FrancophonIA/ELRC3.0 huggingface dataset:
English: Concurrent use of nicorandil and phosphodiesterase 5 inhibitors, e.g. sildenafil, tadalafil, vardenafil, is contraindicated, since it can lead to a serious drop in blood pressure (synergic effect).
Maltese: L-użu ta' nicorandil flimkien ma' inibituri ta' phosphodiesterase 5, eż. sildenafil, tadalafil, vardenafil, huwa kontraindikat, minħabba li jista' jwassal biex il-pressjoni tad-demm tinżel b'mod serju (effett sinerġetiku).
English: The usual starting dose is 10 mg twice daily (bid), in the morning and in the evening preferably.
Maltese: Id-doża tal-bidu s-soltu tkun 10 mg darbtejn kuljum (bid), preferibbilment filgħodu u filgħaxija.
English: In patients concomitantly receiving NSAIDs including acetylsalicylic acid for both cardiovascular prevention and anti-inflammatory doses, there is an increased risk for severe complications such as gastrointestinal ulceration, perforation and haemorrhage (see section 4.4).
Maltese: F'pazjenti li fl-istess żmien qed jirċievu wkoll NSAIDs inkluż acetylsalicylic acid kemm bħala prevenzjoni kardjovaskulari kif ukoll bħala dożi antiinfjammatorji, hemm żieda fir-riskju ta' kumplikazzjonijiet severi bħal ulċerazzjoni, titqib u emorraġija gastrointestinali (ara sezzjoni 4.4).
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Maltese: L-informazzjoni dwar il-prodott tista' sussegwentement tiġi aġġornata mill-awtoritajiet kompetenti tal-iStat Membru, bi ftehim mal-iStat Membru ta' Riferiment, meta jkun hemm il-bżonn, skont ilproċeduri mniżżla f'Kapitlu 4 ta' Titlu III tad-Direttiva 2001/83/EC.
English: G6PD deficiency <Invented name> should be used with caution in patients with glucose-6-phosphate-dehydrogenase deficiency.
Maltese: Defiċjenza ta' G6PD “Isem ivvintat” għandu jintuża b'kawtela f'pazjenti bid-defiċjenza ta' glucose-6-phosphate-dehydrogenase.
English: It possesses a potassium-channel opening effect.
Maltese: Huwa għandu effett li jiftaħ il-kanali tal-potassju.
English: Furthermore, nicorandil has demonstrated a spasmolytic activity in both in vitro and in vivo studies and reverses coronary spasm induced by methacholine or noradrenalin.
Maltese: Barra dan, nicorandil wera attività spażmolitika kemm fl-istudji in vitro kif ukoll in vivo u jreġġa' lura spażmu koronarju kkaġunat minn methacholine jew noradrenalin.
English: The other metabolites accounted for the remaining 20% of radioactive AUC.
Maltese: Il metaboliti l-oħra rrappreżentaw l-20% tal-AUC radjuattiva li kien għad fadal.
English: • Dapoxetine, a medicine used to treat premature ejaculation.
Maltese: • Dapoxetine,mediċina użata fit-trattament ta' eġakulazzjoni prematura.
English: Gastrointestina l ulcerations (stomatitis, aphtosis, mouth ulcer, tongue ulcer, small intestinal ulcer, large intestinal ulcer, anal ulcer) (see below and section 4.4)
Maltese: aftożi, ulċera fil-ħalq, ulċera fl-ilsien, ulċera fil-musrana żżgħira, ulċera fil-musrana l kbira, ulċera flanus) (ara taħt u sezzjoni 4.4)
English: As a precautionary measure, it is preferable to avoid the use of <Invented name> during pregnancy.
Maltese: Bħala prekawzjoni hu preferibbli li ma jintużax “Isem ivvintat” waqt it-tqala.
English: • High potassium levels in the blood (hyperkalaemia)
Maltese: • Livelli għoljin ta' potassju fid-demm (iperkalimja)
English: Gastrointestinal haemorrhage secondary to gastrointestinal ulceration has been reported with nicorandil.
Maltese: Emorraġija gastrointestinali li tiġi minħabba ulċerazzjoni gastrointestinali ġiet irrappurtata b'nicorandil.
English: Nicorandil acts in parts through its organic nitrate moiety.
Maltese: Sa ċertu punt, nicorandil jaħdem permezz tal-parti organika attiva tan-nitrat.
English: ≥65, diabetes, hypertension, peripheral vascular disease, or cerebrovascular disease.
