FrancophonIA/ELRC3.0 huggingface dataset:
English: 17p deletion status was determined based on central laboratory test results.
Maltese: L-istat tat-tħassir ta' 17p ġie determinat abbażi tar-riżultati tat-testijiet tal-laboratorju ċentrali.
English: 67.6% had ALC ≥25 x 109/l.
Maltese: Fil-linja bażi, 46.6% tal-pazjenti kellhom nodi waħda jew aktar ≥5 ċm, u 67.6% kellhom ALC ≥25 x 109 / l.
English: The population estimate for the terminal phase elimination half-life of venetoclax was approximately 26 hours.
Maltese: L-istima tal-popolazzjoni għal nofs ħajja tal-eliminazzjoni tal-fażi terminali ta' venetoclax kienet bejn wieħed u ieħor 26 siegħa.
English: Alternative treatments with less CYP3A induction should be considered.
Maltese: Għandhom jiġu kkunsidrati kuri alternattivi b'anqas induzzjoni ta' CYP3A.
English: CI = confidence interval; CR = complete remission; CRi = complete remission with incomplete marrow recovery, nPR = nodular PR; NR = not reached, ORR = overall response rate;.
Maltese: CI = intervall ta' kunfidenza; CR = remissjoni kompleta; CRi = remissjoni kompleta b'irkupru mhux komplet tal-mudullun, nPR = PR nodulari; NR = mhux milhuq;
English: Women of childbearing potential must use a highly effective method of contraception while taking venetoclax (see section 4.6).
Maltese: In-nisa li jista' jkollhom it-tfal iridu jużaw metodu effettiv ħafna ta' kontraċezzjoni waqt li jieħdu venetoclax (ara sezzjoni 4.6).
English: • urinary tract infection
Maltese: Newtropenija Anemija
English: • the dose will be increased to 50 mg (one 50 mg tablet) once a day for 7 days.
Maltese: 50 mg kartuna tal-pilloli (1 x 50 mg kuljun, pakkett ta' 7 ijiem)
English: Venetoclax can cause rapid reduction in tumour, and thus poses a risk for TLS in the initial 5-week dose-titration phase.
Maltese: Venetoclax jista' jikkawża tnaqqis rapidu fit-tumur, u għaldaqstant huwa ta' riskju għat-TLS fil-fażi tat titrazzjoni tad-doża ta' 5 ġimgħat.
English: It is currently unknown whether venetoclax may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should add a barrier method.
Maltese: Attwalment mhuwiex magħruf jekk venetoclax jistax inaqqas l-effettività ta' kontraċettivi ormonali, u għaldaqstant in-nisa li jkunu qegħdin jużaw kontraċettivi ormonali għandhom iżidu metodu tat-tip barriera.
English: Venetoclax as monotherapy for the treatment of patients with CLL harbouring 17p deletion or TP53 mutation - study M13-982
Maltese: Ir-riżultati tal-effikaċja f'pazjenti b'CLL ittrattati minn qabel bi tneħħija ta' 17p (Studju M13-982)
English: • the starting dose is 20 mg (two 10 mg tablets) once a day for 7 days.
Maltese: • id-doża tal-bidu hija ta' 20 mg (żewġ pilloli ta' 10 mg) darba kuljum għal 7t ijiem.
English: cOf those with MRD assay results available in peripheral blood, 72.5% (121/167) in the venetoclax + rituximab arm and 20% (26/128) in the bendamustine + rituximab arm were found to be MRD negative.
Maltese: venetoclax + rituximab u 20% (26/128) fil-fergħa ta' bendamustine + rituximab nstabu li kienu MRD
English: Grapefruit products, Seville oranges, and starfruit (carambola) should be avoided during treatment with venetoclax as they contain inhibitors of CYP3A.
Maltese: Prodotti tal-grapefruit (tronġa), tal-larinġa tal-bakkaljaw, u tal-karambola għandhom jiġu evitati waqt ittrattament b'Venclyxto b'venetoclax minħabba li fihom inibituri CYP3A.
