FrancophonIA/ELRC3.0 huggingface dataset:
English: During a 12-month pivotal study in adults with LUMIGAN 0.1 mg/ml eye drops, the mean diurnal IOP values measured at any visit over the 12-month study period differed by no more than 1.1 mmHg throughout the day and were never greater than 17.7 mmHg.
Croatian: Tijekom 12-mjesečnog pivotalnog ispitivanja LUMIGAN 0,1 mg/ml kapi za oko u odraslih bolesnika, srednje dnevne vrijednosti intraokularnog tlaka izmjerene pri svakom pregledu u razdoblju 12mjesečnog ispitivanja razlikovale su se najviše 1,1 mmHg kroz dan i nikada nisu bile više od 17,7 mmHg.
English: Marketing Authorisation Holder and Manufacturer Allergan Pharmaceuticals Ireland Castlebar Road
Croatian: Nositelj odobrenja za stavljanje lijeka u promet i proizvođač Allergan Pharmaceuticals Ireland Castlebar Road
English: Bimatoprost penetrates the human cornea and sclera well in vitro.
Croatian: Bimatoprost dobro prolazi kroz ljudsku rožnicu i bjeloočnicu u in vitro uvjetima.
English: Do not keep any unused solution.
Croatian: Svu neiskorištenu otopinu bacite.
English: LUMIGAN has not been studied in patients with compromised respiratory function.
Croatian: LUMIGAN nije ispitivan kod bolesnika s oštećenom funkcijom dišnog sustava.
English: Carton containing 30 or 90 single-dose containers in three or nine aluminium foil pouches, respectively.
Croatian: Kutija s 30 ili 90 jednodoznih spremnika, u tri odnosno devet vrećica od aluminijske folije, Jedna vrećica sadrži 10 jednodoznih spremnika.
English: Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.
Croatian: Prijavljeni su vrlo rijetki slučajevi kalcifikacije rožnice povezani s primjenom očnih kapi koje sadrže fosfat u nekih bolesnika sa značajno oštećenom rožnicom.
English: Approximately 0.7% of patients in the LUMIGAN 0.3 mg/mL single-dose group discontinued due to any adverse event in the 3 month study.
Croatian: Približno 0,7% bolesnika u skupini koja je primala jednodozni LUMIGAN 0,3 mg/ml prekinulo je terapiju zbog neke nuspojave tijekom 3-mjesečnog ispitivanja.
English: In patients with a history of mild liver disease or abnormal alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin at baseline, bimatoprost 0.3 mg/mL eye drops (multi-dose formulation), solution had no adverse effect on liver function over 24 months.
Croatian: Kod bolesnika s anamnezom blage jetrene bolesti ili abnormalne razine alanin-aminotransferaze (ALT), aspartat-aminotransferaze (AST) i/ili bilirubina na početku liječenja, bimatoprost 0,3 mg/ml kapi za oko (višedozni pripravak) nije imao štetni učinak na funkciju jetre tijekom 24 mjeseca.
English: Other side effects reported with eye drops containing phosphates In very rare cases, some patients with severe damage to the clear layer at the front of the eye (the cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment.
Croatian: Ostale nuspojave prijavljene pri primjeni kapi za oči koje sadrže fosfate U vrlo rijetkim slučajevima u nekih su se bolesnika s teškim oštećenjem prednjeg prozirnog sloja oka (rožnice) pojavile mutne mrlje na rožnici zbog nakupljanja kalcija tijekom liječenja.
English: In studies of bimatoprost 0.3 mg/ml in patients with glaucoma or ocular hypertension, it has been shown that the more frequent exposure of the eye to more than one dose of bimatoprost daily may decrease the IOP-lowering effect (see section 4.5).
Croatian: U ispitivanjima otopine bimatoprosta 0,3 mg/ml u bolesnika s glaukomom ili povišenim očnim tlakom, ustanovljeno je da češće izlaganje oka više nego jednoj dozi bimatoprosta dnevno može smanjiti njegovu učinkovitost u snižavanju intraokularnog tlaka (vidjeti dio 4.5).
