FrancophonIA/ELRC3.0 huggingface dataset:
English: One hundred percent of the plasma dexamethasone concentration values for the 350 µg dose group and 90% for the 700 µg dose group were below the lower limit of quantitation (0.05 ng/mL).
Maltese: Mija fil-mija tal-valuri tal konċentrazzjoni ta' dexamethasone fil-plażma għall-grupp li kien qed jieħu doża ta' 350 µg u 90% għall-grupp li kien qed jieħu doża ta' 700 µg kienu taħt il-limitu t'isfel ta'
English: The following side effects may be seen with OZURDEX:
Maltese: L-effetti sekondarji li ġejjin jistgħu jiġu osservati b'OZURDEX:
English: A total of 73 patients (95%) randomised and treated with OZURDEX completed the 26-week study.
Maltese: Total ta' 73 pazjent (95%) li ntgħażlu b'mod każwali u li ġew kkurati b'OZURDEX temmew l-istudju ta' 26 ġimgħa.
English: The incidence of all observed cataract types (i.e. cataract cortical, cataract diabetic, cataract nuclear, cataract subcapsular, cataract lenticular, cataract) was 68% in OZURDEX treated patients with a phakic study eye across the 3 year studies.
Maltese: inċidenza tat-tipi kollha tal-katarretti osservati (i.e. katarretti kortikali, katarretti dijabetiċi, katarretti nukleari, katarretti subkapsulari, katarretti lentikulari, katarretti) kienet ta' 68% f'pazjenti kkurati b'OZURDEX b'għajn fakika li ġiet studjata fl-istudji li damu 3 snin. 59% tal-pazjenti b'għajn fakika li ġiet studjata kienu jeħtieġu operazzjoni tal-katarretti sal-vista finali fit-tielet sena, bil-maġġoranza twettqu fit-tieni u t-tielet sena.
English: In BRVO/CRVO clinical studies, cataract was reported more frequently in patients with phakic lens receiving a second injection (see SmPC section 4.8).
Maltese: Fl-istudji kliniċi BRVO/CRVO, il-katarretti kienu rrappurtati b'mod aktar frekwenti f'pazjenti b'lenti fakiċa li rċivew it-tieni injezzjoni (ara l-SmPC sezzjoni 4.8).
English: A total of 4 patients (1%) treated with OZURDEX had procedures in the study eye for the treatment of IOP elevation.
Maltese: Total ta' 4 pazjenti (1%) ikkurati b'OZURDEX kellhom proċeduri fil-għajn li ġiet studjata għall-kura ta' żieda fl-IOP.
English: Discontinuation rates due to adverse events were similar across treatment and sham groups (13% vs 11%).
Maltese: Irrati tat-twaqqif minħabba avvenimenti avversi kienu simili fil-gruppi tal-kura u l-plaċebo (13% vs
English: A total of 95% of patients completed the 26-week study.
Maltese: Total ta' 95% tal-pazjenti temmew l-istudju ta' 26 ġimgħa.
English: OZURDEX is used to treat adult patients with:
Maltese: OZURDEX jintuża biex jikkura pazjenti adulti b':
English: Allergan Hellas Pharmaceuticals S.A. Τηλ: +30 210 74 73 300
Maltese: Τηλ: +30 210 74 73 300
English: Endpoint
Maltese: Plaċebo
English: Based on the pooled analysis results, treatment with OZURDEX implants showed statistically significantly greater incidence of responders, defined as patients achieving a ≥ 15 letter improvement from baseline in Best Corrected Visual Acuity (BCVA) at 90 days following injection of a single implant, when compared with sham (p < 0.001).
Maltese: Dawk li rrispondew kienu definiti bħala pazjenti li kisbu titjib ta' ≥ 15-il ittra mil-linja bażi fl-aħjar ċarezza mnaqqsa kkoreġuta (BCVA), 90 jum wara l-injezzjoni ta' impjant wieħed, meta mqabbla ma' pazjenti li ngħataw plaċebo (p < 0.001).
