FrancophonIA/ELRC3.0 huggingface dataset:
English: If, for some reason, you are not able to inject the Betaferon immediately, you can keep the reconstituted solution in the syringe in a refrigerator for up to 3 hours before using.
Croatian: Ako iz bilo kojeg razloga niste u mogućnosti odmah injicirati Betaferon, možete pripremljenu otopinu u štrcaljki čuvati u hladnjaku do tri sata prije primjene.
English: − Betaferon contains human albumin and therefore carries a potential risk for transmission of viral diseases.
Croatian: − Betaferon sadrži ljudski albumin te stoga nosi mogući rizik od prijenosa virusnih bolesti.
English: Time to confirmed EDSS progression Kaplan-Meier estimates
Croatian: Vrijeme do potvrđene progresije na EDSS ljestvici Kaplan-Meierove procjene
English: ► If you have more than one sore injection site (multiple lesions) you must stop using Betaferon until your skin has healed.
Croatian: Ako imate više od jednog bolnog mjesta injiciranja (višestruke lezije), morate prestati s uzimanjem lijeka Betaferon dok Vaša koža ne zacijeli.
English: In retrospective meta-analyses including the data of both studies, an overall treatment effect was found which was statistically significant (p=0.0076; 8.0 million IU Betaferon versus all placebo patients).
Croatian: U retrospektivnim meta-analizama koje uključuju podatke iz oba ispitivanja, utvrđen je ukupni učinak liječenja za koje se smatra da je statistički značajan (p = 0,0076; 8,0 milijuna IU lijeka Betaferon naspram svih bolesnika koji su primali placebo).
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 dva relapsa u prethodne dvije godine ili u bolesnika sa sekundarno progresivnom multiplom sklerozom koji nisu imali aktivnu bolest u prethodne dvije godine.
English: Interferons have been reported to reduce the activity of hepatic cytochrome P450-dependent enzymes in humans and animals.
Croatian: Zabilježeno je da interferoni smanjuju aktivnost enzima ovisnih o jetrenom citokromu P450 u ljudi i životinja.
English: In any case, treatment should only be considered for patients classified as high risk.
Croatian: liječenje treba uzeti u obzir samo za bolesnike koji su klasificirani kao visokorizični.
English: Work through each rotation cycle in turn.
Croatian: Naizmjenično prođite kroz svaki ciklus.
English: Skin breakdown and tissue damage (necrosis) around the injection site are reported less frequently.
Croatian: Propadanje kože i oštećenje tkiva (nekroza) oko mjesta injiciranja ne bilježe se često.
English: Betaferon may cause side effects in the central nervous system (see section 4.
Croatian: Betaferon može uzrokovati nuspojave u središnjem živčanom sustavu (pogledajte dio 4. „Moguće nuspojave“).
English: These blood clots could affect your kidneys.
Croatian: Ti krvni ugrušci mogu utjecati na Vaše bubrege.
English: ► If you have only one sore injection site (lesion) and the tissue damage (necrosis) is not too extensive you may continue using Betaferon.
Croatian: Ako imate samo jedno bolno mjesto injiciranja (leziju) i područje oštećenog tkiva (nekroza) nije preveliko, možete nastaviti uzimati Betaferon.
English: After the placebo-controlled phase, patients entered a pre-planned follow-up phase with Betaferon to evaluate the effects of immediate versus delayed start of Betaferon treatment, comparing patients initially randomized to Betaferon ("immediate treatment group") or to placebo ("delayed treatment group").
Croatian: Nakon placebom kontrolirane faze bolesnici ulaze u prethodno planiranu fazu praćenja s lijekom Betaferon da bi se procijenili učinci trenutačnog naspram odgođenog početka liječenja lijekom Betaferon, uspoređujući bolesnike koji su početno randomizirani na Betaferon („skupina s trenutnim liječenjem“) ili na placebo („skupina s odgođenim liječenjem“).
English: Interferon beta-1b has been given without serious adverse events compromising vital functions to adult cancer patients at individual doses as high as 5,500 microgram (176 million IU) intravenously three times a week.
