FrancophonIA/ELRC3.0 huggingface dataset:
English: Studies show that Idelvion is effective at preventing and treating bleeding episodes in patients with haemophilia B, and its safety is comparable to that of other factor IX products.
Croatian: Ispitivanja su pokazala da je Idelvion učinkovit pri sprečavanju i liječenju epizoda krvarenja u bolesnika s hemofilijom B te da je njegova sigurnost usporediva sa sigurnošću drugih proizvoda za liječenje nedostatka faktora IX. Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji stoga je odlučio da koristi od lijeka Idelvion nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: It replaces the missing factor IX, thereby helping the blood to clot and giving temporary control of bleeding.
Croatian: Djelatna tvar lijeka Idelvion, albutrepenonakog alfa, djeluje u tijelu jednako kao ljudski faktor IX. Zamjenjuje faktor IX koji nedostaje te time pomaže pri zgrušavanju krvi i omogućava privremenu kontrolu krvarenja.
English: Give the child something to drink.
Croatian: Dajte djetetu da nešto popije.
English: • if you or your child are repeatedly sick, or
Croatian: • ako ste Vi ili Vaše dijete često bolesni, ili
English: The following medicines are particularly important:
Croatian: Osobito su važni sljedeći lijekovi:
English: Not recommended (no data available)
Croatian: ne preporučuje se (podaci nisu dostupni)
English: It is best to take this in the mornings with breakfast.
Croatian: Najbolje je da tu dozu uzimate ujutro uz doručak.
English: No specific antidote is known.
Croatian: Nije poznat specifični antidot.
English: (nearest)
Croatian: (najbliža)
English: It is usually convenient to take one dose in the morning and one in the evening.
Croatian: Obično se jedna doza uzima ujutro, a jedna navečer.
English: Repeat this procedure every time you need to give the medicine.
Croatian: Ponovite ovaj postupak svaki put kada trebate dati lijek.
English: It is important to complete the whole 5-day course, even if you start to feel better quickly.
Croatian: Važno je da dovršite cijelu 5-dnevnu terapiju, čak i ako se ubrzo počnete osjećati bolje.
English: These may be signs of rare but serious side effects.
Croatian: To mogu biti znakovi rijetkih ali ozbiljnih nuspojava.
English: Don't worry if not all of the powder dissolves.
Croatian: Ne brinite ako se sav prah ne otopi.
English: Date of first authorisation: 22 May 2014 Date of latest renewal:
Croatian: Datum prvog odobrenja: 22.svibnja 2014 Datum posljednje obnove odobrenja:
English: The mixture must be swallowed immediately after its preparation.
Croatian: Mješavina se mora progutati odmah nakon pripreme.
English: • if you are allergic to other medicines
Croatian: • jeste li alergični na druge lijekove
English: Talk to your doctor if this applies to you.
Croatian: Obratite se svom liječniku ako se to odnosi na Vas.
English: However,
Croatian: Međutim,
English: Specific studies have not been conducted to assess the reduction in the risk of complications.
Croatian: Nisu provedena posebna ispitivanja za procjenu smanjenja rizika od komplikacija.
English: Influenza was confirmed in 163 out of 377 index cases.
Croatian: Gripa je potvrđena u 163 od 377 indeks slučajeva.
English: • if your immune system is not working
Croatian: • ako Vam imunološki sustav ne funkcionira
English: 6 years
Croatian: 6 godine
English: The difference is how often it is given.
Croatian: Razlika je u tome koliko često se lijek daje.
English: Draw it up carefully so as not to include air bubbles.
Croatian: Navucite je pažljivo tako da ne bude zračnih mjehurića.
English: The capsule contains a white granulated powder.
Croatian: Kapsula sadrži bijeli granulirani prašak.
English: The undissolved powder is just inactive ingredients.
Croatian: Neotopljeni prah sadrži samo neaktivne sastojke.
English: This includes medicines obtained without a prescription.
Croatian: To uključuje i lijekove koje ste nabavili bez recepta.
