natgillin/translations-raw huggingface dataset:
GANFORT contains two active substances: bimatoprost (0.3 mg/ ml) and timolol (5 mg/ ml).
Zdravilo GANFORT vsebuje dve zdravilni učinkovini: bimatoprost (0, 3 mg/ ml) in timolol (5 mg/ ml).
What is GANFORT used for?
Za kaj se zdravilo GANFORT uporablja?
GANFORT is used to reduce intraocular pressure (the pressure inside the eye).
Zdravilo GANFORT se uporablja za zmanjšanje intraokularnega tlaka (tlaka v očesu).
It is used in patients who have open angle glaucoma (a disease where the pressure in the eye rises because fluid can not drain out of the eye) and in patients with ocular hypertension (the pressure in the eye is higher than normal).
Uporablja se pri bolnikih, ki imajo glavkom odprtega zakotja (bolezen, kjer se tlak v očesu zviša, ker tekočina ne more iztekati iz očesa), in pri bolnikih z očesno hipertenzijo (tlak v očesu je višji od običajnega).
GANFORT contains a combination of two substances, a beta-blocker (timolol) and a prostamide (bimatoprost).
Zdravilo GANFORT vsebuje kombinacijo dveh snovi, zaviralec beta (timolol) in prostamid (bimatoprost).
It is used in patients who do not respond sufficiently to eye drops containing beta-blockers or prostaglandin analogues on their own.
Uporablja se pri bolnikih, ki se ne odzivajo zadostno na kapljice za oči, ki vsebujejo samo zaviralce beta ali samo analoge prostaglandina.
GANFORT can only be obtained with a prescription.
Zdravilo GANFORT se dobi samo na recept.
How is GANFORT used?
Kako se zdravilo GANFORT uporablja?
GANFORT is given as one drop in the affected eye(s) once a day, in the morning.
Zdravilo GANFORT se daje po eno kapljico v prizadeto oko/ prizadeti očesi enkrat dnevno, zjutraj.
How does GANFORT work?
Kako zdravilo GANFORT deluje?
Raised intraocular pressure causes damage to the retina (the light sensitive membrane at the back of the eye) and to the optic nerve that sends signals from the eye to the brain.
Zvišan očesni tlak poškoduje mrežnico (membrana na zadnji strani zrkla, ki je občutljiva za svetlobo) in vidni živec, ki pošilja signale iz očesa v možgane.
By lowering the pressure, GANFORT reduces the risk of damage.
Zdravilo GANFORT z zniževanjem tlaka zmanjša nevarnost poškodb.
GANFORT contains two active substances, bimatoprost and timolol, and these lower the pressure in the eye by different mechanisms.
Zdravilo GANFORT vsebuje dve zdravilni učinkovini: bimatoprost in timolol, ki znižujeta tlak v očesu z različnima mehanizmoma.
Bimatoprost is a prostamide, a substance related to prostaglandin F2 α that works by increasing the outflow of fluid from the eye.
Bimatoprost je prostamid, snov, ki je sorodna prostaglandinu F2α, in zvišuje iztok tekočine iz očesa.
Bimatoprost on its own has already been approved in the European Union under the name Lumigan.
Bimatoprost je bil sam po sebi v Evropski uniji že odobren pod imenom Lumigan.
Timolol is a beta-blocker that works by reducing the production of fluid within the eye.
Timolol je zaviralec beta, ki znižuje nastajanje tekočine v očesu.
Timolol has been commonly used to treat glaucoma since the 1970’ s.
Timolol se pogosto uporablja za zdravljenje glavkoma od 1970- ih let dalje.
How has GANFORT been studied?
Kako je bilo zdravilo GANFORT raziskano?
Four studies were carried out, involving 1,964 patients, aged 25-87 years.
Opravljene so bile štiri raziskave, v katere je bilo vključenih 1964 bolnikov, starih 28- 87 let.
In three of these studies, patients were treated either with GANFORT once a day, or with eye drops containing only timolol or bimatoprost, for 3 months, followed by a further 9 months in two studies.
Bolniki so se zdravili 3 mesece, v dveh raziskavah pa so jih spremljali še 9 mesecev.
In the fourth study, patients were treated with GANFORT or with timolol and bimatoprost given at the same time.