Croatian: Interferon beta-1b primjenjivao se u odraslih bolesnika s rakom bez ozbiljnih štetnih događaja koji ugrožavaju vitalne funkcije pri pojedinačnim dozama visokim i do 5500 mikrograma (176 milijuna IU) intravenski, tri puta tjedno.
English: What you need to know before you use Betaferon
Croatian: Što morate znati prije nego počnete primjenjivati Betaferon
English: If this is severe a doctor may have to remove foreign matter and dead tissue (debridement) and, less often, skin grafting is required and healing may take up to 6 months.
Croatian: Ako je reakcija jaka liječnik će možda morati ukloniti strano tijelo i mrtvo tkivo (obrada rane) te je manje često potrebno presađivanje kože, a cijeljenje može trajati do 6 mjeseci.
English: − Patients with current severe depression and/or suicidal ideation (see sections 4.4 and 4.8).
Croatian: − Bolesnici s trenutnom teškom depresijom i/ili suicidalnim idejama (vidjeti dijelove 4.4 i 4.8).
English: The procedure for the 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: − You will need blood tests to measure the number of your blood cells, blood chemistry and your liver enzymes.
Croatian: − Morat ćete se podvrgnuti krvnim testovima da bi se odredio broj Vaših krvnih stanica, učiniti biokemijske pretrage krvi i jetrenih enzima.
English: This may suggest a disease of the heart muscle (cardiomyopathy) which has been reported rarely in patients using Betaferon.
Croatian: To može ukazivati na bolest srčanog mišića (kardiomiopatija) koja se rijetko bilježi u bolesnika koji primjenjuju Betaferon.
English: Keep a record of where and when you last gave yourself an injection.
Croatian: Zabilježite gdje ste si i kada dali posljednju injekciju.
English: Reproduction studies with rhesus monkeys revealed maternal toxicity and an increased rate of abortion, resulting in prenatal mortality.
Croatian: Ispitivanja reprodukcije s rezus-majmunima otkrila su maternalnu toksičnost te povećani stupanj abortusa koji rezultira prenatalnom smrti.
English: − Always use a sterile (aseptic) technique as described in here.
Croatian: − Uvijek upotrebljavajte sterilne (aseptičke) tehnike injiciranja koje su opisane u nastavku.
English: Fertility No investigations on fertility have been conducted (see section 5.3).
Croatian: Nisu provedena ispitivanja plodnosti (vidjeti dio 5.3).
English: Changes to the liver function values occurred in patients treated with Betaferon during clinical studies.
Croatian: Promjene u vrijednostima jetrene funkcije javljaju se u pacijenata koji su liječeni lijekom Betaferon tijekom kliničkih ispitivanja.
English: NOTE: The injection should be administered immediately after mixing (if the injection is delayed, refrigerate the solution and inject it within 3 hours).
Croatian: Injekciju treba primjeniti odmah nakon miješanja (ako odgodite primjenu injekcije, pohranite otopinu u hladnjak te ju injicirajte u roku od 3 sata).
English: ► Tell your doctor immediately and stop using Betaferon:
Croatian: Odmah obavijestite svog liječnika i prestanite primjenjivati Betaferon:
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 valja izabrati mjesto injiciranja.
English: 1 - Choose an area for the injection (see advice at the start and the diagrams at the end of this Annex), and make a note of it in your medication record.
Croatian: 1 - Odaberite područje injiciranja (pogledajte savjet na početku dijagrama na kraju ovog Dodatka) te zabilježite mjesto u svojim bilješkama o primjeni injekcije.
English: Every other day (once every two days), 1.0 ml of the prepared Betaferon solution (see Annex ‘Selfinjection procedure' in the second part of this leaflet) injected under the skin (subcutaneously).
Croatian: Svaki drugi dan (jednom u dva dana) 1,0 ml pripremljene otopine lijeka Betaferon (pogledajte Dodatak „Postupak samoinjiciranja“ u drugom dijelu ove upute) injicirati pod kožu (supkutano).
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: Kako Betaferon djeluje Multipla skleroza (MS) je dugotrajno stanje koje pogađa središnji živčani sustav (CNS), posebice rad mozga i kralježnične moždine.
