FrancophonIA/ELRC3.0 huggingface dataset:
English: Off-white to slightly yellow powder in a capsule with red cap and orange body, with red imprint “EXELON 6 mg” on body.
Maltese: Trab offwajt li jagħti ħarira fl-isfar, f'kapsula b'għatu aħmar u korp oranġjo, u stampata bl-aħmar “EXELON 6 mg” fuq il-korp.
English: - Exelon 4.6 mg/24 h transdermal patches: Each patch releasing 4.6 mg of rivastigmine per 24 hours is 5 cm and contains 9 mg of rivastigmine.
Maltese: Kull garża terħi 4.6 mg ta' rivastigmine kull 24 siegħa, hija 5 cm u fiha 9 mg rivastigmine.
English: 60 transdermal patches (sachet: paper/PET/alu/PAN) 90 transdermal patches (sachet: paper/PET/alu/PAN) 60 transdermal patches (sachet: paper/PET/PE/alu/PA)
Maltese: EU/1/98/066/028 30 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda (qartas: karta/PET/alu/PAN)
English: Multipack: 60 (2 packs of 30) transdermal patches Multipack: 90 (3 packs of 30) transdermal patches Multipack: 84 (2 packs of 42) transdermal patches
Maltese: Pakkett b'ħafna: 84 (2 pakketti ta' 42) garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda.
English: It was rated as severe in ≤2.2% of patients in these studies and in ≤3.7% of patients treated with Exelon transdermal patches in a Japanese study.
Maltese: Fi studju fil-Ġappun, din tkejlet bħala gravi fi ≤2.2% tal-pazjenti f'dawn l-istudji u fi ≤3.7% tal-pazjenti ttrattati b'Exelon garżi li jipprovdu mediċina li tgħaddi minn ġol-ġilda.
English: What Exelon looks like and contents of the pack Exelon oral solution is supplied as 50 ml or 120 ml of a clear, yellow solution (2.0 mg/ml base) in an amber glass bottle with a child-resistant cap, foam liner, dip tube and self aligning plug.
Maltese: Exelon soluzzjoni orali jiġi bħala 50 ml jew 120 ml soluzzjoni ċara, safra (bażi ta' 2.0 mg/ml), fi flixkun magħmul minn ħġieġ kannella, b'għatu li ma jinfetaħx mit-tfal, b'kisja tal-fowm, b'tubu biex tbill, u b'tapp li jipożizzjona lilu nnifsu.
English: Exelon can be used with food, drink and alcohol.
Maltese: Exelon jista' jintuża mal-ikel, ix-xorb u l-alkoħol.
English: Initial dose Treatment is started with 4.6 mg/24 h.
Maltese: Inkella t-tabib tiegħek jerġa' jibda t-trattament tiegħek b'Exelon b'4.6 mg/24 h.
English: The following adverse reactions, listed below in Table 1, have been accumulated in patients with Alzheimer's dementia treated with Exelon.
Maltese: Ir-reazzjonijiet avversi li ġejjin, elenkati hawn taħt f'Tabella 1, kienu miġbura minn pazjenti kkurati b'Exelon għal dimenzja t'Alzheimer.
English: The following additional adverse reactions have been observed with Exelon transdermal patches: delirium, pyrexia, decreased appetite, urinary incontinence (common), psychomotor hyperactivity (uncommon), erythema, urticaria, vesicles, allergic dermatitis (not known).
Maltese: Ir-reazzjonijiet avversi li ġejjin dehru bil-garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda Exelon: thewdin, deni, tnaqqis fl-aptit, inkontinenza fl-awrina (komuni), attività psikomotorili eċċessiva (mhux komuni), eritema, urtikarja, nfafet, dermatite allerġika (mhux magħrufa).
English: EU/1/98/066/023-026 EU/1/98/066/033-034 EU/1/98/066/039-042 EU/1/98/066/049-050
Maltese: EU/1/98/066/039-042 EU/1/98/066/049-050
English: Exelon might interfere with anticholinergic medicines some of which are medicines used to relieve stomach cramps or spasms (e.g. dicyclomine), to treat Parkinson's disease (e.g. amantadine) or to prevent motion sickness (e.g. diphenhydramine, scopolamine, or meclizine).
