FrancophonIA/ELRC3.0 huggingface dataset:
English: After you have finished each injection, put the needle and syringe into a special container (such as a sharps bin), not in ordinary rubbish.
Croatian: Jednom kad ste završili postupak injiciranja, odložite štrcaljku s iglom u odgovarajući spremnik (spremnik za oštre predmete), ne u običnu kantu za smeće.
English: If you have used more than one injection of Avonex in a three-day period, contact your doctor or pharmacist straight away for advice.
Croatian: Ako ikad primijenite više od jedne injekcije Avonexa u periodu od 3 dana, odmah kontaktirajte svog liječnika ili ljekarnika za savjet.
English: 12 pre-filled pens.
Croatian: 12 napunjenih brizgalica.
English: The pharmacokinetic profile of AVONEX has been investigated indirectly with an assay that measures interferon antiviral activity.
Croatian: Farmakokinetički profil AVONEXA proučavan je indirektno, testom za mjerenje antivirusne aktivnosti interferona.
English: UAB "JOHNSON & JOHNSON" filiāle Latvijā
Croatian: Latvija UAB "JOHNSON & JOHNSON" filiāle Latvijā
English: Now pull off the plastic needle cover.
Croatian: Sada skinite zaštitni plastični pokrov s igle.
English: The active substance in Avonex is a protein called interferon beta-1a.
Croatian: Djelatna tvar Avonexa je protein koji se naziva interferon beta-1a.
English: Tip: Do not use external heat sources such as hot water to warm the syringe.
Croatian: Savjet: Ne koristite vanjske izvore topline poput vruće vode kako biste zagrijali štrcaljku.
English: If you feel dizzy, do not drive.
Croatian: Ako osjećate omaglicu nemojte upravljati vozilom.
English: Patients should be advised to immediately report any symptoms of depression and/or suicidal ideation to their prescribing physician.
Croatian: Bolesnike je potrebno savjetovati da odmah prijave svom liječniku bilo koji simptom depresije i/ili suicidalnih ideja.
English: However, the effects of interferon beta that are dependent on glycosylation are not fully defined.
Croatian: Međutim, nisu u potpunosti utvrđeni učinci interferona beta koji su ovisni o glikozilaciji.
English: Avonex Pens are provided in packs of four or twelve for one or three months of injections.
Croatian: Avonex Pen je dostupan u pakiranjima od četiri ili dvanaest, za jedan ili tri mjeseca injekcija.
English: Tell your doctor as they may be signs of a possible kidney problem.
Croatian: Obavijestite svojeg liječnika jer to mogu biti znakovi mogućih problema s bubrezima.
English: These include MHC Class I, Mx protein, 2' / 5'-oligoadenylate synthetase, β2-microglobulin, and neopterin.
Croatian: Neki od njih su MHC klasa I, Mx protein, 2' / 5'-oligoadenilat sintetaza, β2-mikroglobulin i neopterin.
English: Press the plunger slowly until the syringe is empty.
Croatian: Polagano injicirajte pritiščući klip dok se štrcaljka ne isprazni.
English: Marketing Authorisation Holder and Manufacturer The Marketing Authorisation Holder is:
Croatian: Nositelj odobrenja za stavljanje lijeka u promet i proizvođač Nositelj odobrenja za stavljanje lijeka u promet je:
English: No studies on the effects of AVONEX on the ability to drive and use machines have been performed.
Croatian: Nisu provedene ispitivanja o učincima AVONEXA na sposobnost upravljanja vozilima i rada sa strojevima.
English: Do not lift the pen away from your skin.
Croatian: Nemojte podizati brizgalicu s kože.
English: The formulation does not contain a preservative.
Croatian: Lijek ne sadrži konzervanse.
English: Transient episodes of hypertonia and/or severe muscular weakness that prevent voluntary movements may occur at any time during treatment.
Croatian: Prolazne epizode hipertonije i/ili teška mišićna slabost koje sprječavaju voljne pokrete mogu se javiti bilo kad tijekom liječenja.
English: Do not use any more Avonex until you have spoken to a doctor.
Croatian: Nemojte više primjenjivati Avonex prije nego što razgovarate s liječnikom.
