FrancophonIA/ELRC3.0 huggingface dataset:
English: It may also cause headache, anxiety, nausea, vomiting, and abnormal rapid heart rhythm.
Slovenian: Prav tako lahko povzroči glavobol, tesnobo, siljenje na bruhanje, bruhanje in nenormalno hiter srčni utrip.
English: No dose adjustment or special considerations are anticipated for patients with renal or hepatic impairment (see section 5.2).
Slovenian: Pri bolnikih z okvaro ledvic ali jeter prilagajanje odmerka in posebni ukrepi niso potrebni (glejte poglavje 5.2).
English: Statistical tests for pain as determined from the 100-mm VAS were carried out with a CMH test adjusted for the randomisation strata.
Slovenian: Statistične preskuse za bolečino, katere jakost so določili na 100-milimetrski VAS, so izvedli s preskusom CMH, prilagojenim glede na stratume po randomizaciji.
English: In a pharmacokinetic study evaluating Omidria, systemic exposure to both phenylephrine and ketorolac was minimal and transient.
Slovenian: V farmakokinetični študiji, v kateri so vrednotili zdravilo Omidria, je bila sistemska izpostavljenost tako fenilefrinu kot ketorolaku majhna in prehodna.
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.
Slovenian: Fenilefrin je agonist adrenergičnih receptorjev alfa 1 in deluje kot midriatik, tako da krči radialno mišico šarenice in razširi zenico z malo ali nič cikloplegije.
English: Side effects affecting the body: Common side effects: - inflammation
Slovenian: Neželeni učinki, ki prizadenejo telo: Pogosti neželeni učinki: - vnetje.
English: Only a clear, colourless solution without visible particles should be used.
Slovenian: Uporabiti smete samo bistro, brezbarvno raztopino brez vidnih delcev;
English: In the event of phenylephrine overdose, prompt injection of a rapidly acting alpha-adrenergic blocking agent, such as phentolamine, has been recommended.
Slovenian: V primeru prevelikega odmerjanja fenilefrina je priporočljivo takoj injicirati hitrodelujoči antagonist adrenergičnih receptorjev alfa, kot je fentolamin.
English: SPECIAL STORAGE CONDITIONS Do not store above 25 ˚C.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 25 ˚C.
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.
Slovenian: Statistični preskusi za spremembo premera zenice (mm) med kirurškim posegom glede na izhodišče so bili izvedeni s Cochran-Mantel-Haenszelovim (CMH) preskusom, prilagojenim glede na stratume po randomizaciji.
English: There are no adequate data from the use of phenylephrine hydrochloride or ketorolac trometamol on fertility in humans.
Slovenian: O vplivu uporabe fenilefrinijevega klorida ali trometamolijevega ketorolakata na plodnost pri ljudeh ni zadostnih podatkov.
English: Multipack contains 10 cartons, each carton contains one single-use vial.
Slovenian: Pakiranje z več vialami vsebuje 10 škatel, od katerih vsaka vsebuje eno vialo za enkratno uporabo.
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.
Slovenian: Ketorolak lahko z zaviranjem sinteze prostaglandinov, ki je posledica poškodbe zaradi kirurškega posega ali neposredne mehanske stimulacije šarenice, pomaga tudi preprečiti s kirurškim posegom povzročeno miozo.
English: Preoperative antibiotic, anaesthetics, corticosteroid, mydriatic, and NSAID eye drops may be administered at the discretion of the treating ophthalmologist.
Slovenian: Predoperativne kapljice za oči, ki vsebujejo antibiotike, anestetike, kortikosteroide, midriatike in nesteroidne protivnetne učinkovine, se lahko dajo po presoji lečečega oftalmologa.
English: It may also cause headache, anxiety, nausea, and vomiting, and ventricular arrhythmias.
Slovenian: Prav tako lahko povzroči glavobol, tesnobo, navzeo in bruhanje ter ventrikularne aritmije.
English: Mydriasis was maintained in the Omidria -treated groups, while the placebo-treated groups experienced progressive constriction of the pupil (see figure).
Slovenian: V skupinah, ki so prejele zdravilo Omidria, se je midriaza ohranila, medtem ko so v skupinah, ki so prejele placebo, opazili postopno oženje zenice (glejte sliko).
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
Slovenian: Pogosti neželeni učinki (prizadenejo lahko največ 1 od 10 bolnikov): - bolečine v očesu, - vnetje sprednjega dela očesa, - rdeče oči, - otekanje roženice (prozorne plasti, ki prekriva sprednji del očesa), - občutljivost za svetlobo.
