FrancophonIA/ELRC3.0 huggingface dataset:
English: Mean IOP reductions from baseline at each time point at each visit were greater with SIMBRINZA (6 to 9 mmHg) than monotherapy with either brinzolamide (5 to 7 mmHg) or brimonidine (4 to 7 mmHg).
Croatian: Srednje smanjenje IOT-a u odnosu na početni u svakoj vremenskoj točki pri svakoj posjeti bilo je veće pri primjerni SIMBRINZE (6-9 mmHg) negoli pri monoterapiji brinzolamidom (5-7 mmHg) ili brimonidinom (4-7 mmHg).
English: Brimonidine is rapidly absorbed into the eye following topical administration.
Croatian: Brimonidnin se brzo apsorbira u oko nakon topikalne primjene.
English: The following side effects have been observed with SIMBRINZA and other medicines containing brinzolamide or brimonidine alone.
Croatian: Slijedeće su nuspojave zabilježene sa SIMBRINZOM i drugim lijekovima koji pojedinačno sadrže brinzolamid ili brimonidin.
English: 8 mL round, opaque, low density polyethylene (LDPE) bottles with a LDPE dropper tip and white polypropylene screw cap (Drop-Tainer) containing 5 mL suspension.
Croatian: Okrugle, neprozirne boce od polietilena niske gustoće volumena 8 ml, s nastavkom za kapanje od polietilena niske gustoće i bijelim polipropilenskim zatvaračem s navojem (Drop-Tainer) koje sadrže 5 ml suspenzije.
English: The following adverse reactions have been reported during clinical studies with SIMBRINZA twicedaily dosing and during clinical studies and post-marketing surveillance with the individual components brinzolamide and brimonidine.
Croatian: Sljedeće nuspojave zabilježene su u kliničkim ispitivanjima sa SIMBRINZOM primijenjenom dva puta dnevno te tijekom kliničkih ispitivanja i postmarketinškog praćenja pojedinačnih sastojaka brinzolamida i brimonidina.
English: It should be used with caution in dry eye patients and in patients whose cornea may be compromised.
Croatian: Mora se primjenjivati s oprezom u bolesnika sa suhim okom te u bolesnika kod kojih rožnica može biti ugrožena.
English: Benzalkonium chloride has been reported to cause eye irritation and symptoms of dry eyes and may affect the tear film and corneal surface.
Croatian: Za benzalkonijev klorid je zabilježeno da uzrokuje iritaciju oka, simptome suhog oka te da može utjecati na suzni film i površinu rožnice.
English: Patients receiving monoamine oxidase (MAO) inhibitor therapy (see section 4.5).
Croatian: Bolesnici koji primaju inhibitore monoaminooksidaze (MAO) (vidjeti dio 4.5).
English: What SIMBRINZA looks like and contents of the pack SIMBRINZA eye drops, suspension, is a liquid (white-to-off-white suspension) supplied in a pack containing one or three 5 ml plastic bottles with screw cap.
Croatian: SIMBRINZA kapi za oko, suspenzija je tekućina (bijela do bjelkasta suspenzija) dostupna u pakiranju koje sadrži jednu ili tri plastične boce od 5 ml sa zatvaračem s navojem.
English: The concomitant administration of SIMBRINZA and oral carbonic anhydrase inhibitors is not recommended.
Croatian: Istodobna primjena SIMBRINZE i oralnih inhibitora karboanhidraze se ne preporučuje.
English: Dysgeusia was the most common systemic adverse reaction associated with the use of SIMBRINZA (3.4%).
Croatian: Najčešće prijavljivana sistemska nuspojava povezana s primjenom SIMBRINZE bila je disgeuzija (3,4%).
English: Brimonidine is extensively metabolised by hepatic aldehyde oxidase, with formation of 2oxobrimonidine, 3-oxobrimonidine and 2,3-dioxobrimonidine being the major metabolites.
Croatian: Brimonidin se opsežno metabolizira jetrenom aldehid oksidazom, a glavni su mu metaboliti 2oksobrimonidin, 3-oksobrimonidin i 2,3-dioksobrimonidin.
English: Delayed ocular hypersensitivity reactions have been reported with brimonidine tartrate, with some reported to be associated with an increase in IOP.
Croatian: Odgođene okularne reakcije preosjetljivosti zabilježene su uz primjenu brinzolamidtartarata, od kojih su neke bile povezane s povišenjem IOT-a.
English: The substance is also absorbed into the systemic circulation, where it binds strongly to carbonic anhydrase in red blood cells (RBCs).
