FrancophonIA/ELRC3.0 huggingface dataset:
English: Date of first authorisation: 29/01/2010 Date of latest renewal: 18/09/2014
Croatian: Datum prvog odobrenja: 29/01/2010 Datum posljednje obnove odobrenja: 18/09/2014
English: The absolute bioavailability is approximately 32%.
Croatian: Apsolutna bioraspoloživost iznosi približno 32 %.
English: • Do not give this medicine to children and adolescents below 18 years since there is no relevant indication for this age group.
Croatian: Nemojte davati ovaj lijek djeci i adolescentima u dobi manjoj od 18 godina, budući da u toj dobnoj skupini ne postoji odgovarajuća indikacija.
English: • Fast or irregular heart beats (called palpitations)
Croatian: • brzi ili nepravilni otkucaji srca (zvani palpitacije)
English: • Fainting/ Loss of consciousness
Croatian: • nesvjestica / gubitak svijesti
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate,, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Very rare side effects (may affect up to 1 in 10,000 people) • Other allergic reactions with swelling of the face or throat
Croatian: Vrlo rijetke nuspojave (mogu se javiti u do 1 na 10 000 osoba) • druge alergijske reakcije s oticanjem lica ili grla
English: Food decreases Cmax by approximately 30%, increases tmax by approximately 1 hour and has little effect on AUC.
Croatian: Hrana smanjuje Cmax za približno 30 %, povećava tmax za približno 1 sat i ima malo učinka na AUC.
English: If you take more Silodyx than you should
Croatian: Ako uzmete više Silodyx nego što ste trebali
English: Difference (95% CI) vs placebo
Croatian: Razlika (95 % CI) u odnosu na placebo
English: Talk to your doctor or pharmacist before taking Silodyx
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Silodyx.
English: Exposure to silodosin and its main metabolites does not change significantly with age, even in subjects of age over 75 years.
Croatian: Izloženost silodozinu i njegovim glavnim metabolitima ne mijenja se značajno s dobi, čak niti u ispitanika starijih od 75 godina.
English: * p < 0.001 vs Placebo;°p = 0.002 vs Placebo
Croatian: * p < 0,001 u odnosu na placebo; ° p = 0,002 u odnosu na placebo
English: Contents of the pack and other information What Silodyx contains
Croatian: Sadržaj pakiranja i druge informacije Što Silodyx sadrži
English: 5 hard capsules 10 hard capsules 20 hard capsules 30 hard capsules 50 hard capsules 90 hard capsules 100 hard capsules
Croatian: 5 tvrdih kapsula 10 tvrdih kapsula 20 tvrdih kapsula 30 tvrdih kapsula 50 tvrdih kapsula 90 tvrdih kapsula 100 tvrdih kapsula
English: Other medicines and Silodyx
Croatian: Drugi lijekovi i Silodyx
English: Silodosin has a volume of distribution of 0.81 L/kg and is 96.6% bound to plasma proteins.
Croatian: Silodozin ima volumen distribucije od 0,81 l/kg i 96,6 % je vezan na proteine plazme.
English: The incidence of orthostatic hypotension in placebo-controlled clinical studies was 1.2% with silodosin and 1.0% with placebo.
Croatian: Incidencija ortostatske hipotenzije u placebom kontroliranim kliničkim ispitivanjima bila je 1,2 % uz silodozin i 1,0 % uz placebo.
English: Silodyx does not treat prostate cancer.
Croatian: Silodyx ne liječi rak prostate.
English: It has been demonstrated in vitro that the α1A:α1B binding ratio of silodosin (162:1) is extremely high.
Croatian: Pokazalo se in vitro da je omjer vezanja silodozina za α1A:α1B (162:1) krajnje visok.
English: Elderly No dose adjustment is required in the elderly (see section 5.2).
Croatian: Nije potrebna prilagodba doze u starijih osoba (vidjeti dio 5.2).
English: IPSS Total score
Croatian: IPSS ukupni rezultat
English: Packs of 5, 10, 20, 30, 50, 90, 100 capsules.
