FrancophonIA/ELRC3.0 huggingface dataset:
English: - The other ingredients are benzalkonium chloride (preservative), sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate and purified water.
Maltese: - Is-sustanzi mhux attivi l-oħra huma benzalkonium chloride (preservattiv), sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate u ilma purifikat.
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.
Maltese: Fi studji kliniċi, LUMIGAN 0.3 mg/mL (formulazzjoni b'ħafna dożi) intuża flimkien ma' numru differenti ta' imblokkaturi tar-riċetturi beta ta' l-għajnejn mingħajr l-ebda evidenza ta' interazzjoni.
English: Tel: +48 22 256 37 00
Maltese: Allergan Sp. z o.o. Tel: +48 22 256 37 00
English: There have been rare spontaneous reports of reactivation of previous corneal infiltrates or ocular infections with bimatoprost 0.3 mg/mL eye drops, solution (multi-dose formulation).
Maltese: Kien hemm rapporti spontanji rari ta' attivazzjoni mill-ġdid ta' infiltrati fil-kornea li kienu seħħew filpassat jew infezzjonijiet okulari bi bimatoprost 0.3 mg/mL qtar għall-għajnejn, soluzzjoni (formulazzjoni b'ħafna dożi).
English: In addition to the side effects for LUMIGAN 0.1 mg/ml, the following side effects have been seen with another medicine containing a higher strength of bimatoprost (0.3 mg/ml):
Maltese: Flimkien mal-effetti sekondarji għal LUMIGAN 0.1 mg/ml, l-effetti sekondarji li ġejjin kienu osservati ma' mediċina oħra li b'qawwa ogħla qawwa ta' bimatoprost (0.3 mg/ml):
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 f'saħħithom kienet imneħħija fl-awrina, 25% tad-doża tneħħiet fl-ippurgar.
English: • Swollen eyelids
Maltese: • Infjammazzjoni ġol-għajn
English: LUMIGAN 0.1 mg/ml
Maltese: X'fih LUMIGAN 0.1 mg/ml
English: • Darker eyelashes
Maltese: Effett fuq il-ġilda
English: • Slight redness (up to 44% of people)
Maltese: • Ħmura ħafifa (sa 44% tal-persuni)
English: LUMIGAN is an antiglaucoma preparation.
Maltese: LUMIGAN hu prodott mediċinali għal kontra l-glawkoma.
English: Detailed information on this medicinal product is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu.
English: Allergan Baltics UAB Tel: +371 676 60 831
Maltese: Tel: +371 676 60 831
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).
Maltese: Tabella 2 telenka reazzjonijiet avversi li ġew osservati fi studju kliniku li dam 12-il xahar b'LUMIGAN 0.3 mg/mL (formulazzjoni b'ħafna dożi), iżda li kienu rrappurtati fi frekwenza ogħla milli b'LUMIGAN 0.3 mg/mL (doża waħda).
English: The requirements for submission of periodic safety update report for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq ilportal elettroniku Ewropew tal-mediċini.
English: However, once the pouch is opened use within 30 days.
Maltese: Itlaq tebqet il-għajn t'isfel u agħlaq għajnejk għal 30 sekonda.
English: In addition to the adverse reactions seen with LUMIGAN 0.3 mg/mL single-dose, Table 3 lists additional adverse reactions that were seen with LUMIGAN 0.3 mg/mL (multi-dose formulation).
Maltese: Flimkien mar-reazzjonijiet avversi li kienu osservati b'LUMIGAN 0.3 mg/mL doża waħda, Tabella 3 telenka reazzjonijiet avversi addizzjonali li kienu osservati b'LUMIGAN 0.3 mg/mL (formulazzjoni b'ħafna dożi).
English: • Eyelid twitching
Maltese: • Ġilda xotta
English: There is a potential for the IOP-lowering effect of prostaglandin analogues (e.g. LUMIGAN) to be reduced in patients with glaucoma or ocular hypertension when used with other prostaglandin analogues (see section 4.4).
