FrancophonIA/ELRC3.0 huggingface dataset:
English: - During treatment with Extavia your body may produce substances called neutralising antibodies, which may react with Extavia.
Croatian: - Tijekom liječenja Extavijom Vaše bi tijelo moglo stvarati tvari koje se nazivaju neutralizirajućim protutijelima, koja mogu reagirati s Extavijom.
English: List 2:
Croatian: Popis 2:
English: Furthermore, for the time being there is no well established definition of a high risk patient, although a more conservative approach is to accept at least nine T2 hyperintense lesions on the initial scan and at least one new T2 or one new Gd-enhancing lesion on a follow-up scan taken at least 1 month after the initial scan.
Croatian: Nadalje, za sada ne postoji dobro utvrđena definicija bolesnika s visokim rizikom, iako je konzervativniji pristup prihvatiti najmanje devet T2 hiperintenzivnih lezija na početnoj snimci te najmanje jednu novu T2 leziju ili jednu novu leziju s pojačanim signalom nakon primjene gadolinija na kontrolnoj snimci napravljenoj najmanje 1 mjesec nakon početne snimke.
English: Asymptomatic elevations of serum transaminases, in most cases mild and transient, occurred very commonly in patients treated with Extavia during clinical trials.
Croatian: Asimptomatska povišenja serumskih transaminaza, u većini slučajeva blaga i prolazna, vrlo često su se javljala u bolesnika liječenih Extavijom tijekom kliničkih ispitivanja.
English: * The titration period may be adjusted if any significant adverse reaction occurs.
Croatian: * Razdoblje titracije može se prilagoditi ako dođe do bilo kakve značajne nuspojave.
English: While Extavia does not have any known direct-acting cardiac toxicity, symptoms of the flu-like syndrome associated with beta interferons may prove stressful to patients with pre-existing significant cardiac disease.
Croatian: Iako Extavia nema nikakvu poznatu izravno djelujuću srčanu toksičnost, simptomi sindroma nalik gripi povezanog s beta interferonima mogli bi biti stresni za bolesnike s već postojećom značajnom srčanom bolešću.
English: Your doctor may perform tests to check your kidney function.
Croatian: Vaš liječnik može obaviti pretrage kako bi provjerio funkciju Vaših bubrega.
English: Furthermore, there was a prolongation of the relapse-free interval.
Croatian: Nadalje, došlo je do produljenja intervala bez relapsa.
English: Injection site reactions and necroses were observed less frequently in this study than in the other pivotal studies.
Croatian: Reakcije na mjestu primjene i nekroze bile su uočene s manjom učestalošću u ovom ispitivanju nego u drugim ključnim ispitivanjima.
English: What you need to know before you use Extavia
Croatian: Što morate znati prije nego počnete primjenjivati Extaviju
English: Therefore, the tip cap may contain natural rubber latex, which should not be handled by persons sensitive to this substance.
Croatian: Stoga, zatvarač vrha može sadržavati prirodnu lateks gumu, te njime ne bi smjele rukovati osobe osjetljive na ovu tvar.
English: No formal interaction studies have been carried out to find out whether Extavia affects other medicines or is affected by them.
Croatian: Nisu provedena službena ispitivanja interakcija da bi se otkrilo da li Extavia utječe na druge lijekove ili drugi lijekovi utječu na Extaviu.
English: In-use stability demonstrated for 3 hours at 2°C - 8°C.
Croatian: Stabilnost u primjeni dokazana je za razdoblje od 3 sata na temperaturi 2°C - 8°C.
English: Hypersensitivity to natural or recombinant interferon beta, human albumin or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na prirodni ili rekombinantni interferon beta, ljudski albumin ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Adverse events related to the central nervous system associated with the use of Extavia might influence the ability to drive and use machines in susceptible patients.
Croatian: Štetni događaji koji se odnose na središnji živčani sustav, a povezani su s primjenom Extavije, mogli bi utjecati na sposobnost upravljanja vozilima i rada na strojevima u podložnih bolesnika.