Croatian: Sastojak se također apsorbira u sistemsku cirkulaciju, gdje se čvrsto veže za karboanhidrazu u eritrocitima.
English: Steady-state exposure does not increase in a doseproportional manner.
Croatian: Izloženost u stanju dinamičke ravnoteže ne povećava se na način ovisan o dozi.
English: Benzalkonium chloride, propylene glycol, carbomer 974P, boric acid, mannitol, sodium chloride, tyloxapol, hydrochloric acid and/or sodium hydroxide (to adjust pH) and purified water.
Croatian: Benzalkonijev klorid, propilenglikol, karbomer 974P, boratna kiselina, manitol, natrijev klorid, tiloksapol, kloridna kiselina i/ili natrijev hidroksid (za podešavanje pH) i pročišćena voda.
English: Decrease of elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction(see section 5.1).
Croatian: Snižavanje povišenog intraokularnog tlaka (IOT) kod odraslih bolesnika s glaukomom otvorenog kuta ili okularnom hipertenzijom kod kojih monoterapija ne postiže dovoljno sniženje IOT-a (vidjeti dio 5.1).
English: 2, paraesthesia Very rare: syncope Not known: tremor
Croatian: 2, paraestezija Vrlo rijetko: sinkopa
English: In a topical ocular clinical study comparing the systemic pharmacokinetics of SIMBRINZA administered two or three times daily to brinzolamide and brimonidine administered individually using the same two posologies, the steady-state whole blood brinzolamide and N-desethylbrinzolamide pharmacokinetics were similar between the combination product and brinzolamide administered alone.
Croatian: U topikalnom okularnom kliničkom ispitivanju usporedbe sistemske farmakokinetike SIMBRINZE primijenjene dva ili tri puta dnevno i brinzolamida i brimonidina primijenjenih pojedinačno primjenom istog doziranja, farmakokinetika brinzolamida i N-desetilbrinzolamida u stanju dinamičke ravnoteže u kompletnoj krvi bila je slična između kombiniranog lijeka i brinzolamida primijenjenog pojedinačno.
English: The same types of adverse reactions that are attributable to sulphonamides may occur with topical administration.
Croatian: Isti tip nuspojava koje se povezuju sa sulfonamidima može se pojaviti kod topikalne primjene.
English: Brinzolamide is metabolised by hepatic cytochrome P450 isozymes, specifically CYP3A4, CYP2A6, CYP2B6, CYP2C8 and CYP2C9.
Croatian: Brinzolamid se metabolizira putem jetrenih citokrom P450 izoenzima, posebno CYP3A4, CYP2A6, CYP2B6, CYP2C8 i CYP2C9.
English: Patients on antidepressants which affect noradrenergic transmission (e.g. tricyclic antidepressants and mianserin) (see section 4.5).
Croatian: Bolesnici koji uzimaju antidepresive koji utječu na noradrenergički prijenos (npr. triciklički antidepresivi i mianserin) (vidjeti dio 4.5).
English: Retention in ocular tissues is prolonged due to binding to carbonic anhydrase.
Croatian: Zadržavanje u tkivima oka je produljeno zahvaljujući vezanju na karboanhidrazu.
English: Alcon Cusí, S.A. Camil Fabra 58 08320 El Masnou Barcelona Spain
Croatian: Camil Fabra 58 08320 El Masnou Barcelona Španjolska
English: Oral overdoses of other alpha-2-agonists have been reported to cause symptoms such as hypotension, asthenia, vomiting, lethargy, sedation, bradycardia, arrhythmias, miosis, apnoea, hypotonia, hypothermia, respiratory depression and seizure.
Croatian: U slučajevima predoziranja drugim alfa-2 agonistima peroralnim putem, zabilježeni su simptomi kao što su hipotenzija, astenija, povraćanje, letargija, sedacija, bradikardija, aritmije, mioza, apneja, hipotonija, hipotermija, respiratorna depresija i napadaji.
English: The same types of adverse reactions that are attributable to oral carbonic inhibitors (i.e. acid-base disturbances) may occur with topical administration (see section 4.5).
Croatian: Isti tip nuspojava koje se povezuju s oralnim inhibitorima karboanhidraze (poremećaji acidobazne ravnoteže) mogu se pojaviti kod topikalne primjene (vidjeti dio 4.5).
English: These two components lower intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) and ocular hypertension (OHT) by suppressing the formation of aqueous humour from the ciliary process in the eye.
