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.

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

ucb, inc. - certolizumab pegol (unii: umd07x179e) (certolizumab pegol - unii:umd07x179e) - certolizumab pegol 200 mg in 1 ml - cimzia is indicated for reducing signs and symptoms of crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. cimzia is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis (ra). cimzia is indicated for the treatment of adult patients with active psoriatic arthritis (psa). cimzia is indicated for the treatment of adults with active ankylosing spondylitis (as). [see clinical studies (14.4)] cimzia is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axspa) with objective signs of inflammation [see clinical studies (14.5)]. cimzia is indicated for the treatment of adults with moderate-to-severe plaque psoriasis (pso) who are candidates for systemic therapy or phototherapy [see clinical studies (14.6)] cimzia is con

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)

bayer australia ltd - damoctocog alfa pegol, quantity: 1000 iu - injection, powder for - excipient ingredients: polysorbate 80; calcium chloride dihydrate; glycine; sodium chloride; sucrose; histidine - jivi, damoctocog alfa pegol, is a long-acting recombinant factor viii concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with haemophilia a for:,? routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes,? on-demand treatment and control of bleeding episodes,? per-operative management of bleeding (surgical prophylaxis),jivi does not contain von willebrand factor, and therefore is not indicated in patients with von willebrand?s disease.

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

bayer australia ltd - damoctocog alfa pegol, quantity: 2000 iu - injection, powder for - excipient ingredients: glycine; histidine; sucrose; calcium chloride dihydrate; sodium chloride; polysorbate 80 - jivi, damoctocog alfa pegol, is a long-acting recombinant factor viii concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with haemophilia a for:,? routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes,? on-demand treatment and control of bleeding episodes,? per-operative management of bleeding (surgical prophylaxis),jivi does not contain von willebrand factor, and therefore is not indicated in patients with von willebrand?s disease.

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

bayer australia ltd - damoctocog alfa pegol, quantity: 250 iu - injection, powder for - excipient ingredients: polysorbate 80; sucrose; glycine; calcium chloride dihydrate; histidine; sodium chloride - jivi, damoctocog alfa pegol, is a long-acting recombinant factor viii concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with haemophilia a for:,? routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes,? on-demand treatment and control of bleeding episodes,? per-operative management of bleeding (surgical prophylaxis),jivi does not contain von willebrand factor, and therefore is not indicated in patients with von willebrand?s disease.

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

bayer australia ltd - damoctocog alfa pegol, quantity: 3000 iu - injection, powder for - excipient ingredients: calcium chloride dihydrate; sucrose; sodium chloride; glycine; histidine; polysorbate 80 - jivi, damoctocog alfa pegol, is a long-acting recombinant factor viii concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with haemophilia a for:,? routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes,? on-demand treatment and control of bleeding episodes,? per-operative management of bleeding (surgical prophylaxis),jivi does not contain von willebrand factor, and therefore is not indicated in patients with von willebrand?s disease.

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

bayer australia ltd - damoctocog alfa pegol, quantity: 500 iu - injection, powder for - excipient ingredients: sucrose; calcium chloride dihydrate; polysorbate 80; glycine; sodium chloride; histidine - jivi, damoctocog alfa pegol, is a long-acting recombinant factor viii concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with haemophilia a for:,? routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes,? on-demand treatment and control of bleeding episodes,? per-operative management of bleeding (surgical prophylaxis),jivi does not contain von willebrand factor, and therefore is not indicated in patients with von willebrand?s disease.

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

servier pharmaceuticals llc - calaspargase pegol (unii: t9fvh03hmz) (calaspargase pegol - unii:t9fvh03hmz) - asparlas is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years. asparlas is contraindicated in patients with: - history of serious hypersensitivity reactions, including anaphylaxis, to pegylated l-asparaginase therapy [see warnings and precautions (5.1)] - history of serious pancreatitis during previous l-asparaginase therapy [see warnings and precautions (5.2)] - history of serious thrombosis during previous l-asparaginase therapy [see warnings and precautions (5.3)] - history of serious hemorrhagic events during previous l-asparaginase therapy [see warnings and precautions (5.4)] - severe hepatic impairment [see warnings and precautions (5.5)] risk summary based on published literature studies with l-asparaginase in pregnant animals, asparlas can cause fetal harm when administered to a pregnant woman. there are no available data on asparlas use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, intravenous administration of calaspargase pegol-mknl to pregnant rats during organogenesis at doses 0.2 to 1 times the maximum recommended human doses did not result in adverse developmental outcomes. published literature studies in pregnant rabbits, however, suggest asparagine depletion may cause harm to the animal offspring (see data) . advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively. data animal data in an embryo-fetal development study, calaspargase pegol-mknl was administered intravenously at doses of 75, 150, and 300 u/kg (0.2, 0.6 and 1 times the maximum recommended human dose, respectively, based on auc) to pregnant rats during the period of organogenesis. maternal toxicity of decreased body weight and food consumption was seen at all dose levels resulting in reductions in gravid uterine and placental weights, and slight reductions in fetal body weights. no evidence of structural abnormalities or embryo-fetal mortality were observed in this study at any of the doses tested. published literature studies in which pregnant rabbits were administered l-asparaginase suggested harm to the animal offspring. risk summary there are no data on the presence of calaspargase pegol-mknl in human milk, the effects on the breastfed child, or the effects on milk production. because of the potential for adverse reactions in the breastfed child, advise women not to breastfeed during treatment with asparlas and for 3 months after the last dose. asparlas can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing pregnancy testing is recommended in females of reproductive potential prior to initiating asparlas. contraception advise females of reproductive potential to use effective non-hormonal contraceptive methods during treatment with asparlas and for at least 3 months after the last dose. the safety and effectiveness of asparlas in the treatment of all have been established in pediatric patients 1 month to <17 years (no data for the age group <1 month old). use of asparlas in these age groups is supported by evidence from an adequate and well-controlled trial with additional safety from a second trial. the trials included 208 children with all or lymphoblastic lymphoma treated with asparlas; there were 19 infants (1 month to <2 years old), 128 children (2 years to <12 years old), and 61 adolescents (12 years to <17 years old). there were no clinically meaningful differences in safety or nadir serum asparaginase activity across age groups [see adverse reactions (6.1), clinical studies (14)] .

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

takeda pharmaceuticals australia pty ltd - water for injections, quantity: 5.4 ml - injection, solution - excipient ingredients: - adynovate is a long-acting antihaemophilic factor (recombinant) indicated in haemophilia a (congenital factor viii deficiency) patients for:,? control and prevention of bleeding episodes,? routine prophylaxis to prevent or reduce the frequency of bleeding episodes,? perioperative management (surgical prophylaxis),adynovate is not indicated for the treatment of von willebrand disease.