natgillin/translations-raw huggingface dataset:
AUC: ↑ 10-fold Cmax: ↑ 4-fold
AUC: ↑ 10 puta Cmax: ↑ 4 puta
Cmax: ↑ 2-fold
Cmax: ↑ 1,2 puta
Midazolam IV
Alprazolam Midazolam peroralni
Paediatrics
Antidijabetici
Ketoconazole should be discontinued without any delay if clinical symptoms of hepatitis develop.
Ako se razviju klinički simptomi hepatitisa, liječenje ketokonazolom treba bez odgode prekinuti.
↑in plasma concentrations of tolvaptan have been observed
Primijećeno je ↑ plazmatskih koncentracija tolvaptana
AUC: ↑ 3.0-fold
AUC: ↑ 3,0 puta Erlotinib:
Saquinavir: AUC: ↔
Solifenacin: AUC: ↑ 3,0 puta
Ebastine
Naloksegol
Aprepitant:
Buprenorfin:
AUC: ↑ 1.5-fold Cmax: ↑ 1.5-fold
AUC: ↑ 1,5 puta Cmax: ↑ 1,5 puta Lapatinib:
Potential ↑in plasma concentrations of disopyramide and quinidine
Potencijalno ↑ plazmatskih koncentracija dizopiramida i kinidina
AUC: ↑ 1.6-fold Cmax: ↑ 1.4-fold
Aripiprazol AUC: ↑ 1,6 puta Cmax: ↑ 1,4 puta
Renal impairment
Kinidin Dronedaron
AUC: ↑ 15.3-fold Cmax: ↑ 4.1-fold
AUC: ↑ 15,3 puta Cmax: ↑ 4,1 puta Sirolimus (rapamicin): AUC: ↑ 10,9 puta Cmax: ↑ 4,4 puta
AUC: ↑ 3.6-fold
AUC: ↑ 3,6 puta Nilotinib:
AUC: ↑ 3.2-fold Cmax: ↑ 1.4-fold
Krizotinib AUC: ↑ 3,2 puta Cmax: ↑ 1,4 puta
Cmax: ↑ 6 fold
AUC: ↑ 9 puta Cmax: ↑ 6 puta
Dose adjustment of risperidone may be required.
Može biti potrebna prilagodba doze paklitaksela
Tolbutamide: AUC: ↑ 1.7-fold
Tolbutamid: AUC: ↑ 1,7 puta
Posology
Eplerenon
Apixaban
Paklitaksel
AUC: ↑ 5-fold Cmax: ↑ 1.1 -fold
AUC: ↑ 5 puta Cmax: ↑ 1,1 put
AUC: ↑ 1.4-fold
AUC: ↑ 1,4 puta Imatinib:
AUC: ↑ 2-fold Cmax: ↑1.6-fold
Apiksaban AUC: ↑ 2 puta Cmax: ↑1,6 puta
Other dihydropyridines Verapamil
Ostali dihidropiridini
Cabazitaxel
Triazolam
isavuconazole - certain antidiabetics: repaglinide, saxagliptin, tolbutamide - certain medicines used for mental disorders: buspirone, aripipazole, haloperidol, reboxetine, risperidone - certain heart medicines - verapamil, digoxin, nadolol, aliskiren - certain anticonvulsivants: carbamazepine, phenitoin - certain glucocorticoids - such as budesonide, fluticasone, dexamethasone, methylprednisolone, ciclesonide - certain stong painkillers (narcotics) - such as alfentanyl, fentanyl, buprenorphine (injection and sublingual),
- određene lijekove za snižavanje kolesterola u krvi: simvastatin, atorvastatin, lovastatin - određene lijekove za srce: eplerenon, dronedaron, dizopiramid, felodipin, nizoldipin, ranolazin - određene lijekove za liječenje malarije: kinidin, halofantrin - određene lijekove za teške mentalne poremećaje i tešku depresiju: pimozid, sertindol, lurasidon,
AUC: ↑3.4-fold Cmax: ↑1.6-fold
Midazolam intravenski Midazolam: AUC: ↑ 1,6 puta
How to store Ketoconazole HRA 6.
