FrancophonIA/ELRC3.0 huggingface dataset:
English: The incidence of female genital infections (e.g. vulvovaginal mycotic infection, vaginal infection, vulvovaginal candidiasis and vulvitis) was increased in the sotagliflozin 200 mg and 400 mg group (15% and 17%, respectively) as compared to placebo (4.7%).
Croatian: vulvovaginalne kandidijaze i vulvitisa) bila je povišena u skupini koja je primala sotagliflozin u dozi od 200 mg i 400 mg (15% odnosno 17%) u odnosu na onu koja je primala placebo (4,7%).
English: In healthy subjects following the administration of a single dose of 400 mg [14C]-sotagliflozin indicated that sotagliflozin was extensively metabolized predominantly to M19 which represented 94% of the radioactivity in plasma.
Croatian: Nakon primjene jedne doze [14C]-sotagliflozina od 400 mg u zdravih ispitanika utvrđeno je da se sotagliflozin opsežno metabolizira, prvenstveno do metabolita
English: The mean eGFR was 92 mL/min/1.73 m2 and 5 % had eGFR between 45 and 60 mL/min/1.73 m2.
Croatian: Srednja vrijednost eGFR-a iznosila je 92 ml/min/1,73 m2, a 5% bolesnika imalo je eGFR između 45 i 60 ml/min/1,73 m2.
English: LS mean % Difference from insulin alone, adjusted mean [95%CI]
Croatian: srednja vrijednost (LS) % razlika u odnosu na primjenu samo inzulina, prilagođena srednja vrijednost [95% CI]
English: Insulin Insulin + sotagliflozin 200 mg
Croatian: Inzulin + sotagliflozin 200 mg
English: Patients should be advised to seek medical attention if they experience a combination of symptoms of pain, tenderness, erythema, or swelling in the genital or perineal area, with fever or malaise.
Croatian: osjetljivosti na dodir, eritema ili oticanja u genitalnom ili perinealnom području, praćenih vrućicom ili malaksalošću.
English: The exposure-adjusted incidence rate was 3.12, 4.19 and 0.21 subjects per 100 patient-years for sotagliflozin 200 mg, sotagliflozin 400 mg and placebo.
Croatian: Stopa incidencije prilagođena za izloženost uz sotagliflozin u dozi od 200 mg, sotagliflozin u dozi od 400 mg i placebo iznosila je 3,12, 4,19 odnosno 0,21 ispitanika na 100 bolesnik-godina.
English: - More frequent, at least 2 to 4 times per year, renal function monitoring is recommended in patients with an eGFR below 60 mL/min/1.73 m2.
Croatian: - prije uvođenja sotagliflozina, a zatim periodički, najmanje jednom godišnje (vidjeti dio 4.2) - prije uvođenja istodobne primjene lijekova koji mogu smanjiti funkciju bubrega i periodički nakon toga - u bolesnika kojima je eGFR ispod 60 ml/min/ 1,73 m2 preporučuje se češće praćenje funkcije bubrega (najmanje 2 - 4 puta godišnje)
English: Package leaflet: Information for the patientZynquista 200 mg film-coated tablets sotagliflozin This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za bolesnikaZynquista 200 mg filmom obložene tablete sotagliflozin
English: At week 24, treatment with 400 mg sotagliflozin before the first meal of the day resulted in statistically significant more patients achieving the net benefit primary endpoint (proportion of patients with HbA1c <7.0% at week 24 and no episode of severe hypoglycaemia, and no episode of DKA from randomisation to Week 24) compared with insulin alone (28.6% versus 15.2%) (p-value<0.001) and provided statistically significant mean reductions in HbA1c (p-value <0.001).
Croatian: (udio bolesnika s vrijednošću HbA1c < 7,0% u 24. tjednu bez epizoda teške hipoglikemije i bez epizoda DKA od randomizacije do 24. tjedna) nego kod primjene samo inzulina (28,6% naspram
English: The mean BMI was 28 kg/m2 and 29% had SBP ≥ 130 mmHg.
Croatian: 28 kg/m2, a 29% bolesnika imalo je sistolički krvni tlak ≥ 130 mmHg.
English: Zynquista 200 mg film-coated tablets
Croatian: Zynquista 200 mg filmom obložene tablete
English: This patient is using ZYNQUISTA for the treatment of Type 1 Diabetes Mellitus (T1DM).
