FrancophonIA/ELRC3.0 huggingface dataset:
English: Extavia has been shown to cut down the number of attacks and make them less severe.
Croatian: Pokazalo se da Extavia smanjuje broj napadaja te ih čini manje teškim.
English: The reconstituted product should be inspected visually before use.
Croatian: Rekonstituirani lijek treba vizualno provjeriti prije primjene.
English: In controlled clinical trials serum samples were collected every 3 months for monitoring of development of antibodies to Extavia.
Croatian: U kontroliranim kliničkim ispitivanjima prikupljani su uzorci seruma svaka 3 mjeseca radi praćenja razvoja protutijela na Extaviju.
English: Cases of cardiomyopathy have been reported.
Croatian: Zabilježeni su slučajevi kardiomiopatije.
English: However, this did not seem to be associated with a reduction in clinical efficacy (with regard to time to clinically definite multiple sclerosis (CDMS), time to confirmed EDSS progression and relapse rate).
Croatian: Međutim, čini se da to nije bilo povezano sa smanjenjem kliničke djelotvornosti (s obzirom na vrijeme do klinički defintivne multiple skleroze (KDMS), vrijeme do potvrđene progresije na EDSS-u i stopu relapsa).
English: What Extavia is
Croatian: Što je Extavia
English: There are sparse and inconclusive data on patients who have developed neutralising activity and have completed Extavia therapy.
Croatian: Postoje oskudni i neuvjerljivi podaci za bolesnike koji su razvili neutralizirajuću aktivnost te su dovršili terapiju Extavijom.
English: 16 - Take the needle out of its wrapping and screw it firmly onto the top of the syringe.
Croatian: 16 - Izvadite iglu iz omota i čvrsto je navijte na vrh štrcaljke.
English: The damage to the CNS can occur within an MS attack (relapse).
Croatian: Oštećenje SŽS-a može nastati u sklopu napada MS-a (relapsa).
English: However, the long-term impact of early treatment with Extavia is unknown even in these high risk subgroups as this study was mainly designed to assess the time to CDMS rather than the long-term evolution of the disease.
Croatian: Međutim, dugoročan učinak ranog liječenja Extavijom nije poznat čak ni u tim visoko rizičnim podskupinama, budući da je ovo ispitivanje uglavnom bilo osmišljeno kako bi se procijenilo vrijeme do KDMS-a, a ne dugoročni razvoj bolesti.
English: This might happen several weeks to several years after starting Extavia.
Croatian: To bi se moglo dogoditi nekoliko tjedana do nekoliko godina nakon početka primjene Extavije.
English: In the absence of clinical evidence for liver damage, and after normalisation of liver enzymes, a reintroduction of therapy could be considered with appropriate follow-up of hepatic functions.
Croatian: U nedostatku kliničkog dokaza oštećenja jetre te nakon normalizacije jetrenih enzima, ponovno uvođenje lijeka u terapiju može se razmotriti uz odgovarajući nadzor jetrenih funkcija.
English: Generally, dose titration is recommended at the start of treatment in order to increase tolerability to Extavia (see section 4.2).
Croatian: Općenito se preporučuje titracija doze na početku liječenja kako bi se povećala podnošljivost Extavije (vidjeti dio 4.2).
English: 5 - Holding the syringe like a pencil or a dart, push the needle straight into the skin at a 90˚ angle with a quick, firm motion.
Croatian: 5 - Držeći štrcaljku kao olovku ili pikado strelicu, gurnite iglu ravno u kožu pod kutom od 90° brzim, čvrstim pokretom.
English: Extavia is a type of medicine known as interferon used to treat multiple sclerosis.
Croatian: Extavia je vrsta lijeka poznata kao interferon koji se koristi za liječenje multiple skleroze.
English: The most common side effects are:
Croatian: Najčešće nuspojave su:
English: The risk of spontaneous abortions in pregnant women exposed to interferon beta cannot adequately be evaluated by means of the currently available data, but the data suggest no increased risk so far.
