Europeiska unionen - svenska - EMA (European Medicines Agency)

stada arzneimittel ag - adalimumab - arthritis, rheumatoid; arthritis, juvenile rheumatoid; spondylitis, ankylosing; arthritis, psoriatic; psoriasis; hidradenitis suppurativa; crohn disease; colitis, ulcerative; uveitis - immunsuppressiva - rheumatoid arthritislibmyris in combination with methotrexate, is indicated for:- the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs (dmards) including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. libmyris can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. adalimumab har visat sig minska risken för progression av ledskador mätt med röntgen och förbättra den fysiska funktionen, när det ges i kombination med metotrexat. juvenile idiopathic arthritispolyarticular juvenile idiopathic arthritislibmyris in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more dmard. libmyris can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5. adalimumab har inte studerats hos patienter yngre än 2 år. enthesitis-related arthritislibmyris is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy. axial spondyloarthritisankylosing spondylitis (as)libmyris is indicated for the treatment of adults with severe active as who have had an inadequate response to conventional therapy. axial spondyloarthritis without radiographic evidence of aslibmyris is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated crp and/or mri, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (nsaids). psoriatic arthritislibmyris is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous dmard therapy has been inadequate. adalimumab har visat sig minska risken för progression av perifer ledskada mätt med röntgen hos patienter med polyartikulär symmetrisk subtyper av sjukdomen och för att förbättra fysisk funktion. psoriasislibmyris is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasislibmyris is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. hidradenitis suppurativa (hs)libmyris is indicated for the treatment of active moderate to severe hs (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy (see sections 5. 1 och 5. crohn’s diseaselibmyris is indicated for treatment of moderately to severely active crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. paediatric crohn's diseaselibmyris is indicated for the treatment of moderately to severely active crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. ulcerative colitislibmyris is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. paediatric ulcerative colitislibmyris is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. uveitislibmyris is indicated for the treatment of non-infectious intermediate, posterior and panuveitis 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. paediatric uveitislibmyris is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Europeiska unionen - svenska - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - infliximab - arthritis, psoriatic; spondylitis, ankylosing; colitis, ulcerative; psoriasis; crohn disease; arthritis, rheumatoid - immunsuppressiva - reumatoid arthritisremsima, i kombination med metotrexat är indicerat för minskning av tecken och symtom såväl som förbättring av fysisk funktion hos:vuxna patienter med aktiv sjukdom när svaret på sjukdomsmodifierande antireumatiska läkemedel (dmards), inklusive metotrexat, har varit otillräckligt. vuxna patienter med svår, aktiv och progredierande sjukdom som inte tidigare behandlats med metotrexat eller andra dmard. i dessa patientgrupper, en minskning i graden av utveckling av ledskador mätt med röntgen, har visats. vuxna med crohns diseaseremsima är indicerat för:behandling av måttlig till svår aktiv crohns sjukdom hos vuxna patienter som inte svarat trots fullständig och adekvat naturligtvis av behandling med en kortikosteroid och / eller ett immunsuppressiva eller som är intoleranta eller har medicinska kontraindikationer för sådana behandlingar, behandling av fistulising, aktiv crohns sjukdom hos vuxna patienter som inte svarat trots fullständig och adekvat naturligtvis av behandling med konventionell behandling (inklusive antibiotika, dränage och immunsuppressiv behandling). pediatrisk crohns diseaseremsima är indicerat för behandling av svår, aktiv crohns sjukdom hos barn och ungdomar i åldern sex till 17 år, som inte har svarat på konventionell behandling inklusive en kortikosteroid, en immunomodulator och primär nutritionsbehandling; eller som är intoleranta mot eller har kontraindikationer för sådana behandlingar. infliximab har studerats endast i kombination med konventionella immunosuppressiv terapi. ulcerös colitisremsima är indicerat för behandling av måttlig till svår aktiv ulcerös kolit hos vuxna patienter som har haft ett otillräckligt svar på konventionell behandling inklusive kortikosteroider och 6‑merkaptopurin (6‑mp) eller azatioprin (aza), eller som är intoleranta eller har medicinska kontraindikationer för sådana behandlingar. pediatriska ulcerös colitisremsima är indicerat för behandling av svår aktiv ulcerös kolit hos barn och ungdomar i åldern sex till 17 år, som har haft ett otillräckligt svar på konventionell behandling inklusive kortikosteroider och 6‑mp eller aza, eller som är intoleranta eller har medicinska kontraindikationer för sådana behandlingar. ankyloserande spondylitisremsima är indicerat för behandling av svår, aktiv ankyloserande spondylit, hos vuxna patienter som svarat otillräckligt för att konventionell terapi. psoriasisartrit arthritisremsima är indicerat för behandling av aktiv och progressiv psoriasisartrit hos vuxna patienter, när svaret på tidigare dmard-behandling har varit otillräckligt. remsima bör administreras:i kombination med metotrexat, eller ensam i patienter som visar intolerans mot metotrexat eller för vilka metotrexat är kontraindicerat. infliximab har visat sig förbättra den fysiska funktionen hos patienter med psoriasisartrit och reducera risken för progression av perifer ledskada mätt med röntgen hos patienter med polyartikulär symmetrisk subtyper av sjukdomen. psoriasisremsima är indicerat för behandling av måttlig till svår plackpsoriasis hos vuxna patienter som inte svarat på eller som har en kontraindikation mot, eller som är intoleranta mot annan systemisk behandling, inklusive ciklosporin, metotrexat eller psoralen ultra-violett (puva).

