NAROPIN INFUSION 0.2%

Krajina: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktívna zložka:

ROPIVACAINE HCl

Dostupné z:

DCH AURIGA SINGAPORE

ATC kód:

Pending

Dávkovanie:

2 mg/ml

Forma lieku:

INJECTION

Zloženie:

ROPIVACAINE HCl 2 mg/ml

Spôsob podávania:

SUBCUTANEOUS, EPIDURAL

Typ predpisu:

Prescription Only

Výrobca:

ASTRAZENECA PTY LTD

Stav Autorizácia:

ACTIVE

Dátum Autorizácia:

1997-03-26

Príbalový leták

Naropin
£
£
 Product Information 
1 (23) 

NAROPIN“  
(Ropivacaine Hydrochloride) 

PRODUCT INFORMATION 

(Injection solutions for the production of local or regional
anaesthesia) 

NOT FOR INTRAVENOUS ADMINISTRATION UNDER ANY CIRCUMSTANCES 

NAME OF THE MEDICINE  

The active ingredient in NAROPIN
£
 is ropivacaine hydrochloride. The CAS number 
for the free base is 84057-95-4. The chemical
formula of ropivacaine hydrochloride is 
C
17
H
26
N
2
O.HCl.H
2
O. 

The chemical structure of ropivacaine hydrochloride is: 

H
N
H
CH
3
CH
3
O
N
CH
2
CH
2
CH
3
* HCL

DESCRIPTION 

The chemical name for
ropivacaine hydrochloride is (S)-(-)-propyl-piperidine-2-
carboxylic acid
(2,6-dimethyl-phenyl)-amide hydrochloride monohydrate. It 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 > 99%. It has a pKa of 8.1 (at 25 
qC) and a molecular weight of 328.89. The 
pH of a saturated solution of ropivacaine hydrochloride is 4.5 and
that of a 1% (w/v) 
aqueous solution is 5.0. 

NAROPIN solution for injection is a sterile, isotonic, isobaric,
aqueous solution of 
ropivacaine HCl in Water for Injections BP. 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. The nominal osmolality of NAROPIN 0.2% (2
mg/mL) is 288 
mosmol/kg. The solution is preservative free. 

The presentations of NAROPIN injection solutions are intended for
single use only. 
Any solution remaining from an opened
container should be discarded. 

PHARMACOLOGY 
Naropin
£
£
 Product Information 
2 (23) 

Ropivacaine has both anaesthetic and analgesic effects. At
higher doses it produces 
surgical anaesthesia with motor block, while at lower doses it
p

Súhrn charakteristických

NAROPIN
(Ropivacaine Hydrochloride)
PRODUCT INFORMATION
(Injection solutions for the production of local or regional
anaesthesia)
NOT FOR INTRAVENOUS ADMINISTRATION UNDER ANY CIRCUMSTANCES
NAME OF THE MEDICINE
The active ingredient in NAROPIN is ropivacaine hydrochloride. The CAS
number
for the free base is 84057-95-4. The chemical formula of ropivacaine
hydrochloride is
C
17
H
26
N
2
O.HCl.H
2
O.
The chemical structure of ropivacaine hydrochloride is:
DESCRIPTION
The chemical name for ropivacaine hydrochloride is
(S)-(-)-propyl-piperidine-2-carboxylic
acid (2,6-dimethyl-phenyl)-amide hydrochloride monohydrate. It 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 >
99%. It has a
pKa of 8.1 (at 25 °C) and a molecular weight of 328.89. The pH of a
saturated solution of
ropivacaine hydrochloride is 4.5 and that of a 1% (w/v) aqueous
solution is 5.0.
NAROPIN solution for injection is a sterile, isotonic, isobaric,
aqueous solution of
ropivacaine HCl in Water for Injections BP. 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.
The nominal osmolality of NAROPIN 0.2% (2 mg/mL) is 288 mosmol/kg. The
solution is
preservative free.
The presentations of NAROPIN injection solutions are intended for
single use only. 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, like other local anaesthetics, causes reversible blockade
of impulse
propagation along nerve fibres by preventing the inward movement of
sodium ions through
the cell membrane of the nerve fibres.