FrancophonIA/ELRC3.0 huggingface dataset:
English: After 12 months of treatment, the percentage of patients meeting the primary composite endpoint (composed of all four components mentioned in Table 4) was 84.8% [95% confidence interval 76.2% - 91.3%] for the Cerdelga group compared to 93.6% [95% confidence interval 82.5% - 98.7 %] for the Cerezyme group.
Croatian: 84,8% [95% interval pouzdanosti 76,2% - 91,3%] za skupinu liječenu lijekom Cerdelga u usporedbi s 93,6% [95% interval pouzdanosti 82,5% - 98,7 %] za skupinu liječenu lijekom Cerezyme.
English: After repeated 84 mg twice daily doses of eliglustat in non-PMs, concomitant administration with repeated 400 mg once daily doses of ketoconazole, a strong inhibitor of CYP3A, resulted in a 3.8 and 4.3-fold increase in eliglustat Cmax and AUC0-12, respectively; similar effects would be expected for other strong inhibitors of CYP3A (e.g. clarithromycin, ketoconazole, itraconazole, cobicistat, indinavir, lopinavir, ritonavir, saquinavir, telaprevir, tipranavir, posaconazole, voriconazole, telithromycin, conivaptan, boceprevir).
Croatian: Nakon ponovljenih doza eliglustata od 84 mg dva puta dnevno kod bolesnika koji nisu SM-i, istovremena primjena ponovljenih doza ketokonazola od 400 mg jednom dnevno, jakog inhibitora CYP3A, rezultirala je povišenjem Cmax i AUC0-12 eliglustata od 3,8 odnosno 4,3 puta; slični učinci očekuju se i za ostale jake inhibitore CYP3A (npr. klaritromicin, ketokonazol, itrakonazol, kobicistat, indinavir, lopinavir, ritonavir, sakvinavir, telaprevir, tipranavir, posakonazol, vorikonazol, telitromicin, konivaptan, boceprevir).
English: After a single 84 mg dose, eliglustat Cmax and AUC were similar in CYP2D6 extensive metabolisers (EMs) with severe renal impairment and healthy CYP2D6 extensive metabolisers (EMs).
Croatian: Nakon jednokratne doze od 84 mg, Cmax i AUC eliglustata bili su slični u ekstenzivnih metabolizatora (EM) CYP2D6 s teškim oštećenjem funkcije bubrega i zdravih ekstenzivnih metabolizatora (EM) CYP2D6.
English: • Bloating (abdominal distension)
Croatian: • Nadutost (distenzija abdomena)
English: Pivotal study of Cerdelga in GD1 patients switching from ERT- Study 02607 (ENCORE) Study 02607 was a randomized, open-label, active-controlled, non-inferiority, multicenter clinical study in 159 patients previously stabilised with ERT.
Croatian: Ispitivanje 02607 bilo je randomizirano, otvoreno, multicentrično kliničko ispitivanje neinferiornosti s aktivnom kontrolom na 159 bolesnika prethodno stabiliziranih s ERT-om.
English: After 18 months of Cerdelga treatment in the open-label extension phase, the mean (SD) lumbar spine Bone Mineral Density T-score increased from -1.14 (1.0118) at Baseline (n=34) to -0.918 (1.1601) (n=33) in the normal range.
Croatian: T- vrijednosti mineralne gustoće kosti (engl. bone mineral density, BMD) povećala se s početne vrijednosti -1,14 (1,0118) (n=34) na -0,918 (1,1601) (n=33) u normalnom rasponu.
English: • phenothiazines - antipsychotics (used to treat schizophrenia and psychosis)
Croatian: • fenotiazini - antipshihotici (primjenjuju se za liječenje shizofrenije i psihoze)
English: After a single 0.25 mg dose of digoxin, a P-gp substrate, concomitant administration of 127 mg twice daily doses of eliglustat resulted in a 1.7- and 1.5-fold increase in digoxin Cmax and AUClast, respectively.