English: Additional adverse reactions reported with LUMIGAN 0.3 mg/ml are presented in Table 2.
Croatian: Dodatne nuspojave zabilježene s LUMIGAN-om 0,3 mg/ml navedene su u Tablici 2.
English: In rat peri/postnatal studies, maternal toxicity caused reduced gestation time, foetal death, and decreased pup body weights at 0.3 mg/kg/day (at least 41-times the intended human exposure).
Croatian: U peri/postnatalnim ispitivanjima na štakorima, toksičnost majke prouzročila je skraćenje vremena gestacije, smrt fetusa i smanjenu tjelesnu težinu okota pri dozi 0,3 mg/kg/dan (barem 41 puta većoj od namjeravane izloženosti kod ljudi).
English: • Swelling of the see-through layer which covers the surface of the eye
Croatian: • Oticanje prozirnog sloja koji pokriva površinu oka
English: No interactions are anticipated in humans, since systemic concentrations of bimatoprost are extremely low (less than 0.2 ng/mL) following ocular dosing with bimatoprost 0.3 mg/mL eye drops, solution (multi-dose formulation).
Croatian: Interakcije se ne očekuju kod ljudi jer su sistemske koncentracije bimatoprosta izuzetno niske (manje od 0,2 ng/ml) nakon okularne primjene otopine bimatoprosta 0,3 mg/ml kapi za oko (višedozni pripravak).
English: Paediatric population: The safety and efficacy of LUMIGAN in children aged 0 to 18 years has not yet been established.
Croatian: Pedijatrijska populacija Sigurnost i djelotvornost LUMIGAN-a u djece u dobi od 0 do 18 godina nije još ustanovljena.
English: Table 2 lists adverse reactions that were seen in a 12 month clinical study with LUMIGAN 0.3 mg/mL (multi-dose formulation), but were reported at a higher frequency than with LUMIGAN 0.3 mg/mL (single-dose).
Croatian: Tablica 2 navodi nuspojave primijećene tijekom 12-mjesečnog kliničkog ispitivanja otopine LUMIGAN 0,3 mg/ml (višedozni pripravak), ali su zabilježene s većom učestalošću nego kod primjene jednodoznog LUMIGAN-a 0,3 mg/ml.
English: The colour of your iris may also go darker over time.
Croatian: Nakon nekog vremena, boja šarenice također bi mogla potamniti.
English: Skin and subcutaneous tissue disorders common skin hyperpigmentation (periocular)
Croatian: Poremećaji kože i potkožnog tkiva često hiperpigmentacija kože (periokularno)
English: LUMIGAN 0.3 mg/ml is contraindicated in patients who have had a suspected previous adverse reaction to benzalkonium chloride that has led to discontinuation.
Croatian: LUMIGAN 0,3 mg/ml je kontraindiciran kod bolesnika koji su u prošlosti imali suspektnu nuspojavu na benzalkonijev klorid koja je dovela do prekida terapije.
English: Eye drops, solution, in single-dose container.
Croatian: OBLIK Kapi za oko, otopina u jednodoznom spremniku.
English: In very rare cases, some patients with severe damage to the clear layer at the front of the eye (the cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment.
Croatian: U vrlo rijetkim slučajevima u nekih su se bolesnika s teškim oštećenjem prednjeg prozirnog sloja oka pojavile mutne mrlje na rožnici zbog nakupljanja kalcija tijekom liječenja.
English: Once the pouch is opened, the single dose containers should be used within 30 days.
Croatian: Nakon što se vrećica jednom otvori, jednodozni spremnik treba upotrijebiti unutar 30 dana.
English: This dose expressed as mg/m2 is at least 210 times higher than the accidental dose of one bottle of LUMIGAN 0.1 mg/ml eye drops, solution in a 10 kg child.
