FrancophonIA/ELRC3.0 huggingface dataset:
English: In the comparative period of phase 3 studies in PV patients, bleeding events (including intracranial and gastrointestinal, bruising and other bleeding events) were reported in 16.8% of patients treated with ruxolitinib, 15.3% of patients receiving best available therapy in RESPONSE study and 12.0% of patients receiving best available therapy in RESPONSE 2 study.
Maltese: Fil-perjodu komparattiv tal-istudji ta' fażi 3 fuq pazjenti b'PV, ġew irrappurtati avvenimenti ta' fsada (inklużi avvenimenti intrakranjali u gastrointestinali, ta' tbenġil u avvenimenti oħrajn ta' fsada) f'16.8% tal-pazjenti kkurati b'ruxolitinib u 15.
English: Treatment should be discontinued for platelet counts less than 50,000/mm or absolute neutrophil counts less than 500/mm
Maltese: It-trattament għandu jitwaqqaf meta lammont tal-plejtlits hu anqas minn 50,000/mm jew l-ammonti assoluti ta' newtrofili huma anqas minn 500/mm
English: In a thorough QT study in healthy subjects, there was no indication of a QT/QTc prolonging effect of ruxolitinib in single doses up to a supratherapeutic dose of 200 mg, indicating that ruxolitinib has no effect on cardiac repolarisation.
Maltese: Waqt studju profond tal-QT f'pazjenti b'saħħithom, ma kienx hemm indikazzjoni li l-effett ta' QT/QTc twal minn dożi singoli sa doża supraterapewtika b'ruxolitinib ta' 200 mg, u dan jindika li ruxolitinib m'għandu l-ebda effett fuq ir-ripolarizzazzjoni kardijaka.
English: Jakavi 20 mg tablets are white to almost white elongated tablets with “NVR” debossed on one side and “L20” debossed on the other side.
Maltese: Il-pilloli Jakavi tal-20 mg huma pilloli tawwalija bojod jew kważi bojod b'“NVR” imbuzzata fuq naħa waħda u b'“L20” mbuzzata fuq in-naħa l-oħra.
English: Lipid monitoring and treatment of dyslipidaemia according to clinical guidelines is recommended.
Maltese: Hu rrakkomandat monitoraġġ tal-lipidi u trattament tad-dislipidemija skont illinji gwida kliniċi.
English: Upon discontinuation, MF patients may experience a return of MF symptoms such as fatigue, bone pain, fever, pruritus, night sweats, symptomatic splenomegaly and weight loss.
Maltese: Malli titwaqqaf il-kura, il-pazjenti b'MF jistgħu jesperjenzaw mill-ġdid sintomi ta' MF bħalma huma għeja, uġigħ fl-għadam, deni, ħakk, għaraq billejl, splenomegalija sintomatika u telf tal-piż.
English: Significantly more patients treated with Jakavi (23%) achieved a primary response (p<0.0001) compared to BAT (0.9%).
Maltese: Kien hemm għadd ferm akbar ta' pazjenti mogħtija Jakavi (23%) li kisbu rispons primarju (p<0.
English: In these clinical studies, discontinuation due to adverse events, regardless of causality, was observed in 11.3% of patients.
Maltese: F'dawn l-istudji kliniċi, kien osservat twaqqif tat-terapija minħabba avvenimenti avversi, irrispettivament mill-kawżalità, fi 11.3% tal-pazjenti.
English: Based on studies in healthy subjects, no relevant differences in ruxolitinib pharmacokinetics were observed with regard to gender and race.
Maltese: Abbażi tal-istudji fuq pazjenti b'saħħithom, ma kienx hemm differenzi rilevanti fil-farmakokinetiċi ta' ruxolitinib fejn jidħlu sess u razza.
English: Therefore, no increase in exposure of CYP3A4 substrates is anticipated when combining them with ruxolitinib.
Maltese: Għalhekk, mhux mistennija żieda fl-esponiment għas-sottostrati ta' CYP3A4 meta dawn jiġu kkombinati ma' ruxolitinib.
English: Bleeding (any bleeding including intracranial, and gastrointestinal bleeding, bruising and other bleeding)
Maltese: Fsada (kull fsada inkluż intrakranjali, u fsada gastrointestinali, tbenġil u fsada oħra)
English: Adverse decreases in blood pressure along with increases in heart rate were noted in a dog telemetry study, and an adverse decrease in minute volume was noted in a respiratory study in rats.