Croatian: Ovaj bolesnik uzima lijek ZYNQUISTA za liječenje šećerne bolesti tipa
English: Beginning 6 weeks prior to randomization, insulin dose was adjusted (optimised) to achieve the following glycaemic goals fasting/preprandial, self-monitored blood glucose (SMBG) 4.4-7.2 mmol/L and 2-hour/peak postprandial SMBG glucose <10 mmol/L.
Croatian: samoizmjerena vrijednost glukoze u krvi natašte/prije obroka od 4,4 do 7,2 mmol/l te vršna samoizmjerena postprandijalna vrijednost glukoze u krvi (2 sata nakon obroka) < 10 mmol/l.
English: • The other ingredients are: - tablet core: microcrystalline cellulose (E460i), croscarmellose sodium, colloidal anhydrous silica; magnesium stearate; talc.
Croatian: - jezgra tablete: mikrokristalična celuloza (E460i), umrežena karmelozanatrij, bezvodni koloidni silicijev dioksid, magnezijev stearat, talk - film ovojnica: poli(vinilni alkohol), makrogol, titanijev dioksid (E 171), talk, boja indigo carmine aluminium lake (E132) - tinta za označavanje: šelak, crni željezov oksid (E172), propilenglikol
English: - When needed to prevent hypoglycaemia, insulin dose reduction should be done cautiously to avoid ketosis and DKA (see section 4.2).
Croatian: kako bi se izbjegli ketoza i DKA (vidjeti dio 4.2).
English: The incidence of UTI in female subjects was 12%, 7.0% and 11% and the incidence of UTI in male subjects was 2.3%, 4.0% and 1.8% for sotagliflozin 200 mg, sotagliflozin 400 mg and placebo, respectively.
Croatian: Incidencija infekcija mokraćnih putova uz sotagliflozin u dozi od 200 mg, sotagliflozin u dozi od 400 mg i placebo iznosila je 12%, 7,0% odnosno 11% u žena te 2,3%, 4,0% odnosno 1,8% u muškaraca.
English: Zynquista is used as an addition to insulin treatment in adults with type 1 diabetes with a body mass index (BMI) greater than or equal to 27.
Croatian: Zynquista se koristi kao dodatak liječenju inzulinom u odraslih osoba sa šećernom bolešću tipa 1
English: Pooled analysis of change in SBP in patients with baseline SBP ≥130 mmHg showed greater reduction in SBP at week 12 (-5.4 mmHg for placebo, -9.0 mmHg for sotagliflozin 200 mg and -10.7 mmHg for sotagliflozin 400 mg).
Croatian: 12. tjednu (-5,4 mmHg uz placebo, -9,0 mmHg uz sotagliflozin u dozi od 200 mg i -10,7 mmHg uz sotagliflozin u dozi od 400 mg).
English: Study 3 InTandem 3 (study 3) was a 24-week duration study performed on a background of existing insulin regimen in type 1 diabetes patients with screening HbA1c ≥7.0% to ≤11.0%, to evaluate efficacy and safety of sotagliflozin 400 mg once daily versus insulin alone.
Croatian: To ispitivanje, u kojem su se djelotvornost i sigurnost sotagliflozina u dozi od 400 mg jedanput na dan ocjenjivale u odnosu na inzulin primijenjen samostalno, provedeno je u bolesnika sa šećernom bolešću tipa 1 kojima je vrijednost HbA1c pri probiru iznosila ≥ 7,0% i ≤ 11,0%.
English: HbA1c (%) Baseline (after 6-week insulin optimisation), mean
Croatian: Početna vrijednost (nakon 6-tjedne optimizacije inzulinske terapije), srednja vrijednost
English: Talk to your doctor, pharmacist or nurse before taking Zynquista, and during treatment: • if you have the following symptoms, which may be a sign of a serious condition, diabetic ketoacidosis (see also section 4):
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete lijek Zynquista i tijekom liječenja:
English: As sotagliflozin is taken together with insulin, hypoglycaemia may occur during treatment.
Croatian: Međutim, budući da se sotagliflozin primjenjuje u kombinaciji s inzulinom, bolesnike treba upozoriti na rizik od hipoglikemije.