English: Administering OZURDEX
Maltese: X'fih OZURDEX
English: Patients received up to 7 treatments at intervals no more frequently than approximately every 6 months.
Maltese: Il-pazjenti rċivew sa 7 kuri f'intervalli mhux aktar frekwenti minn madwar kull 6 xhur.
English: One patient treated with OZURDEX required incisional surgery (trabeculectomy) to manage the steroid-induced IOP elevation, 1 patient had a trabeculectomy owing to anterior chamber fibrin blocking the aqueous outflow leading to increased IOP, 1 patient had an iridotomy for narrow angle glaucoma and 1 patient had iridectomy due to cataract surgery.
Maltese: Emorraġija fil-vitriju ġiet irrappurtata fi proporzjon ogħla ta' pazjenti kkurati b'OZURDEX li rċivew terapija antikoagulanti (11%) meta mqabbla ma' dawk li kinux qed jirċievu terapija antikoagulanti (6%). Prodotti mediċinali kontra l-plejtlits, bħal clopidogrel, intużaw f'xi fażi minnhom waqt l-istudji kliniċi f'sa 56% tal-pazjenti.
English: Description of selected adverse reactions Diabetic Macular Oedema
Maltese: Edima Makulari Dijabetika
English: What OZURDEX looks like and contents of the pack
Maltese: Kif jidher OZURDEX u l-kontenut tal-pakkett
English: Escape therapy was permitted at the investigators discretion at any stage but led to subsequent withdrawal from the studies.
Maltese: Terapija escape kienet permessa fid-diskrezzjoni tal-investigaturi fi kwalunkwe stadju iżda wasslet għal irtirar sussegwenti mill-istudji.
English: The clinical safety of OZURDEX in patients with macular oedema following central or branch retinal vein occlusion has been assessed in two Phase III randomised, double-masked, sham-controlled studies.
Maltese: Is-sigurtà klinika ta' OZURDEX f'pazjenti b'edima makulari dijabetika ġiet evalwata f'żewġ studji ta' fażi 3, li fihom il-parteċipanti ntgħażlu b'mod każwali, double-masked, ikkontrollati bi plaċebo.
English: Sham
Maltese: jkun.
English: For patients using concomitant and anti-platelet medication, haemorrhagic adverse events were reported in a slightly higher proportion of patients injected with OZURDEX (up to 29%) compared with the sham group (up to 23%), irrespective of indication or number of treatments.
Maltese: Għal pazjenti li kienu qed jużaw medikazzjoni fl-istess ħin u kontra l-plejtlits, avvenimenti avversi emorraġiċi ġew irrappurtati fi proporzjon kemmxejn ogħla ta' pazjenti injettati b'OZURDEX (sa 29%) meta mqabbla mal-grupp tal-plaċebo (sa 23%), irrispettivament mill indikazzjoni jew numru ta' trattamenti.
English: In BRVO/CRVO clinical studies, cataract was reported more frequently in patients with phakic lens receiving a second injection (see section 4.8).
Maltese: Fl-istudji kliniċi BRVO/CRVO, il-katarretti kienu rrappurtati b'mod aktar frekwenti f'pazjenti b'lenti fakiċa li rċivew it-tieni injezzjoni (ara sezzjoni 4.8).
English: This leaflet was last revised in MM/YYY
Maltese: Deskrizzjoni ta' reazzjonijiet avversi magħżula
English: • Patient information leaflet
Maltese: tkun iċċartet
English: The cumulative response rate curves (time to vitreous haze score of 0) were significantly different for the OZURDEX group compared to the Sham group (p < 0.001), with patients receiving dexamethasone showing an earlier onset and greater treatment response.
Maltese: Il-kurvi tar-rata ta' rispons kumulattiva (żmien sa meta jinkiseb punteġġ ta' ċpar vitreuż ta' 0) kienu differenti b'mod sinifikanti għall-grupp ta' OZURDEX meta mqabbla mal-grupp talPlaċebo (p < 0.001), bil-pazjenti li kienu qed jirċievu dexamethasone li wrew bidu iktar bikri u rispons akbar għall-kura.