Maltese: Tnaqqis avvers fil-pressjoni tad-demm flimkien ma' żidiet fir-rata tal-qalb kienu nnutati fi studju ta' telemetrija fil-klieb, u kien innutat tnaqqis avvers fil-volum ta' minuti waqt studju respiratorju fil-firien.
English: In the randomised period of the pivotal study in PV patients, neutropenia was reported in three patients (1.6%) of which one patient developed CTCAE grade 4 neutropenia.
Maltese: Fil-perjodu randomizzat tal-istudju pivotali fuq pazjenti b'PV, ġiet irrappurtata newtropenija fi tliet pazjenti (1.6%), li pazjent wieħed minnhom żviluppa newtropenija CTCAE fi grad 4.
English: A randomised, open-label, active-controlled phase 3 study (RESPONSE) was conducted in 222 patients with PV who were resistant to or intolerant of hydroxyurea defined based on the European LeukemiaNet (ELN) international working group published criteria.
Maltese: Twettaq studju randomizzat, open-label u kkontrollat b'mod attiv f'fażi 3 (RESPONSE) fuq 222 pazjent b'PV li kienu reżistenti jew intolleranti għal hydroxyurea definita abbażi tal-kriterji ppubblikati tal-grupp ta' ħidma internazzjonali European LeukemiaNet (ELN). 110 pazjenti kienu randomizzati għall-kura b'ruxolitinib u 112-il pazjent għal BAT.
English: Discontinuation due to adverse events, regardless of causality, was observed in 2.2% of patients.
Maltese: Kien osservat twaqqif tat-terapija minħabba avvenimenti avversi, irrispettivament mill-kawżalità, fi 2.2% tal-pazjenti.
English: Clearance was 12.7 l/h in PV patients, with a 42% inter-subject variability and no relationship was apparent between oral clearance and gender, patient age or race, based on a population pharmacokinetic evaluation in PV patients.
Maltese: It-tneħħija kienet ta' 12.7 l/h f'pazjenti b'PV, b'varjabbiltà bejn il-pazjenti ta' 42% u ma kien hemm ebda relazzjoni bejn it-tneħħija orali u s-sess, l-età jew ir-razza tal-pazjent, abbażi ta' evalwazzjoni farmakokinetika tal-popolazzjoni f'pazjenti b'PV.
English: The adverse drug reactions listed below reflect the randomised study period (up to week 32 for RESPONSE and up to week 28 for RESPONSE 2) with equivalent exposure to ruxolitinib and Best Available Therapy (BAT).
Maltese: Ir-reazzjonijiet avversi tal-mediċina elenkati hawn taħt jirriflettu l-perjodu randomised tal-istudju (sal-ġimgħa 32 għal RESPONSE u sa ġimgħa 28 għal RESPONSE 2) b'espożizzjoni ekwivalenti għal ruxolitinib u l-Aħjar Terapija Disponibbli (Best Available Therapy - BAT).
English: Ruxolitinib is mainly metabolised by CYP3A4 (>50%), with additional contribution from CYP2C9.
Maltese: (>50%), bis-sehem ukoll ta' CYP2C9.
English: If efficacy is considered insufficient and blood counts are adequate, doses may be increased by a maximum of 5 mg twice daily, up to the maximum dose of 25 mg twice daily.
Maltese: Jekk l-effikaċja ma titqiesx suffiċjenti u l-ammonti tad-demm ikunu xierqa, id-dożi jistgħu jiżdiedu sa massimu ta' 5 mg darbtejn kuljum, sad-doża massima ta' 25 mg darbtejn kuljum.
English: Dose adjustment with concomitant strong CYP3A4 inhibitors or fluconazole When ruxolitinib is administered with strong CYP3A4 inhibitors or dual inhibitors of CYP2C9 and CYP3A4 enzymes (e.g. fluconazole) the unit dose of ruxolitinib should be reduced by approximately 50%, to be administered twice daily (see section 4.5).
Maltese: Aġġustament tad-doża b'inibituri konkomitanti qawwija ta' CYP3A4 jew fluconazole Meta ruxolitinib jingħata ma' inibituri qawwija ta' CYP3A4 jew inibituri doppji ta' enzimi ta' CYP2C9 u CYP3A4
English: As a precautionary measure, the use of Jakavi during pregnancy is contraindicated (see section 4.3).