English: aOne patient did not harbour the 17p deletion.
Maltese: aPazjent wieħed ma ġarrabx it-tneħħija ta' 17p.
English: How to store Venclyxto
Maltese: X'inhu Venclyxto
English: When resuming treatment after interruption due to TLS, the instructions for prevention of TLS should be followed (see “Prevention of tumour lysis syndrome” above).
Maltese: Meta jitkompla t-trattament wara l-interruzzjoni minħabba t-TLS, għandhom jiġu segwiti l istruzzjonijiet għall-prevenzjoni tat-TLS (ara Prevenzjoni tas-sindromu tal-lijasi tat-tumur iktar 'il fuq).
English: Venclyxto works by blocking a protein in the body called “BCL-2”.
Maltese: Venclyxto jaħdem billi jimblokka proteina fil-ġisem li tissejjaħ “BCL-2”.
English: Venclyxto 10 mg film-coated tablet Pale yellow, round biconvex shaped tablet 6 mm diameter debossed with V on one side and 10 on the other.
Maltese: Venclyxto pillola miksija b'rita ta' 10 mg hija safra ċara, tonda b'dijametru ta' 6 mm, b'V fuq naħa u 10 fuq in-naħa l-oħra.
English: In 168 patients with CLL starting with a daily dose of 20 mg and increasing over 5 weeks to a daily dose of 400 mg in studies M13-982 and M14-032, the rate of TLS was 2%.
Maltese: M13-982 u M14-032, ir-rata tat-TLS kienet 2%.
English: • Venclyxto 100 mg film-coated tablets: iron oxide yellow (E172), polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b).
Maltese: • Venclyxto 100 mg pilloli miksijin b'rita: iron oxide yellow (E172), polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b).
English: Neutropenia Anaemia
Maltese: Komuni ħafna
English: Concomitant use of strong CYP3A inhibitors at initiation and during the dose-titration phase (see sections 4.2 and 4.5).
Maltese: L-użu konkomitanti ta' inibituri ta' CYP3A qawwijin fil-bidu u waqt il-fażi tat-titrazzjoni tad-doża (ara sezzjonijiet 4.2 u 4.5).
English: Median DOR was not reached with median follow up of approximately 23.8 months.
Maltese: Medjan DOR ma ntlaħaqx b'segwitu medjan ta' madwar 23.8 xahar.
English: Efficacy data are presented for 107 patients with data cutoff date 30 April 2015.
Maltese: Id-data tal effikaċja hija ppreżentata għal 107 pazjenti bid-data tal-iskadenza tad-data 30 April 2015. 51 pazjent addizzjonali ġew irreġistrati f'koorti ta' espansjoni tas-sigurtà.
English: • Venclyxto 10 mg film-coated tablets: iron oxide yellow (E172), polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b).
Maltese: • Venclyxto 10 mg pilloli miksijin b'rita: iron oxide yellow (E172), polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b).
English: In the MURANO study, neutropenia was reported in 61% (all grades) of patients on the venetoclax + rituximab arm. Forty-three percent of patients treated with venetoclax + rituximab experienced dose interruption and 3% of patients discontinued venetoclax due to neutropenia.
Maltese: Fl-istudju MURANO, in-newtropenija kienet irrappurtata f'61% (il-gradi kollha) tal-pazjenti fuq il-vina ta' venetoclax + rituximab.
English: Figure 3.
Maltese: Figura 2: Kurvi
English: These patients should be monitored more closely for signs of toxicity (see section 4.8).
Maltese: Dawn il-pazjenti għandhom jiġu segwiti aktar mill-qrib għal sinjali ta' tossiċità (ara sezzjoni 4.8).
English: In venetoclax clinical studies, patients with any measurable lymph node ≥10 cm or those with both an ALC ≥25 x 109/l and any measurable lymph node ≥5 cm were hospitalised to enable more intensive hydration and monitoring for the first day of dosing at 20 mg and 50 mg during the titration phase (see section 4.2).