V četrti raziskavi so bolnike zdravili bodisi z zdravilom GANFORT bodisi s timololom in bimatoprostom uporabljenima sočasno.
All the studies measured how the intraocular pressure changed during the study.
V vseh raziskavah so merili spremembe očesnega tlaka v trajanju raziskav.
One study also looked at how many 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
V eni raziskavi so merili tudi, koliko bolnikov ima 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. eu. int http: / /www. emea. eu. int  EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged patients had an intraocular pressure below 18 mmHg (the pressure is measured in mmHg – in a patient with glaucoma, the value is generally higher than 21 mmHg).
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. eu. int http: // www. emea. eu. int EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged očesni tlak pod 18 mmHg (tlak se meri v mmHg – pri bolnikih za glavkomom je vrednost ponavadi višja od 21 mmHg).
What benefit has GANFORT shown during the studies?
Kakšne koristi je zdravilo GANFORT izkazalo med raziskavami?
Overall, the studies showed that GANFORT is effective in lowering intraocular pressure.
Na splošno so raziskave pokazale, da zdravilo GANFORT učinkovito zmanjšuje očesni tlak.
The values were lowered by about 8-10 mmHg.
Vrednosti so se znižale za približno 8- 10 mmHg.
GANFORT was more effective than timolol on its own, and as effective as bimatoprost on its own.
Zdravilo GANFORT je bilo učinkoviteje od uporabe izključno timolola in enako učinkovito kot uporaba izključno bimatoprosta.
When looking at two of the studies together, where GANFORT was compared with its components given as separate drops (1,061 patients), and at patients whose pressure was not controlled with eye drops containing prostaglandins only (about a third of them), the medicine was more effective than bimatoprost on its own.
Če primerjamo združeni preiskavi, kjer so zdravilo GANFORT primerjali z uporabo sestavin kot ločenih kapljic (1061 bolnikov), in bolnike, katerih tlak ni bil nadzorovan s kapljicami za oči, ki vsebujejo samo prostaglandine (približno tretjina), je bilo zdravilo učinkovitejše od samega bimatoprosta.
GANFORT lowered the pressure to less than 18 mmHg in 18.7% of these patients, against 10.2% with bimatoprost only, and more patients had a drop in pressure of more than 20% in comparison to the pressure before the study (67.9% against 48.9%).
Pri več bolnikih so zabeležili zmanjšanje tlaka za več kot 20% v primerjavi s tlakom pred začetkom raziskave (zdravilo GANFORT 67, 9%; samo bimatoprost 48, 9%).
In addition, GANFORT was shown to be as effective as bimatoprost and timolol given at the same time.
Pole navedenega so dokazali, da je zdravilo GANFORT enako učinkovito kot sočasna uporaba bimatoprosta in timolola.
What is the risk associated with GANFORT?
Kakšna tveganja so povezana z zdravilom GANFORT?
The most common side effects (seen in more than 1 patient in 10) are conjunctival hyperaemia (increased blood supply to the eye, leading to redness of the eye) and growth of eyelashes.
Najpogostejša neželena učinka (opažena pri več kot 1 bolniku od 10) sta bila konjunktivna hiperemija (zvišan dotok krvi v oko, kar povzroči pordelost očesa) in rast trepalnic.
For the full list of all side effects reported with GANFORT, see the Package Leaflet.
Celovit opis neželenih učinkov, o katerih so poročali pri uporabi zdravila GANFORT, najdete v Navodilih za uporabo.
GANFORT should not be used in people who may be hypersensitive (allergic) to bimatoprost, timolol or any of the other ingredients, in patients who have asthma or severe lung disease, or in patients with some heart conditions.
Zdravila GANFORT ne smejo jemati osebe, ki utegnejo biti preobčutljive za (alergične na) bimatoprost, timolol ali katerokoli drugo sestavino zdravila, in bolniki z astmo, hudo pljučno boleznijo ali bolniki z določenimi srčnimi boleznimi.
GANFORT contains benzalkonium chloride, and care should be taken by people who wear soft contact lenses as it can discolour them.
Zdravilo GANFORT vsebuje benzalkonijev klorid, zato morajo osebe, ki nosijo mehke kontaktne leče, paziti, saj lahko ta snov spremeni barvo kontaktnih leč.
