FrancophonIA/ELRC3.0 huggingface dataset:
English: Dexamethasone belongs to a group of medicines called corticosteroids.
Croatian: Deksametazon pripada skupini lijekova koji se nazivaju kortikosteroidima.
English: The implant is approximately 0.46 mm in diameter and 6 mm in length.
Croatian: Implantat ima promjer od otprilike 0,46 mm te dužinu od 6 mm.
English: This is consistent with results from rabbit and monkey ocular metabolism studies.
Croatian: To je u skladu s rezultatima studija metabolizma oka na zečevima i majmunima.
English: Fertility There are no fertility data available.
Croatian: Plodnost Nisu dostupni podaci o utjecaju na plodnost.
English: There is currently no experience of the efficacy or safety of repeat administrations in DME beyond 7 implants.
Croatian: Trenutačno nema iskustava o djelotvornosti ili sigurnosti ponovljene primjene u bolesnika s DME s više od 7 implantata.
English: They should not drive or use machines until this has resolved.
Croatian: Ne bi smjeli upravljati vozilima ili strojevima dok taj učinak ne prođe.
English: A total of 47.3 % of patients experienced at least one adverse reaction.
Croatian: Ukupno 47,3% bolesnika osjetilo je barem jednu nuspojavu.
English: Do not twist or flex the tab.
Croatian: Nemojte okretati ili savijati pločicu.
English: A total of 95% of patients completed the 26-week study.
Croatian: Ukupno 95% bolesnika dovršilo je studiju od 26 tjedana.
English: Patients received up to 7 treatments at intervals no more frequently than approximately every 6 months.
Croatian: Bolesnici su primili do 7 tretmana u intervalima ne češćim od otprilike svakih
English: 3) Redirect towards the centre of the eye into the vitreous cavity.
Croatian: 3) Preusmjerite ga prema središtu oka u vitrealnu šupljinu.
English: Anti-platelet medicinal products, such as clopidogrel, were used at some stage during the clinical studies in up to 56% of patients.
Croatian: Antitrombocitni lijekovi poput klopidogrela korišteni su u određenom stadiju tijekom kliničkih ispitivanja kod do 56% bolesnika.
English: What you need to know before you are given OZURDEX You must not be given OZURDEX
Croatian: Što morate znati prije nego primite OZURDEX Ne smije Vam se dati OZURDEX
English: Do not use if foil pouch seal is damaged.
Croatian: Ne upotrebljavajte ako je hermetički zatvarač vrećice oštećen.
English: If the seal of the foil pouch containing the applicator is damaged, the applicator must not be used.
Croatian: Ako je hermetički zatvarač vrećice koja sadrži aplikator oštećen, aplikator se ne smije koristiti.
English: Additionally, corticosteroids prevent the release of prostaglandins, some of which have been identified as mediators of cystoid macular oedema.
Croatian: Osim toga, kortikosteroidi sprječavaju lučenje prostaglandina, od kojih su neki identificirani kao posrednici cistoidnog makularnog edema.
English: The marketing authorisation holder shall submit periodic safety update reports for this 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 published on the European medicines web-portal.
Croatian: • Periodička izvješća o neškodljivosti Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107.c stavkom 7 Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
English: On the day of the injection, your doctor may use antibiotic eye drops to prevent infection.
Croatian: Na dan ubrizgavanja liječnik će možda koristiti antibiotske očne kapi kako bi spriječio infekciju.
English: Following the intravitreal injection patients should continue to be treated with a broad spectrum antimicrobial.
Croatian: Nakon intravitrealnog ubrizgavanja potrebno je nastaviti bolesnicima davati antimikrobne lijekove širokog spektra.
English: * indicates adverse reactions considered to be related to the intravitreal injection procedure (the frequency of these adverse reactions is proportional to the number of treatments given).
Croatian: * označava nuspojave za koje se smatra da su povezane s postupkom intravitrealne injekcije (učestalost ovih nuspojava proporcionalna je broju primijenjenih tretmana).
