Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
fentanyl citrate, Quantity: 785 microgram (Equivalent: fentanyl, Qty 500 microgram)
Pfizer Australia Pty Ltd
Fentanyl citrate
Injection, solution
Excipient Ingredients: hydrochloric acid; sodium chloride; water for injections; sodium hydroxide
Intravenous, Intramuscular
5x500microgram/10mL
(S8) Controlled Drug
DBL Fentanyl Injection is indicated for analgesic action of short duration during premedication, induction and maintenance of anaesthesia and in the immediate post-operative periods. It may be used as an opioid analgesic supplement in general and regional anaesthesia.,Fentanyl may be used in combination with neuroleptic agents such as droperidol as an anaesthetic premedication, for the induction of anaesthesia and as an adjunct in the maintenance of general and regional anaesthesia. The state of neurolept analgesia may be converted to neurolept anaesthesia by the concurrent administration of 65% nitrous oxide in oxygen.
Visual Identification: Clear, colourless solution free from visible particulate matter.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2004-11-09
DBL™ FENTANYL INJECTION D B L ™ F E N T A N Y L I N J E C T I O N C M I 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. 1. WHY AM I BEING TREATED WITH DBL FENTANYL INJECTION? DBL Fentanyl Injection contains the active ingredient fentanyl citrate. DBL Fentanyl 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 DBL Fentanyl Injection? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE TREATMENT WITH DBL FENTANYL 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 DBL Fentanyl Injection? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with DBL Fentanyl 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 DBL FENTANYL 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 DBL Fentanyl Injection given? in the full CMI. 5. WHAT SHOULD I KNOW DURING TREATMENT WITH DBL FENTANYL INJECTION? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are being given fentanyl. • If you become pregnant while you ar Read the complete document
Version: pfpfenti10921 Supersedes: pfpfenti10720 Page 1 of 21 AUSTRALIAN PRODUCT INFORMATION – DBL™ FENTANYL INJECTION (FENTANYL CITRATE) 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 CNS depressant medicines, such as other opioid analgesics, benzodiazepines, gabapentinoids, cannabis, sedatives, hypnotics, tricyclic antidepressants, antipsychotics, antihistamines, centrally-active anti-emetics, general anaesthetics, tranquilisers, 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 (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE ). 1. NAME OF THE MEDICINE Fentanyl citrate 2. QUALITATIVE AND Q Read the complete document