FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT Alecensa 150 mg hard capsules
Croatian: NAZIV LIJEKA Alecensa 150 mg tvrde kapsule
English: Dose reduction schedule
Croatian: Raspored smanjivanja doze
English: Across clinical trials (NP28761, NP28673, BO28984), 1 out of 405 patients treated with Alecensa (0.2%) had a Grade 3 ILD.
Croatian: U svim kliničkim ispitivanjima (NP28761, NP28673, BO28984), 1 od 405 bolesnika liječenih lijekom Alecensa (0,2%) imao je IBP stupnja 3.
English: ● inflammation of the mucous membrane of the mouth
Croatian: ● upala sluznice usta
English: Capsule shell Hypromellose Carrageenan Potassium chloride Titanium dioxide (E171) Maize starch Carnauba wax
Croatian: Ovojnica kapsule hipromeloza karagenan kalijev klorid titanijev dioksid (E171) kukuruzni škrob karnauba vosak
English: What Alecensa looks like and contents of the pack Alecensa hard capsule are white, with ‘ALE' printed in black ink on the cap and ‘150 mg' printed in black ink on the body.
Croatian: Alecensa tvrde kapsule su bijele kapsule s oznakom „ALE“ otisnutom crnom tintom na kapici kapsule i oznakom „150 mg“ otisnutom crnom tintom na tijelu kapsule.
English: Across clinical trials (NP28761, NP28673, BO28984) two patients with Grade 3-4 AST/ALT elevations had documented drug induced liver injury by liver biopsy.
Croatian: U svim kliničkim ispitivanjima (NP28761, NP28673, BO28984), dva bolesnika s povišenim vrijednostima AST-a/ALT-a stupnja 3-4 imala su dokumentirano oštećenje jetre inducirano djelovanjem lijeka, potvrđeno biopsijom jetre.
English: Proliferative zone extension in GI mucosa in both species was observed at exposures equal to or greater than 20-120% of the human AUC exposure at the recommended dose.
Croatian: Kod obje je vrste primijećeno proširenje proliferacijske zone u sluznici probavnog sustava pri razinama izloženosti koje su bile najmanje 20 - 120% veće od izloženosti u ljudi nakon primjene preporučene doze (na temelju AUC-a).
English: The pharmacokinetics of alectinib has not been studied in patients with severe renal impairment.
Croatian: Farmakokinetika alektiniba nije se ispitivala u bolesnika s teškim oštećenjem bubrežne funkcije.
English: Interstitial lung disease (ILD) / pneumonitis
Croatian: Intersticijska bolest pluća (IBP) / pneumonitis
English: Based on the effects on the combined exposure of alectinib and M4, no dose adjustments are required when Alecensa is co-administered with CYP3A inducers.
Croatian: S obzirom na učinke na kombiniranu izloženost alektinibu i njegovu metabolitu M4, nije potrebno prilagođavati dozu kada se Alecensa primjenjuje istodobno s induktorima CYP3A.
English: Constipation (35%), nausea (19%), diarrhoea (16%) and vomiting (11%) were the most commonly reported gastrointestinal (GI) reactions.
Croatian: Najčešće prijavljene nuspojave u probavnom sustavu bile su konstipacija (35%), mučnina (19%), proljev (16%) i povraćanje (11%).
English: Blisters: Store in the original package in order to protect from moisture.
Croatian: Blisteri: Čuvati u originalnom pakiranju radi zaštite od vlage.
English: Based on in vitro data, CYP3A4 is the primary enzyme mediating the metabolism of both alectinib and its major active metabolite M4, and CYP3A contributes to 40% − 50% of total hepatic metabolism.
Croatian: Prema podacima in vitro, metabolizam i alektiniba i njegova glavnog aktivnog metabolita M4 posredovan je primarno CYP3A4; CYP3A sudjeluje u 40% − 50% ukupnog jetrenog metabolizma.
English: Among patients included in the study, 20% of the patients had previously progressed on crizotinib treatment only, and 80% had previously progressed on crizotinib and at least one chemotherapy treatment.
Croatian: Među bolesnicima uključenima u ispitivanje, 20% bolesnika doživjelo je progresiju tijekom prethodnog liječenja samo krizotinibom, dok je 80% bolesnika doživjelo progresiju tijekom prethodnog liječenja krizotinibom i najmanje jednim kemoterapijskim protokolom.
