FrancophonIA/ELRC3.0 huggingface dataset:
English: Close monitoring is required with frequent or prolonged use.
Croatian: Redovito praćenje potrebno je kod česte ili dugotrajne primjene.
English: Talk to your doctor or pharmacist before using AZARGA if you have or have had in the past:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primijenite AZARGU ako imate ili ste u prošlosti imali:
English: Timolol is metabolised by two pathways.
Croatian: Timolol se metabolizira dvama putovima.
English: The anaesthesiologist should be informed when the patient is receiving timolol.
Croatian: Anesteziolog mora biti informiran kada bolesnik uzima timolol.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: When receiving any other treatment please tell the doctor or nurse that you are taking AZARGA.
Croatian: Kada primate bilo koji drugi lijek, molimo Vas obavijestite liječnika ili medicinsku sestru da uzimate AZARGU.
English: This medicine contains 3.34 µg benzalkonium chloride per drop (= 1 dose) which is equivalent to 0.01% or 0.1 mg/ml.
Croatian: Ovaj lijek sadrži 3,34 µg benzalkonijevog klorida po kapi (= 1 doza), što odgovara 0,01% ili 0,1 mg/ml.
English: Caution is recommended in the concomitant use of this medicinal product with clonidine.
Croatian: Oprez se preporučuje kod istodobne primjene ovog lijeka s klonidinom.
English: 3, blood pressure increased
Croatian: 3, povišeni krvni tlak
English: What AZARGA is and what it is used for
Croatian: Što je AZARGA i za što se koristi
English: If a dose is missed, treatment should be continued with the next dose as planned.
Croatian: Propusti li se doza, liječenje se mora nastaviti tako da se iduća doza primijeni kao što je planirano.
English: • Metabolism: low blood sugar levels.
Croatian: • Metabolizam: niska razina šećera u krvi.
English: If you stop using AZARGA without speaking to your doctor, the pressure in your eye will not be controlled which could lead to loss of sight.
Croatian: Ako prestanete uzimati AZARGU a da se niste posavjetovali s liječnikom, očni tlak više neće biti pod nadzorom što može dovesti do gubitka vida.
English: The following measure is useful to limit the amount of medicine that will come into the blood after application of eye drops: - Keep the eyelid closed, while simultaneously applying gentle pressure to the corner of the eye next to the nose with a finger for at least 2 minutes.
Croatian: Sljedeća mjera je korisna za ograničavanje količine lijeka koji će prijeći u krv nakon primjene kapi za oko: - Držite vjeđu zatvorenom, dok istodobno lagano prstom pritišćete kut oka blizu nosa najmanje
English: • If you have too much acidity in your blood (a condition called hyperchloraemic acidosis).
Croatian: • Ako Vam je kiselost krvi prevelika (stanje koje se naziva hiperkloremijska acidoza).
English: If you use more AZARGA than you should, rinse your eye with warm water.
Croatian: Ako ukapate više AZARGE nego što ste trebali, isperite oko toplom vodom.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from AZARGA therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Mora se donijeti odluka treba li prekinuti dojenje ili prekinuti/suzdržati se od terapije AZARGE uzevši u obzir korist dojenja za dijete i korist terapije za majku.
English: If you are taking another carbonic anhydrase inhibitor (acetazolamide or dorzolamide), talk to your doctor.
Croatian: Ako primjenjujete druge inhibitore karboanhidraze (acetazolamid ili dorzolamid), obavijestite svog liječnika.
English: You may find that your vision is blurred for some time just after using AZARGA.
Croatian: Može se dogoditi da Vam se vid zamuti na neko vrijeme odmah nakon primjene AZARGE.
English: Children and adolescents AZARGA is not recommended for children and adolescents under 18 years.
Croatian: Djeca i adolescenti AZARGA se ne preporučuje djeci i adolescentima ispod 18 godina.
English: If AZARGA is administered until delivery, the neonate should be carefully monitored during the first days of life.