Maltese: Hemm il-potenzjal li l-effett ta' analogi ta' prostaglandin li jbaxxu IOP (eż. LUMIGAN) jitnaqqas f'pazjenti bi glawkoma jew pressjoni okulari għolja meta jintużaw flimkien ma' analogi oħrajn ta' prostaglandin (ara sezzjoni 4.4).
English: Nervous system disorders uncommon dizziness
Maltese: Disturbi fis-sistema nervuża komuni uġigħ ta' ras
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).
Maltese: Fi studji fuq firien qabel it-welid u wara t-twelid, ittossiċità materna wasslet għal tnaqqis tal-perjodu ta' ġestazzjoni, mewt tal-fetu, u tnaqqis fil-piż talfrieħ ta' 0.3 mg/kg/ġurnata (mill-inqas 41-darba aktar mill-espożizzjoni intiża għall-persuni).
English: • Dryness
Maltese: • Dardir
English: • Irritation, when drop is put in the eye
Maltese: • Irritazzjoni, meta tqattar f'għajnejk
English: In clinical studies, over 1800 patients have been treated with LUMIGAN 0.3 mg/ml eye drops, solution.
Maltese: Fi studji kliniċi, aktar minn 1800 pazjent ngħataw il-kura permezz ta' LUMIGAN 0.3 mg/ml.
English: In a 3 month clinical study, approximately 29% of patients treated with LUMIGAN 0.3 mg/mL singledose experienced adverse reactions.
Maltese: Fi studju kliniku li dam 3 xhur, madwar 29% tal-pazjenti kkurati b'LUMIGAN 0.3 mg/mL doża waħda, kellhom reazzjonijiet avversi.
English: LUMIGAN 0.3 mg/ml, eye drops, solution Bimatoprost
Maltese: LUMIGAN 0.3 mg/ml, qtar għall-għajnejn, soluzzjoni Bimatoprost
English: The safety and efficacy of LUMIGAN in children aged 0 to less than 18 years has not been established.
Maltese: Is-sigurtà u l-effikaċja ta' LUMIGAN fi tfal b'età minn 0 sa 18-il sena għadhom ma ġewx determinati s'issa.
English: Eye disorders very common ocular pruritus, growth of eyelashes common corneal erosion, ocular burning, 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 uncommon retinal haemorrhage, uveitis, cystoid macular oedema, iritis, blepharospasm, eyelid retraction, periorbital erythema
Maltese: Disturbi fl-għajnejn komuni ħafna ħakk okulari, tkabbir tax-xagħar ta' xfar tal-għajnejn komuni tgħawwir tal-kornea, ħruq 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 ta' xfar tal-għajnejn jiskura mhux komuni emorraġija fir-retina, uveite, edema makulari ċistojde, irite, blefarospażmu, ritrattazzjoni ta' tebqet il-għajn, eritema periorbitali
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.
Maltese: LUMIGAN 0.3 mg/ml huwa kontraindikat f'pazjenti li kellhom reazzjoni avversa suspettata fil-passat għal benzalkonium chloride li wasslet għall-waqfien tal-kura.
English: LUMIGAN 0.1 mg/ml contains benzalkonium chloride Do not use the drops when you are wearing your lenses.
Maltese: LUMIGAN 0.1 mg/ml fih benzalkonium chloride Tużax il-qtar waqt li tkun liebes il-lentijiet tal-kuntatt.
English: LUMIGAN 0.1 mg/ml, eye drops, solution Bimatoprost
Maltese: LUMIGAN 0.1 mg/ml, qtar għall-għajnejn, soluzzjoni Bimatoprost
English: There have been rare spontaneous reports of reactivation of previous corneal infiltrates or ocular infections with bimatoprost 0.3 mg/ml eye drops, solution.
Maltese: Kien hemm rapporti spontanji rari ta' attivazzjoni mill-ġdid ta' infiltrati fil-kornea li kienu seħħew filpassat jew infezzjonijiet okulari bi bimatoprost 0.3 mg/ml qtar għall-għajnejn, soluzzjoni.
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:
Maltese: Flimkien mal-effetti sekondarji għal LUMIGAN 0.3 mg/mL doża waħda, l-effetti sekondarji li ġejjin ġew osservati bil-formulazzjoni b'ħafna dożi ppreservata ta' LUMIGAN 0.3 mg/mL u jistgħu jseħħu f'pazjenti li jkunu qed jieħdu LUMIGAN 0.3 mg/mL doża waħda:
English: LUMIGAN 0.3 mg/ml contains benzalkonium chloride Do not use the drops when you are wearing your lenses.
