FrancophonIA/ELRC3.0 huggingface dataset:
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava navedenog u . Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.
English: These concentrations are over 10-fold higher than the concentration of each agent administered clinically in patients receiving Omidria.
Croatian: Te koncentracije su bile više od 10-trostruko veće u odnosu na koncentracije svake tvari koja je klinički primijenjena u bolesnika koji su primali lijek Omidria.
English: Statistical tests for pain as determined from the 100-mm VAS were carried out with a CMH test adjusted for the randomisation strata.
Croatian: Statistički testovi za bol kako je utvrđeno iz 100-mm VAS-a bili su provedeni s testom CMH uz prilagođavanje za randomiziranu grupu.
English: Only a clear, colourless solution without visible particles should be used.
Croatian: Smije se primjenjivati samo bistra, bezbojna otopina bez vidljivih čestica.
English: What Omidria contains
Croatian: Što sadrži Omidria
English: Multipack containing 10 (1 pack of 10) single-use vials.
Croatian: Višestruka pakiranja sadrže 10 (1 pakiranje od 10) bočica za jednokratnu primjenu.
English: Common side effects (may affect up to 1 in 10 people): - eye pain - inflammation of the front of the eye - red eyes - swelling of the cornea (the clear layer over the front of the eye) - sensitivity to light
Croatian: Česte nuspojave (mogu zahvatiti do 1 na 10 osoba): - bol u oku - upala prednjeg dijela oka - crvene oči - oticanje rožnice (prozirnog dijela prednje strane oka) - osjetljivost na svjetlo
English: Use within 6 hours of dilution.
Croatian: Primjeniti unutar 6 sati nakon razrjeđivanja.
English: Multipack contains 10 cartons, each carton contains one single-use vial.
Croatian: Višestruko pakiranje sadrži 10 kutija, a svaka kutija sadrži bočicu za jednokratnu primjenu.
English: Uncommon side effects (may affect up to 1 in 100 people): - eye discomfort - eye inflammation - eye irritation - eye redness - problems with the cornea - dilated pupil - blurred vision - reduction in sharpness of vision - small, dark shapes moving in the field of vision - itchy eyes - eyelid pain - sensation of foreign bodies in the eyes - glare - increased eye pressure
Croatian: Manje česte nuspojave (mogu zahvatiti do 1 na 100 osoba): - nelagodan osjećaj u oku - upala oka - nadraženost oka - crvenilo oka - problemi s rožnicom - proširena zjenica - zamagljen vid - smanjene oštrine vida - mali, tamni oblici koji se pomiču u vidnom polju - svrbež očiju - bolni kapci - osjećaj stranih tijela u oku - blještavilo pred očima - povišeni očni tlak
English: A single-dose toxicology study was conducted in African green monkeys exposed to ocular irrigation solutions containing the combination of phenylehphrine and ketorolac used during lens replacement surgery.
Croatian: Ispitivanje toksičnosti jedne doze provedeno je u afričkih zelenih majmuna izloženih otopinama za okularno ispiranje koje su sadržavale kombinaciju fenilefrina i ketorolaka korištenih tijekom kirurškog zahvata zamjene leće.
English: Phenylephrine is an α1-adrenergic receptor agonist and acts as a mydriatic agent by contracting the radial muscle of the iris, dilating the pupil with little or no cycloplegia.
Croatian: Fenilefrin je agonist α1-adrenergičkog receptora i djeluje kao mijadriatičko sredstvo kontrahirajući radijalne mišiće šarenice oka, šireći zjenicu s malo ili bez cikloplegije.
English: Nineteen percent of cataracts were LOCS II Nuclear Grade 2 or 3.
Croatian: 19% katarakta su bile nuklearne LOCS (eng.
English: Statistical tests for the change from baseline in pupil diameter (mm) during surgery were carried out with the Cochran-Mantel-Haenszel (CMH) test adjusted for the randomisation strata.
Croatian: Statistički testovi za promjenu od početne vrijednosti u promjeru zjenice (mm) tijekom kirurškog zahvata provedeni su Cochran-Mantel-Haenszel (CMH) testom uz prilagođavanje za randomiziranu grupu.