Croatian: Pakiranja od 5, 10, 20, 30, 50, 90 i 100 kapsula.
English: The requirements for submission of marketing authorisation holder shall submit periodic safety update reports for this medicinal product in accordance with the requirements 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) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: If you have moderate kidney problems, your doctor will start Silodyx with caution and possibly with a lower dose (see section 3 “Dose”).
Croatian: Ako imate umjerene tegobe s bubrezima, Vaš liječnik će započeti liječenje lijekom Silodyx s oprezom i možda u manjoj dozi (pogledajte dio 3 „Doza “”).
English: Silodyx is available in packs containing 5, 10, 20, 30, 50, 90, 100 capsules.
Croatian: Silodyx je dostupan u pakiranjima od 5, 10, 20, 30, 50, 90, 100 kapsula.
English: Ask your doctor whether or not you should postpone or temporarily stop taking Silodyx when undergoing cataract surgery.
Croatian: Upitajte liječnika trebate li odgoditi ili privremeno prekinuti uzimanje lijeka Silodyx ako idete na operaciju katarakte.
English: • If you have severe liver problems, you should not take Silodyx, as it was not tested in this condition.
Croatian: • Ako imate teških tegoba s jetrom, ne biste smjeli uzimati Silodyx, jer nije ispitan kod takvog stanja.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements..
Croatian: Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Silodyx in all subsets of the paediatric population in BPH (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Silodyx u svim podskupinama pedijatrijske populacije u BHP (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Patients should be informed about the possible occurrence of symptoms related to postural hypotension (such as dizziness) and should be cautioned about driving or operating machines until they know how silodosin will affect them.
Croatian: Bolesnici trebaju biti obaviješteni o mogućoj pojavi simptoma povezanih s posturalnom hipotenzijom (kao što je omaglica) i upozoreni da ne voze i ne rade sa strojevima dok ne vide kako na njih utječe silodozin.
English: Dialysis is unlikely to be of significant benefit since silodosin is highly (96.6%) protein bound.
Croatian: Dijaliza najvjerojatnije neće biti od značajne koristi budući da se silodozin veže za proteine u visokom postotku (96,6 %).
English: The responder rate (i.e. improvement in the IPSS total score by at least 25%) was significantly higher in the silodosin (68%) and tamsulosin group (65%), as compared to placebo (53%).
Croatian: Stopa terapijskog odgovora (tj. poboljšanje ukupnog IPSS rezultata za najmanje 25 %) bila je značajno viša u skupini koja je primala silodozin (68 %) i skupini koja je primala tamsulozin (65 %) u usporedbi s placebom (53 %).
English: What you need to know before you take Silodyx Do not take Silodyx if you are allergic to silodosin or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Silodyx ako ste alergični na silodozin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Silodyx may cause complications during a cataract surgery (eye surgery because of cloudiness of the lens, see section “Warnings and precautions”).
Croatian: Silodyx može prouzročiti komplikacije tijekom operacije katarakte (operacija oka zbog zamućenosti leće, pogledajte dio „Upozorenja i mjere opreza“).
English: What Silodyx looks like and contents of the pack
Croatian: Kako Silodyx izgleda i sadržaj pakiranja
English: Silodyx is used in adult men to treat the urinary symptoms associated with benign enlargement of the prostate (prostatic hyperplasia), such as:
Croatian: Silodyx se primjenjuje u odraslih muškaraca za liječenje urinarnih simptoma povezanih s dobroćudnim povećanjem prostate (hiperplazija prostate), kao što su:
English: Dizziness when standing up and occasionally fainting may occur when taking Silodyx, particularly when starting treatment or if you are taking other medicines that lower blood pressure.
Croatian: Za vrijeme uzimanja lijeka Silodyx mogu nastati omaglica pri ustajanju i povremeno nesvjestica, osobito na početku liječenja ili ako uzimate druge lijekove koji snižavaju krvni tlak.
English: Intraoperative Floppy Iris Syndrome (IFIS) IFIS has been reported during cataract surgery (see section 4.4).