Croatian: Ako se AZARGA primjenjuje do poroda, novorođenče se mora pažljivo pratiti tijekom prvih dana života.
English: Stop using this medicine and contact your doctor immediately if you develop skin rash, severe skin reaction, or severe redness and itching of the eye.
Croatian: Prekinite primjenu ovog lijeka i odmah potražite savjet svog liječnika ukoliko razvijete osip na koži, tešku kožnu reakciju ili jako crvenilo i svrbež oka.
English: Caution is advised if CYP3A4 inhibitors are given concomitantly.
Croatian: Savjetuje se oprez ako se istodobno daju inhibitori CYP3A4.
English: This may result in a decrease in systemic side effects and an increase in local activity (see section 4.4).
Croatian: Rezultat toga može biti smanjen broj sustavnih nuspojava i pojačana lokalna aktivnost (vidjeti dio 4.4).
English: AZARGA is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
Croatian: AZARGA se ne preporučuje za primjenu u djece i adolescenata ispod 18 godina zbog nedostatka podataka o sigurnosti i djelotvornosti.
English: 3, angina pectoris
Croatian: 3, angina pektoris
English: • After using AZARGA, press a finger into the corner of your eye, by the nose for 2 minutes
Croatian: • Nakon što ste ukapali AZARGU, pritisnite prstom kut oka okrenut nosu na 2 minute (slika 3).
English: AZARGA may be used while wearing contact lenses with careful monitoring (see below under ‘Benzalkonium chloride').
Croatian: AZARGA se može primjenjivati za vrijeme nošenja kontaktnih leća uz pozorno praćenje (vidjeti niže pod „Benzalkonijev klorid“).
English: • If you use drops in both eyes, repeat the steps for your other eye.
Croatian: • Trebate li kapati oba oka, ponovite jednak postupak i s drugim okom.
English: The safety and efficacy of AZARGA in children and adolescents aged 0 to 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost primjene AZARGE u djece i adolescenata od 0 do 18 godina nije još ustanovljena.
English: Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines.
Croatian: Privremeno zamućen vid i drugi poremećaji vida mogu utjecati na sposobnost upravljanja vozilima i strojevima.
English: Patients with corneal diseases should be treated with caution.
Croatian: Bolesnike s bolestima rožnice se mora liječiti s oprezom.
English: If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machines.
Croatian: Zamuti li se vid nakon ukapavanja, bolesnik mora pričekati da se vid razbistri prije nego što krene upravljati vozilom ili strojem.
English: Keep the bottle tightly closed when not in use.
Croatian: Držite bočicu dobro zatvorenom kada se ne koristi.
English: AZARGA has minor influence on the ability to drive and use machines.
Croatian: AZARGA ima mali utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
English: • muscular weakness (myasthenia gravis)
Croatian: • mišićnu slabost (mijastenija gravis)
English: What AZARGA contains
Croatian: Što AZARGA sadrži
English: Talk to your doctor before you use AZARGA.
Croatian: Razgovarajte s Vašim liječnikom prije nego što počnete uzimati AZARGU.
English: Do not use AZARGA if you are breast feeding, timolol may get into your milk.
Croatian: Ne koristite AZARGU ako dojite, timolol može prijeći u majčino mlijeko.
English: If you forget to use AZARGA, continue with the next dose as planned.
Croatian: Ako ste zaboravili primijeniti AZARGU, uzmite sljedeću dozu prema planu.
English: • Reproduction: sexual dysfunction, decreased libido, male sexual difficulty.
Croatian: • Reprodukcija: poremećaj spolne funkcije, oslabljen libido, seksualne poteškoće u muškaraca.
English: Throw away the bottle 4 weeks after first opening to prevent infections, and use a new bottle.
Croatian: Da bi se spriječile infekcije, bočicu treba baciti 4 tjedna nakon prvog otvaranja, te uzeti novu bočicu.
English: AZARGA is used to treat high pressure in the eyes, also called glaucoma or ocular hypertension, in adult patients that are more than 18 years of age and in whom high pressure in the eyes cannot be controlled effectively by one medicine alone.
