FrancophonIA/ELRC3.0 huggingface dataset:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 07 January 2010
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI 7 ta' Jannar 2010
English: LUMIGAN has not been studied in patients with compromised respiratory function.
Maltese: LUMIGAN ma kienx studjat f'pazjenti b'funzjoni respiratorja kompromessa.
English: Table 1
Maltese: Tabella 1
English: It is a synthetic prostamide, structurally related to prostaglandin F2 (PGF2), that does not act through any known prostaglandin receptors.
Maltese: Huwa prostamide sintetiku, strutturalment relatat ma' prostaglandin F2 (PGF2), li ma jaħdimx permezz ta' xi riċetturi ta' prostaglandin magħruf.
English: Risk Management Plan (RMP)
Maltese: Pjan tal-ġestjoni tar-riskju (RMP)
English: Tlf/Puh/Tel: +4580884560 (DK) +47 80 01 04 97 (NO) +358 800 115 003 (FI) +46 (0)8 594 100 00 (SE)
Maltese: (DK) +47 80 01 04 97 (NO) +358 800 115 003 (FI) +46 (0)8 594 100 00 (SE)
English: Pharmacotherapeutic group: Ophthalmologicals, prostaglandin analogues, ATC code: S01EE03.
Maltese: Mediċini oftalmoloġiċi, analogi ta' prostaglandin, Kodiċi ATC:
English: It belongs to a group of medicines called prostamides.
Maltese: Jifforma parti minn grupp ta' mediċini magħrufa bħala prostamidi.
English: Hypersensitivity reaction including signs and symptoms of eye allergy and allergic dermatitis
Maltese: Reazzjoni ta' sensittività eċċessiva li tinkludi sinjali u sintomi ta' allerġija fl-għajn u dermatite allerġika
English: Opened (2):
Maltese: Infetaħ (2):
English: Pack contains 5-single-dose containers in a carton.
Maltese: Pakkett fih 5 kontenituri ta' doża waħda f'kartuna.
English: Other medicines and LUMIGAN
Maltese: Mediċini oħra u LUMIGAN
English: Benzalkonium chloride, which is commonly used as a preservative in ophthalmic products, has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy.
Maltese: Kien irrapurtat li benzalkonium chloride, li ġeneralment jintuża bħala preservattiv fi prodotti għallgħajnejn, jikkawża punctate keratopathy u/jew ulcerative keratopathy tossika.
English: Batch:
Maltese: SN:
English: Table 2
Maltese: Tabella 2
English: Opened (1):
Maltese: Infetaħ (1):
English: Respiratory
Maltese: Sistema respiratorja
English: Opened (3):
Maltese: Infetaħ (3):
English: • Itchiness (up to 14% of people)
Maltese: • Ħakk (sa 14% tal-persuni)
English: One ml of solution contains 0.05 mg benzalkonium chloride.
Maltese: Millilitru ta' soluzzjoni fih 0.05 mg ta' benzalkonium chloride.
English: One ml of solution contains 0.2 mg benzalkonium chloride.
Maltese: Millilitru ta' soluzzjoni fih 0.2 mg ta' benzalkonium chloride.
English: Reporting side effects
Maltese: Rappurtar tal-effetti sekondarji
English: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from available data) adverse reactions are presented according to System Organ Class in Table 1 in order of decreased seriousness within each frequency grouping.
Maltese: Komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ]afna(<1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli) reazzjonijiet avversi huma ppreżentati skont il-Sistema tal-Klassifika tal-Organi f'Tabella 1 skont il-gravità tagħhom f'kull kategorija ta' frekwenza.
English: On combining the data from phase III monotherapy and adjunctive LUMIGAN 0.3 mg/ml eye drops, solution usage, the most frequently reported treatment-related adverse events were: growth of eyelashes in up to 45% in the first year with the incidence of new reports decreasing to 7% at 2 years and 2% at 3 years, conjunctival hyperaemia (mostly trace to mild and thought to be of a noninflammatory 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 and 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.
