FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Ako se tijekom prvih 6 dana liječenja propusti titracijska doza na jedan od tih dana, liječenje je potrebno ponovo započeti s novim pakiranjem za titraciju.
English: Siponimod treatment should be suspended until CM has been excluded.
Croatian: Liječenje siponimodom treba obustaviti dok se ne isključi KM.
English: Day 6
Croatian: 6. dan
English: The CYP2C9 genotype influences siponimod CL/F.
Croatian: Genotip CYP2C9 utječe na CL/F siponimoda.
English: Siponimod must not be used in patients with severe hepatic impairment (see section 4.3).
Croatian: Siponimod se ne smije primjenjivati u bolesnika s teškim oštećenjem funkcije jetre (vidjeti dio 4.3).
English: Hazard ratio: 0.79, p=0.0134; (95% Cl: 0.65, 0.95); risk reduction: 21%
Croatian: Omjer hazarda: 0,79, p=0,0134; (95% Cl: 0,65; 0,95); smanjenje rizika: 21%
English: Hazard ratio: 0.63 (95% Cl: 0.47, 0.86); risk reduction: 37%
Croatian: Omjer hazarda: 0,63 (95% Cl: 0,47; 0,86); smanjenje rizika: 37%
English: If necessary, the decrease in heart rate induced by siponimod can be reversed by parenteral doses of atropine or isoprenaline.
Croatian: Ako je nužno, učinak smanjenja srčane frekvencije induciran siponimodom može se poništiti parenteralnim dozama atropina ili izoprenalina.
English: Liver function test increased
Croatian: Povišene vrijednosti rezultata testova funkcije jetre
English: Titration pack 12 film-coated tablets 120 film-coated tablets
Croatian: Filmom obložena tableta Pakiranje za titraciju 12 filmom obloženih tableta 120 filmom obloženih tableta
English: - History of progressive multifocal leukoencephalopathy or cryptococcal meningitis.
Croatian: - Progresivna multifokalna leukoencefalopatija ili kriptokokni meningitis u anamnezi.
English: Siponimod therapy should not be initiated in patients with macular oedema until resolution.
Croatian: Liječenje siponimodom ne smije započeti u bolesnika s makularnim edemom dok se ne povuče.
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.
Croatian: Blijedo crvena, okrugla, bikonveksna filmom obložena tableta s ukošenim rubom, promjera približno 6,1 mm, s logotipom tvrtke s jedne strane i oznakom „T“ s druge strane.
English: Mayzent helps to protect the central nervous system (CNS) from attacks by the body's own immune system.
Croatian: Mayzent pomaže zaštititi središnji živčani sustav (SŽS) od napada vlastitog imunološkog sustava tijela tako što: - smanjuje sposobnost nekih bijelih krvnih stanica (koje se nazivaju limfociti) da se slobodno kreću po tijelu i - sprječava te stanice da dospiju do mozga i kralježnične moždine.
English: 28 film-coated tablets
Croatian: Filmom obložena tableta 28 filmom obloženih tableta
English: • Patients should be instructed to report signs and symptoms of infections immediately to their prescriber during and for up to one month after treatment with siponimod.
Croatian: • Bolesnike je potrebno uputiti da liječniku koji je propisao lijek odmah prijave znakove i simptome infekcije tijekom te do mjesec dana nakon liječenja siponimodom.
English: Percentage of subjects with 6-month CDP
Croatian: Postotak ispitanika s 6-mjesečnim CDP-om
English: In clinical studies, second-degree AV blocks, usually Mobitz type I (Wenckebach), have been observed in less than 1.7% of patients at the time of treatment initiation.
Croatian: I (Wenckebach), bili su opaženi u manje od 1,7% bolesnika u vrijeme početka liječenja.
English: Pale yellow, round, biconvex, bevelled-edged film-coated tablet of approximately 6.1 mm diameter with company logo on one side and “II” on the other side.
Croatian: Blijedo žuta, okrugla, bikonveksna filmom obložena tableta s ukošenim rubom, promjera približno 6,1 mm, s logotipom tvrtke s jedne strane i oznakom „II“ s druge strane.
English: With regard to disease activity, features characteristic of inflammatory activity in SPMS can be relapse- or imaging-related (i.e. Gd-enhancing T1 lesions or active [new or enlarging] T2 lesions).
Croatian: Što se tiče aktivnosti bolesti, značajke na temelju kojih se određuje upalna aktivnost u SPMS-u mogu biti relapsi ili snimci (tj.
