FrancophonIA/ELRC3.0 huggingface dataset:
English: Since a risk to the newborns/infants cannot be excluded, women should not breast-feed during Tasigna treatment and for 2 weeks after the last dose.
Slovenian: Ker tveganja za dojenega novorojenca/otroka ne moremo izključiti, ženske v času zdravljenja z zdravilom Tasigna in še 2 tedna po prejemu zadnjega odmerka ne smejo dojiti.
English: If you have any questions about how Tasigna works or why it has been prescribed for you or your child, ask your doctor.
Slovenian: Če imate kakšna vprašanja glede tega, kako zdravilo Tasigna deluje ali zakaj so ga predpisali vam oziroma vašemu otroku, vprašajte svojega zdravnika.
English: If any of these apply to you or your child, tell your doctor.
Slovenian: Če karkoli od zgoraj navedenega velja za vas ali vašega otroka, povejte svojemu zdravniku.
English: Safety information from two Tasigna treatment discontinuation studies is also provided.
Slovenian: Navedeni so tudi varnostni podatki iz dveh študij prekinitve zdravljenja z zdravilom Tasigna.
English: It is unknown whether nilotinib is excreted in human milk.
Slovenian: Ni znano, ali se nilotinib izloča v materino mleko.
English: If you are taking any of these, your doctor might prescribe other alternative medicines.
Slovenian: Če jemljete katero od teh zdravil, vam bo zdravnik morda predpisal drugo ustrezno zdravilo.
English: Steady-state conditions were essentially achieved by day 8.
Slovenian: Do stanja dinamičnega ravnovesja je v glavnem prišlo do 8. dne.
English: No major differences were observed for safety and efficacy in patients ≥65 years of age as compared to adults aged 18 to 65 years.
Slovenian: Pri bolnikih, starih 65 let ali več, niso opažali večjih razlik glede varnosti in učinkovitosti v primerjavi z odraslimi, starimi 18 do 65 let.
English: Overall, 73% of patients were imatinib-resistant, while 27% were imatinib-intolerant.
Slovenian: Skupno je bilo 73 % bolnikov rezistentnih na imatinib, 27 % pa jih ni prenašalo imatiniba.
English: Contains lactose - see the package leaflet for further information.
Slovenian: Vsebuje laktozo - za več podatkov glejte Navodilo za uporabo.
English: Chronic phase
Slovenian: Kronična faza
English: The hard capsules should be swallowed whole with water.
Slovenian: Trde kapsule je treba pogoltniti cele z vodo.
English: The blood-to-plasma ratio of nilotinib is 0.71.
Slovenian: Razmerje vsebnosti kri/plazma je pri nilotinibu 0,71.
English: Eligibility for discontinuation of treatment
Slovenian: Primernost za prekinitev zdravljenja
English: You should also tell your doctor if you are already taking Tasigna and you are prescribed a new medicine that you have not taken previously during Tasigna treatment.
Slovenian: Zdravniku morate povedati tudi v primeru, da že jemljete zdravilo Tasigna, pa vam predpišejo novo zdravilo, ki ga prej med zdravljenjem z zdravilom Tasigna še niste jemali.
English: Since nilotinib and its metabolites are not renally excreted, a decrease in total body clearance is not anticipated in patients with renal impairment.
Slovenian: Ker se nilotinib in njegovi metaboliti ne izločajo preko ledvic, pri bolnikih z okvaro ledvic ni pričakovati znižanja celotnega telesnega očistka.
English: Genotoxicity studies in bacterial in vitro systems and in mammalian in vitro and in vivo systems with and without metabolic activation did not reveal any evidence for a mutagenic potential of nilotinib.
Slovenian: Študije genotoksičnosti na bakterijskih sistemih in vitro ter na sesalskih sistemih in vitro in in vivo, z metabolično aktivacijo ali brez nje, niso dale nobenega dokaza za mutageni potencial nilotiniba.
English: However, it is recommended that patients experiencing dizziness, fatigue, visual impairment or other undesirable effects with a potential impact on the ability to drive or use machines safely should refrain from these activities as long as the undesirable effects persist (see section 4.8).
Slovenian: Kljub temu velja priporočilo, da bolniki, pri katerih prihaja do omotičnosti, utrujenosti, motenj vida ali drugih neželenih učinkov, ki bi lahko vplivali na sposobnost varne vožnje ali upravljanja s stroji, ne smejo opravljati teh dejavnosti, dokler neželeni učinki vztrajajo (glejte poglavje 4.8).
