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

b braun australia pty ltd - fentanyl citrate, quantity: 157 microgram (equivalent: fentanyl, qty 100 microgram) - injection, solution - excipient ingredients: sodium chloride; water for injections - analgesic action of short duration during anaesthetic periods, premedication, induction and maintenance, and in the immediate post-operative period (recovery room) as the need arises - use as an opioid analgesic supplement in general and regional anaesthesia - administration with a neuroleptic such as droperidol injection as an anaesthetic premedication, for the induction of anaesthesia, and as an adjunct in the maintenance of general and regional anaesthesia.

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

generic health pty ltd - fentanyl citrate, quantity: 0.157 mg - injection, solution - excipient ingredients: sodium hydroxide; sodium chloride; water for injections - fentanyl gh injection is indicated for: ,- analgesic action of short duration during anaesthetic periods, premedication, induction and maintenance, and in the immediate post-operative period (recovery room) as the need arises; ,- use as an opioid analgesic supplement in general and regional anaesthesia; ,- administration with a neuroleptic such as droperidol injection as an anaesthetic premedication, for the induction of anaesthesia, and as an adjunct in the maintenance of general and regional anaesthesia.

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

generic health pty ltd - fentanyl citrate, quantity: 0.785 mg - injection, solution - excipient ingredients: sodium hydroxide; water for injections; sodium chloride - fentanyl gh injection is indicated for: ,- analgesic action of short duration during anaesthetic periods, premedication, induction and maintenance, and in the immediate post-operative period (recovery room) as the need arises; ,- use as an opioid analgesic supplement in general and regional anaesthesia; ,- administration with a neuroleptic such as droperidol injection as an anaesthetic premedication, for the induction of anaesthesia, and as an adjunct in the maintenance of general and regional anaesthesia.

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

pfizer australia pty ltd - gemcitabine hydrochloride, quantity: 2.277 g - injection, solution - excipient ingredients: water for injections; hydrochloric acid; sodium hydroxide - dbl gemcitabine injection is indicated: 1. for treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc). 2. for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. 3. for treatment of patients with fu refractory pancreatic cancer. 4. alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer. 5. in combination with paclitaxel, 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. 6. in combination with carboplatin, for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum-based therapy.

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

bayer australia ltd - octocog alfa, quantity: 2000 iu - injection, diluent for - excipient ingredients: water for injections - kogenate fs is indicated for the treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency). it may also be used in patients with factor viii inhibitors (neutralising antibodies) who continue to respond to infused factor viii. kogenate fs does not contain von willebrand factor and hence is not indicated in von willebrands disease.

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

stada pharmaceuticals australia pty ltd - apomorphine hydrochloride hemihydrate, quantity: 50 mg - injection, solution - excipient ingredients: sodium metabisulfite; water for injections; sodium hydroxide; hydrochloric acid - movapo is indicated to reduce the number and severity of "off" phases in patients with parkinson's disease severely disabled by motor fluctuations refractory to conventional therapy. initiation of therapy with movapo should be undertaken by a specialist unit in a hospital setting. conventional therapy should be continued during "on" phases.

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

stada pharmaceuticals australia pty ltd - apomorphine hydrochloride hemihydrate, quantity: 20 mg - injection, solution - excipient ingredients: sodium metabisulfite; water for injections; sodium hydroxide; hydrochloric acid - movapo is indicated to reduce the number and severity of "off" phases in patients with parkinson's disease severely disabled by motor fluctuations refractory to conventional therapy. initiation of therapy with movapo should be undertaken by a specialist unit in a hospital setting. conventional therapy should be continued during "on" phases.

Australia - engelsk - 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 - engelsk - 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 - engelsk - 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).