FrancophonIA/ELRC3.0 huggingface dataset:
English: In a healthy subjects study, no significant change in nilotinib pharmacokinetics was observed when a single 400 mg dose of nilotinib was administered 10 hours after and 2 hours before famotidine.
Croatian: U ispitivanju provedenom na zdravim ispitanicima nije opažena značajna promjena u farmakokinetici nilotiniba prilikom primjene jednokratne doze od 400 mg nilotiniba 10 sati nakon i 2 sata prije primjene famotidina.
English: Tasigna is used to treat a type of leukaemia called Philadelphia chromosome positive chronic myeloid leukaemia (Ph-positive CML).
Croatian: Tasigna se koristi za liječenje jedne vrste leukemije koja se zove kronična mijeloična leukemija s pozitivnim Philadelphia kromosomom (Ph-pozitivni KML).
English: The overall confirmed HR rate in 137 AP patients was 50%.
Croatian: Ukupna potvrđena stopa HR-a u 137 bolesnika u ubrzanoj fazi bila je 50%.
English: Face oedema, localised oedema
Croatian: Edem lica, lokalizirani edem
English: It is also used in adult and paediatric patients who experienced serious side effects with previous treatment and are not able to continue taking it.
Croatian: Također se primjenjuje u odraslih i pedijatrijskih bolesnika s ozbiljnim nuspojavama na prethodno liječenje koje nisu mogli nastaviti primati.
English: Table 3 Non-haematological adverse reactions (≥5% of all patients)*
Croatian: Tablica 3 Nehematološke nuspojave (≥5% svih bolesnika)*
English: Available toxicological data in animals have shown excretion of nilotinib in milk (see section 5.3).
Croatian: Dostupni toksikološki podaci u životinja pokazali su da se nilotinib izlučuje u mlijeko (vidjeti dio 5.3).
English: If pregnancy is planned during the TFR phase, the patient must be informed of a potential need to re-initiate nilotinib treatment during pregnancy (see sections 4.2 and
Croatian: Ako je planirana trudnoća tijekom TFR faze, bolesnica se mora obavijestiti o mogućoj potrebi za ponovnim započinjanjem liječenja nilotinibom tijekom trudnoće (vidjeti dijelove 4.2 i 4.4).
English: Eighty-five of these 86 patients (98.8%) regained MMR, (one patient discontinued study permanently due to subject decision) and 76 patients (88.4%) regained MR4.5 by the time of the cut-off date.
Croatian: Osamdeset pet od tih 86 bolesnika (98,8%) ponovo je postiglo MMR, (jedan bolesnik trajno je prekinuo ispitivanje vlastitom odlukom), a 76 bolesnika (88,4%) ponovo je postiglo MR4,5 do isključnog datuma.
English: NEL = no evidence of leukaemia/marrow response 114 CP patients had a CHR at baseline and were therefore not assessable for complete haematological response * Missing information on imatinib-resistant/intolerant status for one patient.
Croatian: NEL = nema dokaza za leukemiju/odgovor koštane srži 114 bolesnika u kroničnoj fazi je imalo CHR na početku, pa nisu mogli ući u procjenu kompletnog hematološkog odgovora * Nedostaje podatak o statusu jednog bolesnika s rezistencijom/intolerancijom na imatinib.
English: Loss of major molecular response (MMR=BCR-ABL/ABL ≤0.1%IS) will trigger treatment re-initiation within 4 weeks of when loss of remission is known to have occurred.
Croatian: Gubitak velikog molekularnog odgovora (MMR=BCR-ABL/ABL ≤0,1% IS) potaknut će ponovno započinjanje liječenja u roku od 4 tjedna od trenutka saznanja o gubitku remisije.
English: For laboratory abnormalities, very common events (1/10) not included in Table 3 are also reported.
Croatian: 4. Za abnormalne vrijednosti laboratorijskih nalaza, prijavljeni su vrlo česti događaji (1/10) koji nisu uključeni u Tablicu
English: Figure 4 Kaplan-Meier estimate of treatment-free survival after start of TFR (full analysis set)
Croatian: Slika 4 Kaplan-Meierova procjena preživljenja bez liječenja nakon početka TFR-a (potpuni skup podataka za analizu)
English: Phototoxicity studies
Croatian: Ispitivanja fototoksičnosti
English: Discontinuation due to adverse drug reactions was observed in 16% of chronic phase and 10% of accelerated phase patients.
