FrancophonIA/ELRC3.0 huggingface dataset:
English: An overview of Lenvima and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Lenvima i zašto je odobren u EU-u
English: Lenvima received a marketing authorisation valid throughout the EU on 28 May 2015.
Croatian: Lijek Lenvima dobio je odobrenje za stavljanje u promet koje vrijedi na prostoru EU-a od 28. svibnja
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lenvima have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Lenvima nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Lenvima has been shown to be more effective than placebo (a dummy treatment) at slowing down disease progression in one main study.
Croatian: Utvrđeno je da je lijek Lenvima djelotvorniji od placeba (prividno liječenje) pri usporavanju napretka bolesti u jednom glavnom ispitivanju.
English: The most common side effects with Lenvima (which may affect more than 3 in 10 people) are hypertension (high blood pressure), diarrhoea, decreased appetite and weight, tiredness, nausea (feeling sick), proteinuria (protein in the urine), stomatitis (inflammation of the lining of the mouth), vomiting, dysphonia (speech disturbances), headache and palmar-plantar erythrodysaesthesia syndrome (PPE - rash and numbness on the palms and soles).
Croatian: Najčešće nuspojave lijeka Lenvima (koje se mogu javiti u više od 3 na 10 osoba) jesu hipertenzija (visok krvi tlak), proljev, smanjeni apetit i težina, iscrpljenost, mučnina (slabost), proteinuirija (bjelančevine u mokraći), stomatitis (upala ovojnice usne šupljine), povraćanje, disfonija (poremećaj u govoru), glavobolja i palarno-plantaran sindrom eritrodisastezije (PPE - osip i utrnuće dlanova i tabana).
English: Differentiated thyroid carcinoma
Croatian: Diferencirani karcinom štitnjače
English: Regarding safety, the Agency considered that the majority of adverse effects with Lenvima can be adequately managed by reducing the dose or temporarily interrupting treatment.
Croatian: U pogledu sigurnosti, Agencija je zaključila da se većinom nuspojava povezanih s lijekom Lenvima može primjereno upravljati tako što će se smanjiti doza ili privremeno prekinuti terapija.
English: To manage side effects, the doctor may decide to reduce the dose or stop treatment temporarily.
Croatian: Kako bi se upravljalo nuspojavama, liječnik može odlučiti privremeno smanjiti dozu ili prekinuti terapiju.
English: Lenvima contains the active substance lenvatinib.
Croatian: Lenvima sadrži djelatnu tvar lenvatinib.
English: The study involved 392 adult patients with differentiated thyroid carcinoma that had shown signs of progression in the previous year and did not respond to treatment with radioactive iodine.
Croatian: U ispitivanju su sudjelovala 392 odrasla bolesnika s diferenciranim rakom štitnjače koji je pokazao znakove progresije u prethodnoj godini i nije reagirao na terapiju radioaktivnim jodom.
English: The European Medicines Agency decided that Lenvima's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Lenvima nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: • adults with hepatocellular carcinoma (a type of liver cancer) who did not previously receive a cancer medicine by mouth or by injection and whose cancer is advanced or cannot be removed by surgery.
Croatian: • odraslih osoba s hepatocelularnim karcinomom (vrste raka jetre) koji prethodno nisu primili lijek protiv raka peroralnom primjenom ili injekcijom i u kojih je rak uznapredovao ili se ne može odstraniti kirurškim zahvatom.
English: As for all medicines, data on the use of Lenvima are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Lenvima kontinuirano se prate.
English: Lenvima can only be obtained with a prescription and treatment must be started and supervised by a doctor who is experienced in using cancer medicines.
Croatian: Lenvima se izdaje na liječnički recept, a liječenje mora započeti i nadzirati liječnik s iskustvom u primjeni lijekova protiv raka.
English: For more information about using Lenvima, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Lenvima pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: How is Lenvima used?
Croatian: Kako se Lenvima koristi?
English: The study involved 954 patients with hepatocellular carcinoma who had not previously been treated for their cancer and whose cancer could not be removed by surgery.
Croatian: U ispitivanju je sudjelovalo 954 bolesnika s hepatocelularnim karcinomom koji prethodno nisu liječeni od te vrste raka i u kojih se rak nije mogao odstraniti kirurškim zahvatom.
