FrancophonIA/ELRC3.0 huggingface dataset:
English: Rhokiinsa should not be used during pregnancy unless the clinical condition of the woman requires treatment with netarsudil.
Slovenian: Zdravilo Rhokiinsa se ne sme uporabljati med nosečnostjo, razen če je zdravljenje z netarsudilom potrebno zaradi kliničnega stanja ženske.
English: Netarsudil belongs to a group of medicines called “Rho kinase inhibitors”, which work to reduce the amount of fluid inside the eye and so lower its pressure.
Slovenian: Netarsudil spada v skupino zdravil, imenovanih „zaviralci Rho-kinaze“, ki zmanjšujejo količino tekočine v očesu in znižujejo njen tlak.
English: Opened bottle: 4 weeks after first opening the bottle.
Slovenian: Odprta plastenka: 4 tedni po prvem odprtju plastenke.
English: Conjunctival hyperaemia was the most frequently reported adverse reaction associated with netarsudil treatment in clinical trials and it is attributed to the vasodilation effect of the Rho kinase inhibitor drug class.
Slovenian: Hiperemija veznice je bila neželeni učinek, o katerem so najpogosteje poročali v povezavi z zdravljenjem z netarsudilom v kliničnih preskušanjih, pripisujejo pa ga vazodilatacijskemu učinku skupine zdravil zaviralcev Rho-kinaze.
English: The systemic exposures of netarsudil and its active metabolite, AR-13503, were evaluated in 18 healthy subjects after topical ocular administration of netarsudil once daily (one drop bilaterally in the morning) for 8 days.
Slovenian: Sistemsko izpostavljenost netarsudilu in njegovemu aktivnemu presnovku, AR-13503, so ovrednotili pri 18 zdravih preskušancih po topični očesni uporabi netarsudila enkrat na dan (po ena kapljica v obe očesi zjutraj) v obdobju osmih dni.
English: Continue to hold the bottle, ensuring that the tip doesn't come into contact with anything.
Slovenian: Plastenko še naprej držite in pazite, da se s kapalno konico ničesar ne dotaknete.
English: Day 43
Slovenian: 43. dan
English: Treatment with Rhokiinsa should only be initiated by an ophthalmologist or a healthcare professional qualified in ophthalmology.
Slovenian: Zdravljenje z zdravilom Rhokiinsa sme uvesti samo oftalmolog ali zdravstveni delavec, usposobljen v oftalmologiji.
English: Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface and is known to discolour soft contact lenses.
Slovenian: Poročali so, da benzalkonijev klorid povzroča draženje oči, simptome suhega očesa ter lahko vpliva na solzni film in površino roženice, znano pa je tudi, da povzroči obarvanje mehkih kontaktnih leč.
English: Other medicines and Rhokiinsa Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
English: After topical ocular dosing, netarsudil is metabolised by esterases in the eye to an active metabolite, AR-13503.
Slovenian: Po topični okularni uporabi se netarsudil presnovi z esterazami v očesu v aktivni presnovek AR-13503.
English: Conjunctival hyperaemia was typically mild in severity and sporadic.
Slovenian: Hiperemija veznice je bila praviloma blaga in sporadična.
English: Discontinuation rates due to adverse reactions were 19.3% for the netarsudil treatment group versus 1.7% for the timolol maleate group.
Slovenian: Stopnja prekinitve zdravljenja zaradi neželenih učinkov je bila 19,3 % v skupini, zdravljeni z netarsudilom, in 1,7 % v skupini, zdravljeni s timololijevim maleatom.
English: There are no or limited amount of data from the use of netarsudil in pregnant women.
Slovenian: Podatkov o uporabi netarsudila pri nosečnicah ni oziroma so omejeni.
English: Very common conjunctival hyperaemia1, cornea verticillata1, instillation site pain
Slovenian: Zelo pogosti hiperemija veznice1, cornea verticillata bolečina na mestu vkapanja
English: The recommended dose is one drop in the affected eye or eyes once a day in the evening.
Slovenian: Priporočeni odmerek je ena kapljica v obolelo oko enkrat na dan zvečer.
