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

ge healthcare australia pty ltd - gadoteric acid, quantity: 279.32 mg/ml - solution - excipient ingredients: meglumine; water for injections; tetraxetan - clariscan is indicated, in adults and children, for use with magnetic resonance imaging to provide contrast enhancement for intracranial and spinal lesions with abnormal blood brain barrier or abnormal vascularity, and for whole body imaging (see clinical studies).

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

abbvie pty ltd - adalimumab, quantity: 100 mg/ml - injection, solution - excipient ingredients: mannitol; polysorbate 80; water for injections - rheumatoid arthritis humira 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. humira can be used alone or in combination with methotrexate.,,juvenile idiopathic arthritis humira 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 who have had an inadequate response to one or more disease modifying antirheumatic drugs (dmards). humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis humira 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 humira 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 humira is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn?s disease in adults and children (?6 years) humira 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 of infliximab.,ulcerative colitis humira 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 clinical trials).,psoriasis in adults and children humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. humira is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age 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) humira 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: humira 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.

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

abbvie pty ltd - adalimumab, quantity: 100 mg/ml - injection, solution - excipient ingredients: mannitol; polysorbate 80; water for injections - rheumatoid arthritis humira 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. humira can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis humira 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 who have had an inadequate response to one or more disease modifying antirheumatic drugs (dmards). humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis humira 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 humira 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 humira is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn?s disease in adults and children (?6 years) humira 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 of infliximab.,,ulcerative colitis humira 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 clinical trials).,psoriasis in adults and children humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. humira is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age 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) humira 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 humira 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.

Malta - English - Medicines Authority

baxter holding b.v. kobaltweg 49, 3542ce utrecht, netherlands - calcium chloride, dihydrate, potassium chloride, sodium chloride - solution for infusion - sodium chloride 8.6 g/l potassium chloride 0.3 g/l calcium chloride dihydrate 0.33 g/l - blood substitutes and perfusion solutions

Malta - English - Medicines Authority

fresenius medical care deutschland gmbh d-61346 bad homburg, germany - calcium chloride, dihydrate - solution for infusion - calcium chloride dihydrate 14.7 g - blood substitutes and perfusion solutions

Malta - English - Medicines Authority

stada arzneimittel ag stadastraße 2-18, 61118 bad vilbel, germany - apomorphine hydrochloride - solution for infusion - apomorphine hydrochloride 5 mg/ml - anti-parkinson drugs

Malta - English - Medicines Authority

baxter holding b.v. kobaltweg 49, 3542ce utrecht, netherlands - calcium chloride, dihydrate, potassium chloride, sodium chloride, sodium lactate - solution for infusion - calcium chloride dihydrate 0.27 g/l potassium chloride 0.4 g/l sodium chloride 6 g/l sodium lactate 3.2 g/l - blood substitutes and perfusion solutions

Ireland - English - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - sodium chloride; potassium chloride; calcium chloride dihydrate; sodium lactate - solution for infusion - 0 percent volume/volume - solutions affecting the electrolyte balance; electrolytes

Ireland - English - HPRA (Health Products Regulatory Authority)

b. braun melsungen ag - isoleucine; leucine ; lysine hydrochloride; methionine; phenylalanine; threonine; tryptophan; valine; arginine monoglutamate ; alanine; aspartic acid; glutamic acid ; glycine; proline; serine; magnesium acetate tetrahydrate; sodium acetate trihydrate ; potassium dihydrogen phosphate; potassium hydroxide; sodium hydroxide ; glucose monohydrate; calcium chloride dihydrate; sodium chloride; histidine hydrochloride monohydrate - solution for infusion - unknown - solutions for parenteral nutrition; combinations

Ireland - English - HPRA (Health Products Regulatory Authority)

b. braun melsungen ag - isoleucine; leucine ; lysine hydrochloride; methionine; phenylalanine; threonine; tryptophan; valine; arginine monoglutamate ; alanine; aspartic acid; glutamic acid ; glycine; proline; serine; magnesium acetate tetrahydrate; sodium acetate trihydrate ; potassium dihydrogen phosphate; potassium hydroxide; sodium hydroxide ; glucose monohydrate; calcium chloride dihydrate; sodium chloride; histidine hydrochloride monohydrate - solution for infusion - n/a - solutions for parenteral nutrition; combinations