FrancophonIA/ELRC3.0 huggingface dataset:
English: Moventig 12.5 mg: a mauve coloured, oval, dimensions 10.5 x 5.5 mm film-coated tablet, marked “nGL” on one side and “12.5” on the other side.
Maltese: Moventig 12.5 mg: pillola miksija b'rita b'dimensjonijiet ta' 10.5
English: The dose can be increased to 25 mg if 12.5 mg is well tolerated by the patient (see section 4.5).
Maltese: Id-doża tista' tiżdied għal 25 mg, jekk 12.5 mg hija tollerata sew millpazjent (ara sezzjoni 4.5).
English: A potentially treatmentrelated increased incidence of the skeletal variant bipartite vertebral centrum and a single foetus with anorchism was seen at the highest dose tested in the rat embryo-foetal development study.
Maltese: Inċidenza miżjuda potenzjalment relatata mal-kura tal-varjant skeletali centrum vertebrali tal-bipartit u f'fetu wieħed b'anorchism dehret fl-ogħla doża ttestjata fl-istudju tal-iżvilupp tal-embrijo-fetali fil-firien.
English: PEGylation reduces naloxegol's passive permeability and also renders the compound a substrate for the P-glycoprotein transporter.
Maltese: PEGilazzjoni tnaqqas il-permeabbiltà passiva ta' naloxegol u tagħmel il-kompost sottostrat għattrasportatur P-glikoproteina.
English: Patient assessment of constipation symptoms (PAC-SYM) questionnaire Naloxegol 25 mg dose in the LIR subgroup resulted in a greater improvement (change from baseline) of patient assessment of constipation symptoms (PAC-SYM) total scores compared with placebo in both studies at 12 weeks (Kodiac 4 p=0.023, Kodiac 5 p=0.002).
Maltese: Id-doża ta' 25 mg ta' naloxegol fis-sottogrupp ta' LIP irriżultat f'titjib akbar (bidla mil-linja bażi) tal valutazzjoni tal-pazjent tal-punteġġi totali tas-sintomi ta' stitikezza (PAC-SYM) meta mqabbel ma'
English: Patients assigned to usual care followed a laxative treatment regimen for OIC determined by the investigator according to best clinical judgment, excluding peripheral mu-opioid receptor antagonists.
Maltese: Il-pazjenti assenjati għal kura tas-soltu segwew kors ta' kura b'lassattivi għal OIC iddeterminat mill-investigatur skont l-aqwa ġudizzju kliniku, għajr l-antagonisti tar-riċettur mu-opjojde periferali.
English: The observed neoplastic changes are well known hormonal and centrally mediated effects in the rat which are not relevant for humans.
Maltese: Il-bidliet neoplastiċi osservati huma effetti ormonali u medjati ċentralment magħrufa sew fil-far li mhumiex rilevanti għall bnedmin.
English: Parent naloxegol excreted in the urine accounted for less than 6% of the total administered dose.
Maltese: Naloxegol oriġinali li jiġi eliminat mal-awrina kien jammonta għal inqas minn 6 % tad-doża totali mogħtija.
English: Opioid withdrawal syndrome is a cluster of three or more of the following signs or symptoms: dysphoric mood, nausea, vomiting, muscle aches, lacrimation, rhinorrhoea, pupillary dilation,
Maltese: dardir, rimettar, uġigħ fil-muskoli, għajnejk jibdew idemmgħu iktar, flissjoni, twessigh tal-pupilli,
English: Long-term exposure to naloxegol 25 mg, up to 52 weeks, was generally safe and well tolerated in the treatment of OIC patients with non-cancer-related pain.
Maltese: Esponiment fit-tul għal naloxegol 25 mg, sa 52 ġimgħa, kien ġeneralment sigur u ttollerat sew fil-kura ta' pazjenti OIC b'uġigħ mhux relatat mal-kanċer.
