FrancophonIA/ELRC3.0 huggingface dataset:
English: MN = Multiples of Normal, CI = confidence interval * Excludes patients with a total splenectomy.
Croatian: MN = višekratnik normalne vrijednosti, CI = interval pouzdanosti * Isključuje bolesnike s potpunom splenektomijom.
English: Headache*, dizziness*, dysgeusia
Croatian: Glavobolja*, omaglica*, disgeuzija
English: There is limited experience in the treatment of elderly with eliglustat.
Croatian: Iskustvo u liječenju starijih osoba eliglustatom je ograničeno.
English: • The other ingredients are: o In the capsule: microcrystalline cellulose, lactose monohydrate (see section 2 under ‘Cerdelga contains lactose'), hypromellose and glycerol dibehenate.
Croatian: • Drugi sastojci su: o U kapsuli: mikrokristalična celuloza, laktoza hidrat (vidjeti dio 2 pod „Cerdelga sadrži laktozu“), hipromeloza i gliceroldibehenat.
English: While there was no apparent effect on heart rate, concentration-related increases were observed for the placebo corrected change from baseline in the PR, QRS, and QTc intervals.
Croatian: Iako nije bilo očitog učinka na srčanu frekvenciju, povećanja koja su povezana s koncentracijom opažena su za placebom korigiranu promjenu u odnosu na početnu vrijednost u intervalima PR, QRS i QTc.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER / WALLET
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER/OVITAK
English: Sixteen patients had an efficacy endpoint assessment at year 8.
Croatian: Šesnaest bolesnika imalo je ocjenu mjere ishoda djelotvornosti u 8.godini.
English: Swallow one 84 mg capsule whole once a day with water.
Croatian: Progutajte jednu cijelu kapsulu od 84 mg jednom dnevno s vodom.
English: The principal target organs for eliglustat in toxicology studies are the GI tract, lymphoid organs, the liver in rat only and, in the male rat only, the reproductive system.
Croatian: Glavni ciljni organi za eliglustat u toksikološkim ispitivanjima su GI trakt, limfni organi, jetra samo kod štakora i, reproduktivni sustav samo kod mužjaka štakora.
English: Individual disease parameters of spleen volume, liver volume, haemoglobin levels and platelet count remained stable through 4 years (see Table 5).
Croatian: Pojedinačni parametri bolesti: volumen slezene, volumen jetre, razina hemoglobina i broj trombocita ostali su stabilni tijekom 4 godine (vidjeti Tablicu 5).
English: Genzyme Ireland, Ltd IDA Industrial Park Old Kilmeaden Road, Waterford Ireland
Croatian: Genzyme Ireland, Ltd IDA Industrial Park Old Kilmeaden Road, Waterford Irska
English: Other medicines and Cerdelga
Croatian: Drugi lijekovi i Cerdelga
English: Data indicates that no dosage adjustment is considered necessary (see sections 5.1 and 5.2).
Croatian: Podaci upućuju kako nije potrebno prilagođavanje doze (vidjeti dijelove 5.1 i 5.2).
English: SRT aims to reduce the rate of synthesis of the major substrate glucosylceramide (GL-1) to match its impaired rate of catabolism in patients with GD1, thereby preventing glucosylceramide accumulation and alleviating clinical manifestations.
Croatian: SRT ima za cilj smanjiti brzinu sinteze glavnog supstrata glukozilceramida (GL-1) kako bi se uskladila s njegovom smanjenom brzinom kataboliziranja u bolesnika s GD1 te tako sprječava nakupljanje glukozilceramida i ublažava kliničke manifestacije.
English: MN = Multiples of Normal
Croatian: MN = višekratnik normalne vrijednosti
English: Available pharmacodynamic/toxicological data in animals have shown excretion of eliglustat in milk (see section 5.3).
Croatian: Dostupni farmakodinamički/toksikološki podaci u životinja pokazuju da se eliglustat izlučuje u mlijeko (vidjeti dio 5.3).
English: o Do not consume grapefruit products.
Croatian: o Ne konzumirajte proizvode od grejpa
English: Cerdelga is to be taken orally.
Croatian: Cerdelga se uzima peroralno.
English: Population pharmacokinetic analysis shows that the CYP2D6 predicted phenotype based on genotype is the most important factor affecting pharmacokinetic variability.