English: • Avonex is injected into a muscle, the best area is the upper, outer thigh muscle as shown in the diagram opposite.
Croatian: • Avonex se injicira u mišić, najbolje u gornji, vanjski dio bedrenog mišića, kako je prikazano na grafičkom prikazu nasuprot.
English: Flu-like symptoms associated with AVONEX therapy may prove stressful to patients with underlying cardiac conditions.
Croatian: Simptomi slični gripi koji se javljaju pri liječenju AVONEXOM mogu se pokazati stresnim za bolesnike s navedenim srčanim stanjima u podlozi.
English: Recent clinical studies with patients treated up to three years with AVONEX suggest that approximately 5% to 8% develop neutralising antibodies.
Croatian: Nedavna klinička ispitivanja, tijekom kojih su se kroz tri godine bolesnici liječili AVONEXOM ukazuju na razvoj neutralizirajućih protutijela u približno 5% do 8%
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, npr. edemi, proteinurija i oštećena funkcija bubrega, osobito u bolesnika s većim rizikom od bolesti bubrega.
English: 1 Clean the injection site
Croatian: 1 Očistite mjesto injiciranja
English: Some of these products have been measured in the serum and cellular fractions of blood collected from patients treated with AVONEX.
Croatian: Neke od ovih tvari određuju se u serumu i staničnim frakcijama krvi bolesnika koji su liječeni AVONEXOM.
English: Leave it at room temperature for half an hour.
Croatian: Ostavite da se štrcaljka ugrije Ostavite je na sobnoj temperaturi pola sata.
English: Tip: Do not use external heat sources such as hot water to warm Avonex Pen.
Croatian: Savjet: Ne koristite vanjske izvore topline poput vruće vode kako biste zagrijali Avonex Pen.
English: Interferons alpha and beta are classified as Type I interferons, and interferon gamma is a Type II interferon.
Croatian: Interferoni alfa i beta svrstavaju se u skupinu interferona tipa I, a interferon gama u skupinu interferona tipa II.
English: Limited published data suggest that the safety profile in adolescents from 12 to 16 years of age receiving AVONEX 30 micrograms IM once per week is similar to that seen in adults.
Croatian: Ograničeni objavljeni podaci upućuju da je sigurnosni profil kod adolescenata u dobi od 12 do 16 godina koji dobivaju 30 mikrograma AVONEXA i.m. jednom tjedno sličan kao u odraslih.
English: Three major forms of interferons have been distinguished: alpha, beta, and gamma.
Croatian: Razlikuju se tri glavne skupine interferona: alfa, beta i gama.
English: The effect of high-dose AVONEX administration on P450-dependent metabolism in monkeys was evaluated and no changes in liver metabolising capabilities were observed.
Croatian: Tijekom ispitivanja učinka visokih doza AVONEXA na metabolizam posredovan putem P450 enzima na majmunima nisu primijećene promjene metaboličke sposobnosti jetre.
English: No information is available on the effects of interferon beta-1a on male fertility.
Croatian: Nema dostupnih informacija o učincima interferona beta-1a na mušku plodnost.
English: Biogen Poland Sp. z o.o.
Croatian: Polska Biogen Poland Sp. z o.o.
English: • Place the pen cover on a flat, hard surface.
Croatian: • Stavite zatvarač brizgalice na ravnu, tvrdu površinu.
English: 1Injection site reactions including pain, inflammation and very rare cases of abscess or cellulitis that may require surgical intervention have been reported.
Croatian: 1Izvješteno je o reakcijama na mjestu injiciranja koje uključuju bol, upalu i u vrlo rijetkim slučajevima apsces ili celulitis za koje je ponekad potrebna kirurška intervencija.
English: If you have been told to gradually increase your dose of Avonex, you may need to use an Avostartclip titration kit provided by your doctor.
Croatian: Ako Vam je rečeno da postupno povećavate dozu Avonexa, možda ćete trebati koristiti Avostartclip titracijski pribor kojeg ćete dobiti od svog liječnika.
English: Titrating AVONEX at the initiation of therapy has demonstrated a reduction in the severity and incidence of flu-like symptoms.
