Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
ropivacaine hydrochloride, Quantity: 5 mg/mL
Sandoz Pty Ltd
Ropivacaine hydrochloride
Injection, solution
Excipient Ingredients: water for injections; sodium chloride; hydrochloric acid; sodium hydroxide
Epidural, Intrathecal, Intraarticular, Infiltration
5
(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. 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 for analgesia for longer than 72 hours. (Data for peripheral nerve block administered as a continuous peripheral infusion or intermittent injections support the use for up to 48 hours only).
Visual Identification: A clear colourless solution; Container Type: Ampoule; Container Material: PP; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2011-04-05
_Product Information _ _Page 1 _ _Ropivacaine Sandoz 2/5/7.5/10mg/mL Solution for Injection and Infusion _ _04/2016 _ _Sandoz Pty Ltd_ PRODUCT INFORMATION ROPIVACAINE SANDOZ ® 2/5/7.5/10MG/ML SOLUTION FOR INJECTION AND INFUSION Injection solutions for the production of local or regional anaesthesia NOT FOR INTRAVENOUS ADMINISTRATION UNDER ANY CIRCUMSTANCES NAME OF THE MEDICINE _Ropivacaine hydrochloride (as monohydrate) _ _Chemical Name_ (-)-(2 _S_ )- _N_ -(2,6-Dimethylphenyl)-1-propylpiperidine-2-carboxamide hydrochloride monohydrate. _ _ _Chemical structure _ CAS: 132112-35-7 Empirical formula C 17 H 26 N 2 O.HCl.H 2 O MW: 328.89 DESCRIPTION It is a white crystalline powder and has a water solubility of about 50mg/mL. Ropivacaine hydrochloride was developed as the pure _S_ -(-)-isomer and has an enantiomeric purity of > 99%. 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 Sandoz solution for injection is a sterile, isotonic, isobaric, aqueous solution of ropivacaine hydrochloride (as monohydrate) in Water for Injections BP and sodium chloride. The pH of the solution is adjusted with sodium hydroxide or hydrochloric acid to remain between 4.0 to 6.0 during the approved shelf-life. The nominal osmolality of Ropivacaine Sandoz 0.2% (2mg/mL) is 280-320mosmol/kg. The solution is preservative free. The presentations of Ropivacaine Sandoz injection solutions are intended for single use only. Any solution remaining from an opened container should be discarded. _Product Information _ _ _ _Page 2 _ _Ropivacaine Sandoz 2/5/7.5/10mg/mL Solution for Injection and Infusion _ _04/2016 _ _Sandoz Pty Ltd_ 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 Lees het volledige document
_Product Information _ _Page 1 _ _Ropivacaine Sandoz 2/5/7.5/10mg/mL Solution for Injection and Infusion _ _04/2016 _ _Sandoz Pty Ltd_ PRODUCT INFORMATION ROPIVACAINE SANDOZ ® 2/5/7.5/10MG/ML SOLUTION FOR INJECTION AND INFUSION Injection solutions for the production of local or regional anaesthesia NOT FOR INTRAVENOUS ADMINISTRATION UNDER ANY CIRCUMSTANCES NAME OF THE MEDICINE _Ropivacaine hydrochloride (as monohydrate) _ _Chemical Name_ (-)-(2 _S_ )- _N_ -(2,6-Dimethylphenyl)-1-propylpiperidine-2-carboxamide hydrochloride monohydrate. _ _ _Chemical structure _ CAS: 132112-35-7 Empirical formula C 17 H 26 N 2 O.HCl.H 2 O MW: 328.89 DESCRIPTION It is a white crystalline powder and has a water solubility of about 50mg/mL. Ropivacaine hydrochloride was developed as the pure _S_ -(-)-isomer and has an enantiomeric purity of > 99%. 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 Sandoz solution for injection is a sterile, isotonic, isobaric, aqueous solution of ropivacaine hydrochloride (as monohydrate) in Water for Injections BP and sodium chloride. The pH of the solution is adjusted with sodium hydroxide or hydrochloric acid to remain between 4.0 to 6.0 during the approved shelf-life. The nominal osmolality of Ropivacaine Sandoz 0.2% (2mg/mL) is 280-320mosmol/kg. The solution is preservative free. The presentations of Ropivacaine Sandoz injection solutions are intended for single use only. Any solution remaining from an opened container should be discarded. _Product Information _ _ _ _Page 2 _ _Ropivacaine Sandoz 2/5/7.5/10mg/mL Solution for Injection and Infusion _ _04/2016 _ _Sandoz Pty Ltd_ 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 Lees het volledige document