Croatian: AZARGA se koristi za liječenje visokog tlaka u očima, koji se još naziva glaukom ili očna hipertenzija, u odraslih bolesnika koji su stariji od 18 godina i kod kojih se visoki tlak u očima ne može učinkovito kontrolirati samo s jednim lijekom.
English: Warnings and precautions Only use AZARGA for dropping in your eye(s).
Croatian: Upozorenja i mjere opreza AZARGU primjenjujte samo za ukapavanje u oko (oči).
English: This helps to stop AZARGA getting into the rest of the body.
Croatian: To će pomoći da AZARGA ne otječe dalje u tijelo.
English: One route yields an ethanolamine side chain on the thiadiazole ring and the other giving an ethanolic side chain on the morpholine nitrogen and a second similar side chain with a carbonyl group adjacent to the nitrogen.
Croatian: Jednim putem nastaje etanolaminski bočni lanac na tiadiazolnom prstenu, dok drugim putem nastaje etanolni bočni lanac na morfolinskom dušiku, kao i drugi slični bočni lanac s karbonilnom skupinom u blizini dušika.
English: Do not use this medicine after the expiry date which is stated on the bottle and the carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici i na kutiji iza oznake EXP.
English: In clinical trials, the most common adverse reactions were blurred vision, eye irritation and eye pain, occurring in approximately 2% to 7% of patients.
Croatian: U kliničkim ispitivanjima najčešće nuspojave bile su zamućenje vida, iritacija oka i bol u oku, a pojavile su se kod približno 2% do 7% bolesnika.
English: • Hypersensitivity reactions common to all sulphonamide derivates can occur in patients receiving AZARGA as it is absorbed systemically.
Croatian: • Reakcije preosjetljivosti zajedničke svim derivatima sulfonamida mogu se pojaviti i kod bolesnika koji primaju AZARGU s obzirom da se apsorbira sustavno.
English: 3, gastrointestinal disorder
Croatian: 3, gastrointestinalni poremećaj
English: 3, alopecia
Croatian: 3, alopecija
English: This may lead to a corneal decompensation and oedema and wearing contact lenses might increase the risk for the cornea.
Croatian: To može dovesti do dekompenzacije rožnice i edema, a nošenjem kontaktnih leća može se povećati rizik za rožnicu.
English: Patients with severe peripheral circulatory disturbance/disorders (i.e. severe forms of Raynaud's disease or Raynaud's syndrome) should be treated with caution.
Croatian: Bolesnike sa teškim perifernim cirkulacijskim poremećajima/bolestima (npr. teški oblici Raynaudove bolesti ili Raynaudova sindroma) se mora liječiti s oprezom.
English: Mental alertness
Croatian: Mentalna budnost
English: Eye ointments should be administered last.
Croatian: Masti za oko moraju se primijeniti posljednje.
English: If overdose with AZARGA eye drops occurs, treatment should be symptomatic and supportive.
Croatian: Nastupi li predoziranje AZARGA kapima za oči, liječenje mora biti simptomatsko i potporno.
English: What AZARGA is and what it is used for What you need to know before you use AZARGA How to use AZARGA
Croatian: Što je AZARGA i za što se koristi Što morate znati prije nego počnete primjenjivati AZARGU
English: If you are using other eye drop or eye ointment medicines leave at least 5 minutes between each medicine.
Croatian: Ako primjenjujete druge kapi za oko ili mast za oko pričekajte najmanje 5 minuta između primjene svakog lijeka.
English: • poor blood circulation disease (such as Raynaud's disease or Raynaud's syndrome)
Croatian: • poremećaj krvotoka (kao što je Raynaudova bolest ili Raynaudov sindrom)
English: Timolol metabolism is mediated primarily by CYP2D6.
Croatian: U metabolizmu timolola posreduje prvenstveno CYP2D6.
English: • tell your doctor before you have an operation that you are using AZARGA as timolol may change effects of some medicines used during anaesthesia.
