FrancophonIA/ELRC3.0 huggingface dataset:
English: Results from the human mass balance study demonstrated that alectinib and M4 were the main circulating moieties in plasma with 76% of the total radioactivity in plasma.
Croatian: Rezultati ispitivanja masene bilance u ljudi pokazali su da su alektinib i M4 bile glavne cirkulirajuće tvari u plazmi koje su činile 76% ukupne radioaktivnosti u plazmi.
English: Also some other medicines can affect the way Alecensa works.
Croatian: Isto tako, neki drugi lijekovi mogu utjecati na način djelovanja lijeka Alecensa.
English: In preclinical studies, inhibition of ALK tyrosine kinase activity led to blockage of downstream signalling pathways including STAT 3 and PI3K/AKT and induction of tumour cell death (apoptosis).
Croatian: U pretkliničkim je ispitivanjima inhibicija aktivnosti tirozin kinaze ALK dovela do blokade putova nizvodne signalizacije, uključujući STAT 3 i PI3K/AKT, te indukcije smrti (apoptoze) tumorskih stanica.
English: Alecensa can be prescribed to you as first treatment of your lung cancer, or if you have been previously treated with a medicine containing ‘crizotinib'.
Croatian: Alecensa Vam se može propisati kao prva terapija za rak pluća ili ako ste prethodno bili liječeni lijekom koji sadrži krizotinib.
English: Carcinogenicity Carcinogenicity studies have not been performed to establish the carcinogenic potential of Alecensa.
Croatian: Kancerogenost Nisu provedena ispitivanja kojima bi se utvrdio kancerogeni potencijal lijeka Alecensa.
English: ● Alecensa is taken by mouth.
Croatian: Alecensa se uzima kroz usta.
English: You need to apply sunscreen and lip balm with a Sun Protection Factor of 50 or higher to help prevent sunburn.
Croatian: Morate nanositi kremu za zaštitu od sunca i balzam za usne sa zaštitnim faktorom 50 ili više, kako biste pomogli spriječiti opekline od sunca.
English: Patients who develop symptomatic bradycardia should be managed as recommended in sections 4.2 and 4.4.
Croatian: Bolesnike koji razviju simptomatsku bradikardiju treba zbrinuti u skladu s preporukama u dijelovima 4.2 i 4.4.
English: If you are not sure, talk to your doctor, pharmacist or nurse before taking Alecensa.
Croatian: Ako niste sigurni, obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete lijek Alecensa.
English: Therefore, no dose adjustment is required for co-administered CYP3A substrates.
Croatian: Stoga nije potrebno prilagođavati dozu istodobno primijenjenih supstrata CYP3A.
English: The demographic characteristics of the overall study population were 67% Caucasian, 26% Asian, 56% females, and the median age was 52 years.
Croatian: Demografske značajke cjelokupne ispitivane populacije bile su sljedeće: 67% bolesnika bili su bijelci, 26% Azijci, a 56% žene; medijan dobi iznosio je 52 godine.
English: Alectinib and its major metabolite M4 are highly bound to human plasma proteins (>99%), independent of active substance concentration.
Croatian: Alektinib i njegov glavni metabolit M4 u velikoj se mjeri vezuju za proteine u plazmi ljudi (> 99%), neovisno o koncentraciji djelatne tvari.
English: ● If it is more than 6 hours until your next dose, take the missed dose as soon as you remember.
Croatian: Ako je do sljedeće doze preostalo više od 6 sati, uzmite propuštenu dozu čim se sjetite.
English: ● This means you take a total of 8 capsules (1200 mg) each day.
Croatian: To znači da ćete svaki dan uzeti ukupno 8 kapsula (1200 mg).
English: ALT = alanine aminotransferase; AST = aspartate aminotransferase; CPK = creatine phosphokinase; CTCAE = NCI Common Terminology Criteria for Adverse Events; ILD = interstitial lung disease; ULN = upper limit of normal a
Croatian: ALT = alanin aminotransferaza; AST = aspartat aminotransferaza; CPK = kreatin fosfokinaza; CTCAE (NCI Common Terminology Criteria for Adverse Events) = Zajednički terminološki kriteriji za nuspojave američkog Nacionalnog instituta za rak; IBP = intersticijska bolest pluća; GGN = gornja granica normale a
English: The demographic characteristics of the overall study population were 84% Caucasian, 8% Asian, 55% females.
