FrancophonIA/ELRC3.0 huggingface dataset:
English: What are the risks associated with Insulin lispro Sanofi?
Croatian: Koji su rizici povezani s lijekom Insulin lispro Sanofi?
English: Other information about Insulin lispro Sanofi
Croatian: Ostale informacije lijeku Insulin lispro Sanofi
English: It contains the active substance insulin lispro.
Croatian: Lijek sadržava djelatnu tvar inzulin lispro.
English: Why is Insulin lispro Sanofi approved?
Croatian: Zašto je lijek Insulin lispro Sanofi odobren?
English: How is Insulin lispro Sanofi used?
Croatian: Kako se Insulin lispro Sanofi koristi?
English: What benefits of Insulin lispro Sanofi have been shown in studies?
Croatian: Koje su koristi lijeka Insulin lispro Sanofi dokazane u ispitivanjima?
English: How does Insulin lispro Sanofi work?
Croatian: Kako djeluje Insulin lispro Sanofi?
English: It is given by injection under the skin.
Croatian: Daje se injekcijom pod kožu.
English: What is Betaferon and what is it used for?
Croatian: Što je Betaferon i za što se koristi?
English: Further information on Betaferon can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/betaferon.
Croatian: Više informacija o lijeku Betaferon dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/betaferon.
English: In the other study, no delay in the time to disability progression was seen.
Croatian: U drugom ispitivanju nije primijećena nikakva vremenska odgoda progresije invalidnosti.
English: Other information about Betaferon
Croatian: Ostale informacije o lijeku Betaferon
English: What measures are being taken to ensure the safe and effective use of Betaferon?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Betaferon?
English: Treatment should start with 62.5 micrograms (a quarter of the dose) every other day, increasing progressively over 19 days to reach the recommended dose of 250 micrograms given every other day.
Croatian: Liječenje treba započeti sa 62,5 mikrograma (četvrtinom doze) svakog drugog dana, uz progresivno povećavanje tijekom 19 dana, sve do dostizanja preporučene doze od 250 mikrograma svakog drugog dana.
English: • who have secondary progressive MS (the type of MS that comes after relapsing-remitting MS), when their disease is active.
Croatian: • koji imaju sekundarno progresivni MS (vrstu MS-a koja dolazi nakon relapsno-remitirajućeg MS-a) i čija je bolest aktivna.
English: Betaferon is used in patients:
Croatian: Betaferon se primjenjuje u sljedećih bolesnika:
English: Betaferon must not be used in patients who have severe depression or have thoughts of suicide.
Croatian: Lijek Betaferon ne smiju uzimati bolesnici koji boluju od teške depresije ili imaju suicidalne misli.
English: Betaferon is a medicine used to treat adults who have multiple sclerosis (MS).
Croatian: Betaferon je lijek koji se koristi za liječenje odraslih osoba oboljelih od multiple skleroze (MS).
English: Betaferon must not be used in patients who have decompensated liver disease (when the liver is damaged and can no longer work adequately).
Croatian: Betaferon ne smiju uzimati bolesnici s dekompenziranom bolešću jetre (kada je jetra oštećena i više ne radi ispravno).
English: Side effects are common at the beginning of treatment but usually decrease with further treatment.
Croatian: Nuspojave su česte na početku liječenja, ali se u nastavku liječenja obično smanjuju.
English: As for all medicines, data on the use of Betaferon are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Betaferon kontinuirano se prate.
English: Side effects reported with Betaferon are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Betaferon pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Betaferon 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 Betaferon nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The European Medicines Agency decided that Betaferon'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 Betaferon nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: The most frequent side effects with Betaferon are flu-like symptoms (including fever, chills, joint pain, malaise [feeling unwell], sweating, headache and muscle pain) and reactions at the site of injection.
Croatian: Najčešće su nuspojave lijeka Betaferon simptomi nalik gripi (uključujući vrućicu, zimicu, bol u zglobovima, malaksalost [opće loše osjećanje], znojenje, glavobolju i bol u mišićima) i reakcije na mjestu primjene injekcije.
English: What are the risks associated with Betaferon?
Croatian: Koji su rizici povezani s lijekom Betaferon?
English: Patients can inject Betaferon themselves once they have been trained.
Croatian: Bolesnici si mogu sami ubrizgavati Betaferon nakon što prođu odgovarajuću obuku.