Maltese: dijabete, pressjoni għolja, mard vaskulari periferali, jew mard ċerebrovaskulari.
English: The metabolism of organic nitrates can result in the formation of nitrites which may trigger methemoglobinemia in patients with glucose-6-phosphate dehydrogenase deficiency.
Maltese: tikkawża metemoglobinemija f'pazjenti bid-defiċjenza ta' glucose-6-phosphate dehydrogenase.
English: Very rare conjunctivitis, conjunctival ulcer and corneal ulcer have been reported with nicorandil.
Maltese: Rari ħafna kienu rrappurtati konġuntivite, ulċera fil-konġuntiva u ulċera fil-kornea b'nicorandil.
English: Due to its nitrate moiety, nicorandil relaxes also vascular smooth muscle, particularly in the venous system via an increase in intracellular cyclic guanosine monophosphate (cGMP).
Maltese: Minħabba l-parti attiva ta' nitrate, nicorandil jirrilassa wkoll il-muskolu vaskulari lixx, b'mod partikolari fis-sistema tal-vini permezz ta' żieda fil-guanosine monophosphate ċikliku (cGMP - cyclic guanosine monophosphate) ta' ġewwa ċ-ċelluli.
English: How to store <Invented name> Contents of the pack and other information
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: Nicorandil should be used with care in combination with other medical products that may increase potassium levels, especially in patients with moderate to severe renal impairment (see sections 4.5 and 4.8).
Maltese: Nicorandil għandu jintuża b'attenzjoni flimkien ma' prodotti mediċinali oħra li jistgħu jżidu l-livelli tal-potassju, speċjalment f'pazjenti b'indeboliment minn moderat sa sever tal-kliewi (ara sezzjoni 4.5 u 4.8).
English: • Headache - This especially occurs during the first few days of treatment.
Maltese: • Uġigħ ta' ras - Dan ħafna drabi jseħħ waqt l-ewwel ftit jiem ta' trattament.
English: The volume of distribution of nicorandil after intravenous (iv) dosing is 1.04 L/kg of body weight.
Maltese: Il-volum ta' distribuzzjoni ta' nicorandil wara għoti minn ġol-vini (iv - intravenous) huwa 1.04
English: This effect can be increased in conjunction with alcohol or other medicinal products with blood pressure lowering effect (e.g. vasodilators, tricyclic antidepressants) (see section 4.5).
Maltese: Dan l-effett jista' jiżdied flimkien mal-alkoħol jew ma'prodotti mediċinali oħra b'effett ta' tnaqqis tal-pressjoni taddemm (eż. mediċini vażodilatatorji, antidepressanti triċikliċi) (ara sezzjoni 4.5).
English: <Invented name> is indicated in adults for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or have a contraindication or intolerance to first-line antianginal therapies (such as beta-blockers and/or calcium antagonists).
Maltese: “Isem ivvintat” huwa indikat għall-adulti għat-trattament tas-sintomi ta' pazjenti b'anġina pectoris stabbli li mhumiex ikkontrollati b'mod adegwat jew għandhom kontraindikazzjoni jew intolleranza għat-terapiji ppreferuti ta' kontra l-anġina (bħal imblukkaturi tar-riċetturi beta/jew antagonisti talkalċju).
English: <Invented name> contains a medicine called nicorandil.
Maltese: "Isem ivvintat" fih mediċina li tissejjaħ nicorandil.
English: Gastrointestinal perforations in context of concomitant use of nicorandil and corticosteroids have been reported.
Maltese: Ġie rrappurtat titqib gastrointestinali fil-kuntest tal-użu flimkien ta' nicorandil u kortikosterojdi.
English: • Use of soluble guanylate cyclase stimulator(s) (such as riociguat) since it can lead to a serious fall in blood pressure (see section 4.5)
Maltese: • L-użu ta' stimulatur(i) ta' guanylate cyclase li jinħall (bħal ma hu riociguat) minħabba li dan jista' jwassal għal tnaqqis qawwi fil-pressjoni tad-demm (ara sezzjoni 4.5).
English: Nicorandil has been shown to exert a direct effect on the coronary arteries, both on normal and stenotic segments, without leading to a steal phenomenon.
Maltese: Intwera li nicorandil għandu effett dirett fuq l-arterji koronarji, kemm f'partijiet normali kif ukoll dawk stenotiċi, mingħajr ma jwassal għall-fenomenu steal.
