Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
ropivacaine hydrochloride, Quantity: 20 mg
Fresenius Kabi Australia Pty Ltd
Ropivacaine hydrochloride
Injection, solution
Excipient Ingredients: sodium chloride; hydrochloric acid; sodium hydroxide; water for injections
Epidural, Intrathecal
5 x 10 mL ampoules
(S4) Prescription Only Medicine
Surgical anaesthesia (adults and children over 12 years of age); epidural block for surgery including caesarean section; intrathecal anaesthesia; field block (minor nerve block and infiltration); major nerve block. Analgesia (adults and children over 12 years of age); continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain; field block (minor nerve block and infiltration); continuous peripheral nerve block infusion or intermittent injections for post operative pain management; continuous wound infusion for postoperative pain management (adults only). Analgesia (children aged 0 - 12 years); caudal epidural block in neonates (> 37 weeks gestation and over 2500 g weight), infants and children up to and including 12 years. continous epidural infusion in infants (> 30 days and over 2500 g weight) and children up to and including 12 years; peripheral nerve block in children aged 1 up to and including 12 years. For peri- and postoperative pain management. There are no safety or efficacy data to support the use of ropivacaine hydrochloride for analgesia for longer than 72 hours. (Data for peripheral nerve block administered as a continuous peripheral infusion or intermittent injections and for continuous wound infusion support the use for up to 48 hours only).
Visual Identification: Clear solution; Container Type: Ampoule; Container Material: PP; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2013-06-13
CMI for Ropivacaine Kabi Feb, 2016 Page 1 of 3 ROPIVACAINE KABI Ropivacaine hydrochloride Solution for Injection CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about Ropivacaine Kabi. It does not contain all 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 taking Ropivacaine Kabi against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT ROPIVACAINE KABI IS USED FOR Ropivacaine Kabi is a local anaesthetic (an-es-thet-ic). It is injected into the body where it makes the nerves unable to pass messages to the brain. Depending on the amount used, ropivacaine will either totally stop pain or will cause a partial loss of feeling. Ropivacaine Kabi is used as an anaesthetic to stop the pain of surgery and/or to make childbirth less painful. Ropivacaine Kabi is also used after surgery to treat post-operative pain. Your doctor will have explained why you are being treated with Ropivacaine Kabi and told you what dose you will be given. Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet. Your doctor may prescribe this medicine for another use. Ask your doctor if you want more information. Ropivacaine Kabi is not addictive. BEFORE YOU ARE GIVEN ROPIVACAINE KABI _WHEN YOU MUST NOT TAKE IT _ Ropivacaine Kabi must not be used if: 1. YOU HAVE ANY ALLERGIES TO any ingredient listed at the end of this leaflet any other local anaesthetics 2. YOU HAVE PROBLEMS CONTROLLING YOUR LOW BLOOD PRESSURE 3. YOU HAVE INFLAMMATION AND/OR AN INFECTION AT THE SITE OF INJECTION _BEFORE YOU START TO TAKE IT _ You must tell your doctor if 1. YOU HAVE ANY ALLERGIES TO OTHER SUBSTANCES 2. YOU HAVE ANY OF THESE MEDICAL CONDITIONS problems with your blood pr Baca dokumen lengkap
AUSTRALIAN PRODUCT INFORMATION- ROPIVACAINE KABI (ROPIVACAINE HYDROCHLORIDE) 1 NAME OF THE MEDICINE Ropivacaine hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION/ 3 PHARMACEUTICAL FORM Ropivacaine Kabi solution for injection is a sterile, isotonic, isobaric, aqueous solution of ropivacaine hydrochloride in Water for Injections BP. The pH of the solution is adjusted with sodium hydroxide or hydrochloric acid to remain between 4.0 - 6.0 during the approved shelf-life. The nominal osmolality of Ropivacaine Kabi 0.2% (2 mg/mL) is 288 mosmol/kg. The solution is preservative free. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Surgical anaesthesia (adults and children over 12 years of age) • epidural block for surgery including caesarean section • intrathecal anaesthesia • field block (minor nerve block and infiltration) • major nerve block Analgesia (adults and children over 12 years of age) • continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain • field block (minor nerve block and infiltration) • continuous peripheral nerve block infusion or intermittent injections for post operative pain management • continuous wound infusion for postoperative pain management (adults only) Analgesia (children aged 0 - 12 years) • caudal epidural block in neonates (> 37 weeks gestation and over 2500 g weight), infants and children up to and including 12 years • continuous epidural infusion in infants (> 30 days and over 2500 g weight) and children up to and including 12 years • peripheral nerve block in children aged 1 up to and including 12 years For peri- and postoperative pain management. There are no safety or efficacy data to support the use of ropivacaine hydrochloride for analgesia for longer than 72 hours. (Data for peripheral nerve block administered as a continuous peripheral infusion or intermittent injections and for continuous wound infusion support Baca dokumen lengkap