natgillin/translations-raw huggingface dataset:
At the end of the 6 months, 87% of patients on the combination had improvements in their chest x-rays compared with 56% of patients in the group taking PAS alone. 
Po šestih mesecih so pri rentgenskem slikanju prsnega koša zabeležili izboljšanje pri 87 % bolnikov, ki so prejemali kombinirano zdravljenje, v primerjavi s 56 % bolnikov v skupini, ki je prejemala samo para-aminosalicilno kislino.
How is Granupas used? 
Kako se zdravilo Granupas uporablja?
Granupas can only be obtained with a prescription. 
Izdaja zdravila je le na recept.
In addition,33% of patients in the combination group had no bacteria detected in their phlegm (sputum) compared with 8% in the PAS group. 
Poleg tega bakterije v sluzi (izpljunku) niso zaznali pri 33 % bolnikov v skupini, ki je prejemala kombinirano zdravljenje, v primerjavi z 8 % bolnikov v skupini, ki je prejemala para-aminosalicilno kislino.
This overview was last updated in 06-2019 
Povzetek je bil nazadnje posodobljen 06-2019.
Further information on Miglustat Gen.Orph can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/miglustat-genorph. 
Nadaljnje informacije za zdravilo Miglustat Gen.Orph so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/miglustat-genorph.
• adults (aged 18 years and above) with mild to moderate type-1 Gaucher disease. 
• odraslih (starejših od 18 let) z blago do zmerno obliko Gaucherjeve bolezni tipa 1.
Miglustat Gen.Orph received a marketing authorisation valid throughout the EU on 10 November 2017. 
Za zdravilo Miglustat Gen.Orph je bilo 10. novembra 2017 izdano dovoljenje za promet, veljavno po vsej EU.
• patients of all ages with Niemann-Pick type-C disease, a potentially fatal disease in which glycosphingolipids build up within cells in the brain and elsewhere in the body. 
• bolnikov vseh starosti z Niemann-Pickovo boleznijo tipa C, ki je lahko smrtna in pri kateri se glikosfingolipidi kopičijo v celicah v možganih in drugod v telesu.
Because Miglustat Gen.Orph is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Ker je zdravilo Miglustat Gen.Orph generično zdravilo in je bioekvivalentno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
The European Medicines Agency concluded that, in accordance with EU requirements, Miglustat Gen.Orph has been shown to have comparable quality and to be bioequivalent to Zavesca. 
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Miglustat Gen.Orph primerljivo raven kakovosti kot referenčno zdravilo Zavesca ter da mu je bioekvivalentno.
Studies on the benefits and risks of the active substance in Gaucher disease have already been carried out with the reference medicine, Zavesca, and do not need to be repeated for Miglustat Gen.Orph. 
Študije o koristih in tveganjih učinkovine pri Gaucherjevi bolezni so že bile izvedene z referenčnim zdravilom Zavesca, zato jih ni treba ponoviti za zdravilo Miglustat Gen.Orph.
Miglustat Gen.Orph is used to treat the neurological symptoms of the disease (symptoms affecting the brain and nerves). 
Zdravilo Miglustat Gen.Orph se uporablja za zdravljenje nevroloških simptomov bolezni (simptomov, ki prizadenejo možgane in živce).
For more information about using Miglustat Gen.Orph, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij o uporabi zdravila Miglustat Gen.Orph glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Side effects reported with Miglustat Gen.Orph are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Miglustat Gen.Orph, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Miglustat Gen.Orph is used in patients who cannot receive the standard treatment of enzymereplacement therapy (ERT); 
Zdravilo Miglustat Gen.Orph se uporablja pri bolnikih, ki ne morejo prejemati običajnega encimskega nadomestnega zdravljenja (ERT);
What measures are being taken to ensure the safe and effective use of Miglustat Gen.Orph? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Miglustat Gen.Orph?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Miglustat Gen.Orph have been included in the summary of product characteristics and the package leaflet. 
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Miglustat Gen.Orph upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Miglustat Gen.Orph is a ‘generic medicine'. 
