natgillin/translations-raw huggingface dataset:
Mild to moderate renal impairment does not influence cobimetinib exposure based on the population pharmacokinetic analysis. 
Na podlagi populacijske farmakokinetične analize so ugotovili, da blaga do zmerna okvara ledvic ne vpliva na izpostavljenost kobimetinibu.
Stable disease 
Popolni odziv Delni odziv Stabilna bolezen
The OS p-value (0.0050) crossed the pre-specified boundary (p value <0.0499) f The data cut-off date for this updated PFS analysis and the secondary endpoints of ORR, BOR and DoR is 16 January 2015. 
e p-vrednost za celokupno preživetje (0,0050) je presegla predhodno določeno mejo (p-vrednost < 0,0499).
Unbound cobimetinib exposures were similar between subjects with mild and moderate hepatic impairment compared to subjects with normal hepatic function while subjects with severe hepatic impairment had approximately 2-fold higher exposures (see section 4.2). 
Izpostavljenost prostemu kobimetinibu je bila pri bolnikih z blago in zmerno okvaro jeter podobna kot pri bolnikih z normalnim delovanjem jeter, pri bolnikih s hudo okvaro jeter pa približno
The safety of Cotellic in combination with vemurafenib has been evaluated in 247 patients with advanced BRAF V600 mutated melanoma in Study GO28141.The median time to onset for the first Grade ≥3 adverse events was 0.6 months in the Cotellic plus vemurafenib arm vs 0.8 months in the placebo plus vemurafenib arm. 
Varnost zdravila Cotellic v kombinaciji z vemurafenibom so ocenili pri 247 bolnikih z napredovalim melanomom z mutacijo BRAF V600 v študiji GO28141.
Vemurafenib treatment can be continued when Cotellic treatment is modified, if clinically indicated. 
Med prilagajanjem odmerka zdravila Cotellic je mogoče zdravljenje z vemurafenibom nadaljevati, če je to klinično primerno.
Includes both chorioretinopathy and retinal detachment events indicative of serous retinopathy (see section 4.4) b Combined figure includes reports of photosensitivity reaction, sunburn, solar dermatitis, actinic elastosis 
Obsega poročila o fotosenzibilnostnih reakcijah, sončnih opeklinah, solarnem dermatitisu in aktinični elastozi.
· Diarrhoea 
• bruhanje,
The median PFS for BRAFi-naïve patients was 13.8 months, with median follow-up time of 20.6 months. 
Mediana PFS je bila pri bolnikih, predhodno nezdravljenih z BRAFi, 13,8 meseca
Muscle problems (uncommon: may affect up to 1 in 100 people) Cotellic can result in the breakdown of muscle (rhabdomyolysis), symptoms may include: · muscle aches · muscle spasms and weakness · dark- or red-coloured urine. 
Zdravilo Cotellic lahko povzroči poškodbo mišic (rabdomiolizo); simptomi so lahko:
Cutaneous squamous cell carcinoma, keratoacanthoma and hyperkeratosis 
• nekatere vrste raka kože, npr. bazalnocelični karcinom, ploščatocelični karcinom kože in keratoakantom,
Following confirmation of a BRAF V600 mutation, using the cobas® 4800 BRAF V600 mutation test, 
Po potrditvi mutacije BRAF V600 s testom mutacije cobas® 4800 BRAF V600 so 495 predhodno nezdravljenih bolnikov z neoperabilnim lokalno napredovalim ali metastatskim melanomom randomizirali ali na:
Liver laboratory abnormalities, specifically ALT, AST, and ALP have been observed in patients treated with Cotellic in combination with vemurafenib (see section 4.4). 
Pri bolnikih, zdravljenih z zdravilom Cotellic v kombinaciji z vemurafenibom, so opažali jetrna laboratorijska odstopanja, posebej ALT, AST in AF (glejte poglavje 4.4).
Dose adjustment is not recommended for mild to moderate renal impairment based on the results of the population pharmacokinetic analysis. 