Maltese: LUMIGAN 0.3 mg/ml fih benzalkonium chloride Tużax il-qtar waqt li tkun liebes il-lentijiet tal-kuntatt.
English: Fertility There are no data on the effects of bimatoprost on human fertility.
Maltese: Fertilità M'hemm l-ebda dejta dwar l-effetti ta' bimatoprost fuq il-fertilità tal-bniedem.
English: LUMIGAN 0.1 mg/ml eye drops contains BAK in a concentration of 200 ppm.
Maltese: LUMIGAN 0.1 mg/ml qtar għall-għajnejn fih BAK f'konċentrazzjoni ta' 200 ppm.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati flRMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: What is in this leaflet:
Maltese: Twissijiet u prekawzjonijiet:
English: If you use LUMIGAN 0.3 mg/mL single-dose with another eye medicine, wait at least 5 minutes between using LUMIGAN 0.3 mg/mL single-dose and the other eye medicine.
Maltese: Jekk tuża LUMIGAN 0.3 mg/mL doża waħda flimkien ma' mediċini oħra tal-għajnejn, ħalli millanqas 5 minuti bejn l-użu ta' LUMIGAN 0.3 mg/mL doża waħda u l-mediċina l-oħra.
English: The following pack sizes are available: cartons containing 1 or 3 bottles of 3 ml solution.
Maltese: Jeżistu dawn il-pakketti differenti: kaxxa ta' 1 jew 3 fliexken ta' 3 ml soluzzjoni.
English: LUMIGAN 0.3 mg/mL single-dose
Maltese: INFORMAZZJONI BIL-BRAILLE LUMIGAN 0.3 mg/ml doża waħda
English: If you forget to use LUMIGAN, use a single drop as soon as you remember, and then go back to your regular routine.
Maltese: Jekk tinsa tuża LUMIGAN, qattar qatra waħda hekk kif tiftakar, imbagħad erġa' dur għar-rutina regolari tiegħek.
English: • Asthma
Maltese: • Ażżma
English: The plasma protein binding of bimatoprost is approximately 88%.
Maltese: Fid-demm uman, bimatoprost ikun l-aktar fil-plażma. 88% ta' bimatoprost jeħel mal-proteini tad-demm fil-plażma.
English: Therefore, LUMIGAN should be used with caution in patients with known risk factors for macular oedema (e.g. aphakic patients, pseudophakic patients with a torn posterior lens capsule).
Maltese: Tista' wkoll tirrapporta effetti sekondarji direttament permezz tas-sistema ta' rappurtar nazzjonali mniżżla f'Appendiċi V.
English: • Itching
Maltese: • Nixfa
English: How to store LUMIGAN 0.3 mg/ml Contents of the pack and other information
Maltese: Kif taħżen LUMIGAN 0.3 mg/ml Kontenut tal-pakkett u informazzjoni oħra
English: Colourless solution.
Maltese: Soluzzjoni mingħajr kulur.
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.
Maltese: Wara 12-il xahar, l-inċidenza bi bimatoprost 0.3 mg/ml qtar għall-għajnejn, soluzzjoni kienet ta' 1.5% (ara sezzjoni 4.8 Tabella 2) u ma żdiedetx wara 3 snin ta' kura.
English: LUMIGAN 0.1 mg/ml eye drops, solution
Maltese: LUMIGAN 0.1 mg/ml qtar għall-għajnejn, soluzzjoni
English: LUMIGAN 0.3 mg/ml eye drops, solution
Maltese: LUMIGAN 0.3 mg/ml qtar għall-għajnejn, soluzzjoni
English: Allergan Baltics UAB Tel: + 37 2634 6109
Maltese: Tel: + 37 2634 6109
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.