Croatian: • Prije kirurškog zahvata obavijestite svog liječnika da uzimate AZARGU jer timolol može promijeniti učinke nekih lijekova koji se koriste tijekom anestezije.
English: (predominantly in patients with preexisting bronchospastic disease), dyspnoea
Croatian: (pretežno kod bolesnika s od ranije poznatim bronhospazmom), dispneja
English: Tiny amounts of hydrochloric acid and/or sodium hydroxide are added to keep acidity levels (pH levels) normal.
Croatian: Male količine kloridne kiseline i/ili natrijeva hidroksida dodane su radi održavanja normalne kiselosti (vrijednosti pH).
English: AZARGA should be used with caution, in patients with mild/moderate chronic obstructive pulmonary disease (COPD) and only if the potential benefit outweighs the potential risk.
Croatian: AZARGA se mora primijeniti s oprezom kod bolesnika s blagom/umjerenom kroničnom opstruktivnom plućnom bolešću (KOPB) i samo u slučaju da potencijalna korist nadmašuje potencijalni rizik.
English: Following administration of AZARGA, mean Cmax of timolol was reached at 0.79 ± 0.45 hours.
Croatian: Pri primjeni AZARGE srednja Cmax timolola postignuta je za 0,79 ± 0,45 sati.
English: Brinzolamide is eliminated primarily by renal excretion (approximately 60%).
Croatian: Brinzolamid se prvenstveno eliminira putem bubrega (približno 60%).
English: Do not stop using Azarga without speaking to your doctor first.
Croatian: Ne prekidajte s primjenom AZARGE bez da ste se prije toga savjetovali sa Vašim liječnikom.
English: No specific drug interaction studies have been performed with AZARGA.
Croatian: Nisu provedene posebne studije interakcije AZARGE s drugim lijekovima.
English: The possible role of brinzolamide on corneal endothelial function has not been investigated in patients with compromised corneas (particularly in patients with low endothelial cell count).
Croatian: Moguća uloga brinzolamida na funkciju endotela rožnice nije ispitivana u bolesnika s kompromitiranom rožnicom (pogotovo u bolesnika s malim brojem endotelnih stanica).
English: The lower systemic exposure to timolol following AZARGA administration is not clinically relevant.
Croatian: Manja sustavna izloženost timololu pri primjeni AZARGE nije klinički relevantna.
English: Timolol is absorbed into the systemic circulation.
Croatian: Timolol se apsorbira u sustavnu cirkulaciju.
English: Alcon Cusí, S.A., Camil Fabra 58, 08320 El Masnou, Barcelona, Spain
Croatian: Alcon Cusí, S.A., Camil Fabra 58, 08320 El Masnou, Barcelona, Španjolska
English: Brinzolamide is not an inhibitor of cytochrome P-450 isozymes.
Croatian: Brinzolamid nije inhibitor izoenzima citokroma P-450.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Croatian: Detaljne informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: Due to its negative effect on conduction time, beta-blockers should only be given with caution to patients with first degree heart block.
Croatian: Zbog negativnog učinka na provođenje, beta-blokatori se smiju samo s oprezom primjenjivati kod bolesnika sa srčanim blokom prvog stupnja.
English: About 20% of the dose has been accounted for in urine as metabolite.
Croatian: Oko 20% doze izlučuje se u urin u obliku metabolita.
English: This medicinal product should be used with caution in patients with risk of renal impairment because of the possible risk of metabolic acidosis.
Croatian: Ovaj lijek mora se s oprezom primijeniti kod bolesnika s rizikom od oštećenja funkcije bubrega zbog mogućeg rizika metaboličke acidoze.
English: These findings occurred at doses that caused metabolic acidosis with decreased body weight gain in dams and decreased foetal weights.
Croatian: Taj je nalaz dobiven pri dozama koje su prouzročile metaboličku acidozu, smanjeni prirast tjelesne težine u gravidnih ženki i smanjenu težinu fetusa.
