Australia - English - Department of Health (Therapeutic Goods Administration)

aspen pharmacare australia pty ltd - ropivacaine hydrochloride, quantity: 10 mg/ml - injection, solution - excipient ingredients: sodium chloride; sodium hydroxide; water for injections; hydrochloric acid - 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 2500g weight), infants and children up to and including 12 years. continuous epidural infusion in infants (>30 days and over 2500g 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).

Australia - English - Department of Health (Therapeutic Goods Administration)

aspen pharmacare australia pty ltd - ropivacaine hydrochloride, quantity: 2 mg/ml - injection, solution - excipient ingredients: water for injections; sodium chloride; sodium hydroxide; hydrochloric acid - 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 (adult only). analgesia (children aged 0-12 years). caudal epidural block in neonates (>37 weeks gestation and over 2500g weight), infants and children up to and including 12 years. continuous epidural infusion in infants (>30 days and over 2500g 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 and for continuous wound infusion support the use for up to 48 hours only).

Australia - English - Department of Health (Therapeutic Goods Administration)

aspen pharmacare australia pty ltd - ropivacaine hydrochloride, quantity: 2 mg/ml - injection, solution - excipient ingredients: sodium hydroxide; hydrochloric acid; sodium chloride; water for injections - 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 (adult only). analgesia (children aged 0-12 years). caudal epidural block in neonates (>37 weeks gestation and over 2500g weight), infants and children up to and including 12 years. continuous epidural infusion in infants (>30 days and over 2500g 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 and for continuous wound infusion support the use for up to 48 hours only).

Australia - English - Department of Health (Therapeutic Goods Administration)

aspen pharmacare australia pty ltd - ropivacaine hydrochloride, quantity: 5 mg/ml - injection, solution - excipient ingredients: hydrochloric acid; water for injections; sodium hydroxide; sodium chloride - 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 2500g weight), infants and children up to and including 12 years. continuous epidural infusion in infants (>30 days and over 2500g 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).

Australia - English - Department of Health (Therapeutic Goods Administration)

aspen pharmacare australia pty ltd - ropivacaine hydrochloride, quantity: 5 mg/ml - injection, solution - excipient ingredients: sodium hydroxide; sodium chloride; hydrochloric acid; water for injections - 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 2500g weight), infants and children up to and including 12 years. continuous epidural infusion in infants (>30 days and over 2500g 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).

Australia - English - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - ropivacaine hydrochloride monohydrate, quantity: 211.6 mg - injection, solution - excipient ingredients: sodium chloride; water for injections; sodium hydroxide; hydrochloric acid - 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).

Australia - English - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - ropivacaine hydrochloride monohydrate, quantity: 158.7 mg - injection, solution - excipient ingredients: water for injections; sodium hydroxide; sodium chloride; hydrochloric acid - 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).

Australia - English - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - ropivacaine hydrochloride monohydrate, quantity: 52.9 mg - injection, solution - excipient ingredients: sodium chloride; water for injections; sodium hydroxide; hydrochloric acid - 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).

Australia - English - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - ropivacaine hydrochloride monohydrate, quantity: 42.3 mg - injection, solution - excipient ingredients: water for injections; sodium chloride; sodium hydroxide; hydrochloric acid - 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).

Australia - English - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - ropivacaine hydrochloride monohydrate, quantity: 211.6 mg - injection, solution - excipient ingredients: sodium hydroxide; hydrochloric acid; sodium chloride; water for injections - 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).