FrancophonIA/ELRC3.0 huggingface dataset:
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states
Maltese: Anness I Lista tal-ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali, mnejn jingħata, detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fl-Istati Membri
English: Hungary
Maltese: Greece
English: Sweden
Maltese: Spain
English: FUNGAREST comprimidos 200mg
Maltese: TABLETS 200MG
English: S.C.
Maltese: Dr.
English: Total dose (mg) = Dose (mg/m 2) x BSA (m
Maltese: Doża totali (mg) = Doża (mg/m2) x BSA (m
English: KEY: AZA = azacitidine; CCR = conventional care regimens; CI = confidence interval; HR = hazard ratio
Maltese: KEY: AZA = azacitidine; CCR = (conventional care regimens) korsijiet ta' kura konvenzjonali; CI = (confidence interval) intervall tal-kunfidenza;
English: Dose mg/m (% of recommended starting dose)
Maltese: Doża mg/m (% tad-doża tal-bidu rakkomandata)
English: • intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS),
Maltese: • sindromi majelodisplastiċi (MDS) intermedji-2 u ta' riskju għoli skont l-International Prognostic Scoring System (IPSS),
English: Also contains mannitol.
Maltese: Fih ukoll mannitol.
English: 9/l, and platelets ≥ 75.0 x 10
Maltese: 9/l, u plejtlits ≥ 75.0 x 10
English: 9/L), baseline bone marrow blasts (≤ 50% & > 50%) and prior history of MDS] there was a trend in OS benefit in favour of azacitidine.
Maltese: 9/L), blasts tal-mudullun fil-linja bażi (≤ 50% u > 50%) u storja medika fil-passat ta' MDS], kien hemm tendenza fil-benefiċċju ta' OS favur azacitidine.
English: Recovery* > 21 days
Maltese: Irkuprar* > 21 jum
English: • acute myeloid leukaemia (AML) with 20-30 % blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) classification,
Maltese: • lewkimja majelojde akuta (AML) b'20-30% blasts u displasja multi-lineage, skont il-klassifikazzjoni tal-Organizzazzjoni Dinjija tas-Saħħa (WHO),
English: Azacitidine Celgene contains the active substance ‘azacitidine'.
Maltese: Azacitidine Celgene fih is-sustanza attiva msejħa ‘azacitidine'.
English: 9/l or ANC < 1.5 x 10
Maltese: 9/l u ANC ≥ 1.5 x 10
English: Total dose based on BSA value of 1.8 m
Maltese: Doża totali bbażata fuq il-valur BSA ta' 1.8 m
English: The Cox PH model adjusted for pre-specified baseline prognostic factors defined a HR for azacitidine versus CCR of 0.80 (95% CI= 0.66, 0.99; p = 0.0355).
Maltese: Il-mudell ta' Cox PH aġġustat għal fatturi pronjostiċi fil-linja bażi speċifikati minn qabel, iddefinixxew HR għal azacitidine kontra CCR ta' 0.80 (95% CI= 0.66, 0.99; p = 0.0355).
English: Powder for suspension for injection.
Maltese: Trab għal suspensjoni għall-injezzjoni.
English: 2 D bar code carrying the unique identifier
Maltese: Barcode 2D li jkollu l-identifikatur uniku inkluż
English: 1 vial - 100 mg
Maltese: Kunjett 1 - 100 mg
English: Infections and infestations pneumonia* (including bacterial, viral and fungal), nasopharyngitis sepsis* (including bacterial, viral and fungal), neutropenic sepsis*, respiratory tract infection (includes upper and bronchitis), urinary tract infection, cellulitis, diverticulitis, oral fungal infection, sinusitis, pharyngitis, rhinitis, herpes simplex, skin infection necrotising fasciitis *
Maltese: Infezzjonijiet u infestazzjonijiet pnewmonja* (tinkludi pnewmonja batterjali, virali u fungali), nażofarinġite sepsis* (tinkludi sepsis batterjali, virali u fungali), sepsis newtropenika*, infezzjoni fl-apparat respiratorju (tinkludi infezzjoni fl-apparat respiratorju ta' fuq u bronkite), infezzjoni fl-apparat tal-awrina, ċellulite, divertikulite, infezzjoni fungali orali, sinusite, farinġite, rinite, herpes simplex,infezzjoni tal-ġilda
English: Azacitidine plus best supportive care (BSC) (n = 179) was compared to conventional care regimens (CCR).
