natgillin/translations-raw huggingface dataset:
As a result, these tumour cells can no longer receive the messages transmitted via EGFR that they need to grow and spread to other parts of the body. 
Tako te tumorske celice ne morejo več sprejemati sporočil, ki se prenašajo prek EGFR, in sicer da morajo rasti in se širiti na druge dele telesa.
Vectibix was originally given ‘conditional authorisation' because there was more evidence to come about the medicine. 
Zdravilo Vectibix je prvotno pridobilo „pogojno dovoljenje za promet“, ker je bilo pričakovanih še več dokazov o zdravilu.
This is because growth of these types of cells does not depend on EGFR and they can continue to grow uncontrollably even when EGFR is blocked. 
Rast tovrstnih celic namreč ni odvisna od EGRF, zato lahko nenadzorovano rastejo tudi, ko je EGFR zaviran.
What measures are being taken to ensure the safe and effective use of Vectibix? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Vectibix?
As for all medicines, data on the use of Vectibix are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Vectibix stalno spremljajo.
Vectibix received a conditional marketing authorisation valid throughout the EU on 3 December 2007. 
Za zdravilo Vectibix je bilo 3. decembra 2007 izdano pogojno dovoljenje za promet, veljavno po vsej EU.
It should only be started after the presence of wild-type RAS has been confirmed by an experienced laboratory using a validated test method. 
Uvede se lahko le potem, ko je bila v laboratoriju z izkušnjami na tem področju s pomočjo odobrene testne metode potrjena prisotnost divjega tipa RAS.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vectibix have 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 Vectibix upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
An overview of Vectibix and why it is authorised in the EU 
Pregled zdravila Vectibix in zakaj je odobreno v EU
It must not be used in patients with interstitial pneumonitis or pulmonary fibrosis (lung diseases). 
Prav tako se ne sme uporabljati pri bolnikih z intersticijskim pnevmonitisom ali pljučno fibrozo (obolenjem pljuč).
Other information about Vectibix 
Druge informacije o zdravilu Vectibix
Side effects reported with Vectibix are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Vectibix, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Patients in this study (there was no comparator treatment) lived for an average of 11.2 months without their disease getting worse. 
Bolniki v tej študiji (primerjalnega zdravila ni bilo) so živeli v povprečju 11,2 meseca brez poslabšanja bolezni.
For more information about using Vectibix, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Vectibix glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The most common side effects with Vectibix (in more than 2 patients in 10) were diarrhoea, nausea (feeling sick), vomiting, constipation, abdominal pain (stomach ache), tiredness, fever, lack of appetite, paronychia (nail bed infection), rash, acneiform dermatitis (skin inflammation resembling acne), pruritus (itching), erythema (reddening of the skin) and dry skin. 
Najpogostejši neželeni učinki zdravila Vectibix (opaženi pri več kot 2 bolnikih od 10) so driska, navzeja (slabost), bruhanje, zaprtje, bolečine v trebuhu, utrujenost, zvišana telesna temperatura, pomanjkanje teka, zanohtnica (okužba nohtne posteljice), izpuščaj, akneiformni dermatitis (vnetje kože, ki je podobno aknam), pruritus (srbenje), eritem (pordelost kože) in suha koža.
The dose may need to be modified if severe skin reactions occur and treatment stopped if the reaction does not get better. 
Ob pojavu resnih kožnih reakcij bo treba odmerek morda prilagoditi ali zdravljenje prekiniti, če reakcije ne izzvenijo.
It contains the active substance panitumumab. 
Vsebuje učinkovino panitumumab.
In studies, 93% of the patients receiving Vectibix had side effects affecting the skin, although most of these were mild or moderate. 
V študijah so se pri 93 % bolnikov, ki so prejemali zdravilo Vectibix, pojavili neželeni učinki, ki so prizadeli kožo, vendar pa jih je bila večina blagih ali zmernih.
Treatment with Vectibix should be supervised by a doctor who has experience in the use of cancer therapy. 
Zdravljenje z njim mora nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje rakavih obolenj.
