FrancophonIA/ELRC3.0 huggingface dataset:
English: BPD-DA is also a photosensitiser but its systemic exposure is low (5-10% of the verteporfin exposure, suggesting that most of the active substance is eliminated unchanged).
Maltese: BPD-DA huwa wkoll fotosensitizzatur imma l-espożizzjoni sistemika tiegħu hija baxxa (5-10% ta' l-espożizzjoni ta' verteporfin, li jissuġġerixxi li ħafna mis-sustanza attiva hija eliminata mhux midbula).
English: Visudyne is contraindicated in patients with severe hepatic impairment (see section 4.3).
Maltese: Visudyne huwa kontraindikat f'pazjenti b'indeboliment epatiku sever (ara sezzjoni 4.3).
English: - Keep this leaflet.
Maltese: Reazzjoni anafilattika.
English: The adverse reactions are listed by system organ class and frequency using the following convention: 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: Irreazzjonijet avvesi huma mniżżla permezz tal-iklassifikar bis-sistema tal-organi u bil-frekwenza blużu tal-konvenzjoni li ġejja: 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 magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: Do not use sodium chloride solution (see section 6.2).
Maltese: Tużax soluzzjoni tal-kloridu tas-sodju (ara sezzjoni 6.2).
English: Hyperesthesia.
Maltese: Iperesteżija.
English: The maximum spot size used for the first treatment in the clinical studies was 6,400 m.
Maltese: Id-daqs massimu talparti kkurata użata għall-ewwel trattament fl-istudji kliniċi kien 6,400 m.
English: In vitro studies did not show any significant involvement of oxidative metabolism by cytochrome P450 enzymes.
Maltese: Studji in vitro ma wrew l-ebda involviment sinifikanti ta' metaboliżmu ossidattiv minn enzimi taċ-ċitokromu P450.
English: The following inclusion criteria were considered for the treatment: patients older than 50 years of age, presence of CNV secondary to AMD, presence of classic lesion components in the CNV (defined as a well-demarcated area of the fluorescence on angiography), CNV located subfoveally (involved the geometric centre of the foveal avascular zone), area of classic plus occult CNV 50% of the total lesion surface, greatest linear dimension of the entire lesion 9 Macular Photocoagulation Study (MPS) disc area, and a best-corrected visual acuity between 34 and 73 letters (i.e. approximately 20/40 and 20/200) in the treated eye.
Maltese: Ġew ikkunsidrati għall-kura l-kriterji ta' inklużjoni li ġejjin: pazjenti li għandhom aktar minn 50 sena, preżenza ta' CNV sekondarja għall-AMD, preżenza ta' komponenti klassiċi ta' leżjoni ta' CNV (iddefinita bħala parti demarkata sew tal-fluworexxenza fuq l-anġjografija), CNV li tkun fuq il-fovea (li tinvolvi ċ-ċentru ġeometriku taż-żona avaskulari foveali), erja ta' CNV klassika u okkulta  50% tas-superfiċje totali tal-leżjoni, l-akbar dimensjoni linjari tal-leżjoni kollha  9 erja tad-diska ta' lIstudju ta' Fotokoagulazzjoni Makulari (MPS), u l-aqwa korrezzjoni fl-akutezza viżwali bejn 34 u 73 ittra (i.e. bejn wieħed u ieħor 20/40 u 20/200) fl-għajn ikkurata.
English: Myocardial infarction
Maltese: Infart mijokardiku
English: One multicentre, double-masked, placebo-controlled, randomised study (BPD OCR 003 PM [VIPPM]) was conducted in patients with subfoveal choroidal neovascularisation caused by pathological myopia.
Maltese: Studju multiċentrat, double-masked, ikkontrollat bi plaċebo, randomizzata (BPD OCR 003 PM [VIPPM]) sar fuq pazjenti b'neovaskularizzazzjoni korojdali subfoveali kkawżata minn mijopija patoloġika.