Miglustat Gen.Orph je „generično zdravilo“.
For Niemann-Pick type-C disease, it is two capsules three times a day for patients aged 12 years and over; in younger patients, the dose depends on their weight and height. 
Priporočeni začetni odmerek za Gaucherjevo bolezen tipa 1 je ena kapsula trikrat na dan. Priporočeni začetni odmerek za Niemann-Pickovo bolezen tipa C sta dve kapsuli trikrat na dan za bolnike, starejše od 12 let; odmerek pri mlajših bolnikih je odvisen od njihove telesne mase in višine.
Miglustat Gen.Orph is used to treat the following patients: 
Zdravilo Miglustat Gen.Orph se uporablja za zdravljenje naslednjih bolnikov:
As for every medicine, the company provided studies on the quality of Miglustat Gen.Orph. 
Kot to velja za vsako zdravilo, je podjetje zagotovilo študije o kakovosti zdravila Miglustat Gen.Orph.
An overview of Miglustat Gen.Orph and why it is authorised in the EU 
Pregled zdravila Miglustat Gen.Orph in zakaj je odobreno v EU
What are the benefits and risks of Miglustat Gen.Orph? 
Kakšne so koristi in tveganja, povezani z zdravilom Miglustat Gen.Orph?
As for all medicines, data on the use of Miglustat Gen.Orph are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Miglustat Gen.Orph stalno spremljajo.
What is Miglustat Gen.Orph and what is it used for? 
Kaj je zdravilo Miglustat Gen.Orph in za kaj se uporablja?
The medicine can only be obtained with a prescription and treatment should be supervised by doctors who are experienced in the management of Gaucher disease. 
Predpisovanje in izdaja zdravila Miglustat Gen.Orph je le na recept, zdravljenje z njim pa mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov z Gaucherjevo boleznijo.
The active substance in Miglustat Gen.Orph, miglustat, blocks an enzyme called glucosylceramide synthase. 
Učinkovina zdravila Miglustat Gen.Orph, miglustat, preprečuje delovanje encima, imenovanega glukozilceramidsintaza.
This means that Miglustat Gen.Orph contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Zavesca. 
To pomeni, da vsebuje enako učinkovino in deluje na enak način kot „referenčno zdravilo“, ki je že odobreno v EU in se imenuje Zavesca.
Why is Miglustat Gen.Orph authorised in the EU? 
Zakaj je bilo zdravilo Miglustat Gen.Orph odobreno v EU?
Other information about Miglustat Gen.Orph 
Druge informacije o zdravilu Miglustat Gen.Orph
Miglustat Gen.Orph is available as 100 mg capsules to be taken by mouth. 
Zdravilo Miglustat Gen.Orph je na voljo v obliki 100-miligramskih kapsul, ki se jemljejo peroralno.
Miglustat Gen.Orph is used to treat two inherited diseases that affect the way the body handles fats. 
Zdravilo Miglustat Gen.Orph se uporablja za zdravljenje dveh dednih bolezni, ki vplivata na način presnove maščob v telesu.
Miglustat Gen.Orph is intended for long-term use. 
Zdravilo Miglustat Gen.Orph je namenjeno za dolgotrajno uporabo.
Therefore, the Agency's view was that, as for Zavesca, the benefit of Miglustat Gen.Orph outweighs the identified risk and it can be authorised for use in the EU. 
Zato je menila, da koristi zdravila Miglustat Gen.Orph enako kot pri zdravilu Zavesca odtehtajo znana tveganja in se zdravilo lahko odobri v EU.
How has Miglustat Gen.Orph been studied? 
Kako je bilo zdravilo Miglustat Gen.Orph raziskano?
How does Miglustat Gen.Orph work? 
Kako zdravilo Miglustat Gen.Orph deluje?
How is Miglustat Gen.Orph used? 
Kako se zdravilo Miglustat Gen.Orph uporablja?
