ASTRAZENECA FENTANYL 500 microgram/10mL (as citrate) injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fentanyl citrate, Quantity: 78.6 microgram/mL (Equivalent: fentanyl, Qty 50 microgram/mL)

Available from:

Juno Pharmaceuticals Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intramuscular, Intravenous

Units in package:

10mL x 10

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

INDICATIONS AS AT 31 JULY 2003: Short duration analgesia during pre-medication, induction and maintenance of anaesthesia, and in the immediate post operative period. Opioid analgesic supplement to general and regional anaesthesia. Combination with a neuroleptic as an anaesthetic pre medication for the induction of anaesthesia, and as an adjunct in the maintenance of general and regional anaesthesia.

Product summary:

Visual Identification: Clear colourless particle free solution; Container Type: Ampoule; Container Material: PE; Container Life Time: 18 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1994-05-23

Patient Information leaflet

FENTANYL INJECTION
BP
_Fentanyl citrate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
Fentanyl. It does not contain all the
information that is known about
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 Fentanyl
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET. YOU MAY NEED TO
READ IT AGAIN.
WHAT FENTANYL IS FOR
Fentanyl is a powerful drug used to
relieve pain and produce sleepiness.
It can be used as a premedication
before an operation, or with a general
anaesthetic during an operation. It
can also be used after painful
operations to reduce the pain that you
feel.
Fentanyl belongs to a group of
medicines called opioid (narcotic)
analgesics.
Fentanyl works by changing the
messages that are sent to the brain
about pain.
Your doctor will have explained why
you are being treated with Fentanyl
and told you what dose you will be
given. Follow all directions given to
you by your doctor carefully. They
may differ from the information
contained in this leaflet.
Your doctor may prescribe this
medicine for another use. Ask your
doctor if you want more information.
Fentanyl can be addictive, but when
it is used only to relieve or prevent
pain it is unlikely to become habit
forming.
BEFORE YOU ARE GIVEN
FENTANYL
_WHEN YOU MUST NOT USE IT_
YOU SHOULD NOT BE GIVEN FENTANYL
IF YOU ARE PREGNANT OR
BREASTFEEDING UNLESS YOUR DOCTOR
SAYS IT IS SAFE. ASK YOUR DOCTOR
ABOUT THE RISKS AND BENEFITS
INVOLVED.
We do not know if it is safe for you
to be given Fentanyl while you are
pregnant.
It may affect your baby if it is given
early in pregnancy or in the last
weeks before your baby is due.
We do not know if your baby can
take in Fentanyl from breast milk if
you are breastfeeding.
FENTANYL INJECTION WILL ONLY BE USED
IF THE SOLUTI

Summary of Product characteristics

Product Information v2.0
1 of 16
AUSTRALIAN PRODUCT INFORMATION -
ASTRAZENECA FENTANYL (FENTANYL CITRATE) 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
2 mL sterile solution of pH 4.0 – 7.5 containing 100 μg of fentanyl
(as citrate).
10 mL sterile solution of pH 4.0 – 7.5 containing 500 μg of
fentanyl (as citrate).
F