English: Package leaflet: Information for the patient Moventig 12.5 mg film-coated tablets Moventig 25 mg film-coated tablets naloxegol
Maltese: Moventig 12.5 mg pilloli miksijin b'rita Moventig 25 mg pilloli miksijin b'rita naloxegol
English: Clinical studies of naloxegol did not include sufficient numbers of patients aged 75 years or over to determine whether they respond differently than younger patients, however, based on the mode of action of the active substance there are no theoretical reasons for any requirement for dose adjustments in this age group.
Maltese: L-istudji kliniċi ta' naloxegol ma inkludewx numri suffiċjenti ta' pazjenti li għandhom 75 sena jew aktar biex jiġi ddeterminat jekk dawn jirrispondux b'mod differenti minn pazjenti żgħażagħ, madankollu, abbażi talmod ta' azzjoni tas-sustanza attiva, m'hemm ebda raġuni teoretika għal xi rekwiżit għal aġġustamenti fid-doża f'dan il-grupp ta' età.
English: • stomach pain
Maltese: • uġigħ fl-istonku
English: The effect of race on the pharmacokinetics of naloxegol is small (approximately 20% decrease in the AUC of naloxegol when other groups are compared to Caucasian) and, therefore, no dose adjustment is necessary.
Maltese: L-effett tar-razza fuq il-farmakokinetika ta' naloxegol huwa żgħir (tnaqqis ta' madwar 20 % fl-AUC ta' naloxegol meta gruppi oħra jitqabblu mal-Kawkasi) u, għalhekk, ma huwa meħtieġ ebda aġġustament fid-doża.
English: Strong CYP3A4 inhibitors
Maltese: Inibituri tal-CYP3A4 qawwija
English: Stop taking the medicine and tell your doctor straight away if you develop opioid withdrawal symptoms (if you have a combination of three or more of these symptoms: feeling depressed, nausea, vomiting, muscle aches, increased tearing, runny nose, dilation of the pupils, goosebumps, excess sweating, diarrhoea, yawning, fever or insomnia) which would usually occur within the first few days after starting naloxegol.
Maltese: Is-sindromu tal-irtirar mill-opjojdi huwa ġabra ta' tlieta jew aktar mis-sinjali jew sintomi li ġejjin: burdata disforika, dardir jew rimettar, uġigħ fil-muskoli, żieda fid-dmugħ jew rinorrea, dilazzjoni pupillarja jew piloerezzjoni jew ħruġ ta' għaraq, dijarea, titwib, deni jew nuqqas ta' rqad.
English: In the LIR subgroup, the 25 mg dose increased the symptom responder rates in both studies as compared to placebo (Kodiac 4 p=0.001, Kodiac 5 p=0.005).
Maltese: Fis-sottogrupp LIR, id-doża ta' 25 mg żiedet ir-rati tar-responder tas-sintomi fiż-żewġ studji meta mqabbel ma' plaċebo (Kodiac 4 p=0.001, Kodiac 5 p=0.005).
English: Patients taking a minimum of 30 morphine equivalent units (meu) of opioids per day for at least 4 weeks before enrolment and self-reported OIC were eligible.
Maltese: Kienu eliġibbli l pazjenti li kienu qegħdin jieħdu tal-anqas 30 unità ekwivalenti ta' morfina (meu) ta' opjojdi kuljum għal tal-anqas 4 ġimgħat qabel ir-reġistrazzjoni u l-OIC awto-rapportata.
English: OIC symptom improvement
Maltese: • għaraq eċċessiv
English: In Kodiac 5 the corresponding times to first post dose SBM were 38.2, 12.8, and 18.1 hours, respectively.
Maltese: F'Kodiac 5, plaċebo, il-ħinijiet korrispondenti għall-ewwel SBM ta' wara d-doża kienu 38.2, 12.8, u
English: The primary objective was to assess long-term safety and tolerability for naloxegol 25 mg and to compare with usual care treatment using descriptive statistics.
Maltese: L-objettiv primarju kien li tiġi vvalutata s-sigurtà u t tollerabbiltà fit-tul għal naloxegol 25 mg u li jitqabbel mal-kura tas-soltu permezz ta' statistika deskrittiva.