Croatian: Intraoperacijski sindrom meke šarenice (IFIS) IFIS je bio zabilježen tijekom operacije katarakte (vidjeti dio 4.4).
English: Silodyx belongs to a group of medicines called alpha1A-adrenoreceptor blockers.
Croatian: Silodyx pripada skupini lijekova koji se zovu blokatori alfa1A-adrenergičkih receptora.
English: This effect disappears after discontinuation of Silodyx.
Croatian: Ovaj učinak nestaje nakon prestanka uzimanja lijeka Silodyx.
English: In healthy male subjects of the target age range (n = 16, mean age 55 ± 8 years) after once-a-day oral administration of 8 mg immediately after breakfast for 7 days, the following pharmacokinetic parameters were obtained: Cmax 87 ± 51 ng/mL (sd), tmax 2.5 hours (range 1.0-3.0), AUC 433 ± 286 ng • h/mL.
Croatian: U zdravih muških ispitanika u ciljnom dobnom rasponu (n = 16, srednja vrijednost dobi 55 ± 8 godina) nakon peroralne primjene 8 mg jedanput na dan neposredno nakon doručka tijekom 7 dana, dobili su se sljedeći farmakokinetički parametri: Cmax 87 ± 51 ng/ml (sd), tmax 2,5 sati (raspon 1,0-3,0), AUC 433 ± 286 ng • h/ml.
English: • If you are undergoing eye surgery because of cloudiness of the lens (cataract surgery), it is important that you immediately inform your eye specialist that you are using or have previously used Silodyx.
Croatian: • Ako idete na operaciju oka zbog zamućenja leće (operacija katarakte), važno je da odmah obavijestite svog specijalistu za liječenje očnih bolesti da uzimate ili da ste prije uzimali Silodyx.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu lijeka nacionalnog sustava prijave nuspojava: navedenog u Dodatku V.
English: Silodyx has minor or moderate influence on the ability to drive and use machines.
Croatian: Silodyx malo do umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Paediatric population Silodosin has not been evaluated in patients less than 18 years of age.
Croatian: Silodozin se nije ispitao u bolesnika mlađih od 18 godina.
English: Protein binding of silodosin glucuronide is 91%.
Croatian: Vezanje silodozin glukuronida na proteine plazme je 91 %.
English: A starting dose of 4 mg once daily is recommended in patients with moderate renal impairment (CLCR ≥ 30 to < 50 mL/min), which may be increased to 8 mg once daily after one week of treatment, depending on the individual patient's response.
Croatian: U bolesnika s umjerenim oštećenjem bubrega (CLcr ≥ 30 do < 50 ml/min) preporučuje se početna doza od 4 mg jedanput na dan, koja se može povećati na 8 mg jedanput na dan nakon jednog tjedna liječenja, ovisno o odgovoru pojedinog bolesnika.
English: • If you have ever fainted or felt dizzy when suddenly standing up, please inform your doctor before taking Silodyx.
Croatian: • Ako ste ikad izgubili svijest ili osjetili omaglicu pri naglom ustajanju, obavijestite o tome svog liječnika prije nego što počnete uzimati Silodyx.
English: If you have severe kidney problems, you should not take Silodyx.
Croatian: Ako imate teške tegobe s bubrezima, ne biste smjeli uzimati Silodyx.
English: • Since a benign enlargement of the prostate and prostate cancer may present the same symptoms, your doctor will check you for prostate cancer before starting treatment with Silodyx.
Croatian: • Kako dobroćudno povećanje prostate i rak prostate mogu imati iste simptome, liječnik će Vas pregledati na rak prostate prije nego što počnete uzimati Silodyx.
English: By blocking these receptors, it causes smooth muscle in these tissues to relax.
Croatian: Blokiranjem ovih receptora, Silodyx uzrokuje opuštanje glatkih mišića u tim tkivima.
English: There is no relevant use of Silodyx in the paediatric population for the indication of benign prostatic hyperplasia (BPH).
