Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
fentanyl citrate, Quantity: 157 microgram (Equivalent: fentanyl, Qty 100 microgram)
B Braun Australia Pty Ltd
Fentanyl citrate
Injection, solution
Excipient Ingredients: sodium chloride; water for injections
Intramuscular, Intravenous
2 mL x 10 ampoules
(S8) Controlled Drug
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.
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
Licence status A
2015-09-22
B Braun Midazolam CMI– Version 3.0 Page 1 of 5 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 Przeczytaj cały dokument
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 Przeczytaj cały dokument