FrancophonIA/ELRC3.0 huggingface dataset:
English: No functional or microscopic changes related to the periocular effects have been observed, and the mechanism of action for the periocular changes is unknown.
Slovenian: Mehanizem delovanja za periokularne spremembe ni znan.
English: The elimination half-life, determined after intravenous administration, was approximately 45 minutes; the total blood clearance was 1.5 l/hr/kg.
Slovenian: Razpolovna doba izločanja, določena po intravenskem dajanju, je bila približno 45 minut.
English: After once daily ocular administration of one drop of LUMIGAN 0.3 mg/ml 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.
Slovenian: Po očesnem odmerku ene kapljice zdravila LUMIGAN 0,3 mg/ml enkrat dnevno v obe očesi v dveh tednih, je koncentracija v krvi narasla v 10 minutah po odmerku in se zmanjšala pod spodnjo mejo zaznavnosti (0,025 ng/ml) v 1,5 uri po odmerku.
English: After once daily ocular administration of one drop of 0.3 mg/ml 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.
Slovenian: Po očesnem odmerku ene kapljice bimatoprosta v koncentraciji 0,3 mg/ml enkrat dnevno v obe očesi v dveh tednih, je koncentracija v krvi narasla v 10 minutah po odmerku in se zmanjšala pod spodnjo mejo zaznavnosti (0,025 ng/ml) v 1,5 uri po odmerku.
English: This dose is at least 22 times higher than an accidental dose of the entire content of a pack of LUMIGAN 0.3 mg/mL single-dose (30 x 0.4 mL single-dose containers; 12 mL) in a 10 kg child.
Slovenian: Ta odmerek je najmanj 22-krat večji v primerjavi z odmerkom, če bi otrok, ki tehta 10 kg, nenamerno zaužil celotno pakiranje zdravila LUMIGAN 0,3 mg/ml (enoodmerna oblika), ki vsebuje 30 enoodmernih vsebnikov po 0,4 ml, skupaj 12 ml.
English: LUMIGAN is an antiglaucoma preparation.
Slovenian: Zdravilo LUMIGAN je zdravilo za zdravljenje glavkoma.
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.
Slovenian: V primerjavi z zdravljenjem samo z antagonisti adrenenergičnih receptorjev beta, je adjuvantna terapija z antagonisti adrenenergičnih receptorjev beta in z zdravilom LUMIGAN 0,3 mg/ml (večodmerna oblika) zmanjšala povprečni jutranji (08:00) očesni tlak za -6,5 do -8,1 mmHg.
English: Skin and subcutaneous tissue disorders common skin hyperpigmentation, hypertrichosis uncommon dry skin, eyelid margin crusting, pruritus not known skin discoloration (periocular)
Slovenian: Bolezni kože in podkožja pogosti hiperpigmentacija kože, hipertrihoza občasni suha koža, tvorba krast na robovih vek, pruritus neznana pogostnost sprememba barve kože (periokularno)
English: White opaque low density polyethylene bottles with polystyrene screw cap. Each bottle has a fill volume of 3 ml.
Slovenian: Bele motne plastenke iz polietilena nizke gostote z navojno polistirensko zaporko.
English: Eye drops, solution, in single-dose container.
Slovenian: kapljice za oko, raztopina, v enoodmernem vsebniku brezbarvna raztopina
English: • Slight redness (up to 29 % of people)
Slovenian: • rahla rdečina (do 29 % ljudi).
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.
Slovenian: V primerjavi z zdravljenjem samo z antagonisti adrenenergičnih receptorjev beta, je adjuvantna terapija z antagonisti adrenenergičnih receptorjev beta in z zdravilom LUMIGAN 0,3 mg/ml zmanjšala povprečni jutranji (08:00) očesni tlak za -6,5 do -8,1 mmHg.
English: After twice daily dosing of LUMIGAN 0.3 mg/ml, the mean AUC0-24hr value of 0.0634 ng•hr/ml bimatoprost in the elderly (subjects 65 years or older) were significantly higher than 0.0218 ng•hr/ml in young healthy adults.
Slovenian: Po odmerjanju zdravila LUMIGAN 0,3 mg/ml dvakrat dnevno je bila povprečna AUC0-24hr vrednost bimatoprosta pri starejših (osebe stare 65 let ali starejše) 0,0634 ng•h/ml, kar je znatno več kot pri zdravih mlajših odraslih, kjer dosega 0,0218 ng•h/ml.
