Land: Australien
Språk: engelska
Källa: Department of Health (Therapeutic Goods Administration)
fentanyl citrate, Quantity: 785 microgram (Equivalent: fentanyl, Qty 500 microgram)
Juno Pharmaceuticals Pty Ltd
Injection, solution
Excipient Ingredients: sodium chloride; water for injections; sodium hydroxide
Intravenous, Intramuscular
10mL x 10
(S8) Controlled Drug
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.
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
Registered
2022-10-11
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 Läs hela dokumentet
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 Läs hela dokumentet