FrancophonIA/ELRC3.0 huggingface dataset:
English: A study in 347 previously treated ALK-positive patients showed that those taking Xalkori lived on average for nearly 8 months without their disease getting worse compared with 3 months in patients who were treated with either pemetrexed or docetaxel.
Croatian: Ispitivanje na 347 prethodno liječenih bolesnika koji su ALK-pozitivni pokazalo je da su bolesnici koji su primili Xalkori živjeli u prosjeku gotovo osam mjeseci bez pogoršanja bolesti u usporedbi s tri mjeseca u bolesnika koji su liječeni pemetreksedom ili docetakselom.
English: For the full list of all side effects reported with Xalkori, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Xalkori potražite u uputi o lijeku.
English: How does Xalkori work?
Croatian: Kako djeluje Xalkori?
English: Xalkori contains the active substance crizotinib.
Croatian: Xalkori sadrži djelatnu tvar krizotinib.
English: Side effects are similar in children.
Croatian: Nuspojave su slične u djece.
English: The virus has first been inactivated so that it does not cause any disease.
Croatian: Virus je prvo inaktiviran tako da ne uzrokuje nikakvu bolest.
English: The vaccine is given according to official recommendations.
Croatian: Cjepivo se daje u skladu sa službenim preporukama.
English: Influenza vaccine (whole virion, inactivated)
Croatian: Virus influence (cijeli virion, inaktivirani)
English: If vaccination is necessary, facilities to resuscitate patients need to be immediately available.
Croatian: Ako je cijepljenje potrebno, oprema za reanimaciju bolesnika mora biti odmah dostupna.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vepacel on 17 February 2012.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Vepacel vrijedi na prostoru Europske unije od 17. veljače 2012.
English: The full EPAR for Vepacel 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 lijek Vepacel nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What measures are being taken to ensure the safe and effective use of Vepacel?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Vepacel?
English: Why has Vepacel been approved?
Croatian: Zašto je Vepacel odobren?
English: The immune system will then be able to produce antibodies more quickly when it is exposed to the virus again.
Croatian: Imunosni sustav može zatim brže proizvoditi protutijela nakon što je ponovno izložen virusu.
English: What is the risk associated with Vepacel?
Croatian: Koji su rizici povezani s lijekom Vepacel?
English: This may help to protect against the disease caused by the virus.
Croatian: Ovo može pomoći pri zaštiti od bolesti uzrokovane virusom.
English: According to criteria laid down by the CHMP, a prepandemic vaccine needs to bring about protective levels of antibodies in at least 70% of adults for it to be considered suitable.
Croatian: U skladu s kriterijima koje je odredio CHMP, prepandemijsko cjepivo mora stvoriti zaštitne razine protutijela u najmanje 70% odraslih osoba da bi se moglo smatrati prikladnim.
English: Vepacel contains a flu strain called A/Vietnam/1203/2004 (H5N1).
Croatian: Vepacel sadrži soj gripe naziva A/Vietnam/1203/2004 (H5N1).
English: Other information about Vepacel
Croatian: Ostale informacije o lijeku Vepacel
English: Both studies looked separately at people aged above and below 60 years old.
Croatian: Oba su ispitivanja zasebno istražila osobe u dobi starijoj i mlađoj od 60 godina.
English: Vepacel is a ‘prepandemic' vaccine.
Croatian: Vepacel je „prepandemijsko” cjepivo.
English: Vepacel must not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine or to any of the substances found at trace (very low) levels in the vaccine such as formaldehyde, benzonase, sucrose, trypsin or vero cell protein.
Croatian: Vepacel se ne smije primjenjivati u osoba koje imaju anafilaktičku reakciju (ozbiljnu alergijsku reakciju) na bilo koju komponentu cjepiva ili na bilo koju pomoćnu tvar koja je prisutna u tragovima (vrlo malo) u cjepivu, poput formaldehida, benzonasa, sukroze, tripsina ili proteina vero stanica.
English: Moreover, protective levels of antibodies were seen in 71.6% of patients with a weakened immune system and 77.5% of patients with a long-term illness.
Croatian: Nadalje, zaštitne razine protutijela uočene su u 71,6% bolesnika s oslabljenim imunosnim sustavom i 77,5% bolesnika s dugotrajnom bolešću.
English: The vaccine is given by injection into the shoulder or thigh in two single doses, at least three weeks apart.
Croatian: Cjepivo se daje injekcijom u rame ili bedro, dva puta po jedna doza u razmaku od najmanje tri tjedna.
English: The first main study involved 561 healthy adults, while the second study involved around 3,600 adults including those at higher risk of flu (such as people with a long-term illness or a weakened immune system).
Croatian: Prvim je ispitivanjem obuhvaćena 561 zdrava odrasla osoba, dok je drugim ispitivanjem obuhvaćeno otprilike 3.600 odraslih osoba uključujući i osobe s većim rizikom od gripe (poput osoba s dugoročnom bolešću ili oslabljenim imunosnim sustavom).
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 Vepacel.
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 i svoje preporuke o uvjetima za primjenu lijeka Vepacel.
English: When a person is given the vaccine, the immune system recognises the virus parts as ‘foreign' and makes antibodies against them.
Croatian: Nakon što osoba primi cjepivo, imunosni sustav prepoznaje virusni dio kao „strano” tijelo i stvara protutijela protiv njega.
English: The Committee noted that Vepacel produced a good antibody response in healthy adults and an acceptable response in healthy adults aged 60 and over and in patients with a weakened immune system or long-term illness.
Croatian: Povjerenstvo je napomenulo da cjepivo Vepacel stvara dobar odgovor protutijela u zdravih odraslih bolesnika i prihvatljiv odgovor u zdravih odraslih bolesnika u dobi od 60 godina i starijih te u bolesnika s oslabljenim imunosnim sustavom ili dugoročnom bolešću.
English: No major safety issues were seen during the studies and the side effects seen were generally mild and similar to those seen with other flu vaccines.
Croatian: Nisu uočena nikakva druga sigurnosna pitanja tijekom ispitivanja, a nuspojave su načelno smatrane blagima i sličnima onima uočenima s drugim cjepivima protiv gripe.
English: The most common side effects with Vepacel (seen in more than 1 person in 10) in adults are headache, fatigue (tiredness) and pain at the site of injection.
Croatian: Najčešće nuspojave cjepiva Vepacel (kod više od 1 na 10 osoba) u odraslih osoba su glavobolja, iscrpljenost (umor) i bol u mjestu injekcije.
English: This is a type of vaccine to be used to protect against a new strain of flu that may cause a future influenza pandemic.
Croatian: Ovo je tip cjepiva koje se koristi za zaštitu od novog soja gripe koji može izazvati buduću pandemiju influence.
English: For more information about treatment with Vepacel, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Vepacel pročitajte u uputama o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: All of the studies looked at the ability of the vaccine to trigger the production of antibodies (‘immunogenicity') against H5N1.
Croatian: Sva su ispitivanja istražila sposobnost cjepiva da aktivira stvaranje protutijela („imunogenost”) protiv H5N1.
English: A risk management plan has been developed to ensure that Vepacel is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Vepacel.
English: Vaccination with Vepacel in adults produced an antibody response that met these criteria.
Croatian: Cijepljenje cjepivom Vepacel u odraslih osoba stvorilo je odgovor protutijela koji udovoljava ovim kriterijima.
English: The use of Vepacel was later extended to children from 6 months of age since the vaccine was shown to produce a good antibody response also in this population, with a safety profile similar to that seen in adults.
Croatian: Primjena cjepiva Vepacel kasnije je proširena na djecu u dobi od 6 mjeseci s obzirom na to da je utvrđeno da cjepivo stvara dobar odgovor protutijela u ovoj populaciji sa sigurnosnim profilom sličnim onom uočenom u odraslih osoba.
English: This is a summary of the European public assessment report (EPAR) for Vepacel.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Vepacel.
English: The viruses used in Vepacel are grown in mammal cells (‘vero cells'), as opposed to hen's eggs.
Croatian: Virusi korišteni u cjepivu Vepacel uzgajaju se u stanicama sisavaca („vero stanicama”) umjesto u kokošjim stanicama.
English: A flu pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world.
Croatian: Pandemijska gripa nastupa kada se pojavi novi soj virusa gripe koji se može lako proširiti s jedne osobe na drugu jer ljudi nemaju imunitet (zaštitu) protiv tog soja.
English: Health experts are concerned that a future flu pandemic could be caused by a strain of the H5N1 virus.
Croatian: Zdravstveni stručnjaci zabrinuti su da buduća pandemija gripe može biti uzrokovana sojem virusa H5N1.
English: Vepacel has also been studied in a main study involving 657 healthy children aged 6 months to 17 years, who were given two doses of Vepacel, three weeks apart.
Croatian: Vepacel je također ispitan u glavnom ispitivanju koje je obuhvatilo 657 zdrave djece u dobi od 6 mjeseci do 17 godina, koji su primili dvije doze lijeka Vepacel u razmaku od tri tjedna.
