natgillin/translations-raw huggingface dataset:
The side effects of Caprelsa are listed in Section 4. 
Neželeni učinki zdravila Caprelsa so našteti v poglavju 4.
For more severe skin reactions (such as Stevens-Johnson syndrome), referral of the patient to seek urgent medical advice is recommended. 
V primeru hujših kožnih reakcij (npr. Stevens-Johnsonovega sindroma) je bolnike priporočljivo napotiti na nujno zdravniško obravnavo.
Caprelsa may also act directly on cancer cells to kill them or slow down their growth. 
Zdravilo Caprelsa morda deluje tudi neposredno na rakave celice in jih uniči ali upočasni njihovo rast.
(For vandetanib monitoring, see section 4.2 Posology and Method of administration and section 4.4 Special warnings and precautions for use). 
(Za spremljanje vandetaniba glejte poglavje 4.2, "Odmerjanje in način uporabe", in poglavje 4.4, "Posebna opozorila in previdnostni ukrepi").
QTcF prolongation was > 20 ms in over 91% of patients, > 60 ms in 35%, > 100 ms in 1.7%. 
Podaljšanje intervala QTcF je bilo > 20 ms pri več kot 91 % bolnikov, > 60 ms pri 35 %, > 100 ms pri 1,7 % bolnikov.
The doctor will tell you how many tablets of Caprelsa to give to your child. 
Zdravnik vam bo povedal, koliko tablet zdravila Caprelsa morate dati otroku.
Adverse reactions associated with overdose are to be treated symptomatically; in particular, severe diarrhoea must be managed appropriately. 
Neželene učinke, povezane s prevelikim odmerjanjem, je treba zdraviti simptomatsko; še zlasti je treba ustrezno obravnavati hudo drisko.
The secondary endpoints were evaluation of overall objective response rate (ORR), disease control rate (DCR) defined as, partial response (PR) or complete response (CR) or stable disease (SD) lasting at least 24 weeks, duration of response (DOR), time to worsening of pain based on Brief Pain Inventory (BPI) worst pain scale, and overall survival (OS). 
Sekundarni opazovani dogodki so bili celotni delež objektivnega odziva (ORR - objective response rate), delež obvladanja bolezni (DCR - disease control rate) opredeljen kot delni odziv (PR - partial response) ali popolni odziv (CR - complete response) ali stabilna bolezen (SD - stable disease) v trajanju vsaj 24 mesecev, trajanje odziva (DOR - duration of response), čas do poslabšanja bolečin na podlagi lestvice najhujše bolečine vprašalnika BPI (brief pain inventory) in celokupno preživetje (OS - overall survival).
Treatment should only be continued in pregnant women if the potential benefit to the mother outweighs the risk to the foetus. 
Zdravljenje nosečnice se sme nadaljevati le, če možna korist za mater jasno odtehta tveganje za plod.
However, RET status could not be tested in a large proportion of patients (mainly because of unavailable results for direct sequencing of DNA) and response rate was somewhat lower in the patients with unknown RET status compared with RET mutation positive status: 51.8% vs. 35.9 % respectively. 
Kljub temu, statusa RET ni bilo mogoče določiti pri velikem deležu bolnikov (zlasti zaradi neuporabnosti rezultatov neposrednega določanja zaporedja DNA) in delež odziva je bil pri bolnikih z neznanim statusom RET, v primerjavi s pozitivnim statusom RET, nekoliko manjši: 51,8 % v primerjavi s 35,9 %.
Patients should be monitored for hypertension and controlled as appropriate. 
Bolnike je treba spremljati glede hipertenzije in jo obravnavati kot je ustrezno.
Alanine aminotransferase elevations 
Zvišanje alanin-aminotransferaze
Upon improvement, treatment should be resumed at a reduced dose (see sections 4.2 and 4.8). 
Po izboljšanju je treba zdravilo znova uvesti v manjšem odmerku (glejte poglavji 4.2 in 4.8).
Women of childbearing potential must use effective contraception during therapy and for at least four months following the last dose. 
Ženske v rodni dobi morajo med zdravljenjem, in še vsaj štiri mesece po zadnjem odmerku, uporabljati učinkovito kontracepcijo.
Your doctor may tell you to take Caprelsa at a lower or increased dose (such as two 100 mg tablets or one 100 mg tablet). 
