FrancophonIA/ELRC3.0 huggingface dataset:
English: If you have cough, fever and difficulty breathing or chest pain, this could be a sign of lung infection.
Croatian: Ako primijetite kašalj, vrućicu i otežano disanje ili bol u prsnom košu, to mogu biti znakovi plućne infekcije.
English: If you vomit after taking the dose or forget a dose, take your next dose at your usual time.
Croatian: Ako povratite nakon uzimanja doze ili ako je zaboravite uzeti, uzmite sljedeću dozu u uobičajeno vrijeme.
English: Dose reduction is not required.
Croatian: Nije potrebno smanjivati dozu.
English: Abemaciclib is highly bound to plasma proteins in humans (mean bound fraction approximately 96% to 98%).
Croatian: Abemaciklib se u velikoj mjeri vezuje za proteine u ljudskoj plazmi (srednja vrijednost vezanog udjela iznosi približno 96% do 98%).
English: There should, however, be close monitoring for signs of toxicity.
Croatian: Međutim, potrebno ih je pažljivo nadzirati zbog mogućih znakova toksičnosti.
English: Not all the pack sizes may be marketed.
Croatian: Na tržištu se ne moraju nalaziti sve veličine pakiranja.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucosegalactose malabsorption should not take this medicine.
Croatian: Bolesnice s rijetkim nasljednim poremećajem nepodnošenja galaktoze, potpunog nedostatka laktaze ili malapsorpcije glukoze i galaktoze ne bi smjele uzimati ovaj lijek.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Verzenios in all subsets of the paediatric population in breast cancer (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Verzenios u svim podskupinama pedijatrijske populacije za rak dojke (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Approximately 25% of patients had primary endocrine resistance (progression on endocrine therapy within the first 2 years of adjuvant endocrine therapy or within the first 6 months of first line endocrine therapy for metastatic breast cancer) and for the majority, endocrine resistance developed later.
Croatian: Približno 25% bolesnica imalo je primarnu rezistenciju na endokrinu terapiju (progresija tijekom endokrine terapije unutar prve 2 godine primjene adjuvantne endokrine terapije ili unutar prvih 6 mjeseci primjene endokrine terapije u prvoj liniji liječenja metastatskog raka dojke), dok se u većine bolesnica rezistencija na endokrinu terapiju razvila kasnije.
English: Diarrhoea was the most commonly reported adverse reaction (see Table 6).
Croatian: Proljev je bio najčešće prijavljena nuspojava (vidjeti Tablicu 6).
English: Show the Verzenios carton and this leaflet.
Croatian: Pokažite im kutiju lijeka Verzenios i ovu uputu.
English: PCTFE/PE/PVC blisters sealed with an aluminium foil in a calendar blister card, in packs of 14, 28, 42, 56, 70 or 168 film-coated tablets.
Croatian: PCTFE/PE/PVC blisteri zatvoreni aluminijskom folijom u kalendarskim blister karticama, u pakiranjima s 14, 28, 42, 56, 70 ili 168 filmom obloženih tableta.
English: If you take more Verzenios than you should
Croatian: Ako uzmete više lijeka Verzenios nego što ste trebali
English: 28.18 (23.51, NR)
Croatian: 28,18 (23,51; ND)
English: Frequency gradings are: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), and not known (cannot be estimated from the available data).
Croatian: (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: - Painful swollen leg, chest pain, shortness of breath, rapid breathing or rapid heart rate as these can be signs of blood clots in the vein (which may affect up to 1 in 10 people).
Croatian: - bol i oticanje nogu, bol u prsnom košu, nedostatak zraka, ubrzano disanje ili ubrzan puls, jer to mogu biti znakovi krvnih ugrušaka u venama (mogu se javiti u do 1 na 10 osoba) - proljev (koji se može javiti u više od 1 na 10 osoba)
English: Verzenios film-coated tablets come in different strengths:
Croatian: Verzenios filmom obložene tablete dostupne su u različitim jačinama:
English: Resume at next lower dose unless the dose was already reduced for the toxicity that led to the use of the growth factor.