Maltese: Bħala miżura ta' prekawzjoni, l-użu ta' Jakavi waqt it-tqala hu kontraindikat (ara sezzjoni 4.3).
English: Very common (may affect more than 1 in 10 people): - high level of cholesterol or fat in the blood (hypertriglyceridaemia) - abnormal liver function test results - dizziness - headache - urinary tract infections - weight gain
Maltese: Komuni ħafna (jistgħu jaffettwaw aktar minn persuna waħda minn kull 10): - livell għoli ta' kolesterol jew xaħam fid-demm (ipertrigliċeridemija) - riżultati mhux normali tal-funzjoni tal-fwied - sturdament - uġigħ ta' ras - infezzjonijiet fil-passaġġ tal-awrina - żieda fil-piż
English: This summary was last updated in 06-2017.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f' 06-2017.
English: The full EPAR for Chenodeoxycholic acid Leadiant 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: Among 23 patients for whom data on blood levels of bile acids were available, all had reductions in their levels (average reduction of 56-69 µmol/l).
Maltese: Fost 23 pazjent li dwarhom kien hemm disponibbli data rigward il-livelli tad-demm ta' aċidi biljali, kollha kellhom tnaqqis fil-livelli tagħhom (tnaqqis medju ta' 56-69 µmol/l).
English: Chenodeoxycholic acid Leadiant is a ‘hybrid medicine'.
Maltese: Chenodeoxycholic acid Leadiant huwa ‘mediċina ibrida'.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Chenodeoxycholic acid Leadiant can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Among 14 patients for whom data on urine levels of bile acids were available, 79% (11 out of 14) had reduced levels at their most recent test.
Maltese: Fost 14-il pazjent li dwarhom kien hemm disponibbli data rigward il-livelli tal-urina ta' aċidi biljali, 79% (11 minn 14) kellhom livelli mnaqqsa fit-test l-aktar reċenti tagħhom.
English: Previously known as Chenodeoxycholic acid sigma-tau.
Maltese: Preċedentement magħruf bħala Chenodeoxycholic acid sigma-tau.
English: This means that it is similar to a ‘reference medicine' containing the same active substance.
Maltese: Dan ifisser li huwa simili għal ‘mediċina ta' referenza' msejħa li fiha l-istess sustanza attiva.
English: Chenodeoxycholic acid Leadiant is available as capsules (250 mg) which are taken 3 times a day at approximately the same time every day.
Maltese: Chenodeoxycholic acid Leadiant jiġi bħala kapsuli (250 mg) li jittieħdu 3 darbiet kuljum, kważi fl-istess ħin kuljum.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Chenodeoxycholic acid sigma-tau on 10 April 2017.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Chenodeoxycholic acid sigma-tau fl-10 ta' April 2017.
English: The reference medicine for Chenodeoxycholic acid Leadiant is Xenbilox.
Maltese: Il-mediċina ta' referenza għal Chenodeoxycholic acid Leadiant hija Xenbilox.
English: This is a ‘primary bile acid', which is a main component of bile (a fluid produced by the liver that helps to digest fats).
Maltese: Dan huwa ‘aċidu biljari primarju', li huwa komponent ewlieni tal-bili (fluwidu prodott mill-fwied li jgħin sabiex ix-xaħam jiġi diġestit).
English: Because the number of patients with this condition is low, the disease is considered ‘rare', and Chenodeoxycholic acid Leadiant was designated an ‘orphan medicine' (a medicine used in rare diseases) on 16 December 2014.
Maltese: Peress li l-għadd ta' pazjenti b' din il-kondizzjoni huwa wieħed baxx, il-marda hija kkunsidrata 'rari', u Chenodeoxycholic acid Leadiant ġie kklassifikat bħala 'mediċina orfni' (mediċina użata f' mard rari) fis-16 ta' Diċembru 2014.
English: The side effects seen with Chenodeoxycholic acid Leadiant are constipation and abnormal liver test values; however their frequency could not be reliably estimated from the available limited data.
Maltese: L-effetti sekondarji li ntwerew bi Chenodeoxycholic acid Leadiant huma stitikezza u valuri anormali fittest tal-fwied; madankollu l-frekwenza tagħhom ma setgħetx tiġi stmata b' mod affidabbli mid-data limitata disponibbli.
