FrancophonIA/ELRC3.0 huggingface dataset:
English: Talk to your doctor if you have any of these conditions, or if they worsen whilst taking Avonex.
Croatian: Razgovarajte sa svojim liječnikom ako imate bilo koje od navedenih stanja ili ako se ta stanja pogoršaju dok primjenjujete Avonex.
English: At the present time, it is not known for how long patients should be treated.
Croatian: Trenutno još nije poznato koliko dugo treba trajati liječenje ovim lijekom.
English: Tip: If you twist the needle cover to remove it, you may accidentally remove the needle as well.
Croatian: Savjet: Ako okrećete pokrov igle dok ga skidate, mogli biste slučajno skinuti i iglu.
English: Biogen Norway AS
Croatian: Norge Biogen Norway AS
English: Continue injecting on this new day every week.
Croatian: Svaki idući tjedan nastavite injicirati na taj novi dan.
English: Keep a note of where you have injected each week.
Croatian: Bilježite svaki tjedan gdje ste injicirali.
English: • Dispose of rubbish properly.
Croatian: • Zbrinite otpad pravilno.
English: Genesis Pharma SA
Croatian: Ελλάδα Genesis Pharma SA
English: Tip: The needle cover will come off automatically during step 3, below.
Croatian: Savjet: zaštitni pokrov za iglu automatski će se odvojiti tijekom 3. koraka, vidjeti dolje.
English: No harmful effects on the breastfed newborn/infant are anticipated.
Croatian: Ne očekuju se nikakvi štetni učinci na novorođenče/dojenče na majčinom mlijeku.
English: Do not twist it.
Croatian: Nemojte ga okretati.
English: It can be used to achieve the ¼ or ½ dose increments.
Croatian: Može se koristiti za postizanje povećanja doze za ¼ ili ½.
English: If you need to, use an alcohol wipe to clean the skin at the injection site you've chosen.
Croatian: Ako je potrebno, koristite vatu natopljenu alkoholom kako biste brisanjem očistili kožu na mjestu kojeg ste izabrali za injiciranje.
English: The protein in Avonex is made up of exactly the same ingredients as interferon beta that is found in the human body.
Croatian: Protein u Avonexu je napravljen od točno istih sastojaka kao interferon beta koji se nalazi u ljudskom tijelu.
English: However, the duration of exposure during the first trimester is uncertain, because data were collected when interferon beta use was contraindicated during pregnancy, and treatment likely interrupted when pregnancy was detected and/or confirmed.
Croatian: No, trajanje izloženosti tijekom prvog tromjesečja je nepouzdano jer su podaci prikupljani kada je interferon beta bio kontraindiciran tijekom trudnoće, a liječenje vjerojatno prekidano čim bi se otkrila i/ili potvrdila trudnoća.
English: In some cases these symptoms are associated with flu-like symptoms.
Croatian: U nekim slučajevima ovi simptomi su povezani sa simptomima sličnim gripi.
English: It is important to continue using Avonex regularly.
Croatian: Važno je da nastavite redovito koristiti Avonex.
English: • Firmly press until you hear a “click” to seal the needle.
Croatian: • Pritisnite čvrsto sve dok ne čujete „klik“ kako biste zatvorili iglu.
English: This includes any medicines obtained without a prescription.
Croatian: To uključuje i lijekove nabavljene bez recepta.
English: If it looks like it has been opened, do not use that syringe.
Croatian: Ako Vam se čini da je otvaran, nemojte upotrijebiti tu štrcaljku.
English: Due to the design of the study, patients were followed for variable lengths of time.
Croatian: U skladu s planom ispitivanja, bolesnici su bili praćeni tijekom različitog vremenskog razdoblja.
English: Cessation of therapy with AVONEX should be considered (see also sections 4.3 and 4.8).
Croatian: Treba razmotriti i odluku o prekidu terapije AVONEXOM (vidjeti također dijelove 4.3 i 4.8).
English: Even if you have used Avonex before, some of the information may have changed.