English: ≤3.9 mmol/L: 81.3
Croatian: ≤ 3,1 mmol/l: 14,9 ≤ 3,9 mmol/l: 81,3
English: Baseline, mean in units/day % change from baseline, LS mean % difference from insulin alone, LS mean
Croatian: Početna doza, srednja vrijednost u jedinicama/dan % promjena od početne vrijednosti, srednja vrijednost
English: ≤3.9 mmol/L: 12.2
Croatian: ≤ 3,1 mmol/l: 2,7 ≤ 3,9 mmol/l: 12,2
English: Baseline (after 6-week insulin optimisation), mean Change from baseline, LS mean Difference from insulin alone, LS mean (p-value)
Croatian: Početna vrijednost (nakon 6-tjedne optimizacije inzulinske terapije), srednja vrijednost (LS)
English: Discontinuation due to genital mycotic infections occurred in 1.2%, 1.1% and 0.8% of patients treated with sotagliflozin 200 mg, sotagliflozin 400 mg and placebo, respectively.
Croatian: Liječenje je zbog genitalnih gljivičnih infekcija prekinulo 1,2% bolesnica liječenih sotagliflozinom u dozi od 200 mg,
English: ≤3.9 mmol/L: 11.1
Croatian: ≤ 3,1 mmol/l: 2,3 ≤ 3,9 mmol/l: 11,1
English: ≤3.9 mmol/L: 11.0
Croatian: ≤ 3,1 mmol/l: 2,3 ≤ 3,9 mmol/l: 11,0
English: Difference from insulin alone, LS mean [95%CI]
Croatian: Razlika u odnosu na primjenu samo inzulina, srednja vrijednost (LS) [95% CI]
English: Diabetes Treatment Satisfaction Questionnaire Baseline, mean
Croatian: Upitnik o zadovoljstvu liječenjem šećerne bolesti (DTSQ) Početna srednja vrijednost
English: • yeast infection (thrush) of the vagina (signs may include irritation, itching, unusual discharge or odour)
Croatian: Vrlo česte (mogu se javiti u više od 1 na 10 osoba) • gljivična infekcija rodnice kandidom (znakovi mogu uključivati nadraženost, svrbež, neobičan iscjedak ili neugodan miris)
English: Change from baseline, mean Difference from insulin alone, LS mean [95% CI]
Croatian: Promjena od početne vrijednosti, srednja vrijednost (LS) Razlika u odnosu na primjenu samo inzulina, srednja vrijednost (LS) [95% CI]
English: ≤3.9 mmol/L: 83.7
Croatian: ≤ 3,1 mmol/l: 15,0 ≤ 3,9 mmol/l: 83,7
English: ≤3.1 or ≤3.9 mmol/L
Croatian: ≤ 3,9 mmol/l
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Croatian: Razlika u odnosu na primjenu samo inzulina, srednja vrijednost (LS) (p-vrijednost)
English: Change from baseline, LS mean
Croatian: Promjena od početne vrijednosti, srednja vrijednost
English: Baseline, mean in units % change from baseline, LS mean % difference from insulin alone, LS mean
Croatian: Početna doza, srednja vrijednost u jedinicama % promjena od početne vrijednosti, srednja vrijednost
English: Diabetic ketoacidosis*' †
Croatian: infekcije mokraćnih putova*' †
English: In study 3 there was a significant reduction in FPG of 0.79 mmol/L (p<0.001) with sotagliflozin 400 mg at 24 weeks compared to insulin alone.
Croatian: (p < 0,001) u 24. tjednu uz sotagliflozin u dozi od 400 mg u odnosu na inzulin primijenjen samostalno.
English: Mean baseline values
Croatian: Početna srednja vrijednost
English: During treatment with sotagliflozin - The patient should remain on optimal insulin dosing.
Croatian: - Bolesnik treba nastaviti primjenjivati optimalnu dozu inzulina.
English: • Key signs and symptoms of serious adverse events
Croatian: • Bitni znakovi i simptomi ozbiljnih štetnih događaja
English: Your doctor will be aware of this and will take it into account when monitoring your eye.
Croatian: Vaš liječnik upoznat je sa time i uzet će to u obzir prilikom pregleda Vašeg oka.
English: In the majority of cases recovery occurred within 6 months.
Croatian: U većini slučajeva došlo je do oporavka unutar 6 mjeseci.
English: • When to seek urgent attention from the health care provider
Croatian: • Kada potražiti hitnu pomoć od pružatelja zdravstvene usluge
English: Routine observation is recommended in all above situations.
Croatian: Rutinsko praćenje se preporuča u svim gore navedenim situacijama.
