natgillin/translations-raw huggingface dataset:
Food does not have a clinically relevant effect on eliglustat pharmacokinetics.
Hrana nima klinično pomembnega učinka na farmakokinetiko eliglustata.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Cerdelga therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Cerdelga, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
Eliglustat was not mutagenic in a standard battery of genotoxicity tests and did not show any carcinogenic potential in standard lifetime bioassays in mice and rats.
Eliglustat ni kazal mutagenosti v standardni bateriji testov za genotoksičnost in ni kazal nobenega kancerogenega potenciala v standardnih bioloških testih v celotni življenjski dobi miši in podgan.
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.
Za proučitev dolgoročne varnosti eliglustata pri bolnikih, ki jim je predpisan eliglustat, bo imetnik dovoljenja za promet ustvaril podregister Gaucherjevega registra Mednarodne kooperativne skupine za Gaucherjevo bolezen (ICGG - International Collaborative Gaucher Group), v katerem se bodo zbirali podatki o varnosti v skladu z dogovorjenim protokolom.
After intravenous administration, the volume of distribution was 816 L, suggesting wide distribution to tissues in humans.
Po intravenskem dajanju je prostornina porazdelitve znašala 816 l in je nakazovala široko porazdelitev po tkivih pri ljudeh.
There is limited experience in the treatment of elderly with eliglustat.
Izkušnje pri zdravljenju starejših z eliglustatom so omejene.
In turn this helps your affected organs to work better.
To omogoči boljše delovanje prizadetih organov.
The one URM who received 84 mg twice daily did not have an adequate response.
En URM, ki je prejemal 84 mg dvakrat na dan, ni imel ustreznega odziva.
Cerdelga has not been tested in children and adolescents under 18 years of age.
Zdravilo Cerdelga ni bilo preskušeno pri otrocih in mladostnikih, mlajših od 18 let.
Do not use this medicine after the expiry date which is stated on the carton, sleeve and blister after ‘EXP'.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli, ovoju in pretisnem omotu poleg oznake »EXP«.
It is unknown whether eliglustat or its metabolites are excreted in human milk.
Ni znano, ali se eliglustat in njegovi presnovki izločajo v materino mleko.
Embryofoetal development in rats and rabbits was not affected up to clinically relevant exposure (based on AUC).
Vpliv na embriofetalni razvoj pri podganah in kuncih ni dosegal klinično pomembne izpostavljenosti (na osnovi vrednosti AUC).
Taking Cerdelga with food and drink
Zdravilo Cerdelga skupaj s hrano in pijačo
Gender, body weight, age, and race
Spol, telesna masa, starost in rasa
Based on the population pharmacokinetic analysis, gender, body weight, age, and race had limited or no impact on the pharmacokinetics of eliglustat.
Na osnovi populacijske farmakokinetične analize so imeli spol, telesna masa, starost in rasa omejen vpliv na farmakokinetiko eliglustata ali pa ga sploh niso imeli.
For patients with stable disease who switch from enzyme replacement therapy to eliglustat, monitoring for disease progression (e.g. after 6 months with regular monitoring thereafter) should be performed for all disease domains to evaluate disease stability.
Bolnike s stabilno boleznijo, ki preidejo z nadomestnega encimskega zdravljenja na eliglustat, je treba spremljati glede napredovanja bolezni (npr. po 6 mesecih in redno pozneje), in sicer za vsa področja bolezni, da bi ocenili stabilnost bolezni.
Population pharmacokinetic analysis shows that the CYP2D6 predicted phenotype based on genotype is the most important factor affecting pharmacokinetic variability.
Populacijska farmakokinetična analiza kaže, da je pričakovani fenotip encima CYP2D6 na osnovi genotipa najpomembnejši dejavnik, ki vpliva na farmakokinetično variabilnost.
No significant differences were found in the efficacy and safety profiles of elderly patients and younger patients.