English: The patient information pack should be provided in both the form of patient information booklet and an audio-CD that contain following key elements:
Maltese: Il-pakkett ta' informazzjoni lill-pazjent għandu jiġi pprovdut kemm fis-sura ta' fuljett ta' informazzjoni lill-pazjent u bħala awdjo-CD li jkun fiha l-informazzjoni ewlenija li ġejja:
English: On the day of the injection, your doctor may use antibiotic eye drops to prevent infection.
Maltese: Fil-jum tal-injezzjoni, it-tabib tiegħek jista' juża qtar antibijotiku għall-għajnejn biex tiġi evitata infezzjoni.
English: Patients may experience temporarily reduced vision after receiving OZURDEX by intravitreal injection (see section 4.8).
Maltese: Il-pazjenti jista' jkollhom tnaqqis temporanju fil-vista wara li jirċievu OZURDEX permezz ta' injezzjoni ġol-vitriju (ara sezzjoni 4.8).
English: Anti-platelet medicinal products, such as clopidogrel, were used at some stage during the clinical studies in up to 56% of patients.
Maltese: Prodotti mediċinali kontra l-plejtlits, bħal clopidogrel, intużaw f'xi fażi minnhom waqt l-istudji kliniċi f'sa 56% tal-pazjenti.
English: Migraine
Maltese: KLINIKU
English: Ewopharma d.o.o.
Maltese: FULJETT TA' TAGĦRIF
English: Mean BCVA change from baseline at year 3/Final visit OCT retinal thickness at center subfield mean average change over 3 years, AUC approach (µm)
Maltese: Bidla medja tal-medja tal-ħxuna tar-retina OCT fis sottokamp ċentrali fuq perjodu ta' 3 snin, metodoloġija AUC (µm)
English: OZURDEX was numerically superior to sham in preventing vision loss as shown by a lower of proportion of patients experiencing deterioration of vision of ≥ 15 letters in the OZURDEX group throughout the 6-month assessment period.
Maltese: OZURDEX kien numerikament superjuri għal plaċebo fil-prevenzjoni ta' telf ta' vista kif muri minn proporzjon iktar baxx ta' pazjenti li kellhom deterjorament ta' ≥ 15-il ittra fil-vista fil-grupp li ngħata OZURDEX matul il-perjodu ta' evalwazzjoni ta' 6 xhur.
English: Before your OZURDEX injection tell your doctor if: - You have had cataract surgery, iris surgery (the coloured part of the eye that controls the amount of light that enters into the eye) or surgery to remove the gel (called the vitreous) from within the eye - You are taking any medicines to thin the blood - You are taking any steroid or non-steroidal anti-inflammatory medicines by mouth or applied to the eye - You have had a herpes simplex infection in your eye in the past (an ulcer on the eye that has been there a long time, or sores on the eye)
Maltese: L-użu ta' kortikosterojdi, li jinkludu OZURDEX, jista' jinduċi katarretti (li jinkludu katarretti subkapsulari posterjuri), żieda fl-IOP, glawkoma kkawżata minn sterojdi u jista' jirriżulta f'infezzjonijiet okulari sekondarji.
English: The vision improvement in the DEX700 group was confounded by cataract formation.
Maltese: It-titjib fil-vista fil-grupp ta' DEX700 kien imfixkel mill-formazzjoni tal-katarretti.
English: High pressure in the eye, clouding at the back of the lens, bleeding into the inside of the eye*, worsening of vision*, difficulties in seeing clearly, detachment of the jelly inside the eye from the light-sensitive layer at the back of the eye (vitreous detachment)*, a feeling of spots in front of the eye (including ‘floaters')*, a feeling of looking through mist or fog*, inflammation of the eyelid, eye pain*, seeing flashes of light*, swelling of the layer over the white part of the eye*, redness of the eye*, headache
Maltese: Pressjoni għolja ġol-għajn, ċpar fin-naħa ta' wara tal-lenti, ħruġ ta' demm fin-naħa ta' ġewwa tal-għajn*, vista li tmur għall-agħar*, diffikultajiet biex tara b'mod ċar, qlugħ tal-ġeli fin-naħa ta' ġewwa tal-għajn minn mas-saff sensittiv għad-dawl finnaħa ta' wara tal-għajn (qlugħ tal-vitriju)*, tħoss tikek quddiem l-għajn (li jinkludu ‘depożiti')*, tħossok qisek qed tħares minn ġol-fwar jew ċpar*, infjammazzjoni ta'
English: OZURDEX has not been studied in patients with macular oedema secondary to RVO with significant retinal ischemia.
