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

bristol-myers squibb australia pty ltd - abatacept, quantity: 125.875 mg - injection - excipient ingredients: poloxamer; nitrogen; sucrose; dibasic sodium phosphate; monobasic sodium phosphate; water for injections - orencia in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have had an insufficient response or intolerance to other disease modifying anti-rheumatic drugs (dmards), such as methotrexate or tumour necrosis factor (tnf) blocking agents. a reduction in the progression of joint damage and improvement in physical function have been demonstrated during combination treatment with orencia and methotrexate.,orencia in combination with methotrexate is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.,orencia is indicated for reducing signs and symptoms in paediatric patients 6 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (dmards). orencia may be used as monotherapy or concomitantly with methotrexate (mtx). (there is no clinical trial data for the use of orencia subcutaneous formulation in children, therefore its use in children cannot be recommended.),orencia is indicated for the treatment of active psoriatic arthritis (psa) in adults when the response to previous disease-modifying anti-rheumatic drug (dmard) therapy has been inadequate. orencia can be used with or without non-biologic dmards.,orencia should not be administered concurrently with other biological dmards (eg, tnf inhibitors, rituximab, or anakinra).

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

sanofi-aventis australia pty ltd - ramipril, quantity: 10 mg - tablet, uncoated - excipient ingredients: pregelatinised maize starch; sodium stearylfumarate; hypromellose; microcrystalline cellulose - treatment of hypertension. (data are currently not available to support the use of tritace in renovascular hypertension.) post myocardial infarction heart failure. prevention of progressive renal failure in patients with persistent proteinuria in excess of 1 g/day. for reducing the risk of myocardial infarction, stroke, cardiovascular death or the need for revascularisation procedures in patients 55 years of age or more who have clinical evidence of coronary artery disease, stroke or peripheral vascular disease. for reducing the risk of myocardial infarction, stroke, cardiovascular death or revascularisation procedures in diabetic patients 55 years or more with one or more of the following risk factors: systolic blood pressure > 160 mmhg or diastolic blood pressure > 90 mmhg (or on antihypertensive treatment); total cholesterol > 5.2 mmol/l: hdl cholesterol < 0.9 mmol/l; current smoker; known microalbuminuria; any evidence of previous vascular disease.

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

sanofi-aventis australia pty ltd - ramipril, quantity: 10 mg - capsule, hard - excipient ingredients: indigo carmine; pregelatinised maize starch; titanium dioxide; erythrosine; gelatin; iron oxide black - treatment of hypertension. (data are currently not available to support the use of tritace in renovascular hypertension.) post myocardial infarction heart failure. prevention of progressive renal failure in patients with persistent proteinuria in excess of 1 g/day. for reducing the risk of myocardial infarction, stroke, cardiovascular death or the need for revascularisation procedures in patients 55 years of age or more who have clinical evidence of coronary artery disease, stroke or peripheral vascular disease. for reducing the risk of myocardial infarction, stroke, cardiovascular death or revascularisation procedures in diabetic patients 55 years or more with one or more of the following risk factors: systolic blood pressure > 160 mmhg or diastolic blood pressure > 90 mmhg (or on antihypertensive treatment); total cholesterol > 5.2 mmol/l: hdl cholesterol < 0.9 mmol/l; current smoker; known microalbuminuria; any evidence of previous vascular disease.

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

sanofi-aventis australia pty ltd - ramipril, quantity: 5 mg - tablet, uncoated - excipient ingredients: iron oxide red; microcrystalline cellulose; sodium stearylfumarate; pregelatinised maize starch; hypromellose - treatment of hypertension. (data are currently not available to support the use of tritace in renovascular hypertension.) post myocardial infarction heart failure. prevention of progressive renal failure in patients with persistent proteinuria in excess of 1 g/day. for reducing the risk of myocardial infarction, stroke, cardiovascular death or the need for revascularisation procedures in patients 55 years of age or more who have clinical evidence of coronary artery disease, stroke or peripheral vascular disease. for reducing the risk of myocardial infarction, stroke, cardiovascular death or revascularisation procedures in diabetic patients 55 years or more with one or more of the following risk factors: systolic blood pressure > 160 mmhg or diastolic blood pressure > 90 mmhg (or on antihypertensive treatment); total cholesterol > 5.2 mmol/l: hdl cholesterol < 0.9 mmol/l; current smoker; known microalbuminuria; any evidence of previous vascular disease.