Maltese: Azacitidine flimkien mal-aħjar kura ta' appoġġ (BSC) (n = 179) kien imqabbel ma' korsijiet ta' kura konvenzjonali (CCR).
English: Investigations weight decreased * = rarely fatal cases have been reported
Maltese: *= każijiet fatali rari ġew irrappurtati
English: 9/l and/or absolute neutrophil count (ANC) ≤ 1 x 10
Maltese: 9/l u/jew l-għadd assolut tan-newtrofili (Absolute Neutrophil Count, ANC)
English: Azacitidine Celgene 25 mg/mL powder for suspension for injection Azacitidine
Maltese: Azacitidine Celgene 25 mg/mL trab għal suspensjoni għall-injezzjoni Azacitidine
English: In the ITT analysis of 488 patients (241 azacitidine and 247 CCR), azacitidine treatment was associated with a median survival of 10.4 months versus 6.5 months for those receiving CCR treatment, a difference of 3.8 months, with a stratified log-rank p-value of 0.1009 (two- sided).
Maltese: ITT ta' 488 pazjent (241 azacitidine u 247 CCR), il-kura b'azacitidine kienet assoċjata ma' medjan ta' sopravivenza ta' 10.4 xahar kontra 6.5 xhur għal dawk li kienu qed jirċievu l-kura CCR, differenza ta' 3.8 xhur, b'valur p log-rank stratifikat ta' 0.1009 (two-sided).
English: Following intravenous and subcutaneous administration of C-azacitidine, 85 and 50 % of the administered radioactivity was recovered in urine respectively, while < 1 % was recovered in faeces.
Maltese: C-azacitidine, 85 u 50% tar-radjuattività mogħtija kienet irkuprata fl-awrina rispettivament, filwaqt li < 1% kienet irkuprata fl-ippurgar.
English: Azacitidine Celgene 25 mg/mL powder for suspension for injection
Maltese: IL-PRODOTT MEDIĊINALI Azacitidine Celgene 25 mg/mL trab għal suspensjoni għall-injezzjoni
English: • The recommended dose is 75 mg per m body surface area.
Maltese: • Id-doża rakkomandata hija 75 mg/m ta' erja tas-superfiċje tal-ġisem.
English: Adult population with MDS, CMML and AML (20-30% marrow blasts) Adverse reactions considered to be possibly or probably related to the administration of azacitidine have occurred in 97 % of patients.
Maltese: Popolazzjoni adulta b'MDS, CMML u AML (20-30% blasts tal-mudullun) Reazzjonijiet avversi li huma kkunsidrati li huma possibbilment jew probabbilment relatati mal-għoti ta' azacitidine seħħew f'97% tal-pazjenti.
English: In all pre- specified subgroups age [(< 75 years & ≥ 75 years), gender, race, ECOG performance status (0 or 1 & 2) , baseline cytogenetic risk (intermediate & poor) , geographic region, WHO classification of AML (including AML with myelodysplasia-related changes), baseline WBC count (≤ 5 x10
Maltese: Fis-sottogruppi kollha ta' età speċifikati minn qabel [(< 75 sena u ≥ 75 sena), is-sess tal-persuna, ir-razza, l-istat ta' prestazzjoni ECOG (0 jew 1 u 2), ir-riskju ċitoġenetiku fil-linja bażi (intermedju u batut), ir-reġjun ġeografiku, il-klassifikazzjoni tal-WHO ta' AML (li tinkludi AML b'tibdil relatat ma' majelodisplasija), għadd ta' WBC fil-linja bażi (≤ 5 x10
English: Of the patients in the azacitidine group who were platelet transfusion dependent at baseline, 40.6% (95% CI = 30.9, 50.8) of these patients became platelet transfusion independent during the treatment period, compared with 29.3% of (95% CI = 19.7, 40.4) patients in the combined CCR groups.
