Χώρα: Αυστραλία
Γλώσσα: Αγγλικά
Πηγή: Department of Health (Therapeutic Goods Administration)
remifentanil hydrochloride, Quantity: 1.097 mg (Equivalent: remifentanil, Qty mg)
AFT Pharmaceuticals Pty Ltd
Remifentanil hydrochloride
Injection, powder for
Excipient Ingredients: hydrochloric acid; glycine
Intravenous
5 vials
Medicine Registered
(S8) Controlled Drug
Remifentanil 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 procedures 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 lyophilised powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure and restricted flow insert
Registered
2013-03-20
REMIFENTANIL-AFT Remifentanil (as the hydrochloride) 1mg, 2 mg and 5 mg, Powder for Injection WARNING LIMITATIONS OF USE Remifentanil-AFT 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-AFT 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-AFT 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-AFT 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-AFT USING REMIFENTANIL-AFT 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 Remifentanil-AFT. WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Remifentanil-AFT. It does not contain all of 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 being given Remifentanil-AFT against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it Διαβάστε το πλήρες έγγραφο
REMIFENTANIL-AFT AUSTRALIAN PI WARNINGS LIMITATIONS OF USE Because of the risks associated with the use of opioids, Remifentanil-AFT 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-AFT 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-AFT. 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-AFT. 1 NAME OF THE MEDICINE Remifentanil-AFT. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Remifentanil-AFT Powder for Injection is a sterile, nonpyrogenic, preservative-free white to off-white lyophilised powder for intravenous administration. The product is formulated in glycine and requires reconstitution and dilution before use. Three strengths are available: Remifent Διαβάστε το πλήρες έγγραφο