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

sanofi-aventis australia pty ltd - ramipril, quantity: 2.5 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; hypromellose; iron oxide yellow; pregelatinised maize starch; sodium stearylfumarate - treatment of hypertension. (data are currently not available to support the use of tritace in renovascular hypertension.) post myocardial infarction heart failure. prevention of progressive renal failure in patients with persistent proteinuria in excess of 1 g/day. for reducing the risk of myocardial infarction, stroke, cardiovascular death or the need for revascularisation procedures in patients 55 years of age or more who have clinical evidence of coronary artery disease, stroke or peripheral vascular disease. for reducing the risk of myocardial infarction, stroke, cardiovascular death or revascularisation procedures in diabetic patients 55 years or more with one or more of the following risk factors: systolic blood pressure > 160 mmhg or diastolic blood pressure > 90 mmhg (or on antihypertensive treatment); total cholesterol > 5.2 mmol/l: hdl cholesterol < 0.9 mmol/l; current smoker; known microalbuminuria; any evidence of previous vascular disease.

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

sanofi-aventis australia pty ltd - ramipril, quantity: 1.25 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; pregelatinised maize starch; hypromellose; sodium stearylfumarate - treatment of hypertension. (data are currently not available to support the use of tritace in renovascular hypertension.) post myocardial infarction heart failure. prevention of progressive renal failure in patients with persistent proteinuria in excess of 1 g/day. for reducing the risk of myocardial infarction, stroke, cardiovascular death or the need for revascularisation procedures in patients 55 years of age or more who have clinical evidence of coronary artery disease, stroke or peripheral vascular disease. for reducing the risk of myocardial infarction, stroke, cardiovascular death or revascularisation procedures in diabetic patients 55 years or more with one or more of the following risk factors: systolic blood pressure > 160 mmhg or diastolic blood pressure > 90 mmhg (or on antihypertensive treatment); total cholesterol > 5.2 mmol/l: hdl cholesterol < 0.9 mmol/l; current smoker; known microalbuminuria; any evidence of previous vascular disease.

United States - English - NLM (National Library of Medicine)

pfizer laboratories div pfizer inc - ramipril (unii: l35jn3i7sj) (ramiprilat - unii:6n5u4qfc3g) - ramipril 1.25 mg - altace is indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program's joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms o

United States - English - NLM (National Library of Medicine)

sanofi pasteur inc. - corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) (unii: irh51qn26h) (corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) - unii:irh51qn26h), clostridium tetani toxoid antigen (formaldehyde inactivated) (unii: k3w1n8yp13) (clostridium tetani toxoid antigen (formaldehyde inactivated) - unii:k3w1n8yp13), bordetella pertussis toxoid antigen (glutaraldehyde inactivated) (unii: f4tn0ipy37) (bordetella pertussis toxoid antigen (glutaraldehyde inactivated) - unii:f4tn0ipy37 - corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) 15 [lf] in 0.5 ml - pentacel® is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to haemophilus influenzae type b. pentacel is approved for use as a four dose series in children 6 weeks through 4 years of age (prior to fifth birthday). a severe allergic reaction (eg, anaphylaxis) after a previous dose of pentacel or any other diphtheria toxoid, tetanus toxoid, or pertussis-containing vaccine, inactivated poliovirus vaccine or h. influenzae type b vaccine, or any ingredient of this vaccine is a contraindication to administration of pentacel. [see description (11). ] encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis-containing vaccine, including pentacel. progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progres