What is Vectibix and what is it used for? 
Kaj je zdravilo Vectibix in za kaj se uporablja?
What benefits of Vectibix have been shown in studies? 
Kakšne koristi zdravila Vectibix so se pokazale v študijah?
It was later confirmed that benefit is limited only to patients with wildtype RAS tumours. 
Kasneje je bilo potrjeno, da so koristi omejene samo na bolnike z divjim tipom gena RAS v tumorjih.
Patients given these combinations lived for an average of 14.8 months and 12.8 months respectively without their disease getting worse. 
Bolniki, ki so prejemali ti kombinaciji so v povprečju živeli 14,8 meseca oziroma 12,8 meseca brez poslabšanja bolezni.
This study involved patients with either wild-type or mutant RAS whose disease had got worse despite treatments that included a fluoropyrimidine, oxaliplatin and irinotecan. 
V tej študiji so sodelovali bodisi bolniki z divjim tipom RAS ali mutiranim RAS, katerih bolezen se je poslabšala kljub zdravljenjem, ki so vključevala fluoropirimidin, oksaliplatin in irinotekan.
Several bowel cancer studies have shown that Vectibix is effective at prolonging life or slowing disease progression in patients with ‘wild-type' RAS tumours that have spread. 
Več študij rakavih obolenj debelega črevesa je pokazalo, da je zdravilo Vecitibix učinkovito pri podaljševanju življenja ali upočasnjevanju slabšanja bolezni pri bolnikih z divjo vrsto RAS tumorjev, ki so se razširili.
What are the risks associated with Vectibix? 
Kakšna tveganja so povezana z zdravilom Vectibix?
Why is Vectibix approved? 
Zakaj je bilo zdravilo Vectibix odobreno?
The studies show Vectibix can be effective when used alone and together with the standard chemotherapy regimens FOLFOX (a combination of fluorouracil with folinic acid and the cancer medicine oxaliplatin) or FOLFIRI (fluorouracil with folinic acid and a different cancer medicine, irinotecan). 
Študije kažejo, da je zdravilo Vectibix lahko učinkovito, kadar se uporabi samostojno ali skupaj s standardnima kemoterapevtskima shemama FOLFOX (kombinacija fluorouracila s folno kislino in zdravila za zdravljenje raka oksaliplatina) ali FOLFIRI (kombinacija fluorouracila s folno kislino in drugega zdravila za zdravljenje raka, irinotekana).
Vectibix must not be used in patients who have had a severe or life-threatening hypersensitivity (allergic) reaction to panitumumab or any of the other ingredients in the past. 
Zdravila Vectibix ne smejo uporabljati osebe, ki so v preteklosti imele življenjsko nevarno preobčutljivostno (alergijsko) reakcijo na panitumumab ali katero koli drugo sestavino zdravila.
Patients receiving Vectibix also had a longer period of time without their disease getting worse: 6.4 months versus 4.6 months. 
Tudi čas preživetja bolnikov brez poslabšanja bolezni se je po prejemanju zdravila Vectibix podaljšal: 6,4 meseca v primerjavi s 4,6 meseca.
Vectibix is available for infusion (drip) into a vein. 
Zdravilo Vectibix je na voljo za infundiranje (kapalno infuzijo) v veno.
Panitumumab does not seem to work against tumour cells that contain mutated (abnormal) RAS genes. 
Zdi se, da panitumumab ne deluje proti tumorskim celicam, ki vsebujejo mutirani (nenormalni) gen RAS.
For the full list of side effects of Vectibix, see the package leaflet. 
Za celoten seznam neželenih učinkov zdravila Vectibix glejte navodilo za uporabo.
Vectibix is a medicine for treating colorectal (bowel) cancer that has spread to other parts of the body. 
Zdravilo Vectibix je zdravilo za zdravljenje rakavega obolenja debelega črevesa in danke, ki se je razširilo na druge dele telesa.
Vectibix is used alone or with other cancer medicines in patients with a type of tumour that has normal (‘wild-type') copies of a gene known as RAS. 