English: Elderly The elderly population has been studied in clinical studies.
Croatian: Starija populacija Starija je populacija ispitana u kliničkim studijama.
English: No dose adjustment is required.
Croatian: Dozu ne treba prilagođavati.
English: Most of these events occurred during or after vitrectomy in both groups.
Croatian: Većina tih događaja dogodila se u obje skupine tijekom vitrektomije ili nakon nje.
English: Date of first authorisation: 13 March 2013 Date of latest renewal: 8 December 2017
Croatian: Datum posljednje obnove odobrenja: 8. prosinca 2017. godine
English: Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree an educational programme with the National Competent Authority.
Croatian: Prije stavljanja na tržište u svakoj državi članici nositelj odobrenja će se dogovoriti o edukacijskom programu sa nacionalnim nadležnim tijelom.
English: No systemic interactions are anticipated.
Croatian: Sistemske interakcije se ne predviđaju.
English: Store in a freezer.
Croatian: Čuvati u zamrzivaču.
English: Currently available data on paediatric use are described in section 5.1.
Croatian: Trenutno dostupni podaci o pedijatrijskoj primjeni opisani su u dijelu 5.1.
English: There is no relevant use of Jetrea in children and adolescents below 18 years old.
Croatian: Nema relevante primjene Jetree u djece i adolescenata u dobi ispod 18 godina.
English: The patient information pack should be provided in printed and in audio format, and contain the following key elements:
Croatian: Informativna pakiranja za bolesnike moraju biti osigurana u tiskanom i audio formatu i sadržavati sljedeće bitne elemente:
English: Combined Placebo
Croatian: Kombinirano Placebo
English: *Ocriplasmin is a truncated form of human plasmin produced by recombinant DNA technology in a Pichia pastoris expression system.
Croatian: *Okriplazmin je skraćeni oblik ljudskog plazmina proizveden tehnologijom rekombinantne DNA u ekspresijskom sustavu Pichia pastoris.
English: The majority of events were non-serious, mild and generally resolved spontaneously.
Croatian: Većinom događaji nisu bili ozbiljni, bili su blagi i obično su prolazili spontano.
English: Caution should be exercised when treating such patients.
Croatian: Nužan je oprez pri liječenju tih bolesnika.
English: (Figure 1).
Croatian: (Slika 1).
English: If an overdose occurs, close monitoring is recommended.
Croatian: Nastupi li predoziranje, preporučuje se pažljivo praćenje.
English: Contents of the pack and other information What Jetrea contains
Croatian: Sadržaj pakiranja i druge informacije Što Jetrea sadrži
English: The macula provides central vision that is needed for everyday tasks such as driving, reading and recognising faces.
Croatian: Makula omogućava središnji vid koji je nužan za obavljanje svakodnevnih aktivnosti poput upravljanja vozilima, čitanja i prepoznavanja lica.
English: This should be taken into consideration when using these tests for the diagnosis or monitoring of other conditions (see section 4.8).
Croatian: Navedeno treba uzeti u obzir kod korištenja tih testova za dijagnozu ili praćenje drugih stanja (vidjeti dio 4.8).
English: This is generally reversible and will usually disappear without treatment.
Croatian: To je općenito reverzibilna nuspojava i obično prolazi bez liječenja.
English: When the disease progresses the traction may eventually result in the formation of a hole in the macula (called a macular hole).
Croatian: Kada bolest napreduje trakcija može u konačnici dovesti do stvaranja rupe u makuli (koja se naziva makularna rupa).
English: If this happens, do not drive or use any tools or machines until your vision improves.
Croatian: Dogodi li se to, nemojte upravljati vozilom niti raditi na strojevima dok Vam se vid ne popravi.
English: All had done so by Month 3.
Croatian: Kod ostalih je to bilo do 3. mjeseca.
English: This information will be taken into account to evaluate if and when Jetrea can be injected into the same eye.
Croatian: Ta informacija će se uzeti u obzir pri procjeni treba li, i kada, dati Jetreu u to oko.
English: Combined JETREA
Croatian: Kombinirano JETREA
English: What Jetrea looks like and contents of the pack
Croatian: Kako Jetrea izgleda i sadržaj pakiranja
English: Retinogram abnormal
Croatian: Abnormalni retinogram
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor/ophthalmologist for advice before being given this medicine.