English: For small children and children who cannot swallow capsules, the contents of the capsules can be mixed with sodium bicarbonate solution 8.4% to make a liquid.
Maltese: Għal tfal żgħar u tfal li ma jistgħux jibilgħu kapsuli, il-kontenuti tal-kapsuli jistgħu jitħalltu ma' soluzzjoni ta' 8.4% ta' bikarbonat tas-sodju biex jifforma likwidu.
English: Most patients also had improvements in symptoms of the disease: all reported an improvement in diarrhoea, 89% of patients showed an improvement in their mental ability, 60% of patients showed improvement in mobility, and 85% and 77% of patients showed psychiatric improvement based on two different scores.
Maltese: Il-biċċa l-kbira tal-pazjenti kellhom ukoll titjib fis-sintomi talmarda: kollha rrapportaw titjib fid-dijarea, 89% tal-pazjenti wrew titjib fil-ħila mentali tagħhom, 60% tal-pazjenti wrew titjib fil-mobbiltà, u 85% u 77% tal-pazjenti wrew titjib psikjatriku bbażat fuq żewġ punteġġi differenti.
English: The name of the product was changed to Chenodeoxycholic acid Leadiant on 12 May 2017.
Maltese: L-isem tal-prodott inbidel u sar Chenodeoxycholic acid Leadiant fit-12 ta' Mejju 2017.
English: This is a summary of the European public assessment report (EPAR) for Chenodeoxycholic acid Leadiant.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Chenodeoxycholic acid Leadiant.
English: Chenodeoxycholic acid Leadiant has been investigated in a study which looked at the records of 35 patients with cerebrotendinous xanthomatosis who received chenodeoxycholic acid for around 9 years.
Maltese: Chenodeoxycholic acid Leadiant ġie investigat fi studju li ħares lejn ir-rekords ta' 35 pazjent bi ksantomatożi ċerebrotendinja li rċevew aċidu ċenodeossikoliku għal madwar 9 snin.
English: Chenodeoxycholic acid Leadiant1
Maltese: Chenodeoxycholic acid Leadiant aċidu ċenodeossikoliku
English: Chenodeoxycholic acid Leadiant is used to treat adults and children from one month of age with cerebrotendinous xanthomatosis.
Maltese: Chenodeoxycholic acid Leadiant jintuża għall-kura ta' adulti u tfal mill-età ta' xahar li jkollhom ksantomatożi ċerebrotendinja (cerebrotendinous xanthomatosis).
English: Other information about Chenodeoxycholic acid Leadiant
Maltese: Aktar informazzjoni dwar Chenodeoxycholic acid Leadiant
English: What information is still awaited for Chenodeoxycholic acid Leadiant?
Maltese: Liema informazzjoni għadha mistennija għal Chenodeoxycholic acid Leadiant?
English: Why is Chenodeoxycholic acid Leadiant approved?
Maltese: Għaliex ġie approvat Chenodeoxycholic acid Leadiant?
English: Chenodeoxycholic acid Leadiant is a medicine that contains the active substance chenodeoxycholic acid.
Maltese: Chenodeoxycholic acid Leadiant huwa mediċina li fiha s-sustanza attiva aċidu ċenodeossikoliku.
English: However, Xenbilox differs from Chenodeoxycholic acid Leadiant in that it is authorised for a different use (to dissolve cholesterol gallstones).
Maltese: Madankollu, Xenbilox huwa differenti minn Chenodeoxycholic acid Leadiant minħabba li huwa awtorizza għal użu differenti (biex jinħallu l-ġebel fil-marrara kkawżati millkolesterol).
English: Chenodeoxycholic acid Leadiant has been authorised under ‘exceptional circumstances'.
Maltese: Chenodeoxycholic acid Leadiant ġie awtorizzat taħt ‘ċirkostanzi ta' eċċezzjoni'.
English: For the list of restrictions, see the package leaflet.
Maltese: Għal-lista sħiħa ta' restrizzjonijiet, ara l-fuljett ta' tagħrif.
English: What are the risks associated with Chenodeoxycholic acid Leadiant?
Maltese: X' inhuma r-riskji assoċjati ma' Chenodeoxycholic acid Leadiant?
English: How is Chenodeoxycholic acid Leadiant used?