Croatian: Fenotip CYP2D6 Populacijska farmakokinetička analiza pokazuje da je predviđen fenotip CYP2D6 temeljen na genotipu najvažniji čimbenik koji utječe na farmakokinetičku varijabilnost.
English: • are an end stage renal disease (ESRD) patient.
Croatian: • ste bolesnik u završnom stadiju bolesti bubrega (ESRD).
English: The list of substances in section 4.5 is not an inclusive list and the prescriber is advised to consult the SmPC of all other prescribed medicinal products for potential drug-drug interactions with eliglustat.
Croatian: Popis tvari u dijelu 4.5 nije konačan te se propisivač savjetuje da pogleda Sažetak opisa svojstava lijeka za sve ostale propisane lijekove zbog mogućih interakcija tih lijekova s eliglustatom.
English: There are no or limited amount of data from the use of eliglustat in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni eliglustata u trudnica ograničeni.
English: All patient number (N)= Per Protocol Population
Croatian: Broj svih bolesnika (N) = Populacija liječena prema planu ispitivanja
English: Heart-rate corrected QT interval using Fridericia's correction (QTcF) was evaluated in a randomized, placebo and active (moxifloxacin 400 mg) controlled cross-over, single-dose study in 47 healthy subjects.
Croatian: QT interval korigiran prema srčanoj frekvenciji primjenom Fridericijeve metode korekcije (QTcF) bio je ocijenjen u randomiziranom, placebom i aktivno (moksifloksacinom od 400 mg) kontroliranom ukriženom ispitivanju s jednokratnom dozom na 47 zdravih ispitanika.
English: Eliglustat is a substrate of the efflux transporter P-gp.
Croatian: Eliglustat je supstrat efluksnog transportera P-gp-a.
English: Lower doses of medicinal products that are CYP2D6 substrates may be required.
Croatian: Možda će biti potrebne niže doze lijekova koji su supstrati CYP2D6.
English: Effects on testes and reversible inhibition of spermatogenesis were observed in rats (see section 5.3).
Croatian: Učinci na testise i reverzibilna inhibicija spermatogeneze zabilježeni su kod štakora (vidjeti dio 5.3).
English: Tabulated list of adverse reactions Adverse reactions are ranked by system organ class and frequency ([very common (≥1/10); common
Croatian: Nuspojave su navedene prema klasifikaciji organskih sustava i učestalosti ([vrlo često (≥ 1/10); često
English: Cerdelga contains the active substance eliglustat which decreases the production of glucosylceramide, thereby preventing its buildup.
Croatian: Cerdelga sadrži djelatnu tvar eliglustat koja smanjuje stvaranje glukozilceramida i tako sprječava njegovo nakupljanje.
English: Avoid consumption of grapefruit or grapefruit juice since it may increase the level of Cerdelga in your blood.
Croatian: Izbjegavajte konzumaciju grejpa ili soka od grejpa jer to može izazvati povišenu razinu lijeka Cerdelga u Vašoj krvi.
English: Patients with pre-existing cardiac conditions
Croatian: Bolesnici s već postojećim srčanim bolestima
English: Effects on skeletal pathology
Croatian: Učinci na patologiju kostiju
English: The recommended dosing regimens (see section 4.2) are based on modelling, either of PK/PD data from the dose-titration regimens applied in the clinical studies for IMs and EMs, or physiologicallybased PK data for PMs.
Croatian: Preporučeni režim doziranja (vidjeti dio 4.2) temelji se na modeliranju ili PK/PD podataka iz režima titracije doza primijenjenog u kliničkim ispitivanjima za IM-e i EM-e ili fiziološki temeljenim PK
English: All PMs received 42 mg eliglustat twice daily, and four of these (80%) had an adequate clinical response.
Croatian: Svi SM-i primili su 42 mg eliglustata dva puta dnevno, a četvero od njih (80%) je imalo adekvatan klinički odgovor.
English: • cinacalcet - calcimimetic (used in some dialysis patients and specific cancers)
Croatian: • cinakalcet - kalcimimetik (primjenjuju se u nekih bolesnika na dijalizi i kod određenih vrsta raka)
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke vrste šećera, prije uzimanja ovog lijeka obratite se svojem liječniku.