Croatian: Nakon jedne doze digoksina od 0,25 mg, supstrata P-gp-a, istovremena primjena doze eliglustata od 127 mg dva puta dnevno rezultirala je povećanjem Cmax i AUClast digoksina od 1,7 odnosno 1,5 puta .
English: Percentage of Patients with stable liver volumea
Croatian: Bolesnici sa stabilnim volumenom jetre (%)
English: o Cerdelga is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1).
Croatian: Cerdelga je indicirana za dugotrajno liječenje odraslih bolesnika s Gaucherovom bolesti tipa 1 (engl.
English: Eliglustat is also contraindicated in patients who are CYP2D6 poor metabolisers (PMs) taking a strong CYP3A inhibitor.
Croatian: Eliglustat je također kontraindiciran u bolesnika koji su spori metabolizatori (SM) CYP2D6, a koji uzimaju jaki inhibitor CYP3A.
English: • dronedarone, quinidine, verapamil - antiarrhythmic medicines (used to treat irregular heartbeat)
Croatian: • dronedaron, kinidin, verapamil - antiaritmici (primjenjuju se za liječenje nepravilnih otkucaja srca)
English: In CYP2D6 extensive metabolisers (EMs) with mild hepatic impairment (Child-Pugh class A), no dosage adjustment is required and the recommended dose is 84 mg eliglustat twice daily.
Croatian: U ekstenzivnih metabolizatora (EM) CYP2D6 s blagim oštećenjem funkcije jetre (Child-Pugh stupanj A) nije potrebna prilagodba doziranja i preporučena doza iznosi 84 mg eliglustata dva puta dnevno.
English: How to take Cerdelga
Croatian: Kako uzimati lijek Cerdelga
English: Absolute Change in Haemoglobin Level (g/dL)
Croatian: Volumen slezene (MN) Razina hemoglobina (g/dl)
English: The overall adverse reaction profile of Cerdelga is based on 1400 patient-years of treatment exposure and pooled results from the primary analysis periods and extension periods of two pivotal Phase 3 studies (ENGAGE and ENCORE), one 8-year, long term Phase 2 study (Study 304) and one supporting Phase 3b study (EDGE).
Croatian: Ukupni profil nuspojava lijeka Cerdelga temelji se na 1400 bolesnik-godina izloženosti liječenju i združenim rezultatima razdoblja primarne analize i razdoblja produžetka dva pivotalna ispitivanja faze
English: The predicted exposures with 84 mg eliglustat once daily in patients who are PMs are expected to be similar to exposures observed with 84 mg eliglustat twice daily in CYP2D6 intermediate metabolisers (IMs).
Croatian: Očekuje se da će predviđena izloženost dozi od 84 mg eliglustata jednom dnevno u bolesnika koji su SM-i biti slična izloženosti opaženoj s dozom od 84 mg dva puta dnevno kod intermedijarnih metabolizatora (IM) CYP2D6.
English: Arthralgia, pain in extremity*, back pain* General disorders and administration site conditions Fatigue
Croatian: Artralgija, bol u ekstremitetima*, bol u leđima* Opći poremećaji i reakcije na mjestu primjene Umor
English: At 84 mg twice daily dosing with eliglustat in non-PMs, it is predicted that the concomitant use of strong or moderate CYP2D6 inhibitors and strong or moderate CYP3A inhibitors would increase Cmax and AUC0-12 up to 17- and 25-fold, respectively.
Croatian: Pri dozi eliglustata od 84 mg dva puta dnevno kod bolesnika koji nisu SM-i, predviđa se da će istovremena primjena jakih ili umjerenih inhibitora CYP2D6 i jakih ili umjerenih inhibitora CYP3A povećati Cmax i AUC0-12 do 17 odnosno 25 puta.
English: • dextromethorphan - cough medicine
Croatian: • dekstrometorfan - lijek protiv kašlja
English: After repeated 84 mg twice daily doses of eliglustat in non-PMs, concomitant administration with repeated 30 mg once daily doses of paroxetine, a strong inhibitor of CYP2D6, resulted in a 7.3- and 8.9-fold increase in eliglustat Cmax and AUC0-12, respectively.