Maltese: Mill-pazjenti fil-grupp ta' azacitidine li kienu dipendenti fuq trasfużjoni ta' plejtlets fil-linja bażi, 40.6% (95% CI = 30.9, 50.8) minn dawn il-pazjenti saru indipendenti minn trasfużjoni ta' plejtlits matul il-perjodu ta' kura, meta mqabbla ma' 29.3% ta' (95% CI = 19.7, 40.4) pazjenti fil-gruppi ta' CCR kombinat.
English: Adult population (MDS, CMML and AML [20-30% marrow blasts]) The efficacy and safety of azacitidine were studied in an international, multicenter, controlled, openlabel, randomised, parallel-group, Phase 3 comparative study (AZA PH GL 2003 CL 001) in adult patients with: intermediate-2 and high-risk MDS according to the International Prognostic Scoring System (IPSS), refractory anaemia with excess blasts (RAEB), refractory anaemia with excess blasts in transformation (RAEB-T) and modified chronic myelomonocytic leukaemia (mCMML) according to the French American British (FAB) classification system.
Maltese: Popolazzjoni adulta (MDS, CMML u AML [20-30% blasts tal-mudullun]) L-effikaċja u s-sigurtà ta' azacitidine kienu studjati fi studju internazzjonali komparattiv, multiċentriku, ikkontrollat, open-label, randomised, parallel-group, ta' Fażi 3 (AZA PH GL 2003 CL 001) f'pazjenti adulti b':
English: Azacitidine Celgene is an anti-cancer agent which belongs to a group of medicines called ‘antimetabolites'.
Maltese: Azacitidine Celgene hi sustanza kontra l-kanċer li tappartjeni għal grupp ta' mediċini msejħa ‘antimetaboliti'.
English: Adult population aged 65 years or older with AML with > 30% marrow blasts The most common serious adverse reactions (≥ 10%) noted from AZA-AML-001 within the azacitidine treatment arm included febrile neutropenia (25.0%), pneumonia (20.3%), and pyrexia (10.6%).
Maltese: Popolazzjoni adulta li jkollha 65 sena jew aktar b'AML bi > 30% ta' blasts tal-mudullun L-iktar reazzjonijiet avversi serji komuni (≥ 10%) osservati minn AZA-AML-001 fil-parti tal-istudju dwar il-kura b'azacitidine kienu jinkludu newtropenija bid-deni (25.0%), pnewmonja (20.3%), u deni (10.6%).
English: 5 How to store Azacitidine Celgene Contents of the pack and other information
Maltese: Kif taħżen Azacitidine Celgene Kontenut tal-pakkett u informazzjoni oħra
English: Reconstituted suspension For storage conditions after reconstitution of the medicinal product, see section 6.3.
Maltese: Suspensjoni rikostitwita Għall-kondizzjonijiet ta' ħażna wara r-rikostituzzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: Azacitidine Celgene is contraindicated in patients with advanced malignant hepatic tumours (see sections 4.3 and 4.4).
Maltese: Azacitidine Celgene hu kontraindikat f'pazjenti b'tumuri epatiċi malinni avvanzati (ara sezzjonijiet 4.3 u 4.4).
English: CCR consisted of BSC alone (n=45), low-dose cytarabine plus BSC (n=158), or standard intensive chemotherapy with cytarabine and anthracycline plus BSC (n=44).
Maltese: azacitidine flimkien ma' BSC (n=241) ġie pparagunat ma' CCR. CCR kienet tikkonsisti f'BSC waħidha (n=45), cytarabine f'doża baxxa flimkien ma' BSC (n=158) jew kimoterapija intensiva standard ma' cytarabine u anthracycline flimkien ma' BSC (n=44).
English: The safety and efficacy of Azacitidine Celgene in children aged 0-17 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Azacitidine Celgene fit-tfal minn età 0 sa 17-il sena għadhom ma ġewx determinati s'issa.
