الاتحاد الأوروبي - الكرواتية - EMA (European Medicines Agency)

janssen-cilag international n.v.    - rilpivirin hidroklorid - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - edurant, u kombinaciji s drugim antiretrovirusne lijekove, je indiciran za liječenje humane imunodeficijencije tip 1 (hiv‑1) infekcija u bolesnika treatment‑naïve antiretrovirusne 12 godina i stariji sa viremija ≤ 100 000 hiv‑1 rna kopija/ml. kao i s drugim антиретровирусными lijekovima генотипическое ispitivanje otpora treba biti vođena pri korištenju edurant.

الاتحاد الأوروبي - الكرواتية - EMA (European Medicines Agency)

gilead sciences ireland uc - Софосбувир, velpatasvir - hepatitis c, kronični - antivirusni lijekovi za sustavnu uporabu - epclusa is indicated for the treatment of chronic hepatitis c virus (hcv) infection in patients 3 years of age and older (see sections 4. 2, 4. 4 i 5.

الاتحاد الأوروبي - الكرواتية - EMA (European Medicines Agency)

gilead sciences international ltd  - emtricitabine, rilpivirine hydrochloride, tenofovir disoproxil fumarate - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - eviplera je indiciran za liječenje odraslih okužen sa virus humane imunodeficijencije tipa 1 (hiv-1) bez poznatih mutacija povezanih s rezistencijom na nenukleozidne reverzne transkriptaze (nnrti) inhibitora klasa, tenofovir ili emtricitabin, i uz virusne opterećenja ≤ 100 000 hiv-1 rna kopija/ml. kao i kod drugih antiretrovirusnih lijekova, genotipske otpor testiranja i/ili povijesnih otpora podataka treba voditi korištenje eviplera.

الاتحاد الأوروبي - الكرواتية - EMA (European Medicines Agency)

takeda pharma a/s - pioglitazon hidroklorid - dijabetes mellitus, tip 2 - lijekovi koji se koriste u dijabetesu - pioglitazone prikazan kao druga ili treća linija tretmana tip 2 dijabetesa, kao što je opisano u nastavku:u monoterapiji:kod odraslih pacijenata (posebno u pacijenata s viškom težine) neadekvatna kontrolirane prehrane i vježbe, za koje je metformin je nepraktično zbog kontraindikacija ili netolerancije. kao dvostruki oralnu terapiju u kombinaciji sa:metforminom kod odraslih pacijenata (posebno u pacijenata s prekomjernom tjelesnom težinom) s nedovoljno dostupnih glikemijski kontrole, unatoč maksimalno переносимую dozu kada monoterapija metforminom;s sa sulfonilurejom samo kod odraslih pacijenata, koji pokazuju netoleranciju метформина ili kojim metformin je kontraindiciran, pri slabom razini glikemijski kontrole, unatoč maksimalno переносимую dozu kada monoterapija s sa sulfonilurejom, kao trostruka пероральная terapija u kombinaciji s:метформина i sulfonilurejom, kod odraslih pacijenata (posebno u pacijenata s prekomjernom tjelesnom težinom) s nedovoljno dostupnih glikemijski kontrole, unatoč dvostruko oralnu terapiju. pioglitazone također pokazala da kombinacija inzulina u tip-2 dijabetesa kod odraslih pacijenata s nedostatnim nadzorom glukoze na inzulin, za koje je metformin nepraktično zbog kontraindikacija ili netolerancije. nakon početka terapije s пиоглитазоном, pacijenti moraju biti revidiran nakon tri do šest mjeseci, za procjenu adekvatnosti odgovora na liječenje (e. smanjenje pokazatelja hba1c). kod bolesnika koji ne pokazuju adekvatan odgovor treba da se ukine pioglitazone. u svjetlu potencijalnih rizika za dugotrajno liječenje, propisane lijekove treba potvrditi u kasnijim rutinske inspekcije da dobro pioglitazone sprema.