Croatian: Nastaviti liječenje sljedećom manjom dozom, osim ako doza već nije bila smanjena zbog toksičnosti koja je dovela do primjene faktora rasta.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinases inhibitors, ATC code: L01XE50
Croatian: Farmakoterapijska skupina: Antineoplastici, inhibitori protein kinaze, ATK oznaka: L01XE50 Mehanizam djelovanja
English: Concentrations of abemaciclib and its active metabolites in cerebrospinal fluid are comparable to unbound plasma concentrations.
Croatian: Koncentracije abemacikliba i njegovih aktivnih metabolita u cerebrospinalnoj tekućini usporedive su s koncentracijama nevezanog lijeka u plazmi.
English: Description of selected adverse reactions
Croatian: Opis odabranih nuspojava Neutropenija
English: Approximately 56% patients had visceral metastases.
Croatian: Približno 56% bolesnica imalo je visceralne metastaze.
English: Specific animal studies to test abemaciclib for carcinogenic potential have not been performed.
Croatian: Nisu provedena posebna ispitivanja kancerogenog potencijala abemacikliba na životinjama.
English: If you get certain side effects while you are taking Verzenios your doctor may lower your dose or stop treatment temporarily or permanently.
Croatian: Ako se tijekom liječenja lijekom Verzenios pojave određene nuspojave, liječnik će Vam možda smanjiti dozu lijeka ili privremeno ili trajno prekinuti liječenje.
English: There are no data from the use of abemaciclib in pregnant women.
Croatian: Nema podataka o primjeni abemacikliba u trudnica.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu
English: A high-fat meal increased combined AUC of abemaciclib and its active metabolites by 9% and increased Cmax by 26%.
Croatian: Obrok s visokim udjelom masti povećao je kombinirani AUC abemacikliba i njegovih aktivnih metabolita za 9%, a Cmax za 26%.
English: Verzenios is not recommended during pregnancy and in women of child-bearing potential not using contraception.
Croatian: Ne preporučuje se primjena lijeka Verzenios tijekom trudnoće ni u žena reproduktivne dobi koje ne koriste kontracepciju.
English: Grade 3 or 4 or requires hospitalisation a NCI CTCAE
Croatian: 3. ili 4. stupanj ili toksičnost koja zahtijeva hospitalizaciju a NCI CTCAE
English: The effect of abemaciclib on fertility in humans is unknown.
Croatian: Nije poznat učinak abemacikliba na plodnost u ljudi.
English: If a patient vomits or misses a dose of Verzenios, the patient should be instructed to take the next dose at its scheduled time; an additional dose should not be taken.
Croatian: Ako bolesnica povrati ili propusti dozu lijeka Verzenios, treba je uputiti da sljedeću dozu uzme prema uobičajenom rasporedu; ne smije uzeti dodatnu dozu.
English: Elevation in AST and/or ALT >3 x ULN WITH total bilirubin >2 x ULN, in the absence of cholestasis
Croatian: Povišenje AST-a i/ili ALT-a >3 x GGN, uz ukupni bilirubin >2 x GGN, bez prisutnosti kolestaze
English: Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.
Croatian: Ovaj lijek se ne smije upotrijebiti ako je pakiranje oštećeno ili se vidi da je otvarano.
English: Effects in lung and skeletal muscle occurred only in rats at exposure levels approximately 2-fold higher than human exposure levels and effects in kidney occurred only in rats at exposure levels approximately 6fold higher than human exposure levels.
Croatian: Učinci na pluća i skeletne mišiće opaženi su samo u štakora pri razinama izloženosti koje su bile približno dvostruko veće od razina izloženosti u ljudi, dok su učinci na bubrege opaženi samo u štakora pri razinama izloženosti koje su bile približno 6 puta veće od razina izloženosti u ljudi.
English: Approximately 39% of patients had received chemotherapy and 44% had received antihormonal therapy in the (neo)adjuvant setting.
