FrancophonIA/ELRC3.0 huggingface dataset:
English: This is equivalent to 3.08 mmol (or 70.77 mg) of sodium and should be taken into consideration for patients on a controlled sodium diet.
Maltese: Dan hu ekwivalenti għal 3.08 mmol (jew 70.77 mg) ta' sodju u għandu jkun ikkonsidrat fil-każ ta' pazjenti li qegħdin fuq dieta kkontrollata tas sodju.
English: The liver is a potential target organ for clofarabine toxicity and 25.2% of patients experienced at least one hepato-biliary disorders adverse event (see sections 4.3 and 4.4).
Maltese: 2% tal-pazjenti batew minn ta' l-anqas każ wieħed avvers ta' disturbi fil-fwied u fil-marrara (ara sezzjonijiet 4.3 u 4.4).
English: Systemic inflammatory response syndrome (SIRS) or capillary leak syndrome SIRS, capillary leak syndrome (signs and symptoms of cytokine release, e.g., tachypnea, tachycardia, hypotension, pulmonary oedema) were reported as an adverse event in 5% (6/115) of paediatric patients (5 ALL, 1 AML) (see section 4.4).
Maltese: takikardija, pressjoni baxxa, edema pulmonari) kienu rrapportati bħala każ avvers f'5% (6/115) talpazjenti pedjatriċi (5
English: • Patients should receive intravenous fluids throughout the 5 day clofarabine administration period to reduce the effects of tumour lysis and other events.
Maltese: • Il-pazjenti għandhom jirċievu fluwidi fil-vina matul il-perijodu ta' 5 ijiem tal-għoti ta' clofarabine biex jitnaqqsu l-effetti ta' lisi tat-tumur u avvenimenti oħra.
English: Excipients: Sodium chloride and water for injections.
Maltese: Is-sustanzi l-oħra huma sodium chloride u ilma għal injezzjonijiet.
English: Common: Maculo-papular rash, petechiae, erythema, pruritic rash, skin exfoliation, generalised rash, alopecia, skin hyperpigmentation, generalised erythema, erythematous rash, dry skin, hyperhidrosis Frequency not known: Stevens Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN)
Maltese: eritema, raxx pruritiku, tqaxxir tal-ġilda, raxx ġeneralizzat, alopeċja, iperpigmentazzjoni tal-ġilda, eritema ġeneralizzata, raxx eritematuż, ġilda xotta,
English: CRp = Complete Remission in the Absence of Total Platelet Recovery
Maltese: RKp - Remissjoni Kompleta finNuqqas ta' Rkupru Komplet ta' Pjastrini
English: 12 mg/m 2/day.
Maltese: 52 mg/m2/kuljum
English: However, the pharmacokinetics of clofarabine in adults with relapsed or refractory AML following administration of a single dose of 40 mg/m clofarabine by intravenous infusion over 1 hour were comparable to those described above in patients aged between 2 to 19 years old with relapsed or refractory ALL or AML following administration of 52 mg/m clofarabine by intravenous infusion over 2 hours for 5 consecutive days.
Maltese: Imma, il-farmakokinetiċi ta' clofarabine fl-adulti b'AML rikadut jew refrattarju wara l-għoti ta' doża waħda ta' 40 mg/m2 ta' clofarabine permezz ta' infużjoni għal ġol-vini fuq perijodu ta' siegħa kienu komparabbli ma' dawk deskritti hawn fuq f'pazjenti ta' bejn is-sentejn u 19-il sena b'ALL jew AML rikadut jew refrattarju wara l-għoti ta' 52 mg/m2 ta' clofarabine permezz ta' infużjoni għal ġol-vini fuq perijodu ta' sagħtejn għal 5 ġranet konsekuttivi.
English: • Recovery of peripheral counts (platelets  100 x 10
Maltese: • Rikopru ta' kownts periferali (plejtlits ≥ 100 x 109/l u ANC ≥ 1.0 x 109/l)
English: Each ml of concentrate contains 1 mg of clofarabine.
