FrancophonIA/ELRC3.0 huggingface dataset:
English: The company that makes Cinryze will ensure that healthcare professionals in all Member States who are expected to prescribe Cinryze are provided with an educational pack instructing them to ensure that caregivers and patients who will give the medicine at home are properly trained.
Croatian: Tvrtka koja proizvodi lijek Cynrize osigurat će da zdravstveni radnici u svim državama članicama, za koje se pretpostavlja da će propisivati Cinryze, dobiju edukativne materijale s uputama koje će osigurati da njegovatelji i bolesnici budu osposobljeni za davanje injekcija kod kuće.
English: Over 50% of patients receiving Cinryze had started having improvements 2 hours into treatment, compared with 33% of patients given placebo.
Croatian: U više od 50 % bolesnika koji su primali lijek Cinryze došlo je do naznaka poboljšanja 2 sata nakon početka liječenja u usporedbi s 33 % bolesnika koji su primili placebo.
English: The second study, involving 24 patients from the first study, looked at the number of attacks over 12week periods when patients were given Cinryze or placebo as prevention.
Croatian: U drugom ispitivanju koje je uključivalo 24 bolesnika iz prvog ispitivanja, pratio se broj napadaja u razdoblju od 12 tjedana u kojem su bolesnici kao prevenciju dobivali lijek Cinryze ili placebo.
English: Based on the evidence from the studies, the CHMP concluded that Cinryze's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Na temelju dokaza iz ispitivanja, CHMP je odlučio da koristi od lijeka Cinryze nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: Cinryze is used to replace the missing C1 inhibitor, correcting the deficiency and helping to prevent or treat angioedema attacks.
Croatian: Lijek Cinryze koristi se kao zamjena za inhibitor C1 koji nedostaje, čime ublažava njegov manjak i pomaže u sprječavanju ili liječenju napadaja angioedema.
English: In the first study, Cinryze or placebo (a dummy treatment) were used to treat angioedema attacks in 71 patients.
Croatian: U prvom ispitivanju, lijek Cinryze ili placebo (prividno liječenje) korišteni su za liječenje napadaja angioedema u 71 bolesnika.
English: Cinryze is also used for routine prevention in adults, adolescents and children from 6 years of age who have severe and frequent angioedema attacks for which prevention with oral medicines is not adequate or in patients whose attacks are not adequately treated.
Croatian: Lijek Cinryze također se koristi za rutinsku prevenciju u odraslih, adolescenata i djece u dobi od 6 godina nadalje koji imaju teške i učestale napadaje angioedema za koje prevencija oralnim lijekovima nije odgovarajuća ili u bolesnika kod kojih napadaji nisu odgovarajuće liječeni.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cinryze 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 Cinryze nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Cinryze contains the active substance C1 inhibitor (human).
Croatian: Cinryze sadrži djelatnu tvar inhibitor C1 (ljudski).
English: The active substance in Cinryze, human C1 inhibitor, is a protein extracted from human blood.
Croatian: Djelatna tvar u lijeku Cinryze, ljudski inhibitor C1, protein je izdvojen iz ljudske krvi.
English: The doctor may decide that the caregivers and patients can carry out the injection provided that they have been adequately trained.
Croatian: Prema odluci liječnika, njegovatelji i bolesnici mogu sami davati injekcije pod uvjetom da su osposobljeni za to na odgovarajući način.
English: Cinryze was more effective than placebo in treating and preventing attacks of angioedema in two main studies involving patients with hereditary angioedema, most of whom were adults.
Croatian: Cinryze je bio učinkovitiji od placeba u liječenju i sprječavanju napadaja angioedema u dva glavna ispitivanja koja su uključivala bolesnike s nasljednim angioedemom, a većina su bili odrasli.
English: How does Cinryze work?
Croatian: Kako djeluje Cinryze?
English: The average number of attacks experienced in patients treated with Cinryze was 6.1 over the 12-week period compared with 12.7 for patients on placebo.