English: CML is a cancer of the blood which makes the body produce too many abnormal white blood cells.
Slovenian: KML je krvni rak, zaradi katerega telo izdeluje preveč nenormalnih levkocitov.
English: If transient interruption of treatment is not possible, close monitoring of the individual for prolongation of the QT interval is indicated (see sections 4.2, 4.5 and 5.2).
Slovenian: Če začasna prekinitev zdravljenja ni možna, je treba posameznika natančno spremljati glede podaljšanja intervala QT (glejte poglavja 4.2, 4.5 in 5.2).
English: No effects were seen in ECG measurements in dogs or monkeys treated for up to 39 weeks or in a special telemetry study in dogs.
Slovenian: Vpliva na meritve EKG niso opažali niti pri psih niti pri opicah, ki so jih z nilotinibom zdravili do 39 tednov, niti v posebni telemetrični študiji na psih.
English: Tasigna should not be used during pregnancy unless the clinical condition of the woman requires treatment with nilotinib.
Slovenian: Zdravila Tasigna ne smete uporabljati med nosečnostjo, razen če je zdravljenje z nilotinibom potrebno zaradi kliničnega stanja ženske.
English: How to take Tasigna - Swallow the hard capsules whole with water.
Slovenian: Kako jemati zdravilo Tasigna - Trde kapsule pogoltnite cele z vodo.
English: No deaths were reported on treatment or after treatment discontinuation in both studies.
Slovenian: V nobeni od obeh študij niso poročali o primerih smrti niti v času zdravljenja niti po njegovi prekinitvi.
English: The hard capsules are red.
Slovenian: Trde kapsule so rdeče.
English: Subsequent analyses reflect when patients completed 24, 36, 48, 60 and 72 months of treatment (or discontinued earlier).
Slovenian: Nadaljnje analize vključujejo podatke bolnikov po zaključenih 24, 36, 48, 60 in 72 mesecih zdravljenja (oziroma tistih, ki so predhodno prenehali s sodelovanjem).
English: The following adverse reactions have been derived from post-marketing experience with Tasigna via spontaneous case reports, literature cases, expanded access programmes, and clinical studies other than the global registration trials.
Slovenian: Naslednji neželeni učinki so pridobljeni iz izkušenj v obdobju trženja zdravila Tasigna, in sicer s spontano sporočenimi primeri, iz literaturnih podatkov, iz programov razširjene uporabe in kliničnih študij, drugih kot v okviru globalnih preskušanj za registracijo zdravila.
English: If clinically significant moderate or severe non-haematological toxicity develops, dosing should be interrupted, and patients should be monitored and treated accordingly.
Slovenian: Če pride do klinično pomembne zmerne ali hude nehematološke toksičnosti, je treba odmerjanje prekiniti in bolnika ustrezno spremljati in zdraviti.
English: As compared to an oral drink solution (pH of 1.2 to 1.3), relative bioavailability of nilotinib capsule is approximately 50%.
Slovenian: V primerjavi s pitjem peroralne raztopine (z vrednostjo pH od 1,2 do 1,3) je relativna biološka uporabnost nilotiniba iz kapsul približno 50 %.
English: Food may enhance the absorption of Tasigna and therefore increase the amount of Tasigna in the blood, possibly to a harmful level.
Slovenian: Hrana lahko poveča absorpcijo zdravila Tasigna in tako poveča količino zdravila Tasigna v krvi, lahko tudi toliko, da postane škodljivo.
English: If you are pregnant or think that you may be, tell your doctor who will discuss with you whether you can take this medicine during your pregnancy.
Slovenian: Če ste noseči ali domnevate, da bi lahko bili, povejte zdravniku, da se bo z vami pogovoril o tem, ali lahko jemljete to zdravilo med nosečnostjo.
English: The apparent elimination half-life estimated from the multiple-dose pharmacokinetics with daily dosing was approximately 17 hours.
Slovenian: Navidezni razpolovni čas izločanja, ocenjen na podlagi farmakokinetike večkratnih odmerkov pri odmerjanju enkrat dnevno, je bil približno 17 ur.
English: 2 Very common
Slovenian: 2 zelo pogosti
English: These are important in the functioning of the heart.
