FrancophonIA/ELRC3.0 huggingface dataset:
English: Recent (i.e. within last 6 months) transaminase and bilirubin levels should be available before initiation of treatment with siponimod.
Slovenian: Pred začetkom zdravljenja s siponimodom je treba pridobiti nedavne podatke o vrednostih aminotransferaz in bilirubina (v času zadnjih 6 mesecev).
English: Mayzent 2 mg film-coated tablets siponimod
Slovenian: Mayzent 2 mg filmsko obložene tablete siponimod
English: Therefore, patients should not drive or use machines during the first day of treatment initiation with siponimod (see section 4.4).
Slovenian: Ker pa se v času uvajanja zdravljenja s siponimodom pri bolnikih občasno lahko pojavlja omotičnost, bolniki prvi dan po uvedbi zdravljenja s siponimodom ne smejo voziti in upravljati strojev (glejte poglavje 4.4).
English: Cases of CM have been reported for another sphingosine 1-phosphate (S1P) receptor modulator.
Slovenian: O primerih kriptokoknega meningitisa so poročali tudi pri uporabi drugega modulatorja receptorja za sfingozin-1-fosfat (S1P).
English: Mayzent 0.25 mg film-coated tablets
Slovenian: Mayzent 0,25 mg filmsko obložene tablete
English: Siponimod concentration increases in an apparent dose proportional manner after multiple once-daily doses of siponimod 0.3 mg to 20 mg.
Slovenian: Po večkratnih odmerkih 0,3 mg do 20 mg enkrat dnevno se koncentracija siponimoda zvišuje na videz sorazmerno z višino odmerka.
English: In the phase III clinical study in patients with SPMS the overall rate of infections was comparable between the patients on siponimod and those on placebo (49.0% versus 49.1%, respectively).
Slovenian: V klinični študiji faze III pri bolnikih s sekundarno progresivno multiplo sklerozo je bila pri uporabi siponimoda celokupna pogostnost okužb podobna kot pri uporabi placeba (49,0 % v primerjavi z 49,1 %), vendar so poročali o večji pogostnosti okužbe s herpes zoster pri bolnikih, ki so prejemali siponimod (2,5 %), kot pri tistih, ki so prejemali placebo (0,7 %).
English: Tablet coating: Polyvinyl alcohol, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), talc, soya lecithin, xanthan gum.
Slovenian: Obloga tablete: polivinilalkohol, titanov dioksid (E171), rumeni železov oksid (E172), rdeči železov oksid (E172), smukec, sojin lecitin, ksantan gumi
English: Titration dose
Slovenian: Titracijski odmerek Režim titriranja Odmerek
English: In healthy subjects, the single maximum tolerated dose was determined to be 25 mg based upon the occurrence of symptomatic bradycardia after single doses of 75 mg. A few subjects received unintended doses of up to 200 mg daily for 3 to 4 days and experienced asymptomatic mild to moderate transient elevations of liver function tests.
Slovenian: Pri zdravih prostovoljcih so na osnovi pojavljanja simptomatske bradikardije po odmerjanju enkratnega odmerka 75 mg ugotovili, da je najvišji enkratni odmerek, ki ga človek prenaša, 25 mg.
English: During the first 6 days of treatment, if a titration dose is missed on one day treatment needs to be re-initiated with a new titration pack.
Slovenian: En ali več izpuščenih odmerkov v času uvajanja zdravljenja Če v prvih 6 dneh zdravljenja bolnik en ali več dni izpusti titracijski odmerek, mora zdravljenje začeti od začetka z novim titracijskim pakiranjem.
English: Mayzent 0.25 mg film-coated tablets Mayzent 2 mg film-coated tablets
Slovenian: Mayzent 0,25 mg filmsko obložene tablete Mayzent 2 mg filmsko obložene tablete
English: A case of cryptococcal meningitis (CM) has been reported for siponimod.
Slovenian: Pri uporabi siponimoda so poročali o primeru kriptokoknega meningitisa.