English: ** All patients transitioned to Cerdelga treatment after 52 weeks a The stability criteria based on changes between baseline and 12 months: haemoglobin level ≤1.5 g/dL decrease, platelet count ≤25% decrease, liver volume ≤20% increase, and spleen volume ≤25% increase.
Croatian: ** Svi bolesnici prešli su na liječenje lijekom Cerdelga nakon 52 tjedna a Kriteriji stabilnosti temeljeni na promjenama između početne vrijednosti i vrijednosti u 12. mjesecu: sniženje razine hemoglobina ≤ 1,5 g/dl, smanjenje broja trombocita ≤ 25%, povećanje volumena jetre ≤ 20% i povećanje volumena slezene ≤ 25%.
English: Fourteen (78%) continued on 84 mg Cerdelga twice daily.
Croatian: Četrnaest (78%) ih je nastavilo s 84 mg lijeka Cerdelga dva puta dnevno.
English: Placental transfer of eliglustat and its metabolites was shown in the rat.
Croatian: Placentalni prijenos eliglustata i njegovih metabolita zabilježen je u štakora.
English: • The active substance is eliglustat (as tartrate).
Croatian: • Djelatna tvar je eliglustat (u obliku eliglustattartarata).
English: Eliglustat did not have effects on CNS or respiratory functions.
Croatian: Eliglustat nije imao učinke na SŽS ni funkcije dišnog sustava.
English: In addition, patient's hepatic or renal status may have an impact on the metabolism of eliglustat.
Croatian: Osim toga, bolesnikov jetreni ili bubrežni status mogu imati utjecaj na metabolizam eliglustata.
English: At maternal toxic doses in rats, foetuses showed a higher incidence of dilated cerebral ventricles, abnormal number of ribs or lumbar vertebrae, and many bones showed poor ossification.
Croatian: Kod toksičnih doza za majku u štakora, fetusi su pokazali veću incidenciju dilatiranih cerebralnih ventrikula, abnormalnog broja rebara ili lumbalnih kralježaka, dok su mnoge kosti pokazale slabo okoštavanje.
English: • amlopidine, ranolazine - used to treat angina pectoris
Croatian: • amlodipin, ranolazin - primjenjuju se za liječenje angine pektoris
English: In this trial with demonstrated ability to detect small effects, the upper bound of the onesided 95% confidence interval for the largest placebo-adjusted, baseline-corrected QTcF was below 10 msec, the threshold for regulatory concern.
Croatian: U ovom ispitivanju s dokazanom sposobnošću za otkrivanje malih učinaka, gornja granica jednostranog 95%-tnog intervala pouzdanosti za najveći QTcF, prilagođen za placebo i korigiran za početnu vrijednost, bila je ispod
English: - If you are a poor metaboliser and use medicines known as strong CYP3A inhibitors (for example itraconazole).
Croatian: - Ako ste spori metabolizator i koristite lijekove koji su poznati kao jaki inhibitori CYP3A (na primjer itrakonazol).
English: It is unknown whether eliglustat or its metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se eliglustat ili njegovi metaboliti u majčino mlijeko.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, various alimentary tract and metabolism products, ATC code: A16AX10.
Croatian: Farmakoterapijska skupina: Ostali lijekovi za probavni sustav i metabolizam, različiti lijekovi za probavni sustav i metabolizam, ATK oznaka: A16AX10.
English: • digoxin -used to treat heart failure and atrial fibrillation
Croatian: • digoksin - primjenjuje se za liječenje zatajenja srca i atrijske fibrilacije
English: During the open-label long term treatment period with Cerdelga (extension phase) the percentage of patients with complete data meeting the composite stability endpoint was maintained at 84.6% (n=136) after 2 years, 84.4% (n=109) after 3 years and 91.1% (n=45) after 4 years.
Croatian: Tijekom otvorenog razdoblja dugoročnog liječenja lijekom Cerdelga (faza produžetka ispitivanja) postotak bolesnika s potpunim podacima koji su postigli kompozitnu mjeru ishoda stabilnosti održan je na 84,6% (n=136) nakon 2 godine; 84,4% (n=109) nakon 3 godine i 91,1% (n=45) nakon 4 godine.