English: The vaccine has been developed so that it can be used before or during a flu pandemic to provide protection against the H5N1 virus.
Croatian: Cjepivo je razvijeno tako da se može koristiti prije ili tijekom pandemije influence kako bi se pružila zaštita protiv virusa H5N1.
English: The CHMP decided that the benefits of Vepacel are greater than its risks and recommended that it be granted a marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Vepacel nadmašuju s njim povezane rizike te je preporučilo davanje odobrenja za stavljanje lijeka u promet.
English: In the second main study, 85.8% of healthy adults under 60 and 80.2% of healthy adults aged 60 and over had protective levels of antibodies.
Croatian: U drugom glavnom ispitivanju, 85,8% zdravih odraslih osoba mlađih od 60 godina i 80,2% zdravih odraslih osoba u dobi od 60 godina i stariji imali su zaštitne razine protutijela.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vepacel, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku, za lijek Vepacel uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza koje zdravstveni djelatnici i bolesnici trebaju primjenjivati.
English: This vaccine contains a strain of the H5N1 virus.
Croatian: Ovo cjepivo sadrži soj virusa H5N1.
English: The study in children showed that vaccination with Vepacel brought about similar levels of antibodies to those seen in adults: at 21 days after the second injection, 85.4% of children aged 9 to 17 years, 72.9% of children aged 3 to 8 years and 68.8% of children aged 6 to 35 months had levels of antibodies that would protect them against H5N1.
Croatian: Ispitivanjem provedenim u djece utvrđeno je da je cijepljenjem cjepivom Vepacel stvorena otprilike podjednaka razina protutijela kao i u odraslih: u 21. danu nakon druge injekcije 85,4% djece u dobi od 9 do 17 godina, 72,9% djece u dobi od 3 do 8 godina i 68,8% djece u dobi od 6 do 35 mjeseci imalo je razinu protutijela koja bi ih zaštitila od H5N1.
English: The booster vaccination (one year after the 2-dose vaccination with Vepacel) also produced a strong antibody response against the strains used in the booster and in Vepacel.
Croatian: Cijepljenje booster dozom (jednu godinu nakon cijepljenja s dvije doze cjepiva Vepacel) proizvelo je snažni odgovor protutijela protiv sojeva koji su korišteni u docjepljivanju i u cjepivu Vepacel.
English: The Committee also noted that Vepacel produced a reasonable antibody response against other H5N1 strains that could potentially cause a flu pandemic.
Croatian: Povjerenstvo je također napomenulo da Vepacel stvara prihvatljiv odgovor protutijela protiv drugih sojeva H5N1 koji mogu prouzročiti pandemijsku gripu.
English: In both studies, participants were given two doses of Vepacel followed by a booster dose (given after six months, one year or two years) of a vaccine containing different strengths of the same H5N1 flu strain as in Vepacel or a different H5N1 flu strain.
Croatian: U oba su ispitivanja sudionici primili dvije doze lijeka Vepacel nakon čega je uslijedila booster doza (primljeno nakon šest mjeseci, jedne godine ili dvije godine) cjepiva različitih jačina istog soja gripe H5N1 kao i u cjepivu Vepacel ili u drugim sojevima gripe H5N1.
English: This may help to provide protection in the event of a pandemic caused by a new strain of the H5N1 virus.
Croatian: Ovo može pomoći pri stvaranju zaštite u slučaju da pandemiju uzrokuje novi soj virusa H5N1.
English: What is Vepacel used for?
Croatian: Za što se Vepacel koristi?
English: In the first main study, at 21 days after the second injection, 72.5% of adults under 60 and 74.1% of adults aged 60 and over had levels of antibodies that would protect them against H5N1.
Croatian: U prvom glavnom ispitivanju, u 21. danu nakon druge injekcije 72,5% odraslih osoba mlađih od 60 i 74,1% u dobi od 60 godina i starijih imali su razine protutijela koje bi ih zaštitile od H5N1.
English: Vepacel is a vaccine for use in adults and children from 6 months of age to protect against flu caused by the H5N1 (“bird flu”) subtype of the influenza A virus.
Croatian: Vepacel je cjepivo za primjenu u odraslih i djece u dobi od 6 mjeseci nadalje za zaštitu protiv gripe uzrokovane podtipom H5N1 („ptičja gripa”) virusa influence A.
English: What benefit has Vepacel shown during the studies?
Croatian: Koje su koristi lijeka Vepacel dokazane u ispitivanjima?
English: In both studies, patients who received Vepacel and a booster with a different H5N1 flu strain produced antibodies that could react with several strains of H5N1 virus.
