Európai Unió - izlandi - EMA (European Medicines Agency)

aventis pharma s.a. - telitrómýsín - sinusitis; tonsillitis; bronchitis, chronic; pharyngitis; community-acquired infections; pneumonia, bacterial - sýklalyf fyrir almenn nota, - Þegar ketek er ávísað skal íhuga opinbera leiðbeiningar um viðeigandi notkun ofantibacterial lyfja og staðbundna útbreiðslu viðnáms. ketek er ætlað fyrir meðferð eftirfarandi sýkingum:Í sjúklingar 18 ára og oldercommunity-keypti lungnabólgu, vægt eða í meðallagi. þegar ritgerð sýkingum af völdum þekkt eða grun beta-laktam - og / eða makrólíða-þola stofnar (samkvæmt sögu af sjúklingum eða national og / eða svæðinu mótstöðu gögn) þakið bakteríueyðandi svið telithromycin:bráð versnað langvarandi bronkítis;bráð ástvini;Í sjúklinga á 12 ára og oldertonsillitis / hálsbólgu af völdum læknafélag pyogenes, sem val þegar beta-laktam sýklalyf eru ekki viðeigandi í löndum / svæði með verulega tíðni makrólíða-s þola. pyogenes, þegar tilstilli ermtr eða mefa.

Európai Unió - izlandi - EMA (European Medicines Agency)

samsung bioepis nl b.v. - adalimumab - spondylitis, ankylosing; arthritis, rheumatoid; uveitis; colitis, ulcerative; psoriasis; arthritis, psoriatic; crohn disease; hidradenitis suppurativa; arthritis - Ónæmisbælandi lyf - liðagigt arthritisimraldi ásamt stendur, er ætlað til:meðferð í meðallagi alvarleg, virk liðagigt í fullorðinn sjúklinga þegar svar við sjúkdómur-að breyta anti-gigt lyf þar stendur hefur verið ófullnægjandi. meðferð alvarlega, virk og framsækið liðagigt í fullorðnir ekki áður meðhöndluð með stendur. imraldi getur verið gefið eitt og sér í málið óþol stendur eða þegar áframhaldandi meðferð með stendur er óviðeigandi. adalimumab hefur verið sýnt fram á að draga úr framvindu sameiginlega skaða sem mæla með x-ray og til að bæta líkamlega virka, þegar gefið ásamt stendur. juvenile idiopathic arthritispolyarticular juvenile idiopathic arthritisimraldi 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). imraldi 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 hefur ekki verið rannsakað í sjúklinga á aldrinum minna en 2 ár. enthesitis-related arthritisimraldi 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)imraldi 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 asimraldi 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 non-steroidal anti-inflammatory drugs (nsaids). psoriasis arthritisimraldi er ætlað fyrir meðferð virk og framsækið psoriasis liðagigt í fullorðnir þegar svar til fyrri sjúkdómur-að breyta anti-gigt lyfjameðferð hefur verið ófullnægjandi. adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5. 1) og til að bæta líkamlega virka. psoriasisimraldi er ætlað fyrir meðferð í meðallagi til alvarlega langvarandi sýklum psoriasis í fullorðinn sjúklingum sem eru mönnum fyrir almenna meðferð. börn sýklum psoriasisimraldi er ætlað fyrir meðferð alvarlega langvarandi sýklum psoriasis í börn og unglingar frá 4 ára aldri sem hafa verið ófullnægjandi svar til eða eru óviðeigandi mönnum fyrir útvortis meðferð og phototherapies. hidradenitis suppurativa (hs)imraldi 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 (see sections 5. 1 5. crohn-diseaseimraldi er ætlað til meðferð við nokkuð að alvarlega virka crohn-sjúkdóm, í fullorðinn sjúklingar sem hafa ekki brugðist þrátt fyrir fullt og fullnægjandi meðferðinni með barksteri og/eða hafin; eða hverjir eru þola eða hafa læknis frábendingar fyrir slíka meðferð. paediatric crohn's diseaseimraldi 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 haveulcerative colitisimraldi 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 mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. paediatric ulcerative colitisimraldi 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. uveitisimraldi 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 corticosteroidsparing, or in whomcorticosteroid treatment is inappropriate. paediatric uveitisimraldi 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.