English: Table 3: Change from baseline to year 8 in study 304
Croatian: Tablica 3: Promjena od početne vrijednosti do 8. godine u ispitivanju 304
English: Dry skin, urticaria*
Croatian: Suha koža, urtikarija*
English: Primary metabolic pathways of eliglustat involve sequential oxidation of the octanoyl moiety followed by oxidation of the 2,3-dihydro-1,4-benzodioxane moiety, or a combination of the two pathways, resulting in multiple oxidative metabolites.
Croatian: Primarni metabolički putevi eliglustata uključuju sekvencijalnu oksidaciju oktanoilne skupine nakon čega slijedi oksidacija 2,3-dihidro-1,4-benzodioksanske skupine ili kombinacija ta dva puta što rezultira višestrukim oksidativnim metabolitima.
English: Eliglustat is a potent and specific inhibitor of glucosylceramide synthase, and acts as a substrate reduction therapy (SRT) for GD1.
Croatian: Eliglustat je potentan i specifičan inhibitor glukozilceramid sintaze i djeluje kao terapija redukcijom supstrata (engl. substrate reduction therapy, SRT) kod GD1.
English: Patients at start of year (N) Patients at end of year (N) Patients with available data (N)
Croatian: Bolesnici na početku godine (N)
English: Three (17%) patients continued to receive 42 mg twice daily.
Croatian: Tri (17%) bolesnika nastavilo je primati 42 mg dva puta dnevno.
English: A limited number of patients aged 65 years (n=10) and over were enrolled in clinical trials.
Croatian: Broj bolesnika uključenih u klinička ispitivanja u dobi od 65 ili više godina bio je ograničen (n=10).
English: Capsule contents Microcrystalline cellulose Lactose monohydrate Hypromellose Glycerol dibehenate
Croatian: Sadržaj kapsule celuloza, mikrokristalična laktoza hidrat hipromeloza gliceroldibehenat
English: Additionally, in a clinical trial in GD1 patients stabilised on enzyme replacement therapy (ERT) (i.e. having already achieved therapeutic goals on ERT prior to initiating Cerdelga treatment), plasma GL-1 levels were normal in most patients and decreased upon Cerdelga treatment.
Croatian: Osim toga, u kliničkom ispitivanju na bolesnicima s GD1 stabiliziranima na enzimskoj nadomjesnoj terapiji (engl. enzyme replacement therapy, ERT) (tj. koji su već postigli terapijske ciljeve na ERT-u prije početka liječenja lijekom Cerdelga), razine GL-1 u plazmi bile su normalne u većine bolesnika i smanjile su se nakon liječenja lijekom Cerdelga.
English: • boceprevir, telaprevir - antiviral (used to treat Hepatitis C)
Croatian: • boceprevir, telaprevir - antivirusni lijek (primjenjuje se za liječenje hepatitisa C)
English: Difference (CerdelgaPlacebo) [95% CI]
Croatian: Razlika (Cerdelgaplacebo) [95% CI]
English: • imatinib - anticancer (used to treat cancer)
Croatian: • imatinib - lijek protiv raka (primjenjuje se za liječenje raka)
English: Not all packs may be marketed in your country.
Croatian: Na tržištu u Vašoj zemlji se ne moraju nalaziti sve veličine pakiranja.
English: In these four studies a total of 393 patients between the ages of 16-75 years received eliglustat for a median duration of 3.5 years (up to 9.3 years).
Croatian: 16-75 godina su primala eliglustat sa medijanom trajanja od 3,5 godine (do 9,3 godina).
English: Dyspepsia, abdominal pain upper*, diarrhoea*, nausea, constipation, abdominal pain*, gastrooesophageal reflux disease, abdominal distension*, gastritis, dysphagia, vomiting*, dry mouth, flatulence
Croatian: proljev*, mučnina, konstipacija, bol u abdomenu*, gastroezofagealna refluksna bolest, distenzija abdomena*, gastritis, disfagija, povraćanje*, suha usta, flatulencija
English: Use of eliglustat in these patients is not recommended (see sections 4.2 and 5.2).
Croatian: Primjena eliglustata u tih bolesnika se ne preporučuje (vidjeti dijelove 4.2 i 5.2).
English: Embryofoetal development in rats and rabbits was not affected up to clinically relevant exposure (based on AUC).
Croatian: Embriofetalni razvoj u štakora i kunića nije bio zahvaćen do klinički značajne izloženosti
English: Mean haemoglobin levels were 12.8 and 12.1 g/dL, and platelet counts were 78.5 and 75.1 x 109/L, respectively.
Croatian: Srednje razine hemoglobina bile su 12,8 i 12,1 g/dl, dok je broj trombocita bio 78,5 odnosno 75,1 x 109/l.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Cerdelga in the subsets of the paediatric population from 24 months to less than 18 years in Gaucher disease Type 1 and Type 3 (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Cerdelga u podskupinama pedijatrijske populacije od 24 mjeseca do manje od 18 godina u Gaucherovoj bolesti tipa 1 i tipa 3 (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Initiation of therapy: CYP2D6 genotyping
Croatian: Početak liječenja: genotipizacija CYP2D6
English: Potassium aluminium silicate (E555) Titanium dioxide (E171) Yellow iron oxide (E172) Indigotine (E132)
Croatian: Ovojnica kapsule želatina kalijev aluminijev silikat (E555) titanijev dioksid (E171) željezov oksid, žuti (E172) indigotin (E132)
English: Reversible inhibition of spermatogenesis was observed in the rat at 10-fold of predicted human exposure based on AUC, a systemically toxic dose.
Croatian: Zabilježena je reverzibilna inhibicija spermatogeneze u štakora kod izloženosti 10 puta više od predviđene izloženosti kod ljudi na temelju AUC-a, sistemski toksične doze.
English: Safety margins for the chronic rat and dog studies ranged between 8-fold and 15-fold using total plasma exposure and 1to 2-fold using unbound (free fraction) plasma exposures.
Croatian: Sigurnosne granice za kronična ispitivanja na štakorima i psima bile su u rasponu od 8 do 15 puta za izloženost ukupnom lijeku u plazmi i 1 do 2 puta za izloženost nevezanom lijeku (slobodnoj frakciji) u plazmi.
English: • rifampicin, rifabutin - antibiotics (used to treat infections)
Croatian: • rifampicin, rifabutin - antibiotici (primjenjuju se za liječenje infekcija)
English: The majority of URMs (80%) received a dose escalation to 127 mg eliglustat twice daily, all of which had adequate clinical responses.
Croatian: Većina UBM-a (80%) primila je dozu koja se povećavala do 127 mg eliglustata dva puta dnevno i svi su imali adekvatan klinički odgovor.
English: Lower doses of substances which are P-gp substrates (e.g. digoxin, colchicine, dabigatran, phenytoin, pravastatin) may be required.
Croatian: Možda će biti potrebne niže doze tvari koje su supstrati P-gp (npr. digoksin, kolhicin, dabigatran,
English: Gaucher disease type 1 is a lifelong condition and you must continue to take this medicine as prescribed by your doctor to gain the maximum benefit from your medicine.
Croatian: Gaucherova bolest tipa 1 je cjeloživotno stanje i morate nastaviti uzimati ovaj lijek prema preporuci
English: One patient (6%) received a further dose escalation to 127 mg twice daily.
Croatian: Jedan bolesnik (6%) je primio daljnje povećanje doze do 127 mg dva puta dnevno.
English: If you stop taking Cerdelga
Croatian: Ako prestanete uzimati lijek Cerdelga
English: Concentration-dependent cardiac effects were observed in nonclinical studies: inhibition of human cardiac ion channels, including potassium, sodium, and calcium, at concentrations ≥ 7-fold of predicted human Cmax; sodium ion channel-mediated effects in an ex-vivo electrophysiology study in dog Purkinje fibres (2-fold of predicted human unbound plasma Cmax); and increases in QRS and PR intervals in dog telemetry and cardiac conduction studies in anaesthesised dogs, with effects seen at concentrations 14-fold of predicted human total plasma Cmax, or 2-fold of predicted human unbound plasma Cmax.
Croatian: U nekliničkim ispitivanjima zabilježeni su srčani učinci ovisni o koncentraciji: inhibicija ljudskih srčanih ionskih kanala, uključujući kalijev, natrijev i kalcijev u koncentracijama ≥ 7 puta od predviđenog Cmax u ljudi; učinci posredovani natrijevim ionskim kanalom u ex-vivo elektrofiziološkom ispitivanju Purkinjeovih vlakana u pasa (2 puta više od predviđenog Cmax nevezane frakcije u plazmi u ljudi); i produljenje QRS i PR intervala u ispitivanjima telemetrije u pasa i srčane provodljivosti u anesteziranih pasa, s učincima vidljivim u koncentracijama 14 puta višim od predviđenog Cmax ukupnog lijeka u plazmi u ljudi ili 2 puta višim od predviđenog Cmax nevezane frakcije u plazmi u ljudi.
