Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
fentanyl citrate, Quantity: 157 microgram (Equivalent: fentanyl, Qty 100 microgram)
Aspen Pharmacare Australia Pty Ltd
Fentanyl citrate
Injection, solution
Excipient Ingredients: sodium chloride; water for injections
Intramuscular, Intravenous
5's and 10's
(S8) Controlled Drug
Short duration analgesia during premedication, induction and maintenance of anaesthesia, and in the immediate postoperative period. Opioid analgesic supplement to general and regional anaesthesia. Combination with a neuroleptic as an anaesthetic premedication for the induction of anaesthesia, and as an adjunct in the maintanance of general and regional anaesthesia.
Visual Identification: Clear and colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2011-08-03
ASPEN FENTANYL – Consumer Medicine Information Page 1 of 5 ASPEN FENTANYL SOLUTION FOR INJECTION _fentanyl citrate _ _ _ CONSUMER MEDICINE INFORMATION (CMI) WARNINGS _LIMITATIONS OF USE _ Aspen 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 _ Aspen Fentanyl poses risks of abuse, misuse and addiction which can lead to overdose and death. Your doctor will monitor you regularly during treatment. _LIFE THREATENING RESPIRATORY DEPRESSION _ Aspen Fentanyl can cause life-threatening or fatal breathing problems (slow, shallow, unusual or no breathing).even when used as recommended. These problems can occur at any time during use, but the risk is higher when first starting Aspen Fentanyl and after a dose increase, if you are older, or have an existing problem with your lungs. Your doctor will monitor you and change the dose as appropriate _ USE OF OTHER MEDICINES WHILE USING ASPEN FENTANYL _ Using Aspen Fentanyl with other medicines that can make you feel drowsy such as sleeping tablets (e.g. benzodiazepines), other pain relievers, antihistamines, antidepressants, antipsychotics, gabapentinoids (e.g. gabapentin and pregabalin), cannabis and alcohol may result in severe drowsiness, decreased awareness, breathing problems, coma and death. Your doctor will minimise the dose and duration of use; and monitor you for signs and symptoms of breathing difficulties and sedation. You must not drink alcohol while using Aspen Fentanyl. WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about ASPEN FENTANYL. It does not contain all the information that is known about ASPEN 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 ASPEN FENTANYL against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, A Read the complete document
Fentanyl-pi-6nov20 1 AUSTRALIAN PRODUCT INFORMATION ASPEN FENTANYL (FENTANYL CITRATE) SOLUTION FOR INJECTION WARNINGS _LIMITATIONS OF USE _ Because of the risks associated with the use of opioids, Aspen Fentanyl injections 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 _ Aspen Fentanyl injections 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 Aspen Fentanyl injections. 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 Aspen Fentanyl injections. 1 NAME OF THE MEDICINE Fentanyl citrate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Aspen Fentanyl solution for injection contains fentanyl citrate 0.0785 mg/mL (equivalent to fentanyl 0.05 mg/mL) as the active ingredient. For the full li Read the complete document