Croatian: Nakon ponovljenih doza eliglustata od 84 mg dva puta dnevno kod bolesnika koji nisu SM-i, istovremena primjena ponovljenih doza paroksetina, jakog inhibitora CYP2D6, u dozi od 30 mg jednom dnevno, rezultirala je povećanjem Cmax i AUC0-12 eliglustata od 7,3 odnosno 8,9 puta.
English: • St. John's wort - (also known as Hypericum perforatum) a herbal preparation obtained without a prescription, used to treat depression and other conditions
Croatian: • gospina trava - (poznata i pod nazivom Hypericum perforatum) biljni pripravak koji se može nabaviti bez recepta i primjenjuje se za liječenje depresije i ostalih stanja Cerdelga može povisiti razine sljedećih vrsta lijekova u krvi:
English: Reinstitution of enzyme replacement therapy or an alternative treatment modality should be considered in individual patients who have a sub-optimal response.
Croatian: U pojedinih bolesnika u kojih je odgovor ispod optimalnih vrijednosti potrebno je razmotriti ponovno uvođenje enzimske nadomjesne terapije ili alternativnog načina liječenja.
English: Mean [95% CI]
Croatian: Srednja vrijednost [95% CI]
English: Platelet Count (x109/L)
Croatian: Volumen jetre (MN) Broj trombocita (x109/l)
English: Percentage Change in Liver Volume MN (%)
Croatian: Promjena od početnog volumena jetre MN (%) Broj trombocita
English: Effects of mild and moderate hepatic impairment were evaluated in a single dose phase 1 study.
Croatian: Oštećenje funkcije jetre: Učinci blagog i umjerenog oštećenja funkcije jetre procijenjeni su u ispitivanju faze 1 s primjenom jednokratne doze.
English: • phenytoin - anti-epileptic (used to treat epilepsy and seizures)
Croatian: • fenitoin - antiepileptik (primjenjuje se za liječenje epilepsije i napadaja)
English: Each capsule contains 84.4 mg of eliglustat (as tartrate).
Croatian: Jedna kapsula sadrži 84,4 mg eliglustata (u obliku eliglustattartarata).
English: • Inflammation of the stomach (gastritis)
Croatian: • Upala želuca (gastritis)
English: At 84 mg once daily dosing with eliglustat in PMs, it is predicted that concomitant use of strong CYP3A inhibitors (e.g. ketoconazole, clarithromycin, itraconazole, cobicistat, indinavir, lopinavir, ritonavir, saquinavir, telaprevir, tipranavir, posaconazole, voriconazole, telithromycin, conivaptan, boceprevir) would increase the Cmax and AUC0-24 of eliglustat 4.3- and 6.2-fold.
Croatian: Pri dozi eliglustata od 84 mg jednom dnevno kod SM-a, predviđa se da će istovremena primjena jakih inhibitora CYP3A (npr. ketokonazol, klaritomicin, itrakonazol, kobicistat, indinavir, lopinavir, ritonavir, sakvinavir, telaprevir, tipranavir, posakonazol, vorikonazol, telitromicin, konivaptan, boceprevir) povećati Cmax i AUC0-24 eliglustata 4,3 i 6,2 puta.
English: • conivaptan - diuretic (used to increase low blood sodium levels)
Croatian: • konivaptan - diuretik (primjenjuje se za povišenje niske razine natrija u krvi)
English: Limited or no data were available in patients with ESRD and in CYP2D6 intermediate metabolisers (IMs) or poor metabolisers(PMs) with severe renal impairment (see sections 4.2 and 4.4).
Croatian: Dostupni podaci bili su ograničeni ili nije bilo dostupnih podataka u bolesnika s ESRD-om i u intermedijarnih metabolizatora (IM) ili sporih metabolizatora (SM) CYP2D6 s teškim oštećenjem funkcije bubrega (vidjeti dijelove 4.2 i 4.4).