English: CNS-ORR in patients with measurable and non-measurable CNS metastases at baseline (IRC)
Croatian: ORR u SŽS-u u bolesnika s mjerljivim i nemjerljivim metastazama u SŽS-u na početku ispitivanja (IRC)
English: These events did not lead to withdrawal from Alecensa treatment.
Croatian: Ti događaji nisu doveli do prekida liječenja lijekom Alecensa.
English: ● abnormal results of blood tests to check for liver disease or bone disorders (high level of alkaline phosphatase)
Croatian: ● odstupanja u nalazima krvnih testova kojima se utvrđuju jetrena bolest ili koštani poremećaji (visoka razina alkalne fosfataze)
English: The safety profile of Alecensa was generally consistent across the pivotal phase III clinical trial BO28984 (ALEX) and phase II trials (NP28761, NP28673).
Croatian: Sigurnosni profil lijeka Alecensa općenito je bio dosljedan u pivotalnom kliničkom ispitivanju faze III BO28984 (ALEX) i ispitivanjima faze II (NP28761, NP28673).
English: ● Capsule shell: hypromellose, carrageenan, potassium chloride, titanium dioxide (E171), maize starch and carnauba wax
Croatian: Ovojnica kapsule: hipromeloza, karagenan, kalijev klorid, titanijev dioksid (E171), kukuruzni škrob i karnauba vosak
English: Study NP28761 was a Phase I/II single arm multicentre study conducted in patients with ALK positive advanced NSCLC who have previously progressed on crizotinib treatment.
Croatian: Ispitivanje NP28761 bilo je multicentrično ispitivanje faze I/II s jednom skupinom provedeno u bolesnika s ALK-pozitivnim uznapredovalim NSCLC-om koji su doživjeli progresiju tijekom prethodnog liječenja krizotinibom.
English: Symptomatic bradycardia can occur with Alecensa (see section 4.8).
Croatian: Kod liječenja lijekom Alecensa može nastupiti simptomatska bradikardija (vidjeti dio 4.8).
English: The data described below reflect exposure to Alecensa in 405 patients with ALK-positive advanced NSCLC who participated in one randomised Phase III clinical trial (BO28984) and in two single-arm phase II clinical trials (NP28761, NP28673).
Croatian: Podaci opisani u nastavku odražavaju izloženost lijeku Alecensa u 405 bolesnika s ALK-pozitivnim uznapredovalim NSCLC-om koji su sudjelovali u jednom randomiziranom kliničkom ispitivanju faze III (BO28984) i dvama kliničkim ispitivanjima s jednom skupinom, faze II (NP28761, NP28673).
English: A total of 87 patients were included in the phase II part of the study and received Alecensa orally, at the recommended dose of 600 mg twice daily.
Croatian: U fazu II ovog ispitivanja uključeno je ukupno 87 bolesnika koji su primali lijek Alecensa peroralno u preporučenoj dozi od 600 mg dvaput na dan.
English: If a contributing concomitant medicinal product is identified and discontinued, or its dose is adjusted, resume at reduced dose (see Table 1) upon recovery to ≤ Grade 1 (asymptomatic) bradycardia or to a heart rate of ≥ 60 bpm, with frequent monitoring as clinically indicated.
Croatian: Ako se utvrdi da je bradikardiji pridonio jedan od istodobno primijenjenih lijekova i ako se njegova primjena ukine ili prilagodi doza, nastaviti liječenje smanjenom dozom (vidjeti Tablicu 1) nakon što se bradikardija ublaži do stupnja ≤ 1 (asimptomatska bradikardija) ili srčani ritam bude ≥ 60 otkucaja u minuti, uz često praćenje sukladno kliničkoj indikaciji.
English: Elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) greater than 5 times the ULN as well as bilirubin elevations of more than 3 times the ULN occurred in patients in pivotal clinical trials with Alecensa (see section 4.8).
Croatian: U bolesnika koji su sudjelovali u pivotalnim kliničkim ispitivanjima lijeka Alecensa zabilježena su povišenja vrijednosti alanin aminotransferaze (ALT) i aspartat aminotransferaze (AST) više od 5 puta iznad GGN-a, kao i povišenja vrijednosti bilirubina više od 3 puta iznad GGN-a (vidjeti dio 4.8).
