FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Imraldi has a highly similar structure, purity and biological activity to Humira and is distributed in the body in the same way.
Croatian: Europska agencija za lijekove zaključila je da, u skladu sa zahtjevima EU-a za bioslične lijekove, lijek Imraldi ima vrlo sličnu strukturu, čistoću i biološku aktivnost kao i lijek Humira te se u tijelu raspoređuje na isti način.
English: Imraldi and other medicines of its class may affect the ability of the immune system to fight off infections and cancer, and there have been some cases of serious infections and blood cancers in patients using adalimumab.
Croatian: Imraldi i drugi lijekovi u tom razredu mogu utjecati na sposobnost imunosnog sustava da se bori protiv infekcija i raka, pa su zabilježeni slučajevi ozbiljnih infekcija i raka krvi u bolesnika koji su liječeni adalimumabom.
English: Imraldi must not be used in patients with active tuberculosis or other severe infections, or in patients with moderate to severe heart failure (an inability of the heart to pump enough blood around the body).
Croatian: Imraldi se ne smije primjenjivati u bolesnika s aktivnom tuberkulozom, drugim teškim infekcijama ili u bolesnika s umjerenim do teškim zatajenjem srca (nesposobnost srca da pumpa dovoljne količine krvi u tijelu).
English: What are the risks associated with Imraldi?
Croatian: Koji su rizici povezani s lijekom Imraldi?
English: It is not intended to provide practical advice on how to use Imraldi.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Imraldi.
English: The active substance in Imraldi, adalimumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a chemical messenger in the body called tumour necrosis factor (TNF).
Croatian: Djelatna tvar u lijeku Imraldi je adalimumab, monoklonsko protutijelo (vrsta proteina) namijenjeno prepoznavanju i vezivanju za kemijski glasnik u tijelu zvan faktor tumorske nekroze (TNF).
English: This messenger is involved in causing inflammation and is found at high levels in patients with the diseases that Imraldi is used to treat.
Croatian: Taj je glasnik uključen u nastanak upale te se u visokim razinama nalazi u bolesnika oboljelih od bolesti za čije se liječenje koristi Imraldi.
English: Imraldi is mostly used in adults when their conditions are severe, moderately severe or getting worse, or when patients cannot use other treatments.
Croatian: Imraldi se prvenstveno koristi u odraslih osoba kod ozbiljnog, umjereno ozbiljnog stanja bolesti ili onog koje se pogoršava, odnosno kad bolesnici ne mogu primiti drugu terapiju.
English: Imraldi contains the active substance adalimumab and is a ‘biosimilar medicine'.
Croatian: Imraldi sadrži djelatnu tvar adalimumab te je „biosličan lijek”.
English: The most common side effects with adalimumab (seen in more than 1 patient in 10) are infections in the nose and throat and sinuses, injection site reactions (redness, itching, bleeding, pain or swelling), headache and muscle and bone pain.
Croatian: Najčešće nuspojave povezane s adalimumabom (zabilježene u više od 1 na 10 bolesnika) jesu infekcije nosa i ždrijela i sinusa, reakcije na mjestu injiciranja (crvenilo, svrbež, krvarenje, bol ili oticanje), glavobolja i bol u mišićno-koštanom sustavu.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Imraldi 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 Imraldi nalaze se i u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: • non-infectious uveitis (inflammation of the layer beneath the white of the eyeball).
Croatian: • neinfektivnog uveitisa (upale sloja ispod bjeloočnice).
English: For detailed information on the use of Imraldi in all conditions, including when it can be used in children, see the summary of product characteristics (also part of the EPAR).
Croatian: Detaljne informacije o primjeni lijeka Imraldi za sva stanja, kao i kada se može primjenjivati u djece, potražite u sažetku opisa svojstva lijeka (također dio EPAR-a).
English: What benefits of Imraldi have been shown in studies?
Croatian: Koje su koristi lijeka Imraldi dokazane u ispitivanjima?
English: For more information about treatment with Imraldi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Imraldi pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: All these data were considered sufficient to conclude that Imraldi will behave in the same way as Humira in terms of effectiveness and safety in its approved uses.
Croatian: Svi ti podatci smatraju se dovoljnima za donošenje zaključka da će lijek Imraldi za odobrene indikacije djelovati jednako kao lijek Humira u pogledu djelotvornosti i sigurnosti.
English: Eye specialists treating uveitis with Imraldi should also take advice from doctors who have experience of using the medicine.
Croatian: Oftalmolozi koji liječe uveitis lijekom Imraldi trebali bi također poslušati savjete liječnika koji imaju iskustvo u primjeni tog lijeka.