English: In pregnant rats, 0.3 mg/kg/day (1000 times the recommended ophthalmic dose) and higher showed increased postimplantation loss and reduced foetal viability.
Slovenian: Pri brejih podganah je odmerek 0,3 mg/kg/dan (1000-kratnik priporočenega oftalmičnega odmerka) in več povečal poimplantacijsko izgubo in zmanjšal viabilnost plodov.
English: Do not stop using Rhokiinsa without first speaking to your doctor.
Slovenian: Ne prenehajte jemati zdravila Rhokiinsa, ne da bi se o tem posvetovali z zdravnikom.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: Warnings and precautions • Do not use Rhokiinsa more than once a day, as you may experience more side effects.
Slovenian: • Zdravila Rhokiinsa ne uporabljajte več kot enkrat na dan, saj se lahko pojavi več neželenih učinkov.
English: • Gently squeeze the bottle to release one drop of Rhokiinsa into your eye.
Slovenian: • Nežno stisnite plastenko in v oko kapnite eno kapljico zdravila Rhokiinsa.
English: Rhokiinsa has negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Rhokiinsa ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: PHARMACEUTICAL FORM Eye drops, solution (eye drops).
Slovenian: FARMACEVTSKA OBLIKA Kapljice za oko, raztopina (kapljice za oko).
English: Other ocular adverse reactions reported are: cornea verticillata (17%), instillation site pain (17%), and conjunctival haemorrhage (8%).
Slovenian: Drugi očesni neželeni učinki, o katerih so poročali, so: cornea verticillata (17 %), bolečina na mestu vkapanja (17 %) in krvavitev v veznico (8 %).
English: Instillation site erythema (8%), corneal staining (7%), blurred vision (6%), increased lacrimation (6%) and erythema of eyelid (5%) were also reported.
Slovenian: Poročali so tudi o eritemu na mestu vkapanja (8 %), obarvanju roženice (7 %), zamegljenem vidu (6 %), povečanem solzenju (6 %) in eritemu veke (5 %).
English: Patients should not instill more than one drop in the affected eye(s) each day.
Slovenian: Bolniki si v obolelo oko ne smejo dati več kot eno kapljico na dan.
English: It should be used with caution in dry eye patients and in patients where the cornea may be compromised.
Slovenian: Pri bolnikih s suhimi očmi in bolnikih, pri katerih je roženica lahko prizadeta, ga je treba uporabljati previdno.
English: Netarsudil dosed twice daily provided slightly larger IOP reductions, but had a less favorable safety profile as reflected in a higher rate and increased severity of ocular adverse reactions.
Slovenian: Netarsudil, ki so ga dajali dvakrat dnevno, je sicer nekoliko bolj znižal IOP, vendar je imel manj ugoden varnostni profil,
English: Netarsudil demonstrated clinically relevant reductions in IOP at all timepoints, however non-inferiority to timolol was not demonstrated in this population with baseline IOP ≥25 mmHg and <30 mmHg (Table 2).
Slovenian: Pri netarsudilu so dokazali klinično pomembno znižanje IOP pri vseh časovnih točkah, vendar neinferiornosti v tej populaciji z izhodiščnim IOP ≥ 25 mmHg in < 30 mmHg v primerjavi s timololom niso dokazali (preglednica 2).
English: The majority of discontinuations in the netarsudil group were associated with ocular adverse reactions, whereas the majority of discontinuations in the timolol group were associated with non-ocular adverse reactions.
Slovenian: Večina prekinitev zdravljenja v skupini, zdravljeni z netarsudilom, je bila povezana z neželenimi učinki na očeh, večina prekinitev zdravljenja v skupini, zdravljeni s timololom, pa je bila povezana z neočesnimi neželenimi učinki.
English: If you forget to use Rhokiinsa
Slovenian: Če ste pozabili uporabiti zdravilo Rhokiinsa
English: With the exception of cornea verticillata (see above), no difference in the safety profile for Rhokiinsa has been observed between subjects aged <65 or ≥65 years.
Slovenian: Z izjemo cornee verticillate (glejte zgoraj) med preskušanci, starimi < 65 let, in preskušanci, starimi ≥ 65 let, niso opazili razlik v varnostnem profilu zdravila Rhokiinsa.