Kako čuvati Ketoconazole HRA 6. Sadržaj pakiranja i druge informacije
AUC: ↑ 5-fold Cmax: ↑ 3.4-fold
Tadalafil: AUC: ↑ 4 puta
Paclitaxel
Apiksaban
Asthenia
Apsorpcija
Antipsychotics, Anxiolytics and Hypnotics Triazolam Alprazolam Midazolam oral
Antipsihotici, anksiolitici i hipnotici
Lactose monohydrate Povidone
Sunitinib Dasatinib Lapatinib
AUC: ↑ 2.1-fold
AUC: ↑ 2,1 puta
Contraindicated due to the risk of QT prolongation (see section 4.3).
Kontraindicirana zbog rizika od produljenja QT intervala (vidjeti dio
AUC: ↑ have been observed
AUC: ↑ 2 puta
Buprenorphine:
Telitromicin:
↑in plasma concentrations of docetaxel have been observed Potential ↑in plasma concentrations of busulfan
Potencijalno ↑ plazmatskih koncentracija busulfana
Dronedarone
Dabigatran
Lapatinib:
Ombitasvir:
Overdose
Dojenje
Take one capsule in the morning and one capsule at night.
Uzmite jednu kapsulu ujutro i jednu kapsulu navečer.
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 kapsula EU/1/14/974/002 196 kapsula EU/1/14/974/003 14 kapsula
The relevance of these findings for humans is not known.
Nije poznat značaj tih nalaza za ljude.
Press down at 1 and at the same time pull at 2.
Za primjenu kroz usta Pritisnite na 1 i istovremeno povucite za 2.
• Pain in arms, legs or back
• Bol u rukama, nogama ili leđima
Take one capsule at the same time every day.
Uzmite jednu kapsulu svaki dan u isto vrijeme.
It may be taken with or without food.
Može se uzimati s hranom ili bez nje.
If you are pregnant, think that you may be pregnant or are planning to have a baby, tell your doctor who will discuss with you whether you can take this medicine during your pregnancy.
Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku koji će s Vama razgovarati o tome smijete li uzimati ovaj lijek tijekom trudnoće.
amiodarone or sotalol.
amiodarona ili sotalola.
Characteristics in specific groups
Značajke u posebnim skupinama
No significant differences were found in the efficacy and safety profiles of elderly patients and younger patients.
Nisu pronađene značajne razlike u profilima djelotvornosti i sigurnosti u starijih i mlađih bolesnika.
Information for the patient:
Informacije za bolesnika:
The patient alert card shall contain the following key elements:
Kartica s upozorenjima za bolesnike će sadržavati sljedeće ključne elemente;
Information for healthcare professionals:
Informacije za zdravstvene radnike:
If you cannot swallow the capsule whole, tell your doctor.
Ako ne možete progutati cijelu kapsulu, obavijestite o tome svojeg liječnika.
Your doctor will determine if Cerdelga is suitable for you before you start taking it, using a simple laboratory test.
Vaš liječnik će odrediti je li Cerdelga prikladna za Vas prije nego što ju počnete uzimati pomoću jednostavne laboratorijske pretrage.
The capsules may be taken with or without food.
Kapsule se mogu uzimati s hranom ili bez nje.
Do not open, crush, dissolve, or chew the capsule before swallowing it.
Nemojte otvarati, drobiti, otapati ili žvakati kapsulu prije gutanja.
Breast-feeding is not recommended during treatment with this medicine.
Dojenje se ne preporučuje tijekom liječenja ovim lijekom.
Cerdelga has not been tested in children and adolescents under 18 years of age.
Cerdelga nije ispitana u djece i adolescenata mlađih od 18 godina.
The size of the capsule is ‘size 2' (dimensions 18.0 x 6.4 mm).
Kapsula je „veličine 2“ (dimenzija 18,0 x 6,4 mm).
Continue taking Cerdelga every day for as long as your doctor tells you.
Nastavite uzimati lijek Cerdelga svaki dan sve dok Vam to kaže Vaš liječnik.
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).
