FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on in vitro results, the systemic concentrations obtained after oral daily doses of 10 mg make inhibition of PgP, CYP3A4 and CYP2D6 unlikely.
Croatian: Na temelju in vitro rezultata, sistemske koncentracije postignute nakon dnevne peroralne doze od 10 mg vjerojatno ne utječu na inhibiciju PgP-a, CYP3A4 i CYP2D6.
English: A total of 118 patients were randomised, 79 to Votubia 10 mg daily and 39 to placebo.
Croatian: Ukupno je 118 bolesnika bilo randomizirano, 79 na 10 mg Votubie dnevno i 39 na placebo.
English: Some of these infections have been severe (e.g. leading to sepsis [including septic shock], respiratory or hepatic failure) and occasionally fatal in adult and paediatric patients (see section 4.8).
Croatian: Neke od ovih infekcija su bile teške (npr. dovele su do sepse [uključujući septički šok], zatajenja disanja ili jetre) i ponekad sa smrtnim ishodom u odraslih i pedijatrijskih bolesnika (vidjeti dio 4.8).
English: In the study, partial-onset seizures were defined as all electroencephalogram (EEG)-confirmed sensory seizures or motor seizures in which a generalised onset had not been demonstrated on a past EEG.
Croatian: U ispitivanju, parcijalni napadaji su definirani kao svi senzorni napadaji ili motorički napadaji potvrđeni elektroencefalogramom (EEG-om) kod kojih pojavnost generaliziranih napadaja nije potvrđena na prethodnim EEG-ima.
English: Menstruation disorders such as delayed periods Higher level of female reproductive hormone (blood follicle stimulating hormone increased)
Croatian: Menstrualni poremećaj kao što je kašnjenje menstruacije Visoka razina ženskog spolnog hormona (povišeni folikulostimulirajući hormon u krvi)
English: • Severe hepatic impairment (Child-Pugh C): Votubia is only recommended if the desired benefit outweighs the risk.
Croatian: • Teško oštećenje funkcije jetre (Child-Pugh C): Votubia se preporučuje samo ako je željena korist veća od rizika.
English: Caution is advised in patients taking Votubia, particularly during concomitant use with active substances known to affect platelet function or that can increase the risk of haemorrhage as well as in patients with a history of bleeding disorders.
Croatian: Savjetuje se oprez u bolesnika koji uzimaju Votubiu, osobito tijekom istodobne primjene s djelatnim tvarima za koje se zna da utječu na funkciju trombocita ili koje mogu povećati rizik od krvarenja, kao i u bolesnika s poremećajima krvarenja u anamnezi.
English: The immune response to vaccination may be affected and, therefore, vaccination may be less effective during treatment with Votubia.
Croatian: Votubia može utjecati na imunološki odgovor na cijepljenje, pa stoga cijepljenje može biti manje djelotvorno tijekom liječenja Votubiom.
English: Votubia may increase the risk of problems with wound healing.
Croatian: Votubia može povećati rizik za probleme vezane uz cijeljenje rane.
English: The evidence is based on analysis of change in sum of angiomyolipoma volume.
Croatian: Dokazi se temelje na analizi promjene u ukupnom volumenu angiomiolipoma.
English: Common side effects (may affect up to 1 in 10 people) Middle ear infection
Croatian: Česte nuspojave (mogu se javiti kod do 1 na 10 osoba) Infekcija srednjeg uha
English: Keep the medicine out of the reach of children.
Croatian: Čuvajte lijek izvan dohvata djece.
English: Concomitant use of angiotensin-converting enzyme (ACE) inhibitors
Croatian: Istodobna primjena inhibitora angiotenzin konvertirajućeg enzima (ACE)
English: The active substance is everolimus.
Croatian: Djelatna tvar je everolimus.
English: It is used to treat children aged 2 years and above and adults with partial seizures with or without secondary generalisation (epilepsy) associated with a genetic disorder called tuberous sclerosis complex (TSC) and which are not controlled by other antiepileptic medicines.
Croatian: On se koristi za liječenje djece u dobi od 2 i više godina te odraslih osoba s parcijalnim napadajima sa ili bez sekundarne generalizacije (epilepsije) koji su povezani s genetskim poremećajem pod nazivom kompleks tuberozne skleroze (KTS) i koji se ne kontroliraju drugim antiepilepticima.