English: • if you notice changes in behaviour or mood (neuropsychiatric events), especially in children and adolescents.
Croatian: • ako primijetite promjene u ponašanju ili raspoloženju (neuropsihijatrijske događaje), naročito u djece i adolescenata.
English: (Note: This compounded suspension should be gently shaken prior to administration to minimise the tendency for air entrapment.)
Croatian: (Napomena: Ovu pripremljenu suspenziju treba nježno protresti prije primjene kako bi se minimiziralo zadržavanje zračnih mjehurića.)
English: Body Weight (rounded to the nearest 0.5 kg)
Croatian: Tjelesna težina (zaokružena na najbližih 0,5 kg)
English: Pour all of the powder into the bowl, whatever the dose you are making.
Croatian: Istresite sav prah u zdjelicu, bez obzira koju dozu pripremate.
English: • Patients, especially children and adolescents, should be closely monitored for the behavioural changes described above.
Croatian: • Bolesnike, a naročito djecu i adolescente, treba pomno nadzirati kako bi se uočile eventualne gore opisane promjene ponašanja.
English: For treating flu, take two doses daily.
Croatian: Za liječenje gripe uzmite dvije doze dnevno.
English: The clinical significance of this finding is not clear, as the study had limited power.
Croatian: Klinički značaj ovog nalaza nije jasan jer je ispitivanje imalo ograničenu statističku snagu.
English: Stir the mixture well.
Croatian: Dobro promiješajte mješavinu.
English: What Ebilfumin is and what it is used for
Croatian: Što je Ebilfumin i za što se koristi
English: 0 - 12 months
Croatian: 0 - 12 mjeseci
English: Look up the child's weight on the left side of the table.
Croatian: Potražite djetetovu tjelesnu težinu na lijevoj strani tablice.
English: In 2008, H275Y was found in > 99 % of circulating H1N1 influenza isolates in Europe.
Croatian: U 2008. godini je H275Y nađen u > 99 % cirkulirajućih H1N1 izolata virusa gripe u Europi.
English: Step 5: Sweeten and give to the child
Croatian: 5. korak: Zasladite i dajte djetetu
English: Rare but serious effects: get medical help at once
Croatian: Rijetke ali ozbiljne nuspojave: odmah zatražite liječničku pomoć
English: No effects on foetal development were observed.
Croatian: Nije primijećen nikakav učinak na fetalni razvoj.
English: • if you are allergic to oseltamivir or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na oseltamivir ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Step 1: Check the dose is correct
Croatian: 1. korak: Provjerite je li doza točna
English: This is usually suitable for children over 1 year.
Croatian: To je obično primjereno za djecu stariju od 1 godine.
English: Influenza, usually called flu, is an infection caused by a virus.
Croatian: Influenca, koja se obično naziva gripom, je infekcija koju izaziva virus.
English: The reported adverse events were consistent with the established safety profile in older children.
Croatian: Prijavljene nuspojave bile su u skladu s utvrđenim sigurnosnim profilom u starije djece.
English: Step 3: Choose the correct amount for your child's weight
Croatian: 3. korak: Odaberite točnu količinu za težinu svog djeteta
English: The contribution of oseltamivir to those events is unknown.
Croatian: Doprinos oseltamivira pri tome nije poznat.
English: Outside epidemic periods, flu-like symptoms are usually caused by a different type of illness.
Croatian: Izvan razdoblja epidemije takve simptome obično izazivaju druge vrste bolesti.
English: • Sleeping difficulties
Croatian: • poteškoće sa spavanjem
English: • Two small bowls (use separate pairs of bowls for each child)
Croatian: • dvije zdjelice (za svako dijete upotrijebite nove dvije zdjelice)
English: If you notice any of these symptoms, especially in younger people, get medical help immediately.
Croatian: Ako primijetite neki od tih simptoma, osobito kod mlađih osoba, odmah zatražite liječničku pomoć.
English: Mix the sweet food and Ebilfumin suspension well.
Croatian: Dobro promiješajte slatku hranu i Ebilfumin suspenziju.