English: The active substance in Lenvima, lenvatinib, is a ‘tyrosine-kinase inhibitor'.
Croatian: Djelatna tvar lijeka Lenvima, lenvatinib, inhibitor je tirozin kinaze.
English: What are the risks associated with Lenvima?
Croatian: Koji su rizici povezani s lijekom Lenvima?
English: Lenvima must not be taken by breastfeeding women.
Croatian: Lijek Lenvima ne smiju uzimati dojilje.
English: • adults with differentiated thyroid carcinoma, a type of cancer originating from the follicular cells of the thyroid gland.
Croatian: • odraslih osoba s diferenciranim karcinomom štitnjače, vrstom raka koji potječe iz folikularnih stanica štitnjače.
English: Lenvima is a cancer medicine used on its own to treat:
Croatian: Lenvima je lijek protiv raka koji se primjenjuje kao monoterapija u liječenju:
English: In patients with differentiated thyroid carcinoma, the medicine showed a clinically relevant improvement in the time patients lived without their disease getting worse.
Croatian: U bolesnika s diferenciranim rakom štitnjače utvrđeno je da je primjena lijeka rezultirala klinički relevantnim produljenjem životnog vijeka bolesnika bez pogoršanja bolesti.
English: Other information about Lenvima
Croatian: Ostale informacije o lijeku Lenvima
English: What benefits of Lenvima have been shown in studies?
Croatian: Koje su koristi od lijeka Lenvima utvrđene u ispitivanjima?
English: For the full list of side effects with Lenvima, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Lenvima potražite u uputi o lijeku.
English: Lenvima has been shown to be at least as effective as the cancer medicine sorafenib at prolonging the time patients lived in one main study.
Croatian: U jednom glavnom ispitivanju lijek Lenvima pokazao se barem jednako djelotvornim u produljenju životnog vijeka bolesnika kao lijek protiv raka sorafenib.
English: In patients with advanced hepatocellular carcinoma who have a poor prognosis and few treatment options, Lenvima was as effective as sorafenib in prolonging their life.
Croatian: Lijek Lenvima bio je jednako djelotvoran kao i sorafenib u produljenju životnog vijeka u bolesnika s uznapredovalim hepatocelularnim karcinomom koji imaju lošu prognozu i malo opcija liječenja.
English: How does Lenvima work?
Croatian: Kako djeluje Lenvima?
English: If not, you can do it easily yourself.
Croatian: No, ako to nije učinjeno, lako ćete ga pripremiti sami.
English: You will not need to prepare it again unless you start a new bottle.
Croatian: Nećete je morati ponovno pripremati, osim ako ne započinjete s novom bocom.
English: Talk to your doctor if this applies to you.
Croatian: Obratite se liječniku ako se to odnosi na Vas.
English: Imprints are blue.
Croatian: Natpisi su plave boje.
English: * This table is not intended to contain all possible weights for this population.
Croatian: * Ova tablica ne može sadržavati sve moguće težine u ovoj populaciji.
English: Stop at the mark that shows the dose you need.
Croatian: Zaustavite se na oznaci koja pokazuje dozu koja Vam je potrebna.
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: You will need to do this every time you need a dose.
Croatian: To ćete morati učiniti svaki puta kada trebate uzeti dozu.
English: Always use 55 ml of water, whatever the dose you need.
Croatian: Uvijek morate upotrijebiti 55 ml vode, bez obzira na dozu koju trebate.
English: • Close the bottle again
Croatian: • Ponovno zatvorite bocu
English: Turn the whole unit upright.
Croatian: Okrenite cijeli sklop u uspravan položaj.
English: You only need to do this once, at the beginning of your course.
Croatian: To ćete trebati učiniti samo jedanput, na početku liječenja.
English: • Convulsions and delirium, including altered level of consciousness
Croatian: • konvulzije i delirij, uključujući promjenu razine svijesti
English: Date of last renewal: 22 May 2012
Croatian: Datum posljednje obnove odobrenja: 22. svibnja 2012.
English: Take this medicine exactly as your doctor has told you.
Croatian: Uvijek uzmite ovaj lijek točno onako kako Vam je rekao liječnik.
English: • Give the medicine into the mouth
Croatian: • Primijenite lijek u usta
English: Sorbitol can have a mild laxative effect.
