ROPIVACAINE ACTAVIS 0.5% (w/v) ropivacaine hydrochloride (as monohydrate) 100 mg/20 mL solution for injection ampoule

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

ropivacaine hydrochloride monohydrate, Quantity: 105.8 mg

Tilgængelig fra:

Medis Pharma Pty Ltd

INN (International Name):

Ropivacaine hydrochloride monohydrate

Lægemiddelform:

Injection, solution

Sammensætning:

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

Indgivelsesvej:

Epidural, Infiltration, Intracutaneous, Intradermal, Intramuscular, Intraneural, Subcutaneous, Mucosal

Enheder i pakken:

5 ampoules

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

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,? continuous wound infusion for postoperative pain management (adults only),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 ACTAVIS for analgesia for longer than 72 hours. (Data for peripheral nerve block administered as a continuous peripheral infusion or intermittent injections and for continuous wound infusion support the use for up to 48 hours only).

Produkt oversigt:

Visual Identification: clear colourless solution for injection; Container Type: Ampoule; Container Material: PP; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Autorisation status:

Registered

Autorisation dato:

2013-02-27

Produktets egenskaber

Ropivacaine Actavis
Solution for injection
PRODUCT INFORMATION
(
Injection solutions for the production of local or regional
anaesthesia
)
NOT FOR INTRAVENOUS ADMINSTRATION UNDER ANY CIRCUMSTANCES
NAME OF THE MEDICINE
Ropivacaine hydrochloride. The chemical name for ropivacaine
hydrochloride is (S)-(-)-propyl-
piperidine-2-carboxylic
acid
(2,6-dimethyl-phenyl)-amide
hydrochloride
monohydrate.
Its
structural formula is:
C
17
H
26
N
2
O.HCl.H
2
O
Molecular weight: 328.89
CAS No.: 84057-95-4
DESCRIPTION
Ropivacaine hydrochloride 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 > 98%. 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 ACTAVIS solution for injection is a sterile, isotonic,
isobaric, aqueous solution of
ropivacaine hydrochloride in Water for Injections. 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 and the
solution also contains sodium chloride. The nominal osmolality of
ROPIVACAINE ACTAVIS 0.2% (2
mg/mL) is 288 mosmol/kg. The solution is preservative free. The
presentations of ROPIVACAINE
ACTAVIS solutions for injection are intended for single use only in
one patient. 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 ACTAVIS – Product information
Page 2 of 20
Ropivacaine, like other local anaesthetics, causes reversible blockade
of impulse propagation
along nerve fibres by preventing the inward movement of sodium ions
thro