English: Platelets (x 10
Maltese: Plejtlits (x 10 9/l)
English: Haematological toxicity is defined as the lowest count reached in a given cycle (nadir) if platelets ≤ 50.0 x 10
Maltese: It-tossiċità ematoloġika hi definita bħala l-inqas għadd li jintlaħaq f'ċiklu partikulari (nadir) jekk il-plejtlits ≤ 50.0 x 10
English: In the ITT analysis of 358 patients (179 azacitidine and 179 CCR), azacitidine treatment was associated with a median survival of 24.46 months versus 15.02 months for those receiving CCR treatment, a difference of 9.4 months, with a stratified log-rank p-value of 0.0001.
Maltese: ITT ta' 358 pazjent (179 azacitidine u 179 CCR), il-kura b'azacitidine kienet assoċjata ma' medjan ta' sopravivenza ta' 24.46 xahar kontra 15.
English: OTHER
Maltese: vaa
English: Cytotoxic
Maltese: Ċitotossiku
English: Following subcutaneous administration of a single 75 mg/m dose, mean exposure values (AUC and Cmax) from subjects with mild, moderate and severe renal impairment were increased by 11-21%, 15-27%, and 41-66%, respectively, compared to normal renal function subjects.
Maltese: Wara l-għoti taħt il-ġilda ta' doża waħda ta' 75 mg/m2, il-valuri medji tal-esponiment (AUC u Cmax) minn individwi b'indeboliment renali ħafif, moderat u sever żdiedu b'11-21%, 15-27%, u 41-66%, rispettivament, meta mqabbla ma' individwi b'funzjoni renali normali.
English: When Azacitidine Celgene is reconstituted using water for injections that has not been refrigerated, chemical and physical in-use stability of the reconstituted medicinal product has been demonstrated at 25 °C for 45 minutes and at 2 °C to 8 °C for 8 hours.
Maltese: Meta Azacitidine Celgene jiġi rikostitwit bl-użu ta' ilma għall-injezzjonijiet li ma jkunx tpoġġa fi friġġ, l-istabbiltà kimika u fiżika waqt l-użu tal-prodott mediċinali rikostitwit intweriet f'temperatura ta' 25°C għal 45 minuta u f'temperatura ta' minn 2°C sa 8°C għal 8 sigħat.
English: Adult population aged 65 years or older with AML with > 30% marrow blasts The results presented below represent the intent-to-treat population studied in AZA-AML-001 (see section 4.1 for the approved indication).
Maltese: Popolazzjoni adulta li jkollha 65 sena jew aktar b'AML bi > 30% ta' blasts tal-mudullun Ir-riżultati ppreżentati hawn taħt jirrappreżentaw il-popolazzjoni b'intenzjoni li tiġi kkurata, studjata fi studju AZA-AML-001 (ara sezzjoni 4.1 għall-indikazzjoni approvata).
English: In patients who achieved CR or CRi, the median duration of remission was 10.4 months (95% CI = 7.2, 15.2) for the azacitidine subjects and 12.3 months (95% CI = 9.0, 17.0) for the CCR subjects.
Maltese: F'pazjenti li kisbu CR jew CRi, it-tul medjan ta' tnaqqis fil-mard kien ta' 10.4 xhur (95% CI = 7.2, 15.2) għal individwi fuq azacitidine, u 12.3 xhur (95% CI = 9.0, 17.0) għal individwi fuq CCR. Intwera wkoll benefiċċju ta' sopravivenza f'pazjenti li ma kisbux rispons sħiħ għal azacitidine meta mqabbla ma' CCR.
English: Other medicines and Azacitidine Celgene
Maltese: Mediċini oħra u Azacitidine Celgene
English: *Recovery = counts ≥ nadir count + (0.5 x [baseline count - nadir count]) Patients with reduced baseline blood counts (i.e. WBC < 3.0 x 10
Maltese: *Irkuprar = għadd ≥ għadd tan-nadir + (0.5 x [għadd fil-linja bażi - għadd tan-nadir])
English: Of the patients in the azacitidine group who were RBC transfusion dependent at baseline, 38.5% (95% CI = 31.1, 46.2) of these patients became RBC transfusion independent during the treatment period, compared with 27.6% of (95% CI = 20.9, 35.1) patients in the combined CCR groups.