Croatian: Rizik spontanog pobačaja u trudnica izloženih interferonu beta ne može biti primjereno ocijenjen pomoću trenutno dostupnih podataka, ali podaci za sada ne upućuju na povećan rizik.
English: The reconstituted solution is to be injected subcutaneously every other day.
Croatian: Način primjene Rekonstituiranu otopinu treba injicirati supkutano svaki drugi dan.
English: There have been no formal clinical trials undertaken in children or adolescents.
Croatian: Nije bilo formalnih kliničkih ispitivanja provedenih u djece ili adolescenata.
English: These will be performed before you start using Extavia, regularly after treatment with Extavia has been initiated and then periodically during treatment, even if you have no particular symptoms.
Croatian: One će se obaviti prije nego počnete uzimati Extaviju, redovito nakon početka liječenja Extavijom te zatim periodički tijekom liječenja, čak i ako nemate nekih osobitih simptoma.
English: Extavia should not be used in children under 12 years of age as there is no information available for this age group.
Croatian: Extavia se ne smije koristi u djece mlađe od 12 godina budući da nema raspoloživih podataka za tu dobnu skupinu.
English: - If you have a heart disease, the flu-like symptoms which often occur at the start of treatment may prove stressful to you.
Croatian: Ako imate srčanu bolest, simptomi nalik gripi koji se često javljaju na početku liječenja mogu biti stresni za Vas.
English: Within this period, the development of neutralising activity was associated with a significant increase in newly active lesions and T2 lesion volume on magnetic resonance imaging.
Croatian: U tom razdoblju razvoj neutralizirajuće aktivnosti bio je povezan sa značajnim povećanjem broja novih aktivnih lezija i volumena T2 lezija na snimkama dobivenim magnetskom rezonancijom.
English: Talk to your doctor, pharmacist or nurse for further information.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri za više informacija.
English: ► Stop using Extavia and tell your doctor immediately if any of these happens to you.
Croatian: Prestanite uzimati Extaviju i odmah obavijestite svog liječnika ako Vam se dogodi išta od gore navedenog.
English: These symptoms may be reduced by taking paracetamol or non-steroidal antiinflammatory medicines such as ibuprofen.
Croatian: Ti se simptomi mogu smanjiti uzimanjem paracetamola ili nesteroidnih protuupalnih lijekova kao što je ibuprofen.
English: From these retrospective subgroup analyses there was evidence to suggest that relapses as well as pronounced EDSS progression (EDSS >1 point or >0.5 point for EDSS >=6 in the previous two years) can help to identify patients with active disease.
Croatian: Iz ovih retrospektivnih analiza podskupina vidljiv je dokaz koji ukazuje da relapsi, baš kao i izražena progresija na EDSS ljestvici (EDSS >1 boda ili >0,5 za EDSS >=6 u prethodne dvije godine) mogu pomoći u identifikaciji bolesnika s aktivnom bolešću.
English: You will also need a disposal unit for used syringes and needles.
Croatian: Trebat će Vam i spremnik za odlaganje korištenih štrcaljki i igala.
English: Detailed instructions for self-injection of Extavia under the skin are provided in the Annex at the back of this leaflet.
Croatian: Detaljne upute o samoinjiciranju Extavije pod kožu dostupne su u Dodatku na poleđini ove upute.
English: Extavia prolonged the time to CDMS by 363 days, from 255 days in the placebo group to 618 days in the Extavia group (based on the 25th percentiles).
Croatian: Extavia je produljila vrijeme do KDMS-a za 363 dana, od 255 dana u placebo skupini do 618 dana u skupini koja je primala Extaviju (na temelju 25. percentila).
English: No harmful effects on the breastfed newborn/infant are anticipated.
Croatian: Ne očekuju se štetni učinci na dojeno novorođenče/dojenče.
English: If you become depressed while you are on Extavia, you may need special treatment and your doctor will closely monitor you and may also consider stopping your treatment.
Croatian: Ako ste postali deprimirani za vrijeme liječenja Extaviju, možda ćete trebati posebno liječenje, a liječnik će Vas nadzirati te će možda razmotriti prekid liječenja.