Zdravnik vam lahko naroči, da jemljite manjši ali višji odmerek zdravila Caprelsa (npr. dve 100-mg tableti ali eno 100-mg tableto).
Prior to launch of CAPRELSA in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority. 
Pred prihodom zdravila CAPRELSA na trg v vsaki državi članici se mora imetnik dovoljenja za promet z zdravilom (MAH) s pristojnim nacionalnim organom dogovoriti glede vsebine in oblike izobraževalnega programa, vključno s sredstvi obveščanja, načini razdeljevanja in vsemi drugimi vidiki programa.
Film-coating Hypromellose Macrogol (300) Titanium dioxide (E171) 
Filmska obloga hipromeloza makrogol (300) titanov dioksid (E171)
Patients aged 5-18 years should be dosed according to the nomogram in Table 1. 
Odmerek za bolnike v starosti od 5 do 18 let je treba določiti z nomogramom v preglednici 1.
months n-vandetanib 231 196 169 140 40 1 0 n-placebo 100 71 57 45 13 0 0 ____ vandetanib 300 mg, ------ placebo, y-axis=PFS, x-axis=time in months, n-vandetanib=number of patients at risk-vandetanib, n-placebo=number of patients at risk-placebo HR = 0.46, 95%CI (0.31-0.69), p = 0.0001 
meseci n-vandetanib 231 196 169 140 40 1 0 n-placebo 100 71 57 45 13 0 0 ____ vandetanib 300 mg, ------ placebo, y-os=PFS, x-os=čas v mesecih, n-vandetanib=število bolnikov s tveganjem-vandetanib, n-placebo=število bolnikov s tveganjem-placebo HR = 0,46, 95 % IZ (0,31-0,69), p = 0,0001
QTc interval should be carefully assessed prior to initiation of treatment. 
Pred začetkom zdravljenja je treba skrbno oceniti interval QTc.
Within a 21 day collection period after a single dose of 14C-vandetanib, approximately 69% was recovered with 44% in faeces and 25% in urine. 
Med 21-dnevnim obdobjem zbiranja po enem samem odmerku 14C-vandetaniba, se ga je izločilo približno 69 %: 44 % v blatu in 25 % v urinu.
Patients / caregivers 
Bolniki / Skrbniki
If it is less than 12 hours to the next dose, the patient should not take the missed dose. 
Če je do naslednjega odmerka manj kot 12 ur, bolnik ne sme vzeti izpuščenega odmerka.
Before initiating vandetanib, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm. 
Pred uvedbo vandetaniba je treba to tveganje skrbno preučiti pri bolnikih z dejavniki tveganja, kot sta hipertenzija ali anamneza anevrizme.
• If your doctor or pharmacist changes your dose of Caprelsa 
• Če vam zdravnik ali farmacevt spremeni odmerek zdravila Caprelsa.
Patients were treated with vandetanib or placebo until they reached objective disease progression. 
Bolnike so zdravili z vandetanibom ali placebom, dokler niso dosegli objektivnega napredovanja bolezni.
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 agreed subsequent updates of the RMP. 
Imetnik dovoljenja za promet z zdravilom bo izvedel farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
In ex vivo plasma samples from colorectal cancer patients at steady state exposure after 300 mg once daily, the mean percentage protein binding was 93.7% (range 92.2 to 95.7%). 
V vzorcih plazme bolnikov s kolorektalnim rakom ex vivo, pri izpostavljenosti v stanju dinamičnega ravnovesja po odmerku 300 mg enkrat na dan, je bil povprečni odstotek vezave na beljakovine 93,7 % (razpon: 92,2 do 95,7 %).
In view of the associated risks, it is important to limit treatment with vandetanib to patients who are in real need for treatment, i.e. with a symptomatic-aggressive course of the disease. 
Glede na tveganja je pomembno omejiti zdravljenje z vandetanibom na tiste bolnike, ki zares potrebujejo zdravljenje, tj. na tiste s simptomatsko-agresivnim razvojem bolezni.
Clinical efficacy in paediatric patients: 
Klinična učinkovitost pri pediatričnih bolnikih:
• Dry eye. 