English: • who have MS of the type known as ‘relapsing-remitting', when the patient has attacks (relapses) between periods with no symptoms (remissions), in patients with at least two relapses within the last two years;
Croatian: • koji boluju od vrste MS-a poznate pod nazivom relapsno-remitirajuća multipla skleroza, kod koje bolesnik ima napadaje (relapse) između razdoblja bez simptoma (remisija) i najmanje dva relapsa u posljednje dvije godine;
English: An overview of Betaferon and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Betaferon i zašto je odobren u EU-u
English: Betaferon was more effective than placebo in reducing the number of annual relapses: patients receiving the medicine had on average 0.84 relapses a year, when patients on placebo had 1.27.
Croatian: Lijek Betaferon bio je učinkovitiji od placeba kada je riječ o smanjenju broja relapsa godišnje: bolesnici koji su primali lijek u prosjeku su imali 0,84 relapsa godišnje, dok su bolesnici koji su primali placebo imali 1,27 relapsa.
English: For more information about using Betaferon, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Betaferon pročitajte uputu o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Betaferon received a marketing authorisation valid throughout the EU on 30 November 1995.
Croatian: Za lijek Betaferon izdano je odobrenje za stavljanje u promet koje je na snazi u EU-u od 30. studenoga
English: Betaferon can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of MS.
Croatian: Betaferon se izdaje samo na recept, a liječenje mora započeti liječnik s iskustvom u liječenju MS-a.
English: Why is Betaferon authorised in the EU?
Croatian: Zašto je lijek Betaferon odobren u EU-u?
English: MS is a disease in which inflammation damages the protective insulation around nerves (demyelination) as well as the nerves themselves.
Croatian: Multipla skleroza je bolest kod koje upala oštećuje zaštitnu izolacijsku ovojnicu oko živaca (demijelinizacija), kao i same živce.
English: The exact way that Betaferon works in MS is not yet known but the active substance, interferon beta-1b, seems to calm down the immune system, and prevents relapses of MS.
Croatian: Još uvijek nije potpuno poznato na koji način lijek Betaferon djeluje kod MS-a, ali čini se da djelatna tvar interferon beta-1b smiruje imunosni sustavi i sprječava relapse MS-a.
English: In both studies, Betaferon showed a reduction (30%) in the number of clinical relapses.
Croatian: U obama ispitivanjima pri primjeni lijeka Betaferon zabilježeno je smanjenje (30 %) u broju kliničkih relapsa.
English: One of the two studies showed a significant delay in the time to disability progression (31% risk reduction due to Betaferon) and in the time to becoming wheelchair bound (39%).
Croatian: U jednome od dva ispitivanja utvrđena je znatna vremenska odgoda progresije invalidnosti (smanjenje rizika od 31 % zbog uzimanja lijeka Betaferon) i vremena do pojave stupnja invalidnosti pri kojem je bolesnik vezan uz invalidska kolica (39 %).
English: Betaferon is available as a powder and solvent that are made up into a solution that supplies a dose of 250 micrograms.
Croatian: Betaferon je dostupan u obliku praška ili otapala od kojih se priprema otopina koja je dovoljna za dozu od 250 mikrograma.
English: Betaferon was shown to reduce the risk of developing clinically defined MS: 28% of the patients who received Betaferon developed MS, compared with 45% of those who received placebo.
Croatian: Utvrđeno je da lijek Betaferon umanjuje rizik od razvijanja klinički definirane multiple skleroze: u 28 % bolesnika koji su uzimali Betaferon razvila se multipla skleroza, u usporedbi s 45 % onih koji su uzimali placebo.
English: The active substance in Betaferon is the protein interferon beta-1b, one of a group of interferons that can be naturally produced by the body to help it fight against viruses and other attacks.
Croatian: Djelatna tvar lijeka Betaferon je interferon beta-1b, bjelančevina iz skupine interferona koju tijelo prirodno proizvodi i koja pomaže u borbi protiv virusa i drugih napada na tijelo.
English: Betaferon was also studied in 487 patients with a single demyelinating event, who received either Betaferon or placebo for two years.
Croatian: Lijek Betaferon ispitivan je i kod 487 bolesnika koji su doživjeli samo jedan događaj demijelinizacije i koji su dvije godine uzimali Betaferon ili placebo.
English: What benefits of Betaferon have been shown in studies?
Croatian: Koje su koristi od lijeka Betaferon utvrđene u ispitivanjima?
English: Betaferon contains the active substance interferon beta-1b.
Croatian: Betaferon sadrži djelatnu tvar interferon beta-1b.
English: Betaferon was studied over a two-year period in 338 patients with relapsing remitting MS who were able to walk unaided, where it was compared with placebo (a dummy treatment).
Croatian: Lijek Betaferon ispitivan je tijekom razdoblja od dvije godine u 338 bolesnika s relapsno-remitirajućim MS-om koji su mogli hodati bez pomoći i uspoređen je s placebom (prividnim liječenjem).