English: N. Ireland
Croatian: Sjeverna Irska
English: The used vial and any unused irrigation solution must be discarded after single use in accordance with local requirements.
Croatian: Korištena bočica i neiskorišteni ostatak otopine irigata moraju se odložiti u otpad nakon jednokratne primjene sukladno lokalnim propisima.
English: There have been reports of serious cardiovascular reactions, including ventricular arrhythmias and myocardial infarctions, in patients using ophthalmic phenylephrine.
Croatian: Prijavljene su ozbiljne kardiovaskularne reakcije, uključujući ventrikularne aritmije i infarkte miokarda, u bolesnika koji koriste oftalmološki fenilefrin.
English: No drug-related adverse events or pathological findings were observed, with combinations of phenylephrine and ketorolac in irrigation solution administered at concentrations up to 7200 µM phenylephrine and 900 µM ketorolac.
Croatian: Nisu uočene nuspojave povezane s lijekom ili patološki nalazi, s kombinacijama fenilferina i ketorolaka u otopini irigata primijenjenoj u koncentracijama do 7200 µM fenilefrina i 900 µM ketorolaka.
English: Before administering the medicinal product
Croatian: Prije primjene lijeka
English: Concomitant use of phenylephrine and atropine may enhance pressor effects and induce tachycardia in some patients.
Croatian: Istovremena primjena fenilefrina i atropina može pojačati učinke presora i inducirati tahikardiju u pojedinih bolesnika.
English: Store the vial in the original package to protect from light.
Croatian: Čuvati u bočici u originalnom pakiranju radi zaštite od svjetlosti.
English: There are no adequate data from the use of phenylephrine hydrochloride or ketorolac trometamol on fertility in humans.
Croatian: Nema odgovarajućih podataka o primjeni fenilefrinklorida ili ketorolaktrometamola na plodnost u ljudi.
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Croatian: Time se omogućuje kontinuirano praćenje omjera koristi i rizikalijeka.
English: The maximum concentration observed in this patient was 1.7 ng/mL, occurring after instillation of topical preoperative phenylephrine drops and prior to exposure to Omidria.
Croatian: Maksimalne koncentracije uočene u ovom bolesniku iznosile su 1,7 ng/mL, a javile su se nakon instilacije topikalnih preoperativnih kapi fenilefrina te prije izlaganja lijeku Omidria.
English: Do not use this medicine after the expiry date which is stated on the carton after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza "Roka valjanosti“.
English: The safety and efficacy of Omidria has not been evaluated in patients with a history of uveitis, iris trauma, or alpha-adrenergic antagonist use.
Croatian: Sigurnost i djelotvornost lijeka Omidria nije ocijenjena u bolesnika s anamnezom uveitisa, traume šarenice ili primjene alfa-adreneričkog antagonista.
English: In the event of phenylephrine overdose, prompt injection of a rapidly acting alpha-adrenergic blocking agent, such as phentolamine, has been recommended.
Croatian: U slučaju predoziranja fenilefrinom, preporučeno je bez odlaganja primijenti injekciju brzodjelujućeg alfaadrenegičkog blokatora, poput fentolamina.
English: Ketorolac is a painkiller that belongs to the group called non-steroidal anti-inflammatory drugs (NSAIDS); it also helps stop the pupil from contracting (getting smaller).
Croatian: Ketorolak je lijek za ublažavanje boli koji se ubraja u grupu nesteroidnih protuupalnih lijekova (NSAIL-i); također pomaže u sprječavanju kontrakcije (sužavanja) zjenica.
English: Anterior chamber inflammation Conjunctival hyperaemia Corneal oedema Photophobia
Croatian: Upala prednje komore Konjuktivalna hiperemija Edem rožnice Fotofobija
English: It is not known whether phenylephrine is excreted in human milk.
Croatian: Nije poznato izlučuje li se fenilefrin u majčino mlijeko u ljudi.
English: It may also cause headache, anxiety, nausea, and vomiting, and ventricular arrhythmias.
Croatian: Može također uzrokovati glavobolju, anksioznost, mučninu i povraćanje, te ventrikularne aritmije.
English: Omidria is not indicated for undiluted use, intravitreal injection, general topical ophthalmic use, or non-ocular systemic use.
