FrancophonIA/ELRC3.0 huggingface dataset:
English: This medicinal product contains approximately 1.6 mEq (approximately 37.6 mg) of sodium per 500 mg dose which should be taken into consideration by patients on a controlled sodium diet.
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila TIENAM Zdravilo vsebuje približno 1,6 mEq natrija (približno 37,6 mg) na 500-mg odmerek.
English: : S ≤4 mg/l, R >8 mg/l
Slovenian: : O ≤4 mg/l, R >8 mg/l
English: system through which a lactate solution is being infused.
Slovenian: Lahko pa se ga daje v intravenski sistem, po katerem je infundirana raztopina laktata.
English: Dose adjustment is necessary for patients with impaired renal function (see section 4.2).
Slovenian: Bolnikom z okvarjenim delovanjem ledvic je treba odmerek prilagoditi (glejte poglavje 4.2).
English: 2: S ≤4 mg/l, R >8 mg/l
Slovenian: 2: O ≤4 mg/l, R >8 mg/l
English: • complicated urinary tract infections
Slovenian: • zapleteno okužbo sečil
English: PHARMACEUTICAL FORM Powder for solution for infusion.
Slovenian: FARMACEVTSKA OBLIKA prašek za raztopino za infundiranje bel do svetlorumen prašek
English: : S ≤2 mg/l, R >8 mg/l
Slovenian: : O ≤2 mg/l, R >8 mg/l
English: Single use.
Slovenian: enkratna uporaba
English: • Streptococcus pneumoniae 4: S ≤2 mg/l, R >2 mg/l
Slovenian: Streptococcus pneumoniae 4: O ≤2 mg/l, R >2 mg/l Drugi streptokoki 4: O ≤2 mg/l, R >2 mg/l
English: • Gram-positive anaerobes: S ≤2 mg/l, R >8 mg/l
Slovenian: Grampozitivni anaerobi: O ≤2 mg/l, R >8 mg/l
English: HOW TO STORE TIENAM
Slovenian: SHRANJEVANJE ZDRAVILA TIENAM
English: Dialysis patients, especially those with background central nervous system (CNS) disease, should be carefully monitored; for patients on haemodialysis, TIENAM is recommended only when the benefit outweighs the potential risk of seizures (see section 4.4).
Slovenian: Za bolnike na hemodializi je zdravilo TIENAM priporočljivo le, če korist odtehta možno tveganje za napade krčev (glejte poglavje 4.4).
English: SPECIAL STORAGE CONDITIONS Do not store above 25C After reconstitution: Diluted solutions should be used immediately.
Slovenian: Po pripravi: Razredčene raztopine je treba uporabiti takoj.
English: Rare pseudomembranous colitis, candidiasis
Slovenian: Infekcijske in parazitske bolezni Redki psevdomembranozni kolitis, kandidoza
English: Very rare polyarthralgia, thoracic spine pain
Slovenian: Zelo redki poliartralgija, bolečine v torakalni hrbtenici
English: Do not freeze the reconstituted solution.
Slovenian: Pripravljene raztopine ne zamrzujte.
English: Slovak Republic: TIENAM i.v.
Slovenian: Slovaška: TIENAM i.v.
English: • Seizures
Slovenian: Žilne bolezni
English: Event
Slovenian: Učinek
English: Both doses should not be taken at the same time.
Slovenian: Obeh odmerkov pa ne sme vzeti hkrati.
English: How many tablets should you take
Slovenian: Koliko tablet morate vzeti
English: ● If you do plan to go into the sun:
Slovenian: • Če nameravate biti na soncu:
English: This is very important, as using more than one medicine at the same time can strengthen or weaken the effect of medicines.
Slovenian: To je zelo pomembno, kajti uporaba več kot enega zdravila hkrati lahko poveča ali zmanjša učinek zdravil.
English: 0 (not applicable)
Slovenian: 0 (ni aplikabilno)
English: They should not be chewed or crushed.
Slovenian: Ne sme se jih žvečiti ali zdrobiti.
English: Stage IIIc/M1A/M1B
Slovenian: Stadij IIIC/M1a/M1b
English: A total of 146 patients were enrolled.
Slovenian: Skupno je bilo vključenih 146 bolnikov.
