FrancophonIA/ELRC3.0 huggingface dataset:
English: Listed side effects include reactions seen within bimatoprost and timolol when used for treating eye conditions:
Croatian: Navedene nuspojave uključuju reakcije koje su opažene kod bimatoprosta i timolola kada se koriste za liječenje bolesti oka:
English: Let go of the lower lid, and close your eye.
Croatian: 4. Otpustite donju vjeđu i zatvorite oko.
English: Mean Cmax and AUC 0-24hrs values were similar on days 7 and 14 at approximately 0.08 ng/ml and 0.09 ng•hr/ml respectively, indicating that a steady drug concentration was reached during the first week of ocular dosing.
Croatian: Srednje vrijednosti Cmax i AUC 0-24h bile su slične 7. i 14. dana i to otprilike 0,08 ng/ml odnosno 0,09 ng•h/ml, što naznačuje da je postignuta stabilna koncentracija lijeka tijekom prvog tjedna okularne primjene.
English: Do not stop using Ganfort without speaking to your doctor.
Croatian: Nemojte prestati primjenjivati GANFORT bez savjetovanja s Vašim liječnikom.
English: After once daily ocular administration of one drop of 0.03% bimatoprost to both eyes for two weeks, blood concentrations peaked within 10 minutes after dosing and declined to below the lower limit of detection (0.025 ng/ml) within 1.5 hours after dosing.
Croatian: Nakon primjene u oba oka po jednu kap 0,03% bimatoprosta jednom dnevno tijekom dva tjedna, koncentracije u krvi dosegle su vrhunac unutar 10 minuta od davanja doze i padale su do razine niže od detekcije (0,025 ng/ml) unutar 1,5 sata nakon primjene.
English: In conclusion, there is evidence to suggest that ophthalmic timolol can be associated with hallucinations, either through systemic effects or through CNS penetration of timolol.
Croatian: Ukratko, određeni dokazi ukazuju na to da se timolol za oftalmološku primjenu može povezati s halucinacijama, bilo putem sistemskih učinaka bilo prodiranjem timolola u SŽS.
English: In two 12-month studies where systemic absorption was measured, no accumulation was observed with either of the individual components.
Croatian: U dvije 12-mjesečne studije u kojima se mjerila sistemska apsorpcija, nije opažena akumulacija bilo koje pojedine komponente.
English: Beta-blockers may also mask the signs of hyperthyroidism.
Croatian: Beta-blokatori mogu zamaskirati i znakove hipertireoze.
English: • Low blood pressure, high blood pressure, swelling or coldness of your hands, feet and extremities, caused by constriction of your blood vessels
Croatian: • Nizak krvni tlak, visoki krvni tlak, otečene ili hladne šake, stopala i ekstremiteti zbog sužavanja krvnih žila
English: Increased iris pigmentation is likely to be permanent, and may lead to differences in appearance between the eyes if only one eye is treated.
Croatian: Pojačana pigmentacija šarenice vjerojatno će biti trajna i može dovesti do različitog izgleda očiju ako se liječi samo jedno oko.
English: While taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge with such allergens and unresponsive to the usual dose of adrenaline used to treat anaphylactic reactions.
Croatian: Tijekom uzimanja beta-blokatora, kod bolesnika s anamnezom atopije ili teške anafilaktičke reakcije na različite alergene, može doći do pojačane reakcije na ponovljeni izazov takvim alergenima i može izostati odgovor na uobičajenu dozu adrenalina koja se koristi u liječenju anafilaktičke reakcije.
English: It is known that ophthalmic beta-blockers (like e.g. timolol) in some cases can cause systemic side effects.
Croatian: Poznato je da oftalmološki beta-blokatori (primjerice, timolol) u nekim slučajevima mogu uzrokovati sistemske nuspojave.
English: Bimatoprost is moderately distributed into body tissues and the systemic volume of distribution in humans at steady-state was 0.67 1/kg.