English: Do not use more than one drop in the affected eye(s) once a day.
Slovenian: Ne uporabite več kot ene kapljice na obolelo oko na dan.
English: • Effects in the eye: Eye redness; fine deposits on the front of the eye and pain where the drops have been put in
Slovenian: • Učinki v očesu: pordelost očesa; drobni depoziti na sprednjem delu očesa in bolečina na mestu vnosa kapljic
English: • Do not touch your eye, eyelid, surrounding areas or other surfaces with the dropper.
Slovenian: • S kapalno konico se ne smete dotakniti očesa, veke, okoliških predelov ali drugih površin.
English: Contact lenses should be removed prior to instillation of netarsudil and may be reinserted 15 minutes following its administration (see section 4.4).
Slovenian: Pred vkapanjem netarsudila je treba odstraniti kontaktne leče, ki se jih sme ponovno vstaviti 15 minut po dajanju zdravila (glejte poglavje 4.4).
English: Each ml of solution contains 150 micrograms benzalkonium chloride.
Slovenian: En ml raztopine vsebuje 150 mikrogramov benzalkonijevega klorida.
English: It is unknown whether netarsudil/metabolites are excreted in human milk.
Slovenian: Ni znano, ali se netarsudil/presnovki izločajo v materino mleko.
English: After opening the bottle: Do not store above 25°C.
Slovenian: Po odprtju plastenke: shranjujte pri temperaturi do 25 °C.
English: The most frequently reported adverse reactions associated with discontinuation in the Rhokiinsa groups were conjunctival hyperemia (5.8%), cornea verticillata (3.7%) and vision blurred (1.4%).
Slovenian: Neželeni učinki, o katerih so najpogosteje poročali in so bili povezani s prekinitvijo zdravljenja v skupini, ki je prejemala zdravilo Rhokiinsa, so bili hiperemija veznice (5,8 %), cornea verticillata (3,7 %) in zamegljen vid
English: If you stop using Rhokiinsa
Slovenian: Če ste prenehali uporabljati zdravilo Rhokiinsa
English: The following side effects have been observed with Rhokiinsa:
Slovenian: Pri zdravilu Rhokiinsa so opazili naslednje neželene učinke:
English: The study was designed to show non-inferiority of netarsudil when dosed once daily in the evening to timolol maleate 0.5% dosed twice daily in patients with a baseline IOP of >20 mmHg and <25 mmHg.
Slovenian: Študija je bila zasnovana za dokaz neinferiornosti netarsudila, ki so ga dajali enkrat na dan zvečer, v primerjavi s timololijevim maleatom 0,5 %, ki so ga dajali dvakrat na dan, pri bolnikih z izhodiščnim IOP > 20 mmHg in < 25 mmHg.
English: There were no quantifiable plasma concentrations of netarsudil (lower limit of quantitation (LLOQ) 0.100 ng/ml) post dose on day 1 and day 8.
Slovenian: Po odmerku na 1. dan in 8. dan ni bilo določljivih koncentracij netarsudila (spodnja meja določljivosti (LLOQ) 0,100 ng/ml) v plazmi.
English: Netarsudil was not mutagenic in a bacterial mutation assay, in a mouse lymphoma assay, or in a rat micronucleus test.
Slovenian: Netarsudil v bakterijskem testu mutacij, v testu mišjega limfoma in testu mikronukleusov pri podganah ni bil mutagen.
English: • Put back the bottle cap to close the bottle.
Slovenian: • Pokrovček namestite nazaj na plastenko in jo zaprite.
English: No effects during pregnancy are anticipated, since systemic exposure to netarsudil is negligible (see section 5.2).
Slovenian: Med nosečnostjo ni pričakovati nobenih učinkov, saj je sistemska izpostavljenost netarsudilu zanemarljiva (glejte poglavje 5.2).