English: At 12 months, the incidence of iris pigmentation with bimatoprost 0.3 mg/mL (multi-dose formulation) was 1.5% (see section 4.8) and did not increase following 3 years treatment.
Slovenian: Po 12 mesecih je bila incidenca pigmentacije irisa z bimatoprostom 0,3 mg/ml (večodmerna oblika) 1,5 % (glejte poglavje 4.8) in se v naslednjih 3 letih zdravljenja ni povečala.
English: The recommended dose is one drop once daily, in the evening, once daily in each eye that needs treatment.
Slovenian: Priporočeni odmerek je ena kapljica zdravila dnevno, ki jo je treba zvečer vkapati v vsako zdravljeno oko.
English: Bimatoprost did not impair fertility in rats up to doses of 0.6 mg/kg/day (at least 103-times the intended human exposure).
Slovenian: Bimatoprost v koncentracijah do 0,6 mg/kg/dan (vsaj 103-krat večja od priporočene izpostavljenosti pri človeku) ni vplival na rodnost pri podganah.
English: Table 1
Slovenian: Preglednica 1
English: Discard four weeks after first opening.
Slovenian: Zavrzite štiri tedne po prvem odprtju.
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
Slovenian: - če uporabljate kontaktne leče (glejte poglavje »Pomembne informacije o nekaterih sestavinah zdravila LUMIGAN 0,1 mg/ml«), - če imate ali ste imeli nizek krvni tlak ali počasen srčni utrip, - če ste imeli virusno okužbo ali vnetje očesa.
English: At 12 months, the incidence of iris pigmentation with bimatoprost 0.3mg/ml was 1.5% (see section 4.8) and did not increase following 3 years treatment.
Slovenian: Po 12 mesecih je bila incidenca pigmentacije irisa z bimatoprostom 0,3 mg/ml 1,5% (glejte poglavje 4.8) in se v naslednjih 3 letih zdravljenja ni povečala.
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.
Slovenian: V 12-mesečni klinični študiji 3. faze so se neželeni učinki pojavili pri približno 38 % bolnikov, ki so prejemali zdravilo LUMIGAN 0,1 mg/ml kapljice za oko, raztopina.
English: • Swelling of the surface of the eye
Slovenian: • otekanje površine oči,
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.
Slovenian: Zdravilo LUMIGAN 0,3 mg/ml (enoodmerna oblika) je čista brezbarvna raztopina v enoodmernih plastičnih vsebnikih s po 0,4 ml raztopine.
English: Do not use this medicine after the expiry date which is stated on the bottle label and the carton after EXP.
Slovenian: Zdravila ne smete uporabljajti po datumu izteka roka uporabnosti, ki je naveden na nalepki plastenke in škatlici poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: During 12 months' monotherapy treatment with LUMIGAN 0.3 mg/ml in adults, versus timolol, mean change from baseline in morning (08:00) intraocular pressure ranged from -7.9 to -8.8 mm Hg.
Slovenian: Med 12 mesečnim zdravljenjem odraslih z zdravilom LUMIGAN 0,3 mg/ml v monoterapiji v primerjavi s timololom, so povprečne spremembe z osnovne vrednosti očesnega tlaka zjutraj (08:00) znašale med -7,9 do -8,8 mm Hg.
English: During 12 months' monotherapy treatment with LUMIGAN 0.3 mg/mL (multi-dose formulation) in adults, versus timolol, mean change from baseline in morning (08:00) intraocular pressure ranged from -7.9 to -8.8 mmHg.
Slovenian: Med 12 mesečnim zdravljenjem odraslih z zdravilom LUMIGAN 0,3 mg/ml (večodmerna oblika) v monoterapiji v primerjavi s timololom, so povprečne spremembe z osnovne vrednosti očesnega tlaka zjutraj (08:00) znašale med -7,9 do -8,8 mmHg.
English: LUMIGAN 0.1 mg/ml contains benzalkonium chloride Do not use the drops when you are wearing your lenses.
Slovenian: Zdravilo LUMIGAN 0,1 mg/ml vsebuje benzalkonijev klorid Ne uporabljajte kapljic, ko nosite kontaktne leče.