English: The following convention has been used for the classification of frequency:
Slovenian: Za razvrstitev pogostnosti je uporabljen naslednji dogovor:
English: Do not take Zelboraf:
Slovenian: Ne jemljite zdravila Zelboraf:
English: LDH normal
Slovenian: LDH normalna
English: This change may have led to the development of melanoma.
Slovenian: Ta sprememba je lahko povzročila nastanek melanoma.
English: Currently available data are described in sections 4.8, 5.1, and 5.2, but no recommendation on a posology can be made.
Slovenian: Trenutno razpoložljivi podatki so opisani v poglavjih 4.8, 5.1 in 5.2, vendar priporočil o odmerjanju ni mogoče dati.
English: In particular, tell your doctor if you are taking:
Slovenian: Še zlasti morate zdravniku povedati, če jemljete:
English: LDH: Lactate Dehydrogenase, ECOG PS: Eastern Cooperative Oncology Group Performance Status
Slovenian: LDH: laktat-dehidrogenaza, ECOG PS: Eastern Cooperative Oncology Group Performance Status
English: Treatment not recommended.
Slovenian: Zdravljenje ni priporočljivo.
English: ● The other ingredients are:
Slovenian: • Druge sestavine zdravila (pomožne snovi) so:
English: Determination of BRAF mutation status
Slovenian: Določanje statusa mutacije BRAF
English: Then take the next dose at the usual time.
Slovenian: Naslednji odmerek vzemite ob običajnem času.
English: It is unclear whether this is a gender or a body size effect.
Slovenian: Ni jasno ali na to razliko vpliva spol ali velikost telesa.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/751/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/12/751/001
English: Safety and efficacy data from pivotal studies were collected from patients taking vemurafenib with or without food.
Slovenian: Podatki o učinkovitosti in varnosti iz ključnih študij so bili zbrani od bolnikov, ki so vemurafenib jemali s hrano ali brez nje.
English: Tell your doctor immediately if you experience any of the following symptoms:
Slovenian: Zdravniku nemudoma sporočite, če opazite katerega koli od naslednjih simptomov:
English: If necessary, your doctor may decide to interrupt your treatment temporarily or stop it altogether.
Slovenian: Če je treba, lahko zdravnik vaše zdravljenje začasno prekine ali ga povsem konča.
English: Call a doctor immediately.
Slovenian: • omedlevica, nemudoma pokličite zdravnika.
English: During treatment, avoid exposing your skin to direct sunlight.
Slovenian: Med zdravljenjem se izogibajte izpostavljanju kože neposredni sončni svetlobi.
English: BORR extracranial n (%)a
Slovenian: BORR ekstrakranialno n (%)a
English: Patients should be instructed to inform their physicians upon the occurrence of any skin changes.
Slovenian: Bolnikom je treba naročiti, naj svojega zdravnika obvestijo o pojavu kakršnih koli sprememb na koži.
English: No studies were performed regarding pre- and postnatal development.
Slovenian: Študij, ki bi obravnavale pre- in postnatalni razvoj, niso izvedli.
English: Please tell your doctor if you are taking an oral contraceptive.
Slovenian: Povejte svojemu zdravniku, če jemljete peroralni kontraceptiv.
English: Before starting treatment, tell your doctor if you are taking, have recently taken or might use any other medicines (including those you have bought for yourself from a pharmacy, supermarket or health store).
Slovenian: Pred začetkom zdravljenja obvestite zdravnika, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo (vključno z zdravili, ki ste jih kupili v lekarni ali specializirani prodajalni).
English: Tell your doctor if you are pregnant or planning to become pregnant.
Slovenian: Zdravniku morate povedati, če ste noseči ali nameravate zanositi.
English: Table 8 shows the treatment effect for all pre-specified stratification variables which are established as prognostic factors.
Slovenian: Preglednica 8 prikazuje učinek zdravljenja vseh vnaprej določenih stratifikacijskih spremenljivk uporabljenih kot prognostični dejavniki.
English: All terms included are based on the highest percentage observed among phase II and phase III clinical trials.
Slovenian: Vsi vključeni izrazi temeljijo na največjem deležu, zabeleženem v kliničnih preskušanjih faze II in III.
English: Total n = 146
Slovenian: Skupaj n = 146
English: It is used to treat adult patients with melanoma that has spread to other parts of the body or cannot be removed by surgery.