Maltese: Exelon jista' jinterferixxi ma' mediċini antikolinerġiċi li wħud minnhom huma mediċini li jintużaw biex itaffu weġgħat fl-istonku jew spażmi (eż. dicyclomine), għal kura tal-marda ta' Parkinson (e.g. amantadine) jew biex jevitaw it-tqalligħ waqt iċ-ċaqliq (eż. diphenhydramine, scopolamine, jew meclizine).
English: Exelon 13.3 mg/24 h transdermal patches are available in packs containing 7 or 30 sachets and in multipacks containing 60 or 90 sachets.
Maltese: Il-garżi li jipprovdu mediċina li tgħaddi minn ġol-ġilda Exelon 13.3 mg/24 h jiġu f'pakketti li jkun fihom 7 jew 30 qartas u f'pakketti b'ħafna li jkun fihom 60 jew 90 qartas.
English: Off-white to slightly yellow powder in a capsule with yellow cap and yellow body, with red imprint “EXELON 1,5 mg” on body.
Maltese: Trab offwajt li jagħti ħarira fl-isfar, f'kapsula b'għatu isfar u korp isfar, u stampata bl-aħmar “EXELON 1.5 mg” fuq il-korp.
English: Exelon capsules 12 mg/day N = 256
Maltese: Kapsuli Exelon 12 mg/jum
English: Exelon 4.6 mg/24 h transdermal patch Exelon 9.5 mg/24 h transdermal patch Exelon 13.3 mg/24 h transdermal patch rivastigmine
Maltese: Exelon 4.6 mg/24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda rivastigmine
English: How to remove your Exelon transdermal patch
Maltese: Jekk tuża Exelon aktar milli suppost
English: Off-white to slightly yellow powder in a capsule with red cap and red body, with white imprint “EXELON 4,5 mg” on body.
Maltese: Trab offwajt li jagħti ħarira fl-isfar, f'kapsula b'għatu aħmar u korp aħmar, u stampata blabjad“EXELON 4.5 mg” fuq il-korp.
English: Exelon 4.6 mg/24 h transdermal patch Exelon 9.5 mg/24 h transdermal patch Exelon 13.3 mg/24 h transdermal patch
Maltese: Exelon 4.6 mg/24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda
English: Exelon 9.5 mg/24 h transdermal patch rivastigmine
Maltese: Exelon 9.5 mg/24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda rivastigmine
English: When normalised to body surface area, the exposure to rivastigmine and its metabolites was approximately equivalent to the maximum recommended human dose of 12 mg/day; however, when compared to the maximum human dose, a multiple of approximately 6-fold was achieved in animals.
Maltese: Meta ġew imqabbla skont l-erja tas-superfiċje tal-ġisem, l esponiment għal rivastigmine u l-metaboli tiegħu kienet bejn wieħed u ieħor ekwivalenti għad-dożamassima rrikkmandata ta' 12 mg kuljum; madankollu, meta mqabbla mad-doża massima fil-bniedem, livelli ta' bejn wieħed u ieħor 6 darbiet aktar kienu milħuqa fl-annimali.
English: Hypertension
Maltese: Epatite
English: Exelon transdermal patches 9.5 mg/24 h N = 251
Maltese: Garżi li jipprovdu mediċina li tgħaddi minn ġol-ġilda Exelon 9.5 mg/24 siegħa N = 251
English: Exelon 13.3 mg/24 h transdermal patch rivastigmine
Maltese: Exelon 13.3 mg/24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda rivastigmine
English: 7 transdermal patches 30 transdermal patches 42 transdermal patches
Maltese: .7 Effetti fuq il-ħila biex issuq u tħaddem magni
English: Hepatitis Skin and subcutaneous tissue disorders Common
Maltese: GĦAMLA FARMAĊEWTIKA Soluzzjoni orali
English: OCT-1 study
Maltese: Studju OCT-1
English: • The recommended interval between each application is 4 hours (for example, you can have your eye drops at 8.00 am, 12.00 am, 4.00 pm and 8.00 pm).