English: 6 - Hold the blister pack on the outside and place it on top of the vial.
Croatian: 6 - Držite blister-pakiranje na vanjskom dijelu i položite ga na vrh bočice.
English: On our example schedule each area is split again into 6 injection sites (which adds up to 48 injection sites all together), left and right: upper, middle and lower part of each area.
Croatian: Na našem oglednom rasporedu svako je područje podijeljeno u 6 područja injiciranja (što ukupno čini 48 mjesta za injiciranje), lijevi i desni gornji,
English: 69% 85% No primary endpoint
Croatian: 69 % 85 % Bez primarnog ishoda Bez primarnog ishoda
English: There is no evidence of an effect of Betaferon 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 učinka lijeka Betaferona na trajanje relapsa ili na simptome između relapsa te nije primijećen značajan učinak na progresiju bolesti u relapsno-remitirajućoj multiploj sklerozi.
English: − Patients with decompensated liver disease (see sections 4.4, 4.5 and 4.8).
Croatian: − Bolesnici s dekompenziranom bolesti jetre (vidjeti dijelove 4.4, 4.5 i 4.8).
English: The relation of multiple sclerosis disease activity as measured by MRI and clinical outcome is currently not fully understood.
Croatian: Odnos aktivnosti bolesti multiple skleroze mjerene MRI snimanjem i kliničkog ishoda trenutno nije potpuno razjašnjen.
English: Patients with anaemia, thrombocytopenia, 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 i leukopenijom (pojedinačno ili u kombinaciji) mogu zahtijevati intenzivnije praćenje kompletne krvne slike, s diferencijalnom krvnom slikom i brojem trombocita.
English: 15 - Remove any air bubbles by gently tapping the syringe and pushing the plunger to the 1-ml mark, or to the volume prescribed by your doctor.
Croatian: 15 - Uklonite mjehuriće zraka laganim tapkanjem štrcaljke te guranjem klipa na oznaku za 1 ml ili do volumena kojeg je propisao Vaš liječnik.
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: Transitory hyperthermia was observed, as well as a significant rise in lymphocytes and a significant decrease in thrombocytes and segmented neutrophils.
Croatian: Primijećena je prolazna hipertermija, kao i značajan porast u broju limfocita i značajno smanjenje broja trombocita i segmentiranih neutrofila.
English: Injection site reactions as well as injection site necroses were observed less frequently in this study than in the other pivotal studies.
Croatian: Reakcije na mjestu injiciranja, kao i nekroze na mjestu injiciranja primjećuju se rjeđe u ovom ispitivanju nego u drugim pivotalnim ispitivanjima.
English: To minimise the risk of injection site necrosis patients should be advised to:
Croatian: Za smanjenje rizika od nekroze na mjestu injiciranja bolesnike treba savjetovati da:
English: If some areas are too difficult for you to reach, you may need a family member or friend to help you with these injections.
Croatian: Ukoliko je neka područja teško dosegnuti, možda će Vam prilikom injiciranja trebati pomoć člana obitelji ili prijatelja.
English: − Always place the used syringes in the proper disposal unit.
Croatian: Uvijek odlažite iskorištene štrcaljke u odgovarajuću posudu za otpad.
English: 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: Zasada ne postoji dobro utvrđena definicija bolesnika s visokim rizikom iako konzervativniji pristup nalaže prihvaćanje najmanje devet T2 hiperintenznih lezija na početnom skenu te najmanje jednu novu T2 leziju ili jednu novu gadolinijem pojačanu leziju na kontrolnom skenu snimljenu najmanje mjesec dana nakon početnog skena.
English: If more than 3 hours pass, discard the reconstituted Betaferon solution and prepare a new injection.
Croatian: Ako je prošlo više od 3 sata, odbacite pripremljenu otopinu lijeka Betaferon i pripremite novu injekciju.
English: There have been no formal clinical trials undertaken in children or adolescents.
Croatian: Nema provedenih službenih kliničkih ispitivanja u djece i adolescenata.
English: 2 - Use an alcohol wipe to clean the skin at the injection site.
Croatian: 2 - Upotrijebite tupfer natopljen alkoholom da biste očistili kožu na mjestu injiciranja.