Slovenian: Uporabljamo ga za zdravljenje odraslih bolnikov z melanomom, ki se je razširil v druge dele telesa in ga ni mogoče odstraniti z operacijo.
English: However, the differences in exposure are not large enough to warrant dose adjustment based on body size or gender.
Slovenian: Razlike v izpostavljenosti niso dovolj velike, da bi zahtevale prilagoditev odmerka glede na velikost telesa ali spol.
English: • ≥ 2x ULN ALP (without other cause for ALP elevation)
Slovenian: • ≥ 2 x ULN ALP (brez drugih vzrokov zvišanja ALP),
English: The median age was 52 years with 19% of patients being older than 65 years.
Slovenian: Mediana starosti je bila 52 let in 19 % bolnikov je bilo starejših od 65 let.
English: ● If your doctor finds this type of skin cancer, he or she will treat it or send you to another doctor for treatment.
Slovenian: • Če zdravnik pri vas odkrije to vrsto kožnega raka, ga bo zdravil ali vas napotil na zdravljenje k drugemu zdravniku.
English: It is highly bound to human plasma proteins in vitro (>99%).
Slovenian: In vitro je v veliki meri vezan na beljakovine v človeški plazmi (> 99 %).
English: Date of latest renewal: 22 September 2016
Slovenian: Datum prve odobritve: 17. februar 2012 Datum zadnjega podaljšanja: 22. september 2016
English: ● The recommended dose is 4 tablets twice a day (a total of 8 tablets).
Slovenian: • Priporočeni odmerek so 4 tablete dvakrat na dan (skupno 8 tablet).
English: ● If you are allergic to vemurafenib or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
Slovenian: • če ste alergični na vemurafenib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: ● Bell's palsy (a form of facial paralysis that is often reversible)
Slovenian: • Bellova paraliza (oblika paralize obraza, ki je velikokrat reverzibilna),
English: Inhibitory Concentration 50 (nM)
Slovenian: Inhibitorne koncentracije (IC50) (nM)
English: ● wear clothing which protects your skin, including your head and face, arms and legs;
Slovenian: • nosite oblačila, ki vam varujejo kožo, tudi glavo in obraz, roke in noge,
English: The possible effect of vemurafenib on other transporters is currently unknown.
Slovenian: Možen vpliv vemurafeniba na druge prenašalce trenutno ni znan.
English: Vemurafenib (%) Dacarbazine (%)
Slovenian: vemurafenib (%) dakarbazin (%)
English: Grade (CTC-AE) (a)
Slovenian: (CTC-AE)(a)
English: Post-hoc survival analyses were undertaken thereafter as described in table 7.
Slovenian: Zatem so naredili post-hoc analizo preživetja, kot je opisano v preglednici 7.
English: Important information about some of the ingredients of Zelboraf This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'.
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Zelboraf To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na tableto, kar v bistvu pomeni "brez natrija".
English: Thus close monitoring is warranted especially after the first few weeks of treatment as accumulation may occur over an extended period of time (several weeks).
Slovenian: Tako je posebej po prvih tednih zdravljenja potreben skrben nadzor, saj lahko po daljšem obdobju (več tednih) pride do kopičenja.
English: Vemurafenib may be taken with or without food, but consistent intake of both daily doses on an empty stomach should be avoided (see section 5.2).
Slovenian: Vemurafenib lahko vzamemo s hrano ali brez nje, izogibati pa se moramo stalnemu jemanju obeh dnevnih odmerkov na prazen želodec (glejte poglavje 5.2).
English: ● Medicines that are known to affect the way your heart beats:
Slovenian: • zdravila, za katera je znano, da vplivajo na bitje srca:
English: Many anticancer medicinal products are substrates of BCRP and therefore there is a theoretical risk for an interaction with vemurafenib.
Slovenian: Številna zdravila za zdravljenje raka so substrati BCRP, zato obstaja teoretično tveganje za medsebojno delovanje z vemurafenibom.
English: Among these patients, 457 were Caucasians.
Slovenian: Med temi bolniki je bilo 457 belcev.
English: A causal relationship between the medicinal product and the adverse event is at least a reasonable possibility.
Slovenian: Vzročna povezava med zdravilom in neželenim dogodkom je vsaj možna.
English: ● This will help to protect you against sunburn.
