Euroopa Liit - sloveeni - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - linagliptin - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - trajenta je navedeno v zdravljenju diabetesa tipa 2 bolezni za izboljšanje glycaemic nadzor v odrasli:kot monotherapyin bolnikov neustrezno nadzorovane z dieto in telesno vadbo sami in za katere metformin ni primeren zaradi nestrpnosti, ali kontraindiciran zaradi ledvične oslabitve. kot kombinacija therapyin kombinaciji z metforminom, ko dieto in telesno vadbo plus metformin sam ne zagotavljajo ustrezne glycaemic nadzor. v kombinaciji z sulfonil sečnine in metforminom, ko dieto in telesno vadbo plus dvojno zdravljenje s temi zdravili ne zagotavljajo ustrezne glycaemic nadzor. v kombinaciji z inzulina, z metforminom ali brez, ko je ta režim sam, z dieto in telesno vadbo, ne zagotavlja ustrezne glycaemic nadzor.

Euroopa Liit - sloveeni - EMA (European Medicines Agency)

pfizer europe ma eeig - tigecycline - bacterial infections; skin diseases, bacterial; soft tissue infections - antibacterials za sistemsko uporabo, - tygacil is indicated in adults and in children from the age of eight years for the treatment of the following infections: , complicated skin and soft tissue infections (cssti), excluding diabetic foot infections, complicated intra-abdominal infections (ciai) , tygacil should be used only in situations where other alternative antibiotics are not suitable. upoštevati je treba uradne smernice za ustrezno uporabo protibakterijsko agenti. ustrezno uporabo protibakterijsko agenti.

Euroopa Liit - sloveeni - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - ambrisentan - hipertenzija, pljučnica - antihipertenzivi, - volibris is indicated for treatment of pulmonary arterial hypertension (pah) in adult patients of who functional class (fc) ii to iii, including use in combination treatment (see section 5.  efficacy has been shown in idiopathic pah (ipah) and in pah associated with connective tissue disease. volibris is indicated for treatment of pah in adolescents and children (aged 8 to less than 18 years) of who functional class (fc) ii to iii including use in combination treatment. efficacy has been shown in ipah, familial, corrected congenital and in pah associated with connective tissue disease (see section 5.

Euroopa Liit - sloveeni - EMA (European Medicines Agency)

bayer ag - rivaroksaban - arthroplasty, replacement; venous thromboembolism - antitrombotična sredstva - xarelto, co-daje z acetilsalicilne kisline (asa) samostojno ali s asa plus clopidogrel ali ticlopidine, je označen za preprečevanje atherothrombotic dogodkov pri odraslih bolnikih po akutni koronarni sindrom (acs) s povišano srčno biomarkerje. xarelto, co-administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events. preprečevanje venska trombembolija (vte) pri odraslih bolnikih, ki so v postopku izbirni kirurški zamenjavi kolka ali kolena. zdravljenje globoke venske tromboze (dvt) in pljučna embolija (pe), in preprečevanje ponavljajočih se dvt in pe pri odraslih. adultsprevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Euroopa Liit - sloveeni - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - glecaprevir, pibrentasvir - hepatitis c, kronični - antivirusi za sistemsko uporabo - maviret is indicated for the treatment of chronic hepatitis c virus (hcv) infection in adults and children aged 3 years and older. maviret coated granules is indicated for the treatment of chronic hepatitis c virus (hcv) infection in children 3 years and older.

Euroopa Liit - sloveeni - EMA (European Medicines Agency)

gilead sciences ireland uc - sofosbuvir, velpatasvir, voxilaprevi - hepatitis c, kronični - antivirusi za sistemsko uporabo - vosevi is indicated for the treatment of chronic hepatitis c virus (hcv) infection in patients aged 12 years and older and weighing at least 30 kg. (glej točki 4. 2, 4. 4 in 5.

Euroopa Liit - sloveeni - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - niraparib (tosilate monohydrate) - fallopian tube neoplasms; peritoneal neoplasms; ovarian neoplasms - antineoplastična sredstva - zejula is indicated: , as monotherapy for the maintenance treatment of adult patients with advanced epithelial (figo stages iii and iv) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. , as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.

Euroopa Liit - sloveeni - EMA (European Medicines Agency)

teva b.v. - imatinib mesilate - dermatofibrosarcoma; gastrointestinal stromal tumors; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastična sredstva - imatinib teva b. is indicated for the treatment of: , paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. , pediatričnih bolnikih s ph+ cml v kronični fazi po izpadu interferon-alfa terapije, ali v pospešeni fazi ali pišu krize. odrasli bolniki s ph+ cml v blastni krizi. , odraslih in pediatričnih bolnikih, ki so na novo zboleli za philadelphia kromosom pozitivno acute lymphoblastic levkemijo (ph+ all), ki je integriran z kemoterapijo. odrasli bolniki z relapsed ali ognjevzdržni ph+ all, kot monotherapy. odrasli bolniki z myelodysplastic/myeloproliferative bolezni (mds/mpd), ki je povezana z trombocitov, pridobljenih iz rastni dejavnik receptorjev (pdgfr) gena ponovno ureditev. odrasli bolniki z napredno hypereosinophilic sindromom (hes) in/ali kronično eozinofilno levkemijo (cel) z fip1l1-pdgfra preureditev. učinek imatinib na izid presaditev kostnega mozga, ni bilo določeno. imatinib teva b. is indicated for: , the treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). , adjuvant zdravljenje odraslih bolnikov, ki so na veliko nevarnost ponovitve naslednje resekcija kit (cd117)-pozitivno bistvo. bolniki, ki imajo nizko ali zelo nizko tveganje za ponovitev, ne bi smel imeti adjuvant treatment. , zdravljenje odraslih bolnikov z unresectable dermatofibrosarcoma protuberans (dfsp) in odraslih bolnikih s ponavljajočimi in/ali metastatskim dfsp, ki niso primerni za operacijo. v izobraževanju odraslih in pediatričnih bolnikov, učinkovitost imatinib temelji na splošno hematoloških in postopek citogenetske stopnjo odziva in napredovanje-free survival v cml, na hematoloških in postopek citogenetske stopnjo odziva, v ph+ all, mds/mpd, na hematoloških stopnjo odziva, v hes/cel in na cilj stopnjo odziva pri odraslih bolnikih z unresectable in/ali metastatskim bistvo in dfsp in na ponovitev-free survival v adjuvant bistvo. izkušnje z imatinib pri bolnikih z mds/mpd, povezanih z pdgfr gena ponovno ureditev je zelo omejena. ni kontroliranih preskušanjih, dokazujejo kliničnih koristi ali poveča preživetje pri teh bolezni.

Euroopa Liit - sloveeni - EMA (European Medicines Agency)

merck sharp & dohme b.v. - doravirine, lamivudine, tenofovir disoproxil fumarate - okužbe z virusom hiv - antivirusi za zdravljenje okužb z virusom hiv, kombinacije - delstrigo je indiciran za zdravljenje odraslih, okuženih z virusom hiv 1 brez preteklosti ali sedanjosti dokazov odpornost proti nnrti razred, lamivudine, ali tenofovir. delstrigo is also indicated for the treatment of adolescents aged 12 years and older weighing at least 35 kg who are infected with hiv-1 without past or present evidence of resistance to the nnrti class, lamivudine, or tenofovir and who have experienced toxicities which preclude the use of other regimens that do not contain tenofovir disoproxil.

Euroopa Liit - sloveeni - EMA (European Medicines Agency)

atnahs pharma netherlands b.v. - macimorelin acetat - diagnostične tehnike, endokrine - macimorelin - to zdravilo je samo za diagnostično uporabo.  ghryvelin is indicated for the diagnosis of growth hormone deficiency (ghd) in adults.