FrancophonIA/ELRC3.0 huggingface dataset:
English: Nausea Constipation, dyspepsia, vomiting, dry mouth, diarrhoea, abdominal pain, gastritis, flatulence, abdominal distension,
Croatian: Mučnina Zatvor, dispepsija, povraćanje, suha usta, proljev, bol u abdomenu, gastritis, flatulencija, distenzija abdomena, hipersekrecija sline, bolest gastroezofagealnog refluksa, aftozni stomatitis
English: The concomitant use of safinamide and fluoxetine or fluvoxamine should be avoided (see section 4.4), this precaution is based on the occurrence of serious adverse reactions (e.g. serotonin syndrome), although rare, that have occurred when SSRIs and dextromethorphan have been used with MAO inhibitors.
Croatian: Ova mjera opreza temelji se na pojavi ozbiljnih nuspojava (npr. serotoninskog sindroma), koji se, iako rijetko, javlja kada se SSRI-ijevi i dekstrometorfan primjenjuju zajedno s MAO inhibitorima.
English: Xadago 50 mg film-coated tablets Xadago 100 mg film-coated tablets
Croatian: Xadago 50 mg filmom obložene tablete Xadago 100 mg filmom obložene tablete
English: 20091 Bresso (MI) - Italy Tel: +39 02 665241
Croatian: 20091 Bresso (MI) - Italija tel: +39 02 665241 fax: +39 02 66501492 e-mail: info.zambonspa@zambongroup.com
English: Xadago 100 mg tablets safinamide
Croatian: NAZIV LIJEKA Xadago 100 mg tablete safinamid
English: Ankylosing spondylitis, flank pain, joint swelling, musculoskeletal pain, myalgia, neck pain, osteoarthritis, synovial cyst
Croatian: Ankilozantni spondilitis, bol u boku, oticanje zglobova, mišićno-koštana bol, mialgija, bol u vratu, osteoartritis, sinovijalna cista
English: Xadago 50 mg tablets safinamide
Croatian: NAZIV LIJEKA Xadago 50 mg tablete safinamid
English: Xadago 50 mg film-coated tablets
Croatian: Xadago 50 mg filmom obložene tablete
English: Xadago 100 mg are orange to copper, round, biconcave film-coated tablets 9 mm diameter with metallic gloss, embossed with “100” on one side of the tablet.
Croatian: Xadago 100 mg su okrugle, bikonkavne, filmom obložene tablete promjera 9 mm, narančaste do bakrene boje metalik odsjaja, s otisnutom jačinom „100“ na jednoj strani tablete.
English: Xadago 100 mg film-coated tablets
Croatian: Xadago 100 mg filmom obložene tablete
English: Orange to copper, round, biconcave, film-coated tablet of 9 mm diameter with metallic gloss, embossed with the strength “100” on one side of the tablet.
Croatian: Okrugla, bikonkavna, filmom obložena tableta promjera 9 mm, narančaste do bakrene boje metalik odsjaja, s otisnutom jačinom „100“ na jednoj strani tablete.
English: Orange to copper, round, biconcave, film-coated tablet of 7 mm diameter with metallic gloss, embossed with the strength “50” on one side of the tablet.
Croatian: Okrugla, bikonkavna, filmom obložena tableta promjera 7 mm, narančaste do bakrene boje metalik odsjaja, s otisnutom jačinom „50“ na jednoj strani tablete.
English: Male rat fertility was not affected.
Croatian: Nije bilo učinka na plodnost mužjaka štakora.