Dok istovremeno pritišćete palcem i prstom na jednom kraju košuljice (1) lagano izvucite blister/ovitak da biste otvorili košuljicu (2).
The capsules should be swallowed whole, preferably with water, and should not be crushed, dissolved, or opened.
Kapsule treba progutati cijele, najbolje s vodom i ne smiju se drobiti, otapati niti otvarati.
In the event of acute overdose, the patient should be carefully observed and given symptomatic treatment and supportive care.
U slučaju akutnog predoziranja, bolesnika treba pomno motriti i dati mu simptomatsku terapiju i potpornu njegu.
What Cerdelga is and what it is used for
Što je Cerdelga i za što se koristi
Eliglustat is moderately bound to human plasma proteins (76 to 83%) and is mainly distributed in plasma.
Eliglustat se umjereno veže za ljudske proteine plazme (76% do 83%) i uglavnom se distribuira u plazmi.
As a result the amount of this medicine in the blood can differ between patients which could affect how a patient would respond.
Zbog toga se količina ovog lijeka u krvi može razlikovati između bolesnika što može imati utjecaj na bolesnikov odgovor.
Standard Deviation
Standardna devijacija
As a precautionary measure, it is recommended to avoid the use of Cerdelga during pregnancy.
Kao mjera opreza, preporučuje se izbjegavati primjenu lijeka Cerdelga tijekom trudnoće.
Your doctor will determine which medicines you can use based on how fast your body breaks down eliglustat.
Vaš liječnik će odrediti koje lijekove možete koristiti ovisno o brzini kojom Vaše tijelo razgrađuje eliglustat.
Do not stop taking Cerdelga without talking to your doctor.
Nemojte prestati uzimati lijek Cerdelga bez razgovora s Vašim liječnikom.
Contents of the pack and other information What Cerdelga contains
Sadržaj pakiranja i druge informacije Što Cerdelga sadrži
o Always consult the doctor who prescribed eliglustat before you start using other medicines.
o Uvijek se savjetujte s liječnikom koji Vam je propisao eliglustat prije nego što počnete uzimati druge lijekove.
Cerdelga must not be used with certain type of medicines.
Cerdelga se ne smije uzimati s određenim vrstama lijekova.
(≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
(≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000)]).
Medicines that must not be taken in combination with each other and Cerdelga
Lijekovi koji se ne smiju uzimati u kombinaciji jedni s drugima i lijekom Cerdelga
Reports from the subregistry are to be submitted with each PSUR.
Izvješća iz pod registra se moraju podnositi sa svakim PSUR-om.
Date of first authorisation: 19 January 2015 Date of latest renewal:
Datum prvog odobrenja: 19. siječnja 2015.
- If you are allergic to eliglustat or any of the other ingredients of this medicine (listed in section 6).
Ako ste alergični na eliglustat ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
For these patients, monitoring for further improvement or an alternative treatment modality should be considered.
Za te je bolesnike potrebno razmotriti praćenje daljnjeg poboljšanja ili alternativni način liječenja.
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.
Mora se donijeti odluka da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom Cerdelga uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
People differ in the speed that their body breaks down this medicine.
Ljudi se razlikuju po brzini kojom njihovo tijelo razgrađuje ovaj lijek.
Please tell your doctor or pharmacist if you are using, or have recently used, or might use, any other medicines.
Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
The majority of extension phase discontinuations were due to transition to commercial product from year 3 onwards.
Većina prekida liječenja u fazi produžetka dogodila se zbog prelaska na komercijalni lijek u 3. godini i nadalje.
• cilostazol - used to treat cramp-like pain in your legs when you walk caused by insufficient blood supply in your legs
• cilostazol - primjenjuje se za liječenje bolova nalik grčevima u Vašim nogama kada hodate što je uzrokovano nedovoljnom opskrbom Vaših nogu krvlju
Gender, body weight, age, and race
Spol, tjelesna težina, dob i rasa
After intravenous administration, the volume of distribution was 816 L, suggesting wide distribution to tissues in humans.