Europeiska unionen - svenska - EMA (European Medicines Agency)

abbott laboratories ltd. - adalimumab - spondylitis, ankylosing; arthritis, rheumatoid; arthritis, psoriatic; crohn disease - immunsuppressiva - reumatoid arthritistrudexa i kombination med metotrexat är indicerat för:behandling av måttlig till svår, aktiv reumatoid artrit hos vuxna patienter, när svaret på sjukdomsmodifierande antireumatiska läkemedel, inklusive metotrexat, har varit otillräckligt. behandling av svår, aktiv och progredierande reumatoid artrit hos vuxna som inte tidigare behandlats med metotrexat. trudexa kan ges som monoterapi vid intolerans mot metotrexat eller när fortsatt behandling med metotrexat är olämplig. trudexa har visat sig minska risken för progression av ledskador mätt med röntgen och förbättra den fysiska funktionen, när det ges i kombination med metotrexat. psoriasisartrit arthritistrudexa är indicerat för behandling av aktiv och progressiv psoriasisartrit hos vuxna när svaret på tidigare sjukdomsmodifierande anti-reumatiska läkemedel har varit otillräcklig. ankyloserande spondylitistrudexa är indicerat för behandling av vuxna med svår aktiv ankyloserande spondylit som har haft ett otillräckligt svar på konventionell terapi. crohns diseasetrudexa är indicerat för behandling av svår, aktiv crohns sjukdom hos patienter som inte svarat trots fullständig och adekvat naturligtvis av behandling med en kortikosteroid och/eller ett immunosuppressant, eller som är intoleranta eller har medicinska kontraindikationer för sådana behandlingar. för induktion behandling, trudexa bör ges i kombination med cortiocosteroids. trudexa kan ges som monoterapi vid intolerans mot kortikosteroider eller när fortsatt behandling med kortikosteroider är olämpligt (se avsnitt 4.

Europeiska unionen - svenska - EMA (European Medicines Agency)

pharmaand gmbh - peginterferon alfa-2a - hepatitis c, chronic; hepatitis b, chronic - immunstimulatorer, - chronic hepatitis b adult patients pegasys is indicated for the treatment of hepatitis b envelope antigen (hbeag)-positive or hbeag-negative chronic hepatitis b (chb) in adult patients with compensated liver disease and evidence of viral replication, increased alanine aminotransferase (alt) and histologically verified liver inflammation and/or fibrosis (see sections 4. 4 och 5. paediatric patients 3 years of age and older pegasys is indicated for the treatment of hbeag-positive chb in non-cirrhotic children and adolescents 3 years of age and older with evidence of viral replication and persistently elevated serum alt levels. med hänsyn till beslutet att påbörja behandling i pediatriska patienter (se avsnitt 4. 2, 4. 4 och 5. chronic hepatitis c adult patients pegasys is indicated in combination with other medicinal products, for the treatment of chronic hepatitis c (chc) in patients with compensated liver disease (see sections 4. 2, 4. 4 och 5. för hepatit c-virus (hcv) genotyp specifik aktivitet, se avsnitt 4. 2 och 5. paediatric patients 5 years of age and older pegasys in combination with ribavirin is indicated for the treatment of chc in treatment-naïve children and adolescents 5 years of age and older who are positive for serum hcv-rna. när beslut fattas om att inleda behandling i barndomen, är det viktigt att tänka på tillväxthämning orsakad av kombinationsbehandling. reversibiliteten av tillväxthämning är osäker. beslutet om behandling bör göras från fall till fall (se avsnitt 4.