Croatian: Ta doza, izražena u mg/m2, najmanje je 210 puta veća od slučajno progutane doze jedne bočice otopine LUMIGAN 0,1 mg/ml kapi za oko kod djeteta od 10 kg.
English: Patients with COPD, asthma or compromised respiratory function due to other conditions should be treated with caution.
Croatian: Stoga je potreban oprez u bolesnika s KOPB-om, astmom ili kompromitiranom respiratornom funkcijom zbog drugog uzroka.
English: If you stop using LUMIGAN 0.3 mg/mL single-dose LUMIGAN 0.3 mg/mL single-dose should be used every day to work properly.
Croatian: Ako prestanete primjenjivati jednodozni LUMIGAN 0,3 mg/ml Jednodozni LUMIGAN 0,3 mg/ml treba primjenjivati svakodnevno da bi bio djelotvoran.
English: Wipe off any excess that runs down the cheek.
Croatian: Obrišite višak lijeka koji je iscurio niz obraz.
English: Please tell your doctor or pharmacist, if: - You have any breathing problems - You have liver or kidney problems - You have had a cataract surgery in the past - You have or have had low blood pressure or low heart rate - You have had a viral infection or inflammation of the eye
Croatian: Obavijestite svog liječnika ili ljekarnika ako: imate bilo kakvih problema s disanjem imate problema s jetrom ili bubrezima ste imali operaciju mrene u prošlosti imate ili ste imali nizak krvni tlak ili spore otkucaje srca ste imali virusnu infekciju ili upalu oka.
English: Skin and subcutaneous tissue disorders common skin hyperpigmentation, hypertrichosis uncommon dry skin, eyelid margin crusting, pruritus not known skin discoloration (periocular)
Croatian: Poremećaji kože i potkožnog tkiva često hiperpigmentacija kože, hipertrihoza manje često suha koža, kraste po rubu vjeđe, svrbež nepoznato diskoloracija kože (periokularno)
English: Respiratory, thoracic and mediastinal disorders not known asthma, asthma exacerbation, COPD exacerbation and dyspnoea
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja nepoznato astma,egzacerbacija astme, egzacerbacija KOBP-a i dispneja
English: Take one single-dose container from the pouch and hold it upright (with the cap pointing upwards) and twist off the cap.
Croatian: Uzmite jedan jednodozni spremnik iz vrećice, držite ga uspravno i odvrnite zatvarač.
English: LUMIGAN 0.3 mg/mL single-dose has not been studied in patients wearing contact lenses.
Croatian: Jednodozni LUMIGAN 0,3 mg/ml nije ispitivan u bolesnika koji nose kontaktne leće.
English: In clinical studies, LUMIGAN 0.3 mg/mL (multi-dose formulation) was used concomitantly with a number of different ophthalmic beta-blocking agents without evidence of interactions.
Croatian: U kliničkim ispitivanjima kapi LUMIGAN 0,3 mg/ml (višedozni pripravak) primijenjene su istovremeno s drugim oftalmološkim beta-blokatorima i nije bilo dokaza o interakcijama.
English: Warnings and precautions: Talk to your doctor or pharmacist before you use LUMIGAN 0.3 mg/ml:
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego primijenite LUMIGAN 0,3 mg/ml.
English: Bimatoprost 0.3 mg/ml eye drops, solution contains the preservative benzalkonium chloride, which may be absorbed by soft contact lenses.
Croatian: Otopina bimatoprost 0,3 mg/ml kapi za oko sadrži konzervans benzalkonijev klorid, koji bi mogle apsorbirati mekane kontaktne leće.
English: If LUMIGAN is accidentally ingested, the following information may be useful: in two-week oral rat and mouse studies, doses up to 100 mg/kg/day did not produce any toxicity.