Croatian: Bimatoprost se umjereno distribuira po tjelesnim tkivima te je sistemski volumen distribucije u ljudi u stanju dinamičke ravnoteže iznosio 0,67 l/kg.
English: It is not known if bimatoprost is excreted in human breast milk but it is excreted in the milk of the lactating rat.
Croatian: Nije poznato izlučuje li se bimatoprost u majčino mlijeko u ljudi, ali se izlučuje u mlijeko štakorica u laktaciji.
English: Periorbital tissue pigmentation has been reported to be reversible in some patients.
Croatian: Pigmentacija periorbitalnog tkiva u nekih je bolesnika bila reverzibilna.
English: To avoid contamination, do not let the tip of the bottle touch your eye or anything else.
Croatian: Kako biste izbjegli zagađenje, nemojte vrškom bočice doticati oko niti bilo koju drugu površinu.
English: Tell your doctor if you are using or intend to use medicines to lower blood pressure, heart medicine, medicines to treat diabetes, quinidine (used to treat heart conditions and some types of malaria) or medicines to treat depression known as fluoxetine and paroxetine.
Croatian: Obavijestite svog liječnika ako primjenjujete ili namjeravate primijeniti lijekove za snižavanje krvnog tlaka, lijekove za srce, lijekove za dijabetes, kinidin (koji se primjenjuje za liječenje srčanih poremećaja i nekih vrsta malarije) ili lijekove za depresiju poznate kao fluoksetin i paroksetin.
English: If you forget to use GANFORT single-dose, use a single drop as soon as you remember, and then go back to your regular routine.
Croatian: Ako ste zaboravili primijeniti jednodozni GANFORT, primijenite jednu kap čim se sjetite, a nakon toga se vratite uobičajenoj rutini.
English: No adequate clinical data in exposed pregnancies are available.
Croatian: Nema adekvatnih klinčkih podataka u izloženim trudnoćama.
English: GANFORT should be used every day to work properly.
Croatian: Kapi GANFORT treba primjenjivati svakodnevno da bi bile djelotvorne.
English: GANFORT should not be used in children and teenagers under 18.
Croatian: GANFORT se ne smije koristiti kod djece i adolescenata mlađih od 18 godina.
English: Contact lenses must be removed prior to application, with at least a 15-minute wait before reinsertion.
Croatian: Prije primjene, potrebno je ukloniti kontaktne leće i pričekati najmanje 15 minuta prije njihovog ponovnog umetanja.
English: If GANFORT is administered until delivery, the neonate should be carefully monitored during the first days of life.
Croatian: Ako se GANFORT primjenjuje do poroda, potrebno je pažljivo pratiti novorođenče tijekom prvih dana života.
English: If more than one topical ophthalmic medicinal product is to be used, each one should be instilled at least 5 minutes apart.
Croatian: Ako treba koristiti više od jednog topikalnog oftalmološkog lijeka, treba ih primjenjivati u razmacima od najmanje 5 minuta.
English: Patients using GANFORT with other prostaglandin analogues should be monitored for changes to their intraocular pressure.
Croatian: Bolesnike koji koriste GANFORT zajedno s drugim analozima prostaglandina treba nadzirati u smislu promjena intraokularnog tlaka.
English: Beta-blockers are excreted in breast milk.
Croatian: Beta-blokatori se izlučuju u majčino mlijeko.
English: This helps to stop GANFORT single-dose getting into the rest of the body.
Croatian: To pomaže u sprečavanju ulaska jednodoznog GANFORT-a u ostatak tijela.
English: Timolol is a beta1 and beta2 non-selective adrenergic receptor blocking agent that does not have significant intrinsic sympathomimetic, direct myocardial depressant, or local anaesthetic (membrane-stabilising) activity.
Croatian: Timolol je tvar koja neselektivno blokira beta1 i beta2 adrenergične receptore i koja nema značajnu intrinzičnu simpatomimetsku aktivnost, ne izaziva izravnu depresiju miokarda niti ima lokalni anestetski učinak (stabilizacijom membrane).
English: Sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block, not controlled with pace-maker.