Maltese: U KWANTITATTIVA Kull ml ta' konċentrat fih 1 mg ta' clofarabine.
English: Any patient who experiences a severe non-hematologic toxicity (US NCI CTC Grade 3 toxicity) on a third occasion, a severe toxicity that does not recover within 14 days (excluding nausea/vomiting) or a life-threatening or disabling non-infectious non-hematologic toxicity (US NCI CTC Grade 4 toxicity) should be withdrawn from treatment with clofarabine (see section 4.2).
Maltese: Kwalunkwe pazjent li jkollu tossiċità mhux ematoloġika severa għat-tielet darba (tossiċità Grad 3 ta' CTC tal-NCI ta' l-US), tossiċità severa li ma tirkuprax fi żmien 14-il ġurnata (ħlief għal dardir/rimettar) jew tossiċità mhux infettiva u mhux ematoloġika li tirriżulta f'diżabilita` jew tkun potenzjalment fatali (tossiċità Grad 4 ta' CTC tal-NCI ta' l-US) m'għandux jibqa' jingħata trattament bi clofarabine (ara sezzjoni 4.2).
English: In the majority of patients (8/10), the pericardial effusion and pericarditis were deemed to be asymptomatic and of little or no clinical significance on echocardiographic assessment.
Maltese: Fil każ tal-biċċa l-kbira tal-pazjenti (8/10), l-effużjoni perikardjali u l-perikardite kienu meqjusa li kienu asimptomatiċi u ta' importanza żgħira jew ta' l-ebda sinifikat kliniku skond assessjament ekocardjografiku.
English: • Complete disappearance of circulating blasts
Maltese: • Kien hemm assenza kompleta ta' ċelluli primittivi ċirkulanti
English: Clear, practically colourless solution with a pH of 4.5 to 7.5 and an osmolarity of 270 to 310 mOsm/l.
Maltese: Soluzzjoni ċara prattikament bla kulur b'pH ta' minn 4.5 sa 7.5 u ożmolarità ta' minn
English: Very common: Vomiting, nausea, diarrhoea Common: Mouth haemorrhage, gingival bleeding, haematemesis, abdominal pain, stomatitis, upper abdominal pain, proctalgia, mouth ulceration Frequency not known: Pancreatitis elevations in serum amylase and lipase, enterocolitis, neutropaenic colitis, caecitis
Maltese: Pankreatite, żidiet fil-livelli ta' amylase u lipase fis-serum, enterokolite, kolite newtropenika, keċite
English: Before enrolling in the trial, 58 of the 61 patients (95%) had received 2 to 4 different induction regimens and 18/61 (30%) of these patients had undergone at least 1 prior haematological stem cell transplant (HSCT).
Maltese: Qabel ma nkitbu għal din il-prova, 58 minn 61 pazjent (95%) kienu rċevew minn 2 sa 4 reġimeni differenti ta' induzzjoni u 18/61 (30%) minn dawn il-pazjenti kienu rċevew minn qabel ta' l-anqas trapjant wieħed ta' ċelluli steminali ematoloġikali (HSCT).
English: Nine of 17 ALL patients were treated with clofarabine 52 mg/m2/day.
Maltese: Pazjent wieħed waqqaf il-kura wara li ngħata 52 mg/m2/kuljum ta'
English: oC to 8 oC).
Maltese: u 4.4).
English: This is equivalent to 3.08 mmol (or 70.77 mg) of sodium.
Maltese: 77 mg) ta' sodium.
English: breathlessness, cough; - vomiting blood, stomach ache, pain in the bottom; - bleeding inside the head, stomach, intestine or lungs, mouth or gums, mouth ulcers, inflamed mouth lining; - yellowing of the skin and eyes (also called jaundice), or other liver disorders; - bruising, hair loss, changes to skin colour, increased sweating, dry skin, or other skin problems; - pain in the chest wall or bones, neck or back pain, pain in limbs, muscles, or joints; - blood in urine; - failure of organs, pain, increased muscle tension, water retention and swelling in parts of the body, including the arms and legs, changes in mental state, feeling hot, cold or abnormal; - clofarabine may affect the levels of certain substances in the blood.