Croatian: Nema relevantne primjene lijeka Silodyx u pedijatrijskoj populaciji za indikaciju benigne hiperplazije prostate (BPH).
English: • medicines which lower blood pressure (in particular, medicines called alpha1-blockers, such as prazosin or doxazosin) as there may be the potential risk that the effect of these medicines is increased whilst taking Silodyx.
Croatian: • lijekove koji snižavaju krvni tlak (osobito lijekove koji se zovu blokatori alfa1-receptora, kao što su prazosin ili doksazosin), jer postoji mogući rizik od pojačanog učinka tih lijekova za vrijeme uzimanja lijeka Silodyx.
English: • medicines for epilepsy or rifampicin (a medicine to treat tubercolosis), since the effect of Silodyx may be reduced.
Croatian: • lijekove protiv epilepsije ili rifampicin (lijek za liječenje tuberkuloze), budući da mogu smanjiti učinak lijeka Silodyx.
English: Silodyx is not intended for use by women.
Croatian: Lijek Silodxy nije namijenjen za primjenu u žena.
English: The active substance is silodosin.
Croatian: Djelatna tvar je silodozin.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • prilikom svake izmjene sustava za upravljanje rizicom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
English: IPSS Irritative symptoms
Croatian: IPSS simptomi iritacije
English: In a Phase IV clinical trial performed in Europe, with a mean baseline IPSS total score of 18.9 points, 77.1% were responders to silodosin (as assessed by a change from baseline in the IPSS total score of at least 25%).
Croatian: U kliničkom ispitivanju Faze IV provedenom u Europi, s prosječnim početnim ukupnim IPSS rezultatom od 18,9 bodova, 77,1 % bolesnika odgovorilo je na terapiju silodozinom (što je procijenjeno na temelju promjene ukupnog IPSS rezultata od najmanje 25 % od početne vrijednosti).
English: • antifungal medicines (such as ketoconazole or itraconazole), medicines used for HIV-AIDS (such as ritonavir) or medicines used after transplants to prevent organ rejection (such as cyclosporin) because these medicines can increase the blood concentration of Silodyx.
Croatian: • lijekove protiv gljivica (kao što su ketokonazol ili itrakonazol), lijekove koji se primjenjuju kod HIV-a/SIDA-e (kao što je ritonavir) ili lijekove koji se koriste nakon presađivanja organa da bi se spriječilo njegovo odbacivanje (kao što je ciklosporin), zato što ti lijekovi mogu povećati koncentraciju lijeka Silodyx u krvi.
English: Capsule content Starch, pregelatinised (maize) Mannitol (E421) Magnesium stearate Sodium laurilsulfate
Croatian: Sadržaj kapsule škrob, prethodno geliran (kukuruzni) manitol (E421) magnezijev stearat natrijev laurilsulfat
English: In all studies, patients who did not respond to placebo during a 4-week placebo run-in phase were randomised to receive the study treatment.
Croatian: U svim ispitivanjima, bolesnici koji nisu imali odgovor na placebo tijekom uvodne placebo Faze u trajanju od
English: What Silodyx is and what it is used for What Silodyx is
Croatian: Što je Silodyx i za što se koristi Što je Silodyx
English: If you stop taking Silodyx
Croatian: Ako prestanete uzimati Silodyx
English: It is important that you immediately inform your eye specialist if you are using or have previously used Silodyx.
Croatian: Važno je da odmah obavijestite svog specijalistu za očne bolesti ako uzimate ili ste prethodno uzimali
English: If you forget to take Silodyx
Croatian: Ako ste zaboravili uzeti Silodyx
English: Urorec may reduce the amount of sperm, and so could temporarily affect your ability to father a child.
Croatian: Silodyx može smanjiti količinu sperme, stoga bi mogao privremeno utjecati na vašu sposobnost začeća.
English: Silodyx is selective for the receptors located in the prostate, bladder and urethra.
Croatian: Silodyx se selektivno veže za receptore koji se nalaze u prostati, mokraćnom mjehuru i mokraćnoj cijevi.