English: Betaferon treatment should be stopped in patients whose condition does not improve.
Croatian: Liječenje lijekom Betaferon treba prekinuti ako se stanje bolesnika ne poboljša.
English: Betaferon has also been studied in 1,657 patients in two studies of secondary progressive MS patients who were able to walk, where it was compared with placebo.
Croatian: Betaferon je također ispitivan u dvama ispitivanjima na 1 657 bolesnika oboljelih od sekundarno progresivnog MS-a koji su mogli hodati.
English: • who have experienced the signs of MS for the first time, and these are severe enough to need treatment with injected corticosteroids (anti-inflammatory medicines).
Croatian: • koji su prvi put iskusili znakove MS-a i ti su znakovi dovoljno jaki da ih je potrebno liječiti injekcijama kortikosteroida (protuupalnih lijekova).
English: How is Betaferon used?
Croatian: Kako djeluje Betaferon?
English: Betaferon is used when the patient is considered to be at high risk of developing MS. Before using Betaferon, doctors need to exclude other causes for the symptoms;
Croatian: Prije uporabe lijeka Betaferon liječnik mora isključiti druge uzroke simptoma;
English: For the full list of side effects and restrictions with Betaferon, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Betaferon potražite u uputi o lijeku.
English: Date of first authorisation: 18 February 2019
Croatian: Datum prvog odobrenja: 18. veljače 2019
English: Prins Bernhardplein 200 1097JB Amsterdam Netherlands
Croatian: Prins Bernhardplein 200 1097JB Amsterdam Nizozemska
English: • an examination to check the nerves in your arms and legs
Croatian: • pregled za provjeru živaca Vaših ruku i nogu
English: ATC Code: A16AX06
Croatian: ATK oznaka: A16AX06
English: Weight loss, decreased appetite
Croatian: Gubitak težine, smanjen apetit
English: • Always take this medicine exactly as your doctor has told you.
Croatian: Uvijek primjenjujte ovaj lijek točno onako kako Vam je savjetovao liječnik.
English: Hard capsule
Croatian: Tvrda kapsula.
English: Hard capsule 84 capsules 84x1 capsules
Croatian: Tvrda kapsula 84 kapsule 84x1 kapsula
English: • measurement of vitamin B12 levels
Croatian: • mjerenje razine vitamina B12
English: The greatest prevalence was observed between 6 and 12 months.
Croatian: Najveća prevalencija primijećena je između 6 i
English: - if you are allergic to miglustat or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na miglustat ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: Quinto dè Stampi Rozzano (MI)
Croatian: Quinto dé Stampi Rozzano (MI)
English: {MM/YYYY}
Croatian: <{MM/GGGG}>
English: You should not take Miglustat Dipharma if you are pregnant or thinking of becoming pregnant.
Croatian: Miglustat Dipharma ne smijete uzeti ako ste trudni ili ako namjeravate zatrudnjeti.
English: Miglustat Dipharma can be taken with or without food.
Croatian: Miglustat Dipharma se može uzeti s hranom ili bez nje.
English: This leaflet was last revised in {MM/YYYY} Other sources of information
Croatian: Ova uputa je zadnji puta revidirana u: {MM/GGGG}
English: 20089 Quinto dè Stampi - Rozzano (MI)
Croatian: 20089 Quinto dè Stampi - Rozzano (MI) Italija
English: Do not stop taking Miglustat Dipharma without talking to your doctor.
Croatian: Nemojte prestati uzimati Miglustat Dipharma bez razgovora s liječnikom.
English: They may lower the amount of Miglustat Dipharma in your body.
Croatian: To može sniziti količinu lijeka Miglustat Dipharma u Vašem tijelu.
English: If you do lose some weight when you start treatment with Miglustat Dipharma don't worry.
Croatian: Ako izgubite na težini kad počnete liječenje lijekom Miglustat Dipharma, ne brinite.
English: The tests will help the doctor decide whether these effects are due to your disease or other existing conditions, or due to side effects of Miglustat Dipharma (see section 4 for further details).
Croatian: Ove pretrage će pomoći liječniku ustanoviti jesu li ti učinci posljedica ove bolesti ili drugih postojećih bolesti ili su posljedica nuspojava lijeka Miglustat Dipharma (za daljnje pojedinosti vidjeti dio 4).
English: Most patients get one or more of these side effects mentioned above, usually at the start of treatment or at intervals during treatment.
Croatian: Kod većine bolesnika dođe do jedne ili više ovih nuspojava, obično na početku liječenja ili u razmacima tijekom liječenja.