English: If you take more Ebilfumin than you should
Croatian: Ako uzmete više lijeka Ebilfumin nego što ste trebali
English: People who find it hard to take capsules can use a liquid form of this medicine (oral suspension).
Croatian: Osobe koje imaju poteškoća s uzimanjem kapsula mogu uzimati tekući oblik ovog lijeka (oralnu suspenziju).
English: Other medicines and Ebilfumin
Croatian: Drugi lijekovi i Ebilfumin
English: They help to ease or prevent the symptoms of the flu virus infection.
Croatian: Oni ublažavaju ili sprječavaju simptome infekcije virusom gripe.
English: Contents of the pack and other information What Ebilfumin contains
Croatian: Sadržaj pakiranja i druge informacije Što Ebilfumin sadrži
English: The frequency of these effects is reduced if the medicinal product is taken with food.
Croatian: Njihova se učestalost smanjuje ako se lijek uzima s hranom.
English: The following serious side effects have been rarely reported since oseltamivir has been marketed:
Croatian: Sljedeće ozbiljne nuspojave prijavljene su rijetko nakon stavljanja oseltamivira u promet:
English: Of those, 851 children received treatment with oseltamivir suspension.
Croatian: Od njih je 851 dijete primalo oseltamivir oralnu suspenziju.
English: • Altered level of consciousness
Croatian: • promjena razine svijesti
English: These medicines prevent the flu virus from spreading inside the body.
Croatian: Ovi lijekovi sprječavaju širenje virusa gripe u tijelu.
English: Additionally, this study was too small to reliably assess individual types of major malformations; moreover women exposed to oseltamivir and women unexposed could not be made fully comparable, in particular whether or not they had influenza.
Croatian: Isto tako, ovo je ispitivanje bilo premalo da bi se pouzdano procijenile pojedinačne vrste značajnih malformacija; osim toga, žene izložene oseltamiviru i one koje mu nisu bile izložene nije bilo moguće posve usporediti, osobito s obzirom na to jesu li imale gripu ili ne.
English: But if Ebilfumin is stopped earlier than your doctor told you, the symptoms of flu may come back.
Croatian: No, ako Ebilfumin prestanete uzimati ranije nego što Vam je to liječnik savjetovao, mogu se ponovno pojaviti simptomi gripe.
English: These reactions were seen at doses of 657 mg/kg and higher.
Croatian: Te su reakcije primijećene kod doze od 657 mg/kg i više.
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: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107. c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Foetal exposure in the rats and rabbits was approximately 15 to 20 % of that of the mother.
Croatian: Ekspozicija fetusa u štakora i kunića iznosila je približno 15 % do 20 % ekspozicije majke.
English: * Depending on the capsule strength used.
Croatian: * Ovisno o upotrijebljenoj jačini kapsule
English: A few cases resulted in self-injury, some with fatal outcome.
Croatian: U nekoliko su slučajeva doveli do samoozljeđivanja, ponekad sa smrtnim ishodom.
English: Patients should be closely monitored for behavioural changes, and the benefits and risks of continuing treatment should be carefully evaluated for each patient (see section 4.8).
Croatian: Bolesnike treba pomno nadzirati radi promjena u ponašanju, a koristi i rizike nastavka liječenja treba pažljivo procijeniti za svakog pojedinog bolesnika (vidjeti dio 4.8) Pomoćne tvari
English: Use the appropriate size capsule instead.
Croatian: Umjesto toga upotrijebite kapsulu odgovarajuće jačine.
English: For dosing, see section 4.2.
Croatian: Za doziranje vidjeti dio 4.2.
English: Talk to your doctor or pharmacist before taking Ebilfumin.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Ebilfumin.
English: Balkanpharma-Dupnitsa AD 3 Samokovsko Shosse Str. Dupnitsa 2600
Croatian: Balkanpharma-Dupnitsa AD 3 Samokovsko Shosse Str.
English: The median duration of illness in influenza B infected subjects did not differ significantly between the treatment groups in individual studies.