Croatian: Bolesnici liječeni lijekom Cinryze imali su u prosjeku 6,1 napadaj u razdoblju od 12 tjedana u usporedbi s 12,7 napadaja u bolesnika koji su primali placebo.
English: The company provided data on the use of Cinryze in 91 adults and children with hereditary angioedema to prevent attacks when undergoing a medical, surgical or dental procedure.
Croatian: Tvrtka je prikupila podatke o primjeni lijeka Cinryze u 91 odraslog bolesnika i djece s nasljednim angioedemom za sprječavanje napadaja prilikom medicinskog, stomatološkog ili kirurškog zahvata.
English: There will also be a training leaflet for patients that should be kept at home.
Croatian: Bolesnici će u okviru osposobljavanja dobiti i upute koje će čuvati kod kuće.
English: For treatment of angioedema attacks in adults, adolescents and children over 2 years and weighing more than 25 kg, the patient is given 1,000 Units at the first sign of an angioedema attack.
Croatian: Za liječenje napadaja angioedema u odraslih, adolescenata i djece starije od 2 godine i tjelesne težine veće od 25 kg, bolesniku se daje 1000 jedinica na prvi znak napadaja angioedema.
English: What benefits of Cinryze have been shown in studies?
Croatian: Koje su koristi lijeka Cinryze utvrđene u ispitivanjima?
English: Cinryze is a medicine used to treat angioedema (swelling) attacks in adults, adolescents and children over 2 years with hereditary angioedema.
Croatian: Lijek Cinryze koristi se za liječenje napadaja angioedema (oticanje) u odraslih, adolescenata i djece starije od 2 godine s nasljednim angioedemom.
English: For prevention before a medical, dental or surgical procedure in adults, adolescents and children over 2 years and weighing more than 25 kg, Cinryze is given as 1,000 Units within the 24 hours before the procedure.
Croatian: Za sprječavanje napadaja prije medicinskog, stomatološkog ili kirurškog zahvata u odraslih, adolescenata i djece starije od 2 godine i tjelesne težine veće od 25 kg, Cinryze se daje u dozi od 1000 jedinica 24 sata prije postupka.
English: Supportive data on the effectiveness of Cinryze in children aged 2 to 5 years were also provided.
Croatian: Prikupljeni su i podaci u djece u dobi od 2 do 5 godina koji su potkrijepili učinkovitost lijeka Cinryze.
English: In the second study, Cinryze was given as prevention to 6 children with hereditary angioedema.
Croatian: U drugom ispitivanju, Cinryze je kao prevenciju primilo šestero djece s nasljednim angioedemom.
English: For the full list of all side effects and restrictions with Cinryze, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja zabilježenih pri primjeni lijeka Cinryze potražite u uputi o lijeku.
English: How is Cinryze used?
Croatian: Kako se Cinryze koristi?
English: In the first study, Cinryze was used to treat angioedema attacks in 9 children with hereditary angioedema.
Croatian: U prvom ispitivanju lijek Cinryze primijenjen je za liječenje napadaja angioedema u devetero djece s nasljednim angioedemom.
English: The dose is reduced to 500 Units in children aged 2 to 11 years weighing 10 to 25 kg.
Croatian: U djece u dobi od 2 do 11 godina i tjelesne težine od 10 do 25 kg, doza je smanjena na 500 jedinica.
English: The dose is reduced to 500 Units in children aged 2 to 11 years weighing 10 to 25 kg. For routine prevention in adults and adolescents, Cinryze is given as 1,000 Units every 3 or 4 days.
Croatian: Za rutinsku prevenciju u odraslih i adolescenata, Cinryze se daje u dozi od 1000 jedinica svaka 3 ili 4 dana.
English: Meat and offal: cattle: 22 days.
Croatian: 1 bočica Meso i jestive iznutrice: goveda: 22 dana
English: Invented name
Croatian: Izmišljen o ime
English: EU number
Croatian: EU broj odobrenja
English: Subcutaneous use Vial (glass) 500 ml
Croatian: Govedo Subkutana upotreba Bočica (staklo)
English: Packaging Content Package size
Croatian: Pakovanje Sastav Veličina pakovan ja
English: Cattle
Croatian: Karencija
English: The company presented data from three main studies involving over 3,000 patients.
Croatian: Tvrtka je dostavila podatke iz triju glavnih ispitivanja koja su obuhvatila više od 3 000 bolesnika.
English: 10 November 2017 EMA/727596/2017 EMEA/H/C/004165
Croatian: EMA/727596/2017 EMEA/H/C/004165
English: What is Plivensia?
Croatian: Što je Plivensia?
English: It was to be available as a solution for injection in pre-filled pens and syringes (50 mg).
Croatian: Trebao je biti dostupan kao otopina za injekciju u napunjenim brizgalicama i štrcaljkama (50 mg).
English: The main measure of effectiveness was a reduction in symptoms of 20% or more, based on a standard rating score (ACR-20), after 16 weeks of treatment.
Croatian: Glavna mjera djelotvornosti bilo je smanjenje simptoma za 20 % ili više nakon 16 tjedana liječenja na temelju standardne ljestvice (ACR 20).
English: On 26 October 2017, Janssen-Cilag International NV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Plivensia, for the treatment of rheumatoid arthritis.
Croatian: Dana 26. listopada 2017. tvrtka Janssen-Cilag International NV službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) kako želi povući svoj zahtjev za odobrenje za stavljanje u promet lijeka Plivensia za liječenje reumatoidnog artritisa.
English: Withdrawal of the marketing authorisation application for Plivensia (sirukumab)
Croatian: Povlačenje zahtjeva za izdavanje odobrenja za stavljanje u promet lijeka Plivensia (sirukumab)
English: The CHMP's main concern was that the long-term safety of Plivensia had not been well characterised due to limitations in the design of the main studies.
Croatian: Glavna zabrinutost CHMP-a bila je da dugoročna sigurnost lijeka Plivensia nije dovoljno dobro utvrđena zbog ograničenja u izvedbi glavnih ispitivanja.
English: By blocking interleukin-6, sirukumab reduces inflammation and other symptoms associated with rheumatoid arthritis.
Croatian: Blokiranjem interleukina-6 sirukumab smanjuje upalu i druge simptome povezane s reumatoidnim artritisom.
English: The company informed the CHMP that it will discontinue the ongoing long-term extension study with Plivensia in patients with rheumatoid arthritis.
Croatian: Tvrtka je obavijestila CHMP da će prekinuti dugoročni produžetak ispitivanja lijeka Plivensia u tijeku na bolesnicima s reumatoidnim artritisom.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that, given the need for additional clinical data and the fact that other treatments blocking the action of interleukin-6 are available, it wishes to prioritise other programs in its portfolio.
Croatian: U svojem dopisu kojim obavještava Agenciju o povlačenju zahtjeva, tvrtka je navela da želi dati prednost drugim programima iz svog portfelja s obzirom na potrebu za dodatnim kliničkim podatcima i činjenicu da su dostupni drugi oblici liječenja za blokiranje djelovanja interleukina-6.
English: How does Plivensia work?
Croatian: Kako djeluje Plivensia?
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal the CHMP had some concerns and was of the provisional opinion that Plivensia could not have been approved for the treatment of moderate to severe rheumatoid arthritis.
Croatian: Na temelju pregleda podataka i odgovora tvrtke na popise pitanja CHMP-a, u trenutku povlačenja CHMP je smatrao da postoje razlozi za zabrinutost te je njegovo privremeno mišljenje bilo da nije moguće dati odobrenje za lijek Plivensia za liječenje umjerenog do teškog oblika reumatoidnog artritisa.