English: Therapy with Cerdelga should be initiated and supervised by a physician knowledgeable in the management of Gaucher disease.
Croatian: 4.2 Doziranje i način primjene Liječenje lijekom Cerdelga treba započeti i nadzirati liječnik s odgovarajućim iskustvom u liječenju
English: Pivotal study of Cerdelga in treatment-naïve GD1 patients - study 02507(ENGAGE) Study 02507 was a randomized, double-blind, placebo-controlled, multicenter clinical study in 40 patients with GD1.
Croatian: Ispitivanje 02507 bilo je randomizirano, dvostruko slijepo, placebom kontrolirano, multicentrično kliničko ispitivanje na 40 bolesnika s GD1.
English: • metoprolol - used to lower blood pressure and/or reduce heart rate
Croatian: • kolhicin - primjenjuje se za liječenje gihta • metoprolol - primjenjuje se za snižavanje krvnog tlaka i/ili usporavanje srčanih otkucaja
English: After 9 months of treatment, in Study 02507, bone marrow infiltration by Gaucher cells, as determined by the total Bone Marrow Burden (BMB) score (assessed by MRI in lumbar spine and femur) decreased by a mean of 1.1 points in Cerdelga treated patients (n=19) compared to no change in patients receiving placebo (n=20).
Croatian: Bone Marrow Burden, BMB) (procijenjen MR-om lumbalne kralježnice i bedrene kosti) smanjila se za prosječno 1,1 bod u bolesnika liječenih lijekom Cerdelga (n=19) u usporedbi s izostankom promjene u bolesnika koji su primali placebo (n=20).
English: After repeated 84 mg twice daily doses of Cerdelga, Cmax and AUC0-12 are predicted to be 2.4- and 2.9fold higher in CYP2D6 extensive metabolisers (EMs) with mild hepatic impairment and 6.4- and 8.9fold higher in CYP2D6 extensive metabolisers (EMs) with moderate hepatic impairment compared to healthy CYP2D6 extensive metabolisers (EMs).
Croatian: Nakon ponovljenih doza lijeka Cerdelga od 84 mg dva puta dnevno, predviđa se da će Cmax i AUC0-12 biti 2,4 odnosno 2,9 puta viši u ekstenzivnih metabolizatora (EM) CYP2D6 s blagim oštećenjem funkcije jetre te 6,4 odnosno 8,9 puta viši u ekstenzivnih metabolizatora (EM) CYP2D6 s umjerenim oštećenjem funkcije jetre u usporedbi sa zdravim ekstenzivnim metabolizatorima (EM) CYP2D6.
English: Due to significantly increased eliglustat plasma concentrations, Cerdelga is contraindicated in CYP2D6 extensive metabolisers (EMs) with severe hepatic impairment and in CYP2D6 extensive metabolisers (EMs) with mild or moderate hepatic impairment taking a strong or moderate CYP2D6 inhibitor (see sections 4.2 and 5.2).
Croatian: Zbog značajno povećane koncentracije eliglustata u plazmi, Cerdelga je kontraindicirana u ekstenzivnih metabolizatora (EM) CYP2D6 s teškim oštećenjem funkcije jetre i u ekstenzivnih metabolizatora (EM) CYP2D6 s blagim ili umjerenim oštećenjem funkcije jetre koji uzimaju jak ili umjeren inhibitor CYP2D6 (vidjeti dijelove 4.2 i 5.2).
English: Table 4: Changes from baseline to Month 12 (primary analysis period) in patients with GD1 switching to Cerdelga in study 02607
Croatian: Tablica 4: Promjene od početne vrijednosti do 12. mjeseca (razdoblje primarne analize) u bolesnika s GD1 koji su prešli na lijek Cerdelga u ispitivanju 02607
English: • are an extensive metaboliser and you have moderately reduced liver function.
Croatian: • ste ekstenzivni metabolizator i imate umjereno smanjenu funkciju jetre.
