FrancophonIA/ELRC3.0 huggingface dataset:
English: Year 2 results Placebo-controlled phase
Croatian: Placebom kontrolirana faza
English: Remove them by gently tapping the syringe and pushing the plunger to the respective marking on the syringe.
Croatian: Uklonite ih blagim tapkanjem štrcaljke i guranjem klipa do odgovarajuće oznake na štrcaljki.
English: For relapsing-remitting MS, efficacy has been demonstrated for therapy for the first two years.
Croatian: Za relapsno remitirajuću multiplu sklerozu djelotvornost terapije dokazana je za prve dvije godine.
English: If foam is present -- which can happen if the vial is shaken or swirled too much - let the vial sit undisturbed until the foam settles.
Croatian: Ako je prisutna pjena - što se može dogoditi ako se bočica trese ili okreće presnažno - ostavite bočicu sa strane sve dok se pjena ne slegne.
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 Betaferon.
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 lijeka Betaferon.
English: − During treatment with Betaferon your body may produce substances called neutralising antibodies, which may react with Betaferon (neutralising activity).
Croatian: Tijekom liječenja lijekom Betaferon Vaše tijelo može proizvesti tvari zvane neutralizirajuća protutijela, a koja mogu reagirati s lijekom Betaferon (neutralizirajuća aktivnost).
English: In the different controlled clinical trials in relapsing-remitting multiple sclerosis and secondary progressive multiple sclerosis, between 23% and 41% of the patients developed serum interferon beta1b neutralising activity confirmed by at least two consecutive positive titres; of these patients, between 43% and 55% converted to a stable antibody negative status (based on two consecutive negative titres) during the subsequent observational period of the respective study.
Croatian: U različitim kontroliranim kliničkim ispitivanjima relapsno-remitirajuće multiple skleroze i sekundarno progresivne multiple skleroze između 23 % i 41 % bolesnika razvilo je neutralizirajuću aktivnost u serumu na interferon beta-1b koja je potvrđena s barem dva uzastopna pozitivna titra; od tih bolesnika, između 43 % i 55 % povratilo je stabilan negativni status protutijela (na temelju dva uzastopna negativna titra) tijekom naknadnog razdoblja promatranja u spomenutom ispitivanju.
English: During the post-marketing period very rare reports have been received of worsening of cardiac status in patients with pre-existing significant cardiac disease temporarily associated with the initiation of Betaferon therapy.
Croatian: Tijekom postmarketinškog razdoblja zabilježena su vrlo rijetka izvješća o pogoršanju srčanog stanja u bolesnika s postojećom značajnom bolesti srca koje je prolazno povezano s početkom terapije lijekom Betaferon.
English: Central nervous system-related adverse events associated with the use of Betaferon might influence the ability to drive and use machines in susceptible patients.
Croatian: Nuspojave u središnjem živčanom sustavu koje su povezane s primjenom lijeka Betaferon mogu utjecati na sposobnost upravljanja vozilima i rada sa strojevima u podložnih bolesnika.
English: In both trials secondary progressive multiple sclerosis patients receiving Betaferon showed a reduction in frequency (30%) of clinical relapses.
Croatian: U oba ispitivanja bolesnici sa sekundarno progresivnom multiplom sklerozom koji primaju Betaferon pokazali su redukciju u učestalosti kliničkih relapsa (30 %).
English: To prepare your injection, turn the assembly over so that the vial is on top, cap side pointing down.
Croatian: Za pripremu svoje injekcije preokrenite sklop tako da je bočica na vrhu, a strana zatvarača pokazuje prema dolje.
English: Interferon alpha, interferon beta, and interferon gamma have overlapping yet distinct biologic activities.
Croatian: Interferon alfa, interferon beta i interferon gama posjeduju preklapajuća, ali i zasebna biološka djelovanja.
English: Palpitation *
Croatian: Palpitacije *
English: Betaferon may also be administered with a suitable autoinjector.
Croatian: Betaferon se također može primjenjivati s prikladnim autoinjektorom.
English: The exact cause of MS is unknown.
Croatian: Nije poznat točan uzrok multiple skleroze.
English: 4 Class label for interferon products, see below Pulmonary arterial hypertension.
Croatian: 4 značajka skupine lijekova koji sadrže interferon, vidjeti niže Plućna arterijska hipertenzija
English: Bayer AG Müllerstraße 178 13353 Berlin Germany
Croatian: Proizvođač Bayer AG Müllerstraße 178 13353 Berlin Njemačka
English: Injection site reactions occurred frequently after administration of Betaferon.