Croatian: Ako se LUMIGAN slučajno proguta možda može biti koristan sljedeći podatak: u ispitivanjima na miševima i štakorima koji su na usta primali doze do 100 mg/kg/dan nisu zabilježeni toksični učinci.
English: Less than 9 % of patients discontinued due to any adverse event in the first year with the incidence of additional patient discontinuations being 3 % at both 2 and 3 years.
Croatian: Manje od 9% bolesnika prekinulo je terapiju zbog neke nuspojave u prvoj godini, s incidencijom novih prekida liječenja od 3% kako u 2. tako i u 3. godini.
English: Turn the single-dose container upside down and squeeze it to release 1 drop into the affected eye(s).
Croatian: Okrenite jednodozni spremnik prema dolje i stisnite ga kako bi se otpustila jedna kap u oko/oči koje treba liječiti.
English: If LUMIGAN 0.3 mg/mL singledose is accidentally ingested, the following information may be useful: In short term oral (by gavage) mouse and rat studies, doses up to 100 mg/kg/day of bimatoprost did not produce any toxicity.
Croatian: Ako dođe do nehotičnog gutanja LUMIGAN-a 0,3 mg/ml, mogu biti korisne sljedeće informacije: u kratkoročnim ispitivanjima na štakorima i miševima, doze do 100 mg/kg/dan nisu prouzročile nikakvu toksičnost.
English: On combining the data from phase III monotherapy and adjunctive LUMIGAN 0.3 mg/mL (multi-dose formulation) usage, the most frequently reported adverse reactions were:
Croatian: Kombinacijom podataka faze III monoterapije i kombinirane terapije kapima LUMIGAN 0,3 mg/ml, (višedoznim pripravkom) najčešće prijavljene nuspojave bile su:
English: Exp: Discard 4 weeks after first opening
Croatian: Exp: Bacite 4 tjedna nakon prvog otvaranja.
English: On combining the data from phase III monotherapy and adjunctive LUMIGAN 0.3 mg/ml usage, the most frequently reported adverse reactions were:
Croatian: Kombinacijom podataka faze III monoterapije i kombinirane terapije kapima LUMIGAN 0,3 mg/ml, najčešće prijavljene nuspojave bile su:
English: 8 March 2002 / 20 February 2007
Croatian: Datum prvog odobrenja: 8. ožujka 2002.
English: Affecting the skin
Croatian: Na razini kože
English: MARKETING AUTHORISATION NUMBER EU/1/02/205/003-004
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/02/205/003-004
English: One ml of solution contains 0.05 mg benzalkonium chloride.
Croatian: Jedan ml otopine sadrži 0,05 mg benzalkonijevog klorida.
English: Uncommon side effects These may affect 1 to 9 users in 1000 Affecting the eye
Croatian: Manje česte nuspojave Mogu se javiti kod 1 do 9 na 1000 korisnika
English: LUMIGAN has not been studied in patients with inflammatory ocular conditions, neovascular, inflammatory, angle-closure glaucoma, congenital glaucoma or narrow-angle glaucoma.
Croatian: LUMIGAN nije ispitan kod bolesnika s upalnim stanjima oka, neovaskularnim, upalnim, kongenitalnim glaukomom te glaukomom zatvorenog ili uskog kuta.
English: LUMIGAN 0.3 mg/mL single-dose may cause your eyelashes to darken and grow, and cause the skin around the eyelid to darken too.
Croatian: Jednodozni LUMIGAN 0,3 mg/ml može prouzročiti tamnjenje i rast trepavica te tamnjenje kože oko vjeđe.
English: In a 12-month Phase III clinical study approximately 38 % of patients treated with LUMIGAN 0.1 mg/ml eye drops, solution experienced adverse reactions.
Croatian: U 12-mjesečnom kliničkom ispitivanju faze III, približno 38% bolesnika liječenih LUMIGAN 0,1 mg/ml kapima za oko imalo je nuspojave.