English: • terbinafine, itraconazole, fluconazole, posaconazole, voriconazole - antifungals (used to treat fungal infections)
Croatian: • terbinafin, itrakonazol, flukonazol, posakonazol, vorikonazol - antimikotici (primjenjuju se za liječenje gljivičnih infekcija) • mirabegron - primjenjuju se za liječenje prekomjerno aktivnog mokraćnog mjehura
English: After a single 50 mg dose of metoprolol, a CYP2D6 substrate, concomitant administration of repeated 127 mg twice daily doses of eliglustat resulted in a 1.5- and 2.1-fold increase in metoprolol Cmax and AUC, respectively.
Croatian: Nakon jedne doze metoprolola od 50 mg, supstrata CYP2D6, istovremena primjena ponovljene doze eliglustata od 127 mg dva puta dnevno rezultirala je povišenjem Cmax i AUC metroprolola od 1,5
English: • paroxetine, fluoxetine, fluvoxamine, duloxetine, bupropion, moclobemide - antidepressants (used to treat depression)
Croatian: • paroksetin, fluoksetin, fluvoksamin, duloksetin, bupropion, moklobemid - antidepresivi
English: CYP2D6 inhibitors In intermediate (IMs) and extensive metabolisers (EMs):
Croatian: Inhibitori CYP2D6 Kod intermedijarnih (IM) i ekstenzivnih metabolizatora (EM)
English: Caution should be used with strong or moderate CYP3A inhibitors in intermediate metabolisers (IMs) and extensive metabolisers (EMs).
Croatian: Kod primjene s jakim i umjerenim inhibitorima CYP3A potreban je oprez u intermedijarnih metabolizatora (IM) i ekstenzivnih metabolizatora (EM).
English: How to store Cerdelga
Croatian: Kako čuvati lijek Cerdelga
English: Year 3
Croatian: 3. godina
English: Haemoglobin Level Patients with stable haemoglobin level (%) Change from baseline in Haemoglobin Level (g/dL) Liver Volume Patients with stable liver volume (%)
Croatian: Bolesnici s dostupnim podacima (N) Volumen slezene Bolesnici sa stabilnim volumenom slezene (%)* Promjena u volumenu slezene MN (%)* Razina hemoglobina Bolesnici sa stabilnom razinom hemoglobina (%)
English: In CYP2D6 extensive metabolisers (EMs) with mild, moderate or severe renal impairment, no dosage adjustment is required and the recommended dose is 84 mg eliglustat twice daily (see sections 4.4 and 5.2).
Croatian: U ekstenzivnih metabolizatora (EM) CYP2D6 s blagim, umjerenim ili teškim oštećenjem funkcije bubrega nije potrebna prilagodba doziranja i preporučena doza iznosi 84 mg eliglustata dva puta dnevno (vidjeti dijelove 4.4 i 5.2).
English: After a single 84 mg dose, eliglustat Cmax and AUC were 1.2- and 1.2-fold higher in CYP2D6 extensive metabolisers (EMs) with mild hepatic impairment, and 2.8- and 5.2-fold higher in CYP2D6 extensive metabolisers (EMs) with moderate hepatic impairment compared to healthy CYP2D6 extensive metabolisers (EMs).
Croatian: Nakon jednokratne doze od 84 mg, Cmax eliglustata bio je 1,2 i AUC također 1,2 puta viši u ekstenzivnih metabolizatora (EM) CYP2D6 s blagim oštećenjem funkcije jetre te 2,8 odnosno 5,2 puta viši u ekstenzivnih metabolizatora (EM) CYP2D6 s umjerenim oštećenjem funkcije jetre u usporedbi sa zdravim ekstenzivnim metabolizatorima (EM) CYP2D6.
