FrancophonIA/ELRC3.0 huggingface dataset:
English: Minimum follow-up time (time from last patient first dose to data snapshot date) of 60 months for CP treated with imatinib only and, 48 months for CP treated with imatinib and at least 1 other TKI, AP and BP.
Maltese: Żmien minimu ta' segwitu (żmien mill-ewwel doża tal-aħħar pazjent sad-data tal-ġbir tad-dejta) ta' 60 xahar għal CP ittrattati b'imatinib biss u, 48 xahar għal individwi b'CP ittrattati b'imatinib u b'mill-inqas 1 TKI, AP u BP ieħor.
English: Bosulif 100 mg film-coated tablets bosutinib
Maltese: Bosulif 100 mg pilloli miksijin b'rita bosutinib
English: Time
Maltese: TIKKETTAR
English: Bosutinib minimally inhibits platelet-derived growth factor (PDGF) receptor and c-Kit.
Maltese: Bosunitib huwa wkollinibitur tal-grupp ta' kinasi Src li jinkludu Src, Lyn u Hck, Bosutinib jinibixxi b'mod minimu irriċettur tal-platelet-derived growth factor (PDGF) u c-Kit.
English: A decline over time in estimated glomerular filtration rate (eGFR) has been observed in patients treated with bosutinib in clinical studies.
Maltese: Matul iż-żmien ġie osservat tnaqqis fir-rata stmata ta' filtrazzjoni glomerulari (eGFR) f'pazjenti ttrattati b'bosutinib fl-istudji kliniċi.
English: - cough.
Maltese: - St.
English: Table 1 - Dose adjustments for neutropenia and thrombocytopenia ANCa < 1.0 × 109/L and/or
Maltese: Tagħtix bosutinib sakemm ANC huwa  1.0 x 10
English: Adverse reaction identified post marketing.
Maltese: ADR identifikata wara t-tqegħid fis-suq.
English: The trial randomised 536 patients (268 in each treatment group) with Ph+ or Ph- newly-diagnosed CP CML (intent-to-treat population [ITT]) including 487 patients with Ph+ CML harbouring b2a2 and/or b3a2 transcripts and baseline BCR-ABL copies > 0 (modified intent-to-treat [mITT] population).
Maltese: Prova ta' Fażi 3, open-label, b'2 partijiet, multiċentrika, ta' superjorità, twettqet biex tinvestiga l-effikaċja u s-sigurtà ta' bosutinib 400 mg darba kuljum waħdu, meta mqabbel ma' imatinib 400 mg darba kuljum waħdu, f'pazjenti adulti li ġew iddijanjostikati għall-ewwel darba b'Ph+ CP CML. Filprova, intgħażlu b'mod każwali 536 pazjent (268 f'kull grupp ta' trattament) b'Ph+ jew Ph iddijanjostikati għall-ewwel darba b'CP CML (intent-to-treat population [ITT]), li kienu jinkludu 487 pazjenti b'Ph+ CML harbouring b2a2 u/jew b3a2 transcripts u kopji BCR-ABL fil- linja bażi ta' > 0 (popolazzjoni modified intent-to-treat [mITT]).
English: Bosutinib belongs to a pharmacological class of medicinal products known as kinase inhibitors.
Maltese: Bosunitib jagħmel parti mill-klassi farmakoloġika ta' mediċini magħrufa bħala inibituri tal-kinasi.
English: Pleural effusion Uncommon Pulmonary hypertension, Respiratory failure, Acute pulmonary oedema Gastrointestinal disorders Very common Diarrhoea, Vomiting, Nausea, Abdominal pain (including Abdominal discomfort, Abdominal pain lower, Abdominal pain upper, Abdominal tenderness, Gastrointestinal pain)
Maltese: Gastrite, Emorraġija gastrointestinali (li tinkludi Emorraġija anali, Emorraġija gastrika, Emorraġija intestinali, Emorraġija gastrointestinali filparti t'isfel, Emorraġija fir-rektum)
English: • CP, accelerated phase (AP), and blast phase (BP) Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.