• suho oko;
• The need to counsel patients about the risk of prolonged QTc and PRES and inform them of what symptoms and signs to be aware of and the actions to take; 
• Potreba po svetovanju bolnikom glede tveganj za podaljšanje intervala QTc in PRES ter seznanitev bolnikov o simptomih in znakih na katere morajo biti pozorni ter kako je treba ukrepati.
Rate of change in biomarker levels such as of calcitonin (CTN) and/or carcinoembryonic antigen (CEA) as well as the rate of change of tumour volume during watchful waiting might help to identify not only patients in need for treatment but also the optimal moment to commence treatment with vandetanib. 
Hitrost spreminjanja ravni biokemičnih označevalcev kot je kalcitonin (CTN) in/ali karcinoembrionski antigen (CEA), kakor tudi hitrost spreminjanja volumna tumorja med skrbnim opazovanjem lahko pripomorejo k določitvi ne le bolnikov, ki potrebujejo zdravljenje, temveč tudi optimalnega trenutka za začetek zdravljenja z vandetanibom.
They are seen in 8% of people taking Caprelsa for medullary thyroid cancer. 
Pojavijo se pri 8 % oseb, ki zaradi medularnega raka ščitnice jemljejo zdravilo Caprelsa.
No adjustment in starting dose is required for elderly patients. 
Starejšim bolnikom začetnega odmerka ni potrebno prilagoditi.
- The re-evaluation of treatment efficacy in RET-negative patients based on the re-analysis of archived tumour samples from the pivotal study D4200C00058. 
-Ponovno oceno koristi in tveganj zdravljenja pri RET-negativnih bolnikih na podlagi ponovne analize arhiviranih vzorcev tumorjev iz pivotne študije D4200C00058.
While you are taking Caprelsa, protect yourself when you go outside by always using sunscreen and wearing clothes to avoid exposure to the sun. 
Med jemanjem zdravila Caprelsa se zaščitite, kadar greste ven, tako da vedno uporabite sredstvo za sončenje in nosite oblačila, ki bodo preprečila izpostavljenost soncu.
Monitoring of your blood and your heart: 
Kontrole krvi in srca
Results according to RET status (positive, unknown and RET M918T mutation negative definition) are presented in Table 4. 
Rezultati glede na status RET (določen kot pozitiven, neznan in negativen glede na mutacijo RET M918T) so predstavljeni v Preglednici 4.
The majority of elevations resolve while continuing treatment, others usually resolve after a 1-2 week interruption in therapy. 
Večina zvišanj med nadaljnjim zdravljenjem mine, druga po navadi minejo po 1 do 2 tednih prenehanja zdravljenja.
• pentamidine (used to treat infection) 
• pentamidin (uporablja se za zdravljenje okužbe)
Do not take Caprelsa if any of the above applies to you. 
Ne vzemite zdravila Caprelsa, če kaj od naštetega velja za vas.
No studies to establish the effects of vandetanib on ability to drive and use machines have been conducted. 
Študij o vplivu vandetaniba na sposobnost vožnje in upravljanja strojev niso izvedli.
Considering the data available in adult patients with renal impairment: 
Upoštevaje podatke, ki so na voljo za odrasle bolnike z okvaro ledvic:
Prolongation of ECG QTc interval(*) (**) 
Srčne bolezni podaljšanje intervala QTc (*)
Actually 79 patients were identified by absence of an M918T mutation and no RET mutation identified at any of the other 6 exons tested but in 71 of such patients sequencing of the 6 exons was incomplete. 
Dejansko je bilo 79 bolnikov istovetnih za odsotnost mutacije M918T in mutacija RET ni bila istovetena pri nobenem od 6 preskušanih eksonov, vendar je pri 71 tovrstnih bolnikih določanje zaporedja v 6 eksonih bilo nepopolno.
In the event of an overdose, further doses must be interrupted, and appropriate measures taken to assure that an adverse event has not occurred, i.e. ECG within 24 hours to determine QTc prolongation. 
V primeru prevelikega odmerjanja je treba nadaljnjo uporabo zdravila prekiniti in ustrezno ukrepati za zagotovitev, da se ni pojavil kakšen neželeni učinek, tj. EKG v 24 urah za ugotovitev podaljšanja QTc.