English: Lactose monohydrate, dimyristoyl phosphatidylcholine, egg phosphatidylglycerol, ascorbyl palmitate, butylated hydroxytoluene (E321).
Maltese: Lactose, dimyristoyl phosphatidylcholine, phosphatidylglycerol tal-bajd, ascorbyl palmitate, butylated hydroxytoluene (E321).
English: Rash, urticaria, pruritus
Maltese: Raxx, urtikarija, ħakk
English: Risk of severe decrease of vision
Maltese: Risku ta' tnaqqis sever fil-vista
English: Immune system disorders Common
Maltese: Disturbi fis-sistema immuni Komuni
English: Retinal detachment, retinal haemorrhage, vitreous haemorrhage, retinal oedema.
Maltese: Distakkament tar- retina, emorraġija tar-retina, emorraġija filvitreous humour, edema tar-retina.
English: In relation to VIP-PM extension:
Maltese: B'relazzjoni ma' l-estensjoni VIP-PM:
English: Treatment of the second eye with Visudyne
Maltese: Mediċini oħra u Visudyne
English: A total of 120 patients (81 Visudyne, 39 placebo) were enrolled in the study.
Maltese: Fl-istudju ħadu sehem total ta' 120 pazjent (81 Visudyne, 39 plaċebo).
English: The subgroup of patients with predominantly classic CNV lesions (N=243; Visudyne 159, placebo 84) were more likely to exhibit a larger treatment benefit.
Maltese: Is-sottogrupp ta' pazjenti b'leżjonijiet CNV prinċipalment klassiċi (N=243; Visudyne 159, plaċebo 84) kellhom aktar tendenza li jieħdu benefiċċju akbar mill-kura.
English: In human plasma, 90% of verteporfin is associated with plasma lipoprotein fractions and approximately 6% are associated with albumin.
Maltese: Fil-plażma tal-bniedem, 90% ta' verteporfin jassoċja ma' porzjonijiet ta' lipoproteina tal-plażma u bejn wieħed u ieħor 6% jassoċja ma' l-albumina.
English: A higher percentage of patients who received Visudyne, compared with those who received placebo, experienced adverse events (89.3% versus 82.5 %), associated adverse events (42.7% versus 18.4%) and events leading to discontinuation (6.2% versus 0.9%).
Maltese: Perċentwali ogħla ta' pazjenti li rċevew Visudyne, meta mqabbel ma'dawk li rċevew plaċebo, kellhom każijiet avversi (89.3% kontra 82.5%), każijiet avversi relatati (42.7% kontra 18.4%) u każijiet li wasslu għattwaqqif (6.2% kontra 0.9%).
English: Use of a standard infusion line filter with hydrophilic membranes (such as polyethersulfone) of a pore size of not less than 1.2 μm is recommended.
Maltese: Użu ta' filtru standard tal-linja ta' infużjoni b'membrani idrofiliċi (bħal polyethersulfone) b'pori ta' daqs mhux anqas minn 1.2 μm huwa rrikkmandat.
English: After reconstitution, 1 ml contains 2 mg of verteporfin.
Maltese: Wara r-rikostituzzjoni, 1 ml fih 2 mg ta' verteporfin.
English: • Localised death of skin tissue (necrosis).
Maltese: • Mewt lokalizzata tat-tessut tal-ġilda (nekrożi).
English: 364 patients (244 verteporfin, 120 placebo) were enrolled in this study.
Maltese: 364 pazjent (244 verteporfin, 120 plaċebo) ħadu sehem f'dan l-istudju.
English: What Visudyne contains - The active substance is verteporfin.
Maltese: X'fih Visudyne - Is-sustanza attiva hija verteporfin.
English: The most frequently reported adverse reactions to Visudyne (verteporfin for infusion) are injection site reactions (including pain, oedema, inflammation, extravasation, rashes, haemorrhage, discolouration) and visual impairment (including blurred, fuzzy vision, photopsia, reduced visual acuity and visual field defects, including scotoma and black spots).
Maltese: L-iktar reazzjonijiet avversi għal Visudyne li ġew irrapurtati b'mod frekwenti (verteporfin għallinfużjoni) huma reazzjonijiet fis-sit tal-injezzjoni (inkluż uġigħ, edema, infjammazzjoni, estravasazzjoni, raxxijiet, emoraġġija, telf tal-kulur) u indeboliment fil-vista (inklużi vista mċajpra, mżellġa, fototopsja, akutezza mnaqqsa fil-vista u difetti fil-kamp tal-vista, inkluża skotoma u tikek suwed).
English: The volume of distribution of around 0.60 l/kg at steady state and clearance of around 101 ml/h/kg has been reported following a 10-minute infusion in dose range of 3-14 mg/m2.
Maltese: Kienu rrappurtati volum ta' distribuzzjoni ta' madwar 0.60 l/kg fi stat stabbli u tneħħija ta' madwar 101 ml/h/kg wara infużjoni ta' 10 minuti b'doża ta' bejn 3 u 14-il mg/m2.
English: Severe reduced visual acuity
Maltese: Akutezza tal-vista severament imnaqqsa
English: The studies showed a difference of 15 % between treatment groups (61% for Visudyne-treated patients compared to 46% placebo-treated patients, p<0.001, ITT analysis).
Maltese: L-istudji wrew differenza ta' 15% bejn il-gruppi li ħadu t-trattament (61% għal pazjenti kkurati b'Visudyne imqabbla ma' 46% tal-pazjenti ttrattati bi plaċebo, p<0.001, analiżi
English: Visudyne 15 mg powder for solution for infusion verteporfin
Maltese: Visudyne 15 mg trab għal soluzzjoni għall-infużjoni verteporfin
English: In pregnant rats, intravenous verteporfin doses of 10 mg/kg/day (approximately 40-fold human exposure at 6 mg/m based on AUCinf in female rats) were associated with an increased incidence of anophthalmia/microphthalmia and doses of 25 mg/kg/day (approximately 125-fold the human exposure at 6 mg/m based on AUCinf in female rats) were associated with an increased incidence of wavy ribs and anophthalmia/microphthalmia.
Maltese: F'firien nisa tqal, dożi ta' 10 mg/kg/kuljum verteporfin minn ġol-vina (madwar 40 darba aktar lespożizzjoni tal-bniedem jiġifieri ta' 6 mg/m skont l-AUCinf f'firien nisa) kienu assoċjati ma' żieda flinċidenza ta' anoftalmija/mikroftalmija u dożi ta' 25 mg/kg/kuljum (madwar 125 darba aktar lespożizzjoni tal-bniedem jiġifieri ta' 6 mg/m2 skont l-AUCinf f'firien nisa) kienu assoċjati ma' żieda fl inċidenza ta' kustilji mmewġin u ma' anoftalmija/mikroftalmija.
English: The extent of exposure and the maximal plasma concentration are proportional to the dose between 6 and 20 mg/m
Maltese: Il-medda ta' espożizzjoni u l-konċentrazzjoni massima tal-plasma huma proporzjonali skont id-doża ta' bejn 6 u 20 mg/m
English: Visudyne is also contraindicated in patients with porphyria and in patients with severe hepatic impairment (see “Hepatic impairment” under section 4.2).
Maltese: Visudyne huwa kontra-indikat ukoll f'pazjenti b'porfirja u f'pazjenti b'indeboliment epatiku qawwi (ara “Indeboliment epatiku” taħt sezzjoni 4.2).
English: At month 24, 79% Visudyne patients versus 72% placebo patients had lost less than 3 lines of visual acuity (p=0.38).
Maltese: Fl-24 xahar, 79% tal-pazjenti kkurati b'Visudyne kontra 72% tal-pazjenti kkurati bi plaċebo kienu tilfu anqas minn 3 linji ta' akutezza viżwali (p=0.38).
English: At month 12, the study did not show statistically significant results on the primary efficacy parameter (responder rate 49.3% versus 45.6%, p=0.517).