Maltese: • CP, bil-fażi mgħaġġla (AP), u bil-fażi blast (BP) Ph+ CML li rċevew trattament preċedenti b'inibitur wieħed jew aktar ta' tyrosine kinase [TKI(s)] u li għalihom imatinib, nilotinib u dasatinib mhumiex ikkunsidrati għażliet xierqa ta' trattament.
English: In vitro studies with human liver microsomes indicated that the major cytochrome P450 isozyme involved in the metabolism of bosutinib is CYP3A4 and drug interaction studies have shown that ketoconazole and rifampicin had marked effect on the pharmacokinetics of bosutinib (see section 4.5).
Maltese: Studji in vitro fil-mikrosomi tal-fwied tal-bnedmin indikaw li l-isożima maġġuri ta' cytochrome CYP involuta fil-metaboliżmu ta' bosutinib hija CYP3A4 u studji ta' interazzjoni bejn ilmediċini urew li ketokonazole u rifampicin kellhom effett li jidher sew fuq il-farmakokinetiċi ta' bosutinib (ara sezzjoni 4.5).
English: In a study of 20 healthy subjects, in whom a single dose of 125 mg aprepitant (a moderate CYP3A inhibitor) was co-administered with a single dose of 500 mg bosutinib under fed conditions, aprepitant increased bosutinib Cmax by 1.5-fold, and bosutinib AUC in plasma by 2.0-fold, as compared with administration of bosutinib alone.
Maltese: Fi studju ta' 20 individwu b'saħħtu, li ngħataw doża waħda ta' 125 mg aprepitant (impeditur ta' CYP3A moderat) fl-istess ħin ma' doża waħda ta' 500 mg bosutinib f'kundizzjonijiet mitmugħin, aprepitant żied is-Cmax ta' bosutinib b'darba u nofs, u l-AUC ta' bosutinib fil-plażma b'darbtejn, meta mqabbel mal-għoti ta' bosutinib waħdu.
English: Hold bosutinib until ANC  1.0 × 109/L and platelets 9/L.
Maltese: ANC a < 1.0 x 10 9/L
English: Baseline characteristics for the mITT population were well balanced between the 2 treatment groups with respect to age (median age was 52 years for the bosutinib group and 53 years for the imatinib group with 19.5% and 17.4% of patients 65 years of age or older, respectively); gender (women 42.3% and 44.0%, respectively); and race (Caucasian 77.6% and 77.2%, Asian 12.2% and
Maltese: 5% u 17.4% tal-pazjenti li kellhom 65 sena jew aktar, rispettivament); sess (nisa 42.3% u 44.0%, rispettivament); u razza (Kawkasi 77.6% u 77.2%; Asjatiċi 12.2% u 12.4%, Suwed jew Afrikani Amerikani 4.1% u 4.1%, u Oħrajn 5.7% u 5.8%,, rispettivament).
English: The efficacy results for Ph+ CP CML patients previously treated with imatinib and at least 1 additional TKI (minimum follow-up 48 months, median treatment duration of 9 months and 24.4% still on-treatment at 48 months) and the results for Ph+ CP CML patients previously treated with only imatinib (minimum follow-up 60 months, median treatment duration of 26 months and 40.5% still on-treatment at 60 months) are presented in Table 5.
Maltese: Ir-riżultati tal-effikaċja għal Pazjenti b'Ph+ CP CML li rċevew trattament preċedenti b'imatinib u talanqas TKI wieħed addizzjonali (segwitu minimu ta' 48 xahar, u tul medjan ta' trattament ta' 9 xhur u 24.4% li kienu għadhom fuq it-trattament wara 48 xahar) u r-riżultati għal pazjenti b'Ph+ CP CML li rċevew trattament preċedenti b'imatinib biss (segwitu minimu ta' 60 xahar u tul medjan ta' trattament ta' 26 xhur u 40.5% li kienu għadhom fuq it-trattament wara 60 xahar) huma ppreżentati fit-Tabella 5.
English: The exposure at the highest dose tested in rabbits (10 mg/kg/day) that did not result in adverse foetal effects was 0.9-times and 0.7-times the human exposure resulting from the clinical dose of 400 mg or 500 mg, respectively (based on unbound AUC in the respective species).