Croatian: Sinusna bradikardija, sindrom bolesnog sinusnog čvora, sinusatrijski blok, atrioventrikularni blok drugog ili trećeg stupnja, nekontroliran srčanim elektrostimulatorom.
English: On the basis of the scientific conclusions for bimatoprost / timolol the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing bimatoprost / timolol is unchanged subject to the proposed changes to the product information
Croatian: Na temelju znanstvenih zaključaka za bimatoprost/timolol, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) bimatoprost/timolol nepromijenjen, uz predložene izmjene informacija o lijeku.
English: If you use more GANFORT than you should, it is unlikely to cause you any serious harm.
Croatian: Ako primijenite više GANFORT-a nego što ste trebali, nije vjerojatno da će Vam ozbiljno naštetiti.
English: Tear 1 single-dose container from the strip.
Croatian: Otrgnite jednodozni spremnik sa stripa.
English: There are no adequate data from the use of the bimatoprost / timolol fixed combination in pregnant women.
Croatian: Nema adekvatnih podataka o primjeni fiksne kombinacije bimatoprosta/timolola kod trudnica.
English: No enhancement of the systemic absorption of the individual active substances has been observed.
Croatian: Nije zabilježeno povećanje sistemske apsorpcije pojedinih djelatnih tvari.
English: The frequency of possible adverse reactions listed below is defined using the following convention:
Croatian: Učestalost mogućih nuspojava navedenih u nastavku definirana je koristeći sljedeće načelo: Vrlo često
English: Like all medicines, GANFORT can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes.
Croatian: Promjena pigmentacije posljedica je povećanog sadržaja melanina u melanocitima, a ne povećanja broja melanocita.
English: If GANFORT is accidentally ingested, the following information may be useful: in two-week oral rat and mouse studies, doses of bimatoprost up to 100 mg/kg/day did not produce any toxicity.
Croatian: Ako dođe do nehotične ingestije GANFORT-a, mogu biti korisne sljedeće informacije: u dvotjednim ispitivanjima na štakorima i miševima, peroralne doze bimatoprosta do 100 mg/kg/dan nisu prouzročile nikakvu toksičnost.
English: In two 12-month studies of GANFORT (multi-dose formulation) in which systemic absorption was measured, no accumulation was observed of either of the individual components.
Croatian: U dvije 12-mjesečne studije GANFORT-a (višedozni pripravak) u kojima se mjerila sistemska apsorpcija, nije opažena akumulacija bilo koje pojedine komponente.
English: mainly water, accumulating in the body; chest pain
Croatian: nakupljanje prekomjerne tekućine, uglavnom vode, u tijelu; bol u prsnom košu
English: GANFORT eye drops are used to treat high pressure in the eye in adults, including the elderly.
Croatian: GANFORT kapi za oko koriste se za liječenje visokog očnog tlaka kod odraslih, uključujući starije osobe.
English: GANFORT should not be used during pregnancy unless clearly necessary.
Croatian: GANFORT se ne smije koristiti tijekom trudnoće osim ako je to izričito neophodno.
English: Both treatment groups showed statistically and clinically significant mean decreases from baseline in worse eye IOP at all follow up timepoints throughout the study (p < 0.001).
Croatian: U obje ispitivane skupine zabilježen je statistički i klinički značajan srednje pad vrijednost intraokularnog tlaka u odnosu na polazne vrijednosti u lošijem oku u svim vremenskim točkama mjerenja tijekom ispitivanja (p < 0,001).
English: Each ml of solution contains 0.05 mg of benzalkonium chloride.
Croatian: Jedan ml otopine sadrži 0,05 mg benzalkonijevog klorida.
English: Immune system disorders systemic allergic reactions including anaphylaxis1
Croatian: Poremećaji imunološkog sustava sistemske alergijske reakcije uključujući anafilaksiju1
English: GANFORT has negligible influence on the ability to drive and use machines.
Croatian: GANFORT zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The preservative in GANFORT, benzalkonium chloride, may cause eye irritation.
