FrancophonIA/ELRC3.0 huggingface dataset:
English: The following components (not supplied) are required for proper administration of Brineura and flushing solution (see Figure 1 in section 4.2).
Maltese: Il-komponenti li ġejjin (li mhumiex ipprovduti) huma meħtieġa għal għoti kif suppost ta' Brineura u s soluzzjoni għat-tlaħliħ (ara Figura 1 f'sezzjoni 4.2).
English: In order to further evaluate the treatment effectiveness as a delay in progression of CLN2 motor-language clinical sale and to further evaluate the safety and tolerability of cerliponase alfa, the MAH will submit the results of study 190-203 including at least 5 patients below the age of 2 years.
Maltese: Sabiex tiġi evalwata iktar l-effettività tal-kura bħala progressjoni tardiva ta' skala klinika muturlingwa ta' CLN2 u sabiex jiġu evalwati iktar is-sigurtà u t-tollerabilità ta' cerliponase alfa, l-MAH għandu jissottometti r-riżultati tal-istudju 190-203 li jinkludu mill-inqas
English: The MAH shall ensure that in each MS where BRINEURA is marketed, all HCPs who are expected to handle / administer the product are provided with an educational programme (i.e. a dosing and administration guide), aiming at preventing and/or minimising the important identified risk of Device issues (infection/blockage/dislocation), containing information about: - How to store BRINEURA; - The device-related complications (i.e. infections, device's leakage and/or failure; the integrity of the device should be confirmed by a neurosurgeon); - How to prepare BRINEURA and the flushing solution; - A detailed step-by step description of BRINEURA intra-cerebro-ventricular infusion and the administration of the flushing solution (provided after BRINEURA infusion is complete) - How to monitor the patients receiving BRINEURA.
Maltese: F'żewġ każijiet kliniċi, l-apparati ta' aċċess intraċerebroventrikulari ma wrewx sinjali ta' falliment fil-ħin tal-infużjoni; madankollu, wara t tneħħija, id-degradazzjoni materjali tal-apparati kienet tidher u kienet konsistenti mad-dejta mill ittestjar benchtop tal-apparati ta' aċċess intraċerebroventrikulari.
English: Thaw before use.
Maltese: Twissijiet u prekawzjonijiet
English: Symptoms resolved over time or with administration of antipyretics, antihistamines and/or glucocorticosteroids.
Maltese: Sintomi riżolti matul iż-żmien jew bl-għoti ta' antipiretiċi, antistamini u/jew glukokortikosterojdi.
English: Brineura must be administered using aseptic technique to reduce the risk of infection.
Maltese: Komplikazzjonijiet relatati mal-apparat Brineura jrid jingħata permezz ta' teknika asettika sabiex jitnaqqas ir-riskju ta' infezzjoni.
English: Detach and remove the empty syringe from the pump and disconnect from the infusion line.
Maltese: Aqla' u neħħi s-siringa vojta mill-pompa u ddiskonnetti minn mal-linja ta' infużjoni.
English: PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI 5
English: Each vial of Brineura contains 150 mg of cerliponase alfa in 5 ml of solution.
Maltese: Kull kunjett ta' Brineura fih 150 mg ta' cerliponase alfa f'soluzzjoni ta' 5 ml.
English: Brineura contains the active substance cerliponase alfa, which belongs to a group of medicines known as enzyme replacement therapies.
Maltese: Brineura fih is-sustanza attiva cerliponase alfa, li tappartjeni lill-grupp ta' mediċini magħrufa bħala terapiji għar-rimpjazzament tal-enzimi.
English: Will have obvious instability, and may have intermittent falls.
Maltese: Ikun hemm instabbilità ovvja, u jaf ikun hemm waqgħat intermittenti.
English: The infusion rate for Brineura and the flushing solution is 2.5 ml/hour.
Maltese: Ir-rata ta' infużjoni ta' Brineura u s-soluzzjoni għat-tlaħliħ hija ta' 2.5 ml/siegħa.
English: Store upright in a freezer (-20°C ± 5°C).
Maltese: KONDIZZJONIJIET SPEĊJALI TA' KIF JINĦAŻEN Żomm wieqaf fil-friża (-20°C ± 5°C).
English: Place the syringe containing Brineura into the syringe pump and program the pump to deliver at an infusion rate of 2.5 ml per hour.