Maltese: Kif jintuża Chenodeoxycholic acid Leadiant?
English: Chenodeoxycholic acid Leadiant can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in treating cerebrotendinous xanthomatosis or other diseases of primary bile acid production.
Maltese: Peress li Chenodeoxycholic acid Leadiant ġie approvat taħt ċirkostanzi ta' eċċezzjoni, il-kumpanija li tqiegħed din il-mediċina fis-suq ser tistabbilixxi reġistru għas-sorveljanza tal-benefiċċji u tas-sigurtà tal-mediċina.
English: These patients cannot produce enough of the primary bile acid chenodeoxycholic acid due to genetic abnormalities that result in a lack of the liver enzyme sterol 27 hydroxylase.
Maltese: Dawn il-pazjenti ma jistgħux jipproduċu biżżejjed mill-aċidu biljari primarju, l-aċidu ċenodeossikoliku, minħabba anormalitajiet ġenetiċi bir-riżultat ta' nuqqas tal-enzima tal-fwied l-idrossilażi steroli 27.
English: 21 February 2011
Maltese: 21 ta' Frar 2011
English: EMA/594983/2010 Rev.1 EMEA/H/A-29/1268
Maltese: Rev.1 EMEA/H/A-29/1268
English: Galantamine Stada is a generic medicine based on a ‘reference medicine', Reminyl.
Maltese: Galantamine Stada hija mediċina ġenerika bbażata fuq il-'mediċina ta' referenza', Reminyl.
English: What is Galantamine Stada?
Maltese: X'inhu Galantamine Stada?
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Austria) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance the Czech Republic, Denmark, Estonia, Finland, Ireland, Portugal, Slovakia and Spain).
Maltese: Din hija proċedura fejn Stat Membru wieħed (l'Istat Membru ta' referenza', f'dan il-każ l-Awstrija) jivvaluta mediċina bil-għan li din tingħata awtorizzazzjoni għat-tqegħid fis-suq li tkun valida f'dan il-pajjiż kif ukoll fi Stati Membri oħra (l-'Istati Membri kkonċernati', f'dan il-każ ir-Repubblika Ċeka, id-Danimarka, l-Estonja, il-Finlandja, l-Irlanda, ilPortugall, is-Slovakkja u Spanja).
English: Following the CHMP opinion on 23 September 2010, the Agency was informed on 15 October 2010 that the company withdrew the applications for marketing authorisation in all concerned Member States.
Maltese: Wara l-opinjoni tas-CHMP fit-23 ta' Settembru 2010, fil-15 ta' Ottubru 2010 l-Aġenzija ġiet infurmata li l-kumpanija rtirat l-applikazzjonijiet għall-awtorizzazzjoni għat-tqegħid fis-suq fl-Istati Membri kollha kkonċernati.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Galantamine Stada do not outweigh its risks, and the marketing authorisation cannot be granted in Austria or in other Member States of the EU: Czech Republic, Denmark, Finland, Ireland, Portugal, Slovakia and Spain.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li l-benefiċċji ta' Galantamine Stada mhumiex akbar mir-riskji tiegħu, u l-awtorizzazzjoni għat-tqegħid fis-suq ma tistax tingħata fl-Awstrija jew fi Stati Membri oħrajn tal-UE: ir-Repubblika Ċeka, id-Danimarka, il-Finlandja, lIrlanda, il-Portugall, is-Slovakkja u Spanja.
English: However, the Member States were not able to reach an agreement and the Czech Republic referred the matter to the CHMP for arbitration on 26 March 2010.
Maltese: Madankollu, l-Istati Membri ma setgħux jilħqu qbil u r-Repubblika Ċeka rreferiet il-kwistjoni lis-CHMP għall-arbitraġġ fis-26 ta' Marzu 2010.
English: It is used to treat symptoms of mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Maltese: Jintuża għall-kura ta' sintomi ħfief sa moderatament severi ta' dimenzja tal-Alzheimer, disturb progressiv tal-moħħ li jaffettwa gradwalment il-memorja, il-kapaċità intellettwali u l-imġiba.
English: Alfred E. Tiefenbacher GmbH & Co KG submitted Galantamine Stada to the Austrian medicines regulatory agency for a decentralised procedure.
Maltese: Tiefenbacher GmbH & Co
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Galantamine Stada.