English: Rash, pruritus Angioedema, Skin and mucosal ulcerations (mainly peri-anal ulcerations, genital ulcerations and parastomal ulcerations) (see section
Maltese: Raxx, ħakk Anġjoedima, Ulċerazzjonijie t fil-ġilda u filmukuża (l-aktar ulċerazzjonijiet madwar l-anus,
English: Ikorel and associated names (see Annex I) 10 mg tablets Dancor and associated names (see Annex I) 10 mg tablets Ikorel and associated names (see Annex I) 20 mg tablets] Dancor and associated names (see Annex I) 20 mg tablets
Maltese: Ikorel u ismijiet assoċjati (ara Anness I) 10 mg pilloli Dancor u ismijiet assoċjati (ara Anness I) 10 mg pilloli Ikorel u ismijiet assoċjati (ara Anness I) 20 mg pilloli Dancor u ismijiet assoċjati (ara Anness I) 20 mg pilloli
English: • if you are taking medicines to treat erectile dysfunction such as sildenafil, tadalfil, vardenafil (phosphodiesterase inhibitors) or medicines to treat pulmonary hypertension such as riociguat (guanylate cyclase stimulators).
Maltese: (inibituri ta' phosphodiesterase ) jew mediċini għall-kura ta' ipertensjoni pulmonarja bħal riociguat (stimulaturi ta' guanylate cyclase).
English: • Stomach aches.
Maltese: - Żomm dan il-fuljett.
English: <Invented name> with alcohol
Maltese: "Isem ivvintat". ma' alkoħol
English: The metabolism of nicorandil appears not to be significantly modified by cimetidine or rifampicine, respectively an inhibitor and an inducer of liver microsomal mixed-function oxidases.
Maltese: Il-metaboliżmu ta' nicorandil jidher li ma kienx modifikat b'mod sinifikanti minn cimetidine jew rifampicine, li rispettivament huma inibitur u induttur ta' oxidases b'funzjoni mħallta ta' mikrosomi tal-fwied.
English: Therefore caution is advised when concomitant use of acetylsalicylic acid or NSAIDs and nicorandil is considered (see section 4.5).
Maltese: Għalhekk hija rrakkomandata l-kawtela meta jitqies l-użu flimkien ta' acetylsalicylic acid jew NSAIDs u nicorandil (ara sezzjoni 4.5).
English: Caution is advised when nicorandil is used in combination with other medical products that may increase potassium levels (see sections 4.4 and 4.8).
Maltese: Hija rrakkomandata l-kawtela meta nicorandil jintuża flimkien ma' prodotti mediċinali oħra li jistgħu jżidu l-livelli tal-potassju (ara sezzjonijiet 4.4 u 4.8).
English: • Patients with shock (including cardiogenic shock), severe hypotension, or left ventricular dysfunction with low filling pressure or cardiac decompensation
Maltese: • Pazjenti b'xokk (inkluż xokk kardjoġeniku), pressjoni baxxa severa, jew funzjoni ħażina tal ventrikulu tax-xellug bi pressjoni baxxa waqt li jimtela jew nuqqas ta' kumpens kardijaku.
English: Nicorandil is only slightly bound to human plasma proteins (bound fraction estimated at about 25%).
Maltese: Ftit biss min-nicorandil jintrabat mal-proteini tal-plażma tal-bniedem (huwa stmat li l-porzjon li jintrabat huwa madwar 25%).
English: Metabolism and nutrition disorders
Maltese: Disturbi fil metaboliżmu u n nurtizzjoni
English: Furthermore, the reduction of end-diastolic pressure and wall tension decreases the extravascular component of vascular resistance.
Maltese: Barrra dan, it-tnaqqis fil-pressjoni fi tmiem id-dijastoli u fit-tensjoni tal-membrana ta' barra tal-qalb tnaqqas il-komponent ekstravaskulari tar-reżistenza vaskulari.
English: These metabolites represented the major route of transformation of nicorandil.
Maltese: Dawn il-metaboliti rrappreżentaw il-mezz ewlieni ta' trasformazzjoni ta' nicorandil.
English: Ikorel and associated names (see Annex I) 10 mg tablets Dancor and associated names (see Annex I) 10 mg tablets Ikorel and associated names (see Annex I) 20 mg tablets] Dancor and associated names (see Annex I) 20 mg tablets [See Annex I - To be completed nationally] nicorandil
Maltese: Ikorel u ismijiet assoċjati miegħu (ara Anness I) 10 mg pilloli Dancor u ismijiet assoċjati miegħu (ara Anness I) 10 mg pilloli Ikorel u ismijiet assoċjati miegħu (ara Anness I) 20 mg pilloli Dancor u ismijiet assoċjati miegħu (ara Anness I) 20 mg pillol
English: It is included in the pack to protect <Invented name> tablets from moisture.