Croatian: Čak i ako ste primjenjivali Avonex prije, moguće je da su se neke informacije promijenile.
English: The clinical studies indicate that MS patients can receive AVONEX and corticosteroids or ACTH during relapses.
Croatian: Klinička ispitivanja su pokazala da bolesnici s MS-om mogu istodobno primati AVONEX i kortikosteroide ili ACTH tijekom relapsa.
English: - Pulmonary arterial hypertension: A disease of severe narrowing of the blood vessels in the lungs resulting in high blood pressure in the blood vessels that carry blood from the heart to the lungs.
Croatian: - Plućna arterijska hipertenzija: bolest jakog suženja krvnih žila u plućima što rezultira visokim krvnim tlakom u krvnim žilama koje prenose krv iz srca u pluća.
English: If it looks like it has been opened, do not use that Avonex Pen.
Croatian: Ako Vam se čini da je otvaran, nemojte upotrijebiti taj Avonex Pen.
English: 2The frequency of occurrence is higher at the beginning of treatment.
Croatian: 2Učestalost pojavljivanja je veća na početku liječenja.
English: Sometimes you will need to remind other medical staff that you are being treated with Avonex.
Croatian: Ponekad ćete trebati podsjetiti i ostale medicinske radnike da se liječite Avonexom.
English: Multiple sclerosis is linked to nerve (brain or spinal cord) damage.
Croatian: Multipla skleroza je povezana s oštećenjem živaca (u mozgu ili leđnoj moždini).
English: With appropriate adjustment for the rate of absorption from the injection site, the calculated bioavailability is approximately 40%.
Croatian: Nakon što su učinjena prikladna usklađivanja vezana uz brzinu apsorpcije lijeka iz mjesta primjene injekcije, izračunata vrijednost bioraspoloživosti iznosila je približno 40%.
English: More about depression
Croatian: Više o depresiji
English: The concentration is 30 micrograms per 0.5 ml.
Croatian: Koncentracija je 30 mikrograma po 0,5 ml.
English: • Firmly press the body of the pen down onto the skin to release the safety lock.
Croatian: • Čvrsto pritisnite tijelo brizgalice s uloškom na kožu kako biste otpustili sigurnosnu bravu.
English: Avonex is used to treat Multiple Sclerosis (MS).
Croatian: Avonex se koristi za liječenje multiple skleroze (MS).
English: This may allow you to sleep through the effects.
Croatian: Time možda prespavate te nuspojave.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Using the World Health Organisation (WHO) International Standard for Interferon, 30 micrograms of AVONEX contain 6 million IU of antiviral activity.
Croatian: Prema međunarodnom standardu za interferon Svjetske zdravstvene organizacije (WHO), 30 mikrograma AVONEXA sadrži 6 milijuna IU antivirusne aktivnosti.
English: A reduction of the risk of experiencing a second event was noted in the AVONEX treatment group.
Croatian: Smanjenje rizika za nastup drugog događaja primijećeno je u grupi liječenoj AVONEXOM.
English: This assay is limited in that it is sensitive for interferon but lacks specificity for interferon beta.
Croatian: Taj test je ograničen jer je osjetljiv na interferon, ali nije specifičan za interferon beta.
English: A large amount of data (more than 1000 pregnancy outcomes) from registries and post-marketing experience indicates no increased risk of major congenital anomalies after pre-conception exposure to interferon beta or such exposure during the first trimester of pregnancy.
Croatian: Velika količina podataka (više od 1000 ishoda trudnoće) iz registara i iskustva nakon stavljanja lijeka u promet ukazuje na to da ne postoji povećani rizik od velikih urođenih anomalija nakon izloženosti interferonu beta prije začeća ili takve izloženosti tijekom prvog tromjesečja trudnoće.
English: In clinical trials, this was characterised by two or more acute exacerbations (relapses) in the previous three-years without evidence of continuous progression between relapses; AVONEX slows the progression of disability and decreases the frequency of relapses.