English: Interaction with moderate CYP3A4 inhibitors
Maltese: Interazzjoni ma' indutturi tal-CYP3A4 qawwija
English: The 25 mg dose in the LIR subgroup increased mean days per week compared with placebo with at least 1 complete spontaneous bowel movement (CSBM) in both studies (Kodiac 4 p=0.002, Kodiac 5 p<0.001).
Maltese: Id-doża ta' 25 mg fis-sottogrupp LIR żiedet il-jiem medji fil-ġimgħa meta mqabbel ma' plaċebo b'tal-anqas moviment spontanju sħiħ tal-imsaren (CSBM) fiż-żewġ studji (Kodiac 4 p=0.002, Kodiac 5 p<0.001).
English: For extremity pain, the rate for naloxegol 25 mg was 3.5% versus 3.3% for usual care.
Maltese: Għall-uġigħ fl-estremitajiet, ir-rata għal naloxegol 25 mg kienet ta' 3.5% meta mqabbla ma' 3.3% għall-kura tas-soltu.
English: EMA/132670/2010 EMEA/H/C/512
Maltese: EMEA/H/C/512
English: Cholestagel colesevelam
Maltese: Colesevelam
English: It is available as white tablets (625 mg).
Maltese: Din tiġi bħala pilloli bojod (625 mg).
English: Other information about Cholestagel:
Maltese: Informazzjoni oħra dwar Cholestagel:
English: This summary was last updated in 04-2010.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'04-2010.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Cholestagel to Genzyme Europe B.V. on 10 March 2004.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għal tqegħid fis-suq valida mal-Unjoni Ewropea kollha għal Cholestagel lil Genzyme Europe B.V. fl-10 ta' Marzu 2004.
English: Cholestagel is a medicine that contains the active substance colesevelam.
Maltese: Cholestagel huwa mediċina li fiha s-sustanza attiva colesevelam.
English: This document is a summary of the European Public Assessment Report (EPAR) for Cholestagel.
Maltese: Dan id-dokument huwa sommarju tar-Rapport PubblikU Ewropew ta' Valutazzjoni (EPAR) għal Cholestagel.
English: The marketing authorisation is valid for an unlimited period.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq hija valida għal perjodu illimitat.
English: There was a 16% reduction with 3.8 g Cholestagel (about six tablets).
Maltese: Kien hemm tnaqqis ta' 16% b'3.8 g ta' Cholestagel (madwar sitt pilloli).
English: The final study looked at Cholestagel as an add-on to ezetimibe and a statin in 86 adults with familial hypercholesterolaemia.
Maltese: L-istudju finali ħares lejn Cholestagel bħala żieda ma' ezetimibe u statina f'86 adult b'iperkolesteremija familjari.
English: What is Cholestagel?
Maltese: X'inhu Cholestagel?
English: Lowering cholesterol, especially LDL cholesterol, can reduce the risk of heart disease.
Maltese: Ittnaqqis tal-kolesterol, b'mod speċjali l-kolesterol LDL, jista' jnaqqas ir-riskju tal-mard tal-qalb.
English: Why has Cholestagel been approved?
Maltese: Għaliex ġiet approvata Cholestagel?
English: • as an add-on to a statin (another cholesterol-lowering medicine) and a cholesterol-lowering diet, to further reduce ‘low-density-lipoprotein' (LDL or ‘bad') cholesterol levels in patients who are not adequately controlled with a statin alone;
Maltese: • Bħala żieda ma' statina (mediċina oħra li tnaqqas il-kolesterol) u dieta li tnaqqas il-kolesterol, sabiex tnaqqas aktar il-lipoproteina ta' densità baxxa, livelli ta' kolesterol (LDL jew ‘ħżiena') f'pazjenti li mhumiex ikkontrollati b'mod xieraq bi statina biss;
English: Three of these studies looked at Cholestagel taken in combination with a statin (lovastatin, simvastatin or atorvastatin) in 491 patients, two looked at Cholestagel taken on its own in 592 patients, and one looked at Cholestagel in combination with ezetimibe in 86 patients.