English: CARTON CONTAINING 5 SINGLE-DOSE CONTAINERS
Slovenian: ŠKATLA S 5 ENOODMERNIMI VSEBNIKI
English: What you need to know before you use LUMIGAN 0.1 mg/ml
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo LUMIGAN 0,1 mg/ml
English: Eye drops, solution 1 x 3 ml
Slovenian: kapljice za oko, raztopina 1 x 3 ml
English: LUMIGAN should be used with caution in patients predisposed to low heart rate or low blood pressure.
Slovenian: Pri bolnikih, ki so nagnjeni k počasnemu srčnemu utripu ali nizkemu krvnemu tlaku, je treba zdravilo LUMIGAN uporabljati previdno.
English: - The other ingredients are benzalkonium chloride (preservative), sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate and purified water.
Slovenian: - Druge sestavine zdravila so benzalkonijev klorid (konzervans), natrijev klorid, natrijev dihidrogenfosfat heptahidrat, citronska kislina monohidrat in prečiščena voda.
English: What you need to know before you use LUMIGAN 0.3 mg/ml
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo LUMIGAN 0,3 mg/ml
English: What LUMIGAN 0.1 mg/ml is and what it is used for What you need to know before you use LUMIGAN 0.1 mg/ml How to use LUMIGAN 0.1 mg/ml Possible side effects
Slovenian: Kaj je zdravilo LUMIGAN 0,1 mg/ml in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo LUMIGAN 0,1 mg/ml Kako uporabljati zdravilo LUMIGAN 0,1 mg/ml Možni neželeni učinki
English: LUMIGAN 0.3 mg/ml contains benzalkonium chloride Do not use the drops when you are wearing your lenses.
Slovenian: Zdravilo LUMIGAN 0,3 mg/ml vsebuje benzalkonijev klorid Ne uporabljajte kapljic, ko nosite kontaktne leče.
English: LUMIGAN should be used with caution in patients with a prior history of significant ocular viral infections (e.g. herpes simplex) or uveitis/iritis.
Slovenian: Pri bolnikih s pomembnimi virusnimi okužbami očesa (npr. z virusom herpes simpleks) ali uveitisom/iritisom v anamnezi je treba zdravilo LUMIGAN uporabljati previdno.
English: • ocular pruritus in up to 14% of patients in the first year with the incidence of new reports decreasing to 3% at 2 years and 0% at 3 years.
Slovenian: • okularni pruritus pri do 14 % bolnikov v prvem letu, z upadom števila novih poročil na 3 % pri 2 letih in na 0 % pri 3 letih.
English: Skin and subcutaneous tissue disorders uncommon hirsutism
Slovenian: Bolezni kože in podkožja občasni hirzutizem
English: • Longer eyelashes (up to 45% of people)
Slovenian: • daljše trepalnice (do 45 % ljudi),
English: Sodium phosphate dibasic heptahydrate, citric acid monohydrate, sodium chloride, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water.
Slovenian: Natrijev dihidrogenfosfat heptahidrat, citronska kislina monohidrat, natrijev klorid, klorovodikova kislina ali natrijev hidroksid (za uravnavanje pH) in prečiščena voda.
English: Skin and subcutaneous tissue disorders common pigmentation of periocular skin uncommon hirsutism not known skin discoloration (periocular)
Slovenian: Bolezni kože in podkožja pogosti pigmentacija periokularne kože občasni hirzutizem neznana pogostnost sprememba barve kože (periokularno)
English: Nervous system disorders uncommon headache not known dizziness
Slovenian: Bolezni živčevja občasni glavobol neznana pogostnost omotica
English: Affecting the eye
Slovenian: Učinki na oko:
English: • Skin redness around the eye
Slovenian: • rdečina kože okoli očesa,
English: • Burning sensation in the eye
Slovenian: • pekoč občutek v očesu,
English: In addition to the side effects for LUMIGAN 0.3 mg/mL single-dose, the following side effects have been seen with the preserved multi-dose formulation of LUMIGAN 0.3 mg/mL and may occur in patients taking LUMIGAN 0.3 mg/mL single-dose:
Slovenian: Poleg neželenih učinkov za zdravilo LUMIGAN 0,3 mg/ml (enoodmerna oblika) so pri večodmerni obliki zdravila LUMIGAN 0,3 mg/ml opažali tudi spodnje neželene učinke, ki se lahko pojavijo tudi pri bolnikih, ki uporabljajo zdravilo LUMIGAN 0,3 mg/ml (enoodmerna oblika):
English: In clinical studies, over 1800 patients have been treated with LUMIGAN 0.3 mg/mL (multi-dose formulation).