Croatian: U kliničkim istraživanjima to je okarakterizirano s dvije ili više akutnih egzacerbacija (relapsa) u zadnje tri godine bez dokaza stalnog napredovanja bolesti između relapsa; AVONEX usporava progresiju onesposobljivanja (invalidnosti) i smanjuje učestalost relapsa.
English: If you have used the Avostartclip, the syringe (and the Avostartclip) must be thrown away afterwards.
Croatian: Ako ste koristili Avostartclip, štrcaljku (i Avostartclip) morate baciti poslije uporabe.
English: Tip: Do not press the blue activation button at the same time.
Croatian: Savjet: Nemojte u isto vrijeme pritisnuti plavi gumb za aktivaciju.
English: Avonex works best when you use it: - at the same time - once a week - on a regular basis
Croatian: Avonex djeluje najbolje ako ga koristite: - u isto vrijeme - jednom tjedno - redovito
English: If you have a preferred day for using Avonex, talk to your doctor about managing the dose, to get back to your preferred day.
Croatian: Ako imate neki dan koji preferirate za primjenjivanje Avonexa, razgovarajte sa svojim liječnikom o upravljanju s dozom lijeka, kako biste se vratili na dan koji preferirate.
English: The liquid should be clear and colourless.
Croatian: Tekućina treba biti bistra i bezbojna.
English: Disability progression was measured as an increase in the Expanded Disability Status Scale (EDSS) of 1.0 point, sustained for at least six months.
Croatian: Progresija onesposobljavanja (invalidnosti) mjerena je kao povećanje za 1,0 bod na EDSS (Expanded Disability Status Scale) skali, a održala se tijekom najmanje šest mjeseci.
English: For example, if you are prescribed other medicines, or if you have a blood test, Avonex may affect the other medicines or the test result.
Croatian: Na primjer, ako su Vam propisani drugi lijekovi ili radite krvne pretrage, Avonex može utjecati na druge lijekove ili na rezultate pretraga.
English: Adverse reactions identified from studies (clinical trials and observational studies, with a period of follow-up ranging from two years to six years) and other adverse reactions identified through spontaneous reporting from the market, with unknown frequency, are provided in the table below.
Croatian: Nuspojave identificirane u ispitivanjima (klinička istraživanja i opservacijska ispitivanja s razdobljem praćenja od dvije do šest godina) i ostale nuspojave identificirane spontanim prijavljivanjem s tržišta, s nepoznatom učestalošću, se nalaze u tablici ispod.
English: You may even actually faint.
Croatian: Moguće je da se zaista i onesvijestite.
English: They can also differ with respect to their cellular sites of synthesis.
Croatian: Oni se također mogu razlikovati prema mjestu gdje su sintetizirani u stanici.
English: Talk to a doctor straight away if any of these apply to you.
Croatian: Odmah razgovarajte s liječnikom ako se bilo što od navedenog odnosi na Vas.
English: For example, 100 person-years could be observed in 100 patients who were on treatment for one year or in 200 patients who were on treatment for half a year.
Croatian: Primjerice, 100 bolesnik-godina može biti razmatrano kod 100 bolesnika koji su bili liječeni kroz jednu godinu ili kod 200 bolesnika koji su bili liječeni kroz pola godine.
English: *Class label for interferon beta products (see section 4.4).
Croatian: *Značajka klase lijekova koji sadrže interferon beta (vidjeti dio 4.4).
English: In some cases, these reactions have occurred in the presence of other medicinal products that have been associated with hepatic injury.
Croatian: U nekim slučajevima ove reakcije su se javile s primjenom drugih lijekova koji su bili povezani s oštećenjem jetre.
English: This might happen several weeks to several years after starting Avonex.
Croatian: To bi se moglo dogoditi nekoliko tjedana do nekoliko godina nakon početka primjene Avonexa.
English: The safety and efficacy of AVONEX in children below 12 years of age have not yet been established.
Croatian: Sigurnost i djelotvornost AVONEXA u djece mlađe od 12 godina nisu još ustanovljene.
English: 150 AVONEX-treated patients completed one year on study and 85 completed two years on study.