Med starejšimi in mlajšimi bolniki ni bilo statistično pomembne razlike v profilu učinkovitosti in varnosti.
Nonclinical studies demonstrated a wide distribution of eliglustat to tissues, including bone marrow.
Neklinične študije so pokazale široko porazdelitev eliglustata po tkivih, vključno s kostnim mozgom.
Consumption of grapefruit or its juice should be avoided.
Uživanju grenivke ali njenega soka se je treba izogibati.
It may be taken with or without food.
Zdravilo se lahko jemlje s hrano ali brez.
EU/1/14/974/001 56 capsules EU/1/14/974/002 196 capsules EU/1/14/974/003 14 capsules
EU/1/14/974/001 56 kapsul EU/1/14/974/002 196 kapsul EU/1/14/974/003 14 kapsul
Difference (CerdelgaPlacebo) [95% CI]
Razlika (Cerdelgaplacebo) [95 % IZ]
Each capsule contains 106 mg lactose (as monohydrate).
Ena kapsula vsebuje 106 mg laktoze (v obliki monohidrata).
Electrocardiographic evaluation
Ocena elektrokardiograma
Do not stop taking Cerdelga without talking to your doctor.
Zdravila Cerdelga ne prenehajte jemati, ne da bi se pred tem pogovorili z zdravnikom.
For these patients, monitoring for further improvement or an alternative treatment modality should be considered.
Takšne bolnike je treba spremljati glede nadaljnjega izboljšanja ali pa je treba pri njih razmisliti o drugačnem načinu zdravljenja.
Five Cerdelga-treated patients (26%) achieved a reduction of at least 2 points in the BMB score.
Petim bolnikom, zdravljenim z zdravilom Cerdelga (26 %), se je ocena BMB zmanjšala za vsaj 2 točki.
Based on the aggregate data from all doses tested in this study, Cerdelga met the criteria set in this study to be declared non-inferior to Cerezyme (imiglucerase) in maintaining patient stability.
Glede na agregirane podatke o vseh testiranih odmerkih v tej študiji je zdravilo Cerdelga izpolnilo v študiji postavljena merila za neinferiornost pri vzdrževanju stabilnosti bolnikov v primerjavi z zdravilom Cerezyme (imigluceraza).
In the primary analysis periods of the three clinical studies, a total of 5 PMs and 5 URMs were treated with Cerdelga.
V obdobjih primarne analize treh kliničnih študij je bilo z zdravilom Cerdelga zdravljenih 5 PM in 5 URM.
(N=47)**
Cerezyme (n=47)**
The active substance in this medicine has been shown to pass in trace amounts into breast milk in animals.
Učinkovina v tem zdravilu je v sledeh dokazano prehajala v materino mleko pri živalih.
Median time to reach maximum plasma concentrations occurs between 1.5 to 6 hours after dosing, with low oral bioavailability (<5%) due to significant first-pass metabolism.
Mediana časa za doseganje najvišjih plazemskih koncentracij se pojavi od 1,5 ure do 6 ur po odmerjanju in jo zaznamuje nizka peroralna biološka uporabnost (< 5 %) zaradi pomembno velike presnove prvega prehoda.
Individual disease parameters of spleen volume, liver volume, haemoglobin levels and platelet count remained stable through 4 years (see Table 5).
Posamezni parametri bolezni za prostornino vranice, prostornino jeter, ravni hemoglobina in število trombocitov so ostali stabilni vsa 4 leta (glejte preglednico 5).
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.
Pred prihodom zdravila Cerdelga na trg v posamezni državi članici mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom uskladiti vsebino in obliko izobraževalnega programa, vključno s sredstvi obveščanja, načinom razdeljevanja in vsemi drugimi vidiki programa.
As a result glucosylceramide builds up in your spleen, liver and bones.
Posledično se glukozilceramid kopiči v vranici, jetrih in kosteh.
Effects on skeletal pathology
Učinki na patologijo okostja
The most frequently reported adverse reaction with Cerdelga is dyspepsia, in approximately 6% of the clinical trial patients.