English: The third study compared Plivensia with adalimumab (a monoclonal antibody targeting a chemical messenger called tumour necrosis factor - TNF) in patients who could not take methotrexate or whose condition had not responded adequately to methotrexate; the study looked at the improvement in how patients' joints worked (based on a standard rating score called DAS28-ESR) after 24 weeks of treatment.
Croatian: U trećem ispitivanju lijek Plivensia uspoređen je s adalimumabom (monoklonsko protutijelo koje djeluje na kemijskog glasnika naziva faktor tumorske nekroze - TNF) u bolesnika koji nisu mogli uzimati metotreksat ili čija bolest nije primjereno reagirala na metotreksat; u ispitivanju se istraživalo poboljšanje u radu zglobova bolesnika nakon 24 tjedna liječenja (na temelju standardne ljestvice pod nazivom DAS28-ESR).
English: The active substance in Plivensia, sirukumab, is a monoclonal antibody, a type of protein which has been designed to block a molecule called interleukin-6.
Croatian: Djelatna tvar lijeka Plivensia, sirukumab, monoklonsko je protutijelo, vrsta proteina koja inhibira djelovanje molekule naziva interleukin-6.
English: Withdrawal of the marketing authorisation application for Plivensia (sirukumab) EMA/727596/2017
Croatian: (sirukumab) EMA/727596/2017
English: Plivensia is a medicine that contains the active substance sirukumab.
Croatian: Plivensia je lijek koji sadržava djelatnu tvar sirukumab.
English: The medicine was to be used in patients when treatment with one or more medicines known as disease-modifying anti-rheumatic drugs (DMARDs) had not worked well enough or had led to troublesome side effects.
Croatian: Lijek se trebao primjenjivati u bolesnika u kojih liječenje jednim ili više lijekova poznatih kao antireumatski lijekovi koji mijenjaju tijek bolesti (DMARD-ovi) nije dovoljno dobro djelovalo ili je dovelo do teško podnošljivih nuspojava.
English: Plivensia was expected to be used in adults with moderate to severe rheumatoid arthritis, a disease that causes inflammation of the joints.
Croatian: Lijek Plivensia trebao se koristiti za liječenje odraslih osoba s umjerenim do teškim reumatoidnim artritisom, bolesti koja uzrokuje upalu zglobova.
English: What was Plivensia expected to be used for?
Croatian: Za što se lijek Plivensia trebao koristiti?
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that, because of lack of proven long-term safety, the benefits of Plivensia did not outweigh its risks, and that further studies were needed.
Croatian: Sukladno navedenome, CHMP je u vrijeme povlačenja smatrao kako koristi od lijeka Plivensia ne nadmašuju s njim povezane rizike zbog izostanka potvrde dugoročne sigurnosti te da su potrebna daljnja ispitivanja.
English: Plivensia was to be used with methotrexate (a DMARD) or alone if the patient could not take methotrexate.
Croatian: Lijek Plivensia trebao se primjenjivati s metotreksatom (DMARD) ili kao monoterapija kod bolesnika koji nisu mogli uzimati metotreksat.
English: Two studies compared Plivensia with placebo (a dummy treatment) in patients with moderate to severe rheumatoid arthritis for whom treatment with a DMARD or with an anti-TNF agent (another type of medicine for rheumatoid arthritis) had not worked well enough or had led to troublesome side effects.
Croatian: Lijek Plivensia uspoređen je s placebom (prividno liječenje) u dvama ispitivanjima na bolesnicima s umjerenim do teškim reumatoidnim artritisom u kojih liječenje DMARD-om ili TNF blokatorom (druga vrsta lijeka za liječenje reumatoidnog artritisa) nije dovoljno dobro djelovalo ili je dovelo do teško podnošljivih nuspojava.
English: Interleukin-6 is involved in causing inflammation and is found at high levels in the joints of patients with rheumatoid arthritis.
Croatian: Interleukin-6 jedan je od uzroka upala i utvrđeno je da je u zglobovima bolesnika koji boluju od reumatoidnog artritisa prisutan u velikim količinama.