English: Seizures
Croatian: Cijepljenje
English: Re-initiation of maintenance therapy after treatment interruption If maintenance treatment is interrupted for 4 or more consecutive daily doses, siponimod needs to be re-initiated with a new titration pack.
Croatian: Ako se terapija održavanja prekine propuštanjem 4 ili više uzastopnih dnevnih doza, siponimod je potrebno ponovno započeti s novim pakiranjem za titraciju.
English: If resting heart rate is ≤50 bpm, then beta-blocker treatment should be interrupted until the baseline heart rate is >50 bpm.
Croatian: Ako je srčana frekvencija ≤50 otkucaja u minuti, liječenje beta blokatorom potrebno je prekinuti dok početna srčana frekvencija ne bude
English: Exposure to the sun and protection against the sun Mayzent weakens your immune system.
Croatian: Izloženost suncu i zaštita od sunca
English: Intermediate metabolisers CYP2C9*2*2
Croatian: Srednje brzi metabolizatori CYP2C9*2*2
English: • Patients with the below conditions.
Croatian: • bolesnika s bolestima navedenima u nastavku.
English: Percentage brain volume change relative to baseline (95% CI)
Croatian: Postotak promjene volumena mozga u odnosu na početnu vrijednost (95% CI) Razlika u postotku promjene volumena mozga
English: Pulmonary function test decreased
Croatian: Smanjene vrijednosti na testu plućne funkcije
English: How to store Mayzent
Croatian: Kako čuvati Mayzent
English: Lactose monohydrate Microcrystalline cellulose Crospovidone Glycerol dibehenate Colloidal anhydrous silica
Croatian: Mayzent 2 mg filmom obložene tablete Jezgra tablete laktoza hidrat mikrokristalična celuloza krospovidon gliceroldibehenat koloidni bezvodni silicijev dioksid
English: • Summary of Product Characteristics;
Croatian: • Sažetak opisa svojstava lijeka;
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.
Croatian: U zdravih ispitanika utvrđeno je da je najviša jednokratna podnošljiva doza 25 mg na temelju pojave simptomatske bradikardije nakon jednokratnih doza od 75 mg.
English: Titration pack of 12 film-coated tablets
Croatian: Pakiranje za titraciju s 12 filmom obloženih tableta
English: • A case of cryptococcal meningitis (CM) has been reported for siponimod.
Croatian: • Uz siponimod je bio prijavljen slučaj kriptokoknog meningitisa (KM).
English: • Each tablet contains 2 mg siponimod (as siponimod fumaric acid).
Croatian: • Jedna tableta sadrži 2 mg siponimoda (u obliku siponimod fumaratne kiseline).
English: • dizziness
Croatian: • cjepiva.
English: • Each tablet contains 0.25 mg siponimod (as siponimod fumaric acid).
Croatian: • Jedna tableta sadrži 0,25 mg siponimoda (u obliku siponimod fumaratne kiseline).
English: Mayzent 2 mg film-coated tablets siponimod
Croatian: Mayzent 2 mg filmom obložene tablete siponimod
English: Cases of CM have been reported for another sphingosine 1-phosphate (S1P) receptor modulator.
Croatian: Slučajevi KM-a bili su prijavljeni i kod drugih modulatora sfingozin 1-fosfat (S1P) receptora.
English: There are no or limited amount of data available from the use of siponimod in pregnant women.
Croatian: Podaci o primjeni siponimoda u trudnica ne postoje ili su ograničeni.
English: Mayzent 2 mg film-coated tablets
Croatian: Mayzent 2 mg filmom obložene tablete
English: Each film-coated tablet contains siponimod fumaric acid equivalent to 2 mg siponimod.
Croatian: Jedna filmom obložena tableta sadrži 2 mg siponimoda u obliku siponimod fumaratne kiseline.
English: On your first day of treatment with Mayzent, therefore, you should not drive or use machines.
Croatian: Stoga, ne smijete upravljati vozilima ili strojevima prvog dana liječenja Mayzentom.
English: BLISTERS (pack of 120 film-coated tablets of 0.25 mg)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTERI (pakiranje od 120 filmom obloženih tableta od 0,25 mg)
English: Tablet coating: Polyvinyl alcohol, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), talc, soya lecithin, xanthan gum.
Croatian: Ovojnica tablete: poli(vinilni alkohol), titanijev dioksid (E171), žuti željezov oksid (E172), crveni željezov oksid (E172), talk, sojin lecitin, ksantanska guma.
English: Repeat the first-dose monitoring after the second dose of siponimod.
Croatian: I nakon druge doze ponoviti isto praćenje kao kod prve doze
English: Each tablet contains 0.25 mg siponimod (as fumaric acid).