Slovenian: • To vam bo pomagalo, da se boste obvarovali pred sončnimi opeklinami.
English: If a dose is missed, it can be taken up to 4 hours prior to the next dose to maintain the twice daily regimen.
Slovenian: Če bolnik izpusti odmerek, ga lahko vzame do 4 ure pred naslednjim odmerkom za ohranitev sheme dvakrat na dan.
English: Estimated from 16,403 melanomas with annotated BRAF codon 600 mutations in the public COSMIC database, release 71 (November 2014).
Slovenian: Ocenjeno pri 16403 melanomih z določenimi mutacijami BRAF kodona 600, pridobljenih iz javne podatkovne baze COSMIC, izdaja 71 (november 2014).
English: It can only be used in patients whose cancer has a change (mutation) in the “BRAF” gene.
Slovenian: Zdravilo lahko uporabimo le pri bolnikih, pri katerih ima rak spremembo (mutacijo) v genu “BRAF”.
English: Further monitoring is recommended in particular in patients with moderate to severe hepatic impairment monthly during the first 3 months of treatment followed by every 3 months thereafter or more often as clinically indicated.
Slovenian: Nadaljnje kontrole so priporočljive predvsem pri bolnikih z zmerno do hudo jetrno okvaro, in sicer mesečno prve 3 mesece zdravljenja, potem pa na 3 mesece oziroma pogosteje, če je to klinično indicirano.
English: If you forget to take Zelboraf
Slovenian: Če ste pozabili vzeti zdravilo Zelboraf
English: Zelboraf targets proteins made from this modified gene and slows down or stops the development of your cancer.
Slovenian: Zdravilo Zelboraf je usmerjeno na beljakovine, ki jih ustvarja ta spremenjeni gen, in tako upočasni ali ustavi razvoj vaše bolezni.
English: What Zelboraf is and what it is used for
Slovenian: Kaj je zdravilo Zelboraf in za kaj ga uporabljamo
English: Grade 1 or Grade 2 (tolerable)
Slovenian: Stopnja 1 ali stopnja 2 (prenosljivo)
English: ● use a lip balm and a broad spectrum sunscreen (minimum of Sun Protection Factor (SPF) 30, re-applied every 2 to 3 hours).
Slovenian: • uporabite mazilo za ustnice in sredstvo za sončenje z visoko zaščito (vsaj zaščitni faktor SPF 30; sredstvo znova nanesite vsake 2 do 3 ure).
English: ● Tell your doctor if you have had a different type of cancer than melanoma, as Zelboraf may cause progression of certain types of cancers.
Slovenian: • Zdravniku povejte, če ste imeli drugo vrsto raka, kot je melanom, ker lahko zdravilo Zelboraf povzroči napredovanje nekaterih vrst raka.
English: This may affect the activity of Zelboraf.
Slovenian: Te lahko vplivajo na aktivnost zdravila Zelboraf.
English: If you are taking any of these medicines (or if you are not sure), please talk to your doctor before taking Zelboraf.
Slovenian: Če jemljete katero koli od teh zdravil (ali ste negotovi), se posvetujte z zdravnikom, preden boste vzeli zdravilo Zelboraf.
English: Treatment with vemurafenib should be initiated and supervised by a qualified physician experienced in the use of anticancer medicinal products.
Slovenian: Zdravljenje z vemurafenibom mora uvesti in nadzorovati usposobljen zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
English: No new safety signals were observed in a clinical study with six adolescent patients.
Slovenian: V klinični študiji s šestimi adolescenti niso opazili novih varnostnih signalov.
English: What you need to know before you take Zelboraf
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Zelboraf
English: Temporarily interrupt treatment until QTc decreases below 500 ms.
Slovenian: Zdravljenje začasno prekinite dokler se interval QTc ne zniža pod 500 ms.
English: The combination of this medicine with Zelboraf is not recommended due to increased toxicity to the liver.
Slovenian: Sočasno jemanje tega zdravila z zdravilom Zelboraf ni priporočljivo zaradi povečane toksičnosti za jetra.
English: However, the parent compound was the predominant component (95%) in plasma.
Slovenian: Kljub temu je bila prevladujoča sestavina (95 %) v plazmi matična spojina.
English: ● Tell your doctor if you observe any unusual thickening of the palms of your hands accompanied by tightening of the fingers inward or any unusual thickening of the soles of your feet which may be painful.