English: In patients with advanced solid tumours, Vd was 191 l for the apparent central compartment and 517 l for the apparent peripheral compartment.
Croatian: U bolesnika s uznapredovalim solidnim tumorima, Vd je u prividnom središnjem odjeljku iznosio 191 l, a u prividnom perifernom odjeljku 517 l.
English: The patient must immediately drink all of the oral suspension from the glass.
Croatian: Bolesnik mora odmah popiti svu oralnu suspenziju iz čaše.
English: Dose adjustments should be made if a patient's hepatic (Child-Pugh) status changes during treatment.
Croatian: Dozu se mora prilagoditi ako se bolesnikov jetreni status (prema Child-Pugh klasifikaciji) promijeni tijekom liječenja.
English: Therefore it is assumed that steady-state could be reached earlier in patients <3 years of age (see section 4.2 for dosing recommendations).
Croatian: Stoga se pretpostavlja da se stanje dinamičke ravnoteže može postići ranije u bolesnika mlađih od 3 godine (vidjeti dio 4.2 za preporuke za doziranje).
English: Votubia is indicated for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC) who are at risk of complications (based on factors such as tumour size or presence of aneurysm, or presence of multiple or bilateral tumours) but who do not require immediate surgery.
Croatian: Votubia je indicirana za liječenje odraslih bolesnika s angiomiolipomom bubrega povezanim s kompleksom tuberozne skleroze kod kojih postoji rizik od komplikacija (na temelju čimbenika kao što su veličina tumora ili prisutnost aneurizme, ili prisutnost višestrukih ili obostranih tumora), ali koji ne zahtijevaju hitno kirurško liječenje.
English: Simulations of multiple dose pharmacokinetics support the dosing recommendations in subjects with hepatic impairment based on their Child-Pugh status.
Croatian: Simulacije farmakokinetike višestrukih doza podupiru preporuke o doziranju u ispitanika s oštećenjem funkcije jetre na temelju njihovog Child-Pugh statusa.
English: Hence, concomitant treatment of Votubia and potent inhibitors is not recommended.
Croatian: Dakle, istodobno liječenje Votubiom i potentnim inhibitorima se ne preporučuje.
English: Renal function of patients should be monitored particularly where patients have additional risk factors that may further impair renal function.
Croatian: Kod bolesnika se mora pratiti funkciju bubrega osobito ako bolesnici imaju dodatne čimbenike rizika koji bi mogli dodatno oštetiti funkciju bubrega.
English: In this case, a dose of 2.5 mg daily must not be exceeded (see sections 4.4
Croatian: U tom slučaju, doza ne smije biti veća od 2,5 mg dnevno (vidjeti dijelove 4.4 i 5.2).
English: If, despite these measures, you think you may have become pregnant, ask your doctor for advice before taking any more Votubia.
Croatian: Ukoliko, unatoč ovim mjerama, mislite da ste mogli ostati u drugom stanju, posavjetujte se sa svojim liječnikom prije nego nastavite uzimati Votubiu.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Votubia in one or more subsets of the paediatric population in refractory epilepsy associated with tuberous sclerosis complex (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Votubia u jednoj ili više podskupina pedijatrijske populacije u refraktornoj epilepsiji povezanoj s kompleksom tuberozne skleroze (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Six main metabolites of everolimus have been detected in human blood, including three monohydroxylated metabolites, two hydrolytic ring-opened products, and a phosphatidylcholine conjugate of everolimus.
Croatian: U ljudskoj je krvi nađeno 6 glavnih metabolita everolimusa, uključujući tri monohidroksilirana metabolita, dva hidrolitička produkta otvorene prstenaste stereokonfiguracije, te fosfatidilkolinski konjugat everolimusa.
English: Post-transplant renal impairment (creatinine clearance range 11-107 ml/min) did not affect the pharmacokinetics of everolimus in transplant patients.
Croatian: Oštećenje bubrega nakon presađivanja (raspon klirensa kreatinina 11-107 ml/min) nije utjecalo na farmakokinetiku everolimusa u bolesnika s presatkom.