Maltese: III ta' monoterapija u użu flimkien ma' LUMIGAN 0.3 mg/ml qtar għall-għajnejn, soluzzjoni, l-aktar effetti avversi frekwenti marbuta ma' din il-kura li kienu rrapurtati kienu: żjieda fit-tul tax-xagħar ta' xfar -il għajn f'45% fl-ewwel sena, bin-numru ta' każijiet ġodda jonqos għal 7% wara sentejn u 2% wara tliet snin; iperimija konġunktivali (minn ftit sa ħafifa u maħsuba li hi ta' natura mhux infjammatorja) f'44% fl-ewwel sena bin-numru ta' każijiet ġodda jonqos għal 13% wara sentejn u 12% wara tliet snin, u hakk fl-għajn f'14% tal-pazjenti fl-ewwel sena bin-numru ta' każijiet ġodda jonqos għal 3% wara sentejn u 0% wara tliet snin.
English: Bimatoprost then undergoes oxidation, N-deethylation and glucuronidation to form a diverse variety of metabolites.
Maltese: Bimatoprost imbagħad jgħaddi minn ossidazzjoni, N-deethylation u glukoronidazzjoni biex jifforma varjetà differenti ta' metaboliti.
English: Bimatoprost penetrates the human cornea and sclera well in vitro.
Maltese: Bimatoprost jippenetra sew fil-korneja umana u fl-isklera in vitro.
English: • Worsening of the lung disease called chronic obstructive pulmonary disease (COPD)
Maltese: • Aggravar tal-marda tal-pulmun imsejħa marda pulmonari ostruttiva kronika (COPD)
English: LUMIGAN 0.1 mg/ml contains the preservative benzalkonium chloride (200 ppm), which may be absorbed by soft contact lenses.
Maltese: LUMIGAN 0.1 mg/ml fih il-preservattiv benzalkonium chloride (200 ppm), li jista' jiġi assorbit milllentijiet tal-kuntatt rotob.
English: Co. Mayo
Maltese: Mayo
English: 8 March 2002 / 20 February 2007
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI 8 ta' Marzu 2002/20 ta' Frar 2007
English: Gastrointestinal disorders uncommon nausea
Maltese: Disturbi gastro-intestinali mhux komuni nawseja
English: Each pouch contains 10 single-dose containers.
Maltese: 10 kontenituri ta' doża waħda.
English: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data) adverse reactions are presented according to System Organ Class in Table 1.
Maltese: Komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1000 sa <1/100); rari (≥1/10,000 sa <1/1000); rari ħafna (<1/10,000) u mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli) ir-reazzjonijiet avversi huma ppreżentati skont is-Sistema tal-Klassifika tal-Organi f'Tabella 1.
English: Allergan Baltics UAB Tel: +37 052 072 777
Maltese: Tel: +37 052 072 777
English: The elimination half-life, determined after intravenous administration, was approximately 45 minutes; the total blood clearance was 1.5 l/hr/kg.
Maltese: Il-half-life ta' leliminazzjoni, wara l-għoti ġol-vina, kienet ta' madwar 45 minuta; it-tneħħija totali mid-demm kienet ta' 1.5 l/siegha/kg.
English: Carton containing 5 single-dose containers,
Maltese: Kartuna li fiha 5 kontenituri b'doża waħda,
English: • Retinal bleeding
Maltese: • Emorraġġija retinali
English: Ocular use.
Maltese: Mhux applikabbli.
English: • Dizziness
Maltese: • Uġigħ
English: • Skin discoloration (periocular)
Maltese: • Tibdil fil-kulur tal-ġilda (periokulari)
English: Bimatoprost selectively mimics the effects of newly discovered biosynthesised substances called prostamides.
Maltese: Bimatoprost selettivament jimita l-effetti tas-sustanzi biosintetizzati ġodda magħrufa bħala prostamidi.
English: Limited experience is available with the use of LUMIGAN in patients with open-angle glaucoma with pseudoexfoliative and pigmentary glaucoma, and chronic angle-closure glaucoma with patent iridotomy.
Maltese: Teżisti esperjenza limitata bl-użu ta' LUMIGAN f'pazjenti b'open angle glaucoma u glawkoma psewdoexfoljattiva u pigmentali, u angle-closure glaucoma kronika b'iridotomija evidenti.
English: 90 pack - 18 months
Maltese: Pakkett b'90 - 18-il xahar
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.