Croatian: Reakcije na mjestu injiciranja često se događaju nakon primjene lijeka Betaferon.
English: Absolute neutrophil count decreased (<1,500/mm³) × Λ * °
Croatian: Smanjeni apsolutni broj neutrofila (< 1500/mm³) × Λ
English: Do not remove the vial adapter from the blister pack at this stage.
Croatian: Nemojte vaditi nastavak za bočicu iz blister-pakiranja u ovom koraku.
English: The binding of interferon beta-1b to these receptors induces the expression of a number of gene products that are believed to be the mediators of the biological actions of interferon beta-1b.
Croatian: Vezanje interferona beta-1b na te receptore potiče ekspresiju brojnih produkata gena za koje se smatra da su posrednici u biološkim djelovanjima interferona beta-1b.
English: Your doctor may find changes in your blood and the function of your kidneys.
Croatian: Liječnik Vam može naći promjene u krvi i funkciji bubrega.
English: Patients with monofocal or multifocal onset of the disease were included (i.e. patients with clinical evidence for a single or at least two lesions, respectively, of the central nervous system).
Croatian: Ispitivanje je uključivalo bolesnike s monožarišnim ili višežarišnim nastupom bolesti (tj. bolesnici s kliničkim dokazom pojedinačne ili najmanje dvije lezije na središnjem živčanom sustavu).
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 neka od nuspojava postane ozbiljna ili primijetite nuspojavu koja nije navedena u ovoj uputi, obavijestite o tome svog liječnika, ljekarnika ili medicinsku sestru.
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 Betaferon; of these, 60% (53) returned to negative status based on the last available assessment within the 5 year period.
Croatian: U ispitivanju bolesnika s pojedinačnim kliničkim događajem koji ukazuje na multiplu sklerozu, neutralizirajuća aktivnost mjerena svakih 6 mjeseci zabilježena je barem jedanput u 32 % (89) bolesnika koji su odmah bili liječeni lijekom Betaferon; od toga njih 60 % (53) povratilo je negativan status na temelju posljednje dostupne procjene unutar petogodišnjeg razdoblja.
English: Betaferon prolonged the time to CDMS by 363 days, from 255 days in the placebo group to 618 days in the Betaferon group (based on the 25th percentiles)
Croatian: 255 dana u placebo skupini do 618 dana u skupini koja prima Betaferon (na temelju 25. percentila)
English: Single clinical event suggestive of MS
Croatian: Pojedinačni klinički događaj koji ukazuje na MS
English: There are follow-up data under controlled clinical conditions for patients with relapsing-remitting MS for up to 5 years and for patients with secondary progressive MS for up to 3 years.
Croatian: Postoje podaci dobiveni praćenjem bolesnika u kontroliranim kliničkim uvjetima za bolesnike s relapsno-remitirajućom MS do pet godina te za bolesnike sa sekundarno progresivnom multiplom sklerozom do tri godine.
English: The best places for injections are where the skin is loose and soft, and away from joints, nerves, or 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, kostiju, na primjer područje trbuha, rame, natkoljenica ili stražnjica.
English: INFORMATION IN BRAILLE Betaferon
Croatian: PODACI NA BRAILLEOVOM PISMU Betaferon
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 30 November 1995
Croatian: Datum prvog odobrenja: 30. studeni 1995.
English: − Patients with a history of hypersensitivity to natural or recombinant interferon beta, human albumin or to any of the excipients listed in section 6.1.
Croatian: − Bolesnici s anamnezom preosjetljivosti na prirodni ili rekombinantni interferon beta, ljudski albumin ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: The mechanisms by which interferon beta-1b exerts its actions in multiple sclerosis are not clearly understood.
Croatian: Mehanizmi djelovanja interferona beta-1b u multiploj sklerozi nisu potpuno razjašnjeni.
English: No acute toxicity studies have been carried out.
Croatian: Nisu provedena ispitivanja akutne toksičnosti.
English: Experience with Betaferon in patients with MS is limited, consequently those adverse events which occur very rarely may not yet have been observed.
Croatian: Iskustvo s primjenom lijeka Betaferon u bolesnika koji boluju od multiple skleroze je ograničeno te je zbog toga moguće da štetni događaji koji se javljaju vrlo rijetko još nisu zabilježeni.
English: There is no evidence of Betaferon having an effect on the duration of relapses.
Croatian: Nema dokaza da Betaferon utječe na duljinu trajanja relapsa.
