FrancophonIA/ELRC3.0 huggingface dataset:
English: The best places for injections are where the skin is loose and soft, and away from joints, nerves and bones, for example the abdomen, arm, thigh or buttocks.
Croatian: Najbolja mjesta za injiciranje su tamo gdje je koža opuštena i mekana te daleko od zglobova, živaca i kostiju, na primjer područje trbuha, nadlaktica, natkoljenica ili stražnjica.
English: In the following tables, the most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
Croatian: U tablicama u nastavku koristi se najprimjereniji MedDRA-in naziv za opisivanje određene reakcije i njegovi sinonimi i povezana stanja.
English: However, in-use stability has been demonstrated for 3 hours at 2°C - 8°C.
Croatian: Međutim, stabilnost u primjeni dokazana je za razdoblje od 3 sata na temperaturi 2°C - 8°C.
English: This medicinal product must not be mixed with other medicinal products except for the supplied solvent mentioned in section 6.6.
Croatian: Lijek se ne smije miješati s drugim lijekovima osim s priloženim otapalom navedenim u dijelu 6.6. 6.3 Rok valjanosti
English: To increase tolerability of Extavia in the study of patients with a first clinical event, a dose titration was applied and nonsteroidal anti-inflammatory medicinal products were administered at start of therapy.
Croatian: Kako bi se povećala podnošljivost Extavije u ispitivanju bolesnika s prvim kliničkim događajem, provedeno je titriranje doze te su primijenjeni nesteroidni protuupalni lijekovi na početku terapije.
English: During the post-marketing period very rare reports have been received of temporary worsening of cardiac status at the start of Extavia therapy in patients with pre-existing significant cardiac disease.
Croatian: U razdoblju nakon stavljanja lijeka u promet zabilježeni su vrlo rijetki slučajevi privremenog pogoršanja stanja srca na početku liječenja Extavijom u bolesnika s već postojećom značajnom bolešću srca.
English: If the patient fails to respond, for example a steady progression in Expanded Disability Status Scale (EDSS) for 6 months occurs or treatment with at least 3 courses of adrenocorticotropic hormone (ACTH) or corticosteroids during a one-year period is required despite Extavia therapy, treatment with Extavia should be stopped.
Croatian: Expanded Disability Status Scale, EDSS) tijekom 6 mjeseci ili je potrebno liječenje s najmanje 3 ciklusa adrenokortikotropnog hormona (ACTH) ili kortikosteroida tijekom jednogodišnjeg razdoblja, usprkos terapiji Extavijom, liječenje Extavijom treba prekinuti.
English: Due to the lack of clinical experience in multiple sclerosis patients, the use of Extavia together with immunomodulators other than corticosteroids or ACTH is not recommended.
Croatian: Zbog pomanjkanja kliničkog iskustva u bolesnika s multiplom sklerozom uporaba Extavije zajedno s imunomodulatorima, osim kortikosteroida ili ACTH,se ne preporučuje.
English: In order to obtain adequate efficacy, a dose of 250 microgram (1.0 ml) every other day should be reached.
Croatian: Za postizanje primjerene djelotvornosti treba doći do doze od 250 mikrograma (1,0 ml) svaki drugi dan.
English: Anorexia*
Croatian: Anoreksija*
English: Push the plunger down slowly so that the liquid runs down the inside of the vial.
Croatian: Polako gurnite klip prema dolje tako da se tekućina slijeva po unutrašnjosti bočice.
English: Skin discolouration
Croatian: Diskoloracija kože
English: The risk for progression to CDMS within two years in patients with monofocal onset was 47% for placebo and 24% for Extavia, without gadolinium (Gd-) enhancement 41% and 20%, with less than 9 T2 lesions 39% and 18%.
Croatian: Rizik od progresije u KDMS unutar 2 godine u bolesnika s monofokalnim početkom bio je 47% za placebo i 24% za Extaviju, bez pojačanja signala gadolinijem (Gd-) 41% odnosno 20%, s manje od 9 T2 lezija 39% odnosno 18%.
English: Follow the sequence described in the schedule at the end of the Annex (see Part II “Rotating injection sites”) and you will come back to your first injection site area after 8 injections (16 days).