Croatian: Ako ste trudni ili dojite, ako mislite da ste možda trudni ili planirate imati dijete, posavjetujte se s liječnikom/oftalmologom prije nego što primite ovaj lijek.
English: You will not be given Jetrea more than once into the same eye.
Croatian: Jetreu nećete primiti u isto oko više od jedanput.
English: VMT can cause symptoms such as distorted or decreased vision.
Croatian: VMT može prouzročiti simptome poput izobličenog ili slabijeg vida.
English: One case of lens subluxation/phacodonesis was reported in clinical studies in adults and appears to have been possibly related to treatment with JETREA.
Croatian: Jedan slučaj subluksacije leće/fakodoneze prijavljen je u kliničkim ispitivanjima u odraslih i izgleda da je moguće povezan s liječenjem JETREOM.
English: - if you are allergic to ocriplasmin or any of the other ingredients of this medicine (listed in section 6); - if you have (or suspect you may have) an infection in or around your eye.
Croatian: - ako ste alergični na okriplazmin ili na bilo koji drugi sastojak lijeka (naveden u dijelu 6), - ako imate (ili postoji sumnja da imate) infekciju u oku ili oko njega.
English: % VMA Resolution
Croatian: % povlačenja VMA
English: What Jetrea is and what it is used for
Croatian: Što je Jetrea i za što se koristi
English: There is a risk for a significant decrease in visual acuity during the first week after the injection.
Croatian: Postoji rizik od značajnog smanjenja vidne oštrine tijekom prvog tjedna nakon injekcije.
English: Based on the results of this study, the use of JETREA as an adjunct to vitrectomy in children, to facilitate vitreous separation and removal, is not recommended.
Croatian: Na temelju rezultata ove studije, primjena JETREE kao dopuna vitrektomiji kod djece, kako bi se olakšalo odvajanje i uklanjanje staklovine, nije preporučena.
English: Your ophthalmologist/doctor or pharmacist is responsible for storing this medicine and disposing of any unused solution correctly.
Croatian: Vaš oftalmolog/liječnik ili ljekarnik je odgovoran za čuvanje ovog lijeka i pravilno zbrinjavanje neiskorištene otopine.
English: You will not be given Jetrea into both eyes at the same time.
Croatian: Jetreu nećete primiti u oba oka istodobno.
English: When administered intravenously, ocriplasmin enters the endogenous protein catabolism pathway through which it is rapidly inactivated via its interactions with protease inhibitor α2-antiplasmin or α2-macroglobulin.
Croatian: Kada se primijeni intravenski okriplazmin se razgrađuje putem endogenog katabolizma proteina kojim se brzo inaktivira interakcijama s inhibitorima proteaza α2-antiplazminom ili α2-makroglobulinom.
English: Your doctor/ophthalmologist will monitor you and take corrective measures if needed.
Croatian: Liječnik/oftalmolog će Vas pratiti i poduzeti korektivne mjere bude li potrebno.
English: Jetrea should not be used during pregnancy or breast-feeding unless your doctor/ophthalmologist thinks it is clearly necessary.
Croatian: Jetrea se ne smije primijeniti tijekom trudnoće ni dojenja, osim ako liječnik/oftalmolog ocijeni da je to doista nužno.
English: The diluted solution should be used immediately as it contains no preservatives.
Croatian: Razrijeđena se otopina mora uporabiti odmah jer ne sadrži nikakve konzervanse.
English: The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where JETREA will be marketed, at launch and after launch, all healthcare professionals who are expected to use JETREA are provided with the following items:
Croatian: Nositelj odobrenja će osigurati, nakon rasprava i dogovora sa nacionalnim nadležnim tijelom svake od država članica u kojima će se JETREA staviti na tržište, prilikom stavljanja i nakon stavljanja, da će svim zdravstvenim djelatnicima za koje se očekuje da će primjenjivati JETREU biti osigurane sljedeće stavke:
English: Ocriplasmin is a proteolytic enzyme with serine protease activity which could be present in the eye for several days after intravitreal injection (see section 5.2).
Croatian: Okriplazmin je proteolitički enzim s aktivnošću serinske proteaze koji može biti prisutan u oku tijekom nekoliko dana nakon intravitrealne injekcije (vidjeti dio 5.2).
English: The clinical data on the effects of JETREA overdose are limited.
Croatian: Klinički podaci o učincima predoziranja JETREOM su ograničeni.
