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)

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)

pfizer australia pty ltd - flucloxacillin sodium monohydrate -

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

juno pharmaceuticals pty ltd - flucloxacillin sodium monohydrate, quantity: 2176 mg (equivalent: flucloxacillin, qty 2000 mg) - injection, powder for - excipient ingredients: - treatment of confirmed or suspected staphylococcal infections and other gram-positive coccal infections including pneumonia, skin and skin structure and wound infections, infected burns and cellulitis.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

kotra pharma (m) sdn. bhd. - ceftazidime pentahydrate -

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

aft pharmaceuticals pty ltd - ropivacaine hydrochloride, quantity: 2 mg/ml - injection, intravenous infusion - excipient ingredients: sodium chloride; sodium hydroxide; hydrochloric acid; water for injections - 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 (excluding intermittent top up injections) ? 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) ? continuous epidural infusion in infants (> 30 days and over 2500 g weight) and children 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-aft 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).