Na podlagi rezultatov populacijske farmakokinetične analize bolnikov z blago do zmerno okvaro ledvic odmerka ni treba prilagoditi.
This medicinal product contains lactose. 
Intoleranca za laktozo Zdravilo vsebuje laktozo.
No dose adjustment is recommended in patients with mild or moderate renal impairment based on population pharmacokinetic analysis (see section 5.2). 
Na podlagi populacijske farmakokinetične analize (glejte poglavje 5.2) bolnikom z blago ali zmerno okvaro ledvic odmerka ni treba prilagoditi.
Hepatic impairment 
Nesimptomatski
Manage Grade 4 liver laboratory abnormalities with treatment interruption, dose reduction or with treatment discontinuation of both Cotellic and vemurafenib (see section 4.2). 
zmanjšanjem odmerka ali prenehanjem zdravljenja z zdravilom Cotellic in z vemurafenibom (glejte poglavje 4.2).
Musculoskeletal and connective tissue disorders 
• mišični krči in šibkost,
Table 1 Recommended Cotellic dose modifications 
Priporočena prilagoditev odmerka zdravila Cotellic
Decrease in LVEF from baseline has been reported in patients receiving Cotellic (see section 4.8). 
Pri bolnikih, ki so prejemali zdravilo Cotellic, so poročali o zmanjšanju iztisnega deleža levega prekata (LVEF) v primerjavi z izhodiščem (glejte poglavje 4.8).
Strong CYP3A inhibitors (see section 4.4. 
Močni zaviralci CYP3A (glejte poglavje 4.4): Med zdravljenjem s kobimetinibom se izogibajte sočasni uporabi močnih zaviralcev CYP3A.
ADRs are based on results from a multi-centre, randomised, double-blind, placebo-controlled, Phase III Study (GO28141) that evaluated the safety and efficacy of Cotellic in combination with vemurafenib as compared to vemurafenib alone in previously untreated BRAF V600 mutation-positive patients with unresectable locally advanced (Stage IIIc) or metastatic melanoma (Stage IV). 
Študija je ocenila varnost in učinkovitost zdravila Cotellic v kombinaciji z vemurafenibom v primerjavi s samim vemurafenibom pri predhodno nezdravljenih bolnikih, ki so imeli neoperabilen, lokalno napredovali (stadij IIIc) ali metastatski (stadij IV) melanom z mutacijo BRAF V600.
For information on the posology of vemurafenib, please refer to its SmPC. 
Za informacije o odmerjanju vemurafeniba glejte njegov povzetek glavnih značilnosti zdravila.
Symptoms may include: · feeling dizzy · feeling light-headed · feeling short of breath · feeling tired · feeling like your heart is pounding, racing or beating unevenly · swelling in the legs. 
• občutek utrujenosti, • občutek razbijanja, hitrega bitja ali neenakomernega bitja srca,
Decrease in LVEF from baseline has been reported in patients receiving Cotellic (see section 4.4). 
Pri bolnikih, ki so prejemali zdravilo Cotellic, so poročali o zmanjšanju iztisnega deleža levega prekata (LVEF) v primerjavi z izhodiščem (glejte poglavje 4.4).
Pregnancy and breast-feeding 
Placebo in vemurafenib
Please refer to the vemurafenib SmPC. 
Glejte povzetek glavnih značilnosti vemurafeniba.
Batch 
LVEF
Moderate CYP3A inhibitors (see section 4.4. 
Zmerni zaviralci CYP3A (glejte poglavje 4.4): Previdnost je potrebna, če se kobimetinib uporablja sočasno z zmernimi zaviralci CYP3A.
Lactose intolerance 
• omotičnost,
Symptoms of serous retinopathy include: · blurred vision · distorted vision · partly missing vision · any other changes to your sight. 
Med simptomi serozne retinopatije so: • zamegljen vid,
The European Commission issued a decision on 12 September 2013. 
