natgillin/translations-raw huggingface dataset:
Uncommon urticaria, pruritus 
Občasni urtikarija, srbenje
Patients on haemodialysis 
Bolniki na hemodializi
Very rare flushing 
Zelo redki zardevanje
The urinary recovery of active (non-metabolized) imipenem decreased to approximately 60% of the dose when TIENAM was administered with probenecid. 
Če je bilo zdravilo TIENAM uporabljeno s probenecidom, se je pojavljanje aktivnega (nepresnovljenega) imipenema v urinu zmanjšalo na približno 60% odmerka.
Decreases in valproic acid levels that may fall below the therapeutic range have been reported when valproic acid was co-administered with carbapenem agents. 
Med sočasno uporabo valprojske kisline in karbapenemskih zdravil so poročali o zmanjšanju koncentracije valprojske kisline, ki lahko pade pod terapevtsko območje.
France: TIENAM 
Francija: TIENAM
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams. 
Pri bolnikih, zdravljenih z betalaktamskimi antibiotiki, so poročali o resnih in občasno smrtnih primerih preobčutljivostnih (anafilaktičnih) reakcij.
Anticonvulsant therapy should be continued in patients with a known seizure disorder. 
Pri bolnikih z znano boleznijo, ki jo spremljajo napadi krčev, je treba nadaljevati zdravljenje z antiepileptiki.
Rare hepatic failure, hepatitis 
Redki odpoved jeter, hepatitis
In normal volunteers, intravenous infusion of TIENAM over 20 minutes resulted in peak plasma levels of imipenem ranging from 12 to 20 μg/ml for the 250 mg/250 mg dose, from 21 to 58 μg/ml for the 500 mg/500 mg dose, and from 41 to 83 μg/ml for the 1000 mg/1000 mg dose. 
Pri zdravih prostovoljcih so bile po 20-minutnem intravenskem infundiranju zdravila TIENAM največje koncentracijo imipenema v plazmi: od 12 do 20 µg/ml pri odmerku 250 mg/250 mg, od 21 do 58 µg/ml pri odmerku 500 mg/500 mg in od 41 do 83 µg/ml pri odmerku 1000 mg/1000 mg.
if you are allergic (hypersensitive) to imipenem, cilastatin or any of the other ingredients of TIENAM if you are allergic (hypersensitive) to other antibiotics such as penicillins, cephalosporins, or carbapenems 
če ste alergični (preobčutljivi) na druge antibiotike, npr. peniciline, cefalosporine ali karbapeneme.
The AUC for imipenem following administration of 15/15 mg/kg per body weight of imipenem/cilastatin to paediatric patients was approximately 30% higher than the exposure in adults receiving a 500 mg/500 mg dose. 
AUC za imipenem po uporabi imipenema/cilastatina v odmerku 15/15 mg/kg telesne mase je bila pri pediatričnih bolnikih približno za 30 % večja kot izpostavljenost pri odraslih, ki so dobili odmerek 500 mg/500 mg. Z večjim odmerkom je bila izpostavljenost po uporabi imipenema/cilastatina v odmerku 25/25 mg/kg pri otrocih za 9 % večja kot izpostavljenost odraslih, ki so dobili odmerek 1.000 mg/1.000 mg.
Antibiotic-associated colitis and pseudomembranous colitis have been reported with imipenem/cilastatin and with nearly all other anti-bacterial agents and may range from mild to life-threatening in severity. 
Pri zdravljenu z imipenemom/cilastatinom in z skoraj vsemi drugimi protibakterijskimi zdravili so poročali o z antibiotikom povezanem kolitisu in psevdomembranoznem kolitisu, ki sta lahko blaga do smrtno nevarna.
3: Inferred from cefoxitin susceptibility 
3: sklepanje temelji na podlagi občutljivosti za cefoksitin Enterococcus spp.
Urine concentrations of imipenem exceeded 10 g/ml for up to eight hours after a 500 mg/500 mg dose of TIENAM. 
Koncentracija imipenema v urinu je po odmerku 500 mg/500 mg zdravila TIENAM presegala 10 g/ml do osem ur.
Uncommon hypotension 
Občasni hipotenzija
Norway: Tienam 
Norveška: Tienam
Estonia: TIENAM I.V. 
