Страна: Австралія
мова: англійська
Джерело: Department of Health (Therapeutic Goods Administration)
remifentanil hydrochloride
Pfizer Australia Pty Ltd
Remifentanil hydrochloride
Registered
DBL™ REMIFENTANIL POWDER FOR INJECTION 1 DBL™ REMIFENTANIL POWDER FOR INJECTION Remifentanil hydrochloride CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about DBL Remifentanil powder for injection. 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 DBL Remifentanil powder for injection 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 again. WHAT DBL REMIFENTANIL POWDER FOR INJECTION IS USED FOR DBL Remifentanil powder for injection is an anaesthetic used with other anaesthetic medicines, to produce and/or maintain heavy sleep during your operation. If you are a cardiac patient, it may also be used to help relieve any pain immediately following your operation. DBL Remifentanil powder for injection may also be used for patients in the Intensive Care Unit to maintain sedation and relieve pain. DBL Remifentanil powder for injection belongs to a group of medicines called opioids. It differs from other medicines in this group by its very quick onset and very short duration of action. Your doctor may have prescribed DBL Remifentanil powder for injection for another reason. Ask your doctor if you have any questions about why DBL Remifentanil powder for injection has been prescribed for you. As with other opioids, DBL Remifentanil powder for injection can be addictive. This is unlikely to happen when DBL Remifentanil powder for injection is only used during your operation. BEFORE YOU ARE GIVEN DBL REMIFENTANIL POWDER FOR INJECTION When you must not receive DBL Remifentanil powder for injection You must not receive DBL Remifentanil powder for injection if you have ever had an allergic reaction to remifentanil hydrochloride or any of the ingredien Прочитайте повний документ
Version:pfpremiv11019 Supersedes: Page 1 of 34 AUSTRALIAN PRODUCT INFORMATION –[ DBL™ REMIFENTANIL (REMIFENTANIL HYDROCHLORIDE) POWDER FOR INJECTION] 1. NAME OF THE MEDICINE Remifentanil hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Three strengths are available; 1 mg, 2 mg and 5 mg of remifentanil base (as the hydrochloride salt). 3. PHARMACEUTICAL FORM Powder for Injeciton DBL™ Remifentanil powder for injection is a sterile, non-pyrogenic, preservative-free, white to off-white lyophilised powder for intravenous use. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DBL™ Remifentanil powder 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. 4.2 DOSE AND METHOD OF ADMINISTRATION DBL™ Remifentanil powder for injection should be administered only in a setting fully equipped for the monitoring and support of respiratory and cardiovascular function and by Version:pfpremiv11019 Supersedes: Page 2 of 34 medically qualified persons specifically trained in the use of anaesthetic drugs and the recognition and management of the expected adverse effects of potent opioids, including respiratory and cardiac resuscitation. Such training must include intubation, and assisted ventilation. Continuous infusions of remifentanil must be administered by a calibrated infusion device, where possible Прочитайте повний документ