Ülke: Avustralya
Dil: İngilizce
Kaynak: Department of Health (Therapeutic Goods Administration)
remifentanil hydrochloride, Quantity: 5.485 mg (Equivalent: remifentanil, Qty 5 mg)
Alphapharm Pty Ltd
Remifentanil hydrochloride
Injection, powder for
Excipient Ingredients: glycine; hydrochloric acid
Intravenous Infusion, Intravenous
1 vial, 5 vials
(S8) Controlled Drug
REMIFENTANIL Viatris for Injection is indicated * as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical procedures including cardiac surgery in adults.. * as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical but not cardiac procedures in children aged 1 to 12 years.. * for continuation as an analgesic into the immediate post-operative period under the close supervision of medically qualified persons trained in the use of anaesthetic drugs, during transition to longer acting analgesia following adult cardiac surgery - when endotracheal intubation and controlled ventilation are anticipated.. * for provision of analgesia and sedation in mechanically ventilated intensive care patients.
Visual Identification: White to off-white powder; Container Type: Vial; 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
2012-10-15
REMIFENTANIL ALPHAPHARM _contains the active ingredient remifentanil (as hydrochloride)_ CONSUMER MEDICINE INFORMATION WARNING LIMITATIONS OF USE REMIFENTANIL ALPHAPHARM 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 REMIFENTANIL ALPHAPHARM 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 REMIFENTANIL ALPHAPHARM 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 REMIFENTANIL ALPHAPHARM 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 REMIFENTANIL ALPHAPHARM Using REMIFENTANIL ALPHAPHARM 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 diffi- culties and sedation. You must not drink alcohol while using REMIFENTANIL ALPHAPHARM. WHAT IS IN THIS LEAFLET This leaflet contains answers to some common questions about REMIFENTANIL ALPHAPHARM. It does not contain all the information available on REMIFENTANIL ALPHAPHARM. It does NOT take the place of talking to your doctor or your pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking REMIFENTANIL ALPHAPHARM against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT T Belgenin tamamını okuyun
AUSTRALIAN PRODUCT INFORMATION REMIFENTANIL ALPHAPHARM _remifentanil (as hydrochloride) powder for injection _ WARNINGS _LIMITATIONS OF USE _ Because of the risks associated with the use of opioids, Remifentanil Alphapharm 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 _ Remifentanil Alphapharm 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 Remifentanil Alphapharm. 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 Remifentanil Alphapharm. 1 NAME OF THE MEDICINE Remifentanil (as hydrochloride) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each REMIFENTANIL ALPHAPHARM powder for injection vial contains 1 mg, 2 mg or 5 mg of remifentanil (as hydrochloride) as the active ingredient. Fo Belgenin tamamını okuyun