FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Truxima has a highly similar structure, purity and biological activity to MabThera and is distributed in the body in the same way.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je da, u skladu sa zahtjevima EU-a za bioslične lijekove, lijek Truxima ima vrlo sličnu strukturu, čistoću i biološku aktivnost kao i lijek MabThera te se u tijelu razlaže na isti način.
English: Doctors prescribing Truxima for cancer will be provided with educational material reminding them of the need to use the medicine only by infusion into a vein.
Croatian: Liječnici koji propisuju lijek Truxima dobit će edukativne materijale koji ih podsjećaju na potrebu primjene lijeka samo infuzijom u venu.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Truxima have also 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 Truxima nalaze se također u sažetku opisa svojstava i u uputi o lijeku.
English: The reference medicine for Truxima is MabThera.
Croatian: Referentni lijek za lijek Truxima je MabThera.
English: Depending on the condition it is used to treat, Truxima may be given on its own, or with chemotherapy (other cancer medicines) or medicines used for inflammatory disorders (methotrexate or a corticosteroid).
Croatian: Ovisno o bolesti koja se liječi, Truxima se može primjenjivati kao monoterapija ili uz kemoterapiju (druge lijekove za rak) ili lijekove koji se koriste za upalne poremećaje (metotreksat ili kortikosteroidi).
English: Patients with rheumatoid arthritis, GPA, MPA or pemphigus vulgaris must also not receive Truxima if they have severe heart problems.
Croatian: Bolesnici s reumatoidnim artritisom i bolestima GPA, MPA ili običnim pemfigusom ne smiju primati lijek Truxima ako imaju ozbiljne probleme sa srcem.
English: The company marketing Truxima will provide doctors and patients using the medicine for non-cancer conditions with educational material on the need to give the medicine where facilities for resuscitation are available and on the risk of infection, including PML.
Croatian: Tvrtka koja lijek Truxima stavlja u promet, liječnicima i bolesnicima koji koriste lijek za bolesti koje nisu zloćudne dostavit će edukativni materijal o potrebi davanja lijeka na mjestima u kojima su dostupni odjeli za oživljavanje te o riziku od upale, uključujući PML.
English: The safety of Truxima has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine MabThera.
Croatian: Ocijenjena je sigurnost primjene lijeka Truxima i na temelju svih provedenih ispitivanja nuspojave lijeka smatraju se usporedivima s onima za referentni lijek MabThera.
English: The most common side effects with rituximab are reactions related to the infusion (such as fever, chills and shivering) which occur in the majority of patients after the first infusion.
Croatian: Vrlo česte nuspojave rituksimaba i reakcije povezane s infuzijom (kao što su vrućica, drhtavica i zimica) događaju se kod većine bolesnika nakon prve infuzije.
English: Truxima is a medicine used in adults to treat the following blood cancers and inflammatory conditions:
Croatian: Truxima je lijek koji se koristi za liječenje sljedećih vrsta raka krvi i upala u odraslih:
English: As for all medicines, data on the use of Truxima are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Truxima kontinuirano se prate.
English: (MPA), which are inflammatory conditions of the blood vessels
Croatian: (MPA), upalnih stanja krvnih žila;
English: Truxima has been compared with MabThera given into a vein in a study involving 372 patients with active rheumatoid arthritis.
Croatian: Lijek Truxima uspoređen je s lijekom MabThera primjenom u venu u ispitivanju koje je obuhvaćalo 372 bolesnika s aktivnim reumatoidnim artritisom.
English: • chronic lymphocytic leukaemia (CLL, another blood cancer affecting white blood cells)
Croatian: • kronične limfocitne leukemije (KLL, druge vrste raka krvi koji pogađa bijele krvne stanice);
English: For more information about using Truxima, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Truxima pročitajte uputu o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Truxima must not be used in people who are hypersensitive (allergic) to rituximab, mouse proteins or any of the other ingredients.
Croatian: Lijek Truxima ne smiju upotrebljavati osobe koje su preosjetljive (alergične) na rituksimab, mišje bjelančevine ili bilo koji drugi sastojak lijeka.
English: In GPA and MPA, destroying the B lymphocytes lowers the production of antibodies thought to play an important role in attacking the blood vessels and causing inflammation.
Croatian: U bolesnika s bolestima GPA i MPA uništavanjem B-limfocita smanjuje se proizvodnja protutijela za koja se smatra da imaju važnu ulogu u napadu na krvne žile i uzrokovanju upale.