Croatian: 150 bolesnika koji su liječeni AVONEXOM završilo je jednu godinu kliničke studije, a 85 bolesnika dvije godine.
English: Your doctor will advise you for how long you can use Avonex or when to stop.
Croatian: Liječnik će Vas savjetovati koliko dugo možete koristiti Avonex ili kad prestati.
English: Once a full dose is achieved patients may begin using AVONEX PEN.
Croatian: Jednom kada je dostignuta puna doza bolesnici mogu započeti s uporabom AVONEX PENA.
English: Your pack of Avonex already includes a needle for injection.
Croatian: Vaše pakiranje Avonexa već uključuje iglu za injekciju.
English: These episodes are of limited duration, temporally related to the injections and may recur after subsequent injections.
Croatian: Te epizode su ograničenog trajanja i vremenski povezane s primjenom injekcija, a mogu se ponovno javiti nakon ponovljenih injekcija.
English: • Hold the body of the pen firmly with one hand.
Croatian: • Čvrsto držite tijelo brizgalice jednom rukom.
English: Please check every time you get your prescription refilled to see if the leaflet has been updated.
Croatian: Provjerite svaki put kad dobijete novi recept za lijek je li uputa o lijeku obnovljena.
English: Tip: Take care not to press the blue activation button too early.
Croatian: Savjet: Pazite da ne pritisnete prerano plavi aktivacijski gumb.
English: Name and address of the manufacturers responsible for batch release Biogen (Denmark) Manufacturing ApS, Biogen Allé 1, DK-3400 Hillerød, Denmark.
Croatian: Naziv i adresa proizvođača odgovornih za puštanje serije lijeka u promet Biogen (Denmark) Manufacturing ApS, Biogen Allé 1, DK-3400 Hillerød, Danska.
English: After a single intramuscular dose of AVONEX, serum levels of these products remain elevated for at least four days and up to one week.
Croatian: Poslije jedne intramuskularne doze AVONEXA, koncentracije ovih tvari u serumu ostaju povišene od najmanje četiri dana do jednog tjedna.
English: Each syringe is packed in a sealed plastic tray.
Croatian: Svaka štrcaljka je pakirana u zatvoreni plastični spremnik.
English: • Check the injector shield is fully extended.
Croatian: • Provjerite je li štitnik injektora potpuno produžen.
English: • Do not remove the needle cover.
Croatian: • Nemojte ukloniti pokrov za iglu.
English: This is what causes the symptoms of MS. Avonex seems to work by stopping your body's defence system from attacking the myelin.
Croatian: Čini se da Avonex djeluje tako što sprječava obrambeni sustav tijela da napada mijelin.
English: Find a clean, hard surface to lay out the items needed for your injection.
Croatian: Pronađite čistu, tvrdu površinu i odložite na nju sve dijelove potrebne za injekciju.
English: Interferons are cytokines that mediate antiviral, antiproliferative, and immunomodulatory activities.
Croatian: Interferoni su citokini koji posreduju u antivirusnim, antiproliferativnim i imunomodulirajućim aktivnostima.
English: With one hand, stretch the skin around the injection site.
Croatian: Jednom rukom rastegnite kožu oko mjesta injiciranja.
English: AVONEX PEN is available in pack sizes of four or twelve.
Croatian: AVONEX PEN je dostupan u veličinama pakiranja od četiri ili dvanaest.
English: Talk to your doctor before using Avonex if you have or have had in the past:
Croatian: Obratite se svom liječniku prije nego primijenite Avonex ako imate ili ste u prošlosti imali:
English: Biogen Portugal Sociedade Farmacêutica, Unipessoal Lda.
Croatian: Sociedade Farmacêutica, Unipessoal Lda.
English: At very high doses, anovulatory and abortifacient effects in test animals were observed (see section 5.3).
Croatian: Pri vrlo visokim dozama, u pokusnih životinja primijećeni su anovulatorni i abortivni učinci (vidjeti dio 5.3).
English: It is for a single use only.
Croatian: Namijenjen je isključivo za jednokratnu upotrebu.
English: • Use a different injection site each week.
Croatian: • Koristite različito mjesto injiciranja svaki tjedan.
English: Infections and infestations not known injection site abscess1
Croatian: Infekcije i infestacije nepoznato apsces na mjestu injiciranja1
English: The antibodies of some of those patients reduce the activity of interferon beta-1a in vitro (neutralising antibodies).
Croatian: Protutijela u nekih od tih bolesnika mogu smanjiti aktivnost interferona beta-1a in vitro (neutralizirajuća protutijela).
English: Biogen Inc., 5000 Davis Drive, POB 14627, Research Triangle Park, North Carolina, 27709, USA.
Croatian: Biogen Inc., 250 Binney Street, Cambridge, Massachusetts 02142, SAD Biogen Inc., 5000 Davis Drive, POB 14627, Research Triangle Park, North Carolina, 27709, SAD.
English: Your doctor may want to check your blood pressure, blood (platelet count) and the function of your kidneys.
Croatian: Vaš liječnik može Vam provjeriti krvni tlak, krv (broj trombocita) i funkciju Vaših bubrega.
English: Tell your doctor you are using Avonex:
Croatian: Recite svom liječniku da primjenjujete Avonex:
English: AVONEX should be administered with caution to patients with a history of seizures, to those receiving treatment with anti-epileptics, particularly if their epilepsy is not adequately controlled with anti-epileptics (see sections 4.5 and 4.8).
Croatian: AVONEX treba s osobitom pozornošću davati bolesnicima koji u anamnezi imaju napadaje, bolesnicima koji se liječe antiepilepticima, posebno ako njihova epilepsija nije prikladno kontrolirana antiepilepticima (vidjeti dijelove 4.5 i 4.8).
English: - Patients with current severe depression and/or suicidal ideation (see sections 4.4 and 4.8).
Croatian: - Bolesnici koji trenutno boluju od teških depresija i/ili imaju suicidalne ideje (vidjeti dijelove 4.4 i 4.8).
English: Interferon beta is produced by various cell types including fibroblasts and macrophages.
Croatian: Interferon beta stvaraju različite vrste stanica uključujući fibroblaste i makrofage.
English: Avonex can help to reduce the number of relapses that you have and slow down the disabling effects of MS.
Croatian: Avonex može pomoći u smanjenju broja relapsa i usporiti onesposobljujuće učinke MS-e.
English: Whether the mechanism of action of AVONEX in MS is mediated by the same pathway as the biological effects described above is not known because the pathophysiology of MS is not well established.
Croatian: Nije poznato je li mehanizam djelovanja AVONEXA u MS-i isti kao prethodno opisan slijed bioloških djelovanja, jer patofiziologija MS-e nije u potpunosti razjašnjena.
English: Neutralising antibodies are associated with a reduction in the in vivo biological effects of AVONEX and may potentially be associated with a reduction of clinical efficacy.
Croatian: Neutralizirajuća protutijela povezana su sa smanjenjem bioloških in vivo učinaka AVONEXA, a potencijalno sa smanjenom kliničkom djelotvornosti lijeka.
English: Prepare alcohol wipes and sticking plasters (not supplied) if you need them.
Croatian: 4. Pripremite vatu natopljenu alkoholom i flastere (nisu dostavljeni) ukoliko su Vam potrebni.
English: The estimated risk of a second event was 50% in three years and 39% in two years in the placebo group and 35% (three years) and 21% (two years) in the AVONEX group.
Croatian: Procijenjeni rizik drugog događaja u placebo grupi je bio 50% u tri godine i 39% u dvije godine, a u AVONEX grupi 35% (tri godine) i 21% (dvije godine).
English: Interferons are a family of naturally occurring proteins that are produced by eukaryotic cells in response to viral infection and other biological inducers.
Croatian: Interferoni pripadaju skupini prirodnih proteina koje stvaraju eukariotske stanice kao odgovor na virusnu infekciju i druge biološke uzročnike.
English: AVONEX should be administered with caution to patients with previous or current depressive disorders, in particular to those with antecedents of suicidal ideation (see section 4.3).
Croatian: AVONEX treba primjenjivati s oprezom kod bolesnika sa prethodnim ili trenutnim depresivnim stanjima, posebno kod onih sa prethodnim suicidalnim idejama (vidjeti dio 4.3).
English: The use of various assays to detect serum antibodies to interferons limits the ability to compare antigenicity among different products.
Croatian: Korištenje različitih metoda za određivanje protutijela na interferone u serumu ograničava mogućnost usporedbe antigeničnosti različitih lijekova.
English: • Do not use any area of skin that is bruised, sore, or infected, or if there is an open wound.
Croatian: • Izbjegavajte područja kože s modricama, koja bole ili su inficirana ili ako postoji otvorena rana.
English: Do not use this medicine after the expiry date stated on the label.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici.
English: If clinically needed, the use of Avonex may be considered during pregnancy.
Croatian: U slučaju kliničke potrebe primjena lijeka Avonex može se uzeti u obzir tijekom trudnoće.
English: Clean and stretch the injection site
Croatian: Očistite i rastegnite mjesto injiciranja
English: In any case, treatment should only be considered for patients classified at high risk.
Croatian: U svakom slučaju liječenje treba uzeti u obzir samo za bolesnike koji su klasificirani kao visokorizični.
English: Biogen Hungary Kft.
Croatian: Magyarország Biogen Hungary Kft.
English: This is a specially designed holder to help you with injecting Avonex.
Croatian: To je posebno oblikovan držač koji Vam pomaže injicirati Avonex.
English: The injection site should be varied each week.
Croatian: Mjesto injekcije treba mijenjati svaki tjedan.
English: 5 Check the liquid
Croatian: 5 Provjerite tekućinu
English: Depression and suicidal ideation are known to occur in increased frequency in the multiple sclerosis population and in association with interferon use.
Croatian: Poznata je povećana učestalost depresije i suicidalnih ideja u populaciji s multiplom sklerozom koje su povezane sa primjenom interferona.
English: - Just after an injection, your muscles may feel tense or very weak - as though you are having a relapse.
Croatian: - Odmah nakon injekcije može se javiti napetost ili slabost u mišićima - slično kao kad imate relaps.
English: For further details, speak with your doctor
Croatian: Za više detalja, obratite se svojem liječniku.
English: Interferons have been reported to reduce the activity of hepatic cytochrome P450-dependent enzymes in humans and animals.
Croatian: Utvrđeno je da interferoni smanjuju aktivnost citokrom P450-ovisnih enzima u jetri ljudi i životinja.
English: Biogen Austria GmbH
Croatian: Österreich Biogen Austria GmbH
English: Keep the skin stretched tightly or squeeze the skin around the injection site, and pull out the needle.
Croatian: Držeći kožu i dalje čvrsto rastegnutom ili stiskajući kožu oko mjesta injiciranja, izvucite iglu.
English: Limited information available on the transfer of interferon beta-1a into breast milk, together with the chemical / physiological characteristics of interferon beta, suggests that levels of interferon beta-1a excreted in human milk are negligible.
Croatian: Ograničeni dostupni podaci o prijenosu interferona beta-1a u majčino mlijeko zajedno s kemijskim/fiziološkim karakteristikama interferona beta upućuju na to da su razine interferona beta-1a izlučene u ljudsko mlijeko zanemarive.
English: Patients may develop antibodies to AVONEX.
Croatian: Bolesnici mogu razviti protutijela na AVONEX.
English: Your doctor or nurse will help you use the Avostartclip titration kit.
Croatian: Vaš liječnik ili medicinska sestra će Vam pokazati kako koristiti Avostartclip titracijski pribor.
English: An alternative titration schedule can be achieved by initiating therapy on approximately a ½ dose of AVONEX once a week before increasing to the full dose.
Croatian: Alternativna titracijska shema je započinjanje terapije s približno ½ doze AVONEXA jednom tjedno prije povećanja do pune doze.