FrancophonIA/ELRC3.0 huggingface dataset:
English: Mean improvement in ppFEV1 was observed at the first assessment on Day 15 and sustained throughout the 24-week treatment period.
Maltese: It-titjib medju f'ppFEV1 kien osservat fl-ewwel evalwazzjoni f'Jum 15 u kien sostnut matul il-perjodu kollu ta' kura ta' 24 ġimgħa.
English: No patients treated with Symkevi in combination with ivacaftor experienced a transaminase elevation >3 x ULN associated with elevated total bilirubin >2 x ULN.
Maltese: L-ebda pazjenti kkurati b'Symkevi flimkien ma' ivacaftor ma kellhom żieda fil-livell tattransaminases ta' >3 x ULN assoċjat ma' livell għoli ta' bilirubina totali ta' >2 x ULN.
English: Less than 1% of the administered dose was excreted in urine as unchanged tezacaftor, showing that renal excretion is not the major pathway of tezacaftor elimination in humans.
Maltese: Inqas minn 1% tad-doża mogħtija ġiet eliminata fl-awrina bħala tezacaftor mhux mibdul, li juri li l-eliminazzjoni millkliewi mhijiex il-passaġġ prinċipali tal-eliminazzjoni ta' tezacaftor fil-bnedmin.
English: The NOAEL for viability and growth in the offspring provides an exposure level of approximately 4 times the systemic exposure of ivacaftor and its metabolites when administered as tezacaftor/ivacaftor in adult humans at the MRHD.
Maltese: In-NOAEL għall-vijabilità u l-iżvilupp fil-frieħ jipprovdi livell ta' esponiment ta' madwar 4 darbiet aktar l-esponiment sistemiku ta' ivacaftor u l-metaboliti tiegħu meta jingħata bħala tezacaftor/ivacfator fil-bnedmin adulti fil-MRHD.
English: • The other ingredients are:
Maltese: • Tqala:
English: In Study 3, the change in BMI z-value in the Symkevi in combination with ivacaftor group was maintained and patients previously treated with placebo showed an increase of 0.10 (0.05) kg/m2.
Maltese: Fi Studju 3, ilbidla fil-valur z tal-BMI fil-grupp ta' Symkevi flimkien ma' ivacaftor inżammet, u pazjenti li fil-passat ġew ikkurati bi plaċebo wrew żieda ta' 0.10 (0.05) kg/m2.
English: --1 Modified live bovine viral diarrhoea virus type 1, non-cytopathic parent strain KE-9: 104.0-106.0 TCID50*, Modified live bovine viral diarrhoea virus type 2, non-cytopathic parent strain NY-93: 104.0-106.0 TCID50*.
Maltese: --1 Virus tad-dijarea virali tal-ifrat modifikat ta' tip 1, razza ġenitur mhux ċitopatika KE-9: 104.0-106.0
English: ** Tissue culture infectious dose 50%
Maltese: * Doża infettiva ta' koltura tat-tessut 50%
English: 100 mg / 150 mg Film-coated tablet Oral use blister (PCTFE/PVC/alu)
Maltese: 100 mg / 150 mg Pilloli miksija b'rita Użu orali folja (PCTFE/PVC/alu)
English: Route of Administrati on
Maltese: Mnejn għandu jingħata
English: EMA/752274/2015 EMEA/H/C/002514
Maltese: EMEA/H/C/002514
English: • severe immunodeficiency states, such as acquired immune deficiency syndrome (AIDS);
Maltese: • stati ta' immunodefiċjenza severa, bħas-sindromu tal-immunodefiċjenza akkwiżita (AIDS);
English: The full EPAR for Aubagio 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: Aubagio is available as tablets (14 mg).
Maltese: Aubagio jiġi bħala pilloli (14 mg).
English: Other information about Aubagio
Maltese: Informazzjoni oħra dwar Aubagio
English: Aubagio is a medicine that contains the active substance teriflunomide.
Maltese: Aubagio huwa mediċina li fiha s-sustanza attiva teriflunomide.
English: This is a summary of the European public assessment report (EPAR) for Aubagio.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Aubagio.
English: However, the rate of relapse was 23.4% with Aubagio compared with 15.4% with interferon beta-1a.
Maltese: Madankollu, ir-rata ta' rikaduti kienet ta' 23.4% b'Aubagio meta mqabbla ma' 15.4% b'interferon beta-1a.
English: Why is Aubagio approved?
Maltese: Għal xiex ġiet approvat Aubagio?
English: Aubagio has been studied in four main studies involving over 2,700 adults with relapsing-remitting MS.
Maltese: Aubagio ġie studjat f'erba' studji ewlenin li fihom ħadu sehem aktar minn 2,700 adult bl-MS reċidivaremittenti.
English: Aubagio was found to be more effective than placebo: in patients taking Aubagio, relapses were reduced by around 30% more than in patients taking placebo (the annualised relapse rate was 0.35 for Aubagio compared with 0.53 for placebo).
Maltese: Aubagio nstab li kien aktar effettiv minn plaċebo: f'pazjenti li kienu qed jieħdu Aubagio, ir-rikaduti tnaqqsu b'madwar 30% aktar milli f'pazjenti li kienu qed jieħdu plaċebo (ir-rata ta' rikaduti fis-sena kienet ta' 0.35 għal Aubagio meta mqabbla ma' 0.53 għall-plaċebo).
English: It is used to treat adults with multiple sclerosis (MS), a disease in which inflammation destroys the protective sheath around the nerves.
Maltese: Jintuża fil-kura ta' adulti bi sklerożi multipla (MS), marda li fiha l-infjammazzjoni teqred il-kisja protettiva madwar in-nervituri.
English: The most commonly reported side effects with Aubagio (which may affect more than 1 in 10 people) are headache, diarrhoea, increased liver enzymes, nausea (feeling sick), and alopecia (hair loss).
Maltese: L-effetti sekondarji l-aktar komuni rrapportati b' Aubagio (li jistgħu jolqtu aktar minn persuna 1 minn kull 10) huma wġigħ ta' ras, dijarrea, żieda fl-enzimi tal-fwied, nawżja (dardir), u alopeċja (telf ta' xagħar).
English: A 13.5% rate of permanent discontinuation was seen in patients taking Aubagio, compared with 24% in patients taking interferon beta-1a.
Maltese: F'pazjenti li kienu qed jieħdu Aubagio dehret rata ta' twaqqif permanenti ta' 13.5%, meta mqabbla ma' 24% f'pazjenti li kienu qed jieħdu interferon beta-1a.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Aubagio on 26 August 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Aubagio fis-26 ta' Awwissu 2013.
English: The active substance in Aubagio, teriflunomide, blocks an enzyme called ‘dihydro-orotate dehydrogenase' which is necessary for cells to multiply.
Maltese: Issustanza attiva f'Aubagio, it-teriflunomide, timblokka enzima magħrufa bħala ‘dihydro-orotate dehydrogenase' li hija meħtieġa biex iċ-ċelloli jimmultiplikaw.
English: Regarding its safety, side effects were similar to the immunosuppressant leflunomide, as leflunomide is converted into teriflunomide in the body.
Maltese: Fir-rigward tas-sigurtà tiegħu, l-effetti sekondarji kienu simili għall-immunosuppressant leflunomide, peress li leflunomide jiġi kkonvertit f'teriflunomide fil-ġisem.
English: The recommended dose is 14 mg once a day.
Maltese: Id-doża rakkomandata hija ta' 14 mg darba kuljum.
English: Aubagio was found to be more effective than placebo: after around 9 months (36 weeks), the number of active lesions was around 1 per scan in patients who were taking Aubagio compared with around 2.7 in patients taking placebo.
Maltese: Aubagio nstab li kien aktar effettiv minn plaċebo: wara madwar 9 xhur (36 ġimgħa), l-għadd ta' leżjonijiet attivi kien ta' madwar 1 għal kull analiżi f'pazjenti li kienu qed jieħdu Aubagio meta mqabbla ma' madwar 2.7 f' pazjenti li kienu qed jieħdu plaċebo.
English: A risk management plan has been developed to ensure that Aubagio is used as safely as possible.
Maltese: Pjan ta' ġestjoni tar-riskju ġie żviluppat biex jiżgura li Aubagio jintuża bl-aktar mod sigur possibbli.