English: Ketorolac is excreted in human milk after systemic administration.
Slovenian: Ketorolak se izloča v materino mleko po sistemski uporabi.
English: Analysis Set (n)
Slovenian: Študija 2 Nabor za analizo (n)
English: OTHER SPECIAL WARNING(S), IF NECESSARY Use immediately after dilution.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Zdravilo porabite takoj po redčenju.
English: Phenylephrine may potentiate the cardiovascular depressant effects of some inhalation anesthetic medicinal products.
Slovenian: Fenilefrin lahko okrepi učinke določenih inhalacijskih anestetikov, ki lahko povzročajo depresijo srčno-žilnega sistema.
English: As vision may be temporarily affected following intraocular lens replacement in patients who receive Omidria, patients should be advised not to drive or use machines until vision is clear.
Slovenian: Po vstavitvi umetne intraokularne leče imajo lahko bolniki, ki so prejeli zdravilo Omidria, začasno poslabšan vid, zato je treba bolnikom naročiti, naj ne vozijo ali upravljajo s stroji, dokler se jim vid ne izostri.
English: Clear, colourless to slightly yellow, sterile concentrate for solution for intraocular irrigation.
Slovenian: Bister, brezbarven do rahlo rumenkast sterilen koncentrat za raztopino za intraokularno izpiranje.
English: Omidria will be given to you in a hospital or clinic by a qualified doctor or surgeon who is specialised in eye surgery.
Slovenian: Zdravilo Omidria vam bo dal usposobljen zdravnik ali kirurg, specializiran za kirurške posege na očesu, v bolnišnici ali na kliniki.
English: Your doctor will decide if Omidria is suitable for you.
Slovenian: Omidria primerno za vas.
English: No formal studies have been conducted with Omidria in patients with renal or hepatic impairment.
Slovenian: Uradnih študij z zdravilom Omidria pri bolnikih z okvaro ledvic ali jeter niso izvedli.
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
Slovenian: Občasni neželeni učinki (prizadenejo lahko največ 1 od 100 bolnikov): - neprijeten občutek v očesu, - vnetje očesa, - draženje očesa, - pordelost očesa, - težave z roženico, - razširjena zenica, - zamegljen vid, - zmanjšanje ostrine vida, - majhni temni delci, ki se gibajo v vidnem polju, - srbeče oči, - bolečina v veki, - občutek tujkov v očeh, - bleščanje, - zvišan očesni tlak.
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.
Slovenian: Intraokularne presnovne interakcije so malo verjetne, ker se fenilefrin in ketorolak odstranita iz sprednjega očesnega prekata z izpiranjem med kirurškim posegom in z običajnim kroženjem prekatne vodice po njem.
English: Adverse reactions reported in patients receiving Omidria were typical postoperative findings and most were mild to moderate in intensity and resolved without intervention or any residual effects.
Slovenian: Neželeni učinki, o katerih so poročali pri bolnikih, ki so prejeli zdravilo Omidria, so bili učinki, ki se značilno pojavljajo po operacijah, in so bili večinoma blagi do zmerni ter so izzveneli brez zdravniške pomoči ali posledic.
English: Do not store above 25 ˚C.
Slovenian: Shranjujte pri temperaturi do 25 ˚C.
English: For dilution instructions, see section 6.6.
Slovenian: Za navodila glede redčenja glejte poglavje 6.6.
English: Omidria should not be used during pregnancy.
Slovenian: Zdravilo Omidria se ne sme uporabljati med nosečnostjo.
English: The active substances are phenylephrine (as hydrochloride) and ketorolac (as trometamol).
Slovenian: Zdravilni učinkovini sta fenilefrin (v obliki klorida) in ketorolak (v obliki trometamola).
English: How Omidria is used
Slovenian: Kako se zdravilo Omidria uporablja
English: Excipients: citric acid monohydrate, sodium citrate dihydrate, sodium hydroxide/hydrochloric acid (for pH adjustment), water for injection
Slovenian: Pomožne snovi: citronska kislina monohidrat, natrijev citrat dihidrat, natrijev hidroksid/klorovodikova kislina (za uravnavanje pH), voda za injekcije
English: Omidria must be diluted into 500 mL of irrigation solution before use.
Slovenian: Zdravilo Omidria je treba pred uporabo razredčiti v 500 ml raztopine za izpiranje.
English: Omidria is not recommended in women of childbearing potential not using contraception.