Maltese: OZURDEX hu biex jintuża darba biss.
English: The mean increase from baseline IOP did not exceed 3.2 mmHg across all visits in the OZURDEX group with the mean IOP peaking at the 1.5 month visit post injection, and returning to approximately baseline levels by month 6 following each injection.
Maltese: OZURDEX b'IOP medja li laħqet il-massimu tagħha fil-vista ta' 1.5 xahar wara l-injezzjoni, u reġgħet lura bejn wieħed u ieħor għal-livelli tal-linja bażi sas-6 xahar wara kull injezzjoni.
English: 28 February 2011
Maltese: 28 ta' Frar 2011
English: Fibrates are ‘PPAR agonists'.
Maltese: Il-fibrati huma ‘agonisti tal-PPAR'.
English: This means that they activate a type of receptor called the ‘peroxisome proliferator activated receptor'.
Maltese: Dan ifisser li jattivaw tip ta' reċettur imsejjaħ ‘peroxisome proliferator activated receptor'.
English: • Gemfibrozil.
Maltese: • Gemfibrożil.
English: This medicine has been available since 1981.
Maltese: Din il-mediċina ilha disponibbli mill-1981.
English: • Ciprofibrate.
Maltese: • Ċiprofibratu.
English: This medicine has been available since 1977.
Maltese: Din il-mediċina ilha disponibbli mill-1977.
English: This medicine has been available since 1975.
Maltese: Din il-mediċina ilha disponibbli mill-1975.
English: In 2005, the CHMP's PharmacoVigilance Working Party (PhVWP) noted that there was limited evidence of the long-term benefit of fibrates in reducing cardiovascular risk, compared with the stronger evidence for statins (another type of medicines used for lowering blood cholesterol).
Maltese: Fl-2005, il-Grupp ta' Ħidma tal-Farmakoviġilanza tas-CHMP (PhVWP) innota li kien hemm evidenza limitata dwar il-benefiċċju fit-tul tal-fibrati fit-tnaqqis tar-riskji kardjovaskolari, apparagun mal-evidenza aktar qawwija kwantu għall-istatini (tip ieħor ta' mediċini użati fit-tnaqqis tal-kolesterolu fid-demm).
English: The European Medicines Agency has completed a review of the safety and effectiveness of fibrates.
Maltese: L-Aġenzija Ewropea għall-Mediċini temmet reviżjoni tas-sigurtà u l-effikaċja tal-fibrati.
English: It is marketed mainly under the trade names Bezalip, Cedur, Eulitop and Befizal, as well as generic medicines.
Maltese: Tinbiegħ l-aktar b-ismijiet kummerċjali Bezalip, Cedur, Eulitop u Befizal, kif ukoll mediċini ġeneriċi.
English: This medicine has been available since 1995.
Maltese: Din il-mediċina ilha disponibbli mill-1995.
English: The Committee also looked at the latest data from clinical studies including a trial looking at the effect of using fenofibrate as an ‘add-on' to statins.
Maltese: Il-Kumitat ra wkoll l-aktar dejta reċenti minn studji kliniċi, inkluża prova li studjat l-effett tal-użu tal-fenofibrati bħala ‘additiv' mal-istatini.
English: It is sold in Austria, Cyprus, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, the Netherlands, Portugal, Slovenia, Slovakia, Spain, Sweden and the United Kingdom.
Maltese: Tinbiegħ fl-Awstrija, f'Ċipru, fid-Danimarka, fil-Finlandja, fi Franza, fil-Ġermanja, fil-Greċja, fl-Ungerija, fl-Islanda, fl-Irlanda, fl-Italja, fil-Pajjiżi l-Baxxi, filPortugall, fis-Slovenja, fis-Slovakkja, fi Spanja, fl-Isvezja u fir-Renju Unit.