English: Blood calcium decreased, blood potassium decreased, blood cholesterol decreased, body temperature increased, cardiac murmur, cardiac stress test abnormal, haematocrit decreased, haemoglobin decreased, international normalised ratio decreased, lymphocyte count decreased,
Croatian: Rijetko povišena alkalna fosfataza u krvi, povišen bikarbonat u krvi, povišen kreatinin u krvi, produljen QT elektrokardiograma, abnormalni nalaz pretrage funkcije jetre, abnormalni nalaz analize urina, povišeni krvni tlak, sniženi krvni tlak, abnormalni nalaz postupaka očne dijagnostike opterećenja srca, snižen hematokrit, snižen hemoglobin, snižen međunarodni normaliziran omjer, smanjen broj limfocita, smanjen broj trombocita, povišen lipoprotein vrlo niske gustoće
English: Cardiac disorders
Croatian: Erektilna disfunkcija
English: 95% CI p-value UPDRS II (c) Baseline (b)
Croatian: UPDRS III (c) Početna vrijednost (b) 28,6 Promjena LSM (SE) -4,5
English: Xadago 100 mg film-coated tablets safinamide
Croatian: Xadago 100 mg filmom obložene tablete safinamid
English: Xadago 50 mg film-coated tablets safinamide
Croatian: Xadago 50 mg filmom obložene tablete safinamid
English: No dose adjustment is required in patients with mild hepatic impairment.
Croatian: U bolesnika s blagim oštećenjem jetre nije potrebna prilagodba doze.
English: Microcrystalline cellulose Crospovidone type A Magnesium stearate Silica, colloidal anhydrous
Croatian: FARMACEUTSKI PODACI Popis pomoćnih tvari Jezgra tablete Celuloza, mikrokristalična
English: xadago 100 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU xadago 100 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - filmom obložene tablete
English: ANNEX I
Croatian: Krospovidon vrste A
English: Use in patients with severe hepatic impairment (see section 4.2).
Croatian: Istodobno liječenje petidinom (vidjeti dijelove 4.4 i 4.5) Primjena u bolesnika s teškim oštećenjem jetre (vidjeti dio 4.2).
English: Xadago 50 mg film-coated tablets Xadago 100 mg film-coated tablets safinamide
Croatian: Uputa o lijeku: Informacije za bolesnika Xadago 50 mg filmom obložene tablete Xadago 100 mg filmom obložene tablete safinamid
English: Micturition urgency, polyuria, pyuria, urinary hesitation
Croatian: Hitno mokrenje, poliurija, piurija, otežan početak mokrenja
English: What Xadago looks like and contents of the pack Xadago 50 mg are orange to copper, round, biconcave film-coated tablets of 7 mm diameter with metallic gloss, embossed with “50” on one side of the tablet.
Croatian: Xadago 50 mg su okrugle, bikonkavne, filmom obložene tablete promjera 7 mm, narančaste do bakrene boje metalik odsjaja, s otisnutom jačinom „50“ na jednoj strani tablete.
English: Zambon Italia S.r.l.
Croatian: Zambon Nederland B.V.
English: Tel: +39 02665241
Croatian: Zambon Italia S.r.l. Tel: + 39 02665241
English: BLISTER
Croatian: Nuspojave
English: General warning
Croatian: Opća upozorenja
English: Hepatobiliary disorders
Croatian: Metabolit
English: Tablet core
Croatian: Magnezijev stearat
English: Fax: +39 02 66501492
Croatian: Italija tel: +39 02665241 fax: +39 02 66501492 e-mail: info.zambonspa@zambongroup.com
English: It may harm them,
Croatian: poremećaji štitnjače
English: Symptoms may disappear completely or partly.
Croatian: Simptomi mogu nestati potpuno ili djelomično.
English: The instructions include the following main steps:
Croatian: Upute uključuju sljedeće glavne korake:
English: F) Quick review of the process
Croatian: F) Brzi pregled procesa
English: Please read the instructions carefully and follow them step by step.
Croatian: Molimo pažljivo pročitajte upute i pridržavajte ih se korak po korak.
English: Experience with exposure during the second and third trimester is very limited.
Croatian: Iskustvo s izloženošću tijekom drugog i trećeg tromjesečja vrlo je ograničeno.
English: ► Get a good start!
Croatian: ► Dobro se pripremite za početak!
English: Risk reduction
Croatian: Redukcija rizika
English: Betaferon with food and drink
Croatian: Betaferon s hranom i pićem
English: Betaferon itself does not affect the heart directly.
Croatian: Betaferon sam po sebi ne utječe izravno na srce.
English: This is called a Rotation Cycle.
Croatian: To se naziva rotacijski ciklus.
English: Dear patient,
Croatian: Poštovani bolesniče,
English: This effect continued over the observation period of up to 33 months.