Nakon intravenske primjene, volumen distribucije bio je 816 l, što upućuje na široku distribuciju u tkiva kod ljudi.
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 nije bio mutagen u standardnoj bateriji testova genotoksičnosti i nije pokazivao kancerogeni potencijal u standardnim cjeloživotnim bio-testovima na miševima i štakorima.
• have had a heart attack or heart failure.
• ste imali srčani udar ili zatajenje srca
The MAH shall complete, within the stated timeframe, the below measure:
Nositelj odobrenja će, unutar navedenog vremenskog okvira, provesti niže navedene mjere:
Five Cerdelga-treated patients (26%) achieved a reduction of at least 2 points in the BMB score.
Pet bolesnika liječenih lijekom Cerdelga (26%) postiglo je smanjenje od najmanje 2 boda u rezultatu BMB-a..
This may cause mild increases in the PR, QRS, and QTc intervals.
To može uzrokovati blago produljenje PR, QRS i QTc intervala.
PETG/COC.PETG/PCTFE-aluminium blister Each blister wallets contains 14 hard capsules.
PETG/COC.PETG/PCTFE-aluminijski blister Jedan blister ovitak sadrži 14 tvrdih kapsula.
Based on the population pharmacokinetic analysis, gender, body weight, age, and race had limited or no impact on the pharmacokinetics of eliglustat.
Temeljem populacijske farmakokinetičke analize, spol, tjelesna težina, dob i rasa imali su ograničen ili nikakav učinak na farmakokinetiku eliglustata.
Consumption of grapefruit or its juice should be avoided (see section 4.5).
Treba izbjegavati konzumiranje grejpa ili njegovog soka (vidjeti dio 4.5).
‘Other medicines and Cerdelga.'
„Drugi lijekovi i Cerdelga.“
Nineteen patients completed 4 years of treatment.
Devetnaest bolesnika dovršilo je 4 godine liječenja.
How to pull the blister/wallet from the sleeve
Kako izvući blister/ovitak iz košuljice
Consumption of grapefruit or its juice should be avoided.
Treba izbjegavati konzumiranje grejpa ili njegovog soka.
There are many medicines in these categories and depending on how your body breaks down Cerdelga the effects may differ from person to person.
Mnogi se lijekovi nalaze u tim kategorijama, a ovisno o tome kako Vaše tijelo razgrađuje lijek Cerdelga učinak se može razlikovati od osobe do osobe.
Each pack contains 14, 56 or 196 hard capsules.
Jedno pakiranje sadrži 14, 56 ili 196 tvrdih kapsula.
Eighteen patients completed 8 years of treatment.
Osamnaest bolesnika dovršilo je 8 godina liječenja.
Results of study 304 indicate that skeletal improvements are maintained or continue to improve during at least 8 years of treatment with Cerdelga.
Rezultati ispitivanja 304 upućuju da je poboljšanje kostiju održano ili se nastavilo poboljšavati tijekom najmanje 8 godina liječenja lijekom Cerdelga.
Cerdelga contains lactose
Cerdelga sadrži laktozu
Patients who are URMs may not achieve adequate concentrations to achieve a therapeutic effect.
Bolesnici koji su UBM-i možda neće postići adekvatne koncentracije za postizanje terapijskog učinka.
The safety and efficacy of Cerdelga in children and adolescents under the age of 18 years has not been established.
Sigurnost i djelotvornost lijeka Cerdelga u djece i adolescenata mlađih od 18 godina nisu još ustanovljene.
• Obligation to conduct post-authorisation measure
• Obaveza provođenja mjera nakon davanja odobrenja
Food does not have a clinically relevant effect on eliglustat pharmacokinetics.
Hrana nema klinički značajan učinak na farmakokinetiku eliglustata.
At 2 and 24 hours post-dose, 0.034 % and 0.013 % of labelled dose was detected in foetal tissue, respectively.
Kod 2. i 24. sata nakon doziranja, 0,034% odnosno 0,013% obilježene doze otkriveno je u fetalnom tkivu.
There are no known effects on fertility at normal doses.
Nema poznatih učinaka na plodnost pri uzimanju normalnih doza.