English: • Longer eyelashes (up to 45% of people)
Croatian: • Duže trepavice (do 45% ljudi)
English: This dose expressed as mg/m2 is at least 70-times higher than the accidental dose of one bottle of LUMIGAN 0.3 mg/ml eye drops, solution in a 10 kg child.
Croatian: Ta doza, izražena u mg/m2, najmanje je 70 puta veća od slučajno progutane doze jedne bočice otopine LUMIGAN 0,3 mg/ml kapi za oko kod djeteta od 10 kg.
English: Warnings and precautions Talk to you doctor or pharmacist before you use LUMIGAN 0.3 mg/mL single-dose.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego primijenite jednodozni LUMIGAN 0,3 mg/ml.
English: What LUMIGAN 0.3 mg/ml contains - The active substance is Bimatoprost.
Croatian: Što LUMIGAN 0,3 mg/ml sadrži - Djelatna tvar je bimatoprost.
English: Nervous system disorders common headache
Croatian: Poremećaji živčanog sustava često glavobolja
English: Your sight may become blurred for a short time just after using LUMIGAN.
Croatian: Odmah nakon primjene kapi LUMIGAN, mogli biste nakratko imati zamagljen vid.
English: How to store LUMIGAN 0.3 mg/ml Contents of the pack and other information
Croatian: Kako čuvati jednodozni LUMIGAN 0,3 mg/ml Sadržaj pakiranja i druge informacije
English: Bimatoprost was not mutagenic or carcinogenic in a series of in vitro and in vivo studies.
Croatian: U nizu in vitro i in vivo ispitivanja bimatoprost nije imao mutagena niti kancerogena svojstva.
English: Each single-dose container contains 0.4 ml solution.
Croatian: Svaki jednodozni spremnik sadrži 0,4 ml otopine.
English: Carton containing 5 single-dose containers,
Croatian: Kutija s 5 jednodoznih spremnika,
English: In clinical studies, LUMIGAN was used concomitantly with a number of different ophthalmic beta-blocking agents without evidence of interactions.
Croatian: U kliničkim ispitivanjima LUMIGAN je primijenjen istovremeno s drugim oftalmološkim betablokatorima i nije bilo dokaza o interakcijama.
English: In studies of bimatoprost 0.3 mg/ml in patients with glaucoma or ocular hypertension, it has been shown that the more frequent exposure of the eye to more than one dose of bimatoprost daily may decrease the IOP-lowering effect.
Croatian: U ispitivanjima otopine bimatoprosta 0,3 mg/ml u bolesnika s glaukomom ili povišenim očnim tlakom, ustanovljeno je da češće izlaganje oka više nego jednoj dozi bimatoprosta dnevno može smanjiti njegovu učinkovitost u snižavanju intraokularnog tlaka.
English: • Inflamed, red and itchy eyelids
Croatian: • Upala, crvenilo i svrbež vjeđa
English: • Slight redness (up to 29 % of people)
Croatian: • Lagano crvenilo (do 29 % ljudi)
English: What LUMIGAN 0.3 mg/mL single-dose looks like and contents of the pack LUMIGAN 0.3 mg/mL single-dose is a clear, colourless solution supplied in single-dose plastic containers, each containing 0.4 ml of solution.
Croatian: Kako jednodozni LUMIGAN 0,3 mg/ml izgleda i sadržaj pakiranja Jednodozni LUMIGAN 0,3 mg/ml je bistra bezbojna otopina koja se isporučuje u plastičnim jednodoznim spremnicima od kojih svaki sadrži 0,4 ml otopine.
English: Cardiovascular
Croatian: Kardiovaskularni sustav
English: In clinical studies, bimatoprost 0.3 mg/ml, eye drops, solution was used concomitantly with a number of different ophthalmic beta-blocking agents without evidence of interactions.
Croatian: U kliničkim ispitivanjima otopina bimatoprosta 0,3 mg/ml kapi za oko primijenjena je istovremeno s raznim drugim oftalmološkim beta-blokatorima i nije bilo dokaza o interakcijama.