Maltese: Hija inkluża fil-pakkett sabiex tipproteġi "Isem ivvintat" mill-umdità.
English: • Dizziness
Maltese: Immaniġġjar
English: If ulceration(s) develops, nicorandil should be discontinued (see section 4.8).
Maltese: Jekk tiżviluppa (jiżviluppaw) ulċerazzjoni(jiet), nicorandil għandu jitwaqqaf (ara sezzjoni 4.8).
English: How to store <Invented name>
Maltese: Jekk tieħu "Isem ivvintat" aktar milli suppost
English: Common Uncommo n
Maltese: taħt il-ġilda
English: • if you have heart problems such as cardiogenic shock, or left ventricular failure with low filling pressure or cardiac decompensation or shock.
Maltese: • jekk għandek problemi tal-qalb bħal xokk kardjoġeniku, jew insuffiċjenza tal-ventrikulu tax xellug bi pressjoni baxxa ta' mili jew dekompensazzjoni kardijaka jew xokk.
English: This can develop problems such as bleeding (blood in your stools or vomit), fistula (abnormal tube-like passage from one body cavity to another or to the skin), wholes, abscess, weight loss.
Maltese: Dan jista' jiżviluppa f'problemi bħal fsada (demm fl-ippurgar jew fir-rimettar), fistula (passaġġi mhux normali forma ta' tubi minn kavità waħda tal-ġisem għal oħra jew għall-ġilda), wholes, axxess, tnaqqis fil-piż.
English: Nicorandil, a nicotinamide ester, is a vasodilator agent with a dual mechanism of action, which leads to relaxation of smooth tonic vascular muscles in both venous and arterial part of vessels.
Maltese: Nicorandil, ester ta' nicotinamide, huwa sustanza vażodilatatur b'mekkaniżmu ta' azzjoni doppju, li jwassal għar-rilassament tal-muskoli lixxi toniċi vaskulari kemm fil-parti tal-vini kif ukoll tal-arterji tal-kanali tad-demm.
English: • Feeling sick (nausea)
Maltese: • Tara doppju (diplopja)
English: Cutaneous vasodilatio n with flushing
Maltese: Effetti sekondarji oħra jinkludu:
English: OTHER Do not swallow drying agent.
Maltese: M'għandekx tgħaddiha lil persuni oħra.
English: Ulcerations
Maltese: Fertilità
English: The recommended dose is: - The usual starting dose is 10 mg twice daily.
Maltese: - Id-doża normali biex tibda hija ta' 10 mg darbtejn kuljum.
English: No clinically relevant modifications of the nicorandil pharmacokinetic profile is evidenced in population at risk such as elderly people, liver disease patients and chronic renal failure patients.
Maltese: M'hemm ebda evidenza li f'popolazzjoni f'riskju bħal persuni anzjani, pazjenti b'mard tal-fwied u pazjenti b'insuffiċjenza renali kronika kien hemm xi tibdil, klinikament rilevanti, fil-profil farmakokinetiku ta' nicorandil.
English: Hyperkalaemia
Maltese: GĦAMLA KWALITATTIVA
English: Following exposure to nicorandil at doses that were maternally toxic, embryotoxicity was observed in the rat and rabbit.
Maltese: kien hemm irkupru mit-tossiċità testikulari kkaġunata minn nicorandil, li jindika li l-bidliet osservati huma riversibbli.
English: Absorption After oral administration, nicorandil is absorbed rapidly and completely from the gastrointestinal tract, independent from food intake.
Maltese: Wara għoti mill-ħalq, nicorandil jiġi assorbit malajr u kompletament mill-passaġġ gastrointestinali,
English: QUALITATIVE AND QUANTITAVE COMPOSITION [To be completed nationally]
Maltese: U KWANTITATTIVA [Biex timtela mill-pajjiż partikolari]
English: Caution is advised if nicorandil is used in combination with other medicinal products with blood pressure lowering effect (see section 4.5 and 4.8).
Maltese: Hija rrakkomandata l-kawtela jekk nicorandil jintuża flimkien ma' prodotti mediċinali oħra li għandhom effett li jbaxxu l-pressjoni tad-demm (ara sezzjoni 4.5 u 4.8).
English: Severe hyperkalaemia has been very rarely reported with nicorandil.
Maltese: Iperkalimja severa ġiet irrappurtata b'mod rari ħafna b'nicorandil.