Croatian: Ova dva sastojka snižavaju intraokularni tlak (IOT) u bolesnika s glaukomom otvorenog kuta i okularnom hipertenzijom suprimirajući stvaranje očne vodice u cilijarnom procesu u oku.
English: SIMBRINZA is contraindicated in patients receiving monoamine oxidase inhibitors and in patients on antidepressants which affect noradrenergic transmission (e.g. tricyclic antidepressants and mianserin), (see section 4.3).
Croatian: SIMBRINZA je kontraindicirana u bolesnika koji se liječe inhibitorima monoaminooksidaze i u bolesnika koji se liječe antidepresivima koji utječu na noradrenergički prijenos (npr. triciklički antidepresivi i mianserin) (vidjeti dio 4.3).
English: Brimonidine, an alpha-2 adrenergic agonist, inhibits the enzyme adenylate cyclase and suppresses the cAMP-dependent formation of aqueous humour.
Croatian: Brimonidin, alfa-2-adrenergični agonist, inhibira enzim adenilat ciklaza i suprimira nastanak očne vodice ovisan o cikličkom adenozin monofosfatu (cAMP).
English: Uncommon: cardio-respiratory distress
Croatian: Manje često: kardio - respiratorni distres
English: At the +2 h time point (the time corresponding to the morning efficacy peak) for the primary efficacy visit at Month 3, the percentage of patients with an IOP less than 18 mmHg was 61.7% in the SIMBRINZA group, 40.1% in the Brinzolamide group, and 40.0% in the Brimonidine group.
Croatian: U vremenskoj točki +2 h (vrijeme koje odgovara vršnoj jutarnjoj učinkovitosti) pri primarnoj kontroli učinkovitosti u 3. mjesecu, postotak bolesnika s IOT-om nižim od 18 mmHg iznosio je 61,7% u skupini liječenoj SIMBRINZOM, 40,1% u skupini liječenoj brinzolamidom i 40,0% u onoj liječenoj brimonidinom.
English: Brinzolamide acts by inhibiting the enzyme carbonic anhydrase (CA-II) in the ciliary epithelium that reduces the formation of bicarbonate ions with subsequent reduction in sodium and fluid transport across the ciliary epithelium, resulting in decreased aqueous humour formation.
Croatian: Inihibicijom enzima karboanhidraze (CA-II) u cilijarnim nastavcima brinzolamid usporava stvaranje biokarbonatnih iona s posljedičnim redukcijom transporta natrija i tekućine kroz cilijarne nastavke, čime se smanjuje nastanak očne vodice.
English: There are no or limited amount of data from the use of SIMBRINZA in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni SIMBRINZE u trudnica ograničeni.
English: SIMBRINZA may also cause dizziness, drowsiness or tiredness in some patients.
Croatian: SIMBRINZA u nekih bolesnika također može uzrokovati omaglicu, omamljenost ili umor.
English: This increase in steady-state RBC concentrations of substance-related material did not inhibit RBC carbonic anhydrase activity to levels that are associated with systemic side effects.
Croatian: To povećanje tvari povezanih s djelatnim tvarima u eritrocitima u stanju dinamičke ravnoteže nije inhibiralo aktivnost eritrocitne karboanhidraze do stupnja koji bi bio povezan sa sistemskim nuspojavama.
English: Bring the bottle tip close to the eye. Do this in front of a mirror if it helps.
Croatian: Koristite se ogledalom, ako Vam to pomaže.
English: Mean IOP reductions from baseline at each time point at each visit with SIMBRINZA or the individual components administered concomitantly were similar (7 to 10 mmHg).
Croatian: Srednje smanjenje IOT-a u odnosu na početni u svakoj vremenskoj točki pri svakoj posjeti bilo je slično pri primjeni SIMBRINZE ili njenih komponenata primjenjivanih istodobno (7 do 10 mmHg).
English: Immune system disorders Uncommon: hypersensitivity3 Psychiatric disorders
Croatian: Poremećaji imunološkog sustava Manje često: preosjetljivost Psihijatrijski poremećaji
English: At the +2 h time point (the time corresponding to the morning efficacy peak) for the primary efficacy visit at Month 3, the percentage of patients with an IOP less than 18 mmHg was 65.6% in the SIMBRINZA group and 63.7% in the Brinzolamide + Brimonidine groups.
