FrancophonIA/ELRC3.0 huggingface dataset:
English: What measures are being taken to ensure the safe and effective use of Silodosin Recordati?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Silodosin Recordati?
English: Three main studies in over 1,800 men showed that Silodosin Recordati was effective at reducing symptoms of BPH, such as problems with urinating.
Croatian: Tri glavna ispitivanja na više od 1 800 muškaraca pokazala su da je lijek Silodosin Recordati učinkovit u ublažavanju simptoma BHP-a, kao što su problemi pri mokrenju.
English: Silodosin Recordati is a medicine used to treat the symptoms of benign prostatic hyperplasia (BPH, an enlarged prostate gland) in adults.
Croatian: Silodosin Recordati je lijek za liječenje simptoma benigne hiperplazije prostate (BHP, uvećana žlijezda prostata) u odraslih osoba.
English: For more information about using Silodosin Recordati, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Silodosin Recordati pogledajte uputu o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Silodosin Recordati is not recommended for patients with severe kidney problems.
Croatian: Lijek Silodosin Recordati ne preporučuje se bolesnicima s ozbiljnim problemima s bubrezima.
English: Silodosin Recordati is effective at reducing problems with urinating in men with BPH and its side effects are comparable to those seen with other medicines of the same class.
Croatian: Lijek Silodosin Recordati učinkovito smanjuje probleme pri mokrenju u muškaraca s BHP-om, a njegove nuspojave usporedive su s onima zabilježenim kod drugih lijekova istog razreda.
English: When enlarged, it can cause problems with the flow of urine.
Croatian: Uvećana prostata može uzrokovati probleme s protokom urina.
English: It works by blocking receptors (targets) called alpha1A adrenoreceptors in the prostate gland, the bladder and the urethra (the tube that leads from the bladder to the outside of the body).
Croatian: Ta djelatna tvar djeluje na način da blokira receptore (ciljna mjesta) zvane α-adrenergički receptori u žlijezdi prostati, mokraćnom mjehuru i uretri (cijevi koja vodi od mokraćnog mjehura do vanjskog dijela tijela).
English: The active substance in Silodosin Recordati, silodosin, is an alpha-adrenoreceptor antagonist.
Croatian: Djelatna tvar u lijeku Silodosin Recordati, silodozin, antagonist je α-adrenergičkih receptora.
English: An overview of Silodosin Recordati and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Silodosin Recordati i zašto je odobren u EU-u
English: The European Medicines Agency therefore decided that Silodosin Recordati'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 Silodosin Recordati nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: As for all medicines, data on the use of Silodosin Recordati are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Silodosin Recordati kontinuirano se prate.
English: Other information about Silodosin Recordati
Croatian: Ostale informacije o lijeku Silodosin Recordati
English: IFIS is a condition that makes the iris floppy.
Croatian: IFIS je stanje pri kojem šarenica postaje mekana.
English: Why is Silodosin Recordati authorised in the EU?
Croatian: Zašto je lijek Silodosin Recordati odobren u EU-u?
English: What is Silodosin Recordati and what is it used for?
Croatian: Što je Silodosin Recordati i za što se primjenjuje?
English: What are the risks associated with Silodosin Recordati?
Croatian: Koji su rizici povezani s lijekom Silodosin Recordati?
English: The prostate gland is an organ found at the base of the bladder in men.
Croatian: Žlijezda prostata organ je na donjem dijelu mokraćnog mjehura u muškaraca.
English: For the full list of side effects and restrictions of Silodosin Recordati, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Silodosin Recordati potražite u uputi o lijeku.
English: What benefits of Silodosin Recordati have been shown in studies?
Croatian: Koje su koristi od lijeka Silodosin Recordati utvrđene u ispitivanjima?
English: How does Silodosin Recordati work?
Croatian: Kako djeluje Silodosin Recordati?
English: Two different pack types are available:
Croatian: Dostupne su dvije različite vrste pakiranja:
English: This effect was maintained up to Month 24.
Croatian: Taj se učinak održao do 24. mjeseca.