Estonija: TIENAM I.V.
Imipenem-cilastatin sodium is haemodialyzable. 
Imipenem in natrijeva sol cilastatina se hemodializirata.
For single use only. 
Vsaka viala je samo za enkratno uporabo.
Peak plasma levels of cilastatin, following a 20 minute intravenous infusion of TIENAM, ranged from 21 to 26 μg/ml for the 250 mg/250 mg dose, from 21 to 55 μg/ml for the 500 mg/500 mg dose and from 56 to 88 μg/ml for the 1000 mg/1000 mg dose. 
Največje koncentracije cilastatina v plazmi so bile po 20-minutnem intravenskem infundiranju zdravila TIENAM od 21 do 26 µg/ml pri odmerku 250 mg/250 mg, od 21 do 55 µg/ml pri odmerku 500 mg/500 mg in od 56 do 88 µg/ml pri odmerku 1000 mg/1000 mg.
It is recommended that the INR should be monitored frequently during and shortly after co-administration of antibiotics with an oral anti-coagulant agent. 
Med sočasno uporabo antibiotikov in katerega od peroralnih antikoagulantov ter krajši čas po takšni uporabi je priporočljivo pogosto kontrolirati INR.
Belgium: Tienam 
Belgija: Tienam
Hungary: Tienam 
Madžarska: Tienam
Rare hearing loss 
Redki poslabšanje sluha
Creatinine clearance (ml/min/1.73 m2) 
očistek kreatinina (ml/min/1,73 m2) odmerek v mg (interval v urah)
• Enterobacteriaceae 1: S ≤2 mg/l, R >8 mg/l 
Enterobacteriaceae 1: O ≤2 mg/l, R >8 mg/l
The concentration of the reconstituted solution following the above procedure is approximately 5 mg/ml for both imipenem and cilastatin. 
Koncentracija imipenema in cilastatina v raztopini, pripravljeni po zgoraj opisanem postopku, je približno 5 mg/ml.
Sweden: Tienam 
Švedska: Tienam
Hepatic impairment No dose adjustment is recommended in patients with impaired hepatic function (see section 5.2). 
Okvara jeter Pri bolnikih z okvarjenim delovanjem jeter prilagoditve odmerka ne priporočamo (glejte poglavje 5.2).
Netherlands: TIENAM I.V. 
Nizozemska: TIENAM I.V.
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains: imipenem 500 mg and cilastatin 500 mg. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena viala vsebuje: imipenem 500 mg in cilastatin 500 mg.
Common thrombophlebitis 
Pogosti tromboflebitis
• Moraxalla catarrhalis 4: S ≤2 mg/l, R >2 mg/l 
Moraxalla catarrhalis 4: O ≤2 mg/l, R >2 mg/l
Finland: TIENAM 
Finska: TIENAM
• Haemophilus influenzae 4: S ≤2 mg/l, R >2 mg/l 
Haemophilus influenzae 4: O ≤2 mg/l, R >2 mg/l
Hepatic 
Hematologija
• Complicated infections in the abdomen 
• zapleteno okužbo v trebuhu
Bulgaria: Tienam 
Bolgarija: Tienam
Little absorption of either compound occurs following oral administration. 
Po peroralni uporabi je absorpcija ene in druge učinkovine majhna.
The mean peak plasma levels of imipenem following the 250 mg/250 mg, 500 mg/500 mg, and 1000 mg /1000 mg doses were 17, 39, and 66 μg/ml, respectively. 
Povprečna največja koncentracija imipenema v plazmi je bila po odmerku 250 mg/250 mg 17 µg/ml, po odmerku 500 mg/500 mg 39 µg/ml in po odmerku 1000 mg/1000 mg 66 µg/ml.
Method of administration 
Mehanizem odpornosti
Poland: TIENAM 
Poljska: TIENAM
There is no dose adjustment necessary (see section 
Prilagoditev odmerka ni potrebna (glejte poglavje 4.2).
What TIENAM contains - The active substances are imipenem and cilastatin. 
Zdravilni učinkovini sta imipenem in cilastatin.
Therefore, no dose adjustment is recommended in patients with hepatic impairment (see section 4.2). 
Zato bolnikom z okvaro jeter odmerka ni treba prilagoditi (glejte poglavje 4.2).
