identification: Clear and colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2011-08-03

Patient Information leaflet

ASPEN FENTANYL – Consumer Medicine Information
Page 1 of 5
ASPEN FENTANYL SOLUTION FOR INJECTION
_fentanyl citrate _
_ _
CONSUMER MEDICINE INFORMATION (CMI)
WARNINGS
_LIMITATIONS OF USE _
Aspen Fentanyl 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 _
Aspen Fentanyl 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 _
Aspen Fentanyl 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 Aspen Fentanyl 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 ASPEN FENTANYL _
Using Aspen Fentanyl 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 Aspen Fentanyl.
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask
about ASPEN FENTANYL. It
does not contain all the
information that is known about
ASPEN FENTANYL.
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 ASPEN FENTANYL
against the benefits they expect
it will have for you.
IF YOU HAVE ANY CONCERNS
ABOUT BEING GIVEN THIS
MEDICINE, A

Summary of Product characteristics

Fentanyl-pi-6nov20
1
AUSTRALIAN PRODUCT INFORMATION
ASPEN FENTANYL (FENTANYL CITRATE)
SOLUTION FOR INJECTION
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, Aspen
Fentanyl injections 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 _
Aspen Fentanyl injections 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 Aspen
Fentanyl injections. 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 Aspen Fentanyl injections.
1
NAME OF THE MEDICINE
Fentanyl citrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Aspen Fentanyl solution for injection contains fentanyl citrate 0.0785
mg/mL (equivalent to
fentanyl 0.05 mg/mL) as the active ingredient. For the full li