* The incidence of the adverse reaction was the same or higher with placebo than with Cerdelga in the placebo-controlled pivotal study.
* Incidencija nuspojave bila je ista ili viša s placebom nego s lijekom Cerdelga u pivotalnom placebom kontroliranom ispitivanju.
Effects of eliglustat in toxicology studies were reversible and exhibited no evidence of delayed or recurring toxicity.
Učinci eliglustata u toksikološkim ispitivanjima bili su reverzibilni i nisu ukazali na odgođenu ili ponavljajuću toksičnost.
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.
Temeljem ukupnih podataka svih doza testiranih u ovom ispitivanju, Cerdelga je zadovoljila kriterije neinferiornosti postavljene u ovom ispitivanju u odnosu na Cerezyme (imigluceraza) u održavanju stabilnosti bolesnika.
The one URM who received 84 mg twice daily did not have an adequate response.
Jedan UBM koji je primio 84 mg dva puta dnevno nije imao adekvatan odgovor.
During the open-label long term treatment period with Cerdelga (extension phase), all patients with complete data who continued to receive Cerdelga showed further improvements throughout the extension phase.
U otvorenom razdoblju dugoročnog liječenja lijekom Cerdelga (faza produžetka ispitivanja), svi bolesnici s potpunim podacima koji su nastavili primati lijek Cerdelga pokazali su daljnja poboljšanja tijekom faze produžetka ispitivanja.
What Cerdelga looks like and contents of the pack
Kako Cerdelga izgleda i sadržaj pakiranja
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.
Apsorpcija Medijan vremena za postizanje maksimalnih koncentracija u plazmi pojavljuje se 1,5 do 6 sati nakon doziranja s niskom oralnom bioraspoloživošću (< 5%) zbog značajnog metabolizma prvog prolaza.
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.
Za bolesnike sa stabilnom bolešću koji su prebačeni sa enzimske nadomjesne terapije na eliglustat potrebno je provoditi praćenje zbog progresije bolesti (npr. nakon 6 mjeseci uz redovito praćenje nakon toga) za sve apekte bolesti da bi se mogla ocijeniti stabilnost bolesti.
There were no clinically meaningful differences between groups for any of the four individual disease parameters (see Table 4).
Nije bilo klinički značajnih razlika između skupina za bilo koji od četiri pojedinačna parametra bolesti
Please speak to your doctor regarding these medicines before you start taking Cerdelga.
Razgovarajte sa svojim liječnikom o tim lijekovima prije nego što počnete uzimati lijek Cerdelga.
Cerdelga showed sustained improvements in organ volume and haematological parameters over the 8 year treatment period (see Table 3).
Cerdelga je pokazala kontinuirano poboljšanje u volumenu organa i hematološkim parametrima tijekom osmogodišnjeg razdoblja liječenja (vidjeti Tablicu 3).
If a dose is missed, the prescribed dose should be taken at the next scheduled time; the next dose should not be doubled.
Ako se doza propusti, propisanu dozu treba uzeti u sljedeće vrijeme prema uobičajenom rasporedu;
The most frequently reported adverse reaction with Cerdelga is dyspepsia, in approximately 6% of the clinical trial patients.
Najčešće prijavljivana nuspojava na lijek Cerdelga je dispepsija, kod približno 6% bolesnika iz kliničkih ispitivanja.
If you take more Cerdelga than you should
Ako uzmete više lijeka Cerdelga nego što ste trebali
As a result glucosylceramide builds up in your spleen, liver and bones.
Zbog toga se glukozilceramid nakuplja u Vašoj slezeni, jetri i kostima.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Bolesnici s rijetkim nasljednim poremećajima nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek.
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 Eliglustat se ne smije koristiti istodobno s lijekovima koji mogu utjecati na jetrene enzime koji imaju ulogu u metabolizmu eliglustata.
After intravenous administration, eliglustat total body clearance was 86 L/h.
Nakon intravenske primjene, ukupni tjelesni klirens eliglustata bio je 86 l/h.