Croatian: Prekid primjene lijeka zbog nuspojava vezanih uz primjenu lijeka je uočen u 16% bolesnika u kroničnoj fazi i u 10% bolesnika u ubrzanoj fazi.
English: Regular tests, including blood tests, will be performed during treatment.
Croatian: Tijekom liječenja redovito će se obavljati kontrole, koje uključuju krvne pretrage.
English: Tasigna is available in packs containing 28 or 40 hard capsules and in multipacks of 112 hard capsules (comprising 4 cartons, each containing 28 hard capsules), 120 hard capsules (comprising 3 cartons, each containing 40 hard capsules) or 392 hard capsules (comprising 14 cartons, each containing 28 hard capsules).
Croatian: Tasigna je dostupna u pakiranjima koja sadrže 28 ili 40 tvrdih kapsula ili u višestrukim pakiranjima koja sadrže 112 tvrdih kapsula (sastoje se od 4 kutije, svaka sadrži 28 tvrdih kapsula), 120 tvrdih kapsula (sastoje se od 3 kutije, svaka sadrži 40 tvrdih kapsula) ili 392 tvrde kapsule (sastoje se od 14 kutija, svaka sadrži 28 tvrdih kapsula).
English: The safety of nilotinib in paediatric patients (from 2 to <18 years of age) with Philadelphia chromosome positive CML in chronic phase (n=69) has been investigated in two studies (see section 5.1).
Croatian: Sigurnost nilotiniba u pedijatrijskih bolesnika (u dobi od 2 do <18 godina) s KML-om s pozitivnim Philadelphia kromosomom u kroničnoj fazi (n=69) istraživana je u dva ispitivanja (vidjeti dio 5.1).
English: None of the 21 resistant or intolerant CML patients who were in MMR on treatment had confirmed loss of MMR.
Croatian: Nijedan od 21 rezistentnog ili intolerantnog bolesnika s KML-om koji su bili u MMR-u tijekom terapije nije imao potvrđen gubitak MMR-a.
English: In case lipase elevations are accompanied by abdominal symptoms, nilotinib therapy should be interrupted and appropriate diagnostic measures considered to exclude pancreatitis.
Croatian: U slučaju kada su povišenja serumske lipaze praćena abdominalnim simptomima, terapiju nilotiniba treba prekinuti i napraviti odgovarajuće pretrage kako bi se isključio pankreatitis.
English: In the 2-year rat carcinogenicity study, the major target organ for non-neoplastic lesions was the uterus (dilatation, vascular ectasia, endothelial cell hyperplasia, inflammation and/or epithelial hyperplasia).
Croatian: U dvogodišnjem ispitivanju karcinogenosti kod štakora glavni ciljni organ za ne-neoplasične lezije bila je maternica (dilatacija, vaskularna ektazija, hiperplazija endotelnih stanica, upala i/ili epitelna hiperplazija).
English: Discontinuation of nilotinib therapy should be initiated by a physician experienced in the treatment of patients with CML (see sections 4.4 and 5.1).
Croatian: Prekid terapije nilotinibom mora započeti liječnik s iskustvom u liječenju bolesnika s KML-om (vidjeti dijelove 4.4 i 5.1).
English: Monitoring during Tasigna treatment
Croatian: Praćenje tijekom liječenja Tasignom
English: These antacids should be taken approximately 2 hours before or approximately 2 hours after you take Tasigna.
Croatian: Takve je antacide potrebno uzimati približno 2 sata prije ili približno 2 sata nakon uzimanja Tasigne.
English: Final CSR: April 2021
Croatian: Završno izvješće o kliničkom ispitivanju: travanj, 2021.
English: A single-dose drug-drug interaction study in healthy volunteers with 25 mg warfarin, a sensitive CYP2C9 substrate, and 800 mg nilotinib did not result in any changes in warfarin pharmacokinetic parameters or warfarin pharmacodynamics measured as prothrombin time (PT) and international normalised ratio (INR).
Croatian: Ispitivanje jednokratne doze interakcije lijekova u zdravih dobrovoljaca s 25 mg varfarina, osjetljivog CYP2C9 supstrata, i 800 mg nilotiniba nije dovelo do promjena farmakokinetičkih parametara varfarina ili farmakodinamike varfarina mjerene kao protrombinsko vrijeme (PV) i međunarodni normalizirani omjer (INR - engl. international normalised ratio).
English: No food should be consumed for at least one hour after the dose is taken.