English: • Fenofibrate.
Maltese: • Beżafibratu.
English: Why were fibrates reviewed?
Maltese: Għalxiex ġew riveduti l-fibrati?
English: Consequently, the UK medicines regulatory agency referred the matter to the CHMP on 20 October 2009, to carry out a full assessment of the benefit-risk balance of fibrates and to issue an opinion on whether the marketing authorisations for fibrates-containing medicines should be maintained or varied across the European Union.
Maltese: Għaldaqstant l-aġenzija Brittanika li tirregola l-mediċini rreferiet il-kwistjoni lisCHMP fl-20 ta' Ottubru 2009 biex jagħmel valutazzjoni sħiħa tal-bilanċ bejn il-benefiċċju u r-riskju talfibrati u biex joħroġ opinjoni dwar jekk l-awtorizzazzjonijiet tat-tqegħid fis-suq għall-mediċini li fihom il-fibrati għandhomx jinżammu jew jinbidlu fl-Unjoni Ewropea kollha.
English: Austria, Belgium, Cyprus, Finland, France, Germany; Greece, Hungary, Italy, Luxembourg,
Maltese: Tinbiegħ fil-Belġju, fil-Bulgarija, f'Ċipru, fir-firRepubblika Ċeka, fl-Estonja, fi Franza, fil-Greċja, fl-Ungerija, fil-Latvja, fil-Litwanja, fil
English: It is marketed mainly under the trade name Lipanor or Modalim, as well as generic medicines.
Maltese: Meta r-riċetturi jiġu attivati ttneħħija tax-xaħam titħaffef aktar, u dan jelimina l-kolesterolu u t-trigliċeridi mid-demm.
English: Fibrates are a class of medicines that can be used to lower the level of lipids, such as cholesterol and triglycerides, in the blood.
Maltese: Il-fibrati huma klassi ta' mediċini li jistgħu jintużaw biex ibaxxu l-livell tal-lipidi, bħall-kolesterolu u ttrigliċeridi, fid-demm.
English: It is sold in all EU Member States except Denmark and the Netherlands, as well as in Iceland and Norway;
Maltese: Tinbiegħ fl-Istati Membri kollha tal-UE minbarra fidDanimarka u fil-Pajjiżi l-Baxxi, kif ukoll fl-Islanda u fin-Norveġja;
English: However, the Committee noted that fibrates are more effective than statins in lowering triglyceride levels and therefore their use as a first-line treatment in patients with severe hypertriglyceridaemia (very high blood levels of triglycerides) is still appropriate.
Maltese: Madankollu l-fibrati jistgħu jintużaw fuq pazjenti li ma jkunux jistgħu jieħdu l-istatini (tip ieħor ta' mediċina użata biex tbaxxi l-livelli tax-xaħam fid-demm).
English: Looking at the data, the PhVWP came to the conclusion that there were no new safety issues with fibrates and that fibrate-containing medicines still had a role to play in improving lipid levels, but that they should not be used as first-line treatment.
Maltese: Wara li analizza d-dejta, il-PhVWP wasal għall-konklużjoni li ma kien hemm l-ebda kwistjoni ta' sigurtà ġdida bil-fibrati u li l-mediċini li fihom il-fibrati kien għad kellhom rwol x'jaqdu fit-titjib tal-livelli tal-lipidi, iżda li madankollu m'għandhomx jintużaw bħala kura ewlenija.
English: • Bezafibrate.
Maltese: • Fenofibratu.
English: Blood lipid disorders are a risk factor of heart disease (such as heart attack and stroke) and fibrates are used to improve lipid levels in patients in whom dietary restrictions and exercise have not been enough.
Maltese: Id-disturbi tal-lipidi fid-demm huma fattur ta' riskju tal-mard tal-qalb (bħal attakki tal-qalb u puplesija) u l-fibrati jintużaw biex itejbu l-livelli tal-lipidi f'pazjenti li t-tnaqqis fl-ikel u l-eżerċizzju fiżiku ma jkunux biżżejjed għalihom.