Maltese: Fl-istudji kliniċi ta' venetoclax, il-pazjenti bi kwalunkwe nodula limfatika li tista' titkejjel ≥10 cm jew dawk kemm b'ALC ≥25 x 109/l kif ukoll kwalunkwe nodula limfatika li tista' titkejjel ≥5 cm ġew rikoverati l-isptar sabiex setgħet issirilhom idratazzjoni aktar intensiva u monitoraġġ għall-ewwel jum tad dożaġġ b'20 mg u 50 mg waqt il-fażi tat-titrazzjoni (ara sezzjoni 4.2).
English: If a bile acid sequestrant is to be co-administered with venetoclax, the SmPC for the bile acid sequestrant should be followed to reduce the risk for an interaction, and venetoclax should be administered at least 4-6 hours after the sequestrant.
Maltese: Jekk sekwestrant tal-aċidu biljari għandhu jiġi ko-amministrat ma venetoclax, l-SmPC għas-sekwestrant aċidu biljari għandhu jiġi segwit biex jitnaqqas ir-riskju għallinterazzjoni, u venetoclax għandu jingħata mill-inqas 4-6 sigħat wara s-sekwestrant.
English: M27 was identified as a major metabolite in plasma with an inhibitory activity against BCL-2 that is at least 58-fold lower than venetoclax in vitro.
Maltese: M27 kien identifikat bħala metabolit maġġuri fil-plażma b'attività inibitorja kontra BCL-2 li huwa mill-anqas
English: Iron oxide yellow (E172) Iron oxide red (E172) Iron oxide black (E172) Polyvinyl alcohol (E1203) Titanium dioxide (E171)
Maltese: Iron oxide yellow (E172) Iron oxide red (E172) Iron oxide black (E172) Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol 3350 (E1521) Talc (E553b)
English: Venetoclax also caused single cell necrosis in various tissues, including the gallbladder and exocrine pancreas, with no evidence of disruption of tissue integrity or organ dysfunction; these findings were minimal to mild in magnitude.
Maltese: Kemm iċ-ċelluli B u T kienu affettwati, iżda t-tnaqqis l-aktar sinifikanti seħħ biċ-ċelluli B. Venetoclax ikkawża wkoll nekrożi ta' ċelluli singoli f'diversi tessuti, inkluż il-bużżieqa tal-marrara u frixa eżokrina, mingħajr evidenza ta' tfixkil tal-integrità tat-tessuti jew disfunzjoni tal-organi; dawn is-sejbiet kienu minimi sa ħfief fid-daqs.
English: Venclyxto 50 mg tablets
Maltese: Venclyxto 50 mg pilloli Sentejn
English: Missed dose
Maltese: Twissijiet u prekawzjonijiet
English: o When you are receiving Venclyxto therapy in combination with rituximab, you will receive the 400 mg daily dose for 24 months.
Maltese: o Meta qed tirċievi terapija b'Venclyxto ma' rituximab, inti ser tirċievi d-doża ta' 400 mg kuljum għal 24 xahar.
English: How Venclyxto works
Maltese: Venclyxto.
English: The safety analysis included patients from one phase 3 study (MURANO), two phase 2 studies (M13-982 and M14-032), and one phase 1 study (M12-175).
Maltese: L-analiżi tas sigurtà inkludiet pazjenti minn studju wieħed ta' fażi 3 (MURANO), żewġ studji tal-fażi 2 (M13-982 and
English: Concomitant use of this medicinal product with strong or moderate CYP3A inhibitors increases venetoclax exposure and may increase the risk for TLS at initiation and during the dose-titration phase (see sections 4.2 and 4.3).
Maltese: L-użu konkomitanti ta' dan il-prodott mediċinali ma' inibituri ta' CYP3A qawwijin jew moderati jżid lesponiment ta' venetoclax u jista' jżid ir-riskju ta' TLS fil-bidu u waqt il-fażi tat-titrazzjoni tad-doża (ara sezzjonijiet 4.2 u 4.3).
English: After a single oral administration of 200 mg radiolabeled [14C]-venetoclax to healthy subjects, >99.9% of the dose was recovered in faeces and <0.1% of the dose was excreted in urine within 9 days.