Maltese: • L-intervall rakkomandat bejn kull applikazzjoni huwa ta' 4 sigħat (pereżempju, tista' tieħu l-qtar tiegħek fit-8:00 am, 12:00 pm, 4:00 pm u 8:00 pm).
English: CHOC study
Maltese: Studju CHOC
English: • Store below 25°C.
Maltese: • Aħżen f'temperatura taħt 25°C.
English: Cystadrops contains benzalkonium chloride
Maltese: Cystadrops fih benzalkonium chloride
English: After 30 days of treatment and at a median frequency of 4 instillations per day, an average 30% decrease in the IVCM total score was observed.
Maltese: Wara 30 jum ta' kura u bi frekwenza medjana ta' 4 taqtiriet kuljum, ġie osservat tnaqqis medju ta' 30 % fil-punteġġ IVCM totali.
English: Superiority of Cystadrops was demonstrated compared to the control arm (cysteamine hydrochloride 0.10%) p<0.001 95% CI (2.11; 5.58).
Maltese: Is-superjorità ta' Cystadrops intweriet meta mqabbel malfergħa ta' kontroll (cysteamine hydrochloride 0.10 %) p<0.001 95 % CI (2.11; 5.58).
English: Studies in animals have shown a reduction on fertility (see section 5.3).
Maltese: Studji f'annimali wrew tnaqqis fil-fertilità (ara sezzjoni 5.3).
English: Frequencies are defined as: 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 the available data).
Maltese: Il-frekwenzi huma definiti bħala: 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 ħafna (< 1/10,000), mhux magħrufin (ma tistax tittieħed stima mid-data disponibbli).
English: The mean decrease by 40% in the Cystadrops arm was confirmed at day 90.
Maltese: It-tnaqqis medju ta' 40 % fil-fergħa ta' Cystadrops kien ikkonfermat fil-jum 90.
English: Benzalkonium chloride (see leaflet for further information), disodium edetate, carmellose sodium, citric acid monohydrate, sodium hydroxide, hydrochloric acid, water for injections.
Maltese: Benzalkonium chloride (ara l-fuljett għal aktar informazzjoni), disodium edetate, carmellose sodium, citric acid monohydrate, sodium hydroxide, hydrochloric acid, ilma għall-injezzjonijiet.
English: • Remove the green protective cap (picture 1).
Maltese: • Neħħi t-tapp protettiv aħdar (stampa 1).
English: Viscous, clear solution.
Maltese: Viskuża, soluzzjoni ċara.
English: - The other ingredients are benzalkonium chloride (see section 2 under ‘Cystadrops contains benzalkonium chloride'), disodium edetate, carmellose sodium, citric acid monohydrate, sodium hydroxide, hydrochloric acid and water for injections.
Maltese: - Is-sustanzi l-oħra huma benzalkonium chloride (ara sezzjoni 2 taħt ‘Cystadrops fih benzalkonium chloride'), disodium edetate, carmellose sodium, citric acid monohydrate, sodium hydroxide, hydrochloric acid u ilma għall-injezzjonijiet.
English: This is equivalent to 0.6 g/m2/day in the rat, which is less than half the recommended clinical maintenance dose of cysteamine, i.e. 1.30 g/m2/day.
Maltese: Din hija ekwivalenti għal 0.6 g/m2/kuljum fil-far, li huwa inqas minn nofs id-doża ta' manteniment kliniku rakkomandata ta' cysteamine, jiġifieri 1.30 g/m2/kuljum.
English: Each mL contains mercaptamine hydrochloride equivalent to 3.8 mg mercaptamine (cysteamine).
Maltese: Kull mL fih mercaptamine hydrochloride ekwivalenti għal 3.8 mg mercaptamine (cysteamine).
English: Cystadrops can be used for up to 7 days from the time of opening.
Maltese: Cystadrops jista' jintuża sa 7 ijiem mid data tal-ftuħ.