English: ► If you have only one sore injection site (lesion) and the tissue damage (necrosis) is not too extensive you may continue using Extavia.
Croatian: Ako imate samo jedno bolno mjesto injiciranja (leziju) i područje oštećenog tkiva (nekroza) nije preveliko možete nastaviti uzimati Extaviju.
English: Withdrawal of Extavia should be considered if the levels significantly increase or if they are associated with clinical symptoms such as jaundice.
Croatian: Ukidanje terapije Extavijom treba razmotriti ako se razine znatno povise ili ako su povezane s kliničkim simptomima poput žutice.
English: In the second trial of Extavia in secondary progressive multiple sclerosis, no delay in the time to disability progression was observed.
Croatian: U drugom ispitivanju Extavije u sekundarno progresivnoj multiploj sklerozi nije zabilježena odgoda u vremenu do napretka invalidnosti.
English: Depression and suicidal ideation are known to occur with increased frequency in the multiple sclerosis population and in association with interferon use.
Croatian: Poznato je da se depresija i suicidalne ideje javljaju s povećanom učestalošću u populaciji s multiplom sklerozom te su povezane s uporabom interferona.
English: No formal clinical trials or pharmacokinetic studies have been conducted in children or adolescents.
Croatian: Nisu provedena formalna klinička ispitivanja ili ispitivanja farmakokinetike u djece ili adolescenata.
English: After the placebo-controlled phase, patients entered a pre-planned follow-up phase with Extavia to evaluate the effects of immediate versus delayed start of Extavia treatment, comparing patients initially randomised to Extavia (“immediate treatment group”) or to placebo (“delayed treatment group”).
Croatian: Nakon placebom kontrolirane faze, bolesnici su ušli u unaprijed planiranu fazu naknadnog praćenja s Extavijom, kako bi se ocijenili učinci neposrednog u odnosu na odgođeni početak liječenja Extavijom, uspoređujući bolesnike koji su prvobitno bili randomizirani na primanje Extavije („skupina s neposredno započetim liječenjem“) ili na placebo („skupina s odgođenim početkom liječenja“).
English: The dose should be increased at every fourth injection in four steps (0.25 ml, 0.5 ml, 0.75 ml, 1.0 ml).
Croatian: Dozu treba povećavati pri svakoj četvrtoj injekciji u četiri koraka (0,25 ml, 0,5 ml, 0,75 ml i 1,0 ml).
English: The most serious were reported in patients taking other medicines or who were suffering from diseases that can affect the liver (e.g. alcohol abuse, severe infection).
Croatian: Najozbiljniji su bili zabilježeni u bolesnika koji su uzimali druge lijekove ili koji su bolovali od bolesti koje mogu pogoditi jetru (npr. zlouporaba alkohola, teška infekcija).
English: - Extavia contains human albumin and therefore carries a potential risk for transmission of viral diseases.
Croatian: - Extavia sadrži ljudski albumin te stoga nosi mogući rizik od prijenosa virusnih bolesti.
English: During Extavia treatment you are likely to experience injection site reactions.
Croatian: Tijekom liječenja Extavijom vjerojatno ćete osjetiti reakcije na mjestu davanja injekcije.
English: What Extavia is used for Extavia is for use in patients ► who have experienced for the first time symptoms which indicate a high risk of developing multiple sclerosis.
Croatian: Za što se koristi Extavia Extavia se upotrebljava u bolesnika ► koji su prvi put dobili simptome koji ukazuju na visoki rizik od razvoja multiple skleroze.
English: - If you have severe kidney problems, your doctor may monitor your kidney function during treatment.
Croatian: Ako imate teške probleme s bubrezima liječnik može nadzirati funkciju Vaših bubrega tijekom liječenja.
English: The placebo-controlled phase lasted for 2 years or until the patient developed clinically definite multiple scleroiss (CDMS), whichever came first.
