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

pfizer australia pty ltd - nitrofurantoin, quantity: 100 mg - capsule, hard - excipient ingredients: maize starch; purified talc; lactose monohydrate; gelatin; quinoline yellow; titanium dioxide; sodium lauryl sulfate; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide; simethicone - indications as at 1 january 1991 : treatment of urinary tract infections such as cystitis and pyelitis when due to susceptible pathogens. nitrofurantoin does not reach effective levels in plasma and consequently is not indicated for cortical or perinephric abscesses and in cases of prostatitis.

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

pfizer australia pty ltd - nitrofurantoin, quantity: 50 mg - capsule, hard - excipient ingredients: gelatin; maize starch; quinoline yellow; titanium dioxide; lactose monohydrate; purified talc; sodium lauryl sulfate; propylene glycol; ethanol; butan-1-ol; purified water; isopropyl alcohol; shellac; iron oxide black; simethicone; strong ammonia solution; potassium hydroxide - indications as at 1 january 1991 : treatment of urinary tract infections such as cystitis and pyelitis when due to susceptible pathogens. nitrofurantoin does not reach effective levels in plasma and consequently is not indicated for cortical or perinephric abscesses and in cases of prostatitis.

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

pfizer australia pty ltd - sodium nitrite, quantity: 30 mg/ml - injection, solution - excipient ingredients: water for injections - dbl sodium nitrite injection is indicated as an antidote in the treatment of cyanide poisoning, in conjunction with sodium thiosulfate.

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

sanofi-aventis australia pty ltd - amiodarone hydrochloride, quantity: 200 mg - tablet, uncoated - excipient ingredients: povidone; maize starch; lactose monohydrate; colloidal anhydrous silica; magnesium stearate - severe cases of tachyarrhythmias (eg. wolff-parkinson-white syndrome, supraventricular, nodal and ventricular tachycardias, atrial flutter and fibrillation, ventricular fibrillation) not responding to other therapy. treatment should be initiated in hospital. it is recommended that the patient should be regularly monitored for possible toxicity (eg. thyroid function, chest x-ray, ophthalmological examination, liver function etc.) during the entire course of therapy and for several months after discontinuation.

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

celltrion healthcare australia pty ltd - infliximab, quantity: 120 mg - injection, solution - excipient ingredients: acetic acid; sodium acetate trihydrate; sorbitol; polysorbate 80; water for injections - rheumatoid arthritis in adults remsima in combination with methotrexate, is indicated for the reduction of signs and symptoms and prevention of structural joint damage (erosions and joint space narrowing) in: - patients with active disease despite treatment with methotrexate - patients with active disease who have not previously received methotrexate.,remsima should be given in combination with methotrexate. efficacy and safety in rheumatoid arthritis have been demonstrated only in combination with methotrexate.,ankylosing spondylitis remsima is indicated for the reduction of signs and symptoms and improvement in physical function in patients with active disease.,psoriatic arthritis remsima is indicated for the treatment of the signs and symptoms, as well as for the improvement in physical function in adult patients with active and progressive psoriatic arthritis who have responded inadequately to disease-modifying anti-rheumatic drug (dmard) therapy. remsima may be administered in combination with methotrexate.,psoriasis remsima is indicated for the treatment of adult patients with moderate to severe plaque psoriasis for whom phototherapy or conventional systemic treatments have been inadequate or are inappropriate. safety and efficacy beyond 12 months have not been established.,crohn?s disease in adults remsima is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms and to induce and maintain clinical remission in patients who have an inadequate response to conventional therapies.,refractory fistulising crohn?s disease remsima is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients.,ulcerative colitis in adults remsimais indicated for the treatment of moderately severe to severe active ulcerative colitis in patients who have had an inadequate response to conventional therapy.

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

celltrion healthcare australia pty ltd - infliximab, quantity: 120 mg - injection, solution - excipient ingredients: acetic acid; sodium acetate trihydrate; sorbitol; polysorbate 80; water for injections - rheumatoid arthritis in adults remsima in combination with methotrexate, is indicated for the reduction of signs and symptoms and prevention of structural joint damage (erosions and joint space narrowing) in: - patients with active disease despite treatment with methotrexate - patients with active disease who have not previously received methotrexate.,remsima should be given in combination with methotrexate. efficacy and safety in rheumatoid arthritis have been demonstrated only in combination with methotrexate.,ankylosing spondylitis remsima is indicated for the reduction of signs and symptoms and improvement in physical function in patients with active disease.,psoriatic arthritis remsima is indicated for the treatment of the signs and symptoms, as well as for the improvement in physical function in adult patients with active and progressive psoriatic arthritis who have responded inadequately to disease-modifying anti-rheumatic drug (dmard) therapy. remsima may be administered in combination with methotrexate.,psoriasis remsima is indicated for the treatment of adult patients with moderate to severe plaque psoriasis for whom phototherapy or conventional systemic treatments have been inadequate or are inappropriate. safety and efficacy beyond 12 months have not been established.,crohn?s disease in adults remsima is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms and to induce and maintain clinical remission in patients who have an inadequate response to conventional therapies.,refractory fistulising crohn?s disease remsima is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients.,ulcerative colitis in adults remsimais indicated for the treatment of moderately severe to severe active ulcerative colitis in patients who have had an inadequate response to conventional therapy.