Croatian: Taj se učinak nastavlja tijekom razdoblja promatranja do 33 mjeseca.
English: You can use the following rotation schedule.
Croatian: Možete koristiti sljedeći raspored rotiranja.
English: If you have forgotten to give yourself an injection at the right time do it as soon as you remember and then follow on with the next one 48 hours later.
Croatian: Ako ste si zaboravili dati injekciju u odgovarajuće vrijeme učinite to čim se sjetite i potom nastavite sa sljedećom nakon 48 sati.
English: It is best to use your thumb rather than your nail as it could break.
Croatian: Najbolje je upotrijebiti palac umjesto nokta jer se može slomiti.
English: This will help you to inject the required dose only.
Croatian: To će vam pomoći injicirati samo potrebnu dozu.
English: Date of last renewal: 31 January 2006
Croatian: Datum posljednje obnove odobrenja: 31. siječanj 2006.
English: − Try to give your injection at the same time of day.
Croatian: Pokušajte si davati injekciju svaki put u isto vrijeme dana.
English: ► Tell your doctor immediately:
Croatian: ► Odmah obavijestite svog liječnika:
English: However, there is some data available in children and adolescents from 12 to 16 years.
Croatian: Međutim, dostupno je nešto podataka za djecu i adolescente u dobi od 12 do 16 godina.
English: As you get started, you may find the following helpful:
Croatian: U početku će Vam možda pomoći sljedeće:
English: Based on animal data (see section 5.3), there is a possibly increased risk for spontaneous abortion.
Croatian: Na temelju podataka o životinjama (vidjeti dio 5.3), moguć je povećan rizik od spontanog pobačaja.
English: The syringes have special markings for this dose.
Croatian: Štrcaljke imaju posebnu oznaku za tu dozu.
English: It can cause disability temporarily, such as difficulty walking.
Croatian: Može uzrokovati privremenu nesposobnost kao što su poteškoće u hodanju.
English: Single use.
Croatian: Za jednokratnu uporabu.
English: The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
Croatian: Najprikladniji MedDRA termin koristi se za opisivanje određene reakcije i njezinih sinonima i srodnih stanja.
English: This can lead to shock (collapse) and even be fatal.
Croatian: To stanje može uzrokovati šok (kolaps) te čak biti smrtonosno.
English: As with all therapeutic proteins, there is a potential for immunogenicity.
Croatian: Kao i kod svih terapijskih proteina postoji mogućnost pojave imunogenosti.
English: Laboratory test
Croatian: Laboratorijski testovi
English: Therefore Betaferon should not be used in this population.
Croatian: Stoga se Betaferon ne smije upotrebljavati u toj populaciji.
English: Each single pack contains:
Croatian: Svako pojedinačno pakiranje sadrži:
English: − Never re-use syringes or needles.
Croatian: Nikada ne upotrebljavajte ponovno igle i štrcaljke.
English: Release the plunger, which may go back to its original position.
Croatian: Oslobodite klip koji se može vratiti na svoj prvobitni položaj.
English: The injection site must be changed regularly.
Croatian: Mjesto injiciranja mora se redovno mijenjati.
English: This package meets the patient's needs for the first 12 injections.
Croatian: To pakiranje udovoljava bolesnikovim potrebama za prvih 12 injekcija.
English: − If you have monoclonal gammopathy.
Croatian: Ako imate monoklonsku gamapatiju.
English: The optimal dose has not been fully clarified.
Croatian: Optimalna doza još uvijek nije potpuno utvrđena.
English: If you come back to an area after one Rotation Cycle, choose the most distant injection site within this area.
Croatian: Ako se vraćate na područje nakon jednog ciklusa rotacije odaberite najdalje mjesto injiciranja unutar tog područja.
English: Do not inject a double dose to make up for a forgotten single dose.
Croatian: Nemojte injicirati dvostruku dozu da biste nadoknadili zaboravljenu pojedinačnu dozu.
English: How Betaferon helps fight your disease
Croatian: Kako Vam Betaferon pomaže pobijediti bolest
English: It is not yet clear whether these neutralising antibodies reduce the effectiveness of the treatment.
