국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
alfentanil hydrochloride, Quantity: 0.544 mg/mL
Piramal Critical Care Pty Ltd
Injection, solution
Excipient Ingredients: sodium chloride; water for injections
Intravenous
5 X 2mL
(S8) Controlled Drug
Indications: RAPIFEN is indicated for intravenous use by specialist anaesthetists and their trainees as 1. An analgesic supplement given by incremental intravenous boluses or continuous infusion; and 2. An anaesthetic induction agent where in patients undergoing in-patient surgery, when endotracheal intubation and controlled ventilation are to be used. Because of its rapid onset and short duration of action, intravenous RAPIFEN is particularly suited as a narcotic analgesic for short procedures and outpatients, provided that the patients are maintained under appropriate post-operative surveillance. However, intravenous RAPIFEN is also useful as an analgesic supplement for procedures of medium to long duration, since periods of very painful stimuli can be easily overcome by administration of small increments of RAPIFEN or by adapting the infusion rate.
Visual Identification: Clear, colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1994-10-14
RAPIFEN ® CMI AU 1 RAPIFEN ® _Alfentanil Hydrochloride Injection (equivalent to 0.5 mg/mL alfentanil) _ CONSUMER MEDICINE INFORMATION WARNING LIMITATIONS OF USE RAPIFEN 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 RAPIFEN 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 RAPIFEN 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 RAPIFEN 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 RAPIFEN USING RAPIFEN 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 RAPIFEN. WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about RAPIFEN. It does not contain all the information that is known about RAPIFEN. It does not take the place of talking to your doctor, anaesthetist or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you being given RAPIFEN against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR, ANAESTHETIST OR PHARMACIST. KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAI 전체 문서 읽기
1 RAPIFEN AUSTRALIAN PRODUCT INFORMATION – RAPIFEN (ALFENTANIL HYDROCHLORIDE) INJECTION WARNINGS _LIMITATIONS OF USE _ Because of the risks associated with the use of opioids, RAPIFEN 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 _ RAPIFEN 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 RAPIFEN. 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 on RAPIFEN. 1 NAME OF THE MEDICINE Alfentanil hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of RAPIFEN contains alfentanil hydrochloride equivalent to 0.5mg alfentanil with 9.0mg sodium chloride in water for injection to 1mL. 3 PHARMACEUTICAL FORM RAPIFEN solution for injection is a sterile, clear and colourless sol 전체 문서 읽기