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

fresenius kabi australia pty ltd - irinotecan hydrochloride trihydrate, quantity: 40 mg - injection, concentrated - excipient ingredients: lactic acid; sorbitol; sodium hydroxide; water for injections - irinotecan injection is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.

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

fresenius kabi australia pty ltd - irinotecan hydrochloride trihydrate, quantity: 100 mg - injection, concentrated - excipient ingredients: water for injections; lactic acid; sodium hydroxide; sorbitol - irinotecan injection is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.

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

sandoz pty ltd - fluorouracil, quantity: 5000 mg - injection, solution - excipient ingredients: sodium hydroxide; water for injections - alone or in combination, for the palliative treatment of malignant tumours, particularly of the breast, colon or rectum; and in the treatment of gastric, primary hepatic, pancreatic, uterine (cervical particularly), ovarian and bladder carcinomas. fluorouracil should only be used when other proven measures have failed or are considered impractical.

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

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

sandoz pty ltd - ropivacaine hydrochloride, quantity: 5 mg/ml - injection, solution - excipient ingredients: water for injections; sodium chloride; hydrochloric acid; sodium hydroxide - 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 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. 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)

sandoz pty ltd - ropivacaine hydrochloride, quantity: 5 mg/ml - injection, solution - excipient ingredients: hydrochloric acid; sodium chloride; 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. 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 . - 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. 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)

ucb australia pty ltd t/a ucb pharma division of ucb australia - certolizumab pegol, quantity: 200 mg - injection, solution - excipient ingredients: sodium acetate; sodium chloride; water for injections - rheumatoid arthritis cimzia is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients. ? combined with mtx in case of either an inadequate response or intolerance to previous therapy with one or more disease modifying antirheumatic drugs (dmards) or ? as monotherapy in case of a contraindication or intolerance to mtx (see section 4.2 dose and method of administration). cimzia has been shown to reduce the rate of progression of joint damage as measured by x-ray, when given in combination with mtx. cimzia in combination with mtx is indicated for the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with mtx or other dmards. psoriatic arthritis cimzia is indicated for the treatment of adult patients with active psoriatic arthritis where response to previous disease modifying antirheumatic drug therapy (dmards) has been inadequate. cimzia has been shown to improve physical function.,ankylosing spondylitis cimzia is indicated for the treatment of adult patients with active, ankylosing spondylitis who have been intolerant to or have had inadequate response to at least one nonsteroidal anti-inflammatory drug (nsaid).,non-radiographic axial spondyloarthritis cimzia is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axspa) with objective signs of inflammation as indicated by elevated c reactive protein (crp) and /or magnetic resonance imaging (mri) change, who have had an inadequate response to, or are intolerant to, nonsteroidal anti-inflammatory drugs (nsaids).,plaque psoriasis cimzia is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

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

phebra pty ltd - caffeine, quantity: 20 mg - injection, intravenous infusion - excipient ingredients: sodium citrate dihydrate; water for injections; citric acid monohydrate - cafnea injection is indicated for the short-term treatment of apnoea of prematurity in infants between 28 and 33 weeks gestational age.