English: The diluent should be withdrawn from an unopened container which should be used only once.
Croatian: Otopinu za razrjeđivanje treba uzeti iz neotvaranog spremnika, koji se smije uporabiti samo jedanput.
English: The safety findings observed in study TG-MV-009 were consistent with the known safety profile for JETREA.
Croatian: Sigurnosni nalazi opaženi u ispitivanju TG-MV-009 bili su konzistentni sa znanim sigurnosnim profilom JETREE.
English: The inactive ocriplasmin/α2-antiplasmin complex is cleared from the circulation with a half-life (t1/2) of several hours.
Croatian: Neaktivni kompleks okriplazmin/α2-antiplazmin se iz krvnog optoka uklanja s poluvijekom (t1/2) od nekoliko sati.
English: Patients should be monitored appropriately (see section 4.8 and 5.3).
Croatian: Bolesnike treba prikladno motriti (vidjeti dijelove 4.8 i 5.3).
English: After the injection, your doctor/ophthalmologist will monitor your vision.
Croatian: Nakon injekcije liječnik/oftalmolog će pratiti Vaš vid.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Croatian: Detaljnije informacije ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove : http://www.ema.europa.eu
English: At Month 24, the proportions were 48/145 (33.3%) and 32/73 (43%), respectively.
Croatian: U 24. mjesecu, omjeri su bili 48/145 (33,3%) odnosno 32/73 (43%).
English: Optical coherence tomography abnormal
Croatian: Abnormalna optička koherentna tomografija
English: Active or suspected ocular or periocular infections.
Croatian: Aktivna ili sumnja na okularnu ili periokularnu infekciju.
English: In these cases, patients should not drive or use machines until the visual disturbances have resolved.
Croatian: U tim slučajevima bolesnici ne smiju upravljati vozilima niti raditi sa strojevima sve dok poremećaji vida ne prođu.
English: Use thawed solution by: ----- / ----- / ----
Croatian: Odmrznutu otopinu iskoristiti do: ----- / ----- / ----
English: Intraocular inflammation/infection may be assessed using biomicroscopy between 2 and 7 days following the injection.
Croatian: Prisutnost intraokularne upale/infekcije može se provjeriti biomikroskopijom 2 do 7 dana nakon injekcije.
English: Proper aseptic injection techniques must always be used.
Croatian: Uvijek se treba služiti ispravnim aseptičnim tehnikama davanja injekcije.
English: Other medicines and Jetrea
Croatian: Drugi lijekovi i Jetrea
English: Once removed from the freezer or refrigerator, the medicinal product may be kept below 25 °C for up to 8 hours.
Croatian: Nakon što je izvađen iz zamrzivača ili hladnjaka, lijek se može držati na temperaturi ispod 25 °C
English: These include optical coherence tomography (OCT), ophthalmoscopy (foveal reflex), colour vision test (Roth 28-hue) and full-field ERG.
Croatian: To uključuje optičku koherentnu tomografiju (OCT), oftalmoskopiju (fovealni refleks), test kolornog vida (Roth 28-nijansi) i konvencionalni ERG (engl. full-field).
English: In the sham group, no events occurred prior to vitrectomy.
Croatian: U skupini s placebom, nisu zabilježeni događaji prije vitrektomije.
English: Ellipsoid Zone disruption within and outside the central area has been reported in non-interventional studies and post-marketing reports.
Croatian: Prekid elipsoidne zone unutar i izvan središnjeg područja zabilježen je u neintervencijskim ispitivanjima i prijavama nakon stavljanja lijeka u promet.
English: After opening/dilution
Croatian: Nakon otvaranja/razrjeđivanja
English: Most of the adverse reactions occurred within the first week after the injection.
Croatian: Većina nuspojava javljala se unutar prvog tjedna nakon injekcije.
English: Subretinal fluid and signs and symptoms of impaired photoreceptor function including decreased visual acuity (in some cases severe) were reported in association with these events.
Croatian: Subretinalna tekućina i znakovi i simptomi oštećene funkcije fotoreceptora uključujući smanjenu vidnu oštrinu (u nekim slučajevima jako) zabilježeni su povezano sa ovim događajima.
English: Pharmacotherapeutic group: Ophthalmologicals, Other ophthalmologicals, ATC code: S01XA22
Croatian: Farmakoterapijska skupina: Oftalmici, Ostali oftalmici, ATK oznaka: S01XA22.