Maltese: L-esponiment fl-ogħla doża eżaminata fil-fniek (10 mg/kg/jum) li ma rriżultat fl-ebda effett avvers fuq il-fetu kien 0.9 darbiet u 0.7 darbiet dak tal-esponiment uman li jirriżulta minn doża klinika ta' 400 mg jew 500 mg, rispettivament (fuq bażi tal-AUC mhux imwaħħal fl-ispeċi rispettivi).
English: Belgium
Maltese: България
English: Treatment-naïve CML patients treated with 500 mg showed a median eGFR decline of 5.1 ml/min/1.73 m2 at 3 months, of 9.2 ml/min/1.73 m2 at 12 months and of up to 16.3 ml/min/1.73 m2 until 5 years follow-up for patients on treatment.
Maltese: Pazjenti b'CML li qatt ma rċivew trattament fil-passat, ittrattati b'doża ta' 500 mg, urew tnaqqis medju ta' 5.1 mL/min/1.73 m2 wara 3 xhur, ta' 9.2 mL/min/1.73 m2 wara 12-il xahar, u ta' sa
English: What Bosulif looks like and contents of the pack Bosulif 100 mg film-coated tablets are yellow, oval biconvex, debossed with “Pfizer” on one side and “100” on the other side.
Maltese: Bosulif 100 mg pilloli miksijin b'rita huma sofor, ovali, bikonvessi, mnaqqxa b'“Pfizer” fuq naħa waħda u “100” fuq in-naħa l-oħra.
English: - abnormal build-up of fluid in the lungs (acute pulmonary oedema).
Maltese: Pressjoni għolja pulmonari, Insuffiċjenza respiratorja, Edema pulmonari akuta
English: Bosutinib should be administered with caution to patients who have a history of or predisposition for QTc prolongation, who have uncontrolled or significant cardiac disease including recent myocardial infarction, congestive heart failure, unstable angina or clinically significant bradycardia, or who are taking medicinal products that are known to prolong the QTc (e.g., anti-arrhythmic medicinal products and other substances that may prolong QTc [see section 4.5]).
Maltese: Bosutinib għandu jkun amministrat b'kawtela f'pazjenti li diġà kellhom jew għandhom predispożizzjoni għal titwil talQTc, li għandhom mard tal-qalb mhux ikkontrollat jew sinifikanti nkluż infart mijokardijaku, insuffiċjenza konġestiva tal-qalb, anġina mhux stabbli jew bradikardja klinikament sinifikanti, jew qed jieħdu prodotti mediċinali li huma magħrufa li jtawwlu l-QTc (eż. prodotti mediċinali kontra larritmija u sustanzi oħra li jtawwlu l-QTc [sezzjoni 4.5]).
English: Duration of CHR/OHRe K-M at year 1/2, % (95% CI)c K-M at year 4/5, % (95% CI)
Maltese: K-M f'sena 1/2, % (95% CI)
English: Of the 994 (78%) patients that experienced diarrhoea, 10 patients discontinued bosutinib due to this event.
Maltese: (78%) pazjent li esperjenzaw dijarea, 10 pazjenti waqqfu bosutinib minħabba dijarea.
English: However, bosutinib did not demonstrate a potential for phototoxicity of the skin or eyes in pigmented rats exposed to bosutinib in the presence of UV radiation at bosutinib exposures up to 3-times and 2-times the human exposure resulting from the clinical dose of 400 or 500 mg, respectively (based on unbound Cmax in the respective species).
Maltese: Madankollu, bosutinib ma weriex potenzjal ta' fototossiċità fil-ġilda u fl-għajnejn fi firien li ngħataw il-kulur meta kienu esposti għal bosutinib filpreżenza ta' radjazzjoni UV f'esponimenti ta' bosutinib sa 3 darbiet u darbtejn tal-esponiment uman li jirriżulta minn doża klinika ta' 400 mg jew 500 mg (ibbażat fuq Cmax mhux imwaħħal fl-ispeċi rispettivi).