Croatian: Omidria nije indicirana za nerazrijeđenu primjenu, intravitrealnu injekciju, opću topikalnu oftamološku primjenu ili neokularnu sistemsku primjenu.
English: − Using aseptic technique, withdraw 4.0 mL of concentrate solution using an appropriate sterile needle.
Croatian: Primjenom aseptičke tehnike, izvucite 4,0 mL otopine koncentrata pomoću odgovarajuće sterilne igle.
English: Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate, Dundalk, Co. Louth A91 P9KD
Croatian: Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate, Dundalk, Co.
English: Omidria is indicated in adults for maintenance of intraoperative mydriasis, prevention of intraoperative miosis and reduction of acute postoperative ocular pain in intraocular lens replacement surgery.
Croatian: Omidria je indicirana u odraslih osoba za održavanje intraoperativne midrijaze, prevenciju intraoperativne mioze i smanjenje akutne postoperativne okularne boli pri kirurškom zahvatu zamjene intraokularne leće.
English: Almac Pharma Services Limited Seagoe Industrial Estate, Craigavon, Co. Armagh BT63 5QD
Croatian: Almac Pharma Services Limited Seagoe Industrial Estate, Craigavon, Co.
English: Following dilution do not store above 25 ˚C
Croatian: Nakon razrjeđivanja ne čuvati na temperaturi iznad 25 ˚C.
English: Intraocular use after dilution.
Croatian: Intraokularna primjena nakon razrjeđivanja.
English: There have been reports of bronchospasm or exacerbation of asthma associated with the use of ketorolac ophthalmic solution in patients who either have a known hypersensitivity to aspirin/NSAIDs, or a past medical history of asthma.
Croatian: Prijavljeni su bronhospazam ili egzacerbacija astme povezani s primjenom oftalmološke otopine ketorolaka u bolesnika s poznatom preosjetljivošću na aspirin/NSAIL-ove, ili s medicinskom anamnezom astme.
English: The phenylephrine and ketorolac in Omidria act by distinct mechanisms, to maintain intraoperative mydriasis, to prevent intraoperative miosis, and to reduce acute postoperative pain.
Croatian: Fenilefrin i ketorolak u lijeku Omidria djeluju određenim mehanizmima kako bi održali intraoperativnu midrijazu, spriječili intraoperativnu miozu i smanjili akutnu postoperativnu bol.
English: No dose adjustment or special considerations are anticipated for patients with renal or hepatic impairment (see section 5.2).
Croatian: U bolesnika s oštećenjem funkcije bubrega ili jetre ne očekuju se potreba za prilagodbom doze ili posebna razmatranja (vidjeti dio 5.2).
English: Omidria is not recommended in women of childbearing potential not using contraception.
Croatian: Ne preporučuje se koristiti lijek Omidria u žena reproduktivne dobi koje ne koriste kontracepciju.
English: Intraocular use.
Croatian: Intraokularna primjena.
English: In case of accidental intracameral injection of the concentrated solution, the anterior chamber should be evacuated immediately and irrigated with standard ophthalmological irrigation solution.
Croatian: Ako dođe do slučajne intrakameralne injekcije koncentrirane otopine, sadržaj treba odmah evakuirati iz prednje komore i isprati ju standardnom oftamološkom otopinom irigata.
English: Phenylephrine acts to keep the pupil dilated (widened).
Croatian: Fenilefrin djeluje tako što održava zjenice dilatirane (proširene).
English: There are no data from the use of Omidria in pregnant women.
Croatian: Nema podataka o primjeni lijeka Omidria u trudnica.
English: In Study 1, only 4% of patients in the Omidria group compared to 23% of patients in the placebo group had a pupil diameter < 6 mm at the time of cortical clean-up, and 3% of patients in the Omidria group compared to 28% of patients in the placebo group had a pupil constriction ≥2.5 mm (P < 0.0001 in both instances, Chi-Square test).
Croatian: U ispitivanju 1, samo je 4% bolesnika u grupi koja je liječena lijekom Omidria, u usporedbi s 23% bolesnika u grupi koja je primila placebo, imalo promjer zjenice < 6 mm u trenutku uklanjanja kortikalnog materijala, te 3% bolesnika u grupi liječenoj lijekom Omidria u usporedbi s 28% bolesnika u grupi koja je primala placebo, imalo je konstrikciju zjenice ≥ 2,5 mm (P < 0,0001 u oba slučaja, hi-kvadrat test).