English: When rituximab attaches to CD20, it causes the death of B lymphocytes, which helps in lymphoma and CLL (where B-lymphocytes have become cancerous) and in rheumatoid arthritis (where B lymphocytes are involved in joint inflammation).
Croatian: Kad se rituksimab veže na bjelančevinu CD20, uzrokuje smrt B-limfocita, što pomaže u bolesnika s limfomom i KLL-om (kod kojih su B-limfociti postali kancerogeni) i bolesnika s reumatoidnim artritisom (bolesti pri kojoj su B-limfociti uključeni u upalu zglobova).
English: It is available as a concentrate for making a solution that must be given by infusion (drip) into a vein.
Croatian: Lijek je dostupan kao koncentrat za otopinu koja se mora davati kao infuzija (ukapavanje) u venu.
English: Therefore, the CHMP's view was that, as for MabThera, the benefits of Truxima outweigh the identified risks and it can be authorised for use in the EU.
Croatian: Stoga je stav CHMP-a da, kao i kod lijeka MabThera, koristi od lijeka Truxima nadmašuju identificirane rizike te da lijek može biti odobren za primjenu u EU-u.
English: The active substance in Truxima, rituximab, is a monoclonal antibody (a type of protein) designed to recognise and attach to a protein called CD20 present on the surface of B lymphocytes (types of white blood cells).
Croatian: Djelatna tvar u lijeku Truxima, rituksimab, monoklonsko je protutijelo (vrsta bjelančevine) koje prepoznaje i veže se na bjelančevine pod nazivom CD20 koje se nalaze na površini B-stanica (vrste bijelih krvnih stanica).
English: Supportive studies in patients with rheumatoid arthritis and in patients with advanced follicular lymphoma also indicated that the medicines produced similar responses.
Croatian: Popratna ispitivanja bolesnika s reumatoidnim artritisom i bolesnika s uznapredovalim folikularnim limfomom također ukazuju na to da lijekovi uzrokuju slične odgovore.
English: What benefits of Truxima have been shown in studies?
Croatian: Koje su koristi od lijeka Truxima utvrđene u ispitivanjima?
English: Extensive laboratory studies comparing Truxima with MabThera have shown that rituximab in Truxima is highly similar to rituximab in MabThera in terms of chemical structure, purity and biological activity.
Croatian: Opsežna laboratorijska ispitivanja u kojima je lijek Truxima uspoređen s lijekom MabThera pokazala su da je rituksimab u lijeku Truxima vrlo sličan rituksimabu u lijeku MabThera u pogledu kemijske strukture, čistoće i biološke aktivnosti.
English: All these data were considered sufficient to conclude that Truxima will behave in the same way as MabThera in terms of effectiveness and safety in its authorised uses.
Croatian: Svi ti podatci smatraju se dovoljnima za donošenje zaključka da će lijek Truxima za odobrene indikacije djelovati jednako kao lijek MabThera u pogledu učinkovitosti i sigurnosti primjene.
English: In addition, a study comparing Truxima to MabThera in rheumatoid arthritis adult patients showed that both medicines are similarly effective.
Croatian: Osim toga, ispitivanje u kojem se lijek Truxima usporedio s lijekom MabThera u odraslih bolesnika s reumatoidnim artritisom utvrdilo je da oba lijeka imaju sličnu djelotvornost.
English: The study showed that Truxima and MabThera led to similar levels of rituximab in the blood.
Croatian: Ispitivanjem se pokazalo da se primjenom lijekova Truxima i MabThera stvaraju slične razine rituksimaba u krvi.
English: • follicular lymphoma and diffuse large B cell non-Hodgkin's lymphoma (two types of non-Hodgkin's lymphoma, a blood cancer)
Croatian: • folikularnog limfoma i difuznog ne-Hodgkinovog limfoma velikih B-stanica (dva oblika ne
English: Patients are also to receive an alert card, which they are to carry at all times, instructing them to contact their doctor immediately if they have any of the listed symptoms of infection.
Croatian: Bolesnici će primiti i karticu s upozorenjima koju uvijek trebaju nositi sa sobom i na kojoj piše da se u slučaju navedenih simptoma upale odmah obrate liječniku.
English: • severe rheumatoid arthritis (an inflammatory condition of the joints)
Croatian: • teškog reumatoidnog artritisa (upale zglobova);
English: How does Truxima work?
Croatian: Kako djeluje Truxima?
