Australija - anglų - Department of Health (Therapeutic Goods Administration)

aspen pharmacare australia pty ltd - ropivacaine hydrochloride, quantity: 10 mg/ml - 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. 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)

Australija - anglų - 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).

Australija - anglų - 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).

Australija - anglų - 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).

Airija - anglų - HPRA (Health Products Regulatory Authority)

bioq pharma b.v. - ropivacaine hydrochloride monohydrate - solution for infusion in administration system - 10 milligram(s)/hour - amides; ropivacaine

Naujoji Zelandija - anglų - Medsafe (Medicines Safety Authority)

aft pharmaceuticals ltd - ropivacaine 8.826 mg/ml equivalent to ropivacaine hydrochloride 9.971 mg/ml; ropivacaine 8.826 mg/ml equivalent to ropivacaine hydrochloride 10.0 mg/ml - solution for injection - 10 mg/ml - active: ropivacaine 8.826 mg/ml equivalent to ropivacaine hydrochloride 9.971 mg/ml excipient: hydrochloric acid potassium hydroxide sodium chloride water for injection active: ropivacaine 8.826 mg/ml equivalent to ropivacaine hydrochloride 10.0 mg/ml excipient: hydrochloric acid potassium hydroxide sodium chloride water for injection - ropivacaine-aft is indicated for surgical anaesthesia in 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

Naujoji Zelandija - anglų - Medsafe (Medicines Safety Authority)

aft pharmaceuticals ltd - ropivacaine 1.765 mg/ml equivalent to ropivacaine hydrochloride 1.994 mg/ml; ropivacaine 1.76 mg/ml equivalent to ropivacaine hydrochloride 2 mg/ml - solution for injection - 2 mg/ml - active: ropivacaine 1.765 mg/ml equivalent to ropivacaine hydrochloride 1.994 mg/ml excipient: hydrochloric acid potassium hydroxide sodium chloride water for injection active: ropivacaine 1.76 mg/ml equivalent to ropivacaine hydrochloride 2 mg/ml excipient: hydrochloric acid potassium hydroxide sodium chloride water for injection - ropivacaine-aft is indicated for surgical anaesthesia in 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

Naujoji Zelandija - anglų - Medsafe (Medicines Safety Authority)

aft pharmaceuticals ltd - ropivacaine 6.62 mg/ml equivalent to ropivacaine hydrochloride 7.479 mg/ml; ropivacaine 6.62 mg/ml equivalent to ropivacaine hydrochloride 7.5 mg/ml - solution for injection - 7.5 mg/ml - active: ropivacaine 6.62 mg/ml equivalent to ropivacaine hydrochloride 7.479 mg/ml excipient: hydrochloric acid potassium hydroxide sodium chloride water for injection active: ropivacaine 6.62 mg/ml equivalent to ropivacaine hydrochloride 7.5 mg/ml excipient: hydrochloric acid potassium hydroxide sodium chloride water for injection - ropivacaine-aft is indicated for surgical anaesthesia in 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

Airija - anglų - HPRA (Health Products Regulatory Authority)

mercury pharmaceuticals ltd - ropivacaine hydrochloride - solution for infusion - 2 mg/ml - ropivacaine

Izraelis - anglų - Ministry of Health

neopharm (israel) 1996 ltd - ropivacaine hydrochloride - solution for infusion - ropivacaine hydrochloride 2 mg/ml - ropivacaine - acute pain management :in adults and adolescents above 12 years of age for:- continuous epidural infusion or intermittent bolus administration during postoperative or labour pain.- field blocks.- peripheral nerve block via a continuous infusion or intermittent bolus injections, e.g. postoperative pain management.