Maltese: Fi studju kliniku ta' 6 xhur b'LUMIGAN 0.3 mg/ml, imqabbel ma' latanoprost, kien osservat tnaqqis statistikament superjuri fil-medja IOP ta' filgħodu (li tvarja minn -7.6 sa -8.2 mmHg għal bimatoprost meta mqabbel ma' -6.0 sa -7.2 mmHg għal latanoprost) fl-analiżi kollha li saru matul l-istudju.
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.
Maltese: Fi studju kliniku ta' 6 xhur b'LUMIGAN 0.3 mg/mL (formulazzjoni b'ħafna dożi), imqabbel ma' latanoprost, kien osservat tnaqqis statistikament superjuri fil-medja IOP ta' filgħodu (li tvarja minn -7.6 sa -8.2 mmHg għal bimatoprost meta mqabbel ma' -6.0 sa -7.2 mmHg għal latanoprost) fl-analiżi kollha li saru matul l-istudju.
English: Adverse Reaction
Maltese: RESPONSABBLI
English: 30 pack - 18 months
Maltese: Pakkett bi 30 - 18-il xahar
English: Each single-dose container contains 0.4 ml solution.
Maltese: Kull kontenitur b'doża waħda fih 0.4 ml ta' soluzzjoni.
English: Additional adverse reactions reported with LUMIGAN 0.3 mg/ml are presented in Table 2.
Maltese: Reazzjonijiet avversi addizzjonali rrappurtati b'LUMIGAN 0.3 mg/ml huma ppreżentati f'Tabella 2.
English: Pregnancy
Maltese: Bimatoprost
English: Limited experience is available in patients with open-angle glaucoma with pseudoexfoliative and pigmentary glaucoma, and chronic angle-closure glaucoma with patent iridotomy.
Maltese: Teżisti esperjenza limitata tal-prodott f'pazjenti b'open angle glaucoma u glawkoma psewdoexfoljattiva u pigmentali, u angle-closure glaucoma kronika b'iridotomija evidenti.
English: These may affect 1 to 9 users in 1000
Maltese: Dawn jistgħu jolqtu minn 1 sa 9 utenti minn 1000
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux ativa elenkata fissezzjoni 6.1.
English: • Symptoms of allergic reaction (swelling, redness of the eye and rash of the skin)
Maltese: • Sintomi ta reazzjoni allerġika (nefħa, ħmura ta' l- għajn u raxx fil- ġilda)
English: Eye drops, solution 5 x 0.4 ml
Maltese: U KONTENUT Qtar għall-għajnejn, soluzzjoni 5 x 0.4 ml
English: A 12 week (double-masked, randomized, parallel group ) clinical study compared the efficacy and safety of LUMIGAN 0.3 mg/mL single-dose with LUMIGAN 0.3 mg/mL (multi-dose formulation).
Maltese: Studju kliniku ta' 12-il ġimgħa (double-masked, li fih il-parteċipanti ntgħażlu b'mod każwali, bi grupp parallel) qabbel l-effikaċja u s-sigurtà ta' LUMIGAN 0.3 mg/mL doża waħda ma' LUMIGAN 0.3 mg/mL (formulazzjoni b'ħafna dożi).
English: Bimatoprost is moderately distributed into body tissues and the systemic volume of distribution in humans at steady-state was 0.67 l/kg.
Maltese: Bimatoprost jitqassam b'mod moderat fit-tessuti tal-ġisem u l-volum ta' distribuzzjoni sistemika fiss fin-nies hu ta' 0.67 l/kg.
English: Eye drops, solution 90 x 0.4 ml
Maltese: U KONTENUT Qtar għall-għajnejn, soluzzjoni 90 x 0.4 ml
English: Hydrochloric acid or sodium hydroxide (to adjust pH) Purified water
Maltese: Hydrochloric acid jew Sodium hydroxide (biex tadatta l-pH) Ilma purifikat
English: These may affect 1 to 9 users in 100
Maltese: Dawn jistgħu jolqtu minn 1 sa 9 utenti minn 100.
English: Eye drops, solution 1 x 3 ml
Maltese: U KONTENUT Qtar għall-għajnejn, soluzzjoni 1 x 3 ml
English: Nervous system disorders common headache
Maltese: Disturbi fis-sistema nervuża mhux komuni sturdament
English: Uncommon side effects These may affect 1 to 9 users in 1000 Affecting the eye
Maltese: Effetti sekondarji komuni Dawn jistgħu jolqtu minn 1 sa 9 utenti minn 100.
