FrancophonIA/ELRC3.0 huggingface dataset:
English: The Liprolog range is comprised of fast-acting insulin solutions (Liprolog), longer-acting insulin suspensions (Liprolog Basal), and combinations of both in various proportions (Liprolog Mix):
Croatian: Raspon proizvoda lijeka Liprolog sastoji se od brzo djelujućih otopina inzulina (Liprolog), dugodjelujućih suspenzija inzulina (Liprolog Basal) i kombinacija oboje u različitim omjerima (Liprolog Mix):
English: The Committee recommended that Liprolog be given marketing authorisation.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Liprolog.
English: Liprolog may cause hypoglycaemia (low blood glucose levels) and must not be given to patients whose blood glucose is already low.
Croatian: Liprolog može uzrokovati hipoglikemiju (niske razine glukoze u krvi) te se ne smije primjenjivati u bolesnika čije su razine glukoze u krvi već niske.
English: Liprolog is used to treat patients who have diabetes and need insulin to keep their blood glucose (sugar) level controlled, including patients whose diabetes has just been diagnosed.
Croatian: Liprolog se koristi za liječenje bolesnika sa šećernom bolešću kojima je za održavanje normalne homeostaze glukoze (šećera) potreban inzulin, uključujući i bolesnike kojima je tek dijagnosticirana šećerna bolest.
English: Liprolog contains the active substance insulin lispro.
Croatian: Liprolog sadrži djelatnu tvar inzulin lispro.
English: What is Liprolog used for?
Croatian: Za što se Liprolog koristi?
English: How has Liprolog been studied?
Croatian: Kako je Liprolog ispitivan?
English: What benefit has Liprolog shown during the studies?
Croatian: Koje su koristi lijeka Liprolog utvrđene u ispitivanjima?
English: Liprolog, Liprolog Basal and Liprolog Mix may be given by injection under the skin of the upper arm, thigh, buttock or abdomen (tummy).
Croatian: Mix mogu se primjeniti supkutanom injekcijom u nadlakticu, bedro, stražnjicu ili abdomen (trbuh).
English: How does Liprolog work?
Croatian: Kako djeluje Liprolog?
English: For the full list of all side effects and restrictions with Liprolog, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Liprolog potražite u uputi o lijeku.
English: Liprolog and Humulin R had a similar effect on the control of diabetes, as measured by HbA1c and fasting glucose levels.
Croatian: Na temelju mjerenja HbA1c i razina glukoze u krvi utvrđeno je da su Liprolog i Humulin R imali su slično djelovanje na kontrolu šećerne bolesti.
English: How is Liprolog used?
Croatian: Kako se Liprolog koristi?
English: It can also be used on its own in:
Croatian: Također se može primjenjivati kao monoterapija u:
English: Further information on Venclyxto can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Venclyxto.
Croatian: Više informacija o lijeku Venclyxto nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/Venclyxto.
English: Regarding safety, the medicine's side effects are considered acceptable.
Croatian: U pogledu sigurnosti, nuspojave lijeka smatraju se prihvatljivima.
English: This was converted into a full marketing authorisation on 20 November 2018.
Croatian: Taj je status lijeka promijenjen u potpuno odobrenje za stavljanje u promet dana 20. studenoga 2018.
English: The starting dose is 20 mg daily and the dose is gradually increased over 5 weeks to 400 mg.
Croatian: Početna doza jest 20 mg dnevno koja se postupno povećava tijekom 5 tjedana na 400 mg.
English: Venclyxto is available as tablets (10, 50 and 100 mg) to be taken by mouth once a day with a meal.
Croatian: Venclyxto je dostupan u obliku tableta (10, 50 i 100 mg) koje se uzimaju jednom dnevno uz obrok.
English: By attaching to Bcl-2 and blocking its actions, venetoclax causes the death of cancer cells and thereby slows down the progression of the disease.
Croatian: Vezivanjem za Bcl-2 i blokiranjem njegova djelovanja venetoklaks uzrokuje odumiranje stanica raka i tako usporava napredovanje bolesti.