English: What are the risks associated with Aubagio?
Maltese: X'inhuma r-riskji assoċjati ma' Aubagio?
English: In MS, the body's immune system malfunctions and attacks parts of the central nervous system (the brain and spinal cord), causing the inflammation that damages the nerve sheaths.
Maltese: F'MS, is-sistema immunitarja tal-ġisem ma taħdimx sew u tattakka partijiet mis-sistema nervuża ċentrali (il-moħħ u l-korda spinali), li tikkawża infjammazzjoni li tagħmel ħsara lir-rita tan-nervituri.
English: Although the effects were modest, they were considered to be significant and similar to other MS treatments, although there were no conclusive results available from a direct comparison with interferon beta-1a.
Maltese: Għalkemm l-effetti kienu modesti, kienu meqjusin sinifikanti u simili għal kura oħra għall-MS, għalkemm ma kien hemm l-ebda riżultati konklussivi disponibbli minn tqabbil dirett ma' interferon beta-1a.
English: Two studies involving 2,257 patients compared the effects of Aubagio with placebo in reducing the number of relapses per patient per year (called the ‘annualised relapse rate').
Maltese: Żewġ studji li fihom ħadu sehem 2,257 pazjent qabblu l-effetti ta' Aubagio ma' plaċebo fit-tnaqqis talgħadd ta' rikaduti għal kull pazjent fis-sena (msejħa r-‘rata ta' rikaduti fis-sena').
English: The fourth study involving 324 patients compared the effects of Aubagio with interferon beta-1a (another treatment for MS) on the rate of treatment failure, by looking at the time until patients had their first relapse or permanently stopped their treatment.
Maltese: Ir-raba' studju li fih ħadu sehem 324 pazjent qabbel l-effetti ta' Aubagio ma' interferon beta-1a (kura oħra għall-MS) fuq ir-rata tal-falliment tal-kura, billi ħares lejn iż-żmien sakemm il-pazjenti kellhom lewwel rikaduta jew waqqfu l-kura tagħhom b'mod permanenti.
English: Overall, no conclusion could be reached from this study on any differences between Aubagio and interferon beta-1a for MS treatment.
Maltese: B'mod ġenerali, minn dan l-istudju ma setgħet tintlaħaq l-ebda konklużjoni dwar xi differenzi bejn Aubagio u interferon beta-1a għall-kura tal-MS.
English: The risk of serious side effects affecting the liver and bone marrow was considered manageable and adequately addressed by risk minimisation measures.
Maltese: Ir-riskju ta' effetti sekondarji serji li jaffettwaw il-fwied u l-mudullun kien meqjus maniġġabbli u adegwatament indirizzat permezz ta' miżuri għall-minimizzazzjoni tar-riskji.
English: Aubagio is used in the type of MS known as relapsing-remitting MS, when the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).
Maltese: Aubagio jintuża fit-tip ta' MS magħrufa bħala MS reċidiva-remittenti, meta l-pazjent ikollu rikaduti tas-sintomi segwiti minn perjodi ta' rkupru (remissjonijiet).
English: The exact way teriflunomide works in MS is not known but it is thought to reduce the number of lymphocytes which form part of the immune system and are involved in the inflammation process.
Maltese: Il-mod eżatt kif teriflunomide taħdem flMS mhuwiex magħruf iżda huwa maħsub li jnaqqas l-għadd ta' linfoċti li jiffurmaw parti mis-sistema immuni u li huma involuti fil-proċess ta' infjammazzjoni.
English: In addition, the company that markets Aubagio must ensure that all healthcare professionals who are expected to use Aubagio receive an information pack containing important safety information, including the tests and monitoring that should be carried out in patients before and after starting treatment.
Maltese: Barra minn hekk, il-kumpanija li tqiegħed Aubagio fis-suq għandha tiżgura li l-professjonisti kollha tassaħħa li huma mistennija jużaw Aubagio jirċievu pakkett ta' informazzjoni li jkun fih informazzjoni importanti dwar is-sigurtà, inklużi it-testijiet u l-monitoraġġ li għandhom isiru fuq il-pazjenti qabel u wara l-bidu tal-kura.