Croatian: U oba ispitivanja, bolesnici koji su primili cjepivo Vepacel i booster dozu s drugim sojem gripe H5N1 stvorili su protutijela koja su mogla reagirati s nekoliko sojeva virusa H5N1.
English: Vepacel is a vaccine.
Croatian: Vepacel je cjepivo.
English: What is Vepacel?
Croatian: Što je Vepacel?
English: How is Vepacel used?
Croatian: Kako se Vepacel koristi?
English: How does Vepacel work?
Croatian: Kako Vepacel djeluje?
English: Some children also received a booster dose of a vaccine containing a different H5N1 flu strain after one year.
Croatian: Nakon godine dana pojedina su djeca također primila booster dozu cjepiva koje je sadržavalo drugi soj gripe H5N1.
English: Two main studies provided data on vaccination with Vepacel in adults.
Croatian: Podaci o cijepljenju lijekom Vepacel u odraslih osoba prikupljeni su u dva glavna ispitivanja.
English: For the full list of all side effects reported with Vepacel, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Vepacel potražite u uputi o lijeku.
English: A shortage of supply was expected from November 2015.
Croatian: Od studenog 2015. očekuje se manjak zaliha.
English: The Committee, as a consequence, concluded that
Croatian: Posljedično Odbor je zaključio da
English: CHMP opinion Whereas
Croatian: Mišljenje CHMP-a: Budući da
English: During the previous inspection (January 2014) a number of major deficiencies were already identified.
Croatian: Tijekom prethodnog pregleda (u siječnju 2014.) broj glavnih deficijencija već je bio identificiran.
English: It was decided that a re-inspection would be done after one year to assess the progress in eliminating the major deficiencies.
Croatian: Odlučeno je da se ponovna inspekcija treba provesti nakon jedne godine sa ciljem ocjene napretka u eliminaciji glavnih nedostataka.
English: Therefore, at present the positive benefit-risk cannot be confirmed.
Croatian: Stoga se u ovom trenutku ne može potvrditi pozitivan omjer koristi i rizika.
English: Several such products are available, both derived from human donor tissue and from ceramics.
Croatian: Dostupno je nekoliko takvih proizvoda, oba se isporučuju iz humanog donorskog tkiva i iz keramike.
English: • The Committee reviewed all available data submitted by the MAH during the procedure under Article 20 of Regulation (EC) No 726/2004
Croatian: • Odbor je pregledao sve dostupne podatke dostavljene od strane MAH-a tijekom postupka u skladu sa člankom 20. Uredbe (EZ) br. 726/2004
English: The main concern identified was potential for particulate contamination.
Croatian: Glavni razlog za zabrinutost koji je identificiran bila je potencijal za kontaminaciju.
English: The latest batch was released in January 2015 into the EU market, thus prior to the above inspection.
Croatian: Posljednja serija otpuštena je u siječnju 2015. na tržište EU-a, drugim riječima prije prethodne inspekcije.
English: This has to be applied to the sponge which is thereafter implanted into patients.
Croatian: Isto se primjenjuje na spužvu koja se zatim ugrađuje u bolesnika.
English: As such it is consequently inspected against EU-GMP guidelines.
Croatian: Kao takav posljedično se uspoređuje sa smjernicama EU-a za GMP.
English: The final statement of non-compliance was issued and entered in the Community database by the Netherlands (IGZ) in accordance with Article 111 (7) of Directive 2001/83/EC on 23 July 2015.
Croatian: Izdana je konačna izjava o nesukladnosti i unijeta je u bazu podataka Zajednice od strane Nizozemske (IGZ-a) u skladu sa člankom 111. (7.) Direktive 2001/83/EZ dana 23. srpnja 2015.
English: • There is no alternative manufacturing site authorised within the marketing authorisation dossier;
Croatian: • nema alternativnog proizvodnog mjesta odobrenog u sklopu dosjea za izdavanje odobrenja za stavljanje lijeka u promet;
English: No other ‘morphogenetic proteins' (such as InductOs) are available in the EU but substances known as ‘graft extenders' reduce the required amount of bone graft (but not completely replace the grafts).
Croatian: Nisu dostupni drugi "morfogenetski proteini" (poput lijeka InductOs) u EU-u, no tvari poznate pod nazivom "proširivači presatka" smanjuju potrebnu količinu koštanog presatka (no ne zamjenjuju presatke u potpunosti).
English: From a public health perspective, there was no indication of risks to patients linked to the inspection findings.
Croatian: Sa stajališta javnoga zdravstva, nema indikacije rizika u bolesnika povezanih s nalazima inspekcije.
