FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on PK/PD modelling, eliglustat plasma concentrations 11-fold the predicted human Cmax are expected to cause mean (upper bound of the 95% confidence interval) increases in the PR, QRS, and QTcF intervals of 18.8 (20.4), 6.2 (7.1), and 12.3 (14.2) msec, respectively.
Croatian: Temeljem PK/PD modela, očekuje se da će koncentracije eliglustata u plazmi 11 puta više od predviđenog Cmax za ljude uzrokovati srednja (gornja granica 95%- tnog intervala pouzdanosti) produljenja intervala PR, QRS i QTcF od 18,8 (20,4); 6,2 (7,1), odnosno 12,3 (14,2) ms.
English: Exposures in the carcinogenicity studies were approximately 4-fold and 3-fold greater in mice and rats, respectively, than the mean predicted human eliglustat total plasma exposure, or less than 1-fold using unbound plasma exposure.
Croatian: Izloženosti u ispitivanjima kancerogenosti bile su približno 4 puta više u miševa, odnosno 3 puta više u štakora od srednje predviđene izloženosti ukupnom eliglustatu u plazmi u ljudi ili manje od 1 puta više za izloženost nevezanoj frakciji u plazmi.
English: Long-term clinical outcomes in treatment-naïve GD1 patients - study 304
Croatian: Dugoročni klinički ishodi u prethodno neliječenih bolesnika s GD1 - ispitivanje 304
English: Cerdelga 84 mg hard capsules
Croatian: Cerdelga 84 mg tvrde kapsule
English: Effect of severe renal impairment was evaluated in a single dose phase 1 study.
Croatian: Učinak teškog oštećenja funkcije bubrega procijenjen je u ispitivanju faze 1 primjenom jednokratne doze.
English: In the primary analysis periods of the three clinical studies, a total of 5 PMs and 5 URMs were treated with Cerdelga.
Croatian: U periodima primarne analize tri klinička ispitivanja ukupno je 5 SM-a i 5 UBM-a liječeno lijekom Cerdelga.
English: Individuals with a CYP2D6 poor metaboliser predicted phenotype (approximately 5 to 10% of the population) exhibit higher eliglustat concentrations than intermediate or extensive CYP2D6 metabolisers.
Croatian: Osobe s predviđenim fenotipom slabog metabolizatora CYP2D6 (približno 5 do 10% populacije) pokazuju više koncentracije eliglustata od intermedijarnih ili ekstenzivnih metabolizatora CYP2D6.
English: • dabigatran - anticoagulant (used to thin the blood)
Croatian: • dabigatran - antikoagulans (primjenjuje se za razrjeđivanje krvi)
English: Medicines that may increase the level of Cerdelga in the blood such as:
Croatian: Lijekovi koji mogu povisiti razinu lijeka Cerdelga u krvi, primjerice:
English: Prior to launch of Cerdelga in each Member State the Marketing Authorisation Holder (MAH) must agree the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Croatian: Prije stavljanja u promet lijeka Cerdelga u svakoj državi članici, nositelj odobrenja za stavljanje lijeka u promet mora dogovoriti s nadležnim nacionalnim tijelom sadržaj i oblik edukacijskog programa,
English: Medicines that may decrease the level of Cerdelga in the blood:
Croatian: Lijekovi koji mogu sniziti razinu lijeka Cerdelga u krvi:
English: If you forget to take Cerdelga
Croatian: Ako ste zaboravili uzeti lijek Cerdelga
English: • Change in taste (dysgeusia)
Croatian: • Promjena osjeta okusa (disgeuzija)
English: o In the capsule shell: gelatin, potassium aluminium silicate (E555), titanium dioxide (E171), yellow iron oxide (E172) and indigotine (E132).
Croatian: o U ovojnici kapsule: želatina, kalijev aluminijev silikat (E555), titanijev dioksid (E171), žuti željezov oksid (E172) i indigotin (E132).
English: • Gas (flatulence)
Croatian: • Vjetrovi (flatulencija)
English: In clinical trials in treatment-naïve GD1 patients, plasma GL-1 levels were elevated in the majority of these patients and decreased upon Cerdelga treatment.
Croatian: U kliničkim ispitivanjima s prethodno neliječenim bolesnicima s GD1, razine GL-1 u plazmi bile su povišene u većine tih bolesnika i snizile su se nakon liječenja lijekom Cerdelga.