Croatian: Ako slijedite redoslijed opisan na kraju Dodatka (pogledajte Dio II „Promjena mjesta primjene injekcije“) na mjesto prvog injiciranja vratit ćete se nakon 8 injekcija (16 dana).
English: Injection site reactions occurred frequently after administration of Extavia.
Croatian: Reakcije na mjestu injiciranja često se događaju nakon primjene Extavije.
English: Hepatic injury (including hepatitis), Hepatic failure*
Croatian: Ozljeda jetre (uključujući hepatitis), Zatajenje jetre*
English: - if you have a severe liver disease (see “Warnings and precautions”, “Other medicines and Extavia” and section 4, “Possible side effects”).
Croatian: - ako imate tešku bolest jetre (pogledajte „Upozorenja i mjere opreza“, „Drugi lijekovi i Extavia“ te dio 4, „Moguće nuspojave“).
English: if you notice any unusual bruising, excessive bleeding after injury or if you seem to be catching a lot of infections.
Croatian: Ako primijetite bilo kakvo neuobičajeno stvaranje modrica, prekomjerno krvarenje nakon ozljede ili ako Vam se čini da često dobivate infekcije.
English: If you forget to use Extavia
Croatian: Ako ste zaboravili primijeniti Extaviju
English: Patients with single lesions may continue on Extavia provided the necrosis is not too extensive, as some patients have experienced healing of injection site necrosis whilst on Extavia.
Croatian: Bolesnici s pojedinačnim lezijama mogu nastaviti terapiju Extavijom pod uvjetom da nekroza nije preopsežna jer kod nekih bolesnika dolazi do zacijeljenja nekroze na mjestu injiciranja dok uzimaju Extaviju.
English: Patients should be started at 62.5 microgram (0.25 ml) subcutaneously every other day, and increased slowly to a dose of 250 microgram (1.0 ml) every other day (see Table A).
Croatian: Bolesnici trebaju početi s dozom od 62,5 mikrograma (0,25 ml) supkutano svaki drugi dan, te polako povećavati dozu do 250 mikrograma (1,0 ml) svaki drugi dan (vidjeti Tablicu A).
English: Debridement and, less often, skin grafting are occasionally required and healing may take up to 6 months.
Croatian: Povremeno je potreban debridman i, manje često, presađivanje kože, a zacjeljivanje može potrajati do 6 mjeseci.
English: The most frequently observed adverse reactions are a flu-like symptom complex (fever, chills, arthralgia, malaise, sweating, headache, or myalgia), which is mainly due to the pharmacological effects of the medicinal product, and injection site reactions.
Croatian: Najčešće zabilježene nuspojave su kompleks simptoma nalik gripi (vrućica, zimica, artralgija, malaksalost, znojenje, glavobolja ili mialgija), koji su uglavnom uzrokovani farmakološkim učincima lijeka i reakcijama na mjestu injiciranja.
English: No benefit, attributable to Extavia, in quality of life (as measured by FAMS - Functional Assessment of MS: Treatment Outcomes Index) was seen.
Croatian: Nije uočena nikakva korist koja bi se mogla pripisati Extaviji za kvalitetu života (mjerenu prema Funkcionalnoj procjenu multiple skleroze: Indeks ishoda liječenja).
English: Adults and adolescents from 12-17 years of age The recommended dose of Extavia is 250 microgram (8.0 million IU), contained in 1 ml of the reconstituted solution (see section 6.6), to be injected subcutaneously every other day.
Croatian: Odrasle osobe i adolescenti u dobi od 12 do 17 godina Preporučena doza Extavije je 250 mikrograma (8,0 milijuna IU), sadržanih u 1 ml pripremljene otopine (vidjeti dio 6.6), koja se supkutano injicira svaki drugi dan.
English: No acute toxicity studies have been performed.
Croatian: Nisu provedena ispitivanja akutne toksičnosti.
English: In MS, inflammation destroys the protective sheath (called myelin) around the nerves of the CNS and stops the nerves from working properly.