English: Seizures were reported in 1.7% of patients treated with siponimod compared to 0.4% on placebo in the phase III clinical study in patients with SPMS.
Slovenian: V klinični študiji faze III pri bolnikih s sekundarno progresivno multiplo sklerozo so o epileptičnih napadih poročali pri 1,7 % bolnikov, ki so prejemali siponimod, v primerjavi z 0,4 % bolnikov, ki so prejemali placebo.
English: PBPK modelling indicates a differential CYP2C9 genotype-dependent inhibition and induction of CYP3A4 pathways.
Slovenian: Podatki fiziološkega farmakokinetičnega modeliranja kažejo, da se zaviranje in indukcija metaboličnih procesov, ki vključujejo CYP3A4, razlikujejo glede na genotip CYP2C9.
English: Time to 6-month CDP versus placebo
Slovenian: meseci v študiji siponimod placebo meseci v študiji
English: Nervous system disorders Very common
Slovenian: Žilne bolezni zelo pogosti hipertenzija
English: 4.8 Undesirable effects
Slovenian: 4.8 Neželeni učinki Povzetek varnostnih lastnosti zdravila
English: Mayzent 0.25 mg film-coated tablets Mayzent 2 mg film-coated tablets siponimod
Slovenian: Mayzent 0,25 mg filmsko obložene tablete Mayzent 2 mg filmsko obložene tablete siponimod
English: Stopping siponimod therapy
Slovenian: Prekinitev zdravljenja s siponimodom
English: Rare cases of posterior reversible encephalopathy syndrome (PRES) have been reported for another sphingosine 1-phosphate (S1P) receptor modulator.
Slovenian: Pri uporabi drugega modulatorja receptorja za sfingozin-1-fosfat (S1P) so poročali o redkih primerih sindroma posteriorne reverzibilne encefalopatije (posterior reversible encephalopathy syndrome, PRES).
English: • Perform liver function tests prior to initiating siponimod treatment.
Slovenian: • Pred začetkom zdravljenja s siponimodom določite vrednosti testov delovanja jeter.
English: Mayzent contains the active substance siponimod.
Slovenian: Zdravilna učinkovina v zdravilu Mayzent je siponimod.
English: Confirmed at 6 months [Nominal p-value for endpoints not included in the hierarchical testing and not adjusted for multiplicity]
Slovenian: 25 % [(p=0,0163)] na osnovi Coxovega modeliranja podatkov o času do napredovanja na osnovi modela ponavljajočih se dogodkov povprečje vrednosti v 12. in 24. mesecu do konca 24. meseca ocena potrjena po 6 mesecih [absolutna vrednost p za cilje opazovanja ni bila vključena v hierarhično testiranje in ni prilagojena na večkratnost testiranja] vrednost p ni potrditvena; postopek hierarhičnega testiranja so zaključili, preden je bil dosežen cilj opazovanja
English: Hazard ratio: 0.69 (95% Cl: 0.53, 0.91); risk reduction: 31%
Slovenian: Čas do 6-mesečnega potrjenega napredovanja invalidnosti v primerjavi z uporabo placeba razmerje ogroženosti: 0,69, (95% IZ: 0,53, 0,91); zmanjšanje tveganja: 31%
English: • Visual disturbances such as a shadow or a blind spot in the centre of vision, blurred vision,
Slovenian: • motnje vida, kot je senca ali slepa pega v centralnem delu vidnega polja, zamegljen vid, težave z zaznavanjem barv ali podrobnosti (simptomi makularnega edema, ki je oteklina v predelu rumene pege na mrežnici na očesnem ozadju)
English: Siponimod therapy should not be initiated in patients with macular oedema until resolution.
Slovenian: Bolnikom z makularnim edemom se zdravljenja s siponimodom ne sme uvajati, dokler edem ni odpravljen.
English: Increased hepatic enzymes (mostly ALT elevation) have been reported in MS patients treated with siponimod.