Croatian: U vremenskoj točki +2 h (vrijeme koje odgovara vršnoj jutarnjoj učinkovitosti) pri primarnoj kontroli učinkovitosti u 3. mjesecu, postotak bolesnika s IOT-om nižim od 18 mmHg iznosio je 65,6% u skupini liječenoj SIMBRINZOM i 63,7% u onoj liječenoj brinzolamidom + brimonidinom.
English: How to store SIMBRINZA
Croatian: Kako čuvati SIMBRINZU
English: In a 6-month, controlled, contribution of elements clinical study enrolling 560 patients with openangle glaucoma (including pseudoexfoliation or pigment dispersion component) and/or ocular hypertension who, in the investigator's opinion, were insufficiently controlled on monotherapy or already on multiple IOP-lowering medicinal products, and who had mean baseline diurnal IOP of 26 mmHg, the mean diurnal IOP-lowering effect of SIMBRINZA dosed twice daily was approximately 8 mmHg.
Croatian: U šestomjesečnom, kontroliranom kliničkom ispitivanju doprinosa pojedinih elemenata u 560 bolesnika s glaukomom otvorenog kuta (uključujući pseudoeksfolijativni ili sindrom disperzije pigmenta) i/ili okularnom hipertenzijom u kojih, prema ocjeni ispitivača, nije postignuta dobra kontrola monoterapijom ili su već primali više lijekova za snižavanje IOT-a i u kojih je srednji dnevni IOT na početku iznosio 26 mmHg, SIMBRINZOM primjenjivanom dvaput na dan srednji dnevni očni tlak snižen je za približno 8 mmHg.
English: How to use SIMBRINZA
Croatian: Kako primjenjivati SIMBRINZU
English: SIMBRINZA contains benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses.
Croatian: SIMBRINZA sadrži benzalkonijev klorid, koji može izazvati iritaciju oka i za kojeg je poznato da može promijeniti boju mekih kontaktnih leća.
English: Difference Mean a
Croatian: Razlika Srednja vrijednost a
English: 1 ml of suspension contains 10 mg brinzolamide and 2 mg brimonidine tartrate.
Croatian: 1 ml suspenzije sadrži 10 mg brinzolamida i 2 mg brimonidintartarata.
English: Some patients who dosed with SIMBRINZA experienced decreases in blood pressure similar to those observed with the use of brimonidine as monotherapy.
Croatian: Kod nekih bolesnika koji su primali terapiju SIMBRINZE sniženje krvnog tlaka bilo je slično onome zabilježenom sa primjenom brinzolamida kao monoterapije.
English: 2, hypoaesthesia
Croatian: 2, hipoestezija
English: Studies to determine the effects of age, race, and renal or hepatic impairment have not been conducted with SIMBRINZA.
Croatian: Ispitivanja učinaka dobi, rase, spola, te oštećenja bubrežne i jetrene funkcije na SIMBRINZU nisu provedena.
English: No specific drug interaction studies have been performed with SIMBRINZA.
Croatian: Nisu provedena posebna ispitivanja interakcije SIMBRINZE s drugim lijekovima.
English: OUTER CARTON 5 ml BOTTLE
Croatian: KUTIJA ZA 5 ml BOCU
English: In a 6-month, controlled, non-inferiority clinical study enrolling 890 patients with open-angle glaucoma (including pseudoexfoliation or pigment dispersion component) and/or ocular hypertension who, in the investigator's opinion, were insufficiently controlled on monotherapy or already on multiple IOP-lowering medicinal products, and who had mean baseline diurnal IOP of 26 to 27 mmHg, non-inferiority of SIMBRINZA compared to brinzolamide 10 mg/mL + brimonidine 2 mg/mL dosed concomitantly was demonstrated at all visits throughout the study with respect to mean diurnal IOP reduction from baseline (Table 1).
Croatian: U šestomjesečnom, kontroliranom kliničkom ispitivanju neinferiornosti u 890 bolesnika s glaukomom otvorenog kuta (uključujući pseudoeksfolijativni i sindrom disperzije pigmenta) i/ili okularnom hipertenzijom u kojih, prema ocjeni ispitivača, nije postignuta dobra kontrola monoterapijom ili su već primali više lijekova za snižavanje IOT-a, i u kojih je srednji dnevni IOT na početku iznosio 26 do 27 mmHg, neinferiornost SIMBRINZE u usporedbi s brinzolamidom 10 mg/ml + brimonidinom 2 mg/ml primjenjivanima istodobno, dokazana je pri svim posjetima tijekom ispitivanja s obzirom na smanjenje srednjeg dnevnog IOT-a u odnosu na početni (tablica 1).
English: No accumulation occurs during chronic administration.