English: Date of first authorisation: 16 July 2008 Date of latest renewal: 17 December 2012
Croatian: Datum posljednje obnove odobrenja: 17. prosinca 2012.
English: You should take Clopidogrel Zentiva for as long as your doctor continues to prescribe it.
Croatian: Clopidogrel Zentiva trebate uzimati sve dok Vam ga liječnik propisuje.
English: What Clopidogrel Zentiva is and what it is used for What you need to know before you take Clopidogrel Zentiva How to take Clopidogrel Zentiva Possible side effects
Croatian: Što je Clopidogrel Zentiva i za što se koristi Što morate znati prije nego počnete uzimati Clopidogrel Zentiva Kako uzimati Clopidogrel Zentiva Moguće nuspojave
English: - If you suffer from severe liver disease.
Croatian: • ako patite od teške bolesti jetre.
English: Some other medicines may influence the use of Clopidogrel Zentiva or vice versa.
Croatian: Neki lijekovi mogu utjecati na djelovanje lijeka Clopidogrel Zentiva i obratno.
English: The other ingredients are (see section 2 ‘Clopidogrel Zentiva contains lactose' and ‘Clopidogrel Zentiva contains hydrogenated castor oil'):
Croatian: Drugi sastojci su (vidjeti dio 2. „Clopidogrel Zentiva sadrži laktozu“ i „Clopidogrel Zentiva sadrži hidrogenirano ricinusovo ulje“):
English: What Clopidogrel Zentiva is and what it is used for
Croatian: Što je Clopidogrel Zentiva i za što se koristi
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.
English: For the 7, 14, 28 and 84 tablets pack sizes, you can check the day on which you last took a tablet of Clopidogrel Zentiva by referring to the calendar printed on the blister.
Croatian: Za pakiranja od 7, 14, 28 i 84 tablete možete provjeriti dan kada ste zadnji put uzeli tabletu lijeka Clopidogrel Zentiva pomoću kalendara otisnutog na blisteru.
English: You should have been told that ‘oral anticoagulants' are more effective than acetylsalicylic acid or the combined use of Clopidogrel Zentiva and acetylsalicylic acid for this condition.
Croatian: Trebalo Vam je biti rečeno da su za ovo stanje 'oralni antikoagulansi' učinkovitiji od acetilsalicilatne kiseline ili kombinirane primjene lijeka Clopidogrel Zentiva i acetilsalicilatne kiseline.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 2 or section 6.1.
Croatian: • Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 2 ili dijelu 6.1.
English: This is linked to the way your medicine works as it prevents the ability of blood clots to form.
Croatian: To je povezano s načinom na koji lijek djeluje, jer sprječava mogućnost stvaranja krvnih ugrušaka.
English: If you take more Clopidogrel Zentiva than you should
Croatian: Ako uzmete više lijeka Clopidogrel Zentiva nego što ste trebali
English: As a precautionary measure, breast-feeding should not be continued during treatment with Clopidogrel Zentiva.
Croatian: Kao mjera opreza, treba prestati s dojenjem za vrijeme liječenja lijekom Clopidogrel Zentiva.
English: What you need to know before you take Clopidogrel Zentiva Do not take Clopidogrel Zentiva:
Croatian: Što morate znati prije nego počnete uzimati Clopidogrel Zentiva Nemojte uzimati Clopidogrel Zentiva
English: If you forget to take a dose of Clopidogrel Zentiva, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Croatian: Ako zaboravite uzeti jednu dozu lijeka Clopidogrel Zentiva, ali se toga sjetite u roku od 12 sati, odmah uzmite tabletu, a sljedeću tabletu uzmite u uobičajeno vrijeme.
English: While you are taking Clopidogrel Zentiva:
Croatian: Dok uzimate Clopidogrel Zentiva:
English: Other medicines and Clopidogrel Zentiva
Croatian: Drugi lijekovi i Clopidogrel Zentiva
English: Film-coated tablet (tablet).