Slovenian: Pri bolnikih z multiplo sklerozo, ki so prejemali siponimod, so poročali o zvišanih vrednostih jetrnih encimov (večinoma o zvišani vrednosti alanin- aminotransferaze, ALT).
English: Mayzent 0.25 mg film-coated tablets siponimod
Slovenian: Mayzent 0,25 mg filmsko obložene tablete siponimod
English: • A negative pregnancy test result is required prior to initiation of treatment in women of childbearing potential.
Slovenian: • Pri ženskah v rodni dobi je pred začetkom zdravljenja treba opraviti nosečnostni test, ki mora biti negativen.
English: Hypertension was more frequently reported in patients on siponimod (12.6%) than in those given placebo (9.0%) in the phase III clinical study in patients with SPMS.
Slovenian: V klinični študiji faze III pri bolnikih s sekundarno progresivno multiplo sklerozo so o hipertenziji poročali pogosteje pri bolnikih, ki so prejemali siponimod (12,6 %), kot pri tistih, ki so prejemali placebo (9,0 %).
English: • if you have never had chickenpox and have not been vaccinated against it. You may be at greater risk of complications if you develop chickenpox during Mayzent treatment.
Slovenian: • če nikoli niste preboleli noric in niste bili cepljeni proti noricam.
English: Although the majority of cases occurred within 3 to 4 months of commencing siponimod, cases were also reported in patients treated with siponimod for more than 6 months (see section 4.4).
Slovenian: O makularnem edemu so pogosteje poročali pri bolnikih, ki so prejemali siponimod (1,8 %), kot pri tistih, ki so prejemali placebo (0,2 %) Čeprav je do večine primerov prišlo v prvih 3-4 mesecih po začetku zdravljenja, so o nekaj primerih poročali tudi pri bolnikih, ki so siponimod prejemali več kot 6 mesecev (glejte poglavje 4.4).
English: How to store Mayzent
Slovenian: Shranjevanje zdravila Mayzent
English: Neoplasms benign, malignant and unspecified (incl.
Slovenian: Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi) pogosti melanocitni nevus
English: Your doctor may need to stop or reduce your Mayzent dose if the white blood cell count is too low.
Slovenian: Če bo število belih krvnih celic prenizko, vam bo zdravnik morda moral znižati odmerek ali prekinil jemanje zdravila Mayzent.
English: • new moles
Slovenian: • nova kožna znamenja
English: Sun.
Slovenian: NYHA).
English: • Adjust the maintenance dose to 1 mg in patients with CYP2C9*2*3 or *1*3 genotypes.
Slovenian: • Bolnikom z genotipom CYP2C9*2*3 ali *1*3 prilagodite vzdrževalni odmerek na 1 mg.
English: These observations were slightly higher (approximately 0.15 L mean change from baseline in FEV1) in patients with respiratory disorders such as chronic obstructive pulmonary disease (COPD) or asthma treated with siponimod.
Slovenian: Pri bolnikih, ki so prejemali siponimod in so imeli katero od respiratornih bolezni, kot sta kronična obstruktivna pljučna bolezen (KOPB) ali astma, so bile te spremembe nekoliko večje (povprečna sprememba od izhodiščne vrednosti FEV1 je bila približno 0,15 l).
English: You should not breast-feed while you are taking Mayzent.
Slovenian: V času jemanja zdravila Mayzent ne smete dojiti.
English: Repeat the first-dose monitoring after the second dose of siponimod.
Slovenian: Po prejemu drugega odmerka siponimoda je treba ponoviti enak postopek spremljanja kot po prvem odmerku.
English: Caution should be exercised when siponimod is initiated in patients receiving beta blockers due to the additive effects on lowering heart rate (see section 4.4).
Slovenian: Zaradi možnosti aditivnega delovanja na srčno frekvenco je pri uvajanju zdravljenja s siponimodom pri bolnikih, ki prejemajo zaviralce adrenergičnih receptorjev beta, potrebna previdnost (glejte poglavje 4.4).