English: Eliglustat is an inhibitor of P-gp and CYP2D6 in vitro; concomitant administration of eliglustat with P-gp or CYP2D6 substrate substances may increase the plasma concentration of those substances.
Croatian: Eliglustat je in vitro inhibitor P-gp i CYP2D6; istovremena primjena eliglustata i tvari supstrata P-gp ili CYP2D6 može povećati koncentracije tih tvari u plazmi.
English: Fifteen (79%) of these patients received a dose escalation to 84 mg eliglustat twice daily; 4 (21%) patients continued to receive 42 mg twice daily.
Croatian: Petnaest (79%) od tih bolesnika primalo je dozu koja se povećavala do 84 mg eliglustata dva puta dnevno; 4 (21%) bolesnika nastavilo je primati 42 mg dva puta dnevno.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Cerdelga in all subsets of the paediatric population in Gaucher disease Type 2 (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Cerdelga u svim podskupinama pedijatrijske populacije u Gaucherovoj bolesti tipa 2 (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Study 304 was a single-arm, open-label, multicenter study of Cerdelga in 26 patients.
Croatian: Ispitivanje 304 bilo je otvoreno, multicentrično ispitivanje jedne skupine s lijekom Cerdelga na 26 bolesnika.
English: Before initiation of treatment with Cerdelga, patients should be genotyped for CYP2D6 to determine the CYP2D6 metaboliser status (see section 4.2, Special populations).
Croatian: Prije početka liječenja lijekom Cerdelga bolesnike treba genotipizirati za CYP2D6 kako bi se odredio status metabolizatora CYP2D6 (vidjeti dio 4.2, Posebne populacije).
English: o Before initiation of treatment with Cerdelga, patients should be genotyped for CYP2D6 to determine the CYP2D6 metaboliser status.
Croatian: o Prije početka liječenja lijekom Cerdelga, bolesnicima se mora genotipizirati CYP2D6 kako bi se odredio CYP2D6 metabolizatorski status.
English: 5% (40.57%) [n=39], 74.6% (49.57%) [n=35], and 86.8% (54.20%) [n=12]; mean reduction in spleen volume (MN) 46.5% (9.75%) [n=38], 54.2% (9.51%) [n=32], and 65.6% (7.43%) [n=13]; and mean reduction in liver volume (MN) 13.7% (10.65%) [n=38], 18.5% (11.22%) [n=32], and 23.4% (10.59%) [n=13].
Croatian: Rezultati (promjena od početnih vrijednosti) nakon 18 mjeseci, 30 mjeseci i 4,5 godina izloženosti lijeku Cerdelga za sljedeće mjere ishoda su: apsolutna promjena razine hemoglobina (g/dl) iznosila je 1,1 (1,03) [n=39], 1,4 (0,93) [n=35] i 1,4 (1,31) [n=12]; srednja vrijednost povećanja broja trombocita (mm3) iznosila je 58,5% (40,57%) [n=39], 74,6% (49,57%) [n=35] i 86,8% (54,20%) [n=12]; srednja vrijednost smanjenja volumena slezene (MN) iznosila je 46,5% (9,75%) [n=38], 54,2% (9,51%) [n=32] i 65,6% (7,43%) [n=13] te srednja vrijednost smanjenja volumena jetre (MN) iznosila je 13,7% (10,65%) [n=38], 18,5% (11,22%) [n=32] i 23,4% (10,59%) [n=13].
English: The combination of these medicines will interfere with your body's ability to break down Cerdelga and this can result in higher levels of the active substance in your blood (see the section ‘Other medicines and Cerdelga' for an expanded list of medicines).
Croatian: Kombinacija tih lijekova će utjecati na sposobnost Vašeg tijela da razgradi lijek Cerdelga što može rezultirati višim razinama djelatne tvari u Vašoj krvi (vidjeti dio „Drugi lijekovi i Cerdelga“ za prošireni popis lijekova).
English: Use of Cerdelga under these conditions results in substantially elevated eliglustat plasma concentrations (see section 4.4 and 4.5).
Croatian: Cerdelga u tim uvjetima uzrokuje značajno povišenje koncentracija eliglustata u plazmi (vidjeti dio 4.4
English: For use of eliglustat with one strong or moderate inhibitor of CYP2D6 or CYP3A, see section 4.5.
Croatian: Za primjenu eliglustata s jednim jakim ili umjerenim inhibitorom CYP2D6 ili CYP3A, vidjeti dio 4.5.