Croatian: Pri kroničnoj primjeni nema nakupljanja.
English: Brimonidine administered orally is excreted in breast milk.
Croatian: Peroralno primijenjen brimonidin izlučuje se u majčino mlijeko.
English: , erythema
Croatian: , eritem
English: You should remove contact lenses before using this medicine and put them back 15 minutes afterwards.
Croatian: Kontaktne leće potrebno je izvaditi prije primjene lijeka te nakon toga pričekati najmanje 15 minuta prije ponovnog stavljanja leća.
English: SIMBRINZA 10 mg/ml + 2 mg/ml eye drops, suspension brinzolamide/brimonidine tartrate
Croatian: SIMBRINZA 10 mg/ml + 2 mg/ml kapi za oko, suspenzija brinzolamid/brimonidintartarat
English: Nasolacrimal occlusion or gently closing the eyelid after instillation may help reduce the occurrence of this effect (see section 4.2).
Croatian: Pojava ovog učinka može se smanjiti nazolakrimalnom okluzijom ili blagim zatvaranjem vjeđe nakon ukapavanja (vidjeti dio 4.2).
English: Acid-base disturbances have been reported with oral carbonic anhydrase inhibitors.
Croatian: Acidobazni poremećaji zabilježeni su kod oralnih inhibitora karboanhidraze.
English: The subjects experienced symptoms of CNS depression, typically temporary coma or low level of consciousness, lethargy, somnolence, hypotonia, bradycardia, hypothermia, pallor, respiratory depression and apnoea, and required admission to intensive care with intubation if indicated.
Croatian: Kod bolesnika su se javili simptomi depresije središnjeg živčanog sustava, tipična privremena koma ili niska razina svijesti, letargija, somnolencija, hipotonija, bradikardija, hipotermija, bljedilo, respiratorna depresija i apneja, koji su zahtijevali prijem u jedinicu intenzivne skrbi i prema potrebi intubaciju.
English: SIMBRINZA is contraindicated in neonates and infants aged less than 2 years in the decrease of elevated intraocular pressure (IOP) with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction because of safety concerns (see section 4.3).
Croatian: SIMBRINZA je iz sigurnosnih razloga kontraindicirana u novorođenčadi i dojenčadi mlađe od 2 godine za snižavanje povišenog intraokularnog tlaka (IOT) s glaukomom otvorenog kuta ili okularnom hipertenzijom kod kojih monoterapija ne postiže dovoljno sniženje IOT-a (vidjeti dio 4.3).
English: One ml of suspension contains 10 mg of brinzolamide and 2 mg of brimonidine tartrate equivalent to 1.3 mg brimonidine.
Croatian: Jedan ml suspenzije sadrži 10 mg brinzolamida i 2 mg brimonidintartarata, što odgovara 1,3 mg brimonidina.
English: In study CQVJ499A2402, SIMBRINZA + travoprost-timolol maleate eye drops demonstrated superior IOPlowering efficacy from baseline compared to Vehicle + travoprost-timolol maleate eye drops after 6 weeks of treatment, with between-treatment difference in model-adjusted mean change from baseline in diurnal IOP of -2.15 mmHg (95% CI, -2.8, -1.5; p-value <0.001).
Croatian: U ispitivanju CQVJ499A2402, SIMBRINZA + travoprost-timololmaleat kapi za oči pokazali su superiornu učinkovitost sniženja IOT-a u odnosu na početnu vrijednost u usporedbi s vehikulumom + travoprost-timololmaleat kapima za oči nakon 6 tjedana liječenja, s razlikom između liječenja u prema modelu prilagođenoj srednjoj vrijednosti promjene u odnosu na početnu vrijednost dnevnog IOT-a od -2,15 mmHg (95% CI, -2,8; -1,5; p-vrijednost<0,001).
English: In study CQVJ499A2401, SIMBRINZA + PGA (i.e. travoprost, latanoprost, or bimatoprost) demonstrated superior IOP-lowering efficacy from baseline compared to Vehicle + PGA after 6 weeks of treatment, with between-treatment difference in model-adjusted mean change from baseline in diurnal IOP of -3.44 mmHg (95% CI, -4.2, -2.7; p-value <0.001).
Croatian: U ispitivanju CQVJ499A2401, SIMBRINZA + PGA (tj. travoprost, latanoprost ili bimatoprost) pokazali su superiornu učinkovitost sniženja IOT-a u odnosu na početnu vrijednost u usporedbi s vehikulumom + PGA-om nakon 6 tjedana liječenja, s razlikom između liječenja u prema modelu prilagođenoj srednjoj vrijednosti promjene u odnosu na početnu vrijednost dnevnog IOT-a od -3,44 mmHg (95% CI, -4,2; -2,7; p-vrijednost<0,001).