Najbolj pogost poročani neželeni učinek zdravila Cerdelga je dispepsija, ki se pojavi pri približno 6 % bolnikov v kliničnih študijah.
• cilostazol - used to treat cramp-like pain in your legs when you walk caused by insufficient blood supply in your legs
• cilostazol - uporablja se za zdravljenje krčevitih bolečin v nogah, ki se pojavljajo med hojo in so posledica nezadostnega pretoka krvi v nogah
What Cerdelga is and what it is used for
Kaj je zdravilo Cerdelga in za kaj ga uporabljamo
Absolute Change in Haemoglobin Level (g/dL)
Sprememba koncentracije hemoglobina od izhodišča (g/dl)
Genzyme Ireland Ltd IDA Industrial Park Old Kilmeaden Road Waterford
Proizvajalec Genzyme Ireland Ltd IDA Industrial Park Old Kilmeaden Road Waterford
While pressing your thumb and finger together at one end of the sleeve (1) gently pull the blister/wallet out to open the sleeve (2).
Odstranjevanje pretisnega omota/zloženke iz ovoja Med pritiskanjem s palcem in kazalcem skupaj na eni strani ovoja (1) nežno povlecite pretisni omot/zgibanko navzven, da odprete ovoj (2).
If a dose is missed, the prescribed dose should be taken at the next scheduled time; the next dose should not be doubled.
Če se odmerek izpusti, naj se predpisani odmerek vzame ob naslednjem načrtovanem času.
PETG/COC.PETG/PCTFE-aluminium blister Each blister wallets contains 14 hard capsules.
Pretisni omot iz aluminija PETG/COC.PETG/PCTFE Vsaka zloženka v pretisnem omotu vsebuje 14 trdih kapsul.
Genzyme Ireland, Ltd IDA Industrial Park Old Kilmeaden Road, Waterford Ireland
Genzyme Ireland, Ltd IDA Industrial Park Old Kilmeaden Road, Waterford
Available pharmacodynamic/toxicological data in animals have shown excretion of eliglustat in milk (see section 5.3).
Razpoložljivi farmakodinamično/toksikološki podatki pri živalih kažejo na izločanje eliglustata v mleko (glejte poglavje 5.3).
A lactation study in the rat showed that 0.23% of labelled dose was transferred to pups during 24 hours post-dose, indicating milk excretion of eliglustat and/or its related materials.
Študija laktacije pri podganah je pokazala, da se v 24 urah po odmerku 0,23 % označenega odmerka prenese na mladiča, kar nakazuje, da se eliglustat in/ali njegove povezane snovi izločajo v mleku.
All PMs received 42 mg eliglustat twice daily, and four of these (80%) had an adequate clinical response.
Vsi PM so prejemali 42 mg eliglustata dvakrat na dan in štirje od njih (80 %) so imeli ustrezen klinični odziv.
Pack sizes of 14 hard capsules in 1 blister wallet, 56 hard capsules in 4 blister wallets of 14 capsules each or 196 hard capsules in 14 blister wallets of 14 capsules each
Škatla s 14 trdimi kapsulami v 1 zgibanki , s 56 trdimi kapsulami v 4 zgibankah s po 14 kapsulami v vsakem pretisnem omotu ali s 196 trdimi kapsulami v 14 zgibankah s po 14 kapsulami v vsakem pretisnem omotu.
• The active substance is eliglustat (as tartrate).
• Učinkovina je eliglustat (v obliki tartrata).
Data indicates that no dosage adjustment is considered necessary (see sections 5.1 and 5.2).
Podatki kažejo, da ni potrebno prilagajati odmejanja (glejte poglavji 5.1 in 5.2).
Some treatment-naïve patients showed less than 20% spleen volume reduction (sub-optimal results) after 9 months of treatment (see section 5.1).