Croatian: Približno 39% bolesnica primalo je kemoterapiju, a njih 44% antihormonsku terapiju u sklopu (neo)adjuvantnog liječenja.
English: However, cytotoxic effects to the male reproductive tract in rats and dogs indicate that abemaciclib may impair fertility in males (see section 5.3).
Croatian: Međutim, citotoksični učinci na reproduktivni sustav opaženi u mužjaka štakora i pasa ukazuju na to da bi abemaciklib mogao smanjiti plodnost muškaraca (vidjeti dio 5.3).
English: - if you are allergic to abemaciclib or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Verzenios: - ako ste alergični na abemaciklib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: Patients with prior (neo)adjuvant endocrine therapy must have completed this therapy at least 12 months before study randomisation.
Croatian: Bolesnice koje su prethodno primale (neo)adjuvantnu endokrinu terapiju morale su završiti tu terapiju najmanje 12 mjeseci prije randomizacije u ispitivanje.
English: Verzenios plus aromatase inhibitor
Croatian: Verzenios plus inhibitor aromataze
English: Patients should be advised to be cautious when driving or using machines in case they experience fatigue or dizziness during treatment with Verzenios (see section 4.8).
Croatian: Bolesnicama treba savjetovati da budu oprezne pri upravljanju vozilima ili radu sa strojevima ako tijekom liječenja lijekom Verzenios osjete umor ili omaglicu (vidjeti dio 4.8).
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, razgovarajte sa svojim liječnikom prije nego što uzmete ovaj lijek.
English: These circulating metabolites are active with similar potency to abemaciclib.
Croatian: Ti su cirkulirajući metaboliti aktivni i imaju sličnu potentnost kao abemaciklib.
English: Suspend abemaciclib dose for at least 48 hours after the last dose of blood cell growth factors was administered and until toxicity resolves to Grade 2 or less.
Croatian: Odgoditi primjenu abemacikliba dok ne prođe najmanje 48 sati od primjene posljednje doze faktora rasta krvnih stanica i dok se toksičnost ne ublaži do 2. ili nižeg stupnja.
English: Special populations
Croatian: Posebne populacije Starije osobe
English: Approximately 22% of patients had bone-only disease, and 53% patients had visceral metastases.
Croatian: Približno 22% bolesnica imalo je samo koštanu bolest, dok je 53% bolesnica imalo visceralne metastaze.
English: These proteins are abnormally active in some cancer cells and make them grow out of control.
Croatian: Ti su proteini prekomjerno aktivni u nekim stanicama raka, što dovodi do njihova nekontrolirana rasta.
English: 4.4 Special warnings and precautions for use
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Neutropenija
English: Verzenios is a cancer medicine containing the active substance abemaciclib.
Croatian: Verzenios je lijek za liječenje raka koji sadrži djelatnu tvar abemaciklib.
English: You can take the tablets either with or without food, just avoid grapefruit and grapefruit juice (see section 2 “Verzenios with food and drink”).
Croatian: Tablete možete uzimati s hranom ili bez nje, ali izbjegavajte grejp i sok od grejpa (pogledajte dio 2.
English: In patients receiving an aromatase inhibitor or fulvestrant alone, 78.4% reported an increase in serum creatinine (all laboratory grades).
Croatian: Među bolesnicama koje su primale samo inhibitor aromataze ili fulvestrant, njih 78,4% prijavilo je povišenje serumske vrijednosti kreatinina (bilo kojeg laboratorijskog stupnja).
English: It is given together with hormonal therapies, such as aromatase inhibitors or fulvestrant.
Croatian: Primjenjuje se zajedno s hormonskim terapijama, kao što su inhibitori aromataze ili fulvestrant.
English: If you are able to have children, you should use adequate contraceptive methods (e.g., double -barrier contraception such as condom and diaphragm) during therapy and for at least 3 weeks after completing therapy.
Croatian: Ako možete zatrudnjeti, trebate koristiti učinkovite metode kontracepcije (npr. dvostruku mehaničku kontracepciju, kao što su prezervativ i dijafragma) tijekom liječenja i još najmanje 3 tjedna po njegovu završetku.
