DBL FENTANYL 100 microgram/2mL (as citrate) injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fentanyl citrate, Quantity: 157 microgram (Equivalent: fentanyl, Qty 100 microgram)

Available from:

Pfizer Australia Pty Ltd

INN (International Name):

Fentanyl citrate

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intravenous, Intramuscular

Units in package:

5x100microgram/2mL

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

DBL Fentanyl Injection is indicated for analgesic action of short duration during premedication, induction and maintenance of anaesthesia and in the immediate post-operative periods. It may be used as an opioid analgesic supplement in general and regional anaesthesia.,Fentanyl may be used in combination with neuroleptic agents such as droperidol as an anaesthetic premedication, for the induction of anaesthesia and as an adjunct in the maintenance of general and regional anaesthesia. The state of neurolept analgesia may be converted to neurolept anaesthesia by the concurrent administration of 65% nitrous oxide in oxygen.

Product summary:

Visual Identification: Clear, colourless solution free from visible particulate matter.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2004-11-09

Patient Information leaflet

DBL™ FENTANYL INJECTION
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I BEING TREATED WITH DBL FENTANYL INJECTION?
DBL Fentanyl Injection contains the active ingredient fentanyl
citrate. DBL Fentanyl Injection is a short-term pain reliever that
belongs to a group of medicines called opioid analgesics. It is most
commonly used to relieve severe pain. It may also be used just
before, or during, an operation, to help the anaesthetic work better.
For more information, see Section 1. Why am I being treated with DBL
Fentanyl Injection? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE TREATMENT WITH DBL FENTANYL INJECTION?
Do not use if you have ever had an allergic reaction to fentanyl or
any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become pregnant
or are breastfeeding.
For more information, see Section 2. What should I know before
treatment with DBL Fentanyl Injection? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with DBL Fentanyl Injection and affect
how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW IS DBL FENTANYL INJECTION GIVEN?
Your doctor will decide what dose of fentanyl you will receive. This
depends on your age, physical condition and other factors, such
as your weight.
More instructions can be found in Section 4. How is DBL Fentanyl
Injection given? in the full CMI.
5.
WHAT SHOULD I KNOW DURING TREATMENT WITH DBL FENTANYL INJECTION?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are being
given fentanyl.
•
If you become pregnant while you ar

Summary of Product characteristics

Version: pfpfenti10921
Supersedes: pfpfenti10720
Page 1 of 21
AUSTRALIAN
PRODUCT
INFORMATION
–
DBL™
FENTANYL
INJECTION
(FENTANYL
CITRATE)
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 CNS depressant medicines, such as
other opioid analgesics,
benzodiazepines, gabapentinoids, cannabis, sedatives, hypnotics,
tricyclic antidepressants,
antipsychotics,
antihistamines,
centrally-active
anti-emetics,
general
anaesthetics,
tranquilisers, 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 (see Section
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
).
1.
NAME OF THE MEDICINE
Fentanyl citrate
2.
QUALITATIVE AND Q