Nekaterim še nezdravljenim bolnikom se je volumen vranice po 9 mesecih zdravljenja zmanjšal za manj kot 20 % (suboptimalni rezultati) (glejte poglavje 5.1).
Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Nizozemska
Reports from the subregistry are to be submitted with each PSUR.
Poročila tega podregistra mora predložiti z vsakim posodobljenim poročilom o varnosti zdravila (PSUR).
• cinacalcet - calcimimetic (used in some dialysis patients and specific cancers)
• cinakalcet - kalcimimetik (uporablja se pri nekaterih bolnikih na dializi in specifičnih oblikah raka)
In poor metabolisers (PMs):
Slabi presnavljalci (PM):
Grapefruit products contain one or more components that inhibit CYP3A and can increase plasma concentrations of eliglustat.
Izdelki z grenivko vsebujejo eno ali več sestavin, ki delujejo kot zaviralci encima CYP3A in lahko povzročijo povečanje plazemskih koncentracij eliglustata.
• The other ingredients are: o In the capsule: microcrystalline cellulose, lactose monohydrate (see section 2 under ‘Cerdelga contains lactose'), hypromellose and glycerol dibehenate.
• Druge sestavine zdravila so: o v kapsuli: mikrokristalna celuloza, laktoza monohidrat (glejte poglavje 2, odstavek »Zdravilo Cerdelga vsebuje laktozo«), hipromeloza in glicerildibehenat.
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.
o Sočasna uporaba eliglustata s takšnimi zdravili ali pri bolnikih z ledvično ali jetrno okvaro lahko zmanjša učinkovitost eliglustata ali zviša koncentracijo eliglustata v bolnikovi krvi.
(≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Neželeni učinki so razvrščeni po organskem sistemu in pogostnosti ([zelo pogosti (≥1/10); pogosti (≥1/100 do 1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000)]).
In mature male rats, no effects on sperm parameters were observed at systemically non-toxic doses.
Pri odraslih podganjih samcih pri sistemsko netoksičnih odmerkih niso opazili nobenih učinkov na parametre semenčic.
After intravenous administration, eliglustat total body clearance was 86 L/h.
Po intravenskem dajanju je skupni telesni očistek za eliglustat znašal 86 l/uro.
o Eliglustat should not be used concomitantly with medicines that may have an impact on liver enzymes that play a role in the metabolism of eliglustat.
o Eliglustata se ne sme uporabljati hkrati z zdravili, ki bi lahko vplivala na jetrne encime, udeležene v presnovi eliglustata.
Table 3: Change from baseline to year 8 in study 304
Preglednica 3: sprememba od izhodišča do 84. leta v študiji 304
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.
Seznam snovi v poglavju 4.5 ni izčrpen; zdravnik, ki predpisuje zdravilo, mora upoštevati povzetke glavnih značilnosti vseh drugih predpisanih zdravil, kar zadeva možna medsebojna delovanja zdravil z eliglustatom.
• amlopidine, ranolazine - used to treat angina pectoris
• amlopidin, ranolazin - uporablja se za zdravljenje angine pektoris
• metoprolol - used to lower blood pressure and/or reduce heart rate
• metoprolol - uporablja se za zniževanje krvnega tlaka in/ali srčnega utripa
• Obligation to conduct post-authorisation measure
• Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet z zdravilom
After oral administration, the majority of the administered dose is excreted in urine (41.8%) and faeces (51.4%), mainly as metabolites.
Po peroralnem dajanju se večji delež danega odmerka izloči z urinom (41,8 %) in blatom (51,4%), pretežno v obliki presnovkov.
• Acid reflux disease (gastrooesophageal reflux disease)
• refluks (gastroezofagealna refluksna bolezen)
Capsule contents Microcrystalline cellulose Lactose monohydrate Hypromellose Glycerol dibehenate
Vsebina kapsule: mikrokristalna celuloza laktoza monohidrat hipromeloza glicerildibehenat
• mirabegron - used to treat overactive bladders
• mirabegron - uporablja se za zdravljenje prekomerno aktivnega mehurja
Pharmacotherapeutic group: Other alimentary tract and metabolism products, various alimentary tract and metabolism products, ATC code: A16AX10.