GANFORT may cause a darkening of the eyelid or of the iris of the eye.
Zdravilo GANFORT lahko povzroči temnenje kože veke in irisa očesa.
Why has GANFORT been approved?
Zakaj je bilo zdravilo GANFORT odobreno?
The Committee for Medicinal Products for Human Use (CHMP) concluded that GANFORT has shown that it is effective, and that it can provide a benefit in improving compliance in patients who do not respond to single component eye drops.
Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da je bila učinkovitost zdravila GANFORT dokazana in da je zdravilo GANFORT lahko koristno, kar se tiče večje ustreznosti pri bolnikih, ki se ne odzivajo na kapljice za oko s posamezno sestavino.
They decided that GANFORT’ s benefits are greater than its risks for the treatment of open-angle glaucoma or ocular hypertension in patients who do not respond sufficiently to topical beta-blockers or prostaglandin analogues.
Odbor meni, da so koristni učinki zdravila GANFORT večji od tveganj za zdravljenje glavkoma odprtega zakotja in okularne hipertenzije pri bolnikih, ki se ne odzivajo zadostno na topične zaviralce beta ali analoge prostaglandina.
They recommended that GANFORT be given marketing authorisation.
Zato je priporočil odobritev dovoljenja za promet z zdravilom GANFORT.
Other information about GANFORT:
Druge informacije o zdravilu GANFORT:
The European Commission granted a marketing authorisation valid throughout the European Union for GANFORT to Allergan Pharmaceuticals Ireland on 19 May 2006.
Evropska Komisija je dovoljenje za promet z zdravilom GANFORT, veljavno po vsej Evropski uniji, odobrila družbi Allergan Pharmaceuticals Ireland dne 19. maja 2006.
The full EPAR for GANFORT can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo GANFORT je na voljo tukaj.
Route of administration
EU/ 1/ 06/ 340/ 001
Package size
1 plastenka
GANFORT 300 micrograms/ ml + 5 mg/ ml eye drops, solution
GANFORT 300 mikrogramov/ ml + 5 mg/ ml kapljice za oko, raztopina
One ml of solution contains 0.3 mg of bimatoprost and 5 mg of timolol (as 6.8 mg of timolol maleate).
1 ml raztopine vsebuje 0, 3 mg bimatoprosta in 5 mg timolola (v obliki 6, 8 mg timololijevega maleata)
Contains benzalkonium chloride 0.05 mg/ ml.
Vsebuje 0, 05 mg/ ml benzalkonijevega klorida.
Colourless to slightly yellow solution.
Brezbarvna do rahlo rumenkasta raztopina.
Reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.
Zmanjšanje očesnega tlaka (IOT) pri bolnikih z glavkomom odprtega zakotja ali očesno hipertenzijo, ki se nezadostno odzivajo na terapijo z lokalnimi zaviralci receptorjev beta ali analogi prostaglandina.
Recommended dosage in adults (including the elderly)
Priporočeno odmerjanje pri odraslih (vključno s starostniki)
The recommended dose is one drop of GANFORT in the affected eye(s) once daily, administered in the morning.
Priporočeni odmerek je ena kapljica v prizadeto oko (oči) enkrat dnevno, zjutraj.
If more than one topical ophthalmic product is to be used, the different products should be instilled at least 5 minutes apart.
Če je potrebno uporabiti več kot eno lokalno očesno zdravilo, je potrebno različna zdravila vkapati v razmiku najmanj 5 minut.
Use in renal and hepatic impairment
Uporaba pri okvarah ledvic in jeter
GANFORT has not been studied in patients with hepatic or renal impairment.
Zdravila GANFORT pri bolnikih z okvaro jeter ali ledvic niso preučevali.
Use in children and adolescents
Uporaba pri otrocih in adolescentih
GANFORT has only been studied in adults and therefore its use is not recommended in children or adolescents.
Zdravilo GANFORT je bilo preučevano le pri odraslih, zato njegova uporaba pri otrocih in mladostnikih ni priporočljiva.
Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock.
Sinusna bradikardija, atrioventrikularni (AV) blok druge in tretje stopnje, prikrito srčno popuščanje, kardiogeni šok.
Like other topically applied ophthalmic agents, GANFORT may be absorbed systemically.