English: Re-use may lead to infection or other illness/injury.
Croatian: Ponovna uporaba može dovesti do infekcije ili drugih bolesti/ozljeda.
English: Check that:
Croatian: Provjerite da:
English: Comparative control up to Month 3.
Croatian: Komparativna kontrola do 3. mjeseca.
English: 2870 Puurs Belgium
Croatian: 2870 Puurs Belgija
English: • Aggressive posterior (AP)-ROP
Croatian: • Agresivni posteriorni (AP)-ROP
English: Populations with limited data
Croatian: Populacije s ograničenim podacima
English: However, evidence of reversibility was observed after recovery.
Croatian: Međutim, uočena je reverzibilnost nakon oporavka.
English: If this happens, do not drive or use machines until this resolves.
Croatian: Ako se to dogodi, nemojte upravljati vozilima ili strojevima dok to ne prođe.
English: The effect at 12 months was consistent in most subgroups.
Croatian: Učinak nakon 12 mjeseci bio je dosljedan u većini podskupina.
English: • When to seek urgent attention from the health care provider
Croatian: • Kada treba zatražiti hitnu pomoć zdravstvenog djelatnika
English: Group III vPDT
Croatian: III. skupina vPDT
English: • Key signs and symptoms of serious adverse events including increased intraocular pressure,
Croatian: • Ključni znakovi i simptomi ozbiljnih štetnih događaja koji uključuju povišeni intraokularni tlak,
English: THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY:
Croatian: SLJEDEĆE INFORMACIJE NAMIJENJENE SU SAMO ZDRAVSTVENIM RADNICIMA:
English: This lack of information should be considered by the physician when treating such patients.
Croatian: Ovaj manjak informacija liječnik treba uzeti u obzir prilikom liječenja takvih bolesnika.
English: Number of injections up to Month 12:
Croatian: Broj injekcija do 12. mjeseca:
English: • an intraocular pressure of ≥30 mmHg;
Croatian: • da je intraokularni tlak ≥30 mmHg;
English: • the syringe is not damaged.
Croatian: • štrcaljka nije oštećena.
English: For PDR and RVO, treatment intervals may also be gradually extended, however there are insufficient data to conclude on the length of these intervals.
Croatian: Za PDR i RVO, intervali liječenja također se mogu postupno produžiti, međutim postojeći podaci nedostatni su da bi se donio zaključak o duljini tih intervala.
English: No carcinogenicity or mutagenicity data are available.
Croatian: Ne postoje podaci o karcinogenosti niti mutagenosti.
English: There is limited experience in patients older than 75 years with DME.
Croatian: Postoji ograničeno iskustvo u bolesnika starijih od 75 godina s DME-om.
English: Final study report:
Croatian: Završno izvješće o ispitivanju:
English: Treatment initiation at the time of diagnosis should be considered.
Croatian: Potrebno je razmotriti započinjanje liječenja u vrijeme dijagnosticiranja.
English: The treatment is started with one injection of Lucentis per month.
Croatian: Liječenje započinje jednom injekcijom Lucentisa mjesečno.
English: In these diseases, Lucentis can help to stabilise and in many cases improve your vision.
Croatian: U ovim bolestima Lucentis može pomoći stabilizirati, a u mnogim slučajevima i poboljšati
English: The apparent systemic half-life was approximately 6 days.
Croatian: Prividni sistemski poluvijek iznosio je približno 6 dana.
English: If a patient died or switched study treatment before or at week 24, then the patient was considered as having active ROP and unfavourable structural outcomes at week 24.
Croatian: Ako je bolesnik umro ili promijenio ispitivano liječenje prije ili u 24. tjednu, smatralo se da je bolesnik imao aktivan ROP i nepovoljne strukturalne ishode u 24. tjednu.
English: • performed or planned intraocular surgery within the previous or next 28 days.
Croatian: • intraokularnog kirurškog zahvata obavljenog unutar prethodnih 28 dana ili planiranog unutar idućih 28 dana.
English: For other subscales of this questionnaire no treatment differences could be established.