English: SPECIAL STORAGE CONDITIONS Store in the original package and keep the bottle tightly closed in order to protect from moisture
Croatian: POSEBNE MJERE ČUVANJA Čuvati u originalnom pakiranju i držati bocu čvrsto zatvorenom radi zaštite od vlage
English: ● medicines used to stop seizures or fits (anti-epileptics such as phenytoin, carbamazepine, or phenobarbital)
Croatian: ● lijekovi koji se koriste za zaustavljanje napadaja (antiepileptici kao što su fenitoin,
English: Among the patients included in the study, 26% of the patients had previously progressed on crizotinib treatment only, and 74% had previously progressed on crizotinib and at least one chemotherapy treatment.
Croatian: Među bolesnicima uključenima u ispitivanje, 26% bolesnika doživjelo je progresiju tijekom prethodnog liječenja samo krizotinibom, dok je 74% bolesnika doživjelo progresiju tijekom prethodnog liječenja krizotinibom i najmanje jednim kemoterapijskim protokolom.
English: Photosensitivity to sunlight has been reported with Alecensa administration (see section 4.8).
Croatian: Kod primjene lijeka Alecensa prijavljena je fotoosjetljivost na sunčevu svjetlost (vidjeti dio 4.8).
English: Based on the effects on the combined exposure of alectinib and M4, no dose adjustments are required when Alecensa is co-administered with CYP3A inhibitors.
Croatian: S obzirom na učinke na kombiniranu izloženost alektinibu i njegovu metabolitu M4, nije potrebno prilagođavati dozu kada se Alecensa primjenjuje istodobno s inhibitorima CYP3A.
English: The primary endpoint of the trial was to demonstrate superiority of Alecensa versus crizotinib based on Progression Free survival (PFS) as per investigator assessment using RECIST 1.1.
Croatian: Primarna mjera ishoda ispitivanja bila je dokazati superiornost lijeka Alecensa u odnosu na krizotinib na temelju preživljenja bez progresije bolesti (engl. progression-free survival, PFS) prema ocjeni ispitivača temeljenoj na verziji 1.1 Kriterija za ocjenu odgovora kod solidnih tumora (engl.
English: [19.9; NE]
Croatian: [6,9; NP]
English: The following side effects may happen with this medicine.
Croatian: Kod primjene ovog lijeka mogu se javiti sljedeće nuspojave.
English: Investigations Weight increased
Croatian: ● povećanje tjelesne težine
English: Study NP28673 was a Phase I/II single arm, multicentre study conducted in patients with ALK-positive advanced NSCLC who have previously progressed on crizotinib treatment.
Croatian: Ispitivanje NP28673 bilo je multicentrično ispitivanje faze I/II s jednom skupinom, provedeno u bolesnika s ALK-pozitivnim uznapredovalim NSCLC-om koji su doživjeli progresiju tijekom prethodnog liječenja krizotinibom.
English: In BO28984 (ALEX; N=152) the median duration of exposure to Alecensa was 17.9 months, whereas the median duration of exposure to crizotinib was 10.7 months.
Croatian: N=152) iznosio je 17,9 mjeseci, dok je medijan trajanja izloženosti krizotinibu iznosio 10,7 mjeseci.
English: 450 mg twice daily
Croatian: 450 mg dvaput na dan
English: Duration of response (INV) Median (months) [95 % CI]
Croatian: Trajanje odgovora (ispitivač) Medijan (mjeseci) [95 % CI]
English: 79639 Grenzach-Wyhlen
Croatian: D 79639 Grenzach-Wyhlen NJEMAČKA
English: Co-administration of multiple oral doses of 400 mg posaconazole twice daily, a strong CYP3A inhibitor, with a single oral dose of 300 mg alectinib increased alectinib exposure Cmax and AUCinf by 1.18 and 1.75-fold respectively, and reduced M4 Cmax and AUCinf by 71% and 25% respectively.The effect on the combined exposure of alectinib and M4 was minor, reducing Cmax by 7% and increasing AUCinf 1.36-fold.
Croatian: Istodobna primjena višestrukih oralnih doza posakonazola, snažnog inhibitora CYP3A, od 400 mg dvaput na dan s jednokratnom oralnom dozom alektiniba od 300 mg povećala je izloženost alektinibu: Cmax 1,18 puta, a AUCinf 1,75 puta te smanjila Cmax i AUCinf metabolita M4 za 71% odnosno 25%.
English: Concurrent elevations in ALT or AST greater than or equal to three times the ULN and total bilirubin greater than or equal to two times the ULN, with normal alkaline phosphatase, occurred in one patient (0.2%) treated in Alecensa clinical trials.