English: Truxima contains the active substance rituximab.
Croatian: Truxima sadržava djelatnu tvar rituksimab.
English: How is Truxima used?
Croatian: Kako se Truxima primjenjuje?
English: For the full list of side effects of Truxima, see the package leaflet.
Croatian: Potpuni popis zabilježenih nuspojava povezanih s lijekom Truxima potražite u uputi o lijeku.
English: It works by attaching to receptors known as beta-2 receptors found in the muscles.
Croatian: Djeluje vezujući se na receptore poznate pod nazivom receptori beta-2 koji se nalaze u mišićima.
English: It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors in various types of immune cells.
Croatian: Djeluje na sličan način kao hormoni kortikosteroida koji se prirodno pojavljuju u tijelu, te smanjuje aktivnost imunosnog sustava tako što se vezuje na receptore u različitim tipovima imunosnih stanica.
English: Budesonide/Formoterol Teva can be used for the regular treatment of asthma.
Croatian: Budesonide/Formoterol Teva može se koristiti za redovito liječenje astme.
English: Budesonide/Formoterol Teva is also used to relieve the symptoms of severe chronic obstructive pulmonary disease (COPD) in adults who have had exacerbations (flare-ups) of the disease in the past despite regular treatment.
Croatian: Teva također se koristi za ublažavanje simptoma ozbiljne kronične opstruktivne pulmonalne bolesti (KOPB-a) u odraslih osoba koje su imale eksacerbacije (pogoršanja) bolesti u prošlosti usprkos redovitom liječenju.
English: The full EPAR and risk management plan summary for Budesonide/Formoterol Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Teva nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Therefore, the CHMP's view was that, as for Symbicort Turbohaler, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a kako koristi, kao i kod lijeka Symbicort Turbohaler, nadmašuju utvrđene rizike.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Budesonide/Formoterol Teva 160/4.5 microgram and 320/9 microgram have been shown to have comparable quality and to be equivalent to the corresponding strengths of Symbicort Turbohaler.
Croatian: Teva od 160/4.5 mikrograma i 320/9 mikrograma posjeduje usporedivu kvalitetu te je bioekvivalentan lijeku Symbicort Turbohaler odgovarajuće jačine.
English: The two active substances in Budesonide/Formoterol Teva are well known and are present in several medicines used to treat asthma and COPD, either alone or in combination with other medicines.
Croatian: Teva dobro su poznate i prisutne u nekoliko lijekova koji se koriste za liječenje astme i KOPB-a, samostalno ili u kombinaciji s drugim lijekovima.
English: This is a summary of the European public assessment report (EPAR) for Budesonide/Formoterol Teva.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Budesonide/Formoterol Teva.
English: Studies were carried out to show that Budesonide/Formoterol Teva is bioequivalent to the reference medicine (i.e. produces the same level of the active substance in the body) and that the two medicines act in the same way.
Croatian: Teva bioekvivalentan referentnom lijeku (odnosno da stvara iste razine djelatne tvari u organizmu) te da dva lijeka djeluju na isti način.
English: What measures are being taken to ensure the safe and effective use of Budesonide/Formoterol Teva?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Budesonide/Formoterol Teva?
English: It is not intended to provide practical advice on how to use Budesonide/Formoterol Teva.
Croatian: Svrha sažetka nije davati praktične savjete o načinu korištenja lijeka Budesonide/Formoterol Teva.
English: This means that it is similar to a ‘reference medicine' containing the same active substances, but Budesonide/Formoterol Teva is given using a different inhaler.
Croatian: To znači da je sličan „referentom lijeku” koji sadrži iste djelatne tvari, no Budesonide/Formoterol
English: What is Budesonide/Formoterol Teva and what is it used for?
Croatian: Što je Budesonide/Formoterol Teva i za što se koristi?
English: A risk management plan has been developed to ensure that Budesonide/Formoterol Teva is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Budesonide/Formoterol Teva.
English: The reference medicine for Budesonide/Formoterol Teva is Symbicort Turbohaler.
Croatian: Teva je Symbicort Turbohaler.
English: What are the benefits and risks of Budesonide/Formoterol Teva?
Croatian: Koje su koristi i rizici lijeka Budesonide/Formoterol Teva?
English: For more information about treatment with Budesonide/Formoterol Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Teva pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: The Committee recommended that Budesonide/Formoterol Teva be given marketing authorisation.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Budesonide/Formoterol Teva.