United States - English - NLM (National Library of Medicine)

sanofi pasteur inc. - corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) (unii: irh51qn26h) (corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) - unii:irh51qn26h), clostridium tetani toxoid antigen (formaldehyde inactivated) (unii: k3w1n8yp13) (clostridium tetani toxoid antigen (formaldehyde inactivated) - unii:k3w1n8yp13), bordetella pertussis toxoid antigen (glutaraldehyde inactivated) (unii: f4tn0ipy37) (bordetella pertussis toxoid antigen (glutaraldehyde inactivated) - unii:f4tn0ipy37 - corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) 15 [lf] in 0.5 ml - daptacel® is a vaccine indicated for active immunization against diphtheria, tetanus and pertussis as a five-dose series in infants and children 6 weeks through 6 years of age (prior to seventh birthday). a severe allergic reaction (e.g., anaphylaxis) after a previous dose of daptacel or any other tetanus toxoid, diphtheria toxoid, or pertussis-containing vaccine, or any other component of this vaccine is a contraindication to administration of daptacel. [see description (11). ] because of uncertainty as to which component of the vaccine may be responsible, none of the components should be administered. alternatively, such individuals may be referred to an allergist for evaluation if further immunizations are to be considered. encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis-containing vaccine, inclu

United States - English - NLM (National Library of Medicine)

sanofi pasteur inc. - corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) (unii: irh51qn26h) (corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) - unii:irh51qn26h), clostridium tetani toxoid antigen (formaldehyde inactivated) (unii: k3w1n8yp13) (clostridium tetani toxoid antigen (formaldehyde inactivated) - unii:k3w1n8yp13), bordetella pertussis toxoid antigen (glutaraldehyde inactivated) (unii: f4tn0ipy37) (bordetella pertussis toxoid antigen (glutaraldehyde inactivated) - unii:f4tn0ipy37), bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated) (unii: 8c367iy4ey) (bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated) - unii:8c367iy4ey), bordetella pertussis pertactin antigen (unii: 63gd90pp8x) (bordetella pertussis pertactin antigen - unii:63gd90pp8x), bordetella pertussis fimbriae 2/3 antigen (unii: 1o0600285a) (bordetella pertussis fimbriae 2/3 antigen - unii:1o0600285a), poliovirus type 1 antigen (formaldehyde inactivated) (unii: 0lvy784c09) (poliovirus type 1 antigen (formaldehyde inactivated) - unii:0lvy784c09), poliovirus type 2 antigen (formaldehyde inactivated) (unii: 23je9kdf4r) (poliovirus type 2 antigen (formaldehyde inactivated) - unii:23je9kdf4r), poliovirus type 3 antigen (formaldehyde inactivated) (unii: 459rom8m9m) (poliovirus type 3 antigen (formaldehyde inactivated) - unii:459rom8m9m) - pentacel® is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to haemophilus influenzae type b. pentacel is approved for use as a four dose series in children 6 weeks through 4 years of age (prior to fifth birthday). a severe allergic reaction (eg, anaphylaxis) after a previous dose of pentacel or any other diphtheria toxoid, tetanus toxoid, or pertussis-containing vaccine, inactivated poliovirus vaccine or h. influenzae type b vaccine, or any ingredient of this vaccine is a contraindication to administration of pentacel [see description (11) ]. encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis-containing vaccine, including pentacel. progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy is a contraindication to administration of any pertussis-containing vaccine including pentacel. pertussis vaccine should not be administered to individuals with such conditions until a treatment regimen has been established and the condition has stabilized. the safety and effectiveness of pentacel was established in the age group 6 weeks through 18 months on the basis of clinical studies [see clinical trials experience (6.1) and clinical studies (14) ]. the safety and effectiveness of pentacel in the age group 19 months through 4 years is supported by evidence in children 6 weeks through 18 months. the safety and effectiveness of pentacel in infants less than 6 weeks of age and in children 5 to 16 years of age have not been established.