English: For information on the doses to be used for each condition and other information on the use of Imraldi, see the package leaflet.
Croatian: Informacije o dozama koje se koriste za svako stanje, kao i druge informacije o primjeni lijeka Imraldi, potražite u uputi o lijeku.
English: Laboratory studies comparing Imraldi with Humira have shown that the active substance in Imraldi is highly similar to that in Humira in terms of structure, purity and biological activity.
Croatian: Laboratorijska ispitivanja u kojima su uspoređivani lijekovi Imraldi i Humira pokazala su da je djelatna tvar u lijeku Imraldi vrlo slična djelatnoj tvari u lijeku Humira u pogledu strukture, čistoće i biološke aktivnosti.
English: For practical information about using Imraldi, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Imraldi bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svojem liječniku ili ljekarniku.
English: How is Imraldi used?
Croatian: Kako se Imraldi koristi?
English: Studies have also shown that giving Imraldi produces similar levels of the active substance in the body to giving Humira.
Croatian: Ispitivanja su dokazala i da primjena lijeka Imraldi dovodi do slične razine djelatne tvari u tijelu kao i primjena lijeka Humira.
English: How does Imraldi work?
Croatian: Kako djeluje Imraldi?
English: • plaque psoriasis (a disease causing red, scaly patches on the skin)
Croatian: • plak psorijaze (bolesti koja uzrokuje crvene ljuskave lezije na koži)
English: For the full list of side effects and restrictions with Imraldi, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja pri primjeni lijeka Imraldi potražite u uputi o lijeku.
English: • psoriatic arthritis (a disease causing red, scaly patches on the skin with inflammation of the joints)
Croatian: • psorijatičnog artritisa (bolesti koja uzrokuje crvene ljuskave lezije na koži i upalu zglobova)
English: Annually within the annual reassessment
Croatian: Godišnje unutar godišnje ponovne procjene
English: The maximum blood FVIII activity must not exceed 200%.
Croatian: Maksimalna aktivnost FVIII u krvi ne smije premašiti 200%.
English: <There are also links to other websites about rare diseases and treatments.
Croatian: <Tamo se također nalaze poveznice na druge internetske stranice o rijetkim bolestima i liječenjima istih.
English: Before starting reconstitution you will need the following:
Croatian: Prije početka rekonstitucije potrebno je sljedeće:
English: It may harm them,
Croatian: Pomoćne tvari:
English: Tris Base
Croatian: Tris baza
English: You must contact your doctor immediately if you have any of the following early symptoms:
Croatian: Morate se odmah obratiti svom liječniku ako se pojavi bilo koji od sljedećih ranih simptoma:
English: Your doctor will also check if the bleeding is adequately controlled.
Croatian: Vaš će liječnik također provjeriti je li krvarenje primjereno kontrolirano.
English: The following information is intended for healthcare professionals only: INSTRUCTIONS FOR PREPARATION AND ADMINISTRATION Preparation
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim radnicima: UPUTE ZA PRIPREMU I PRIMJENU
English: ATC code: B02BD14
Croatian: ATK oznaka: B02BD14
English: Always use this medicine exactly as your doctor has told you.
Croatian: Uvijek primijenite ovaj lijek točno onako Vam je rekao Vaš liječnik.
English: If severe and sudden allergic reactions occur, the injection must be stopped immediately.
Croatian: Ako se jave teške i iznenadne alergijske reakcije, injekcija se mora odmah prekinuti.
English: A positive response was observed in 95% (19/20) of subjects evaluated at 8 hours and 100% (18/18) at 16 hours.
Croatian: Pozitivan odgovor zabilježen je u 95% (19/20) ispitanika procijenjenih nakon 8 sati i 100% (18/18) nakon 16 sati.
English: A total of 24/28 (86%) had successful control (resolution) of the initial bleeding episode.
Croatian: Ukupno 24/28 (86%) imalo je uspješnu kontrolu (prestanak) početnog krvarenja.
English: If any of these symptoms occur, the injection should be stopped.
Croatian: Ako se u Vas pojavi bilo koji od ovih simptoma, injekcija se treba zaustaviti.
English: Of these 11 subjects, eight had eventual successful treatment (73%).
Croatian: Od tih 11 ispitanika, kod osam je liječenje konačno imalo uspjeha (73%).
English: You should contact your doctor if you missed a dose and do not know how to compensate for this.
Croatian: Obavijestite svog liječnika ako ste propustili dozu i ne znate kako to nadoknaditi.
English: The length of treatment depends on clinical judgement.
Croatian: Trajanje liječenja ovisi o kliničkoj procjeni.