English: • They should review the treatment of patients who are receiving fibrates to help control their lipid levels to ensure that the patient is receiving the most appropriate treatment.
Maltese: • Għandhom jirrevedu l-kura tal-pazjenti li qegħdin jingħataw il-fibrati biex jikkontrollaw il-livelli tallipidi tagħhom ħalli jiżguraw li l-pazjent ikun qed jingħata l-aktar kura xierqa.
English: Currently, four fibrates are available in the European Union:
Maltese: Bħalissa fl-Unjoni Ewropea hemm erba' fibrati disponibbli:
English: This receptor can be found in many cells throughout the body, where it is involved in breaking down dietary fat, especially triglycerides and cholesterol.
Maltese: Dan ir-reċettur jinsab f'ħafna ċelloli fil-ġisem kollu, u jkun involut fittneħħija tax-xaħam mill-ikel, b'mod speċjali t-trigliċeridi u l-kolesterolu.
English: alopecia
Maltese: alopeċja
English: 11 Ion Mihalache Blvd. 011171 Bucharest Romania
Maltese: Sindan-Pharma S.R.L. 11 Ion Mihalache Blvd. 011171 Bucharest Ir-Rumanija
English: - The active substance is topotecan.
Maltese: - Is-sustanza attiva hija topotecan.
English: Each vial contains 2.07 mg (0.09 mmol) sodium.
Maltese: Kull fjala fiha 2.07 mg (0.09 mmol) sodium.
English: In vitro, topotecan did not inhibit human P450 enzymes CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, CYP3A or CYP4A nor did it inhibit the human cytosolic enzymes dihydropyrimidine or xanthine oxidase.
Maltese: In vitro, topotecan ma inibixxiex l-enżimi P450 umani CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, CYP3A jew CYP4A, u lanqas inibizzjoni tal-enżimi ċitostoliċi umani diidropirimidina jew ossidasi tal-ksantina (xanthine oxidase).
English: - Allergic (hypersensitivity) reactions (including rash).
Maltese: • Reazzjonijiet allerġiċi ( sensittività eċċessiva) (inkluż raxx)
English: Combination therapy (cervical carcinoma)
Maltese: Terapija kkombinata (karċinoma ċervikali)
English: Then seek medical evaluation by a physician.
Maltese: Imbagħad fittex l evalwazzjoni medika ta' tabib.
English: 220 Hafnarfjörður Iceland
Maltese: Hafnarfjörður L-Iżlanda
English: Cisplatin 50 mg/m2 on day 1, + Topotecan 0,75 mg/m2 on days 1-3, every 21 days
Maltese: Cisplatin 50 mg/m2 fil-jum 1, + Topotecan 0,75 mg/ m2 filjiem 1-3, kull 21 jum
English: hypersensitivity reaction including rash
Maltese: reazzjoni ta' sensittività eċċessiva inkluż raxx
English: Median (95 % CI) Hazard ratio (95 % CI) Log rank p-value
Maltese: Medjan (95% CI) Proporzjon ta' periklu (95% CI ) Valur-p log rank
English: extravasation3
Maltese: estravażazzjoni3
English: Total or pronounced alopecia was observed in 30 % of patients and partial alopecia in 15 % of patients.
Maltese: Alopeċja kompleta jew qawwija ġiet osservata f'30 % tal-pazjenti u alopeċja parzjali f'15 % tal pazjenti.
English: The unadjusted hazard ratio for the oral topotecan plus BSC group relative to the BSC alone group was 0.64 (95 % CI: 0.45, 0.90).
Maltese: Il-proporzjon aġġustat tal-periklu għat-topotecan orali malgrupp BSC relattiva għall-grupp BSC waħdu kien 0.64 (95 % CI: 0.45, 0.90).
English: Median survivals for the two groups were 25.0 and 24.7 weeks respectively.
Maltese: Sopravivenzi medji għaż-żewġ gruppi kienu 25.0 u 24.7 ġimgħat rispettivament.