Slovenian: Zdravila Omidria ne uporabljajte pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
English: The medicine is used to keep the pupil dilated (widened) during surgery and to reduce eye pain after the procedure.
Slovenian: Zdravilo se uporablja za ohranjanje razširjene zenice med kirurškim posegom in zmanjšanje bolečine v očesu po posegu.
English: Subjects with VAS = 0 at all times Subjects with VAS ≥ 40 at any time
Slovenian: Preskušanci z VAS = 0 ob vseh časovnih točkah
English: What you need to know before Omidria is used
Slovenian: Kaj morate vedeti, preden vam bodo dali zdravilo Omidria
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.
Slovenian: Varnost in učinkovitost zdravila Omidria nista bili ovrednoteni pri bolnikih, ki so kdaj imeli uveitis, poškodbo šarenice ali so kdaj uporabljali antagoniste adrenergičnih receptorjev alfa.
English: Colourless 5-mL type-1 glass vial closed with a butyl rubber stopper and a polypropylene flip-off cap.
Slovenian: Brezbarvna 5-mililitrska steklena viala (steklo tipa I), zaprta z zamaškom iz butilne gume in polipropilensko odstranljivo zaporko.
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
Slovenian: Druge sestavine zdravila so: - citronska kislina monohidrat - natrijev citrat dihidrat - natrijev hidroksid (za uravnavanje bazičnosti) - klorovodikova kislina (za uravnavanje kislosti) - voda za injekcije
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.
Slovenian: Zdravilo Omidria je indicirano pri odraslih za ohranjanje midriaze med operacijo, preprečevanje mioze med operacijo in zmanjšanje akutne postoperativne bolečine v očesu pri kirurški vstavitvi umetne intraokularne leče.
English: Non-clinical data reported in the literature for the individual components in Omidria revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity, carcinogenic potential, or toxicity to reproduction and development.
Slovenian: Predklinični podatki za posamezni učinkovini iz literature na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti, kancerogenega potenciala, vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
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.
Slovenian: Priporočeni odmerek je 4,0 ml zdravila Omidria, razredčenega v 500 ml raztopine za izpiranje, ki se uporabi za intraokularno izpiranje prizadetega očesa med kirurškim posegom.
English: Intraocular use.
Slovenian: Intraokularna uporaba
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).
Slovenian: V študiji 1 so imeli med čiščenjem lečne skorje premer zenice < 6 mm samo 4 % bolnikov v skupini z zdravilom Omidria, medtem ko je bilo v skupini s placebom takih bolnikov 23 %, zoženje zenice za ≥ 2,5 mm pa so opazili pri 3 % bolnikov v skupini z zdravilom Omidria in 28 % bolnikov v skupini s placebom (p < 0,0001 v obeh primerih, hi-kvadratni preskus).
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.
Slovenian: Raztopina za izpiranje, ki vsebuje zdravilo Omidria, je namenjena za uporabo med kirurškim posegom po enakem postopku, kot se uporabljajo standardne raztopine za izpiranje.
English: What Omidria contains
Slovenian: Kaj vsebuje zdravilo Omidria
English: It contains the active substances phenylephrine and ketorolac.
Slovenian: Vsebuje zdravilni učinkovini fenilefrin in ketorolak.
English: After dilution, the solution contains 0.081 mg/mL phenylephrine and 0.023 mg/mL ketorolac.
Slovenian: Po redčenju raztopina vsebuje 0,081 mg/ml fenilefrina in 0,023 mg/ml ketorolaka.
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.
Slovenian: Fenilefrin in ketorolak v zdravilu Omidria delujeta preko različnih mehanizmov, s katerimi ohranjata midriazo med operacijo, preprečujeta miozo med operacijo in zmanjšata akutno bolečino po operaciji.
English: Only a clear, colourless to slightly yellow solution without visible particles should be used.
Slovenian: Uporabiti smete samo bistro, brezbarvno do rahlo rumenkasto raztopino brez vidnih delcev;
English: Phenylephrine acts to keep the pupil dilated (widened).
Slovenian: Fenilefrin deluje tako, da ohranja zenico razširjeno.
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.
Slovenian: V povezavi z uporabo raztopine za oko, ki vsebuje ketorolak, so poročali o bronhospazmih in eksacerbacijah astme pri bolnikih, ki so bili bodisi dokazano preobčutljivi za acetilsalicilno kislino/nesteroidna protivnetna zdravila bodisi so imeli astmo v anamnezi.
English: Omidria should not be used during breast-feeding.