English: Experience with Extavia in patients with multiple sclerosis (MS) is limited, consequently those adverse events which occur very rarely may not yet have been observed.
Croatian: Iskustvo s Extavijom je ograničeno u bolesnika s multiplom sklerozom (MS), pa sukladno tome oni štetni događaji koji se javljaju vrlo rijetko možda još nisu bili uočeni.
English: Multiple sclerosis (MS) is a long-term condition that affects the central nervous system (CNS), particularly the functioning of the brain and spinal cord.
Croatian: Multipla skleroza (MS) dugoročna je bolest koja pogađa središnji živčani sustav (SŽS), osobito funkcioniranje mozga i leđne moždine.
English: Interferon beta-1b has been given to adult cancer patients at individual doses as high as 5,500 microgram (176 million IU) intravenously three times a week without serious adverse events compromising vital functions.
Croatian: Interferon beta-1b primjenjivao se u odraslih bolesnika oboljelih od raka u individualnim dozama do 5500 mikrograma (176 milijuna IU) intravenski tri puta tjedno bez ozbiljnih štetnih događaja koji bi ugrozili vitalne funkcije.
English: After preparing the solution you should use it immediately.
Croatian: Nakon pripreme otopine treba je odmah upotrijebiti.
English: Although no natural rubber latex is detected in the cap, the safe use of Extavia pre-filled syringe in latex-sensitive individuals has not been studied and there is therefore a potential risk for hypersensitivity reactions which cannot be completely ruled out.
Croatian: Iako u zatvaraču nije pronađena prirodna lateks guma, sigurna primjena Extavia napunjene štrcaljke u pojedinaca osjetljivih na lateks nije bila ispitivana pa stoga postoji potencijalni rizik od reakcija preosjetljivosti koji se ne može u potpunosti isključiti.
English: Patients treated with Extavia should be advised to immediately report any symptoms of depression and/or suicidal ideation to their prescribing physician.
Croatian: Bolesnike koji se liječe Extavijom treba savjetovati da odmah prijave svaki simptom depresije i/ili suicidalne ideje svom liječniku.
English: There is evidence that the patients included in this study had overall less active disease than in the other study in secondary progressive multiple sclerosis.
Croatian: Postoje dokazi da su bolesnici koji su uključeni u to ispitivanje ukupno gledano imali manje aktivnu bolest nego u drugom ispitivanju sekundarno progresivne multiple skleroze.
English: Work through each rotation cycle in turn.
Croatian: Redom prođite kroz svaki ciklus.
English: The two studies showed inconsistent results for the primary endpoint time to confirmed progression, representing delay of disability progression:
Croatian: Ta dva ispitivanja pokazala su nedosljedne rezultate za primarnu mjeru ishoda vremena do potvrđene progresije, koja predstavlja odgodu napretka invalidnosti.
English: Note: Be careful not to touch the exposed end of the syringe.
Croatian: Napomena: Pritom pazite da ne dotaknete otkriveni vrh štrcaljke.
English: What Extavia is and what it is used for What you need to know before you use Extavia How to use Extavia
Croatian: Što je Extavia i za što se koristi Što morate znati prije nego počnete primjenjivati Extaviju Kako primjenjivati Extaviju
English: What Extavia looks like and contents of the pack Extavia is a powder and solvent for solution for injection.
Croatian: Kako Extavia izgleda i sadržaj pakiranja Extavia je prašak i otapalo za otopinu za injekciju.
English: The powder is white to off-white in colour.
Croatian: Prašak je bijele do bjelkaste boje.
English: When you use the solution, warm it up by holding the syringe or vial in your hands before injecting to avoid pain.
Croatian: Kada želite primijeniti otopinu, zagrijte je tako da držite štrcaljku ili bočicu u rukama prije injiciranja da biste izbjegli bol.
English: If reactions are severe, Extavia should be discontinued and appropriate medical intervention instituted.
Croatian: Ako su reakcije teške, treba prekinuti uzimanje Extavije i medicinski interventirati na odgovarajući način.
English: If this occurs and a relationship to Extavia is suspected, treatment should be discontinued.