Croatian: Kod MS-a, upala uništava zaštitnu ovojnicu (koja se naziva mijelin) oko živaca u središnjem živčanom sustavu i sprečava pravilno funkcioniranje živaca.
English: The effect of alternate-day administration of 250 microgram (8.0 million IU) Extavia on drug metabolism in multiple sclerosis patients is unknown.
Croatian: Učinak primjene 250 mikrograma (8,0 milijuna IU) Extavije svakog drugog dana na metabolizam lijeka u bolesnika s multiplom sklerozom nije poznat.
English: Maximum serum levels of about 40 IU/ml were found 1-8 hours after subcutaneous injection of 500 microgram (16.0 million IU) interferon beta-1b.
Croatian: Maksimalne razine u serumu od oko 40 IU/ml pronađene su 1-8 sati nakon supkutane injekcije 500 mikrograma (16,0 milijuna IU) interferona beta-1b.
English: If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist or nurse.
Croatian: Ako se bilo koja od nuspojava pogorša, ili ako primijetite bilo koju nuspojavu koja nije navedena u ovoj uputi, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
English: Cases of pancreatitis were observed with Extavia use, often associated with hypertriglyceridaemia.
Croatian: Uz primjenu Extavije zabilježeni su slučajevi pankreatitisa, često povezanog s hipertrigliceridemijom.
English: Please refer to section 3 of the leaflet, “How to use Extavia”, for further details on how to use Extavia.
Croatian: Pogledajte dio 3 Upute o lijeku, „Kako primjenjivati Extaviju“, za više pojedinosti o tome kako primjenjivati Extaviju.
English: ► Tell your doctor immediately and stop using Extavia: if you experience symptoms such as itching all over your body, swelling of your face and/or your tongue or sudden shortness of breath.
Croatian: Odmah se obratite liječniku i prestanite koristiti Extaviju: ako osjetite simptome kao što su svrbež po cijelom tijelu, oticanje lica i/ili jezika ili iznenadna nedostatak zraka.
English: To minimise the risk of injection site necrosis patients should be advised to: use an aseptic injection technique, rotate the injection sites with each dose.
Croatian: Za smanjenje rizika od nekroze na mjestu injiciranja bolesnike treba savjetovati da: koriste aseptične načine injiciranja, mijenjaju mjesto injiciranja sa svakom dozom.
English: RR-MS, SP-MS and single clinical event suggestive of MS In all multiple sclerosis studies Extavia was effective in reducing disease activity (acute inflammation in the central nervous system and permanent tissue alterations) as measured by magnetic resonance imaging (MRI).
Croatian: RR-MS, SP-MS i jednokratan klinički događaj koji upućuje na MS U svim ispitivanjima multiple skleroze, Extavia je bila djelotvorna u smanjivanju aktivnosti bolesti (akutne upale u središnjem živčanom sustavu i trajne promjene tkiva), mjerene snimanjem magnetskom rezonancijom (MR).
English: PART III: EXTAVIA Medication record
Croatian: DIO III: Bilješke o injiciranju lijeka EXTAVIA
English: In multifocal patients, the risk for CDMS was independent from MRI findings at baseline, indicating a high risk for CDMS because of the dissemination of the disease based on clinical findings.
Croatian: U multifokalnih bolesnika rizik od KDMS-a nije ovisio od nalazima na snimci MR-om napravljenoj na početku, što upućuje na visoki rizik od KDMS-a zbog diseminacije bolesti na temelju kliničkih nalaza.
English: Common (1/100 to
Croatian: Često (1/100 i
English: Solvent for Extavia For subcutaneous use after reconstitution.
Croatian: Otapalo za lijek Extavia Za supkutanu primjenu nakon pripreme otopine.
English: The reconstituted product is colourless to light yellow and slightly opalescent to opalescent.
Croatian: Rekonstituirani lijek je bezbojan do svijetlo žut te blago opalescentan do opalescentan.
English: Secondary Progressive Multiple Sclerosis (North American Study)
Croatian: Sekundarno progresivna multipla skleroza (Sjevernoameričko ispitivanje)
English: The 30-gauge needles provided with the application kit for the administration of this medicine can be used either for manual injection OR with an ExtaviPro 30G auto-injector.