English: How to use Rhokiinsa
Slovenian: Kako uporabljati zdravilo Rhokiinsa
English: • General side effects: Increased allergic symptoms; dizziness; blurred vision; nasal discomfort and pain; redness or itching of the skin; rash on skin; inflammation of the cartilage; picking of the skin
Slovenian: • Splošni neželeni učinki: povečani alergijski simptomi; omotica; zamegljen vid; nelagodje in bolečina v nosu; pordelost ali srbenje kože; izpuščaj na koži; vnetje hrustanca; praskanje kože
English: The European Medicines Agency has waived the obligation to submit the results of studies with Rhokiinsa in all subsets of the paediatric population for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Rhokiinsa za vse podskupine pediatrične populacije pri zniževanju zvišanega intraokularnega tlaka pri bolnikih z glavkomom odprtega zakotja ali očesno hipertenzijo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2.)
English: In pregnant rabbits, 3 mg/kg/day (10000 times the recommended ophthalmic dose) and higher showed an increase in post-implantation loss and a decrease in foetal weight.
Slovenian: Pri brejih kuncih je odmerek 3 mg/kg/dan (10000-kratnik priporočenega oftalmičnega odmerka) in več povečal poimplantacijsko izgubo in zmanjšal telesno maso plodov.
English: Pharmacotherapeutic group: Ophthalmologicals, antiglaucoma preparations and miotics, ATC code: S01EX05
Slovenian: 5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: zdravila za očesne bolezni, zdravila za zdravljenje glavkoma in zdravila za zožitev zenice, koda ATC: S01EX05 Mehanizem delovanja
English: Due to netarsudil's vasodilating properties, other eye drops should be administered before.
Slovenian: Zaradi vazodilatacijskih lastnosti netarsudila je treba najprej uporabiti druge kapljice za oko.
English: However, while no effects on the breastfed newborn/infant are anticipated since the systemic exposure of breast-feeding women to netarsudil is expected to be negligible, no relevant clinical data are available (see section 5.2).
Slovenian: Učinkov na dojenega novorojenčka/dojenčka sicer ni pričakovati, saj je sistemska izpostavljenost doječih mater netarsudilu zanemarljiva, vendar ustrezni klinični podatki niso na voljo (glejte poglavje 5.2).
English: Rhokiinsa contains an active substance called netarsudil.
Slovenian: Zdravilo Rhokiinsa vsebuje učinkovino, imenovano netarsudil.
English: Table 1: Mean IOP by visit: PP population with baseline IOP <25 mmHg Study Visit and Time Point
Slovenian: Preglednica 1: Povprečni IOP po obiskih: populacija PP z izhodiščnim IOP < 25 mmHg
English: Eye ointments should be administered last.
Slovenian: Mazila za oko se dajejo nazadnje.
English: • Bring the bottle tip close to the eye. Do this in front of a mirror if it helps.
Slovenian: Če vam pomaga, to počnite pred ogledalom.
English: Netarsudil, a Rho kinase inhibitor, is believed to reduce IOP by increasing outflow of aqueous humor.
Slovenian: Domneva se, da netarsudil, zaviralec Rho-kinaze, znižuje IOP s povečevanjem odtoka prekatne vodke.
English: Rhokiinsa is used to lower pressure in the eyes in adults who have an eye condition known as glaucoma or who have raised pressure in their eyes.
Slovenian: Zdravilo Rhokiinsa se uporablja za zniževanje tlaka v očeh pri odraslih z očesno boleznijo, imenovano glavkom, ali tistih s povišanim tlakom v očeh.
English: The tip of the dispensing container should avoid contacting the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution.
Slovenian: S konico kapalnega dela vsebnika se ne dotikajte očesa, okoliških struktur, prstov ali drugih površin,
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to development.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti in vpliva na sposobnost razvoja ne kažejo posebnega tveganja za človeka.
English: The incidences of hyperemia and vision blurred were sporadic in nature.
Slovenian: Hiperemija in zamegljen vid sta se pojavljala sporadično.
English: • Effects in the eye: Infection or inflammation of the eye; dryness of the eye or small breaks in the film of liquid on the surface of the eye; eye discharge; itchy eyelids; clouding of the eye and vision may decrease somewhat; eye pain; feeling of grittiness or having something in the eye; general eye redness shortly after drops are put in; spots or patches of eye redness; eye inflammation caused by an allergic reaction or prominent blood vessels; eyes can become watery, sensitive to light; swelling around the eye; blurred vision
Slovenian: • Učinki v očesu: okužba ali vnetje očesa; izsušenost očesa ali majhne razpoke v tekočinskem filmu na površini očesa; izcedek iz očesa; srbeče veke; zameglitev očesa z nekoliko poslabšanim vidom; bolečina v očesu; občutek zrnatosti ali tujka v očesu; splošna pordelost očesa kmalu po vnosu kapljic; točkovna ali lisasta pordelost očesa; vnetje očesa zaradi alergijske reakcije ali izrazite žile; oči lahko postanejo solzne, občutljive na svetlobo; oteklina okoli očesa; zamegljen vid
English: However, no effects are anticipated, since systemic exposure to netarsudil is negligible (see section 5.2).
Slovenian: Učinkov ni pričakovati, saj je sistemska izpostavljenost netarsudilu zanemarljiva (glejte poglavje 5.2).
English: If topical overdose of netarsudil should occur, the eye(s) may be flushed with tap water.
Slovenian: Če pride do prevelikega topičnega odmerjanja netarsudila, lahko oko (oči) sperete z vodo iz pipe.
English: Completion rates in Phase 3 studies were lower in the netarsudil treatment group when compared with the timolol maleate group.
Slovenian: Delež bolnikov, ki so v študijah 3. faze zaključili zdravljenje, je bil nižji v skupini, zdravljeni z netarsudilom, kot v skupini, zdravljeni s timololijevim maleatom.
English: Conjunctival Hyperaemia
Slovenian: Hiperemija veznice
English: The non-inferiority margin applied was a difference in mean IOP ≤1.5 mmHg for all time points over all visits through 3 months and ≤1.0 mmHg at a majority of these time points.
Slovenian: 9 časovnih točk, izmerjen ob 8:00, 10:00 in 15:00 na 15., 43. in 90. dan. Uporabljena meja neinferiornosti je bila razlika v povprečnem IOP za ≤ 1,5 mmHg pri vseh časovnih točkah pri vseh obiskih v trimesečnem obdobju, in ≤ 1,0 mmHg pri večini od teh časovnih točk.
English: Once opened, do not store above 25°C.
Slovenian: Po odprtju shranjujte pri temperaturi do 25 °C.
English: Rhokiinsa is indicated for the reduction of elevated intraocular pressure (IOP) in adult patients with primary open-angle glaucoma or ocular hypertension.
Slovenian: 4.1 Terapevtske indikacije Zdravilo Rhokiinsa je indicirano za zniževanje povišanega intraokularnega tlaka (IOP - intraocular pressure) pri odraslih bolnikih s primarnim glavkomom odprtega zakotja ali očesno hipertenzijo.
English: The cornea verticillata seen in netarsudil-treated patients were first noted at 4 weeks of daily dosing.
Slovenian: Corneo verticillato, ki so jo opazili pri bolnikih, zdravljenih z netarsudilom, so prvič zaznali po
English: Each ml of solution contains 200 micrograms netarsudil (as mesylate).
Slovenian: En ml raztopine vsebuje 200 mikrogramov netarsudila (v obliki mesilata).
English: Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
Slovenian: V primeru uporabe kontaminirane raztopine lahko pride do resnih poškodb očesa in posledične izgube vida.
English: Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi
English: • Twist off the bottle cap, and lie the cap on a clean surface on its side.
Slovenian: • Odvijte pokrovček plastenke in ga odložite na čisto površino.
English: The IOP reduction with netarsudil dosed once daily was non-inferior to the effect of timolol 0.5% dosed twice daily in patients with baseline IOP of <25 mmHg (Table 1).
Slovenian: Znižanje IOP pri bolnikih z izhodiščnim IOP < 25 mmHg je bilo pri netarsudilu, ki so ga dajali enkrat na dan, neinferiorno v primerjavi z učinkom timolola 0,5 %, ki so ga dajali dvakrat na dan (preglednica 1).
English: visual field defect
Slovenian: Občasni omotica, izpad vidnega polja
English: Only one plasma concentration at 0.11 ng/ml for the active metabolite was observed for one subject on day 8 at 8 hours post-dose.