Croatian: Hranu ne treba uzimati najmanje jedan sat nakon uzimanja doze.
English: By 1 year
Croatian: Do 1. godine
English: The median duration of exposure was 60.5 months (range 0.1-70.8 months).
Croatian: Medijan trajanja izloženosti lijeku bio je 60,5 mjeseci (raspon od 0,1-70,8 mjeseci).
English: Elevations of bilirubin and hepatic transaminases should be managed by withholding nilotinib temporarily, dose reduction and/or discontinuation of nilotinib (see section 4.2).
Croatian: Povećanja vrijednosti bilirubina i jetrenih transaminaza treba zbrinjavati privremenim ukidanjem nilotiniba, smanjenjem doze i/ili obustavom primjene nilotiniba (vidjeti dio 4.2).
English: Complete cytogenetic response (CCyR) was defined as 0% Ph+ metaphases in the bone marrow based on a minimum of 20 metaphases evaluated.
Croatian: Potpuni citogenetski odgovor (CCyR - engl. complete cytogenetic response) je određen kao 0% Ph+ metafaza u koštanoj srži na temelju najmanje 20 procijenjenih metafaza.
English: In the same study as above, administration of an antacid (aluminium hydroxide/magnesium hydroxide/simethicone) 2 hours before or after a single 400 mg dose of nilotinib also did not alter nilotinib pharmacokinetics.
Croatian: U istome, prethodno spomenutome ispitivanju primjena antacida (aluminij hidroksid/magnezij hidroksid/simetikon) 2 sata prije ili poslije jednokratne doze od 400 mg nilotiniba također nije promijenila farmakokinetiku nilotiniba.
English: Myelosuppression was generally reversible and usually managed by withholding Tasigna temporarily or dose reduction (see section 4.2).
Croatian: Mijelosupresija je u pravilu reverzibilna i najčešće se može riješiti privremenim prestankom primjene ili smanjenjem doze Tasigne (vidjeti dio 4.2).
English: Insomnia, depression, anxiety
Croatian: Nesanica, depresija, anksioznost
English: Nilotinib has been evaluated in safety pharmacology, repeated-dose toxicity, genotoxicity, reproductive toxicity, phototoxicity and carcinogenicity (rats and mice) studies.
Croatian: Kod nilotiniba su provedena ispitivanja farmakološke sigurnosti primjene, toksičnosti ponovljenih doza, genotoksičnosti, reproduktivne toksičnosti, fototoksičnosti i karcinogenosti (na štakorima i miševima).
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.
Croatian: Nakon neuspjeha liječenja imatinibom, zabilježene su 24 različite Bcr-Abl mutacije u 42% bolesnika s KML-om u kroničnoj i u 54% bolesnika s KML-om u ubrzanoj fazi u kojih se ispitivala mutacija.
English: Exposures at the lowest dose levels at which the liver effects were seen were lower than the exposure in humans at a dose of 800 mg/day.
Croatian: Izloženosti uz najniže razine doza pri kojima su zamijećeni učinci na jetru bile su niže nego izloženost u ljudi u dozi od 800 mg/dan.
English: Cardiac failure, cyanosis
Croatian: Zatajenje srca, cijanoza
English: For a dose of 300 mg twice daily, 150 mg hard capsules are available.
Croatian: Za dozu od 300 mg dva puta na dan, dostupne su tvrde kapsule od 150 mg.
English: Tasigna is available in a wallet containing 28 hard capsules and in a carton containing 28 or 40 hard capsules.
Croatian: Tasigna je dostupna u džepnom pakiranju koje sadrži 28 tvrdih kapsula te u kutiji koja sadrži 28 ili 40 tvrdih kapsula.
English: The median time on treatment with nilotinib was 13.80 months (range: 0.7-30.9 months).
Croatian: Medijan vremena na terapiji nilotinibom bio je 13,80 mjeseci (raspon: 0,7-30,9 mjeseci).
English: - pancreas and liver function in the body to see how Tasigna is tolerated.
Croatian: - funkcija gušterače i jetre u tijelu da se vidi kako se Tasigna podnosi. - elektroliti u tijelu (kalij, magnezij).
English: Close monitoring for an effect on the QTc interval is advisable and a baseline ECG is recommended prior to initiating nilotinib therapy and as clinically indicated.
Croatian: Savjetuje se pažljivo praćenje utjecaja na QT interval te se preporučuje učiniti bazični EKG prije početka liječenja nilotinibom, kao i kada je klinički indicirano.
