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

arrotex pharmaceuticals pty ltd - ciclosporin, quantity: 50 mg - capsule, soft - excipient ingredients: gelatin; titanium dioxide; tricaprin; sorbitan oleate; lecithin; purified water; ethyl lactate; polysorbate 20; iron oxide black; peg-40 hydrogenated castor oil; glycerol - ciclosporin is indicated: ? as an immunosuppressive agent for the prevention of graft rejection following kidney, liver and heart allogeneic transplantation. ? for induction and/or maintenance of remission in the nephrotic syndrome. ciclosporin is not a first-line agent. its use should be restricted to occasions when steroids and cytostatic drugs have failed, or are not tolerated, or are considered inappropriate, and when renal function is unimpaired (see section 4.4 special warnings and precautions for use). ? for the treatment of severe, active rheumatoid arthritis in patients for whom classical slow-acting antirheumatic agents (including methotrexate) are inappropriate or ineffective. ? in patients with severe psoriasis in whom conventional therapy is ineffective or inappropriate and the disease has caused a significant interference with quality of life. ? for the treatment of severe atopic dermatitis when other treatment is ineffective or inappropriate.,careful monitoring of all ciclosporin-treated patients is mandatory. ciclosporin should only be used by medical practitioners who are experienced in the use of immunosuppressive therapy (see section 4.4 special warnings and precautions for use).

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

arrotex pharmaceuticals pty ltd - ciclosporin, quantity: 100 mg - capsule, soft - excipient ingredients: gelatin; iron oxide black; ethyl lactate; lecithin; polysorbate 20; glycerol; sorbitan oleate; purified water; tricaprin; peg-40 hydrogenated castor oil; titanium dioxide - ciclosporin is indicated: ? as an immunosuppressive agent for the prevention of graft rejection following kidney, liver and heart allogeneic transplantation. ? for induction and/or maintenance of remission in the nephrotic syndrome. ciclosporin is not a first-line agent. its use should be restricted to occasions when steroids and cytostatic drugs have failed, or are not tolerated, or are considered inappropriate, and when renal function is unimpaired (see section 4.4 special warnings and precautions for use). ? for the treatment of severe, active rheumatoid arthritis in patients for whom classical slow-acting antirheumatic agents (including methotrexate) are inappropriate or ineffective. ? in patients with severe psoriasis in whom conventional therapy is ineffective or inappropriate and the disease has caused a significant interference with quality of life. ? for the treatment of severe atopic dermatitis when other treatment is ineffective or inappropriate.,careful monitoring of all ciclosporin-treated patients is mandatory. ciclosporin should only be used by medical practitioners who are experienced in the use of immunosuppressive therapy (see section 4.4 special warnings and precautions for use).

Israeli - Kiingereza - Ministry of Health

astrazeneca (israel) ltd - selumetinib as hyd-sulfate - hard capsule - selumetinib as hyd-sulfate 10 mg - selumetinib - koselugo is indicated for the treatment of pediatric patients 2 years of age and older withneurofibromatosis type 1 (nf1) who have symptomatic, inoperable plexiform neurofibromas (pn).

Israeli - Kiingereza - Ministry of Health

astrazeneca (israel) ltd - selumetinib as hyd-sulfate - hard capsule - selumetinib as hyd-sulfate 25 mg - selumetinib - koselugo is indicated for the treatment of pediatric patients 2 years of age and older withneurofibromatosis type 1 (nf1) who have symptomatic, inoperable plexiform neurofibromas (pn).

Australia - Kiingereza - APVMA (Australian Pesticides and Veterinary Medicines Authority)