English: Patients should be monitored for signs of hepatic injury.
Croatian: Bolesnike treba motriti radi uočavanja znakova oštećenja jetre.
English: Problems with your small blood vessels (capillaries) may develop when using medicines like Betaferon (systemic capillary leak syndrome).
Croatian: Problemi s Vašim malim krvnim žilama (kapilarama) mogu nastati prilikom uporabe lijekova kao što je Betaferon (sindrom povećane propusnosti sistemskih kapilara).
English: 4 - Gently pinch the skin together around the disinfected injection site (to raise it up a little).
Croatian: 4 -Lagano uhvatite kožu oko dezinficiranog mjesta injiciranja (da biste ju blago podigli).
English: 8 - Pick up the syringe.
Croatian: 8 - Uzmite štrcaljku.
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 mogu biti simptomi pada broja krvnih stanica ili trombocita u Vašoj krvi (stanice koje pomažu da se krv zgruša).
English: Patients treated with Betaferon should be advised to report any symptoms of depression and/or suicidal ideation to their prescribing physician immediately.
Croatian: Bolesnike koji se liječe lijekom Betaferon treba savjetovati da odmah prijave svaki simptom depresije i/ili suicidalne ideje svom liječniku.
English: If the solution is discoloured or contains particles, discard it and start again with a new single pack of supplies.
Croatian: Ako je otopina promijenila boju ili sadrži čestice, odbacite ju i počnite ponovno s novim pojedinačnim pakiranjem.
English: Triple pack 4
Croatian: Trostruko pakiranje 4
English: With the titration pack, withdraw solution only up to the mark on the syringe:
Croatian: S titracijskim pakiranjem povucite otopinu samo do oznake na štrcaljki:
English: Betaferon should also be used with caution in patients who suffer from pre-existing cardiac disorders.
Croatian: Betaferon također treba upotrebljavati s oprezom u bolesnika koji već imaju srčane poremećaje.
English: After mixing Betaferon, you should give the injection immediately (if Betaferon is not used immediately, see section 5.
Croatian: Nakon miješanja lijeka Betaferon trebate odmah primijeniti injekciju (ako se Betaferon ne iskoristi odmah, pogledajte dio 5. „Kako čuvati
English: When you use the solution, warm it up in your hands before injecting to avoid pain.
Croatian: Prije primjene otopinu ugrijte rukama da biste izbjegli bol.
English: ► Important tips to keep in mind
Croatian: Važne stvari koje morate zapamtiti
English: From day 19 you are injecting the full dose 1.0 ml.
Croatian: Od dana 19 ubrizgavajte punu dozu od 1,0 ml.
English: Betaferon is a type of medicine known as interferon used to treat multiple sclerosis.
Croatian: Betaferon je vrsta lijeka poznata kao interferon koji se koristi za liječenje multiple skleroze.
English: Interferon beta-1b also enhances the suppressor activity of peripheral blood mononuclear cells.
Croatian: Interferon beta-1b također povećava supresorsku aktivnost mononuklearnih stanica iz periferne krvi.
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: − If you have severe kidney problems your doctor may monitor your kidney function during treatment.
Croatian: Ako imate teške probleme s bubrezima, Vaš liječnik može nadzirati funkciju Vaših bubrega tijekom liječenja.
English: Interferon beta-1b has been shown to possess both antiviral and immunoregulatory activities.
Croatian: Dokazano je da interferon beta-1b posjeduje i antivirusna i imunoregulatorna djelovanja.
English: Other things to consider when using Betaferon
Croatian: Ostale stvari koje morate razmotriti prilikom primjene lijeka Betaferon
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: RelapsingRemitting Multiple Sclerosis
Croatian: Relapsno remitirajuća multipla skleroza
English: No benefit, attributable to immediate Betaferon treatment, in quality of life (as measured by FAMS - Functional Assessment of MS: Treatment Outcomes Index) was seen.
Croatian: Nije zamijećena korist koja se može pripisati trenutnom liječenju lijekom Betaferon što se tiče kvalitete života (mjerena uz pomoć FAMS - Funkcionalne procjene multiple skleroze: Indeks ishoda liječenja).