Slovenian: Ti elektroliti so pomembni za delovanje srca.
English: Forty patients (58.0%) had relative dose intensity superior to 90%.
Slovenian: Štirideset bolnikov (58,0 %) je prejelo zdravljenje z relativno jakostjo odmerjanja več kot 90 %.
English: (0.0032% IS < BCR-ABL/ABL ≤0.01% IS).
Slovenian: (0,0032 % po IS < BCR-ABL/ABL ≤0,01 % po IS).
English: Not all packs may be marketed in your country.
Slovenian: V vaši državi na trgu morda ni vseh navedenih pakiranj.
English: Do not use more than one teaspoon of apple sauce for each hard capsule and do not use any food other than apple sauce.
Slovenian: Pri tem ne smete uporabiti več kot ene čajne žličke jabolčnega soka za vsako trdo kapsulo in nobenega drugega živila, ki ni jabolčni sok.
English: If event occurs after dose reduction, consider discontinuing treatment.
Slovenian: Če do dogodka pride po znižanju odmerka, je treba razmisliti o dokončni ukinitvi odmerjanja.
English: The median highest prior imatinib dose had been 600 mg/day.
Slovenian: Mediana najvišjega predhodnega odmerka imatiniba je bila 600 mg/dan.
English: Up to 0.32 m
Slovenian: do 0,32 m
English: Reactivation of hepatitis B in patients who are chronic carriers of this virus has occurred after these patients received BCR-ABL tyrosine kinase inhibitors.
Slovenian: Reaktivacija hepatitisa B pri bolnikih, ki so kronični prenašalci tega virusa, se je pojavila, potem ko so ti bolniki prejeli zaviralce BCR-ABL tirozin-kinaze.
English: Tasigna was administered on a continuous basis (twice daily 2 hours after a meal and with no food for at least one hour after administration) unless there was evidence of inadequate response or disease progression.
Slovenian: Zdravilo Tasigna so bolniki prejemali neprekinjeno (dvakrat dnevno 2 uri po obroku, po aplikaciji zdravila pa vsaj eno uro niso uživali hrane), razen če so odkrili nezadosten odziv ali napredovanje bolezni.
English: Therapy should be initiated by a physician experienced in the diagnosis and the treatment of patients with CML.
Slovenian: Zdravljenje mora začeti zdravnik, izkušen v diagnostiki in zdravljenju bolnikov s KML.
English: In paediatric patients, treatment must be interrupted until the event returns to Grade 1.
Slovenian: Pri pediatričnih bolnikih je treba zdravljenje prekiniti, dokler se vrednosti ne znižajo do stopnje 1.
English: Do not stop taking this medicine unless your doctor tells you to do so.
Slovenian: Ne prenehajte jemati tega zdravila, če vam tega ni naročil zdravnik.
English: Since these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to nilotinib exposure.
Slovenian: Ker so o teh neželenih učinkih poročali spontano pri bolnikih iz populacij nedoločljive velikosti, ni vedno mogoče zanesljivo določiti pogostnosti teh neželenih učinkov oziroma ugotoviti njihove vzročne povezave z izpostavljenostjo nilotinibu.
English: Carcinogenicity studies
Slovenian: Študije karcinogenosti
English: Isolated reports of intentional overdose with nilotinib were reported, where an unspecified number of Tasigna hard capsules were ingested in combination with alcohol and other medicinal products.
Slovenian: Poročali so o posameznih primerih namernega zaužitja prevelikega odmerka nilotiniba, v katerih so posamezniki zaužili neopredeljeno število trdih kapsul zdravila Tasigna skupaj z alkoholom in drugimi zdravili.
English: Other medicines and Tasigna Tasigna may interfere with some other medicines.
Slovenian: Druga zdravila in zdravilo Tasigna Zdravilo Tasigna lahko vpliva na nekatera druga zdravila in obratno.
English: Patients were within six months of diagnosis and were previously untreated, with the exception of hydroxyurea and/or anagrelide.
Slovenian: Bolnikom so postavili diagnozo v zadnjih šestih mesecih pred vključitvijo v študijo in predhodno še niso bili zdravljeni, razen s hidroksiureo in/ali z anagrelidom.
English: Rifampicin, a potent CYP3A4 inducer, decreases nilotinib Cmax by 64% and reduces nilotinib AUC by 80%.