English: An Article 20 of Regulation (EC) No 726/2004 was initiated by the EC on 23 July 2015 for the above concerns and their impact on the benefit-risk balance of InductOs to be determined and to decide if the relevant marketing authorisation should be maintained, varied, suspended or revoked.
Croatian: Uredbe (EK) br. 726/2004 uveo je EZ dana 23. srpnja 2015. za prethodno navedene bojazni, a njihov utjecaj na omjer koristi i rizika lijeka InductOs tek treba utvrditi i odlučiti ako se relevantna odobrenja za stavljanje lijeka u promet trebaju održati, varirati, suspendirati ili povući.
English: ACS has been classified as an excipient of InductOs.
Croatian: ACS je klasificiran kao ekscipijent lijeka InductOs.
English: On the basis of the above and taking into account that InductOs has no alternative ACS manufacturing site authorised:
Croatian: Na temelju prethodno navedenog i uzimajući u obzir da lijek InductOs ne postoji alternativno proizvodno mjesto ACS-a koje bi bilo odobreno:
English: Consequently, the Netherlands issued a draft statement of GMP non -compliance for this manufacturer which is the only existent one.
Croatian: Posljedično, Nizozemska je izdala nacrt izjave o nesukladnosti GMP-a za ovog proizvođača, koji je jedini postojeći.
English: This action determined that no new batches of InductOs could be produced nor released in the EU.
Croatian: Ovom se radnjom utvrdilo da se nove serije lijeka InductOs ne mogu proizvesti ili pustiti u promet u EU-u.
English: On 23 July 2015, the CHMP also adopted a list of questions to be addressed by the MAH.
Croatian: Dana 23. srpnja 2015. CHMP je također usvojio popis pitanja na koja nositelj odobrenja treba dostaviti odgovor.
English: InductOs, is a kit for implant, authorised centrally since 2002 for single level lumbar interbody spine fusion as a substitute for autogenous bone graft in adults with degenerative disc disease who have had at least 6 months of non-operative treatment for this condition.
Croatian: InductOs, je komplet za usadak, središnje odobren od 2002. godine za fuziju kralježnice jedne razine lumbalnog međutijela kao zamjena autogenog koštanog presatka u odraslih osoba s degenerativnom bolesti diska koji su primili najmanje 6 mjeseci neoperativnog liječenja za ovo stanje.
English: As mentioned above, the April 2015 inspection found that the corrective action plan failed and the contamination of ACS with particulate matter was not under control and quality system not aiming for continuous improvement.
Croatian: Kako je prethodno navedeno, inspekcijom u travnju 2015. utvrdilo se da korektivan plan djelovanja nije bio uspješan te da kontaminacija ACS-a česticama ispod granice vidljivosti nije pod kontrolom i da sustav kvalitete nije usmjeren na kontinuirano poboljšanje.
English: On 23 July, the CHMP considered the need to take provisional measures to be applied immediately, notably a withdrawal from the market and/or suspension of the marketing authorisation, as requested by the EC.
Croatian: Dana 23. srpnja, CHMP je razmotrio potrebu za privremenim mjerama koje treba neodloživo primijeniti, između ostalog povlačenje s tržišta i/ili suspenzija odobrenja za stavljanje lijeka u promet, kako je zatražio EZ.
English: Healthcare professionals using InductOs were advised to follow the instructions in the product information as usual and a Direct Health Care Professional Communication (DHPC) was adopted and agreed to be distributed on 12 August by the MAH.
Croatian: Zdravstveni djelatnici koji koriste lijek InductOs dobili su savjet da se pridržavaju uputa u informacijama o proizvodu kao i obično, te je usvojeno izravno pismo upućeno zdravstvenim djelatnicima (DHPC) i usuglašeno je da ga 12. kolovoza distribuira nositelj odobrenja.
English: The kit consists of a powder containing the active substance, dibotermin alfa, a solvent and a matrix (absorbable collagen sponge, ACS).
Croatian: Komplet se sastoji od praška koji sadrži djelatnu tvar, dibotermin alfa, otapalo i matriks (apsorbirajuću kolagensku spužvu, ACS).
English: Therefore, and taking into account the assessment of the latest PSUR for InductOs dated April 2015 showing no signals in this regard, the CHMP was of the view that there was no need to adopt provisional measures for InductOs.
Croatian: Stoga, uzimajući u obzir ocjenu najnovijeg PSUR-a za lijek InductOs iz travnja 2015. koja nije pokazivala ikakve signale u vezi s ovim, CHMP je bio mišljenja da nema potrebe za usvajanjem privremenih mjera za lijek InductOs.