Maltese: Mill-pazjenti fil-grupp ta' azacitidine li kienu dipendenti fuq trasfużjoni ta' RBC fil-linja bażi, 38.5% (95% CI = 31.1, 46.2) minn dawn il-pazjenti saru indipendenti minn trasfużjoni ta' RBC matul il-perjodu ta' kura, meta mqabbla ma' 27.
English: >5 x 10
Maltese: 9/L u >5 x 10
English: Overall response rate (complete remission [CR] + complete remission with incomplete blood count recovery [CRi]) as determined by the IRC was 27.8% in the azacitidine group and 25.1% in the combined CCR group (p = 0.5384).
Maltese: Ir-rata ta' rispons globali (tnaqqis ta' mard komplet [CR] + tnaqqis ta' mard komplet b'irkupru mhux komplet ta' għadd tad-demm [CRI]) kif determinat mill-IRC kienet ta' 27.8% fil-grupp ta' azacitidine u 25.
English: The Azacitidine Celgene suspension may be prepared immediately before use and the reconstituted suspension should be administered within 45 minutes.
Maltese: Is-suspensjoni ta' Azacitidine Celgene tista' tkun ippreparata immedjatament qabel l-użu u s-suspensjoni rikostitwita għandha tingħata fi żmien 45 minuta.
English: In patients who were RBC transfusion dependent at baseline and achieved transfusion independence on treatment, the median duration of RBC transfusion independence was 13.9 months in the azacitidine group and was not reached in the CCR group.
Maltese: F'pazjenti li kienu dipendenti fuq trasfużjoni ta' RBC fil-linja bażi u li kisbu indipendenza mit-trasfużjonijiet waqt li kienu fuq il-kura, it-tul medjan ta' indipendenza minn trasfużjoni ta' RBC kien ta' 13.9 xhur fil-grupp ta' azacitidine, u ma ntlaħaqx fil-grupp ta' CCR.
English: How to use Azacitidine Celgene
Maltese: Tużax Azacitidine Celgene
English: The efficacy and safety of azacitidine was studied in an international, multicentre, controlled, openlabel, parallel group Phase 3 study in patients 65 years and older with newly diagnosed de novo or secondary AML with >30% bone marrow blasts according to the WHO classification, who were not eligible for HSCT.
Maltese: L-effikaċja u s-sigurtà ta' azacitidine ġew studjati fi studju ta' Fażi 3, internazzjonali, multiċentriku, ikkontrollat, open-label, ta' grupp parallel, li twettaq f'pazjenti li kellhom 65 sena jew aktar, b'AML ma għadhom kif ġew dijanjostikati de novo jew AML ddijanjostikata għall-ewwel de novo jew sekondarja bi > 30% blasts tal-mudullun skont il-klassifikazzjoni tal-WHO, li ma kinux eliġibbli għal HSCT.
English: 21 days (28 day treatment cycle), for a median of 6 cycles (range: 1 to 28), BSC- only patients for a median of 3 cycles (range: 1 to 20), low-dose cytarabine patients for a median of 4 cycles (range 1 to 25) and standard intensive chemotherapy patients for a median of 2 cycles (range: 1 to 3, induction cycle plus 1 or 2 consolidation cycles).
Maltese: Azacitidine ingħata f'doża SC ta' 75 mg/m2/jum għal 7 ijiem, segwit minn perjodu ta' mistrieħ ta' 21 jum (ċiklu ta' kura ta' 28 jum), għal medjan ta' 6 ċikli (medda: 1 sa 28), pazjenti fuq BSC biss għal medjan ta' 3 ċikli (medda: 1 sa 20), pazjenti fuq cytarabine ta' doża baxxa għal medjan ta' 4 ċikli (medda 1 sa 25) u pazjenti fuq kimoterapija intensiva standard għal medjan ta' 2 ċikli (medda: 1 sa 3, ċiklu ta' induzzjoni flimkien ma' 1 jew 2 ċikli ta' konsolidazzjoni).