Maltese: ansjetà, uġigħ ta' ras, deni, għeja; tħossok u tkun marid, dijarea (tagħmel imsarnek); ħmura fil-wiċċ, ħakk, ġilda infjammata, infjammazzjoni tal-linji mukużi (niedjin) bħal ħalq u partijiet oħra; int għandek mnejn ikollok aktar infezzjonijiet minn normal għax Evoltra jista' jbaxxi n-numru ta' ċerti tipi ta' celluli tad-demm; raxx tal-ġilda, li jista' jkun bil-ħakk, aħmar u bl-uġigħ jew tistelaħ il-ġilda, li jinkludi lkefef tal-idejn u l-qiegħ tas-saqajn, jew tikek żgħar ħomor jew vjola taħt il-ġilda;
English: However, as clofarabine is not detectably metabolised by the cytochrome P450 (CYP) enzyme system, pathways of non-renal elimination currently remain unknown.
Maltese: Biss, peress li clofarabine mhux metabolizzat b'mod li jidher bis-sistema ta' l enżim cytochrome P450 (CYP), s'issa għadna ma nafux fejn huma l-passaġġi tat-tneħħija li ma jinvolvux il-kliewi.
English: • An M1 marrow that did not qualify for CR or CRp
Maltese: Mudullun M1 li ma jikkwalifikax għal RK jew RKp
English: *Each ml of concentrate contains 1 mg of clofarabine.
Maltese: 200 ml * Kull ml ta' konċentrat fih 1 mg ta' clofarabine.
English: Three patients died of adverse events considered by the study investigator to be related to treatment with clofarabine: one patient died from respiratory distress, hepatocellular damage, and capillary leak syndrome; one patient from VRE sepsis and multi-organ failure; and one patient from septic shock and multi-organ failure.
Maltese: Tliet pazjenti mietu minħabba avvenimenti avversi li kienu kkunsidrati mill-investigatur ta' l-istudju li kienu marbuta mal-kura bi clofarabine: wieħed bi problemi respiratorji, ħsara epatoċellulari, u sindrome tat-tnixxija kapillari; pazjent wieħed minn infezzjoni VRE u insuffiċjenza ta' diversi organi; u pazjent wieħed minn xokk settiku u insuffiċjenza ta' diversi organi.
English: Common: Haematuria* Common: Renal failure, acute renal failure
Maltese: Komuni: Anoreksja, nuqqas t'aptit, deidratazzjoni Frekwenza mhux magħrufa: iponatrimja
English: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), including fatal cases, have been reported (see section 4.8).
Maltese: Ġew irrapportati s-sindromu ta' Stevens-Johnson (SJS - Stevens - Johnson syndrome) kif ukoll nekroliżi epidermali tossika (TEN - toxic epidermal necrolysis), inklużi każijiet fatali (ara sezzjoni 4.8). Clofarabine għandu jitwaqqaf għal raxx li jinvolvi tqaxxir jew infafet, jew jekk ikun hemm suspett ta' SJS jew TEN.
English: Further treatment with clofarabine, generally at a lower dose, can be considered when patients are stabilised and organ function has returned to baseline.
Maltese: Aktar trattament bi clofarabine, ġeneralment b'doża aktar baxxa, jista' jitqies meta l-pazjenti ikunu stabilizzati u l-funzjoni ta' l-organu tkun marret lura għal-linja bażi.
English: A multi-centre, phase II, open-label, non-comparative study of clofarabine was conducted to determine the overall remission (OR) rate in heavily pretreated patients (≤ 21 years old at initial diagnosis) with relapsed or refractory ALL defined using the French-American-British classification.