English: • medicines used for treating problems in getting or keeping an erection (such as sildenafil or tadalafil), since the concomitant use with Silodyx might lead to a slight decrease in blood pressure.
Croatian: • lijekove koji se primjenjuju u liječenju otežanog postizanja i održavanja erekcije (kao što su sildenafil ili tadalafil), budući da istovremeno uzimanje lijeka Silodyx može dovesti do sniženja krvnog tlaka.
English: The treatment with Silodyx may lead to an abnormal ejaculation (decrease in the amount of semen released during sex) that may temporarily affect male fertility.
Croatian: • Liječenje lijekom Silodyx može dovesti do poremećaja ejakulacije (smanjenja količine sjemena koje se oslobađa u spolnom odnosu), što može privremeno narušiti plodnost u muškarca.
English: • Dizziness, including dizziness when standing up (see also above, in this section)
Croatian: • omaglica, uključujući omaglicu pri ustajanju (vidjeti također gore, u istom ovom dijelu) • curenje iz nosa ili začepljen nos
English: Not known
Croatian: Vrlo rijetko Nepoznato
English: How to take Silodyx
Croatian: Kako uzimati Silodyx
English: Yellow, opaque, hard gelatin capsule, size 3 (approximately 15.9 x 5.8 mm).
Croatian: Žuta, neprozirna, tvrda želatinska kapsula, veličine 3 (približno 15,9 x 5,8 mm).
English: Silodyx 8 mg are white, opaque, hard gelatin capsules, size 0 (approximately 21.7 x 7.6 mm).
Croatian: Silodyx 8 mg su bijele, neprozirne, tvrde želatinske kapsule, veličine 0 (približno 21,7 x 7,6 mm).
English: For special patient populations, one capsule of Silodyx 4 mg daily is recommended (see below).
Croatian: preporučuje se jedna kapsula lijeka Silodyx 4 mg na dan (vidjeti niže).
English: Silodyx 4 mg are yellow, opaque, hard gelatin capsules, size 3 (approximately 15.9 x 5.8 mm).
Croatian: Silodyx 4 mg su žute, neprozirne tvrde želatinske kapsule, veličine 3 (približno 15,9 x 5,8 mm).
English: Recordati Industria Chimica e Farmaceutica S.p.A.
Croatian: Recordati Industria Chimica e Farmaceutica S.p.A. Via M. Civitali 1
English: White, opaque, hard gelatin capsule, size 0 (approximately 21.7 x 7.6 mm).
Croatian: Bijela, neprozirna, tvrda želatinska kapsula, veličine 0 (približno 21,7 x 7,6 mm).
English: Package Leaflet: Information for the patient Silodyx 8 mg hard capsules
Croatian: Uputa o lijeku: Informacije za bolesnika Silodyx 8 mg tvrde kapsule
English: What Silodyx is used for
Croatian: Za što se Silodyx koristi
English: Takeda Italia S.p.A. Tel: +39 06 502601
Croatian: Tel: + 39 06 502601
English: The recommended dose is one capsule of Silodyx 8 mg daily.
Croatian: Doziranje Preporučena doza je jedna kapsula lijeka Silodyx 8 mg na dan.
English: For this purpose Silodyx 4 mg hard capsules are available.
Croatian: U tu su svrhu dostupne tvrde kapsule Silodyx od 4 mg.
English: Tamsulosin
Croatian: Tamsulozin
English: Always use this medicine exactly as your doctor or pharmacist has told you.
Croatian: Uvijek uzmite ovaj lijek točno onako kako.
English: Allergic-type reactions including facial swelling, swollen tongue and pharyngeal oedema1
Croatian: Poremećaji imunološkog sustava alergijske reakcije uključujući i oticanje lica, oticanje jezika i edem ždrijela1
English: In patients with severe renal impairment administration of Silodyx is not recommended.
Croatian: U bolesnika s teškim oštećenjem funkcije bubrega ne preporučuje se primjena lijeka Silodyx.
English: The recommended dose is one capsule of Silodyx 8 mg per day by oral administration.