Slovenian: • Zdravniku povejte, če opazite kakršno koli neobičajno zadebelitev dlani, ki jo spremlja zategovanje prstov proti dlani, ali kakršno koli neobičajno zadebelitev podplatov, ki je lahko boleča.
English: ● The active substance is vemurafenib.
Slovenian: • Učinkovina je vemurafenib.
English: Table 2: Dose modification schedule based on prolongation of the QT interval QTc value
Slovenian: Preglednica 2: Shema prilagajanja odmerka glede na podaljšanje intervala QT Vrednost intervala QTc
English: Unexplained abdominal pain should be promptly investigated (including measurement of serum amylase and lipase).
Slovenian: Nepojasnjeno bolečino v trebuhu je treba nemudoma preiskati (vključno z določitvijo serumske amilaze in lipaze).
English: ● Swallow the tablets whole with a glass of water.
Slovenian: • Tablete morate zaužiti cele in s kozarcem vode.
English: The maximum tolerated dose could not be determined.
Slovenian: Največjega prenosljivega odmerka ni bilo mogoče določiti.
English: It is currently unknown whether vemurafenib is a substrate also to other transport proteins.
Slovenian: Trenutno ni znano, ali je vemurafenib tudi substrat drugih prenašalnih beljakovin.
English: ● Do not take Zelboraf regularly on an empty stomach.
Slovenian: • Izogibajte se stalnemu jemanju zdravila Zelboraf na prazen želodec.
English: Grenzach-Wyhlen Germany
Slovenian: Grenzach-Wyhlen Nemčija
English: ● Usually, this lesion appears on sun-damaged skin, remains local and can be cured by surgical removal.
Slovenian: • Po navadi se ta sprememba pojavi na koži, poškodovani od sonca, ostane lokalno omejena in jo je mogoče ozdraviti s kirurško odstranitvijo.
English: Other medicines and Zelboraf
Slovenian: Druga zdravila in zdravilo Zelboraf
English: Abnormal findings should be managed according to clinical practices.
Slovenian: Nenormalne spremembe je treba obravnavati v skladu s klinično prakso.
English: ● Change in liver laboratory tests results or liver injury, including severe liver injury where liver is injured to the extent that it is not able to fully perform its function
Slovenian: • spremembe v izvidih jetrnih testov ali poškodba jeter, vključno s hudo poškodbo, ko jetra ne morejo v celoti opravljati svoje funkcije,
English: Very rare < 1/10,000
Slovenian: Zelo redki: < 1/10.000
English: Based on the criteria for drug induced liver injury developed by an international expert working group of clinicians and scientists, liver injury was defined as any one of the following laboratory abnormalities:
Slovenian: V skladu z merili za poškodbo jeter, povzročeno z zdravili, ki jih je razvila mednarodna strokovna delovna skupina, sestavljena iz zdravnikov in znanstvenikov, je bila poškodba jeter opredeljena kot ena od spodnjih laboratorijskih nenormalnosti:
English: ● Take 4 tablets in the morning.
Slovenian: • Vzemite 4 tablete zjutraj, potem vzemite 4 tablete zvečer.
English: The effects of Zelboraf in people younger than 18 years old are not known.
Slovenian: Učinki zdravila Zelboraf pri otrocih, mlajših od 18 let, niso znani.
English: ● Swelling of the face, lips or tongue
Slovenian: • oteklost obraza, ustnic ali jezika,
English: ● Changes in electrical activity of the heart (QT prolongation)
Slovenian: • spremembe v električni aktivnosti srca (podaljšanje QT),
English: ● It is not known whether the ingredients in Zelboraf pass into human milk.
Slovenian: • Ni znano, ali sestavine zdravila Zelboraf prehajajo v materino mleko.
English: ● Allergic reactions that may include swelling of the face and difficulty breathing
Slovenian: • alergijske reakcije, ki lahko vključujejo otekel obraz in težko dihanje,
English: The tablets are to be swallowed whole with water.
Slovenian: Tablete je treba zaužiti cele, z vodo.
English: ● Tell your doctor if you have a heart disorder, such as an alteration of the electrical activity of your heart called “QT prolongation”.
Slovenian: • Zdravniku morate povedati, če imate motnjo delovanja srca, kot je spremenjena električna aktivnost srca, imenovana "podaljšanje intervala QT".