Slovenian: Zdravilo Omidria se ne sme uporabljati med dojenjem.
English: Use within 6 hours of dilution.
Slovenian: Razredčeno raztopino porabite v 6 urah po redčenju.
English: Clear, colourless to slightly yellow, solution with a pH: 6.3 ±0.3.
Slovenian: FARMACEVTSKA OBLIKA koncentrat za raztopino za intraokularno izpiranje Bistra, brezbarvna do rahlo rumenkasta raztopina s pH: 6,3 ± 0,3.
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.
Slovenian: V primeru nenamernega injiciranja koncentrirane raztopine v očesni prekat je treba tekočino takoj odstraniti in sprednji očesni prekat izprati s standardno raztopino za izpiranje očesa.
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.
Slovenian: Na voljo je v viali za enkratno uporabo, oblikovani tako, da je mogoče 4,0 ml koncentrata za redčenje dovesti v 500 ml raztopine za izpiranje za okularno uporabo.
English: Omidria must be administered in a controlled surgical setting by a qualified ophthalmological surgeon experienced in intraocular lens replacement surgery.
Slovenian: Zdravilo Omidria mora dati usposobljen kirurg oftalmolog, ki ima izkušnje s kirurško vstavitvijo umetne intraokularne leče, v nadzorovanem kirurškem okolju.
English: The solution should be used within 6 hours of preparation.
Slovenian: Raztopino uporabite v 6 urah po pripravi;
English: − 4.0 mL of concentrate solution should be injected into a 500 mL bag /bottle of irrigation solution.
Slovenian: − 4,0 ml koncentrirane raztopine vbrizgajte v 500 mililitrsko vrečko/stekleničko z raztopino za izpiranje;
English: − Using aseptic technique, withdraw 4.0 mL of concentrate solution using an appropriate sterile needle.
Slovenian: − z ustrezno sterilno iglo odvzemite 4,0 ml koncentrirane raztopine in pri tem uporabite aseptično tehniko;
English: The following warnings and precautions related to topical ophthalmic use of phenylephrine and ketorolac should be considered with the use of Omidria:
Slovenian: Pri uporabi zdravila Omidria je treba upoštevati naslednja opozorila in previdnostne ukrepe, povezane z lokalno očesno uporabo fenilefrina in ketorolaka:
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.
Slovenian: Po redčenju v 500 ml raztopine za izpiranje raztopina vsebuje 0,081 mg/ml fenilefrina in 0,023 mg/ml ketorolaka.
English: Omidria is indicated for addition to irrigation solution used during intraocular lens replacement procedures only.
Slovenian: Zdravilo Omidria je indicirano samo za dodajanje raztopini za izpiranje, ki se uporablja med vstavljanjem umetne intraokularne leče.
English: − No other medicinal products should be added to the prepared irrigation solution.
Slovenian: − v pripravljeno raztopino za izpiranje ne dodajajte nobenih drugih zdravil.
English: METHOD OF ADMINISTRATION Intraocular use after dilution.
Slovenian: POSTOPEK UPORABE Intraokularna uporaba po redčenju.
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).
Slovenian: V študiji 2 so imeli med čiščenjem lečne skorje premer zenice < 6 mm samo 4 % bolnikov v skupini z zdravilom Omidria, medtem ko je bilo v skupini s placebom takih bolnikov 23 %, zoženje zenice za ≥ 2,5 mm pa so opazili pri 1 % bolnikov v skupini z zdravilom Omidria in 27 % bolnikov v
English: This is known as intraocular lens replacement.
Slovenian: Poseg se imenuje vstavitev umetne intraokularne leče.
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.
Slovenian: Pri uporabi raztopine za izpiranje, ki je vsebovala kombinacijo fenilefrina in ketorolaka v koncentracijah do 7200 µM fenilefrina in 900 µM ketorolaka, niso opazili nobenih z zdravilom povezanih neželenih učinkov ali patoloških sprememb.
English: Each 4.0 mL vial of solution contains 40.6 mg (10.2 mg/mL) of phenylephrine and 11.5 mg (2.88 mg/mL) of ketorolac.
Slovenian: Ena 4,0-mililitrska viala z raztopino vsebuje 40,6 mg (10,2 mg/ml) fenilefrina in 11,5 mg (2,88 mg/ml) ketorolaka.
English: Vasoconstriction occurs in the conjunctival circulation and in other ocular vessels to the extent that they are exposed to drug.
Slovenian: V ožilju očesne veznice in drugih očesnih žilah pride do vazokonstrikcije, katere obseg je odvisen od stopnje izpostavljenosti žil zdravilu.