Croatian: Još uvijek nije jasno da li ta neutralizirajuća protutijela smanjuju djelotvornost liječenja.
English: Talk to your doctor if you stop or wish to stop treatment.
Croatian: Razgovarajte sa svojim liječnikom ako prekinete ili želite prekinuti liječenje.
English: Do not freeze the solution, and do not wait longer than 3 hours to inject it.
Croatian: Ne zamrzavajte otopinu i nemojte čekati dulje od 3 sata na injiciranje.
English: Betaferon is available in pack sizes of:
Croatian: Betaferon je dostupan u pakiranjima od:
English: Robust evidence for benefit on this outcome parameter could not be demonstrated for 'immediate' treatment.
Croatian: Robustni dokaz koristi tog parametra ishoda ne može se iskazati za "trenutačno" liječenje.
English: Your doctor will closely monitor you during treatment.
Croatian: Vaš će Vas liječnik pomno nadzirati tijekom liječenja.
English: This is called demyelination.
Croatian: To se naziva demijelinizacija.
English: This is to keep it sterile.
Croatian: Tako ćete ga održati sterilnim.
English: New adverse events have not been associated with the development of neutralising activity.
Croatian: Novi štetni događaji nisu povezani s razvojem neutralizirajuće aktivnosti.
English: PART I: STEP BY STEP INSTRUCTIONS
Croatian: DIO 1: UPUTE KORAK PO KORAK
English: Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription.
Croatian: Obavijestite svog liječnika ili ljekarnika ako primjenjujete, nedavno ste primijenili ili biste mogli primijeniti bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta.
English: Interferons have molecular weights ranging from 15,000 to 21,000 Daltons.
Croatian: Interferoni imaju molekularnu težinu u rasponu od 15 000 do 21 000 daltona.
English: Dissolve the powder completely without shaking.
Croatian: Otopite prašak u potpunosti bez protresanja.
English: INSTRUCTIONS ON USE (text for inside the lid)
Croatian: UPUTE ZA UPORABU (tekst za unutrašnjost poklopca)
English: − Prepare each dose only when you are ready for an injection.
Croatian: Pripremite svaku dozu samo kad ste spremni za injekciju.
English: At the present time, it is not known how long the patient should be treated for.
Croatian: U ovom trenutku nije poznato koliko dugo se bolesnik treba liječiti.
English: The majority of patients in both treatment groups had no disability progression over the 5-year period.
Croatian: Većina bolesnika u obje skupine za liječenje nije imala napredak invalidnosti tijekom razdoblja od 5 godina.
English: No malformations have been observed in the surviving animals.
Croatian: Na preživjelim životinjama nisu primijećene malformacije.
English: In one single genotoxicity study (Ames test), no mutagenic effect has been observed.
Croatian: Tijekom jednokratnog ispitivanja genotoksičnosti (Amesov test) nije primijećen mutageni učinak.
English: Number of patients completed the trial phase
Croatian: Broj bolesnika koji su dovršili fazu ispitivanja
English: 13 - If the plunger has moved back to its original position push it in again and hold it in place.
Croatian: 13 - Ako se klip pomaknuo nazad u svoj prvobitni položaj, ponovno ga gurnite i držite na mjestu.
English: *Betaferon is formulated to contain a calculated overfill of 20 %.
Croatian: *Betaferon je formuliran s proračunatim suviškom od 20 %.
English: These may be symptoms of a serious allergic reaction (hypersensitivity), which may become life threatening.
Croatian: To mogu biti simptomi ozbiljne alergijske reakcije (preosjetljivost), koja može postati opasna po život.
English: This is a disorder of the immune system where an abnormal protein is found in the blood.
Croatian: To je poremećaj imunološkog sustava kod kojeg se u krvi nalaze abnormalni proteini.
English: A risk of transmission of Creutzfeld-Jacob disease (CJD) cannot be ruled out.
Croatian: Rizik od prijenosa Creutzfeld-Jacobove bolesti (CJD) ne može se isključiti.
English: This is often associated with an increase of certain blood fats (triglycerides).