Date of first authorisation: 19 July 2006 Date of latest renewal: 21 July 2011 
Datum prve odobritve: 19. julij 2006 Datum zadnjega podaljšanja: 21. julij 2011
Risk management plan (RMP) 
• Načrt za obvladovanje tveganja (RMP)
These can usually be treated by your doctor. 
Običajno jih lahko zdravi vaš zdravnik.
- If you have high blood pressure. 
- če imate visok krvni tlak.
The nominal alpha value for this analysis was 0.0094. 
Nominalna alfa vrednost te analize je bila 0,0094.
The absolute bioavailability is not known. 
Absolutna biološka uporabnost ni znana.
- If you are taking Neomycin or other antibiotics. 
- če jemljete neomicin ali druge antibiotike.
Dose reductions were only partially successful in alleviating adverse reactions. 
Zmanjšanja odmerkov so bila le delno uspešna pri lajšanju neželenih učinkov.
The tablets should be swallowed with a glass of water. 
Tablete je treba zaužiti z vodo (kozarec vode).
Effects of other antibiotics have not been studied, but will likely depend on their ability to interfere with microorganisms with glucuronidase activity. 
Učinkov ostalih antibiotikov niso preučevali, vendar so najverjetneje odvisni od njihovega delovanja na mikroorganizme z glukuronidazno aktivnostjo.
Laboratory parameter, (in % of samples investigated) 
Laboratorijski kazalec (v % preučevanih vzorcev)
Such events are either uncommon or less frequent than uncommon. 
Ti dogodki se pojavljajo občasno ali celo manj pogosto kot občasno.
- If you have a heart disorder, such as an abnormal electrical signal called "prolongation of the QT interval". 
- če imate motnje v delovanju srca, kot npr. nenormalen električni signal imenovan »podaljšanje intervala QT«.
This booklet was last revised in {month YYYY}. 
Navodilo je bilo nazadnje revidirano dne {mesec LLLL}
Tell your doctor if any of these affect you. 
Obvestite zdravnika, če kar koli od naštetega velja tudi za vas.
Analyses of demographic data suggest that there is no relationship between pharmacokinetics and age (up to 65 years), gender or body weight. 
Analize demografskih podatkov kažejo, da ni povezave med farmakokinetiko in bolnikovo starostjo (do 65 let), spolom ali telesno maso.
Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), not known (cannot be estimated from the available data). 
Pogostnost je opredeljena kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
In this case your doctor will interrupt the treatment. 
V takem primeru bo zdravnik zdravljenje prenehal.
Disease specific warnings 
Za bolezen specifična opozorila
The study was stopped after a planned interim analysis of OS had crossed the prespecified efficacy boundary. 
Študija je bila ustavljena po načrtovani vmesni analizi celokupnega preživetja, ker je bila presežena vnaprej določena meja učinkovitosti.
It is important to take this medicine at about the same times each day, so that there is a steady amount in the bloodstream. 
Pomembno je, da to zdravilo jemljete vsak dan ob približno istem času, saj se tako vzdržuje stalna vrednost zdravila v krvnem obtoku.
The elimination half-life of sorafenib is approximately 25 - 48 hours. 
Razpolovna doba izločanja sorafeniba je približno 25 do 48 ur.
Your doctor may tell you to stop taking this medicine. 
Zdravnik vam bo morda svetoval, da to zdravilo prenehate jemati.
The median delivered cumulative radioactive iodine activity before enrollment was approximately 14.8 GBq. 
Mediana dovedena kumulativna radioaktivnost joda pred vključitvijo je bila približno 14,8 GBq.
- If you are going to have surgery, or if you had an operation recently. 
- če je pri vas načrtovan kirurški poseg oz. ste pred kratkim imeli kirurški poseg.
Before initiating Nexavar, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm. 
Pred uvedbo zdravila Nexavar je treba to tveganje skrbno preučiti pri bolnikih z dejavniki tveganja, kot sta hipertenzija ali anamneza anevrizme.
Sorafenib should not be used during pregnancy unless clearly necessary, after careful consideration of the needs of the mother and the risk to the foetus. 