Kot pri drugih lokalnih očesnih zdravilih, se tudi zdravilo GANFORT lahko absorbira sistemsko.
Due to the beta-adrenergic component, timolol, the same types of cardiovascular and pulmonary adverse reactions as seen with systemic beta-blockers may occur.
Zaradi beta adrenergične sestavine, timolola, se lahko pojavijo enake vrste neželenih učinkov srčno - žilnega sistema in dihal kot pri sistemskih zaviralcih receptorjev beta.
Cardiac failure should be adequately controlled before beginning GANFORT therapy.
Pred začetkom zdravljenja z zdravilom GANFORT je potreben ustrezen nadzor nad srčnim popuščanjem.
Patients with a history of severe cardiac disease should be watched for signs of cardiac failure and have their pulse rates checked.
Bolnike s hudo srčno boleznijo v anamnezi je potrebno opazovati zaradi morebitnega pojava znakov srčnega popuščanja in jim preverjati srčni utrip.
Cardiac and respiratory reactions, including death due to bronchospasm in patients with asthma, and, rarely, death in association with cardiac failures have been reported following administration of timolol maleate.
Po uporabi timololijevega maleata pri bolnikih z astmo so poročali o kardiorespiratornih reakcijah, vključno s smrtjo zaradi bronhospazma in redko o smrti zaradi srčnega popuščanja.
Beta-blockers may also mask the signs of hyperthyroidism and cause worsening of Prinzmetal angina, severe peripheral and central circulatory disorders and hypotension.
Zaviralci receptorjev beta lahko prikrijejo znake hipertiroidizma in povzročijo poslabšanje Prinzmetalove angine pektoris, hude periferne in centralne motnje krvnega obtoka in padec krvnega tlaka.
Beta-adrenergic blocking agents should be administered with caution in patients subject to spontaneous hypoglycemia or to diabetic patients (especially those with labile diabetes) as beta-blockers may mask the signs and symptoms of acute hypoglycemia.
Zaviralce adrenergičnih receptorjev beta je potrebno uporabljati previdno pri bolnikih, ki so nagnjeni k spontani hipoglikemiji ali pri sladkornih bolnikih (posebej tistih z nestabilno sladkorno boleznijo), ker lahko zaviralci receptorjev beta prikrijejo znake in simptome akutne hipoglikemije.
While taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic reaction to a variety of allergens may be unresponsive to the usual dose of adrenaline used to treat anaphylactic reactions.
Bolniki z anamnezo atopije ali hude anafilaktične reakcije na vrsto različnih alergenov lahko med jemanjem zaviralcev beta postanejo neodzivni na običajne odmerke adrenalina, ki se uporabljajo za zdravljenje anafilaktičnih reakcij.
In patients with a history of mild liver disease or abnormal alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/ or bilirubin at baseline, bimatoprost had no adverse reactions on liver function over 24 months.
Pri bolnikih z anamnezo blage bolezni jeter ali nenormalnimi izhodiščnimi vrednosti alanin - aminotransferaze (ALT), aspartat- aminotransferaze (AST) in/ ali celokupnega bilirubina, bimatoprost v 24 mesecih uporabe ni imel neželenega učinka na delovanje jeter.
Before treatment is initiated, patients should be informed of the possibility of eyelash growth, darkening of the eyelid skin and increased iris pigmentation since these have been observed during treatment with bimatoprost and GANFORT.
Pred zdravljenjem je potrebno bolnika obvestiti o možnih spremembah, ki so jih opazili med zdravljenjem z bimatoprostom in zdravilom GANFORT, to je o rasti trepalnic, temnenju kože veke in povečani pigmentaciji irisa.
Some of these changes may be permanent, and may lead to differences in appearance between the eyes if only one eye is treated.
Nekatere od teh sprememb so lahko trajne in lahko vodijo do razlik v izgledu oči, če je zdravljeno le eno oko.
After discontinuation of GANFORT, pigmentation of iris may be permanent.
Po prenehanju uporabe zdravila GANFORT lahko pigmentacija irisa ostane trajna.
After 12 months treatment with GANFORT, the incidence of iris pigmentation was 0.2%.
Po 12 mesecih zdravljenja z zdravilom GANFORT je bila incidenca pigmentacije irisa 0, 2%.
After 12 months treatment with bimatoprost eye drops alone, the incidence was 1.5% and did not increase following 3 years treatment.
