FrancophonIA/ELRC3.0 huggingface dataset:
English: Another study in 389 patients with CLL who received at least one previous treatment showed that patients treated with Venclyxto plus rituximab lived longer without their disease getting worse (progression-free survival) than patients treated with rituximab and bendamustine (another cancer medicine).
Slovenian: Druga študija s 389 vsaj enkrat predhodno zdravljenimi bolniki s KLL je pokazala, da je bilo ob zdravljenju z zdravilom Venclixto in rituksimabom obdobje brez bolezni ali brez njenega poslabšanja (podaljševanje časa preživetja brez napredovanja bolezni) daljše kot pri bolnikih, ki so se zdravili s rituksimabom in bendamustinom (drugo zdravilo proti raku).
English: Venclyxto must not be used with medicines known as ‘strong CYP3A inhibitors' during the early stages of treatment and must also not be used with St. John's wort (a herbal preparation used to treat anxiety and depression).
Slovenian: Zdravilo Venclyxto se v zgodnjih fazah zdravljenja ne sme uporabljati skupaj z zdravili, znanimi kot močni zaviralci CYP3A, in se prav tako ne sme uporabljati sočasno s šentjanževko (pripravkom rastlinskega izvora za zdravljenje anksioznosti in depresije).
English: The active substance in Venclyxto, venetoclax, attaches to a protein called Bcl-2.
Slovenian: Učinkovina v zdravilu Venclyxto, venetoklaks, se veže na beljakovino Bcl-2.
English: What are the risks associated with Venclyxto?
Slovenian: Kakšna tveganja so povezana z zdravilom Venclyxto?
English: What benefits of Venclyxto have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Venclyxto izkazalo v študijah?
English: Venclyxto is a cancer medicine used to treat adults with a blood cancer known as chronic lymphocytic leukaemia (CLL).
Slovenian: Venclyxto je zdravilo za zdravljenje krvnega raka, znanega kot kronična limfocitna levkemija (KLL), pri odraslih bolnikih.
English: Studies have shown that a high proportion of patients have their cancer cells partially or completely cleared following treatment with Venclyxto on its own.
Slovenian: Študije so pokazale, da so rakave celice pri velikem deležu bolnikov po zdravljenju samo z zdravilom Venclyxto delno ali popolnoma izginile.
English: When used in combination with rituximab, Venclyxto was shown to prolong the time patients lived without their disease getting worse.
Slovenian: Zdravilo Venclixto v kombinaciji z rituksimabom je dokazano podaljšalo čas preživetja bolnikov brez napredovanja bolezni.
English: Other information about Venclyxto
Slovenian: Druge informacije o zdravilu Venclyxto:
English: The most common side effects with Venclyxto used on its own (seen in more than 1 in 5 people) are low levels of neutrophils (a type of white blood cell), diarrhoea, nausea, anaemia (low red blood cell counts), nose and throat infection and tiredness.
Slovenian: Najpogostejši neželeni učinki zdravila Venclyxto (ki so se pojavili pri več kot 1 bolniku od 5) so zmanjšano število nevtrofilcev (vrste belih krvnih celic), driska, navzea, anemija (nizke ravni rdečih krvnih celic), okužba nosu in grla ter utrujenost.
English: The most common serious side effects (seen in more than 2 in 100 people) in patients receiving Venclyxto in combination with rituximab or on its own are pneumonia (lung infection), fever associated with reduced neutrophils and tumour lysis syndrome (a complication caused by breakdown of cancer cells).
Slovenian: Najpogostejši resni neželeni učinki (ki so se pojavili pri več kot 2 bolnikih od 100) pri bolnikih, ki so se zdravili z zdravilom Venclyxto v kombinaciji z rituksimabom, so pljučnica (okužba pljuč), povišana telesna temperatura, povezana z znižanimi vrednostmi nevtrofilcev, in sindrom tumorske lize (zaplet, ki ga povzroča razgradnja rakavih celic).
English: Studies showed patients with particular genetic mutations (17p deletion or TP53 mutations) that make them unsuitable for chemo-immunotherapy responding well to Venclyxto used on its own.
Slovenian: Študije kažejo, da se bolniki z določenimi genskimi mutacijami (delecijo 17p ali mutacijami TP53), zaradi katerih so neprimerni za kemoimunoterapijo, na zdravljenje dobro odzovejo.
English: The most common side effects when Venclyxto is used with rituximab are low level of neutrophils, diarrhoea and nose and throat infection.
Slovenian: Najpogostejši neželeni učinki zdravila Venclyxto v kombinaciji s rituksimabom so zmanjšano število nevtrofilcev, driska ter okužba nosu in grla.
English: For the full list of side effects with Venclyxto, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Venclyxto, glejte navodilo za uporabo.
English: Venclyxto contains that active substance venetoclax.
Slovenian: Zdravilo Venclyxto vsebuje zdravilno učinkovino venetoklaks.
English: How is Venclyxto used?
Slovenian: Kako se zdravilo Venclyxto uporablja?
English: Patients should have taken Venclyxto at the daily dose of 400 mg for 7 days before starting therapy with rituximab.
Slovenian: Kadar se zdravilo Venclyxto uporablja v kombinaciji z rituksimabom, je priporočen odmerek tega zdravila 400 mg enkrat na dan. Bolniki naj bi sedem dni jemali 400-miligramski dnevni odmerek zdravilaVenclyxto, preden začnejo zdravljenje z rituksimabom.
English: How does Venclyxto work?
Slovenian: Kako zdravilo Venclyxto deluje?
English: Safety studies have shown that the strain is safe for turkeys.
Slovenian: Študije varnosti so pokazale, da je sev varen za purane.
English: For further information see the summary of product characteristics.
Slovenian: Za več informacij glejte povzetek glavnih značilnosti zdravila.
English: However, precautionary measures must be followed in order to avoid direct or indirect contact between vaccinated chickens and turkeys.
Slovenian: Kljub temu je treba upoštevati previdnostne ukrepe, da se prepreči neposreden ali posreden stik med cepljenimi piščanci in purani.
English: The full EPAR for Vectormune ND 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 Vectormune ND je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: In the future if the animals are exposed to a similar virus and/or to a virus expressing a similar fusion protein, the immune system will be able to respond more quickly.
Slovenian: Če so živali pozneje izpostavljene podobnemu virusu in/ali virusu, ki izraža podoben fuzijski protein, se lahko imunski sistem nanj hitreje odzove.
English: This is a summary of the European public assessment report (EPAR) for Vectormune ND.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Vectormune ND.
English: The European Commission granted a marketing authorisation valid throughout the EU for Vectormune ND on 8 September 2015.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Vectormune ND, veljavno po vsej Evropski uniji, izdala 8. septembra 2015.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Vectormune ND'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 Vectormune ND večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: The vaccine protects against a type of Marek disease virus that can cause visible infection.
Slovenian: Cepivo ščiti pred tisto vrsto virusa Marekove bolezni, ki lahko povzroči vidno okužbo.
English: As the vaccine is stored in liquid nitrogen, it is important that any handling is done by appropriately trained personnel in a well-ventilated area and that precautions are taken when preparing the vaccine.
Slovenian: Cepivo se shranjuje v tekočem dušiku, zato je pomembno, da z njim rokuje usposobljeno osebje v dobro prezračevanem prostoru in da se pri pripravi cepiva upoštevajo previdnostni ukrepi.
English: ND is a viral infection of chickens which causes gasping and coughing, nervous signs (drooping wings, twisting of the head and neck, circling and paralysis), swelling of the tissues around the eyes and neck, greenish watery diarrhoea and reduced egg production.
Slovenian: Atipična kokošja kuga je virusna okužba pri piščancih, ki povzroča sopenje in kašelj, znake obolenja živcev (povešena krila, obračanje glave in vratu, kroženje in paralizo), otekanje tkiv okoli oči ter vratu, zelenkasto vodeno drisko in zmanjšano nesnost.
English: Two field studies were conducted in around 120,000 broiler chickens to evaluate the effects of the vaccine.
Slovenian: Za ocenjevanje učinkov cepiva so izvedli dve terenski študiji pri približno 120 000 pitovnih piščancih.
English: Chickens become infected at an early age via inhalation of dander (flakes of skin) containing the virus which can remain infectious for several months after being shed from the body.
Slovenian: Piščanci se okužijo v zgodnjem življenjskem obdobju z vdihavanjem prhljaja (delčkov odpadle kože), ki vsebuje virus, ki je lahko kužen še več mesecev po tem, ko odpade s telesa.
English: The withdrawal period for meat and eggs from chickens treated with Vectormune ND is ‘zero' days, which means that there is no mandatory waiting time.
Slovenian: Karenca za meso in jajca piščancev, zdravljenih z zdravilom Vectormune ND, je nič dni, kar pomeni, da ni obvezne čakalne dobe.
English: The vaccine can be given to one-day-old chicks as a single injection under the skin or directly into 18-day-old eggs containing embryos (unhatched developing chicks).
Slovenian: Cepivo se lahko uporablja pri en dan starih piščancih v obliki enkratnega injiciranja pod kožo ali neposrednega injiciranja v 18 dni stara jajca, ki vsebujejo zarodke (še ne izvaljene piščance v razvoju).
English: Other information about Vectormune ND
Slovenian: Druge informacije o zdravilu Vectormune ND
English: Vectormune ND is available as a suspension and solvent to be made into a suspension for injection and can only be obtained with a prescription.
Slovenian: Zdravilo Vectormune ND je na voljo v obliki suspenzije in vehikla za pripravo suspenzije za injiciranje, njegovo predpisovanje in izdaja pa je le na recept.
English: When Vectormune ND is given to chickens or eggs, the animals' immune system recognises the virus as ‘foreign' and makes antibodies against it.
Slovenian: Ko piščance ali jajca cepimo s cepivom Vectormune ND, imunski sistem živali prepozna virus kot „tujek“ in začne proti njemu tvoriti protitelesa.
English: What are the risks associated with Vectormune ND?
Slovenian: Kakšna tveganja so povezana z zdravilom Vectormune ND?
English: What is Vectormune ND and what is it used for?
Slovenian: Kaj je zdravilo Vectormune ND in za kaj se uporablja?
English: Since no natural outbreaks of ND and MD occurred the chickens were challenged (exposed to infection) in the laboratory.
Slovenian: Ker ni bilo nobenega naravnega izbruha atipične kokošje kuge in Marekove bolezni, so piščance okužbi izpostavili v laboratoriju.
English: What benefits of Vectormune ND have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Vectormune ND izkazalo v študijah?
English: For MD protection starts at one week of age and lasts for the risk period of infection with MD.
Slovenian: Zaščita proti Marekovi bolezni se razvije pri enem tednu starosti in traja celotno obdobje tveganja za okužbo z Marekovo boleznijo.
English: Since Vectormune ND is a live vaccine, the vaccine strain is excreted from vaccinated birds and may spread to turkeys.
Slovenian: Cepivo Vectormune ND je živo cepivo, zato se sev cepiva izloča iz cepljenih ptic in se lahko razširi na purane.
English: Why is Vectormune ND approved?
Slovenian: Zakaj je bilo zdravilo Vectormune ND odobreno?
English: Vectormune ND is a veterinary vaccine used to protect chickens against Newcastle disease (ND) and Marek's disease (MD).
Slovenian: Vectormune ND je cepivo za uporabo v veterinarski medicini, ki se uporablja za zaščito piščancev pred atipično kokošjo kugo (boleznijo Newcastle) in Marekovo boleznijo.
English: The active substance in Vectormune ND is a turkey herpesvirus (rHVT/ND) that does not cause disease in chickens and has been modified so that it also produces one of the proteins of a strain of Newcastle disease virus (D-26 lentogenic strain).
Slovenian: Zdravilna učinkovina v zdravilu Vectormune ND je puranji virus herpesa (rHVT/ND), ki ne povzroča bolezni pri piščancih in ki je bil spremenjen tako, da proizvaja tudi eno od beljakovin seva virusa bolezni Newcastle D 26 (lentogeni sev D-26).
English: MD is a herpesvirus infection of chickens which can cause paralysis of the wings and legs and causes tumours in various organs.
Slovenian: Marekova bolezen je okužba z virusom herpesa pri piščancih, ki lahko povzroči paralizo kril in nog ter nastanek tumorjev v različnih organih.
English: It is not intended to provide practical advice on how to use Vectormune ND.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Birds infected with MD virus can be carriers and shedders of the virus for life.
Slovenian: Ptice, okužene z virusom Marekove bolezni, so lahko prenašalke in raznašalke virusa celo življenje.
English: For ND protection starts at 3 weeks of age and lasts until 9 weeks of age for broilers (chickens bred for meat) and 18 weeks of age for layers (chickens bred for egg production).
Slovenian: Zaščita proti atipični kokošji kugi se pri pitovnih piščancih (piščancih za vzrejo mesa) razvije pri starosti treh tednov in traja do devetih tednov starosti, pri nesnicah (piščancih za proizvodnjo jajc) pa traja do 18. tedna starosti.
English: Newcastle disease and Marek's disease vaccine (live recombinant)
Slovenian: cepivo proti atipični kokošji kugi in Marekovi bolezni (živo, rekombinantno)
English: For practical information about using Vectormune ND, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Vectormune ND naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
English: For more information about treatment with Vectormune ND, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Vectormune ND naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
English: The modified turkey herpesvirus in Vectormune ND is closely related to MD herpesvirus and will also produce the fusion protein which forms part of the outer coat of ND virus.
Slovenian: Spremenjeni puranji virus herpesa v cepivu Vectormune ND je zelo soroden virusu herpesa Marekove bolezni in bo ustvaril fuzijski protein, ki tvori del zunanje ovojnice virusa atipične kokošje kuge.
English: Twenty-two Vectormune ND vaccinated day-old layer chickens from this study were challenged at day 21 in the laboratory with ND strain and had no clinical signs for up to 2 weeks after challenge while all of 12 unvaccinated birds used for comparison died.
Slovenian: Na 21. dan študije so v laboratoriju sevu atipične kokošje kuge izpostavili 22 en dan starih nesnic, ki so bile v okviru študije cepljene s cepivom Vectormune ND, pri čemer se pri njih klinični znaki niso pokazali še najmanj dva tedna po izpostavitvi virusu, medtem ko je vseh 12 necepljenih ptic, ki so jih uporabili kot primerjalno skupino, umrlo.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Vectormune ND, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Slovenian: V povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in lastniki ali skrbniki živali.
English: This will help protect the chickens against ND and MD.
Slovenian: To pomaga zaščititi piščance pred atipično kokošjo kugo in Marekovo boleznijo.
English: How does Vectormune ND work?
Slovenian: Kako zdravilo Vectormune ND deluje?
English: In a third field study around 10,000 one-day-old layer chickens were vaccinated with Vectormune ND and a similar number with a vaccine against ND alone.
Slovenian: V tretji terenski študiji je bilo s cepivom Vectormune ND cepljenih približno 10 000 en dan starih nesnic, podobno število pa je bilo cepljenih s cepivom samo proti atipični kokošji kugi.
English: How is Vectormune ND used?
Slovenian: Kako se zdravilo Vectormune ND uporablja?
English: No signs of MDV or NDV outbreaks were detected from samples taken from both groups at days 35, 66, 102 and completion at day 118.
Slovenian: Pri vzorcih, ki so jih iz obeh skupin odvzeli na 35., 66., 102. in zadnji, 118. dan študije, niso našli nobenih znakov izbruha atipične kokošje kuge ali Marekove bolezni.
English: For the full list of restrictions, see the package leaflet.
Slovenian: Znanih neželenih učinkov cepiva Vectormune ND ni. Za celoten seznam omejitev glejte navodilo za uporabo.
English: Four-week-old chickens from vaccinated eggs were challenged with ND virus and 86% of the chickens were protected compared with 0-10% in the unvaccinated group.
Slovenian: Štiri tedne stare piščance iz cepljenih jajc so v laboratoriju izpostavili virusu atipične kokošje kuge in ugotovili, da je bilo zaščitenih 86 % cepljenih piščancev, v necepljeni skupini pa 0-10 %.
English: In the second field study, a group of 18-day-old eggs containing embryos and a group of one-day-old chicks were vaccinated with Vectormune ND.
Slovenian: V drugi terenski študiji so s cepivom Vectormune ND cepili skupino 18 dni starih jajc z zarodki in skupino en dan starih piščancev.
English: Five-week-old chickens from the vaccinated eggs were challenged with ND virus and 91% of vaccinated chickens were protected compared with no protection in the unvaccinated group.
Slovenian: Pet tednov stare piščance iz cepljenih jajc so v laboratoriju izpostavili virusu atipične kokošje kuge in ugotovili, da je bilo 91 % cepljenih piščancev zaščitenih, medtem ko v necepljeni skupini zaščite ni bilo.
English: In the first field study a group of 18-day-old eggs containing embryos and a group of one-day-old chicks were vaccinated with Vectormune ND.
Slovenian: V prvi terenski študiji so s cepivom Vectormune ND cepili skupino 18 dni starih jajc z zarodki in skupino en dan starih piščancev.
English: Four-week-old chickens from the group of one-day-old vaccinated chicks were challenged with ND virus and Vectormune ND provided protection in 95% of the chickens compared with 0-10% in the non-vaccinated group.
Slovenian: Štiri tedne stare piščance iz skupine cepljenih, en dan starih piščancev so v laboratoriju izpostavili virusu atipične kokošje kuge, pri čemer je cepivo Vectormune ND omogočilo 95-odstotno zaščito, medtem ko je bila zaščita v necepljeni skupini od 0- do 10-odstotna.
English: Nineday-old broilers from the group of chicks vaccinated at one-day-old were challenged with MD virus and 82% of the chickens were protected compared with 12% in the unvaccinated group.
Slovenian: Devet dni stare pitovne piščance iz skupine cepljenih, en dan starih piščancev so v laboratoriju izpostavili virusu Marekove bolezni in ugotovili, da je bilo zaščitenih 82 % cepljenih piščancev, v necepljeni skupini pa 12 %.
English: Nine-day-old chickens from vaccinated eggs were challenged with MD virus and 88% of the chickens were protected compared with 9-12% in the unvaccinated group.
Slovenian: Devet dni stare piščance iz cepljenih jajc so v laboratoriju izpostavili virusu Marekove bolezni in ugotovili, da je bilo zaščitenih 88 % cepljenih piščancev, v necepljeni skupini pa 9-12 %.
English: Nine-day-old broilers from vaccinated eggs were challenged with MD virus and 85% of the chickens were protected compared with 9% in the unvaccinated group.
Slovenian: Devet dni stare pitovne piščance iz cepljenih jajc so v laboratoriju izpostavili virusu Marekove bolezni in ugotovili, da je bilo zaščitenih 85 % cepljenih piščancev, v necepljeni skupini pa 9 %.
English: Five-week-old chickens from the vaccinated one-day-old chicks were challenged with ND virus and 81% of vaccinated chickens were protected compared with no protection in the unvaccinated group.
Slovenian: Pet tednov stare piščance iz skupine cepljenih, en dan starih piščancev so v laboratoriju izpostavili virusu atipične kokošje kuge in ugotovili, da je bilo 81 % cepljenih piščancev zaščitenih, medtem ko v necepljeni skupini niso ugotovili zaščite.
English: Nine-dayold broilers from the chicks vaccinated at one-day-old were challenged with MD virus and Vectormune ND provided protection to 90% of the chickens compared with 9-12% in the unvaccinated group.
Slovenian: Devet dni stare pitovne piščance iz skupine cepljenih, en dan starih piščancev so v laboratoriju izpostavili virusu Marekove bolezni, pri čemer je cepivo Vectormune ND omogočilo 90-odstotno zaščito, medtem ko je bila zaščita v necepljeni skupini od 9- do 12-odstotna.
English: Especially tell your doctor:
Slovenian: Še zlasti pa povejte zdravniku:
English: Adopted at the 26-29 November 2018 PRAC
Slovenian: Sprejeto na seji odbora PRAC, ki je potekala od 26. do 29. novembra 2018
English: <Product name> may need to be discontinued.
Slovenian: Zdravilo <ime zdravila> bo morda treba ukiniti.
English: If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor straight away.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, takoj obvestite zdravnika.
English: 1 see section 4.4
Slovenian: 1 Glejte poglavje 4.4
English: Your treatment with <medicinal product> may need to be continued during pregnancy if the potential benefit outweighs the potential risk to you and your unborn baby.
Slovenian: Zdravljenje z zdravilom <ime zdravila> bo morda treba nadaljevati med nosečnostjo, če potencialna korist prevlada nad potencialnim tveganjem za vas in vašega nerojenega otroka.
English: If you could get pregnant, use reliable contraception from the time you start treatment and during treatment.
Slovenian: Če bi lahko zanosili, od začetka zdravljenja in med zdravljenjem uporabljajte zanesljivo kontracepcijo.
English: Fournier´s gangrene has to be treated immediately.
Slovenian: Fournierovo gangreno je treba takoj začeti zdraviti.
English: Re-exposure may result in recurrence of acute pancreatitis, with decreased time to onset.
Slovenian: Ponovna izpostavljenost lahko povzroči ponovitev akutnega pankreatitisa, pri čemer se čas do izbruha skrajša.
English: Thiamazole (synonym: methimazole)
Slovenian: Tiamazol (sinonim: metimazol)
English: Perindopril - Raynaud's phenomenon (EPITT no 19248)
Slovenian: Perindopril - Raynaudov fenomen (EPITT št. 19248)
English: If Fournier's gangrene is suspected, X should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Slovenian: Če obstaja sum na Fournierovo gangreno, je treba zdravilo X ukiniti in uvesti takojšnje zdravljenje (vključno z antibiotiki in kirurško odstranitvijo prizadetega tkiva).
English: What you need to know before you use Victoza In particular, tell your doctor, pharmacist or nurse if you are using medicines containing any of the following active substances:
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Victoza Še zlasti je pomembno, da takoj obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete zdravila, ki vsebujejo katero koli od spodaj navedenih učinkovin:
English: Other medicines and Trulicity
Slovenian: Druga zdravila in zdravilo Trulicity
English: Frequency ‘not known': Raynaud's phenomenon
Slovenian: Pogostnost „neznana“: Raynaudov fenomen