English: Verzenios therapy should be initiated and supervised by physicians experienced in the use of anti-cancer therapies.
Croatian: Liječenje lijekom Verzenios moraju započeti i nadzirati liječnici s iskustvom u primjeni lijekova za liječenje raka.
English: In the therapeutic dose range of 50-200 mg, the increase in plasma exposure (AUC) and Cmax is approximately dose proportional.
Croatian: Kod primjene doza unutar terapijskog raspona od 50 do 200 mg plazmatska izloženost (AUC) i Cmax povećavaju se približno proporcionalno dozi.
English: Abemaciclib blocks the effects of proteins called cyclin-dependent kinase 4 and 6.
Croatian: Abemaciklib blokira djelovanje proteina koji se zovu kinaze 4 i 6 ovisne o ciklinu.
English: Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza oznake 'EXP'.
English: Abemaciclib absorption is slow, with a Tmax of 8 hours and a mean absolute bioavailability of approximately 45 %.
Croatian: Apsorpcija abemacikliba je spora, uz Tmax od 8 sati i srednju vrijednost apsolutne bioraspoloživosti od približno 45%.
English: [%] (95% CI) a Measurable disease defined per RECIST version 1.1 b Complete response + partial response c Complete response + partial response + stable disease for ≥ 6 months N=number of patients; CI=confidence interval; NR=not reached.
Croatian: [%] (95% CI) a Mjerljiva bolest definirana prema verziji 1.1 RECIST kriterija b Potpun odgovor + djelomičan odgovor c Potpun odgovor + djelomičan odgovor + stabilna bolest tijekom ≥ 6 mjeseci
English: Verzenios plus fulvestrant prolonged progression-free survival with neither a clinically meaningful or significant detriment to health-related quality of life.
Croatian: Verzenios je u kombinaciji s fulvestrantom produljio preživljenje bez progresije bolesti, a pritom nije imao klinički važnog ili značajnog štetnog utjecaja na kvalitetu života vezanu uz zdravlje.
English: The geometric mean hepatic clearance (CL) of abemaciclib was 21.8 L/h (39.8% CV), and the mean plasma elimination half-life for abemaciclib in patients was 24.8 hours (52.1% CV).
Croatian: Geometrijska srednja vrijednost jetrenog klirensa abemacikliba iznosila je 21,8 l/h (39,8% CV), dok je srednja vrijednost poluvijeka eliminacije abemacikliba iz plazme bolesnica iznosila 24,8 sati (52,1% CV).
English: Investigator assessment, number of events
Croatian: Ocjena ispitivača, broj događaja (%)
English: Effects of other medicinal products on the pharmacokinetics of abemaciclib
Croatian: Učinci drugih lijekova na farmakokinetiku abemacikliba
English: Concomitant use of CYP3A4 inducers should be avoided due to the risk of decreased efficacy of abemaciclib (see section 4.5).
Croatian: Treba izbjegavati istodobnu primjenu induktora CYP3A4 zbog rizika od smanjene djelotvornosti abemacikliba (vidjeti dio 4.5).
English: No dose adjustment is necessary for patients treated with moderate or weak CYP3A4 inhibitors.
Croatian: Nije potrebno prilagođavati dozu u bolesnica koje se liječe umjerenim ili slabim inhibitorima CYP3A4.
English: No large change (that is, >20 ms) in the QTcF interval was detected at the mean observed maximal steady state abemaciclib concentration following a therapeutic dosing schedule.
Croatian: Nije utvrđena velika promjena QTcF intervala (tj. promjena za > 20 ms) pri srednjoj vrijednosti opažene maksimalne koncentracije abemacikliba u stanju dinamičke ravnoteže kada se lijek primjenjivao prema terapijskom rasporedu doziranja.
English: Verzenios is for oral use.
Croatian: Verzenios je namijenjen za peroralnu primjenu.