English: While Betaferon 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 Betaferon nema poznate izravne toksične učinke na srce, simptomi sindroma nalik gripi povezani s interferonom beta mogu se pokazati stresnim za bolesnike s postojećom značajnom bolešću srca.
English: Two controlled clinical trials with Betaferon 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) were performed.
Croatian: Provedena su dva kontrolirana klinička ispitivanja s lijekom Betaferon koja uključuju ukupno 1657 bolesnika sa sekundarno progresivnom multiplom sklerozom (početne vrijednosti EDSS od 3 do 6,5, tj. bolesnici su mogli hodati).
English: By following this sequence, you will give each area a chance to recover before receiving another injection.
Croatian: Pridržavanjem ovog slijeda svakom ćete području omogućiti oporavak prije davanja druge injekcije.
English: − rotate the injection sites with each injection (see Annex ‘Self-injection procedure', Part II, in the second part of this leaflet).
Croatian: − mijenjati mjesta injiciranja sa svakom injekcijom (pogledajte Dodatak „ Postupak samoinjiciranja“, Dio II u drugom dijelu ove upute).
English: This might happen several weeks to several years after starting Betaferon.
Croatian: To bi se moglo dogoditi nekoliko tjedana do nekoliko godina nakon početka primjene lijeka Betaferon.
English: No influence on the monkey oestrous cycle has been observed.
Croatian: Nije primijećen utjecaj na rasplodni ciklus u rezus-majmuna.
English: This will give each injection site a chance to fully recover before receiving another injection.
Croatian: To će svakom mjestu injiciranja dati priliku da se potpuno oporavi prije nove injekcije.
English: 3 - Clean the top of the vial with an alcohol wipe, moving the wipe in one direction only.
Croatian: 3 - Očistite vrh bočice tupferom natopljenim alkoholom pomičući tupfer u samo jednom smjeru.
English: If your depression and/or suicidal thoughts are severe, you will not be prescribed Betaferon (see also ‘Do not use Betaferon').
Croatian: Ako su Vaša depresija i/ili misli o samoubojstvu ozbiljni, liječnik Vam neće propisati Betaferon (pogledajte također „Nemojte primjenjivati Betaferon“).
English: Betaferon is for use in patients
Croatian: Betaferon se upotrebljava u bolesnika
English: In the second trial of Betaferon in secondary progressive multiple sclerosis, no delay in the time to disability progression was observed.
Croatian: U drugom ispitivanju lijeka Betaferon u sekundarnoj progresivnoj multiploj sklerozi nije zabilježena odgoda u vremenu do napretka invalidnosti.
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 62,5 mikrograma (0,25 ml) supkutano svaki drugi dan te polako povećavati dozu do doze od 250 mikrograma (1,0 ml) svaki drugi dan (vidjeti tablicu A).
English: Talk to your doctor before you start using Betaferon:
Croatian: Obratite se svom liječniku prije nego primijenite Betaferon:
English: Your doctor or nurse can tell you more about this.
Croatian: Vaš liječnik ili medicinska sestra reći će Vam više o toj mogućnosti.
English: During Betaferon treatment you are likely to experience injection site reactions.
Croatian: Tijekom liječenja lijekom Betaferon vjerojatno ćete osjetiti reakcije na mjestu davanja injekcije.
English: If you experience any break in the skin, which may be associated with swelling or fluid leaking out from the injection site:
Croatian: Ako dođe do puknuća kože koje može biti povezano s oticanjem ili curenjem tekućine s mjesta injiciranja:
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 primjenom interferona.
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 Betaferon.
Croatian: Bolesnike s 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 lijekom Betaferon.
English: Keep the syringe in a horizontal position and the vial below the syringe.
Croatian: Držite štrcaljku u vodoravnom položaju, a bočicu ispod štrcaljke.
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: Štetni događaji i laboratorijske abnormalnosti sa stopama incidencije ≥ 10 % i pripadajući postotci za placebo; značajno povezane nuspojave < 10 % temeljeno na podacima iz kliničkih ispitivanja.
English: 19, 21, 23 et seq.
Croatian: 19, 21, 23 i dalje