Croatian: Igle veličine 30 G priložene uz set za primjenu ovog lijeka mogu se koristiti za ručno ubrizgavanje ILI s autoinjektorom ExtaviPro 30G.
English: In two years, the risk was 85% in the placebo group and 69% in the Extavia group (Hazard Ratio = 0.57, 95% confidence interval (0.46, 0.71), p<0.00001).
Croatian: U dvije godine rizik je bio 85% u placebo skupini i 69% u skupini koja je primala Extaviju (omjer hazarda = 0,57, interval pouzdanosti 95% (0,46, 0,71), p<0,00001).
English: Secondary Progressive Multiple Sclerosis (European Study)
Croatian: Sekundarno progresivna multipla skleroza (Europsko ispitivanje)
English: Caution should be exercised when Extavia is administered in combination with medicinal products that have a narrow therapeutic index and are largely dependent on the hepatic cytochrome P450 system for clearance, e.g. anti-epileptics.
Croatian: Treba biti oprezan prilikom primjene Extavije u kombinaciji s lijekovima koji imaju uski terapijski indeks te su uvelike ovisni o sustavu jetrenog citokroma P450 zbog klirensa, primjerice antiepileptici.
English: The administration of cytokines to patients with a pre-existing monoclonal gammopathy has been associated with the development of systemic capillary leak syndrome with shock-like symptoms and fatal outcome.
Croatian: Primjena citokina u bolesnika s postojećom monoklonalnom gamapatijom povezuje se s razvojem sindroma povećane propustljivosti sistemskih kapilara uz simptome nalik šoku i sa smrtnim ishodom.
English: Class label for interferon beta products (see section 4.4).
Croatian: Značajka skupine lijekova koji sadrže interferon beta (vidjeti dio 4.4).
English: However, it is known that the biological response-modifying properties of interferon beta-1b are mediated through its interactions with specific cell receptors found on the surface of human cells.
Croatian: Ipak, poznato je da su biološka svojstva interferona beta-1b koja modificiraju reakciju rezultat njegovih interakcija sa specifičnim staničnim receptorima koji se nalaze na površini ljudskih stanica.
English: For details on storage conditions see section 5 of the leaflet, “How to store Extavia”.
Croatian: Za pojedinosti o uvjetima čuvanja pogledajte dio 5 Upute o lijeku, „Kako čuvati Extaviju“.
English: Psychiatric disorders Depression
Croatian: Psihijatrijski poremećaji Depresija
English: Before preparing your injection, decide where you are going to inject.
Croatian: Prije pripreme injekcije odlučite se za mjesto injiciranja.
English: 3 - Remove the cap from the needle by pulling and not twisting it.
Croatian: 3 - Uklonite zatvarač s igle povlačenjem, a ne okretanjem.
English: Single clinical event indicating a high risk of developing multiple sclerosis: Extavia has been shown to delay progression to definite multiple sclerosis.
Croatian: Pojedinačni klinički događaj koji ukazuje na visoki rizik od razvoja multiple skleroze: Pokazalo se da Extavija odgađa napredak pojave klinički jasne multiple skleroze.
English: In patients with a single clinical event suggestive of multiple sclerosis, efficacy has been demonstrated over a period of three years.
Croatian: U bolesnika s jednokratnim kliničkim događajem koji upućuje na multiplu sklerozu dokazana je djelotvornost tijekom razdoblja od tri godine.
English: An example of a medication record is also included (see Annex Part III).
Croatian: Također je uključen i primjer bilježenja podataka o injiciranju (pogledajte dodatak Dio III).
English: Cases of nephrotic syndrome with different underlying nephropathies including collapsing focal segmental glomerulosclerosis (FSGS), minimal change disease (MCD), membranoproliferative glomerulonephritis (MPGN) and membranous glomerulopathy (MGN) have been reported during treatment with interferon beta products.
Croatian: Slučajevi nefrotskog sindroma s različitim podležećim nefropatijama uključujući kolabirajuću fokalnu segmentalnu glomerulosklerozu (FSGS), bolest minimalnih promjena (engl. minimal change disease, MCD), membranoproliferativni glomerulonefritis (MPGN) i membransku glomerulopatiju (MGN) zabilježeni su za vrijeme terapije lijekovima koji sadrže interferon beta.
