FrancophonIA/ELRC3.0 huggingface dataset:
English: If women of a sexually mature age are treated, effective contraception must be performed during treatment and for at least six months after.
Maltese: Jekk nisa ta' età sesswalment matur ser jiġu trattati, kontraċezzjoni effettiva għandha tiġi implimentata waqt it-trattament u għal tal-anqas 6 xhur wara.
English: How to store Nordimet
Maltese: X'fih Nordimet
English: The solution is to be visually inspected prior to use.
Maltese: Rappurtar ta' reazzjonijiet avversi suspettati.
English: Open the blister pack by peeling back the top layer all the way off the blister pack as shown.
Maltese: Id-data ta' meta jiskadi tirreferi għall-aħħar ġurnata ta' dak ix-xahar.
English: PRE-FILLED SYRINGE CARTON OUTER LABEL CONTAINS BLUE BOX
Maltese: Żomm is-siringa fil-kartuna ta' barra, sabiex tipproteġiha mid-dawl.
English: In therapy-refractory cases the weekly dose may be increased up to 20 mg/m² BSA per week.
Maltese: F'każijiet terapewtiċi-refrattorji d-doża kull ġimgħa tista' tiżdied għal sa 20 mg/m² BSA fil-ġimgħa.
English: The available evidence does not indicate an increased risk of malformations or miscarriage if the father takes methotrexate less than 30 mg/week.
Maltese: L-evidenza disponibbli ma tindikax riskju ogħla ta' malformazzjonijiet jew korrimenti fit-tqala jekk ilmissier jieħu inqas minn 30 mg/ġimgħa methotrexate.
English: For Orlistat 60 mg capsules:
Maltese: Għal Orlistat 60 mg kapsuli:
English: • “- acarbose (an anti-diabetic drug used to treat type 2 diabetes mellitus).
Maltese: • “acarbose (mediċina kontra d-dijabete wżata biex tikkura dijabete mellitus tat-tip 2).
English: “Other medicines and [Product name]”
Maltese: “Mediċini oħra u [Isem tal-prodott]”
English: For Orlistat 120 mg capsules: “[Product name] is not recommended for people taking acarbose (an anti-diabetic drug used to treat type 2 diabetes mellitus).”
Maltese: Għal Orlistat 120 mg kapsuli: “[Isem tal-prodott] mhux irrakkomandat għall-persuni li jieħdu acarbose (mediċina kontra d-dijabete wżata biex tikkura dijabete mellitus tat-tip 2).
English: • “Hepatitis (inflammation of the liver).
Maltese: • “Epatite (infjammazzjoni tal-fwied).
English: PACKAGE LEAFLET
Maltese: TAL-PRODOTT]
English: See Chapter 2, take extra care with [Product name]”
Maltese: Ara Kapitlu 2, oqgħod attent ħafna b'[Isem tal-prodott].
English: • “oxalate nephropathy (build up of calcium oxalate which may lead to kidney stones).
Maltese: • Nefropatija kkawżata minn Oxalate (akkumulazzjoni ta' calcium oxalate li tista' twassal għal ġebel fil-kliewi).
English: Symptoms can include yellowing skin and eyes, itching, dark coloured urine, stomach pain and liver tenderness (indicated by pain under the front of the rib cage on your right hand side), sometimes with loss of appetite.”
Maltese: Sintomi jistgħu jinkludu sfurija tal-ġilda u l-għajnejn, ħakk, awrina skura, uġigħ fl-istonku u tenerezza fil-fwied (indikat minn uġigħ taħt il-parti ta' quddiem tal-kustilji fuq in-naħa tal-lemin tiegħek), xi kultant b'telf ta' aptit.
English: SECTION 4 - POSSIBLE SIDE EFFECTS
Maltese: ANNESS III
English: Section 4.8 “Hepatitis that may be serious”
Maltese: “Epatite li tista' tkun serja”
English: ANNEX III AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCTS CHARACTERISTICS AND PACKAGE LEAFLET
Maltese: EMENDI LI GĦANDHOM IKUNU INKLUŻI FIS-SEZZJONIJIET RILEVANTI
English: Note: These amendments to the summary of product characteristics and package leaflet are valid at the time of the Commission Decision.