Maltese: Poġġi s-siringa li fiha Brineura fil-pompa tas-siringa u pprogramma l-pompa sabiex tagħti infużjoni b'rata ta' 2.5 ml kull siegħa.
English: Anaphylaxis
Maltese: infezzjoni.
English: Remove the green flip-off caps from both Brineura vials.
Maltese: Ma twettqux studji dwar ir-riproduzzjoni fl annimali bi Brineura.
English: Vision and seizure scores when combined with CLN2 score (motor and language domains) remain stable.
Maltese: Punteġġi tal-vista u tal-aċċessjonijiet meta kombinati mal-punteġġ CLN2 (dominji tal-mutur u l lingwa) jibqgħu stabbli.
English: Initiate infusion of Brineura at a rate of 2.5 ml per hour.
Maltese: Ibda l-infużjoni ta' Brineura b'rata ta' 2.5 ml kull siegħa.
English: How Brineura works
Maltese: darba biss.
English: Brineura has a green flip-off cap and flushing solution has a yellow flip-off cap.
Maltese: Huma wkoll responsabbli għar-rimi kif suppost tal-fdal ta' Brineura.
English: Discard the empty syringe in accordance with local requirements.
Maltese: Teżisti esperjenza limitata fi ftit pazjenti ta' sentejn.
English: This medicinal product contains 44 mg sodium per vial of Brineura and flushing solution.
Maltese: Kontenut ta' sodium Dan il-prodott mediċinali fih 44 mg sodium f'kull kunjett ta' Brineura u soluzzjoni għat-tlaħliħ.
English: For single use only
Maltese: L-Istati Uniti
English: Limited data are available for children aged 2 years and no clinical data is available in children below 2 years of age (see section 5.1).
Maltese: Hemm data limitata disponibbli għal tfal ta' sentejn u ma hemm l-ebda data klinika disponibbli għal tfal ta' taħt is-sentejn (ara sezzjoni 5.1).
English: Very common Common
Maltese: Komuni ħafna
English: Brineura must not be administered as long as there are signs of acute intracerebroventricular access device leakage, device failure, or device-related infection (see section 4.2 and 4.4).
Maltese: infużjoni ta' Brineura (ara sezzjoni 4.2 u 4.3).
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: UŻU Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi tal-Prodott, sezzjoni 4.2).
English: Very common side effects (may affect more than 1 in 10 people): fever vomiting feeling irritable convulsions (seizures) reactions during or shortly after being given the medicine, such as hives, itching or flushing, swollen lips, tongue and/or throat, shortness of breath, hoarseness, turning blue around finger tips or lips, low muscle tone, fainting or incontinence
Maltese: It-tabib tiegħek ser jimmonitorja lilek jew lit-tifel/tifla tiegħek għal sintomi ta' reazzjonijiet allerġiċi li jipperikolaw il-ħajja, bħal urtikarja, ħakk jew ħmura, xofftejn, ilsien u/jew griżmejn minfuħin, qtugħ ta' nifs,
English: Five patients experienced a single point decrease, and 3 patients experienced a 2 point decrease.
Maltese: 5 pazjenti li għadhom m'għalqux is-sentejn.
English: Brineura and flushing solution excipients: Sodium phosphate dibasic heptahydrate; Sodium dihydrogen phosphate monohydrate; Sodium chloride;
Maltese: Sodium phosphate dibasic heptahydrate;
English: These studies used the aggregate of the motor and language domains of a disease-specific clinical rating scale (see Table 3) to assess disease progression.
Maltese: Dawn l-istudji użaw l-aggregat tal-oqsma tal-mutur u l-lingwa ta' skala ta' klassifikazzjoni klinika dwar mard speċifiku (ara Tabella 3) biex tiġi evalwata l-progressjoni tal-marda.
English: Pyrexiac Feeling jittery Pain
Maltese: FULJETT TA' TAGĦRIF
English: Common side effects (may affect up to 1 in 10 people): device-related bacterial infections slower heart beat device does not function correctly due to a blockage detected during preparation for infusion
Maltese: Effetti sekondarji komuni (minn 1 sa 10 persuni) - infezzjonijiet batterjali relatati mal-apparat - taħbit tal-qalb bil-mod
English: A syringe volume of 10 to 20 ml is recommended.
Maltese: 20 ml hu rakkomandat.
English: Prepare the scalp for intracerebroventricular infusion using aseptic technique per institution standard of care.