Maltese: Wara li tqattret fl-għajn ta' qatra waħda ta' LUMIGAN 0.3 mg/ml kuljum fiż-żewġ għajnejn għal ħmistax, il-konċentrazzjonijiet fid-demm laħqu l-massimu f'10 minuti wara l-għotja tad-doża u naqsu sa taħt l-inqas limitu ta' osservazzjoni (0.025 ng/ml) f'1.5 sigħat wara l-għotja tad-doża.
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.
Maltese: Wara li tqattret fl-għajn ta' qatra waħda ta' LUMIGAN 0.3 mg/mL kuljum fiż-żewġ għajnejn għal ħmistax, il-konċentrazzjonijiet fid-demm laħqu l-massimu f'10 minuti wara l-għotja tad-doża u naqsu sa taħt l-inqas limitu ta' osservazzjoni (0.025 ng/ml) f'1.5 sigħat wara l-għotja tad-doża.
English: There have been reports of bacterial keratitis associated with the use of multiple dose containers of topical ophthalmic products.
Maltese: Kien hemm rapporti ta' keratite kkawżata minn batterja assoċjati mal-użu ta' kontenituri b'dożi multipli ta' prodotti oftalmiċi topiċi.
English: At 3 months, the incidence of iris hyperpigmentation with bimatoprost 0.3 mg/mL single dose was 0.3%.
Maltese: Wara 3 xhur, l-inċidenza ta' iperpigmentazzjoni tal-ħabba tal-għajn b'bimatoprost 0.3 mg/mL doża waħda kienet ta' 0.3%.
English: Name and address of the manufacturer responsible for batch release
Maltese: Isem u indirizz tal-manifattur responsabbli għall-ħrug tal-lott
English: LUMIGAN 0.3 mg/mL, eye drops, solution, in Single-dose container Bimatoprost
Maltese: LUMIGAN 0.3 mg/ml, qtar għall-għajnejn, soluzzjoni, f'Kontenitur b'doża waħda Bimatoprost
English: LUMIGAN 0.3 mg/mL, eye drops, solution, in single-dose container Bimatoprost
Maltese: LUMIGAN 0.3 mg/mL, qtar għall-għajnejn, soluzzjoni, f'kontenitur b'doża waħda Bimatoprost
English: Do not store above 25°C.
Maltese: Taħżinx f'temperatura 'l fuq minn 25oC.
English: Animal studies have shown excretion of bimatoprost in breast milk.
Maltese: Studji speċifiċi dwar l-interazzjoni ma' prodotti mediċinali oħra ma kienux imwettqa b'Lumigan.
English: One ml of solution contains 0.3 mg bimatoprost
Maltese: Ml wiehed fih 0.3mg Bimatoprost
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
Maltese: X'għandek tkun taf qabel ma tuża LUMIGAN 0.3 mg/ml Kif għandek tuża LUMIGAN 0.3 mg/ml Effetti sekondarji possibbli
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.
Maltese: Wara li tqattret fl-għajn ta' qatra waħda ta' 0.3 mg/ml bimatoprost kuljum fiż-żewġ għajnejn għal ħmistax, il-konċentrazzjonijiet fid-demm laħqu l-massimu f'10 minuti wara l-għotja tad-doża u naqsu sa taħt l-inqas limitu ta' osservazzjoni (0.025 ng/ml) f'1.5 sigħat wara l-għotja tad-doża.
English: OUTER CARTON CONTAINING 30 SINGLE-DOSE CONTAINERS
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KARTUNA TA' BARRA BI 30 KONTENITURI TA' DOŻA WAĦDA
English: Clear, single-dose Low Density Polyethylene (LDPE) containers with a twist-off tab.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Kontenituri ċari, b'doża waħda, tal-Polyethylene ta' Densità Baxxa (LDPE) b'tab li jista' jitqaċċat.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: • Diffikultà biex tara b'mod ċar
English: Co. Mayo Ireland
Maltese: Castlebar Road Westport Co. Mayo L-Irlanda
English: Opened:
Maltese: JIS:
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).
Maltese: L-ebda interazzjoni ma hi mistennija fin-nies, minħabba li l-konċentrazzjonijiet sistemiċi ta' bimatoprost huma baxxi ħafna (inqas minn 0.2 ng/mL) wara l-użu fl-għajn bi bimatoprost 0.3 mg/mL qtar għall-għajnejn, soluzzjoni (formulazzjoni b'ħafna dożi).