English: Uncommon Pericarditis
Maltese: Dijarea u rimettar
English: Complete cytogenetic response by Month 12, a secondary endpoint, was defined as the absence of Ph+ metaphases in chromosome banding analysis of ≥ 20 metaphases derived from bone marrow aspirate or MMR if an adequate cytogenetic assessment was unavailable.
Maltese: Rispons ċitoġenetiku komplet sa Xahar 12, punt aħħari sekondarju, kien definit bħala l-assenza ta' metafażijiet Ph+ f'analiżi tal-banding tal-kromożomi ta' ≥ 20 metafażi miksuba minn aspirate talmudullun jew MMR, jekk evalwazzjoni ċitoġenetika adegwata ma kinitx disponibbli.
English: Dizziness, Dysgeusia Ear and labyrinth disorders Common
Maltese: Sturdament, Indeboliment fis-sens tat-togħma Disturbi fil-widnejn u fis-sistema labirintika Komuni
English: Statistically significant comparison at the pre-specified significance level; based on CMH test stratified by geographical region and Sokal score at randomisation.
Maltese: Paragun statistikament sinifikanti fil-livell ta' sinifikanza speċifikat minn qabel; ibbażat fuq it-test CMH stratifikat skont ir-reġjun ġeografiku u l-punteġġ Sokal meta saret l-għażla każwali.
English: The exposure camparison across species indicates that exposures that did not elicit adverse events in the 6- and 9-month toxicity studies in rats and dogs, respectively, were similar to the human exposure resulting from a clinical dose of 400 mg or 500 mg (based on unbound AUC in the respective species).
Maltese: Il-paragun tal-esponiment flispeċi jindika li l-esponimenti li ma wasslux għal avvenimenti avversi fl-istudji tossiċi ta' 6 u 9 xhur fil-firien u l-klieb, rispettivament, kienu simili tal-esponiment uman li jirriżulta minn doża klinika ta' 400 mg jew 500 mg (ibbażat fuq Cmax mhux imwaħħal fl-ispeċi rispettivi).
English: Following administration of a single dose of bosutinib (500 mg) with food in healthy subjects, the absolute bioavailability was 34%.
Maltese: Wara l-amministrazzjoni ta' doża waħda ta' bosutinib (500 mg) mal-ikel f'pazjenti b'saħħithom, ilbijodisponibilità assoluta kienet 34 %.
English: In patients with moderate renal impairment (creatinine clearance [CLCr] 30 to 50 mL/min, estimated by the Cockcroft-Gault formula), the recommended dose of bosutinib is 300 mg daily with food (see sections 4.4 and 5.2).
Maltese: F'pazjenti b'indeboliment moderat tal-kliewi (tneħħija tal-kreatinina [CLCr, creatinine clearance] ta' 30 sa 50 mL/min, stmata skont il-formula Cockcroft-Gault), id-doża rakkomandata ta' bosutinib hija ta' 300 mg kuljum mal-ikel (ara sezzjonijiet 4.4 u 5.2).
English: Pretreated and advanced stage CML patients on 500 mg showed a median eGFR decline of 5.3 ml/min/1.73 m2 at 3 months, of 7.6 ml/min/1.73 m2 at 12 months and of up to 10.9 ml/min/1.73 m2 in up to 4 years on treatment.
Maltese: 5.3 ml/min/1.73 m wara 3 xhur, ta' 7.6 ml/min/1.73 m2 wara 12-il xahar u sa 10.
English: Dose reduction is recommended for patients with moderate or severe renal impairment (see sections 4.2 and 5.2).
Maltese: It-tnaqqis fid-doża hu rakkomandat għal pazjenti b'indeboliment moderat jew sever tal-kliewi (ara sezzjonijiet 4.2 u 5.2).
English: The median time to MMR for responders was 24.7 weeks versus 36.3 weeks for the bosutinib treatment and imatinib treatment groups, respectively, in the mITT population.
Maltese: Iż-żmien medjan biex MMR għal persuni li rrispondew kien ta' 24.7 ġimgħa, kontra 36.3 ġimgħat għall-gruppi ta' trattament bi bosutinib u b'imatinib, rispettivament, filpopolazzjoni mITT.