Table 3: Summary of other efficacy findings in study 58 ORRa 
Povzetek drugih izsledkov o učinkovitosti v študiji 58
• Failure of the lungs to function properly. 
• nezmožnost ustreznega delovanja pljuč;
Most patients (81.3%) had undergone partial or total thyroidectomy prior to study entry. 
Pri večini bolnikov (81,3 %) je bila pred vstopom v študijo opravljena delna ali popolna odstranitev ščitnice.
Frequent ECG monitoring of the QTc interval should be continued. 
Nadaljevati je treba pogosto spremljanje intervala QTc.
These findings occurred at clinically-relevant plasma concentrations, were largely reversible within 4 weeks of cessation of dosing and were attributable to inhibition of vascular endothelial growth factor receptor (VEGFR) or EGFR. 
Te spremembe so se pojavile pri klinično pomembnih koncentracijah v plazmi, bile so v veliki meri reverzibilne v 4 tednih po prenehanju uporabe zdravila in so jih pripisali zavrtju receptorja žilnega endotelijskega rastnega dejavnika (VEGFR) ali EGFR.
ECGs and blood tests should also be obtained as clinically indicated during this period and afterwards. 
Prav tako je treba med tem obdobjem in pozneje posneti EKG in opraviti preiskave krvi kot je klinično indicirano.
A randomised, double-blind, placebo-controlled study (Study 58) was conducted to demonstrate safety and efficacy of vandetanib 300 mg versus placebo. 
Opravljena je bila randomizirana, dvojno slepa, s placebom kontrolirana študija (študija 58) varnosti in učinkovitosti 300 mg vandetaniba v primerjavi s placebom.
Table 4: Summary of efficacy findings in a segment of patients according to RET mutation status 
Povzetek ugotovitev glede učinkovitosti pri delu bolnikov glede na status mutacije RET
Due to the increased thrombotic risk in patients with cancer, the use of anticoagulation is frequent. 
Zaradi večjega tveganja za trombozo je uporaba antikoagulantov pri bolnikih z rakom pogosta.
Survival status and the median final overall survival (81.6 months in the vandetanib arm and 80.4 months in the placebo arm) were similar across both treatment arms. 
Stanje preživetja in mediano končno celokupno preživetje (81,6 meseca v skupini z vandetanibom in 80,4 meseca v skupini s placebom) sta bila v obeh terapevtskih skupinah podobna.
Patients should not take a double dose (two doses at the same time) to make up for a forgotten dose. 
Bolnik ne sme vzeti dvojnega odmerka (dveh odmerkov hkrati), če je pozabil vzeti prejšnji odmerek.
Their frequency is presented in Table 2, adverse reactions using Council for International Organizations of Medical Sciences (CIOMS III), listed by MedDRA System Organ Class (SOC) and at the preferred term level and then by frequency classification. 
Njihova pogostnost je prikazana v Preglednici 2, neželeni učinki zdravila z uporabo CIOMS III (Council for International Organizations of Medical Sciences) ter navajanja po organskih sistemih (SOC - System Organ Class) po MedDRA na ravni prednostnega termina in nato po razvrstitvi pogostnosti.
Dosing for paediatric patients should be on the basis of BSA in mg/m2. 
Odmerjanje pri pediatričnih bolnikih mora temeljiti na telesni površini v mg/m2.
Biliary excretion of unchanged vandetanib is one of the excretion pathways for vandetanib. 
Biliarno izločanje nespremenjenega vandetaniba je ena od poti izločanja vandetaniba.
When establishing RET mutation status, tissue samples should be obtained if possible at the time of initiation of treatment rather than at the time of diagnosis (see sections 4.1 and 5.1). 
Če je mogoče, je treba za določitev statusa mutacije RET pridobiti tkivne vzorce ob uvedbi zdravljenja in ne ob času postavitve diagnoze (glejte poglavji 4.1 in 5.1).
For patients who have difficulty swallowing, vandetanib tablets may be dispersed in half a glass of non-carbonated drinking water. 
Bolniki, ki imajo težave s požiranjem, lahko tablete vandetaniba raztopijo v pol kozarca negazirane pitne vode.
Vandetanib may be administered until disease progression or until the benefits of treatment continuation do no longer outweigh its risk, thereby considering the severity of adverse events (see sections 4.8) in relation to the degree of clinical stabilization of the tumour status. 