English: Single use only.
Croatian: Isključivo za jednokratnu uporabu.
English: The treatment effect as assessed by BCVA at day 90 was thus supported by this anatomical finding.
Croatian: Učinak liječenja procijenjen BCVA na 90. dan stoga je podržan ovim anatomskim rezultatima.
English: The OZURDEX matrix slowly degrades to lactic acid and glycolic acid through simple hydrolysis, then further degrades into carbon dioxide and water.
Croatian: OZURDEX matrica se polagano razgrađuje u mliječnu kiselinu i glikolnu kiselinu putem jednostavne hidrolize, te se dalje razgrađuje na ugljični dioksid i vodu.
English: What OZURDEX looks like and contents of the pack
Croatian: Kako OZURDEX izgleda i sadržaj pakiranja
English: Only 1 patient out of 368 required cataract surgery during the first treatment and 3 patients out of 302 during the second treatment.
Croatian: Kod samo jednog bolesnika od njih 368 bila je potrebna operacija katarakte tijekom prvog liječenja i kod 3 bolesnika od 302 tijekom drugog liječenja.
English: Other medicines and OZURDEX
Croatian: Drugi lijekovi i OZURDEX
English: Statistical superiority was maintained up to and including week 26 (p ≤ 0.014) as shown in Table 6.
Croatian: Statistička superiornost održala se do uključujući 26. tjedna (p ≤ 0,014) kao što je prikazano u Tablici 6.
English: Therefore, although the systemic exposure of dexamethasone would be expected to be very low after local, intraocular treatment, OZURDEX is not recommended during pregnancy unless the potential benefit justifies the potential risk to the foetus.
Croatian: Stoga, iako se može očekivati da će sistemska izloženost deksametazonu biti vrlo niska nakon lokalne intraokularne primjene, ne preporučuje se koristiti OZURDEX tijekom trudnoće osim ako potencijalna korist opravdava potencijalni rizik za plod.
English: Overall, 42% of patients required IOP-lowering medications in the study eye at some stage during the 3 year studies, with the majority of these patients requiring more than one medication.
Croatian: Općenito, 42% bolesnika trebalo je lijekove za snižavanje IOT-a u ispitivanom oku u nekom od stadija ispitivanja tijekom 3 godine, s time da je većini tih bolesnika bilo potrebno više od jednog lijeka.
English: Immediately after injecting OZURDEX, use indirect ophthalmoscopy in the quadrant of injection to confirm successful implantation.
Croatian: Odmah nakon ubrizgavanja lijeka OZURDEX, upotrijebite indirektnu oftalmoskopiju u kvadrantu ubrizgavanja kako biste potvrdili uspješnu implantaciju.
English: OZURDEX should not be used during pregnancy or breast-feeding unless your doctor thinks it is clearly necessary.
Croatian: OZURDEX se ne bi trebao koristiti tijekom trudnoće ili dojenja osim ako Vaš liječnik smatra to neophodnim.
English: No mutagenicity, carcinogenicity, reproductive or developmental toxicity data are available for OZURDEX.
Croatian: Nisu dostupni podaci o mutagenosti, kancerogenosti, reproduktivnoj ili razvojnoj toksičnosti za OZURDEX.
English: The plunger is controlled by a lever on the side of the applicator body.
Croatian: Klipom se upravlja polugom koja se nalazi na boku tijela aplikatora.
English: Detailed instructions for your doctor on how to carry out the OZURDEX injection are provided in the medicine carton.
Croatian: Detaljne upute za Vašeg liječnika kako provesti ubrizgavanje lijeka OZURDEX nalaze se u kutiji s lijekom.
English: What OZURDEX is and what it is used for
Croatian: Što je OZURDEX i za što se koristi
English: OZURDEX should be used with caution in patients taking anti-coagulant or anti-platelet medicinal products.
Croatian: OZURDEX treba koristiti s oprezom kod bolesnika koji uzimaju antikoagulantne ili antitrombocitne lijekove.