Europeiska unionen - svenska - EMA (European Medicines Agency)

sandoz gmbh - adalimumab - arthritis, rheumatoid; arthritis, psoriatic; spondylitis, ankylosing; uveitis; hidradenitis suppurativa; colitis, ulcerative; arthritis, juvenile rheumatoid; crohn disease; skin diseases, papulosquamous - immunsuppressiva - rheumatoid arthritishyrimoz in combination with methotrexate, is indicated for:- the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. hyrimoz kan ges som monoterapi vid intolerans mot metotrexat eller när fortsatt behandling med metotrexat är olämplig. adalimumab har visat sig minska risken för progression av ledskador mätt med röntgen och förbättra den fysiska funktionen, när det ges i kombination med metotrexat. juvenile idiopathic arthritis- polyarticular juvenile idiopathic arthritishyrimoz in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (dmards). hyrimoz kan ges som monoterapi vid intolerans mot metotrexat eller när fortsatt behandling med metotrexat är olämplig. adalimumab har inte studerats hos patienter yngre än 2 år. - enthesitis-related arthritishyrimoz is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy. axial spondyloarthritis- ankylosing spondylitis (as)hyrimoz is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. - axial spondyloarthritis without radiographic evidence of ashyrimoz is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated crp and / or mri, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs. psoriatic arthritishyrimoz is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. adalimumab har visat sig minska risken för progression av perifer ledskada mätt med röntgen hos patienter med polyartikulär symmetrisk subtyper av sjukdomen och för att förbättra fysisk funktion. psoriasishyrimoz is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasishyrimoz is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. hidradenitis suppurativa (hs)hyrimoz is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy. crohn’s diseasehyrimoz is indicated for treatment of moderately to severely active crohn’s disease in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. paediatric crohn's diseasehyrimoz is indicated for the treatment of moderately to severely active crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and / or an immunomodulator, or who are intolerant to or have contraindications for such therapies.  paediatric ulcerative colitishyrimoz is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. ulcerative colitishyrimoz is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. uveitishyrimoz is indicated for the treatment of non-infectious intermediate, posterior and panuveitis 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. paediatric uveitishyrimoz is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Europeiska unionen - svenska - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - idecabtagene vicleucel - multiple myeloma; neoplasms; cancer; neoplasms, plasma cell; hemostatic disorders; vascular diseases; cardiovascular diseases; paraproteinemias; blood protein disorders; hematologic diseases; hemic and lymphatic diseases; hemorrhagic disorders; infectious mononucleosis; lymphoproliferative disorders; immunoproliferative disorders; immune system diseases - antineoplastiska medel - abecma is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti cd38 antibody and have demonstrated disease progression on the last therapy.

Europeiska unionen - svenska - EMA (European Medicines Agency)