Maltese: Wara għoti wieħed mill-ħalq ta' venetoclax radjutikkettat [14C] ta' 200 mg lil individwi b'saħħithom, >99.9%
English: Discontinuation and dose reductions due to adverse reactions Discontinuations due to adverse reactions occurred in 16% of patients treated with the combination of venetoclax and rituximab in the MURANO study.
Maltese: Twaqqif minħabba reazzjonijiet avversi seħħew f'16% tal-pazjenti ttrattati bil-kombinazzjoni ta' venetoclax u rituximab fl-istudju MURANO.
English: Drink the same amount of water (at least 1.5 to 2 litres daily) two days before and on the day that your dose is increased.
Maltese: Għandek tkompli tixrob mill-anqas 1.5 sa 2 litri ta' ilma dakinhar li tibda
English: Preparations containing St. John's wort are contraindicated during treatment with venetoclax, as efficacy may be reduced (see section 4.3).
Maltese: John's wort huma kontro-indikati waqt it-trattament b'venetoclax, minħabba li l-effikaċja tista' tonqos (ara sezzjoni 4.3).
English: Febrile neutropenia Lymphopenia
Maltese: Newtropenija Anemija Linfopenija
English: Venetoclax was not genotoxic in bacterial mutagenicity assay, in vitro chromosome aberration assay and in vivo mouse micronucleus assay.
Maltese: Venetoclax ma kienx ġenotossiku fl-assaġġ tal-mutaġeniċità batterjali, fl-assaġġ tal-aberrazzjoni tal kromosoma in vitro u fl-assaġġ tal-mikronukleu tal-ġrieden in vivo.
English: How to store Venclyxto 6.
Maltese: Kif taħżen Venclyxto 6.
English: Number of events (%) Disease progression Death events
Maltese: TLS kliniku), inkluż 2 episodji fatali u
English: Fatigue
Maltese: Tilqim
English: Drinking plenty of water, at least 1.5 to 2 litres per day, helps to remove cancer cell breakdown products from your body through urine, and may decrease your risk of getting TLS (see section 3).
Maltese: Li tixrob ħafna ilma, mill-inqas 1.5 sa 2 litri kuljum, jgħin sabiex jitneħħew il-prodotti tat-tkissir tal-ċelluli tal-kanċer minn ġismek permezz tal-awrina, u jista' jnaqqas ir-riskju li jkollok TLS (ara sezzjoni 3).
English: Of the 194 patients with previously treated CLL who received venetoclax in combination with rituximab, 50% were 65 years or older.
Maltese: Mill-194 pazjent b'CLL li kienu ttrattati qabel li ħadu venetoclax flimkien ma' rituximab, 50% kellhom 65 sena jew aktar.
English: In the MURANO study, dose interruptions due to adverse reactions occurred in 71% of patients treated with the combination of venetoclax and rituximab; the most common adverse reaction that led to dose interruption of venetoclax was neutropenia (43%).
Maltese: Fl-istudju MURANO, interruzzjonijiet fid-doża minħabba reazzjonijiet avversi seħħew f'71% tal-pazjenti ttrattati bil-kombinazzjoni ta 'venetoclax u rituximab, l-iktar reazzjoni avversa komuni li wasslet għal interruzzjoni tad-doża ta' venetoclax kienet in-newtropenja (43%).
English: Additional efficacy results for the pre-specified primary analysis are shown in Table 5 and Figure 2 and Figure 3.
Maltese: Riżultati ta' effikaċja addizzjonali għall-analiżi primarja speċifikata minn qabel jidhru fit-Tabella 5 u l-Figura 2 u l-Figura 3.
English: For patients who are on a steady daily dose of Venclyxto, the venetoclax dose should be reduced by 50% when used concomitantly with moderate CYP3A inhibitors and by 75% when used concomitantly with strong CYP3A inhibitors.