English: Statistical superiority was achieved at week 3 and maintained up to and including week 26 (p < 0.001) as shown in Table 6.
Croatian: Statistička superiornost postignuta je u 3. tjednu i održala se do uključujući 26. tjedna (p < 0,001) kao što je prikazano u Tablici
English: In DME, anti-coagulant therapy was used in 8% of patients.
Croatian: Kod DME, antikoagulantna terapija korištena je u 8% bolesnika.
English: Of the patients who were treated in the open label phase, 98% received an OZURDEX injection between 5 and 7 months after the initial treatment.
Croatian: Od bolesnika koji su liječeni u otvorenoj fazi, 98% je primilo injekciju lijeka OZURDEX između 5. i 7. mjeseca nakon početnog liječenja.
English: This leaflet was last revised in MM/YYY
Croatian: Ova uputa je zadnji puta revidirana u MM.GGGG.
English: Your doctor will ask you to use antibiotic eye drops daily for 3 days before and after each injection to prevent any eye infection.
Croatian: Vaš liječnik će Vas uputiti da svakodnevno koristite antibiotske kapi za oko, 3 dana prije i 3 dana nakon svakog ubrizgavanja, kako bi se spriječila infekcija oka.
English: 1) Hold the long axis of the applicator parallel to the limbus.
Croatian: 1) Držite dužu os aplikatora paralelno u odnosu na rub rožnice (limbus).
English: A total of 54 % of patients experienced at least one adverse reaction.
Croatian: Ukupno 54% bolesnika osjetilo je barem jednu nuspojavu.
English: No patient required removal of the implant by vitrectomy to control IOP.
Croatian: U niti jednog bolesnika nije bilo potrebno ukloniti implantat uz vitrektomiju radi kontrole IOT-a.
English: Do not advance the needle past the point where the sleeve of the applicator touches the conjunctiva.
Croatian: Ne uvodite iglu dalje od točke u kojoj silikonski omotač aplikatora dodiruje konjunktivu.
English: • Advanced glaucoma which cannot be adequately controlled by medicinal products alone.
Croatian: • uznapredovali glaukom koji ne može biti kontroliran na odgovarajući način samo lijekovima.
English: Hold the applicator in one hand and pull the safety tab straight off the applicator.
Croatian: Držite aplikator u jednoj ruci i skinite sigurnosnu pločicu s aplikatora ravnim potezom.
English: • Vision loss caused by a blockage of veins in the eye.
Croatian: • gubitkom vida prouzročenim začepljenjem vena u oku.
English: OZURDEX is used to treat adult patients with:
Croatian: OZURDEX se koristi za liječenje odraslih bolesnika s:
English: Advance the needle until you enter the vitreous cavity.
Croatian: Gurajte iglu dok ne uđe u vitrealnu šupljinu.
English: OZURDEX may have a moderate influence on the ability to drive and use machines.
Croatian: OZURDEX može umjereno utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: Very common (may affect more than 1 in 10 people):
Croatian: Vrlo često (mogu se javiti kod više od 1 na 10 osoba):
English: The use of OZURDEX in children and adolescents has not been studied and is therefore not recommended.
Croatian: Uporaba lijeka OZURDEX kod djece i adolescenata nije ispitivana i stoga nije preporučljiva.
English: There is no experience of using OZURDEX in pregnant women or during breast-feeding.
Croatian: Ne postoje iskustva o uporabi lijeka OZURDEX kod trudnica ili tijekom dojenja.
English: Алерган България ЕООД Тел.
Croatian: България Алерган България ЕООД
English: The adverse reaction profile of 341 patients analysed following a second injection of OZURDEX, was similar to that following the first injection.
Croatian: Profil nuspojava kod 341 bolesnika koji su analizirani nakon druge injekcije lijeka OZURDEX bio je sličan profilu nakon prve injekcije.
