Австралия - английски - Department of Health (Therapeutic Goods Administration)

celltrion healthcare australia pty ltd - rituximab, quantity: 500 mg - injection, concentrated - excipient ingredients: sodium citrate dihydrate; polysorbate 80; water for injections; sodium chloride - non-hodgkin?s lymphoma truxima is indicated for treatment of patients with: -cd20 positive, previously untreated, stage iii/iv follicular, b-cell non-hodgkin?s lymphoma; - cd20 positive, relapsed or refractory low grade or follicular, b-cell non-hodgkin's lymphoma; - cd20 positive, diffuse large b-cell non-hodgkin?s lymphoma, in combination with chemotherapy.,chronic lymphocytic leukaemia truxima is indicated for the treatment of patients with cd20 positive chronic lymphocytic leukaemia (cll) in combination with chemotherapy.,rheumatoid arthritis truxima (rituximab) in combination with methotrexate is indicated for the treatment of adult patients with severe, active rheumatoid arthritis who have had an inadequate response or intolerance to at least one tumour necrosis factor (tnf) inhibitor therapy. truxima has been shown to reduce the rate of progression of joint damage as measured by xray when given in combination with methotrexate.,granulomatosis with polyangiitis (wegener?s) (gpa) and microscopic polyangiitis (mpa) truxima in combination with glucocorticoids is indicated for the induction of remission in patients with severely active granulomatosis with polyangiitis (gpa, also known as wegener?s granulomatosis) and microscopic polyangiitis (mpa). the efficacy and safety of retreatment with rituximab have not been established.

Австралия - английски - 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.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - amivantamab, quantity: 350 mg - injection, concentrated - excipient ingredients: methionine; disodium edetate; histidine; polysorbate 80; histidine hydrochloride monohydrate; water for injections; sucrose - rybrevant has provisional approval for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) that has an activating epidermal-growth factor receptor (egfr) exon 20 insertion mutation, whose disease has progressed on or after platinum-based chemotherapy.,the decision to approve this indication has been made on the basis of objective response rate and duration of response in a single arm study. continued approval of this indication depends on verification and description of benefit in a confirmatory study.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

baxter healthcare pty ltd - sodium chloride, quantity: 9 g/l - injection, intravenous infusion - excipient ingredients: hydrochloric acid; water for injections - indications as at 9 october 2002: sodium chloride (0.9%) intravenous infusion is indicated for extracellular fluid replacement and in the management of metabolic alkalosis in the presence of fluid loss, and for restoring or maintaining the concentration of sodium and chloride ions.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

baxter healthcare pty ltd - sodium chloride, quantity: 9 g/l - injection, intravenous infusion - excipient ingredients: water for injections; hydrochloric acid - indications as at 9 october 2002: sodium chloride (0.9%) intravenous infusion is indicated for extracellular fluid replacement and in the management of metabolic alkalosis in the presence of fluid loss, and for restoring or maintaining the concentration of sodium and chloride ions.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

baxter healthcare pty ltd - sodium chloride, quantity: 9 g/l - injection, intravenous infusion - excipient ingredients: water for injections; hydrochloric acid - indications as at 9 october 2002: sodium chloride (0.9%) intravenous infusion is indicated for extracellular fluid replacement and in the management of metabolic alkalosis in the presence of fluid loss, and for restoring or maintaining the concentration of sodium and chloride ions.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

baxter healthcare pty ltd - sodium chloride, quantity: 9 g/l - injection, intravenous infusion - excipient ingredients: water for injections; hydrochloric acid - indications as at 9 october 2002: sodium chloride (0.9%) intravenous infusion is indicated for extracellular fluid replacement and in the management of metabolic alkalosis in the presence of fluid loss, and for restoring or maintaining the concentration of sodium and chloride ions.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

baxter healthcare pty ltd - sodium chloride, quantity: 9 g/l - injection, intravenous infusion - excipient ingredients: water for injections; hydrochloric acid - indications as at 9 october 2002: sodium chloride (0.9%) intravenous infusion is indicated for extracellular fluid replacement and in the management of metabolic alkalosis in the presence of fluid loss, and for restoring or maintaining the concentration of sodium and chloride ions.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - idursulfase, quantity: 6 mg - injection, intravenous infusion - excipient ingredients: sodium chloride; water for injections; dibasic sodium phosphate heptahydrate; monobasic sodium phosphate monohydrate; polysorbate 20 - for the long term treatment of patients with hunter syndrome (mucopolysaccharidosis ii, mps ii) for the long term treatment of patients with hunter syndrome (mucoplysaccharidosis ii, mps ii).

Австралия - английски - Department of Health (Therapeutic Goods Administration)

baxter healthcare pty ltd - sodium chloride, quantity: 9 g - injection - excipient ingredients: water for injections - normal saline can be used as the vehicle for many parenteral drugs and as an electrolyte replenisher for maintenance or replacement of deficits of extracellular fluid. it can also be used as a sterile irrigation medium.