English: Tell your doctor if you are taking medicines containing imiglucerase, which are sometimes used at the same time as Miglustat Dipharma.
Croatian: Obavijestite svog liječnika ako uzimate lijekove koji sadrže imiglucerazu, koji se ponekad uzimaju istodobno s lijekom Miglustat Dipharma.
English: Maximum plasma concentrations are reached about 2 hours after dose.
Croatian: Maksimalne koncentracije u plazmi dostignute su u roku od oko 2
English: If you get a slight tremor, usually trembling hands, seek medical advice from your doctor as soon as possible.
Croatian: Ako imate blagi tremor, koji se uobičajeno očituje drhtanjem ruku, zatražite savjet svog liječnika što je prije moguće.
English: The average half-life is 6-7 hours.
Croatian: Prosječni poluvijek je 6
English: Talk to your doctor or pharmacist before taking Miglustat Dipharma
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Miglustat Dipharma
English: There are no pharmacokinetic data available in patients with liver impairment or in the elderly (> 70 years).
Croatian: Nema dostupnih farmakokinetičkih podataka za bolesnike s oštećenjem funkcije jetre ili za starije bolesnike (> 70 godina).
English: Miglustat has been used in clinical trials at doses ten times higher than the recommended dose: this caused decreases in white blood cells and other side effects similar to those described in section 4.
Croatian: Miglustat Dipharma je korišten u kliničkim ispitivanjima u deset puta većim dozama od preporučenih: to je uzrokovalo smanjenje broja bijelih krvnih stanica i druge nuspojave slične onima opisanima u dijelu 4.
English: • if you suffer from liver disease
Croatian: • ako patite od bolesti bubrega • ako patite od bolesti jetre
English: What Miglustat Dipharma looks like and contents of the pack
Croatian: Kako Miglustat Dipharma izgleda i sadržaj pakiranja
English: This study also indicated that miglustat has no or limited effect on the pharmacokinetics of imiglucerase.
Croatian: To ispitivanje ukazuje također na to da miglustat nema nikakav ili ima ograničen učinak na farmakokinetiku imigluceraze.
English: Among the 41 patients enrolled in the trial 14 patients were treated with miglustat for more than 3 years.
Croatian: Od 41 bolesnika uključenih u ispitivanje 14 bolesnika je liječeno miglustat duže od 3 godine.
English: PCTFE/PVC and Aluminium blister containing 12 (perforated unit dose) or 21 (non-perforated) capsules.
Croatian: PCTFE/PVC i aluminijska blister pakiranja koja sadrže 12 (perforirana jedinična doza) ili 21 (neperforirana) kapsulu.
English: Following administration of a single dose of 100 mg 14C-miglustat to healthy volunteers, 83% of the radioactivity was recovered in urine and 12% in faeces.
Croatian: 7 sati.Nakon davanja jedne doze od 100 mg 14C-miglustata zdravim dobrovoljcima, 83% radioaktivno označenog lijeka izlučeno je u urinu a 12% u fecesu.
English: The efficacy of miglustat in children and adolescents aged 0-17 years with type 1 Gaucher disease has not been established.
Croatian: Djelotvornost miglustata kod djece i adolescenata u dobi od 0 do 17 godina s Gaucherovom bolesti tipa 1 nije ustanovljena.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: U sklopu svake kategorije učestalosti, nuspojave su prikazane prema padajućoj ozbiljnosti.
English: An open-label, non-comparative, 2-year study enrolled 42 patients with type 1 Gaucher disease, who had received a minimum of 3 years of ERT and who fulfilled criteria of stable disease for at least 2 years.
Croatian: Otvoreno, nekomparativno 2-godišnje ispitivanje uključivalo je 42 bolesnika s Gaucherovom bolesti tipa 1, koji su najmanje 3 godine primali ERT a koji su zadovoljavali kriterij stabilne bolesti od najmanje 2 godine.
English: What Miglustat Dipharma is and what it is used for
Croatian: Što je Miglustat Dipharma i za što se koristi
English: Data to support safety and efficacy of miglustat in Niemann-Pick type C disease come from a prospective open-label clinical trial and a retrospective survey.
Croatian: Podatci koji podupiru sigurnost i djelotvornost miglustat u Niemann-Pickovoj bolesti tipa C potječu iz prospektivnog otvorenog kliničkog ispitivanja i retrospektivne analize.