Croatian: Ako se to dogodi i posumnja se na povezanost s Extavijom, liječenje je potrebno prekinuti.
English: Absolute neutrophil count decreased (<1500/mm³)
Croatian: Smanjeni apsolutni broj neutrofila (<1500/mm³)
English: The list also includes side effects which occurred commonly (may affect up to 1 in 10 people) but were significantly associated with the treatment:
Croatian: Popis uključuje i nuspojave koje se često javljaju (mogu se javiti u do 1 na 10 osoba), ali su u značajnoj mjeri povezane s terapijom:
English: In general, treatment should be started at a low dose of 0.25 ml (62.5 microgram).
Croatian: Općenito gledano, liječenje treba početi pri niskoj dozi od 0,25 ml (62,5 mikrograma).
English: A large amount of data (more than 1,000 pregnancy outcomes) from interferon beta registries, national registries and post-marketing experience indicates no increased risk of major congenital anomalies, after pre-conception exposure or exposure during the first trimester of pregnancy.
Croatian: Velika količina podataka (više od 1000 ishoda trudnoće) iz registara trudnoće uz interferon beta, nacionalnih registara i iskustva nakon stavljanja lijeka u promet ne ukazuje na povećani rizik od velikih urođenih anomalija nakon izloženosti prije začeća ili izloženosti tijekom prvog tromjesečja trudnoće.
English: Note: It may be necessary to adjust the plunger position back and forth a few times to ensure the excess air bubbles are gone and there is 1 ml of solution in the syringe.
Croatian: Napomena: Možda će trebati klip pomaknuti naprijed-nazad nekoliko puta da biste bili sigurni da nema mjehurića zraka i da je u štrcaljki 1 ml otopine.
English: Adverse Event and Laboratory Abnormalities
Croatian: Štetni događaji i laboratorijske abnormalnosti
English: Talk to your doctor before using Extavia:
Croatian: Obratite se svom liječniku prije nego primijenite Extaviju:
English: The relation of multiple sclerosis disease activity as measured by MRI and clinical outcome is currently not fully understood.
Croatian: Odnos između aktivnosti multiple skleroze mjerene MR-om i kliničkog ishoda trenutačno nije potpuno jasan.
English: In any case, treatment should only be considered for patients classified as high risk.
Croatian: U svakom slučaju, liječenje treba uzeti u obzir samo u bolesnika za koje se smatra da su visokorizični.
English: Table 1 Adverse events and laboratory abnormalities with incidence rates ≥10% and the respective percentages under placebo; significantly associated side effects <10% based on reports from clinical trials
Croatian: Tablica 1 Štetni događaji i laboratorijske abnormalnosti sa stopama incidencije ≥10% i pripadajući postotci za placebo; u značajnoj mjeri povezane nuspojave <10% na temelju izvješća iz kliničkih ispitivanja
English: Using Extavia with other medicines that modify the immune system response is not recommended, except anti-inflammatory medicines called corticosteroids or the adrenocorticotropic hormone (ACTH).
Croatian: Uporaba s drugim lijekovima koji mijenjaju odgovor imunološkog sustava nije preporučljiva, osim protuupalnih lijekova zvanih kortikosteroidi ili adrenokortikotropni hormon (ACTH).
English: 2 - Use an alcohol swab to clean the skin at the injection site.
Croatian: 2 - Upotrijebite tupfer natopljen alkoholom da biste očistili kožu na mjestu injiciranja.
English: Extavia serum levels were followed in patients and volunteers by means of a bioassay that was not completely specific.
Croatian: Razine Extavije u serumu bile su praćene u bolesnika i dobrovoljaca pomoću biotesta koji nije bio potpuno specifičan.
English: ► Stop injecting Extavia and talk to your doctor.
Croatian: Prestanite primjenjivati Extaviju i obratite se svom liječnikom.
English: 3 - Clean the top of the vial with an alcohol swab, moving the swab in one direction only.
Croatian: 3 - Očistite vrh bočice tupferom natopljenim alkoholom, pomičući tupfer samo u jednom smjeru.