Croatian: Demografske značajke cjelokupne ispitivane populacije bile su sljedeće: 84% bolesnika bili su bijelci, 8% Azijci, a 55% žene.
English: Look out for these while you are taking Alecensa.
Croatian: Pripazite na te znakove dok uzimate lijek Alecensa.
English: No patients had events of Grade ≥ 3 severity.
Croatian: Ni u jednog bolesnika nije zabilježen događaja stupnja ≥ 3.
English: These patients were treated with the recommended dose of 600 mg twice daily.
Croatian: Ti su bolesnici bili liječeni preporučenom dozom od 600 mg dvaput na dan.
English: Alectinib caused embryo-foetal toxicity in pregnant rats and rabbits.
Croatian: Alektinib je uzrokovao embriofetalnu toksičnost u skotnih ženki štakora i kunića.
English: For all patients with hepatic impairment, appropriate monitoring (e.g. markers of liver function) is advised, see section 4.4.
Croatian: Kod svih bolesnika s oštećenjem jetrene funkcije preporučuje se odgovarajuće praćenje (npr. pokazatelja jetrene funkcije), vidjeti dio 4.4.
English: M4 is a substrate of P-gp.
Croatian: M4 je supstrat P-gp-a.
English: What Alecensa contains
Croatian: Što Alecensa sadrži
English: INFORMATION IN BRAILLE alecensa
Croatian: PODACI NA BRAILLEOVOM PISMU alecensa
English: The capsules are provided in blisters and are available in cartons containing 224 hard capsules (4 packs of 56).
Croatian: Kapsule dolaze u blisterima, a dostupne su u pakiranjima koja sadrže 224 tvrde kapsule (4 pakiranja od 56 tvrdih kapsula).
English: ORR results for studies NP28673 and NP28761 were consistent across subgroups of baseline patient characteristics such as age, gender, race, ECOG performance status, Central Nervous System (CNS) metastasis and prior chemotherapy use, especially when considering the small number of patients in some subgroups.
Croatian: Rezultati za ORR u ispitivanjima NP28673 i NP28761 bili su konzistentni u svim podskupinama prema početnim značajkama bolesnika, poput dobi, spola, rase, funkcionalnog ECOG statusa, metastaza u središnjem živčanom sustavu (SŽS) i prethodne primjene kemoterapije, osobito uzimajući u obzir malen broj bolesnika u pojedinim podskupinama.
English: Severe myalgia and CPK elevations
Croatian: Teška mialgija i povišene vrijednosti CPK-a
English: Metabolite M1b was detected as a minor metabolite from in vitro and in human plasma in healthy subjects.
Croatian: M1b pronađen je kao sporedan metabolit in vitro i u plazmi zdravih ispitanika.
English: Sometimes your doctor may lower your dose, stop your treatment for a short time or stop your treatment completely if you feel unwell.
Croatian: Ponekad će Vam liječnik možda smanjiti dozu, privremeno prekinuti primjenu lijeka ili posve obustaviti liječenje ako se osjećate loše.
English: These include medicines that treat fungal infections (antifungals such as ketoconazole, itraconazole, voriconazole, posaconazole) and medicines that treat certain types of bacterial infection (antibiotics such as telithromycin)
Croatian: To uključuje lijekove za liječenje gljivičnih infekcija (antimikotike kao što su ketokonazol, itrakonazol, vorikonazol, posakonazol) i lijekove za liječenje nekih vrsta bakterijskih infekcija (antibiotike kao što je telitromicin)
English: * Includes one Grade 5 event ** Increased alkaline phosphatase was reported in the post-marketing period and in pivotal phase II and phase III clinical trials.
Croatian: * Uključuje jedan događaj stupnja 5 ** Povišena vrijednost alkalne fosfataze prijavljena je nakon stavljanja lijeka u promet te u pivotalnim kliničkim ispitivanjima faze II i faze III.
English: The dose of Alecensa should be reduced in steps of 150 mg twice daily based on tolerability.