Slovenian: 8. dan 8 ur po odmerku opazili koncentracijo aktivnega presnovka v plazmi 0,11 ng/ml.
English: • Effects in the eye: Increased fluid pressure inside the eye; inflammation of the coloured part of the eye (the iris); bulging of iris; growth of eyelashes; eyelid dryness; eye disease related to diabetes; excess folds of the conjunctiva; blindness; blurred, double and halo vision; cataracts; abnormal turning outward of the lower eyelid; small colored spots on the eye surface; eye dryness caused by inflammation of the glands of the eyelids; eye allergy; eyelid crusting; glassy eyes; loss of eyelashes; tiredness
Slovenian: • Učinki v očesu: zvišan tlak tekočine v očesu; vnetje obarvanega dela očesa (šarenice); izbočena šarenica; rast trepalnic; suhost vek; očesna bolezen, povezana s sladkorno boleznijo; čezmerno gubanje veznice; slepota; zamegljen in dvojni vid ter videnje sija okrog luči; katarakte; neobičajno obračanje spodnje veke navzven; majhna obarvana mesta na očesni površini; suhost očesa zaradi vnetja žlez v vekah; očesna alergija; kraste na vekah; steklaste oči; izpadanje trepalnic; utrujenost
English: Table 2: Mean IOP by visit: PP population with baseline IOP ≥25 and <30 mmHg Study Visit and Time Point
Slovenian: Preglednica 2: Povprečni IOP po obiskih: populacija PP z izhodiščnim IOP ≥ 25 in < 30 mmHg
English: What Rhokiinsa looks like and contents of the pack Rhokiinsa is a clear, liquid eye drop solution in a plastic bottle.
Slovenian: Zdravilo Rhokiinsa je bistra, tekoča raztopina kapljic za oko v plastenki.
English: Do not swallow or inject.
Slovenian: da ne kontaminirate raztopine.
English: This medicinal product contains benzalkonium chloride.
Slovenian: Zdravilo Rhokiinsa vsebuje benzalkonijev klorid.
English: EXPIRY DATE
Slovenian: Občasni ekskoriacija
English: A randomised, double-blind, multicentre Phase 3 clinical trial compared the efficacy and safety of netarsudil once daily with that of timolol maleate 0.5% twice daily in reducing IOP in a total of 708 patients with open-angle glaucoma or ocular hypertension.
Slovenian: V randomiziranem, dvojno slepem, multicentričnem kliničnem preskušanju 3. faze so primerjali učinkovitost in varnost netarsudila enkrat na dan z učinkovitostjo in varnostjo timololijevega maleata
English: Systemic exposure to netarsudil following topical ocular administration has been shown to be negligible.
Slovenian: 4.9 Preveliko odmerjanje Dokazali so, da je sistemska izpostavljenost netarsudilu po topični očesni uporabi zanemarljiva.
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Rhokiinsa Vsebina pakiranja in dodatne informacije
English: System Organ Classification
Slovenian: Organski sistem
English: Rhokiinsa 200 micrograms/ml eye drops, solution netarsudil
Slovenian: Rhokiinsa 200 mikrogramov/ml kapljice za oko, raztopina netarsudil
English: Rhokiinsa contains benzalkonium chloride This medicine contains approximately 150 micrograms benzalkonium chloride in each ml of solution.
Slovenian: To zdravilo vsebuje približno 150 mikrogramov benzalkonijevega klorida v enem ml raztopine.
English: PARTICULARS TO APPEAR ON OUTER PACKAGING OUTER CARTON
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA
English: NAME OF THE MEDICINAL PRODUCT Rhokiinsa 200 micrograms/ml eye drops, solution netarsudil
Slovenian: IME ZDRAVILA Rhokiinsa 200 mikrogramov/ml kapljice za oko, raztopina
English: Frequency Adverse reactions instillation site erythema, instillation site discomfort, instillation site pruritis, vital dye staining cornea present, intraocular pressure increased
Slovenian: Neželeni učinki prisotno obarvanje roženice z vitalnim barvilom, zvišan intraokularni tlak