Slovenian: Rifampicin, ki je močan induktor CYP3A4, zniža Cmax nilotiniba za 64 % in zmanša njegovo AUC za 80 %.
English: The absolute bioavailability of nilotinib has not been determined.
Slovenian: Absolutne biološke uporabnosti nilotiniba niso določali.
English: In vitro, nilotinib is a relatively strong inhibitor of CYP3A4, CYP2C8, CYP2C9, CYP2D6 and UGT1A1, with Ki value being lowest for CYP2C9 (Ki=0.13 microM).
Slovenian: In vitro je nilotinib sorazmerno močan zaviralec CYP3A4, CYP2C8, CYP2C9, CYP2D6 in UGT1A1, pri čemer je vrednost Ki najnižja za CYP2C9 (Ki=0,13 mikroM).
English: The heart rate will also be checked using a machine that measures electrical activity of the heart (a test called an “ECG”).
Slovenian: Z napravo za merjenje električne aktivnosti srca vam bodo posneli srčni utrip (preiskava se imenuje “EKG”).
English: If you are the parent of a child who is being treated with Tasigna, tell the doctor if any of the above conditions apply to your child.
Slovenian: Če imate otroka, ki ga zdravijo z zdravilom Tasigna, zdravniku povejte, če karkoli od zgoraj navedenega morda velja za vašega otroka.
English: Older people (age 65 years and over) Tasigna can be used by people aged 65 years and over at the same dose as for other adults.
Slovenian: Starejši ljudje (stari 65 let in več) Ljudje, stari 65 let in več, lahko uporabljajo zdravilo Tasigna v enakih odmerkih kot drugi odrasli.
English: Show them the pack of hard capsules and this package leaflet.
Slovenian: Pokažite jim škatlo s trdimi kapsulami in to Navodilo za uporabo.
English: Tasigna may be given in combination with haematopoietic growth factors such as erythropoietin or granulocyte colony-stimulating factor (G-CSF) if clinically indicated.
Slovenian: Zdravilo Tasigna se lahko daje v kombinaciji s hematopoetskimi rastnimi dejavniki, kot sta eritropoetin ali granulocitne kolonije stimulirajoči faktor (G-CSF), če je to klinično indicirano.
English: - Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.
Slovenian: - Ne uporabljajte tega zdravila, če opazite, da je ovojnina poškodovana ali da je bila že odprta.
English: Complete cytogenetic response (CCyR) was defined as 0% Ph+ metaphases in the bone marrow based on a minimum of 20 metaphases evaluated.
Slovenian: Popolni citogenetični odziv (CCyR) je bil opredeljen kot 0 % Ph+ metafaz v kostnem mozgu na osnovi pregledanih najmanj 20 metafaz.
English: After imatinib failure, 24 different BCR-ABL mutations were noted in 42% of chronic phase and 54% of accelerated phase CML patients who were evaluated for mutations.
Slovenian: Po neuspešnem zdravljenju z imatinibom so zabeležili 24 različnih BCR-ABL mutacij pri 42 % bolnikov v kronični fazi in pri 54 % bolnikov v pospešeni fazi KML, ki so jih pregledovali glede mutacij.
English: Besides standard study parameters, evaluations of developmental landmarks, CNS effects, mating and fertility were performed.
Slovenian: Poleg standardnih študijskih parametrov so ocenjevali še razvojne mejnike, vpliv na osrednje živčevje, parjenje in plodnost.
English: Patients who lose MMR must re-initiate treatment within 4 weeks of when loss of remission is known to have occurred.
Slovenian: Bolniki, pri katerih pride do izgube odziva MMR, morajo ponovno začeti z zdravljenjem v 4 tednih od takrat, ko je bilo ugotovljeno poslabšanje po remisiji.
English: The juvenile animals did not exert increased sensitivity to nilotinib relative to adults.
Slovenian: V primerjavi z odraslimi živalmi pri mladičih ni bilo opaziti povečane občutljivost za nilotinib.
English: dihydroergotamine).
Slovenian: dihidroergotamin).
English: Median duration of therapy in days (25th-75th percentiles)
Slovenian: mediana trajanja zdravljenja v dnevih (25.-75. percentil)
English: Complete blood counts should be performed every two weeks for the first 2 months and then monthly thereafter, or as clinically indicated.