Croatian: Za ostale podljestvice ovog upitnika nisu se mogle ustanoviti nikakve terapijske razlike.
English: The administration of more than three injections per eye has not been studied.
Croatian: Primjena više od tri injekcije po oku nije ispitana.
English: Month 24(%)
Croatian: 24. mjesecu (%)
English: Please see section 4 (“Possible side effects”) for more detailed information on side effects that could occur during Lucentis therapy.
Croatian: Molimo vidjeti dio 4 („Moguće nuspojave“) za detaljnije informacije o nuspojavama do kojih bi moglo doći tijekom terapije Lucentisom.
English: The severity of the inflammatory response generally diminished with subsequent injections or during recovery.
Croatian: Jačina upalnog odgovora općenito se smanjila sa sljedećim injekcijama ili tijekom oporavka.
English: Other medicines and Lucentis
Croatian: Drugi lijekovi i Lucentis
English: Difference in proportion (%), CI
Croatian: Razlika u udjelu (%), CI
English: Please find information for adults on the other side of this leaflet.
Croatian: Informacije za odrasle potražite s druge strane ove upute.
English: Date of first authorisation: 22 January 2007 Date of latest renewal: 11 November 2016
Croatian: Datum posljednje obnove odobrenja: 11. studenog 2016.
English: Microscopic ocular changes were related to inflammation and did not indicate degenerative processes.
Croatian: Mikroskopske promjene na oku bile su povezane s upalom i nisu ukazivale na degenerativni proces.
English: For information on preparation of Lucentis, see section 6.6.
Croatian: Za informacije o pripremi Lucentisa vidjeti dio 6.6.
English: Systemic clearance was slightly lower, but this was not clinically significant.
Croatian: Sistemski je klirens bio malo snižen, no to nije bilo klinički značajno.
English: b p-value for pairwise comparison is one-sided.
Croatian: b p-vrijednost za uspoređivanje po parovima je jednostrana.
English: If you are pregnant, think you may be pregnant or planning to become pregnant, discuss this with your doctor before treatment with Lucentis.
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, razgovarajte o tome sa svojim liječnikom prije liječenja Lucentisom.
English: Women of childbearing potential/contraception in females
Croatian: Žene reproduktivne dobi/kontracepcija u žena
English: Make sure that the pack contains:
Croatian: Provjerite sadrži li pakiranje sljedeće:
English: The interval between two doses injected into the same eye should be at least four weeks.
Croatian: Interval između dviju doza ubrizganih u isto oko mora biti najmanje četiri tjedna.
English: The patient information pack should be provided in both the form of patient information booklets and an audio-CD that contain following key elements:
Croatian: Informacijski paket za bolesnike treba biti i u obliku knjižice s informacijama za bolesnika i kao audio-CD koji sadrže sljedeće ključne elemente:
English: However, no special considerations are needed in this population.
Croatian: Međutim, za tu populaciju bolesnika nisu potrebne nikakve posebne mjere.
English: BCVA ≥84 letters at
Croatian: BCVA ≥84 slova u
English: If disease activity recurs, the treatment interval should be shortened accordingly.
Croatian: Ako se ponovno vrati aktivnost bolesti, interval liječenja treba sukladno tome skratiti.
English: Pregnancy and breast-feeding - Women who could become pregnant must use effective contraception during treatment and for at least three further months after the last injection of Lucentis.
Croatian: Trudnoća i dojenje - Žene koje mogu zatrudnjeti moraju koristiti učinkovitu kontracepciju tijekom liječenja te još najmanje tri mjeseca nakon zadnje injekcije Lucentisa.
English: Mean number of injections (Months 0-11)
Croatian: Srednji broj injekcija (mjeseci 0-11)
English: Month 12 -10.5 (16.6) +7.2 (14.4) -9.5 (16.4) +11.3 (14.6) Month 24 -14.9 (18.7) +6.6 (16.5) -9.8 (17.6) +10.7 (16.5)
Croatian: 12. mjesec -10,5 (16,6) +7,2 (14,4) -9,5 (16,4) 24. mjesec -14,9 (18,7) +6,6 (16,5) -9,8 (17,6)
English: A PK/PD analysis showed no clear relationship between systemic ranibizumab concentrations and systemic VEGF concentrations.