Maltese: Tlieta minn dawn l-istudji ħarsu lejn Cholestagel meħud flimkien ma' statin ((lovastatin, simvastatin jew atorvastatin) f'491 pazjent, tnejn ħarsu lejn Cholestagel meħud waħdu f'592 pazjent u wieħed ħares lejn Cholestagel flimkien ma' ezetimibe f'86 pazjent.
English: The combination of Cholestagel and ezetimibe was more effective than ezetimibe taken with placebo: there was a fall of 32% in LDL-cholesterol levels in the patients taking Cholestagel and a fall of 21% in those taking placebo.
Maltese: Il-kombinazzjoni ta' Cholestagel u ezetimibe kienet aktar effikaċi minn ezetimibe meħud ma' plaċebo; kien hemm tnaqqis ta' 32% f'livelli ta' kolesterol LDL f'pazjenti li jieħdu Cholestagel u tnaqqis ta' 21% f'dawk li jieħdu plaċebo.
English: This combination can also be used in patients who have familial hypercholesterolaemia (primary hypercholesterolaemia that runs in the family).
Maltese: Din ilkombinazzjoni tista' tintuża wkoll f'pazjenti li għandhom iperkolesteremija familjari (iperkolesteremija primarja li tkun fil-familja).
English: When added to ezetimibe and a statin, Cholestagel caused a reduction of 11% in LDL-cholesterol levels after six weeks in patients with familial hypercholesterolaemia, compared with a rise of 7% when adding placebo.
Maltese: Meta miżjud ma' ezetimibe u ma' statina, Cholestagel kkawwżat tnaqqis ta' 11% fil-livelli ta' kolesterol LDL wara sitt ġimgħat f'pazjenti b'iperkolesteremija familjari, mqabbel ma' plaċebo miżjud.
English: In studies, the most common side effects with Cholestagel (seen in more than 1 patient in 10) were flatulence (gas) and constipation.
Maltese: Fl-istudji, l-aktar effetti sekondarji komuni b'Cholestagel (innutati f'aktar minn pazjent 1 minn 10) kienu l-gass fl-istonku (gass) u stitikezza.
English: In the studies looking at Cholestagel taken on its own, more than half of the patients receiving 3.8 or 4.5 g Cholestagel (about six to seven tablets) had a decrease in LDL-cholesterol level of 15 to 18% after six weeks.
Maltese: Fl-istudji li ħarsu lejn Cholestagel meta meħuda waħdu, aktar minn nofs il-pazjenti li kienu qed jirċievu Cholestagel 3.8 jew 4.5 g (madwar sitta jew seba' pilloli) kellhom tnaqqis fil-livelli tal-kolesterol LDL ta' 15 sa 18% wara sitt ġimgħat.
English: How has Cholestagel been studied?
Maltese: Kif ġiet studjat Cholestagel?
English: • as an add-on to a cholesterol-lowering diet, to reduce total-cholesterol and LDL-cholesterol levels in patients who cannot take statins;
Maltese: • Bħala żieda ma' dieta li tnaqqas il-livelli ta' kolesterol, biex inaqqas il-kolesterol totali u l-livelli ta' kolesterol f'pazjenti li ma jistgħux jieħdu statini;
English: • together with ezetimibe (another cholesterol-lowering medicine), with or without a statin.
Maltese: • Flimkien ma' ezetimibe (mediċina oħra li tnaqqas il-kolesterol), bi jew mingħajr statina.
English: Looking at the results of the three studies in which Cholestagel was used with a statin, there was an 8% reduction in LDL-cholesterol levels with 2.3 g Cholestagel (about four tablets) after six weeks, as compared to placebo.
Maltese: Ħarsa lejn ir-riżultati tat-tliet studji li fihom ġie użat Cholestagel ma' statina, kien hemm tnaqqis ta' 8% ta' livelli ta' kolesterol LDL b'2.3 g Cholestagel (madwar erba' pilloli) wara sitt ġimgħat, meta mqabbel ma' plaċebo.