English: PARTICULARS TO APPEAR ON THE INNER PACKAGING
Slovenian: PODATKI NA NOTRANJI OVOJNINI
English: Specialised pre-natal monitoring will be performed.
Slovenian: Dogovorili se boste za posebne preglede za spremljanje otroka pred rojstvom.
English: Polyvinyl alcohol Titanium dioxide (E171) Yellow iron oxide (E172) Red iron oxide (E172) Talc
Slovenian: Obloga tablete polivinilalkohol titanov dioksid (E171) rumeni železov oksid (E172) rdeči železov oksid (E172) smukec sojin lecitin ksantan gumi
English: Polyvinyl alcohol Titanium dioxide (E171) Red iron oxide (E172) Black iron oxide (E172) Talc
Slovenian: Obloga tablete polivinilalkohol titanov dioksid (E171) rdeči železov oksid (E172) črni železov oksid (E172) smukec sojin lecitin ksantan gumi
English: By acting as a functional antagonist on S1P1 receptors on lymphocytes, siponimod prevents egress from lymph nodes.
Slovenian: Siponimod na receptorjih S1P1 na limfocitih deluje kot funkcionalni antagonist in tako preprečuje izstop limfocitov iz bezgavk, kar zmanjša obseg ponovnega vstopa limfocitov T v centralni živčni sistem (CŽS), to pa zmanjša obseg vnetja v centralnem živčevju.
English: • Arrange an ophthalmological evaluation prior to initiating therapy and follow-up evaluations while receiving therapy in patients with a history of diabetes mellitus, uveitis or underlying/co-existing retinal disease.
Slovenian: • Pri bolnikih z anamnezo sladkorne bolezni, uveitisa ali obstoječe oziroma sočasno prisotne bolezni mrežnice je treba opraviti oftalmološki pregled pred začetkom zdravljenja in izvajati kontrolne preglede v času prejemanja siponimoda.
English: Bradyarrhythmic effects are more pronounced when siponimod is added to beta-blocker therapy.
Slovenian: Kadar bolnik poleg zdravljenja z zaviralci adrenergičnih receptorjev beta začne prejemati siponimod, so bradiaritmični učinki močneje izraženi.
English: Discontinue treatment if significant liver injury is confirmed.
Slovenian: Če izvidi potrdijo pomembno okvaro jeter, prekinite zdravljenje.
English: Because of the potential additive effect on heart rate, treatment with siponimod should generally not be initiated in patients who are concurrently treated with these substances (see section 4.4).
Slovenian: Bolnikom, ki se že zdravijo z navedenimi učinkovinami, se zaradi možnosti aditivnega učinka na srčno frekvenco zdravljenja s siponimodom načeloma ne sme uvesti (glejte poglavje 4.4).
English: It is recommended that siponimod be discontinued if a patient develops macular oedema.
Slovenian: Če pri bolniku pride do makularnega edema, se priporoča prekinitev zdravljenja s siponimodom.
English: • Counsel the patient in case of inadvertent pregnancy.
Slovenian: • Če pride do nenačrtovane nosečnosti, je treba poskrbeti za ustrezno strokovno svetovanje bolnici.
English: Time to 3-month CDP versus placebo
Slovenian: Čas do 3-mesečnega potrjenega napredovanja invalidnosti v primerjavi z uporabo placeba
English: Tablet coating
Slovenian: Kožni tumorji
English: Pale red, round, biconvex, bevelled-edged film-coated tablet of approximately 6.1 mm diameter with company logo on one side and “T” on the other side.
Slovenian: 6,1 mm, z logotipom družbe na eni strani in oznako “T” na drugi.
English: These may be symptoms of a condition called posterior reversible encephalopathy syndrome (PRES).
Slovenian: • če imate simptome, kot so nenaden pojav hudega glavobola, zmedenost, napad s krči in motnje vida: lahko gre za simptome bolezni, ki jo imenujemo sindrom posteriorne reverzibilne encefalopatije (posterior reversible encephalopathy syndrome, PRES).