Maltese: Applika pressjoni b'mod delikat u orbot is-sit ta' infużjoni skont listandards tal-kura tal-istituzzjoni.
English: Withdraw flushing solution
Maltese: kwistjonijiet tal-apparat
English: Limited preclinical safety data of cerliponase alfa were generated from single dose toxicity studies in monkeys and repeated-dose studies in a dachshund dog model of classic late infantile neuronal ceroid lipofuscinosis type 2.
Maltese: 5.3 Tagħrif ta' qabel l-użu kliniku dwar is-sigurtà Tagħrif limitat ta' qabel l-użu kliniku dwar is-sigurtà ta' cerliponase alfa ġie ġġenerat minn studji ta' tossiċità b'dożi singoli fix-xadini u studji b'dożi ripetuti fil-mudell ta' klieb Dachshund ta' neuronal ceroid lipofuscinosis tat-tip 2 klassika u tardiva.
English: CSF samples should routinely be sent for testing to detect subclinical device infections.
Maltese: Kampjuni ta' CSF għandhom jintbagħtu regolarment għall-ittestjar sabiex jiġu maqbuda infezzjonijiet tal-apparat sottokliniku.
English: The exposure to these substances is respectively estimated to 565,000 patient-years, 555,470 patient-years and 66,052 patient-years worldwide.
Maltese: L-esponiment għal dawn is-sustanzi huwa rispettivament stmat għal 565 000 pazjent-sena, 555 470 pazjent-sena u 66 502 pazjent-sena fid-dinja kollha.
English: In the EU, three SGLT2 inhibitors are currently authorised as monocomponent and as fixed dose combination with metformin: canagliflozin (Invokana and Vokanamet), dapagliflozin (Forxiga and Xigduo) and empagliflozin (Jardiance and Synjardy).
Maltese: Fl-UE, tliet inibituri tal-SGLT2 huma attwalment awtorizzati bħala monokomponent u bħala kombinazzjoni ta' doża fissa b'metformina: canagliflozin (Invokana u Vokanamet), dapagliflozin (Forxiga u Xigduo) u empagliflozin (Jardiance u Synjardy).
English: DKA most commonly occurs in patients with type 1 diabetes mellitus (T1DM) and is usually accompanied by high blood glucose levels (>250 mg/dL).
Maltese: Id-DKA sseħħ blaktar mod komuni f'pazjenti bid-dijabete mellitus tat-tip 1 (T1DM) u ġeneralment hija akkumpanjata minn livelli għoljin ta' glukożju fid-demm (>250 mg/dL).
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data for SGLT2 inhibitors-containing medicinal products.
Maltese: • Il-PRAC ikkunsidra l-proċedura skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004 bħala riżultat tad-data ta' farmakoviġilanza għall-prodotti mediċinali li fihom l-inibituri tal-SGLT2.
English: Limited data from clinical trials suggest that DKA occurs with common frequency in T1DM patients.
Maltese: Data limitata minn provi kliniċi tissuġġerixxi li DKA sseħħ bi frekwenza komuni f'pazjenti bit-T1DM.
English: A search in Eudravigilance (EV) database was performed by the EMA on 19 May 2015 for the three SGLT2 inhibitors.
Maltese: Twettaq tiftix fil-bażi tad-data tal-Eudravigilance (Eudraviġilanza) (EV) mill-EMA fid-19 ta' Mejju 2015 għat-tliet inibituri tal-SGLT2.
English: SGLT2 is expressed in the proximal renal tubules and is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen.
Maltese: L-SGLT2 huwa espress fit-tubuli renali prossimali u huwa responsabbli għall-maġġoranza talassorbiment mill-ġdid ta' glukożju ffiltrat mil-lumen tubulari.
English: Based on the data available, the PRAC considered that there was no indication of a different risk between the products.
Maltese: Abbażi tad-data disponibbli, il-PRAC ikkunsidra li ma kienx hemm indikazzjoni ta' riskju differenti bejn il-prodotti.
English: In absence of insulin the metabolism switches from using glycogenolysis to lipolysis as a source of energy, which produces ketone bodies.
Maltese: Fin-nuqqas talinsulina, il-metaboliżmu jaqleb mill-użu tal-glikoġenolisi għal-lipolisi bħala sors ta' enerġija, li jipproduċi l-korpi ketoni.