English: What OZURDEX is and what it is used for What you need to know before you are given OZURDEX How OZURDEX is used
Croatian: Što je OZURDEX i za što se koristi Što morate znati prije nego što primite OZURDEX Kako primjenjivati OZURDEX
English: Effects in non-clinical studies were observed only at doses considered sufficiently in excess of the maximum dose for human indicating little relevance to clinical use.
Croatian: U nekliničkim ispitivanjima zapaženi su učinci samo pri ekspozicijama dozama koje su znatno veće od maksimalno dozvoljenih u ljudi, što ukazuje na njihov mali značaj za kliničku primjenu.
English: In cases in which the implant cannot be visualised, take a sterile cotton bud and lightly depress over the injection site to bring the implant into view.
Croatian: U slučajevima kada implantat ne može biti vizualiziran, uzmite sterilni štapić s vatom te lagano pritisnite iznad mjesta ubrizgavanja kako bi implantat postao vidljiv.
English: The following side effects may be seen with OZURDEX:
Croatian: Sljedeće nuspojave mogu se primijetiti primjenjujući OZURDEX :
English: The proportion of responders at each time point was always greater after the second treatment compared with the first treatment.
Croatian: Udio bolesnika koji su reagirali na liječenje u svakom terminu uvijek je bio veći nakon drugog liječenja u usporedbi s prvim liječenjem.
English: The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where OZURDEX is marketed, at launch and after launch all ophthalmological clinics where OZURDEX is expected to be used are provided with an up-to-date patient information pack.
Croatian: Nositelj odobrenja mora osigurati da se, nakon provedene rasprave i postignutog dogovora s nadležnim vlastima, u svakoj državi članici u kojoj se OZURDEX nalazi na tržištu, u trenutku stavljanja i nakon stavljanja na tržište, svim oftalmološkim klinikama u kojima se očekuje da će se OZURDEX koristiti dostavi najnoviji komplet informacija za bolesnika..
English: It is a potent promoter of vascular permeability.
Croatian: Riječ je o snažnom pokretaču vaskularne propusnosti.
English: The European Medicines Agency has waived the obligation to submit the results of studies with OZURDEX in all subsets of the paediatric population for retinal vascular occlusion and also for diabetic macular oedema (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka OZURDEX u svim podskupinama pedijatrijske populacije za retinalne vaskularne okluzije kao i za dijabetički makularni edem (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Retreatment may be performed after approximately 6 months if the patient experiences decreased vision and/or an increase in retinal thickness, secondary to recurrent or worsening diabetic macular oedema.
Croatian: Tretman se može ponoviti nakon otprilike 6 mjeseci ako se kod bolesnika pojavi slabljenje vida i/ili zadebljanje mrežnice sekundarno ponovnoj pojavi ili pogoršanju dijabetičkog makularnog edema.
English: Repeat doses should be considered when a patient experiences a response to treatment followed subsequently by a loss in visual acuity and in the physician's opinion may benefit from retreatment without being exposed to significant risk (see section 5.1).
Croatian: Potrebno je razmotriti ponavljanje doze kada bolesnik osjeti reakciju na liječenje nakon koje slijedi smanjenje oštrine vida i ako mu, prema mišljenju liječnika, ponovljeni tretman može koristiti, a da nije izložen značajnom riziku (vidjeti dio 5.1).
English: Escape therapy was permitted at the investigators discretion at any stage but led to subsequent withdrawal from the studies.
Croatian: Liječenje u slučaju neuspjeha tretmana bilo je dozvoljeno prema diskrecionom pravu ispitivača u bilo kojem stadiju ispitivanja, ali je to dovelo do isključivanja ispitanika iz daljnjeg ispitivanja.
English: The rate and magnitude of IOP elevation following OZURDEX treatment did not increase upon repeated injection of OZURDEX.
Croatian: Stopa i veličina porasta IOT-a nakon injekcije lijeka OZURDEX nije rasla s ponavljanjem injekcija lijeka OZURDEX.
English: After OZURDEX treatment you may experience some reduced vision for a short time.