English: It must not be used by patients who:
Slovenian: Ne smejo ga uporabljati bolniki, ki imajo:
English: • have certain heart problems;
Slovenian: • določena obolenja srca;
English: • have or have had asthma;
Slovenian: • astmo ali so imeli astmo v preteklosti;
English: Brinzolamide has been authorised in the European Union (EU) as Azopt since 2000.
Slovenian: Brinzolamid je v Evropski uniji (EU) odobren od leta 2000 kot zdravilo Azopt.
English: The European Commission granted a marketing authorisation valid throughout the EU for Azarga on 25 November 2008.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Azarga, veljavno po vsej Evropski uniji, odobrila 25. novembra 2008.
English: • have severely reduced kidney function.
Slovenian: • močno zmanjšano delovanje ledvic.
English: It is available as eye drops.
Slovenian: Na voljo je v obliki kapljic za oči.
English: Azarga brinzolamide / timolol
Slovenian: Azarga brinzolamid/timolol
English: The full EPAR for Azarga can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Azarga je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Azarga?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Azarga?
English: Other information about Azarga
Slovenian: Druge informacije o zdravilu Azarga
English: This is a summary of the European public assessment report (EPAR) for Azarga.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Azarga.
English: Azarga must not be used in patients who are hypersensitive (allergic) to the active substances, any of the other ingredients, other beta blockers (such as some heart medicines) or sulphonamides (an antibiotic).
Slovenian: Zdravila Azarga se ne sme uporabljati pri bolnikih, ki so preobčutljivi za (alergični na) zdravilni učinkovini zdravila, katero koli od sestavin zdravila, druge zaviralce receptorjev beta (kot so npr. nekatera zdravila za srce) ali sulfonamide (antibiotik).
English: What benefit has Azarga shown during the studies?
Slovenian: Kakšne koristi je zdravilo Azarga izkazalo med študijami?
English: A risk management plan has been developed to ensure that Azarga is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Azarga je bil pripravljen načrt obvladovanja tveganj.
English: If it is used with another eye medicine, the different medicines should be used at least 5 minutes apart.
Slovenian: Če se uporablja sočasno z drugim zdravilom za oči, mora med dajanjem obeh zdravil preteči najmanj 5 minut.
English: In both studies, the main measure of effectiveness was the change in IOP over the first six months of treatment.
Slovenian: V obeh študijah je bilo glavno merilo učinkovitosti sprememba očesnega tlaka v prvih šestih mesecih zdravljenja.
English: • have hyperchloraemic acidosis (excess acid in the blood caused by too much chloride);
Slovenian: • hiperkloremično acidozo (prekomerno količino kisline v krvi, ki jo povzroča prevelika koncentracija klorida);
English: For more information about treatment with Azarga, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Azarga preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: It is used in adults with open-angle glaucoma (a disease where the pressure in the eye rises because fluid cannot drain out of the eye) or ocular hypertension (when the pressure in the eye is higher than normal).
Slovenian: Uporablja se pri odraslih, ki imajo glavkom z odprtim zakotjem (bolezen, pri kateri se očesni tlak zvišuje, ker tekočina ne more iztekati iz očesa) ali okularno hipertenzijo (očesni tlak je višji od običajnega).
English: The most common side effects with Azarga (seen in between 1 and 10 patients in 100) are blurred vision, eye pain and eye irritation.
Slovenian: Najpogostejši neželeni učinki zdravila Azarga (opaženi pri 1 do 10 bolnikih od 100) so zamegljenost vida, bolečine v očesu in draženje v očesu.
English: The Committee decided that Azarga's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Zaključil je, da so koristi zdravila Azarga večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: By lowering the pressure, Azarga reduces the risk of damage.
Slovenian: Zdravilo Azarga z zniževanjem tlaka zmanjša nevarnost poškodb.
English: Brinzolamide is a carbonic anhydrase inhibitor that works by blocking an enzyme called carbonic anhydrase, which produces bicarbonate ions in the body.
Slovenian: Brinzolamid je zaviralec karboanhidraze in deluje tako, da zavira encim, imenovan karboanhidraza, ki v telesu tvori bikarbonatne ione.
