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

actavis australia pty ltd - ropivacaine hydrochloride monohydrate; ropivacaine hydrochloride -

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

galen ltd - ropivacaine hydrochloride - solution for infusion - 2mg/1ml

Israel - English - Ministry of Health

propharm ltd - ropivacaine hydrochloride - solution for injection - ropivacaine hydrochloride 10 mg / 1 ml - ropivacaine - ropivacaine 10 mg/ml is indicated in adults and adolescents aged above 12 years of age for:surgical anaesthesia: lumbar epidural administration for surgery

United States - English - NLM (National Library of Medicine)

app pharmaceuticals, llc - ropivacaine hydrochloride monohydrate (unii: v910p86109) (ropivacaine - unii:7io5lya57n) - ropivacaine 5 mg in 1 ml

New Zealand - English - Medsafe (Medicines Safety Authority)

fresenius kabi new zealand limited - ropivacaine hydrochloride 7.5 mg/ml equivalent to ropivacaine 6.64 mg/ml;   - solution for injection - 7.5 mg/ml - active: ropivacaine hydrochloride 7.5 mg/ml equivalent to ropivacaine 6.64 mg/ml   excipient: hydrochloric acid sodium chloride sodium hydroxide water for injection - 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 postoperative pain management · continuous wound infusion for postoperative pain management (adults only) analgesia (children aged 0-12 years of age) · 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

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

aspen pharmacare australia pty ltd - ropivacaine hydrochloride, quantity: 2 mg/ml - injection, solution - excipient ingredients: hydrochloric acid; sodium hydroxide; water for injections; 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: 2 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: 7.5 mg/ml - injection, solution - excipient ingredients: sodium hydroxide; water for injections; 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).

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

aspen pharmacare australia pty ltd - ropivacaine hydrochloride, quantity: 7.5 mg/ml - injection, solution - excipient ingredients: sodium hydroxide; hydrochloric acid; water for injections; 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: 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)