English: - Eye ulcerations
Maltese: - Ulċerazzjonijiet gastrointestinali
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON for 10 mg and 20 mg
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KARTUNA TA' BARRA għal 10 mg u 20 mg
English: Based on available information, the time between starting nicorandil use and the onset of ulceration ranges from shortly after initiating nicorandil treatment to several years after starting nicorandil.
Maltese: Abbażi tal-informazzjoni disponibbli, iż-żmien minn meta jibda' jintuża nicorandil u l-bidu talulċerazzjoni dvarja minn ftit wara li jinbeda t-trattament b'nicorandil għal diversi snin wara li jinbeda nicorandil.
English: Packaging Content Package size
Maltese: Kontenut Daqs tal-pakkett
English: EU/2/04/044/014 Aivolsin 625 mg/g Granules for use in drinking water
Maltese: EU/2/04/044/013 Aivlosin 42.5 mg/g Trab għall-ħalq Ħnieżer
English: EU Number
Maltese: Jum
English: Withdrawal Period
Maltese: Ippakkjar
English: Chickens and turkeys
Maltese: Perjodu ta' Tiżmim
English: 42.5 mg/g 20 kg Meat and offal 2 days
Maltese: 42.5 mg/g 20 kg Laħam u ġewwieni tal-annimali:
English: Oral powder aluminium foil/polyester laminated bag
Maltese: Speċi li fuqhom għandu jintuża l-prodott
English: The full EPAR for Foscan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This summary was last updated in 03-2016.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f' 03-2016.
English: Foscan is a solution for injection containing the active substance temoporfin (1 mg/ml).
Maltese: Foscan huwa soluzzjoni għall-injezzjoni li fiha s-sustanza attiva temoporfina (1 mg/ml).
English: The dose is 0.15 mg per kilogram body weight.
Maltese: Id-doża hija 0.5 mg għal kull kilo tal-piż tal-ġisem.
English: This is a summary of the European public assessment report (EPAR) for Foscan.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Foscan.
English: The most common side effects with Foscan (seen in more than 1 patient in 10) are pain in the illuminated area (such as pain in the face), headache, pain at the injection site, haemorrhage (bleeding), scarring, necrotising stomatitis (death of cells or tissue in the mouth), dysphagia (difficulty swallowing), oedema (swelling) in the illuminated area (such as swelling of the face and tongue) and constipation.
Maltese: L-effetti sekondarji l-aktar komuni b'Foscan (li dehru f'aktar minn pazjent 1 minn 10) huma wġigħ fiżżona lluminata, uġigħ fil-punt tal-injezzjoni, emorraġija (fsada), immarkar, nekrożi tal-ħalq (mewt taċċelluli jew tat-tessut tal-ħalq), disfaġija (diffikultà biex tibla'), edema(nefħa)fiż-żona lluminata (bħal nefħa fil-wiċċ u l-ilsien) u stitikezza.
English: Foscan temoporfin
Maltese: Sommarju tal-EPAR għall-pubbliku temoporfina
English: The active substance in Foscan, temoporfin, is a photosensitising agent (a substance that changes when exposed to light).
Maltese: Is-sustanza attiva f'Foscan, temoporfina, hija aġent fotosensitizzanti (sustanza li tinbidel meta esposta għad-dawl).
English: It is used in patients in whom other treatments have stopped working, and who are not suitable for radiotherapy (treatment with radiation), surgery or systemic chemotherapy (medicines used to treat cancer; ‘systemic' means that they are given as treatments throughout the body).
Maltese: Jintuża fil-pazjenti li għalihom trattamenti oħra ma baqgħux jaħdmu u li mhumiex adatti għal trattament ta' radjoterapija (trattament bir-radjazzjoni), kirurġija jew kimoterapija sistemika (mediċini użati fit-trattament tal-kanċer; 'sistemika' tfisser li jingħataw bħala trattamenti fil-ġisem kollu).
English: Why has Foscan been approved?
Maltese: Għaliex ġie approvat Foscan?
English: The first three studies looked at whether the tumour was eradicated after up to three treatments with Foscan in a total of 189 patients.
Maltese: L-ewwel tliet studji eżaminaw jekk it-tumur ġiex eliminat wara massimu ta' tliet ċikli ta' trattament b'Foscan fuq total ta' 189 pazjent.
English: What is the risk associated with Foscan?
Maltese: Għal xiex jintuża Foscan?
English: When Foscan is injected, temoporfin is distributed within the body, including within the tumour.