Uporablja se samostojno ali skupaj z drugimi zdravili za zdravljenje raka pri bolnikih z vrsto tumorja, ki ima nemutirane (tj. divjega tipa) kopije gena, znanega kot RAS.
• Patients with wild-type tumours who received Vectibix alone had no disease progression for an average of 16 weeks in a study of 463 patients, compared with 8 weeks in those who did not receive Vectibix and only had supportive care. 
• V študiji s 463 bolniki z divjim tipom tumorja se pri tistih, ki so prejemali zdravilo Vectibix samostojno, bolezen ni poslabšala v povprečju 16 tednov, v primerjavi z osmimi tedni pri tistih, ki niso prejemali zdravila Vectibix in so imeli samo podporno zdravljenje.
Vectibix can only be obtained with a prescription. 
Predpisovanje in izdaja zdravila Vectibix je le na recept.
The active substance in Vectibix, panitumumab, is a monoclonal antibody, a type of protein that has been designed to attach to and block a target called EGFR on certain cells, including some tumour cells. 
Učinkovina v zdravilu Vectibix, panitumumab, je monoklonsko protitelo, vrsta beljakovine, ki je bilo zasnovano tako, da na površini rakavih celic in v nekaterih tumorjih, prepozna prijemališče, imenovano EGFR, se veže nanj in ga zavre.
How does Vectibix work? 
Kako zdravilo Vectibix deluje?
How is Vectibix used? 
Kako se zdravilo Vectibix uporablja?
• Around 73% of patients given Vectibix plus FOLFIRI and 78% of those given Vectibix with FOLFOX had some reduction in signs of cancer in a study of 80 previously untreated patients. 
• V študiji, ki je zajemala 80 predhodno nezdravljenih bolnikov, so se pri okoli 73 % bolnikov, ki so prejemali zdravilo Vectibix skupaj s shemo FOLFIRI, in 78 % tistih, ki so prejemali zdravilo Vectibix skupaj s shemo FOLFOX, znaki raka nekoliko zmanjšali.
• Patients receiving Vectibix in combination with FOLFOX lived for an average of 10.1 months without the disease getting worse in a study of 1,183 previously untreated patients compared with 7.9 months for those receiving FOLFOX alone. 
• V študiji, ki je zajemala 1 183 predhodno nezdravljenih bolnikov, so tisti, ki so prejemali zdravilo Vectibix v kombinaciji s shemo FOLFOX v povprečju živeli 10,1 meseca brez poslabšanja bolezni, v primerjavi s 7,9 meseca pri tistih, ki so prejemali samo shemo FOLFOX.
Vectibix must not be used with oxaliplatin-containing chemotherapy in patients whose tumour contains the mutated RAS gene or for whom the RAS status is not known. 
Zdravilo Vectibix se pri bolnikih, pri katerih ni bilo potrjeno, da njihovi tumorji vsebujejo mutirani gen RAS, ali pri katerih stanje gena RAS ni znano, ne sme uporabljati skupaj s kemoterapijo, ki vsebuje oksaliplatin.
• Patients given Vectibix in combination with FOLFIRI lived for 16.2 months in a study of 1,186 previously treated patients compared with 13.9 months in patients receiving FOLFIRI alone. 
• V študiji s 1 186 predhodno zdravljenimi bolniki so tisti, ki so prejemali zdravilo Vectibix skupaj s shemo FOLFIRI, živeli 16,2 meseca v primerjavi s tistimi, ki so prejemali samo shemo FOLFIRI in so živeli 13, 9 meseca.
• Around 59% of patients who received Vectibix plus FOLFIRI in a study of 154 previously untreated had some reduction in signs of cancer. 
• V študiji s 154 predhodno nezdravljenimi bolniki so se pri 59 % tistih, ki so prejemali zdravilo Vectibix skupaj s shemo FOLFIRI, znaki rakavega obolenja nekoliko zmanjšali.
Some studies also report an association with lower doses. 
Nekatere študije poročajo tudi o povezavi z nižjimi odmerki.
• The PRAC also concluded that there was need for further risk minimisation measures such as information to healthcare professionals. 
• PRAC je prav tako zaključil, da so potrebni dodatni ukrepi za zmanjšanje tveganja, na primer informacije za zdravstvene delavce.
Major vascular events were increased by about one third by a coxib (rate ratio [RR] 1.37, 95% confidence interval [CI] 1.14-1.66; p=0.0009) or diclofenac (1.41, 1.12-1.78; p=0.0036), mainly due to an increase in major coronary events (coxibs: 1.76, 1.31-2.37; p=0.0001; diclofenac: 1.70, 1.19-2.41; p=0.0032). 
Večji vaskularni dogodki so se povečali za približno tretjino pri koksibu (razmerje stopnje [RS] 1,37, 95-odstotni interval zaupanja [IZ] 1,14−1,66; p = 0,0009) ali pri diklofenaku (1,41, 1,12−1,78; p = 0,0036), v glavnem zaradi povečanja števila večjih koronarnih dogodkov (koksibi: 1,76, 1,31−2,37; p = 0,0001; diklofenak: 1,70, 1,19−2,41; p = 0,0032).
This review was conducted by the Pharmacovigilance Risk Assessment Committee (PRAC). 
Pregled je izvedel Odbor za oceno tveganja na področju farmakovigilance (PRAC).
Diclofenac is a non-steroidal anti-inflammatory drug (NSAID). 
Diklofenak je nesteroidno protivnetno zdravilo (NSAID).
Key elements for a direct healthcare professional communication were agreed, together with the timelines for distribution. 
Dogovorili so se o ključnih elementih za neposredno komunikacijo z zdravstvenimi delavci in o časovnem načrtu za distribucijo;
Overall summary of the scientific evaluation of diclofenac containing medicinal products (systemic formulations) (see Annex I) 
Splošni povzetek znanstvenega vrednotenja zdravil, ki vsebujejo diklofenak (sistemske formulacije) (glejte Prilogo I)
These are appropriately reflected in the product information. 
Omenjeni neželeni učinki so ustrezno navedeni v informacijah o zdravilu.
The PRAC concluded that diclofenac is effective in reducing inflammation and pain. 
PRAC je zaključil, da je diklofenak učinkovit pri zmanjšanju vnetja in bolečine.
Therefore in accordance with Articles 31 and 32 of Directive 2001/83/EC, the PRAC recommends the variation of the marketing authorisations for all medicinal products referred to in Annex I and for which the amendments to the product information are set out in annex III of the recommendation. 
V skladu s členoma 31 in 32 Direktive 2001/83/ES zato PRAC priporoča spremembo dovoljenj za promet za vsa zdravila, ki so navedena v Prilogi I in za katera so spremembe informacij o zdravilu navedene v Prilogi III priporočila.
The available information on the dose effect of diclofenac is limited. 
Razpoložljive informacije o razmerju odmerek/učinek za diklofenak so omejene.
Annex II Scientific conclusions and grounds for variation to the terms of the marketing authorisations 
Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj za promet z zdravilom
Another evaluation conducted by the CHMP in 20122 considered all available published evidence to date from meta-analysis of clinical trials and observational studies, and also epidemiological studies. 
V drugi oceni, ki jo je odbor CHMP izvedel leta 20122, so upoštevali vse dotedanje razpoložljive objavljene dokaze iz metaanaliz kliničnih preskušanj in opazovalnih študij ter epidemioloških študij.
• The PRAC considered that diclofenac containing medicinal products are effective in their approved indications. 
• PRAC je menil, da so zdravila, ki vsebujejo diklofenak, učinkovita pri odobrenih indikacijah;
The PRAC considered that the recommendation for update of the product information should be applicable to all medicinal products containing diclofenac (systemic formulations), regardless of dose. 
PRAC je menil, da bi moralo priporočilo za posodobitev informacij o zdravilu veljati za vsa zdravila, ki vsebujejo diklofenak (sistemske formulacije), ne glede na odmerek.
Furthermore, a proactive communication of these new measures through a direct healthcare professional communication (DHPC) was recommended. 