Croatian: Dozu lijeka Alecensa treba smanjivati u koracima od 150 mg dvaput na dan u skladu s podnošljivošću.
English: A risk for induction of CYP2B6 and PXR regulated enzymes apart from CYP3A4 cannot be completely excluded.
Croatian: Ne može se posve isključiti rizik od indukcije CYP2B6 i enzima reguliranih PXR-om osim CYP3A4.
English: Effect of transporters on alectinib disposition
Croatian: Učinak prijenosnika na dispoziciju alektiniba
English: As elimination of alectinib is predominantly through metabolism in the liver, hepatic impairment may increase the plasma concentration of alectinib and/or its major metabolite M4.
Croatian: Budući da se alektinib pretežno eliminira metabolizmom u jetri, oštećenje jetrene funkcije može povećati plazmatske koncentracije alektiniba i/ili njegova glavnog metabolita M4.
English: It is unknown whether alectinib and its metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se alektinib i njegovi metaboliti u majčino mlijeko.
English: Alectinib absorbs UV light between 200 and 400 nm and demonstrated a phototoxic potential in an in vitro photosafety test in cultured murine fibroblasts after UVA irradiation.
Croatian: Alektinib apsorbira UV svjetlost duljine 200 - 400 nm te je pokazao fototoksični potencijal u in vitro testu fotosigurnosti na kulturama mišjih fibroblasta nakon izlaganja UVA zrakama.
English: The events generally occurred during the first 3 months of treatment, were usually transient and resolved upon temporary interruption of Alecensa treatment (reported for 1.5% and 3.0% of the patients, respectively) or dose reduction (2.2% and 1.2%, respectively).
Croatian: Ti su se događaji uglavnom javljali tijekom prva 3 mjeseca liječenja, obično su bili prolazne prirode te su se povukli nakon privremenog prekida liječenja lijekom Alecensa (prijavljeno u 1,5% odnosno 3,0% bolesnika) ili smanjenja doze (2,2% odnosno 1,2%).
English: Primary efficacy parameter
Croatian: Primarni parametar djelotvornosti
English: No starting dose adjustment is required in patients with underlying mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment.
Croatian: Nije potrebno prilagođavati početnu dozu u bolesnika s podležećim blagim (Child-Pugh stadij A) ili umjerenim (Child-Pugh stadij B) oštećenjem jetrene funkcije.
English: Your doctor will do blood tests at least every 2 weeks for the first month and as needed during treatment with Alecensa.
Croatian: Liječnik će provoditi krvne pretrage najmanje svaka 2 tjedna tijekom prvog mjeseca te prema potrebi tijekom liječenja lijekom Alecensa.
English: Formation of metabolite M1b and its minor isomer M1a is likely to be catalyzed by a combination of CYP isozymes (including isozymes other than CYP3A) and aldehyde dehydrogenase (ALDH) enzymes.
Croatian: Nastanak metabolita M1b i njegova sporednog izomera M1a vjerojatno je kataliziran kombinacijom CYP izoenzima (uključujući izoenzime osim CYP3A) i enzima aldehid dehidrogenaze (ALDH).
English: Hypersensitivity to alectinib or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na alektinib ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Patients should be monitored for pulmonary symptoms indicative of pneumonitis.
Croatian: Bolesnike je potrebno nadzirati zbog moguće pojave plućnih simptoma koji ukazuju na pneumonitis.
English: 224 (4 packs of 56) hard capsules
Croatian: 224 (4 pakiranja od 56) tvrde kapsule
English: What Alecensa is Alecensa is a cancer medicine that contains the active substance alectinib.
Croatian: Što je Alecensa Alecensa je lijek za liječenje raka koji sadrži djelatnu tvar alektinib.
English: ● medicines used to treat tuberculosis (e.g. rifampicin, rifabutin)
Croatian: ● lijekovi koji se koriste za liječenje tuberkuloze (npr. rifampicin, rifabutin).
English: ● slow heart beat (bradycardia).
Croatian: ● usporene otkucaje srca (bradikardiju)
English: Liver function, including ALT, AST, and total bilirubin should be monitored at baseline and then every 2 weeks during the first 3 months of treatment.