Farmakoterapevtska skupina: druga zdravila za zdravljenje bolezni prebavil in presnove, različna zdravila za zdravljenje bolezni prebavil in presnove, oznaka ATC: A16AX10.
There are no or limited amount of data from the use of eliglustat in pregnant women.
Podatkov o uporabi eliglustata pri nosečnicah ni oziroma so omejeni.
As a precautionary measure, it is recommended to avoid the use of Cerdelga during pregnancy.
Iz previdnostnih razlogov se je med nosečnostjo uporabi zdravila Cerdelga bolje izogibati.
Cerdelga is to be taken orally.
Zdravilo Cerdelga se jemlje peroralno.
There are no known effects on fertility at normal doses.
Učinki na plodnost v normalnih odmerkih niso znani.
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.
Gaucherjeva bolezen tipa 1 je doživljenjska bolezen, zato morate za največje koristi zdravila, ki vam ga predpiše zdravnik, nadaljevati z njegovim jemanjem.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Če vas je zdravnik obvestil, da ne prenašate določenih vrst sladkorjev, se pred jemanjem tega zdravila obrnite na zdravnika.
Lower doses of medicinal products that are CYP2D6 substrates may be required.
Morda bodo potrebni nižji odmerki zdravil, ki delujejo kot substrati encima CYP2D6.
Eliglustat did not have effects on CNS or respiratory functions.
Eliglustat ni imel učinka na centralni živčni sistem ali dihalne funkcije.
Use of Cerdelga under these conditions results in substantially elevated eliglustat plasma concentrations (see section 4.4 and 4.5).
Uporaba zdravila Cerdelga v teh pogojih povzroči močno zvišanje plazemskih koncentracij eliglustata (glejte poglavji 4.4 in 4.5).
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.
Po 30 mesecih oziroma 4,5 leta zdravljenje se je vrednost T dodatno povečala na -0,722 (1,1250) (n = 27) oziroma 0,533 (0,8031) (n = 9).
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.
Interval QT, ki je popravljen na srčni utrip po Fridericiju (QTcF), je bil ocenjen v randomizirani, z aktivno učinkovino in placebom nadzorovani (moksifloksacin 400 mg) navzkrižni študiji z enkratnim odmerkom pri 47 zdravih preskušancih.
Therapy with Cerdelga should be initiated and supervised by a physician knowledgeable in the management of Gaucher disease.
Zdravljenje z zdravilom Cerdelga naj uvedejo in nadzorujejo zdravniki, ki imajo izkušnje z obvladovanjem Gaucherjeve bolezni.
• have an irregular, or abnormal heart beat, inluding a heart condition called long QT syndrome.
• če imate nepravilen ali nenormalen srčni utrip, vključno s srčnim obolenjem, imenovanim sindrom dolgega intervala QT,
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.
Primarne presnovne poti eliglustata vključujejo zaporedno oksidacijo oktanoilne skupine, ki ji sledi oksidacija 2,3-dihidro-1,4-benzodioksanske skupine ali kombinacije obeh poti, zaradi česar nastane več oksidativnih presnovkov.
- If you are a poor metaboliser and use medicines known as strong CYP3A inhibitors (for example itraconazole).
- če ste slab presnavljalec in jemljete zdravila, ki so močni zaviralci CYP3A (na primer itrakonazol).
Patients with pre-existing cardiac conditions
Bolniki z obstoječimi srčnimi obolenji
At the time of the highest plasma concentration (59-fold higher than normal therapeutic conditions), the subject experienced dizziness marked by disequilibrium, hypotension, bradycardia, nausea, and vomiting.