English: Table 2: Change from baseline to Month 9 (primary analysis period) in treatment-naïve patients with GD1 receiving treatment with Cerdelga in study 02507
Croatian: Tablica 2: Promjena od početka do 9. mjeseca (razdoblje primarne analize) u prethodno neliječenih bolesnika s GD1 koji su u ispitivanju 02507 liječeni lijekom Cerdelga
English: Talk to your doctor or pharmacist before taking Cerdelga, if you:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete lijek Cerdelga, ako: • se trenutno liječite ili ćete uskoro započeti liječenje bilo kojim od lijekova navedenih u dijelu
English: Monitoring of clinical response
Croatian: KLINIČKI PODACI
English: Cerdelga is indicated in patients who are CYP2D6 poor metabolisers (PMs), intermediate metabolisers (IMs) or extensive metabolisers (EMs).
Croatian: Cerdelga je indicirana u bolesnika koji su spori metabolizatori (SM), intermedijarni metabolizatori (IM) ili ekstenzivni metabolizatori (EM) CYP2D6.
English: Package leaflet: Information for the patient Cerdelga 84 mg hard capsules eliglustat This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za bolesnika Cerdelga 84 mg tvrde kapsule eliglustat
English: The use of a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor is contraindicated in IMs and EMs.
Croatian: Istovremena primjena jakih ili umjerenih inhibitora CYP2D6 s jakim ili umjerenim inhibitorima CYP3A kontraindicirana je kod IM-a i EM-a.
English: • are an intermediate or poor metaboliser and you have any level of reduced liver function.
Croatian: • ste intermedijarni ili spori metabolizator i imate bilo koji stupanj smanjenja funkcije jetre.
English: Cerdelgab Mean [95% CI])
Croatian: Cerdelgab Srednja vrijednost [95% CI])
English: Agents whose exposure may be increased by eliglustat
Croatian: Tvari kojima eliglustat može povećati izloženost
English: Caution should be used with weak CYP3A inhibitors in poor metabolisers (PMs).
Croatian: Kod primjene sa slabim inhibitorima CYP3A potreban je oprez u sporih metabolizatora (SM).
English: Cerdelga is meant to be used in patients whose body breaks down this medicine at normal speed (known as intermediate metabolisers and extensive metabolisers) or slow speed (known as poor metabolisers).
Croatian: (poznati kao intermedijarni metabolizatori i ekstenzivni metabolizatori) ili sporom brzinom (poznati kao spori metabolizatori).
English: CYP2D6 ultra-rapid metabolisers (URMs) and indeterminate metabolisers Eliglustat should not be used in patients who are CYP2D6 ultra-rapid metabolisers (URMs) or indeterminate metabolisers (see section 4.4).
Croatian: Eliglustat se ne smije primjenjivati u bolesnika koji su ultrabrzi metabolizatori (UBM) ili neodređeni metabolizatori CYP2D6 (vidjeti dio 4.4).
English: o Caution should be used with moderate CYP2D6 inhibitors in intermediate metabolisers (IMs) and extensive metabolisers (EMs).
Croatian: o Kod primjene s umjerenim inhibitorima CYP2D6 potreban je oprez u intermedijarnih metabolizatora (IM) i ekstenzivnih metabolizatora (EM).
English: Each capsule contains 84 mg of eliglustat (as tartrate)
Croatian: Jedna kapsula sadrži 84 mg eliglustata (u obliku eliglustattartarata)
English: The recommended dose is 84 mg eliglustat once daily in CYP2D6 poor metabolisers (PMs).
Croatian: Preporučena doza je 84 mg eliglustata jednom dnevno kod sporih metabolizatora (SM) CYP2D6.
English: N Baseline Value (Mean)
Croatian: N Početna vrijednost (srednja vrijednost)
English: Composite Stability Endpoint Patients who are Stable on Cerdelga (%)
Croatian: Kompozitna mjera ishoda stabilnosti Bolesnici koji su stabilni tijekom liječenja lijekom
English: • are an intermediate or poor metaboliser and you have reduced kidney function.
Croatian: • ste intermedijarni ili spori metabolizator i imate smanjenu funkciju bubrega.
English: The recommended dose is 84 mg eliglustat twice daily in CYP2D6 intermediate metabolisers (IMs) and extensive metabolisers (EMs).