Croatian: Filmom obložena tableta.
English: If you become pregnant while taking Clopidogrel Zentiva, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Croatian: Ako zatrudnite za vrijeme uzimanja lijeka Clopidogrel Zentiva, odmah se posavjetujte s liječnikom, jer nije preporučeno uzimati klopidogrel za vrijeme trudnoće.
English: The recommended dose, including for patients with a condition called ‘atrial fibrillation' (an irregular heartbeat), is one 75 mg tablet of Clopidogrel Zentiva per day to be taken orally with or without food, and at the same time each day.
Croatian: Preporučena doza, uključujući za bolesnike sa stanjem zvanim "fibrilacija atrija" (nepravilni otkucaji srca), je jedna tableta lijeka Clopidogrel Zentiva od 75 mg dnevno koja se uzima kroz usta, s obrokom ili bez obroka, i u isto vrijeme svaki dan.
English: Clopidogrel Zentiva contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products.
Croatian: Clopidogrel Zentiva sadrži klopidogrel i pripada skupini lijekova koji se nazivaju antitrombocitni lijekovi.
English: If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Clopidogrel Zentiva in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever.
Croatian: Ako ste imali jaku bol u prsištu (nestabilna angina ili srčani udar), liječnik Vam može propisati Clopidogrel Zentiva u kombinaciji s acetilsalicilatnom kiselinom, tvari prisutnom u mnogim lijekovima za ublažavanje boli i snižavanje temperature.
English: In a relative bioavailability study in adults, the constituted solution of clopidogrel showed a similar extent and slightly higher rate of absorption of the main circulating (inactive) metabolite compared to the authorised tablet.
Croatian: U relativnoj studiji biodostupnosti lijeka u odraslih, konstituirana otopina klopidogrela pokazala je sličan raspon i neznatno veću brzinu apsorpcije glavnog cirkulirajućeg (inaktivnog) metabolita, u usporedbi s tabletom.
English: What Clopidogrel Zentiva looks like and contents of the pack
Croatian: Kako Clopidogrel Zentiva izgleda i sadržaj pakiranja
English: NSAIDs: in a clinical study conducted in healthy volunteers, the concomitant administration of clopidogrel and naproxen increased occult gastrointestinal blood loss.
Croatian: Nesteroidni protuupalni lijekovi (NSAIL): u jednoj kliničkoj studiji provedenoj na zdravim dobrovoljcima, istodobna primjena klopidogrela i naproksena povećala je gubitak krvi okultnim krvarenjem iz probavnog trakta.
English: Patients randomized in the ACTIVE program were those presenting with documented AF, i.e., either permanent AF or at least 2 episodes of intermittent AF in the past 6 months, and had at least one of the following risk factors: age ≥75 years or age 55 to 74 years and either diabetes mellitus requiring drug therapy, or documented previous MI or documented coronary artery disease; treated for systemic hypertension; prior stroke, transient ischaemic attack (TIA), or non-CNS systemic embolus; left ventricular dysfunction with left ventricular ejection fraction <45%; or documented peripheral vascular disease.
Croatian: Bolesnici randomizirani u programu ACTIVE imali su dokumentiranu fibrilaciju atrija (AF), tj. ili permanentnu AF ili najmanje 2 epizode intermitentne AF u zadnjih 6 mjeseci te su imali najmanje jedan od sljedećih faktora rizika: dob ≥75 godina ili 55 do 74 godine te ili dijabetes koji zahtijeva terapiju lijekovima ili dokumentirani prethodni infarkt miokarda ili dokumentiranu bolest koronarnih arterija; ako su primali terapiju za sistemsku hipertenziju; prethodni moždani udar, prolazni ishemijski napadaj (TIA) ili ne-CNS sistemska embolija; disfunkcija lijevog ventrikula s ejekcijskom frakcijom lijevog ventrikula <45% ili dokumentirana periferna vaskularna bolest.