Európai Unió - izlandi - EMA (European Medicines Agency)

novartis europharm ltd. - aliskiren - háþrýstingur - lyf sem hafa áhrif á renín-angíótensín kerfið - meðferð við nauðsynlegum háþrýstingi.

Európai Unió - izlandi - EMA (European Medicines Agency)

mylan ireland limited - sitagliptin hydrochloride monohydrate, metformin hydrochloride - sykursýki, tegund 2 - lyf notuð við sykursýki - for adult patients with type 2 diabetes mellitus:sitagliptin/metformin hydrochloride mylan is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. sitagliptin/metformin hydrochloride mylan is indicated in combination with a sulphonylurea (i. , þrefaldur samsetning meðferð) sem viðbót til að fæði og æfing í sjúklingar ekki nægilega stjórn á eigin hámarks þolað skammt af sjúklingar og sulphonylurea. sitagliptin/metformin hydrochloride mylan is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (pparg) agonist (i. , a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a pparg agonist. sitagliptin/metformin hydrochloride mylan is also indicated as add-on to insulin (i. , triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Európai Unió - izlandi - EMA (European Medicines Agency)

accord healthcare s.l.u. - metformin hydrochloride, sitagliptin hydrochloride monohydrate - sykursýki, tegund 2 - lyf notuð við sykursýki - for adult patients with type 2 diabetes mellitus:it is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. it is indicated in combination with a sulphonylurea (i. , þrefaldur samsetning meðferð) sem viðbót til að fæði og æfing í sjúklingar ekki nægilega stjórn á eigin hámarks þolað skammt af sjúklingar og sulphonylurea. it is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (pparγ) agonist (i. , a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a pparγ agonist. it is also indicated as add-on to insulin (i. , triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Európai Unió - izlandi - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - sitagliptin fumarate, metformin hydrochloride - sykursýki, tegund 2 - lyf notuð við sykursýki - for adult patients with type 2 diabetes mellitus:sitagliptin/metformin hydrochloride sun is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. sitagliptin/metformin hydrochloride sun is indicated in combination with a sulphonylurea (i. , þrefaldur samsetning meðferð) sem viðbót til að fæði og æfing í sjúklingar ekki nægilega stjórn á eigin hámarks þolað skammt af sjúklingar og sulphonylurea. sitagliptin/metformin hydrochloride sun is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (pparγ) agonist (i. , a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a pparγ agonist. sitagliptin/metformin hydrochloride sun is also indicated as add-on to insulin (i. , triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Európai Unió - izlandi - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - sitagliptin fumarate - sykursýki, tegund 2 - lyf notuð við sykursýki - for adult patients with type 2 diabetes mellitus, sitagliptin sun is indicated to improve glycaemic control:as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. - a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance. - a peroxisome proliferator-activated receptor gamma (pparγ) agonist (i. a thiazolidinedione) when use of a pparγ agonist is appropriate and when diet and exercise plus the pparγ agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. - a pparγ agonist and metformin when use of a pparγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. sitagliptin sun is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Európai Unió - izlandi - EMA (European Medicines Agency)

accord healthcare s.l.u. - sitagliptin hydrochloride - sykursýki, tegund 2 - lyf notuð við sykursýki - for adult patients with type 2 diabetes mellitus, sitagliptin accord is indicated to improve glycaemic control:as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. - a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance. - a peroxisome proliferator-activated receptor gamma (ppary) agonist (i. a thiazolidinedione) when use of a ppary agonist is appropriate and when diet and exercise plus the ppary agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. - a ppary agonist and metformin when use of a ppary agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. sitagliptin accord is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Európai Unió - izlandi - EMA (European Medicines Agency)

janssen-cilag international nv - canagliflozin - sykursýki, tegund 2 - lyf notuð við sykursýki - invokana is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:as monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsin addition to other medicinal products for the treatment of diabetes. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 og 5.

Európai Unió - izlandi - EMA (European Medicines Agency)

novartis europharm ltd - valsartan, amlodipine (as amlodipine besilate) - háþrýstingur - lyf sem hafa áhrif á renín-angíótensín kerfið - meðferð við nauðsynlegum háþrýstingi. mælt er ætlað sjúklingum sem blóðþrýstingur er ekki nægilega stjórn á meðferð eða valsartan sér.