stada arzneimittel ag - adalimumab - arthritis, psoriatic; arthritis, juvenile rheumatoid; arthritis, rheumatoid; colitis, ulcerative; crohn disease; hidradenitis suppurativa; psoriasis; spondylitis, ankylosing; uveitis - immunsuppressiva - rheumatoid arthritishukyndra in combination with methotrexate, is indicated for:- the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs (dmards) including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. hukyndra can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. adalimumab har visat sig minska risken för progression av ledskador mätt med röntgen och förbättra den fysiska funktionen, när det ges i kombination med metotrexat. juvenile idiopathic arthritispolyarticular juvenile idiopathic arthritishukyndra in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more dmard. hukyndra can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5. adalimumab har inte studerats hos patienter yngre än 2 år. enthesitis-related arthritishukyndra is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5. axial spondyloarthritisankylosing spondylitis (as)hukyndra is indicated for the treatment of adults with severe active as who have had an inadequate response to conventional therapy. axial spondyloarthritis without radiographic evidence of ashukyndra is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated crp and/or mri, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (nsaids). psoriatic arthritishukyndra is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous dmard therapy has been inadequate. adalimumab har visat sig minska risken för progression av perifer ledskada mätt med röntgen hos patienter med polyartikulär symmetrisk subtyper av sjukdomen (se avsnitt 5. 1) och för att förbättra fysisk funktion. psoriasishukyndra is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasishukyndra is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. hidradenitis suppurativa (hs)hukyndra is indicated for the treatment of active moderate to severe hs (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy (see sections 5. 1 och 5. crohn’s diseasehukyndra is indicated for treatment of moderately to severely active crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. paediatric crohn's diseasehukyndra is indicated for the treatment of moderately to severely active crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. ulcerative colitishukyndra is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. paediatric ulcerative colitishukyndra is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. uveitishukyndra is indicated for the treatment of non-infectious intermediate, posterior and panuveitis 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. paediatric uveitishukyndra is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Europeiska unionen - svenska - EMA (European Medicines Agency)

chanelle pharmaceuticals manufacturing ltd - imidakloprid, moxidektin - antiparasitic products, insecticides and repellents, macrocyclic lactones, milbemycins - cats; dogs; ferrets - for cats suffering from, or at risk from, mixed parasitic infections:• the treatment and prevention of flea infestation (ctenocephalides felis),• the treatment of ear mite infestation (otodectes cynotis),• the treatment of notoedric mange (notoedres cati),• the treatment of the lungworm eucoleus aerophilus (syn. capillaria aerophila) (adults),• the prevention of lungworm disease (l3/l4 larvae of aelurostrongylus abstrusus),• the treatment of the lungworm aelurostrongylus abstrusus (adults),• the treatment of the eye worm thelazia callipaeda (adults),• the prevention of heartworm disease (l3 and l4 larvae of dirofilaria immitis),• the treatment of infections with gastrointestinal nematodes (l4 larvae, immature adults and adults of toxocara cati and ancylostoma tubaeforme). det veterinärmedicinska läkemedlet kan användas som en del av en behandlingsstrategi för loppalergidermatit (fad).  for ferrets suffering from, or at risk from, mixed parasitic infections:• the treatment and prevention of flea infestation (ctenocephalides felis),• the prevention of heartworm disease (l3 and l4 larvae of dirofilaria immitis).  for dogs suffering from, or at risk from, mixed parasitic infections:• the treatment and prevention of flea infestation (ctenocephalides felis),• the treatment of biting lice (trichodectes canis),• the treatment of ear mite infestation (otodectes cynotis), sarcoptic mange (caused by sarcoptes scabiei var. canis), demodicosis (caused by demodex canis),• the prevention of heartworm disease (l3 and l4 larvae of dirofilaria immitis),• the treatment of circulating microfilariae (dirofilaria immitis),• the treatment of cutaneous dirofilariosis (adult stages of dirofilaria repens)• the prevention of cutaneous dirofilariosis (l3 larvae of dirofilaria repens),• the reduction of circulating microfilariae (dirofilaria repens),• the prevention of angiostrongylosis (l4 larvae and immature adults of angiostrongylus vasorum),• the treatment of angiostrongylus vasorum and crenosoma vulpis,• the prevention of spirocercosis (spirocerca lupi),• the treatment of eucoleus (syn. capillaria) boehmi (adults),• the treatment of the eye worm thelazia callipaeda (adults),• the treatment of infections with gastrointestinal nematodes (l4 larvae, immature adults and adults of toxocara canis, ancylostoma caninum and uncinaria stenocephala, adults of toxascaris leonina and trichuris vulpis). det veterinärmedicinska läkemedlet kan användas som en del av en behandlingsstrategi för loppalergidermatit (fad).