Croatian: Jetrenu funkciju, uključujući ALT, AST i ukupni bilirubin, treba odrediti na početku liječenja i pratiti svaka 2 tjedna tijekom prva 3 mjeseca liječenja.
English: ● sirolimus, a medicine used to prevent the body's immune system from rejecting a transplanted kidney, heart or liver
Croatian: ● sirolimus, lijek koji se koristi za sprječavanje imunološkog sustava tijela da odbaci presađen bubreg, srce ili jetru
English: ● This means you take a total of 6 capsules (900 mg) each day.
Croatian: To znači da ćete svaki dan uzeti ukupno 6 kapsula (900 mg).
English: What Alecensa is and what it is used for
Croatian: Što je Alecensa i za što se koristi
English: Take special care when driving and using machines as you may develop problems with vision or slowing of the heartbeat or low blood pressure that can lead to fainting or dizziness while you are taking Alecensa.
Croatian: Budite posebno oprezni kada upravljate vozilom ili radite sa strojevima jer se dok uzimate lijek Alecensa mogu razviti problemi s vidom ili usporeni otkucaji srca ili nizak krvni tlak koji može dovesti do nesvjestice ili omaglice.
English: Patient demographics were consistent with that of a NSCLC ALK positive population.
Croatian: Demografske značajke bolesnika bile su u skladu s onima u populaciji s ALK-pozitivnim NSCLC-om.
English: This is because Alecensa can affect the way some other medicines work.
Croatian: Naime, Alecensa može utjecati na način djelovanja nekih drugih lijekova.
English: The geometric mean volume of distribution at steady state (Vss) of alectinib following IV administration was 475 L, indicating extensive distribution into tissues.
Croatian: Geometrijska srednja vrijednost volumena distribucije alektiniba u stanju dinamičke ravnoteže (Vss) nakon i.v. primjene iznosila je 475 l, što ukazuje na opsežnu distribuciju u tkiva.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreeed subsequent updates of the RMP.
Croatian: Plan upravljanja rizikom (RMP) Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: System organ class ADRs (MedDRA)
Croatian: Organski sustav Nuspojave (MedDRA)
English: Secondary efficacy parameters
Croatian: Sekundarni parametri djelotvornosti
English: Age, body weight, race and gender had no clinically meaningful effect on the systemic exposure of alectinib and M4.
Croatian: Dob, tjelesna težina, rasa i spol nisu imali klinički značajnog učinka na sistemsku izloženost alektinibu i njegovu metabolitu
English: Alectinib did not inhibit OATP1B1/OATP1B3, OAT1, OAT3 or OCT2 at clinically relevant concentrations in vitro.
Croatian: Alektinib nije inhibirao OATP1B1/OATP1B3, OAT1, OAT3 ni OCT2 in vitro pri klinički značajnim koncentracijama.
English: ● abnormal results of blood tests to check for liver problems (high levels of alanine aminotransferase, aspartate aminotransferase and bilirubin)
Croatian: ● odstupanja u nalazima krvnih pretraga kojima se provjerava postoje li jetrene tegobe (visoke razine alanin aminotransferaze, aspartat aminotransferaze i bilirubina)
English: Based on preclinical data, alectinib is not a substrate of p-glycoprotein or BCRP, which are both efflux transporters in the blood brain barrier, and is therefore able to distribute into and be retained within the central nervous system.
Croatian: Pretklinički podaci pokazali su da alektinib nije supstrat p-glikoproteina ni BCRP-a, koji su oba efluksni prijenosnici u krvno-moždanoj barijeri, te stoga može ulaziti u središnji živčani sustav i zadržavati se u njemu.
English: M4 has shown similar in vitro potency and activity against ALK.
Croatian: M4 je pokazao sličnu potentnost i aktivnost protiv ALK-a in vitro.
English: ● nefazodone, a medicine used to treat depression
Croatian: ● nefazodon, lijek koji se koristi za liječenje depresije
English: Alecensa can cause severe or life-threatening inflammation of the lungs during treatment.
Croatian: Alecensa može uzrokovati tešku ili po život opasnu upalu pluća tijekom liječenja.