The mean peak plasma levels of cilastatin following the 250 mg/250 mg, 500 mg/500 mg, and 1000 mg/1000 mg doses were 22, 42, and 72 µg/ml respectively. 
Povprečna največja koncentracija cilastatina v plazmi je bila po odmerku 250 mg/250 mg 22 µg/ml, po odmerku 500 mg/500 mg 42 µg/ml in po odmerku 1000 mg/1000 mg 72 µg/ml.
Streptococcus viridans group 
Skupina Streptococcus viridans Gramnegativni aerobi:
Each vial contains imipenem monohydrate equivalent to 500 mg imipenem anhydrate and cilastatin sodium equivalent to 500 mg cilastatin. 
Ena viala vsebuje 500 mg imipenema v obliki imipenem monohidrata in 500 mg cilastatina v obliki natrijevega cilastatinata.
Nausea and vomiting appear to occur more frequently in patients with low number of white blood cells 
Pogosti siljenje na bruhanje, bruhanje, driska; siljenje na bruhanje in bruhanje sta pogostejša pri bolnikih z majhnim številom belih krvnih celic oteklost in pordelost vzdolž vene, ki je izredno občutljiva na dotik izpuščaj nenormalno delovanje jeter, ki ga pokažejo preiskave krvi povečanje števila nekaterih belih krvnih celic
No accumulation of imipenem in plasma or urine has been observed with regimens of TIENAM, administered as frequently as every six hours, in patients with normal renal function. 
Pri bolnikih z normalnim delovanjem ledvic niso ugotovili kopičenja imipenema v plazmi ali urinu niti med uporabo zdravila TIENAM na šest ur.
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. 
Pomembne informacije o nekaterih sestavinah zdravila TIENAM Zdravilo vsebuje približno 1,6 mEq natrija (približno 37,6 mg) na 500-mg odmerek.
: S ≤4 mg/l, R >8 mg/l 
: O ≤4 mg/l, R >8 mg/l
system through which a lactate solution is being infused. 
Lahko pa se ga daje v intravenski sistem, po katerem je infundirana raztopina laktata.
Dose adjustment is necessary for patients with impaired renal function (see section 4.2). 
Bolnikom z okvarjenim delovanjem ledvic je treba odmerek prilagoditi (glejte poglavje 4.2).
2: S ≤4 mg/l, R >8 mg/l 
2: O ≤4 mg/l, R >8 mg/l
• complicated urinary tract infections 
• zapleteno okužbo sečil
PHARMACEUTICAL FORM Powder for solution for infusion. 
FARMACEVTSKA OBLIKA prašek za raztopino za infundiranje bel do svetlorumen prašek
: S ≤2 mg/l, R >8 mg/l 
: O ≤2 mg/l, R >8 mg/l
Single use. 
enkratna uporaba
• Streptococcus pneumoniae 4: S ≤2 mg/l, R >2 mg/l 
Streptococcus pneumoniae 4: O ≤2 mg/l, R >2 mg/l Drugi streptokoki 4: O ≤2 mg/l, R >2 mg/l
• Gram-positive anaerobes: S ≤2 mg/l, R >8 mg/l 
Grampozitivni anaerobi: O ≤2 mg/l, R >8 mg/l
HOW TO STORE TIENAM 
SHRANJEVANJE ZDRAVILA TIENAM
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). 
Za bolnike na hemodializi je zdravilo TIENAM priporočljivo le, če korist odtehta možno tveganje za napade krčev (glejte poglavje 4.4).
SPECIAL STORAGE CONDITIONS Do not store above 25C After reconstitution: Diluted solutions should be used immediately. 
Po pripravi: Razredčene raztopine je treba uporabiti takoj.
Rare pseudomembranous colitis, candidiasis 
Infekcijske in parazitske bolezni Redki psevdomembranozni kolitis, kandidoza
Very rare polyarthralgia, thoracic spine pain 
Zelo redki poliartralgija, bolečine v torakalni hrbtenici
Do not freeze the reconstituted solution. 
Pripravljene raztopine ne zamrzujte.
Slovak Republic: TIENAM i.v. 
Slovaška: TIENAM i.v.
• Seizures 
Žilne bolezni
Event 
Učinek
Both doses should not be taken at the same time. 
Obeh odmerkov pa ne sme vzeti hkrati.
How many tablets should you take 
Koliko tablet morate vzeti
● If you do plan to go into the sun: 
• Če nameravate biti na soncu:
This is very important, as using more than one medicine at the same time can strengthen or weaken the effect of medicines. 
To je zelo pomembno, kajti uporaba več kot enega zdravila hkrati lahko poveča ali zmanjša učinek zdravil.
0 (not applicable) 
0 (ni aplikabilno)
They should not be chewed or crushed. 
Ne sme se jih žvečiti ali zdrobiti.
Stage IIIc/M1A/M1B 
Stadij IIIC/M1a/M1b
A total of 146 patients were enrolled. 
Skupno je bilo vključenih 146 bolnikov.
The following convention has been used for the classification of frequency: 
Za razvrstitev pogostnosti je uporabljen naslednji dogovor:
Do not take Zelboraf: 
Ne jemljite zdravila Zelboraf:
LDH normal 
LDH normalna
This change may have led to the development of melanoma. 
Ta sprememba je lahko povzročila nastanek melanoma.
Currently available data are described in sections 4.8, 5.1, and 5.2, but no recommendation on a posology can be made. 
Trenutno razpoložljivi podatki so opisani v poglavjih 4.8, 5.1 in 5.2, vendar priporočil o odmerjanju ni mogoče dati.
In particular, tell your doctor if you are taking: 
Še zlasti morate zdravniku povedati, če jemljete:
LDH: Lactate Dehydrogenase, ECOG PS: Eastern Cooperative Oncology Group Performance Status 
LDH: laktat-dehidrogenaza, ECOG PS: Eastern Cooperative Oncology Group Performance Status
Treatment not recommended. 
Zdravljenje ni priporočljivo.
● The other ingredients are: 
• Druge sestavine zdravila (pomožne snovi) so:
Determination of BRAF mutation status 
Določanje statusa mutacije BRAF
Then take the next dose at the usual time. 
Naslednji odmerek vzemite ob običajnem času.
It is unclear whether this is a gender or a body size effect. 
Ni jasno ali na to razliko vpliva spol ali velikost telesa.
MARKETING AUTHORISATION NUMBER(S) EU/1/12/751/001 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/12/751/001
Safety and efficacy data from pivotal studies were collected from patients taking vemurafenib with or without food. 
Podatki o učinkovitosti in varnosti iz ključnih študij so bili zbrani od bolnikov, ki so vemurafenib jemali s hrano ali brez nje.
Tell your doctor immediately if you experience any of the following symptoms: 
Zdravniku nemudoma sporočite, če opazite katerega koli od naslednjih simptomov:
If necessary, your doctor may decide to interrupt your treatment temporarily or stop it altogether. 
Če je treba, lahko zdravnik vaše zdravljenje začasno prekine ali ga povsem konča.
Call a doctor immediately. 
• omedlevica, nemudoma pokličite zdravnika.
During treatment, avoid exposing your skin to direct sunlight. 
Med zdravljenjem se izogibajte izpostavljanju kože neposredni sončni svetlobi.
BORR extracranial n (%)a 
BORR ekstrakranialno n (%)a
Patients should be instructed to inform their physicians upon the occurrence of any skin changes. 
Bolnikom je treba naročiti, naj svojega zdravnika obvestijo o pojavu kakršnih koli sprememb na koži.
No studies were performed regarding pre- and postnatal development. 
Študij, ki bi obravnavale pre- in postnatalni razvoj, niso izvedli.
Please tell your doctor if you are taking an oral contraceptive. 
Povejte svojemu zdravniku, če jemljete peroralni kontraceptiv.
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). 
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).
Tell your doctor if you are pregnant or planning to become pregnant. 
Zdravniku morate povedati, če ste noseči ali nameravate zanositi.
Table 8 shows the treatment effect for all pre-specified stratification variables which are established as prognostic factors. 
Preglednica 8 prikazuje učinek zdravljenja vseh vnaprej določenih stratifikacijskih spremenljivk uporabljenih kot prognostični dejavniki.
All terms included are based on the highest percentage observed among phase II and phase III clinical trials. 
Vsi vključeni izrazi temeljijo na največjem deležu, zabeleženem v kliničnih preskušanjih faze II in III.