English: When Azacitidine Celgene is reconstituted using refrigerated (2 °C to 8 °C) water for injections, the chemical and physical in-use stability of the reconstituted medicinal product has been demonstrated at 2 °C to 8 °C for 22 hours.
Maltese: Meta Azacitidine Celgene jiġi rikostitwit bl-użu ta' ilma għall-injezzjonijiet li jkun tpoġġa fi friġġ (2°C sa 8°C), l-istabbiltà kimika u fiżika tal-prodott mediċinali rikostitwit, waqt li jkun qed jintuża intweriet f'temperatura ta' 2°C sa 8°C għal 22 siegħa.
English: How to store Azacitidine Celgene
Maltese: X'inhu Azacitidine Celgene
English: Reconstituted Azacitidine Celgene should be injected subcutaneously (insert the needle at a 45-90° angle) using a 25-gauge needle into the upper arm, thigh or abdomen.
Maltese: Azacitidine Celgene rikostitwit għandu jkun injettat taħt il-ġilda (daħħal il-labra f'angolu ta' 45-90°) billi tuża labra 25-gauge fil-parti ta' fuq tad-driegħ, koxxa jew addome.
English: < 75.0 x 10
Maltese: < 1.5 x 10 9/l jew plejtlits < 75.0 x 10
English: # at risk months months
Maltese: # f'riskju xhur xhur
English: Absorption Following subcutaneous administration of a single 75 mg/m dose, azacitidine was rapidly absorbed with peak plasma concentrations of 750 ± 403 ng/mL occurring at 0.5 h after dosing (the first sampling point).
Maltese: Assorbiment Wara l-għoti taħt il-ġilda ta' doża waħda ta' 75 mg/m2, azacitidine kien assorbit b'mod mgħaġġel b'konċentrazzjonijiet massimi ta' azacitidine fil-plażma ta' 750 ± 403 ng/mL li seħħew wara 0.5 siegħa wara d-dożaġġ (l-ewwel darba li ttieħed kampjun).
English: Patients without reduced baseline blood counts (i.e. White Blood Cells (WBC) ≥ 3.0 x 10
Maltese: Pazjenti mingħajr għadd imnaqqas taċ-ċelluli tad-demm fil-linja bażi (i.e. Ċelluli Bojod tad-Demm (WBC) ≥ 3.0 x 10
English: Azacitidine Celgene is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with:
Maltese: Azacitidine Celgene huwa indikat għall-kura ta' pazjenti adulti li mhumiex eliġibbli għal trapjant b'ċelluli staminali ematopojetiċi (HSCT) li għandhom:
English: VIAL LABEL
Maltese: Iċċensurat
English: The survival benefits of azacitidine were consistent regardless of the CCR treatment option (BSC alone, low-dose cytarabine plus BSC or standard induction chemotherapy plus BSC) utilised in the control arm.
Maltese: Il-benefiċċji tas-sopravivenza ta' azacitidine kienu konsistenti irrispettivament mill-għażla tal-kura CCR (BSC waħidha, doża baxxa ta' cytarabine flimkien ma' BSC jew kimoterapija tal-induzzjoni standard flimkien ma' BSC) użati fil-parti tal-kontroll tal-istudju.
English: 9/l.
Maltese: ≤ 1 x 10 9/l.
English: Each pack contains one vial of Azacitidine Celgene.
Maltese: Kull pakkett fih kunjett wieħed ta' Azacitidine Celgene.
English: What Azacitidine Celgene looks like and contents of the pack Azacitidine Celgene is a white powder for suspension for injection and is supplied in a glass vial containing 100 mg of azacitidine.
Maltese: Kif jidher Azacitidine Celgene u l-kontenut tal-pakkett Azacitidine Celgene hu trab għal suspensjoni għall-injezzjoni abjad u hu fornut f'kunjett tal-ħġieġ li fih 100 mg ta' azacitidine.
English: Recovery is defined as an increase of cell line(s) where haematological toxicity was observed of at least half of the difference of nadir and the baseline count plus the nadir count (i.e. blood count at recovery ≥ nadir count + (0.5 x [baseline count - nadir count]).