English: - if you have been told that you have problems with your kidneys.
Maltese: - Għid lit-tabib tiegħek jekk qalulek li għandek problemi bil-kliewi tiegħek.
English: Increasing exposure (area under curve [AUC]) in patients with moderate and severe renal impairment during studies was observed.
Maltese: [AUC, area under curve]) f'pazjenti b'insuffiċjenza renali moderata u severa kienet osservata waqt l-istudji.
English: Clinical study in imatinib-resistant or intolerant CML in CP, AP, and BP A single-arm, Phase 1/2 open-label, multicentre trial was conducted to evaluate the efficacy and safety of bosutinib 500 mg once daily in patients with imatinib-resistant or -intolerant CML with separate cohorts for chronic, accelerated, and blast phase disease previously treated with 1 prior TKI (imatinib) or more than 1 TKI (imatinib followed by dasatinib and/or nilotinib).
Maltese: Studju kliniku fuq CML f'CP, f'AC, u f'BP reżistenti jew li ma ttollerax imatinib Saret prova b'fergħa unika, tal-Fażi 1/2 b'tikketta miftuħa, multiċentrika biex tevalwa l-effikaċja u ssigurtà ta' bosutinib 500 mg darba kuljum f'pazjenti b'CML reżistenti jew li ma ttollerawx imatinib bi gruppi separati għall-marda fil-fażi kronika, mgħaġġla, u blast li rċevew trattament preċedenti b'inibitur ta' TKI 1 imatinib jew aktar minn TKI 1 (imatinib segwit minn dasatinib u/jew nilotinib).
English: Each film-coated tablet contains 500 mg bosutinib (as monohydrate).
Maltese: Kull pillola miksija b'rita fiha 500 mg bosutinib (bħala monoidrat).
English: Based on a population pharmacokinetic analysis increasing exposure (AUC) in patients with moderate and severe renal impairment at initiation of treatment during studies was observed (see sections 4.2 and
Maltese: Fuq bażi tal-analiżi farmakokinetika żieda fl-esponiment (AUC) f'pazjenti b'insuffiċjenza renali moderata u severa filbidu tat-trattament kienet osservata waqt l-istudji (ara sezzjonijiet 4.2 u 5.2).
English: Infections Bosutinib may predispose patients to bacterial, fungal, viral, or protozoan infections.
Maltese: Infezzjonijiet Bosutinib jista' jippredisponi lil pazjenti għal infezzjonijiet batterjali, fungali, virali jew protożonali.
English: 0.0208b
Maltese: L01XE14
English: MMR at Month 12 (95% CI)
Maltese: K-M f'sena 1/2% (95% CI)
English: Each film-coated tablet contains 400 mg bosutinib (as monohydrate).
Maltese: Kull pillola miksija b'rita fiha 400 mg bosutinib (bħala monoidrat).
English: In an oral study of bosutinib in dogs, bosutinib did not produce changes in blood pressure, abnormal atrial or ventricular arrhythmias, or prolongation of the PR, QRS, or QTc of the ECG at exposures up to 3-times the human exposure resulting from the clinical dose of 400 mg and 2-times the human exposure resulting from the clinical dose of 500 mg (based on unbound Cmax in the respective species).
Maltese: Fi studju orali ta' bosutinib fil-klieb, bosutinib m'għamilx tibdil fil-pressjoni tad-demm, arritmiji fl-atriju jew ventrikolu mhux normali, jew titwil tal-PR, tal-QRS, jew tal-QTc tal- ECG f'esponimenti 3 darbiet tal-esponiment uman, li jirriżulta mid-doża klinika ta' 400 mg, u darbtejn tal-esponiment uman, li jirriżulta mid-doża klinika ta' 500 mg (ibbażat fuq Cmax mhux imwaħħal fl-ispeċi rispettivi).
English: Foetal exposure to bosutinib-derived radioactivity during pregnancy was demonstrated in a placental transfer study in gravid Sprague-Dawley rats.
Maltese: L-esponiment tal-fetu għal radjoattività li ġejja minn bosutinib waqt it-tqala kienet murija fl-istudju tat-trasferiment tal-plaċenta fil-firien tat-tip Sprague-Dawley.