Maltese: II, open-label, mhux-komparattiv ta' clofarabine sar biex jiddetermina r rata tar-remissjoni totali (RT) f'pazjenti li ngħataw trattament intensiv minn qabel (≤ 21 sena meta saret dijanjosi inizjali) b'ALL rikaduta jew refrattorja definit permezz ta' l-użu tal-klassifika Franċiża
English: - (Number of patients with a CR + Number of patients with a CRp) ÷ Number of eligible patients who received clofarabine
Maltese: • (Numru ta' pazjenti b'RK + Numru ta' pazjenti li għandhom RKp) ÷ Numru ta' pazjenti eliġibbli li rċevew il-clofarabine
English: OUTER CARTON
Maltese: OĦRA TAL
English: Patients undergoing treatment with clofarabine should be evaluated and monitored for signs and symptoms of tumour lysis syndrome and cytokine release (e.g. tachypnoea, tachycardia, hypotension, pulmonary oedema) that could develop into Systemic Inflammatory Response Syndrome (SIRS), capillary leak syndrome and/or organ dysfunction (see section 4.8).
Maltese: Pazjenti li qed jirċievu trattament bi clofarabine għandhom ikunu evalwati u mmonitorjati għal sinjali u sintomi tas-sindromu tal-lysis tat-tumur u ħruġ ta' ċitokini (p.e. takipneja, takikardija, ipotensjoni, odema pulmonari) li jistgħu jiżviluppaw f'Sindromu ta' Rispons Infjammatorju Sistemiku (SIRS),
English: Severe hepatotoxic events have been reported in a Phase 1/2 combination study of clofarabine in paediatric patients with relapsed or refractory acute leukaemia.
Maltese: Il-biċċa l kbira tal-avvenimenti avversi kardijaċi kienu rrappurtati fl-ewwel 2 ċikli.
English: Read the package leaflet before use.
Maltese: Jista' jkun li mhux il-pakketti tad-daqsijet kollha jkunu fis-suq.
English: These infections may lead to septic shock, respiratory failure, renal failure, and/or multiorgan failure.
Maltese: insuffiċjenza renali, u/jew insuffiċjenza f'diversi organi.
English: The safety profile of clofarabine has not been established in patients with severe renal impairment or patients receiving renal replacement therapy (see section 4.3).
Maltese: Il-profil tas-sigurtà ta' clofarabine ma ġiex stabbilit f'pazjenti b'indeboliment sever tal-kliewi jew f'pazjenti li kienu qed jirċievu terapija tas-sostituzzjoni tal-kliewi (ara sezzjoni 4.3).
English: Evoltra contains salt
Maltese: Jekk tuża Evoltra aktar milli suppost
English: Nederland sanofi-aventis Netherlands B.V. Tel: +31 20 245 4000
Maltese: Slovenija sanofi-aventis d.o.o. Tel: +386 1 560 4800
English: Patients with cardiac disease and those taking medicinal products known to affect blood pressure or cardiac function should be closely monitored during treatment with clofarabine (see sections 4.5 and 4.8).
Maltese: Pazjenti li qed jieħdu prodotti mediċinali li huma magħrufa li jaffettwaw l-pressjoni tad-demm jew funzjoni kardijaka għandhom ikunu monitorjati sewwa matul it-trattament b'clofarabine (ara sezzjonijiet 4.4 u 4.8).
English: Where follow-up data are available, the majority of bilirubin elevations returned to  grade 2 within 10 days.
Maltese: Fejn hemm dejta follow-up disponibbli, il maġġoranza taż-żidiet fil-bilirubina reġgħu lura għal ≤ grad 2 fi żmien 10 ijiem.
English: Common: Hyperbilirubinaemia, jaundice, venoocclusive disease, increases in alanine (ALT)* and aspartate (AST)* aminotransferases, hepatic failure Uncommon: Hepatitis
Maltese: Għalhekk, clofarabine hu kontra-indikat f'pazjenti b'indeboliment epatiku sever (ara sezzjoni 4.3) u għandu jintuża bir-reqqa f'pazjenti b'indeboliemt epatiku ħafif għal moderat (ara sezzjoni 4.4).
English: Your treatment with Evoltra has been prescribed by a qualified doctor experienced in treating leukaemia.
