FrancophonIA/ELRC3.0 huggingface dataset:
English: Marketing Authorisation Holder KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Slovenian: Imetnik dovoljenja za promet z zdravilom KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija
English: Each film-coated tablet contains sildenafil citrate equivalent to 50 mg sildenafil.
Slovenian: Ena filmsko obložena tableta vsebuje sildenafilijev citrat, kar ustreza 50 mg sildenafila.
English: Vizarsin 50 mg film-coated tablets Sildenafil
Slovenian: Vizarsin 50 mg filmsko obložene tablete sildenafil
English: 4 x 1 film-coated tablet: EU/1/09/551/010 8 x 1 film-coated tablet: EU/1/09/551/011 12 x 1 film-coated tablet: EU/1/09/551/012
Slovenian: 4 x 1 filmsko obložena tableta: EU/1/09/551/010 8 x 1 filmsko obložena tableta: EU/1/09/551/011 12 x 1 filmsko obložena tableta: EU/1/09/551/012
English: Vizarsin 50 mg orodispersible tablets
Slovenian: Vizarsin 50 mg orodisperzibilne tablete
English: Vizarsin orodispersible tablets are available in boxes of 1 orodispersible tablet in blisters and also in boxes of 2 x 1, 4 x 1, 8 x 1 or 12 x 1 orodispersible tablet in a perforated unit dose blisters.
Slovenian: Vizarsin orodisperzbilne tablete so na voljo v škatlah z 1 orodisperzibilno tableto v pretisnem omotu in v škatlah po 2 x 1, 4 x 1, 8 x 1 ali 12 x 1 orodisperzibilno tableto v perforiranih pretisnih omotih za enkratni odmerek.
English: Fatigue, Feeling hot
Slovenian: občutek vročine in občutek utrujenosti.
English: I/*H
Slovenian: I\ /.'
English: 4 x 1 film-coated tablet: EU/1/09/551/006 8 x 1 film-coated tablet: EU/1/09/551/007 12 x 1 film-coated tablet: EU/1/09/551/008
Slovenian: 4 x 1 filmsko obložena tableta: EU/1/09/551/006 8 x 1 filmsko obložena tableta: EU/1/09/551/007 12 x 1 filmsko obložena tableta: EU/1/09/551/008
English: 1 film-coated tablet: EU/1/09/551/001
Slovenian: 1 filmsko obložena tableta: EU/1/09/551/001
English: Since sildenafil clearance is reduced in patients with severe renal impairment (creatinine clearance <30 ml/min) a 25 mg dose should be considered.
Slovenian: Pri bolnikih s hudo ledvično okvaro (očistek kreatinina < 30 ml/min) se očistek sildenafila zmanjša, zato je priporočeni začetni odmerek 25 mg. Glede na učinkovitost in prenašanje se odmerek lahko postopoma zveča na 50 mg do 100 mg, če je potrebno.
English: Vizarsin 100 mg orodispersible tablets Sildenafil
Slovenian: Vizarsin 100 mg orodisperzibilne tablete sildenafil
English: 1 film-coated tablet: EU/1/09/551/009
Slovenian: 1 filmsko obložena tableta: EU/1/09/551/009
English: 1 film-coated tablet: EU/1/09/551/005
Slovenian: 1 filmsko obložena tableta: EU/1/09/551/005
English: Vizarsin 25 mg film-coated tablets are available in boxes of 1 film-coated tablet in blisters and also in boxes of 4 x 1, 8 x 1 or 12 x 1 film-coated tablet in a perforated unit dose blisters.
Slovenian: Vizarsin 25 mg filmsko obložene tablete so na voljo v škatlah z 1 filmsko obloženo tableto v pretisnem omotu in v škatlah po 4 x 1, 8 x 1 ali 12 x 1 filmsko obloženo tableto v perforiranih pretisnih omotih za enkratni odmerek.
English: 4 x 1 film-coated tablet: EU/1/09/551/002 8 x 1 film-coated tablet: EU/1/09/551/003 12 x 1 film-coated tablet: EU/1/09/551/004
Slovenian: 4 x 1 filmsko obložena tableta: EU/1/09/551/002 8 x 1 filmsko obložena tableta: EU/1/09/551/003 12 x 1 filmsko obložena tableta: EU/1/09/551/004
English: Vizarsin 100 mg film-coated tablets are available in boxes of 1 film-coated tablet in blisters and also in boxes of 4 x 1, 8 x 1 or 12 x 1 film-coated tablet in a perforated unit dose blisters.
Slovenian: Vizarsin 100 mg filmsko obložene tablete so na voljo v škatlah z 1 filmsko obloženo tableto v pretisnem omotu in v škatlah po 4 x 1, 8 x 1 ali 12 x 1 filmsko obloženo tableto v perforiranih pretisnih omotih za enkratni odmerek.
English: Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and not eliminated in the urine.
Slovenian: Ker je večina sildenafina vezana na beljakovine v plazmi in se ne izloča v seču, ni pričakovati, da bi hemodializa pospešila očistek.
English: Retinal haemorrhage, Arteriosclerotic retinopathy, Retinal disorder, Glaucoma,
Slovenian: Bolezni živčevja glavobol omotica zaspanost, hipestezija cerebrovaskularni insult, tranzitorni ishemični napad, konvulzije,* ponavljajoče konvulzije,* sinkopa
English: Vizarsin 50 mg film-coated tablets are available in boxes of 1 film-coated tablet in blisters and also in boxes of 4 x 1, 8 x 1 or 12 x 1 film-coated tablet in a perforated unit dose blisters.
Slovenian: Vizarsin 50 mg filmsko obložene tablete so na voljo v škatlah z 1 filmsko obloženo tableto v pretisnem omotu in v škatlah po 4 x 1, 8 x 1 ali 12 x 1 filmsko obloženo tableto v perforiranih pretisnih omotih za enkratni odmerek.
English: 2 x 1 orodispersible tablet: EU/1/09/551/024 4 x 1 orodispersible tablet: EU/1/09/551/025 8 x 1 orodispersible tablet: EU/1/09/551/026 12 x 1 orodispersible tablet: EU/1/09/551/027 24 x 1 orodispersible tablet: EU/1/09/551/029
Slovenian: 2 x 1 orodisperzibilna tableta: EU/1/09/551/024 4 x 1 orodisperzibilna tableta: EU/1/09/551/025 8 x 1 orodisperzibilna tableta: EU/1/09/551/026 12 x 1 orodisperzibilna tableta: EU/1/09/551/027 24 x 1 orodisperzibilna tableta: EU/1/09/551/029
English: Vizarsin 25 mg orodispersible tablets Sildenafil
Slovenian: Vizarsin 25 mg orodisperzibilne tablete sildenafil
English: Vizarsin 100 mg orodispersible tablets
Slovenian: Vizarsin 100 mg orodisperziblne tablete
English: The orodispersible tablet should be placed in the mouth on the tongue, where it will rapidly disperse in saliva, so it can be easily swallowed.
Slovenian: Ker se v slini hitro razpusti, jo je mogoče brez težav pogoltniti.
English: 2 x 1 orodispersible tablet: EU/1/09/551/019 4 x 1 orodispersible tablet: EU/1/09/551/020 8 x 1 orodispersible tablet: EU/1/09/551/021 12 x 1 orodispersible tablet: EU/1/09/551/022 24 x 1 orodispersible tablet: EU/1/09/551/028
Slovenian: 2 x 1 orodisperzibilna tableta: EU/1/09/551/019 4 x 1 orodisperzibilna tableta: EU/1/09/551/020 8 x 1 orodisperzibilna tableta: EU/1/09/551/021 12 x 1 orodisperzibilna tableta: EU/1/09/551/022 24 x 1 orodisperzibilna tableta: EU/1/09/551/028
English: 1 orodispersible tablet: EU/1/09/551/013 2 x 1 orodispersible tablet: EU/1/09/551/014 4 x 1 orodispersible tablet: EU/1/09/551/015 8 x 1 orodispersible tablet: EU/1/09/551/016 12 x 1 orodispersible tablet: EU/1/09/551/017
Slovenian: 1 orodisperzibilna tableta: EU/1/09/551/013 2 x 1 orodisperzibilna tableta: EU/1/09/551/014 4 x 1 orodisperzibilna tableta: EU/1/09/551/015 8 x 1 orodisperzibilna tableta: EU/1/09/551/016 12 x 1 orodisperzibilna tableta: EU/1/09/551/017
English: Vizarsin 50 mg orodispersible tablets Sildenafil
Slovenian: Vizarsin 50 mg orodisperzibilne tablete sildenafil
English: Put the tablet on the tongue as soon as it is removed from the packaging.
Slovenian: Tableto takoj položite na jezik.
English: 2 x 1 orodispersible tablet: EU/1/09/551/014 4 x 1 orodispersible tablet: EU/1/09/551/015 8 x 1 orodispersible tablet: EU/1/09/551/016 12 x 1 orodispersible tablet: EU/1/09/551/017
Slovenian: 2 x 1 orodisperzibilna tableta: EU/1/09/551/014 4 x 1 orodisperzibilna tableta: EU/1/09/551/015 8 x 1 orodisperzibilna tableta: EU/1/09/551/016 12 x 1 orodisperzibilna tableta: EU/1/09/551/017
English: Based on efficacy and tolerability, the dose may be increased step-wise to 50 mg up to 100 mg as necessary.
Slovenian: Pri bolnikih z jetrno okvaro (npr. s cirozo) se očistek sildenafila zmanjša, zato je priporočeni začetni odmerek 25 mg. Glede na učinkovitost in prenašanje se odmerek lahko postopoma zveča na 50 mg do 100 mg, če je to potrebno.
English: In a few seconds it begins disintegrating in the mouth and subsequently can be swallowed with or without water.
Slovenian: Lahko jo pogoltnete z vodo ali brez nje.
English: Retinal haemorrhage, Arteriosclerotic retinopathy, Retinal disorder, Glaucoma, Visual field defect, Diplopia,
Slovenian: Motnje reprodukcije in dojk krvavitev iz penisa, priapizem,* hematospermija, dolgotrajna erekcija
English: Your mouth should be empty before taking the tablet.
Slovenian: Ko vzamete tableto, v ustih ne smete imeti hrane.
English: They should not be pushed through the foil in the blister pack as this will cause damage to the tablet.
Slovenian: Orodisperzibilna tableta Vizarsin je krhka in je ne smete potisniti skozi pretisni omot, ker se lahko poškoduje.
English: Tip the tablet out onto your hand.
Slovenian: Tableto raztopite v ustih.
English: (E420)), crospovidone, calcium silicate and magnesium stearate (E572).
Slovenian: neohesperidin-dihidrohalkon (E959), eterično olje zelene mete, eterično olje poprove mete (ki vsebuje sorbitol (E420)), krospovidon, kalcijev silikat in magnezijev stearat (E572).
English: Dry mouth
Slovenian: Okvara jeter
English: 747 70 Opava-Komárov Czech Republic
Slovenian: 747 70 Opava-Komárov Češka republika
English: Iskedyl Fort tablets
Slovenian: Iskedyl Fort tablete
English: 28703 San Sebastian de los Reyes (Madrid) Spain
Slovenian: 28703 San Sebastian de los Reyes (Madrid) Španija
English: Czech Republic TEVA Czech Industries s.r.o.
Slovenian: Češka republika TEVA Czech Industries s.r.o.
English: Ferraz 80, 5º 28008 Madrid Spain
Slovenian: Ferraz 80, 5º 28008 Madrid Španija
English: PRT Lagoas Park, Edifício 11 2740-270 Porto Salvo Portugal
Slovenian: PRT Lagoas Park, Edifício 11 2740-270 Porto Salvo Portugalska
English: Arzneimittelvertriebs GmbH, Anton Anderer Platz 6/1, A-1210 Vienna Austria
Slovenian: Arzneimittelvertriebs GmbH, Anton Anderer Platz 6/1, A-1210 Vienna Avstrija
English: ISKEDYL, solution injectable en ampoule solution for injection IV/IM
Slovenian: ISKEDYL, solution injectable en ampoule raztopina za injekcije IV/IM
English: ARKOLEON 11, KATO PATISSIA, 10445 Greece
Slovenian: ARKOLEON 11, KATO PATISSIA, 10445 Grčija
English: Capsule hard
Slovenian: Trda kapsula
English: ERGODAVUR GOTAS 1 mg (monodose suchet)
Slovenian: ERGODAVUR GOTAS 1 mg (vrečka z enkratnim odmerkom)
English: FINIXFARM EPE DERVENAKION 38 & SAHINI, GERAKAS, 15344 Greece
Slovenian: FINIXFARM EPE DERVENAKION 38 & SAHINI, GERAKAS, 15344 Grčija
English: 3mg/cap capsules, soft
Slovenian: 3 mg/kap kapsule, mehke
English: ANTOR LTD P. MAVROMIHALI 1 VRILISSIA 15235 Greece
Slovenian: ANTOR LTD P. MAVROMIHALI 1 VRILISSIA 15235 Grčija
English: Annex I List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, marketing authorisation holder(s) in the member states
Slovenian: Priloga I Seznam imen, farmacevtskih oblik, jakosti zdravil, poti uporabe zdravila,
English: ARGONAFTWN 22, ARGYROUPOLI, 16452 Greece
Slovenian: ARGONAFTWN 22, ARGYROUPOLI, 16452 Grčija
English: 2.5 mg (1:1:1) prolonged-release capsule, soft
Slovenian: 2,5 mg (1:1:1) kapsula s podaljšanim sproščanjem, mehka
English: G. KORONIS DILOU 9, PERISTERI, ATTIKIS, 12134 Greece
Slovenian: G. KORONIS DILOU 9, PERISTERI, ATTIKIS, 12134
English: 0.10 g / 0.80 g oral solution
Slovenian: 0,10 g / 0,80 g peroralna raztopina peroralna uporaba
English: powder for oral solution for single dose
Slovenian: prašek za peroralno raztopino za enkratni odmerek
English: 6MG/SINGLE DOSE
Slovenian: MG/ENKRATNI ODMEREK
English: This summary was last updated in November 2016.
Slovenian: Povzetek je bil nazadnje posodobljen novembra 2016.
English: This will help protect the pigs against the infection and reduce the risk of disease.
Slovenian: S tem prašiče zaščitimo pred okužbo in zmanjšamo tveganje za bolezen.
English: The vaccine reduced the number of pigs with moderate to severe diarrhoea compared to non-vaccinated pigs.
Slovenian: Cepivo je zmanjšalo število prašičev z zmerno do hudo drisko v primerjavi z necepljenimi prašiči.
English: The strains of bacteria in the vaccine have these proteins but do not produce the toxins that cause the disease.
Slovenian: Sevi bakterij v cepivu vsebujejo ti beljakovini, vendar ne proizvajajo toksinov, ki povzročajo bolezen.
English: The effectiveness of the vaccine was studied in four laboratory studies in pigs that looked chiefly at the incidence, severity and duration of diarrhoea as well as the presence of disease-causing E. coli in the animals' excrement.
Slovenian: Učinkovitost cepiva so proučevali v štirih laboratorijskih študijah na prašičih, pri katerih so v glavnem ugotavljali pojavnost, resnost in trajanje driske ter prisotnost E. coli, ki povzroča bolezen, v živalskih iztrebkih.
English: E. coli O8:K87 / O141:K94 vaccine (live)
Slovenian: cepivo z E. coli O8:K87/O141:K94 (živo)
English: Two studies showed the vaccine starts to be effective 7 days after vaccination and two studies showed protection lasts for 21 days after vaccination.
Slovenian: Dve študiji sta pokazali, da začne cepivo učinkovati sedem dni po cepljenju, dve študiji pa, da zaščita traja 21 dni po cepljenju.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Coliprotec F4/F18's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Coliprotec F4/F18 večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: The full EPAR for Coliprotec F4/F18 can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila Coliprotec F4/F18 je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: This is more likely to occur at weaning time when the piglet no longer receives protecting antibodies through the sow's milk.
Slovenian: To se najpogosteje zgodi ob odstavitvi, ko prašiček s svinjinim mlekom ne prejema več zaščitnih protiteles.
English: Although E. coli bacteria are naturally found in the gut, some strains (known as enterotoxigenic strains) produce toxins that cause diarrhoea and can result in dehydration, weight loss and occasionally death of the animal.
Slovenian: Čeprav so bakterije E. coli naravno prisotne v črevesju, pa nekateri sevi (imenovani enterotoksigeni sevi) proizvajajo toksine, ki povzročajo drisko, kar lahko privede do dehidracije, izgube telesne mase in včasih tudi smrti živali.
English: Two studies used the F4 strain while the other two used the F18 strain.
Slovenian: V dveh študijah so uporabljali sev F4, v drugih dveh pa sev F18.
English: Coliprotec F4/F18 contains two strains of live E. coli bacteria (O8:K87 and O141:K94) which do not produce toxins that cause disease.
Slovenian: Cepivo Coliprotec F4/F18 vsebuje dva seva živih bakterij E. coli (O8:K87 in O141:K94), ki ne proizvajata toksinov, ki povzročajo bolezen.
English: In case of spillage onto skin, the affected area should be rinsed with water and medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Slovenian: V primeru razlitja na koži je treba prizadeto območje izprati z vodo, nemudoma poiskati zdravniško pomoč in zdravniku pokazati navodilo za uporabo ali nalepko.
English: The vaccine starts to be effective 7 days after vaccination and protection lasts for 21 days after vaccination.
Slovenian: Učinkovati začne sedem dni po cepljenju, zaščita pa traja 21 dni po cepljenju.
English: This is a summary of the European public assessment report (EPAR) for Coliprotec F4/F18.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Coliprotec F4/F18.
English: Pigs aged 17 - 18 days were vaccinated with Coliprotec F4/F18 and then artificially infected with E. coli strains.
Slovenian: Prašiče, stare 17-18 dni, so cepili s cepivom Coliprotec F4/F18 in nato umetno okužili s sevi E. coli.
English: The types of E. coli associated with post-weaning diarrhoea often produce proteins called F4 and F18 on their outer coat that allows them to attach to the cells of the gut.
Slovenian: Vrste E. coli, ki so povezane z drisko po odstavitvi, na svoji zunanji ovojnici pogosto tvorijo beljakovini, imenovani F4 in F18, zaradi katere se lahko vežejo na celice črevesja.
English: The European Commission granted a marketing authorisation valid throughout the EU for Coliprotec F4/F18 on 9 January 2017.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Coliprotec F4/F18, veljavno po vsej Evropski uniji, izdala 09/01/2017.
English: Coliprotec F4/F18 is available as a lyophilisate (a freeze-dried pellet) which is made up into a suspension with water to be given by mouth.
Slovenian: Cepivo Coliprotec F4/F18 je na voljo v obliki liofilizata (pelet, posušenih z zamrzovanjem), iz katerega se z vodo pripravi suspenzija, ki se daje peroralno.
English: In the future, if the animals are exposed to disease-causing bacteria with the F4 or F18 proteins, the immune system will be able to respond more quickly.
Slovenian: Ob morebitni ponovni izpostavitvi bakterijam z beljakovino F4 ali F18, ki povzročajo bolezen, se bo imunski sistem lahko odzval hitreje.
English: For practical information about using Coliprotec F4/F18, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Coliprotec F4/F18 naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
English: The withdrawal period for meat from pigs treated with Coliprotec F4/F18 is ‘zero' days, which means there is no mandatory waiting time.
Slovenian: Karenca za meso prašičev, cepljenih s cepivom Coliprotec F4/F18, je nič dni, kar pomeni, da ni obvezne čakalne dobe.
English: Coliprotec F4/F18 is a vaccine used to protect pigs from 18 days of age against post-weaning diarrhoea caused by E. coli.
Slovenian: Zdravilo Coliprotec F4/F18 je cepivo, ki se uporablja za zaščito prašičev, starejših od 18 dni, pred drisko zaradi E. coli po odstavitvi.
English: For more information about treatment with Coliprotec F4/F18, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Coliprotec F4/F18 naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
English: Coliprotec F4/F18 is a vaccine.
Slovenian: Zdravilo Coliprotec F4/F18 je cepivo.
English: In case of accidental ingestion, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Slovenian: V primeru nenamernega zaužitja nemudoma poiščite zdravniško pomoč in zdravniku pokažite navodilo za uporabo ali nalepko.
English: When Coliprotec F4/F18 is given to pigs, the animals' immune system recognises the bacteria as ‘foreign' and makes antibodies against them.
Slovenian: Ko prašiče cepimo s cepivom Coliprotec F4/F18, njihov imunski sistem bakterije prepozna kot „tujke“ in proti njim razvije protitelesa.
English: What is Coliprotec F4/F18 and what is it used for?
Slovenian: Kaj je zdravilo Coliprotec F4/F18 in za kaj se uporablja?
English: What benefits of Coliprotec F4/F18 have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Coliprotec F4/F18 izkazalo v študijah?
English: What are the risks associated with Coliprotec F4/F18?
Slovenian: Kakšna tveganja so povezana z zdravilom Coliprotec F4/F18?
English: Why is Coliprotec F4/F18 approved?
Slovenian: Zakaj je bilo zdravilo Coliprotec F4/F18 odobreno?
English: Other information about Coliprotec F4/F18?
Slovenian: Druge informacije o zdravilu Coliprotec F4/F18
English: There are currently no known side effects associated with Coliprotec F4/F18.
Slovenian: Znanih neželenih učinkov zdravila Coliprotec F4/F18 ni.
English: How does Coliprotec F4/F18 work?
Slovenian: Kako zdravilo Coliprotec F4/F18 deluje?
English: How is Coliprotec F4/F18 used?
Slovenian: Kako se zdravilo Coliprotec F4/F18 uporablja?
English: Coliprotec F4/F18 is given by mouth to pigs as a single dose either as a drench or by addition to the drinking water.
Slovenian: Prašičem se daje peroralno v obliki enkratnega odmerka bodisi z drenažno aplikacijo bodisi kot dodatek v vodo za pitje.
English: The recommended dose is one tablet taken once a day with food for 8 or 12 weeks.
Slovenian: Priporočeni odmerek je ena tableta, ki se jemlje enkrat na dan skupaj s hrano v obdobju 8 ali 12 tednov.
English: Vosevi must not be used together with certain medicines such as:
Slovenian: Zdravilo Vosevi se ne sme jemati sočasno z določenimi zdravili, kot so:
English: What measures are being taken to ensure the safe and effective use of Vosevi?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Vosevi?
English: Other information about Vosevi
Slovenian: Druge informacije o zdravilu Vosevi
English: The full EPAR for Vosevi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Vosevi je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The clearance rates with Vosevi were typically above 95%.
Slovenian: Stopnje izčistkov z zdravilom Vosevi so bile običajno višje od 95 %.
English: This is a summary of the European public assessment report (EPAR) for Vosevi.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Vosevi.
English: Sofosbuvir/velpatasvir has been authorised in the EU as Epclusa since July 2016.
Slovenian: Sofosbuvir/velpatasvir je v EU odobren od julija 2016 kot zdravilo Epclusa.
English: It is not intended to provide practical advice on how to use Vosevi.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: The European Medicines Agency therefore decided that Vosevi's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Vosevi večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
English: Vosevi sofosbuvir / velpatasvir / voxilaprevir
Slovenian: Vosevi sofosbuvir/velpatasvir/voksilaprevir
English: What are the risks associated with Vosevi?
Slovenian: Kakšna tveganja so povezana z zdravilom Vosevi?
English: What benefits of Vosevi have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Vosevi izkazalo v študijah?
English: What is Vosevi and what is it used for?
Slovenian: Kaj je zdravilo Vosevi in za kaj se uporablja?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vosevi have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Vosevi upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Vosevi is available as tablets containing 400 mg sofosbuvir, 100 mg velpatasvir and 100 mg voxilaprevir.
Slovenian: Zdravilo Vosevi je na voljo v obliki tablet, ki vsebujejo 400 mg sofosbuvirja, 100 mg velpatasvirja in 100 mg voksilaprevirja.
English: The fact that Vosevi can be given for 8 weeks (instead of the usual 12) to patients who do not have liver cirrhosis is considered an advantage.
Slovenian: Dejstvo, da je zdravilo Vosevi bolnikom, ki nimajo ciroze jeter, mogoče dajati 8 tednov (namesto običajnih 12), velja za prednost.
English: The most common side effects with Vosevi (which may affect more than 1 in 10 people) are headache, nausea (feeling sick) and diarrhoea.
Slovenian: Najpogostejši neželeni učinki zdravila Vosevi (ki se lahko pojavijo pri več kot 1 bolniku od 10) so glavobol, navzea (slabost) in driska.