Croatian: To je često povezano s porastom određenih masnoća u krvi (triglicerida).
English: ► Talk to your doctor if you injected too much Betaferon or injected it too often.
Croatian: Razgovarajte sa svojim liječnikom ako injicirate previše lijeka Betaferon ili ga injicirate prečesto.
English: You will find that within a few weeks your treatment will become a natural part of your routine.
Croatian: Otkrit ćete da ovaj postupak unutar nekoliko tjedana liječenja postaje dio Vaše svakodnevnice.
English: Please note:
Croatian: NAPOMENA:
English: Interferons are proteins produced by the body that help fight against attacks on the immune system such as viral infections.
Croatian: Interferoni su proteini koje proizvodi tijelo te koji pomažu u borbi protiv napada na imunološki sustav kao što su virusne infekcije.
English: - medicines which affect the production of blood cells.
Croatian: - lijekovima koji utječu na stvaranje krvnih stanica.
English: The table also includes side effects which occurred in less than 10% but were significantly associated with the treatment.
Croatian: Tablica također uključuje nuspojave koje su se dogodile u manje od 10% bolesnika, ali su bile značajno povezane s liječenjem).
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije uzimanja ovog lijeka.
English: In addition you will need a disposal unit for used syringes and needles.
Croatian: Pored toga trebate posudu za otpad za iskorištene štrcaljke i igle.
English: ► who have experienced symptoms for the first time which indicate a high risk of developing multiple sclerosis.
Croatian: ► koji su iskusili simptome po prvi put što ukazuje na visoki rizik od razvoja multiple skleroze.
English: Three major classes of interferons have been identified: alpha, beta, and gamma.
Croatian: Identificirane su tri glavne klase interferona: alfa, beta i gama.
English: Neutralising antibodies are not produced in all patients.
Croatian: Neutralizirajuća protutijela ne nastaju u svih bolesnika.
English: Some analyses suggest that this effect might be larger in patients with higher titre levels of neutralising activity.
Croatian: Neke analize sugeriraju da taj učinak može biti veći u bolesnika s višim razinama titra neutralizirajuće aktivnosti.
English: Table 3: Primary efficacy results of the BENEFIT and the BENEFIT Follow-up study
Croatian: Tablica 3: Rezultati primarne djelotvornosti ispitivanja BENEFIT i ispitivanja praćenja BENEFIT
English: No harmful effects on the breastfed newborn/infant are anticipated.
Croatian: Ne predviđaju se štetni učinci na dojeno novorođenče/dojenče.
English: Patients with mild disease and those unable to walk were not studied.
Croatian: Bolesnici s blagom bolešću te oni koji ne mogu hodati nisu bili uključeni u ispitivanja.
English: Your doctor also needs to know the following whilst you are using Betaferon:
Croatian: Vaš liječnik također mora znati sljedeće dok uzimate Betaferon:
English: Any disease other than multiple sclerosis that could better explain signs and symptoms of the patient had to be excluded.
Croatian: Bilo koja bolest osim multiple skleroze koja bi mogla bolje objasniti znakove i simptome bolesnika morala je biti isključena.
English: The development of neutralising activity in these studies is associated with a reduction in clinical efficacy only with regard to relapse activity.
Croatian: Razvoj neutralizirajuće aktivnosti u tim ispitivanjima povezan je sa smanjenjem kliničke djelotvornosti samo s obzirom na aktivnost relapsa.
English: If you are especially sensitive, this might affect your ability to drive or use machines.
Croatian: Ako ste posebno osjetljivi, to može utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: ► Tell your doctor if any of the above applies to you.
Croatian: Obavijestite svog liječnika ako se išta od gore navedenog odnosi na Vas.
English: C) Reconstituting the solution, step by step 1 - Wash your hands thoroughly with soap and water before beginning this process.
Croatian: C) Priprema otopine za injekciju, korak po korak 1 - Temeljito operite ruke sapunom i vodom prije početka tog procesa.
English: ► Stop injections with Betaferon and talk to your doctor
Croatian: Prekinite injiciranje lijeka Betaferon i porazgovarajte sa svojim liječnikom.