English: These medicines can interfere with your body's ability to break down Cerdelga and this can result in higher levels of Cerdelga in your blood.
Croatian: Ti lijekovi mogu utjecati na sposobnost Vašeg tijela da razgradi lijek Cerdelga i to može uzrokovati više razine lijeka Cerdelga u Vašoj krvi.
English: Because eliglustat is predicted to cause mild increases in ECG intervals at substantially elevated plasma concentrations, use of eliglustat should be avoided in patients with cardiac disease (congestive heart failure, recent acute myocardial infarction, bradycardia, heart block, ventricular arrhythmia), long QT syndrome, and in combination with Class IA (e.g. quinidine) and Class III (e.g. amiodarone, sotalol) antiarrhythmic medicinal products.
Croatian: Budući da se predviđa da će eliglustat kod značajno povišenih koncentracija u plazmi uzrokovati blago produljenje EKG intervala, treba izbjegavati primjenu eliglustata u bolesnika sa srčanim bolestima (kongestivno zatajenje srca, nedavni akutni infarkt miokarda, bradikardija, srčani blok, ventrikularna aritmija), sindromom dugog QT intervala i u kombinaciji s antiaritmicima klase IA (npr. kinidin) i klase III (npr. amiodaron, sotalol).
English: o This patient is using eliglustat (Cerdelga) for the treatment of Gaucher Disease type 1.
Croatian: o Ovaj bolesnik koristi eliglustat (Cerdelga) za liječenje Gaucherove bolesti tipa 1.
English: After 18 and 30 months of treatment, BMB score had decreased by a mean 2.2 points (n=18) and 2.7 (n=15), respectively for the patients originally randomised to Cerdelga, compared to a mean decrease of 1 point (n=20) and 0.8 (n=16) in those originally randomised to placebo.
Croatian: Nakon 18 i 30 mjeseci liječenja, rezultat BMB-a se smanjio za prosječno 2,3 boda (n=18) i 2,7 bodova (n=15) za bolesnike koji su početno randomizirani na lijek Cerdelga u odnosu na prosječno smanjenje za 1 bod (n=20) i 0,8 (n=16) u onih koji su početno randomizirani na placebo.
English: o Using eliglustat together with such products or in patients with hepatic or renal impairment may either make eliglustat less effective, or it may increase the eliglustat levels in the patient's blood.
Croatian: o Primjena eliglustata u kombinaciji s takvim lijekovima ili u bolesnika s oštećenjem funkcije jetre ili bubrega može ili smanjiti učinak eliglustata ili povećati razine eliglustata u bolesnikovoj krvi.
English: The effect of severe hepatic impairment was not studied in subjects with any CYP2D6 phenotype (see sections 4.2, 4.3 and 4.4).
Croatian: Učinak teškog oštećenja funkcije jetre nije proučavan u ispitanika s bilo kojim CYP2D6 fenotipom (vidjeti dijelove 4.2, 4.3 i 4.4).
English: Cerdelga capsules have a pearl blue-green opaque cap and a pearl white opaque body with “GZ02” printed in black on the capsule.
Croatian: Kapsule Cerdelga imaju biserno plavo-zelenu neprozirnu kapicu i biserno bijelo neprozirno tijelo s crno tiskanom oznakom „GZ02“ na kapsuli.
English: Each capsule contains 106 mg lactose (as monohydrate).
Croatian: Jedna kapsula sadrži 106 mg laktoze (u obliku laktoze hidrata).
English: In study 02607, lumbar spine and femur BMD T- and Z-scores were maintained within the normal range in patients treated with Cerdelga for up to 4 years.
Croatian: U ispitivanju 02607, T- i Z- vrijednosti mineralne gustoće kosti lumbalne kralježnice i bedrene kosti bile su održane unutar normalnog raspona vrijednosti u bolesnika liječenih lijekom Cerdelga do 4 godine.