English: LUMIGAN 0.3 mg/mL single-dose achieved non-inferior IOP-lowering efficacy to LUMIGAN 0.3 mg/mL (multi-dose formulation) for worse eye IOP change from baseline in patients with glaucoma or ocular hypertension.
Croatian: Jednodozni LUMIGAN 0,3 mg/ml nije bio manje djelotvoran u snižavanju intraokularnog tlaka u usporedbi s LUMIGAN-om 0,3 mg/ml (višedozni pripravak) u promjeni tlaka u bolesnijem oku u odnosu na polazne vrijednosti u bolesnika s glaukomom ili povišenim intraokularnim tlakom.
English: These may affect 1 to 9 users in 1000
Croatian: Mogu se javiti kod 1 do 9 na 1000 korisnika
English: These may affect 1 to 9 users in 100
Croatian: Mogu se javiti kod 1 do 9 na 100 korisnika
English: OUTER CARTON CONTAINING 90 SINGLE-DOSE CONTAINERS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA KOJA SADRŽI 90 JEDNODOZNIH SPREMNIKA
English: • Inflammation within the eye
Croatian: • Upala unutar oka
English: White opaque low density polyethylene bottles with polystyrene screw cap. Each bottle has a fill volume of 3 ml.
Croatian: Bijele, neprozirne bočice od polietilena niske gustoće s polistirenskim zatvaračem s navojem.
English: • Headaches
Croatian: • Glavobolje
English: LUMIGAN 0.3 mg/mL single-dose is an antiglaucoma preparation.
Croatian: Jednodozni LUMIGAN 0,3 mg/ml je pripravak za liječenje glaukoma.
English: At 3 months, the incidence of iris hyperpigmentation with bimatoprost 0.3 mg/mL single dose was 0.3%.
Croatian: Nakon 3 mjeseca primjene jednodoznog bimatoprosta 0,3 mg/ml incidencija hiperpigmentacije šarenice bila je 0,3%).
English: • conjunctival hyperaemia (mostly trace to mild and thought to be of a non-inflammatory nature) in up to 44 % in the first year with the incidence of new reports decreasing to 13 % at 2 years and 12 % at 3 years
Croatian: • konjunktivna hiperemija (većinom u tragovima do blaga i vjerojatno neupalne prirode) i do 44% u prvoj godini primjene s padom incidencije novih prijava na 13% u drugoj i 12% u trećoj godini primjene.
English: One ml of solution contains 0.2 mg benzalkonium chloride.
Croatian: Jedan ml otopine sadrži 0,2 mg benzalkonijevog klorida.
English: CARTON CONTAINING THREE BOTTLES
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA KOJA SADRŽI TRI BOČICE
English: Eye irritation and discolouration of the soft contact lenses may also occur because of the presence of benzalkonium chloride.
Croatian: Zbog prisutnosti benzalkonijevog klorida mogu se pojaviti također iritacija oka i mijenjanje boje mekanih kontaktnih leća.
English: • Crusting on the edge of the eyelid
Croatian: • Stvaranje krastica na rubu vjeđe
English: LUMIGAN 0.1 mg/ml”) - You have or have had low blood pressure or low heart rate - You have had a viral infection or inflammation of the eye
Croatian: nosite kontaktne leće (pogledajte „Važne informacije o nekim sastojcima kapi LUMIGAN 0,1 mg/ml“) imate ili ste imali nizak krvni tlak ili spore otkucaje srca ste imali virusnu infekciju ili upalu oka.
English: Compared to treatment with beta-blocker alone, adjunctive therapy with beta-blocker and LUMIGAN 0.3 mg/mL (multi-dose formulation) lowered mean morning (08:00) intraocular pressure by -6.5 to -8.1 mmHg.