English: Hydrochloric acid (for pH adjustment)
Croatian: Kloridna kiselina (za podešavanje pH)
English: − The bag must be visually inspected for particulate matter.
Croatian: Vrećicu treba vizualno pregledati kako bi se uočila čestična tvar.
English: The other ingredients are - Citric acid monohydrate - Sodium citrate dihydrate - Sodium hydroxide (to adjust alkalinity level) - Hydrochloric acid (to adjust acidity level) - Water for injection
Croatian: Drugi sastojci su: - citratna kiselina hidrat - natrijev citrat dihidrat - natrijev hidroksid (za podešavanje razine lužnatosti) - kloridna kiselina (za prilagodbu razine kiselosti) - voda za injekcije
English: The Omidria-containing irrigation solution is intended to be used during the surgical procedure in the same manner that the standard irrigation solution would be used.
Croatian: Otopina irigata koja sadrži lijek Omidria predviđena je za primjenu tijekom kirurškog zahvata na isti način na koji bi se koristila standardna otopina irigata.
English: No formal studies have been conducted with Omidria in patients with renal or hepatic impairment.
Croatian: Nisu provedena formalna ispitivanja s lijekom Omidria u bolesnika s oštećenjem funkcije bubrega ili jetre.
English: Clear, colourless to slightly yellow, sterile concentrate for solution for intraocular irrigation.
Croatian: Bistar, bezbojan do blago žućkast, sterilni koncentrat za otopinu za irigat za oko.
English: Omidria must be administered in a controlled surgical setting by a qualified ophthalmological surgeon experienced in intraocular lens replacement surgery.
Croatian: Lijek Omidria se mora primjenjivati u kontroliranom kirurškom okruženju od strane kvalificiranoga oftamološkog kirurga iskusnog u izvođenju kirurškog zahvata zamjene intraokularne leće.
English: Intraocular metabolic interactions are unlikely because phenylephrine and ketorolac are removed from the anterior chamber by irrigation during the surgical procedure and by normal aqueous humour circulation postoperatively.
Croatian: Intraokularne metaboličke interakcije nisu izgledne budući da se fenilefrin i ketorolak uklanjanju iz prednje komore ispiranjem tijekom kirurškog zahvata te postoperativno normalnom cirkulacijom očne vodice.
English: Ketorolac is excreted in human milk after systemic administration.
Croatian: Ketorolak se izlučuje u majčino mlijeko nakon sistemske primjene.
English: Ketorolac, by inhibiting prostaglandin synthesis secondary to ocular surgical insult or direct mechanical stimulation of the iris, may also contribute to the prevention of surgically induced miosis.
Croatian: Inhibirajući sintezu prostaglandina do koje dolazi nakon kirurške ozljede oka ili izravnom mehaničkom stimulacijom šarenice, ketorolak može također doprinijeti prevenciji kirurški inducirane mioze.
English: Vasoconstriction occurs in the conjunctival circulation and in other ocular vessels to the extent that they are exposed to drug.
Croatian: Vazokonstrikcija nastupa u konjuktivalnoj cirkulaciji, te u drugim očnim krvnim žilama u onoj mjeri kojoj su izloženi lijeku.
English: Excipients: citric acid monohydrate, sodium citrate dihydrate, sodium hydroxide/hydrochloric acid (for pH adjustment), water for injection
Croatian: Pomoćne tvari: monohidrat limunske kiseline, dihidrat natrij citrata, natrij hidroksid/hidrokloridna kiselina (za prilagodbu pH), voda za injekciju
English: In a pharmacokinetic study evaluating Omidria, systemic exposure to each of phenylephrine and ketorolac was minimal and transient.
Croatian: U farmakokinetičkom ispitivanju koje je ocjenjivalo lijek Omidria, sistemsko izlaganje fenilefirinu i ketorolaku bilo je minimalno i prolazno.