Slovenian: V prvih 2 mesecih je treba pregledati kompletno krvno sliko vsaka dva tedna, kasneje pa enkrat mesečno oziroma glede na klinične potrebe.
English: There is no experience with the use of this medicine in children below 2 years of age.
Slovenian: Z uporabo tega zdravila pri otrocih, ki so stari manj kot 2 leti, ni nobenih izkušenj.
English: The long-term effects of treating children with Tasigna for long periods of time are not known.
Slovenian: Dolgoročni učinki dolgotrajnega zdravljenja otrok z zdravilom Tasigna niso znani.
English: It may be given with hydroxyurea or anagrelide if clinically indicated.
Slovenian: Lahko se daje s hidroksiureo ali z anagrelidom, če je to klinično indicirano.
English: Table 5 Grade 3-4 laboratory abnormalities*
Slovenian: Preglednica 5 Nepravilnosti laboratorijskih izvidov pri stopnji 3-4*
English: Table 6 Kinase profile of nilotinib (phosphorylation IC50 nM)
Slovenian: Preglednica 6 Pregled učinka nilotiniba na kinaze (IC50 nM za fosforilacijo)
English: Based on a reduction in body weight in both genders and a delayed preputial separation in males (which may be associated with the reduction in weight), the No-Observed-Effect-Level in juvenile rats was considered to be 6 mg/kg/day.
Slovenian: Na podlagi zmanjšanja telesne mase pri obeh spolih in kasnejšega ločevanja prepucija pri samcih (kar je lahko povezano z zmanjšanjem telesne mase) menijo, da je višina odmerka brez opaznega škodljivega učinka 6 mg/kg/dan.
English: Haematological Response (%) Overall (95%CI) Complete NEL
Slovenian: hematološki odziv (%) vsi skupaj (95-odstotni IZ) popolni
English: It is therefore crucial to perform frequent monitoring of BCR-ABL transcript levels and complete blood count with differential in order to detect possible loss of remission (see section 4.2).
Slovenian: Iz tega razloga je ključnega pomena pogosto določanje ravni prepisov BCR-ABL in kompletne krvne slike skupaj z diferencialno krvno sliko z namenom ugotavljanja morebitnega poslabšanja po remisiji (glejte poglavje 4.2).
English: Of these patients 30/36 (83%) were treatment resistant not intolerant.
Slovenian: Izmed 36 bolnikov jih je bilo 30 (83 %) rezistentnih na zdravljenje oziroma ga niso prenašali.
English: Accelerated phase (n=137)*
Slovenian: pospešena faza (n=137)*
English: Final CSR: April 2021
Slovenian: april 2021
English: In case lipase elevations are accompanied by abdominal symptoms, nilotinib therapy should be interrupted and appropriate diagnostic measures considered to exclude pancreatitis.
Slovenian: V primeru, da so ob zvišanju koncentracije lipaze prisotni tudi abdominalni simptomi, je treba jemanje nilotiniba prekiniti in razmisliti o ustreznih diagnostičnih ukrepih za izključitev možnosti pankreatitisa.
English: Median duration of treatment was 561 days for CP patients and 264 days for AP patients (see Table 10).
Slovenian: Zdravljenje je mediano trajalo 561 dni pri bolnikih v kronični fazi in 264 dneva pri bolnikih v pospešeni fazi (glejte preglednico 10).
English: Nilotinib did not have effects on CNS or respiratory functions.
Slovenian: Nilotinib ni vplival na centralno živčevje oziroma na dihalne funkcije.
English: Patients with BCR-ABL levels ≤10% at 3 months of treatment show a greater overall survival at 72 months compared to those who did not achieve this molecular response level (94.5% vs. 77.1% respectively [p=0.0005]).
Slovenian: Pri bolnikih z ravnijo BCR-ABL ≤10 % po 3 mesecih zdravljenja je bila stopnja celokupnega preživetja po 72 mesecih večja v primerjavi s tistimi, ki niso dosegli te ravni molekularnega odziva (94,5 % v primerjavi z 77,1 %, [p=0,0005]).
English: - Breast-feeding is not recommended during treatment with Tasigna and for two weeks after the last dose.