Maltese: It-trattament tiegħek b'Evoltra kien mogħti lilek minn tabib ikkwalifikat li għandu esperjenza fit trattament tal-lewkimja.
English: Evoltra is a potent antineoplastic agent with potentially significant haematological and non-haematological adverse reactions (see section 4.8).
Maltese: 4.4 Twissijiet speċjali u prekawzjonijiet għall-użu Evoltra hi aġent antineplastiku qawwi u għandha reazzjonijiet avversi ematoloġikali u nonematoloġikali li huma potenzjalment sinifikanti (ara sezzjoni 4.8).
English: Evoltra 1 mg/ml concentrate for solution for infusion must be diluted prior to administration.
Maltese: Evoltra 1 mg/ml ta' konċentrat għal soluzzjoni għall-infużjoni għandha tkun dilwita qabel ma tingħata.
English: Haverhill
Maltese: Treddigħ
English: • Respiratory status, blood pressure, fluid balance and weight throughout and immediately after the 5 day clofarabine administration period.
Maltese: • L-istatus respiratorju, pressjoni tad-demm, bilanċ tal-fluwidu u piż matul u immedjatament wara l perijodu ta' 5 ġranet ta' għoti ta' clofarabine.
English: Very common: Febrile neutropaenia Common: Neutropaenia
Maltese: Komuni ħafna: Newtropenija bid-deni Komuni:
English: The majority of elevations in ALT and AST occurred within 10 days of clofarabine administration and returned to  grade 2 within 15 days.
Maltese: Il-biċċa l-kbira ta' elevazzjonijiet f'ALT u AST ġraw fi żmien 10 ijiem min meta ngħata l clofarabine u reġgħu lura għal ≤ grad 2 fi żmien 15-il jum.
English: Immediate discontinuation of therapy, careful observation and initiation of appropriate supportive measures are recommended.
Maltese: Il-waqfien immedjat tat-terapija, osservanza bir-reqqa u bidu ta' mizuri appoġġjati adattati huma rrakkomandati.
English: Benefit/risk balance
Maltese: Il-bilanċ tal-benefiċċju/riskju
English: Nimesulide-containing medicinal products for systemic use are currently authorised in 17 Member States on prescription only and marketed in 15 Member States (Bulgaria, Czech Republic, Cyprus, France, Greece, Hungary, Italy, Latvia, Lithuania, Malta, Poland, Portugal, Romania, Slovakia and Slovenia).
Maltese: Prodotti mediċinali li fihom Nimesulide għall-użu sistemiku huma attwalment awtorizzati fi 17-il Stat Membru bi preskrizzjoni medika biss u mqiegħda fis-suq fi 15-il Stat Membru (il-Bulgarija, irRepubblika Ċeka, Ċipru, Franza, il-Greċja, l-Ungerija, l-Italja, il-Latvja, il-Litwanja, Malta, il-Polonja, il-Portugall, ir-Rumanija, is-Slovakkja u s-Slovenja).
English: The risk of gastrointestinal complications due to nimesulide is lower than for ketorolac, piroxicam, indomethacin and azopropazone, but not proven to be consistently different from other NSAIDs such as celecoxib, ibuprofen, naproxen, ketoprofen, diclofenac, sulindac and meloxicam.
Maltese: Ir-riskju ta' kumplikazzjonijiet gastro-intestinali minħabba nimesulide huwa aktar baxx milli għal ketorolac, piroxicam, indomethacin u azopropazone, imma ma ġiex ippruvat li huwa konsistentement differenti mill-NSAIDs l-oħra bħal celecoxib, ibuprofen, naproxen, ketoprofen, diclofenac, sulindac u meloxicam.
English: Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) with preferred COX-2 inhibition authorised in Europe since 1985.
Maltese: Nimesulide huwa mediċina anti-infjammatorja mhux sterojdi (NSAID) b'inibizzjoni ppreferuta għal COX-2 li ilha awtorizzata fl-Ewropa mill-1985.