English: 3, bradycardia
Croatian: 3, bradikardija
English: • If you have now or have had in the past respiratory problems such as asthma, severe long lasting obstructive bronchitis (severe lung condition which may cause wheezing, difficulty in breathing and/or long standing cough) or other types of breathing problems.
Croatian: • Ako sada imate poteškoća s disanjem ili ste ih imali u prošlosti, npr. astmu, teški dugotrajni opstruktivni bronhitis (teško stanje pluća koje može uzrokovati piskanje, otežano disanje i/ili dugotrajni kašalj) ili drugu vrstu poteškoća s disanjem.
English: • Ear: ringing in the ears, sensation of spinning or dizziness.
Croatian: • Uho: zvonjava u ušima, osjećaj vrtnje ili omaglice.
English: • disturbances of heart rate such as slow heart beat
Croatian: • poremećaje otkucaja srca kao što su usporeni otkucaji srca
English: However, at therapeutic doses of timolol in eye drops it is not likely that sufficient amounts would be present in breast milk to produce clinical symptoms of beta-blockade in the infant.
Croatian: Ipak, kod terapijskih doza timolola u kapima za oko nije vjerojatna pojava dovoljne količine u majčinom mlijeku koja bi uzrokovala kliničke simptome betablokade kod dojenčeta.
English: You may experience a decreased heart rate, decreased blood pressure, heart failure, difficulty breathing and your nervous system may be affected
Croatian: Može se pojaviti smanjeni broj otkucaja srca, sniženi krvni tlak, zatajenje srca, poteškoće s disanjem i može biti utjecaja na Vaš živčani sustav.
English: 2, cerebrovascular accident syncope
Croatian: 2, cerebrovaskularni incident sinkopa
English: The effect on intra-ocular pressure or the known effects of systemic beta-blockade may be potentiated when timolol is given to the patients already receiving a systemic beta-blocking agent.
Croatian: Učinak na intraokularni tlak ili poznati učinci sustavne beta-blokade mogu biti pojačani kada se timolol daje bolesnicima koji već primaju sustavni beta-blokator.
English: Common: punctate keratitis
Croatian: Često: točkasti keratitis
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake grupe učestalosti nuspojave su poredane u padajućem nizu prema stupnju ozbiljnosti.
English: One drop in the affected eye or eyes, twice a day.
Croatian: Jedna kap u oko ili oči koje se liječe dvaput na dan.
English: • Hyperchloraemic acidosis (see section 4.2).
Croatian: • Hiperkloremijska acidoza (vidjeti dio 4.2).
English: Eye drops, suspension
Croatian: Kapi za oko, suspenzija
English: AZARGA has not been studied in patients with narrow-angle glaucoma and its use is not recommended in these patients.
Croatian: AZARGA nije ispitivana u bolesnika s glaukomom uskog kuta i njena se primjena u tih bolesnika ne preporučuje.
English: Rare: insomnia Not known: depression
Croatian: Rijetko: nesanica1 Nepoznato: depresija
English: Benzalkonium chloride has also been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy.
Croatian: Zabilježeno je da benzalkonijev klorid uzrokuje točkastu keratopatiju i/ili toksičnu ulcerativnu keratopatiju.
English: Timolol is a non-selective adrenergic-blocking agent that has no intrinsic sympathomimetic, direct myocardial depressant or membrane-stabilising activity.
Croatian: Timolol je neselektivni adrenergički blokator bez unutarnje simpatomimetičke aktivnosti, bez izravne depresijske aktivnosti na miokard i bez stabilizacijske aktivnosti na membrane.
English: One ml of suspension contains 0.10 mg benzalkonium chloride.
Croatian: Jedan ml suspenzije sadrži 0,10 mg benzalkonijeva klorida.
English: • Severe allergic rhinitis
Croatian: • Teški alergijski rinitis.
English: Only use AZARGA in both eyes if your doctor told you to. Take it for as long as your doctor told you to.
Croatian: Kapajte AZARGU u oba oka samo ako Vas je tako uputio Vaš liječnik.