Maltese: Fit-12-il xahar, listudju ma weriex riżultati statistikament sinifikanti fuq il-parametru primarju ta' l-effikaċja (rata ta' rispons 49.3% kontra 45.6%, p=0.517).
English: Agents such as calcium channel blockers, polymixin B, and radiation therapy are known to alter the vascular endothelium.
Maltese: Aġenti bħall-imblukkaturi tal-kanal tal-kalċju, polymixin B, u terapija bir-radjazzjoni huma magħrufa li jbiddlu l-endoteljum vaskulari.
English: Pharmacotherapeutic group: Ophthalmologicals, Antineovascularisation agents, ATC code: S01LA01
Maltese: Oftalmoloġiċi, Aġenti kontra neo-vaskularizzazzjoni, Kodiċi ATC:
English: Visudyne has been studied in two randomised, placebo-controlled, double-masked, multicentre studies (BPD OCR 002 A and B or Treatment of Age-related Macular Degeneration with Photodynamic Therapy [TAP]).
Maltese: Visudyne ġie studjat f'żewġ studji randomizzati, ikkontrollati bi plaċebo, double-masked, u multiċentriċi (BPD OCR 002 A u B jew Kura ta' Deġenerazzjoni Makulari relatata ma' l-Età jew Terapija Fotodinamika [TAP]).
English: Tell your doctor or pharmacist if you are taking any of the following medicines, as they may increase your sensitivity to light: - tetracyclines or sulphonamides (used to treat bacterial infection), - phenothiazines (used to treat psychiatric disorders, or nausea and vomiting), - sulfonylurea (used to treat diabetes), - medicines used to lower blood sugar, - thiazide diuretics (used to reduce high blood pressure), - griseofulvin (used to treat fungal infection), - calcium channel blockers (used to treat high blood pressure, angina and abnormal heart rhythms), - antioxidants such as beta-carotene or medicines that can remove or inactivate free radicals (such as dimethylsulfoxide (DMSO), formate, mannitol and alcohol), - vasodilators (used to widen blood vessels resulting from smooth muscle relaxation), - or, if you are undergoing radiation therapy,
Maltese: Għid lit-tabib jew lill-ispiżjar tiegħek jekk tkun qed tieħu xi waħda mill-mediċini li ġejjin, billi dawn jistgħu jżidu s-sensittività tiegħek għad-dawl: - tetraċilini jew sulfonamidi (użati biex jitrattaw infezzjoni batterjali), - phenothiazines (użati biex jitrattaw disturbi psikoloġiċi, jew nawżea u rimettar), - sulfonylurea (użati biex titratta d-dijabete), - mediċini biex ibaxxu l-livelli ta' zokkor fid-demm, - thiazide diuretics (użati biex inaqqsu l-pressjoni tad-demm għolja), - griseofulvin (uzata biex tikkura infezzjoni tal-fungu), - imblukkaturi tal-kanal tal-kalċju (użati sabiex jikkkuraw pressjoni għolja tad-demm, anġina u ritmi mhux normali tal-qalb), - antiossidanti bħal beta-karotene jew mediċini li jistgħu jneħħu jew jiddisattiva radikali liberi
English: 7.5 ml of reconstituted solution contains 15 mg of verteporfin.
Maltese: 7.5 ml ta' soluzzjoni mħallta fiha 15-il mg verteporfin.
English: Visudyne 15 mg powder for solution for infusion
Maltese: Visudyne 15 mg trab għal soluzzjoni għall-infużjoni
English: The study did not show statistically significant results on the primary efficacy parameter at month 12 (15-letter responder rate 62.7% versus 55.0%, p=0.150; 30-letter responder rate 84.0% versus 83.3%, p=0.868) or at month 24 (15-letter responder rate 53.3% versus 47.5%, p=0.300; 30letter responder rate 77.5% versus 75.0%, p=0.602).