English: EXAMPLE OF A MEDICATION RECORD:
Croatian: PRIMJER BILJEŠKI O PRIMJENI LIJEKA:
English: No separate investigations were performed regarding the influence of Extavia on the cardiovascular system, respiratory system and the function of endocrine organs.
Croatian: Nisu provedena zasebna ispitivanja utjecaja Extavije na srčanožilni sustav, dišni sustav te funkciju endokrinih organa.
English: List 1:
Croatian: Popis 1:
English: Metabolism and nutrition disorders Blood glucose decreased (<55 mg/dl)
Croatian: Poremećaji metabolizma i prehrane Snižena razina glukoze u krvi (< 55 mg/dl)
English: - Keep your syringes and syringe disposal unit out of the sight and reach of children; lock the supplies away if possible.
Croatian: - Držite štrcaljke i otpadni materijal izvan pogleda i dohvata djece; ako je moguće, čuvajte potrebne zalihe pod ključem.
English: Please refer to the rotation schedule at the end of this Annex to learn how to choose an injection site.
Croatian: Molimo pogledajte raspored rotacije na kraju upute za samoinjiciranje kako biste naučili kako treba izabrati mjesto injiciranja.
English: From various studies mean clearance rates and half-lives of disposition phases from serum were estimated to be at most 30 ml·min
Croatian: Iz raznih ispitivanja srednja vrijednost brzine klirensa i poluvijeka faze raspoloživosti u serumu bile su procijenjene na najviše 30 ml·min
English: It has been demonstrated in vitro that Extavia cross-reacts with natural interferon beta.
Croatian: U in vitro uvjetima dokazano je da Extavia križno reagira s prirodnim interferonom beta.
English: Contents of the pack and other information Annex - self-injection procedure
Croatian: Sadržaj pakiranja i druge informacije Prilog - postupak samoinjiciranja
English: This medicinal product contains human albumin and hence carries a potential risk for transmission of viral diseases.
Croatian: Ovaj lijek sadrži ljudski albumin te stoga nosi mogući rizik od prijenosa virusnih bolesti.
English: There is no evidence of Extavia having an effect on the duration of relapses.
Croatian: Nema dokaza da Extavia ima učinak na trajanje relapsa.
English: Rotation Cycle 1: Upper left section of each area Rotation Cycle 2: Lower right section of each area Rotation Cycle 3: Middle left section of each area Rotation Cycle 4 Upper right section of each area Rotation Cycle 5: Lower left section of each area Rotation Cycle 6:
Croatian: 1. ciklus promjene: Gornji lijevi dio svakog područja 2. ciklus promjene: Donji desni dio svakog područja 3. ciklus promjene: Srednji lijevi dio svakog područja 4. ciklus promjene: Gornji desni dio svakog područja 5. ciklus promjene: Donji lijevi dio svakog područja 6. ciklus promjene: Srednji desni dio svakog područja
English: Patients with anaemia, thrombocytopenia or leukopenia (alone or in any combination) may require more intensive monitoring of complete blood cell counts, with differential and platelet counts.
Croatian: Bolesnici s anemijom, trombocitopenijom ili leukopenijom (pojedinačno ili u kombinaciji) mogu zahtjevati intenzivnije praćenje kompletne krvne slike s diferencijalnom krvnom slikom i brojem trombocita.
English: The procedure for self-administration by the patient should be reviewed periodically, especially if injection site reactions have occurred.
Croatian: Postupak samoprimjene lijeka od strane bolesnika treba redovito provjeravati, posebno ako su se javile reakcije na mjestu injiciranja.
English: ** Class label for interferon products, see below “Pulmonary arterial hypertension”.
Croatian: ** Značajka skupine lijekova koji sadrže interfereon, vidjeti niže „Plućna arterijska hipertenzija“.
English: The recommended dose is every other day (once every two days), 1.0 ml of the prepared Extavia solution (see Annex “Self-injection procedure” in the second part of this leaflet) injected under the skin (subcutaneously).
Croatian: Preporučena doza je svaki drugi dan (jednom svaka dva dana) 1,0 ml pripremljene otopine Extavije (pogledajte Dodatak „Postupak samoinjiciranja“ u drugom dijelu ove upute) injicirati pod kožu (supkutano).