English: Cholestagel is used to lower cholesterol levels in adults with primary hypercholesterolaemia (high blood cholesterol levels).
Maltese: Cholestagel jintuża biex ibaxxi l-livelli tal-kolesterol fl-adulti b'iperkolesterolemija primarja (livelli għoljin ta' kolesterol fid-demm). ‘Primarja' tfisser li m'hemm l-ebda marda li tikkawża l-livelli għoljin ta' kolesterol.
English: The active substance in Cholestagel, colesevelam, is not absorbed by the body, but stays in the gut, where it attaches to substances called bile acids and carries them out of the body in the faeces.
Maltese: Is-sustanza attiva f'Cholestagel, colesevelam, ma tiġix assorbita mill-ġisem, iżda tibqa' fil-musrana, fejn teħel ma' sustanzi msejħa aċidi biljari u ġġorrhom 'il barra mill-ġisem mal-feċi.
English: For more information about treatment with Cholestagel, read the Package Leaflet (also part of the EPAR).
Maltese: Għal aktar informazzjoni dwar it-trattament b'Cholestagel, aqra l-Fuljett ta' Tagħrif (ukoll parti mill-EPAR).
English: What is the risk associated with Cholestagel?
Maltese: X'inhu r-riskju assoċjat ma' Cholestagel?
English: How does Cholestagel work?
Maltese: Liema benefiċċju wera Cholestagel waqt l-istudji mwettqa?
English: In the longer study, the decrease seen at six weeks with 3.8 g Cholestagel (about six tablets) was maintained for six months.
Maltese: Fl-istudju t-twil, it-tnaqqis li deher wara sitt ġimgħat b'Cholestagel 3.8 g (madwar sitt pilloli) inżamm għal sitt xhur.
English: For the full list of all side effects reported with Cholestagel, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' effetti sekondarji kollha rrappurtati b'Cholestagel, ara l-Fuljett ta' Tagħrif.
English: Cholestagel has been compared with placebo (a dummy treatment) in seven main studies involving adults with primary hypercholesterolaemia.
Maltese: Cholestagel tqabbel ma' plaċebo (trattament finta) f'seba' studji ewlenin li jinvolvu adulti b'iperkolesterolemija primarja.
English: The maximum dose is seven tablets a day when it is taken on its own, and six tablets a day when it is taken with other medicines.
Maltese: Id-doża massima hija ta' seba' pilloli kuljum meta din tittieħed waħidha, u sitt pilloli kuljum meta tittieħed ma' mediċini oħra.
English: Harald Enzmann (Germany)
Maltese: Harald Enzmann (Il-Ġermanja)
English: Andrea Laslop (Austria)
Maltese: Andrea Laslop (L-Awstrija)
English: What is bufexamac?
Maltese: X'inhu bufexamac?
English: Bufexamac is a non-steroidal anti-inflammatory drug (NSAID).
Maltese: Bufexamac huwa mediċina mhux sterojdali kontra l-infjammazzjoni (NSAID).
English: Medicines containing bufexamac have been authorised in Austria, Bulgaria, the Czech Republic, France, Hungary, Italy, Latvia, Lithuania, Luxembourg, Portugal, Romania and Slovakia.
Maltese: Il-mediċini li fihom bufexamac ġew awtorizzati fl-Awstrija, fil-Bulgarija, fir-Repubblika Ċeka, fi Franza, fl-Ungerija, fl-Italja, fil-Latvja, fil-Litwanja, fil-Lussemburgu, fil-Portugall, fir-Rumanija u fl-Islovakkja.
English: NSAIDs work by blocking an enzyme called cyclo-oxygenase, which is involved in the production of prostaglandins.
Maltese: L-NSAIDs jaħdmu billi jimblukkaw enzima li tissejjaħ cyclo-oxygenase, li hija nvoluta fil-produzzjoni ta' prostaglandini.
English: They may be available as creams, rectal ointments and suppositories, and under the following invented names: Parfenac, Bufal, Calmaderm, Fansamac, Mastu S, Parfenoide, Proctosan, and other trade names.