Maltese: Dan l-istudju ma weriex riżultati statistikament sinifikanti fuq il-parametru primarju ta' l-effikaċja fit-12-il xahar (15-il ittra b'rata ta' rispons ta' 62.7% kontra 55.0%, p=0.150; 30 ittra b'rata ta' rispons ta' 84.
English: - You will be sensitive to bright light for 48 hours after the infusion.
Maltese: - Se tkun sensittiv għal dawl qawwi għal 48 siegħa wara l-infużjoni.
English: Toxicity observed following multiple doses of verteporfin without light was associated mainly with effects on the haematopoietic system.
Maltese: It-tossiċità osservata wara dożi ripetuti ta' verteporfin mingħajr dawl kienet assoċjata primarjament ma' effetti fuq is-sistema ematopojetika.
English: - The other ingredients are dimyristoyl phosphatidylcholine, egg phosphatidylglycerol, ascorbyl palmitate, butylated hydroxytoluene (E321) and lactose monohydrate.
Maltese: - Is-sustanzi mhux attivi l-oħra huma dimyristoyl phosphatidylcholine, phosphatidylglycerol talbajd, ascorbyl palmitate, butylated hydroxytoluene (E321) u lactose monohydrate.
English: For the light activation of Visudyne, a diode laser generating non-thermal red light (wavelength 689 nm  3 nm) is used via a slit lamp mounted fibre optic device and a suitable contact lens.
Maltese: Għall-attivazzjoni ta' Visudyne bid-dawl, jintuża lejżer tad-dajowd li jiġġenera dawl aħmar mhux termali (wavelength 689 nm  3 nm) minn ġo strument tal-fibra ottika armat fuq slit lamp, u lenti talkuntatt addattata.
English: The renal excretion of verteporfin and its metabolite is minimal (<1% of the verteporfin dose) and thus, clinically significant changes in verteporfin exposure in patients with renal impairment are unlikely.
Maltese: Leskrezzjoni mill-kliewi ta' verteporfin u l-metaboliti tiegħu hi minima (<1% tad-doża ta' verteporfin) u għaldaqstant, mhuwiex probabbli li jkun hemm tibdiliet sinjifikanti klinikament fl-espożizzjoni għal verteporfin f'pazjenti b'indeboliment ta-kliewi.
English: The VIO study included patients with occult with no classic subfoveal CNV with a visual acuity score of 73-34 letters (20/40-20/200), and patients with lesions >4 MPS disc areas were to have baseline visual acuity <65 letters (<20/50).
Maltese: L-istudju VIO, kien jinkludi pazjenti b'okkult mingħajr CNV subfoveali klassiku b'punteġġ flakutezza viżwali ta' 73-34 ittra (20/40-20/200) u pazjenti b'leżjonijiet >4
English: Malaise
Maltese: Dispnea
English: The two regioisomers of verteporfin exhibit similar pharmacokinetic properties of distribution and elimination and thus both isomers are considered verteporfin as a whole from the pharmacokinetic perspective.
Maltese: Iż-żewġ reġjoiżomeri ta' verteporfin juru propertajiet farmakokinetiċi simili ta' distribuzzjoni u eliminazzjoni u għaldaqstant iż-żewġ iżomeri jitqiesu verteporfin b'mod sħiħ minn perspettiva farmakokinetika.
English: Adults, including the elderly (≥65 years old) Visudyne photodynamic therapy (PDT) is a two-step process:
Maltese: Adulti, inklużi l-anzjani (65 sena)
English: This 15% difference between treatment groups was confirmed at 24 months (53% Visudyne versus 38% placebo, p<0.001).
Maltese: Din id-differenza ta' 15%, bejn il-gruppi li ħadu t-trattament ġiet ikkonfermata wara l-24 xahar (53% Visudyne kontra 38% plaċebo, p<0.001).
English: Pack containing 1 vial.
Maltese: Visudyne jiġi f'pakketti li jkun fihom kunjett 1 ta' trab.
English: A lower percentage of Visudyne patients had events leading to death (n=4 [1.8%] versus n=3 [2.6%]); no death was considered to be related to treatment.