Croatian: Konzervans u GANFORT-u, benzalkonijev klorid, može nadražiti oko.
English: Make sure that the single-dose container is intact before use.
Croatian: Provjerite da jednodozni spremnik nije ranije oštećen.
English: Reduction of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.
Croatian: Snižavanje intraokularnog tlaka (IOT) u odraslih bolesnika s glaukomom širokog kuta ili okularnom hipertenzijom, koji ne pokazuju dostatan odgovor na topikalnu primjenu beta-blokatora ili analoga prostaglandina.
English: This medicine does not contain a preservative.
Croatian: Ovaj lijek ne sadrži konzervans.
English: Eye drops, solution, in single-dose container.
Croatian: Kapi za oko, otopina, u jednodoznom spremniku.
English: GANFORT works by reducing the production of liquid and also increasing the amount of liquid that is drained.
Croatian: GANFORT djeluje tako što smanjuje proizvodnju tekućine i ujedno povećava količinu tekućine koja istječe.
English: If GANFORT single-dose is accidentally ingested, the following information may be useful: in 2-week oral mice and rats studies, doses of bimatoprost up to 100 mg/kg/day did not produce any toxicity; this corresponds to a human equivalent dose of 8.1 and 16.2 mg/kg, respectively.
Croatian: Ako dođe do nehotične ingestije jednodoznog GANFORT-a mogu biti korisne sljedeće informacije: u dvotjednim ispitivanjima na štakorima i miševima, peroralne doze bimatoprosta do 100 mg/kg/dan nisu prouzročile nikakvu toksičnost; ta doza odgovara humanoj dozi od 8,1 odnosno 16,2 mg/kg.
English: Additional adverse reactions that have been seen with either of the active substances (bimatoprost or timolol), and may potentially occur also with GANFORT are listed below in Table 2:
Croatian: Dodatne nuspojave opažene s jednom od djelatnih tvari (bimatoprost ili timolol), i koje bi se također mogle pojaviti s otopinom GANFORT navedene su u Tablici 2:
English: No enhancement of the systemic absorption of the individual active substances has been observed with GANFORT (multi-dose formulation).
Croatian: Nije zabilježeno povećanje sistemske apsorpcije pojedinih djelatnih tvari s GANFORT-om (višedozni pripravak).
English: GANFORT single-dose eye drops are used to treat high pressure in the eye in adults, including the elderly.
Croatian: Jednodozni GANFORT kapi za oko koriste se za liječenje visokog očnog tlaka kod odraslih, uključujući starije osobe.
English: Increased brown iris pigmentation has also been observed during treatment with GANFORT (multi-dose formulation).
Croatian: Povećana smeđa pigmentacija šarenice također je primijećena tijekom liječenja GANFORT-om (višedozni pripravak).
English: To avoid contamination, do not let the open-end of the single-dose container touch your eye or anything else.
Croatian: Kako biste spriječili kontaminaciju, nemojte vrškom jednodoznog spremnika doticati oko niti bilo koju drugu površinu.
English: Wait at least 15 minutes after using the eye drops before putting your lenses back in your eyes.
Croatian: Pričekajte najmanje 15 minuta nakon primjene kapi za oko prije vraćanja kontaktnih leća u oči.
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 utjecaja na vrijeme provođenja, beta-blokatori se smiju davati samo uz oprez kod bolesnika sa srčanim blokom prvog stupnja.
English: What GANFORT looks like and contents of the pack
Croatian: Kako GANFORT izgleda i sadržaj pakiranja
English: After discontinuation of GANFORT, pigmentation of iris may be permanent.
Croatian: Nakon prekida primjene GANFORT-a, različita pigmentacija šarenice može ostati trajna.
English: All single-dose containers should be kept in the pouch and discarded after 10 days from the first opening of the pouch.
Croatian: Jednodozni spremnik treba držati u vrećici i baciti nakon 10 dana od prvog otvaranja vrećice.
English: GANFORT single-dose is a colourless to slightly yellow solution supplied in single-dose plastic containers, each containing 0.4 ml of solution.
