Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
rocuronium bromide, Quantity: 100 mg
Baxter Healthcare Pty Ltd
Rocuronium bromide
Injection, solution
Excipient Ingredients: sodium acetate; sodium chloride; glacial acetic acid; sodium hydroxide; water for injections
Intravenous
10mL
(S4) Prescription Only Medicine
Adjunct to general anaesthesia to facilitate endotracheal intubation during routine induction, to provide muscle relaxation and to facilitate mechanical ventilation in adults, children and infants over 1 month of age. Adjunct to general anaesthesia to facilitate endotracheal intubation during rapid sequence induction when suxamethonium is contraindicated, however, this has not been studied in infants and children. Adjunct in the intensive care unit (ICU) to facilitate mechanical ventilation.
Visual Identification: A clear, colourless to yellow or orange solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
2011-08-16
ROCURONIUM BAXTER 1 ROCURONIUM BAXTER 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 ROCURONIUM BAXTER? ROCURONIUM BAXTER contains the active ingredient rocuronium bromide. ROCURONIUM BAXTER is one of a group of medicines called muscle relaxants. ROCURONIUM BAXTER is used during an operation as part of the general anaesthetic. When you have an operation, your muscles must be completely relaxed. This makes it easier for the surgeon to perform the operation. For more information, see Section 1. Why am I using ROCURONIUM BAXTER? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE ROCURONIUM BAXTER Do not use if you have ever had an allergic reaction to ROCURONIUM BAXTER 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 ROCURONIUM BAXTER? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with ROCURONIUM BAXTER 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 ROCURONIUM BAXTER IS GIVEN • ROCURONIUM BAXTER will be given by a doctor. It will not be given to you until you are asleep from the anaesthetic. • It will be injected into a vein before and/or during an operation. It will be given as a single injection or continuous infusion. More instructions can be found in Section 4. How do I use ROCURONIUM BAXTER? in the full CMI. 5. WHAT SHOULD I KNOW AFTER HAVING ROCURONIUM BAXTER? DRIVING OR USING MACHINES • Your doctor will tell you when it is safe to drive and operate potentially dangerous machinery after you have been given ROCURONIUM BAXTER. For more information, see Section 5. What should I know after having ROCURONIUM BAXTER? in th Přečtěte si celý dokument
Version 2.0 1 AUSTRALIAN PRODUCT INFORMATION ROCURONIUM BAXTER (ROCURONIUM BROMIDE) INJECTION SOLUTION 1 NAME OF THE MEDICINE Rocuronium bromide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ROCURONIUM BAXTER 50 mg/5 mL: 5 mL of solution contains 50 mg rocuronium bromide. ROCURONIUM BAXTER 100 mg/10 mL: 10 mL of solution contains 100 mg rocuronium bromide. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM ROCURONIUM BAXTER is a clear, colourless to yellow or orange solution. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Adjunct to general anaesthesia to facilitate endotracheal intubation during routine induction, to provide muscle relaxation and to facilitate mechanical ventilation in adults, children and infants over 1 month of age. Adjunct to general anaesthesia to facilitate endotracheal intubation during rapid sequence induction when suxamethonium is contraindicated, however, this has not been studied in infants and children. Rocuronium is also indicated as an adjunct in the intensive care unit (ICU) to facilitate mechanical ventilation. 4.2 D OSE AND METHOD OF ADMINISTRATION ROCURONIUM BAXTER is administered by intravenous bolus or infusion Like other neuromuscular blocking agents, ROCURONIUM BAXTER should only be administered by, or under supervision of, experienced clinicians who are familiar with the action and use of these drugs. The product is for single patient use and contains no antimicrobial agent. As with other neuromuscular blocking agents, the dosage of rocuronium bromide should be individualised in each patient. The anaesthetic method used, the duration of surgery, the method of sedation and the expected duration of mechanical ventilation, the possible interaction with other drugs that are administered concomitantly and the condition of the patient should be taken Version 2.0 2 into account when determining the dose. The use of an appropriate neuromuscular monitoring technique is recommended for evaluation of the neuromuscular block and the recovery. I Přečtěte si celý dokument