Maltese: L-Aġenzija Ewropea għall-Mediċini temmet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost l-Istati Membri tal-Unjoni Ewropea (UE) dwar l-awtorizzazzjoni tal-mediċina Galantamine Stada.
English: Galantamine Stada is a medicine that contains the active substance galantamine.
Maltese: Galantamine Stada hija mediċina li fiha s-sustanza attiva galantamine.
English: In patients with Alzheimer's disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other).Galantamine works by blocking acetylcholinesterase, an enzyme that breaks down acetylcholine.
Maltese: Fil-pazjenti bil-marda tal-Alzheimer, ċerti ċelloli nervużi jmutu fil-moħħ, u dan iwassal għal livelli baxxi tan-newrotrasmettitur acetylcholine (sustanza li tħalli ċ-ċelloli nervużi jikkomunikaw ma' xulxin).
English: The grounds for the referral were that bioequivalence studies, to show that Galantamine Stada produces the same levels of active substance in the body as Reminil, had not been conclusive.
Maltese: Ir-raġunijiet għar-riferiment kienu li l-istudji ta' bijoekwivalenza, biex jintwera li Galantamine Stada jipproduċi l-istess livelli tas-sustanza attiva fil-ġisem bħal Reminil, ma wasslux għall-konklużjoni.
English: Why was Galantamine Stada reviewed?
Maltese: Għalxiex ġie rivedut Galantamine Stada?
English: By blocking this enzyme, galantamine allows levels of acetylcholine to be increased in the parts of the brain associated with intellectual function.
Maltese: Billi jimblokka lil din l-enzima, galantamine jippermetti żieda fil-livelli ta' acetylcholine fil-partijiet tal-moħħ assoċjati mal-funzjoni intellettwali.
English: The CHMP therefore concluded that the benefits of Galantamine Stada do not outweigh its risks and recommended that the marketing authorisation should not be granted in the concerned Member States.
Maltese: Għaldaqstant, is-CHMP ikkonkluda li l-benefiċċji ta' Galantamine Stada mhumiex ikbar mirriskji tiegħu u rrakkomanda li fl-Istati Membri kkonċernati, l-awtorizzazzjoni għat-tqegħid fis-suq ma għandhiex tingħata.
English: MA(EU) Number
Maltese: Numru ta' l-EU
English: (Invented) name
Maltese: (konċentrazzjoni)
English: Prior to launch of the product in each Member State, the Marketing Authorisation Holder shall agree the content and format of a Safety Information Communication with the national competent authority, including the need and the timing of any follow-up Safety Communication Information, as well as the distribution list of such information.
Maltese: Qabel it-tnedija tal-prodott f'kull Stat Membru, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq għandu jasal għall-ftehim mal-awtorità nazzjonali kompetenti dwar il-kontenut u l-format ta' Komunikazzjoni Informattiva dwar is-Sigurtà, inkluż dwar il-ħtieġa u ż-żmien ta' kwalunkwe segwitu għall-Komunikazzjoni Informattiva dwar is-Sigurtà kif ukoll dwar il-lista tad-distribuzzjoni ta' din linformazzjoni.
English: The risk of medication error due to the higher concentration than the dilution concentration of the originator, with potentially life-threatening consequences.
Maltese: Ir-riskju ta' żball terapewtiku kaġun ta' konċentrazzjoni ogħla mill-konċentrazzjoni tas-sustanza dilwita tal-prodott oriġinali, b'konsegwnezi potenzjalment letali.
English: The Marketing Authorisation Holder (MAH) should ensure that, at launch, all Healthcare Professionals who are expected to use and/or prescribe Topotecan Eagle are provided with a Safety Information Communication.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jiżgura li fi żmien it-tnedija lprofessjonisti kollha fil-qasam tas-saħħa li jkunu mistennija jużaw u/jew jippreskrivu Topotecan Eagle jingħataw Komunikazzjoni Informattiva dwar is-Sigurtà.
English: The anticipated effects of overdose (e.g. bone marrow suppression).
Maltese: Formula għar-rapporti ta' żbalji terapewtiċi.
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Maltese: L-Istati Membri għandhom jiggarantixxu li l-kundizzjonijiet jew ir-restrizzjonijiet kollha rigward l-użu sigur u effikaċi tal-prodott mediċinali deskritt hawn taħt ikunu implimentati: