B. BRAUN FENTANYL fentanyl (as citrate) 500 micrograms/10 mL solution for injection ampoule

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:

B Braun 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:

10 mL x 5 ampoules, 10 mL x 10 ampoules

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

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: Sterile, clear colourless solution, practically free from visible particles; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2015-09-22

Patient Information leaflet

B Braun Midazolam CMI– Version 3.0
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FENTANYL B. BRAUN INJECTION
FOR INTRAVENOUS OR INTRAMUSCULAR USE ONLY
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about B. BRAUN FENTANYL
injection. 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 B. BRAUN FENTANYL
against the benefits this medicine is expected to have for you.
If you have any concerns about receiving B. BRAUN FENTANYL, ask your
doctor or pharmacist. Keep this leaflet
with your medicine. You may need to read it again.
WHAT B. BRAUN FENTANYL IS USED FOR
B. BRAUN FENTANY L injection is used to provide short-term pain relief
and to help anaesthesia when you have
an operation. It is a strong painkiller for use in hospitals.
B. BRAUN FENTANYL injection contains a medicine called fentanyl. It
belongs to a group of medicines known as
narcotic analgesics or opioids. Fentanyl relieves pain by blocking the
nerves in the brain that recognise pain
messages from the body.
Your doctor may have prescribed B. BRAUN FENTANYL for another reason.
Ask your doctor if you have any
questions about why this medicine has been prescribed for you.
B. BRAUN FENTANYL may be addictive. Addiction is unlikely in patients
who receive it under medical
supervision.
You may be at more risk of addiction if:
•
You or someone in your family have a history of drug and alcohol abuse
or mental illness
•
You require repeated injections of
B. BRAUN FENTANYL
•
You need increasingly larger
doses of B. BRAUN FENTANYL to control your pain.
WARNING
LIMITATIONS OF USE
B. BRAUN 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
B. BRAUN FENTANYL poses risks of abuse, misuse and addiction which can
lead to overdose and death.
Your doctor will monitor you

Summary of Product characteristics

B Braun Fentanyl PI – Version 3.0
Page 1 of 15
AUSTRALIAN PRODUCT INFORMATION
B. BRAUN FENTANYL (FENTANYL
CITRATE) SOLUTION FOR INJECTION
FOR INTRAVENOUS OR INTRAMUSCULAR USE ONLY
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids,
B.BRAUN 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 _
B.BRAUN 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
B.BRAUN
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
B.BRAUN FENTANYL
.
1.
NAME OF THE MEDICINE
Fentanyl citrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
B. Braun Fentanyl for Injection contains fentanyl 50 micrograms per mL
(as fentanyl citrate).
For the ful