Sorafeniba se ne sme uporabljati med nosečnostjo, razen če je to nujno potrebno, po skrbnem pretehtanju nujnosti zdravljenja za mater in tveganja za plod.
P-gp-substrates 
P-gp substrati
Nexavar may reduce fertility in both men and women. 
Zdravilo Nexavar lahko zmanjša plodnost tako pri moških kot ženskah.
The safety and efficacy of Nexavar in children and adolescents aged < 18 years have not yet been established. 
Varnost in učinkovitost zdravila Nexavar pri otrocih in mladostnikih, starih manj kot 18 let, nista bili dokazani.
Majority of patients had papillary carcinoma (56.8%), followed by follicular (25.4%) and poorly differentiated carcinoma (9.6%). 
Večina bolnikov je imela papilarni karcinom (56,8 %), nato pa sta sledila folikularni (25,4 %) in slabo diferencirani karcinom (9,6 %).
- If you get chest pain or heart problems. 
- če se pojavijo bolečine v prsnem košu ali težave s srcem.
The PFS analysis was conducted at 342 events in 769 patients. 
Analiza PFS je bila pri 769 bolnikih izvedena po 342 dogodkih.
Secondary endpoints included overall survival (OS), tumour response rate and duration of response. 
Sekundarni končni izid študije je vključeval celokupno preživetje (OS - Overall Survival), stopnjo odziva tumorja in trajanje odziva.
The effect of Nexavar may be decreased. 
Učinek zdravila Nexavar se lahko zmanjša.
In vitro binding of sorafenib to human plasma proteins is 99.5 %. 
In vitro se na humane plazemske beljakovine veže 99,5 % sorafeniba.
Because sorafenib could harm infant growth and development (see section 5.3), women must not breast-feed during sorafenib treatment. 
Ker lahko sorafenib škoduje rasti in razvoju otroka (glejte poglavje 5.3), ženske med zdravljenjem s sorafenibom ne smejo dojiti.
No complete response (CR) according to RECIST was observed. 
Popolnega odziva (CR, complete response) po kriterijih RECIST niso opazili.
An interim analysis (second interim analysis) for overall survival was conducted at 367 deaths in 903 patients. 
Vmesna analiza (druga vmesna analiza) celokupnega preživetja je bila pri 903 bolnikih izvedena po 367 smrtnih dogodkih.
Blood pressure should be monitored regularly and treated, if required, in accordance with standard medical practice. 
Krvni tlak je treba redno spremljati in ga, če je to potrebno, uravnavati v skladu s standardno klinično prakso.
This is equivalent to a daily dose of 800 mg or four tablets a day. 
To ustreza dnevnemu odmerku 800 mg ali štirim tabletam na dan.
- If you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall. 
- če imate ali ste imeli anevrizmo (razširitev in oslabitev stene krvne žile) ali raztrganino v steni krvne žile.
There are no data on the use of sorafenib in pregnant women. 
Podatkov o uporabi sorafeniba pri nosečnicah ni.
Environmental Risk Assessment information is available in the EPAR of this medicine (see section 6.6). 
Ocena tveganja za okolje je na voljo v evropskem javnem poročilu o oceni zdravila (EPAR) (glejte poglavje 6.6).
Severe hypocalcaemia should be corrected to prevent complications such as QT-prolongation or torsade de pointes (see section QT prolongation). 
Hudo hipokalciemijo je treba korigirati, da se preprečijo zapleti, kot so podaljšanje intervala QT ali torsade de pointes (glejte poglavje Podaljšanje intervala QT).
Baseline demographics and patient characteristics were well balanced for both treatment groups. 
Demografske značilnosti in izhodiščne značilnosti bolnikov so bile za obe skupini bolnikov primerljive.
Environmental Risk assessment studies have shown that sorafenib tosylate has the potential to be persistent, bioaccumulative and toxic to the environment. 
Študije ocene tveganja za okolje so pokazale, da je lahko sorafenibijev tosilat v okolju obstojen, bioakumulativen in strupen za okolje.