Europeiska unionen - svenska - EMA (European Medicines Agency)

pfizer europe ma eeig - infliximab - arthritis, psoriatic; spondylitis, ankylosing; colitis, ulcerative; psoriasis; crohn disease; arthritis, rheumatoid - immunsuppressiva - reumatoid arthritisinflectra, i kombination med metotrexat är indicerat för minskning av tecken och symtom såväl som förbättring av fysisk funktion hos:vuxna patienter med aktiv sjukdom när svaret på sjukdomsmodifierande antireumatiska läkemedel (dmards), inklusive metotrexat, har varit otillräckligt. vuxna patienter med svår, aktiv och progredierande sjukdom som inte tidigare behandlats med metotrexat eller andra dmard. i dessa patientgrupper, en minskning i graden av utveckling av ledskador mätt med röntgen, har visats. vuxna med crohns diseaseinflectra är indicerat för:behandling av måttlig till svår aktiv crohns sjukdom hos vuxna patienter som inte svarat trots fullständig och adekvat naturligtvis av behandling med en kortikosteroid och / eller ett immunosuppressant, eller som är intoleranta eller har medicinska kontraindikationer för sådana behandlingar, behandling av fistulising, aktiv crohns sjukdom hos vuxna patienter som inte svarat trots fullständig och adekvat naturligtvis av behandling med konventionell behandling (inklusive antibiotika, dränage och immunsuppressiv behandling). pediatrisk crohns diseaseinflectra är indicerat för behandling av svår, aktiv crohns sjukdom hos barn och ungdomar i åldern sex till 17 år, som inte har svarat på konventionell behandling inklusive en kortikosteroid, en immunomodulator och primär nutritionsbehandling; eller som är intoleranta mot eller har kontraindikationer för sådana behandlingar. infliximab har studerats endast i kombination med konventionella immunosuppressiv terapi. ulcerös colitisinflectra är indicerat för behandling av måttlig till svår aktiv ulcerös kolit hos vuxna patienter som har haft ett otillräckligt svar på konventionell behandling inklusive kortikosteroider och 6‑merkaptopurin (6‑mp) eller azatioprin (aza), eller som är intoleranta eller har medicinska kontraindikationer för sådana behandlingar. pediatriska ulcerös colitisinflectra är indicerat för behandling av svår aktiv ulcerös kolit hos barn och ungdomar i åldern sex till 17 år, som har haft ett otillräckligt svar på konventionell behandling inklusive kortikosteroider och 6‑mp eller aza, eller som är intoleranta eller har medicinska kontraindikationer för sådana behandlingar. ankyloserande spondylitisinflectra är indicerat för behandling av svår, aktiv ankyloserande spondylit hos vuxna patienter som svarat otillräckligt för att konventionell terapi. psoriasisartrit arthritisinflectra är indicerat för behandling av aktiv och progressiv psoriasisartrit hos vuxna patienter, när svaret på tidigare dmard-behandling har varit otillräckligt. inflectra bör administreras:i kombination med metotrexat, eller ensam i patienter som visar intolerans mot metotrexat eller för vilka metotrexat är kontraindicerat. infliximab har visat sig förbättra den fysiska funktionen hos patienter med psoriasisartrit och reducera risken för progression av perifer ledskada mätt med röntgen hos patienter med polyartikulär symmetrisk subtyper av sjukdomen. psoriasisinflectra är indicerat för behandling av måttlig till svår plackpsoriasis hos vuxna patienter som inte svarat på eller som har en kontraindikation mot, eller som är intoleranta mot annan systemisk behandling, inklusive ciklosporin, metotrexat eller psoralen ultra-violett (puva).

Europeiska unionen - svenska - EMA (European Medicines Agency)

viatris limited - klopidogrelbesilat - peripheral vascular diseases; stroke; myocardial infarction - antitrombotiska medel - secondary prevention of atherothrombotic events clopidogrel is indicated in:adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. adult patients suffering from acute coronary syndrome. non-st segment elevation acute coronary syndrome (unstable angina or non-q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (asa). st-segmentet höjd akut hjärtinfarkt, i kombination med asa i medicinskt behandlade patienter berättigade till trombolysbehandling. in patients with moderate to high-risk transient ischaemic attack (tia) or minor ischaemic stroke (is) clopidogrel in combination with asa is indicated in:adult patients with moderate to high-risk tia (abcd2 score ≥4) or minor is (nihss ≤3) within 24 hours of either the tia or is event. prevention of atherothrombotic and thromboembolic events in atrial fibrillation:in adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin k antagonists (vka) and who have a low bleeding risk, clopidogrel is indicated in combination with asa for the prevention of atherothrombotic and thromboembolic events, including stroke. för ytterligare information hänvisas till avsnitt 5.