English: Very common Rash (including Rash generalised, Rash macular, Rash maculo-papular, Rash papular, Rash pruritic)
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda Komuni ħafna Raxx (li jinkludi Raxx ġeneralizzat, Raxx makulari, makulo-papulari, Raxx papulari, Raxx pruritiku)
English: In the Phase 3 study in patients with newly-diagnosed CP CML who started bosutinib treatment at 400 mg, a total of 46 patients (17.2%) received dose escalations to 500 mg.
Maltese: Fl-istudju ta' Fażi 3 f'pazjenti li ġew iddijanjostikati għall-ewwel darba b'CP CML, li bdew ittrattament bi bosutinib f'doża ta' 400 mg, total ta' 46 pazjent (17.2%) irċivew żidiet fid-doża għal 500 mg.
English: These medicines should be avoided during your treatment with Bosulif.
Maltese: Dawn il-mediċini għandhom ikunu evitati waqt it-trattament b'Bosulif.
English: Caution is recommended in patients with previous history of pancreatitis.
Maltese: Kawtela hija rrakkomandata f'pazjenti li diġà kellhom pankreatite.
English: If transaminase elevations ≥ 3 × ULN occur concurrently with bilirubin elevations > 2 × ULN and alkaline phosphatase < 2 × ULN, bosutinib should be discontinued (see section 4.4).
Maltese: Barra minn hekk, iddijarea u r-rimettar jistgħu jiġu kkontrollati wkoll billi bosutinib jitwaqqaf temporanjament, titnaqqas id-doża, u/jew jitwaqqaf it-trattament b'bosutinib (ara sezzjonijiet 4.2 u 4.8).
English: - itching, urticaria (hives), acne.
Maltese: - Ħakk, urtikarja (ħmura tal-ġilda li titla' bħal ħobż ħobż), akne.
English: The following active substances may reduce the effectiveness of Bosulif: - rifampicin, used to treat tuberculosis.
Maltese: Dawn is-sustanzi attivi li ġejjin jistgħu jnaqqsu l-effikaċja ta' Bosulif: - rifampicin, użat biex jittratta t-tuberkulosi.
English: Bosutinib inhibits the abnormal BCR-ABL kinase that promotes CML.
Maltese: Dawn ir-reazzjonijiet avversi huma preżentati skont is-sistema talklassifika tal-organi u l-frekwenza.
English: The primary efficacy endpoint of the study was the major cytogenetic response (MCyR) rate at Week 24 in patients with imatinib-resistant CP CML previously treated with only 1 prior TKI (imatinib).
Maltese: L-endpoint primarju tal-effikaċja tal-istudju kien ir-rata tar-rispons ċitoġeniku maġġuri (MCyR) fl24 Ġimgħa f'pazjenti b'CP CML reżistenti għal imatinib li rċevew trattament preċedenti b'TKI 1 biss (imatinib).
English: Each film-coated tablet contains 100 mg bosutinib (as monohydrate).
Maltese: Kull pillola miksija b'rita fiha 100 mg bosutinib (bħala monoidrat).
English: In the Phase 3 clinical study in patients with newly diagnosed Ph+ CP CML treated with bosutinib 500 mg, QTcF interval changes > 60 ms from baseline were observed in 2 (0.8%) of 248 patients receiving bosutinib.
Maltese: Fl-istudju kliniku ta' Fażi 3 f'pazjenti li ġew iddijanjostikati għall ewwel darba b'CP CML, ittrattati b'bosutinib 400 mg, ma kien hemm l-ebda pazjenti fil-grupp ta' trattament ta' bosutinib b'żieda ta' > 60 ms mil-linja bażi meta l-intervall tal-QT kien ikkoreġut billi ntużat il-formula Fridericia (QTcF). Fil-Fażi 3 tal-istudju kliniku f'pazjenti li għadhom kif ġew dijanjostikati b'Ph+ CP CML ittrattati bi bosutinib 500 mg, bidliet fl-intervall tal-QTcF ta' > 60 ms mill-linja bażi kienu osservati fi 2 (0.8%) minn 248 pazjent li qed jirċievu Bosulif.