English: You must mix the dispersible tablets with water to create a cloudy liquid (known as an oral suspension).
Croatian: Tablete za oralnu suspenziju morate pomiješati s vodom kako biste dobili zamućenu tekućinu (koja se naziva oralna suspenzija).
English: While taking Votubia, be vigilant for symptoms and signs of infection; if a diagnosis of infection is made, institute appropriate treatment promptly and consider interruption or discontinuation of Votubia.
Croatian: Za vrijeme uzimanja Votubie, potrebno je biti na oprezu zbog mogućnosti pojave simptoma i znakova infekcije; u slučaju potvrde dijagnoze infekcije, odmah je potrebno započeti odgovarajuće liječenje i razmotriti privremeni ili trajni prekid primjene Votubie.
English: Grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Croatian: Stupnjevi se temelje na Zajedničkoj terminologiji za nuspojave (CTCAE) v3.0 Nacionalnog instituta za rak (NCI)
English: Non-infectious pneumonitis is a class effect of rapamycin derivatives, including everolimus.
Croatian: Neinfektivni pneumonitis je učinak specifičan za cijelu skupinu derivata rapamicina, uključujući everolimus.
English: Light fat meals reduced AUC by 32% and Cmax by 42%.
Croatian: Obroci s malom količinom masti smanjili su AUC za 32%, a Cmax za 42%.
English: In tuberous sclerosis complex syndrome, inactivating mutations in the TSC1 or the TSC2 gene lead to hamartoma formation throughout the body.
Croatian: U sklopu sindroma kompleksa tuberozne skleroze, inaktivacijska mutacija gena TSC1 ili gena TSC2, dovodi do stvaranja hamartoma na brojnim mjestima u organizmu.
English: The blood-to-plasma ratio of everolimus, which is concentration-dependent over the range of 5 to 5,000 ng/ml, is 17% to 73%.
Croatian: Omjer koncentracija everolimusa u krvi i plazmi, koji je u rasponu doza od 5 do 5000 ng/ml ovisan o dozi, iznosi 17% do 73%.
English: The filled syringe should be placed into a container (with the tip pointing up) for 3 minutes, until the Votubia dispersible tablets are in suspension.
Croatian: Napunjenu štrcaljku staviti u posudu (s vrhom okrenutim prema gore) na 3 minute dok se Votubia tablete za oralnu suspenziju ne suspendiraju.
English: Put the oral syringe into the patient's mouth.
Croatian: Stavite štrcaljku u usta bolesnika.
English: For cases where symptoms of non-infectious pneumonitis are severe, Votubia therapy should be discontinued and the use of corticosteroids may be indicated until clinical symptoms resolve.
Croatian: U slučajevima kada su simptomi neinfektivnog pneumonitisa teški mora se prekinuti terapija Votubiom, a primjena kortikosteroida može biti indicirana do prestanka kliničkih simptoma.
English: What Votubia tablets contain
Croatian: Što Votubia tablete sadrže
English: If toxicity is tolerable, no dose adjustment required.
Croatian: Stupanj 2 Ako je toksičnost podnošljiva, nije potrebno prilagođavanje doze.
English: One patient met the pre-specified criteria for treatment success (>75% reduction in SEGA volume) and was temporarily taken off trial therapy; however, SEGA re-growth was evident at the next assessment at 4.5 months and treatment was restarted.
Croatian: Jedan je bolesnik udovoljio unaprijed specificiranim kriterijima prosudbe uspješnosti liječenja (smanjenje volumena SEGA-e za >75%) te je privremeno prekinuto liječenje u okviru ispitivanja; no kako je pri sljedećoj procjeni nakon 4,5 mjeseci ponovno uočen rast tumora, liječenje je nastavljeno.
English: Tell your doctor if you experience any excessive thirst or increased frequency of urination.
Croatian: Obavijestite svog liječnika ako pojačano žeđate ili ako češće mokrite.
English: Inhibition of the mTORC1 signalling pathway interferes with the translation and synthesis of proteins by reducing the activity of S6 ribosomal protein kinase (S6K1) and eukaryotic elongation factor 4E-binding protein (4EBP-1) that regulate proteins involved in the cell cycle, angiogenesis and glycolysis.