Po 12 mesecih zdravljenja s kapljicami za oko, ki so vsebovale samo bimatoprost, je bila incidenca 1, 5% in se v naslednjih 3 letih zdravljenja ni povečala.
Cystoid macular oedema has been reported with GANFORT.
Pri uporabi zdravila GANFORT so opazili pojava cistoidnega edema makule.
Therefore, GANFORT should be used with caution in patients with known risk factors for macular oedema (e. g. aphakic patients, pseudophakic patients with a torn posterior lens capsule).
Zato je potrebna previdnost pri uporabi zdravila GANFORT pri bolnikih z znanimi dejavniki tveganja za edem makule (npr. bolniki z afakijo, bolniki s psevdofakijo oziroma s poškodovano zadnjo lečno kapsulo).
Contact lenses must be removed prior to application, with at least a 15-minute wait before reinsertion.
Pred uporabo zdravila je potrebno odstraniti kontaktne leče in počakati najmanj 15 minut pred ponovno namestitvijo.
Benzalkonium chloride has been reported to cause punctate keratopathy and/ or toxic ulcerative keratopathy.
Obstajajo poročila, da benzalkonijev klorid povzroča točkasto keratopatijo in/ ali toksično ulcerozno keratopatijo.
GANFORT has not been studied in patients with inflammatory ocular conditions, neovascular, inflammatory, angle-closure glaucoma, congenital glaucoma or narrow-angle glaucoma.
Zdravilo GANFORT ni bil preizkušen pri bolnikih z očesnimi vnetji, neovaskularnimi vnetji, glavkomom zaprtega zakotja, kongenitalnim glavkomom ali glavkomom zoženega zakotja.
There is a potential for additive effects resulting in hypotension, and/ or marked bradycardia when eye drops containing timolol are administered concomitantly with oral calcium channel blockers, guanethidine, or beta-blocking agents, anti-arrhythmics, digitalis glycosides or parasympathomimetics.
Pri sočasni uporabi kapljic za oko s timololom, in oralnih zaviralcev kalcijevih kanalčkov, gvanetidinom ali zaviralci receptorjev beta, antiaritmiki, digitalisovi glikozidi ali parasimpatomimetiki, obstaja možnost aditivnega učinka, ki se kaže kot hipotenzija in/ ali izrazita bradikardija.
Beta-blockers can mask the signs and symptoms of hypoglycaemia (see section 4.4).
Zaviralci receptorjev beta lahko povečajo hipoglikemični učinek zdravil proti sladkorni bolezni, ter lahko prikrijejo znake in simptome hipoglikemije (glejte poglavje 4. 4).
The hypertensive reaction to sudden withdrawal of clonidine can be potentiated when taking beta-blockers.
Hipertenzivna reakcija, ki nastopi ob nenadni ukinitvi klonidina, lahko postane pri jemanju zaviralcev beta še močnejša.
Pregnancy There are no adequate data from the use of GANFORT in pregnant women.
Nosečnost Ni ustreznih podatkov o uporabi zdravila GANFORT pri nosečnicah.
Bimatoprost No adequate clinical data in exposed pregnancies are available.
Bimatoprost Na voljo ni ustreznih kliničnih podatkov o izpostavljenosti nosečnic.
Animal studies have shown reproductive toxicity at high maternotoxic doses (see section 5.3).
Študije na živalih so pokazale reproduktivno toksičnost ob visokih maternotoksičnih odmerkih (glejte poglavje 5. 3).
Timolol Epidemiological studies have not revealed malformative effects but shown a risk for intra uterine growth retardation when beta-blockers are administered by the oral route.
Timolol Epidemiološke študije niso pokazale škodljivih učinkov na razvoj ploda, vendar pa je bilo ob oralni uporabi zaviralcev beta ugotovljeno tveganje za upočasnitev intrauterine rasti.
In addition, signs and symptoms of beta-blockade (e. g. bradycardia, hypotension, respiratory distress and hypoglycaemia) have been observed in the neonate when beta-blockers have been administered until delivery.
Poleg tega so pri novorojencih opazili znake in simptome zaviranja receptorjev beta (npr. bradikardija, hipotenzija, dihalna stiska in hipoglikemija) če so zaviralce receptorjev beta uporabljali pred porodom.