English: Since brinzolamide and its main metabolite are excreted predominantly by the kidney, AZARGA is therefore contraindicated in patients with severe renal impairment (see section 4.3).
Croatian: Budući da se brinzolamid i njegov glavni metabolit pretežno izlučuju putem bubrega, AZARGA je kontraindicirana u bolesnika s teško oštećenom bubrežnom funkcijom (vidjeti dio 4.3).
English: It is expected that inhibitors of CYP3A4 such as ketoconazole, itraconazole, clotrimazole, ritonavir and troleandomycin will inhibit the metabolism of brinzolamide by CYP3A4.
Croatian: Očekuje se da će inhibitori CYP3A4, poput ketokonazola, itrakonazola, klotrimazola, ritonavira i troleandomicina inhibirati metabolizam brinzolamida posredovan izoenzimom CYP3A4.
English: • Brinzolamide and timolol are absorbed systemically.
Croatian: • Brinzolamid i timolol se apsorbiraju sustavno.
English: One of the active ingredients may impair the ability to perform tasks requiring mental alertness and/or physical coordination.
Croatian: Jedan od djelatnih sastojaka može umanjiti sposobnost obavljanja zadataka koji zahtijevaju mentalnu budnost i/ili tjelesnu koordinaciju.
English: Instruct patients to keep the bottle tightly closed when not in use.
Croatian: Bolesnika treba uputiti da bočicu čuva čvrsto zatvorenu kad nije u uporabi.
English: In a pharmacokinetic study, healthy subjects received oral brinzolamide (1 mg) twice daily for 2 weeks to shorten the time to reach steady-state prior to starting AZARGA administration.
Croatian: U ispitivanju farmakokinetike zdravi su ispitanici peroralno primali brinzolamid (1 mg) dvaput na dan tijekom 2 tjedna, kako bi se skratilo vrijeme do postizanja stanja dinamičke ravnoteže prije početka primjene AZARGE.
English: Beta-blockers can mask the signs and symptoms of hypoglycaemia (see section 4.4).
Croatian: Beta-blokatori mogu prikriti znakove i simptome hipoglikemije (vidjeti dio 4.4).
English: AZARGA can affect, or be affected by, other medicines you are taking, including other eye drops for the treatment of glaucoma.
Croatian: AZARGA može utjecati na druge lijekove i drugi lijekovi mogu utjecati na AZARGU, uključujući druge kapi za oko koje uzimate za liječenje glaukoma.
English: Studies in animals have shown that following oral administration brinzolamide is excreted in breast milk, see section 5.3.
Croatian: Ispitivanja na životinjama pokazala su da se nakon oralne primjene brinzolamid izlučuje u majčino mlijeko, vidjeti dio 5.3.
English: The use of two topical beta-adrenergic blocking agents or two local carbonic anhydrase inhibitors is not recommended (see section 4.5).
Croatian: Lokalna primjena dva beta-adrenergička blokatora ili dva lokalna inhibitora karboanhidraze se ne preporučuje (vidjeti dio 4.5).
English: To reduce the systemic absorption, see section 4.2.
Croatian: Da bi se smanjila sustavna apsorpcija, vidjeti dio 4.2.
English: Additional adverse reactions associated with the use of the individual components that may potentially occur with AZARGA are included in the table above.
Croatian: Dodatne nuspojave povezane s primjenom svakog sastojka posebno, koje bi se mogle javiti i pri primjeni AZARGE, uključene su u tablicu iznad.
English: If signs of serious reactions or hypersensitivity occur, discontinue the use of this medicinal product.
Croatian: Jave li se znakovi ozbiljnih reakcija ili preosjetljivosti, primjenu ovog lijeka treba prekinuti.
English: It is likely to be caused by passage of the eye drops in the nasopharynx via the nasolacrimal canal and is attributable to brinzolamide.
Croatian: Vjerojatno je uzrokovana ulaskom kapi za oko u nazofarinks kroz nazolakrimalni kanal i može se pripisati brinzolamidu.