Croatian: Inhibicija mTORC1 signalnog puta interferira s translacijom i sintezom proteina tako da smanjuje aktivnost S6 ribosomske protein kinaze (S6K1) i proteina koji veže eukariotski faktor elongacije 4E (4EBP-1 - engl.
English: In the pivotal phase II study, 22 of the 28 SEGA patients studied were below the age of 18 years and in the pivotal phase III study, 101 of the 117 SEGA patients studied were below the age of 18 years.
Croatian: U ključnom ispitivanju faze II, 22 od 28 bolesnika oboljelih od SEGA-e uključenih u ispitivanje bila su mlađa od 18 godina, a u ključnom ispitivanju faze III, 101 od 117 ispitivanih bolesnika oboljelih od SEGA-e bilo je mlađe od 18 godina.
English: In juvenile rat toxicity studies, systemic toxicity included decreased body weight gain, food consumption, and delayed attainment of some developmental landmarks, with full or partial recovery after cessation of dosing.
Croatian: U ispitivanjima toksičnosti provedenim na mladim štakorima, sistemska toksičnost očitovala se usporenim dobivanjem na težini, smanjenjem unosa hrane i odgođenim postignućem nekih razvojnih obilježja, uz potpun ili djelomičan oporavak nakon obustavljanja tretmana.
English: At the final analysis, the skin lesion response rate had increased to 68.2% (95% CI: 58.5, 76.9), with one patient reporting a confirmed complete clinical skin lesion response and no patients experiencing progressive disease as their best response.
Croatian: U završnoj analizi, stopa odgovora kožnih lezija se povećala na 68,2% (95% CI: 58,5, 76,9), uz jednog bolesnika koji je prijavio potpuni klinički odgovor kožnih lezija te niti jednog bolesnika koji je doživio progresiju bolesti kao najbolji odgovor.
English: Table 1 Votubia starting dose for patients with TSC and refractory seizures
Croatian: Tablica 1 Početna doza Votubie za bolesnike s KTS-om i refraktornim napadajima
English: Light fat meals reduced AUC by 29.5% and Cmax by 50.2%.
Croatian: Obroci s malom količinom masti smanjili su AUC za 29,5%, a Cmax za 50,2%.
English: Caution should be exercised when Votubia is taken in combination with orally administered CYP3A4 substrates with a narrow therapeutic index due to the potential for drug interactions.
Croatian: Potreban je oprez pri uzimanju Votubie u kombinaciji s peroralno primijenjenim CYP3A4 supstratima s uskim terapijskim indeksom zbog mogućih interakcija među lijekovima.
English: Based on non-clinical findings, male and female fertility may be compromised by treatment with everolimus (see section 5.3).
Croatian: Na temelju nekliničkih podataka, plodnost u muškaraca i žena može biti smanjena zbog liječenjem everolimusom (vidjeti dio 5.3).
English: According to independent central radiology review Angiomyolipoma responses were confirmed with a repeat scan.
Croatian: Prema neovisnom centralnom radiološkom očitanju Odgovori angiomiolipoma bili su potvrđeni ponovljenim snimanjem.
English: Three randomised, double-blind, placebo-controlled pivotal phase III studies, including double-blind and open label treatment periods, and a non-randomised, open-label, single-arm phase II study contribute to the safety profile of Votubia (n=612, including 409 patients <18 years of age; median duration of exposure 36.8 months [range 0.5 to 83.2]).
Croatian: Tri randomizirana, dvostruko slijepa, placebom kontrolirana ključna ispitivanja faze III, uključujući dvostruko slijepa i otvorena razdoblja liječenja, i jedno ne-randomizirano, otvoreno ispitivanje faze II s jednom skupinom doprinose sigurnosnom profilu Votubie (n=612, uključujući 409 bolesnika mlađih od 18 godina; medijan trajanja izloženosti 36,8 mjeseca [raspon 0,5 do 83,2]).
English: A diagnosis of non-infectious pneumonitis should be considered in patients presenting with non-specific respiratory signs and symptoms such as hypoxia, pleural effusion, cough or dyspnoea, and in whom infectious, neoplastic and other non-medicinal causes have been excluded by means of appropriate investigations.