Croatian: Preporučena doza je jedna kapsula lijeka Silodyx od 8 mg na dan primjenom kroz usta.
English: How to store Silodyx
Croatian: Kako čuvati Silodyx
English: In the active-controlled clinical study conducted in Europe, silodosin 8 mg once daily was shown to be non inferior to tamsulosin 0.4 mg once daily: the adjusted mean difference (95% CI) in the IPSS Total Score between treatments in the per-protocol population was 0.4 (-0.4 to 1.1).
Croatian: 8 mg jedanput na dan nije inferioran tamsulozinu od 0,4 mg jedanput na dan: prilagođena prosječna razlika (95 % CI) u ukupnom IPSS rezultatu između terapijskih skupina koje su završile ispitivanje prema planu (engl.
English: Silodyx 4 mg and 8 mg hard capsules
Croatian: Silodyx 4 mg i 8 mg tvrde kapsule
English: Zambon Nederland B.V. Tel: + 31 33 4504370
Croatian: Tel: + 31 33 4504370
English: No dose adjustment is required for patients with mild renal impairment (CLCR ≥ 50 to ≤ 80 mL/min).
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim oštećenjem funkcije bubrega (CLcr ≥ 50
English: What Silodyx is and what it is used for What you need to know before you take Silodyx How to take Silodyx
Croatian: Što morate znati prije nego počnete uzimati Silodyx
English: Silodyx 4 mg hard capsules Each hard capsule contains 4 mg silodosin.
Croatian: Silodyx 4 mg tvrde kapsule Jedna tvrda kapsula sadrži 4 mg silodozina.
English: Silodyx 4 mg hard capsules Silodyx 8 mg hard capsules
Croatian: Silodyx 4 mg tvrde kapsule Silodxy 8 mg tvrde kapsule
English: Silodosin
Croatian: Silodozin
English: Silodyx 8 mg hard capsules silodosin
Croatian: Silodyx 8 mg tvrde kapsule silodozin
English: Silodyx 4 mg hard capsules silodosin
Croatian: Silodyx 4 mg tvrde kapsule silodozin
English: Silodyx 8 mg hard capsules
Croatian: Silodyx 8 mg tvrde kapsule
English: Silodyx 4 mg hard capsules
Croatian: Silodyx 4 mg tvrde kapsule
English: Each hard capsule contains 8 mg silodosin.
Croatian: Jedna tvrda kapsula sadrži 8 mg silodozina
English: • Abnormal ejaculation (less or no noticeable semen is released during sex, see section “Warnings and precautions”)
Croatian: • poremećaj ejakulacije (smanjeno ili neprimjetno oslobađanje sjemena u spolnom odnosu,
English: Dizziness
Croatian: OBLIK
English: Pharmacotherapeutic group: Urologicals, alpha-adrenoreceptor antagonists, ATC code: G04CA04.
Croatian: ATK oznaka: G04CA04.
English: This four-week period is one ‘cycle'.
Croatian: To razdoblje od četiri tjedna predstavlja jedan „ciklus”.
English: Vidaza azacitidine
Croatian: Vidaza azacitidin
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vidaza on 17 December 2008.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Vidaza na snazi u Europskoj uniji od 17. prosinca 2008.
English: Treatment continues for at least six cycles and then for as long as it benefits the patient.
Croatian: Terapija se nastavlja tijekom najmanje šest ciklusa te zatim onoliko dugo koliko bolesnik od nje ima koristi.
English: What measures are being taken to ensure the safe and effective use of Vidaza?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Vidaza?
English: The full EPAR for Vidaza can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Vidaza nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The effect of Vidaza was similar in all three diseases.
Croatian: Djelovanje lijeka Vidaza bilo je slično u slučaju sve tri bolesti.
English: It is given as an injection under the skin of the upper arm, thigh or abdomen (tummy) every day for one week, followed by three weeks with no treatment.
Croatian: Primjenjuje se kao potkožna injekcija u nadlakticu, bedro ili abdomen (trbuh) svaki dan tijekom tjedan dana, nakon čega slijede tri tjedna bez terapije.