English: AUC change from baseline in pupil diameter (mm) during surgery (Co-primary endpoint) [Mean(SD)] Diameter < 6 mm at any time Diameter < 6 mm at cortical clean-up ≥ 2.5 mm pupillary constriction Study 2
Croatian: Promjena AUC-a od početne vrijednosti u promjeru zjenice (mm) tijekom kirurškog zahvata (koprimarni ishod) [srednja vrijednost (SD)] Promjer < 6 mm u bilo kojem trenutku Promjer < 6 mm u trenutku uklanjanja kortikalnog materijala ≥ 2,5 mm suženje zjenice
English: − 4.0 mL of concentrate solution should be injected into a 500 mL bag /bottle of irrigation solution.
Croatian: − 4,0 mL otopine koncentrata treba ubrizgati u vrećicu/bocu od 500 mL otopine irigata.
English: Omidria will be given to you in a hospital or clinic by a qualified doctor or surgeon who is specialised in eye surgery.
Croatian: Lijek Omidria primjenjuje kvalificirani liječnik ili kirurg, koji je specijaliziran za provođenje kirurškog zahvata na oku, u bolnici ili klinici.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Single use only.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Samo za jednokratnu uporabu.
English: This is known as intraocular lens replacement.
Croatian: Ovaj se zahvat zove zamjena intraokularne leće.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA
English: The recommended dose is 4.0 mL of Omidria diluted in 500 mL of irrigation solution administered by intraocular irrigation to the affected eye during surgery.
Croatian: Preporučena doza iznosi 4,0 mL lijeka Omidria razrijeđenog u 500 mL otopine irigata, a primjenjuje se intraokularnim ispiranjem u zahvaćeno oko tijekom kirurškog zahvata.
English: This medicine can have a major influence on the ability to drive and use machines.
Croatian: Omidria može značajno utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: After dilution, the solution contains 0.081 mg/mL phenylephrine and 0.023 mg/mL ketorolac.
Croatian: Nakon razrjeđivanja, otopina sadrži 0,081 mg/mL fenilefrina i 0,023 mg/mL ketorolaka.
English: Foreign body sensation in eyes Glare
Croatian: Nelagodan osjećaj u očima Upala oka
English: What you need to know before Omidria is used
Croatian: Što morate znati prije nego počnete primjenjivati lijek Omidria
English: Omidria is indicated for addition to irrigation solution used during intraocular lens replacement procedures only.
Croatian: Omidria je indicirana za dodavanje otopini irigata koja se koristi samo tijekom postupka zamijene leće.
English: Concentrate for solution for intraocular irrigation.
Croatian: Koncentrat za otopinu za irigat za oko.
English: Only a clear, colourless to slightly yellow solution without visible particles should be used.
Croatian: Smije se primjenjivati samo bistra, bezbojna do blago žućkasta otopina bez vidljivih čestica.
English: Omidria is used as a solution to rinse the eye (irrigation solution) during surgery to replace the lens.
Croatian: Omidria se koristi kao otopina za ispiranje oka (otopina irigata) tijekom kirurškog zahvata zamjene leće.
English: Omidria should not be used during pregnancy.
Croatian: Omidria se ne smije koristiti tijekom trudnoće.
English: After dilution in 500 mL of irrigation solution, the solution contains 0.081 mg/mL of phenylephrine and of 0.023 mg/mL ketorolac.
Croatian: Nakon razrjeđivanja u 500 mL otopine irigata, otopina sadrži 0,081 mg/mL fenilefrina i 0,023 mg/mL ketorolaka.
English: In Study 2, only 4% of patients in the Omidria group compared to 23% of patients in the placebo group had a pupil diameter < 6 mm at cortical clean-up, and 1% of patients in the Omidria group compared to 27% of patients in the placebo group had a pupil constriction ≥ 2.5 mm (P < 0.0001, Chi-Square test).
Croatian: U ispitivanju 2, samo je 4% bolesnika u grupi koja je liječena lijekom Omidria, u usporedbi s 23% bolesnika u grupi koja je primila placebo, imalo promjer zjenice < 6 mm u trenutku kortikalnog čišćenja, te 1% bolesnika u grupi liječenoj lijekom Omidria u usporedbi s 27% bolesnika u grupi koja je primala placebo placebo, imalo je
English: Preoperative antibiotic, anaesthetics, corticosteroid, mydriatic, and NSAID eye drops may be administered at the discretion of the treating ophthalmologist.