English: Those instructions are also available as an animated movie on www.cystadrops.net ‘QR code to be included'
Maltese: Dawk l-istruzzjonijiet huma disponibbli wkoll bħala film animat fuq www.cystadrops.net ‘Għandu jiġi inkluż il-kodiċi QR'
English: What Cystadrops contains - The active substance is cysteamine (mercaptamine), as hydrochloride.
Maltese: X'fih Cystadrops - Is-sustanza attiva hija cysteamine (mercaptamine), bħala hydrochloride.
English: Carmellose sodium Citric acid monohydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Maltese: Citric acid monohydrate Sodium hydroxide (għall-aġġustament tal-pH) Hydrochloric acid (għall-aġġustament tal-pH) Ilma għall-injezzjonijiet
English: Benzalkonium chloride, which is commonly used as a preservative in ophtalmic products, has also been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy.
Maltese: Benzalkonium chloride, li huwa komunament użat bħala preservattiv fi prodotti oftalmiċi, ġie wkoll rapportat li jikkawża punctate keratopathy u/jew keratopatija bl-ulċeri tossika.
English: Clinical data on safety and efficacy were collected during the 2 clinical trials (OCT-1 and CHOC studies).
Maltese: Inġabret dejta klinika dwar is-sigurtà u l-effikaċja matul iż-żewġ provi kliniċi (studji OCT-1 u CHOC).
English: Teratogenic effects have been described in rats when cysteamine is administered over the period of organogenesis at a dose of 100 mg/kg/day.
Maltese: Ġew deskritti effetti teratoġeniċi fil-firien meta cysteamine ngħata matul il-perjodu ta' organogenesi f'doża ta' 100 mg/kg/kuljum.
English: Preclinical data on oral cysteamine:
Maltese: Dejta ta' qabel l-użu kliniku dwar cysteamine orali:
English: Date of first authorisation: 19 January 2017 10.
Maltese: Data tal-ewwel awtorizzazzjoni: 15 jannar 2017
English: How to store Cystadrops 6.
Maltese: Kif taħżen Cystadrops 6.
English: • visual impairement
Maltese: • indeboliment fil-vista
English: Cysteamine reduces corneal cystine crystal accumulation acting as a cystine-depleting agent by converting cystine to cysteine and cysteine-cysteamine mixed disulfides.
Maltese: Cysteamine inaqqas l-akkumulazzjoni ta' kristalli ċistina fil-kornea bħala aġent li jnaqqas iċ-ċistina u jikkonverti ċ-ċistina f'cysteine u disulfides imħalltin cysteine-cysteamine.
English: 15 patients were exposed to Cystadrops.
Maltese: 15-il pazjent kienu esposti għal Cystadrops.
English: You may find that your vision is blurred for a few minutes just after using Cystadrops.
Maltese: Jista' jkun li l-vista tiegħek tkun imċajpra għal ftit minuti eżatt wara li tuża Cystadrops.
English: Common : abnormal sensation in eye, dry eye, foreign body sensation in eye, eyelid oedema, eyelid irritation, visual impairment, hordeolum
Maltese: Komuni: sensazzjoni mhux normali fl-għajnejn, għajnejn nexfin, sensazzjoni ta' xi ħaġa ġewwa l-għajnejn, edema filkpiepel tal-għajnejn, irritazzjoni fil-kpiepel tal-għajnejn, indeboliment fil-vista, hordeolum
English: The efficacy and safety results are similar in both paediatric and adult populations.
Maltese: Ir-riżultati tal-effikaċja u s-sigurtà huma simili fil-popolazzjoni pedjatrika u adulta.
English: In total 15 paediatric patients were exposed to Cystadrops whereof 3 subjects (including one 2 year and one 3 year old subject) being less than 6 years of age.
Maltese: Total ta' 15-il pazjent ġew esposti għal Cystadrops li minnhom 3 individwi (inkluż individwu ta' sentejn u ieħor ta' 3 snin) kellhom inqas minn 6 snin.