English: Pat Evt Cen
Croatian: Bol Dog Cen
English: Safety information from two Tasigna treatment discontinuation studies is also provided.
Croatian: Navedene su i sigurnosne informacije iz dvaju ispitivanja prekida liječenja Tasignom.
English: Cardiovascular events were reported in a randomised Phase III study in newly diagnosed CML patients and observed in post-marketing reports.
Croatian: Kardiovaskularni događaji bili su zabilježeni u randomiziranom ispitivanju faze III na bolesnicima s novodijagnosticiranim KML-om i uočeni u izvješćima nakon stavljanja lijeka u promet.
English: If you forget to take Tasigna
Croatian: Ako ste zaboravili uzeti Tasignu
English: In 11 AP patients, evaluated for efficacy, treatment induced a 36% overall HR rate.
Croatian: U 11 bolesnika u ubrzanoj fazi u kojih je procijenjena djelotvornost, ukupna HR stopa dobivena liječenjem iznosi 36%.
English: Nilotinib therapy should be re-initiated at 300 mg twice daily or at a reduced dose level of 400 mg once daily if the patient had a dose reduction prior to discontinuation of therapy.
Croatian: Terapiju nilotinibom potrebno je ponovo započeti u dozi od 300 mg dvaput na dan ili u smanjenoj dozi od 400 mg jedanput na dan ako je bolesniku bila smanjena doza prije prekida terapije.
English: - Patients who are no longer benefiting from previous treatment for CML: The recommended dose is 800 mg per day.
Croatian: - Bolesnici kojima više ne pomaže prethodna terapija za KML: Preporučena doza je 800 mg na dan.
English: Nilotinib is a potent inhibitor of the ABL tyrosine kinase activity of the BCR-ABL oncoprotein both in cell lines and in primary Philadelphia-chromosome positive leukaemia cells.
Croatian: Nilotinib je snažan inhibitor aktivnosti ABL tirozin kinaze BCR-ABL onkoproteina i u staničnim linijama i u primarnim Philadelphia-kromosom pozitivnim leukemijskim stanicama.
English: Depression, insomnia, anxiety
Croatian: Depresija, nesanica, anksioznost
English: How Tasigna works
Croatian: Kako Tasigna djeluje
English: Most responders achieved a HR early with nilotinib treatment (median 1.0 months) and these have been durable (median duration of confirmed HR was 24.2 months).
Croatian: Većina bolesnika postigla je HR brzo nakon liječenja nilotinibom (medijan 1,0 mjesec) i to se zadržalo (medijan trajanja potvrđenog HR-a je bio 24,2 mjeseci).
English: QTcF of >500 msec was observed in <1% of these patients.
Croatian: QTcF od >500 msek opažen je u <1% ovih bolesnika.
English: Cytogenetic Response (%) Major (95%CI) Complete Partial
Croatian: Citogenetski odgovor (%) Veliki (95%CI) Kompletan Djelomičan
English: Prior bone marrow transplant * Missing information on imatinib-resistant/intolerant status for one patient.
Croatian: Prethodna transplantacija koštane srži * Nedostaje podatak o statusu jednog bolesnika s rezistencijom/intolerancijom na imatinib.
English: Pregnancy and breast-feeding - Tasigna is not recommended during pregnancy unless clearly necessary.
Croatian: - Tasigna se ne preporučuje tijekom trudnoće, osim ako je neophodno potrebno.
English: An increase in serum exposure to nilotinib between the first dose and steady state was approximately 2-fold for daily dosing and 3.8-fold for twice-daily dosing.
Croatian: Povećanje serumske izloženosti nilotinibu između prve doze i stanja dinamičke ravnoteže bilo je otprilike 2 puta za doziranje jedanput na dan i 3,8 puta za doziranje dva puta na dan.
English: Skin papilloma
Croatian: Kožni papilom
English: One hard capsule contains 117.08 mg lactose monohydrate.
Croatian: Jedna tvrda kapsula sadrži 117,08 mg laktoze hidrata.
English: Increased post-implantation loss was observed in both the fertility study, which involved treatment of both males and females, and the embryotoxicity study, which involved treatment of females.
Croatian: Povećani postimplantacijski gubici opaženi su u ispitivanjima plodnosti u oba spola, kao i u embriotoksičnom ispitivanjima, u kojima su bile liječene ženke.
English: In a juvenile development study, nilotinib was administered via oral gavage to juvenile rats from the first week post partum through young adult (day 70 post partum) at doses of 2, 6 and 20 mg/kg/day.