Croatian: Preoperativno se mogu primijeniti kapi za oko koje sadrže antibiotike, anestetike, kortikosteroide, midrijatike i NSAIL ako tako odluči ordinirajući oftamolog.
English: Visual acuity reduced Vitreous floaters Eye pruritus
Croatian: Zamagljen vid Smanjena oštrina vida Opaciteti u staklovini Pruritus oka
English: − The vial should be visually inspected for particulate matter.
Croatian: − Bočicu treba vizualno pregledati kako bi se uočila čestična tvar.
English: Side effects affecting the body: Common side effects: - inflammation
Croatian: Nuspojave koje zahvaćaju tijelo: Česte nuspojave: - upala
English: Omidria must be diluted into 500 mL of irrigation solution before use.
Croatian: Omidria se prije primjene mora razrijediti u 500 mL otopine irigata.
English: Supplied in a single-use vial designed to deliver 4.0 mL of concentrate for dilution into 500 mL of irrigation solution for ocular use.
Croatian: Isporučuje se u bočici za jednokratnu primjenu za isporuku 4,0 mL koncentrata za razrjeđivanje u 500 mL otopine irigata za primjenu za oko.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti I.: Sažetak opisa svojstava lijeka, dio 4.2.).
English: The use of Omidria during intraocular lens replacement surgery may cause vision to be temporarily affected.
Croatian: Primjena lijeka Omidria tijekom kirurškog zahvata zamjene intraokularne leće može privremeno utjecati na vid. (vidjeti dio 4.7).
English: Pupil diameter was measured throughout the surgical procedure.
Croatian: Promjer zjenice mjeren je tijekom kirurškog postupka.
English: How Omidria is used
Croatian: Kako se Omidria primjenjuje
English: The following warnings and precautions related to topical ophthalmic use of phenylephrine and ketorolac should be considered with the use of Omidria:
Croatian: Prilikom primjene lijeka Omidria treba uzeti u obzir sljedeća upozorenja i mjere opreza povezane s topikalnom oftalmološkom primjenom fenilefrina i ketorolaka:
English: The active substances are phenylephrine (as hydrochloride) and ketorolac (as trometamol).
Croatian: Djelatne tvari su fenilefrin (u obliku fenilefrinklorida) i ketorolak (u obliku ketorolaktrometamola).
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for intraocular irrigation 1 vial.
Croatian: OBLIK I SADRŽAJ Koncentrat za otopinu za intraokularno ispiranje 1 bočica
English: Conjunctival oedema Corneal disorder Mydriasis
Croatian: Konjuktivalni edem Poremećaj rožnice Midrijaza
English: Detectable phenylephrine plasma concentrations were observed in only one of 14 patients.
Croatian: U samo jednom na 14 bolesnika otkrivene su mjerljive koncentracije fenilefrina u plazmi.
English: Subjects with VAS = 0 at all times Subjects with VAS ≥ 40 at any time Study 2
Croatian: Vrijednost AUC za VAS rezultat za bol u oku za 12 sati (koprimarni ishod) [srednja vrijednost ±SD] Ispitanici s VAS = 0 u svakom trenutku Ispitanici s VAS ≥ 40 u bilo kojem trenutku Ispitivanje 2
English: It contains the active substances phenylephrine and ketorolac.
Croatian: Sadrži djelatne tvari fenilefrin i ketorolak.
English: In Study 2, the CMH weighted mean difference (Omidria - placebo) in the mean AUC was -4.58 mm [95% confidence interval: -6.92, -2.24] (P < 0.001).
Croatian: U ispitivanju 2, CMH ponderirana srednja razlika (Omidria - placebo) u srednjem AUC iznosila je -4,58 mm [95% interval pouzdanosti: -6,92, -2,24] (P < 0,001).
English: Colourless 5-mL type-1 glass vial closed with a butyl rubber stopper and a polypropylene flip-off cap.
Croatian: I zatvorena zatvaračem od butilne gume i polipropilenskom „flip-off“ kapicom