English: INFORMATION IN BRAILLE
Maltese: Informazzjoni Oħra
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.
Maltese: Fi studji kliniċi, bimatoprost 0.3 mg/ml, eye drops, solution intuża flimkien ma' numru differenti ta' imblokkaturi tar-riċetturi beta ta' l-għajnejn mingħajr l-ebda evidenza ta' interazzjoni.
English: Adverse reactions reported in phosphate containing eye drops:
Maltese: Reazzjonijiet avversi rrappurtati bi qtar tal-għajnejn li fih fosfat:
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.
Maltese: Din id-doża hi mill-inqas 22 darba ogħla minn doża aċċidentali tal-kontenut kollu ta' pakkett ta' LUMIGAN 0.3 mg/mL doża waħda (30 x 0.4 mL kontenitur b'doża waħda; 12 mL) f'tifel/tifla ta' 10 kg.
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.
Maltese: Meta mqabbel mal-kura permezz ta' imblokkatur tar-riċetturi beta biss, it-terapija flimkien ta' imblokkatur tar-riċetturi beta u LUMIGAN 0.3 mg/ml naqqsu l-medja ta' pressjoni fl-għajn ta' filgħodu (08.00) b'-6.5 sa -8.1 mmHg.
English: Carton containing 30 or 90 single-dose containers in three or nine aluminium foil pouches, respectively.
Maltese: Kartuna li fiha 30 jew 90 kontenitur b'doża waħda fi tliet jew disa' boroż tal-fojl tal-aluminju, rispettivament.
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.
Maltese: Meta mqabbel mal-kura permezz ta' imblokkatur tar-riċetturi beta biss, it-terapija flimkien ta' imblokkatur tar-riċetturi beta u LUMIGAN 0.3 mg/mL (formulazzjoni b'ħafna dożi), naqqsu l-medja ta' pressjoni fl-għajn ta' filgħodu (08.00) b'-6.5 sa -8.1 mmHg.
English: Cardiovascular
Maltese: FARMAĊEWTIKU
English: One ml of solution contains 0.3 mg bimatoprost.
Maltese: U KWANTITATTIVA Ml wieħed fih 0.3 mg bimatoprost.
English: Eye drops, solution 30 x 0.4 ml
Maltese: U KONTENUT Qtar għall-għajnejn, soluzzjoni 30 x 0.4 ml
English: • Slight redness (up to 29 % of people)
Maltese: • Ħmura ħafifa (sa 29% tal-persuni)
English: There have been a limited number of spontaneous reports of bradycardia or hypotension with bimatoprost 0.3 mg/mL eye drops, solution (multi-dose formulation).
Maltese: Kien hemm numru limitat ta' rapporti spontanji ta' bradikardija jew pressjoni baxxa bi bimatoprost 0.3 mg/mL qtar għall-għajnejn, soluzzjoni (formulazzjoni b'ħafna dożi).
English: • Cystoid macular oedema (swelling of the retina within the eye leading to worsening vision)
Maltese: • Edima makulari (nefħa tar-retina ġol-għajn li twassal għal aggravar tal-vista)
English: Investigations common liver function test abnormal
Maltese: Investigazzjonijiet komuni test tal-funzjoni tal-fwied b'riżultat anormali
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
Maltese: • iperimija konġunktivali (minn ftit sa ħafifa u maħsuba li hi ta' natura mhux infjammatorja) f'44% fl-ewwel sena bin-numru ta' każijiet ġodda jonqos għal 13% wara sentejn u 12% wara tliet snin
English: Bimatoprost was not mutagenic or carcinogenic in a series of in vitro and in vivo studies.
Maltese: Bimatoprost ma kienx mutaġeniku jew karċinoġeniku f'serje ta' studji in vitro u in vivo.
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 bimatoprost concentration was reached during the first week of ocular dosing.
Maltese: Il-medja talvaluri ta' Cmax u AUC 0-24hsiegħat kienu simili fis-7 u l-14-il ġurnata f'ammonti ta' madwar 0.08 ng/ml u 0.09 ng•siegħa/ml rispettivament, u dan jindika li konċentrazzjoni fissa ta' bimatoprost ntlaħaqet matul l-ewwel ġimgħa ta' l-għotja fl-għajn.