Maltese: Perċentwali aktar baxxa ta' pazjenti b'Visudyne kellhom każijiet li wasslu għall-mewt (n=4 [1.8%] kontra n=3 [2.6%]); l-ebda mewta ma kienet meqjusa relatata malkura.
English: For a dose of 6 mg/m body surface (see section 4.2) dilute the required amount of Visudyne solution in dextrose 50 mg/ml (5%) solution for infusion to a final volume of 30 ml.
Maltese: Għal doża ta' 6 mg/m tas-superfiċje tal-ġisem (ara sezzjoni 4.2) iddilwixxi l-ammont meħtieġ ta' soluzzjoni Visudyne fi destrożju 50 mg/ml (5%) soluzzjoni għall-infużjoni għall-volum finali ta' 30 ml.
English: Visudyne is indicated for the treatment of - adults with exudative (wet) age-related macular degeneration (AMD) with predominantly classic subfoveal choroidal neovascularisation (CNV) or - adults with subfoveal choroidal neovascularisation secondary to pathological myopia.
Maltese: b'neovaskularizzazzjoni korojdali subfoveali li hija prinċipalment klassika (CNV) jew, - adulti b'neovaskularizzazzjoni korojdali subfoveali sekondarja għal mijopija patoloġika.
English: Nausea.
Maltese: Nawżea.
English: The second step is the light activation of Visudyne at 15 minutes after the start of the infusion (see “Method of administration”).
Maltese: It-tieni stadju huwa l-attivazzjoni ta' Visudyne bid-dawl, 15-il minuta wara l-bidu ta' l-infużjoni (ara “Metodu ta' kif għandu jingħata”).
English: The greatest linear dimension of the choroidal neovascular lesion is estimated using fluorescein angiography and fundus photography.
Maltese: L-akbar dimensjoni lineari tal-leżjoni neovaskulari korojdali tiġi kkalkulata bl-użu ta' anġjografija bi fluorescein u fotografija tal-fundus.
English: Reconstitute Visudyne in 7.0 ml water for injections to produce 7.5 ml of a 2.0 mg/ml solution.
Maltese: Irrikostitwixxi Visudyne f'7.0 ml ilma għall-injezzjonijiet sabiex tagħmel 7.5 ml ta' soluzzjoni ta' 2.0 mg/ml.
English: This study also included patients with classic containing CNV with a visual acuity score >70 letters (20/40).
Maltese: Dan l-istudju kien jinkludi wkoll pazjenti li kellhom punteġġ ta' akutezza viżwali ta' > 70 ittra (20/40).
English: However, photodynamic therapy (PDT) induces the formation of reactive oxygen species and has been reported to result in DNA damage including DNA strand breaks, alkali-labile sites, DNA degradation, and DNA-protein cross links which may result in chromosomal aberrations, sister chromatid exchanges (SCE) and mutations.
Maltese: Madanakollu, terapija fotodinamika (PDT) twassal biex jiffurmaw speċi reattivi tal-ossiġnu u kien irrappurtat li wasslet għal ħsara fid-DNA inkluż għal interruzzjoni tal-filament tadDNA, siti alkali-labile, degradazzjoni tad-DNA, u retikulazzjoni tal-proteina tad-DNA li tista' twassal għal aberrazzjonijiet kromosomali, skambju tal-aħwa kromatide (SCE) u mutazzjonijiet.
English: The ester group of verteporfin is hydrolysed via plasma and hepatic esterases, leading to the formation of benzoporphyrin derivative diacid (BPD-DA).
Maltese: Il-grupp ta' l-ester ta' verteporfin huwa idrolizzat permezz ta' l-esterases tal-plażma u epatiċi, li jwassal għall-formazzjoni ta' diaċidu idderivat minn benzoporphyrin (BPD-DA).
English: Anaphylactic reaction.
Maltese: Mhux applikabbli.
English: • General disorders: rash, hives, itching
Maltese: • Disturbi ġenerali: raxx, urtikarja, ħakk.