English: Respiratory, thoracic and mediastinal disorders not known asthma, asthma exacerbation, COPD exacerbation and dyspnoea
Maltese: Disturbi respiratorji, toraċiċi u medjastinali mhux magħrufa ażżma, aggravar tal-ażżma, aggravar ta' COPD u qtugħ ta' nifs.
English: • Darker iris colour
Maltese: • Xagħar tal-għajnejn iktar skur
English: OUTER CARTON CONTAINING 90 SINGLE-DOSE CONTAINERS
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA BORŻA LI FIHA 10 KONTENITURI
English: LUMIGAN has not been studied in patients with inflammatory ocular conditions, neovascular, inflammatory, angle-closure glaucoma, congenital glaucoma or narrow-angle glaucoma.
Maltese: LUMIGAN ma kienx studjat f'pazjenti b'kondizzjonijiet infjammatorji fl-għajn, neovaskulari, infjammatorji, glawkoma angle-closure, glawkoma konġenitali jew glawkoma narrow-angle.
English: Marketing Authorisation Holder and Manufacturer Allergan Pharmaceuticals Ireland Castlebar Road
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqeghid fis-Suq u l-Manifattur Allergan Pharmaceuticals Ireland
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:
Maltese: III ta' monoterapija u użu flimkien ma' LUMIGAN 0.3 mg/mL (formulazzjoni b'ħafna dożi), l-aktar reazzjonijiet avversi frekwenti li kienu rrapurtati kienu:
English: What LUMIGAN 0.1 mg/ml contains
Maltese: Kif jidher LUMIGAN 0.1 mg/ml u l-kontenut tal-pakkett:
English: How to store LUMIGAN 0.1 mg/ml Contents of the pack and other information
Maltese: Kif taħżen LUMIGAN 0.1 mg/ml Kontenut tal-pakkett u informazzjoni oħra
English: What LUMIGAN 0.3 mg/ml looks like and contents of the pack LUMIGAN is a colourless clear eye drop solution in a pack containing either 1 plastic bottle or 3 plastic bottles each with a screw cap. Each bottle is approximately half full and contains 3 millilitres of solution.
Maltese: LUMIGAN hu soluzzjoni ta' qtar għall-għajnejn mingħajr kulur, li jinsab f'pakketti li fihom 1 flixkun tal-plastik jew 3 fliexken tal-plastik kull wieħed b'għatu tal-kamin.
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.
Maltese: LUMIGAN 0.3 mg/mL doża waħda hi soluzzjoni ċara, bla kulur, fornuta f'kontenituri tal-plastik b'doża waħda, u kull wieħed fih 0.4 ml ta' soluzzjoni.
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.
Maltese: Tużax LUMIGAN 0.3 mg/ml - Jekk int allerġiku għal bimatoprost jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis sezzjoni 6) - jekk kellek tieqaf tuża qtar għall-għajnejn fil-passat minħabba effett sekondarju tal-preservattiv benzalkonium chloride.
English: • Itchy eyes
Maltese: • Ħruq
English: • Itchy and swollen eyelids
Maltese: • il-għajn aktar skura
English: • Ocular burning
Maltese: • Aggravar tal-ażżma
English: • Red and itchy eyelids
Maltese: • Għajnejn xotti
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.
Maltese: Fi studji li damu żmien qasir dwar l-għoti orali (permezz ta' gavage) fil-ġrieden u l-firien, dożi sa 100 mg/kg/kuljum ta' bimatoprost ma pproduċew l-ebda tossiċità.
English: • Inflamed eyelids
Maltese: • Teqbet il-għajnejn infjammati
English: • Swelling of the eyelid
Maltese: TWISSIJA(IET) SPEĊJALI
English: Annex I List of medicinal products and presentations
Maltese: Lista ta' prodotti mediċinali u preżentazzjonijiet
English: The Netherlands
Maltese: In-Netherlands
English: Urokinase Devrimed 100.000 IE, poeder voor oplossing voor injectie/infusie
Maltese: IE, poeder voor oplossing voor injectie/infusie
English: United Kingdom Syner-Medica Ltd. Syner-Med House,
Maltese: Ir-Renju Unit
English: Urokinase Devrimed 500.000 IE, poeder voor oplossing voor injectie/infusie
Maltese: Urokinase Devrimed 500.000
English: CR8 2AD,
Maltese: Urokinase Devrimed 25.