الاتحاد الأوروبي - الكرواتية - EMA (European Medicines Agency)

gilead sciences ireland uc - ледипасвир, софосбувир - hepatitis c, kronični - antivirusni lijekovi za sustavnu uporabu - harvoni is indicated for the treatment of chronic hepatitis c (chc) in adult and paediatric patients aged 3 years and above (see sections 4. 2, 4. 4 i 5. virus hepatitisa c (hcv) genotip-specifične aktivnosti vidi 4. 4 i 5.

الاتحاد الأوروبي - الكرواتية - EMA (European Medicines Agency)

roche registration gmbh - sakvinavir - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - invirase je indiciran za liječenje bolesnika odraslih inficiranih hiv-1. invirase treba dati samo u kombinaciji s ritonavirom i drugim antiretrovirusnim lijekovima.

الاتحاد الأوروبي - الكرواتية - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - cistična fibroza - drugi proizvodi respiratornog sustava - kalydeco tablets are indicated:as monotherapy for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 i 5. in a combination regimen with tezacaftor/ivacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cftr gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t. in a combination regimen with ivacaftor/tezacaftor/elexacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who have at least one f508del mutation in the cftr gene (see section 5. kalydeco granules are indicated for the treatment of infants aged at least 4 months, toddlers and children weighing 5 kg to less than 25 kg with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cftr gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 i 5. in a combination regimen with ivacaftor/tezacaftor/elexacaftor for the treatment of cystic fibrosis (cf) in paediatric patients aged 2 to less than 6 years who have at least one f508del mutation in the cftr gene.

الاتحاد الأوروبي - الكرواتية - EMA (European Medicines Agency)

merck sharp and dohme b.v - posakonazol - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimikotika za sustavnu uporabu - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 i 5. 1):- invasive aspergillosisnoxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections  4. 2 i 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. noxafil gastro-resistant tablets are also indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections 4. 2 i 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 i 5. 1):- invasive aspergillosisnoxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adult and paediatric patients from 2 years of age (see sections 4. 2 i 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. noxafil concentrate for solution for infusion is also indicated for prophylaxis of invasive fungal infections in the following adult and paediatric patients from 2 years of age (see sections 4. 2 i 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (gvhd) and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil gastro resistant powder and solvent for oral suspension is indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age (see sections 4. 2 i 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. noxafil gastro-resistant powder and solvent for oral suspension is indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2  years of age:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high  risk of developing invasive fungal infections;- haematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high  risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil oral suspension is indicated for use in the treatment of the following fungal infections in adults (see section 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products;- oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. noxafil oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis.

الاتحاد الأوروبي - الكرواتية - EMA (European Medicines Agency)

janssen-cilag international nv - danmavir - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). in deciding to initiate treatment with prezista co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens:for the treatment of hiv 1 infection in antiretroviral treatment (art) experienced adult patients, including those that have been highly pre treated. for the treatment of hiv 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. in deciding to initiate treatment with prezista co administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). prezista 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv 1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (art) naïve. art experienced with no darunavir resistance associated mutations (drv rams) and who have plasma hiv 1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 106/l. in deciding to initiate treatment with prezista in such art experienced patients, genotypic testing should guide the use of prezista.

الاتحاد الأوروبي - الكرواتية - EMA (European Medicines Agency)

janssen-cilag international nv - bedaquiline fumarate - tuberkuloza, višestruko otporna - antimikobakterija - sirturo namijenjen je za korištenje u sklopu odgovarajuće kombinacije lijekova za plućne bolesti tuberkuloze s više otporne na lijekove (МЛУ-tb) kod odraslih i adolescenata oboljelih (12 godina manje od 18 godina, a tijelo manje mase 30 kg) za učinkovito liječenje ne može biti sastavljen od razmatranja održivosti, ili prenosivost. treba uzeti u obzir formalne preporuke za odgovarajuće korištenje antibakterijskih posrednika.