If GANFORT is administered until delivery, the neonate should be carefully monitored during the first days of life.
Če se je zdravilo GANFORT uporabljal pred porodom, je potrebno novorojenca prve dni po rojstvu skrbno opazovati.
Animal studies with timolol have shown reproductive toxicity at doses significantly higher than would be used in clinical practice (see section 5.3).
Študije na živalih so pokazale reproduktivno toksičnost pri odmerkih, bistveno višjih od tistih, kot bi jih uporabili v klinični praksi (glejte poglavje 5. 3).
Consequently, GANFORT should not be used during pregnancy unless clearly necessary.
V kolikor ni nujno potrebno se zdravilo GANFORT ne uporablja med nosečnostjo.
Lactation Timolol is excreted in breast milk.
Dojenje Timolol se izloča v materino mleko.
As with any ocular treatment, if transient blurred vision occurs at instillation, the patient should wait until the vision clears before driving or using machinery.
Bolniki morajo pred vožnjo ali upravljanjem s stroji počakati, da simptomi minejo.
No adverse drug reactions (ADRs) specific for GANFORT have been observed in clinical studies.
V kliničnih študijah niso opazili specifičnih neželenih učinkov zdravila GANFORT.
The ADRs have been limited to those earlier reported for bimatoprost and timolol.
Neželeni učinki so bili omejeni na tiste, o katerih so že poročali v zvezi z uporabo bimatoprosta in timolola.
The majority of ADRs were ocular, mild in severity and none were serious.
Nobeden od njih ni bil resnejše narave.
Based on 12-month clinical data, the most commonly reported ADR was conjunctival hyperaemia (mostly trace to mild and thought to be of a non-inflammatory nature) in approximately 26% of patients and led to discontinuation in 1.5% of patients.
Po kliničnih podatkih, zbranih v 12 mesecih, je bil najpogostejši neželeni učinek konjunktivna hiperemija (večinoma komaj zaznavna do blaga in domnevno nevnetnega izvora), ki se je pojavila pri približno 26% bolnikov, pri 1, 5% bolnikov pa je bilo zaradi tega zdravljenje prekinjeno.
The following ADRs were reported during clinical trials with GANFORT (within each frequency grouping, undesirable effects are presented in order of decreasing seriousness):
V kliničnih preskušanjih z zdravilom GANFORT so poročali o naslednjih neželenih učinkih (v razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti):
4 Nervous system disorders Uncommon (≥ 1/ 1000 to < 1/ 100): headache
4 Bolezni živčevja Občasni (≥1/ 1. 000 do < 1/ 100): glavobol
Eye disorders Very common (≥ 1/ 10): conjunctival hyperaemia, growth of eyelashes.
Zelo pogosti (≥1/ 10): konjunktivna hiperemija, rast trepalnic.
Common (≥ 1/ 100 to < 1/ 10): superficial punctuate keratitis, corneal erosion, burning sensation, eye pruritus, stinging sensation in the eye, foreign body sensation, eye dryness, eyelid erythema, eye pain, photophobia, eye discharge, visual disturbance, eyelid pruritus.
Pogosti (≥1/ 100 do < 1/ 10): superfacialni točkasti keratitis, erozija roženice, pekoče oči, očesni pruritus, občutek zbadanja v očesu, občutek tujka v očesu, suhe oči, eritem vek, bolečine v očeh, fotofobija, očesni izcedek, motnje vida, pruritus vek.
Uncommon (≥ 1/ 1000 to < 1/ 100): iritis, eye irritation, conjunctival oedema, blepharitis, epiphora, eyelid oedema, eyelid pain, visual acuity worsened, asthenopia, trichiasis.
Občasni (≥1/ 1. 000 do < 1/ 100): iritis, iritacije oči, konjunktivni edem, blefaritis, solzenje, edem vek, boleče veke, slabšanje ostrine vida, astenopija, trihiaza.
Not known: cystoid macular oedema.
Neznana: cistoidni edem makule.
Respiratory, thoracic and mediastinal disorders Uncommon (≥ 1/ 1000 to < 1/ 100): rhinitis
Bolezni dihal, prsnega koša in mediastinalnega prostora Občasni (≥1/ 1. 000 do < 1/ 100): rinitis