Croatian: Sorbitol može imati blag laksativni učinak.
English: Fill it with water to the indicated level.
Croatian: Napunite je vodom do označene razine
English: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja fruktoze ne bi smjeli uzimati ovaj lijek.
English: Your pharmacist may have prepared the medicine for you when you collected your prescription.
Croatian: Ljekarnik je možda za Vas pripremio lijek nakon što ste mu dali recept.
English: The oral suspension can be used by people who find it hard to take capsules.
Croatian: Oralnu suspenziju mogu koristiti osobe kojima je teško uzimati kapsule.
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 % bilo influenca-pozitivno.
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: 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)
English: Triplex blister pack (PVC/PE/PVDC, sealed with aluminium foil).
Croatian: Trostruko blister pakiranje (PVC/PE/PVDC, zatvoreno aluminijskom folijom).
English: (Regarding neuropsychiatric disorders, see section 4.4.)
Croatian: (Za neuropsihijatrijske poremećaje, vidjeti dio 4.4).
English: If you notice any of these symptoms, especially in younger people, get medical help immediately.
Croatian: Ako primijetite neki od tih simptoma, osobito u mlađih osoba, odmah zatražite liječničku pomoć.
English: Home preparation
Croatian: Priprema kod kuće
English: • Neuropsychiatric disorders, as described below.
Croatian: • neuropsihijatrijski poremećaji opisani u nastavku.
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 u kojih može biti potrebno drugačije doziranje zbog nezrelosti fizioloških funkcija.
English: Infant (<1 year) * Full genotyping was not performed in all studies.
Croatian: Dojenčad (< 1 godine) * Potpuna genotipizacija nije provedena u svim ispitivanjima.
English: Foetal exposure in the rats and rabbits was approximately 15 to 20 % of that of the mother.
Croatian: Izloženost fetusa u štakora i kunića iznosila je približno 15 % do 20 % izloženosti majke.
English: You must use the amount of Tamiflu prescribed by the doctor.
Croatian: Morate uzimati onu količinu lijeka Tamiflu koju je propisao liječnik.
English: You may drink and eat something after taking the medicine.
Croatian: Nakon uzimanja lijeka možete nešto pojesti i popiti.
English: The protection against influenza lasts only as long as Tamiflu is administered.
Croatian: Zaštita od gripe traje samo dok se Tamiflu uzima.
English: The binding of the oseltamivir carboxylate to human plasma protein is negligible (approximately 3 %).
Croatian: Vezanje oseltamivirkarboksilata za proteine plazme je zanemarivo (približno 3 %).
English: - The appropriate use of Tamiflu for prevention of influenza should be determined on a case by case basis by the circumstances and the population requiring protection.
Croatian: - Prikladnost upotrebe lijeka Tamiflu za prevenciju gripe određuje se za svaki slučaj zasebno, na temelju okolnosti i populacije koja zahtijeva zaštitu.
English: Always shake well before use.
Croatian: Uvijek dobro protresite bocu prije upotrebe.
English: What Tamiflu is and what it is used for
Croatian: Što je Tamiflu i za što se koristi
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Tamiflu in one or more subsets of the paediatric population in influenza.
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Tamiflu u jednoj ili više podskupina pedijatrijske populacije kod gripe.
English: But if Tamiflu is stopped earlier than your doctor told you, the symptoms of flu may come back.
Croatian: No, ako Tamiflu prestanete uzimati ranije nego što Vam je to liječnik savjetovao, mogu se ponovno pojaviti simptomi gripe.
English: The contribution of Tamiflu to those events is unknown.
Croatian: Doprinos lijeka Tamiflu pri tome nije poznat.
English: The powder is a granulate or clumped granulate with a white to light yellow colour.
Croatian: Prašak je granulat ili grudasti granulat bijele do svijetložute boje.
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 boci ili je dodate na naljepnicu s uputama ljekarnika.
English: The ARs listed in the tables below fall into the following categories: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), and very rare (< 1/10,000).
Croatian: Nuspojave navedene u sljedećim tablicama razvrstane su prema učestalosti u sljedeće kategorije: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000) i vrlo rijetko (< 1/10 000).
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 Tamiflu is right for you.