English: Do not use SIMBRINZA - if you are allergic to brinzolamide or brimonidine tartrate or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to sulphonamides (examples include medicines used to treat diabetes and infections and also diuretics (water tablets)) - if you are taking a monoamine oxidase (MAO) inhibitors (examples include medicines to treat depression or Parkinson's disease) or certain antidepressants.
Croatian: (naveden u dijelu 6.). - ako ste alergični na sulfonamide (primjeri uključuju lijekove za liječenje šećerne bolesti i infekcija te diuretike (lijekove za izmokravanje)) - ako uzimate inhibitore monoaminooksidaze (MAO) (primjeri uključuju lijekove za liječenje depresije ili Parkinsonove bolesti) ili određene antidepresive.
English: SIMBRINZA has not been studied in patients with hepatic impairment and caution is therefore recommended in this population (see section 4.4).
Croatian: SIMBRINZA nije ispitana u bolesnika s oštećenom jetrenom funkcijom, stoga se u toj populaciji preporučuje oprez (vidjeti dio 4.4).
English: How to store SIMBRINZA Contents of the pack and other information
Croatian: Kako SIMBRINZA izgleda i sadržaj pakiranja
English: 1, libido decreased
Croatian: 1, smanjen libido
English: SIMBRINZA is absorbed systemically and this may therefore occur with topical administration (see section 4.7).
Croatian: SIMBRINZA se apsorbira sistemski, stoga su ti učinci mogući i pri topikalnoj primjeni (vidjeti dio 4.7).
English: SIMBRINZA is contraindicated in patients with severe renal impairment (see section 4.3).
Croatian: SIMBRINZA je kontraindicirana u bolesnika s teško oštećenom bubrežnom funkcijom (vidjeti dio 4.3).
English: 2, peripheral oedema adverse reaction observed with SIMBRINZA 2 additional adverse reaction observed with brinzolamide monotherapy additional adverse reaction observed with brimonidine monotherapy
Croatian: 2, periferni edem nuspojave zabilježene sa SIMBRINZOM dodatne nuspojave zabilježene kod primjene brinzolamida kao monoterapije dodatne nuspojave zabilježene kod primjene brimonidina kao monoterapije
English: 1, abnormal vision
Croatian: 1, abnormalan vid
English: The percentages of patients with an IOP measurement less than 18 mmHg were greater in the SIMBRINZA group than in the Brinzolamide group at 9 of 12 assessments through Month 6 and were greater in the SIMBRINZA group than in the Brimonidine group at all 12 assessments through Month 6.
Croatian: Postotak bolesnika s IOT-om nižim od 18 mmHg bio je veći u skupini liječenoj SIMBRINZOM negoli u onoj liječenoj brinzolamidom pri 9 od ukupno 12 kontrola do 6. mjeseca ispitivanja, te je bio veći u skupini liječenoj SIMBRINZOM negoli u onoj liječenoj brimonidinom tijekom svih 12 kontrola do 6. mjeseca ispitivanja.
English: Studies in rabbits showed that maximum brinzolamide ocular concentrations following topical administration are in the anterior tissues such as cornea, conjunctiva, aqueous humour and iris-ciliary body.
Croatian: Ispitivanja na kunićima pokazala su maksimalnu okularnu koncentraciju brinzolamida nakon topikalne primjene u prednjim tkivima oka kao što su rožnica, konjunktiva, očna vodica i šarenica-cilijarno tijelo.
English: Not known (frequency cannot be estimated from the available data)
Croatian: Nepoznato ( učestalost se ne može procijeniti iz dostupnih podataka) - Nuspojave na oku: smanjeni rast trepavica
English: SIMBRINZA contains brinzolamide, which is a sulphonamide inhibitor of carbonic anhydrase with systemic absorption.
Croatian: SIMBRINZA sadrži brinzolamid, koji je sulfonamidni inhibitor karboanhidraze i sistemski se apsorbira.
English: Serious adverse reactions following inadvertent ingestion with the brimonidine component of SIMBRINZA by paediatric subjects have been reported.
Croatian: Zabilježene su ozbiljne nuspojave nakon nehotičnog gutanja sastojka SIMBRINZE brimonidina u pedijatrijskih bolesnika.