English: A reduction of fertility was observed in rats at 375 mg/kg/day, a dose at which body weight gain was retarded.
Maltese: Ġie osservat tnaqqis fil-fertilità filfirien bi 375 mg/kg/kuljum, doża li biha ż-żieda fil-piż tal-ġisem kienet imdewma.
English: • swollen eyelid
Maltese: • għajnejn xotti
English: Common side effects (may affect up to 1 in 10 people)
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa 1 minn 10 persuni)
English: A mean decrease in corneal cystine crystal deposits of 30%, in comparison with baseline, was maintained over time with a median dosing regimen of 3 drops/eye/day (range 1-3 drops) for 7 of the 8 patients.
Maltese: Tnaqqis medju fiddepożiti ta' kristalli ċistina fil-kornea ta' 30 %, meta mqabbel mal-linja bażi, inżamm matul iż-żmien b'reġim ta' dożaġġ medjan ta' 3 taqtiriet/għajn/kuljum (medda 1 - 3 taqtiriet) għal 7 mit-8 pazjenti.
English: Each mL contains 3.8 mg of cysteamine (mercaptamine), as hydrochloride.
Maltese: Kull mL fih 3.8 mg ta' cysteamine (mercaptamine), bħala hydrochloride.
English: • Cystadrops can be used for up to 7 days from the time of opening.
Maltese: • Cystadrops jista' jintuża sa 7 ijiem mid-data tal-ftuħ.
English: • Remove the metal seal (picture 2).
Maltese: • Neħħi s-siġill tal-metall (stampa 2).
English: The efficacy was assessed with In-Vivo Confocal Microscopy total score (IVCM score) by quantifying the cystine crystals in the 7 layers of the cornea.
Maltese: L-effikaċja ġiet evalwata b'punteġġ totali In-Vivo Confocal Microscopy (punteġġ IVCM) billi ġew ikkwantifikati l-kristalli ċistina fis-7 saffi tal-kornea.
English: Two clinical trials were performed with Cystadrops: a single arm clinical trial on 8 children and adults (OCT-1 study) and a randomised, multi-centre, open label, active controlled phase III clinical trial (CHOC study) conducted on 32 patients.
Maltese: Saru żewġ provi kliniċi b'Cystadrops: prova klinika b'fergħa waħda fuq 8 itfal u adulti (studju OCT-1) u prova klinika randomizzata, b'multi-ċentru, b'tikketta mikxufa, kontrollata b'mod attiv ta' fażi
English: Studies in animals have shown reproductive toxicity, including teratogenesis (see section 5.3).
Maltese: Studji f'annimali urew effett tossiku fuq is-sistema riproduttiva, inkluż teratogenesi (ara 5.3).
English: How to use Cystadrops 4.
Maltese: Kif għandek tuża Cystadrops 4.
English: Each mL of eye drops solution contains 0.1 mg of benzalkonium chloride.
Maltese: Kull mL ta' soluzzjoni ta' qtar għall-għajnejn fih 0.1 mg ta' benzalkonium chloride.
English: Cystadrops 3.8 mg/mL eye drops solution cysteamine
Maltese: Cystadrops 3.8 mg/mL soluzzjoni ta' qtar għall-għajnejn cysteamine
English: Reproduction studies showed embryofoetotoxic effects (resorptions and post-implantation losses) in rats at the 100 mg/kg/day dose level and in rabbits receiving cysteamine 50 mg/kg/day.
Maltese: Studji tar-riproduzzjoni wrew effetti tossiċi fuq l-embriju u l-fetu (telf mill-assorbiment mill-ġdid u wara l-impjantazzjoni) f'firien fil-livell ta' doża ta' 100 mg/kg/kuljum u fi fniek li rċevew cysteamine 50 mg/kg/kuljum.
English: The following adverse reactions were reported during clinical trials and the French NPU programme with Cystadrops.
Maltese: Ir-reazzjonijiet avversi li ġejjin ġew rapportati matul il-provi kliniċi u l-programm Franċiż NPU b'Cystadrops.