English: • goldenseal - (also known as Hydrastis canadensis) a herbal preparation obtained without a prescription, used as a digestive aid.
Croatian: • cimetidin, ranitidin - antacidi (primjenjuju se za liječenje probavnih smetnji) • kanadska žutika - (također poznata kao Hydrastis canadensis) biljni pripravak koji se može nabaviti bez recepta, primjenjuje se kao pomoć pri probavi.
English: • have a slow heart rate.
Croatian: • imate usporene srčane otkucaje
English: The MAH shall ensure that in each Member State where Cerdelga is marketed, all healthcare professionals who are expected to prescribe Cerdelga are provided with a prescriber guide.
Croatian: Nositelj odobrenja će osigurati da su svi zdravstveni radnici za koje se očekuje da će propisivati lijek Cerdelga, u svakoj državi članici gdje je lijek Cerdelga u prometu, opskrbljeni priručnikom za propisivanje.
English: Use of a strong CYP3A inducer (e.g. rifampicin, carbamazepine, phenobarbital, phenytoin, rifabutin and St. John's wort) with eliglustat is not recommended in IMs, EMs and PMs.
Croatian: Primjena jakog induktora CYP3A (npr. rifampicin, karbamazepin, fenobarbital, fenitoin, rifabutin i gospina trava) s eliglustatom se ne preporučuje kod IM-a, EM-a i SM-a.
English: Cerdelga contains the active substance eliglustat and is used for the long term treatment of adult patients with Gaucher disease type 1.
Croatian: Cerdelga sadrži djelatnu tvar eliglustat i koristi se za dugoročno liječenje odraslih bolesnika s Gaucherovom bolesti tipa 1.
English: In rat repeated dose toxicity studies, seminiferous epithelial degeneration and segmental hypoplasia of the testes was seen at 10-fold of predicted human exposure based on AUC.
Croatian: U ispitivanjima toksičnosti ponovljenih doza na štakorima, epitelna degeneracija sjemenih kanalića i segmentna hipoplazija testisa zabilježena je kod 10 puta veće izloženosti od predviđene izloženosti u ljudi na temelju AUC-a.
English: Capsule with pearl blue-green opaque cap and pearl white opaque body with “GZ02” printed in black on the body of the capsule.
Croatian: Kapsula s biserno plavo-zelenom, neprozirnom kapicom i biserno bijelim, neprozirnim tijelom s crno tiskanom oznakom „GZ02“ na tijelu kapsule.
English: • diltiazem - antihypertensive (used to increase blood flow and decrease heart rate)
Croatian: • diltiazem - antihipertenziv (primjenjuje se za povećanje protoka krvi i smanjenje brzine srčanih otkucaja)
English: In the Cerdelga group 3 (15%) patients received a starting dose of 42 mg eliglustat twice daily during the 9-month primary analysis period and 17 (85%) patients received a dose escalation to 84 mg twice daily based on plasma trough concentration.
Croatian: U skupini liječenoj lijekom Cerdelga 3 (15%) bolesnika primala su početnu dozu od 42 mg eliglustata dva puta dnevno tijekom 9-mjesečnog razdoblja primarne analize, a 17 (85%) bolesnika primalo je dozu koja se povećavala do 84 mg dva puta dnevno na temelju najniže koncentracije u plazmi.
English: Eliglustat is metabolised primarily by CYP2D6 and to a lesser extent by CYP3A4.
Croatian: Eliglustat se primarno metabolizira pomoću CYP2D6 i u manjoj mjeri pomoću CYP3A4.
English: • isoniazid - used to treat tuberculosis.
Croatian: • izoniazid - primjenjuje se kod liječenja tuberkuloze
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE PACKAGING FOR SINGLE BLISTER SLEEVE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU MEĐUPAKIRANJE ZA POJEDINAČNI BLISTER: KOŠULJICA
English: In intermediate (IMs) and extensive metabolisers (EMs):
Croatian: Kod intermedijarnih (IM) i ekstenzivnih metabolizatora (EM):
English: In order to investigate the long-term safety of eliglustat in patients prescribed eliglustat, the MAH is to create a sub-registry to the International Collaborative Gaucher Group (ICGG) Gaucher Registry to collect safety data according to an agreed protocol.
Croatian: U svrhu ispitivanja dugoročne sigurnosti eliglustata u bolesnika kojima je propisan eliglustat, nositelj odobrenja će izraditi pod-registar u sklopu Registra Gaucherove bolesti
English: • ciprofloxacin, clarithromycin, erythromycin, telithromycin - antibiotics (used to treat infections)
Croatian: • ciprofloksacin, klaritromicin, eritromicin, telitromicin - antibiotici (primjenjuju se za liječenje infekcija)
English: Caution should be used with weak CYP3A inhibitors (e.g. amlodipine, cilostazol, fluvoxamine, goldenseal, isoniazid, ranitidine, ranolazine) in PMs.
Croatian: Oprez je potreban sa slabim inhibitorima CYP3A (npr. amlodipin, cilostazol, fluvoksamin, kanadska žutika, izoniazid, ranitidin, ranolazin) kod SM-a.
English: After 30 months and 4.5 years of treatment, the T-score further increased to -0.722 (1.1250) (n=27) and -0.533 (0.8031) (n=9), respectively.
Croatian: 30 mjeseci i 4,5 godina liječenja, T vrijednost dodatno se povećala na -0,722 (1,1250) (n=27)
English: What you need to know before you take Cerdelga 3.
Croatian: Što morate znati prije nego što počnete uzimati lijek Cerdelga
English: Concomitant administration of substances affecting CYP2D6 or CYP3A4 activity may alter eliglustat plasma concentrations.
Croatian: Istovremena primjena tvari koje utječu na aktivnost CYP2D6 ili CYP3A4 može promijeniti koncentracije eliglustata u plazmi.
English: Each capsule contains 84 mg eliglustat.
Croatian: Jedna kapsula sadrži 84 mg eliglustata.
English: In poor metabolisers (PMs):
Croatian: Kod sporih metabolizatora (SM):
English: • atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, ritonavir, saquinavir, tipranavir antiretrovirals (used to treat HIV)
Croatian: • atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, ritonavir, sakvinavir, tipranavir antiretrovirusni lijekovi (primjenjuju se za liječenje HIV-a)
English: - If you are an extensive metaboliser and you have severely reduced liver function.
Croatian: - Ako ste ekstenzivni metabolizator i imate jako smanjenu funkciju jetre
English: o Use of eliglustat with strong CYP3A inducers substantially decreases the exposure to eliglustat, which may reduce the therapeutic effectiveness; therefore concomitant administration is not recommended.
Croatian: o Primjena eliglustata s jakim induktorima CYP3A značajno smanjuje izloženost eliglustatu, što može smanjiti terapijsku učinkovitost, stoga se istodobna primjena ne preporučuje.
English: Use of eliglustat under these conditions results in substantially elevated plasma concentrations of eliglustat.
Croatian: Primjena eliglustata u tim uvjetima rezultira značajnim povišenjem koncentracija eliglustata u plazmi.
English: • cobicistat - used to improve the effects of antiretrovirals (used to treat HIV)
Croatian: • kobicistat - primjenjuje se za poboljšanje učinka antiretrovirusnih lijekova (primjenjuju se za liječenje HIV-a)
English: Cerdelga 84 mg hard capsules eliglustat
Croatian: Cerdelga 84 mg tvrde kapsule eliglustat
English: Concomitant use of eliglustat with CYP2D6 or CYP3A4 inhibitors in CYP2D6 extensive metabolisers (EMs) with mild hepatic impairment can result in further elevation of eliglustat plasma concentrations, with the magnitude of the effect depending on the enzyme inhibited and the potency of the inhibitor.
Croatian: Istovremena primjena eliglustata s inhibitorima CYP2D6 ili CYP3A4 u ekstenzivnih metabolizatora (EM) CYP2D6 s blagim oštećenjem funkcije jetre može dovesti do daljnjeg porasta koncentracije eliglustata u plazmi s opsegom učinka koji ovisi o inhibiranom enzimu i potentnosti inhibitora.
English: Tell your doctor if you are breast-feeding.
Croatian: Obavijestite svojeg liječnika ako dojite.
English: • are taking an antiarrhythmic medicine (used to treat irregular heart beat) like quinidine,
Croatian: • imate bilo kakve druge srčane smetnje • uzimate antiaritmike (primjenjuju se za liječenje nepravilnih otkucaja srca) poput kinidina,
English: These medicines are known as strong or moderate CYP2D6 inhibitors and strong or moderate CYP3A inhibitors.
Croatian: Ti su lijekovi poznati kao jaki ili umjereni inhibitori CYP2D6 i jaki ili umjereni inhibitori CYP3A.
English: - If you are an extensive metaboliser and you have mildly or moderately reduced liver function while taking a strong or moderate CYP2D6 inhibitor.
Croatian: - Ako ste ekstenzivni metabolizator i imate blago ili umjereno smanjenu funkciju jetre, a uzimate jak ili umjeren inhibitor CYP2D6
English: In the Cerdelga group 34 (32%) patients received a dose escalation to 84 mg eliglustat twice daily and 51 (48%) to 127 mg twice daily during the 12month primary analysis period , and 21 (20%) patients continued to receive 42 mg twice daily.
Croatian: U skupini liječenoj lijekom Cerdelga, 34 (32%) bolesnika primalo je dozu koja se povećavala do 84 mg eliglustata dva puta dnevno, a 51 (48%) bolesnik dozu koja se povećavala do 127 mg dva puta dnevno tijekom 12-mjesečnog razdoblja primarne analize, a 21 (20%) bolesnik je nastavio primati 42 mg dva puta dnevno.
English: After oral administration, the majority of the administered dose is excreted in urine (41.8%) and faeces (51.4%), mainly as metabolites.
Croatian: Nakon peroralne primjene, većina primijenjene doze izlučuje se mokraćom (41,8%) i stolicom
English: After repeated oral doses of 84 mg eliglustat twice daily, eliglustat elimination half-life is approximately 4-7 hours in non-PMs and 9 hours in PMs.
Croatian: Nakon ponovljenih peroralnih doza eliglustata od 84 mg dva puta dnevno poluvrijeme eliminacije eliglustata približno je 4-7 sati kod bolesnika koji nisu SM-i i 9 sati kod SM-a.
English: o In the printing ink: shellac, black iron oxide (E172), propylene glycol and ammonia solution, concentrated.
Croatian: o U tinti za označavanje: šelak, crni željezov oksid (E172), propilenglikol i amonijak, koncentrirana otopina.
English: These include certain antidepressants (tricyclic antidepressants, e.g. nortriptyline, amitriptyline, imipramine, and desipramine), phenothiazines, dextromethorphan and atomoxetine).
Croatian: Tu spadaju određeni antidepresivi (triciklički antidepresivi, npr. nortriptilin, amitriptilin, imipramin i dezipramin),
English: Black iron oxide (E172) Propylene glycol Ammonia solution, concentrated
Croatian: šelak željezov oksid, crni (E172) propilenglikol amonijak, koncentrirana otopina
English: Use of a moderate CYP3A inhibitor with eliglustat is not recommended in PMs.
Croatian: Primjena umjerenog inhibitora CYP3A s eliglustatom se ne preporučuje kod SM-a.
English: Agents that may increase eliglustat exposure
Croatian: Tvari koje mogu povećati izloženost eliglustatu
English: Some treatment-naïve patients showed less than 20% spleen volume reduction (sub-optimal results) after 9 months of treatment (see section 5.1).
Croatian: Praćenje kliničkog odgovora Neki bolesnici koji prije nisu bili liječeni pokazali su nakon 9 mjeseci liječenja (vidjeti dio 5.1)
English: Cerdelga patients and 3 of 3 Cerezyme patients remained within therapeutic goals for GD1.
Croatian: Od bolesnika koji nisu zadovoljili kriterije stabilnosti za pojedine komponente, 12 od 15 bolesnika liječenih lijekom Cerdelga i 3 od 3 bolesnika liječenih lijekom Cerezyme ostalo je unutar terapijskih ciljeva za GD1.
English: • nortryptyline, amitriptyline, imipramine, desipramine - antidepressants (used to treat depression)
Croatian: • nortriptilin, amitriptilin, imipramin, dezipramin - antidepresivi (primjenjuju se za liječenje depresije)
English: Agents that may decrease eliglustat exposure
Croatian: Tvari koje mogu smanjiti izloženost eliglustatu
English: • carbamazepine, phenobarbital, phenytoin -anti-epileptics (used to treat epilepsy and seizures)
Croatian: • karbamazepin, fenobarbital, fenitoin - antiepileptici (primjenjuju se za liječenje epilepsije i napadaja)
English: - If you are an intermediate or extensive metaboliser and use medicines known as strong or moderate CYP2D6 inhibitors (examples are quinidine and terbinafine) used in combination with strong or moderate CYP3A inhibitors (examples are erythromycin and itraconazole).
Croatian: Ako ste intermedijarni ili ekstenzivni metabolizator i koristite lijekove koji su poznati kao jaki ili umjereni inhibitori CYP2D6 (primjeri su kinidin i terbinafin) u kombinaciji s jakim ili umjerenim inhibitorima CYP3A (primjeri su eritromicin i itrakonazol).