Croatian: Jednodozni GANFORT bezbojna je do lagano žućkasta otopina koja se isporučuje u plastičnim jednodoznim spremnicima od kojih jedan sadrži 0,4 ml otopine.
English: The safety and efficacy of GANFORT in children aged 0 to 18 years has not been established.
Croatian: Sigurnost i djelotvornost GANFORT-a u djece u dobi od 0 do 18 godina nisu ustanovljene.
English: If you use more GANFORT single-dose than you should, it is unlikely to cause you any serious harm.
Croatian: Ako primijenite više jednodoznog GANFORT-a nego što ste trebali, nije vjerojatno da će Vam ozbiljno naštetiti.
English: To help you remember, write down the date that you opened it in the space on the carton.
Croatian: zabilježite datum kada ste je otvorili u za to predviđen prostor na kutiji.
English: GANFORT can affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma.
Croatian: Na GANFORT mogu utjecati drugi primijenjeni lijekovi, ili on može utjecati na njih, uključujući ostale kapi za oko za liječenje glaukoma.
English: GANFORT single-dose achieved noninferior IOP-lowering efficacy to GANFORT (multi-dose formulation): the upper limit of the 95% CI of the between-treatment difference was within the pre-defined 1.5 mm Hg margin at each timepoint evaluated (hours 0, 2, and 8) at week 12 (for the primary analysis), and also at weeks 2 and 6, for mean worse eye IOP change from baseline (worse eye IOP refers to the eye with the higher mean diurnal IOP at baseline).
Croatian: GANFORT nije bio manje učinkovit od GANFORT-a (višedozni pripravak) u snižavanju intraokularnog tlaka: gornja granica intervala pouzdanosti od 95% razlikovanja između ispitivanih skupina bila je unutar predefinirane granice od 1,5 mmHg u svakoj vremenskoj točci mjerenja (nakon 0, 2 i 8 sati) u 12. tjednu (za primarnu analizu), te u 2. i 6. tjednu za srednju vrijednost promjene intraokularnog tlaka u lošijem oku u odnosu na polazne vrijednosti (oko s lošijim intraokularnim tlakom smatra se oko u kojem je na početku ispitivanja izmjeren viši srednji dnevni intraokularni tlak).
English: Respiratory reactions, including death due to bronchospasm in patients with asthma, have been reported following administration of some ophthalmic beta-blockers.
Croatian: Respiratorne reakcije, uključujući smrt uslijed bronhospazma kod bolesnika s astmom prijavljene su nakon primjene određenih oftalmoloških beta-blokatora.
English: GANFORT single-dose should not be used in children and teenagers under 18.
Croatian: Jednodozni GANFORT se ne smije koristiti kod djece i adolescenata mlađih od 18 godina.
English: Reactive airway disease including bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease.
Croatian: Reaktivna bolest dišnih puteva, uključujući bronhalnu astmu ili anamnezu bronhalne astme, teška kronična opstruktivna bolest pluća.
English: Mean changes from baseline worse eye IOP ranged from -9.16 to -7.98 mm Hg for GANFORT (single-dose) group, and from -9.03 to -7.72 mm Hg for the GANFORT (multi-dose formulation) group across the 12-week study.
Croatian: Srednja promjena introkularnog tlaka u odnosu na polazne vrijednosti u lošijem oku kretala se između -9,16 i -7,98 mm Hg za skupinu koja je primala jednodozni GANFORT i -9,03 i -7,72 mm Hg za skupinu koja je primala GANFORT (višedozni pripravak) tijekom 12-tjednog ispitivanja.
English: Based on this outcome, update of section 4.8 of the Summary of Product Characteristic to add ‘hallucination' with the frequency ‘not known' is recommended.
Croatian: S obzirom na takav ishod, preporučuje se ažuriranje dijela 4.8. sažetka opisa svojstava lijeka dodavanjem nuspojave „halucinacije” s učestalošću „nepoznato”.
English: GANFORT single-dose works by reducing the production of liquid and also increasing the amount of liquid that is drained.