Preiskovanci so pri najvišji plazemski koncentraciji, ki je bila 59-krat višja od običajne terapevtske koncentracije, poročali o omotici, ki so jo zaznamovali neravnovesje, hipotenzija, bradikardija, slabost in bruhanje.
You may experience dizziness marked by loss of balance, slow heart rate, nausea, vomiting and lightheadedness.
Pri vas se lahko pojavi omotica, ki jo zaznamujejo neravnovesje, počasen krvni utrip, slabost, bruhanje in vrtoglavica.
Cerdelga has negligible or no influence on the ability to drive and use machines.
Zdravilo Cerdelga nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
** 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.
** Po 52 tednih so vsi bolniki prešli na zdravljenje z zdravilom Cerdelga a Merila stabilnosti na osnovi sprememb od izhodišča do 12. meseca: zmanjšanje ravni hemoglobina ≤1,5 g/dl, zmanjšanje števila trombocitov ≤25 %, zvečanje prostornine jeter ≤20 % in zvečanje prostornine vranice ≤25 %.
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.
Glavni ciljni organi za eliglustat v toksikoloških študijah pri podganah so gastrointestinalni (GI) trakt, limfoidni organi in jetra, pri podganjih samcih pa samo reproduktivni sistem.
Effects on testes and reversible inhibition of spermatogenesis were observed in rats (see section 5.3).
Opazili so učinke na moda in reverzibilno inhibicijo spermatogeneze pri podganah (glejte poglavje 5.3).
• have a slow heart rate.
• če imate počasen srčni utrip,
Do not open, crush, dissolve, or chew the capsule before swallowing it.
Kapsulo pred zaužitjem ne smete zdrobiti, raztopiti ali odpirati.
Cerdelga contains the active substance eliglustat which decreases the production of glucosylceramide, thereby preventing its buildup.
Zdravilo Cerdelga vsebuje učinkovino eliglustat, ki zmanjšuje nastajanje glukozilceramida in posledično preprečuje njegovo kopičenje.
* The incidence of the adverse reaction was the same or higher with placebo than with Cerdelga in the placebo-controlled pivotal study.
* V s placebom nadzorovani ključni študiji je bila pojavnost neželenega učinka pri placebu enaka ali višja kot pri zdravilu Cerdelga.
Gaucher disease type 1 is a rare, inherited condition in which a substance called glucosylceramide is not effectively broken down by your body.
Gaucherjeva bolezen tipa 1 je redka, prirojena bolezen, pri kateri vaše telo ne razgrajuje snovi, imenovane glukozilceramid, učinkovito.
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.
V tem preskušanju z dokazano sposobnostjo zaznavanja majhnih učinkov je zgornja meja enostranskega 95-odstotnega intervala zaupanja za največji, s placebom prilagojeni in glede na izhodišče popravljeni interval QTcF pod 10 ms, tj. vrednostjo, ki predstavlja mejo za skrb z vidika ureditev.
Avoid consumption of grapefruit or grapefruit juice since it may increase the level of Cerdelga in your blood.
Izogibajte se uživanju grenivke ali njenega soka, saj lahko povzroči povišane ravni zdravila Cerdelga v krvi.
Lower doses of substances which are P-gp substrates (e.g. digoxin, colchicine, dabigatran, phenytoin, pravastatin) may be required.
Morda bodo potrebni nižji odmerki snovi, ki delujejo kot substrati za Pglikoprotein (npr. digoksin, kolhicin, dabigatran, fenitoin, pravastatin).
Continue taking Cerdelga every day for as long as your doctor tells you.
Zdravilo Cerdelga vzemite vsak dan, dokler vam zdravnik ne svetuje drugače.
Effect of severe renal impairment was evaluated in a single dose phase 1 study.
Vpliv hude okvare ledvic so ocenili v študiji 1. faze z enkratnim odmerkom.
o Patients should be informed that consumption of grapefruit or its juice should be avoided.
o Bolnikom je treba naročiti, naj se izogibajo uživanju grenivk in pitju soka grenivk.