English: UV sunscreens are not effective in protecting against photosensitivity reactions.
Maltese: Issunscreens ma joffru l-ebda protezzjoni kontra reazzjonijiet ta' fotosensittività.
English: Other side effects:
Maltese: • Disturbi ġenerali:
English: Do not use normal sodium chloride solutions or other parenteral solutions.
Maltese: Tużax soluzzjonijiet ta' sodium chloride normali jew taħlitiet oħra parenterali.
English: Breast-feeding
Maltese: CHEPLAPHARM
English: There are two types of choroidal neovascularisation: classic and occult.
Maltese: Hemm żewġ tipi ta' neovaskularizzazzjoni korojdali, klassika u okkulta.
English: The acute and light-dependent toxicity of verteporfin was characterised by dose dependent localised deep-tissue damage as a consequence of the pharmacological effect of PDT with verteporfin.
Maltese: It-tossiċità akuta u dipendenti fuq id-dawl ta' verteporfin kienet ikkaretterizzata bi ħsara lokalizzata u profonda fit-tessut dipendenti mid-doża bħala konsegwenza tal-effett farmakoloġiku ta' PDT b'verteporfin.
English: Visudyne has not been studied in patients with renal impairment.
Maltese: Visudyne ma ġiex studjat f'pazjenti b'indeboliment renali.
English: Each vial contains 15 mg of verteporfin.
Maltese: Kull kunjett fih 15 mg ta' verteporfin.
English: After Visudyne treatment you may have some vision problems, such as abnormal or decreased vision, which may be temporary.
Maltese: Wara kura b'Visudyne jista' jkollok xi problemi fil-vista, bħal vista mhux normali u mnaqqsa, li tista' tkun temporanja.
English: • General disorders: Hypersensitivity (allergic reactions), syncope (fainting), headache, lightheadedness, breathlessness.
Maltese: Ipersensittività (reazzjonijiet allerġiċi), sinkope (ħass ħażin), uġigħ ta'ras, sturdament, qtugħ ta' nifs.
English: • General disorders: changes in heart rate.
Maltese: • Disturbi ġenerali: ma tħossokx f'sikktek.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu
English: Although there is no clinical evidence, theoretical data suggest that antioxidants (e.g. beta-carotene) or medicinal products which scavenge free radicals (e.g. dimethylsulfoxide (DMSO), formate, mannitol or alcohol) might quench the activated oxygen species generated by verteporfin, resulting in decreased verteporfin activity.
Maltese: Minkejja li m'hemmx evidenza klinika, dejta teoretika tissuġġerixxi li l-antiossidanti (eż. betakarotene) jew prodotti mediċinali li jiskavenġaw radikali liberi (eż. dimethylsulfoxide (DMSO), formate, mannitol jew alkoħol) jafu jrażżnu dawk l-ispeċi attivati bl-ossiġenu ġġenerati b'verteporfin, li jwasslu għal tnaqqis fl-attività ta' verteporfin.
English: Plasma elimination half-life mean values ranged from approximately 5-6 hours for verteporfin.
Maltese: Valuri medji tal-half-life ta' l-eliminazzjoni tal-plażma varjaw minn bejn wieħed u ieħor 5-6 sigħat għal verteporfin.
English: Anaesthesia
Maltese: FARMAĊEWTIKU
English: Patients who receive Visudyne will become photosensitive for 48 hours after the infusion.
Maltese: Pazjenti li qed jirċievu Visudyne isiru fotosensittivi għal 48 siegħa wara l-infużjoni.
English: Severely reduced visual acuity, equivalent to 4 lines or more, within seven days after treatment was reported in 2.1 % of the verteporfin-treated patients in the placebo-controlled ocular Phase III clinical studies and in less than 1 % of patients in uncontrolled clinical studies.
Maltese: III ikkontrollati bi plaċebo u f'inqas minn 1% ta' pazjenti fi studji kliniċi mhux ikkontrollati.