English: Abemaciclib was teratogenic and caused decreased foetal weight at maternal exposures similar to the recommended human dose.
Croatian: Abemaciklib je imao teratogen učinak i uzrokovao je smanjenje težine ploda pri razinama izloženosti majke koje su bile slične onima koje se postižu kod primjene preporučene doze u ljudi.
English: If you miss a dose of Verzenios
Croatian: Ako ste propustili dozu lijeka Verzenios
English: Patient requires administration of blood cell growth factors
Croatian: Bolesnici je potrebno primijeniti faktore rasta krvnih stanica.
English: Placebo plus aromatase inhibitor
Croatian: Placebo plus inhibitor aromataze
English: • Watering eyes
Croatian: • suzenje očiju
English: After a single oral dose of [14C] -abemaciclib, approximately 81% of the dose was excreted in faeces and 3.4% excreted in urine.
Croatian: Nakon peroralne primjene jedne doze [14C]-abemacikliba približno 81% doze izlučilo se u feces, dok se 3,4% izlučilo u mokraću.
English: Randomised Phase 3 Study MONARCH 2: Verzenios in combination with fulvestrant
Croatian: Randomizirano ispitivanje faze 3 MONARCH 2: Verzenios u kombinaciji s fulvestrantom
English: Grade 1 or 2
Croatian: 1. ili 2. stupanj
English: Abemaciclib prevents retinoblastoma protein (Rb) phosphorylation, blocking cell cycle progression from the G1 to the S-phase of cell division, leading to suppression of tumour growth.
Croatian: Abemaciklib sprječava fosforilaciju retinoblastomskog proteina (Rb), blokirajući tako progresiju staničnog ciklusa od G1 faze do S faze stanične diobe, što dovodi do supresije rasta tumora.
English: In a clinical study in patients with breast cancer, there was no clinically-relevant pharmacokinetic drug interaction between abemaciclib and anastrozole, fulvestrant, exemestane, letrozole or tamoxifen.
Croatian: U kliničkom ispitivanju provedenom u bolesnica s rakom dojke nisu opažene klinički značajne farmakokinetičke interakcije između abemacikliba i anastrozola, fulvestranta, eksemestana, letrozola i tamoksifena.
English: The most commonly occurring adverse reactions are diarrhoea, infections, neutropenia, anaemia, fatigue, nausea, vomiting and decreased appetite.
Croatian: Najčešće su nuspojave proljev, infekcije, neutropenija, anemija, umor, mučnina, povraćanje i smanjen tek.
English: Hepatic metabolism is the main route of clearance for abemaciclib.
Croatian: Jetreni metabolizam predstavlja glavni put klirensa abemacikliba.
English: Patients receiving abemaciclib should not breast-feed.
Croatian: Bolesnice koje uzimaju abemaciklib ne smiju dojiti.
English: In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.
Croatian: U žena u predmenopauzi ili perimenopauzi endokrinu terapiju treba primjenjivati u kombinaciji s agonistom hormona koji oslobađa luteinizirajući hormon (engl. luteinising hormone-releasing hormone, LHRH).
English: Adverse reactions reported in phase 3 studies of abemaciclib in combination with endocrine therapy (N=768)
Croatian: Tablica 6. Nuspojave prijavljene u ispitivanjima faze 3 u kojima se abemaciklib primjenjivao u kombinaciji s endokrinom terapijom (N=768)
English: In patients with severe (Child Pugh C) hepatic impairment, a decrease in dosing frequency to once daily is recommended (see section 5.2).
Croatian: U bolesnica s teškim oštećenjem jetrene funkcije (ChildPugh stadij C) preporučuje se smanjiti učestalost primjene na jedanput na dan (vidjeti dio 5.2).
English: Alternatively, the abemaciclib dose may be reduced to 50 mg once daily or discontinued.
Croatian: Druga je mogućnost smanjiti dozu abemacikliba na 50 mg jedanput na dan ili prekinuti liječenje.