Croatian: Preporučena doza je 84 mg eliglustata dva puta dnevno kod intermedijarnih metabolizatora (IM) i ekstenzivnih metabolizatora (EM) CYP2D6.
English: o A dose of eliglustat 84 mg once daily should be considered when a strong CYP2D6 inhibitor is used concomitantly in intermediate metabolisers (IMs) and extensive metabolisers (EMs).
Croatian: Potrebno je razmotriti dozu od 84 mg eliglustata jednom dnevno kada se u intermedijarnih metabolizatora (IM) i ekstenzivnih metabolizatora (EM) istovremeno primjenjuje jaki inhibitor CYP2D6.
English: In CYP2D6 EMs with end stage renal disease (ESRD), eliglustat is not recommended (see sections 4.4 and 5.2).
Croatian: Eliglustat se ne preporučuje kod EM-a CYP2D6 u završnom stadiju bolesti bubrega (eng. end stage renal disease, ESRD) (vidjeti dijelove 4.4 i 5.2).
English: Caution should be used with moderate CYP2D6 inhibitors in IMs and EMs.
Croatian: Kod primjene s umjerenim inhibitorima CYP2D6 potreban je oprez kod IM-a i EM-a.
English: If you take more capsules than you were told to, consult your doctor immediately.
Croatian: Vam je rečeno, odmah se savjetujte sa svojim liječnikom.
English: Eliglustat is extensively metabolized with high clearance, mainly by CYP2D6 and to a lesser extent CYP3A4.
Croatian: Biotransformacija Eliglustat se opsežno metabolizira uz visoki klirens, uglavnom putem CYP2D6 i u manjoj mjeri
English: Cerdelgab Mean [95% CI]
Croatian: Cerdelgab Srednja vrijednost [95% CI]
English: Patients who are CYP2D6 intermediate metabolisers (IMs) or extensive metabolisers (EMs) taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor, and patients who are CYP2D6 poor metabolisers (PMs) taking a strong CYP3A inhibitor.
Croatian: Bolesnici koji su intermedijarni metabolizatori (IM) ili ekstenzivni metabolizatori (EM) CYP2D6 i uzimaju jak ili umjeren inhibitor CYP2D6 istovremeno s jakim ili umjerenim inhibitorom CYP3A te bolesnici koji su spori metabolizatori (SM) CYP2D6 i uzimaju jaki inhibitor CYP3A.
English: The use of strong CYP3A inhibitors is contraindicated in PMs.
Croatian: Primjena jakih inhibitora CYP3A kontraindicirana je kod SM-a.
English: Contents of the pack and other information
Croatian: Kako čuvati lijek Cerdelga Sadržaj pakiranja i druge informacije
English: In extensive metabolisers (EMs) with severe hepatic impairment: see sections 4.2 and 4.3.
Croatian: U ekstenzivnih metabolizatora (EM) s teškim oštećenjem funkcije jetre: vidjeti dijelove 4.2 i 4.3.
English: Cerdelga is contraindicated in patients who are CYP2D6 intermediate metabolisers (IMs) or extensive metabolisers (EMs) taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor, and in patients who are CYP2D6 poor metabolisers (PMs) taking a strong CYP3A inhibitor (see section 4.3).
Croatian: Cerdelga je kontraindicirana u bolesnika koji su intermedijarni metabolizatori (IM) ili ekstenzivni metabolizatori (EM) CYP2D6, a uzimaju jaki ili umjereni inhibitor CYP2D6 istovremeno s jakim ili umjerenim inhibitorom CYP3A i u bolesnika koji su spori metabolizatori (SM) CYP2D6, a uzimaju jaki inhibitor CYP3A (vidjeti dio 4.3).
English: Swallow one 84 mg capsule whole twice a day with water.
Croatian: Ako ste intermedijarni metabolizator ili ekstenzivni metabolizator: Progutajte jednu cijelu kapsulu od 84 mg dva puta dnevno s vodom.