Slovenian: V kliničnih študijah je bilo z zdravilom LUMIGAN 0,3 mg/ml kapljice za oko (večodmerna oblika) zdravljenih več kot 1800 bolnikov.
English: Batch:
Slovenian: EXP:
English: PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Slovenian: PODATKI, KI MORAJO BITI NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: - The other ingredients are sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate and purified water.
Slovenian: - Druge sestavine zdravila so natrijev klorid, natrijev dihidrogenfosfat heptahidrat, citronska kislina monohidrat in prečiščena voda.
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.
Slovenian: V 3-mesečni študiji je približno 0,7 % bolnikov v skupini, ki je prejemala zdravilo LUMIGAN 0,3 mg/ml (enoodmerna oblika), zaradi katerega koli neželenega učinka prenehalo uporabljati zdravilo.
English: What LUMIGAN 0.3 mg/ml is and what it is used for What you need to know before you use LUMIGAN 0.3 mg/ml How to use LUMIGAN 0.3 mg/ml Possible side effects
Slovenian: Kaj je zdravilo LUMIGAN 0,3 mg/ml in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo LUMIGAN 0,3 mg/ml Kako uporabljati zdravilo LUMIGAN 0,3 mg/ml Možni neželeni učinki
English: Eye disorders very common ocular pruritus, growth of eyelashes common asthenopia, conjunctival oedema, photophobia, tearing, increased iris pigmentation; blurred vision
Slovenian: Očesne bolezni zelo pogosti očesni pruritus, rast trepalnic pogosti astenopija, edem veznice, fotofobija, solzenje, povečana pigmentacija irisa, zamegljen vid
English: Eye drops, solution 3 x 3 ml
Slovenian: kapljice za oko, raztopina 3 x 3 ml
English: Eye irritation and discolouration of the soft contact lenses may also occur because of the presence of benzalkonium chloride.
Slovenian: Zaradi prisotnosti benzalkonijevega klorida lahko pride do draženja oči in obarvanja mehkih kontaktnih leč.
English: Eye drops, solution 90 x 0.4 ml
Slovenian: kapljice za oko, raztopina 90 x 0,4 ml
English: Benzalkonium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, sodium chloride, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water
Slovenian: Benzalkonijev klorid, natrijev dihidrogenfosfat heptahidrat, citronska kislina monohidrat, natrijev klorid, klorovodikova kislina ali natrijev hidroksid (za uravnavanje pH) in prečiščena voda.
English: Monkeys administered ocular bimatoprost concentrations of 0.3 mg/ml 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.
Slovenian: V enoletni študiji, kjer so opice enkrat dnevno prejemale v oko bimatoprost v koncentraciji 0,3 mg/ml, so opazili povečanje pigmentacije irisa in reverzibilni, z odmerkom pogojene, periokularne učinke, za katere sta bila značilna izrazit zgornji in/ali spodnji sulkus in širjenje palpebralne fisure.
English: Bimatoprost is biotransformed by any of multiple enzymes and pathways, and no effects on hepatic drug metabolising enzymes were observed in preclinical studies.
Slovenian: Bimatoprost se biotransformira s katerimkoli od številnih encimov ali poti.
English: Monkeys administered ocular bimatoprost concentrations of 0.3 mg/mL 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.
Slovenian: V enoletni študiji, kjer so opice enkrat dnevno prejemale v oko bimatoprost v koncentraciji 0,3 mg/ml, so opazili povečanje pigmentacije irisa in reverzibilne, z odmerkom pogojene, periokularne učinke, za katerega sta bila značilna izrazita zgornji in/ali spodnji sulkus in širjenje palpebralne fisure.
English: - Talk to your doctor, if: - You have any breathing problems - You have liver or kidney problems - You have had a cataract surgery in the past - You have dry eye - You have or have had any problems with your cornea (front transparent part of the eye) - You wear contact lenses (see “Important information about some of the ingredients of
Slovenian: - Obvestite svojega zdravnika, če: - imate kakršnekoli težave z dihanjem, - če imate težave z jetri ali ledvicami, - če ste bili v preteklosti operirani za sivo mreno, - če imate suhe oči, - če imate ali ste imeli težave z roženico (sprednji, prozorni del očesa),
English: At 12 months, the incidence with bimatoprost 0.3 mg/ml eye drops, solution was 1.5% (see section 4.8 Table 2) and did not increase following 3 years treatment.
