FrancophonIA/ELRC3.0 huggingface dataset:
English: eczema, vasodilatation
Croatian: , vezikulobulozni osip, ekcem, vazodilatacija
English: (n=392
Croatian: (n=392f)
English: Ritonavir 100 mg once daily
Croatian: Elbasvir 50 mg jednom dnevno
English: Atazanavir should be discontinued if severe rash develops.
Croatian: Ako se razvije teški osip, primjenu atazanavira treba prekinuti.
English: This summary was last updated in 11-2014.
Croatian: Ovaj sažetak je posljednji put ažuriran u 11. 2014.
English: The recommended dose is 200 mg taken twice a day (around 12 hours apart).
Croatian: Preporučena doza je 200 mg dva puta na dan (u razmaku od otprilike 12 sati).
English: The full EPAR and risk management plan summary for Vargatef can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Vargatef nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Vargatef is available as capsules (100 and 150 mg) to be taken by mouth, preferably with food.
Croatian: Vargatef je dostupan kao kapsule (100 i 150 mg) koje se uzimaju peroralno, po mogućnosti sa hranom.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vargatef on 21 November 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Vargatef na snazi u Europskoj uniji od 21. studenog 2014.
English: Vargatef must not be used in patients who are hypersensitive (allergic) to nintedanib, peanut or soya, or any of the other ingredients.
Croatian: Vargatef se ne smije koristiti u bolesnika koji su preosjetljivi (alergični) must na nintedanib, kikiriki ili soju ili bilo koje druge sastojke.
English: If severe side effects persist, treatment should be permanently discontinued.
Croatian: Ako se ozbiljne nuspojave nastave, liječenje treba odmah prekinuti.
English: This is a summary of the European public assessment report (EPAR) for Vargatef.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Vargatef.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Vargatef's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučilo je da koristi od lijeka Vargatef nadmašuju s njim povezane rizike te je preporučilo njegovo odobrenje za korištenje u Europskoj uniji.
English: By blocking these enzymes, nintedanib helps to reduce the growth and spread of the cancer and to cut off the blood supply that keeps cancer cells growing.
Croatian: Inhibirajući ove enzime, nintedanib pomaže u smanjivanju rasta i širenju raka, te prekida opskrbu krvlju koja održava rast stanica raka.
English: Other information about Vargatef
Croatian: Ostale informacije o lijeku Vargatef
English: Why is Vargatef approved?
Croatian: Zašto je Vargatef odobren?
English: What measures are being taken to ensure the safe and effective use of Vargatef?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Vargatef?
English: What is Vargatef and what is it used for?
Croatian: Što je Vargatef i za što se koristi?
English: In addition, the company that markets Vargatef will conduct studies to find ways to identify those patients who are most likely to benefit from treatment with the medicine.
Croatian: Nadalje, tvrtka koja stavlja u promet lijek Vargatef provest će ispitivanje kako bi pronašla način za identificiranje onih bolesnika koji su najizgledniji da će imati koristi od liječenja ovim lijekom.
English: These enzymes can be found in certain receptors (such as VEGF, FGF and PDGF receptors) on the surface of cancer cells and on the cells of the surrounding tissue (e.g. blood vessel), where they activate several processes including cell division and the growth of new blood vessels.
Croatian: Ovi se enzimi nalaze u određenim receptorima (poput receptora VEGF, FGF i PDGF) na površini stanica raka i u stanicama koje okružuju tkivo (primjerice krvne žile), pri čemu se aktivira nekoliko postupaka, uključujući diobu stanica i rast krvnih žila.
English: Treatment with Vargatef may continue after stopping docetaxel, for as long as the disease improves or remains stable and the side effects are tolerable.
Croatian: Liječenje lijekom Vargatef može se nastaviti nakon prekida liječenjem docetakselom, tako dugo dok se bolest ne poboljša ili ostane stabilna, a nuspojave su podnošljive.
English: It is not intended to provide practical advice on how to use Vargatef.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Vargatef.
English: The most common side effects with Vargatef (which may affect more than 1 in 10 people) include diarrhoea, vomiting and increased blood levels of certain liver enzymes (a sign of possible liver problems).
Croatian: Najčešće nuspojave lijeka Vargatef (mogu se javiti u više od 1 na 10 osoba) uključuju proljev, povraćanje i poviše vrijednosti određenih jetrenih enzima u krvi (znak mogućih problema s jetrom).
English: If severe side effects develop, the doctor may decide to interrupt treatment with Vargatef and resume it at a lower dose.
Croatian: Ako se razviju ozbiljne nuspojave, liječnik može donijeti odluku o prekidu liječenja lijekom Vargatef te nastaviti sa nižom dozom.
English: The medicine is used in combination with a chemotherapy medicine called docetaxel in patients who have already received previous treatment with chemotherapy.
Croatian: Lijek se koristi u kombinaciji s kemoterapijskim lijekom naziva docetaksel u bolesnika koji su već primili prethodno liječenje kemoterapijom.
English: A risk management plan has been developed to ensure that Vargatef is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Vargatef.
English: Vargatef is used to treat a type of non-small cell lung cancer called ‘adenocarcinoma', when the cancer is locally advanced, metastatic (when cancer cells have spread from the original site to other parts of the body) or locally recurrent (when the cancer has come back in the same area).
Croatian: Vargatef se koristi za liječenje karcinoma pluća ne-malih stanica poznatim pod nazivom „adenokarcinom“, ako je karcinom lokalno uznapredovao, metastazirao (nakon što su se stanice karcinoma proširile s izvornog mjesta u druge dijelove tijela) ili lokalno rekurentan (ako su se stanice karcinom vratile u neke dijelove tijela).
English: The CHMP noted that Vargatef was effective at slowing down disease progression and prolonging life in the subgroup of patients with non-small cell lung cancer of the adenocarcinoma type.
Croatian: CHMP je napomenuo da je Vargatef djelotvoran u usporavanju progresije bolesti i produčjivanju života u podgrupi bolesnika s karcinom pluća ne-malih stanica tipa adenocarcinoma.
English: The active substance in Vargatef, nintedanib, blocks the activity of some enzymes known as tyrosine kinases.
Croatian: Djelatna tvar lijeka Vargatef, nintedanib, inhibira djelovanje pojedinih enzima poznatih pod nazivom tirozin kinaza.
English: Vargatef can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the use of cancer medicines.
Croatian: Vargatef se izdaje samo na liječnički recept, a liječenje mora započeti i nadzirati liječnik s iskustvom u primjeni terapije protiv raka.
English: What are the risks associated with Vargatef?
Croatian: Koji su rizici povezani s lijekom Vargatef?
English: In addition, Vargatef led to an improvement in overall survival (how long patients lived) in the subgroup of patients with non-small cell lung cancer of the adenocarcinoma type: overall survival was 12.6 months in patients treated with Vargatef plus docetaxel, compared with 10.3 months in patients treated with docetaxel alone.
Croatian: Nadalje, Vargatef je uzrokovao poboljšanje u cjelokupnom preživljenju (koliko su dugo bolesnici preživjeli) u podgrupi bolesnika s karcinomom pluća ne-malih stanica tipa adenokarcinoma: ukupno preživljnje je bilo 12,6 mjeseci u bolesnika liječenih lijekom Vargatef i docetakselom u usporedbi s 10,3 mjeseci u bolesnika liječenih monoterapijom docetakselom.
English: In a main study involving 1,314 patients with advanced or recurrent non-small cell lung cancer that did not respond to a previous treatment, Vargatef taken in combination with docetaxel was shown to be more effective than docetaxel alone at delaying progression of the cancer.
Croatian: U glavnom ispitivanju koje je obuhvatilo 1.314 bolesnika s uznapredovalim ili rekuretnim karcinomom pluća ne-malih stanica koji nisu odgovorili na prethodno liječenje, utvrđeno je da je Vargatef primijenjen u kombinaciji s docetakselom bio djelotvorniji od monoterapije docetakselom u odgodi progresije karcinoma.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom cycle, Vargatef is given on days 2 to 21 with docetaxel being given on day 1.
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vargatef, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Vargatef nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Vargatef is a cancer medicine used to treat adults with a type of lung cancer known as non-small cell lung cancer.
Croatian: Vargatef je citostatik koji se koristi za liječenje odraslih osoba s tipom raka pluća poznatim kao karcinom pluća ne-malih stanica.
English: For more information about treatment with Vargatef, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Vargatef pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku
English: Progression-free survival (the time patients lived without their disease getting worse) was 3.5 months in patients receiving Vargatef plus docetaxel, compared with 2.7 months in patients receiving docetaxel alone.
Croatian: Preživljenje bez progresije (vrijeme tijekom kojeg su bolesnici preživjeli bez progresije bolesti) iznosilo je 3,5 mjeseca koji su primali lijek Vargatef zajedno s docetakselom, u usporedbi s 2,7 mjeseca u bolesnika koji su primali samo monoterapiju docetakselom.
English: Regarding its safety, although more side effects were reported in patients treated with Vargatef plus docetaxel than in those treated with docetaxel alone, the side effects were considered manageable with dose reductions, supportive treatments and treatment interruptions.
Croatian: Vezano uz sigurnu primjenu, iako je prijavljeno više nuspojava u bolesnika liječenih lijekom Vargatef plus docetakselom u odnosu na one liječene monoterapijom docetakselom, nuspojave se smatraju upravljivima s smanjenim dozama, podržavaju liječenje i prekide liječenja.
English: Vargatef contains the active substance nintedanib.
Croatian: Vargatef sadrži djelatnu tvar nintedanib.
English: Because Vargatef must not be given on the same day as docetaxel and because docetaxel is given on day 1 of a 21-day treatment
Croatian: Vargatef ne smije primjenjivati na isti dan kao docetaksel i budući da se docetaksel primjenjuje prvog dana 21-dnevnog ciklusa liječenja, Vargatef se primjenjuje 2 do 21 s docetakselom koji s primjenjuje prvog dana.
English: For practical information about using Vargatef, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Vargatef pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: How does Vargatef work?
Croatian: Kako djeluje Vargatef?
English: How is Vargatef used?
Croatian: Kako se Vargatef koristi?
English: What benefits of Vargatef have been shown in studies?
Croatian: Koje su koristi lijeka Vargatef utvrđene u ispitivanjima?
English: For the full list of all side effects and restrictions with Vargatef, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja s lijekom Vargatef, potražite u uputi o lijeku.
English: This summary was last updated in July 2014.
Croatian: Sažetak je posljednji put dopunjen u srpnju 2014.
English: The period of protection is 8 weeks.
Croatian: Razdoblje imunizacije je 8 tjedana.
English: These reactions are very rare (affecting less than 1 bird in 10,000).
Croatian: Ove su reakcije vrlo rijetke (zahvaćaju manje od 1 ptice na 10.000).
English: In the future if the animals are exposed to the virus the immune system will be able to respond more quickly.
Croatian: U buduće ako se životinje izlože virusu, imuni sustav moći će brže reagirati.
English: Hands and equipment should be washed and disinfected after vaccination to avoid spread of the virus.
Croatian: Ruke i oprema trebaju se oprati i dezinficirati nakon cjepiva kako bi se izbjeglo širenje virusa.
English: If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).
Croatian: Ako želite više informacija na temelju preporuka CVMP-a, pročitajte znanstvenu raspravu (također dio EPAR-a).
English: The Committee recommended that a further overdose study should be submitted.
Croatian: Odbor je preporučio dostavljanje daljnjih ispitivanja o predoziranju.
English: The effectiveness of the vaccine was first studied in a number of laboratory studies in chickens.
Croatian: Djelotvornost cjepiva je prvi put ispitana u nizu laboratorijskih ispitivanja u pilića.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Croatian: Cijepiva „uče“ imunosni sustav (prirodnu obranu tijela) kako da se brani od bolesti.
English: After vaccination a mild short lived reaction in the airways, including a nasal discharge, may occur for at least 10 days.
Croatian: Nakon cijepljenja može nastupiti blaga kratkotrajna reakcija u zračnim putovima, uključujući i pražnjenje nosa, u trajanju od najmanje 10 dana.
English: If vaccinating by spray masks with eye protection should be worn when handling the product.
Croatian: Ako se imunizacija provodi sprejanjem, maske sa zaštitom za oči trebaju se nositi prilikom rukovanja proizvodom.
English: The laboratory studies showed that the vaccine had its full effect by three weeks and that protection lasted for eight weeks; protection was not affected by antibodies transmitted from the mother.
Croatian: Laboratorijskim ispitivanjima utvrđeno je da su cjepiva bila potpuno djelotvorna do tri tjedna te da je zaštita trajala do osam tjedana; na zaštitu nisu djelovala protutijela prenesena s majke.
English: The vaccine is to be made up into a suspension for use.
Croatian: Za uporabu cjepivo treba pripremiti kao suspenziju.
English: This will help protect them against infectious bronchitis.
Croatian: Ovo pomaže pri zaštiti životinja od zaraznog bronhitisa.
English: The vaccine is given to chickens from 1 day of age or older by spraying onto the chickens or by applying drops into the eyes or nostrils.
Croatian: Cjepivo se primjenjuje u pilića od prvoga dana ili starijih prskanjem na piliće ili primjenom kapljica u oči ili nosnice.
English: Nobilis IB Primo QX must not be given to birds which are laying eggs or within 4 weeks before the start of the laying period.
Croatian: Nobilis IB Primo QX se ne smije primjenjivati u ptica koje nesu jaja ili unutar 4 tjedna prije početka razdoblja nesenja jaja.
English: Unvaccinated chicks were retained as controls to show the effectiveness of the challenge.
Croatian: Necijepljeni pilići su zadržani kao kontrole kako bi se pokazala djelotvornost izlaganja.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Nobilis IB Primo QX on 4 September 2014.
Croatian: Europska komisija dodijelila je odobrenje za stavljanje u promet koje je na snazi na teritoriju Europske unije za proizvod Nobilis IB Primo QX dana 4. rujna 2014.
English: Control groups of birds were unvaccinated to show the effectiveness of the challenge.
Croatian: Kontrolne grupe ptica nisu bile cijepljene kako bi se dokazalo djelovanje izlaganja.
English: The benefit/risk balance may be found in the scientific discussion module of this EPAR.
Croatian: Omjer koristi i rizika dostupan je u modulu znanstvene rasprave ovog EPAR-a.
English: The purpose of the studies was to establish how long it took for chickens to be fully protected, the length of time protection lasts against infectious bronchitis due to QX-like variants, as well as the influence of maternal antibodies (transmitted from the mother) on the effectiveness of the vaccine.
Croatian: Svrha ispitivanja bilo je utvrditi razdoblje potrebno do potpune zaštite pilića, duljinu trajanja zaštite od zaraznog bronhitisa uzrokovanog varijantama sličnima QX, kao i utjecaj majčinih protutijela (prenose se s majke) na djelotvornost cjepiva.
English: Live avian infectious bronchitis virus strain D388
Croatian: Živi atenuirani avijarni virus zaraznog bronhitisa soj D388
English: The avian infection bronchitis virus in Nobilis IB Primo QX has been attenuated (weakened) so that it does not cause disease.
Croatian: Avijirani virus zaraznog bronhitisa u VMP-u Nobilis IB Primo QX je atenuiran (oslabljen) tako da ne može uzrokovati bolest.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Nobilis IB Primo QX exceed the risks for the approved indication and recommended that Nobilis IB Primo QX be given a marketing authorisation.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) zaključio je da koristi lijeka Nobilis IB Primo QX nadmašuju rizike za odobrenu indikaciju i preporučio je da se za VMP Nobilis IB Primo QX odobrenje za stavljanje VMP-a u promet.
English: When Nobilis IB Primo QX is given to chickens the animals' immune system recognises the virus as ‘foreign' and makes antibodies against it.
Croatian: Nakon što se Nobilis IB Primo QX primjeni u pilića imunosni sustav životinje prepoznaje virus kao „strano tijelo“ i stvara protutijela protiv njega.
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption or eggs or milk used for human consumption.
Croatian: Karencija je razdoblje koje treba proći od primjene VMP-a do klanja životinja i konzumacije mesa u ljudskoj prehrani ili jaja ili mlijeka u ljudskoj prehrani.
English: Two groups of 28 birds were challenged with the virus 3 weeks after vaccination, one group with a QX strain and the second group with another strain called M41.
Croatian: Dvije grupe od 28 ptica izloženo je virusu 3 tjedna nakon cijepljenja, jedna grupa je izložena soju QX, a druga grupa drugom soju naziva M41.
English: Nobilis IB Primo QX is available as a lyophilisate (freeze-dried powder) which may be supplied with a solvent.
Croatian: Nobilis IB Primo QX dostupan je kao liofilizat (smrzavanjem osušeni prašak) koji se može isporučiti s otapalom.
English: The withdrawal period for Nobilis IB Primo QX for chickens is zero days.
Croatian: Razdoblje karencije za Nobilis IB Primo QX za piliće iznosi nula dana.
English: In a second study 42 broiler chickens were spray vaccinated at 1 day old and challenged 3 weeks after vaccination with a QX strain of the virus.
Croatian: U drugom ispitivanju 42 brojler pilića u dobi od 1 dana cijepljena su sprejanjem i izložena su 3 tjedna nakon cijepljenja sojem QX virusa.
English: In the first field study 100% of the birds vaccinated with Nobilis IB Primo QX mixed with Nobilis IB Ma5 were protected from the QX strain and 90% were protected from M41, compared with none of the unvaccinated birds.
Croatian: U prvom terenskom ispitivanju 100% ptica cijepljenih VMP-om Nobilis IB Primo QX pomiješanim s Nobilis IB Ma5 bilo je zaštićeno od soja QX, a 90% je bilo zaštićeno od M41, u usporedbi s nijednom necijepljenom pticom.
English: Nobilis IB Primo QX is a veterinary vaccine that contains live attenuated (weakened) avian infectious bronchitis virus strain D388.
Croatian: Nobilis IB Primo QX je veterinarsko cjepivo koje sadrži živi atenuirani (oslabljeni) avijarni virus zaraznog bronhitisa soj D388.
English: Nobilis IB Primo QX is used to protect chickens against viral infectious bronchitis caused by strains of infectious bronchitis virus known as QX-like variants, such as strain D388.
Croatian: Nobilis IB Primo QX koristi se za imunizaciju pilića protiv virusnog zaraznog bronhitisa uzrokovanog sojevima virusa zaraznog bronhitisa poznatog kao varijante slične QX virusu, poput primjerice soja D388.
English: In the first study broiler chickens (chickens bred for meat) were spray vaccinated with both Nobilis IB Primo QX and Nobilis IB Ma5, a vaccine against a Massachusetts strain of infectious bronchitis virus.
Croatian: U prvom su ispitivanju brojler pilići (pilići uzgajani zbog mesa) cijepljeni sprejem VMP-ova Nobilis IB Primo QX i Nobilis IB Ma5, cjepivom protiv soja Massachusetts virusa zaraznog bronhitisa.
English: The effectiveness of Nobilis IB Primo QX was investigated in two field studies.
Croatian: Djelotvornost VMP-a Nobilis IB Primo QX bila je ispitana u dva terenska ispitivanja.
English: The second field study showed 93% of the Nobilis IB Primo QX vaccinated birds and none of the unvaccinated birds to be protected from the challenge.
Croatian: Drugim terenskim ispitivanjem utvrđeno je da je 93% ptica cijepljenih VMP-om Nobilis IB Primo QX i nijedna necijepljena ptica bilo zaštićeno prilikom izlaganja.
English: What is the withdrawal period?
Croatian: Što je karencija?
English: Other information about Nobilis IB Primo QX:
Croatian: Ostale informacije o VMP-u Nobilis IB Primo QX:
English: What is the risk associated with Nobilis IB Primo QX?
Croatian: Koji su rizici povezani s VMP-om Nobilis IB Primo QX?
English: Why has Nobilis IB Primo QX been approved?
Croatian: Zašto je Nobilis IB Primo QX odobren?
English: What is Nobilis IB Primo QX?
Croatian: Što je Nobilis IB Primo QX?
English: Nobilis IB Primo QX is a vaccine.
Croatian: Nobilis IB Primo QX je cijepivo.
English: What benefit has Nobilis IB Primo QX shown during the studies?
Croatian: Koje su koristi VMP-a Nobilis IB Primo QX utvrđene u ispitivanjima?
English: What is Nobilis IB Primo QX used for?
Croatian: Za što se Nobilis IB Primo QX koristi?
English: How does Nobilis IB Primo QX work?
Croatian: Kako djeluje Nobilis IB Primo QX ?
English: How has Nobilis IB Primo QX been studied?
Croatian: Kako je Nobilis IB Primo QX ispitivan?
English: - If you have been told that you (as the patient) or your child (as the patient) have an abnormal circulation within the heart.
Croatian: - ako Vam je rečeno da Vi (kao bolesnik) ili Vaše dijete (kao bolesnik) imate poremećenu srčanu cirkulaciju.
English: Not relevant.
Croatian: Nije relevantno.
English: The potential risk for humans is unknown.
Croatian: Nije poznata moguća opasnost za ljude.
English: They were considered so inert that testing was not required.
Croatian: Smatraju se toliko inertnima da ispitivanje nije bilo potrebno.
English: Among metallic construction materials, only stainless steel can be recommended.
Croatian: Od metalnog konstrukcijskog materijala može se preporučiti samo nehrđajući čelik.
English: Common Uncommon Rare Very rare
Croatian: Manje često Rijetko Vrlo rijetko
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Kao svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: In order to avoid all incidents, the following instructions should be absolutely respected.
Croatian: Kako biste izbjegli sve nezgode, morate se strogo pridržavati sljedećih uputa.