Evropska komisija je sklep izdala 12. septembra 2013.
The company that markets these medicines is Sanofi-Aventis. 
Družba, ki trži ta zdravila, je Sanofi-Aventis.
The amount of the medicine in the blood should be measured to ensure that effective levels have been reached. 
Izmeriti je treba količino zdravila v krvi, da se zagotovi, da so bile dosežene ravni učinkovitosti zdravila.
Targocid is authorised in the EU via national procedures. 
Zdravilo Targocid so odobrili v EU z nacionalnimi postopki.
Why was Targocid reviewed? 
Zakaj je bilo zdravilo Targocid pregledano?
On 30 May 2013, the European Medicines Agency completed a review of Targocid. 
Evropska agencija za zdravila je 30. maja 2013 dokončala pregled zdravila Targocid.
Targocid is also available in the EU under other trade names: Targosid, Teicomid. 
Zdravilo Targocid je v EU na voljo tudi pod naslednjimi tržnimi imeni: Targosid, Teicomid.
The Committee also harmonised other sections of the SmPC, including sections 4.3 (contraindications), 4.5 (interactions with other medicines), 4.6 (use in pregnancy and breast feeding), 4.8 (undesirable effects), 5.1 (pharmacodynamic properties), 5.2 (pharmacokinetic properties) and 5.3 (preclinical safety data). 
Odbor je prav tako uskladil druga poglavja v povzetku glavnih značilnosti zdravila, vključno s poglavji 4.3 (kontraindikacije), 4.5 (medsebojno delovanje z drugimi zdravili), 4.6 (uporaba v nosečnosti in med dojenjem), 4.8 (neželeni učinki), 5.1 (farmakodinamične lastnosti), 5.2 (farmakokinetične lastnosti) in 5.3 (predklinični podatki o varnosti).
The Committee did not recommend the use of Targocid to prevent infections. 
Odbor ni priporočil uporabe zdravila Targocid za preprečevanje okužb.
Targocid should be used to treat severe infections where standard antibiotic treatment is not suitable. 
Zdravilo Targocid je treba uporabljati za zdravljenje resnih okužb, pri katerih standardno antibiotično zdravljenje ni ustrezno.
The Committee also agreed on specific dose ranges for adults and children (from birth) for the various infections. 
Odbor je prav tako sprejel določene razpone odmerkov za odrasle in otroke (od rojstva) za različne okužbe.
What is Targocid? 
Kaj je zdravilo Targocid?
This prevents the bacteria from building their cell walls, and eventually kills them. 
S tem bakterijam prepreči izgradnjo celičnih sten in jih sčasoma uniči.
Prolonged use may encourage the growth of bacteria against which it is not active. 
Podaljšana uporaba lahko spodbudi rast bakterij, proti katerim zdravilo ni učinkovito.
The Committee asked the company that markets the medicine to submit a risk management plan for the safe use of Targocid, including a study to monitor the safety of the increased initial dose recommendations (12 mg per kg body-weight twice daily). 
Odbor je pozval družbo, ki trži zdravilo, da predloži načrt za obvladovanje tveganja za varno uporabo zdravila Targocid, vključno s študijo za spremljanje varnosti priporočil glede povečanega začetnega odmerka (12 mg/kg telesne mase dvakrat na dan).
Patients should be particularly carefully monitored if given higher initial doses (12 mg per kg body-weight twice daily). 
Bolnike je treba zlasti pozorno spremljati, če so prejeli višje začetne odmerke (12 mg/kg telesne mase dvakrat na dan).
Since Targocid is only effective against certain kinds of bacteria, it should be used in combination with other antibiotics if necessary, and in line with official recommendations on antibiotic use. 
Ker je zdravilo Targocid učinkovito samo proti določenim vrstam bakterij, ga je treba po potrebi uporabljati v kombinaciji z drugimi antibiotiki in v skladu z uradnimi priporočili o uporabi antibiotikov.