English: The risk for progression to CDMS within 2 years was higher in monofocal patients with at least 9 T2-lesions or Gd-enhancement on brain MRI at baseline.
Croatian: Rizik od progresije do CDMS unutar dvije godine bio je veći u monožarišnih bolesnika s najmanje 9 T2 lezija ili gadolinijem izraženih povećanja na početnoj MRI snimci mozga.
English: In rare cases, pancreatitis was observed with Betaferon use, often associated with hypertriglyceridaemia.
Croatian: U rijetkim slučajevima primijećen je pankreatitis prilikom primjene lijeka Betaferon, često povezan s hipertrigliceridemijom.
English: Cases of pulmonary arterial hypertension (PAH) have been reported with interferon beta products.
Croatian: Slučajevi plućne arterijske hipertenzije (PAH) prijavljeni su s lijekovima koji sadrže interferon beta.
English: Pulmonary arterial hypertension has been seen at various time points during treatment, including several years after starting treatment with Betaferon.
Croatian: Plućna arterijska hipertenzija uočena je u različitim vremenskim točkama tijekom liječenja, i do nekoliko godina nakon početka liječenja lijekom Betaferon.
English: Interferon beta-1b has been shown to change the response of the immune system and to help to reduce disease activity.
Croatian: Pokazalo se da interferon beta-1b mijenja reakciju imunološkog sustava te pomaže smanjiti aktivnost bolesti.
English: Metabolism and nutrition disorders Blood glucose decreased (<55 mg/dl) ×
Croatian: Snižena razina glukoze u krvi (< 55 mg/dl) ×
English: Injection site necrosis has been reported in patients using Betaferon (see section 4.8).
Croatian: Nekroza na mjestu injiciranja zabilježena je u bolesnika koji primjenjuju Betaferon (vidjeti dio 4.8).
English: The most serious events often occurred in patients exposed to other drugs or substances known to be associated with hepatotoxicity or in the presence of comorbid medical conditions (e.g. metastasising malignant disease, severe infection and sepsis, alcohol abuse).
Croatian: Najozbiljniji događaji su se često javljali u bolesnika koji su bili izloženi drugim lijekovima ili tvarima za koje se zna da su povezane s hepatotoksičnošću ili u prisustvu komorbidnih medicinskih stanja (primjerice metastazirajuće maligne bolesti, teška infekcija i sepsa, zlouporaba alkohola).
English: These blood tests will be in addition to the tests, which are normally done to monitor your MS.
Croatian: Ti krvni testovi provodit će se pored ostalih testova koji se inače provode za praćenje multiple skleroze.
English: Periodic monitoring of early signs or symptoms, e.g. oedema, proteinuria and impaired renal function is recommended, especially in patients at higher risk of renal disease.
Croatian: Preporučuje se periodičko praćenje ranih znakova ili simptoma, primjerice edema, proteinurije i oštećene funkcije bubrega, posebno kod bolesnika s višim rizikom od bubrežne bolesti.
English: Sterile white to off-white powder.
Croatian: Sterilni bijeli do bjelkasti prašak.
English: Patients with single lesions may continue on Betaferon provided the necrosis is not too extensive, as some patients have experienced healing of injection site necrosis whilst on Betaferon.
Croatian: Bolesnici s pojedinačnim lezijama mogu nastaviti terapiju lijekom Betaferon pod uvjetom da nekroza nije preopsežna jer kod nekih bolesnika dolazi do cjeljenja nekroze na mjestu injiciranja dok uzimaju Betaferon.
English: Vomiting Λ
Croatian: Λ
English: Detailed instructions for self-injection of Betaferon under the skin are provided in Part IE of the Annex 'Self-injection procedure'.
Croatian: Detaljne upute za samoinjiciranje lijeka Betaferon pod kožu dostupne su u dijelu IE dodatka „Postupak samoinjiciranja“.
English: Secondary Progressive Multiple Sclerosis (North American Study)
Croatian: Sekundarna progresivna multipla skleroza (Sjevernoameričko ispitivanje)
English: The titration period may be adjusted, if any significant adverse reaction occurs.
Croatian: Razdoblje titracije može se prilagoditi u slučaju pojave značajnih nuspojava.
English: Push it down firmly until you feel it snap into place on the vial.
Croatian: Čvrsto ga gurnite prema dolje sve dok ne osjetite da je škljocnuo na mjesto na bočici.
English: (peripheral oedema), lack/loss of strength (asthenia), chills, sweating, malaise
Croatian: (periferni edemi), manjak/gubitak snage (astenija), zimica, znojenje, malaksalost
English: Prompt treatment of nephrotic syndrome is required and discontinuation of treatment with Betaferon should be considered.
