ROPIVACAINE SANDOZ ropivacaine hydrochloride (as monohydrate) 100mg/20mL solution for injection ampoule

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

ropivacaine hydrochloride, Quantity: 5 mg/mL

Commercializzato da:

Sandoz Pty Ltd

INN (Nome Internazionale):

Ropivacaine hydrochloride

Forma farmaceutica:

Injection, solution

Composizione:

Excipient Ingredients: water for injections; sodium chloride; hydrochloric acid; sodium hydroxide

Via di somministrazione:

Epidural, Intrathecal, Intraarticular, Infiltration

Confezione:

5

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

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).

Dettagli prodotto:

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

Stato dell'autorizzazione:

Licence status A

Data dell'autorizzazione:

2011-04-05

Foglio illustrativo

_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

Scheda tecnica

_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