Fentanyl GH Solution for Injection 500 microgram/10 mL ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fentanyl citrate, Quantity: 0.785 mg

Available from:

Generic Health Pty Ltd

INN (International Name):

Fentanyl citrate

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium hydroxide; water for injections; sodium chloride

Administration route:

Intravenous, Intramuscular

Units in package:

10 ampoules, 5 ampoules, 1 ampoule

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

Fentanyl GH Injection is indicated for: ,- analgesic action of short duration during anaesthetic periods, premedication, induction and maintenance, and in the immediate post-operative period (recovery room) as the need arises; ,- use as an opioid analgesic supplement in general and regional anaesthesia; ,- administration with a neuroleptic such as droperidol injection as an anaesthetic premedication, for the induction of anaesthesia, and as an adjunct in the maintenance of general and regional anaesthesia.

Product summary:

Visual Identification: Clear, colourless to almost colourless solution.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2013-12-13

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
FENTANYL GH
(FENTANYL CITRATE) SOLUTION FOR INJECTION
WARNING
LIMITATIONS OF USE
Fentanyl GH 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
Fentanyl GH 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
Fentanyl GH 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 Fentanyl GH 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 FENTANYL GH
Using Fentanyl GH with other medicines that can make you feel drowsy
such as sleeping tablets (eg.
benzodiazepines), other pain relievers, antihistamines,
antidepressants, antipsychotics, gabapentinoids
(eg. 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 Fentanyl GH.
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Fentanyl GH. 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
receiving Fentanyl GH against
the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS
ABOUT RECEIVING FENTANYL GH,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT FENTANYL GH IS
USED FOR
Fentanyl GH injection is a

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – FENTANYL GH
(FENTANYL CITRATE) SOLUTION FOR INJECTION
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, fentanyl
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 _
Fentanyl 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 fentanyl. 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 fentanyl.
1
NAME OF THE MEDICINE
Fentanyl citrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fentanyl GH is available in an ampoule containing 100 micrograms/2 mL
or 500 micrograms/10 mL of
fentanyl (as citrate).
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
T