País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
ropivacaine hydrochloride
Sandoz Pty Ltd
Ropivacaine hydrochloride
Registered
_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 Leia o documento completo
_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 Leia o documento completo