English: In case of concomitant therapy with other topical ocular medicinal products, an interval of ten minutes should be allowed between successive applications.
Maltese: F'każ ta' terapija konkomitanti ma' prodotti mediċinali topikali għall-għajnejn oħra, għandu jingħata intervall ta' għaxar minuti bejn applikazzjonijiet suċċessivi.
English: Pharmacotherapeutic group: Ophtalmologicals, other ophtalmologicals, ATC code: S01XA21.
Maltese: Oftalmoloġiċi, oftalmoloġiċi oħra, Kodiċi ATC:
English: The dose could be decreased progressively (to a minimum total daily dose of 1 drop in each eye) depending on the results of ophthalmic examination (such as, corneal cystine crystal deposits, photophobia).
Maltese: Id-doża tista' titnaqqas progressivament (għal doża totali minima kuljum ta' qatra f'kull għajn) skont ir-riżultati tal-eżami oftalmiku (bħal pereżempju depożiti ta' kristall ċistina fil-kornea, fotofobija).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Cystadrops in one or more subsets of the paediatric population in the treatment of corneal cystine crystal deposits in cystinosis patients (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini ddifferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'Cystadrops f'wieħed jew iktar kategoriji tal-popolazzjoni pedjatrika fil-kura ta' depożiti ta' kristalli ċistina fil-kornea f'pazjenti b'ċistinożi (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: 5 mL solution in a 10 mL amber glass vial closed by a bromobutyl stopper and sealed with an aluminium tear-off cap. A PVC dropper applicator with HDPE closure is packed separately and included in each carton box.
Maltese: Soluzzjoni ta' 5 mL f'kunjett tal-ħġieġ ta' kulur ambra ta' 10 mL magħluq b'tapp tal-bromobutyl u ssiġillat b'tapp tal-aluminju li jiċċarrat.
English: Similarly to other topically administered ocular products, systemic absorption is likely to occur.
Maltese: Hemm probabbiltà li jseħħ assorbiment sistemiku bħalma jseħħ fi prodotti oħra mogħtija b'mod topiku.
English: The IVCM total score was the primary efficacy endpoint.
Maltese: Il-punteġġ IVCM totali kien l-punt ta' tmiem primarju tal-effikaċja.
English: Cystadrops 3.8 mg/mL eye drops solution cysteamine (mercaptamine)
Maltese: Informazzjoni għall-pazjent Cystadrops 3.8 mg/mL soluzzjoni ta' qtar għall-għajnejn cysteamine (mercaptamine)
English: If you stop using Cystadrops, cystine crystals accumulation in the eye (cornea) may increase and lead to increased sensitity to light (photophobia), corneal deterioration (keratopathy) and loss of vision.
Maltese: L-akkumulazzjoni tal-kristalli fl-għajn tista' twassal għal żieda fis-sensittività għad-dawl (fotofobija), deterjorament tal-kornea (keratopatija) u telf ta' vista.
English: Cystadrops is indicated for the treatment of corneal cystine crystal deposits in adults and children from 2 years of age with cystinosis.
Maltese: Cystadrops huwa indikat għall-kura ta' depożiti ta' kristall ċistina fil-kornea f'adulti u tfal minn sentejn ‘il fuq b'ċistinożi.
English: • Write down the date you opened the vial in the space on the carton.
Maltese: • Iċċekkja d-data tal-ftuħ li ktibt fuq il-kaxxa tal-kartun.
English: The drop will go in here (picture 6).
Maltese: Il-qatra tmur hemm (stampa 6).
English: • Keep Cystadrops at room temperature (it will facilitate the use of the dropper).
Maltese: • Żomm Cystadrops f'temperatura tal-kamra (din tiffaċilita l-użu tal-qattara).
English: • To avoid sticky eyes in the morning, it is recommended to apply the last drop of the day at least 30
Maltese: • Biex tevita li jkollok għajnejk iwaħħlu, huwa rakkomandat li tapplika l-aħħar qatra tal-jum tal inqas 30 minuta qabel ma tidħol torqod.