Croatian: Medijan trajanja bolesti u osoba zaraženih gripom B nije se znatno razlikovao među liječenim skupinama u pojedinačnim ispitivanjima.
English: In addition, there is evidence from observational studies showing benefit of the current dosing regimen in this patient population.
Croatian: Osim toga, dokazi iz opservacijskih ispitivanja ukazuju na korisne učinke sadašnjeg režima doziranja u ovoj populaciji bolesnica.
English: These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease.
Croatian: Ovi događaji mogu nastupiti kod encefalitisa ili encefalopatije, ali se mogu javiti i bez očite teške bolesti.
English: PVC/PE/PVdC/Al blisters or HDPE containers with LDPE lid (and a desiccant).
Croatian: PVC/PE/PVdC/Al blisteri ili spremnici (HDPE) sa zatvaračem (LDPE) (i sredstvom za sušenje).
English: If you notice any of these symptoms, get medical help immediately.
Croatian: Ako primijetite neki od tih simptoma, odmah zatražite liječničku pomoć.
English: The binding of the oseltamivir carboxylate to human plasma protein is negligible (approximately 3 %).
Croatian: Vezanje oseltamivir karboksilata za proteine plazme je zanemarivo (približno 3 %).
English: For adult patients with a weak immune system, treatment will continue for 10 days.
Croatian: U odraslih bolesnika s oslabljenim imunološkim sustavom liječenje će trajati 10 dana.
English: A second study was completed in 334 asthmatic children aged 6 to 12 years old of which 53.6 % were influenza-positive.
Croatian: Drugo ispitivanje provedeno je u 334 astmatične djece u dobi od 6 do 12 godina, od kojih je 53,6 %
English: However, in one observational study, while the overall malformation risk was not increased, the results for major congenital heart defects diagnosed within 12 months of birth were not conclusive.
Croatian: Međutim, u jednom opservacijskom ispitivanju, iako ukupni rizik od malformacija nije bio povećan, rezultati za značajne urođene srčane greške dijagnosticirane unutar 12 mjeseci nakon rođenja nisu omogućavali donošenje čvrstih zaključaka.
English: The protection against influenza lasts only as long as oseltamivir is administered.
Croatian: Zaštita od gripe traje samo dok se oseltamivir uzima.
English: Ebilfumin is not a vaccine: it treats infection, or prevents the flu virus spreading.
Croatian: Ebilfumin nije cjepivo: on liječi infekciju ili sprječava širenje virusa.
English: Infants less than 1 year (0 to 12 months)
Croatian: Dojenčad mlađa od 1 godine (0 do 12 mjeseci)
English: Patients who are unable to swallow capsules may receive appropriate extemporaneous formulation, see section 6.6 for preparation.
Croatian: Bolesnici koji ne mogu progutati kapsule, mogu primati odgovarajuće pripremljene formulacije, vidjeti dio 6.6 o načinu pripreme.
English: Treatment and prevention of influenza in adults and adolescents:
Croatian: Liječenje i prevencija gripe u odraslih i adolescenata:
English: The use of antivirals for the treatment and prevention of influenza should be determined on the basis of official recommendations.
Croatian: O primjeni antivirusnih lijekova za liječenje i prevenciju gripe treba odlučiti na temelju službenih preporuka.
English: The mixture should be stirred and given entirely to the patient.
Croatian: Mješavinu treba promiješati i u cijelosti dati bolesniku.
English: Insufficient data are available for these patients, in whom different dosing may be required due to the immaturity of physiological functions.
Croatian: Nema dovoljno podataka za ovakve bolesnike kod kojih može biti potrebno drugačije doziranje zbog nezrelosti fizioloških funkcija.
English: The suspension is caused by some of the excipients of Ebilfumin capsules, which are insoluble.)
Croatian: Suspenziju uzrokuju neke od pomoćnih tvari Ebilfumin kapsula koje su netopljive.)
English: The effects on breast-fed infants are unknown.