Slovenian: - Dojenje ni priporočeno v času jemanja zdravila Tasigna in še dva tedna po zadnjem odmerku.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE08
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, zaviralci protein kinaze, oznaka ATC: L01XE08
English: Safety pharmacology studies
Slovenian: Farmakološke študije varnosti
English: Women of childbearing potential have to use highly effective contraception during treatment with nilotinib and for up to two weeks after ending treatment.
Slovenian: Ženske v rodni dobi morajo med zdravljenjem z nilotinibom in še dva tedna po zaključku zdravljenja uporabljati zelo učinkovito kontracepcijo.
English: For a dose of 400 mg once daily (see dose adjustments below), 200 mg hard capsules are available.
Slovenian: Za odmerjanje 400 mg enkrat dnevno (glejte prilagajanje odmerkov spodaj) so na voljo 200-miligramske trde kapsule.
English: Tasigna demonstrated efficacy in patients harboring a variety of BCR-ABL mutations associated with imatinib resistance, except T315I.
Slovenian: Zdravilo Tasigna je bilo učinkovito pri bolnikih z različnimi BCR-Abl mutacijami, povezanimi z rezistenco na imatinib, z izjemo T315I.
English: If your doctor recommends that you discontinue treatment with Tasigna Your doctor will regularly evaluate your treatment with a specific diagnostic test and decide whether you should continue to take this medicine.
Slovenian: Če vam zdravnik priporoči, da prekinete zdravljenje z zdravilom Tasigna Zdravnik bo redno ocenjeval vaše zdravljenje s pomočjo specifičnih diagnostičnih preiskav in presojal, ali je pri vas potrebno nadaljnje zdravljenje s tem zdravilom ali ne.
English: There is a limited amount of data on pregnancies in patients while attempting treatment-free remission (TFR).
Slovenian: O nosečnosti pri bolnicah v času poskušanja vzdrževanja remisije brez zdravljenja (TFR - treatment-free remission) je na voljo le malo podatkov.
English: Tasigna is available in a wallet containing 28 hard capsules and in a carton containing 28 or 40 hard capsules.
Slovenian: Zdravilo Tasigna je na voljo v zloženkah, ki vsebujejo 28 trdih kapsul in v škatlah, ki vsebujejo 28 ali 40 trdih kapsul.
English: The long-term effects of prolonged treatment with nilotinib in paediatric patients are unknown.
Slovenian: Dolgoročni učinki dolgotrajnega zdravljenja z nilotinibom pri pediatrični populaciji niso znani.
English: Repeated-dose toxicity studies in dogs of up to 4 weeks' duration and in cynomolgus monkeys of up to 9 months' duration revealed the liver as the primary target organ of toxicity of nilotinib.
Slovenian: Študije toksičnosti ponovljenih odmerkov s psi, ki so trajale do 4 tedne, in z opicami vrste javanski makak, ki so trajale do 9 mesecev, so razkrile, da so glavni tarčni organ toksičnosti nilotiniba jetra.
English: If you have questions about how long to take Tasigna, talk to your doctor.
Slovenian: Če imate vprašanja o tem, kako dolgo je treba jemati zdravilo Tasigna, se pogovorite z zdravnikom.
English: Imatinib intolerance included patients who discontinued imatinib because of toxicity and were not in major cytogenetic response at time of study entry.
Slovenian: Neprenašanje imatiniba je vključevalo bolnike, ki so prenehali jemati imatinib zaradi toksičnosti, ob vstopu v študijo pa niso kazali pomembnega citogenetičnega odziva.
English: For patients who fail to achieve MMR after three months of treatment re-initiation, BCR-ABL kinase domain mutation testing should be performed.
Slovenian: Pri bolnikih, ki ne dosežejo odziva MMR v treh mesecih po ponovni uvedbi zdravljenja, je treba izvesti preiskavo glede mutacije na predelu za BCR-ABL kinazo.
English: No ECG changes or hepatotoxicity were reported.
Slovenian: O EKG spremembah in toksičnosti za jetra niso poročali.
English: Hypophosphataemia (including blood phosphorus decreased)
Slovenian: hipofosfatemija (vključno z znižano koncentracijo fosforja v krvi)
English: The hard capsules are red/light yellow.
Slovenian: Trde kapsule so rdeče/svetlo rumene.
English: Efficacy was based on 321 CP patients and 137 AP patients enrolled.
Slovenian: Učinkovitost so ocenjevali na podlagi vključenih 321 bolnikov v kronični fazi in 137 bolnikov v pospešeni fazi.