Croatian: Placebom kontrolirana faza je trajala 2 godine ili dok se u bolesnika nije razvila klinički definitivna multipla skleroza (KDMS), što god da je nastupilo ranije.
English: For relapsing-remitting multiple sclerosis, efficacy has been demonstrated for therapy for the first two years.
Croatian: Za relapsno-remitirajuću multiplu sklerozu dokazana je djelotvornost liječenja u prve dvije godine.
English: 2 - Remove the flip off cap from the Extavia vial.
Croatian: 2 - Skinite “flip off” kapicu s bočice Extavije.
English: The following instructions and pictures explain how to prepare Extavia for injection and how to inject Extavia yourself.
Croatian: Sljedeće upute i slike objašnjavaju Vam kako ćete sami pripremiti Extaviju za injekciju i kako si injicirati Extaviju.
English: ► If you have more than one sore injection sites (multiple lesions) you must stop using Extavia until your skin has healed.
Croatian: Ako imate više od jednog bolnog mjesta primjene (višestruke lezije), morate prestati uzimati Extaviju dok Vam koža ne zacijeli.
English: Treatment is not recommended in patients with relapsing-remitting multiple sclerosis who have experienced less than 2 relapses in the previous 2 years or in patients with secondary-progressive multiple sclerosis who have had no active disease in the previous 2 years.
Croatian: Liječenje se ne preporučuje u bolesnika s relapsno-remitirajućom multiplom sklerozom, koji su doživjeli manje od 2 relapsa u prethodne 2 godine, ili u bolesnika sa sekundarno progresivnom multiplom sklerozom, koji nisu imali aktivnu bolest u prethodne 2 godine.
English: These symptoms may suggest problems with your liver.
Croatian: Ti bi simptomi mogli upućivati na poteškoće s jetrom.
English: Extavia should be administered with caution to patients with previous or current depressive disorders, in particular to those with antecedents of suicidal ideation (see section 4.3).
Croatian: Extaviju treba primjenjivati s oprezom u bolesnika s prethodnim ili trenutnim depresivnim poremećajima, posebice u onih s prethodnim suicidalnim idejama (vidjeti dio 4.3).
English: The titration period may be adjusted, if any significant adverse reaction occurs.
Croatian: Razdoblje titracije može se prilagoditi ako dođe do bilo kakve značajne nuspojave.
English: However, limited published data suggest that the safety profile in adolescents from 12 to 17 years of age receiving Extavia 8.0 million IU subcutaneously every other day is similar to that seen in adults.
Croatian: Međutim, ograničeni objavljeni podaci upućuju na to da je sigurnosni profil u adolescenata u dobi od 12 do 17 godina koji primaju Extaviju 8,0 milijuna IU supkutano svaki drugi dan sličan onome u odraslih.
English: In the different controlled clinical trials, between 23% and 41% of the patients developed serum interferon beta-1b neutralising activity confirmed by at least two consecutive positive titres.
Croatian: U različitim kontroliranim kliničkim ispitivanjima između 23% i 41% bolesnika razvilo je neutralizirajuću aktivnost u serumu na interferon beta-1b potvrđenu pomoću najmanje dva uzastopna pozitivna titra.
English: No data are available on the use of Extavia in children under 12 years of age and therefore Extavia should not be used in this population.
Croatian: Nema dostupnih podataka o primjeni Extavije u djece mlađe od 12 godina te se stoga Extavia u toj populaciji ne smije primjenjivati.
English: These instructions also tell you how to prepare the Extavia solution for injection.
Croatian: Te Vam upute također govore kako pripremiti otopinu Extavia za injekciju.
English: • Medicine
Croatian: • Lijek
English: If the patient experiences any break in the skin, which may be associated with swelling or drainage of fluid from the injection site, the patient should be advised to consult with his/her physician before continuing injections with Extavia.
Croatian: Ako kod bolesnika dođe do pucanja kože koje može biti povezano s oticanjem ili drenažom tekućine s mjesta injiciranja, bolesnika treba obavijestiti da se posavjetuje s njegovim/njezinim liječnikom prije nastavka uzimanja injekcija Extavije.
