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

Active ingredient:

ropivacaine hydrochloride monohydrate, Quantity: 105.8 mg

Available from:

Medis Pharma Pty Ltd

INN (International Name):

Ropivacaine hydrochloride monohydrate

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

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

Units in package:

5 ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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).

Product summary:

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

Authorization status:

Registered

Authorization date:

2013-02-27