오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - ropivacaine hydrochloride, quantity: 150 mg - injection, solution - excipient ingredients: sodium chloride; hydrochloric acid; sodium hydroxide; 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. continous 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 hydrochloride 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).

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - ropivacaine hydrochloride, quantity: 75 mg - injection, solution - excipient ingredients: sodium chloride; hydrochloric acid; sodium hydroxide; 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. continous 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 hydrochloride 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).

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - ropivacaine hydrochloride, quantity: 50 mg - injection, solution - excipient ingredients: sodium chloride; hydrochloric acid; sodium hydroxide; 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. continous 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 hydrochloride 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).

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - ropivacaine hydrochloride, quantity: 40 mg - injection, solution - excipient ingredients: sodium chloride; hydrochloric acid; sodium hydroxide; 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. continous 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 hydrochloride 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).

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - ropivacaine hydrochloride, quantity: 20 mg - injection, solution - excipient ingredients: sodium chloride; hydrochloric acid; sodium hydroxide; 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. continous 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 hydrochloride 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).

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - guselkumab, quantity: 100 mg - injection, solution - excipient ingredients: water for injections; histidine; sucrose; polysorbate 80; histidine hydrochloride monohydrate - plaque psoriasis,tremfya is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.,psoriatic arthritis,tremfya is indicated for the treatment of adult patients with active psoriatic arthritis, who have had an inadequate response to, or are intolerant to prior dmard therapy.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - guselkumab, quantity: 100 mg - injection, solution - excipient ingredients: water for injections; sucrose; histidine hydrochloride monohydrate; histidine; polysorbate 80 - plaque psoriasis,tremfya is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.,psoriatic arthritis,tremfya is indicated for the treatment of adult patients with active psoriatic arthritis, who have had an inadequate response to, or are intolerant to prior dmard therapy.

싱가포르 - 영어 - HSA (Health Sciences Authority)

astrazeneca singapore pte ltd - eculizumab - infusion, solution concentrate - 300 mg / vial - eculizumab 300 mg / vial

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - ustekinumab, quantity: 135 mg - injection, solution - excipient ingredients: histidine hydrochloride monohydrate; sucrose; polysorbate 80; methionine; disodium edetate; water for injections; histidine - crohn?s disease,stelara is indicated for the treatment of adult patients with moderately to severely active crohn?s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a tnf alpha antagonist or have medical contraindications to such therapies.,ulcerative colitis,stelara is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - ustekinumab, quantity: 90 mg - injection, solution - excipient ingredients: histidine hydrochloride monohydrate; sucrose; water for injections; polysorbate 80; histidine - plaque psoriasis,adults - stelara is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.,paediatric population, 6 years and older - stelara is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from 6 years of age who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.,psoriatic arthritis (psa),stelara, alone or in combination with methotrexate, is indicated for the treatment of signs and symptoms of active psoriatic arthritis in adult patients (18 years and older) where response to previous non-biological dmard therapy has been inadequate.,crohn?s disease,stelara is indicated for the treatment of adult patients with moderately to severely active crohn?s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a tnf alpha antagonist or have medical contraindications to such therapies.,ulcerative colitis,stelara is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.