English: What OBIZUR is and what it is used for
Croatian: Što je OBIZUR i za što se koristi
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11 November 2015
Croatian: Datum prvog odobrenja: 11. Studenog 2015
English: This being a marketing authorisation under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Croatian: Budući je ovo odobrenje u iznimnim okolnostima, a temeljem članka 14(8) Uredbe (EZ) br. 726/2004, nositelj odobrenja će, unutar navedenog vremenskog okvira, provoditi sljedeće mjere:
English: OBIZUR is indicated in adults.
Croatian: OBIZUR je indiciran u odraslih.
English: The healthcare professionals training material shall contain the following key elements:
Croatian: Materijal za obuku zdravstvenih radnika sadržavat će sljedeće ključne dijelove:
English: Use aseptic technique during the reconstitution procedure.
Croatian: Koristiti aseptičku tehniku tijekom postupka rekonstitucije.
English: You should be aware of the early signs of allergic reactions (see section 4 for signs and symptoms).
Croatian: Zbog toga morate znati prepoznati rane znakove alergijskih reakcija (vidjeti dio 4 za znakove i simptome).
English: Initial Phase
Croatian: Početna faza
English: All initial bleeding episodes had a positive response to treatment at 24 hours after initial dosing as assessed by the primary investigator.
Croatian: Svi početni slučajevi krvarenja imali su pozitivan odgovor na liječenje 24 sata nakon početne primjene doze prema procjeni glavnog ispitivača.
English: One pack of OBIZUR contains 1, 5 or 10 each of the following
Croatian: Jedno pakiranje lijeka OBIZUR sadrži 1, 5 ili 10 svakog od sljedećeg
English: It is a glycoprotein.
Croatian: Radi se o glikoproteinu.
English: Frequencies have been evaluated according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: Nuspojave su prikazane prema sljedećim kategorijama učestalosti: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000) te nepoznato (ne može se procijeniti iz dostupnih podataka).
English: • An on-line video to further elaborate on the required calculation and administration of the drug
Croatian: • On-line video s dodatnom razradom potrebnog izračuna i primjene lijeka
English: The manufacturing process is free of human serum and human protein products and does not contain any additional animal derived materials.
Croatian: U proizvodnom postupku ne koriste se ljudski serum ni proizvodi ljudskih proteina, niti bilo kakvi dodatni materijali životinjskog podrijetla.
English: Dose (U/kg)
Croatian: Doza (U/kg)
English: The BHK cells are cultured in media that contains fetal bovine serum.
Croatian: BHK stanice su kultivirane u mediju koji sadrži fetalni goveđi serum.
English: The specific activity of OBIZUR is approximately 10,000 U/mg protein.
Croatian: Specifična aktivnost lijeka OBIZUR iznosi približno 10 000 U/mg proteina.
English: The educational programme is aimed to minimize the risk of dose dispensing errors.
Croatian: Edukacijski program treba umanjiti opasnost od pogrešaka u izdavanju doze.
English: Initial Dose (Units per kg)
Croatian: Početna doza (jedinica po kg)
English: The osmolality of the formulation buffer ranges between 59 and 65 10% mOsm/kg H2O.
Croatian: Osmolalnost pufera formulacije u rasponu je od 59 do 65 10% mOsm/kg H2O.
English: Common side effects (may affect up to 1 in 10 people) - Development of antibodies against the medicine
Croatian: Česte nuspojave (mogu se javiti u do 1 na 10 osoba) - Razvoj protutijela protiv lijeka
English: The required initial dose of OBIZUR for a patient is calculated using the following formula:
Croatian: Potrebna početna doza lijeka OBIZUR za bolesnika izračunava se korištenjem sljedeće formule:
English: <This leaflet is available in all EU/EEA languages on the European Medicines Agency website.>
Croatian: <Ova Uputa o lijeku je dostupna na svim EU/EEA jezicima na internetskoj stranici Europske agencije za lijekove.>
English: OTHER Baxalta Logo
Croatian: DRUGO Logotip Baxalta
English: Subjects were in a non-bleeding state.
Croatian: Ispitanici su bili u stanju bez krvarenja.
English: Use in children and adolescents below 18 years with congenital or in rare cases of acquired haemophilia is currently not approved.
Croatian: Primjena u djece i adolescenata u dobi ispod 18 godina s kongenitalnom ili u rijetkim slučajevima stečenom hemofilijom trenutno nije odobrena.
English: Remove the plastic package (Figure E).
Croatian: Ukloniti plastično pakiranje (Slika E).
English: The dose and frequency of administration should be based on results of Factor VIII activity (to be maintained within recommended limits) and on the clinical response achieved.