English: The studies also looked at the effect of Aubagio on the changes in the patients' level of disability and showed that the risk of disability getting worse was reduced by 30% in comparison with placebo after around two and a half years (132 weeks) of treatment.
Maltese: Listudji ħarsu wkoll lejn l-effett ta' Aubagio fuq it-tibdil fil-livell ta' diżabilità tal-pazjenti u wrew li rriskju li d-diżabilità taggrava tnaqqas b'30% meta mqabbel ma' plaċebo wara madwar sentejn u nofs (132 ġimgħa) ta' kura.
English: Aubagio is given by mouth which was considered to be an advantage over other medicines such as interferon beta-1a.
Maltese: Aubagio jingħata mill-ħalq li kien meqjus ta' vantaġġ fuq mediċini oħra bħal interferon beta1a.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Aubagio's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Aubagio huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: With fewer lymphocytes, there is less inflammation, helping to control the symptoms of MS.
Maltese: B'inqas linfoċti, ikun hemm inqas infjammazzjoni, li jgħin jikkontrolla s-sintomi tal-MS.
English: In general, headache, diarrhoea, nausea and alopecia are mild to moderate, resolve with time and do not usually lead to treatment being stopped.
Maltese: B'mod ġenerali, l-uġigħ ta' ras, id-dijarea, id-dardir u l-alopeċja huma ħfief għal moderati, jirrisolvu maż-żmien u ġeneralment ma jwasslux biex il-kura titwaqqaf.
English: In studies, Aubagio was shown to reduce relapses and delay the progression of disability in patients with relapsingremitting MS.
Maltese: Fl-istudji, Aubagio intwera li jnaqqas ir-rikaduti u jittardja l-progressjoni tad-diżabilità f'pazjenti bl-MS reċidiva-remittenti.
English: • severe liver disease;
Maltese: • mard gravi fil-fwied;
English: One study involving 179 patients compared the effects of Aubagio with placebo (a dummy treatment) on the number of active lesions (developing areas of damage) in the brain detected by a brain scan.
Maltese: Studju wieħed li fih ħadu sehem 179 pazjent qabbel l-effetti ta' Aubagio ma' plaċebo (kura finta) fuq lgħadd ta' leżjonijiet attivi (żoni ta' ħsara li qed jiżviluppaw) fil-moħħ skoperti minn analiżi tal-moħħ.
English: For the full list of all side effects reported with Aubagio, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtata b'Aubagio, ara l-fuljett ta' tagħrif.
English: What measures are being taken to ensure the safe and effective use of Aubagio?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat użu sigur u effettiv ta' Aubagio??
English: Tel.: +49 3641 5195330 Fax: +49 3641 5195331
Maltese: Telefon: +49 3641 5195330 Fax: +49 3641 5195331
English: Plasma protein binding is at 85-87 %.
Maltese: Irrabta ma' proteini tal-plażma hi ta' 85-87%.
English: Foscan is non-irritant.
Maltese: Foscan mhux irritanti.
English: Common: Anaemia
Maltese: Komuni: Anemija
English: Foscan contains ethanol (alcohol):
Maltese: Foscan fih ethanol (alkoħol):
English: Date of first authorisation: 24 October 2001 Date of latest renewal: 22 September 2011
Maltese: Data tal-aħħar tiġdid: 22 ta' Settembru 2011
English: Foscan is photosensitive.
Maltese: Foscan hu fotosensittiv.
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 magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Vascular rupture: see section 4.3
Maltese: Qsim vaskulari: ara sezzjoni 4.3
English: EU/1/01/197/003 (1 ml) EU/1/01/197/004 (3 ml) EU/1/01/197/005 (6 ml)
Maltese: EU/1/01/197/003 (1 ml) EU/1/01/197/004 (3 ml)
English: Oximeters must be repositioned at least every 10-15 minutes to avoid the risk of local skin burns.
Maltese: L-oximeters għandhom jiġu poġġuti mill-ġdid mill-inqas kull 10-15-il minuta biex jiġi evitat riskju ta' ħruq lokali tal-ġilda.
English: • Hypersensitivity to porphyrins.
Maltese: • Sensittività eċċessiva għal porphyrins
English: Excipients with known effect Each ml contains 376 mg of ethanol anhydrous and 560 mg of propylene glycol.
