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

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

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

Commercializzato da:

Juno Pharmaceuticals Pty Ltd

Forma farmaceutica:

Injection, solution

Composizione:

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

Via di somministrazione:

Intravenous, Intramuscular

Confezione:

10mL x 10

Tipo di ricetta:

(S8) Controlled Drug

Indicazioni terapeutiche:

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.

Dettagli prodotto:

Visual Identification: Clear colourless particle free solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2022-10-11

Foglio illustrativo

Fentanyl Juno Injection
1
FENTANYL JUNO INJECTION
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.
[Include if applicable]
1.
WHY AM I BEING TREATED WITH FENTANYL JUNO INJECTION?
Fentanyl Juno Injection contains the active ingredient fentanyl
citrate. Fentanyl Juno 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
Fentanyl Juno Injection?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE TREATMENT WITH FENTANYL JUNO 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 Fentanyl Juno Injection?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Fentanyl Juno 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 FENTANYL JUNO 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 Fentanyl Juno
Injection given?
in the full CMI.
5.
WHAT SHOULD I KNOW DURING TREATMENT WITH FENTANYL JUNO INJECTION?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are being
given fentanyl.
•
If you become pregnant whil

Scheda tecnica

Product Information v2.1
1 of 16
AUSTRALIAN PRODUCT INFORMATION -
FENTANYL JUNO (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 micrograms of
fentanyl (as citrate).
10 mL sterile solution of pH 4.0 – 6.5 containing 500 micrograms of
fentanyl (as citr