HR (95% CI) 
RO (95-% IZ)
Age, MSKCC prognostic group, ECOG PS and prior therapy did not affect the treatment effect size. 
Starost, prognoza po kriterijih MSKCC, ECOG PS in predhodno zdravljenje niso vplivali na terapevtski učinek.
If it is nearly time for the next dose, forget about the missed one and carry on as normal. 
Če je že skoraj čas za naslednji odmerek, pozabljenega odmerka ne vzemite, temveč počakajte do naslednjega rednega odmerka.
The effect of sorafenib on PFS was consistent independent of geographic region, age above or below 60 years, gender, histological subtype, and presence or absence of bone metastasis. 
Učinek sorafeniba na PFS je bil dosledno neodvisen od geografskega območja, starosti nad ali pod 60 leti, spola, histološkega podtipa in prisotnosti ali odsotnosti zasevkov v kosteh.
Similar effects were not induced in adult dogs. 
Pri odraslih psih teh učinkov niso opazili.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder . 
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
Other clinically relevant laboratory abnormalities observed in the study 5 are shown in table 2. 
Druge klinično pomembne nenormalne vrednosti laboratorijskih preiskav, ki so jih opazili v študiji 5, so prikazane v preglednici 2.
Dogs showed tubular degeneration in the testes and oligospermia. 
Pri psih so opazili tubulno degeneracijo testisov in oligospermijo.
Therefore, the decision to resume sorafenib therapy following a major surgical intervention should be based on clinical judgement of adequate wound healing. 
Zato mora odločitev o ponovni uvedbi zdravljenja s sorafenibom po velikem kirurškem posegu temeljiti na klinični oceni ustreznosti celjenja ran.
In vitro studies of CYP enzyme induction 
In vitro študije indukcije CYP encimov
Before initiating treatment, physicians are recommended to carefully evaluate the prognosis in the individual patient considering maximum lesion size (see section 5.1), symptoms related to the disease (see section 5.1) and progression rate. 
Priporoča se, da zdravniki pred uvedbo zdravljenja skrbno pretehtajo napoved izida zdravljenja za vsakega posameznega bolnika; pri tem je treba upoštevati največjo velikost lezije (glejte poglavje 5.1), simptome, povezane z boleznijo (glejte poglavje 5.1) in stopnjo napredovanja bolezni.
PFS was evaluated by blinded independent radiological review using RECIST criteria. 
PFS je bilo ovrednoteno s slepo neodvisno oceno radioloških posnetkov po kriterijih RECIST.
- If you get any bleeding problems, or are taking warfarin or phenprocoumon. 
- če se pojavijo kakršne koli težave zaradi krvavitev ali če jemljete varfarin ali fenprokumon.
In animals, sorafenib and/or its metabolites were excreted in milk. 
Pri živalih so se sorafenib in/ali njegovi presnovki izločali v mleko.
Elderly population No dose adjustment is required in the elderly (patients above 65 years of age). 
Starejšim bolnikom (starim več kot 65 let) odmerka zdravila ni treba prilagajati.
Approximately half of the patients had an ECOG performance status of 0, and half of the patients were in the low risk MSKCC prognostic group. 
Približno polovica bolnikov je imela oceno stanja zmogljivosti po ECOG 0 in polovica jih je bila po kriterijih MSKCC razvrščena v prognostično skupino z majhnim tveganjem.
Sorafenib has been shown to prolong the QT/QTc interval (see section 5.1), which may lead to an increased risk for ventricular arrhythmias. 
Sorafenib podaljša interval QT/QTc (glejte poglavje 5.1), kar lahko zveča tveganje za pojav ventrikularnih aritmij.
Metastases were present in the lungs in 86%, lymph node in 51% and bone in 27% of the patients. 
Zasevki so bili prisotni v pljučih pri 86 %, limfnih žlezah pri 51 % in v kosteh pri 27 % bolnikov.
Psychiatric disorders depression 
Psihiatrične motnje depresija
- If you have diabetes. 
- če imate sladkorno bolezen.
