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

fresenius kabi australia pty ltd - gemcitabine hydrochloride, quantity: 2277.2 mg (equivalent: gemcitabine, qty 2000 mg) - injection, powder for - excipient ingredients: sodium hydroxide; mannitol; hydrochloric acid; sodium acetate - gemcitabine kabi is indicated for, the treatment of patients with locally advanced or metastatic non-small cell lung cancer. treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. gemcitabine is also indicated for patients with 5-fu refractory pancreatic cancer. alone or in combination with cisplatin, for the treatment of patients with bladder cancer. in combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated. in combination with carboplatin, for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum-based therapy.

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

fresenius kabi australia pty ltd - gemcitabine hydrochloride, quantity: 1138.6 mg (equivalent: gemcitabine, qty 1000 mg) - injection, powder for - excipient ingredients: hydrochloric acid; sodium acetate; sodium hydroxide; mannitol - gemcitabine kabi is indicated for, the treatment of patients with locally advanced or metastatic non-small cell lung cancer. treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. gemcitabine is also indicated for patients with 5-fu refractory pancreatic cancer. alone or in combination with cisplatin, for the treatment of patients with bladder cancer. in combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated. in combination with carboplatin, for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum-based therapy.

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

fresenius kabi australia pty ltd - gemcitabine hydrochloride, quantity: 227.72 mg (equivalent: gemcitabine, qty 200 mg) - injection, powder for - excipient ingredients: mannitol; sodium acetate; hydrochloric acid; sodium hydroxide - gemcitabine kabi is indicated for, the treatment of patients with locally advanced or metastatic non-small cell lung cancer. treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. gemcitabine is also indicated for patients with 5-fu refractory pancreatic cancer. alone or in combination with cisplatin, for the treatment of patients with bladder cancer. in combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated. in combination with carboplatin, for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum-based therapy.

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

fresenius kabi australia pty ltd - ropivacaine hydrochloride, quantity: 400 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).

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

fresenius kabi australia pty ltd - ropivacaine hydrochloride, quantity: 200 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).

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

fresenius kabi australia pty ltd - ropivacaine hydrochloride, quantity: 200 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).

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

fresenius kabi australia pty ltd - ropivacaine hydrochloride, quantity: 100 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).

Australia - English - 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).

Australia - English - 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).

Australia - English - 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).