English: This medicinal product must not be mixed with other medicinal products except for the supplied solvent mentioned in section 6.6.
Croatian: Lijek ne smije miješati s drugim lijekovima osim s priloženim otapalom navedenim u dijelu 6.6.
English: The length of treatment will be decided by your doctor together with you.
Croatian: Duljinu liječenja određuje Vaš liječnik skupa s Vama.
English: What Betaferon is and what it is used for
Croatian: Što je Betaferon i za što se koristi
English: Do not attempt to inject yourself until you are sure that you understand how to prepare the injection solution and give the injection to yourself.
Croatian: Ne pokušavajte sami primijeniti lijek dok niste sigurni da ste razumjeli kako pripremiti otopinu injekcije i kako si je sami dati.
English: You need to choose a new site for each injection to allow the area time to recover and help prevent infection.
Croatian: Morate odabrati novo mjesto za svaku injekciju da biste omogućili da se područje oporavi te pomogli spriječiti infekciju.
English: Carcinogenicity studies have not been performed.
Croatian: Nisu provedene studije karcinogenosti.
English: − You will have a check of the function of your thyroid gland, regularly or whenever thought necessary by your doctor for other reasons.
Croatian: Bit ćete podvrgnuti provjeri funkcije štitne žlijezde, redovito ili kad god to liječnik smatra potrebnim iz drugih razloga.
English: With triple pack “4” you can inject the full dose 1.0 ml.
Croatian: S trostrukim pakiranjem „4“ možete injicirati punu dozu od 1,0 ml.
English: − If you have had depression or are depressed or previously had thoughts of suicide.
Croatian: Ako ste imali depresiju ili ste depresivni ili ste imali prethodne misli o samoubojstvu.
English: The robustness of the treatment effect was also shown by the delay of progression to multiple sclerosis according to McDonald criteria (Table 3).
Croatian: Robustnost učinka liječenja pokazana je i odgodom u napretku bolesti do multiple skleroze prema McDonaldovim kriterijima (Tablica 3).
English: Other medicines and Betaferon
Croatian: Drugi lijekovi i Betaferon
English: The triple packs are highlighted in different colours (see section 6.5).
Croatian: Trostruka pakiranja istaknuta su različitim bojama (vidjeti dio 6.5).
English: These symptoms may suggest problems with your liver.
Croatian: Ti simptomi mogu ukazivati na probleme s jetrom.
English: Each triple pack contains the syringes you will require for preparing each dose.
Croatian: Svako trostruko pakiranje sadrži štrcaljke koje su potrebne za pripravu svake doze.
English: Experience with other interferons suggests a potential for impairment of male and female fertility.
Croatian: Iskustva s drugim interferonima ukazuju na moguće oštećenje plodnosti kod muškaraca i žena.
English: No long-term studies have been conducted.
Croatian: Nisu provedena dugoročna ispitivanja.
English: This will either be done by your doctor or nurse or by yourself after you have been carefully trained.
Croatian: Vaš liječnik ili medicinska sestra ili Vi sami nakon što ste prošli temeljitu obuku.
English: Your doctor may decide, together with you, to change the time interval between increases in the dose depending on side effects you may experience at the start of treatment.
Croatian: Vaš liječnik može odlučiti zajedno s Vama o promjeni vremenskog intervala za povećanje doze, ovisno o nuspojavama koje ste možda iskusili od početka liječenja.
English: What Betaferon looks like and contents of the pack
Croatian: Kako Betaferon izgleda i sadržaj pakiranja
English: Each cycle will be 8 injections (16 days), given in area 1 through to area 8 in turn.
Croatian: Svaki ciklus sastoji se od 8 injekcija (16 dana) koje se naizmjenično daju od područja 1 do područja 8.
English: Rare cases of cardiomyopathy have been reported.
Croatian: Zabilježeni su rijetki slučajevi kardiomiopatije.
English: The decision to continue or discontinue treatment should be based on all aspects of the patient's disease status rather than on neutralising activity status alone.
Croatian: Odluka o nastavku ili prekidu liječenja bolesnika treba se više temeljiti na svim aspektima statusa bolesti nego na samom statusu neutralizirajuće aktivnosti.