The CHMP agreed to harmonise the warnings and precautions for the medicine. 
Odbor CHMP se je strinjal, da bo uskladil opozorila in previdnostne ukrepe za zdravilo.
On 17 November 2011, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Targocid in the EU. 
Evropska komisija je 17. novembra 2011 zadevo napotila na odbor CHMP z namenom uskladitve dovoljenj za promet z zdravilom Targocid v EU.
This includes initial doses as well as doses for maintenance treatment and doses to be used in patients with reduced kidney function. 
To vključuje začetne odmerke kot tudi odmerke za vzdrževalno zdravljenje ter odmerke, ki se uporabljajo pri bolnikih z okvarjenim delovanjem ledvic.
• bacteraemia (bacterial infection in the blood) resulting from any of the above. 
• bakteriemije (bakterijske okužba krvi), do katere pride zaradi katerega koli zgoraj navedenega vzroka.
These include the fact that Targocid may cause serious life-threatening hypersensitivity (allergic) reactions which require immediate cessation of the medicine and emergency treatment; care is needed in patients who are allergic to another antibiotic, vancomycin, as they may be at greater risk. 
To vključuje dejstvo, da lahko zdravilo Targocid povzroči resne življenjsko nevarne preobčutljivostne (alergijske) reakcije, ki zahtevajo takojšnjo prekinitev jemanja zdravila in urgentno zdravljenje; previdnost je potrebna pri bolnikih z alergijo na antibiotik vankomicin, saj je lahko pri teh bolnikih tveganje večje.
It is only effective against certain types of bacteria (called Gram-positive bacteria) and should be used in combination with other antibiotics if necessary. 
Zdravilo je učinkovito samo proti določenim vrstam bakterij (imenovanim po Gramu pozitivne bakterije) in ga je treba po potrebi uporabljati v kombinaciji z drugimi antibiotiki.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Targocid in the European Union (EU). 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je treba uskladiti informacije o predpisovanju zdravila Targocid v Evropski uniji (EU).
The CHMP agreed that Targocid should be used by injection or infusion to treat the following infections in adults and children: 
Odbor CHMP se je strinjal, da je treba zdravilo Targocid uporabljati za injiciranje ali infundiranje za zdravljenje naslednjih okužb pri odraslih in otrocih:
This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed. 
Zaradi tega je prišlo do razlik med državami članicami glede tega, kako se zdravilo lahko uporablja, kar se izraža v razlikah med povzetki glavnih značilnosti zdravila, označevanji in navodili za uporabo v državah, v katerih se zdravilo trži.
• endocarditis (infection of the inner lining of the heart - most commonly the valves of the heart); 
• endokarditisa (okužbe notranje stene srca - najpogosteje srčnih zaklopk);
• complicated infections of the skin and soft-tissues; 
• zapletenih okužb kože in mehkih tkiv;
Other possible effects for which treatment may need to be stopped or altered include infusion-related reactions called ‘red man syndrome', severe skin rashes, thrombocytopenia (low blood-levels of cells called platelets that are important for clotting), kidney damage, and effects on hearing. 
Med druge možne neželene učinke, zaradi katerih bi bilo treba zdravljenje morda prekiniti ali spremeniti, spadajo reakcije, povezane z infundiranjem (imenovane sindrom rdečega moža), resni kožni izpuščaji, trombocitopenija (nizka raven trombocitov v krvi, ki so pomembni za strjevanje krvi), okvara ledvic ter vpliv na sluh.
For certain types of infections, a higher initial dose of 12 mg per kg body-weight twice daily (used in a few member states of the EU), was agreed by the CHMP. 
V zvezi z določenimi vrstami okužb je odbor CHMP sprejel višji začetni odmerek 12 mg/kg telesne mase dvakrat na dan (uporablja se v nekaj državah članicah EU).
It is used by injection or infusion (drip) to treat serious bacterial infections. 