Croatian: Doza i učestalost primjene moraju se temeljiti na rezultatima aktivnosti faktora VIII (potrebno je održavati unutar preporučenih granica) i o postignutom kliničkom odgovoru.
English: Wipe the rubber stopper with an alcohol swab (not supplied) and allow it to dry prior to use.
Croatian: Prebrisati gumeni čep vatom natopljenom alkoholom (nije isporučeno) i pričekati da se osuši prije korištenja.
English: Prior to launch of Obizur in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Croatian: Prije puštanja lijeka OBIZUR u promet u svakoj zemlji članici, nositelj odobrenja (MAH) mora dogovoriti sadržaj i oblik edukacijskog programa, uključujući način komunikacije, oblike distribucije i sve ostale aspekte programa nadležnog nacionalnog tijela.
English: Efficacy and safety data in patients with acquired haemophilia are limited (see section 5.1).
Croatian: Podaci o djelotvornosti i sigurnosti u bolesnika sa stečenom hemofilijom su ograničeni (vidjeti dio 5.1).
English: Talk to your doctor if you are on a controlled sodium diet.
Croatian: Obavijestite svog liječnika ako ste na dijeti s kontroliranim unosom natrija.
English: Those with pre-existing cardiovascular disease and the elderly are at particular risk.
Croatian: Naročito postoji rizik kod osoba s postojećom kardiovaskularnom bolesti i starijih osoba.
English: Tmax (h)
Croatian: t½ (h) Tmax (h)
English: The Factor VIII/von Willebrand factor complex consists of two molecules (Factor VIII and von Willebrand factor) with different physiological functions.
Croatian: Kompleks faktor VIII/von Willebrandov faktor sastoji se od dvije molekule (faktora VIII i von Willebrandovog faktora) koje imaju različite fiziološke funkcije.
English: The MAH shall ensure that in each Member State where Obizur is marketed, all healthcare professionals who are expected to prescribe and dispense Obizur have access to/are provided with the following educational package:
Croatian: MAH će osigurati da u svakoj zemlji članici u kojoj je OBIZUR pušten u promet svi zdravstveni radnici koji trebaju propisivati i izdavati OBIZUR imaju pristup/dobiju sljedeći edukacijski paket:
English: Development of inhibitory antibodies
Croatian: Razvoj inhibicijskih protutijela
English: Talk to your doctor if you have had a cardiovascular disease in the past or if you have a known risk of thrombosis (diseases from blood clots in normal vasculature), because the possiblity of developing thromboembolic diseases at high and sustained blood Factor VIII levels cannot be excluded.
Croatian: Recite svom liječniku ako ste imali kardiovaskularnu bolest u prošlosti ili ako imate poznati rizični faktor za trombozu (bolest prouzročena krvnim ugrušcima u normalnim žilama), jer se ne može isključiti mogućnost razvijanja tromboembolijskih bolesti kod visokih i dugotrajnih razina faktora krvi VIII.
English: Using aseptic technique, administer using the following procedure:
Croatian: Aseptičkom tehnikom primijeniti korištenjem sljedećeg postupka:
English: Measurement of Factor VIII activity must always be carried out using the same assay methodology on any one patient.
Croatian: Mjerenje aktivnosti Faktora VIII mora se uvijek provoditi istom metodom na svakom bolesnikom.
English: • The healthcare professionals training material
Croatian: • Materijal za obuku zdravstvenih radnika
English: What you need to know before you use OBIZUR
Croatian: Što morate znati prije nego počnete primjenjivati OBIZUR
English: Therefore, OBIZUR must only be administered when considered clinically necessary.
Croatian: Stoga se OBIZUR smije primjenjivati samo kada se smatra kliničkim neophodnim.
English: OBIZUR temporarily replaces the inhibited endogenous Factor VIII that is needed for effective haemostasis.
Croatian: OBIZUR privremeno zamjenjuje inhibirani endogeni faktor VIII koji je potreban za učinkovitu hemostazu.
English: One Unit (U) of Factor VIII activity is equivalent to that quantity of Factor VIII in one ml of normal human plasma.
Croatian: Jedna jedinica (U) aktivnosti faktora VIII jednaka je količini faktora VIII u jednom ml normalne ljudske plazme.
English: • Do not administer OBIZUR in the same tubing or container with other medicinal products for injection.
Croatian: • Lijek OBIZUR se ne smije primijeniti iz iste cjevčice ili spremnika s drugim lijekovima za ubrizgavanje.