English: Table A Schedule for dose titration*
Croatian: A Raspored titriranja doze*
English: If TMA is diagnosed, prompt treatment is required (considering plasma exchange) and immediate discontinuation of Extavia is recommended.
Croatian: Ako se dijagnosticira TMA, potrebno je bez odlaganja započeti liječenje (razmotriti plazmaferezu) i preporučuje se odmah prekinuti liječenje Extavijom.
English: Therapy with Extavia was well accepted in the study of patients with a single clinical event as indicated by a high rate of trial completion (92.8% in the Extavia group).
Croatian: Liječenje Extavijom bilo je dobro prihvaćeno u ispitivanju s bolesnicima s jednokratnim kliničkim događajem, na što je upućivao visoki postotak bolesnika koji su dovršili ispitivanje (92,8% u skupini koja je primala Extaviju).
English: The treatment with Extavia should be initiated under the supervision of a physician experienced in the treatment of the disease.
Croatian: Liječenje s Extavijom treba započeti pod nadzorom liječnika koji ima iskustva u liječenju bolesti.
English: Rare (1/10,000 to
Croatian: Rijetko (1/10 000 i <1/1000)
English: Limited information available on the transfer of interferon beta-1b into breast milk, together with the chemical / physiological characteristics of interferon beta, suggests that levels of interferon beta-1b excreted in human milk are negligible.
Croatian: Dostupni ograničeni podaci o prijelazu interferona beta-1b u majčino mlijeko, skupa s kemijskim/fiziološkim osobinama interferona beta, upućuju da su razine interferona beta-1b izlučene u majčino mlijeko zanemarive.
English: Select an injection site.
Croatian: Odaberite mjesto injiciranja.
English: • 1 Extavia vial (with powder for solution for injection)
Croatian: • 1 bočica Extavije (s praškom za otopinu za injekciju)
English: • Patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses.
Croatian: • Bolesnika sa sekundarno progresivnom multiplom sklerozom s aktivnom bolešću što se dokazuje relapsima.
English: General disorders and administration site conditions Injection site reaction (various kinds)
Croatian: Opći poremećaji i reakcije na mjestu primjene Reakcije na mjestu primjene (različite vrste)
English: Within the study period of two years, CDMS occurred in 45% of the placebo group compared to 28% of the Extavia group (Kaplan-Meier estimates).
Croatian: U dvogodišnjem razdoblju ispitivanja, KDMS se javio u 45% placebo skupine u usporedbi s 28% skupine koja je primala Extaviju (Kaplan-Meierove procjene).
English: After your injection, fill in the used injection site and date in the table in your injection record (see the example: Keeping track of your injection sites and dates).
Croatian: - Nakon injiciranja unesite mjesto i datum injiciranja u tablicu praćenja injiciranja (pogledajte primjer: „Bilježenje mjesta i datuma primjene injekcije“).
English: The most serious events often occurred in patients exposed to other medicinal products or substances known to be associated with hepatotoxicity or in the presence of co-morbid medical conditions (e.g. metastasising malignant disease, severe infection and sepsis, alcohol abuse).
Croatian: Najozbiljniji događaji često su se javljali u bolesnika izloženih drugim lijekovima ili tvarima za koje se zna da su povezane s hepatotoksičnošću ili u slučaju istodobnog postojanja drugih bolesti (npr. metastazirajuće zloćudne bolesti, teške infekcije i sepse, alkoholizma).
English: Do not use this medicine if you notice it contains particles or is discoloured.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da sadrži čestice ili je promijenjene boje.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per ml, i.e. essentially ‘sodiumfree'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po ml, tj. zanemarive količine natrija.
English: Generally, dose titration is recommended at the start of treatment.
Croatian: Na početku liječenja se općenito preporučuje titriranje doze.
English: if you notice pain in your belly which is radiating to your back , and/or you feel sick or have a fever.
Croatian: Ako primijetite bol u trbuhu koja se širi prema leđima i/ili osjećate mučninu ili imate vrućicu.