English: Faecal elimination of total topotecan accounted for 18 % while faecal elimination of N-desmethyl topotecan was 1.7 %.
Maltese: L-eliminazzjoni mal-ħmieġ ta' topotecan totali kienet ta' 18 % filwaqt li l-eliminazzjoni mal-ħmieġ ta' N-desmethyl topotecan kienet ta' 1.7 %.
English: Volume for 50 microgram/ml solution
Maltese: 50 mikrogramma/ml.
English: See leaflet for further information.
Maltese: Ara l fuljett għal aktar informazzjoni.
English: In addition, 5 % of all patients treated (1 % of courses) developed sepsis (see section 4.4).
Maltese: Barra minn hekk, 5% talpazjenti ttrattati (1 % tal-korsijiet) kellhom sepsis (ara sezzjoni 4.4).
English: An O-glucuronidation metabolite of topotecan and N-desmethyl topotecan has been identified in the urine.
Maltese: Metabolit O-glucuronidation ta' topotecan u Ndesmethyl topotecan ġew identifikati fl-awrina.
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) and 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), u mhux magħrufa (ma jistgħux jiġu stmati mid-dejta disponibbli).
English: (95 % CI) Hazard ratio (95 % CI) N = total number of patients treated.
Maltese: (95 % CI) Proporzjon ta' periklu (95% CI) N = numru totali ta' pazjenti ttrattati.
English: Yellow lyophilisate.
Maltese: Lijofilizat isfar.
English: Frequently reported non-haematological effects were gastrointestinal such as nausea (52 %), vomiting (32 %), diarrhoea (18 %), constipation (9 %) and mucositis (14 %).
Maltese: Mhux ematoloġiċi Effetti mhux ematoloġiċi li ġew irrappuratati b'mod frekwenti kienu dawk gastro-intestinali bħal dardir (52 %), rimettar (32 %), dijarrea (18 %), stitikezza (9 %) u mukożite (14 %).
English: Date of first authorisation: 6 January 2011 Date of latest renewal: 5 October 2015
Maltese: Data tal-ewwel awtorizzazzjoni: 6 ta' Jannar 2011
English: Overdoses have been reported in patients being treated with intravenous topotecan (up to 10 fold of the recommended dose) and topotecan capsules (up to 5 fold of the recommended dose).
Maltese: 10 darbiet id-doża rakkomandata) u bil-kapsuli ta' topotecan (sa 5 darbiet id-doża rakkomandata).
English: Mean half-life increased from 1.9 hours to 4.9 hours.
Maltese: 1.9 sigħat għal 4.9 sigħat.
English: Tumour types included were Ewing's sarcoma/primitive neuroectodermal tumour, neuroblastoma, osteoblastoma, and rhabdomyosarcoma.
Maltese: It-tipi ta' tumuri kienu jinkludu sarkoma ta' Ewing/ tumur newroektodermali primittiv, newroblastoma, osteoblastoma, u rabdomijosarkoma.
English: When given in combination with cisplatin (cisplatin day 1, topotecan days 1 to 5), the clearance of topotecan was reduced on day 5 compared to day 1 (19.1 l/h/m2 compared to 21.3 l/h/m2 [n = 9]) (see section 4.5).
Maltese: topotecan kienet imnaqqsa fil-jum 5 meta mqabbla mal-jum 1 (19.1 l/h/m2 meta mqabbel ma' 21.3 l/h/m2 [n = 9]) (ara sezzjoni 4.5).
English: anaphylactic reaction angioedema urticaria
Maltese: reazzjoni anafilattika anġoedima urtikarja
English: 1 x 1 mg vial
Maltese: (1) x 1 mg fjal
English: The topotecan-O-glucuronide and N-desmethyl topotecan-O-glucuronide in the urine were less than 2.0 %.
Maltese: L- O-glucuronide ta' topotecan u l- O-glucuronide ta' Ndesmethyl topotecan fl-awrina kienu anqas minn 2.0 %.
English: 1 x 4 mg vial
Maltese: (1) x 4 mg fjal