Croatian: Učinci na dojenčad nisu poznati.
English: Ebilfumin can be taken with or without food, although taking it with food can reduce the chance of feeling or being sick (nausea or vomiting).
Croatian: Ebilfumin možete uzeti s hranom ili bez nje, no uzimanje s hranom može smanjiti mogućnost mučnine i povraćanja.
English: You must tell your doctor if you are pregnant, if you think you are pregnant or if you are trying to get pregnant so that your doctor can decide if Ebilfumin is right for you.
Croatian: Morate obavijestiti svog liječnika ako ste trudni, mislite da biste mogli biti trudni ili pokušavate zatrudnjeti kako bi mogao odlučiti je li Ebilfumin primjeren lijek za Vas.
English: Give the whole contents of the second bowl (Ebilfumin suspension with sweet food added) to the child straight away.
Croatian: Djetetu odmah dajte cijeli sadržaj druge zdjelice (Ebilfumin suspenziju s dodanom slatkom hranom).
English: The recommended dose is based on the patient's body weight.
Croatian: Preporučena doza određuje se na temelju tjelesne težine bolesnika.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with oseltamivir in one or more subsets of the paediatric population in influenza.
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja oseltamivira u jednoj ili više podskupina pedijatrijske populacije kod gripe.
English: Give the whole contents of the bowl to the patient straight away.
Croatian: Bolesniku odmah dajte cijeli sadržaj zdjelice.
English: Exposure does not exceed that for treatment of infants < 1 year (3 mg/kg twice daily) and is anticipated to result in a comparable safety profile (see Section 4.8).
Croatian: Izloženost ne prekoračuje onu za liječenje dojenčadi <1 godine (3 mg/kg dvaput dnevno) i očekuje se da rezultira usporedivim sigurnosnim profilom (vidjeti dio 4.8).
English: In general, the safety profile in the patients “at risk” was qualitatively similar to that in otherwise healthy adults/adolescents.
Croatian: Profil sigurnosti u „rizičnih“ bolesnika općenito je bio kvalitativno sličan onomu u inače zdravih odraslih osoba ili adolescenata.
English: What Ebilfumin looks like and contents of the pack
Croatian: Kako Ebilfumin izgleda i sadržaj pakiranja
English: Be careful with the powder, because it may irritate your skin and eyes.
Croatian: Pažljivo rukujte prahom jer može nadražiti kožu i oči.
English: At least 75 % of an oral dose reaches the systemic circulation as the active metabolite.
Croatian: Barem 75 % peroralne doze u sistemsku cirkulaciju dolazi u obliku aktivnog metabolita.
English: Be careful with the powder: it may irritate your skin and eyes.
Croatian: Pažljivo rukujte prahom: može Vam nadražiti kožu i oči.
English: These side effects mostly occur after the first dose of the medicine and will usually stop as treatment continues.
Croatian: One se najčešće pojavljuju nakon prve doze lijeka i obično se povlače po nastavku liječenja.
English: The total duration of fever was reduced by one day in the groups treated with oseltamivir.
Croatian: Ukupno trajanje vrućice smanjilo se za jedan dan u skupini koja se liječila oseltamivirom.
English: The 2009 H1N1 influenza (“swine flu”) was almost uniformly susceptible to oseltamivir, with only sporadic reports of resistance in connection with both therapeutic and prophylactic regimens.
Croatian: H1N1 gripa u 2009. godini („svinjska gripa“) je bila gotovo bez iznimke osjetljiva na oseltamivir, sa samo sporadičnim izvještajima o rezistenciji povezanoj i s terapijskim i s profilaktičkim režimima
English: It is recommended that this information be provided by either affixing an ancillary label to the bottle or adding a statement to the pharmacy label instructions.
Croatian: Preporučuje se da ovu informaciju ili napišete na dodatnu naljepnicu na bočici ili je dodate na naljepnicu s uputama ljekarnika.
English: In the overall treatment population, influenza infection was confirmed in 67 % (range 46 % to 74 %) of the recruited patients.