English: Considering the above, the PRAC was of the view that DKA should be included in the product information of all SGLT2 inhibitors with the frequency rare.
Maltese: B'kunsiderazzjoni ta' dak li ntqal hawn fuq, il-PRAC kien tal-fehma li DKA għandha tkun inkluża fl-informazzjoni tal-prodott tal-inibituri tal-SGLT2 bil-frekwenza rari.
English: In order to minimise this risk, the PRAC considered that physicians and patients should be warned through the PI to consider the risk of atypical DKA in the occurrence of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness.
Maltese: Sabiex jiġi minimizzat ir-riskju, il-PRAC ikkunsidra li t-tobba u l-pazjenti għandhom jiġu avżati permezz tal-PI sabiex iqisu r-riskju ta' DKA atipika fl-okkorrenza ta' sintomi mhux speċifiċi bħal nawżja, rimettar, anoressija, uġigħ addominali, għatx eċċessiv, diffikultà biex tieħu nifs, konfużjoni, għejja mhux tassoltu jew ħedla.
English: Taking into account the severity of these cases and the general pattern seen across these medicinal products, the European Commission requested, on the 10 of June 2015 and pursuant to Article 20 of Regulation No 726/2004, the opinion of the Agency on whether the marketing authorisation of canagliflozin-, dapagliflozin- and empagliflozin-containing medicinal products, should be maintained, varied, suspended or revoked.
Maltese: Meta titqies is-severità ta' dawn il-każijiet u l-mudell ġenerali li jidher f'dawn il-prodotti mediċinali, il-Kummissjoni Ewropea talbet, fl-10 ta' Ġunju 2015 u skont l-Artikolu 20 tar-Regolament Nru 726/2004, l-opinjoni tal-Aġenzija dwar jekk l-awtorizzazzjoni għat-tqegħid fis-suq ta' prodotti mediċinali li fihom canagliflozin, dapagliflozin u empagliflozin għandhiex tinżamm, tiġi varjata, tiġi sospiża jew tiġi revokata.
English: Moreover, risk factors reported in the cases are consistent with those previously reported in the literature and the risks factors inherent to the patient population (e.g. patients with low beta-cell function reserve, restricted food intake or severe dehydration, sudden reduction in insulin dose and increased insulin requirements due to acute medical illness, surgery or alcohol abuse).
Maltese: Iż-żmien għal bidu relattivament twil osservat fi provi kliniċi jissuġġerixxi fatturi ta' kontribut li jikkawżaw l-iżvilupp ta' DKA. Barra minn hekk, il-fatturi tar-riskju rrapportati fil-każijiet huma konsistenti ma' dawk irrapportati qabel fil-letteratura u l-fatturi tar-riskju inerenti għall-popolazzjoni tal-pazjenti (eż. pazjenti b'riserva baxxa tal-funzjoni taċ-ċellula beta, teħid ristrett tal-ikel jew deidrazzjoni severa, tnaqqis f'daqqa fid-doża tal-insulina u żieda fir-rekwiżiti tal-insulina minħabba mard mediku akut, kirurġija jew abbuż mill-alkoħol).
English: This is not an approved indication for SGLT2 inhibitors containing products.
Maltese: Din mhijiex indikazzjoni approvata għal prodotti li fihom l-inibituri tal-SGLT2.
English: • The PRAC further concluded that a risk of DKA, including with atypical presentation, is also associated with the use of SGLT2 inhibitors in patients with T1DM.
Maltese: • Il-PRAC ikkonkluda wkoll li riskju ta' DKA, inkluż bi preżentazzjoni atipika, huwa assoċjat ukoll mal-użu tal-inibituri tal-SGLT2 f'pazjenti b'T1DM.
English: The PRAC further concluded that a risk of DKA, including with atypical presentation, is also associated with SGLT2 inhibitors treatment in patients with T1DM.
Maltese: Il-PRAC ikkonkluda wkoll li riskju ta' DKA, inkluż bi preżentazzjoni atipika, huwa wkoll assoċjat ma' kura bl-inibituri tal-SGLT2 f'pazjenti bit-T1DM.
English: In a study that reported population-based rates of DKA, the incidence rate of DKA in T2DM patients, requiring hospital admission, was reported to be 0.5 per 1,000 patient-years.