Croatian: Istodobno povišene vrijednosti ALT-a ili AST-a tri ili više puta iznad GGN-a i vrijednost ukupnog bilirubina dva ili više puta iznad GGN-a, uz normalne vrijednosti alkalne fosfataze, zabilježene su u jednog bolesnika (0,2%) liječenog u kliničkim ispitivanjima lijeka Alecensa.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains alectinib hydrochloride equivalent to 150 mg alectinib.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tvrda kapsula sadrži 150 mg alektiniba u obliku alektinibklorida.
English: A total of 138 patients were included in the phase II part of the study and received Alecensa orally, at the recommended dose of 600 mg twice daily.
Croatian: U fazu II ovog ispitivanja uključeno je ukupno 138 bolesnika koji su primali lijek Alecensa peroralno u preporučenoj dozi od 600 mg dvaput na dan.
English: Alecensa treatment
Croatian: Liječenje lijekom Alecensa
English: The primary endpoint was to evaluate the efficacy of Alecensa by ORR as per central IRC assessment using RECIST version 1.1.
Croatian: Mjera primarnog ishoda bila je ocijeniti djelotvornost lijeka Alecensa na temelju ORR-a prema ocjeni središnjeg IRC-a temeljenoj na verziji 1.1. RECIST kriterija.
English: This is to check you do not have any liver problems while taking Alecensa.
Croatian: Na taj će način provjeriti imate li jetrenih tegoba tijekom liječenja lijekom Alecensa.
English: ECOG PS (0/1 vs. 2), race (Asian vs. non-Asian), and CNS metastases at baseline (yes vs. no) were stratification factors for randomisation.
Croatian: Stratifikacijski faktori za randomizaciju bili su funkcionalni ECOG (Eastern Cooperative Oncology Group) status (0/1 naspram 2), rasa (Azijci naspram ostalih) i metastaze u središnjem živčanom sustavu (da ili ne).
English: ALK-positive NSCLC status should be established prior to initiation of Alecensa therapy.
Croatian: Prije započinjanja terapije lijekom Alecensa potrebno je utvrditi ALK-pozitivan status NSCLC-a.
English: The co-primary endpoint was to evaluate the ORR as per central IRC assessment using RECIST 1.1 in patients with prior exposure of cytotoxic chemotherapy treatments.
Croatian: Mjera ko-primarnog ishoda bila je ocijeniti ORR prema ocjeni središnjeg IRC-a temeljenoj na verziji 1.1. RECIST kriterija u bolesnika prethodno izloženih citotoksičnoj kemoterapiji.
English: This event led to withdrawal from Alecensa treatment.
Croatian: Taj je događaj doveo do prekida liječenja lijekom Alecensa.
English: Temporarily withhold until recovery to baseline or to ≤ 2.5 times ULN, then resume at the same dose.
Croatian: Privremeno odgoditi primjenu lijeka do oporavka na početnu vrijednost ili vrijednost ≤ 2,5 puta iznad GGN-a, a zatim nastaviti liječenje istom dozom.
English: ● lapatinib, a medicine used to treat certain types of breast cancer
Croatian: ● lapatinib, lijek koji se koristi za liječenje određenih vrsta raka dojke
English: Median time to onset for constipation, nausea, diarrhea, and/or vomiting events across clinical trials (NP28761, NP28673, BO28984) was 21 days.
Croatian: Medijan vremena do nastupa konstipacije, mučnine, proljeva i/ili povraćanja u svim kliničkim ispitivanjima (NP28761, NP28673, BO28984) iznosio je 21 dan.
English: Concurrent elevations in ALT or AST greater than or equal 3 times the ULN and total bilirubin greater than or equal 2 times the ULN, with normal alkaline phosphatase, occurred in one patient treated in Alecensa clinical trials.
Croatian: Istodobno povišene vrijednosti ALT-a ili AST-a 3 ili više puta iznad GGN-a i vrijednost ukupnog bilirubina 2 ili više puta iznad GGN-a, uz normalne vrijednosti alkalne fosfataze, zabilježene su u jednog bolesnika liječenog u kliničkim ispitivanjima lijeka Alecensa.
English: Glyceryl monooleate
Croatian: karnauba vosak bijeli šelak glicerilmonooleat
English: ● Do not take Alecensa if you are pregnant.
Croatian: Nemojte uzimati lijek Alecensa ako ste trudni, jer on može naškoditi Vašem djetetu.
English: Nervous system disorders Dysgeusia 2)
Croatian: Poremećaji živčanog sustava disgeuzija često
English: In the phase III clinical trial BO28984, Grade 3 or 4 bilirubin elevations occurred in 3.3% of patients receiving Alecensa versus no patient receiving crizotinib.