English: Alectinib and M4 are not substrates of BCRP or organic anion-transporting polypeptide (OATP) 1B1/B3.
Croatian: Alektinib i M4 nisu supstrati BCRP-a ni polipeptidnog prijenosnika organskih aniona (engl. organic anion transporting polypeptide, OATP) 1B1/B3.
English: In addition to crizotinib, patients may have received previous treatment with chemotherapy.
Croatian: Osim krizotiniba, bolesnici su prethodno mogli primati i kemoterapiju.
English: There is no specific antidote for overdose with Alecensa.
Croatian: Nema specifičnog protulijeka za predoziranje lijekom Alecensa.
English: Stratified log-rank p-value p <0.0001
Croatian: Stratificirana log-rang p-vrijednost p < 0,0001
English: Although PK simulations for Alecensa do not indicate a low exposure in patients with extreme body weight (i.e. >130 kg), alectinib is widely distributed and clinical studies for alectinib enrolled patients within a range of body weights of 36.9−123 kg.
Croatian: Iako farmakokinetičke simulacije za lijek Alecensa ne ukazuju na nisku izloženost u bolesnika ekstremno visoke tjelesne težine (tj. > 130 kg), alektinib se opsežno raspodjeljuje, a u klinička ispitivanja alektiniba bili su uključeni bolesnici čija je tjelesna težina bila unutar raspona od 36,9 - 123 kg.
English: ● Do not take this medicine after the expiry date which is stated on the carton and either the blister or the bottle after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenoga na kutiji i blisteru ili boci iza oznake „Rok valjanosti“ ili „EXP“.
English: Time to CNS progression (IRC)*, ** Number of patients with event n (%)
Croatian: Vrijeme do progresije u SŽS-u (IRC)*, ** Broj bolesnika s događajem, n (%)
English: These studies were conducted in rats and monkeys at exposures equal to or greater than 2.6- and 0.5-fold, respectively, of the human exposure, measured by AUC, at the recommended dose of 600 mg twice daily.
Croatian: Ta su ispitivanja provedena na štakorima i majmunima pri razinama izloženosti koje su bile najmanje 2,6 odnosno 0,5 puta veće od izloženosti u ljudi,određene na temelju AUC-u, nakon primjene preporučene doze od 600 mg dvaput na dan.
English: The geometric mean Metabolite/Parent ratio at steady state is 0.399.
Croatian: Geometrijska srednja vrijednost omjera metabolita i ishodišnog spoja u stanju dinamičke ravnoteže iznosi 0,399.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Alecensa in all subsets of the paediatric population in lung carcinoma (small cell and non-small cell carcinoma) (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Alecensa u svim podskupinama pedijatrijske populacije za karcinom pluća (karcinom malih stanica i karcinom nemalih stanica) (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Cardiac disorders Bradycardia4)
Croatian: Srčani poremećaji bradikardija4)
English: Heart rate less than 60 beats per minute (bpm).
Croatian: Srčana frekvencija manja od 60 otkucaja u minuti.
English: ● you may feel tired, weak or short of breath due to a reduction in the number of red blood cells,
Croatian: ● možda ćete osjećati umor, slabost ili nedostatak zraka zbog smanjenog broja crvenih krvnih stanica, poznatog pod nazivom anemija
English: How Alecensa works
Croatian: Kako Alecensa djeluje
English: Multiple doses of esomeprazole, a proton pump inhibitor, 40 mg once daily, demonstrated no clinically relevant effect on the combined exposure of alectinib and M4.
Croatian: Višestruke doze esomeprazola, inhibitora protonske pumpe, od 40 mg jedanput na dan nisu pokazale klinički značajan učinak na kombiniranu izloženost alektinibu i njegovu metabolitu
English: ● if you have an inherited problem called ‘galactose intolerance', ‘congenital lactase deficiency' or
Croatian: ● ako imate nasljedni poremećaj pod nazivom „nepodnošenje galaktoze“, „potpuni nedostatak laktaze“ ili „malapsorpcija glukoze i galaktoze“
English: ILD/pneumonitis of any severity grade
Croatian: IBP/pneumonitis bilo kojeg stupnja težine
English: The most common adverse drug reactions (ADRs) (≥ 20%) were constipation (35%), oedema (30%, including oedema peripheral, oedema, generalised oedema, eyelid oedema, periorbital oedema, face oedema and localised oedema), and myalgia (28%, including myalgia and musculoskeletal pain).