Total n = 146 
Skupaj n = 146
It is used to treat adult patients with melanoma that has spread to other parts of the body or cannot be removed by surgery. 
Uporabljamo ga za zdravljenje odraslih bolnikov z melanomom, ki se je razširil v druge dele telesa in ga ni mogoče odstraniti z operacijo.
However, the differences in exposure are not large enough to warrant dose adjustment based on body size or gender. 
Razlike v izpostavljenosti niso dovolj velike, da bi zahtevale prilagoditev odmerka glede na velikost telesa ali spol.
• ≥ 2x ULN ALP (without other cause for ALP elevation) 
• ≥ 2 x ULN ALP (brez drugih vzrokov zvišanja ALP),
The median age was 52 years with 19% of patients being older than 65 years. 
Mediana starosti je bila 52 let in 19 % bolnikov je bilo starejših od 65 let.
● If your doctor finds this type of skin cancer, he or she will treat it or send you to another doctor for treatment. 
• Če zdravnik pri vas odkrije to vrsto kožnega raka, ga bo zdravil ali vas napotil na zdravljenje k drugemu zdravniku.
It is highly bound to human plasma proteins in vitro (>99%). 
In vitro je v veliki meri vezan na beljakovine v človeški plazmi (> 99 %).
Date of latest renewal: 22 September 2016 
Datum prve odobritve: 17. februar 2012 Datum zadnjega podaljšanja: 22. september 2016
● The recommended dose is 4 tablets twice a day (a total of 8 tablets). 
• Priporočeni odmerek so 4 tablete dvakrat na dan (skupno 8 tablet).
● If you are allergic to vemurafenib or any of the other ingredients of this medicine (listed in section 6 of this leaflet). 
• če ste alergični na vemurafenib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
● Bell's palsy (a form of facial paralysis that is often reversible) 
• Bellova paraliza (oblika paralize obraza, ki je velikokrat reverzibilna),
Inhibitory Concentration 50 (nM) 
Inhibitorne koncentracije (IC50) (nM)
● wear clothing which protects your skin, including your head and face, arms and legs; 
• nosite oblačila, ki vam varujejo kožo, tudi glavo in obraz, roke in noge,
The possible effect of vemurafenib on other transporters is currently unknown. 
Možen vpliv vemurafeniba na druge prenašalce trenutno ni znan.
Vemurafenib (%) Dacarbazine (%) 
vemurafenib (%) dakarbazin (%)
Grade (CTC-AE) (a) 
(CTC-AE)(a)
Post-hoc survival analyses were undertaken thereafter as described in table 7. 
Zatem so naredili post-hoc analizo preživetja, kot je opisano v preglednici 7.
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'. 
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".
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). 
Tako je posebej po prvih tednih zdravljenja potreben skrben nadzor, saj lahko po daljšem obdobju (več tednih) pride do kopičenja.
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). 
Vemurafenib lahko vzamemo s hrano ali brez nje, izogibati pa se moramo stalnemu jemanju obeh dnevnih odmerkov na prazen želodec (glejte poglavje 5.2).
● Medicines that are known to affect the way your heart beats: 
• zdravila, za katera je znano, da vplivajo na bitje srca:
Many anticancer medicinal products are substrates of BCRP and therefore there is a theoretical risk for an interaction with vemurafenib. 
Številna zdravila za zdravljenje raka so substrati BCRP, zato obstaja teoretično tveganje za medsebojno delovanje z vemurafenibom.
Among these patients, 457 were Caucasians. 
Med temi bolniki je bilo 457 belcev.
A causal relationship between the medicinal product and the adverse event is at least a reasonable possibility. 
Vzročna povezava med zdravilom in neželenim dogodkom je vsaj možna.
● This will help to protect you against sunburn. 
• To vam bo pomagalo, da se boste obvarovali pred sončnimi opeklinami.
If a dose is missed, it can be taken up to 4 hours prior to the next dose to maintain the twice daily regimen. 
Če bolnik izpusti odmerek, ga lahko vzame do 4 ure pred naslednjim odmerkom za ohranitev sheme dvakrat na dan.
Estimated from 16,403 melanomas with annotated BRAF codon 600 mutations in the public COSMIC database, release 71 (November 2014). 