Croatian: U razvojnom ispitivanju u mladih štakora, nilotinib se mladim štakorima davao putem prisilne peroralne primjene od prvog tjedna nakon okota do mlađe odrasle dobi (70 dana nakon okota) u dozama od 2, 6 i 20 mg/kg/dan.
English: Repeated-dose toxicity studies
Croatian: Ispitivanja toksičnosti ponovljenih doza
English: Administration of Tasigna 30 minutes or 2 hours after food increased bioavailability of nilotinib by 29% or 15%, respectively (see sections 4.2, 4.4 and 4.5).
Croatian: Primjena Tasigne 30 minuta nakon hrane povećava bioraspoloživost nilotiniba za 29%, a 2 sata nakon hrane za 15% (vidjeti dijelove 4.2, 4.4 i 4.5).
English: In clinical studies, patients with uncontrolled or significant cardiac disease (e.g., recent myocardial infarction, congestive heart failure, unstable angina or clinically significant bradycardia) were excluded.
Croatian: Bolesnici s nekontroliranim ili značajnim srčanim poremećajima (kao što je nedavni infarkt miokarda, kongestivno zatajenje srca, nestabilna angina ili klinički značajna bradikardija) bili su isključeni iz kliničkih ispitivanja.
English: The bioavailability of nilotinib might be reduced in patients with total gastrectomy (see section 5.2).
Croatian: Bioraspoloživost nilotiniba mogla bi biti smanjena u bolesnika s potpunom gastrektomijom (vidjeti dio 5.2).
English: Of CP patients without a baseline CHR, 70% achieved a CHR, median time to CHR was 1 month and median duration of CHR was 32.8 months.
Croatian: Od bolesnika u kroničnoj fazi bez CHR-a na početku, njih 70% je postiglo CHR, medijan vremena do CHR-a je bilo mjesec dana, a medijan trajanja CHR-a 32,8 mjeseci.
English: - The other ingredients are lactose monohydrate, crospovidone type A, poloxamer 188, colloidal anhydrous silica, magnesium stearate.
Croatian: - Drugi sastojci su laktoza hidrat, krospovidon vrsta A, poloksamer 188, bezvodni koloidni silicijev dioksid, magnezijev stearat.
English: There was no relevant increase in exposure to nilotinib when the dose was increased from 400 mg twice daily to 600 mg twice daily.
Croatian: Nije bilo značajnog povećanja izloženosti nilotinibu kod povećanja doze od 400 mg dva puta na dan na 600 mg dva puta na dan.
English: • Unit packs containing 28 hard capsules in a wallet.
Croatian: • jedinična pakiranja koja sadrže 28 tvrdih kapsula u džepnom pakiranju.
English: Carriers of HBV who require treatment with nilotinib should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy (see section 4.8).
Croatian: Nositelje virusa HBV kojima je potrebno liječenje nilotinibom potrebno je pozorno nadzirati radi utvrđivanja eventualnih znakova i simptoma aktivne infekcije HBV-om tijekom terapije te nekoliko mjeseci nakon završetka terapije (vidjeti dio 4.8).
English: In a retrospective analysis, 91% (234/258) of patients on nilotinib 300 mg twice daily achieved BCR-ABL levels ≤10% at 3 months of treatment compared to 67% (176/264) of patients on imatinib 400 mg once daily.
Croatian: U retrospektivnoj analizi 91% (234/258) bolesnika koji su primali nilotinib 300 mg dva puta na dan postiglo je razine BCR-ABL ≤10% nakon 3 mjeseca liječenja, u usporedbi sa 67% (176/264) bolesnika koji su primali imatinib 400 mg jedanput na dan.
English: - if you have sudden heart palpitations, severe muscle weakness or paralysis, seizures or sudden changes in your thinking or level of alertness, tell your doctor immediately as this may be a sign of a fast breakdown of cancer cells called tumour lysis syndrome.
Croatian: - ako osjećate iznenadno lupanje srca, tešku slabost ili paralizu mišića, napadaje ili iznenadne promjene u razmišljanju ili stupnju koncentracije, odmah obavijestite o tome svojega liječnika jer bi to mogao biti znak ubrzanog raspadanja tumorskih stanica koje se naziva sindrom lize tumora.
English: Discontinuation due to adverse drug reactions was observed in 10% of patients.
Croatian: Prekid primjene lijeka zbog nuspojava bio je uočen u 10% bolesnika.