Maltese: Għal pazjenti li huma fuq doża ta' kuljum stabbli ta' Venclyxto, id-doża ta' venetoclax għandha titnaqqas b'mill-anqas 50% meta użata b'mod konkomitanti ma' inibituri ta' CYP3A moderati u mill-anqas b'75% meta użata b'mod konkomitanti ma' inibituri ta' CYP3A qawwijin.
English: There is no specific antidote for venetoclax.
Maltese: M'hemmx antidotu speċifiku għal venetoclax.
English: България АбВи ЕООД
Maltese: TWISSIJA(IET) SPEĊJALI
English: The most commonly occurring adverse reactions (≥20%) of any grade in patients receiving venetoclax in the combination study with rituximab were neutropenia, diarrhoea, and upper respiratory tract infection.
Maltese: L-aktar reazzjonijiet avversi komuni li seħħew (≥20%) ta' kwalunkwe grad f'pazjenti li rċevew venetoclax fl-istudju kkombinat ma' rituximab kienu newtropenja, dijarea, u infezzjoni fin-naħa ta' fuq tal-apparat respiratorju.
English: Blood chemistry (potassium, uric acid, phosphorus, calcium, and creatinine) should be assessed and pre-existing abnormalities corrected.
Maltese: Il-kimika tad-demm (potassium, uric acid, fosfru, calcium, u krejatinina) għandha tiġi vvalutata u anormalitajiet li jeżistu minn qabel għandhom jiġu kkoreġġuti.
English: It is recommended that venetoclax should be administered with a meal (see section 4.2).
Maltese: Huwa rrakkomandat li venetoclax għandu jingħata ma' ikla (ara sezzjoni 4.2).
English: For an orally administered P-gp or BCRP substrate sensitive to inhibition in the gastrointestinal tract (e.g., dabigatran exetilate), its administration should be separated from venetoclax administration as much as possible to minimise a potential interaction.
Maltese: Għallamministrazzjoni mill-ħalq ta' P-gp jew BCRP sottostrat sensittiv għall inibizzjoni fil-passaġġ gastro intestinali (eż, exetilate dabigatran), l-amministrazzjoni tiegħu għandha tkun separata mill-amministrazzjoni ta' venetoclax kemm jista' jkun biex jimminimizzaw interazzjoni potenzjali.
English: Following multiple oral administrations, maximum plasma concentration of venetoclax was reached 5-8 hours after dose.
Maltese: Wara diversi għoti mill-ħalq, il-konċentrazzjoni massima tal-plażma ta' venetoclax intlaħqet 5-8 sigħat wara d-doża.
English: Efficacy results for the pre-specified primary analysis (data cut-off date 8 May 2017) were also assessed by an Independent Review Committee (IRC) demonstrating a statistically significant 81% reduction in the risk of progression or death for patients treated with venetoclax + rituximab (hazard ratio: 0.19 [95% CI: 0.13,
Maltese: Ir-riżultati tal-effikaċja għall-analiżi primarja speċifikata minn qabel (data ta' skadenza 8 ta' Mejju 2017) ġew ivvalutati wkoll minn Kumitat ta 'Reviżjoni Indipendenti (IRC) li juri tnaqqis statistikament sinifikanti ta'
English: Tumour lysis syndrome Hyperuricaemia
Maltese: Newtropenija bid-deni Linfopenija
English: • a medicine used to treat heart problems known as digoxin
Maltese: • mediċina użata sabiex tittratta l-problemi tal-qalb magħrufa bħala digoxin
English: Venclyxto 10 mg tablets
Maltese: Venclyxto 10 mg pilloli Sentejn
English: Venetoclax daily dose
Maltese: Dijarea Rimettar Dardir
English: Overall Survivale
Maltese: TA' EĊĊIPJENTI
English: Venetoclax had no effect on QTc interval and there was no relationship between venetoclax exposure and change in QTc interval.
Maltese: Venetoclax ma kellu l-ebda effett fuq l-intervall QTc u ma kienx hemm relazzjoni bejn l-esponiment ta' venetoclax u l-bidla fl-intervall QTc.
