オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

medsurge pharma pty ltd - ketorolac trometamol, quantity: 10 mg - injection - excipient ingredients: sodium chloride; sodium hydroxide; water for injections; hydrochloric acid; ethanol - ketorolac medsurge solution for injection is indicated for the short-term management of moderately severe, acute pain following surgical procedures. the total duration of ketorolac use should not exceed five days. it is recommended that ketorolac parenteral be used in the immediate post-operative period. patients can then be converted to the oral formulation (dependent on their analgesic needs), as outlined in the section 4.2 dose and method of administration (refer to conversion from parenteral to oral therapy). the total period of treatment utilising the oral and/or intramuscular route of administration is not to exceed five days. note that oral dosage forms are available from other brands.,general,ketorolac medsurge solution for injection is not recommended for use as an obstetrical pre-operative medication or for obstetrical analgesia because it has not been adequately studied for use in these circumstances and because the known effects of drugs that inhibit prostaglandin biosynthesis on uterine contraction and foetal circulation.,there is no satisfactory evidence for the use of ketorolac medsurge solution for injection in acute exacerbations of chronic painful inflammatory conditions (e.g. rheumatoid or osteoarthritis).

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

medsurge pharma pty ltd - ketorolac trometamol, quantity: 30 mg - injection - excipient ingredients: sodium chloride; ethanol; sodium hydroxide; hydrochloric acid; water for injections - ketorolac medsurge solution for injection is indicated for the short-term management of moderately severe, acute pain following surgical procedures. the total duration of ketorolac use should not exceed five days. it is recommended that ketorolac parenteral be used in the immediate post-operative period. patients can then be converted to the oral formulation (dependent on their analgesic needs), as outlined in the section 4.2 dose and method of administration (refer to conversion from parenteral to oral therapy). the total period of treatment utilising the oral and/or intramuscular route of administration is not to exceed five days. note that oral dosage forms are available from other brands.,general,ketorolac medsurge solution for injection is not recommended for use as an obstetrical pre-operative medication or for obstetrical analgesia because it has not been adequately studied for use in these circumstances and because the known effects of drugs that inhibit prostaglandin biosynthesis on uterine contraction and foetal circulation.,there is no satisfactory evidence for the use of ketorolac medsurge solution for injection in acute exacerbations of chronic painful inflammatory conditions (e.g. rheumatoid or osteoarthritis).

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

aspen pharmacare australia pty ltd - morphine sulfate pentahydrate, quantity: 10 mg/ml - injection, suspension - excipient ingredients: dioleoylphosphatidylcholine; dipalmitoylphosphatidylglycerol; cholesterol; triolein; tricaprylin; sodium chloride; dilute hydrochloric acid; water for injections - for the relief of post-operative pain following major orthopaedic, abdominal, or pelvic surgery via the lumbar epidural route at a maximum recommended dose of 10 mg. appropriate monitoring must be maintained for at least 48 hours - see precautions.

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - heparin sodium, quantity: 10 iu/ml - injection, solution - excipient ingredients: water for injections; sodium chloride; sodium hydroxide; hydrochloric acid - indications as at 01 june 2001 : maintenance of the patency of intravenous injection devices.