English: In particular, tell you doctor or pharmacist before taking Verzenios if you are taking the following:
Croatian: Osobito je važno da prije uzimanja lijeka Verzenios kažete svom liječniku ili ljekarniku ako uzimate neki od sljedećih lijekova:
English: Aluminium/aluminium perforated unit dose blisters of 28 x 1 film-coated tablets.
Croatian: Perforirani aluminij/aluminij blisteri s jediničnim dozama s 28 x 1 filmom obloženom tabletom.
English: Common Muscular weakness
Croatian: • mišićna slabost
English: Grade 4 (>20.0 x ULN)
Croatian: 4. stupanj (> 20,0 x GGN)
English: Abemaciclib is a potent and selective inhibitor of cyclin-dependent kinases 4 and 6 (CDK4 and CDK6), and most active against Cyclin D1/CDK4 in enzymatic assays.
Croatian: Abemaciklib je potentan i selektivan inhibitor kinaza 4 i 6 ovisnih o ciklinu (engl. cyclin-dependent kinases 4/6, CDK4 i CDK6), a u enzimskim je testovima najaktivniji protiv ciklina D1/CDK4.
English: The primary biotransformation is hydroxylation to a metabolite that circulates with an AUC that is 77% of parent drug.
Croatian: Primarni put biotransformacije je hidroksilacija u cirkulirajući metabolit čiji AUC iznosi 77% AUC-a ishodišnog spoja.
English: What you need to know before you take Verzenios Do not take Verzenios:
Croatian: Što morate znati prije nego počnete uzimati Verzenios
English: The primary target organ findings of potential relevance to humans included gastrointestinal and haematolymphopoietic organ effects in rats and dogs in studies up to 13 weeks duration.
Croatian: Nalazi na primarnim ciljnim organima koji mogu biti značajni za ljude obuhvaćali su učinke na probavni i hematolimfopoetski sustav u štakora i pasa u ispitivanjima koja su trajala do 13 tjedana.
English: You will have regular blood tests before and during treatment to check whether Verzenios affects your blood (white blood cells, red blood cells, platelets) or the concentration in your blood of enzymes from your liver.
Croatian: Što će Vaš liječnik provjeriti prije i tijekom liječenja Prije i tijekom liječenja lijekom Verzenios redovito ćete obavljati krvne pretrage kako bi se provjerilo utječe li Verzenios na Vašu krvnu sliku (bijele krvne stanice, crvene krvne stanice, krvne pločice) ili na koncentraciju jetrenih enzima u krvi.
English: The majority of patients (96%) had metastatic disease at baseline.
Croatian: Većina je bolesnica (96%) na početku ispitivanja imala metastatsku bolest.
English: If toxicity does not resolve within 24 hours to Grade 1 or less, suspend dose until resolution.
Croatian: Ako se toksičnost ne ublaži do 1. ili nižeg stupnja unutar 24 sata, odgoditi primjenu doze do povlačenja toksičnosti.
English: a NCI Common Terminology Criteria for Adverse Events (CTCAE) b ANC: Grade 1: ANC < LLN - 1500/mm3; Grade 2: ANC 1000 - <1500/mm3; Grade 3: ANC 500 - <1000/mm3; Grade 4: ANC <500/mm3
Croatian: National Cancer Institute Common Terminology Criteria for Adverse Events, NCI CTCAE) b ABN: 1. stupanj: ABN < DGN - 1500/mm3; 2. stupanj: ABN 1000 - < 1500/mm3; 3. stupanj: ABN 500 - < 1000/mm3; 4. stupanj: ABN < 500/mm3 DGN = donja granica normale Tablica
English: Women of childbearing potential/Contraception in females Women of childbearing potential should use highly effective contraception methods (e.g. double-barrier contraception) during treatment and for at least 3 weeks after completing therapy (see section 4.5).
Croatian: Žene reproduktivne dobi trebaju koristiti visokoučinkovite metode kontracepcije (npr. dvostruku mehaničku kontracepciju) tijekom liječenja i još najmanje 3 tjedna po njegovu završetku (vidjeti dio 4.5).