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).
Maltese: Edima makulari taċ-ċistojde kienet rappurtata b'mod mhux komuni (≥1/1,000 sa <1/100) wara kura bi bimatoprost 0.3 mg/mL qtar għall-għajnejn (formulazzjoni b'ħafna dożi).
English: • Blurred vision
Maltese: • Diffikultajiet fil-vista
English: Benzalkonium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, sodium chloride, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water
Maltese: Benzalkonium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, sodium chloride, hydrochloric acid jew sodium hydroxide (biex tadatta l-pH) u ilma purifikat
English: Bimatoprost 0.3 mg/ml eye drops, solution contains the preservative benzalkonium chloride, which may be absorbed by soft contact lenses.
Maltese: Bimatoprost 0.3 mg/ml qtar għall-għajnejn, soluzzjoni fih il-preservattiv benzalkonium chloride, li jista' jiġi assorbit mill-lentijiet tal-kuntatt rotob.
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.
Maltese: Fil-każ ta' pazjenti bi storja ta' mard ħafif tal-fwied jew alanine aminotransferase (ALT) abnormali, aspartate aminotransferase (AST) u/jew bilirubin fil-linja bażi, bimatoprost 0.3 mg/ml qtar għallgħajnejn, soluzzjoni ma kellux effett avvers fuq il-funzjoni tal-fwied fuq perjodu ta' 24 xahar.
English: Bimatoprost is eliminated primarily by renal excretion, up to 67% of an intravenous dose administered to healthy adult volunteers was excreted in the urine, 25% of the dose was excreted via the faeces.
Maltese: Bimatoprost jiġi eliminat primarjament mill-kliewi, sa 67% mid-doża mogħtija mill-vina lil voluntiera adulti f'saħħithom kienet imneħħija fl-awrina, 25% tad-doża tneħħiet fl-ippurgar.
English: Eye drops, solution 3 x 3 ml
Maltese: U KONTENUT Qtar għall-għajnejn, soluzzjoni 3 x 3ml
English: Paediatric population
Maltese: Popolazzjoni pedjatrika:
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.
Maltese: Matul l-ewwel 12-il xahar ta' kura monoterapika b'LUMIGAN 0.3 mg/mL (formulazzjoni b'ħafna dożi) fl-adulti, imqabbel ma' timolol, il-bidla mill-linja bażi minn pressjoni fl-għajn ta' filgħodu (08:00) varjat minn -7.9 sa -8.8 mmHg.
English: If you use LUMIGAN with another eye medicine, wait at least five minutes between using LUMIGAN and the other eye medicine.
Maltese: Jekk tuża LUMIGAN flimkien ma' mediċini oħra tal-għajnejn, ħalli mill-anqas 5 minuti bejn l-użu ta' LUMIGAN u l-mediċina l-oħra.
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).
Maltese: Bimatoprost ma ħalliex effetti negattivi fuq il-fertilità fil-firien b'dożi ta' 0.6 mg/kg/kuljum (millinqas 103 darba aktar mill-espożizzjoni rakkomandata għall-persuni).
English: One ml of solution contains 0.1 mg bimatoprost.
Maltese: U KWANTITATTIVA Ml wieħed fih 0.1 mg bimatoprost.