Croatian: Dijagnozu neinfektivnog pneumonitisa mora se uzeti u obzir u bolesnika s nespecifičnim respiratornim znakovima i simptomima kao što su hipoksija, pleuralni izljev, kašalj ili dispneja, te u kojih su odgovarajućim pretragama isključeni infekcija, novotvorine i drugi ne medicinski uzroci.
English: Not all pack sizes or strengths may be marketed in your country.
Croatian: Na tržištu u Vašoj zemlji se ne moraju nalaziti sve veličine pakiranja ili sve jačine.
English: If toxicity recurs at Grade 3, consider discontinuation.
Croatian: Ako se vrati toksičnost stupnja 3, razmotriti prekid terapije.
English: The evidence is based on analysis of change in SEGA volume.
Croatian: Dokazi se temelje na analizi promjene volumena SEGA-e.
English: If this is the case, your doctor may need to prescribe a different dose of Votubia or stop treatment, either for a short time or permanently.
Croatian: U tom slučaju liječnik će Vam možda propisati drugačiju dozu Votubie ili prekinuti liječenje, bilo privremeno, bilo trajno.
English: Approximately 5 ml of water and 4 ml of air should be drawn into the syringe.
Croatian: Uvući otprilike 5 ml vode i 4 ml zraka u štrcaljku.
English: In rabbits, embryotoxicity was evident in an increase in late resorptions.
Croatian: U kunića se embriotoksičnost očitovala porastom učestalosti kasnih resorpcija zametka.
English: The study consisted of three phases: an 8-week baseline observation phase; an 18-week double-blind, placebo-controlled core treatment phase (composed of titration and maintenance periods), an extension phase of ≥48 weeks in which all patients received Votubia and a post-extension phase of ≤48 weeks in which all patients received Votubia.
Croatian: Ispitivanje se sastojalo od tri faze: 8-tjedne početne faze opažanja; 18-tjedne dvostruko slijepe, placebom kontrolirane faze osnovnog liječenja (koje se sastojalo od titriranja doze i razdoblja održavanja), faze nastavka liječenja od ≥48 tjedana u kojoj su svi bolesnici primali Votubiu i faze nakon nastavka liječenja od ≤48 tjedana u kojoj su svi bolesnici primali Votubiu.
English: The estimated angiomyolipoma progression-free rates at 24 months and 48 months were 91.6% and 83.1%, respectively.
Croatian: Procijenjene stope bez progresije angiomiolipoma u 24. mjesecu i 48. mjesecu bile su 91,6%, odnosno 83,1%.
English: The long-term follow-up of patients randomised to everolimus and patients randomised to placebo who thereafter crossed over to everolimus demonstrated durable responses.
Croatian: Dugoročno praćenje bolesnika kojima je randomizacijom dodijeljen everolimus i onih kojima je dodijeljen placebo koji su nakon toga prešli na everolimus pokazalo je dugotrajne odgovore.
English: If you are following a specific diet to reduce the frequency of your seizures, please inform your doctor before taking Votubia.
Croatian: Ako ste na posebnoj vrsti prehrane radi smanjenja učestalosti Vaših napadaja, molimo da o tome obavijestite Vašeg liječnika prije uzimanja Votubie.
English: Post-hoc sub-group analysis of EXIST-2 (study CRAD001M2302) carried out at time of primary analysis demonstrated that angiomyolipoma response rate is reduced below the threshold of 5 ng/ml (Table 5).
Croatian: Post-hoc analiza podskupine u ispitivanju EXIST-2 (ispitivanje CRAD001M2302) provedena u vrijeme primarne analize pokazala je da je stopa odgovora angiomiolipoma smanjena ispod praga od 5 ng/ml (Tablica 5).
English: Votubia is not to be used in children below the age of 2 years with TSC and seizures.
Croatian: Votubia se ne smije koristiti u djece mlađe od 2 godine s KTS-om i napadajima.
English: In patients with TSC and refractory seizures receiving Votubia dispersible tablets, a trend was observed toward lower Cmin normalised to dose (as mg/m2) in younger patients.
Croatian: U bolesnika s KTS-om i refraktornim napadajima koji su primali Votubia tablete za oralnu suspenziju, uočen je trend prema nižem Cmin normaliziranom prema dozi (kao mg/m2) u mlađih bolesnika.