English: Other information about Budesonide/Formoterol Teva
Croatian: Ostale informacije o lijeku Budesonide/Formoterol Teva
English: Budesonide/Formoterol Teva budesonide / formoterol
Croatian: Budesonide/Formoterol
English: How is Budesonide/Formoterol Teva used?
Croatian: Kako se Budesonide/Formoterol Teva koristi?
English: Budesonide/Formoterol Teva is a ‘hybrid medicine'.
Croatian: Teva je „hibridni lijek”.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Budesonide/Formoterol Teva, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Teva nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Budesonide/Formoterol Teva on 19 November 2014.
Croatian: Teva na snazi u Europskoj uniji od 19. studenoga 2014.
English: Budesonide/Formoterol Teva is a medicine that contains the active substances budesonide and formoterol.
Croatian: Teva je lijek koji sadrži djelatne tvari budezonid i formoterol.
English: How does Budesonide/Formoterol Teva work?
Croatian: Kako djeluje Budesonide/Formoterol Teva?
English: For practical information about using Budesonide/Formoterol Teva, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Teva pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: Why is Budesonide/Formoterol Teva approved?
Croatian: Zašto je Budesonide/Formoterol
English: The benefits and risks of Budesonide/Formoterol Teva are therefore taken to be the same as those of the reference medicine.
Croatian: Pretpostavlja se stoga da su koristi i rizici lijeka Budesonide/Formoterol
English: MA (EU) number (Invented) name
Croatian: Broj EU odobrenja (Zaštićeno) ime Doza
English: National Competent Authorities of Member State(s) or Reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Croatian: Nacionalna nadležna tijela države(a) članice(a) ili referentne(ih) države(a) članice(a), ako je primjenjivo, treba(ju) osigurati da nositelj(i) odobrenja ispuni(e) sljedeće uvjete:
English: The MAHs should identify a specific patient population for which the benefits of the product outweigh the risk.
Croatian: Nositelji odobrenja trebaju identificirati specifičnu populaciju bolesnika za koju koristi lijeka nadmašuju rizike.
English: Conditions for the lifting of the suspension of the Marketing Authorisations
Croatian: Uvjeti za ukidanje suspenzije odobrenja za stavljanje lijeka u promet
English: Annex IV Conditions for the lifting of the marketing authorisation
Croatian: Dodatak IV Uvjeti za ukidanje suspenzije odobrenja za stavljanje lijeka u promet
English: • women who are pregnant;
Croatian: • trudnice
English: However, it withdrew this application during the initial assessment of the medicine.
Croatian: Međutim, povukla je zahtjev tijekom početnog postupka ocjene lijeka.
English: Thalidomide Celgene must never be used by the following groups:
Croatian: Thalidomide Celgene nikad ne smiju koristiti sljedeće skupine:
English: The company will also collect information on whether the medicine is used outside its approved indication.
Croatian: Tvrtka će prikupiti i informacije o tome primjenjuje li se lijek izvan odobrene indikacije.
English: This can help to slow down the progression of multiple myeloma.
Croatian: Na taj se način može usporiti napredak multiplog mijeloma.
English: • women who could become pregnant, unless they take all of the necessary steps to ensure that they are not pregnant before treatment and that they do not become pregnant during or soon after treatment;
Croatian: • žene koje bi mogle zatrudnjeti, osim ako poduzmu sve potrebne mjere kako bi bile sigurne da nisu trudne prije početka liječenja odnosno kako ne bi zatrudnjele tijekom ili nakon liječenja
English: In patients over 75 years of age a starting dose of 100 mg (2 capsules) a day is recommended.
Croatian: Za bolesnike starije od 75 godina preporučuje se početna doza od 100 mg (2 kapsule) dnevno.
English: • patients who are unable to follow or to comply with the requirement to use contraceptives.
Croatian: • bolesnici koji ne mogu slijediti ili se ne mogu pridržavati potrebnih mjera kontracepcije.
English: Previously known as Thalidomide Pharmion.
Croatian: Prethodno poznat kao Thalidomide Pharmion.
English: Thalidomide Celgene can be used for a maximum of 12 treatment cycles, with each cycle lasting 6 weeks.
Croatian: Thalidomide Celgene može se koristiti tijekom najviše 12 ciklusa liječenja, pri čemu svaki ciklus traje šest tjedana.
English: The recommended dose is 200 mg (4 capsules) a day, taken at the same time, preferably at bedtime.