English: Eye disorders very common conjunctival hyperaemia, ocular pruritus, growth of eyelashes common superficial punctate keratitis, corneal erosion, ocular burning, ocular irritation, allergic conjunctivitis, blepharitis, worsening of visual acuity, asthenopia, conjunctival oedema, foreign body sensation, ocular dryness, eye pain, photophobia, tearing, eye discharge, visual disturbance/blurred vision, increased iris pigmentation, eyelash darkening, eyelid erythema, eyelid pruritus uncommon retinal haemorrhage, uveitis, cystoid macular oedema, iritis, blepharospasm, eyelid retraction, periorbital erythema, eyelid oedema not known periorbital and lid changes including deepening of the eyelid sulcus ocular discomfort
Maltese: Disturbi fl-għajnejn komuni ħafna iperemija tal-konġuntiva, ħakk okulari, tkabbir tax-xagħar talgħajnejn komuni keratite punctate superfiċjali, tgħawwir tal-kornea, ħruq flgħajnejn, irritazzjoni flgħajnejn, konġuntivite allerġika, blefarite, iċ-ċarezza tal-vista tmur għall-agħar, astenopja, edema tal-konġuntiva, sensazzjoni ta' oġġett barrani, nixfa fl-għajnejn, uġigħ flgħajnejn, fotofobia, dmugħ, ħruġ ta' likwidu mill-għajnejn, disturb tal-vista/vista mċajpra, żieda fil-pigmentazzjoni talħabba tal-għajn, ix-xagħar talgħajnejn jiskura, eritema ta' tebqet il-għajn, ħakk ta' tebqet il-għajn mhux komuni emorraġija fir-retina, uveite, edema makulari ċistojde, irite, blefarospażmu, ritrattazzjoni ta' tebqet il-għajn, eritema periorbitali, edima f'tebqet ilgħajn mhux magħrufa bidliet periorbitali u ta' tebqet il-għajn li jinkludu li s-sulkus ta' tebqet il-għajn ikun aktar filfond, skumdità fl-għajn
English: • Burning
Maltese: • Sturdament
English: Reduction of elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension in adults (as monotherapy or as adjunctive therapy to beta-blockers).
Maltese: Tnaqqis ta' pressjoni għolja fl-għajn f'open-angle glawkoma u pressjoni għolja fl-għajn fl-adulti (bħala monoterapija jew bħala terapija miżjuda ma' imblokkaturi tar-riċetturi beta).
English: LUMIGAN 0.3 mg/mL single-dose also achieved equivalent IOP lowering efficacy with LUMIGAN 0.3 mg/mL (multi-dose formulation) in average eye IOP at each follow-up timepoint at weeks 2, 6 and 12.
Maltese: LUMIGAN 0.3 mg/mL doża waħda kiseb ukoll effikaċja ekwivalenti li tbaxxi l-IOP meta mqabbel ma' LUMIGAN 0.3 mg/mL (formulazzjoni b'ħafna dożi) f'IOP medja fl-għajnejn f'kull punt ta' żmien ta' follow-up f'ġimgħat 2, 6 u 12.
English: Other side effects reported with eye drops containing phosphates.
Maltese: Effetti sekondarji oħrajn irrappurati bi qtar tal-għajnejn li fih fosfat.
English: Sodium phosphate dibasic heptahydrate, citric acid monohydrate, sodium chloride, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water.
Maltese: Sodium phosphate dibasic heptahydrate, citric acid monohydrate, sodium chloride, hydrochloric acid jew sodium hydroxide (għall-aġġustament tal-pH) u ilma ppurifikat.
English: BOTTLE
Maltese: Treddigħ
English: In clinical studies, over 1800 patients have been treated with LUMIGAN 0.3 mg/mL (multi-dose formulation).
Maltese: Fi studji kliniċi, aktar minn 1800 pazjent ingħataw il-kura permezz ta' LUMIGAN 0.3 mg/mL (formulazzjoni b'ħafna dożi).
English: • Longer eyelashes
Maltese: • Vista mċajpra
English: • Darker eyelid colour
Maltese: Effett fuq il-ġisem
English: LUMIGAN 0.3 mg/mL single-dose is an antiglaucoma preparation.
Maltese: LUMIGAN 0.3 mg/mL doża waħda hu prodott mediċinali għal kontra l-glawkoma.
English: The frequency of these symptoms is not known.
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ.
English: Tel: +385 1 6646 563
Maltese: Ewopharma d.o.o. Tel: +385 1 6646 563
English: Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu.
English: • Slight redness (up to 24% of people)
Maltese: • Ħmura ħafifa (sa 24% tal-persuni)
English: LUMIGAN 0.3 mg/ml
Maltese: X'fih LUMIGAN 0.3 mg/ml
English: Cystoid macular oedema has been uncommonly reported (≥1/1,000 to <1/100) following treatment with bimatoprost 0.3 mg/ml eye drops.
Maltese: Edima makulari taċ-ċistojde kienet rappurtata b'mod mhux komuni (≥1/1,000 sa <1/100) wara kura bi bimatoprost 0.3 mg/ml qtar għall-għajnejn.