Croatian: Jedna tableta sadrži 0,25 mg siponimoda (u obliku fumaratne kiseline).
English: Tablet coating: Polyvinyl alcohol, titanium dioxide (E171), red iron oxide (E172), black iron oxide (E172), talc, soya lecithin, xanthan gum.
Croatian: Ovojnica tablete: poli(vinilni alkohol), titanijev dioksid (E171), crveni željezov oksid (E172), crni željezov oksid (E172), talk, sojin lecitin, ksantanska guma.
English: Each tablet contains 2 mg siponimod (as fumaric acid).
Croatian: Jedna tableta sadrži 2 mg siponimoda (u obliku fumaratne kiseline).
English: Mayzent is for oral use.
Croatian: Mayzent se uzima kroz usta.
English: Mayzent 0.25 mg film-coated tablets
Croatian: Mayzent 0,25 mg filmom obložene tablete
English: Change from baseline in T2 lesion volume (mm
Croatian: T2 lezija u odnosu na početnu vrijednost (mm
English: • Visual disturbances such as a shadow or a blind spot in the centre of vision, blurred vision,
Croatian: • Poremećaji vida poput sjene ili slijepe točke u središtu vidnog polja, zamagljen vid, problemi s razabiranjem boja ili detalja (simptomi makularnog edema, oticanja u makularnom području mrežnice u stražnjem dijelu oka)
English: Titration pack
Croatian: Pakiranje za titraciju
English: Mayzent 0.25 mg film-coated tablets Mayzent 2 mg film-coated tablets
Croatian: Mayzent 0,25 mg filmom obložene tablete Mayzent 2 mg filmom obložene tablete
English: Each film-coated tablet contains siponimod fumaric acid equivalent to 0.25 mg siponimod.
Croatian: Jedna filmom obložena tableta sadrži 0,25 mg siponimoda u obliku siponimod fumaratne kiseline.
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.
Croatian: U kliničkom ispitivanju faze III u bolesnika s SPMS-om, napadaji su bili prijavljeni u 1,7% bolesnika liječenih siponimodom u usporedbi s 0,4% na placebu.
English: A case of cryptococcal meningitis (CM) has been reported for siponimod.
Croatian: Kod liječenja siponimodom bio je prijavljen slučaj kriptokoknog meningitisa (KM).
English: Mayzent 0.25 mg film-coated tablets siponimod
Croatian: Mayzent 0,25 mg filmom obložene tablete siponimod
English: For 2 mg siponimod given once daily over 10 days, a mean Cmax of 30.4 ng/ml and mean AUCtau of 558 h*ng/ml were observed on day 10.
Croatian: Za 2 mg siponimoda koji se daje jedanput dnevno tijekom 10 dana, srednji Cmax od 30,4 ng/ml i srednji
English: Clinical endpoints
Croatian: Kliničke mjere ishoda
English: Mayzent 0.25 mg film-coated tablets Mayzent 2 mg film-coated tablets siponimod
Croatian: Mayzent 0,25 mg filmom obložene tablete Mayzent 2 mg filmom obložene tablete siponimod
English: Neoplasms benign, malignant and unspecified (incl.
Croatian: Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe) Često
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.
Croatian: • ako nikada niste imali vodene kozice i niste se cijepili protiv njih.
English: A transient, dose-dependent decrease in heart rate was observed during the initial dosing phase and plateaued at doses ≥5 mg. Bradyarrhythmic events (AV blocks and sinus pauses) were detected with a higher incidence under siponimod treatment compared to placebo.
Croatian: Događaji bradiaritmije (AV blokovi i sinusne pauze) bili su opaženi uz veću incidenciju kod terapije siponimodom u usporedbi s placebom.
English: Suspension of treatment with siponimod should be considered if a patient develops a serious infection.
Croatian: Ako se u bolesnika razvije ozbiljna infekcija potrebno je razmotriti privremeni prekid liječenja siponimodom.
English: Where at the 6-hour time point the ECG shows: New onset second-degree or higher AV block, or QTc interval ≥500 msec If pharmacological treatment is required, monitoring should be continued overnight and 6-hour monitoring should be repeated after the second dose.