Slovenian: Pri uporabi bimatoprosta 0,3 mg/ml, kapljic za oko, raztopine, je bila incidenca po 12 mesecih 1,5 % (glejte poglavje 4.8, preglednica 2) in se v naslednjih 3 letih zdravljenja ni povečala.
English: There have been reports of bacterial keratitis associated with the use of multiple dose containers of topical ophthalmic products.
Slovenian: Povezano z uporabo večodmernih vsebnikov lokalnih očesnih zdravil poročajo o nastanku bakterijskega keratitisa.
English: Each single-dose container contains 0.4 ml solution.
Slovenian: En enoodmerni vsebnik vsebuje 0,4 ml raztopine.
English: General disorders and administration site conditions common instillation site irritation
Slovenian: Splošne težave in spremembe na mestu aplikacije občasni astenija
English: Eye drops, solution 5 x 0.4 ml
Slovenian: kapljice za oko, raztopina 5 x 0,4 ml
English: What LUMIGAN 0.1 mg/ml is and what it is used for
Slovenian: Kaj je zdravilo LUMIGAN 0,1 mg/ml in za kaj ga uporabljamo
English: LUMIGAN 0.1 mg/ml eye drops contains BAK in a concentration of 200 ppm.
Slovenian: Zdravilo LUMIGAN 0,1 mg/ml kapljice za oko, vsebuje benzalkonijev klorid v koncentraciji 200 ppm.
English: LUMIGAN has not been studied in patients with inflammatory ocular conditions, neovascular, inflammatory, angle-closure glaucoma, congenital glaucoma or narrow-angle glaucoma.
Slovenian: Zdravila LUMIGAN niso preizkušali pri bolnikih z očesnimi vnetji, neovaskularnim in z vnetjem pogojenim glavkomom zaprtega zakotja, kongenitalnim glavkomom ali glavkomom zoženega zakotja.
English: Table 3
Slovenian: Preglednica 3
English: Cardiovascular
Slovenian: PLASTENKA
English: Eye drops, solution 30 x 0.4 ml
Slovenian: kapljice za oko, raztopina 30 x 0,4 ml
English: What LUMIGAN 0.3 mg/ml contains - The active substance is Bimatoprost.
Slovenian: Kaj vsebuje zdravilo LUMIGAN 0,3 mg/ml - Učinkovina je bimatoprost.
English: • Red eyelids
Slovenian: • rdeče veke.
English: Carton containing 5 single-dose containers,
Slovenian: Škatla, ki vsebuje 5 enoodmernih vsebnikov.
English: What LUMIGAN 0.3 mg/mL single-dose is and what it is used for What you need to know before you use LUMIGAN 0.3 mg/mL single-dose How to use LUMIGAN 0.3 mg/mL single-dose Possible side effects
Slovenian: Kaj je zdravilo LUMIGAN 0,3 mg/ml (enoodmerna oblika) in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo LUMIGAN 0,3 mg/ml (enoodmerna oblika) Kako uporabljati zdravilo LUMIGAN 0,3 mg/ml (enoodmerna oblika) Možni neželeni učinki
English: Reporting side effects
Slovenian: Poročanje o neželenih učinkih
English: • Eyelid shrinking, moving away from surface of the eye
Slovenian: • krčenje veke oz. veka se odmakne od površine očesa,
English: POUCH CONTAINING 10 SINGLE-DOSE CONTAINERS
Slovenian: VREČKA Z 10 ENOODMERNIMI VSEBNIKI
English: Most were ocular, mild to moderate, and none was serious:
Slovenian: Večina je bila blagih do zmernih učinkov na oko, noben ni bil resen:
English: What LUMIGAN 0.3 mg/ml is and what it is used for
Slovenian: Kaj je zdravilo LUMIGAN 0,3 mg/ml in za kaj ga uporabljamo
English: • Tired eyes
Slovenian: • lepljive oči
English: Your sight may become blurred for a short time just after using LUMIGAN.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Takoj po uporabi zdravila LUMIGAN je lahko vid za kratek čas zamegljen.
English: LUMIGAN 0.3 mg/mL single-dose is an antiglaucoma preparation.
Slovenian: Zdravilo LUMIGAN 0,3 mg/ml (enoodmerna oblika) je zdravilo za zdravljenje glavkoma.