Croatian: Potrebno je hitno liječenje nefrotskog sindroma te treba razmotriti prekid terapije lijekom Betaferon.
English: Betaferon is a sterile white to off-white powder for solution for injection.
Croatian: Betaferon je sterilni, bijeli do bjelkasti prašak za otopinu za injekciju.
English: Due to the lack of clinical experience in multiple sclerosis patients, the use of Betaferon together with immunomodulators other than corticosteroids or ACTH is not recommended.
Croatian: Zbog pomanjkanja kliničkog iskustva u bolesnika s multiplom sklerozom primjena Betaferona zajedno s imunomodulatorima, osim kortikosteroida ili ACTH, se ne preporučuje.
English: Your doctor may want to check your blood pressure, blood (platelet count) and the function of your kidney.
Croatian: Vaš liječnik može Vam provjeriti krvni tlak, krv (broj trombocita) i funkciju Vaših bubrega.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING TITRATION PACK WITH 4x1 TRIPLE PACK (3 VIALS/3 PRE-FILLED SYRINGES), FOR FIRST 12 INJECTIONS/TREATMENT DAYS (INCLUDING BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU TITRACIJSKO PAKIRANJE S 4x1 TROSTRUKIM PAKIRANJEM (3 BOČICE/3 NAPUNJENE ŠTRCALJKE)), ZA PRVIH 12 INJEKCIJA/DANA LIJEČENJA (UKLJUČUJUĆI PLAVI OKVIR)
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: Ograničene dostupne informacije o prenošenju interferona beta-1b u majčino mlijeko, zajedno s kemijskim/fiziološkim karakteristikama interferona beta, upućuju na zaključak da su razine interferona beta-1b izlučene u majčinom mlijeku zanemarive.
English: The recommended dose of Betaferon 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: Preporučena doza lijeka Betaferon je 250 mikrograma (8,0 milijuna IU), sadržanih u 1 ml rekonstituirane otopine (vidjeti dio 6.6), koja se supkutano injicira svaki drugi dan.
English: One of the two studies demonstrated a statistically significant delay in the time to disability progression (Hazard Ratio = 0.69, 95% confidence interval (0.55, 0.86), p=0.0010, corresponding to a 31% risk reduction due to Betaferon) and in the time to becoming wheelchair bound (Hazard Ratio = 0.61, 95% confidence interval (0.44, 0.85), p=0.0036, corresponding to a 39% risk reduction due to Betaferon) in patients who received Betaferon.
Croatian: Jedno od dva ispitivanja pokazalo je statistički značajnu odgodu u vremenu do napretka invalidnosti (omjer hazarda = 0,69, interval pouzdanosti 95 % (0,55; 0,86), p = 0,0010 odgovara smanjenju rizika od 31 % zbog primjene lijeka Betaferon) te vremena koje je potrebno da bolesnik postane vezan za invalidska kolica (omjer hazarda = 0,61; interval pouzdanosti 95 % (0,44; 0,85), p = 0,0036, odgovara smanjenju rizika od 39 % zbog primjene lijeka Betaferon) u bolesnika koji su liječeni lijekom Betaferon.
English: 16 - Next, hold the blue vial adapter with the attached vial and remove it from the syringe by twisting it and then pulling it down, away from the syringe.
Croatian: 16 - Potom držite nastavak plave bočice s pričvršćenom bočicom i uklonite ga sa štrcaljke okretanjem i potom povlačenjem prema dolje,
English: Stopping Betaferon is not known to lead to acute withdrawal symptoms.
Croatian: Nije poznato da prekid terapije lijekom Betaferon uzrokuje akutne simptome povlačenja.
English: Secondary Progressive Multiple Sclerosis (European Study)
Croatian: Sekundarna progresivna multipla skleroza (Europsko ispitivanje)
English: However, it is known that the biologic 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: AREA 5
Croatian: i 5.
English: For each titration step use the complete amount of solvent for reconstitution of the Betaferon powder, then draw up the required dose into the syringe.
Croatian: Za svaki korak titracije upotrijebite potpunu količinu otapala za pripremu otopine za injekciju iz praška lijeka Betaferon, a potom uvucite potrebnu dozu u štrcaljku.
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 u dodatku Dio III).
English: Patients exhibiting depression should be monitored closely during therapy with Betaferon and treated appropriately.