Croatian: Ako nakon 6 sati EKG pokaže: Novonastali AV blok drugog ili višeg stupnja, ili QTc interval ≥500 msec
English: Polyvinyl alcohol Titanium dioxide (E171) Red iron oxide (E172) Black iron oxide (E172) Talc
Croatian: Ovojnica tablete poli(vinilni alkohol) titanijev dioksid (E171) crveni željezov oksid (E172) crni željezov oksid (E172) talk sojin lecitin ksantanska guma
English: Polyvinyl alcohol Titanium dioxide (E171) Yellow iron oxide (E172) Red iron oxide (E172) Talc
Croatian: Ovojnica tablete poli(vinilni alkohol) titanijev dioksid (E171) žuti željezov oksid (E172) crveni željezov oksid (E172) talk sojin lecitin ksantanska guma
English: Extensive metabolisers CYP2C9*1*1
Croatian: Spori metabolizatori CYP2C9*2*3
English: It must not be used by patients who:
Croatian: Ne smije se koristiti u bolesnika koji:
English: • have or have had asthma;
Croatian: • imaju ili su imali astmu;
English: • have certain heart problems;
Croatian: • imaju određene probleme sa srcem;
English: Therefore, care should be taken by people who wear soft contact lenses.
Croatian: Stoga, potrebno je obratiti pozornost na osobe koje nose meke kontaktne leće.
English: The suspension needs to be shaken well before use.
Croatian: Suspenzija se mora dobro protresti prije primjene.
English: It is available as eye drops.
Croatian: Dostupan je kao kapi za oči.
English: This summary was last updated in 03-2014.
Croatian: Sažetak je posljednji put ažuriran u 03. 2014.
English: Brinzolamide has been authorised in the European Union (EU) as Azopt since 2000.
Croatian: Brinzolamid je odobren u Europskoj uniji (EU) kao Azopt od 2000. godine.
English: In both studies, the main measure of effectiveness was the change in IOP over the first six months of treatment.
Croatian: U oba ispitivanja, glavna mjera djelotvornosti bila je promjena u IOP-u tijekom prvih šest mjeseci liječenja.
English: If it is used with another eye medicine, the different medicines should be used at least 5 minutes apart.
Croatian: Ako se primjenjuje s drugim lijekom za oči, različiti se lijekovi moraju koristiti u razmaku od najmanje 5 minuta.
English: • have severely reduced kidney function.
Croatian: • imaju ozbiljno smanjenu funkciju bubrega.
English: Azarga brinzolamide / timolol
Croatian: Azarga brinzolamid / timolol
English: By lowering the pressure, Azarga reduces the risk of damage.
Croatian: Snižavanjem tlaka Azarga snižava rizik od oštećenja.
English: Bicarbonate is required for the production of the aqueous humour.
Croatian: Bikarbonat je potreban za stvaranje vodenog humora.
English: Azarga is used to reduce intra-ocular pressure (IOP, pressure inside the eye).
Croatian: Azarga se koristi za snižavanje intraokularnog tlaka (IOP, tlaka unutar oka).
English: Timolol is a beta blocker that has been commonly used to treat glaucoma since the 1970s.
Croatian: Timolol je beta blokator koji se uobičajeno koristi za liječenje glaukoma od 1970-ih.
English: The combination of the two active substances has an additive effect, reducing the pressure inside the eye more than either medicine alone.
Croatian: Kombinacija dvije djelatne tvari ima aditivno djelovanje pri čemu se snižava tlak unutar oka više nego pojedinačnim lijekovima.
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).
Croatian: Koristi se u odraslih osoba s glaukomom otvorenog kuta (bolesti pri kojoj se tlak u oku povisi zato što tekućina ne može iscuriti iz oka) ili s očnom hipertenzijom (kada je tlak u oku viši od normalnog).
English: • have hyperchloraemic acidosis (excess acid in the blood caused by too much chloride);
Croatian: • imaju hiperkloremijsku acidozu (prekomjernu kiselinu u krvi koja uzrokuje previše klorida);
English: IOP was measured in ‘millimetres of mercury' (mmHg).
Croatian: IOP je izmjeren u „milimetrima žive” (mmHg).
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).
Croatian: Azarga se ne smije koristiti u bolesnika koji su preosjetljivi (alergični) na djelatne tvari, bilo koju pomoćnu tvar, druge beta blokatore (poput određenih lijekova za srce) ili sulfonamida (antibiotik).
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.
Croatian: Povišeni IOP uzrokuje oštećenje šarenice (površine osjetljive na svjetlo u stražnjem dijelu oka) i optičkog živca koji šalje signale iz oka u mozak.
English: Other information about Azarga
Croatian: Ostale informacije o lijeku Azarga
English: This is a summary of the European public assessment report (EPAR) for Azarga.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Azarga.
English: If the other eye medicine is an eye ointment it should be used last.
Croatian: Ako je drugi lijek za oči mast za oči, mast se mora koristiti posljednja.
English: What measures are being taken to ensure the safe and effective use of Azarga?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Azarga?