Croatian: Titriranje AVONEXA na početku terapije je pokazalo smanjenje težine i incidencije simptoma sličnih gripi.
English: UAB "JOHNSON & JOHNSON" Eesti filiaal
Croatian: Eesti UAB "JOHNSON & JOHNSON" Eesti filiaal
English: If you have decided to start treatment with Avonex, your doctor may provide you with an Avostartclip titration kit.
Croatian: Ako ste odlučili započeti liječenje Avonexom, Vaš liječnik Vam može dati Avostartclip titracijski pribor.
English: Serious side effects: get medical help Serious allergic reactions
Croatian: Ozbiljne nuspojave: potražite medicinsku pomoć Ozbiljne alergijske reakcije Ako Vam se pojavi bilo koje od sljedećeg:
English: Avonex works best when you use it at the same time, once a week, on a regular basis.
Croatian: Avonex djeluje najbolje kad se koristi u isto vrijeme, jednom tjedno, redovito.
English: Chronic Toxicity: In a 26-week repeated dose toxicity study in rhesus monkeys by intramuscular route once per week, administered in combination with another immunomodulating agent, an anti CD40 ligand monoclonal antibody, no immune response toward interferon beta-1a and no signs of toxicity were demonstrated.
Croatian: Kronična toksičnost: tijekom ispitivanja toksičnosti ponovljenih doza koje je trajalo 26 tjedana, gdje se jednom tjedno rhesus majmunima intramuskularno davao interferon beta-1a u kombinaciji s drugom imunomodulirajućom tvari, anti CD40 ligand monoklonalnim protutijelom, nije bilo imunološkog odgovora na interferon beta-1a niti znakova toksičnosti.
English: Tip: Continue to hold the pen firmly on the skin.
Croatian: Savjet: Nastavite držati brizgalicu s uloškom čvrsto na koži.
English: It should be clear and colourless.
Croatian: Treba biti bistra i bezbojna.
English: Carcinogenesis: No carcinogenicity data for interferon beta-1a are available in animals or humans.
Croatian: Kancerogeneza: nema dostupnih podataka o kancerogenom djelovanju interferona beta-1a na ljude ili životinje.
English: The activity against other standards is not known.
Croatian: Nije poznato kakvu bi aktivnost lijek pokazao uporabom drugih standarda.
English: - Patients with a history of hypersensitivity to natural or recombinant interferon beta or to any excipients listed in section 6.1.
Croatian: - Bolesnici koji u anamnezi imaju preosjetljivost na prirodni ili rekombinantni interferon beta ili na neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Treatment with Avonex can help to prevent you from getting worse, although it will not cure MS.
Croatian: Liječenje Avonexom može pomoći u sprječavanju pogoršanja bolesti, međutim neće izliječiti MS-u.
English: Air bubble(s) are normal.
Croatian: Mjehurić(i) zraka su normalna pojava.
English: Treatment should be discontinued if the patient develops chronic progressive MS.
Croatian: Liječenje treba prekinuti u slučaju razvoja kronične progresivne MS-e.
English: Transient neurological symptoms that may mimic MS exacerbations may occur following injections.
Croatian: Prolazni neurološki simptomi koji mogu nalikovati egzacerbaciji MS-e mogu se javiti nakon davanja injekcije.
English: If you are new to Avonex, your doctor may advise you to gradually increase your dose so that you can adjust to the effects of Avonex before taking the full dose.
Croatian: Ako prvi put počinjete uzimate Avonex, vaš liječnik Vas može savjetovati da postupno povećavate dozu kako biste se lakše prilagodili učincima Avonexa prije primjene pune doze.
English: Prompt treatment of nephrotic syndrome is required and discontinuation of treatment with AVONEX should be considered.
Croatian: Potrebno je brzo liječenje nefrotskog sindroma i treba se razmotriti prestanak liječenja AVONEXOM.
English: Make sure the windows of the pen are visible.
Croatian: Prozorčići na brizgalici moraju biti vidljivi.
English: If TMA is diagnosed, prompt treatment is required (considering plasma exchange) and immediate discontinuation of AVONEX is recommended.