Maltese: Fi studju li rrapporta rati abbażi talpopolazzjoni ta' DKA, ir-rata tal-inċidenza ta' DKA fil-pazjenti bit-T2DM, li kienu jeħtieġu li jiddaħħlu flisptar, kienet irrapportata li hi ta' 0.5 għal kull 1,000 sena-pazjent.
English: The glucose is partially excreted via the urine, leading to polyuria, dehydration, and compensatory thirst and polydipsia.
Maltese: Il-glukożju huwa parzjalment eliminat permezz talawrina, li jwassal għal poliurja, deidrazzjoni, u għatx kumpensatorju u polidipsja.
English: When considering all the data submitted by the MAHs from clinical and non-clinical studies, postmarketing reports and in published literature, in relation to the risk of diabetic ketoacidosis (DKA) in association with SGLT2 inhibitors, the PRAC was of the view that a small excess risk could not be excluded in patients with T2DM.
Maltese: Meta titqies id-data kollha ppreżentata mill-MAHs minn studji kliniċi u mhux kliniċi, rapporti ta' wara ttqegħid fis-suq u f'letteratura ppubblikata, fir-rigward tar-riskju tal-ketoaċidożi dijabetika (DKA) flimkien mal-inibituri tal-SGLT2, il-PRAC kien tal-fehma li riskju żgħir tal-eċċess ma jistax jiġi eskluż f'pazjenti bit-T2DM.
English: No subset of the population at increased risk could be identified from the analysis of cases reported in clinical studies.
Maltese: L-ebda subsett tal-popolazzjoni f'riskju miżjud ma seta' jiġi identifikat mill-analiżi tal-każijiet irrapportati fi studji kliniċi.
English: In addition, the PRAC considered that “DKA with atypical presentation” should be added as an important identified risk to the Risk Management Plan (RMP) of those products.
Maltese: Barra minn hekk, il-PRAC ikkunsidra li "DKA bi preżentazzjoni atipika" għandha tiżdied bħala riskju identifikat importanti mal-Pjan tal-Ġestjoni tar-Riskju (RMP) ta' dawn il-prodotti.
English: Sodium-glucose co-transporter 2 (SGLT2) inhibitors are used together with diet and exercise in patients with type 2 diabetes, either alone or in combination with other diabetes medicines.
Maltese: L-inibituri tal-ko-trasportatur 2 ta' sodju-glukożju (SGLT2) jintużaw flimkien ma' dieta u eżerċizzju f'pazjenti bid-dijabete tat-tip 2, jew waħedhom jew f'kombinazzjoni ma' mediċini oħrajn tad-dijabete.
English: In view of the above, the PRAC considered that the benefit-risk balance of Forxiga, XigDuo, Invokana, Vokanamet, Jardiance and Synjardy remains favourable subject to the agreed amendments to the product information.
Maltese: Fid-dawl ta' dan ta' hawn fuq, il-PRAC ikkunsidra li l-bilanċ bejn il-benefiċċju u r-riskju ta' Forxiga, XigDuo, Invokana, Vokanamet, Jardiance u Synjardy jibqa' favorevoli soġġett għall-emendi maqbula għall-informazzjoni tal-prodott.
English: • The PRAC reviewed the totality of the data submitted by the marketing authorisation holders in relation to the risk of DKA in association with SGLT2 inhibitors-containing products and in support of the efficacy of SGLT2 inhibitors-containing products.
Maltese: • Il-PRAC ikkunsidra li l-effikaċja ta' dawn il-prodotti ntweriet b'mod adegwat fl-indikazzjonijiet attwalment awtorizzati tagħhom fil-monoterapija u f'kombinazzjoni bħala żieda mad-dieta u leżerċizzju sabiex jitjieb il-kontroll gliċemiku f'pazjenti adulti bit-T2DM.
English: The MAHs are required to submit the final study report to the EMA as they become available.
Maltese: Il-MAHs huma mitlubin li jippreżentaw ir-rapport ta' studju finali lill-EMA meta dan isir disponibbli.
English: • The PRAC therefore, was of the view that the risk of DKA should be minimised by its inclusion in the product information with a warning highlighting to healthcare professional and patients the possible atypical presentation of DKA to be considered in the occurrence of non-specific symptoms, together with the risk factors, and recommendations regarding treatment discontinuation.