Vandetanib se lahko uporablja do napredovanja bolezni ali do tedaj, ko koristi nadaljnjega zdravljenja ne odtehtajo več njegovih tveganj; pri tem je treba upoštevati izrazitost neželenih dogodkov (glejte poglavje 4.8) v primerjavi s stopnjo klinične stabilizacije stanja tumorja.
In the placebo arm, a total of 51 (51%) of patients had progressed: 46 (46%) by RECIST progression and 5 (5%) by death in the absence of progression. 
V kraku s placebom se je napredovanje pojavilo pri skupaj 51 (51 %) bolnikov; pri 46 (46 %) so ugotovili napredovanje po RECIST in 5 (5 %) bolnikov je umrlo, ne da bi se pojavilo napredovanje.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist straight away. 
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, takoj obvestite svojega zdravnika ali farmacevta.
Patients with no M918T mutation and other mutations not tested or negative (n=79)* 
Bolniki brez mutacije M918T in brez preskušanja za druge mutacije ali pa so te negativne (n = 79)*
M918T mutation is the most frequent mutation observed in patients with sporadic MTC; however it cannot be ruled out that some patients tested RET negative for M918T mutation might be positive for mutation on other exons. 
Mutacija M918T je najpogostejša mutacija, opažena pri bolnikih s sporadničnim MTC; kljub temu se ne more izključiti možnosti, da so nekateri bolniki, preskušani za mutacijo RET, negativni za mutacijo M918T, lahko pozitivni za mutacijo na drugih eksonih.
The MAH shall ensure that in each Member State where CAPRELSA is marketed, all healthcare professionals (HCPs) and patients / caregivers who are expected to prescribe, dispense and use CAPRELSA have access to/are provided with an educational package containing: 
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vseh državah članicah, kjer se zdravilo CAPRELSA trži, vsi zdravstveni delavci in bolniki/skrbniki, za katere se pričakuje, da bodo predpisovali, izdajali in uporabljali zdravilo Caprelsa, prejeli paket izobraževalnih gradiv, ki vsebuje:
If you forget to take Caprelsa 
Če ste pozabili vzeti zdravilo Caprelsa
PVC/ PVDC/Alu blisters, sealed with aluminium foil, each containing 30 film-coated tablets. 
Pretisni omoti iz PVC/PVDC/Alu, zapečateni z aluminijasto folijo; en pretisni omot vsebuje 30 filmsko obloženih tablet.
The precise mechanism of action of vandetanib in locally advanced or metastatic MTC is unknown. 
Jasen mehanizem delovanja vandetaniba pri lokalno napredovalem ali metastatskem MTC ni znan.
N-desmethyl-vandetanib and vandetanib-N-oxide circulate at concentrations of approximately 11% and 1.4% of those of vandetanib. 
N-desmetil-vandetanib in vandetanib-N-oksid krožita v koncentracijah, ki so približno 11 % in 1,4 % koncentracije vandetaniba.
The safety and efficacy of Caprelsa in children below 5 years of age have not been established. 
Varnost in učinkovitost zdravila Caprelsa pri otrocih, mlajših od 5 let nista bili dokazani.
Long term safety data in paediatric patients are not available. 
Dolgoročnih podatkov o varnosti pri pediatričnih bolnikih ni na voljo.
• If you may become pregnant you must use effective contraception when you are taking Caprelsa and for at least four months after the last dose of Caprelsa. 
• Če bi lahko zanosili, morate med jemanjem zdravila Caprelsa in še vsaj štiri mesece po zadnjem odmerku zdravila Caprelsa uporabljati učinkovito kontracepcijo.
Additional monitoring of QTc, electrolytes and renal function are required especially in case of diarrhoea, increase in diarrhoea/dehydration, electrolyte imbalance and/or impaired renal function. 
Dodatno spremljanje intervala QTc, elektrolitov in delovanja ledvic je zahtevano zlasti v primeru driske, pogostejšega pojavljanja driske/dehidracije, elektrolitskega neravnovesja in/ali okvare delovanja ledvic.
Your doctor may also prescribe other medicines to help control your side effects. 
Predpiše vam lahko tudi druga zdravila za pomoč pri obvladovanju neželenih učinkov.