Croatian: U kliničkom ispitivanju faze III BO28984, povišenja vrijednosti bilirubina stupnja 3 ili 4 zabilježena su u 3,3% bolesnika koji su primali lijek Alecensa te ni u jednog bolesnika liječenog krizotinibom.
English: Temporarily withhold until recovery to ≤ Grade 1 (asymptomatic) bradycardia or to a heart rate of ≥ 60 bpm.
Croatian: Privremeno odgoditi primjenu lijeka dok se bradikardija ne ublaži do stupnja ≤ 1 (asimptomatska bradikardija) ili dok srčana frekvencija ne bude ≥ 60 otkucaja u minuti.
English: ● topotecan, a medicine used to treat certain types of cancer
Croatian: ● topotekan, lijek koji se koristi za liječenje određenih vrsta raka
English: NAME OF THE MEDICINAL PRODUCT Alecensa 150 mg hard capsules alectinib
Croatian: NAZIV LIJEKA Alecensa 150 mg tvrde kapsule alektinib
English: Increased blood creatine phosphokinase
Croatian: Teška mialgija i povišene vrijednosti kreatin fosfokinaze (CPK)
English: How to take Alecensa
Croatian: Kako uzimati lijek Alecensa
English: Cases of ILD/pneumonitis have been reported in clinical trials with Alecensa (see section 4.8).
Croatian: U kliničkim ispitivanjima lijeka Alecensa prijavljeni su slučajevi IBP-a/pneumonitisa (vidjeti dio 4.8).
English: * Key secondary endpoints part of the hierarchical testing ** Competing risk analysis of CNS progression, systemic progression and death as competing events *** 2 patients in the crizotinib arm and 6 patients in the alectinib arm had CR CI = confidence interval; CNS = central nervous system; CR = complete response; DOR = duration of response; HR = hazard ratio; IRC = Independent Review Committee; INV = investigator; NE = not estimable; ORR = objective response rate; PFS = progression free survival
Croatian: * Glavne sekundarne mjere ishoda koje su bile dio hijerarhijskog ispitivanja ** Analiza konkurentnih rizika (engl. competing risk analysis) kod koje su konkurentni događaji progresija u SŽS-u, sistemska progresija i smrt *** Potpuni odgovor zabilježen je u 2 bolesnika u skupini liječenoj krizotinibom i 6 bolesnika u skupini liječenoj alektinibom
English: Table 3 ADRs reported in Alecensa clinical trials (NP28761, NP28673, BO28984; N=405) and during post-marketing
Croatian: Tablica 3 Nuspojave lijeka prijavljene u kliničkim ispitivanjima lijeka Alecensa (NP28761, NP28673, BO28984; N=405) te nakon stavljanja lijeka u promet
English: CNS responders n (%)
Croatian: Bolesnici s odgovorom u SŽS-u, n (%)
English: CI = confidence interval; DOR = duration of response; IRC = independent review committee; NE = not estimable; ORR = objective response rate; PFS= progression free survival; RE = response evaluable a
Croatian: CI (engl. confidence interval) = interval pouzdanosti; CR (engl. complete response) = potpuni odgovor; DOR (engl. duration of response) = trajanje odgovora; HR (engl. hazard ratio) = omjer hazarda; IRC = neovisno ocjenjivačko povjerenstvo; NP = ne može se procijeniti; ORR (engl. objective response rate) = stopa objektivnog odgovora; PFS (engl. progression free survival) = preživljenje bez progresije bolesti; SŽS = središnji živčani sustav
English: Temporarily withhold until recovery to baseline or to ≤ 2.5 times ULN, then resume at reduced dose as per Table 1.
Croatian: Privremeno odgoditi primjenu lijeka do oporavka na početnu vrijednost ili vrijednost ≤ 2,5 puta iznad GGN-a, zatim nastaviti liječenje smanjenom dozom u skladu s Tablicom 1.
English: Table 3 lists the ADRs occurring in patients who received Alecensa across two phase II clinical trials (NP28761, NP28673) and one phase III clinical trial (BO28984; ALEX), and during post-marketing.
Croatian: U Tablici 3 prikazane su nuspojave lijeka koje su se javile u bolesnika liječenih lijekom Alecensa u dvama kliničkim ispitivanjima faze II (NP28761, NP28673) i jednom kliničkom ispitivanju faze III (BO28984; ALEX) te nakon stavljanja lijeka u promet.