English: Since some patients have had tingling or numbness in the hands and feet, or a decrease in body weight, while taking Miglustat Dipharma, your doctor will perform the following tests before treatment and during treatment with Miglustat Dipharma:
Croatian: Budući da su neki bolesnici imali trnce ili ukočenost u rukama i stopalima ili smanjenje tjelesne težine tijekom uzimanja lijeka Miglustat Dipharma, vaš liječnik će prije i tijekom liječenja lijekom Miglustat
English: 100 mg three times a day 100 mg twice a day
Croatian: 200 mg triput dnevno 200 mg dvaput dnevno 100 mg triput dnevno 100 mg dvaput dnevno 100 mg jednom dnevno
English: In type 1 Gaucher disease, a substance called glucosylceramide is not removed from your body.
Croatian: Kod Gaucherove bolesti tipa 1 tvar zvana glukozilceramid se ne uklanja iz Vašeg tijela.
English: Miglustat Dipharma has negligible influence on the ability to drive and use machines.
Croatian: Miglustat Dipharma zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: In type 1 Gaucher disease, these tremors were described as an exaggerated physiological tremor of the hands.
Croatian: Ti su tremori opisani kao pretjerani fiziološki tremor ruku.
English: Regular monitoring of vitamin B12 level is recommended because of the high prevalence of vitamin B12 deficiency in patients with type 1 Gaucher disease.
Croatian: Preporučuje se redovito praćenje razine vitamina B12 zbog visoke prevalencije nedostatka vitamina B12
English: Limited data suggest that co-administration of miglustat and enzyme replacement with imiglucerase in patients with type 1 Gaucher disease may result in decreased exposure to miglustat (approximate reductions of 22% in Cmax and 14% in AUC were observed in a small parallel-group study).
Croatian: Ograničeni podatci ukazuju na to da istodobna primjena miglustata i enzimskog nadomjestka s imiglucerazom u bolesnika s Gaucherovom bolesti tipa 1 može za posljedicu imati smanjenu izloženost miglustatu (približno smanjenje od 22% u Cmax i 14% u AUC zabilježeno u malom ispitivanju s paralelnim skupinama).
English: Capsule content Magnesium stearate
Croatian: Sadržaj kapsule magnezijev stearat
English: Detailed information on this medicinal prodcut is available on the website of the European Medicines Agency http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: Depression, insomnia, libido decreased
Croatian: Depresija, nesanica, smanjen libido
English: In addition, inhibitory action on a non-lysosomal glycosylceramidase has been demonstrated experimentally in vitro.
Croatian: Osim toga, inhibitorno djelovanje nelizosomalne glikozilceramidaze eksperimentalno se pokazalo in vitro.
English: In vitro, glucosylceramide synthase is inhibited by miglustat with an IC50 of 20-37 μM.
Croatian: In vitro, miglustat inhibira glukozilceramid sintazu sa IC50 koji iznosi 20-37 µM.
English: The survey included a case series of 66 patients treated with miglustat outside of the clinical trial for a mean duration of 1.5 years.
Croatian: Analiza je uključivala seriju slučajeva od 66 bolesnika liječenih miglustat izvan kliničkog ispitivanja u prosječnom trajanju od 1,5 godine.
English: Of these, 18 patients at baseline were within established therapeutic goals for liver and spleen volume, haemoglobin levels, and platelet counts, and 16 patients remained within all these therapeutic goals at month 24.
Croatian: Među njima je bilo 18 bolesnika s početnim volumenom jetre i slezene, razinama hemoglobina i brojem trombocita unutar utvrđenih terapijskih ciljeva, a 16 bolesnika je ostalo unutar svih tih terapijskih ciljeva u 24 mjesecu.
English: Your doctor will perform some tests before and during treatment with Miglustat Dipharma to assess this (see section 2).
Croatian: Liječnik će provesti neke pretrage prije i za vrijeme liječenja lijekom Miglustat Dipharma kako bi to procijenio (vidjeti dio 2).
English: Miglustat Dipharma contains the active substance miglustat which belongs to a group of medicines that affect metabolism.
Croatian: Miglustat Dipharma sadrži djelatnu tvar miglustat koja pripada skupini lijekova koji djeluju na metabolizam.
English: If you take more Miglustat Dipharma than you should
Croatian: Ako uzmete više lijeka Miglustat Dipharma nego što ste trebali
English: Miglustat is mainly eliminated by renal excretion, with urinary recovery of unchanged substance accounting for 70-80% of the dose.
Croatian: Miglustat se uglavnom eliminira izlučivanjem bubrezima, pri čemu se u urinu pronašlo 70-80% doze neizmijenjenog lijeka.
English: Miglustat Dipharma is only used when a patient is considered unsuitable for treatment with enzyme replacement therapy.
Croatian: Miglustat Dipharma se primjenjuje samo kada se smatra da bolesnik nije pogodan za enzimsko nadomjesno liječenje.