Croatian: Ako se dijagnosticira TMA, potrebno je bez odlaganja započeti liječenje (razmotriti plazmaferezu) i preporučuje se odmah prekinuti s liječenjem AVONEXOM.
English: This binding initiates a complex cascade of intracellular events that leads to the expression of numerous interferon-induced gene products and markers.
Croatian: Ovo vezanje uzrokuje kompleksan niz međusobno povezanih biokemijskih reakcija unutar stanice, što dovodi do ekspresije brojnih, interferonom induciranih produkata gena i markera.
English: Titration using the pre-filled syringe can be achieved by initiating therapy on ¼ dose increments per week reaching the full dose (30 micrograms/week) by the fourth week.
Croatian: Koristeći napunjenu štrcaljku titriranje se može provesti započinjanjem terapije ¼ doze te tolikim povišenjem doze svaki tjedan postižući tako punu dozu (30 mikrograma/tjedan) u četvrtom tjednu.
English: - The pen is broken.
Croatian: Brizgalica je slomljena.
English: Symptoms may include increased bruising, bleeding, fever, extreme weakness, headache, dizziness or light-headedness.
Croatian: Simptomi mogu uključivati povećanu pojavu modrica, krvarenje, vrućicu, ekstremnu slabost, glavobolju, omaglicu ili ošamućenost.
English: The window will now appear yellow when the full dose has been delivered.
Croatian: Kad je dostavljena cijela doza prozorčić će biti obojen žuto.
English: Endocrine disorders not known hypothyroidism, hyperthyroidism
Croatian: Endokrini poremećaji nepoznato hipotireoza, hipertireoza
English: Take paracetamol or ibuprofen half an hour before your Avonex injection and continue taking it for up to a day.
Croatian: Uzmite paracetamol ili ibuprofen pola sata prije injekcije Avonexa i nastavite ih uzimati jedan dan.
English: These effects have been seen in people using Avonex, but we do not know how likely they are to happen.
Croatian: Ove nuspojave su opažene u ljudi koji su dobivali Avonex, međutim nije poznato koja je vjerojatnost njihove pojavnosti.
English: Following intramuscular administration of AVONEX, serum antiviral activity levels peak between 5 and 15 hours post-dose and decline with a half-life of approximately 10 hours.
Croatian: Nakon intramuskularne primjene AVONEXA, antivirusna aktivnost u serumu dostigne svoj maksimum za 5 do 15 sati te počinje opadati s poluvijekom od približno 10 sati.
English: Three simple ways to help reduce the impact of flu-like symptoms:
Croatian: Tri su jednostavna načina za ublažavanje simptoma sličnih gripi:
English: Uncommon (≥1/1, 000 to <1/100 patient-years); Rare (≥1/10, 000 to <1/1,000 patient-years); Very rare (<1/10,000 patient-years);
Croatian: vrlo često (≥1/10 bolesnik-godina); često (≥1/100 i <1/10 bolesnik-godina); manje često (≥1/1000 i <1/100 bolesnik-godina); rijetko (≥1/10 000 i <1/1000 bolesnik-godina); vrlo rijetko (<1/10 000 bolesnik-godina);
English: 3 Extend the injector shield
Croatian: 3 Produžite štitnik injektora
English: Limited data of the efficacy/safety of AVONEX 15 micrograms IM once per week (n=8) as compared to no treatment (n=8) with follow up for 4 years showed results in line to those seen in adults, although the EDSS scores increased in the treated group over the 4 year follow-up thus indicating disease progression.
Croatian: Ograničeni podaci o djelotvornosti/sigurnosti 15 mikrograma AVONEXA i.m. jednom tjedno (n=8) u usporedbi s podacima bez liječenja (n=8) s kontrolom kroz 4 godine pokazali su rezultate koji su u skladu s onima kod odraslih, iako su EDSS rezultati porasli u liječenoj grupi kroz 4 godine praćenja, upućujući stoga na napredovanje bolesti.
English: Local Tolerance: Intramuscular irritation has not been evaluated in animals following repeated administration to the same injection site.
Croatian: Lokalna podnošljivost: intramuskularna iritacija nakon ponavljane primjene injekcije na isto mjesto nije bila procijenjena u životinja.