English: It is noted that 23% of the hepatic cases reported for nimesulide involved patients treated for more chronic indications.
Maltese: Ġie nnutat li 23% tal-każijiet epatiċi rrapportati għal nimesulide kienu jinvolvu pazjenti li rċevew kura għal indikazzjonijiet aktar kroniċi.
English: The absolute risk for hospital admission for hepatoxicity is approximately 30-35 per 100,000 person-years and the absolute risk for abnormal liver function tests is approximately 1%.
Maltese: Ir-riskju assolut għal ammissjoni fl-isptar għal epatotossiċità huwa ta' madwar 30-35 kull 100,000 sena ta' persuna u rriskju assolut għal testijiet dwar il-funzjoni abnormali tal-fwied huwa ta' madwar 1%.
English: It is indicated as second line treatment for acute pain, symptomatic treatment of painful osteoarthritis and primary dysmenorrhoea.
Maltese: Hija indikata bħala kura sekondarja għall-uġigħ akut, il-kura sintomatika tal-osteoartrite bl-uġigħ u d-dismenorrea primarja.
English: No new safety issue with respect to cardiovascular disorders, renal safety, skin, immunological and nervous system safety has arisen from the data submitted during this review.
Maltese: L-ebda kwistjoni ġdida dwar is-sigurtà fir-rigward ta' disturbi kardjovaskulari, is-sigurtà renali, ilġilda, is-sigurtà immunoloġika u tas-sistema nervuża ma rriżultat mid-dejta sottomessa matul din ir-reviżjoni.
English: • The Committee considered the referral made under article 31 of Directive 2001/83/EC, for medicinal products containing nimesulide for systemic use.
Maltese: • Il-Kumitat ikkunsidra r-riferiment li sar skont l-Artikolu 31 tad-Direttiva 2001/83/KE, għallprodotti mediċinali li fihom nimesulide għall-użu sistemiku.
English: Further to that the results of the SALT study became available.
Maltese: Wara r-riżultati tal-istudju SALT saru disponibbli.
English: Restriction of the maximum dose to 100 mg twice daily (with withdrawal of the marketing authorisations for the 200 mg), restriction of the therapeutic indications to the three above mentioned and warnings, precaution for use and contraindications were introduced.
Maltese: Ġiet introdotta restrizzjoni tad-doża massima għal 100 mg darbtejn kuljum (bl-irtirar talawtorizzazzjonijiet għat-tqegħid fis-suq għall-200 mg), restrizzjoni tal-indikazzjonijiet terapewtiċi għat-tlieta msemmija hawn fuq u t-twissijiet, prekawzjoni għall-użu u l-kontra-indikazzjonijiet.
English: This referral procedure was concluded in 2004 (European Commission decision issued on 26 April 2004) and the product information was subsequently updated.
Maltese: Din il-proċedura ta' riferiment ġiet konkluża fl-2004 (id-deċiżjoni tal-Kummissjoni Ewropea nħarġet fis26 ta' April 2004) u l-informazzjoni dwar il-prodott ġiet aġġornata sussegwentement.
English: It was noted that the majority of hepatic disorders (56%) occurred after two weeks of treatment.
Maltese: Ġie nnotat li l-maġġoranza tad-disturbi epatiċi (56%) seħħew wara ġimagħtejn ta' kura.
English: Overall summary of the scientific evaluation of nimesulide-containing medicinal products for systemic use (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' prodotti mediċinali li fihom nimesulide għall-użu sistemiku (ara Anness I)
English: Data available including a new epidemiological study (FVG GI study) confirms that all NSAIDs can induce damage to the gastroduodenal mucosa and increase the risk of upper gastrointestinal complications (UGIC).
Maltese: Id-dejta disponibbli li tinkludi studju epidemjoloġiku ġdid (studju FVG GI) tikkonferma li l-NSAIDs kollha jistgħu jikkawżaw ħsara lil-mukoża gastroduwodenali u jżidu r-riskju ta' kumplikazzjonijiet gastro-intestinali ta' fuq (UGIC).