What Nexavar is and what it is used for 
Kaj je zdravilo Nexavar in za kaj ga uporabljamo
- The active substance is sorafenib. 
- Učinkovina je sorafenib.
You must not breast-feed your baby during Nexavar treatment, as this medicine may interfere with the growth and development of your baby. 
Med zdravljenjem z zdravilom Nexavar ne smete dojiti, saj zdravilo lahko vpliva na rast in razvoj otroka.
If you intend to have a high fat meal, take the tablets at least 1 hour before or 2 hours after the meal. 
Če nameravate zaužiti mastno hrano, vzemite tablete najmanj eno uro pred obrokom hrane ali dve uri po njem.
Eight metabolites of sorafenib have been identified, of which five have been detected in plasma. 
Odkrili so osem presnovkov, pet od njih v plazmi.
CI=Confidence interval, HR=Hazard ratio (sorafenib over placebo) * statistically significant as the p-value was below the prespecified O'Brien Fleming stopping boundary of 0.0077 ** independent radiological review 
IZ = interval zaupanja, RO = razmerje ogroženosti (sorafenib v primerjavi s placebom) * statistično značilno, ker je bila vrednost p pod vnaprej določeno vrednostjo O'Brien-Flemingove zgornje meje 0,0077 ** neodvisna ocena radioloških posnetkov
Overall Survival (OS) [median, weeks (95% 
Celokupno preživetje [mediana, tedni (95-% IZ)] Čas do napredovanja [mediana, tedni
If you become pregnant while being treated with Nexavar, immediately tell your doctor who will decide if the treatment should be continued. 
Če med zdravljenjem z zdravilom Nexavar zanosite, o tem takoj obvestite zdravnika, ki bo presodil, ali smete nadaljevati z zdravljenjem.
After improvement of non-haematological adverse reactions, the dose of Nexavar may be increased. 
Po izboljšanju nehematoloških neželenih učinkov se lahko odmerek zdravila Nexavar zveča.
In healthy volunteers treated with a 5-day regimen of neomycin the average exposure to sorafenib decreased by 54%. 
Pri zdravih prostovoljcih, ki so bili pet dni zdravljeni z neomicinom, se je povprečna izpostavljenost sorafenibu zmanjšala za 54 %.
Rash and hand foot skin reaction are usually CTC (Common Toxicity Criteria) Grade 1 and 2 and generally appear during the first six weeks of treatment with sorafenib. 
Po CTC (Common Toxicitiy Criteria) so 1. in 2. stopnje in se ponavadi pojavijo v prvih šestih tednih zdravljenja s sorafenibom.
If you have missed a dose, take it as soon as you remember. 
Če ste pozabili vzeti odmerek zdravila Nexavar, ga vzemite takoj ko se spomnite.
Furthermore, the sorafenib batch tested in the standard genotoxicity battery included 0.34 % PAPE. 
Poleg tega je v skupini standardnih genotoksičnih študij sorafenib vključeval 0,34 % PAPE.
Administration of rifampicin for 5 days before administration of a single dose of sorafenib resulted in an average 37 % reduction of sorafenib AUC. 
Uporaba rifampicina pet dni pred uporabo enkratnega odmerka sorafeniba zmanjša AUC sorafeniba za 37 %.
Nexavar can raise blood pressure, and your doctor will usually monitor your blood pressure and may give you a medicine to treat your high blood pressure. 
Zdravilo Nexavar lahko zviša krvni tlak; zdravnik bo spremljal vrednosti krvnega tlaka in vam, če bo potrebno, predpisal zdravila za zdravljenje visokega krvnega tlaka.
The clinical significance of these findings is unknown (see section 4.4). 
Klinični pomen teh ugotovitev ni znan (glejte poglavje 4.4).
The preclinical safety profile of sorafenib was assessed in mice, rats, dogs and rabbits. 
Predklinični varnostni profil sorafeniba so ocenjevali pri miših, podganah, psih in kuncih.
EU/1/06/342/001 
ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/06/342/001