English: After repeated 84 mg twice daily doses of eliglustat in PMs, concomitant administration of repeated 600 mg once daily doses of rifampicin resulted in an approximately 95% decrease in eliglustat exposure.
Croatian: Nakon ponovljenih doza eliglustata od 84 mg dva puta dnevno kod SM-a, istovremena primjena ponovljenih doza rifampicina od 600 mg jednom dnevno rezultirala je smanjenjem izloženosti eliglustatu od približno 95%.
English: Use of eliglustat with strong CYP3A inducers substantially decreases the exposure to eliglustat, which may reduce the therapeutic effectiveness of eliglustat; therefore concomitant administration is not recommended (see section 4.5).
Croatian: Primjena eliglustata s jakim induktorima CYP3A značajno smanjuje izloženost eliglustatu, što može smanjiti terapijski učinak eliglustata te se stoga ne preporučuje njihova istovremena primjena (vidjeti dio 4.5).
English: The MAH shall ensure that in each Member State where Cerdelga is marketed, all patients who are prescribed Cerdelga are provided with a patient alert card.
Croatian: MAH će osigurati da su svi bolesnici kojima je propisan lijek Cerdelga opskrbljeni s karticom s upozorenjima za bolesnike, u svakoj državi članici gdje je lijek Cerdelga u prometu.
English: Following repeated dosing of eliglustat 84 mg twice daily in non-PMs and once daily in PMs, steady state was reached by 4 days, with an accumulation ratio of 3-fold or less.
Croatian: Nakon ponovljenog doziranja eliglustata od 84 mg dva puta dnevno kod bolesnika koji nisu SM-i i jednom dnevno kod SM-a stanje dinamičke ravnoteže dosegnuto je za 4 dana, s omjerom nakupljanja od 3 puta ili manje.
English: Strong CYP3A inducers
Croatian: Jaki induktori CYP3A
English: After repeated 127 mg twice daily doses of eliglustat in non-PMs, concomitant administration of repeated 600 mg once daily doses of rifampicin (a strong inducer of CYP3A as well as the efflux transporter P-gp) resulted in an approximately 85% decrease in eliglustat exposure.
Croatian: Nakon ponovljenih doza eliglustata od 127 mg dva puta dnevno kod bolesnika koji nisu SM-i, istovremena primjena ponovljenih doza rifampicina od 600 mg jednom dnevno (jak induktor CYP3A kao i efluksnog transportera P-gp) rezultirala je smanjenjem izloženosti eliglustatu od približno 85%.
English: Use of Cerdelga under these conditions results in substantially elevated eliglustat plasma concentrations.
Croatian: Primjena lijeka Cerdelga u tim uvjetima rezultira značajnim povišenjem koncentracija eliglustata u plazmi.
English: • aprepitant - antiemetic (used to reduce vomiting)
Croatian: • aprepitant - antiemetik (primjenjuje se za smirenje povraćanja)
English: What you need to know before you take Cerdelga Do not take Cerdelga
Croatian: Što morate znati prije nego počnete uzimati lijek Cerdelga
English: Table 5: Changes from Month 12 (primary analysis period) to Month 48 in patients with GD1 in the Long Term Treatment Period on Cerdelga in study 02607
Croatian: Tablica 5: Promjene od 12. mjeseca (razdoblje primarne analize) do 48. mjeseca u bolesnika s GD1 u razdoblju dugoročnog liječenja lijekom Cerdelga u ispitivanju 02607
English: Adverse reactions from long term clinical trial data reported in at least 4 patients are presented in Table 1.Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Nuspojave iz podataka iz dugoročnih kliničkih ispitivanja prijavljene kod barem 4% bolesnika prikazane su u Tablici 1.
English: Steady state PK exposure could not be predicted in CYP2D6 intermediate metabolisers (IMs) and poor metabolisers (PMs) with mild and moderate hepatic impairment due to limited or no single-dose data.
Croatian: Izloženost u PK stanju dinamičke ravnoteže ne može se predvidjeti u intermedijarnih metabolizatora (IM) i sporih metabolizatora (SM) CYP2D6 s blagim i umjerenim oštećenjem funkcije jetre zbog ograničenih podataka ili nepostojanja podataka koji se odnose na jednokratnu dozu.
English: Year 4
Croatian: 4. godina