Croatian: Preporučena doza iznosi 200 mg (4 kapsule) dnevno i uzima se u isto vrijeme, po mogućnosti prije spavanja.
English: The most common side effects with Thalidomide Celgene used together with melphalan and prednisone (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils, a type of white blood cell), leucopenia (low white blood cell counts), anaemia (low red blood cell counts), lymphopenia (low levels of lymphocytes, another type of white blood cell), thrombocytopenia (low levels of platelets in the blood), peripheral neuropathy (nerve damage causing tingling, pain and numbness in the hands and feet), tremor (shaking), dizziness, paraesthesia (unusual sensations like pins and needles), dysaesthesia (reduced sense of touch), sleepiness, constipation and peripheral oedema (swelling, usually in the legs).
Croatian: Najčešće su nuspojave lijeka Thalidomide Celgene u kombinaciji s melfalanom i prednizonom (opažene u više od 1 na 10 bolesnika) neutropenija (niska razina neutrofila, vrste bijelih krvnih stanica), leukopenija (niska razina bijelih krvnih stanica), anemija (niska razina crvenih krvnih stanica), limfopenija (niska razina limfocita, druge vrste bijelih krvnih stanica), trombocitopenija (niska razina trombocita), periferna neuropatija (oštećenje živaca koje uzrokuje trnce, bol i utrnulost u rukama i stopalima), tremor (drhtanje), omaglica, parestezija (neobičan osjet poput bockanja iglama), dizestezija (smanjeni osjet dodira), pospanost, zatvor i periferni edem (oticanje, obično nogu).
English: Thalidomide Celgene is available as capsules (50 mg).
Croatian: Lijek Thalidomide Celgene dostupan je u obliku kapsula (50 mg).
English: The European Medicines Agency concluded that, provided that very strict measures are put in place to avoid exposure of unborn children to thalidomide, Thalidomide Celgene's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da, pod uvjetom da se uvedu stroge mjere za sprječavanje izloženosti nerođene djece talidomidu, koristi lijeka Thalidomide Celgene nadmašuju s njim povezane rizike i da može biti odobren za primjenu u EU-u.
English: Each Member State will also ensure that educational materials and patient cards are provided as necessary to prescribers and patients.
Croatian: Svaka država članica također će zajamčiti da se edukativni materijali i kartice za bolesnike prema potrebi isporučuju propisivačima lijeka i bolesnicima.
English: Thalidomide Celgene received a marketing authorisation valid throughout the EU on 16 April 2008.
Croatian: Za lijek Thalidomide Celgene izdano je odobrenje za stavljanje u promet koje je na snazi u EU-u od 16. travnja 2008.
English: The doctor may delay, reduce or stop doses if the patient gets certain side effects, including blood clots, nerve damage, rash, low heart rate, fainting or sleepiness.
Croatian: Liječnik može odgoditi, smanjiti ili prekinuti davanje lijeka ako u bolesnika dođe do nuspojava kao što su krvni ugrušci, oštećenje živaca, osip, usporavanje otkucaja srca, nesvjestica ili pospanost.
English: Patients receiving melphalan and prednisone lived for an average of 33.2 months from the start of the study, compared with 51.6 months when the treatment also included Thalidomide Celgene.
Croatian: Bolesnici koji su primali melfalan i prednizon živjeli su u prosjeku 33,2 mjeseca od početka ispitivanja, u usporedbi s 51,6 mjeseci u slučajevima kad je terapija uključivala i Thalidomide Celgene.
English: It will provide educational kits for healthcare workers and brochures for patients, detailing the steps that need to be taken for the medicine to be used safely.
Croatian: Osigurat će edukativne komplete za zdravstvene radnike i brošure za bolesnike s detaljnim opisom mjera koje je potrebno poduzeti kako bi se lijek sigurno primjenjivao.
English: ema.europa.eu/en/medicines/human/EPAR/thalidomide-celgene-previously-thalidomide-pharmion.
Croatian: Više informacija o lijeku Thalidomide Celgene nalazi se na internetskim stranicama Agencije: ema.europa.eu/en/medicines/human/EPAR/thalidomide-celgene-previously-thalidomidepharmion.
English: Thalidomide is a powerful human ‘teratogen', meaning that it has harmful effect on the unborn child, causing severe and life-threatening birth defects.
Croatian: Talidomid je snažan humani teratogen, što znači da ima štetan učinak na nerođeno dijete i uzrokuje teške i po život opasne prirođene anomalije.