English: Nilotinib is a moderate CYP3A4 inhibitor.
Croatian: Nilotinib je umjereni CYP3A4 inhibitor.
English: Hepatotoxicity, toxic hepatitis, jaundice
Croatian: Hepatotoksičnost, toksični hepatitis, žutica
English: If you have questions about when to take this medicine, talk to your doctor or pharmacist.
Croatian: Ako imate pitanja o tome kada uzeti ovaj lijek, razgovarajte sa svojim liječnikom ili ljekarnikom.
English: Nilotinib is primarily metabolised by CYP3A4, with possible minor contribution from CYP2C8.
Croatian: Nilotinib se prvenstveno metabolizira putem CYP3A4, uz mogući manji utjecaj CYP2C8.
English: Post authorisation efficacy study (PAES): In order to investigate the efficacy of nilotinib in paediatric patients with Ph+ CML-CP resistant or intolerant to either imatinib or dasatinib and in newly diagnosed patients, the MAH should submit the final results of the phase II CAMN107A2203 study.
Croatian: Ispitivanje djelotvornosti nakon davanja odobrenja za stavljanje lijeka u promet (PAES): Kako bi se ispitala djelotvornost nilotiniba u pedijatrijskih bolesnika s Ph+ KML-om u kroničnoj fazi, s rezistencijom ili intolerancijom na imatinib ili dasatinib i u novodijagnosticiranih bolesnika, nositelj odobrenja će predati konačne rezultate ispitivanja CAMN107A2203 faze II.
English: Tasigna may need to be temporarily withheld and/or dose reduced for haematological toxicities (neutropenia, thrombocytopenia) that are not related to the underlying leukaemia (see Table 2).
Croatian: Primjena Tasigne može se privremeno prekinuti i/ili se može smanjiti doza pri pojavi hematološke toksičnosti (neutropenija, trombocitopenija) koja nije povezana s podležećom leukemijom (vidjeti Tablicu 2).
English: The absorption and bioavailability of nilotinib are increased if it is taken with food, resulting in a higher serum concentration (see sections 4.2, 4.4 and 5.2).
Croatian: Hrana može povećati apsorpciju i bioraspoloživost nilotiniba, čime se postiže viša koncentracija u serumu (vidjeti dijelove 4.2, 4.4 i 5.2).
English: How long to take Tasigna
Croatian: Koliko dugo uzimati Tasignu
English: The No-Observed-Effect-Level for the skin neoplastic lesions was 100 mg/kg/day, representing approximately 10 to 20 times the human exposure at the maximum approved dose of 800 mg/day (administered as 400 mg twice daily).
Croatian: Razina bez uočenih učinaka za neoplastične lezije na koži bila je 100 mg/kg/dan, što predstavlja otprilike 10 do 20 puta veću izloženost od one u ljudi pri najvišoj odobrenoj dozi od 800 mg/dan (primijenjenoj kao 400 mg dvaput dnevno).
English: If signs of severe fluid retention appear during treatment with nilotinib, the aetiology should be evaluated and patients treated accordingly (see section 4.2 for instructions on managing non-haematological toxicities).
Croatian: Ako se pojave znakovi teškog oblika zadržavanja tekućine tijekom liječenja nilotinibom, potrebno je ocijeniti etiologiju i bolesnike liječiti sukladno tome (vidjeti dio 4.2 za upute o zbrinjavanju nehematoloških toksičnosti).
English: The hard capsules are red/light yellow.
Croatian: Tvrde kapsule su crvene/svijetložute boje.
English: Alterations included increased alanine aminotransferase and alkaline phosphatase activity and histopathology findings (mainly sinusoidal cell or Kupffer cell hyperplasia/hypertrophy, bile duct hyperplasia and periportal fibrosis).
Croatian: Promjene su uključivale povećanje aktivnosti alanin aminotransferaze i alkalne fosfataze i patohistološke nalaze (uglavnom hiperplazija/hipertrofija sinusoidalnih stanica ili Kupfferovih stanica, hiperplazija žučnog voda i periportalna fibroza).
English: Dehydration, increased appetite, gout, dyslipidaemia
Croatian: Dehidracija, povećan apetit, giht, dislipidemija
English: Pain, chills, feeling body temperature change (including feeling hot, feeling cold), malaise
Croatian: Bol, zimica, osjećaj promjene tjelesne temperature (uključujući osjećaj vrućine i osjećaj hladnoće), malaksalost