Riik: Austraalia
keel: inglise
Allikas: Department of Health (Therapeutic Goods Administration)
sugammadex sodium, Quantity: 544 mg
Merck Sharp & Dohme (Australia) Pty Ltd
Sugammadex
Injection, solution
Excipient Ingredients: sodium hydroxide; water for injections; hydrochloric acid
Intravenous
5 mL vials x 10
(S4) Prescription Only Medicine
Reversal of neuromuscular blockade induced by rocuronium or vecuronium in patients 2 years of age and older.
Visual Identification: A clear and colourless to slightly yellow solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store between 2-30 degrees Celsius
Licence status A
2008-11-28
BRIDION ® B R I D I O N ® 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. 1. WHY AM I USING BRIDION? BRIDION contains the active ingredient sugammadex sodium. BRIDION is used to speed up recovery of your muscles after an operation. For more information, see Section 1. Why am I using BRIDION? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE BRIDION? Do not use if you have ever had an allergic reaction to BRIDION 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 I use BRIDION? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with BRIDION 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 DO I USE BRIDION? • BRIDION is given as a single injection through an intravenous line. The doctor will work out the dose of BRIDION you need based on your weight and how much muscle relaxant is still affecting you. More instructions can be found in Section 4. How do I use BRIDION? in the full CMI. 5. WHAT SHOULD I KNOW AFTER BEING GIVEN BRIDION? DRIVING OR USING MACHINES • Your doctor will tell you when it is safe to drive and operate potentially dangerous machinery. For more information, see Section 5. What should I know after being given BRIDION? in the full CMI. 6. ARE THERE ANY SIDE EFFECTS? Like all medicines, BRIDION can cause side effects, but not everyone gets them. If these side effects occur while you are under anaesthetic, they will be seen and treated by your anaesthetist. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI. BRIDION® 1 BRIDION ® ACTIVE INGREDIENT(S): _sugamma Lugege kogu dokumenti
Page 1 of 22 AUSTRALIAN PRODUCT INFORMATION BRIDION ® (SUGAMMADEX) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Sugammadex (as sodium salt) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Sugammadex is a white to off-white powder. It is soluble at room temperature in water, normal saline and 5% mannitol in water. Bridion solution for injection contains sugammadex 100 mg/mL. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Bridion solution for injection is a clear and colourless to slightly yellow solution. The pH is between 7 and 8 and osmolality is between 300 and 500 mOsm/kg. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reversal of neuromuscular blockade induced by rocuronium or vecuronium in patients 2 years of age and older. 4.2 DOSE AND METHOD OF ADMINISTRATION The use of an appropriate neuromuscular monitoring technique is recommended to monitor the recovery of neuromuscular blockade. Adequacy of the reversal of the neuromuscular block needs to be based on a clinical assessment of the patient and not train-of-four responses alone, unless quantitative (numeric) assessment is made of neuromuscular function. Patients should be monitored for clinical signs of residual blockade (e.g. difficulty maintaining a patent airway, generalised weakness, inadequate ventilatory effort) following cessation of the anaesthetic and extubation. The recommended dose of sugammadex depends on the level of neuromuscular blockade to be reversed. The recommended dose does not depend on the anaesthetic regimen. ADULTS Sugammadex can be used to reverse different levels of rocuronium or vecuronium-induced neuromuscular blockade: Page 2 of 22 Routine reversal A dose of 4.0 mg/kg sugammadex is recommended if recovery has reached 1 - 2 post-tetanic counts (PTC) following rocuronium- or vecuronium-induced blockade. Median time to recovery of the T 4 /T 1 ratio to 0.9 is around 3 minutes (see SECTION 5.1 PHARMACODYNAMIC PROPERTIES, CLINICAL TRIALS). A dose of 2.0 mg/kg sugammadex is recommended, i Lugege kogu dokumenti