ROPIVACAINE SANDOZ ropivacaine hydrochloride (as monohydrate) 75mg/10mL solution for injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ropivacaine hydrochloride

Available from:

Sandoz Pty Ltd

INN (International Name):

Ropivacaine hydrochloride

Authorization status:

Registered

Patient Information leaflet

_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

Summary of Product characteristics

_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