Croatian: PK/PD analiza pokazala je da ne postoji jasna veza između sistemskih koncentracija ranibizumaba i sistemskih koncentracija VEGF-a.
English: Note: The plunger rod is not attached to the rubber stopper - this is to prevent air being drawn into the syringe.
Croatian: Napomena: Potisni klip nije spojen na gumeni čep - time se sprečava uvlačenje zraka u štrcaljku.
English: The effect of ranibizumab treatment was similar irrespective of the presence of retinal ischaemia.
Croatian: Učinak liječenja ranibizumabom bio je sličan bez obzira na prisutnost retinalne ishemije.
English: It binds with high affinity to the VEGF-A isoforms (e.g. VEGF110, VEGF121 and VEGF165), thereby preventing binding of VEGF-A to its receptors VEGFR-1 and VEGFR-2.
Croatian: Visokim se afinitetom veže na izoforme VEGF-A (npr. na VEGF110, VEGF121 i VEGF165), čime se sprječava vezanje VEGF-A na njegove receptore VEGFR-1 i VEGFR-2.
English: 62.9% of Group II patients did not require injections in the second 6 months of the study.
Croatian: 62,9% bolesnika II. skupine nije trebalo injekcije u drugih 6 mjeseci ispitivanja.
English: With both TE regimens, more than 70% of patients maintained their BCVA with an average visit frequency of ≥2 months.
Croatian: Uz oba LIP režima, više od 70% bolesnika održalo je svoj BCVA uz prosječnu učestalost posjeta od ≥2 mjeseca.
English: Studies in cynomolgus monkeys do not indicate direct or indirect harmful effects with respect to pregnancy or embryonal/foetal development (see section 5.3).
Croatian: Ispitivanja u cinomolgus majmuna ne ukazuju na izravne ili neizravne štetne učinke na trudnoću ili embrionalni/fetalni razvoj (vidjeti dio 5.3).
English: Women of childbearing potential should use effective contraception during treatment.
Croatian: Žene u reproduktivnoj dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja.
English: The treatment is started with one injection of Lucentis in each eye (some babies may only need treatment in one eye).
Croatian: Liječenje započinje jednom injekcijom Lucentisa u svako oko (u neke dojenčadi može biti potrebno liječenje samo jednog oka).
English: Prepare
Croatian: Priprema
English: (maintenance of vision, primary endpoint)
Croatian: (zadržavanje vida, primarna mjera ishoda)
English: There are no data available on fertility.
Croatian: Nema dostupnih podataka o plodnosti.
English: 30-Jun-2023
Croatian: 30. lipnja 2023.
English: Please tell your doctor immediately if you develop any of these side effects.
Croatian: Molimo odmah obavijestite svog liječnika ako se kod Vas razvije bilo koja od ovih nuspojava.
English: Key outcome measures are summarised in Table 5 (RESTORE and Extension) and Figure 4 (RESTORE).
Croatian: Ključne mjere ishoda sažete su u Tablici 5 (RESTORE i Produžetak) i na Slici 4 (RESTORE).
English: The dose should be withheld and treatment should not be resumed earlier than the next scheduled treatment in the event of:
Croatian: Dozu ne treba dati, a liječenje ne treba nastaviti ranije od roka predviđenog za primjenu iduće doze, u slučaju:
English: Your doctor will advise you and decide how long you should be treated with Lucentis.
Croatian: Liječnik će Vas savjetovati i odlučiti koliko dugo trebate biti liječeni Lucentisom.
English: The treatment procedure may induce temporary visual disturbances, which may affect the ability to drive or use machines (see section 4.8).
Croatian: Liječenje može izazvati privremene poremećaje vida, što može utjecati na sposobnost upravljanja vozilima ili rada sa strojevima (vidjeti dio 4.8).
English: By binding to VEGF-A, Lucentis can block its actions and prevent this abnormal growth and swelling.