English: Azarga is used when treatment with a medicine containing only one active substance has been tried but has not reduced the IOP sufficiently.
Croatian: Azarga se koristi kada usprkos primjene liječenja lijekom koji sadrži samo jednu djelatnu tvar, nije nastupilo dostatno sniženje IOP-a.
English: Brinzolamide is a carbonic anhydrase inhibitor that works by blocking an enzyme called carbonic anhydrase, which produces bicarbonate ions in the body.
Croatian: Brinzolamid je inhibitor karbonske anhidraze koja djeluje blokirajući enzime naziva karbonska anhidraza, koja stvara bikarbonatne ione u tijelu.
English: In the second study, IOP had fallen from around 26 mmHg by around 8.3 mmHg after six months in both groups of patients.
Croatian: U drugom ispitivanju, IOP se snizio s otprilike 26 mmHg za otprilike 8,3 mmHg nakon šest mjeseci u obje grupe bolesnika.
English: Azarga has been studied in two main studies involving a total of 960 adults with open-angle glaucoma or ocular hypertension.
Croatian: Azarga se ispitivao u dva glavna ispitivanja koja su obuhvatila ukupno 960 odraslih osoba s glaukomom otvorenog kuta ili okularnom hipertenzijom.
English: Azarga was more effective than either of the active substances used alone and was as effective as the combination of timolol and dorzolamide.
Croatian: Azarga je bio djelotvorniji od bilo koje djelatne tvari koja se koristila samostalno te je bio podjednako učinkovit kao kombinacija timolola i dorzolamida.
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.
Croatian: Najčešće nuspojave lijeka Azarga (kod između 1 i 10 osoba na 100 osoba) su zamućen vid, bol u oku i nadraženost oka.
English: • have a severe allergic rhinitis (allergy affecting the nose and airways);
Croatian: • imaju ozbiljan alergijski rinitis (alergiju koja zahvaća nos i zračne putove);
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.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) zaključilo je da kombinacija dvije djelatne tvari lijeka Azarga olakšava terapiju i pomaže bolesnicima u pridržavanju svoje terapije.
English: For more information about treatment with Azarga, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Azarga pročitajte u uputama o lijeku (također dio EPAR-a) odnosno obratite se svom liječniku ili ljekarniku.
English: The second was a 12-month study comparing Azarga with the combination of timolol and dorzolamide (another carbonic anhydrase inhibitor) in 437 patients.
Croatian: Drugo ispitivanje je bilo 12-mjesečno ispitivanje koje je usporedilo lijek Azarga s kombinacijom timolola i dorzolamida (drugi inhibitor karbonske anhidraze) u 437 bolesnika.
English: A risk management plan has been developed to ensure that Azarga is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Azarga.
English: What is Azarga?
Croatian: Što je Azarga?
English: • have severe chronic obstructive pulmonary disease (COPD, a disease causing narrowing of the airways);
Croatian: • imaju kroničnu opstruktivnu pulmonalnu bolest (KOPB, bolest koja uzrokuje sužavanje zračnih putova);
English: Azarga contains benzalkonium chloride, which is known to discolour soft contact lenses.
Croatian: Azarga sadrži benzalkonijev klorid, za koji je poznato da mijenja boju mekih kontaktnih leća.
English: In the first study, IOP fell from around 21 mmHg by 8.0 to 8.7 mmHg in the patients using Azarga.
Croatian: U prvom je ispitivanju nastupilo snižavanje IOP-a s otprilike 21 mmHg za 8,0 na 8,7 mmHg u bolesnika koji koriste lijek Azarga.
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.
Croatian: Objašnjava kako je Povjerenstvo za lijekove za uporabu u ljudi (CHMP) ocijenilo lijek da bi donijelo odluku o izdavanju odobrenja za stavljanje lijeka u promet i preporučilo uvjete uporabe za lijek Azarga.
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.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku, za lijek Azarga uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju primjenjivati.
English: Why has Azarga been approved?
Croatian: Zašto je Azarga odobren?
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.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Azarga vrijedi na prostoru Europske unije od 25. studenog 2008. Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Azarga: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What is the risk associated with Azarga?
Croatian: Koji su rizici povezani s lijekom Azarga?
English: The Committee decided that Azarga's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Povjerenstvo je odlučilo da koristi od lijeka Azarga nadmašuju s njim povezane rizike te je preporučilo izdavanje odobrenja za stavljanje lijeka u promet.
English: Azarga is a medicine that contains two active substances, brinzolamide and timolol.
Croatian: Azarga je lijek koji sadrži dvije djelatne tvari, brinzolamid i timolol.