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

celltrion healthcare australia pty ltd - infliximab, quantity: 120 mg - injection, solution - excipient ingredients: acetic acid; sodium acetate trihydrate; sorbitol; polysorbate 80; water for injections - rheumatoid arthritis in adults remsima in combination with methotrexate, is indicated for the reduction of signs and symptoms and prevention of structural joint damage (erosions and joint space narrowing) in: - patients with active disease despite treatment with methotrexate - patients with active disease who have not previously received methotrexate.,remsima should be given in combination with methotrexate. efficacy and safety in rheumatoid arthritis have been demonstrated only in combination with methotrexate.,ankylosing spondylitis remsima is indicated for the reduction of signs and symptoms and improvement in physical function in patients with active disease.,psoriatic arthritis remsima is indicated for the treatment of the signs and symptoms, as well as for the improvement in physical function in adult patients with active and progressive psoriatic arthritis who have responded inadequately to disease-modifying anti-rheumatic drug (dmard) therapy. remsima may be administered in combination with methotrexate.,psoriasis remsima is indicated for the treatment of adult patients with moderate to severe plaque psoriasis for whom phototherapy or conventional systemic treatments have been inadequate or are inappropriate. safety and efficacy beyond 12 months have not been established.,crohn?s disease in adults remsima is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms and to induce and maintain clinical remission in patients who have an inadequate response to conventional therapies.,refractory fistulising crohn?s disease remsima is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients.,ulcerative colitis in adults remsimais indicated for the treatment of moderately severe to severe active ulcerative colitis in patients who have had an inadequate response to conventional therapy.

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

guerbet australia pty ltd - ioversol, quantity: 678 mg/ml (equivalent: iodine, qty 320 mg/ml) - injection, solution - excipient ingredients: trometamol; sodium calcium edetate; water for injections; trometamol hydrochloride; sodium hydroxide - this product accepted for registration as 'currently supplied' at the time of commencement of the act. indications approved as specified in the letter of 19 april 1993 from dr h. arora are as follows: optiray is indicated in adults for angiography throughout the cardiovascular system by conventional or digital subtraction techniques. these include cerebral, coronary, peripheral, visceral and renal arteriography, aortography, left ventriculography and venography. optiray may be used in intravenous excretory urography. optiray 320 is indicated in children (excluding neonates) for angiography, contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography.

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

guerbet australia pty ltd - ioversol, quantity: 678 mg/ml (equivalent: iodine, qty 320 mg/ml) - injection, solution - excipient ingredients: trometamol; sodium calcium edetate; water for injections; trometamol hydrochloride; sodium hydroxide - this product accepted for registration as 'currently supplied' at the time of commencement of the act. indications approved as specified in the letter of 19 april 1993 from dr h. arora are as follows: optiray is indicated in adults for angiography throughout the cardiovascular system by conventional or digital subtraction techniques. these include cerebral, coronary, peripheral, visceral and renal arteriography, aortography, left ventriculography and venography. optiray may be used in intravenous excretory urography. optiray 320 is indicated in children (excluding neonates) for angiography, contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography.

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

guerbet australia pty ltd - ioversol, quantity: 678 mg/ml (equivalent: iodine, qty 320 mg/ml) - injection, solution - excipient ingredients: trometamol; sodium calcium edetate; water for injections; trometamol hydrochloride; sodium hydroxide - this product accepted for registration as 'currently supplied' at the time of commencement of the act. indications approved as specified in the letter of 19 april 1993 from dr h. arora are as follows: optiray is indicated in adults for angiography throughout the cardiovascular system by conventional or digital subtraction techniques. these include cerebral, coronary, peripheral, visceral and renal arteriography, aortography, left ventriculography and venography. optiray may be used in intravenous excretory urography. optiray 320 is indicated in children (excluding neonates) for angiography, contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography.