FrancophonIA/ELRC3.0 huggingface dataset:
English: Instanyl is used in patients who are already using opioids (a group of painkillers that includes morphine and fentanyl) to control long-term cancer pain.
Croatian: Instanyl se primjenjuje u bolesnika koji već uzimaju opioidnu terapiju (skupina analgetika koja obuhvaća morfin i fentanil) za kontrolu kronične karcinomske boli.
English: Instanyl must not be used in patients who are not already taking opioids to maintain pain control, who have severe respiratory depression (inhibition of breathing) or who have severe obstructive lung conditions (diseases that severely impede breathing).
Croatian: Instanyl se ne smije primjenjivati u bolesnika koji nisu prethodno uzimali opioide za kontrolu boli, bolesnika s teškom respiratornom depresijom (inhibicija disanja) ili koji imaju kronične opstruktivne bolesti pluća (bolesti koje ozbiljno utječu na disanje).
English: Treatment with Instanyl should be started by and remain under the supervision of a doctor who has experience in the management of opioid treatment in cancer patients.
Croatian: Liječenje lijekom Instanyl treba započeti i nadzirati liječnik s iskustvom u primjeni opioidne terapije u bolesnika s karcinomom.
English: The highest dose was 200 microgram given as one spray in one nostril and the patients were allowed to take a second spray after 10 minutes if there had been insufficient pain relief.
Croatian: Najjača doza iznosila je 200 mikrograma u jednoj dozi spreja u jednu nosnicu, a bolesnici su mogli uzeti sljedeću dozu nakon deset minuta ako bol nije bila dostatno ublažena.
English: It must also not be used in patients who have had facial radiotherapy (treatment with radiation to the face) or who have recurrent episodes of epistaxis (nosebleeds).
Croatian: Ne smije se primjenjivati ni u bolesnika koji su primili radioterapiju lica (liječenje zračenjem lica) ili koji imaju epizode epistakse (krvarenje iz nosa) koje se ponavljaju.
English: Instanyl is a medicine used to treat breakthrough pain in adults with cancer.
Croatian: Instanyl je lijek koji se primjenjuje za zbrinjavanje probojne boli u odraslih osoba oboljelih od raka.
English: How does Instanyl work?
Croatian: Kako djeluje Instanyl?
English: The number of breakthrough pain episodes that responded to treatment was also higher among patients who received Instanyl than those who received placebo.
Croatian: Broj epizoda probojne boli kod kojih je zabilježen odgovor na liječenje bio je također veći među bolesnicima koji su primali lijek Instanyl u odnosu na bolesnike koji su primali placebo.
English: Instanyl has been shown to provide rapid relief of pain in patients with cancer.
Croatian: Dokazano je da lijek Instanyl dovodi do brzog ublažavanja boli u bolesnika s rakom.
English: The number of patients who responded to treatment was also higher in the Instanyl group than in the placebo group.
Croatian: Broj bolesnika koji su odgovorili na liječenje također je bio veći u skupini koja je primala lijek Instanyl u odnosu na skupinu koja je primala placebo.
English: It must not be used in patients treated with medicines containing sodium oxybate (used to treat narcolepsy, a sleep disorder).
Croatian: Ne smije se primjenjivati ni u bolesnika liječenih lijekovima koji sadrže natrijev oksibat (primjenjuje se za liječenje narkolepsije, poremećaja spavanja).
English: The active substance in Instanyl, fentanyl, is an opioid.
Croatian: Fentanil, djelatna tvar u lijeku Instanyl, je opioid.
English: In Instanyl, fentanyl is contained inside a nasal spray.
Croatian: U lijeku Instanyl fentanil je sadržan u spreju za nos.
English: The first dose of Instanyl is 50 micrograms (one spray of the lowest strength) in one nostril; this is increased as necessary until reaching the dose that gives the patient adequate pain relief.
Croatian: Prva doza lijeka Instanyl je 50 mikrograma (jedno štrcanje spreja najmanje jačine) u jednu nosnicu.
English: For the full list of side effects with Instanyl, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Instanyl potražite u uputi o lijeku.
English: In the future if the animals are exposed to a similar virus the immune system will be able to respond more quickly.
Croatian: U budućnosti, ako životinje budu izložene virusu, imunosni sustav može brže odgovoriti.
English: The full EPAR for Innovax-ILT can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za VMP Innovax-ILT nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
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 i neizravan kontakt cijepljenih pilića i pura.
English: This is a summary of the European public assessment report (EPAR) for Innovax-ILT.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o cjepivu Innovax-ILT.
English: The disease is caused by a herpesvirus and can be mild (causing watery eyes, nasal discharge and mild inflammation of the windpipe) or severe, causing dyspnoea (difficulty breathing), respiratory depression and coughing up of blood.
Croatian: Bolest je uzrokovana herpesvirusom i može biti blaga (uzrokuje suzne oči, sekret u nosu i blagu upalu dišnih putova) ili ozbiljna uzrokujući dispneju (otežano disanje), respiratornu depresiju i iskašljavanje krvi.
English: The European Commission granted a marketing authorisation valid throughout the EU for Innovax-ILT on 3 July 2015.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za VMP Innovax-ILT na snazi u Europskoj uniji od 3. srpnja 2015.
English: When Innovax-ILT is given to chickens, the animals' immune system recognises the virus as ‘foreign' and makes antibodies against it.
Croatian: Kada se cjepivo Innovax-ILT da pilićima, imunosni sustav životinje prepoznaje virus kao „strano tijelo” i proizvodi antitijela protiv njega.
English: The vaccine can be given to one-day-old chicks as a single injection under the skin in the neck.
Croatian: Cjepivo se primjenjuje u pilića starih jedan dan kao jedna potkožna injekcija u vrat.
English: The withdrawal period for meat and eggs from chickens treated with Innovax-ILT is ‘zero' days, which means that there is no mandatory waiting time.
Croatian: Razdoblje karencije za meso i jaja pilića liječenih VMP-om Innovax-ILT iznosi „nula” dana, drugim riječima, nema obveznog perioda čekanja.
English: Birds infected with MD virus can be carriers and shedders of the virus for life.
Croatian: Ptice koje su zaražene virusom MD-a mogu biti prijenosnici i nositelji virusa cijeli život.
English: Protection against ILT starts 4 weeks after vaccination and lasts 60 weeks.
Croatian: Zaštita protiv ILT-a započinje 4 tjedna nakon cijepljenja i traje 60 tjedana.
English: ILT is an infection of the airways which may affect growth and decrease egg production in chickens.
Croatian: ILT je upala dišnih putova koja može utjecati na rast i smanjenje proizvodnje jaja u pilića.
English: It is not intended to provide practical advice on how to use Innovax-ILT.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni cjepiva Innovax-ILT.
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 postaju zaraženi u ranoj dobi udisanjem peruti (kožnih pahuljica) koja sadrži virus, a može ostati zarazna nekoliko mjeseci nakon što se oguli s tijela.
English: MD is another herpesvirus infection of chickens which can cause paralysis of the wings and legs and causes tumours in various organs.
Croatian: MD je druga herpesvirusna infekcija pilića koja može uzrokovati paralizu krila i nogu te uzrokuje tumore raznih organa.
English: What is Innovax-ILT and what is it used for?
Croatian: Što je Innovax-ILT i za što se koristi?
English: Innovax-ILT contains live turkey herpesvirus strain HVT/ILT-138.
Croatian: Innovax-ILT sadrži živi herpesvirus pura soj HVT/ILT-138.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that InnovaxILT'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 Innovax-ILT nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: As the vaccine is stored in liquid nitrogen, it is important that any handling is done in a well-ventilated area and that precautions are taken when preparing the vaccine.
Croatian: Budući da se cjepivo čuva u tekućem dušiku, važno je da se njime rukuje u dobro ventiliranim prostorijama te da se prilikom pripreme cjepiva poduzimaju mjere opreza.
English: Innovax-ILT is available as a suspension and solvent to be made into a suspension for injection and can only be obtained with a prescription.
Croatian: Innovax-ILT je dostupan kao suspenzija i otapalo za pripremu suspenzije za injekciju i izdaje se samo na recept.
English: Innovax-ILT is a vaccine containing turkey herpesvirus serotype 3, a type of herpesvirus which is closely related to MD virus but does not cause disease in chickens.
Croatian: Innovax-ILT je cjepivo koje sadrži herpesvirus pura serotip 3, tip herpesvirusa koji je usko povezan s virusom MD-a no ne uzrokuje bolest u pilića.
English: This will help protect the chickens against ILT and MD.
Croatian: To pomaže u zaštiti pilića od ILT-a i MD-a.
English: Chickens were taken from the field trial and challenged (exposed to infection) in the laboratory to demonstrate protection after vaccination.
Croatian: Pilići su uzeti iz terenskog ispitivanja i izloženi zarazi u laboratoriju kako bi se dokazala zaštita nakon cijepljenja.
English: Safety studies have shown that the strain is safe for turkeys.
Croatian: Ispitivanja sigurne primjene pokazala su da je soj siguran u pura.
English: Since Innovax-ILT is a live vaccine, the vaccine strain is excreted from vaccinated birds and may spread to turkeys.
Croatian: Budući da je Innovax-ILT živo cjepivo, soj cjepiva dobiva se iz cijepljenih ptica i može se proširiti na pure.
English: Innovax-ILT is a veterinary vaccine used to protect chickens against infectious laryngotracheitis (ILT) and Marek's disease (MD).
Croatian: Innovax-ILT je veterinarsko cjepivo koje se koristi za zaštitu pilića protiv zaraznog laringotraheitisa (ILT) i virusa Marekove bolesti (MB).
English: The turkey herpesvirus strain HVT/ILT-138 has been modified so that it will produce the glycoproteins gD and gI which form part of the outer coat of the ILT virus.
Croatian: Herpesvirus pura soj HVT/ILT-138 modificiran je tako da će stvarati glikoproteine gD i gI koji su dio vanjskog omotača virusa ILT-a.
English: What are the risks associated with Innovax-ILT?
Croatian: Koji su rizici povezani s cjepivom Innovax-ILT?
English: The level of protection in general was higher when Innovax-ILT was given alone.
Croatian: Razina zaštite bila je načelno veća kada se Innovax-ILT primjenjivao samostalno.
English: Avian infectious laryngotracheitis and Marek's disease vaccine (live recombinant)
Croatian: Cjepivo protiv ptičjeg zaraznog laringotraheitisa (ILT) i virusa Marekove bolesti (MB) (živo rekombinirano)
English: A field trial in chickens was performed to evaluate the effects of the vaccine against ILT and MD. Mortality was low, no disease related signs were observed and the condition of the chickens was good throughout the trial, indicating effectiveness of the vaccine.
Croatian: Smrtnost je bila niska, nisu uočeni znakovi povezani s bolesti i stanje pilića bilo je dobro tijekom cijelog ispitivanja, što ukazuje na djelotvornost cjepiva.
English: Protection against MD starts 9 days after vaccination and lasts for life.
Croatian: Zaštita protiv MD-a započinje 9 tjedana nakon cijepljenja i traje cijeli život.
English: Why is Innovax-ILT approved?
Croatian: Zašto je VMP Innovax-ILT odobren?
English: Other information about Innovax-ILT
Croatian: Ostale informacije o VMP-u Innovax-ILT
English: When Innovax-ILT is given mixed with Nobilis Rismavac protection against MD starts at 5 days after vaccination.
Croatian: Kada se Innovax-ILT primjenjuje zajedno s cjepivom Nobilis Rismavac, zaštita protiv MD-a počinje 5. dana nakon cijepljenja.
English: To evaluate the effects of the vaccine against MD, chickens vaccinated either with Innovax-ILT alone or Innovax-ILT mixed with Nobilis Rismavac (a vaccine which also protects against Marek's disease) were infected with very virulent strains of the MD virus.
Croatian: Kako bi se ocijenilo djelovanje cjepiva protiv MD-a, pilići cijepljeni samo cjepivom InnovaxILT ili cjepivom Innovax-ILT pomiješanim s cjepivom Nobilis Rismavac (cjepivom koje također sadrži zaštitu protiv Marekove bolesti) zaraženi su izrazito virulentnim sojevima virusa MD-a.
English: When Innovax-ILT was applied mixed with Nobilis Rismavac, the start of protection against ILT was delayed by up to 10 weeks after vaccination.
Croatian: U slučaju kada je Innovax-ILT primijenjen u kombinaciji s cjepivom Nobilis Rismavac, početak zaštite protiv ILT-a bio je odgođen do 10 tjedana nakon cijepljenja.
English: For further information see the summary of product characteristics.
Croatian: Za više informacija pročitajte sažetak opisa svojstava VMP-a.
English: In a second challenge study the effectiveness of the vaccination with Innovax-ILT alone and InnovaxILT mixed with Nobilis Rismavac was also examined by evaluation of protection after infection under laboratory conditions with the ILT virus.
Croatian: U drugom ispitivanju izazova, djelotvornost cijepljenja samo cjepivom Innovax-ILT i cjepivom InnovaxILT pomiješanim s cjepivom Nobilis Rismavac bila je također ispitana tako što se ocijenila zaštita nakon infekcije virusom ILT-a u laboratorijskim uvjetima.
English: What benefits of Innovax-ILT have been shown in studies?
Croatian: Koje su koristi cjepiva Innovax-ILT utvrđene u ispitivanjima?
English: For practical information about using Innovax-ILT, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Praktične informacije o primjeni cjepiva Innovax-ILT vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: How does Innovax-ILT work?
Croatian: Kako djeluje Innovax-ILT?
English: Safety information has been included in the summary of product characteristics and the package leaflet for Innovax-ILT, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Croatian: U sažetku opisa svojstava VMP-a kao i u uputi o VMP-u Innovax-ILT nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se veterinari te vlasnici životinja ili uzgajivači trebaju pridržavati.
English: How is Innovax-ILT used?
Croatian: Kako se Innovax-ILT koristi?
English: For more information about treatment with Innovax-ILT, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Dodatne informacije o terapiji VMPom Innovax-ILT vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: Chickens showed significant protection after both vaccination with Innovax-ILT alone and Innovax-ILT mixed with Nobilis Rismavac.
Croatian: U pilića je uočena visoka razina zaštite i nakon cijepljenja samo cjepivom Innovax-ILT i nakon cijepljenja cjepivom Innovax-ILT pomiješanim s cjepivom Nobilis Rismavac.
English: Chickens showed varying levels of protection after vaccination with either Innovax-ILT alone or Innovax-ILT mixed with Nobilis Rismavac.
Croatian: U pilića su uočene različite razine zaštite i nakon cijepljenja samo cjepivom Innovax-ILT i nakon cijepljenja cjepivom Innovax-ILT pomiješanim s cjepivom Nobilis Rismavac.
English: It is available as tablets (50, 100, 200, 300 and 400 mg).
Croatian: Lijek je dostupan u tabletama (50, 100, 200, 300 i 400 mg).
English: Trobalt retigabine
Croatian: Trobalt retigabin
English: Other information about Trobalt
Croatian: Druge informacije o Trobaltu
English: The European Commission granted a marketing authorisation valid throughout the European Union for Trobalt on 28 March 2011.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za Trobalt vrijedi na prostoru Europske unije na dan 28. ožujka 2011. godine.
English: The full EPAR for Trobalt can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za Trobalt može se naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: In the first study, the main measure of effectiveness was the change in the number of seizures per month.
Croatian: U prvom je ispitivanju glavna mjera djelotvornosti bila promjena u broju napadaja mjesečno.
English: This will stop further transmission of electrical impulses thereby preventing epileptic seizures.
Croatian: Na ovaj se način zaustavlja daljnji prijenos električnih impulsa, te se stoga sprječavaju epileptični napadaji.
English: It is used in epilepsy with or without ‘secondary generalisation' (when the excessive electrical activity reaches the whole brain).
Croatian: Lijek se koristi u liječenju epilepsije s ili bez „sekundarne generalizacije” (nakon što prekomjerna električna aktivnost dosegne cijeli mozak).
English: Trobalt was more effective than placebo in reducing the number of seizures.
Croatian: Trobalt je bio djelotvorniji od placeba u smanjivanju broja napadaja.
English: In the other two studies, the main measure of effectiveness was the number of patients whose number of seizures was at least halved.
Croatian: U druga dva ispitivanja, glava mjera djelotvornosti bio je broj bolesnika, čiji se broj napadaja barem prepolovio.
English: The recommended maintenance dose is between 600 mg a day and a maximum of 1,200 mg a day.
Croatian: Preporučena doza održavanja je između 600 mg na dan do maksimalno 1.200 mg na dan.
English: This is a summary of the European public assessment report (EPAR) for Trobalt.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Trobalt.
English: The effect of Trobalt at 600 mg a day was inconclusive in this study.
Croatian: Djelotvornost Trobalta u dozi od 600 mg na dan bila je nedefinirana u ovom ispitivanju.
English: Epilepsy is caused by excessive electrical activity in the nerve cells of the brain.
Croatian: Epilepsiju uzrokuje prekomjerna električna aktivnost u živčanim stanicama mozga.
English: What measures are being taken to ensure the safe use of Trobalt?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna primjena Trobalta?
English: However, because of the risk of retinal discolouration, which could possibly result in impaired vision, the CHMP concluded that the use of Trobalt should be restricted only to those patients for whom other anti-epileptic medicines have proved inadequate or have not been tolerated.
Croatian: No, s obzirom na rizik od diskoloracije rožnice, što može rezultirati oštećenjem vida, CHMP je zaključio da se uporaba Trobalta mora ograničiti samo na one bolesnike, za koje u se drugi antiepileptički lijekovi pokazali neprimjerenima ili ih bolesnici nisu dobro podnosili.
English: What is the risk associated with Trobalt?
Croatian: Koji su rizici povezani s Trobaltom?
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Trobalt.
Croatian: Objašnjava kako je Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) ocijenilo lijek da bi donijelo svoje mišljenje u korist davanja odobrenja za stavljanje lijeka u promet te svoje preporuke za uvjete za primjenu lijeka Trobalt.
English: Treatment with Trobalt starts with one 100 mg tablet three times a day for one week; the dose is then increased weekly by 50 mg per dose according to the patient's response.
Croatian: Trobalta je jedna tableta od 100 mg tri puta na dan tijekom tjedan dana; doza se zatim povisuje svaki tjedan za 50 mg u skladu s odgovorom bolesnika.
English: This compared with a reduction of 13% in the placebo group.
Croatian: Za usporedbu, u placebo grupi došlo je do smanjenja od 13%.
English: The company that makes Trobalt must ensure that doctors who are expected to prescribe Trobalt receive an information pack containing important safety information, including information on the risk of pigment changes in the eye and discolouration of the nails, lips and skin, and on the need for a full eye examination at the start of treatment and at least every 6 months during treatment.
Croatian: Proizvođač tog lijeka mora osigurati da liječnici, za koje se očekuje da će propisivati Trobalt, zaprime informacijski paket s važnim sigurnosnim informacijama, uključujući i informacije o riziku od pigmentnih promjena oka i promjene boje noktiju, usana i kože, te o potrebi detaljnog pregleda očiju prije početka liječenja i najmanje svakih 6 mjeseci tijekom liječenja.
English: Trobalt is used in combination with other anti-epileptic medicines to treat adults with drug-resistant partial-onset seizures (epileptic fits) that cannot be treated with other combinations of medicines.
Croatian: Trobalt se koristi u kombinaciji s drugim antiepileptičkim lijekovima za liječenje odraslih osoba s parcijalnim napadajima (epileptični napadaji) rezistentnima na lijekove, koji se ne mogu liječiti drugim kombinacijama lijekova.
English: Trobalt must not be used in people who are hypersensitive (allergic) to retigabine or any of the other ingredients.
Croatian: Trobalt ne smiju uzimati osobe koje su hiperosjetljive (alergične) na retigabin ili bilo koji drugi sastojak.
English: These are pores that let potassium move in and out of the cell and play a role in terminating electrical impulses.
Croatian: To su pore koje dozvoljavaju ulazak kalija u stanicu i izlazak kalija iz stanice, te igraju značajnu ulogu u otkazivanju električnih impulsa.
English: Trobalt has been compared with placebo (a dummy treatment) in three main studies involving a total of 1,244 patients whose seizures were not adequately controlled with other anti-epileptic medicines.
Croatian: Trobalt je uspoređen s placebom (lažnim liječenjem) u tri glavna ispitivanja koja su obuhvatila ukupno 1.244 bolesnika, čiji napadaji nisu primjereno kontrolirani drugim antiepileptičkim lijekovima.
English: This is a type of epilepsy where too much electrical activity in one part of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness or a sudden sense of fear.
Croatian: Ovo je tip epilepsije, pri kojoj previše električne aktivnosti u jednom dijelu mozga uzrokuje simptome poput iznenadnih trzaja jednog dijela tijela, iskrivljenog sluha, osjeta njuha ili vida, tuposti ili iznenadnog osjećaja straha.
English: For more information about treatment with Trobalt, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju Trobaltom pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: The active substance in Trobalt, retigabine, is an anti-epileptic medicine.
Croatian: Djelatna tvar u Trobaltu, retigabin, jest antiepileptički lijek.
English: The CHMP noted that Trobalt is effective at reducing the number of seizures.
Croatian: CHMP smatra da je Trobalt djelotvoran u smanjivanju broja napadaja.
English: Why has Trobalt been approved?
Croatian: Zašto je Trobalt odobren?
English: Trobalt acts by keeping the potassium channels open.
Croatian: Trobalt djeluje tako što održava kalijeve kanale otvorenima.
English: What is Trobalt?
Croatian: Što je Trobalt?