• Acid reflux disease (gastrooesophageal reflux disease)
• Bolest vraćanja kiseline (gastroezofagealna refluksna bolest)
No dosing recommendation for URMs can be given.
Ne može se dati preporuka doze za UBM-e.
a Cerezyme/Cerdelga - Originally Randomized to Cerezyme b Cerdelga - Originally Randomized to Cerdelga
a Cerezyme/Cerdelga - početno randomizirani na lijek Cerezyme b Cerdelga - početno randomizirani na lijek Cerdelga
In mature male rats, no effects on sperm parameters were observed at systemically non-toxic doses.
U odraslih mužjaka štakora nisu zabilježeni učinci na parametre sperme u sistemski netoksičnim dozama.
Cerdelga has no or negligible influence on the ability to drive and use machines.
Cerdelga ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
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.
U vrijeme najviše koncentracije u plazmi (59 puta više od normalnih terapijskih uvjeta), ispitanik je imao omaglicu karakteriziranu poremećajem ravnoteže, hipotenzijom, bradikardijom, mučninom i povraćanjem.
You may experience dizziness marked by loss of balance, slow heart rate, nausea, vomiting and lightheadedness.
Možete osjećati omaglicu praćenu gubitkom ravnoteže, usporene srčane otkucaje, mučninu, povraćanje i ošamućenost.
The active substance in this medicine has been shown to pass in trace amounts into breast milk in animals.
Pokazalo se da djelatna tvar u ovom lijeku u tragovima prelazi u majčino mlijeko u životinja.
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
Veličina pakiranja od 14 tvrdih kapsula u 1 blister ovitku, 56 tvrdih kapsula u 4 blister ovitka sa 14 kapsula u svakom ili 196 tvrdih kapsula u 14 blister ovitaka sa 14 kapsula u svakom.
Nonclinical studies demonstrated a wide distribution of eliglustat to tissues, including bone marrow.
Neklinička ispitivanja pokazala su široku distribuciju eliglustata u tkiva, uključujući koštanu srž.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Ispitivanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak obzirom na reproduktivnu toksičnost (vidjeti dio 5.3).
If you are a poor metaboliser:
Ako ste spori metabolizator:
Use of eliglustat in patients with pre-existing cardiac conditions has not been studied during clinical trials.
Primjena eliglustata u bolesnika s već postojećim srčanim bolestima nije ispitivana u kliničkim ispitivanjima.
Do not use this medicine after the expiry date which is stated on the carton, sleeve and blister after ‘EXP'.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, košuljici i blisteru iza oznake „EXP“.
In turn this helps your affected organs to work better.
To pomaže boljem radu zahvaćenih organa.
Electrocardiographic evaluation
Elektrokardiografska procjena
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.
Ispitivanje laktacije u štakora pokazalo je da se 0,23% obilježene doze prenijelo na mladunčad tijekom 24 sata nakon doziranja, upućujući na izlučivanje eliglustata i/ili s njime povezanih tvari u mlijeko.
Grapefruit products contain one or more components that inhibit CYP3A and can increase plasma concentrations of eliglustat.
Proizvodi od grejpa sadržavaju jednu ili više komponenata koje inhibiraju CYP3A i mogu povisiti koncentracije eliglustata u plazmi.
The build-up prevents these organs from working properly.
To nakupljanje sprječava pravilan rad tih organa.
The highest eliglustat plasma concentration observed to date occurred in a Phase 1 single-dose dose escalation study in healthy subjects, in a subject taking a dose equivalent to approximately 21 times the recommended dose for GD1 patients.
Najviša koncentracija eliglustata u plazmi opažena do danas pojavila se u ispitivanju faze 1 povećanja jednokratne doze u zdravih ispitanika, u jednog ispitanika koji je uzimao dozu ekvivalentnu približno 21 puta većoj od preporučene doze za bolesnike s GD1.
Gaucher disease type 1 is a rare, inherited condition in which a substance called glucosylceramide is not effectively broken down by your body.
Gaucherova bolest tipa 1 je rijetko, nasljedno stanje kod kojeg se tvar koja se zove glukozilceramid ne razgrađuje učinkovito u Vašem tijelu.