Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
vecuronium bromide, Quantity: 10 mg
Sun Pharma ANZ Pty Ltd
Vecuronium bromide
Injection, powder for
Excipient Ingredients: citric acid; sodium hydroxide; mannitol; dibasic sodium phosphate; phosphoric acid
Intravenous
1, 4, 10 and 20 vials
(S4) Prescription Only Medicine
VECURONIUM SUN is a skeletal muscle relaxant for use as an adjunct to general anaesthesia in adults and children for all surgical procedures.
Visual Identification: White to off-white lyophilized cake in 10 ml colorless tubular glass vial.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2015-04-28
1 VECURONIUM SUN CMI V2 VECURONIUM SUN _Vecuronium bromide _ _ _ CONSUMER MEDICINE INFORMATION _ _ _ _ WHAT IS IN THIS LEAFLET This leaflet is a summary of some of the information about the drug Vecuronium SUN It does not contain all the available information. It does not take the place of talking to your doctor. All medicines have risks and benefits. Your doctor has weighed the risks of you having Vecuronium SUN against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR. KEEP THIS LEAFLET. You may need to read it again. WHAT VECURONIUM SUN IS USED FOR Vecuronium SUN is one of a group of medicines called muscle relaxants. Muscle relaxants are 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. Normally the nerves send messages to the muscles by impulses. Vecuronium SUN acts by blocking these impulses so the muscles are relaxed. Because the muscles needed for breathing also become relaxed you will need help with your breathing (artificial respiration) during and after your operation until you can breathe on your own. During the operation the effect of the muscle relaxants is constantly checked and if necessary some more drug is given. At the end of the operation the effects of Vecuronium SUN are allowed to wear off and you can start breathing on your own. Sometimes another drug is given to help speed this up. Vecuronium SUN can also be used in Intensive Care to keep your muscles relaxed. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT THIS MEDICINE. Vecuronium SUN is not addictive. BEFORE YOU ARE GIVEN VECURONIUM SUN _WHEN YOU MUST NOT BE GIVEN _ _IT _ YOU MUST NOT BE GIVEN VECURONIUM SUN IF YOU HAVE AN ALLERGY TO: • any medicine containing vecuronium bromide • any of the ingredients listed at the end of this leaflet Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or di Læs hele dokumentet
Page 1 of 12 VECURONIUM SUN PI V3.1 AUSTRALIAN PRODUCT INFORMATION VECURONIUM SUN _(vecuronium bromide)_ 1 NAME OF THE MEDICINE Vecuronium bromide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Vecuronium SUN 10mg: 10mL vials each containing 10.0 mg sterile lyophilised vecuronium bromide. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Powder for injection. It is an odourless, bitter tasting white to creamy white, microcrystalline powder. At 25 o C (pH 3), its solubility is 16 mg/mL, and pKa is 8.97. Because vecuronium bromide hydrolyses rapidly in water, a ready-for-use aqueous solution form is not available. Following reconstitution with solvent (Water for Injections) the resultant solution is isotonic and has a pH of 4. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vecuronium SUN is a skeletal muscle relaxant for use as an adjunct to general anaesthesia in adults and children for all surgical procedures. 4.2 DOSE AND METHOD OF ADMINISTRATION Vecuronium SUN should be administered in carefully adjusted dosage by or under the supervision of experienced clinicians who are familiar with the action and use of these drugs. The drug should not be administered unless facilities for intubation, artificial respiration, oxygen therapy, suction and reversal agents are immediately available. To avoid microbial contamination, Vecuronium SUN should be used without delay once reconstituted and any residue should be discarded. RECONSTITUTION Vecuronium SUN 10mg: The contents of each vial should be dissolved in 5mL water for injections. After reconstitution, Vecuronium SUN is administered intravenously either as a bolus injection or as a continuous infusion. When calculating the dose of neuromuscular blocking agents the following factors must be taken into account: • The anaesthetic technique used, potential interactions with the drugs used before and during anaesthesia, and the condition of the individual patient. The use of an appropriate neuromuscular monitoring technique is recom Læs hele dokumentet