Croatian: Morate obavijestiti svog liječnika ako ste trudni, mislite da ste trudni ili pokušavate zatrudnjeti kako bi mogao odlučiti je li Tamiflu primjeren lijek za Vas.
English: • if you have chronic heart disease or respiratory disease.
Croatian: • ako imate kroničnu srčanu ili plućnu bolest
English: PHARMACEUTICAL FORM AND CONTENTS 10 hard capsules
Croatian: OBLIK I SADRŽAJ 10 tvrdih kapsula
English: Do not take a double dose to make up for a forgotten capsule.
Croatian: Ne uzimajte dvostruku dozu da biste nadoknadili propuštenu kapsulu.
English: Shake the bottle well for 15 seconds.
Croatian: Zatvorenu bocu dobro tresite 15 sekundi.
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: For example: If a 6-month-old weighs 8 kg, the dose is 8 kg x 3mg per kg = 24 mg
Croatian: Primjerice: Ako 6-mjesečno dijete ima 8 kg, doza je 8 kg x 3 mg po kg = 24 mg
English: Stage 1: Prepare a new bottle of the medicine
Croatian: 1. korak Pripremite novu bocu lijeka
English: Treatment of influenza B infection: Overall, 15 % of the influenza-positive population were infected by influenza B, proportions ranging from 1 to 33 % in individual studies.
Croatian: Liječenje infekcije gripom B: Ukupno je 15 % influenca-pozitivne populacije bilo zaraženo gripom B, a odnosi su u pojedinačnim ispitivanjima varirali od 1 % do 33 %.
English: The MAH shall agree the communication plan for the DHPC letter with the National Competent Authority in the Member States where the letter will be distributed.
Croatian: Nositelj odobrenja će dogovoriti plan komunikacije Pisma zdravstvenim radnicima s nadležnim nacionalnim tijelom u državi članici u kojoj će se pismo distribuirati.
English: For preventing flu or after being exposed to an infected person, take one dose daily for 10 days.
Croatian: Za prevenciju gripe ili nakon kontakta sa zaraženom osobom uzimajte jednu dozu dnevno tijekom 10 dana.
English: Tamiflu 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: Tamiflu možete uzeti s hranom ili bez nje, no uzimanje s hranom može smanjiti mogućnost mučnine i povraćanja.
English: Method of administration Swallow the capsules whole with water.
Croatian: Način primjene Progutajte kapsule cijele s vodom.
English: Tamiflu is not a vaccine: it treats infection, or prevents the flu virus spreading.
Croatian: Tamiflu nije cjepivo: on liječi infekciju ili sprječava širenje virusa.
English: Pack-size of one bottle.
Croatian: Veličina pakiranja: 1 boca.
English: If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
Croatian: Ako bilo koja nuspojava postane ozbiljna ili primijetite bilo koju nuspojavu koja nije navedena u ovoj uputi, potrebno je obavijestiti liječnika ili ljekarnika.
English: Tamiflu contains oseltamivir, which belongs to a group of medicines named neuraminidase inhibitors.
Croatian: Tamiflu sadrži oseltamivir, koji pripada skupini lijekova pod nazivom inhibitori neuraminidaze.
English: Add all 55 ml of water into the bottle, recap the bottle and shake the closed bottle well for 15 seconds.
Croatian: Dodajte svih 55 ml vode u bocu, zatvorite je te zatvorenu bocu dobro tresite 15 sekundi.
English: Give the whole contents of the second bowl (Tamiflu liquid mixture with sweet food added) to the child straight away.
Croatian: Djetetu odmah dajte cijeli sadržaj druge zdjelice (Tamiflu tekuću mješavinu s dodanom slatkom hranom).
English: For home preparation, separate dispensers should be provided for taking the correct volume of water and for measuring the Tamiflu-water mixture.
Croatian: Za pripremu kod kuće treba osigurati odvojene štrcaljke za uzimanje točnog volumena vode i za odmjeravanje potrebne količine mješavine Tamiflu-voda.
English: Treatment and prevention of influenza in children:
Croatian: Liječenje i prevencija gripe u djece:
English: The lower predicted exposure however, remains above inhibitoy 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.
English: The indication is based on clinical studies of naturally occurring influenza in which the predominant infection was influenza A.
Croatian: Ova se indikacija temelji na kliničkim ispitivanjima gripe koja se prirodno pojavljivala, u kojima je predominatna bila infekcija gripom A.