Croatian: Bolesnike koji pokazuju znakove depresije treba pomno nadzirati tijekom terapije lijekom Betaferon te liječiti na odgovarajući način.
English: Caution should be exercised when Betaferon 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 lijeka Betaferon u kombinaciji s lijekovima koji imaju uski terapijski indeks te su uvelike ovisni o sustavu jetrenog citokroma P450 zbog klirensa, primjerice antiepileptici.
English: The absolute bioavailability of subcutaneously administered interferon beta-1b was approximately
Croatian: Apsolutna bioraspoloživost supkutano primjenjenog interferona beta-1b bila je približno 50 %.
English: When starting treatment with Betaferon, it is tolerated best by gradually increasing the dose, i.e. starting with just 0.25 ml of the medication and then increasing, after every 3rd injection, first to 0.5 ml, then to 0.75 ml and then finally to the full dose (1 ml) of Betaferon.
Croatian: Kad započinjete liječenje lijekom Betaferon, on se najbolje podnosi postupnim povećavanjem doze, primjerice počinjući s 0,25 ml lijeka i potom povećavajući dozu nakon svake treće injekcije prvo do 0,5 ml, a zatim do 0,75
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 multižarišnih bolesnika rizik od nastanka CDMS-a nije ovisio o početnim MRI nalazima što ukazuje na visoki rizik od CDMS-a jer se širenje bolesti temeljilo na kliničkim nalazima.
English: A number of these products have been measured in the serum and cellular fractions of blood collected from patients treated with interferon beta-1b.
Croatian: Neki od tih produkata izmjereni su u serumu i staničnim frakcijama krvi bolesnika koji se liječe interferonom beta-1b.
English: Currently it is not possible to predict which patients belong to this group.
Croatian: Trenutačno nije moguće predvidjeti koji bolesnici pripadaju skupini kod koje se javljaju neutralizirajuća tijela.
English: Part of a titration pack.
Croatian: Dio titracijskog pakiranja.
English: Before preparing your injection, decide where you are going to inject.
Croatian: Prije priprave injekcije odlučite se za mjesto injiciranja.
English: Side effects derived only during post-marketing:
Croatian: Nuspojave prikupljene samo nakon stavljanja na tržište:
English: Single clinical event indicating a high risk of developing multiple sclerosis: Betaferon 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 Betaferon odgađa napredak pojave klinički jasne multiple skleroze.
English: Betaferon can be used during breast-feeding.
Croatian: Betaferon se može koristiti tijekom dojenja.
English: Treatment with Betaferon should be started under the supervision of a doctor who is experienced in the treatment of multiple sclerosis.
Croatian: Liječenje lijekom Betaferon treba početi pod nadzorom liječnika koji ima iskustva u liječenju multiple skleroze.
English: Inspect the reconstituted product visually before use.
Croatian: Prije uporabe vizualno pregledajte rekonstituirani lijek.
English: 'Warnings and precautions' and follow the instructions in Part II ‘Rotating injection sites' and Part III (Betaferon Medication Record) of the Annex 'Self-injection procedure'.
Croatian: Pogledajte dio 2 „Upozorenja i mjere opreza“ i pridržavajte se uputa u Dijelu II „Rotacija mjesta injiciranja“ i Dijelu III (Bilješke o injiciranju lijeka Betaferon) dodatka „Postupak samoinjiciranja“.
English: Injection site reactions usually become less frequent over time.
Croatian: Reakcije na mjestu injiciranja s vremenom postaju manje česte.
English: Flu-like symptoms may also be reduced by administration of non-steroidal anti-inflammatory drugs.
Croatian: Simptomi nalik gripi mogu se također smanjiti primjenom nesteroidnih protuupalnih lijekova.
English: To increase tolerability of Betaferon, a dose titration was applied and non-steroidal anti-inflammatory drugs were administered at start of therapy.
Croatian: Da bi se povećala podnošljivost lijeka Betaferon primjenjivala se titracija doze i nesteroidni protuupalni lijekovi na samom početku terapije.
English: The effect of alternate-day administration of 250 microgram (8.0 million IU) of Betaferon on drug metabolism in multiple sclerosis patients is unknown.
Croatian: Učinak primjene 250 mikrograma (8,0 milijuna IU) lijeka Betaferon svakog drugog dana na metabolizam lijeka u bolesnika s multiplom sklerozom nije poznat.
English: It has been demonstrated in vitro that Betaferon cross-reacts with natural interferon beta.
Croatian: U in vitro uvjetima dokazano je da Betaferon križno reagira s prirodnim interferonom beta.