English: Ocular use.
Maltese: L.U.
English: If you use Cystadrops with another eye medicine Ensure that there is at least a 10 minute gap between using Cystadrops and the other eye medicine.
Maltese: Jekk tuża Cystadrops ma' mediċina għall-għajnejn oħra Kun żgur li hemm tal-inqas perjodu ta' 10 minuti bejn l-użu ta' Cystadrops u l-mediċina l-oħra għallgħajnejn.
English: For ocular use.
Maltese: • Aħsel idejk.
English: Eye drops solution 1 vial of 5 mL
Maltese: Kunjett ta' 5 mL
English: A trend towards a lower IVCM total score in Cystadrops arm was observed at day 30.
Maltese: Ġiet osservata xejra lejn punteġġ IVCM totali iktar baxx fil-grupp ta' Cystadrops fil-jum 30.
English: • irritation of eyelid
Maltese: • irritazzjoni fil-kappell tal-għajn
English: What is cystinosis
Maltese: X'inhi ċistinożi
English: Cystadrops 3.8 mg/mL eye drops solution
Maltese: Cystadrops 3.8 mg/mL soluzzjoni ta' qtar għall-għajnejn
English: Genotoxicity studies have been performed: induction of chromosome aberrations in cultured eukaryotic cell lines has been reported and specific studies with cysteamine did not show any mutagenic effects in the Ames test or any clastogenic effect in the mouse micronucleus test.
Maltese: Twettqu studji dwar il-ġenotossiċità: ġiet irrapportata induzzjoni ta' aberrazzjonijiet tal-kromożomi f'linji ta' ċelloli ewkarjotiċi kkulturati u studji speċifiċi b'cysteamine ma wrew l-ebda effett mutaġenetiku fit-test Ames jew xi test klastoġeniku fit-test tal-mikronukleu fil-ġrieden.
English: Very common : eye pain, vision blurred, eye irritation, ocular hyperaemia, eye pruritus, lacrimation increased, deposit eye
Maltese: Komuni ħafna: uġigħ fl-għajnejn, vista mċajpra, irritazzjoni flgħajnejn, iperimija okulari, ħakk fl-għajnejn, żieda fit-tidmigħ, depożitu fl-għajn
English: • 1 dropper applicator.
Maltese: Effetti sekondarji possibbli 5.
English: Cystadrops contains benzalkonium chloride which may cause eye irritation.
Maltese: Cystadrops fih benzalkonium chloride li jista' jikkawża irritazzjoni fl-għajn.
English: Benzalkonium chloride may cause eye irritation and is known to discolour soft contact lenses.
Maltese: Benzalkonium chloride jista' jikkawża irritazzjoni fl-għajn u hu magħruf li jtellef il-kulur tal-lentijiet ta' kuntatt rotob.
English: This study was a randomised, controlled trial to assess the efficacy and the safety profile of Cystadrops following a period of 90 days of treatment at a dose regimen of 4 drops/eye/day.
Maltese: Dan l-istudju kien prova randomizzata, kkontrollata biex tevalwa l-effikaċja u l-profil ta' sigurtà ta' Cystadrops wara perjodu ta' 90 jum ta' kura b'reġim ta' doża ta' 4 taqtiriet/għajn/kuljum.
English: Superiority of Cystadrops was also demonstrated for photophobia rated by the investigator compared to the control arm (cysteamine hydrochloride 0.10%) p< 0.048 95% CI (0.23; 1.14).
Maltese: Is-superjorità ta' Cystadrops intweriet ukoll għall-fotofobija stmata mill-investigatur meta mqabbla mal-fergħa ta' kontroll (cysteamine hydrochloride 0.10 %) p< 0.
English: This study assessed the safety and efficacy of Cystadrops during 5 years.
Maltese: Dan l-istudju evalwa s-sigurtà u l-effikaċja ta' Cystadrops matul 5 snin.
English: remove remove remove metal seal vial green protective cap grey stopper
Maltese: neħħi neħħi neħħi siġill talmetall kunjett tapp protettiv aħdar tapp griż