English: Elevations of CPK occurred in 43% of 362 patients with CPK laboratory data available across clinical trials (NP28761, NP28673, BO28984) with Alecensa.
Croatian: Povišenja vrijednosti CPK-a nastupila su u 43% od 362 bolesnika za koje su bili dostupni laboratorijski podaci o vrijednostima CPK-a u svim kliničkim ispitivanjima lijeka Alecensa (NP28761, NP28673, BO28984).
English: Permanently discontinue if no contributing concomitant medicinal product is identified.
Croatian: Trajno obustaviti liječenje ako se utvrdi da bradikardiji nije pridonio nijedan od istodobno primijenjenih lijekova.
English: [14.8, NE]
Croatian: [14,8; NP]
English: Other side effects Tell your doctor, pharmacist or nurse if you notice any of the following side effects:
Croatian: Ostale nuspojave Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako primijetite bilo koju od sljedećih nuspojava: Vrlo česte (mogu se javiti u više od 1 na 10 osoba):
English: In the phase II clinical trials (NP28761, NP28673; N=253), the median duration of exposure to Alecensa was 11 months.
Croatian: Medijan trajanja izloženosti lijeku Alecensa u kliničkim ispitivanjima faze II (NP28761, NP28673; N=253) iznosio je 11 mjeseci.
English: Mothers should be advised against breast-feeding while receiving Alecensa.
Croatian: Majkama treba savjetovati da ne doje tijekom liječenja lijekom Alecensa.
English: ORR (IRC) in patients pre-treated with chemotherapy Responders N (%) [95% CI]
Croatian: ORR (IRC) u populaciji u kojoj se mogao ocijeniti odgovor Broj bolesnika s odgovorom, N (%) [95% CI]
English: In vitro metabolism studies showed that CYP3A4 is the main CYP isozyme mediating alectinib and its major metabolite M4 metabolism, and is estimated to contribute 40-50% of alectinib metabolism.
Croatian: Ispitivanja metabolizma in vitro pokazala su da je CYP3A4 glavni CYP izoenzim koji posreduje u metabolizmu alektiniba i njegova glavnog metabolita M4.
English: ALK positive non-small cell lung cancer
Croatian: ALK-pozitivan rak pluća nemalih stanica (NSCLC) Prethodno neliječeni bolesnici
English: In the phase III clinical trial BO28984 15% of patients treated with Alecensa had post-dose heart rate values below 50 bpm versus 20% of patients treated with crizotinib.
Croatian: U kliničkom ispitivanju faze III BO28984, srčana frekvencija ispod 50 otkucaja u minuti nakon primjene doze zabilježena je u 15% bolesnika koji su primali lijek Alecensa te u 20% bolesnika liječenih krizotinibom.
English: Median time to Grade 3 CPK elevation was 14 days across clinical trials (NP28761, NP28673, BO28984).
Croatian: Medijan vremena do povišenja vrijednosti CPK-a na stupanj 3 iznosio je 14 dana u svim kliničkim ispitivanjima (NP28761, NP28673, BO28984).
English: If a contributing concomitant medicinal product is identified and discontinued, or its dose is adjusted, resume at previous dose upon recovery to ≤ Grade 1 (asymptomatic) bradycardia or to a heart rate of ≥ 60 bpm.
Croatian: Ako se utvrdi da je bradikardiji pridonio jedan od istodobno primijenjenih lijekova i ako se njegova primjena ukine ili prilagodi doza, nastaviti liječenje dotadašnjom dozom nakon što se bradikardija ublaži do stupnja ≤ 1 (asimptomatska bradikardija) ili srčani ritam bude ≥ 60 otkucaja u minuti.
English: Alecensa contains sodium
Croatian: Alecensa sadrži natrij
English: Severe myalgia and creatine phosphokinase (CPK) elevation Myalgia or musculoskeletal pain was reported in patients in pivotal trials with Alecensa, including Grade 3 events (see section 4.8).
Croatian: U pivotalnim ispitivanjima lijeka Alecensa prijavljeni su slučajevi mialgije ili mišićno-koštane boli, uključujući događaje stupnja 3 (vidjeti dio 4.8).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BOTTLE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA ZA BOCU
English: CNS responders n (%) [95% CI]
Croatian: Broj bolesnika s odgovorom, N (%) [95% CI]
English: CNS-DOR, median (months) [95% CI]
Croatian: DOR u SŽS-u, medijan (mjeseci) [95% CI]