English: Do not use OBIZUR: - if you are allergic to susoctocog alfa or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to hamster proteins (trace amounts may be present in Obizur arising from the manufacturing process)
Croatian: Nemojte primjenjivati OBIZUR: - ako ste alergični na susoktokog alfa ili neki drugi sastojak ovog lijeka (naveden u dijelu 6) - ako ste alergični na proteine hrčka (iz proizvodnog postupka mogu biti u tragovima prisutni u lijeku OBIZUR)
English: High and sustained Factor VIII activity in blood may predispose to thromboembolic events.
Croatian: Visoka i dugotrajna aktivnost Faktora VIII u krvi može pogodovati tromboembolijskim događajima.
English: Factor VIII is necessary for the blood to form clots and stop bleedings.
Croatian: Faktor VIII je nužan u krvi kako bi se stvorio ugrušak i zaustavila krvarenja.
English: To collect and analyse immediate and long-term data on clinical efficacy and safety of all patients with acquired haemophilia and who are treated with Obizur, the MAH must conduct a surveillance programme/ registry according to an agreed protocol and for an indefinite time.
Croatian: Za prikupljanje i analizu neposrednih i dugoročnih podataka o kliničkoj učinkovitosti i sigurnosti u svih bolesnika sa stečenom hemofilijom i u onih liječenih lijekom OBIZUR, nositelj odobrenja mora provoditi program nadzora/registar u skladu s dogovorenim protokolom te u neodređenom vremenu.
English: Positive test for inhibitory antibodies against porcine Factor VIII (see section 4.4)
Croatian: Pozitivan test na inhibitorska protutijela protiv svinjskog faktora VIII (vidjeti dio 4.4)
English: Therefore, OBIZUR should be used during pregnancy and lactation only if clearly indicated.
Croatian: Stoga tijekom trudnoće i dojenja OBIZUR treba primjenjivati isključivo ako je jasno indiciran.
English: One, five, ten pre-filled syringes with solvent One, five, ten vial adapters
Croatian: Jedna, pet, deset napunjenih štrcaljki s otapalom Jedan, pet, deset adaptera za bočicu
English: OBIZUR (antihaemophilic Factor VIII (recombinant), porcine sequence) is a purified protein that has 1448 amino acids with an approximate molecular mass of 175kDa.
Croatian: OBIZUR (koagulacijski faktor VIII (rekombinantni), svinjska sekvencija) je pročišćeni protein sa 1448 aminokiselina s približnom molekularnom masom od 175kDa.
English: If venous catheterisation is required, the risk of catheter-related complications such as catheter site thrombosis should be considered.
Croatian: Ako je neophodna venska kateterizacija, treba uzeti u obzir komplikacije vezane uz kateter, kao što je tromboza na mjestu katetera.
English: There is a rare chance that you may experience an allergic reaction to OBIZUR.
Croatian: Postoji mala mogućnost da u Vas nastupi alergijska reakcija na OBIZUR.
English: Immediately after release in the patient's circulation, Factor VIII binds to von Willebrand factor (vWF).
Croatian: Odmah nakon otpuštanja u krvotok bolesnika, faktor VIII se veže na von Willebrandov faktor (vWF).
English: It is recommended that treatment should be based on clinical judgement and not based on detection of inhibitory antibodies by the Bethesda assay.
Croatian: Preporučuje se da liječenje temelji na kliničkoj procjeni, a ne na detekciju inhibitorskih protutijela Bethesda testom.
English: The physician educational material should contain:
Croatian: Edukacijski materijal za liječnika treba sadržavati:
English: A positive response was one where bleeding had stopped or was reduced, with clinical improvement or with Factor VIII activity above a pre-specified target.
Croatian: Pozitivnim odgovorom smatra se prestanak ili smanjenje krvarenja, s kliničkim poboljšanjem ili s aktivnošću faktora VIII iznad unaprijed definiranog cilja.
English: Severe symptoms, including difficulty in breathing and (near) fainting, require emergency treatment.
Croatian: Teški simptomi koji uključuju poteškoće u disanju te (skorašnju) nesvjesticu zahtijevaju hitnu medicinsku pomoć.
English: Name and batch number
Croatian: Naziv i broj serije
English: Frequency and Duration of Subsequent Dosing
Croatian: Sljedeća doza Učestalost i trajanje sljedećeg doziranja
English: Solvent Sterilised water for injections
Croatian: Otapalo Sterilizirana voda za injekcije
English: It requires clinical supervision of the bleeding status of the patient.
Croatian: Potrebno je kliničko praćenje krvarenja u bolesnika.
English: • Large sterile syringe to contain the final volume of reconstituted product
Croatian: • Velika sterilna štrcaljka koja će sadržati završni volumen rekonstituiranog lijeka