Croatian: Nakon ubrizgavanja lijeka OZURDEX možete kratkotrajno iskusiti oslabljeni vid.
English: • Vision loss due to diabetic macular oedema (DME), if you have already had an operation for cataract, or if you have not previously responded to, or are not suitable for, other types of treatment.
Croatian: • gubitkom vida zbog dijabetičkog makularnog edema (DME), ako ste već operirali kataraktu ili ranije niste imali pozitivan odgovor ili niste bili prikladan kandidat za druge oblike liječenja.
English: Long-term systemic treatment with glucocorticoids during pregnancy increases the risk for intra-uterine growth retardation and adrenal insufficiency of the newborn child.
Croatian: Dugotrajna sistemska terapija glukokortikosteroidima tijekom trudnoće povećava rizik od intrauterinog zaostajanja u rastu ploda i adrenalne insuficijencije kod novorođenčeta.
English: The intravitreal injection procedure should be carried out under controlled aseptic conditions which include the use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent).
Croatian: Postupak intravitrealnog ubrizgavanja treba se provesti u kontroliranim aseptičnim uvjetima koji uključuju uporabu sterilnih rukavica, sterilnog prekrivača i sterilnog spekuluma za vjeđu (ili drugu odgovarajuću opremu).
English: The patient information pack should be provided in both the form of patient information booklet and an audio-CD that contain following key elements:
Croatian: Komplet informacija za bolesnika mora biti u obliku brošure i u obliku CD audio zapisa te mora sadržavati sljedeće ključne elemente:
English: The applicator and a packet of drying material are sealed in a foil pouch which is inside a carton.
Croatian: Aplikator i paketić sa sredstvom za sušenje hermetički su zatvoreni u vrećici koja se nalazi unutar kartonske kutije.
English: Before withdrawing the applicator from the eye, make sure that the actuator button is fully pressed and has locked flush with the applicator surface.
Croatian: Prije izvlačenja aplikatora iz oka, provjerite da je gumb za aktivaciju u potpunosti pritisnut i da je čvrsto zaglavljen u ravnini s površinom aplikatora.
English: Therefore OZURDEX is not recommended.
Croatian: Stoga se uporaba lijeka OZURDEX ne preporučuje.
English: The recommended dose is one implant to be given by injection into your eye.
Croatian: Preporučena doza je jedan implantat koji se primjenjuje ubrizgavanjem u oko.
English: By Day 180 the mean retinal thickness reduction (-119.3 microns) compared with sham was not significant.
Croatian: Na 180. dan prosječno smanjenje debljine mrežnice (-119,3 mikrona) u usporedbi s placebo postupkom nije bilo značajno.
English: The incidence of increased IOP (24.9 %) was similar to that seen following the first injection and likewise returned to baseline by open-label day 180.
Croatian: Incidencija povišenog očnog tlaka (24,9%) bila je slična onoj nakon prvog ubrizgavanja te se on također vratio na početnu razinu do 180. dana otvorenog ispitivanja.
English: RVO and uveitis
Croatian: RVO i uveitis
English: If a patient presents with symptoms such as blurred vision or other visual disturbances, consider evaluating for possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Croatian: Ako se u bolesnika pojave simptomi poput zamagljenog vida ili drugih smetnji vida, razmotrite procjenu mogućih uzroka koji mogu uključivati kataraktu, glaukom ili rijetke bolesti poput središnje serozne korioretinopatije (engl. central serous chorioretinopathy, CSCR), koji su prijavljeni nakon sistemske i topikalne primjene kortikosteroida.
English: Dexamethasone exposure to the healthy/untreated eye via contralateral diffusion has been observed in rabbits following delivery of the implant to the posterior segment of the eye.
Croatian: Izlaganje deksametazonu kod zdravog/neliječenog oka putem kontralateralne difuzije primijećeno je kod zečeva nakon postavljanja implantata u stražnji segment oka.