Uporablja se za injiciranje ali (kapalno) infundiranje za zdravljenje resnih bakterijskih okužb.
Regular blood and kidney function tests and monitoring of any effects on hearing are recommended during treatment. 
Med zdravljenjem se priporoča izvajanje rednih krvnih preiskav in pregledov delovanja ledvic ter spremljanje kakršnih koli vplivov na sluh.
• hospital- or community-acquired pneumonia (infection of the lung caught in or outside hospital); 
• pljučnice, pridobljene v bolnišnici ali zunaj nje (bolnišnična ali zunajbolnišnična okužba pljuč);
The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU. 
Odbor CHMP je ob upoštevanju predloženih podatkov in znanstvene razprave znotraj odbora odločil, da je treba uskladiti povzetke glavnih značilnosti zdravila, označevanje in navodila za uporabo v vsej EU.
• peritonitis (inflammation of the peritoneum, the membrane lining the abdominal cavity) in patients undergoing ‘continuous ambulatory peritoneal dialysis'; 
• peritonitisa (vnetja potrebušnice, tj. membrane, ki obdaja trebušno votlino) pri bolnikih, ki prejemajo kontinuirano ambulantno peritonealno dializo;
Targocid is an antibiotic that contains the active substance teicoplanin. 
Targocid je antibiotik, ki vsebuje zdravilno učinkovino teikoplanin.
• complicated urinary tract infections (infections of the structures that carry urine); 
• zapletenih okužb sečil (okužb struktur za odvajanje urina);
• bone and joint infections; 
• okužb kosti in sklepov;
The Committee also agreed that Targocid could be taken by mouth to treat diarrhoea and colitis (inflammation of the bowel) associated with infection by bacteria called Clostridium difficile. 
Odbor se je prav tako strinjal, da se lahko zdravilo Targocid jemlje peroralno za zdravljenje driske in kolitisa (vnetja črevesja), povezanih z okužbo z bakterijo Clostridium difficile.
The active substance, teicoplanin, is one of a group of antibiotics known as glycopeptides. 
Zdravilna učinkovina, teikoplanin, je antibiotik iz skupine glikopeptidov, ki deluje tako, da se veže na površino bakterij.
It can also be given by mouth to treat diarrhoea and colitis (inflammation of the bowel) caused by infection with a bacterium called Clostridum difficile. 
Zdravilo se lahko daje tudi peroralno za zdravljenje driske in kolitisa (vnetja črevesja) zaradi okužbe z bakterijo Clostridum difficile.
Targocid was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh). 
Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMD(h)) je ugotovila, da je za zdravilo Targocid potrebna uskladitev.
Such medicines include: 
Tovrstna zdravila so:
Results in children aged below 12 years are not yet available. 
Rezultati pri otrocih, mlajših od 12 let, še niso na voljo.
Further information on Sovaldi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Nadaljnje informacije o zdravilu Sovaldi so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The recommended dose is one tablet taken once a day with food, normally for 12 or 24 weeks. 
Priporočeni odmerek je ena tableta, ki se jemlje enkrat na dan skupaj s hrano, običajno 12 ali 24 tednov.
Sovaldi received a marketing authorisation valid throughout the EU on 16 January 2014. 
Zdravilo Sovaldi je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 16. januarja 2014.
What measures are being taken to ensure the safe and effective use of Sovaldi? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Sovaldi?
The European Medicines Agency decided that Sovaldi's benefits are greater than its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je zaključila, da so koristi zdravila Sovaldi večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
The Agency considered that adding Sovaldi to standard treatment is of benefit to patients. 
Agencija je menila, da je dodajanje zdravila Sovaldi standardnemu zdravljenju koristno za bolnike.
• rifampicin and rifabutin (antibiotics); 
• rifampicin in rifabutin (antibiotika);
Sovaldi is available as 400 mg tablets. 
Zdravilo Sovaldi je na voljo v obliki 400-miligramskih tablet.