English: Redness, swelling, discolouration, inflammation, pain, hypersensitivity, necrosis and non-specific reactions were significantly associated with 250 microgram (8.0 million IU) Extavia treatment.
Croatian: Crvenilo, oticanje, promjena boje, upala, bol, preosjetljivost, nekroza i nespecifične reakcije značajno su povezane s liječenjem Extavijom 250 mikrograma (8,0 milijuna IU).
English: Instructions for keeping track of your injection sites and dates
Croatian: Upute za praćenje mjesta i datuma injiciranja
English: No influence on the monkey oestrous cycle has been observed.
Croatian: Nije primijećen utjecaj na spolni ciklus u rezus-majmuna.
English: The following adverse event listings are based on reports from clinical trials (Table 1, adverse events and laboratory abnormalities) and from post-marketing surveillance (Table 2, frequencies - where known - based on pooled clinical trials (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)) of Extavia use.
Croatian: Sljedeći se popisi štetnih događaja temelje na izvješćima iz kliničkih ispitivanja (Tablica 1, štetni događaji i laboratorijske abnormalnosti) te na praćenju primjene lijeka Extavia nakon stavljanja u promet (Tablica 2, učestalosti - ako su poznate - na temelju objedinjenih kliničkih ispitivanja (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)).
English: By following this schedule, you will come back to your first area (e.g. the right side of the abdomen) after 8 injections (16 days).
Croatian: Pridržavanjem ovog rasporeda vraćate se na područje gdje ste dali prvu injekciju (primjerice, na desnoj strani trbuha) nakon 8 injekcija (16 dana).
English: In retrospective meta-analyses including the data of both studies, a statistically significant overall treatment effect was found (p=0.0076; 8.0 million IU Extavia versus all placebo patients).
Croatian: U retrospektivnim meta-analizama koje su uključivale podatke iz oba ispitivanja otkriven je statistički značajan ukupan terapijski učinak (p=0,0076; 8,0 milijuna IU Extavije naspram svih bolesnika koji su primali placebo).
English: To reconstitute and inject your medicine you will need to use an ExtaviPro 30G application kit (supplied separately to your medicine), which contains the following components and instructions on how to use them:
Croatian: Za pripremu otopine i injiciranje lijeka trebat ćete koristiti ExtaviPro 30G set za primjenu (nabavlja se zasebno od lijeka), koji sadrži sljedeće komponente i upute za njihovo korištenje:
English: Relapsing-remitting multiple sclerosis (RR-MS)
Croatian: Relapsno-remitirajuća multipla skleroza (RR-MS)
English: If excessive foaming is present - which can happen if the vial is shaken or swirled too vigorously - let the vial sit undisturbed until the foam settles.
Croatian: Ako ima previše pjene - što se može dogoditi ako se bočica trese ili okreće presnažno - ostavite bočicu sa strane sve dok se pjena ne slegne.
English: 4 - Where possible gently pinch the skin together around the disinfected injection site (to raise it up a little).
Croatian: - Tamo gdje je to moguće lagano uhvatite kožu oko dezinficiranog mjesta injiciranja (da biste ju blago podigli).
English: Cessation of therapy with Extavia should be considered (see also sections 4.3 and 4.8).
Croatian: Potrebno je razmotriti prekid terapije Extavijom (vidjeti također dijelove 4.3 i 4.8).
English: Pulmonary arterial hypertension has been seen at various time points during treatment, including several years after starting treatment with Extavia.
Croatian: Plućna arterijska hipertenzija uočena je u različitim vremenskim točkama tijekom liječenja, i do nekoliko godina nakon početka liječenja Extavijom.
English: See section 2 “Warnings and precautions” and follow the instructions under “Rotating injection sites” in the Annex at the back of this leaflet.
Croatian: Pogledajte dio 2 „Upozorenja i mjere opreza“ te slijedite upute pod „Promjena mjesta primjene“ u Prilogu na kraju ove upute.