Croatian: Vežući se za VEGF-A, Lucentis može blokirati njegova djelovanja i spriječiti taj abnormalan rast i oticanje.
English: These medical devices are not included within the Lucentis pack.
Croatian: Ovi medicinski proizvodi nisu uključeni u pakiranje Lucentisa.
English: p<0.0001for both studies
Croatian: p<0,0001 za oba ispitivanja
English: - There is no experience of using Lucentis in pregnant women.
Croatian: - Nema iskustva s primjenom Lucentisa u trudnica.
English: There is a potential for immunogenicity with Lucentis.
Croatian: Postoji potencijal za imunogenost Lucentisa.
English: 30-Jun-2020
Croatian: 30. lipnja 2020.
English: Following intravitreal administration, no signs of systemic toxicity were detected.
Croatian: Nakon intravitrealne primjene nisu uočeni znakovi sistemske toksičnosti.
English: Patients who experience these signs must not drive or use machines until these temporary visual disturbances subside.
Croatian: Bolesnici u kojih se jave ti znakovi, ne smiju voziti ni rukovati strojevima, sve dok ti privremeni poremećaji vida ne prođu.
English: In the 26-week study, the severity of the vitreous inflammation increased with the number of injections.
Croatian: U ispitivanju koje je trajalo 26 tjedana, težina vitrealne upale povećavala se s brojem injekcija.
English: The treatment of visual impairment due to CNV should be determined individually per patient based on disease activity.
Croatian: Liječenje oštećenja vida uzrokovanog CNV-om treba odrediti individualno za svakog bolesnika na temelju aktivnosti bolesti.
English: For the primary endpoint the pre-specified significance level for the one-sided p-value was 0.025.
Croatian: Za mjeru primarnog ishoda unaprijed utvrđena razina značajnosti za jednostranu p-vrijednost iznosila je 0,025.
English: Alcon-Couvreur NV Rijksweg 14
Croatian: Alcon-Couvreur N.V. Rijksweg 14
English: Eligible patients had one of the following retinal findings in each eye:
Croatian: Bolesnici prikladni za ispitivanje imali su jednu od sljedećih stanja mrežnice u svakom oku:
English: In addition, patients should be monitored during the week following the injection to permit early treatment if an infection occurs.
Croatian: Osim toga, bolesnike treba pratiti tjedan dana nakon injekcije, kako bi se moglo započeti rano liječenje ako se pojavi infekcija.
English: (letters)
Croatian: (slova)
English: (stage 3+) or AP-ROP (aggressive posterior ROP) disease.
Croatian: (stadij 3+) ili AP-ROP-om (agresivnim posteriornim ROP-om).
English: * observed only in DME population
Croatian: * uočeno samo u populaciji bolesnika s DME-om
English: Tell your baby's doctor if your baby is receiving, has recently received or might receive any other medicines.
Croatian: Obavijestite djetetovog liječnika ako Vaše dijete prima, nedavno je primilo ili bi moglo primiti bilo koje druge lijekove.
English: The doctor will also give your baby a local anaesthetic to reduce or prevent any pain.
Croatian: Liječnik će dati Vašem djetetu i lokalni anestetik da smanji ili spriječi bilo kakvu bol.
English: Table 10 Outcomes at Week 24 (RAINBOW)
Croatian: Tablica 10 Ishodi u 24. tjednu (RAINBOW)
English: 90429 Nuremberg
Croatian: 90429 Nürnberg
English: Lucentis is indicated in adults for:
Croatian: Lucentis je indiciran u odraslih za:
English: Mean number of injections (months 0-23) p<0.0001 for assessment of non-inferiority to PRN
Croatian: Srednji broj injekcija (mjeseci 0-23) p<0,0001 za procjenu neinferiornosti prema režimu p.p.
English: Patients with active severe intraocular inflammation.
Croatian: Bolesnici s aktivnom teškom intraokularnom upalom.
English: If any of the above is not true, discard the pre-filled syringe and use a new one.
Croatian: 4. Ako bilo što od gore navedenog nije u skladu s opisom, bacite napunjenu štrcaljku i upotrijebite novu.