Croatian: U usporedbi s liječenjem samo beta-blokatorima, kombinirano liječenje beta-blokatorima i kapima LUMIGAN 0,3 mg/ml (višedozni pripravak) smanjilo je prosječni jutarnji (08:00) intraokularni tlak za -6,5 do -8,1 mmHg.
English: LUMIGAN 0.1 mg/ml eye drops contains BAK in a concentration of 200 ppm.
Croatian: LUMIGAN 0,1 mg/ml kapi za oko sadrže benzalkonijev klorid u koncentraciji od 200 ppm.
English: The safety and efficacy of LUMIGAN in children aged 0 to 18 years has not been established.
Croatian: Sigurnost i djelotvornost LUMIGAN-a u djece u dobi od 0 do 18 godina nije još ustanovljena.
English: In a 6-month clinical study with LUMIGAN 0.3 mg/mL (multi-dose formulation), versus latanoprost, a statistically superior reduction in morning mean IOP (ranging from -7.6 to -8.2 mmHg for bimatoprost versus -6.0 to -7.2 mmHg for latanoprost) was observed at all visits throughout the study.
Croatian: 6-mjesečnom kliničkom ispitivanju s kapima LUMIGAN 0,3 mg/ml (višedozni pripravak), u usporedbi s latanoprostom, zabilježeno je statistički veće snižavanje jutarnjeg prosječnog intraokularnog tlaka (u rasponu od -7,6 do -8,2 mmHg za bimatoprost u usporedbi s -6,0 do7,2 mmHg za latanoprost) na svim pregledima tijekom ispitivanja.
English: Clear, single-dose Low Density Polyethylene (LDPE) containers with a twist-off tab.
Croatian: Prozirni jednodozni spremnici od polietilena niske gustoće sa zatvaračem na odvrtanje.
English: What LUMIGAN 0.1 mg/ml contains
Croatian: Što LUMIGAN 0,1 mg/ml sadrži
English: Adverse reactions reported in phosphate containing eye drops:
Croatian: Nuspojave prijavljene pri primjeni kapi koje sadrže fosfat:
English: In a 6-month clinical study with LUMIGAN 0.3 mg/ml, versus latanoprost, a statistically superior reduction in morning mean IOP (ranging from -7.6 to -8.2 mmHg for bimatoprost versus -6.0 to -7.2 mmHg for latanoprost) was observed at all visits throughout the study.
Croatian: 6-mjesečnom kliničkom ispitivanju s LUMIGAN-om 0,3 mg/ml, u usporedbi s latanoprostom, zabilježeno je statistički veće smanjenje jutarnjeg prosječnog intraokularnog tlaka (u rasponu od -7,6 do -8,2 mmHg za bimatoprost u usporedbi s -6,0 do -7,2 mmHg za latanoprost) na svim pregledima tijekom ispitivanja.
English: Compared to treatment with beta-blocker alone, adjunctive therapy with beta-blocker and LUMIGAN 0.3 mg/ml lowered mean morning (08:00) intraocular pressure by -6.5 to -8.1 mmHg.
Croatian: U usporedbi s liječenjem samo beta-blokatorima, kombinirano liječenje beta-blokatorima i kapima LUMIGAN 0,3 mg/ml smanjilo je prosječni jutarnji (08:00) intraokularni tlak za 6,5 do 8,1 mmHg.
English: • conjunctival hyperaemia (mostly trace to mild and thought to be of a non-inflammatory nature) in up to 44% in the first year with the incidence of new reports decreasing to 13% at 2 years and 12% at 3 years
Croatian: • konjunktivna hiperemija (većinom u tragovima do blaga i vjerojatno neupalne prirode) i do 44% u prvoj godini primjene s padom incidencije od 13% u drugoj i 12% u trećoj godini primjene prema novijim izvješćima.
English: Discard four weeks after first opening.
Croatian: Bacite četiri tjedna nakon prvog otvaranja.
English: Patients with hepatic and renal impairment:
Croatian: Bolesnici s oštećenjem bubrega i jetre