English: Secondary progressive multiple sclerosis (SP-MS) Two controlled clinical trials were performed with Extavia involving a total of 1,657 patients with secondary progressive multiple sclerosis (baseline EDSS 3 to 6.5, i.e. patients were able to walk).
Croatian: Sekundarno progresivna multipla skleroza (SP-MS) Dva kontrolirana klinička ispitivanja provedena su s Extavijom, a uključivala su ukupno 1657 bolesnika sa sekundarno progresivnom multiplom sklerozom (početni EDSS 3 do 6,5, tj. bolesnici su mogli hodati).
English: Patients with pre-existing significant cardiac disease, such as congestive heart failure, coronary artery disease or arrhythmia, should be monitored for worsening of their cardiac condition, particularly during initiation of treatment with Extavia.
Croatian: Bolesnike s već postojećim značajnim srčanim poremećajima kao što su kongestivno zatajenje srca, bolest srčanih arterija ili aritmija treba nadzirati radi pogoršanja stanja njihova srca, posebice tijekom početka terapije Extavijom.
English: Extavia can be used during breast-feeding.
Croatian: Extavia se smije koristiti tijekom dojenja.
English: Serious hypersensitivity reactions (severe acute reactions such as bronchospasm, anaphylaxis and urticaria) may occur.
Croatian: Mogu se javiti teške reakcije preosjetljivosti (teške akutne reakcije poput bronhospazma, anafilakse i urtikarije).
English: If you stop using Extavia
Croatian: Ako prestanete primjenjivati Extaviju
English: - Be consistent - use this medicine as described in section 3 of the leaflet, “How to use Extavia”.
Croatian: - Budite dosljedni - primjenjujte ovaj lijek kako je opisano u dijelu 3 upute, „Kako primjenjivati
English: In both trials there was a reduction (30%) in frequency of clinical relapses in patients with secondary progressive multiple sclerosis patients receiving Extavia.
Croatian: U oba ispitivanja došlo je do smanjenja (30%) učestalosti kliničkih relapsa u bolesnika sa sekundarno progresivnom multiplom sklerozom koji su primali Extaviju.
English: Relapsing-remitting multiple sclerosis: People with relapsing-remitting MS have occasional attacks or relapses during which symptoms become noticeably worse.
Croatian: Relapsno remitirajuća multipla skleroza: Osobe s relapsno remitirajućom multiplom sklerozom imaju povremene napade ili relapse tijekom kojih se simptomi vidno pogoršavaju.
English: Aspartate aminotransferase increased (SGOT >5 times baseline)
Croatian: Povišena aspartat aminotransferaza (SGOT >5 puta početna vrijednost)
English: Gamma-glutamyltransferase increased, Hepatitis
Croatian: Povišenje gamaglutamiltransferaze, Hepatitis
English: Patients exhibiting depression should be monitored closely during therapy with Extavia and treated appropriately.
Croatian: Bolesnike koji pokazuju znakove depresije treba pomno nadzirati tijekom terapije Extavijom te liječiti na odgovarajući način.
English: Changes to liver function values occurred in patients treated with Extavia during clinical studies.
Croatian: Promjene u vrijednostima jetrene funkcije javile su se u bolesnika liječenih Extavijom tijekom kliničkih ispitivanja.
English: Very common side effects which have occurred in clinical trials with Extavia (may affect more than 1 in 10 people) and at a higher percentage than those observed with placebo.
Croatian: Vrlo česte nuspojave koje su se javljale u kliničkim ispitivanjima s Extavijom (mogu se javiti u više od 1 na 10 osoba) te u višem postotku nego što je uočeno za placebo.
English: • Patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis (see section 5.1).
Croatian: • Bolesnika s pojedinačnim procesom demijelinizacije i aktivnim upalnim procesom ako je on dovoljno težak da opravda liječenje intravenskim kortikosteroidima, ako su alternativne dijagnoze isključene te ako je utvrđeno da bolesnik ima veliki rizik od razvoja klinički jasne multiple skleroze (vidjeti dio 5.1).