English: Neutropenia
Maltese: Idratazzjoni
English: • itraconazole ketoconazole, posaconazole, or voriconazole for fungal infections
Maltese: • mediċina użata sabiex tipprevjeni r-riġettar tal-organi magħrufa bħala sirolimus
English: Your doctor may also give you medicines to help prevent the build up of uric acid in your body before you start treatment with Venclyxto.
Maltese: Barra minn hekk mediċini oħra jistgħu jaffetwaw il-mod kif jaħdem Venclyxto.
English: Additional efficacy results in MURANO Investigator assessed
Maltese: Riżultati ta' effikaċja addizzjonali f'MURANO
English: If a moderate CYP3A inhibitor must be used, the initiation and titration doses of venetoclax should be reduced by at least 50%.
Maltese: 1% tad-doża kienet eliminata fl-awrina fi żmien 9t ijiem.
English: The starting dose is 20 mg of venetoclax once daily for 7 days.
Maltese: Id-doża tal-bidu hija ta' 20 mg ta' venetoclax darba kuljum għal 7t ijiem.
English: Tumour lysis syndrome, including fatal events, has occurred in patients with previously treated CLL with high tumour burden when treated with venetoclax.
Maltese: Is-sindromu tal-lijasi tat-tumur, inklużi avvemimenti fatali, seħħ f'pazjenti tas-CLL ittrattati minn qabel b'piż tat-tumur għoli meta ttrattati b'venetoclax.
English: Therefore, women of childbearing potential must use highly effective contraceptive measures while taking venetoclax and for 30 days after stopping treatment.
Maltese: kontraċezzjoni effettivi ħafna waqt li jkunu qed jieħdu venetoclax u sa 30 jum wara li jwaqqfu t-trattament.
English: The median time since diagnosis was 8.3 years (range: 0.3 to 18.5 years; N=96).
Maltese: Iż-żmien medjan sa mid-dijanjosi kien ta' 8.3 snin (firxa: 0.3 sa 18.5 sena; N=96). L
English: • irregular heart beat
Maltese: • qalb tħabbat b'mod irregolari
English: For events of clinical TLS or blood chemistry changes requiring more than 48 hours to resolve, treatment should be resumed at a reduced dose (see Table 2).
Maltese: Għal avvenimenti ta' TLS kliniku jew bidliet fil-kimika taddemm li jeħtieġu aktar minn 48 siegħa sabiex jgħaddu, it-trattament għandu jitkompla b'doża mnaqqsa (ara Tabella 2).
English: Median, months (95% CI)
Maltese: Medjan, xuhur (95% CI)
English: Sepsis Urinary tract infection
Maltese: Sepsis Infezzjoni fl-apparat tal-awrina
English: Patients randomised to BR received bendamustine at 70 mg/m2 on Days 1 and 2
Maltese: Pazjenti randomised għal BR irċevew bendamustine f'70 mg / m2 f'Jiem 1 u 2 għal 6 ċikli u rituximab kif deskritt hawn fuq.
English: The recommended dose of venetoclax is 400 mg once daily.
Maltese: Id-doża rakkomandata ta' venetoclax hija ta' 400 mg darba kuljum.
English: • you have any kidney problems as your risk for a side effect called tumour lysis syndrome may increase
Maltese: • għandek xi problemi bil-kliewi minħabba li r-riskju ta' effett sekondarju li jissejjaħ sindromu tal-lijasi tat-tumur jista' jiżdied
English: What Venclyxto is and what it is used for 2.
Maltese: X'inhu Venclyxto u gћalxiex jintuża 2.
English: CI = confidence interval; CR = complete remission; CRi = complete remission with incomplete marrow recovery, DOR = duration of response; IRC = independent review committee; nPR = nodular PR; NA = not available; NR = not reached; ORR = overall response rate; PFS = progression-free survival, PR = partial remission; TTR = time to first response.
Maltese: ORR = ir-rata ta' rispons; OS = sopravivenza totali; PFS = sopravivenza bla progressjoni, PR = remissjoni parzjali, TTR = żmien għall-ewwel rispons
English: At the time of evaluation, median duration of treatment with venetoclax was 14.3 months (range: 0.1 to 31.4 months).