Ocenjeno pri 16403 melanomih z določenimi mutacijami BRAF kodona 600, pridobljenih iz javne podatkovne baze COSMIC, izdaja 71 (november 2014).
It can only be used in patients whose cancer has a change (mutation) in the “BRAF” gene. 
Zdravilo lahko uporabimo le pri bolnikih, pri katerih ima rak spremembo (mutacijo) v genu “BRAF”.
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. 
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.
If you forget to take Zelboraf 
Če ste pozabili vzeti zdravilo Zelboraf
Zelboraf targets proteins made from this modified gene and slows down or stops the development of your cancer. 
Zdravilo Zelboraf je usmerjeno na beljakovine, ki jih ustvarja ta spremenjeni gen, in tako upočasni ali ustavi razvoj vaše bolezni.
What Zelboraf is and what it is used for 
Kaj je zdravilo Zelboraf in za kaj ga uporabljamo
Grade 1 or Grade 2 (tolerable) 
Stopnja 1 ali stopnja 2 (prenosljivo)
● use a lip balm and a broad spectrum sunscreen (minimum of Sun Protection Factor (SPF) 30, re-applied every 2 to 3 hours). 
• uporabite mazilo za ustnice in sredstvo za sončenje z visoko zaščito (vsaj zaščitni faktor SPF 30; sredstvo znova nanesite vsake 2 do 3 ure).
● Tell your doctor if you have had a different type of cancer than melanoma, as Zelboraf may cause progression of certain types of cancers. 
• Zdravniku povejte, če ste imeli drugo vrsto raka, kot je melanom, ker lahko zdravilo Zelboraf povzroči napredovanje nekaterih vrst raka.
This may affect the activity of Zelboraf. 
Te lahko vplivajo na aktivnost zdravila Zelboraf.
If you are taking any of these medicines (or if you are not sure), please talk to your doctor before taking Zelboraf. 
Če jemljete katero koli od teh zdravil (ali ste negotovi), se posvetujte z zdravnikom, preden boste vzeli zdravilo Zelboraf.
Treatment with vemurafenib should be initiated and supervised by a qualified physician experienced in the use of anticancer medicinal products. 
Zdravljenje z vemurafenibom mora uvesti in nadzorovati usposobljen zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
No new safety signals were observed in a clinical study with six adolescent patients. 
V klinični študiji s šestimi adolescenti niso opazili novih varnostnih signalov.
What you need to know before you take Zelboraf 
Kaj morate vedeti, preden boste vzeli zdravilo Zelboraf
Temporarily interrupt treatment until QTc decreases below 500 ms. 
Zdravljenje začasno prekinite dokler se interval QTc ne zniža pod 500 ms.
The combination of this medicine with Zelboraf is not recommended due to increased toxicity to the liver. 
Sočasno jemanje tega zdravila z zdravilom Zelboraf ni priporočljivo zaradi povečane toksičnosti za jetra.
However, the parent compound was the predominant component (95%) in plasma. 
Kljub temu je bila prevladujoča sestavina (95 %) v plazmi matična spojina.
● 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. 
• 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.
● The active substance is vemurafenib. 
• Učinkovina je vemurafenib.
Table 2: Dose modification schedule based on prolongation of the QT interval QTc value 
Preglednica 2: Shema prilagajanja odmerka glede na podaljšanje intervala QT Vrednost intervala QTc
Unexplained abdominal pain should be promptly investigated (including measurement of serum amylase and lipase). 
Nepojasnjeno bolečino v trebuhu je treba nemudoma preiskati (vključno z določitvijo serumske amilaze in lipaze).
● Swallow the tablets whole with a glass of water. 
• Tablete morate zaužiti cele in s kozarcem vode.
The maximum tolerated dose could not be determined. 
Največjega prenosljivega odmerka ni bilo mogoče določiti.
It is currently unknown whether vemurafenib is a substrate also to other transport proteins. 
Trenutno ni znano, ali je vemurafenib tudi substrat drugih prenašalnih beljakovin.
● Do not take Zelboraf regularly on an empty stomach. 
• Izogibajte se stalnemu jemanju zdravila Zelboraf na prazen želodec.
Grenzach-Wyhlen Germany 
Grenzach-Wyhlen Nemčija