Croatian: U ukupno liječenoj populaciji, infekcija virusom gripe potvrđena je u 67 % (raspon 46 % do 74 %) bolesnika uključenih u ispitivanje.
English: Instruct the parent or caregiver that any remaining material following completion of therapy must be discarded.
Croatian: Napomenite roditelju ili njegovatelju da se sva eventualno preostala količina lijeka nakon završetka liječenja mora odbaciti.
English: • if the influenza symptoms get worse or the fever continues tell your doctor as soon as possible.
Croatian: • ako se simptomi gripe pogoršavaju ili ako vrućica potraje, što prije obavijestite liječnika.
English: Do not take Ebilfumin.
Croatian: Nemojte uzimati Ebilfumin.
English: Ebilfumin will not change the effectiveness of a flu vaccine, and you might be prescribed both by your doctor.
Croatian: Ebilfumin neće promijeniti učinkovitost cjepiva protiv gripe i liječnik Vam može propisati i
English: Ebilfumin contains oseltamivir, which belongs to a group of medicines named neuraminidase inhibitors.
Croatian: Ebilfumin sadrži oseltamivir, koji pripada skupini lijekova pod nazivom inhibitori neuraminidaze.
English: Add the water to the powder in the bowl.
Croatian: Dodajte vodu u zdjelicu s prahom.
English: Reykjavíkurvegi 76-78, 220 Hafnarfjörður Iceland
Croatian: Reykjavíkurvegi 76-78, 220 Hafnarfjörður Island
English: Developing oseltamivir-resistant virus during treatment was more frequent in children than adults, ranging from less than 1% in adults to 18% in infants aged below 1 year.
Croatian: Razvoj virusa rezistentnih na oseltamivir tijekom liječenja zabilježen je češće u djece nego u odraslih, a kretao se u rasponu od manje od 1% u odraslih do 18% u dojenčadi mlađe od 1 godine.
English: It can be used when you have flu symptoms, and the flu virus is known to be going round in your community.
Croatian: Može se koristiti kada imate simptome gripe, a poznato je da virus gripe kruži u zajednici.
English: The column on the right of the table shows how much of the liquid mixture you will need to draw up.
Croatian: U stupcu na desnoj strani tablice navodi se koliko tekuće mješavine trebate navući.
English: Due to the wide safety margin of the active metabolite, no dose adjustments are required in adults due to their immunocompromised status.
Croatian: S obzirom na široku sigurnosnu marginu aktivnog metabolita, nije potrebno prilagođavati dozu u odraslih bolesnika prema statusu imunokompromitiranosti.
English: The virulence of influenza epidemics is not predictable and varies within a region and from season to season, therefore the number needed to treat (NNT) in order to prevent one case of influenza illness varies.
Croatian: Virulentnost gripe nije predvidiva i razlikuje se od područja do područja te od sezone do sezone, zbog čega varira i broj osoba koje treba liječiti (NNT = number needed to treat) da bi se spriječio jedan slučaj gripe.
English: Of the older subjects, 64 % were influenza-positive and of those with chronic cardiac and/or respiratory disease 62 % were influenza-positive.
Croatian: Među starijim ispitanicima bilo je 64 % influencapozitivnih, a među onima s kroničnim srčanim ili respiratornim oboljenjima bilo je 62 % influencapozitivnih.
English: The majority of these ARs were reported on a single occasion on either the first or second treatment day and resolved spontaneously within 1-2 days.
Croatian: U većini slučajeva, navedene nuspojave su se pojavile jednokratno, prvi ili drugi dan uzimanja lijeka i spontano su nestajale unutar 1-2 dana.
English: The lower predicted exposure however, remains above inhibitory concentrations (IC95 values) and at a therapeutic level for a range of influenza virus strains.
Croatian: Međutim, ta niža predviđena razina izloženosti i dalje se nalazi iznad inhibicijskih koncentracija (vrijednosti IC95) i na razini kojom se ostvaruje terapijski učinak na čitav niz sojeva virusa gripe.