Maltese: L-irkuprar hu definit bħala żieda ta' linja(i) taċ-ċelluli fejn it-tossiċità ematoloġika tkun ġiet osservata f'mill-inqas nofs id-differenza tan-nadir u l-għadd fil-linja bażi flimkien mal-għadd tan-nadir (i.e. għadd taċ-ċelluli tad-demm fl-irkuprar ≥ għadd tan-nadir + (0.5 x [għadd fil-linja bażi - għadd tan-nadir]).
English: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline haematology laboratory values, is 75 mg/m of body surface area, injected subcutaneously, daily for 7 days, followed by a rest period of 21 days (28-day treatment cycle).
Maltese: Id-doża tal-bidu rakkomandata għall-ewwel ċiklu ta' kura, għall-pazjenti kollha mingħajr ma jingħata kas tal-valuri ematoloġiċi tal-laboratorju fil-linja bażi, hi ta' 75 mg/m ta' erja tas-superfiċje tal-ġisem, injettata taħt il-ġilda, kuljum għal 7 ijiem, segwita minn perjodu ta' serħan ta' 21 jum (ċiklu tal-kura ta' 28 jum).
English: New injections should be given at least 2.5 cm from the previous site and never into areas where the site is tender, bruised, red, or hardened.
Maltese: Injezzjonijiet ġodda għandhom jingħataw mill-inqas 2.5 ċm mill-post ta' qabel u qatt f'żoni fejn il-ġilda tkun ratba, imbenġla, ħamra, jew iebsa.
English: In patients with one or more cytogenetic abnormalities at baseline, the percentage of patients with a major cytogenetic response was similar in the azacitidine and combined CCR groups.
Maltese: F'pazjenti b'anormalità ċitoġenika waħda jew aktar fil-linja bażi, il-perċentwali ta' pazjenti b'rispons ċitoġeniku maġġuri kien simili fil-gruppi kkurati b'azacitidine u b'CCR kombinat.
English: 9/l or platelets
Maltese: 9/l) qabel l-ewwel kura
English: The absolute bioavailability of azacitidine after subcutaneous relative to intravenous administration (single 75 mg/m doses) was approximately 89% based on area under the curve (AUC).
Maltese: Il-bijodisponibilità assoluta ta' azacitidine wara l-għoti taħt il-ġilda meta mqabbla mal-għoti ġol-vina (dożi waħidhom ta' 75 mg/m kienet ta' madwar 89% ibbażata fuq l-erja taħt il-kurva (AUC).
English: Azacitidine was administered at a subcutaneous dose of 75 mg/m daily for 7 days, followed by a rest period of 21 days (28-day treatment cycle) for a median of 9 cycles (range = 1-39) and a mean of 10.2 cycles.
Maltese: Il-punt aħħari primarju tal-istudju kienet is-sopravivenza totali. azacitidine ingħata taħt il-ġilda f'doża ta' 75 mg/m kuljum għal 7 ijiem, segwit minn perjodu ta' serħan ta' 21 jum (ċiklu tal-kura ta' 28 jum) għall-medjan ta' 9 ċikli (medda = 1-39) u medja ta' 10.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom26 January 2018
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom26 ta' Jannar 2018 EMA/41972/2018
English: EMA/41972/2018
Maltese: (binimetinib) EMA/41972/2018
English: What is Balimek?
Maltese: X'inhu Balimek?
English: The active substance in Balimek, binimetinib, blocks proteins called MEK1 and MEK2.
Maltese: Is-sustanza attiva f'Balimek, binimetinib, timblokka proteini msejħa MEK1 u MEK2. Dawn il-proteini jħeġġu t-tkabbir ta' ċelloli ġodda.
English: The company presented data from one main study comparing Balimek with dacarbazine (a cancer medicine used for treating melanoma).
Maltese: Il-kumpanija ppreżentat data minn studju ewlieni wieħed li qabbel Balimek ma' dacarbazine (mediċina kontra l-kanċer li tintuża biex tikkura l-melanoma).
English: How does Balimek work?
Maltese: Kif jaħdem Balimek?