Maltese: Wara l-injezzjoni ta' Foscan, it-temoporfina tinxtered mal-ġisem, inkluż fit-tumur.
English: In all studies, the response was assessed between 12 and 16 weeks after the final treatment with Foscan, but Foscan was not compared with any other treatment.
Maltese: Fl-istudji kollha, ir-rispons ġie vvalutat bejn il-ġimgħa 12 u 16 wara l-aħħar trattament b'Foscan, madankollu Foscan ma tqabbilx ma' trattamenti oħra.
English: Foscan has been studied in four main studies involving a total of 409 patients with head or neck cancer.
Maltese: Foscan ġie studjat f'erba' studji ewlenin imwettqa fuq total ta' 409 pazjenti li jbatu minn kanċer tar-ras jew tal-għonq.
English: However, in the study looking at improving symptoms of advanced head and neck cancer, 28 (22%) of the 128 patients assessed had a significant improvement in their most troubling symptom.
Maltese: Madankollu, fl-istudju li analizza t-titjib tas-sintomi fil-pazjenti b'kanċer tar-ras u tal-għonq fi stadju avvanzat, 28 pazjent (22%) fuq total ta' 128 li ġew osservati, urew titjib sinifikanti tas-sintomi l-aktar fastidjużi.
English: For the full list of all side effects reported with Foscan, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati b'Foscan, ara lfuljett ta' tagħrif.
English: The medicine is given by an indwelling intravenous cannula (a thin tube permanently inserted into a vein) as a single slow injection over at least six minutes.
Maltese: Il-mediċina tingħata permezz ta' kannula intravenuża permanenti (tubu rqiq mdaħħal permanentement f'vina) b'injezzjoni waħda mogħtija bil-mod fuq tul ta' żmien ta' mhux inqas minn sitt minuti.
English: The fourth study looked at the reduction of symptoms in 220 patients with advanced head or neck cancer who could not receive surgery or radiotherapy.
Maltese: Ir-raba' studju eżamina t-tnaqqis tas-sintomi f'220 pazjent b'kanċer tar-ras jew tal-għonq fi stadju avvanzat, li ma setgħux jiġu sottoposti għal kirurġija jew radjoterapija.
English: How has Foscan been studied?
Maltese: Kif ġie studjat Foscan?
English: When it is illuminated with laser light of a specific wavelength, temoporfin is activated and reacts with oxygen in the cells to create a highly reactive and toxic type of oxygen.
Maltese: Meta tiddawwal bid-dawl tal-lejżer b'wejvlengt speċifiku, it-temoporfina tiġi attivata u tirreaġixxi mal-ossiġnu preżenti fiċ-ċelluli, b'hekk jinħoloq tip ta' ossiġnu reattiv u tossiku ħafna.
English: The CHMP concluded that Foscan's effects on relieving the symptoms associated with advanced head and neck cancer were of interest.
Maltese: Is-CHMP kkonkluda li l-effetti ta' Foscan fuq it-taffija tas-sintomi assoċjati mal-kanċer tar-ras u l-għonq kienu ta' interess.
English: The medicine can only be obtained with a prescription.
Maltese: Kull żona tat-tumur għandha tkun imdawla tal-anqas darba waqt kull trattament.
English: Four days later, the entire surface of the tumour and the surrounding 0.5 cm margin is illuminated with light from a laser at a specific wavelength, using a fibre-optic cable.
Maltese: Wara erbat ijiem, iż-żona kollha tat-tumur u l-marġni ta' 0.5 ċm ta' madwarha jiddawlu minn dawl mixħut minn lejżer b'wejvlengt speċifiku permezz ta' kejbil tal-fibra ottika.
English: Foscan must only be given in a specialist cancer centre where a team can assess the patient's treatment under the supervision of a doctor who has experience in photodynamic therapy (treatment that uses light).
Maltese: Foscan għandu jintuża esklussivament f'ċentru speċjalizzat fil-kura tal-kanċer li fih ikun hemm tim li jivvaluta t-trattament tal-pazjent taħt is-superviżjoni ta' tabib b'esperjenza fit-terapija fotodinamika (trattament li juża l-azzjoni tad-dawl).
English: By restricting the illumination to the tumour, cell damage is limited to the tumour cells, leaving other areas of the body unaffected.
Maltese: Peress li t-tidwil ikun limitat għat-tumur, issir ħsara liċ-ċelluli tumurali biss, mingħajr ma jintlaqtu partijiet oħra tal-ġisem.