English: The Committee for Medicinal Products for Human Use (CHMP) noted that combining the two active substances in Azarga simplifies therapy and helps patients to stick to their treatment.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je menil, da kombinacija obeh zdravilnih učinkovin v zdravilu Azarga poenostavi zdravljenje in bolnikom pomaga vzdrževati redno uporabo zdravila.
English: Raised IOP causes damage to the retina (the light-sensitive surface at the back of the eye) and to the optic nerve that sends signals from the eye to the brain.
Slovenian: Povišani intraokularni tlak povzroča poškodbe očesne mrežnice (na svetlobo občutljivega sloja, ki se nahaja v ozadju očesa) in optičnega živca, ki pošilja signale od oči do možganov.
English: Azarga has been studied in two main studies involving a total of 960 adults with open-angle glaucoma or ocular hypertension.
Slovenian: Zdravilo Azarga so raziskali v dveh glavnih študijah, ki sta vključevali skupno 960 odraslih z glavkomom odprtega zakotja ali očesno hipertenzijo.
English: Azarga was more effective than either of the active substances used alone and was as effective as the combination of timolol and dorzolamide.
Slovenian: Zdravilo Azarga je bilo učinkovitejše od katere koli od obeh učinkovin, uporabljenih posamično, in enako učinkovito kot kombinacija timolola in dorzolamida.
English: If the other eye medicine is an eye ointment it should be used last.
Slovenian: Če gre pri tem drugem zdravilu za mazilo za oči, le-tega nanesemo nazadnje.
English: Azarga is used to reduce intra-ocular pressure (IOP, pressure inside the eye).
Slovenian: Zdravilo Azarga se uporablja za zmanjševanje intraokularnega tlaka (tlaka znotraj očesa).
English: IOP was measured in ‘millimetres of mercury' (mmHg).
Slovenian: Očesni tlak se meri v „milimetrih živega srebra“ (mmHg).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Azarga, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Azarga in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Azarga contains benzalkonium chloride, which is known to discolour soft contact lenses.
Slovenian: Zdravilo Azarga vsebuje benzalkonijev klorid, za katerega je znano, da razbarva mehke kontaktne leče.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Azarga.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The two substances work by reducing the production of the aqueous humour (the watery fluid in the eye) in different ways.
Slovenian: Obe učinkovini delujeta tako, da na različen način zmanjšujeta tvorbo prekatne vodke (vodene tekočine v očesu).
English: • have a severe allergic rhinitis (allergy affecting the nose and airways);
Slovenian: • hudi alergijski rinitis (alergijo, ki prizadene nosno votlino in dihalne poti);
English: What is the risk associated with Azarga?
Slovenian: Kakšna tveganja so povezana z zdravilom Azarga?
English: Timolol is a beta blocker that has been commonly used to treat glaucoma since the 1970s.
Slovenian: Timolol je zaviralec receptorjev beta, ki se od sedemdesetih let prejšnjega stoletja uporablja za zdravljenje glavkoma.
English: The combination of the two active substances has an additive effect, reducing the pressure inside the eye more than either medicine alone.
Slovenian: Učinka obeh zdravilnih učinkovin v kombinaciji se seštevata, saj njuna kombinacija zmanjšuje tlak v očesu bolj kot katera koli od obeh učinkovin posamično.
English: Azarga is used when treatment with a medicine containing only one active substance has been tried but has not reduced the IOP sufficiently.
Slovenian: Zdravilo Azarga se uporablja, kadar je bilo pri bolniku preizkušeno zdravljenje z zdravilom, ki vsebuje le eno zdravilno učinkovino, vendar to ni zadostno zmanjšalo intraokularnega tlaka.
English: • have severe chronic obstructive pulmonary disease (COPD, a disease causing narrowing of the airways);
Slovenian: • hudo kronično obstruktivno pljučno bolezen (KOPB, tj. obolenje, ki povzroča zožitev dihalnih poti);