English: After mixing Extavia, you should administer the injection immediately (if this medicine is not used immediately, see section 5 of the leaflet, “How to store Extavia”).
Croatian: Nakon miješanja Extavije injekciju je potrebno odmah primijeniti (ako se ovaj lijek ne upotrijebi odmah, pogledajte dio 5 Upute o lijeku, „Kako čuvati Extaviju“).
English: As you get started, you may find the following tips helpful:
Croatian: U početku će Vam možda pomoći sljedeće:
English: Patients with decompensated liver disease (see sections 4.4, 4.5 and 4.8).
Croatian: Bolesnici s dekompenziranom bolešću jetre (vidjeti dijelove 4.4, 4.5 i 4.8).
English: To reduce the risk of side effects at the start of treatment, your doctor should start you on a low dose of Extavia and increase it gradually (see section 3, “How to use Extavia”).
Croatian: Da bi se smanjio rizik od nuspojava na početku liječenja, liječnik bi Vam za početak trebao propisati nisku dozu Extavije te je postupno povećavati (pogledajte dio 3, „Kako primjenjivati Extaviju“).
English: To help you rotate the injection sites appropriately, we recommend that you keep a record of the date and location of your injection.
Croatian: Kako bismo Vam pomogli da pravilno mijenjate mjesta injiciranja, preporučamo da vodite bilješke o datumu i mjestu injiciranja.
English: Your doses will then be increased gradually to the full dose of 1.0 ml (250 microgram).
Croatian: Vaše doze će se potom postupno povećavati na punu dozu od 1,0 ml (250 mikrograma).
English: Patients with monofocal or multifocal onset of the disease were included (i.e. patients with clinical evidence of a single or at least two lesions, respectively, of the central nervous system).
Croatian: Bili su uključeni bolesnici s monofokalnim ili multifokalnim počecima bolesti (tj. bolesnici s kliničkim dokazom jedne, odnosno najmanje dvije lezije središnjeg živčanog sustava).
English: The schedule shown in the diagram below will help you to vary the sites appropriately.
Croatian: Raspored prikazan na donjem dijagramu pomoći će Vam da pravilno mijenjate mjesta injiciranja.
English: - If you have ever had seizures or if you are taking medicines to treat epilepsy (antiepileptics), you doctor will monitor your treatment carefully (see also “Other medicines and Extavia” and section 4, “Possible side effects”).
Croatian: Ako ste ikad imali epileptičke napadaje ili ako uzimate lijekove za liječenje epilepsije (antiepileptike), liječnik će pažljivo pratiti Vaše liječenje (pogledajte također „Drugi lijekovi i Extavia“ i dio 4, „Moguće nuspojave“).
English: These may be symptoms of a fall in your blood cell count or in the number of platelets in your blood (cells, which help the blood to clot).
Croatian: To bi mogli biti simptomi smanjenja broja krvnih stanica ili broja trombocita u Vašoj krvi (stanica koje pomažu u zgrušavanju krvi).
English: In the study of patients with a single clinical event suggestive of multiple sclerosis, neutralising activity measured every 6 months was observed at least once in 32% (89) of the patients treated immediately with Extavia.
Croatian: U ispitivanju na bolesnicima s jednim kliničkim događajem koji je upućivao na multiplu sklerozu, neutralizirajuća aktivnost mjerena svakih 6 mjeseci bila je uočena barem jedanput u 32% (89) bolesnika koji su odmah bili liječeni Extavijom.
English: There is no evidence of an effect of Extavia on the duration of relapses or on symptoms in between relapses, and no significant effect was seen on the progression of the disease in relapsing-remitting multiple sclerosis.
Croatian: Nema dokaza za učinak Extavije na trajanje relapsa ili na simptome između relapsa, te nije uočen značajan učinak na progresiju bolesti kod relapsno-remitirajuće multiple skleroze.
English: The Extavia powder is provided in a 3-millilitre vial.
Croatian: Extavia prašak pakiran je u bočici od 3 mililitra.