English: (y) As of December 30, 2010, a total of 549 patients were evaluable for PFS and 439 patients were evaluable for overall response rate.
Slovenian: Do 30. decembra 2010 so skupno 549 bolnikom ocenili preživetje brez napredovanja bolezni in 439 bolnikom celokupni odziv.
English: Forty-nine percent of patients failed ≥ 2 prior therapies.
Slovenian: Pri 49 % bolnikov je bilo neuspešnih 2 ali več predhodnih zdravljenj.
English: PHARMACEUTICAL FORM AND CONTENTS 56 x 1 film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 56 x 1 filmsko obložena tableta
English: ● If you experience side effects, your doctor may decide to carry on your treatment but lower your dose.
Slovenian: • Če se pojavijo neželeni učinki, se bo vaš zdravnik morda vseeno odločil za nadaljevanje zdravljenja, vendar bo zmanjšal odmerek.
English: See monitoring measures in section 4.4.
Slovenian: Za ukrepe spremljanja glejte poglavje 4.4.
English: Biliary excretion appears to be another important elimination pathway.
Slovenian: Zdi se, da je tudi izločanje z žolčem pomembna pot izločanja.
English: ● Tell your doctor if you have kidney or liver problems.
Slovenian: • Zdravniku morate povedati, če imate težave z ledvicami ali jetri.
English: Carcinogenicity studies have not been conducted with vemurafenib.
Slovenian: Študij kancerogenosti z vemurafenibom niso izvedli.
English: Results from the phase II study (NP22657) in patients who failed at least one prior therapy
Slovenian: Rezultati študije faze II (NP22657) pri bolnikih, pri katerih je bilo neuspešno vsaj eno predhodno zdravljenje
English: Hazard Ratio 95% Confidence Interval
Slovenian: 95-% interval zaupanja
English: ● Zelboraf is not recommended for use during pregnancy unless your doctor considers that the benefit for the mother outweighs the risk for the baby.
Slovenian: • Zdravila Zelboraf ni priporočljivo uporabljati med nosečnostjo, razen če zdravnik meni, da je korist zdravljenja za mater pomembnejša od morebitnega tveganja za otroka.
English: ● Sunburn, being more sensitive to sunlight
Slovenian: • sončne opekline, večja občutljivost za sončno svetlobo,
English: Results from the phase I study (NO25390) in paediatric patients
Slovenian: Rezultati iz študije faze I (NO25390) pri pediatričnih bolnikih
English: • ≥ 3x ULN ALT with simultaneous elevation of bilirubin concentration > 2x ULN
Slovenian: • ≥ 3 x ULN ALT s hkratnim zvišanjem koncentracije bilirubina > 2 x ULN.
English: Mutations in the BRAF gene result in constitutive activation of BRAF proteins, which can cause cell proliferation without associated growth factors.
Slovenian: Mutacije v genu BRAF povzročijo konstitutivno aktivacijo beljakovine BRAF, kar lahko spodbudi proliferacijo celic brez pridruženih rastnih faktorjev.
English: Do not chew or crush the tablets.
Slovenian: Tablet ne žvečite ali drobite.
English: Serum creatinine elevations were mostly mild (>1-1.5x ULN) to moderate (>1.5-3x ULN) and observed to be reversible in nature (see table 4).
Slovenian: Zvišanja serumskega kreatinina so bila večinoma blaga (> 1-1,5x ULN) do zmerna (> 1,5-3x ULN); ugotovili so, da so po naravi reverzibilna (glejte preglednico 4).
English: ● Regularly during your treatment and up to 6 months after your treatment, your doctor needs to check your skin for a type of cancer called “cutaneous squamous cell carcinoma”.
Slovenian: • Zdravnik vam mora med zdravljenjem in še 6 mesecev po zdravljenju redno pregledovati kožo zaradi vrste raka, imenovanega "ploščatocelični karcinom kože".
English: The median number of brain target lesions at baseline was 2 (range 1 to 5), in both cohorts.
Slovenian: Mediana števila ciljnih lezij v možganih v izhodišču je bila v obeh skupinah 2 (razpon od 1 do 5).
English: Table 4: Creatinine changes from baseline in the phase III study
Slovenian: Preglednica 4: Spremembe kreatinina glede na izhodišče v študiji faze III