English: Storage after reconstitution
Croatian: Čuvanje nakon pripreme
English: Patients and investigators remained blinded to the initial treatment allocation.
Croatian: Bolesnici i ispitivači nisu bili upoznati s terapijom koja je bolesnicima u početku bila dodijeljena.
English: Further subgroup analyses indicated a high risk for progression to CDMS within 2 years in monofocal patients with at least 9 T2lesions (55% risk for placebo, 26% for Extavia) or Gd-enhancement (63% versus 33%).
Croatian: Daljnje analize podskupina ukazale su na visoki rizik od progresije u KDMS unutar 2 godine u monofokalnih bolesnika s najmanje 9 T2-lezija (55% rizik za placebo, 26% za Extaviju) ili pojačanjem signala gadolinijem (63% u odnosu na 33%).
English: Throw the swab away.
Croatian: Bacite tupfer.
English: At present it is not known how long treatment with Extavia should last.
Croatian: Zasada nije poznato koliko dugo treba trajati liječenje Extavijom.
English: It can be extensive and may involve muscle fascia as well as fat and therefore can result in scar formation.
Croatian: Ona može biti opsežna i uključivati fasciju mišića kao i masno tkivo te stoga rezultirati nastajanjem ožiljka.
English: 5 - Remove the swab from the top of the vial.
Croatian: 5 - Maknite tupfer s vrha bočice.
English: 6 - Holding the edges securely, remove and discard the packaging ensuring the vial adapter remains on the vial.
Croatian: 6 - Čvrsto držeći rubove, maknite i odložite pakovanje pazeći da nastavak ostane na bočici.
English: ► Rare (may affect up to 1 in 1,000 people):
Croatian: ► Rijetke (mogu se javiti u do 1 na 1000 osoba):
English: Leave the swab on top of the vial.
Croatian: Ostavite tupfer na vrhu bočice.
English: • 30-gauge needles for injecting your medicine
Croatian: • Igle veličine 30 G za injiciranje Vašeg lijeka
English: 14 - Remove any excess air bubbles by gently tapping the syringe.
Croatian: 14 -Uklonite sve suvišne mjehuriće zraka laganim tapkanjem štrcaljke.
English: C) Reconstituting and drawing up the solution for injection, step by step D) Making the injection manually (to make an injection with the ExtaviPro 30G auto injector, refer to the instructions for use provided with the auto-injector)
Croatian: C) Priprema i izvlačenje otopine za injekciju, korak po korak D) Ručno davanje injekcije (za davanje injekcije s ExtaviPro 30G autoinjektorom pogledajte upute za uporabu priložene uz autoinjektor)
English: In the pivotal study of patients with a single clinical event suggestive of multiple sclerosis an auto-injector was used in the majority of patients.
Croatian: U pivotalnom ispitivanju bolesnika s pojedinačnim kliničkim događajem koji ukazuje na multiplu sklerozu autoinjektor je korišten u većine bolesnika.
English: Blood triglycerides increased
Croatian: Povišenje triglicerida u krvi
English: 250 microgram (8.0 million IU) per ml after reconstitution.
Croatian: 250 mikrograma (8,0 milijuna IU) po ml nakon pripreme otopine za primjenu.
English: Within the study period of three years, CDMS occurred in 51% of the delayed treatment group compared to 37% of the immediate treatment group (Kaplan-Meier estimates).
Croatian: U trogodišnjem razdoblju ispitivanja KDMS se javio u 51% skupine s odgođenim početkom liječenja, u usporedbi s 37% skupine s neposredno započetim liječenjem (Kaplan-Meierove procjene).
English: 3 ml vial (clear type I glass) with a butyl rubber stopper (type I) and aluminium overseal containing 300 microgram (9.6 million IU) of (recombinant interferon beta-1b) powder.
Croatian: Bočica od 3 ml (prozirno staklo tipa I) s butilnim gumenim čepom (tip I) i aluminijskom zaštitnom kapicom, koja sadrži 300 mikrograma (9,6 milijuna IU) praška (rekombinantnog interferona beta-1b).