Other information about Sovaldi 
Druge informacije o zdravilu Sovaldi
• carbamazepine, phenobarbital and phenytoin (medicines for epilepsy). 
• karbamazepin, fenobarbital in fenitoin (zdravila za zdravljenje epilepsije).
As for all medicines, data on the use of Sovaldi are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Sovaldi stalno spremljajo.
Why is Sovaldi authorised in the EU? 
Zakaj je zdravilo Sovaldi odobreno v EU?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sovaldi have also been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Sovaldi upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Side effects reported with Sovaldi are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Sovaldi, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
An overview of Sovaldi and why it is authorised in the EU 
Pregled zdravila Sovaldi in zakaj je odobreno v EU
Blood tests 12 weeks after the end of treatment showed no sign of the virus in 96% of patients (48 out of 50) aged 12 to 18 years. 
Preiskave krvi 12 tednov po koncu zdravljenja niso pokazale nobenega znaka virusa pri 96 % (48 od 50) bolnikov, starih od 12 do 18 let.
What are the risks associated with Sovaldi? 
Kakšna tveganja so povezana z zdravilom Sovaldi?
What benefits of Sovaldi have been shown in studies? 
Kakšne koristi je zdravilo Sovaldi izkazalo v študijah?
For further information about using Sovaldi, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Sovaldi glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The study is being carried out in light of data suggesting that patients treated with these medicines who have had liver cancer could be at risk of their cancer returning early. 
Ta študija se izvaja na podlagi podatkov, ki kažejo, da pri bolnikih, ki se zdravijo s temi zdravili in so preboleli raka jeter, obstaja tveganje njegove zgodnje ponovitve.
Sovaldi allows the virus to be cleared without the patient having to take peginterferon alfa or with only short courses of this medicine (which can cause serious side effects, including reduced growth in adolescents). 
Zdravilo Sovaldi omogoča, da se okužba ozdravi, ne da bi moral bolnik jemati peginterferon alfa, ali pa so potrebni le kratkotrajni ciklusi zdravljenja s tem zdravilom (ki lahko povzroči resne neželene učinke, vključno z zastojem rasti pri mladostnikih).
Sovaldi must not be used together with certain types of medicines which can reduce the effects of Sovaldi. 
Zdravilo Sovaldi se ne sme uporabljati sočasno z določenimi zdravili, ki lahko zmanjšajo njegove učinke.
What is Sovaldi and what is it used for? 
Kaj je zdravilo Sovaldi in za kaj se uporablja?
Treatment with Sovaldi was as effective (67% patients - 171 out of 256 - had no sign of the virus) as peginterferon-based treatment (67% of patients - 162 out of 243). 
Zdravljenje z zdravilom Sovaldi je bilo enako učinkovito (nobenih znakov virusa pri 67 % bolnikov, tj. pri 171 od 256 bolnikov) kot zdravljenje na osnovi peginterferona (67 % bolnikov, tj. 162 od 243 bolnikov).
In addition, virus resistance to Sovaldi is very uncommon and Sovaldi works against all types of hepatitis C virus. 
Poleg tega je odpornost virusa proti zdravilu Sovaldi zelo redka, zdravilo pa deluje proti vsem vrstam virusa hepatitisa C.
Regarding safety, the Agency noted that, although there is limited information in some groups of patients such as those with decompensated liver disease (where the liver is damaged and no longer works properly), no side effects specific to Sovaldi have been identified, and those that occur are mainly due to combined treatment with ribavirin or interferons. 
V zvezi z varnostjo je agencija izpostavila, da so podatki za nekatere skupine bolnikov, na primer za tiste z dekompenzirano boleznijo jeter (poškodovanimi jetri, ki ne delujejo več normalno), sicer omejeni, vendar niso odkrili nobenih neželenih učinkov, povezanih z zdravilom Sovaldi, tisti, ki so jih opazili, pa so bili v glavnem posledica kombiniranega zdravljenja z ribavirinom ali interferoni.