Maltese: Parfenac, Bufal, Calmaderm, Fansamac, Mastu S, Parfenoide, Proctosan, u ismijiet kummerċjali oħrajn.
English: In December 2009, the German medicines regulatory agency completed a review of the benefits and risks of bufexamac-containing medicines.
Maltese: F'Diċembru 2009, l-aġenzija regolatorja tal-mediċini Ġermaniża temmet reviżjoni tal-benefiċċji u rriskji ta' mediċini li fihom bufexamac.
English: 27 July 2010
Maltese: 27 ta' Lulju 2010
English: • Patients currently using bufexamac-containing medicines should speak to their doctor so they can switch to an appropriate alternative treatment.
Maltese: • Pazjenti li bħalissa qed jużaw mediċini li fihom bufexamac għandhom ikellmu lit-tabib tagħhom sabiex ikunu jistgħu jaqilbu għal kura alternattiva xierqa.
English: It can also be used, in combination with other substances, to control the symptoms of inflammation that can occur around the anus in patients with haemorrhoids (piles) or an anal fissure (a tear in the lining of the anal canal).
Maltese: Jista' jintuża wkoll, f'kombinazzjoni ma' sustanzi oħra, biex jikkontrolla ssintomi ta' infjammazzjoni li jista' jkun hemm madwar l-anu f'pazjenti li għandhom l-emorrojdi (murliti) jew qasma anali (tiċrita fil-kisja tal-kanal tal-anu).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of bufexamac do not outweigh its risks, and recommended that the marketing authorisations for medicines containing bufexamac be revoked (withdrawn) throughout the European Union (EU).
Maltese: IlKumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li l-benefiċċji ta' bufexamac ma jisbqux ir-riskji tiegħu, u rrakkomanda li l-awtorizzazzjonijiet għat-tqegħid fis-suq għall-mediċini li fihom bufexamac jiġu revokati (irtirati) madwar l-Unjoni Ewropea (UE).
English: Bufexamac is used to control the symptoms of inflammation of the skin (such as redness and itching) in diseases such as eczema and dermatitis.
Maltese: Bufexamac jintuża biex jikkontrolla s-sintomi ta' infjammazzjoni tal-ġilda (bħall-ħmura u ħakk) f'mard bħall-ekżema u d-dermatite.
English: The CHMP also noted that bufexamac is a ‘sensitizer' causing reactions to get worse with repeated exposure.
Maltese: Is-CHMP innota wkoll li bufexamac huwa ‘sensitizzant' li jikkawża l-iggravar tar-reazzjonijiet ma' espożizzjoni ripetuta.
English: The European Medicines Agency has completed a review of the safety and effectiveness of bufexamac.
Maltese: L-Aġenzija Ewropea tal-Mediċini temmet reviżjoni dwar is-sigurtà u l-effikaċja ta' bufexamac.
English: During this review, the agency obtained information from the companies marketing bufexamac in Germany, and looked at published studies on the effectiveness of bufexamac.
Maltese: Waqt din ir-reviżjoni, l-aġenzija kisbet informazzjoni millkumpaniji li jqiegħdu bufexamac fis-suq fil-Ġermanja, u ħarset lejn studji ppubblikati dwar l-effikaċja ta' bufexamac.
English: The risk of developing a contact allergic reaction to bufexamac is high, and the risk is even higher in patients with pre-disposing conditions, such as certain forms of eczema, for which bufexamac is frequently prescribed.
Maltese: Huwa wkoll probabbli li ddiffikultà li ssir differenzazzjoni bejn kura li falliet u reazzjoni allerġika wasslet biex il-każijiet ta' reazzjonijiet allerġiċi b'kuntatt jiġu rrapportati inqas.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of bufexamac-containing medicines do not outweigh their risks, and therefore recommended that all marketing authorisations be revoked in the EU.
Maltese: Barra minn hekk, meta ħares lejn xi studji kkontrollati aktar riċenti, is-CHMP innota li l-effikaċja ta' bufexamac ma ntweritx.