English: Extavia should be administered with caution to patients with a history of seizures, to patients receiving treatment with anti-epileptics, and in particular to patients with epilepsy who are not adequately controlled with anti-epileptics (see sections 4.5 and 4.8).
Croatian: Extaviju je potrebno oprezno primjenjivati u bolesnika s epileptičkim napadajima u anamnezi, u bolesnika koji se liječe antiepilepticima, te osobito u bolesnika s epilepsijom čije stanje nije primjereno kontrolirano antiepilepticima (vidjeti dijelove 4.5 i 4.8).
English: This may suggest a disease of the heart muscle (cardiomyopathy) which has been reported in patients using Extavia.
Croatian: To bi moglo upućivati na bolest srčanog mišića (kardiomiopatiju) koja je zabilježena u bolesnika koji uzimaju Extaviju.
English: Powder - white to off-white in colour.
Croatian: Prašak - bijele do bjelkaste boje.
English: • 1 pre-filled syringe of solvent for Extavia (sodium chloride solution)
Croatian: • 1 napunjena štrcaljka otapala za Extaviju (otopina natrijevog klorida)
English: Your doctor or nurse can tell you more about this.
Croatian: Vaš Liječnik ili medicinska sestra će Vam više reći o toj mogućnosti.
English: Prompt treatment of nephrotic syndrome is required and discontinuation of treatment with Extavia should be considered.
Croatian: Potrebno je odmah započeti s liječenjem nefrotskog sindroma i razmotriti prekid liječenja Extavijom.
English: - You will need blood tests to determine your blood cell count, blood chemistry and your liver enzymes.
Croatian: - Morat ćete obaviti krvne pretrage da bi se odredila krvna slika, biokemijski parametri krvi i jetreni enzimi.
English: Other medicines and Extavia Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako primjenjujete, nedavno ste primijenili ili biste mogli primijeniti bilo koje druge lijekove.
English: Extavia should also be used with caution in patients who suffer from pre-existing cardiac disorders.
Croatian: Extaviju također treba upotrebljavati s oprezom u bolesnika koji već imaju srčane poremećaje.
English: Interferon alpha, interferon beta, and interferon gamma have overlapping yet distinct biological activities.
Croatian: Interferon alfa, interferon beta i interferon gama posjeduju preklapajuće, ali i zasebne biološke aktivnosti.
English: Interferon beta-1b has been shown to possess both antiviral and immunoregulatory activity.
Croatian: Dokazano je da interferon beta-1b posjeduje i antivirusna i imunoregulatorna djelovanja.
English: Myalgia * °
Croatian: Mijalgija * °
English: Dispose of the vial and the remaining unused portion of the solution into the disposal unit.
Croatian: Odložite bočicu i preostalu neiskorištenu količinu otopine u posudu za otpad.
English: Extavia may cause serious side effects.
Croatian: Extavia može uzrokovati teške nuspojave.
English: These may be reduced by the use of an auto-injector device.
Croatian: One se mogu smanjiti korištenjem autoinjektora.
English: Note: If the solution is discoloured or contains particles, discard it and start again with a new syringe and vial from your package.
Croatian: Ako je otopina promijenila boju ili sadrži čestice, odbacite ju i počnite ponovno s novom štrcaljkom i bočicom iz pakiranja.
English: If you experience any break in the skin, associated with swelling or fluid leaking out from the injection site:
Croatian: Ako osjetite bilo kakvo puknuće kože, povezano s oticanjem ili curenjem tekućine iz mjesta primjene:
English: 1 - Choose a site for the injection (refer to the section “Choosing an injection site” and the diagrams at the end of this leaflet) and make a note of it in your medication record.
Croatian: 1 - Odaberite mjesto injiciranja (vidjeti dio „Odabir mjesta injiciranja“ i dijagram na kraju ove Upute) te zabilježite mjesto u svojim bilješkama o primjeni injekcije.