Croatian: Najčešće nuspojave lijeka (≥ 20%) bile su konstipacija (35%), edem (30%, uključujući periferni edem, edem, generalizirani edem, edem vjeđe, periorbitalni edem, edem lica i lokalizirani edem) i mialgija (28%, uključujući mialgiju i mišićno-koštanu bol).
English: Do not expose yourself to the sun for any long period of time while you are taking Alecensa and for 7 days after you stop.
Croatian: Nemojte se izlagati suncu tijekom duljih razdoblja dok uzimate lijek Alecensa i još 7 dana nakon prestanka liječenja.
English: Patients should be monitored for pulmonary symptoms indicative of pneumonitis (see sections 4.2 and 4.4).
Croatian: Bolesnike je potrebno nadzirati zbog moguće pojave plućnih simptoma koji ukazuju na pneumonitis (vidjeti dijelove 4.2 i 4.4).
English: The recommended dose of Alecensa is 600 mg (four 150 mg capsules) taken twice daily with food (total daily dose of 1200 mg).
Croatian: Preporučena doza lijeka Alecensa je 600 mg (četiri kapsule od 150 mg) dvaput na dan s hranom (ukupna dnevna doza od 1200 mg).
English: (range 0.5 - 29.0)
Croatian: (raspon: 0,5 - 29,0)
English: ● Do not breast-feed while taking this medicine.
Croatian: Nemojte dojiti dok uzimate ovaj lijek.
English: Baseline demographic and disease characteristics for Alecensa were median age 58 years (54 years for crizotinib), 55% female (58% for crizotinib), 55% non-Asian (54% for crizotinib), 61% with no smoking history (65% for crizotinib), 93% ECOG PS of 0 or 1 (93% for crizotinib), 97% Stage IV disease (96% for crizotinib), 90% adenocarcinoma histology (94% for crizotinib), 40% CNS metastases at baseline (38% for crizotinib) and 17% having received prior CNS radiation (14% for crizotinib).
Croatian: Demografske značajke i značajke bolesti na početku ispitivanja bile su sljedeće: medijan dobi iznosio je 58 godina (54 godine za krizotinib), 55% ispitanika bile su žene (58% za krizotinib), 55% ispitanika nisu bili Azijci (54% za krizotinib), 61% ispitanika nije imalo pušenje u anamnezi (65% za krizotinib), 93% ispitanika imalo je funkcionalni ECOG status 0 ili 1 (93% za krizotinib), 97% ispitanika imalo je bolest stadija IV (96% za krizotinib), 90% ispitanika imalo je histološki nalaz adenokarcinoma (94% za krizotinib), 40% ispitanika imalo je metastaze u središnjem živčanom sustavu (SŽS) na početku ispitivanja (38% za krizotinib), a u 17% je prethodno primijenjeno zračenje SŽS-a (14% za krizotinib).
English: Most of these events were of mild or moderate severity; Grade 3 events were reported for diarrhea (0.7%), nausea (0.5%), and vomiting (0.2%).
Croatian: Većina tih događaja bila je blage ili umjerene težine; događaji stupnja 3 prijavljeni su za proljev (0,7%), mučninu (0,5%) i povraćanje (0,2%).
English: Based on in vitro data, alectinib is not a substrate of P-gp.
Croatian: Prema podacima in vitro, alektinib nije supstrat P-gp-a.
English: Table 1 Dose reduction schedule
Croatian: Tablica 1 Raspored smanjivanja doze
English: There are no or limited amount of data from the use of Alecensa in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni lijeka Alecensa u trudnica ograničeni.
English: The accumulation ratio for the twice-daily 600 mg regimen was approximately 6-fold.
Croatian: Omjer akumulacije kod režima doziranja od 600 mg dvaput na dan bio je približno šesterostruk.
English: (range 0.3 - 27.0)
Croatian: (raspon: 0,3 - 27,0)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 February 2017
Croatian: Datum prvog odobrenja: 16. veljače 2017.