English: Wipe off any excess that runs down the cheek.
Slovenian: Obrišite odvečno tekočino, ki steče po licu.
English: Most were ocular, mild to moderate, and none were serious.
Slovenian: Večinoma so se pojavljali na očesu, bili so blagi do zmerni in niso bili resni.
English: Cystoid macular oedema has been uncommonly reported (≥1/1,000 to <1/100) following treatment with bimatoprost 0.3 mg/mL eye drops (multi-dose formulation).
Slovenian: Občasno (≥1/1.000 do <1/100) so poročali o cistoidnem makularnem edemu kot posledici zdravljenja z bimatoprostom 0,3 mg/ml kapljicami za oko (večodmerna oblika).
English: 5 pack - Do not store above 25°C 30 pack - No special requirements for storage 90 pack - No special requirements for storage 6.5 Nature and contents of container
Slovenian: Pakiranje s 5 vsebniki - ne shranjujte pri temperaturi nad 25 °C.
English: • Irritation, when drop is put in the eye
Slovenian: • draženje pri uporabi kapljic,
English: What LUMIGAN 0.3 mg/mL single-dose is and what it is used for
Slovenian: Kaj je zdravilo LUMIGAN 0,3 mg/ml (enoodmerna oblika) in za kaj ga uporabljamo
English: • Crusting on the edge of the eyelid
Slovenian: • tvorba krast na robovih vek,
English: What LUMIGAN 0.3 mg/mL single-dose contains - The active substance is bimatoprost.
Slovenian: Kaj vsebuje zdravilo LUMIGAN 0,3 mg/ml (enoodmerna oblika) - Učinkovina je bimatoprost.
English: How to store LUMIGAN 0.1 mg/ml Contents of the pack and other information
Slovenian: Shranjevanje zdravila LUMIGAN 0,1 mg/ml Vsebina pakiranja in dodatne informacije
English: One ml of solution contains 0.1 mg bimatoprost.
Slovenian: En ml raztopine vsebuje 0,1 mg bimatoprosta.
English: Concomitant use of LUMIGAN and antiglaucomatous agents other than topical beta-blockers has not been evaluated during adjunctive glaucoma therapy.
Slovenian: Sočasna uporaba zdravila LUMIGAN in drugih zdravil proti glavkomu, poleg lokalnih antagonistov adrenenergičnih receptorjev beta med adjuvantno terapijo glavkoma, ni bila raziskana.
English: In clinical studies, over 1800 patients have been treated with LUMIGAN 0.3 mg/ml.
Slovenian: V kliničnih študijah je bilo z z zdravilom LUMIGAN 0,3 mg/ml, zdravljenih prek 1800 bolnikov.
English: One ml of solution contains 0.3 mg bimatoprost.
Slovenian: En ml raztopine vsebuje 0,3 mg bimatoprosta.
English: What you need to know before you use LUMIGAN 0.3 mg/mL single-dose
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo LUMIGAN 0,3 mg/ml (enoodmerna oblika)
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).
Slovenian: V peri-/postnatalnih študijah pri podganah je pri odmerkih  0,3 mg/kg/dan (ustreza najmanj 41-kratni predvideni izpostavljenosti pri človeku), prišlo do toksičnosti pri samicah, zaradi česar se je zmanjšal čas brejosti, prišlo do smrti fetusa in zmanjšane telesne mase skotenih mladičev.
English: Most were ocular, mild and none was serious:
Slovenian: Večina je bila blagih učinkov na oko, noben ni bil resen:
English: • Itchiness (up to 14% of people)
Slovenian: • srbenje (do 14 % ljudi).
English: LUMIGAN 0.3 mg/mL single-dose should only be applied to the eye
Slovenian: Zdravilo LUMIGAN 0,3 mg/ml (enoodmerna oblika) uporabljajte samo za vkapanje v oko.
English: LUMIGAN 0.3 mg/mL, eye drops, solution, in Single-dose container Bimatoprost
Slovenian: LUMIGAN 0,3 mg/ml, kapljice za oko, raztopina, v enoodmernem vsebniku bimatoprost
English: How to store LUMIGAN 0.3 mg/ml Contents of the pack and other information
Slovenian: Shranjevanje zdravila LUMIGAN 0,3 mg/ml Vsebina pakiranja in dodatne informacije