English: Although there is a risk of tumour lysis syndrome, a complication that occurs when the cancer cells are being destroyed too quickly, this risk can be contained through preventive measures, such as increasing the dose gradually or reducing the dose, if needed.
Croatian: Iako postoji rizik od sindroma lize tumora, komplikacije zbog prebrze razgradnje stanica raka, taj se rizik može ograničiti preventivnim mjerama kao što je postupno povećavanje ili smanjivanje doze kad je to potrebno.
English: Venclyxto (venetoclax)
Croatian: Venclyxto (venetoklaks)
English: Venclyxto received a conditional marketing authorisation valid throughout the EU on 5 December 2016.
Croatian: Lijek Venclyxto dobio je uvjetno odobrenje za stavljanje u promet koje je na snazi na prostoru EU-a od 5. prosinca 2016.
English: A high response rate was also seen in patients whose previous treatment with ibrutinib or idelalisib failed.
Croatian: Visoki postotak reakcije zabilježen je i u bolesnika u kojih je prethodno liječenje ibrutinibom ili idelalisibom bilo neuspješno.
English: What measures are being taken to ensure the safe and effective use of Venclyxto?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Venclyxto?
English: When Venclyxto is used in combination with rituximab, the recommended dose of Venclyxto is 400 mg once a day.
Croatian: Kad se Venclyxto uzima u kombinaciji s rituksimabom, preporučena doza lijeka Venclyxto je 400 mg jednom dnevno.
English: Side effects reported with Venclyxto are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Venclyxto pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Venclyxto have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Venclyxto nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: If the patient experiences certain side effects, treatment may be stopped temporarily or the dose reduced.
Croatian: Ako se u bolesnika razviju određene nuspojave, terapiju će možda trebati privremeno prekinuti ili smanjiti dozu.
English: Venclyxto can be used in combination with rituximab (another cancer medicine) in patients who have received at least one previous treatment.
Croatian: Venclyxto se može primjenjivati u kombinaciji s rituksimabom (drugim lijekom protiv raka) u bolesnika koji su prethodno barem jednom primili terapiju.
English: This protein is present in high amounts in CLL cancer cells, where it helps the cells survive for longer in the body and makes them resistant to cancer medicines.
Croatian: Ta je bjelančevina prisutna u velikim količinama u stanicama raka KLL i pomaže da te stanice dulje prežive u organizmu te jača njihovu otpornost na lijekove protiv raka.
English: Venclyxto is a cancer medicine used to treat adults with a blood cancer known as chronic lymphocytic leukaemia (CLL).
Croatian: Venclyxto je lijek protiv raka krvi za liječenje odraslih s vrstom raka krvi naziva kronična limfocitna leukemija (KLL).
English: In another study of 127 patients with or without 17p deletion or TP53 mutation, the response rate was 70%.
Croatian: U drugom ispitivanju na 127 bolesnika s delecijom 17p ili bez nje, odnosno s mutacijom TP53, stopa odgovora bila je 70 %.
English: Venclyxto should be taken for 24 months from day 1 of the first cycle of rituximab.
Croatian: Venclyxto se mora uzimati tijekom 24 mjeseca od prvog dana prvog ciklusa terapije rituksimabom.
English: The European Medicines Agency decided that Venclyxto's benefits outweigh its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Venclyxto nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: A high proportion of patients respond to Venclyxto after other treatments have failed or are unsuitable.
Croatian: Veliki udio bolesnika reagirao je na lijek Venclyxto nakon što druge terapije nisu bile uspješne ili prikladne.
English: As for all medicines, data on the use of Venclyxto are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Venclyxto kontinuirano se prate.
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).
Croatian: Još jedno ispitivanje na 389 bolesnika s KLL-om koji su primili barem jednu prethodnu terapiju pokazalo je da su bolesnici na terapiji lijekom Venclyxto zajedno s rituksimabom živjeli duže bez pogoršanja bolesti (preživljenje bez pogoršanja bolesti) od bolesnika liječenih kombinacijom rituksimaba i bendamustina (drugih lijekova protiv raka).
English: Patients in this second study had all previously taken B-cell receptor pathway inhibitors.
Croatian: Bolesnici koji su sudjelovali u tom drugom ispitivanju prethodno su uzimali inhibitore signalnih puteva B-staničnih receptora.
English: • patients who do not have these genetic changes after treatments with chemo-immunotherapy and a B-cell receptor pathway inhibitor have both failed.
Croatian: • bolesnika koji nemaju te genetske promjene, nakon što liječenje i kemoimunoterapijom i inhibitorima signalnih puteva B-staničnih receptora nije bilo uspješno.
English: In a main study of 107 previously treated patients with CLL and 17p deletion, 75% responded partially or completely to Venclyxto.
Croatian: U glavnom ispitivanju na 107 prethodno liječenih bolesnika s KLL-om i delecijom 17p, 75 % tih bolesnika djelomično je ili potpuno reagiralo na terapiju lijekom Venclyxto.
English: What is Venclyxto and what is it used for?
Croatian: Što je Venclyxto i za što se primjenjuje?
English: Why is Venclyxto authorised in the EU?
Croatian: Zašto je lijek Venclyxto odobren u EU-u?
English: Venclyxto should be started and supervised by a doctor with experience of cancer medicines and can only be obtained with a prescription.
Croatian: Terapiju lijekom Venclyxto treba započeti i nadzirati liječnik iskusan u primjeni lijekova protiv raka, a lijek se izdaje samo na liječnički recept.
English: When used in combination with rituximab, Venclyxto was shown to prolong the time patients lived without their disease getting worse.
Croatian: Kod primjene zajedno s rituksimabom, pokazalo se da Venclyxto produžuje vrijeme koje su bolesnici proveli bez pogoršanja bolesti.
English: • patients with particular genetic changes (17p deletion or TP53 mutation) that make them unsuitable for chemo-immunotherapy (a type of cancer treatment).
Croatian: • bolesnika s posebnim genetskim promjenama (delecija 17p ili mutacija TP53) zbog kojih ne mogu primiti kemoimunoterapiju (vrstu terapije protiv raka).
English: For more information about using Venclyxto, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Venclyxto pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Patients should have taken Venclyxto at the daily dose of 400 mg for 7 days before starting therapy with rituximab.
Croatian: Bolesnici moraju uzimati dnevne doze lijeka Venclyxto od 400 mg tijekom 7 dana prije početka terapije rituksimabom.
English: An overview of Venclyxto and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Venclyxto i zašto je odobren u EU-u
English: Other information about Venclyxto
Croatian: Ostale informacije o lijeku Venclyxto
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).
Croatian: Venclyxto se ne smije primjenjivati s lijekovima poznatima kao „snažni inhibitori CYP3A” u ranim fazama liječenja ni s gospinom travom (biljnim pripravkom za liječenje tjeskobe i depresije).
English: In these patients, Venclyxto is used when medicines known as B-cell receptor pathway inhibitors (ibrutinib and idelalisib) are not suitable or have failed.
Croatian: U tih se bolesnika Venclyxto primjenjuje kad lijekovi poznati kao inhibitori signalnih puteva B-staničnih receptora nisu prikladni ili su se pokazali neuspješnima.
English: When Venclyxto is used on its own, treatment should continue for as long as the patient improves or remains stable and the side effects are tolerable.
Croatian: Kad se Venclyxto primjenjuje kao monoterapija, terapiju treba nastaviti sve dok se stanje bolesnika ne poboljša ili ostaje stabilno, a nuspojave se može kontrolirati.
English: What are the risks associated with Venclyxto?
Croatian: Koji su rizici povezani s lijekom Venclyxto?
English: The active substance in Venclyxto, venetoclax, attaches to a protein called Bcl-2.
Croatian: Djelatna tvar u lijeku Venclyxto, venetoklaks, vezuje se za bjelančevinu Bcl-2.
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.