• Inflammation of the diverticula (small bulging pouches that can form in your digestive system). 
• vnetje divertikula (majhna, izbokla vrečica, ki lahko nastane v vaših prebavilih);
There is no experience with Caprelsa in patients 5-8 years of age in this study. 
V tej študiji ni bilo izkušenj z zdravilom Caprelsa pri bolnikih, starih od 5 do 8 let.
• Signs or symptoms of the safety concerns and when to seek attention from a HCP; 
• Znake in simptome varnostnih tveganj in kdaj je treba poiskati zdravniško pomoč.
In order to confirm the efficacy and safety of Caprelsa in RET-negative patients, the MAH should submit: 
Za potrditev učinkovitosti in varnosti zdravila Caprelsa pri bolnikih, negativnih za RET, mora imetnik dovoljenja za promet predložiti:
Diarrhoea is a disease related symptom as well as a known undesirable effect of vandetanib. 
Driska je z boleznijo povezan simptom, kakor tudi znan neželeni učinek vandetaniba.
• vitamin K antagonists and dabigatran often referred to as ‘blood thinners' 
• antagoniste vitamina K in dabigatran, ki jih pogosto imenujejo 'zdravila za redčenje krvi'
Twenty-eight of the 231 patients (12.1%) on vandetanib and 3 of the 99 (3.0%) on placebo discontinued treatment because of an adverse event. 
Osemindvajset od 231 (12,1 %) prejemnikov vandetaniba in 3 od 99 (3,0 %) prejemnikov placeba je zdravljenje prekinilo zaradi neželenega dogodka.
Starting vandetanib dose was 100mg/m2/day for all patients except for one who started at 150mg/m2/day. 
Začetni odmerek vandetaniba je bil 100 mg/m2/dan pri vseh bolnikih razen pri enem, ki je zdravljenje začel s 150 mg/m2/dan.
Do not take a double dose (two doses at the same time) to make up for a forgotten tablet. 
Ne vzemite dvojnega odmerka (dveh odmerkov hkrati), če ste pozabili vzeti prejšnjo tableto.
• 1, 3 and 6 weeks after starting Caprelsa 
• 1, 3 in 6 tednov po začetku zdravljenja z zdravilom Caprelsa,
There was no statistically significant difference in final OS (HR 0.99, 95.002% CI 0.72, 1.38, p=0.9750). 
Končno celokupno preživetje se ni statistično značilno razlikovalo (HR 0,99, 95,002 % IZ 0,72, 1,38, p = 0,9750).
In addition, vandetanib inhibits epidermal growth factor (EGF)-stimulated EGF receptor tyrosine kinase in tumour cells and endothelial cells. 
Poleg tega vandetanib zavira z epidermalnim rastnim dejavnikom (EGF) stimulirani EGF receptor tirozin-kinazo v tumorskih celicah in endotelijskih celicah.
The analysis was performed using a log rank test with treatment as the only factor. 
Analiza je bila izvedena s testom log-rang in zdravljenjem kot edinim faktorjem.
Adverse reactions associated with overdose may be prolonged due to the long half-life of vandetanib (see section 5.2). 
Trajanje neželenih učinkov povezanih s prevelikim odmerjanjem je lahko podaljšano zaradi dolgega razpolovnega časa vandetaniba (glejte poglavje 5.2).
Effects noted in other studies included inhibition of human ether-à-go-go related gene (hERG) current and prolongation of QTc interval in dogs. 
Med učinki, ugotovljenimi v drugih študijah, sta bila zavrtje toka hERG (humanega ether-a-go-go povezanega gena) in podaljšanje intervala QTc pri psih.
An ECG, and levels of serum potassium, calcium and magnesium and thyroid stimulating hormone (TSH) should be obtained at baseline, at 1, 3, 6 and 12 weeks after starting treatment and every 3 months for at least a year thereafter. 
Snemanje EKG in meritve serumskih ravni kalija, kalcija in magnezija ter tiroideo-stimulirajočega hormona (TSH) je treba opraviti izhodiščno, nato 1, 3, 6 in 12 tednov po začetku zdravljenja ter vsake 3 mesece vsaj eno leto potem.
Reduction in dose may be necessary (see section 4.8). 
Morda bo potrebno zmanjšanje odmerka (glejte poglavje 4.8).