Croatian: Jednodozni GANFORT djeluje tako što smanjuje proizvodnju tekućine i ujedno povećava količinu tekućine koja istječe.
English: Symptoms of systemic timolol overdose include: bradycardia, hypotension, bronchospasm, headache, dizziness, shortness of breath, and cardiac arrest.
Croatian: Simptomi sistemskog predoziranja timololom uključuju: bradikardiju, hipotenziju, bronhospazam, glavobolju, omaglicu, manjak zraka i srčani zastoj.
English: • Heart failure; irregularity or stopping of the heartbeat; slow or fast heartbeat; too much fluid,
Croatian: • Zatajenje srca; nepravilnost ili zaustavljanje srčanih otkucaja; brzi ili spori otkucaji srca,
English: Contents of the pack and other information What GANFORT single-dose contains
Croatian: Sadržaj pakiranja i druge informacije Što jednodozni GANFORT sadrži
English: Based on 12-month clinical data, the most commonly reported adverse reaction 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.
Croatian: Na temelju 12-mjesečnih kliničkih podataka, najčešće prijavljena nuspojava bila je hiperemija konjunktive (uglavnom neznatna ili blagog oblika te se smatralo da nije upalne prirode) u približno 26% bolesnika, a koja je kod 1,5% bolesnika dovela do prekida terapije.
English: Monkeys administered ocular bimatoprost concentrations of ≥0.03% daily for 1 year had an increase in iris pigmentation and reversible dose-related periocular effects characterised by a prominent upper and/or lower sulcus and widening of the palpebral fissure.
Croatian: Majmuni kojima su u oko davane koncentracije bimatoprosta od ≥ 0,03% dnevno tijekom 1 godine imali su povećanu pigmentaciju šarenice i reverzibilne periokularne učinke vezane uz dozu karakterizirane prominentnim gornjim i/ili donjim sulkusom i proširenjem palpebralne fisure.
English: Very common conjunctival hyperaemia.
Croatian: Vrlo često hiperemija konjunktive.
English: Epidemiological studies have not revealed malformative effects but have shown a risk for intra uterine growth retardation when beta-blockers are administered by the oral route.
Croatian: Epidemiološka ispitivanja nisu otkrila malformativne učinke, ali su pokazala rizik od intrauterinog zaostajanja u rastu kada se beta-blokatori primjenjuju peroralno.
English: Do not stop using GANFORT single-dose without speaking to your doctor.
Croatian: Nemojte prestati primjenjivati jednodozni GANFORT bez savjetovanja s Vašim liječnikom.
English: GANFORT contains Benzalkonium chloride
Croatian: GANFORT sadrži benzalkonijev klorid
English: In the publication: Nanda T, Rasool N, Callahan AB, Stamper RL, Odel JG. Ophthalmic Timolol Hallucinations: A Case Series and Review of the Literature.
Croatian: U znanstvenom radu: Nanda T, Rasool N, Callahan AB, Stamper RL, Odel JG.
English: What GANFORT single-dose is and what it is used for
Croatian: Što je jednodozni GANFORT i za što se koristi
English: Iris colour changes seen with ophthalmic administration of bimatoprost may not be noticeable for several months to years.
Croatian: Promjena boje šarenice zbog oftalmičke primjene bimatoprosta može ostati neprimjetna nekoliko mjeseci do nekoliko godina.
English: GANFORT single-dose has negligible influence on the ability to drive and use machines.
Croatian: Jednodozni GANFORT zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Other medicines and GANFORT single-dose
Croatian: Drugi lijekovi i jednodozni GANFORT
English: Based on this outcome, removal of the note in the SmPC in section 4.8 linking the ADR ‘Superior sulcus deepening' to only products containing preservative is recommended.
Croatian: S obzirom na takav ishod, preporučuje se uklanjanje napomene u dijelu 4.8. sažetka opisa svojstava lijeka u kojoj se nuspojava „Produbljivanje gornjeg sulkusa” povezuje samo s lijekovima koji sadrže konzervans.