Croatian: Najčešće nuspojave lijeka Venclyxto kad ga se primjenjuje kao monoterapiju (koje se mogu javiti u više od 1 na 5 osoba) jesu niske razine neutrofila (vrste bijelih krvnih stanica), proljev, mučnina, anemija (niske razine crvenih krvnih stanica), infekcija nosa i grla te umor.
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.
Croatian: Ispitivanja su pokazala da su bolesnici s posebnim genetskim mutacijama (delecija 17p ili mutacija TP53) za koje kemoinunoterapija nije bila prikladna dobro reagirali na lijek Venclyxto kao monoterapiju.
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.
Croatian: Ispitivanja su pokazala da su stanice raka djelomično ili potpuno spontano nestale kod velikog broja bolesnika nakon monoterapije lijekom Venclyxto.
English: The most common side effects when Venclyxto is used with rituximab are low level of neutrophils, diarrhoea and nose and throat infection.
Croatian: Najčešće nuspojave kad se Venclyxto primjenjuje zajedno s rituksimabom su niske razine neutrofila, proljev te infekcije nosa i grla.
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).
Croatian: Najčešće ozbiljne nuspojave lijeka Venclyxto u kombinaciji s rituksimabom ili kao monoterapija (koje se mogu javiti u više od 2 na 100 osoba) jesu upala pluća (infekcija pluća), vrućica povezana sa smanjenim brojem neutrofila i sindrom lize tumora (smrtonosna komplikacija zbog razgradnje stanica raka).
English: How does Venclyxto work?
Croatian: Kako djeluje Venclyxto ?
English: What benefits of Venclyxto have been shown in studies?
Croatian: Koje su koristi od lijeka Venclyxto utvrđene u ispitivanjima?
English: Venclyxto contains that active substance venetoclax.
Croatian: Lijek Venclyxto sadrži djelatnu tvar venetoklaks.
English: How is Venclyxto used?
Croatian: Kako se Venclyxto primjenjuje?
English: For the full list of side effects with Venclyxto, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Venclyxto potražite u uputi o lijeku.
English: However, precautionary measures must be followed in order to avoid direct or indirect contact between vaccinated chickens and turkeys.
Croatian: No potrebno je pridržavati se mjera opreza kako bi se izbjegao izravan ili neizravan kontakt cijepljenih pilića i purana.
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.
Croatian: Ako životinje u budućnosti budu izložene sličnom virusu i/ili virusu koji oslobađa slični fuzijski protein, imunosni sustav moći će brže odgovoriti.
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.
Croatian: Cjeloviti EPAR za VMP Vectormune ND nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The vaccine protects against a type of Marek disease virus that can cause visible infection.
Croatian: Cjepivo štiti protiv vrste virusa Marekove bolesti koji može prouzročiti vidljivu infekciju.
English: The European Commission granted a marketing authorisation valid throughout the EU for Vectormune ND on 8 September 2015.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za VMP Vectormune ND na snazi u Europskoj uniji od 8. rujna 2015.
English: Newcastle disease and Marek's disease vaccine (live recombinant)
Croatian: Cjepivo protiv newcastleske bolesti i Marekove bolesti (živo rekombinirano)
English: Safety studies have shown that the strain is safe for turkeys.
Croatian: Ispitivanja sigurne primjene pokazala su da je soj siguran u purana.
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.
Croatian: Razdoblje karencije za meso i jaja pilića liječenih VMP-om Vectormune ND iznosi „nula” dana, drugim riječima, nema obaveznog razdoblja čekanja.
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).
Croatian: Cjepivo se može dati pilićima starima jedan dan kao jednokratna injekcija pod kožu ili izravno u jaja stara 18 dana koja sadržavaju zametke (neizvaljene piliće u razvoju).
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.
Croatian: Budući da se cjepivo drži u tekućem dušiku, važno je da njime uvijek rukuje odgovarajuće osposobljeno osoblje u dobro prozračenom prostoru te da se prilikom pripreme cjepiva provode mjere opreza.
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.
Croatian: Newcastleska bolest virusna je infekcija pilića koja uzrokuje dahtanje i kašalj, znakove nervoze (padanje krila, zaokretanje glave i vrata, kruženje i paralizu), oticanje tkiva oko očiju i vrata, zelenkasti vodenasti proljev i smanjenu nesivost.
English: When Vectormune ND is given to chickens or eggs, the animals' immune system recognises the virus as ‘foreign' and makes antibodies against it.
Croatian: Kada se Vectormune ND da pilićima, imunosni sustav životinje prepoznaje virus kao „strano tijelo” i protiv njega proizvodi antitijela.
English: Since Vectormune ND is a live vaccine, the vaccine strain is excreted from vaccinated birds and may spread to turkeys.
Croatian: Budući da je Vectormune ND živo cjepivo, soj cjepiva dobiva se iz cijepljenih ptica i može se proširiti na purane.
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.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji odlučio je da koristi od VMP-a Vectormune ND nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: What is Vectormune ND and what is it used for?
Croatian: Što je Vectormune ND i za što se koristi?
English: Birds infected with MD virus can be carriers and shedders of the virus for life.
Croatian: Ptice zaražene virusom Marekove bolesti mogu biti prijenosnici i nositelji virusa cijeli život.
English: Other information about Vectormune ND
Croatian: Ostale informacije o VMP-u Vectormune ND
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.
Croatian: Pilići dobivaju infekciju u ranoj dobi udisanjem peruti (ljuskica kože) koja sadržava virus i može biti zarazna i nekoliko mjeseci nakon što se oljušti s kože.
English: Why is Vectormune ND approved?
Croatian: Zašto je Vectormune ND odobren?
English: What are the risks associated with Vectormune ND?
Croatian: Koji su rizici povezani s VMP-om Vectormune ND?
English: This is a summary of the European public assessment report (EPAR) for Vectormune ND.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) veterinarsko-medicinskog proizvoda Vectormune ND.
English: It is not intended to provide practical advice on how to use Vectormune ND.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni VMP-a Vectormune ND.
English: For MD protection starts at one week of age and lasts for the risk period of infection with MD.
Croatian: U slučaju Marekove bolesti zaštita počinje u dobi od tjedan dana i traje tijekom razdoblja rizika od infekcije virusom Marekove bolesti.
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).
Croatian: Djelatna je tvar VMP-a Vectormune ND herpesvirus purana (rHVT/ND) koji ne uzrokuje bolest u pilića i modificiran je tako da može proizvesti i jedan od proteina iz soja virusa newcastleske bolesti (lentogeni soj virusa D-26).
English: Vectormune ND is a veterinary vaccine used to protect chickens against Newcastle disease (ND) and Marek's disease (MD).
Croatian: Vectormune ND veterinarsko je cjepivo koje se koristi za zaštitu pilića protiv newcastleske bolesti i Marekove bolesti.
English: For further information see the summary of product characteristics.
Croatian: Dodatne informacije potražite u sažetku opisa svojstava.
English: Since no natural outbreaks of ND and MD occurred the chickens were challenged (exposed to infection) in the laboratory.
Croatian: Budući da nije bilo prirodnog izbijanja newcastleske i Marekove bolesti, pilići su izloženi infekciji u laboratoriju.
English: MD is a herpesvirus infection of chickens which can cause paralysis of the wings and legs and causes tumours in various organs.
Croatian: Marekova bolest herpesvirusna je infekcija pilića koja može uzrokovati paralizu krila i nogu te uzrokuje tumore raznih organa.
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.
Croatian: Modificirani herpesvirus purana u VMP-u Vectormune ND blisko je srodan herpesvirusu Marekove bolesti te će također proizvesti fuzijski protein koji čini dio vanjske ovojnice virusa newcastleske bolesti.
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).
Croatian: U slučaju newcastleske bolesti zaštita počinje u dobi od 3 tjedna i traje do dobi od 9 tjedana u brojlera (tovnih pilića) i 18 tjedana u nesilica (kokoši uzgajanih za proizvodnju jaja).