국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
ropivacaine hydrochloride monohydrate, Quantity: 105.8 mg
Medis Pharma Pty Ltd
Ropivacaine hydrochloride monohydrate
Injection, solution
Excipient Ingredients: sodium chloride; water for injections; hydrochloric acid; sodium hydroxide
Epidural, Infiltration, Intracutaneous, Intradermal, Intramuscular, Intraneural, Subcutaneous, Mucosal
5 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,? 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 ACTAVIS 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 colourless solution for injection; Container Type: Ampoule; Container Material: PP; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2013-02-27
Ropivacaine Actavis Solution for injection PRODUCT INFORMATION ( Injection solutions for the production of local or regional anaesthesia ) NOT FOR INTRAVENOUS ADMINSTRATION UNDER ANY CIRCUMSTANCES NAME OF THE MEDICINE Ropivacaine hydrochloride. The chemical name for ropivacaine hydrochloride is (S)-(-)-propyl- piperidine-2-carboxylic acid (2,6-dimethyl-phenyl)-amide hydrochloride monohydrate. Its structural formula is: C 17 H 26 N 2 O.HCl.H 2 O Molecular weight: 328.89 CAS No.: 84057-95-4 DESCRIPTION Ropivacaine hydrochloride is a white crystalline powder and has a water solubility of about 50 mg/mL. Ropivacaine hydrochloride was developed as the pure S-(-)-isomer and has an enantiomeric purity of > 98%. It has a pKa of 8.1 (at 25 °C), the pH of a saturated solution of ropivacaine hydrochloride is 4.5 and that of a 1% (w/v) aqueous solution is 5.0. ROPIVACAINE ACTAVIS solution for injection is a sterile, isotonic, isobaric, aqueous solution of ropivacaine hydrochloride in Water for Injections. 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 and the solution also contains sodium chloride. The nominal osmolality of ROPIVACAINE ACTAVIS 0.2% (2 mg/mL) is 288 mosmol/kg. The solution is preservative free. The presentations of ROPIVACAINE ACTAVIS solutions for injection are intended for single use only in one patient. Any solution remaining from an opened container should be discarded. PHARMACOLOGY Ropivacaine has both anaesthetic and analgesic effects. At higher doses it produces surgical anaesthesia with motor block, while at lower doses it produces a sensory block including analgesia with little motor block. The duration and intensity of ropivacaine sensory block is not improved by the addition of adrenaline. ROPIVACAINE ACTAVIS – Product information Page 2 of 20 Ropivacaine, like other local anaesthetics, causes reversible blockade of impulse propagation along nerve fibres by preventing the inward movement of sodium ions thro 전체 문서 읽기