English: 120 High Street,
Maltese: Urokinase Devrimed 100.
English: 120 tablets
Maltese: 120 pillola
English: EE-11415 Tallinn
Maltese: EE-11415
English: UAB "JOHNSON & JOHNSON" filiāle Latvijā Mūkusalas iela 101
Maltese: JOHNSON" filiāle Latvijā Mūkusalas iela 101
English: Contains lactose and sodium.
Maltese: Fih lactose u sodium.
English: Date of latest renewal: 26 May 2016
Maltese: Data tal-aħħar tiġdid: 26 ta' Mejju 2016
English: Via C. Janssen IT-04100 Borgo San Michele Latina
Maltese: Janssen IT-04100 Borgo San Michele Latina
English: Potential risks
Maltese: Riskji possibbli
English: Janssen-Cilag Pharma GmbH Vorgartenstraße 206B A-1020 Wien
Maltese: Janssen-Cilag Pharma GmbH Vorgartenstraße 206B
English: See section 4.
Maltese: Ara s-sezzjoni 4.
English: Mangion Building, Triq Ġdida fi Triq Valletta MT-Ħal-Luqa LQA 6000
Maltese: angion Building, Triq Ġdida fi Triq Valletta MT-Ħal-Luqa
English: Adverse reaction and frequency
Maltese: Reazzjonjiet avversi u frekwenza
English: 2D barcode carrying the unique identifier included.
Maltese: Barcode 2D li jkollu l-identifikatur uniku inkluż.
English: Hazard ratio < 1 favours ZYTIGA
Maltese: Proprzjon ta' periklu < 1 jiffavorixxi ZYTIGA
English: CBC III, Karadžičova 12 SK-821 08 Bratislava Tel: +421 232 408 400
Maltese: III, Karadžičova 12 SK-821 08 Bratislava Tel: +421 232 408 400
English: Johnson & Johnson România SRL Str. Tipografilor nr. 11-15, Clădirea S-Park, Corp B3-B4, Etaj 3 013714 Bucureşti.
Maltese: Tipografilor nr. 11-15, Clădirea S-Park, Corp B3-B4, Etaj 3 013714 Bucureşti.
English: Iron oxide black (E172) Iron oxide red (E172) Macrogol 3350
Maltese: Kisja tar-rita Iron oxide iswed (E172) Iron oxide aħmar (E172) Macrogol 3350
English: Lung irritation (also called allergic alveolitis).
Maltese: Irritazzjoni pulmonari (li tissejjaħ ukoll alveolite allerġika).
English: Slovenská republika Johnson & Johnson, s.r.o.
Maltese: Slovenská republika Johnson & Johnson, s.r.o. CBC
English: Hazard ratio <1 favors AA-P.
Maltese: Proporzjon ta' periklu <1 jiffavorixxi AA-P.
English: Placebo (N = 398)
Maltese: Plaċebo (N=398)
English: IS-210 Garðabær Sími: +354 535 7000
Maltese: Garðabær Sími: +354 535 7000
English: C-abiraterone in human plasma is 99.8%.
Maltese: C fil-plażma tal-bnedmin huwa ta' 99.8%.
English: Reporting of side effects
Maltese: Rapportar tal-effetti sekondarji
English: UAB "JOHNSON & JOHNSON" Eesti filiaal Lõõtsa 2
Maltese: JOHNSON" Eesti filiaal Lõõtsa
English: Respiratory, thoracic and mediastinal disorders rare: allergic alveolitis
Maltese: Disturbi respiratorji, toraċiċi u medjastinali rari: alveolite allerġika
English: Date of first authorisation: 05 September 2011
Maltese: Data tal-ewwel awtorizzazzjoni: 05 Settembru 2011
English: SI-1000 Ljubljana Tel: +386 1 401 18 00
Maltese: Ljubljana Tel: +386 1 401 18 00