English: • 30 ml dose cup for measuring water
Croatian: • Čaša za doziranje od 30 ml za mjerenje vode
English: Furthermore, almost twice as many patients in the placebo arm experienced seizure exacerbation relative to the Votubia LT and HT arms.
Croatian: Nadalje, gotovo dvostruko više bolesnika u placebo skupini imalo je egzacerbaciju napadaja u odnosu na skupine Votubia DN i GN.
English: In a population pharmacokinetic analysis of 170 patients with advanced solid tumours, no significant influence of creatinine clearance (25-178 ml/min) was detected on CL/F of everolimus.
Croatian: U analizi populacijske farmakokinetike u 170 bolesnika s uznapredovalim solidnim tumorima, nije zabilježen značajni utjecaj klirensa kreatinina (25-178 ml/min) na CL/F everolimusa.
English: ≥18 years b n=21
Croatian: ≥18 godina b n=21
English: The prescribed dose of Votubia dispersible tablets should be placed in a small glass (maximum size 100 ml) containing approximately 25 ml of water.
Croatian: Staviti propisanu dozu Votubia tableta za oralnu suspenziju u malu čašu (maksimalne veličine od 100 ml) koja je prethodno napunjena s otprilike 25 ml vode.
English: Hypertriglyceridaemia, hyperlipidaemia, hypophosphataemia, hyperglycaemia Psychiatric disorders
Croatian: Hipertrigliceridemija, hiperlipidemija, hipofosfatemija, hiperglikemija Psihijatrijski poremećaji
English: It is not known whether everolimus is excreted in human breast milk.
Croatian: Nije poznato izlučuje li se everolimus u majčino mlijeko u ljudi.
English: An interaction study in healthy subjects demonstrated that co-administration of an oral dose of midazolam, a sensitive CYP3A substrate probe, with everolimus resulted in a 25% increase in midazolam Cmax and a 30% increase in midazolam AUC(0-inf).
Croatian: Ispitivanje interakcije u zdravih ispitanika pokazalo je da je istodobna primjena peroralne doze midazolama, osjetljivog CYP3A4 supstrata, s everolimusom rezultirala 25%-tnim povećanjem Cmax midazolama i 30%-tnim povećanjem AUC(0-inf) midazolama.
English: If these side effects get severe please tell your doctor and/or pharmacist.
Croatian: Ako navedene nuspojave postanu teške, molimo obavijestite Vašeg liječnika i/ili ljekarnika.
English: The number of oncology patients with an adverse reaction leading to discontinuation of everolimus was higher in patients ≥65 years of age (20% versus 13%).
Croatian: Broj onkoloških bolesnika s nuspojavama zbog kojih je došlo do prekida primjene everolimusa bio je viši u bolesnika u dobi od 65 godina ili starijih (20% u odnosu na 13%).
English: Age category
Croatian: Dobna kategorija
English: Patients <18 years of age:
Croatian: Bolesnici u dobi od 18 godina ili stariji:
English: Higher proportions of responders were evident for all response categories in the Votubia LT and HT arms relative to placebo (Figure 1).
Croatian: Viši udjeli bolesnika s odgovorom bili su očigledni za sve kategorije odgovora u skupinama Votubia DN i GN u odnosu na placebo (Slika 1).
English: Patients were randomised in a 2:1 ratio to receive either Votubia or matching placebo.
Croatian: Bolesnici su bili randomizirani u omjeru 2:1 za primanje ili Votubie ili odgovarajućeg placeba.
English: The overall safety profile in this study was consistent with that established for everolimus in the oncology and TSC settings, with the exception of a slightly increased frequency of oral candidiasis which was reported in 2.2% (n=2/92) of patients.
Croatian: Ukupni sigurnosni profil u ovom ispitivanju bio je u skladu s profilom everolimusa za onkološke bolesnike i bolesnike s KTS-om, uz iznimku blago povećane učestalosti oralne kandidijaze koja je bila zabilježena u 2,2% (n=2/92) bolesnika.
English: Assess the everolimus trough level 2 weeks after initiating the additional inducer.
Croatian: Potrebno je odrediti najnižu razinu everolimusa 2 tjedna nakon početka primjene dodatnog induktora.