English: What Tamiflu is and what it is used for What you need to know before you take Tamiflu How to take Tamiflu
Croatian: Što je Tamiflu i za što se koristi Što morate znati prije nego počnete uzimati Tamiflu Kako uzimati Tamiflu
English: once daily mg per kg = mg for each kilogram of the infant's body weight.
Croatian: jednom dnevno mg po kg = mg po svakom kilogramu tjelesne težine dojenčeta.
English: Considering the margins of exposure in relation to the expected exposure in the human use, these findings do not change the benefit-risk of Tamiflu in its adopted therapeutic indications.
Croatian: Uzimajući u obzir granice izloženosti u odnosu na očekivanu izloženost u ljudi, ta otkrića ne mijenjaju odnos koristi i rizika pri primjeni lijeka Tamiflu u prihvaćenim terapijskim indikacijama.
English: Information for the user
Croatian: Informacija za korisnika
English: • if you are allergic (hypersensitive) to oseltamivir or any of the other ingredients of Tamiflu listed in section 6.
Croatian: • ako ste alergični (preosjetljivi) na oseltamivir ili neki drugi sastojak lijeka Tamiflu naveden u dijelu 6.
English: Information for healthcare professionals only
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim radnicima
English: Based on preclinical data, there is no evidence that Tamiflu has an effect on male or female fertility (see section 5.3).
Croatian: Na temelju nekliničkih podataka nema dokaza da Tamiflu utječe na mušku ili žensku plodnost (vidjeti dio 5.3).
English: Amount of Tamiflu suspension
Croatian: Količina Tamiflu suspenzije
English: This will make sure that the bottle adapter fits in the bottle in the right position.
Croatian: Na ovaj način ćete osigurati da se nastavak za bocu nalazi u pravilnom položaju.
English: Absorbed oseltamivir is primarily (> 90 %) eliminated by conversion to oseltamivir carboxylate.
Croatian: Apsorbirani oseltamivir uglavnom se (> 90 %) eliminira pretvorbom u oseltamivirkarboksilat.
English: • Ear inflammation and other ear disorders
Croatian: • upala uha i drugi poremećaji uha
English: Adults, adolescents and infants and children 1 year of age or older who are unable to swallow intact capsules
Croatian: Odrasli, adolescenti te dojenčad i djeca u dobi od 1 godine ili starija koji ne mogu progutati cijelu kapsulu
English: Other medicines and Tamiflu Tell your doctor or pharmacist if you are taking any other medicines, or have recently taken any.
Croatian: Drugi lijekovi i Tamiflu Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzimali bilo koje druge lijekove, uključujući lijekove koje ste nabavili bez recepta.
English: What Tamiflu looks like and contents of the pack
Croatian: Kako Tamiflu izgleda i sadržaj pakiranja
English: The suspension is caused by some of the excipients of Tamiflu capsules, which are insoluble.)
Croatian: Suspenziju uzrokuju neke od pomoćnih tvari Tamiflu kapsula koje su netopljive.)
English: To make a smaller single dose, you need:
Croatian: Da biste pripremili jednu manju dozu, potrebno Vam je:
English: • Add all the water, close and shake Pour all of the water from the jug into the bottle, onto the powder.
Croatian: • Dodajte svu vodu, zatvorite i protresite Izlijte cjelokupnu količinu vode iz čašice u bocu, na prašak.
English: When only 75 mg capsules are available, and doses of 30 mg or 45 mg are needed, the preparation of Tamiflu suspension involves additional steps.
Croatian: Kada su dostupne samo kapsule od 75 mg, a potrebne su doze od 30 mg ili 45 mg, priprema Tamiflu suspenzije uključuje dodatne korake.
English: Rare but serious effects: get medical help at once (These may affect up to 1 in 1,000 people) During Tamiflu treatment, rare events have been reported that include
Croatian: Rijetke, ali ozbiljne nuspojave: odmah zatražite liječničku pomoć (mogu se javiti u do 1 na 1000 osoba) Tijekom liječenja lijekom Tamiflu prijavljeni su rijetki događaji koji uključuju:
English: Final volume of the bottle after reconstitution is 65 ml.
Croatian: Konačni volumen nakon pripreme iznosi 65 ml.