Maltese: Kull ml fih 376 mg ta' ethanol anidru u 560 mg ta' propylene glycol.
English: implying an illumination time of approximately 200 seconds.
Maltese: illuminazzjoni ta' madwar 200 sekonda.
English: The active substance is temoporfin.
Maltese: Is-sustanza attiva hi temoporfin.
English: EU/1/01/197/003 EU/1/01/197/004 EU/1/01/197/005
Maltese: EU/1/01/197/005
English: - The other ingredients are ethanol anhydrous (E1510) and propylene glycol (E1520).
Maltese: - Is-sustanzi l-oħra huma ethanol (E1510) u propylene glycol (E1520).
English: This medicinal product contains 48 vol % ethanol (alcohol), i.e up to 4.2 g per dose, equivalent to 84 ml of beer, 35 ml wine per dose.
Maltese: Dan il-prodott mediċinali fih 48 vol % ta' ethanol (alkoħol), i.e sa 4,2 g f'kull doża, li hija ekwivalenti għal 84 ml ta' birra, 35 ml inbid għal kull doża.
English: • This product contains 48 vol % ethanol (alcohol), i.e up to 4.2 g per dose, equivalent to 84 ml of beer, 35 ml wine per dose.
Maltese: • 48% tal-piż tal-prodott huwa ethanol (alkoħol), i.e sa 4,2 g kull doża, li hu ekwivalenti għal 84 ml ta' birra, 35 ml ta' inbid kull doża.
English: Blister, erythema, skin hyperpigmentations, photosensitivity reaction, skin necrosis
Maltese: Infafet, ħmura tal-ġilda, iperpigmentazzjoni talġilda, reazzjoni fotosensittiva, nekrosi tal-ġilda
English: The dose is 0.15 mg/kg bodyweight.
Maltese: Id-doża hi ta' 0.15 mg/kg piż tal-ġisem.
English: Temoporfin is a photosensitising agent used in the photodynamic therapy of tumours.
Maltese: Temoporfin hija mediċina fotosensitizzanti li tintuża fit-terapija fotodinamika ta' tumuri.
English: Some pulse oximeters may produce light of a wavelength close to that used for the photoactivation of Foscan.
Maltese: Xi pulse oximeters jistgħu jipproduċu dawl li jkun fih wavelength li tkun qrib dik użata għallfotoattivazzjoni ta' Foscan.
English: Ethanol, anhydrous (E1510) Propylene glycol (E1520)
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti Ethanol, mhux idrat (E1510) Propylene glycol (1520)
English: You may watch television.
Maltese: Tista' tara t-televiżjoni.
English: Do NOT flush with aqueous solutions such as sodium chloride 9 mg/ml (0.9 %) solution for injection or water for injections.
Maltese: TLAĦLAĦX b'soluzzjonijiet akweji bħal soluzzjoni ta' 9 mg/ml (0.9 %) sodium chloride jew ilma għall-injezzjonijiet.
English: All patients who receive Foscan will become temporarily photosensitive.
Maltese: Il-pazjenti kollha li jingħataw Foscan se jsiru temporanjament fotosensittivi.
English: Solution for injection 1 mg/1 ml Solution for injection 3 mg/3 ml Solution for injection 6 mg/6 ml Sterile filter
Maltese: Soluzzjoni għall-injezzjoni 1 mg/1 ml Soluzzjoni għall-injezzjoni 3 mg/3 ml Soluzzjoni għall-injezzjoni 6 mg/6 ml Filtru sterili
English: Skin photosensitivity reactions are caused by visible light; therefore ultraviolet sunscreens provide no protection.
Maltese: Reazzjonijiet ta' fotosensittività tal-ġilda huma kkawżati minn dawl viżibbli; għalhekk ultraviolet sunscreens ma jipprovdu l-ebda protezzjoni.
English: Animal studies have shown some haematological and blood chemistry changes (decreased platelets, erythrocytes and haemoglobin, increased neutrophils, fibrinogen, bilirubin, triglyceride and cholesterol).
Maltese: Studji fuq l-annimali urew xi bidliet ematoloġiċi u fil-kimika tad-demm (tnaqqis fl-għadd tal-plejtlets, tal-eritroċiti u tal-emoglobina u żjieda ta' newtrofili, ta' fibrinoġen, ta' bilirubin, ta' trigliċeridi u ta' kolesterol).