Maltese: Fiż-żmien tal evalwazzjoni, id-dewmien medjan tat-trattament b'venetoclax kien 14.3 xhur (medda: 0.1 sa 31.4 xahar).
English: If a narrow therapeutic index P-gp or BCRP substrate must be used, it should be used with caution.
Maltese: Inibituri P-gp u BCRP Venetoclax huwa sottostrat ta' P-gp u BCRP.
English: 8 (8 x 1) vials
Maltese: 8 (8 x 1) kunjetti
English: MA (EU) Numbers (Invented) name
Maltese: Numru tal-MA (EU) Isem (Ivvintat)
English: Concentrate for solution for infusion
Maltese: Konċentrat għal soluzzjoni għall-infużjoni
English: Intravenous use vial (glass)
Maltese: Użu għal ġol-vini kunjett (ħġieġ) 10 ml
English: The mean daily dose in the pivotal study was 20mg/10mg oxycodone hydrochloride/naloxone hydrochloride.
Maltese: Id-doża medja ta' kuljum fl-istudju pivitali kienet ta' 20mg/10mg oxycodone hydrochloride/naloxone hydrochloride.
English: Some patients may benefit from higher daily doses up to a maximum of 60 mg/30 mg oxycodone.
Maltese: Xi pazjenti jistgħu jibbenefikaw minn dożi ta' kuljum ogħla sa massimu ta' 60 mg/30 mg oxycodone.
English: Annex III Amendments to the summary of product characteristics
Maltese: Anness III Emendi għas-sommarju tal-karatteristiċi tal-prodott
English: Note: These amendments are to be incorporated to the valid summary of product characteristics, labelling and package leaflet which are the final versions achieved during the Coordination group procedure.
Maltese: Nota: Dawn l-emendi għandhom jiġu inkorporati fis-sommarju tal-karatteristiċi talprodott, tikkettar u fuljett ta' tagħrif validi li huma l-verżjonijiet finali miksuba waqt il-proċedura talgrupp ta' Koordinazzjoni.
English: 4.2 Posology and method of administration
Maltese: .2 Pożoloġija u metodu ta' kif għandu jingħata
English: [The below wording should replace the previous wording] Titration on a weekly basis is recommended in case higher doses are required.
Maltese: [Il-kliem ta' hawn taħt għandu jissostitwixxi l-kliem preċedenti] F'każ li jkunu meħtieġa dożi ogħla hija rakkomandata titrazzjoni fuq bażi ta' kull ġimgħa.
English: • Bioequivalence vis-à-vis an EU reference medicinal product has been demonstrated, based on relevant data, in accordance with the requirements of Article 10 of Directive 2001/83/EC (e.g. a bioequivalence study conducted vis-à-vis the EU reference medicinal product).
Maltese: • Il-bijoekwivalenza fir-rigward tal-prodott mediċinali ta' referenza tal-UE ntweriet, abbażi ta' dejta rilevanti, skont ir-rekwiżiti tal-Artikolu 10 tad-Direttiva 2001/83/KE (eż. studju ta' bijoekwivalenza mwettaq fir-rigward tal-prodott mediċinali ta' referenza tal-UE).
English: For the suspension of the marketing authorisations referred to in annex IB to be lifted, the competent authorities shall ensure that the below conditions have been completed by the marketing authorisation holder(s)
Maltese: Sabiex titneħħa s-sospensjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq imsemmija fl-anness IB, lawtoritajiet kompetenti għandhom jiżguraw li l-kundizzjonijiet t'hawn taħt ġew issodisfati middetentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq.
English: The active substance is trientine.
Maltese: Is-sustanza attiva hi trientine.
English: EU/1/17/1199/001 72 film-coated tablets EU/1/17/1199/002 96 film-coated tablets
Maltese: EU/1/17/1199/001 72 pillola miksija b'rita EU/1/17/1199/002 96 pillola miksija b'rita