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - adalimumab, quantity: 80 mg - injection, solution - excipient ingredients: sodium chloride; sucrose; polysorbate 80; water for injections - rheumatoid arthritis,adalicip is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. adalicip can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis,polyarticular juvenile idiopathic arthritis,adalicip in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older weighing greater than or equal to 30 kg who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). adalicip can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis,adalicip is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis,adalicip is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis,adalicip is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis. crohn?s disease in adults and children (greater than or equal to 6 years; weighing greater than or equal to 40 kg) adalicip is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; ? who have had an inadequate response to conventional therapies or, ? who have lost response to or are intolerant to infliximab,ulcerative colitis,adalicip is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time (see section 5.1 pharmacodynamic properties -clinical trials).,psoriasis in adults and children,adalicip is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,adalicip is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age weighing greater than or equal to 40 kg who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age),adalicip is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis,adalicip is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: sodium chloride; sucrose; polysorbate 80; water for injections - rheumatoid arthritis,adalicip is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. adalicip can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis,polyarticular juvenile idiopathic arthritis,adalicip in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older weighing greater than or equal to 30 kg who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). adalicip can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis,adalicip is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis,adalicip is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis,adalicip is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis. crohn?s disease in adults and children (greater than or equal to 6 years; weighing greater than or equal to 40 kg) adalicip is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; ? who have had an inadequate response to conventional therapies or, ? who have lost response to or are intolerant to infliximab,ulcerative colitis,adalicip is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time (see section 5.1 pharmacodynamic properties -clinical trials).,psoriasis in adults and children,adalicip is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,adalicip is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age weighing greater than or equal to 40 kg who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age),adalicip is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis,adalicip is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: sodium chloride; sucrose; polysorbate 80; water for injections - rheumatoid arthritis,adalicip is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. adalicip can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis,polyarticular juvenile idiopathic arthritis,adalicip in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older weighing greater than or equal to 30 kg who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). adalicip can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis,adalicip is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis,adalicip is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis,adalicip is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis. crohn?s disease in adults and children (greater than or equal to 6 years; weighing greater than or equal to 40 kg) adalicip is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; ? who have had an inadequate response to conventional therapies or, ? who have lost response to or are intolerant to infliximab,ulcerative colitis,adalicip is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time (see section 5.1 pharmacodynamic properties -clinical trials).,psoriasis in adults and children,adalicip is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,adalicip is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age weighing greater than or equal to 40 kg who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age),adalicip is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis,adalicip is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - propofol, quantity: 10 g/l - injection, emulsion - excipient ingredients: medium chain triglycerides; water for injections; glycerol; sodium hydroxide; soya oil; egg lecithin; oleic acid - induction of general anaesthesia in children and adults,fresofol (1 percent) mct / lct is a short-acting intravenous anaesthetic agent suitable for induction of general anaesthesia in adults and children aged one month and older.,maintenance of general anaesthesia in children and adults,fresofol (1 percent) mct / lct is a short acting intravenous anaesthetic agent suitable for maintenance of general anaesthesia in adults and children aged 3 years and older.,fresofol (1 percent) mct / lct may also be used for maintenance of general anaesthesia in children aged from one month to 3 years for procedures not exceeding 60 minutes, unless alternative anaesthetic agents should be avoided.,fresofol (1 percent) mct / lct has no analgesic properties. ,sedation during intensive care in adults,fresofol (1 percent) mct / lct may also be used in adults for sedation of ventilated patients receiving intensive care.,conscious sedation for surgical and diagnostic procedures in adults,fresofol (1 percent) mct / lct may also be used in adults for monitored conscious sedation for surgical and diagnostic procedures.

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - propofol, quantity: 10 g/l - injection, emulsion - excipient ingredients: medium chain triglycerides; egg lecithin; sodium hydroxide; water for injections; oleic acid; glycerol; soya oil - induction of general anaesthesia in children and adults,fresofol (1 percent) mct / lct is a short-acting intravenous anaesthetic agent suitable for induction of general anaesthesia in adults and children aged one month and older.,maintenance of general anaesthesia in children and adults,fresofol (1 percent) mct / lct is a short acting intravenous anaesthetic agent suitable for maintenance of general anaesthesia in adults and children aged 3 years and older.,fresofol (1 percent) mct / lct may also be used for maintenance of general anaesthesia in children aged from one month to 3 years for procedures not exceeding 60 minutes, unless alternative anaesthetic agents should be avoided.,fresofol (1 percent) mct / lct has no analgesic properties. ,sedation during intensive care in adults,fresofol (1 percent) mct / lct may also be used in adults for sedation of ventilated patients receiving intensive care.,conscious sedation for surgical and diagnostic procedures in adults,fresofol (1 percent) mct / lct may also be used in adults for monitored conscious sedation for surgical and diagnostic procedures.

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - propofol, quantity: 10 g/l - injection, emulsion - excipient ingredients: medium chain triglycerides; sodium hydroxide; water for injections; glycerol; oleic acid; soya oil; egg lecithin - induction of general anaesthesia in children and adults,fresofol (1 percent) mct / lct is a short-acting intravenous anaesthetic agent suitable for induction of general anaesthesia in adults and children aged one month and older.,maintenance of general anaesthesia in children and adults,fresofol (1 percent) mct / lct is a short acting intravenous anaesthetic agent suitable for maintenance of general anaesthesia in adults and children aged 3 years and older.,fresofol (1 percent) mct / lct may also be used for maintenance of general anaesthesia in children aged from one month to 3 years for procedures not exceeding 60 minutes, unless alternative anaesthetic agents should be avoided.,fresofol (1 percent) mct / lct has no analgesic properties. ,sedation during intensive care in adults,fresofol (1 percent) mct / lct may also be used in adults for sedation of ventilated patients receiving intensive care.,conscious sedation for surgical and diagnostic procedures in adults,fresofol (1 percent) mct / lct may also be used in adults for monitored conscious sedation for surgical and diagnostic procedures.