English: Free radical scavengers
Maltese: Scavengers radikali liberi
English: Ethnic groups/races
Maltese: Gruppi/razez etniċi
English: 26 rue de la Chapelle 68330 Huningue France
Maltese: Delpharm Huningue S.A.S. 26 rue de la Chapelle 68330 Huningue Franza
English: CHEPLAPHARM Arzneimittel GmbH Ziegelhof 24
Maltese: Arzneimittel GmbH Ziegelhof 24
English: Retinal pigment epithelial tear, macular oedema.
Maltese: Retinal pigment epithelial tear, edema makulari.
English: A total of 609 patients were enrolled (402 Visudyne, 207 placebo).
Maltese: Ħadu sehem total ta' 609 pazjenti (402 Visudyne, 207 plaċebo).
English: Pathological myopia
Maltese: Mijopja patoloġika
English: Single and repeated dose toxicity
Maltese: Tossiċità minn doża singola u ripetuta
English: Date of first authorisation: 27 July 2000 Date of latest renewal: 05 May 2010
Maltese: Data tal-aħħar tiġdid: 5 ta' Mejju 2010
English: Verteporfin, also referred to as benzoporphyrin derivative monoacids (BPD-MA) consists of a 1:1 mixture of the equally active regioisomers BPD-MAC and BPD-MAD.
Maltese: Verteporfin, magħruf ukoll bħala monoaċidi derivattivi ta' benzoporfirin (BPD-MA) jikkonsisti f' taħlita 1:1 tar-reġjoiżomers attivi ndaqs BPD-MAC u BPD-MAD.
English: Hypercholesteraemia.
Maltese: Iperkolesteremija.
English: It is possible that concomitant use of other photosensitising medicinal products (e.g. tetracyclines, sulphonamides, phenothiazines, sulfonylurea, hypoglycaemic medicinal products, thiazide diuretics, and griseofulvin) could increase the potential for photosensitivity reactions.
Maltese: Huwa possibbli li l-użu konkomitanti ta' prodotti mediċinali oħra fotosensitizzanti (eż. tetracyclines, sulphonamides, phenothiazines, sulfonylurea, prodotti mediċinali ipogliċemiċi, dijuretiċi thiazide, u griseofulvin) jista' jżid il-potenzjal ta' reazzjonijiet ta' fotosensittività.
English: Ophthalmic toxicity
Maltese: Tossiċità oftalmika
English: Cmax after a 10-minute infusion of 6 and 12 mg/m body surface area in the target population is approximately 1.5 and 3.5 µg/ml, respectively.
Maltese: Cmax wara infużjoni ta' 10 minuti ta' 6 u 12 mg/m erja tas-superfiċje tal-ġisem fil-popolazzjoni indirizzata hija bejn wieħed u ieħor 1.5 u 3.5 µg/ml, rispettivament.
English: 339 patients (225 verteporfin, 114 placebo) were enrolled in this study.
Maltese: 339 pazjent (225 verteporfin, 114 plaċebo) ħadu sehem f'dan listudju.
English: Lactose monohydrate Egg phosphatidylglycerol Dimyristoyl phosphatidylcholine Ascorbyl palmitate Butylated hydroxytoluene (E321)
Maltese: Lactose monohydrate Phosphatidylglycerol tal-bajd Dimyristoyl phosphatidylcholine Ascorbyl palmitate Butylated hydroxytoluene (E321)
English: The percentage of patients who lost less than 1.5 lines was 64% for Visudyne and 49% for placebo (p=0.106).
Maltese: Il-perċentwali ta' pazjenti li tilfu anqas minn 1.5 linji kienet 64% għal Visudyne u 49% għal plaċebo (p=0.106).
English: Chemical and physical in-use stability has been demonstrated for 4 hours at 25°C.
Maltese: Intweriet stabbilità kimika u fiżika għal 4 sigħat f'25°C.
English: Visudyne precipitates in sodium chloride solution.
Maltese: Visudyne jippreċipita f'soluzzjoni ta' sodium chloride.