English: In Study 1, the CMH weighted mean difference (Omidria - placebo) in the mean AUC was -5.20 mm [95% confidence interval: -7.31, -3.09] (P < 0.001).
Slovenian: V študiji 1 je tehtana sredina (Omidria-placebo) povprečne AUC po CMH znašala -5,20 mm [95-odstotni interval zaupanja: -7,31, -3,09] (p < 0,001).
English: Intraocular use after dilution.
Slovenian: Intraokularna uporaba po redčenju.
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).
Slovenian: V študiji 2 je tehtana sredina (Omidria-placebo) povprečne AUC po CMH znašala -4,58 mm [95-odstotni interval zaupanja: -6,92, -2,24] (p < 0,001).
English: In Study 1, the CMH weighted mean difference (Omidria - placebo) in the mean area-under-the curve (AUC) was 0.58 mm [95% confidence interval: 0.48, 0.68] (P < 0.0001).
Slovenian: V študiji 1 je tehtana sredina (Omidria-placebo) povprečne površine pod krivuljo (AUC) po CMH znašala 0,58 mm [95-odstotni interval zaupanja: 0,48, 0,68] (p < 0,0001).
English: NAME OF THE MEDICINAL PRODUCT Omidria 10 mg/mL + 3 mg/mL concentrate for solution for intraocular irrigation
Slovenian: IME ZDRAVILA Omidria 10 mg/ml + 3 mg/ml koncentrat za raztopino za intraokularno izpiranje
English: - if you are allergic to phenylephrine or ketorolac or any of the other ingredients of this medicine
Slovenian: - če ste alergični na fenilefrin ali ketorolak ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če imate očesno bolezen, imenovano glavkom z zaprtim zakotjem.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON
Slovenian: PODATKI NA ZUNANJI OVOJNINI NOTRANJA ŠKATLA
English: In Study 2, the CMH weighted mean difference (Omidria - placebo) in the mean AUC was 0.59 mm [95% confidence interval: 0.49, 0.69] (P < 0.0001).
Slovenian: V študiji 2 je tehtana sredina (Omidria-placebo) povprečne AUC po CMH znašala 0,59 mm [95-odstotni interval zaupanja: 0,49, 0,69] (p < 0,0001).
English: The following information is intended for healthcare professionals only: To prepare Omidria for intraocular irrigation, dilute 4.0 mL of Omidria concentrate in 500 mL of standard ophthalmological irrigation solution.
Slovenian: Zdravilo Omidria pripravite za intraokularno izpiranje tako, da 4,0 ml koncentrata zdravila Omidria razredčite v 500 ml standardne oftalmološke raztopine za izpiranje.
English: There have been reports of serious cardiovascular reactions, including ventricular arrhythmias and myocardial infarctions, in patients using ophthalmic phenylephrine.
Slovenian: Pri bolnikih, ki so uporabljali fenilefrin za oko so poročali o resnih srčno-žilnih neželenih učinkih, med katerimi so bile tudi ventrikularne aritmije in srčni infarkti.
English: 6.6 Special precautions for disposal and other handling To prepare Omidria for intraocular irrigation, dilute 4.0 mL of concentrate in 500 mL of standard ophthalmological irrigation solution.
Slovenian: Zdravilo Omidria pripravite za intraokularno izpiranje, tako da 4,0 ml koncentrata razredčite v 500 ml standardne oftalmološke raztopine za izpiranje.
English: General disorders and administration site conditions
Slovenian: Splošne težave in spremembe na mestu aplikacije vnetje bolečine
English: Each 4 mL of solution in the vial contains phenylephrine hydrochloride equivalent to 40.6 mg (10.2 mg/mL) of phenylephrine and ketorolac trometamol equivalent to 11.5 mg (2.88 mg/mL) of ketorolac.
Slovenian: Ena viala s 4 ml raztopine vsebuje fenilefrinijev klorid, ki ustreza 40,6 mg (10,2 mg/ml) fenilefrina, in trometamolijev ketorolakat, ki ustreza 11,5 mg (2,88 mg/ml) ketorolaka.
English: How Omidria is stored
Slovenian: Shranjevanje zdravila Omidria
English: AUC 12 hour ocular pain VAS score (Co-primary endpoint) [Mean±SD]
Slovenian: AUC rezultatov za bolečino v očesu 12 ur po operaciji na VAS (soprimarni opazovani dogodek) [povprečna ± standardni odklon]