English: Nimesulide was subject of an Article 31 referral to the CHMP in 2002, following national suspension of the Marketing Authorisations for nimesulide-containing medicinal products in Finland, and subsequently in Spain due to concerns regarding hepatotoxicity.
Maltese: Nimesulide kien is-suġġett ta' riferiment skont l-Artikolu 31 lis-CHMP fl-2002, wara sospensjoni nazzjonali tal-Awtorizzazzjonijiet għat-Tqegħid fis-Suq tal-prodotti mediċinali li fihom nimesulide filFinlandja, u sussegwentement fi Spanja minħabba tħassib fir-rigward tal-epatotossiċità.
English: The absolute risk for acute liver failure indicated for transplantation is 5.64 [2.43-11.11] per million person-years and 5.90 per billion DDDs (defined daily doses).
Maltese: 11] kull miljun sena ta' persuna u 5.90 kull biljun DDDs (dożi definiti ta' kuljum).
English: In May 2007, following new information regarding cases of fulminant hepatic failure associated with the use of nimesulide, Ireland suspended the marketing authorisations for all systemic medicinal products containing nimesulide and a procedure under Article 107 was started.
Maltese: F'Mejju 2007, wara informazzjoni ġdida dwar każijiet ta' insuffiċjenza epatika fulminanti assoċjati mal-użu ta' nimesulide, l-Irlanda ssospendiet l-awtorizzazzjonijiet għat-tqegħid fis-suq għallprodotti mediċinali sistemiċi kollha li fihom nimesulide u nbdiet proċedura skont l-Artikolu 107.
English: Moreover, considering that the review and assessment of the available data for nimesulide under the Article 107 focused on the hepatic safety of nimesulide and that only limited information regarding the gastrointestinal toxicity profile of nimesulide was considered, it was agreed that a full risk-benefit assessment should be conducted in the framework an Article 31 procedure, where the risks of nimesulide should be weighted vis-à-vis the gastrointestinal risks of other NSAIDs.
Maltese: Barra minn hekk, meta wieħed iqis li r-reviżjoni u l-evalwazzjoni tad-dejta disponibbli għal nimesulide skont l-Artikolu 107 iffukat fuq is-sigurtà epatika ta' nimesulide u kienet ikkunsidrata biss informazzjoni limitata dwar il-profil tat-tossiċità gastro-intestinali ta' nimesulide, ġie miftiehem li għandha ssir evalwazzjoni sħiħa tar-riskju-benefiċċju fil-qafas ta' proċedura skont l-Artikolu 31, fejn ir-riskji ta' nimesulide għandhom jiġu peżati vis-à-vis ir-riskji gastro-intestinali ta' NSAIDs oħra.
English: Overall, gastrointestinal toxicity of nimesulide is regarded to be comparable to other available NSAIDs.
Maltese: B'mod ġenerali, it-tossiċità gastro-intestinali ta' nimesulide hija meqjusa komparabbli ma' NSAIDs oħra disponibbli.
English: The CHMP reviewed the data submitted by the marketing authorisation holders from clinical and non-clinical studies, epidemiological studies and spontaneous reports.
Maltese: Is-CHMP irreveda d-dejta sottomessa mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq minn studji kliniċi u mhux kliniċi, studji epidemjoloġiċi u minn rapporti spontanji.
English: • The Committee, in light of the above, considered that there is a risk of chronic use of nimesulide in “symptomatic treatment of painful osteoarthritis” and concludes that the riskbenefit balance of nimesulide-containing medicinal products for systemic use is no longer favourable in this indication.
Maltese: • Fid-dawl ta' dan t'hawn fuq, il-Kumitat ikkunsidra li hemm riskju ta' użu kroniku ta' nimesulide fil-“kura sintomatika ta' osteoartrite bl-uġigħ” u kkonkluda li l-bilanċ tar-riskju-benefiċċju ta' prodotti mediċinali li fihom nimesulide għall-użu sistemiku ma għadux favorevoli għal din lindikazzjoni.