English: Bosutinib exhibits dose proportional increases in AUC and Cmax, over the dose range of 200 to 600 mg. Food increased bosutinib Cmax 1.8-fold and bosutinib AUC 1.7-fold compared to the fasting state.
Maltese: Bosutinib juri żidiet proporzjonali fid-doża fl-AUC u Cmax, fil-medda tad-dożi ta' 200 sa 600 mg.
English: Cardiac disorders Common
Maltese: Disturbi vaskulari Komuni
English: Annex related to the Art. 127a
Maltese: Anness relatat mal-artiklu 127a
English: - Prior to prescribing (where appropriate, and in agreement with the National Competent Authority, dispensing) all healthcare professionals who intend to prescribe (and dispense) pomalidomide are provided with a physician information pack containing the following: - Educational Health Care Professional's kit - Educational brochures for Patients - Patient cards - Summary of Product Characteristics (SmPC) and Package Leaflet and Labelling.
Maltese: - Kitt edukattiv għall-Professjonisti fil-Qasam tal-Kura tas-Saħħa - Pamflets edukattivi għall-pazjenti - Kards tal-pazjent - Sommarju tal-Karatteristiċi tal-Prodott (SPC) u Fuljett ta' Tagħrif u Tikkettar
English: The Member State shall ensure that the MAH shall implement a pregnancy prevention programme (PPP) within their territory.
Maltese: L-Istat Membru għandu jiżgura li l-MAH jimplimenta Programm tal-Prevenzjoni tat-Tqala (PPP, Pregnancy Prevention Programme) fit-territorju tiegħu.
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: The Member State shall agree the details of a controlled distribution system with the Marketing Authorisation Holder (MAH) and must implement such programme nationally to ensure that: - Prior to launch, all doctors who intend to prescribe pomalidomide and all pharmacists who may dispense pomalidomide receive a Direct Healthcare Professional Communication as described below.
Maltese: L-Istat Membru għandu jiftiehem dwar id-dettalji ta' sistema ta' distribuzzjoni kkontrollata madDetentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH, Marketing Authorisation Holder) u jrid jimplimenta programm bħal dan b'mod nazzjonali biex jiżgura li: - Qabel it-tnedija, it-tobba kollha li jkollhom l-intenzjoni li jagħtu riċetta għal pomalidomide, u l ispiżjara kollha li jistgħu jagħtu pomalidomide, jirċievu Komunikazzjoni Diretta tal
English: Details of the PPP including the set-up of national measures to assess the effectiveness of and compliance with the PPP should be agreed with the National Competent Authorities in each Member State and put in place prior to the marketing of the product.
Maltese: Id-dettalji tal-PPP li jinkludu l-ħolqien ta' miżuri nazzjonali biex jevalwaw l-effettività ta' u l-konformità mal-PPP għandhom jiġu miftehma mal-Awtoritajiet Kompetenti Nazzjonali f'kull Stat Membru u għandhom ikunu implimentati qabel it-tqegħid fis-suq tal-prodott.
English: Invented name Strength Pharmaceutical Form Route of Administration Packaging Package size EU/1/09/605/001 Temomedac
Maltese: Mnejn jingħata Il-pakkett
English: Solvent: 1.7 ml
Maltese: Konċentrat: 0.5 ml; Solvent: 1.7 ml
English: 5 x 1012 vg/ml Concentrate and solvent for solution for injection
Maltese: 5 x 1012 vg/ml Konċentrat u solvent għal soluzzjoni għal injezzjoni
English: Solvent: vial (COC)
Maltese: Konċentrat: kunjett (COC); Solvent: kunjett (COC)
English: Subretinal use
Maltese: Qawwa
English: 1 concentrate vial + 2 solvent vials
Maltese: Kunjett ta' konċentrat wieħed+ 2 kunjetti ta' konċentrat
English: Ref.: EMEA/405817/2009 EMEA/H/C/1139
Maltese: EMEA/523277/2009 EMEA/H/C/1139
English: This summary was last updated in 06-2009.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 06-2009.