English: You will be provided with an Avostartclip titration kit.
Croatian: Dobit ćete titracijski pribor Avostartclip.
English: The instructions on how to inject yourself are at the end of this leaflet (see section 7, How to inject AVONEX PEN).
Croatian: Instrukcije o tome kako si samostalno dati injekciju se nalaze na kraju ove upute o lijeku (vidjeti dio 7, Kako injicirati Avonex Pen).
English: If you have problems handling the syringe, talk to your doctor about using a syringe grip.
Croatian: Ako imate problema pri rukovanju štrcaljkom, razgovarajte sa svojim liječnikom o korištenju držača za štrcaljku.
English: Renal and urinary disorders rare nephrotic syndrome, glomerulosclerosis (see section 4.4 ‘special warnings and precautions')
Croatian: Poremećaji bubrega i mokraćnog sustava rijetko nefrotski sindrom, glomeruloskleroza (vidjeti dio 4.4 ‘Posebna upozorenja i mjere opreza pri uporabi')
English: No teratogenic effects or effects on foetal development have been observed, but the available information on the effects of interferon beta-1a in the peri- and postnatal periods is limited.
Croatian: Nisu bili primijećeni teratogeni učinci ili učinci na razvoj ploda, ali raspoložive informacije o utjecaju interferona beta-1a tijekom peri- i postnatalnog perioda su ograničeni.
English: In the study, the cumulative percentage of patients who developed disability progression (by Kaplan-Meier life table analysis) by the end of two years was 35% for placebo-treated patients and 22% for AVONEX-treated patients.
Croatian: U ispitivanju je kumulativni postotak bolesnika u kojih je došlo do progresije onesposobljenosti (invalidnosti) (prema Kaplan-Meier analizi životne tablice), po završetku dvije godine, iznosio 35% za one koji su primali placebo, a 22% u bolesnika koji su liječeni AVONEXOM.
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 jednim demijelinizacijskim događajem i aktivnim upalnim procesom, ako zbog težine zahtijeva liječenje intravenskim kortikosteroidima, ako je isključena druga dijagnoza i ako je utvrđeno postojanje visokog rizika za razvoj klinički definirane multiple skleroze (vidjeti dio 5.1).
English: In order to improve the traceability of this medicine, your doctor or pharmacist should record the name and the lot number of the product you have been given in your patient file.
Croatian: Radi poboljšanja sljedivosti ovog lijeka liječnik ili ljekarnik u Vaš karton trebaju zabilježiti naziv i broj serije lijeka koji Vam je dan.
English: If there's anything you're not sure about or you have a problem, check with your doctor or pharmacist.
Croatian: Ako postoji nešto oko čega niste sigurni ili imate problem, provjerite to sa svojim liječnikom ili ljekarnikom
English: Side effects seen in clinical trials
Croatian: Nuspojave opažene u kliničkim istraživanjima
English: This is to limit flu-like symptoms which some people experience when they start using Avonex.
Croatian: To pomaže pri ublažavanju simptoma sličnih gripi koji se javljaju kod nekih ljudi kad počnu primjenjivati Avonex.
English: 4 pre-filled pens.
Croatian: 4 napunjene brizgalice.
English: • Hold the body of the pen at a right angle to the injection site with one hand.
Croatian: • Držite tijelo brizgalice jednom rukom pod pravim kutom prema mjestu injiciranja.
English: If you have depression, your doctor may still prescribe Avonex for you, but it's important to let your doctor know if you have had depression or any similar problems affecting your moods.
Croatian: Moguće je da Vam liječnik propiše Avonex i ako patite od depresije, ali važno je da liječniku kažete da patite od depresije ili bilo kojeg drugog problema koji utječe na Vaše raspoloženje.
English: The AVOSTARTCLIP titration kit is designed for use with the pre-filled syringe only.
Croatian: Titracijski pribor AVOSTARTCLIP projektiran je samo za uporabu s napunjenom štrcaljkom.
English: In order to obtain adequate efficacy, a dose of 30 micrograms once a week should be reached and maintained after the initial titration period.
Croatian: Nakon početnog titracijskog razdoblja treba postići dozu od 30 mikrograma jednom tjedno i održavati ju kako bi se osigurala odgovarajuća djelotvornost.
English: This makes the injection more comfortable than using straight from the refrigerator.
Croatian: Na taj je način injiciranje puno ugodnije nego injiciranje odmah nakon vađenja iz hladnjaka.
English: 3 Give the injection
Croatian: 3 Davanje injekcije
English: Avonex is made by:
Croatian: Avonex proizvodi:
English: Each pre-filled syringe of AVONEX contains a single dose only.
Croatian: Jedna napunjena štrcaljka AVONEXA sadrži samo jednu dozu.
English: Tip: Make sure the injection needle is firmly attached to the syringe.
Croatian: Savjet: Uvjerite se da je igla za injekciju dobro pričvršćena na štrcaljku.
English: Nephrotic Syndrome: 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: Nefrotski sindrom: Slučajevi nefrotskog sindroma s različitim nefropatijama u podlozi, uključujući kolapsnu fokalnu segmentalnu glomerulosklerozu (FSGS), bolest minimalnih promjena, (engl. minimal change disease, MCD), membranoproliferativni glomerulonefritis (MPGN) i membransku glomerulopatiju (MGN) zabilježeni su tijekom liječenja lijekovima koji sadrže interferon-beta.
English: These are the side effects that people reported when Avonex was being tested.
Croatian: To su nuspojave koje su prijavljene kad je Avonex bio testiran.
English: Hold the syringe so that the white cap is facing up.
Croatian: Primite štrcaljku tako da je bijeli zatvarač okrenut prema gore.
English: There are more details on how to inject Avonex at the end of this leaflet.
Croatian: Više detalja o tome kako injicirati Avonex nalazi se na kraju ove upute.
English: Avonex may affect other medicines or be affected by them.
Croatian: Avonex može utjecati na druge lijekove ili oni mogu utjecati na Avonex.
English: • Do not re-use the Avonex Pen.
Croatian: • Nemojte ponovno upotrijebiti Avonex Pen.
English: Side effects seen in clinical trials.
Croatian: Nuspojave opažene u kliničkim istraživanjima.
English: Tip: The best area is the upper, outer thigh.
Croatian: Savjet: Najbolje mjesto je gornji, vanjski dio bedra.
English: • Avonex Pen has been designed to function only with the supplied needle.
Croatian: • Avonex Pen dizajniran je tako da funkcionira samo s priloženom iglom.
English: Check the blister tray contains one pre-filled syringe and one injection needle (see picture “Contents of the plastic tray”).
Croatian: Provjerite nalaze li se napunjena štrcaljka i igla za injekciju unutar spremnika (vidjeti sliku „Sadržaj plastičnog spremnika“).
English: Biogen GmbH
Croatian: Deutschland Biogen GmbH
English: Store in a refrigerator (between 2°C and 8°C).
Croatian: Čuvati u hladnjaku (između 2 °C i 8 °C).
English: Take paracetamol or ibuprofen half an hour before your Avonex Pen injection and continue taking it for up to a day.
Croatian: 2. Uzmite paracetamol ili ibuprofen pola sata prije Avonex Pen injekcije i nastavite ih uzimati jedan dan.
English: As you keep using your injections, the flu-like symptoms gradually decrease.
Croatian: S dužim korištenjem injekcija će se simptomi slični gripi postupno smanjivati.
English: Psychiatric disorders common not known depression (see section 4.4), insomnia suicide, psychosis, anxiety, confusion, emotional lability
Croatian: Psihijatrijski poremećaji često nepoznato depresija (vidjeti dio 4.4), nesanica samoubojstvo, psihoza, anksioznost, konfuzija,
English: If there's anything you're not sure about, check with your doctor or pharmacist.
Croatian: Ako postoji nešto oko čega niste sigurni, provjerite to sa svojim liječnikom ili ljekarnikom.
English: If you are using a syringe that has an Avostartclip attached, you will receive a lower dose of Avonex.
Croatian: Ako koristite štrcaljku s pričvršćenim Avostartclipom, dobit ćete manju dozu Avonexa.