English: Start on Day 8 with 10-15 minutes outdoors.
Maltese: Mat-8 ġurnata ibda oħroġ barra għal 10-15-il minuta.
English: The requirements for submission of periodic safety update reports 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 webportal.
Maltese: Ir-rekwiżiti tar-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 l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq ilportal elettroniku Ewropew tal-mediċini.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti (elenkati fis-sezzjoni 6.1).
English: In a clinical trial of 147 patients with advanced head and neck squamous cell carcinoma, tumour response, defined as a reduction of a minimum of 50 % of the tumour mass for a minimum of four weeks, was observed in 25 % after a single treatment.
Maltese: Fi prova klinika li saret fuq 147 pazjent b'karċinoma avvanzata taċ-ċelluli skwamużi fir-ras u fl-għonq, riżultat pożittiv fuq it-tumur, definit bħala tnaqqis mill-anqas 50% tal-massa tat-tumur għallinqas għal erba' ġimgħat, kien osservat f'25% tal-pazjenti wara trattament wieħed.
English: 96 hours after the administration of Foscan, the treatment site is to be illuminated with light at 652 nm from an approved laser source.
Maltese: 96 siegħa wara li jingħata Foscan, is-sit li jkun qed jiġi kkurat għandu jkun illuminat b' dawl ta'652 nm minn sors ta' laser approvat.
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, ATC code: L01XD05.
Maltese: Aġenti antineoplastiċi, aġenti antineoplastiċi oħrajn, Kodiċi ATC:
English: Foscan 1 mg/ml solution for injection Temoporfin
Maltese: Foscan 1 mg/ml soluzzjoni għall-injezzjoni Temoporfin
English: You can increase your exposure by another 15 minutes each day i.e. second day 30 minutes, third day 45 minutes, fourth day 60 minutes and so on.
Maltese: Tista' żżid l-espożizzjoni tiegħek bi 15-il minuta kuljum, i.e. it-tieni ġurnata 30 minuta, it-tielet ġurnata 45 minuta, ir-raba' ġurnata 60 minuta, u tibqa' sejjer hekk.
English: • Vascular rupture
Maltese: Disturbi vaskulari
English: Exposure to ambient light after overdose carries an increased risk of photosensitivity reactions.
Maltese: Espożizzjoni għal dawl naturali wara doża eċċessiva iżżid r-riskju ta' reazzjonijiet fotosensittivi.
English: Temoporfin is a low clearance substance with a terminal plasma half-life of 65 hours in patients.
Maltese: Temoporfin huwa sustanza li għandha r-rata ta' tneħħija baxxa, b'half-life terminali fil-plażma ta' 65 siegħa fil-pazjenti.
English: Constipation, stomatitis necrotising, dysphagia Common:
Maltese: Stitikezza, stomatite nekrotizzanti, diffikultà biex tibla'
English: Like all medicines, Foscan can cause side effects.
Maltese: Bħal kull mediċina oħra, Foscan jista' jikkawża effetti sekondarji.
English: Foscan 1 mg/ml solution for injection
Maltese: Foscan 1 mg/ml soluzzjoni għall-injezzjoni
English: Day 1 (0-24 hours)
Maltese: L-1 Ġurnata (0-24 siegħa)
English: Temoporfin is bound to plasma lipoproteins and high density proteins such as albumin in the blood.
Maltese: Temoporfin jingħaqad ma' lipoproteini tal-plażma u ma' proteini ta' densità għolja bħal albumina fid-demm.
English: Thirty-seven patients received at least 2 treatments with Foscan.
Maltese: Sebgħa u tletin pazjent ingħataw mill-anqas 2 trattamenti b'Foscan.
English: An in vitro study with human liver tissue has shown no potential for drug interaction through inhibition of cytochrome P-450 enzymes by temoporfin.
Maltese: Studju in vitro fuq it-tessut tal-fwied tal-bniedem ma wera l-ebda potenzjal għal interazzjoni tal-mediċina permezz ta' l-impediment ta' l-enżimi ta' ċitrokroma P-450 b'temoporfin.