Odbor je priporočil tudi proaktivno obveščanje o teh novih ukrepih z neposrednim sporočilom za zdravstveno osebje.
Risk minimisation measures (in the form of contraindications and warnings in the product information) were implemented at the time for Cox-2 inhibitors. 
Takrat so uvedli ukrepe za zmanjšanje tveganja (v obliki kontraindikacij in opozoril v informacijah o zdravilu) za zaviralce Cox-2.
The data available (in particular data from the MEDAL1 programme) suggested that the risk of arterial thrombotic events with diclofenac was similar to that for coxibs, but firm conclusions could not be drawn and further epidemiological studies were needed to obtain additional data. 
Razpoložljivi podatki (zlasti podatki iz programa MEDAL1) so pokazali, da je bilo tveganje za pojav arterijskih trombotičnih dogodkov pri diklofenaku podobno tveganju pri koksibih, vendar trdnih sklepov ni bilo mogoče sprejeti in potrebne so bile nadaljnje epidemiološke študije za pridobitev dodatnih podatkov.
A new review was considered necessary and was initiated to address the cardiovascular safety concerns for diclofenac and their impact on the benefit-risk balance of diclofenac containing medicinal products (systemic formulations). 
Potreben je bil nov pregled, ki so ga nato sprožili, da bi ocenili pomisleke glede srčno-žilne varnosti za diklofenak in njihov vpliv na razmerje med koristmi in tveganji za zdravila, ki vsebujejo diklofenak (sistemske formulacije).
The PRAC acknowledged the conclusions of previous reviews with regards to the cardiovascular safety of diclofenac. 
PRAC je potrdil sklepe predhodnih pregledov glede srčno-žilne varnosti diklofenaka.
Recognised risks associated with NSAID treatment in general, and with diclofenac treatment in particular, include serious gastrointestinal effects including PUB (perforation, ulcer, bleeding), cardio-renal effects, hepatic effects and skin reactions (including Stevens Johnson syndrome and toxic epidermal necrolysis). 
Med znana tveganja, ki so na splošno povezana z zdravljenjem z nesteroidnimi protivnetnimi zdravili in zlasti povezana z zdravljenjem z diklofenakom, spadajo resni gastrointestinalni učinki, vključno s PUK (perforacija, ulkus, krvavitev), kardiorenalni učinki, učinki na jetra in kožne reakcije (vključno s StevensJohnsonovim sindromom in toksično epidermalno nekrolizo).
In 2006 it was concluded that a small increase in the absolute risk of thrombotic events could not be excluded for NSAIDs as a class, especially when used at high-doses and long-term therapy, although the risk was considered to be higher for the selective cyclooxygenase-2 (Cox-2) inhibitors (also known as coxibs) compared to NSAIDs. 
Leta 2006 je odbor zaključil, da rahlega povečanja absolutnega tveganja za pojav trombotičnih dogodkov ni mogoče izključiti za skupino nesteroidnih protivnetnih zdravil, kar velja zlasti pri uporabi zdravil v visokih odmerkih in za dolgotrajno zdravljenje, čeprav je odbor menil, da je bilo tveganje večje za selektivne zaviralce ciklooksigenaze-2 (Cox-2) (znane tudi pod imenom koksibi) kot za nesteroidna protivnetna zdravila.
Although the data point towards a dose dependent effect on thrombotic risk associated with the use of diclofenac, particularly at high dose, it is difficult to establish a clear cut-off dose above which the risks become significantly increased. 
Čeprav podatki kažejo na od odmerka odvisen učinek na trombotično tveganje, povezano z uporabo diklofenaka, zlasti pri visokih odmerkih, je težko določiti natančno mejno vrednost odmerka, po kateri se tveganja znatno povečajo.
The data available today do not allow conclusion on the specific mechanisms underlying the cardiovascular thrombotic risks of diclofenac, although several studies have explored different options and it can be noted that is unlikely that one single mechanism would explain the risk. 
Trenutno razpoložljivi podatki ne omogočajo sklepanja o specifičnih mehanizmih, ki so vzrok za srčno-žilna trombotična tveganja diklofenaka, čeprav so v več študijah preučili različne možnosti in je mogoče zabeležiti, da je malo verjetno, da bi tveganje razložili s samo enim mehanizmom.
• The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, for diclofenac containing medicinal products (systemic formulations). 
• PRAC je obravnaval napotitev po členu 31 Direktive 2001/83/ES, ki je bila na podlagi farmakovigilančnih podatkov sprožena za zdravila, ki vsebujejo diklofenak (sistemske formulacije);
Data provided by the MAHs in writing and at an oral explanation and relevant data made available by independent researchers were also considered. 
Preučili so tudi podatke, ki so jih predložili imetniki dovoljenja za promet z zdravilom v pisni obliki, njihove ustne obrazložitve in relevantne podatke, ki so jih prispevali neodvisni raziskovalci.
Results of the ‘safety of non-steroidal anti-inflammatory drugs' (SOS) research project funded by the European Commission under the Seventh Framework Programme were considered in the review that concluded that available evidence regarding diclofenac seemed to consistently point towards a less favourable cardiovascular risk profile compared to other NSAIDs, and similar risks as those of Cox-2 inhibitors. 
Rezultate raziskovalnega projekta (SOS) o „varnosti nesteroidnih protivnetnih zdravil“, ki je ga v okviru sedmega okvirnega programa financirala Evropska komisija, so preučili v pregledu, v katerem so zaključili, da razpoložljivi dokazi o diklofenaku dosledno kažejo na manj ugoden profil srčno-žilnega tveganja v primerjavi z drugimi nesteroidnimi protivnetnimi zdravili in na tveganja, ki so podobna tveganjem zaviralcev Cox-2.
Evidence available from a new meta-analysis of randomised clinical trials conducted by an independent research group was included in the review. 
V pregled so bili vključeni dokazi iz nove metaanalize randomiziranih kliničnih preskušanj, ki jo je izvedla neodvisna raziskovalna skupina.
It was observed that these are similar to those of selective Cox-2 inhibitors. 
Ugotovili so, da so tveganja podobna tveganjem selektivnih zaviralcev Cox-2;
Based on the available data to date, the PRAC therefore concluded that the cardiovascular thrombotic risk cannot be excluded across all doses of diclofenac, especially in patients with pre-existing co-morbidities. 
Na podlagi razpoložljivih podatkov je odbor PRAC zaključil, da srčno-žilnega trombotičnega tveganja ni mogoče izključiti za vse odmerke diklofenaka, zlasti ne pri bolnikih s predhodno obstoječimi sočasnimi obolenji.
The PRAC therefore recommended an amendment to the product information for diclofenac to include an updated contraindication in patients with established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease. 
PRAC je zato priporočil spremembo informacij o zdravilu za diklofenak, tako da bo v informacije vključena posodobljena kontraindikacija pri bolnikih z ugotovljenim kongestivnim srčnim popuščanjem (NYHA II-IV), ishemično boleznijo srca, periferno arterijsko boleznijo in/ali cerebrovaskularnim obolenjem.
Considering that an increased cardiovascular risk with diclofenac is observed, and this appears similar to that of selective Cox-2 inhibitors, it therefore follows that any risk minimisation in place for Cox-2 inhibitors with respect to cardiovascular risk should also apply to diclofenac. 
Glede na to, da so zabeležili povečano srčno-žilno tveganje z diklofenakom, ki se zdi podobno tveganju selektivnih zaviralcev Cox-2, je treba vsak ukrep za zmanjšanje tveganja, sprejet za zaviralce Cox-2 glede srčno-žilnega tveganja, vpeljati tudi za diklofenak.
Meta-analyses of observational data and individual observational studies also consistently indicated that diclofenac is associated with a similar level of risk as Cox-2 inhibitors. 
Metaanalize opazovalnih podatkov in posameznih opazovalnih študij prav tako dosledno kažejo, da je diklofenak povezan s podobno stopnjo tveganja kot zaviralci Cox2.