English: In order to verify the impact of the intervention on clinical outcome or disease progression and to confirm previous efficacy assumptions, the MAH should conduct and submit the results of the ongoing prospective, open-label, multicentre study.
Croatian: Da bi se provjerio učinak intervencije na klinički ishod ili progresiju bolesti i potvrdile prethodne pretpostavke o djelotvornosti, nositelj odobrenja dužan je provoditi i podnositi rezultate prospektivnog, otvorenog, multicentričnog ispitivanja koje je u tijeku.
English: After injection any unused product must be discarded.
Croatian: Nakon primjene injekcije sav neiskorišteni lijek mora se baciti.
English: What Lucentis is used for Lucentis is used in adults to treat several eye diseases causing vision impairment.
Croatian: Za što se Lucentis koristi Lucentis se koristi u odraslih za liječenje nekoliko očnih bolesti koje uzrokuju oštećenje vida.
English: In patients with wet AMD, DME, PDR and RVO, initially, three or more consecutive, monthly injections may be needed.
Croatian: U bolesnika s vlažnim AMD-om, DME-om, PDR-om i RVO-om moguće je da će u početku biti potrebno tri ili više uzastopnih mjesečnih injekcija.
English: In all groups, ranibizumab was administered monthly until BCVA was stable for at least three consecutive monthly assessments.
Croatian: U svim skupinama, ranibizumab je primijenjen mjesečno sve dok BCVA nije bio stabilan na najmanje tri uzastopne mjesečne procjene.
English: No dose adjustment is required in the elderly.
Croatian: Starijim osobama nije potrebno prilagoditi dozu.
English: On TE, ranibizumab was administered at treatment intervals of 2-3 months.
Croatian: Na LIP režimu, ranibizumab je bio primijenjen u intervalima liječenja od 2-3 mjeseca.
English: Detailed instructions for use are given at the end of the leaflet under “How to prepare and administer Lucentis”.
Croatian: Detaljne upute za primjenu navedene su na kraju ove upute, pod naslovom „Kako pripremiti i primijeniti Lucentis ”.
English: - In some patients the eye pressure may increase for a short period directly after the injection.
Croatian: - U nekih bolesnika može u kratkom periodu nakon dobivanja injekcije porasti očni tlak.
English: Treatment success
Croatian: Uspješnost liječenja
English: The long-term safety profile in preterm infants has not been established.
Croatian: Dugoročni sigurnosni profil u prijevremeno rođene dojenčadi nije još ustanovljen.
English: DRSS = diabetic retinopathy severity score, n = number of patients who satisfied the condition at the visit, N = total number of study eyes.
Croatian: DRSS = ocjena težine dijabetičke retinopatije, n = broj bolesnika koji su ispunjavali uvjet prilikom posjeta, N = ukupni broj ispitivanih očiju.
English: • The treatment of retinopathy of prematurity (ROP) with zone I (stage 1+, 2+, 3 or 3+), zone II
Croatian: • Liječenje retinopatije nedonoščadi (ROP) s bolešću zone I (stadij 1+, 2+, 3 ili 3+), zone II
English: Your doctor will also give you a local anaesthetic to reduce or prevent any pain you might have with the injection.
Croatian: Liječnik će Vam dati i lokalni anestetik da smanji ili spriječi bol koju bi injekcija mogla izazvati.
English: In all groups, monthly treatment was re-initiated upon a decrease in BCVA due to DME progression and continued until stable BCVA was reached again.
Croatian: U svim skupinama, mjesečna terapija ponovno je započeta nakon smanjenja BCVA zbog progresije DME-a te nastavljena dok opet nije postignut stabilan BCVA.
English: Prior to launch in each Member State the MAH shall agree the final educational material with the National Competent Authority.
Croatian: Prije stavljanja u promet u svakoj državni članici nositelj odobrenja usuglasit će se s nadležnim nacionalnim tijelom oko konačnog oblika edukativnog materijala.
English: Treatment of PDR
Croatian: Liječenje PDR-a