English: There are no adequate data from the use of intravitreally administered dexamethasone in pregnant women.
Croatian: Ne postaje adekvatni podaci o uporabi intravitrealno primijenjenog deksametazona kod trudnica.
English: Corticosteroids have been shown to inhibit the expression of VEGF.
Croatian: Dokazano je da kortikosteroidi mogu inhibirati ekspresiju
English: Clinical efficacy and safety Diabetic Macular Oedema
Croatian: Klinička djelotvornost i sigurnost Dijabetički makularni edem
English: Monitoring may consist of a check for perfusion of the optic nerve head immediately after the injection, tonometry within 30 minutes following the injection, and biomicroscopy between two and seven days following the injection.
Croatian: Promatranje se može sastojati od provjere perfuzije glave vidnog živca odmah nakon ubrizgavanja, tonometrije u roku od 30 minuta nakon injiciranja te biomikroskopije između dva i sedam dana nakon injiciranja.
English: This could be attributable to the intravitreous injection procedure or to concomitant use of topical and/or systemic corticosteroid or Non-steroidal anti-inflammatory medications.
Croatian: To bi se moglo pripisati postupku intravitrealnog ubrizgavanja ili istovremenoj topikalnoj i/ili sistemskoj primjeni kortikosteroida ili nesteroidnih protuupalnih lijekova.
English: Carefully remove the cap from the applicator.
Croatian: Pažljivo skinite zatvarač s aplikatora.
English: Very common (≥ 1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000
Croatian: vrlo često ((≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i
English: Intravitreal use.
Croatian: Intravitrealna uporaba.
English: As expected with ocular steroid treatment and intravitreal injections, increases in intraocular pressure (IOP) may be seen.
Croatian: Kao što se može i očekivati kod liječenja oka steroidima i intravitrealnih injekcija, može doći do povišenja intraokularnog tlaka (IOT).
English: This can lead to swelling of the clear layer in the front of the eye and cause blurred vision.
Croatian: To može dovesti do oteknuća prozirnog sloja prednjeg dijela oka i biti uzrok zamućenog vida.
English: The needle is protected by a cap and the lever by a safety tab.
Croatian: Igla je zaštićena zatvaračem (kapicom), a poluga sigurnosnom pločicom.
English: One carton contains one applicator with one implant which will be used once and thrown away.
Croatian: Jedna kartonska kutija sadrži jedan aplikator s jednim implantatom za jednokratnu uporabu, nakon koje aplikator treba baciti.
English: Occasionally the injection of OZURDEX may cause an infection inside the eye, pain or redness in the eye, or a detachment or tear of the retina.
Croatian: Ponekad injekcija lijeka OZURDEX može izazvati infekciju u oku, bol ili crvenilo u oku, ili odljepljivanje ili puknuće mrežnice.
English: Then, in a sterile field, open the foil pouch and gently place the applicator on a sterile tray.
Croatian: Nakon toga, u sterilnom polju otvorite vrećicu i pažljivo stavite aplikator na sterilni pladanj.
English: PHARMACEUTICAL PARTICULARS 6.6 Special precautions for disposal and other handling
Croatian: FARMACEUTSKI PODACI 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom
English: The patient should be instructed to self-administer broad spectrum antimicrobial drops daily for 3 days before and after each injection.
Croatian: Bolesnika treba uputiti da si sam svakodnevno ukapava u oko antibiotske kapi širokog spektra, tijekom 3 dana prije i 3 dana nakon svakog injiciranja.
English: A total of 401 patients (94 %) randomised and treated with OZURDEX completed the initial treatment period (up to day 180).
Croatian: Ukupno 401 bolesnik (94%) odabran slučajnim odabirom i liječen lijekom OZURDEX dovršio je početno razdoblje liječenja (do 180. dana).
English: The injection of OZURDEX into both eyes at the same time has not been studied and is not recommended.
Croatian: Ubrizgavanje lijeka OZURDEX u oba oka istovremeno nije ispitivano i nije preporučljivo.