axichem pty ltd - oxyfluorfen; n-methyl-2-pyrrolidone; liquid hydrocarbon - emulsifiable concentrate - oxyfluorfen diphenyl ether active 240.0 g/l; n-methyl-2-pyrrolidone solvent other 108.0 g/l; liquid hydrocarbon solvent other 606.0 g/l - herbicide - apple - dormant treatment | brassica vegetables | broccoli | cabbage | cauliflower | cotton (prior to sowing) | custard apple | - amsinckia | amsinckia, yellow burrweed - seedling | barley grass | barnyard or water grass | bellvine - seedling (ipomoea spp.) | blackberry nightshade | bladder ketmia | caltrop - tribulis terrestis | capeweed | capeweed - seedling | chickweed | cleavers | common cotula or carrot weed | cotula or carrot weed - seedling | crowsfoot grass | crowsfoot grass - seedling | deadnettle | deadnettle - seedling | dock | erodium, crowfoot or storksbill | fat hen | field bindweed | fumitory | fumitory - pink & white | giant or black pigweed | groundsel | groundsel (s. vulgaris) - seedling | hillside burrgrass | liverseed grass - seedling | liverseed or urochloa grass | lovegrass | marshmallow - seedling | perennial pigweed | pigeon grass | plantain | potato or yellow weed | potato weed - seedling | prickly lettuce | red natal grass | red pigweed (p. oleracea) - seedling | redshank - prince of wales feather | redshank (a. cruentus) - seedling | refer to glyphosate 360 g/l label | refer to glyphosate 450 g/l label | refer

Australia - Kiingereza - APVMA (Australian Pesticides and Veterinary Medicines Authority)

axichem pty ltd - cloquintocet-mexyl; clodinafop-propargyl; n-methyl-2-pyrrolidone; liquid hydrocarbon - emulsifiable concentrate - cloquintocet-mexyl acetate active 60.0 g/l; clodinafop-propargyl pyridine active 240.0 g/l; n-methyl-2-pyrrolidone solvent other 100.0 g/l; liquid hydrocarbon solvent other 575.0 g/l - herbicide - wheat - see label - annual ryegrass | canary grass - phalaris minor | paradoxa grass | wild oat | annual phalaris | canary grass | dwarf canary grass | lesser canary grass

Umoja wa Ulaya - Kiingereza - EMA (European Medicines Agency)

instituto grifols s.a. - human normal immunoglobulin - mucocutaneous lymph node syndrome; guillain-barre syndrome; bone marrow transplantation; purpura, thrombocytopenic, idiopathic; immunologic deficiency syndromes - immune sera and immunoglobulins, - replacement therapy in adults, children and adolescents (0-18 years) in: , primary immunodeficiency syndromes with impaired antibody production;, hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic luekaemia, in whom prophylactic antibiotics have failed;, hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who failed to respond to pneumococcal immunisation;, hypogammaglobulinaemia in patients after allogenic haematopoietic-stem-cell transplantation (hsct);, congenital aids with recurrent bacterial infections. , immunomodulation in adults, children and adolescents (0-18 years) in: , primary immune thrombocytopenia (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count;, guillain barré syndrome;, kawasaki disease.

Umoja wa Ulaya - Kiingereza - EMA (European Medicines Agency)

accord healthcare s.l.u. - filgrastim - neutropenia - immunostimulants, - grastofil is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia.the safety and efficacy of grastofil are similar in adults and children receiving cytotoxic chemotherapy.grastofil is indicated for the mobilisation of peripheral blood progenitor cells (pbpcs).in patients, children or adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (anc) of ≤ 0.5 x 109/l, and a history of severe or recurrent infections, long term administration of grastofil is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.grastofil is indicated for the treatment of persistent neutropenia (anc less than or equal to 1.0 x 109/l) in patients with advanced hiv infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

Umoja wa Ulaya - Kiingereza - EMA (European Medicines Agency)

pfizer europe ma eeig  - filgrastim - neutropenia; hematopoietic stem cell transplantation; cancer - immunostimulants, - filgrastim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia.the safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.filgrastim is indicated for the mobilisation of peripheral blood progenitor cells (pbpcs).in patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (anc) of ≤0.5 x 109/l and a history of severe or recurrent infections, long-term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.filgrastim is indicated for the treatment of persistent neutropenia (anc ≤1.0 x 109/l) in patients with advanced hiv infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

Australia - Kiingereza - APVMA (Australian Pesticides and Veterinary Medicines Authority)

axichem pty ltd - triadimenol; n-methyl-2-pyrrolidone - emulsifiable concentrate - triadimenol triazole active 250.0 g/l; n-methyl-2-pyrrolidone solvent other 600.0 g/l - fungicide