Maltese: • Għaldaqstant il-PRAC kien tal-fehma li r-riskju ta' DKA għandu jkun minimizzat bl-inklużjoni tiegħu fl-informazzjoni tal-prodott bi twissija lil professjonisti tal-kura tas-saħħa u lill-pazjenti, li tenfasizza l-preżentazzjoni atipika ta' DKA sabiex titqies fl-okkorrenza ta' sintomi mhux speċifiċi flimkien mal-fatturi tar-riskju, u r-rakkomandazzjonijiet rigward it-twaqqif tal-kura.
English: Several postauthorisation safety studies are planned or ongoing in order to compare the incidence of DKA in SGLT2 inhibitors and other anti-hyperglycaemic agents.
Maltese: Inħarġet twissija tas-sigurtà dwar DKA mill-FDA għal din il-klassi terapewtika fl-istess xahar.
English: However, cases reported with SLGT2 inhibitors occurred in patients with T2DM as well as T1DM.
Maltese: Madankollu, każijiet irrapportati b'inibituri tal-SLGT2 seħħew f'pazjenti b'T2DM kif ukoll b'T1DM.
English: Forty-six cases of DKA were also reported in patients on SGLT2 inhibitors for T1DM, which is not currently an approved indication for these products.
Maltese: Sitta u erbgħin każ ta' DKA ġew irrapportati wkoll f'pazjenti fuq l-inibituri tal-SGLT2 għat-T1DM, li attwalment mhuwiex indikazzjoni approvata għal dawn il-prodotti.
English: This is not an approved indication for SGLT2 inhibitors containing products, nevertheless the PRAC considered that healthcare professionals should be warned of this risk and reminded that patients with T1DM should not be treated with SGLT2 inhibitors.
Maltese: Din mhijiex indikazzjoni approvata għal prodotti li fihom l-inibituri tal-SGLT2, madankollu l-PRAC ikkunsidra li l-professjonisti tal-kura tas-saħħa għandhom jiġu avżati b'dan ir-riskju u fakkar li l-pazjenti b'T1DM ma għandhomx jiġu kkurati bl-inibituri tal-SGLT2.
English: Importantly, DKA with atypical presentation may occur in association with SGLT2 inhibitors.
Maltese: B'mod importanti, DKA bi preżentazzjoni atipika tista' sseħħ f'assoċjazzjoni mal-inibituri tal-SGLT2.
English: DKA typically occurs in T1DM patients with high blood glucose concentrations.
Maltese: Normalment, DKA isseħħ f'pajenti bit-T1DM b'konċentrazzjonijiet għoljin ta' glukożju fid-demm.
English: DKA cases were reported in all three SGLT2 currently authorised in the EU, suggestive of a class effect.
Maltese: Il-każijiet ta' DKA ġew irrapportati fit-tliet SGLT2 kollha attwalment awtorizzati fl-UE, u dan jissuġġerixxi effett ta' klassi.
English: In addition, the MAHs are required to clarify the mechanism behind SGLT2 inhibitors-induced DKA.
Maltese: Preżentazzjoni atipika ta' DKA f'pazjenti bid-dijabete tat-tip 2 tista' ddewwem id-dijanjożi u l-kura.
English: The full EPAR for Jevtana 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: Jevtana contains the active substance cabazitaxel.
Maltese: Jevtana fih is-sustanza attiva cabazitaxel.
English: This is a summary of the European public assessment report (EPAR) for Jevtana.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Jevtana.
English: Why has Jevtana been approved?
Maltese: Għaliex ġie approvat Jevtana?
English: Other information about Jevtana
Maltese: Informazzjoni oħra dwar Jevtana
English: The European Commission granted a marketing authorisation valid throughout the European Union for Jevtana on 17 March 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Jevtana fis-17 ta' Marzu 2011.
English: The effects of Jevtana were compared with another cancer medicine, mitoxantrone.
Maltese: L-effetti ta' Jevtana tqabblu ma' mediċina oħra kontra l-kanċer, il-mitoxantrone.
English: The active substance in Jevtana, cabazitaxel, belongs to the group of cancer medicines known as ‘taxanes'.
Maltese: Is-sustanza attiva f'Jevtana, il-cabazitaxel, tagħmel parti mill-grupp ta' mediċini kontra l-kanċer magħrufin bħala ‘tassini'.
English: Both medicines were given in combination with prednisone or prednisolone.
Maltese: Iż-żewġ mediċini ngħataw f'kombinazzjoni mal-prednisone jew ilprednisolone.