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 - calcium chloride dihydrate, quantity: 100 mg/ml - injection, solution - excipient ingredients: sodium hydroxide; water for injections; hydrochloric acid - parental administration of calcium is indicated in the treatment of hypocalcaemia where rapid increase in plasma calcium is required, such as in hypocalcaemic tetany and tetany due to parathyroid deficiency. intravenous calcium is also indicated to antagonise the cardiotoxicity of hyperkalaemia.

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

dentsply sirona pty ltd - prilocaine hydrochloride, quantity: 30 mg/ml; felypressin, quantity: 0.03 iu/ml - injection, solution - excipient ingredients: sodium chloride; water for injections; hydrochloric acid; sodium hydroxide; sodium acetate; chlorobutanol hemihydrate; acetic acid - indications as at 23 july 2003 : citanest is indicated for the production of local anaesthesia in routine dental procedures and oral surgery by means of infiltration and nerve block tecniques.

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

baxter healthcare pty ltd - glucose, quantity: 250 g/l - injection, solution - excipient ingredients: water for injections - this product accepted for registration/listing as 'currently supplied' at the time of commencement of the act. indications held in artg paper records. (old code)

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

sandoz pty ltd - fluorouracil, quantity: 1000 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, rectum; and in the treatment of gastric, primary hepatic, pancreatic, uterine (cervcial 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)

aspen pharmacare australia pty ltd - fondaparinux sodium, quantity: 2.5 mg - injection, solution - excipient ingredients: sodium chloride; water for injections - arixtra is indicated for the prevention of venous thromboembolic events (vte) in patients undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee or hip replacement surgery.,arixtra is indicated for the prevention of venous thromboembolic events (vte) in patients undergoing abdominal surgery who are at risk of thromboembolic complications.,arixtra is indicated for the treatment of acute deep venous thrombosis (dvt) and acute pulmonary embolism (pe).,arixtra is indicated for the treatment of unstable angina or non-st segment elevation myocardial infarction (ua/nstemi) for whom urgent (<120 min) invasive management (pci) is not indicated.,arixtra is indicated for the treatment of st segment elevation myocardial infarction (stemi) in patients who are managed without any form of initial reperfusion therapy.

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

pfizer australia pty ltd - cefotaxime sodium, quantity: 1.048 g - injection, powder for - excipient ingredients: - indications: cefotaxime is indicated for the treatment of the following types of injection when caused by susceptible micro-organisms: infections of the respiratory tract (upper and lower). infections of the urinary tract. septicaemia - concomitant therapy with an aminoglycoside may be instituted prior to isolation of the causative organism. intra-abdominal infection. gonorrhoea (including gonorrhoea caused by beta lactamase producing strains of n. gonorrhoeae). ear, nose and throat infections. skin and skin structure infections. bone and joint infections. meningitis - cefotaxime should be combined with an appropriate alternative antibiotic (ampicillin, chloramphenicol or pencillin g) for initial therapy in children, (excluding neonates) pending the availability of culture and sensitivity results. in adults, the empirical use of cefotaxime should be restricted to patients suspected of having meningitis caused by gram negative enteric bacilli. cefotaxime may be used for the prevention of post-operative infection in obstetrical surgery, vaginal and abdominal hysterectomy and biliary surgery. in serious cases, cefotaxime may be used, if considered appropriate,before the results of sensitivity tests become available. the emergency of resistance to cefotaxime may complicate treatment.

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

pfizer australia pty ltd - fluorouracil, quantity: 50 mg/ml - injection, solution - excipient ingredients: water for injections; sodium hydroxide - fluorouracil is indicated 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)

aspen pharmacare australia pty ltd - lidocaine hydrochloride, quantity: 20 mg/ml; adrenaline (epinephrine) acid tartrate, quantity: 22.7 microgram/ml (equivalent: adrenaline (epinephrine), qty microgram/ml) - injection, solution - excipient ingredients: sodium metabisulfite; water for injections; sodium chloride; hydrochloric acid; sodium hydroxide - xylocaine solutions are indicated for the production of local or regional anaesthesia by the following techniques: infiltration, intravenous regional anaesthesia - excluding solutions with adrenaline, peripheral nerve block such as intercostal block, major plexus block such as brachial plexus block, epidural block, subarachnoid block.

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

aspen pharmacare australia pty ltd - bupivacaine hydrochloride, quantity: 3.75 mg/ml (equivalent: bupivacaine hydrochloride monohydrate, qty 3.96 mg/ml) - injection, solution - excipient ingredients: sodium hydroxide; sodium chloride; water for injections - indications as at 4 april 2000: marcain solutions are indicated for the production of local or regional anaesthesia and analgesia in individuals as follows: surgical anaesthesia - epidural block for surgery, field block (minor and major nerve blocks and infiltration). analgesia - continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain. - field block (minor nerve block and infiltration). the choice of 4 strengths, 0.125%, 0.25%, 0.375% and 0.5%, makes it possible to vary the degree of motor blockade.