Maltese: Nota: Dawn l-emendi għas-sommarju tal-karatteristiċi tal-prodott u l-fuljett ta' tagħrif huma valida fiżżmien tad-Deċiżjoni tal-Kummissjoni.
English: Temozolomide Sandoz 5 mg
Maltese: Qawwa Għamla farmaċewtika
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 February 2017
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 ta' Frar 2017
English: Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/117)
Maltese: Riżultat ta' proċedura ta' riferiment skont l-Artikolu 35 tadDirettiva 2001/82/KE (EMEA/V/A/117)
English: What is gentamicin?
Maltese: X'inhu gentamicin?
English: Gentamicin is an aminoglycoside antibiotic indicated for the treatment of a variety of bacterial infections.
Maltese: Gentamicin hu antibijotiku aminoglikosid indikat għall-kura ta' varjetà ta' infezzjonijiet batterjali.
English: Belgium noted that there are different approved withdrawal periods for cattle and pigs for veterinary medicinal products containing gentamicin presented as solutions for injection across the European Union, e.g. cattle meat and offal from 28 days to 210 days; cattle milk from 2 to 7 days, with some of the products stating ‘do not use in cows whose milk is intended for human consumption'; and pig meat and offal from 28 days to 150 days.
Maltese: Il-Belġju nnota li hemm perjodi ta' tiżmim approvati differenti għall-frat u l-ħnieżer għal prodotti mediċinali veterinarji li fihom gentamicin u li huma ppreżentati bħala soluzzjonijiet għall-injezzjoni madwar l-Unjoni Ewropea, eż. minn 28 jum sa 210 ijiem għal-laħam tal-frat u l-ġewwieni tal-annimal, minn jumejn sa sebat ijiem għall-ħalib tal-frat, b'xi wħud mill-prodotti li jiddikjaraw “tużahx f'baqar li lħalib tagħhom hu intiż għall-konsum mill-bniedem”; u minn 28 jum sa 150 jum għal-laħam tal-ħnieżer u l-ġewwieni tal-annimal.
English: On 8 January 2016, Belgium initiated a procedure under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to cattle and pigs, due to concerns related to the withdrawal periods set for the aforementioned products.
Maltese: Fit-8 ta' Jannar 2016, il-Belġju beda proċedura skont l-Artikolu 35 tad-Direttiva 2001/82/KE għallprodotti mediċinali veterinarji li fihom gentamicin u li huma ppreżentati bħala soluzzjonijiet għall
English: On 10 November 2016, the European Medicines Agency (the Agency) completed a review of the consumer safety of the withdrawal periods for cattle (meat and milk) and pigs (meat and offal) for veterinary medicinal products containing gentamicin presented as solutions for injection.
Maltese: Fl-10 ta' Novembru 2016, l-Aġenzija Ewropea għall-Mediċini (l-Aġenzija) temmet reviżjoni tassikurezza tal-konsumatur tal-perjodi ta' tiżmim għall-frat (laħam u ħalib) u għall-ħnieżer (laħam u ġewwieni tal-annimal) għal prodotti mediċinali veterinarji li fihom gentamicin li huma ppreżentati bħala soluzzjonijiet għall-injezzjoni.
English: Proprietary data and scientific references on residue depletion were provided by the marketing authorisation holders.
Maltese: Id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq ippreżentaw data proprjetarja u referenzi xjentifiċi dwar it-tnaqqis ta' residwu.
English: In veterinary medicine gentamicin is used mainly as a solution for injection for cattle, pigs, horses, cats and dogs.
Maltese: F'mediċina veterinarja, gentamicin prinċipalment jintuża bħala soluzzjoni għall-injezzjoni għall-frat, il-ħnieżer, iż-żwiemel, il-qtates u l-klieb.
English: Based on the evaluation of the currently available data, the CVMP concluded that the overall benefitrisk balance for veterinary medicinal products containing gentamicin presented as solutions for injection is positive and agreed that the withdrawal periods for cattle (meat and milk) and pigs (meat and offal) should be amended to provide assurance for consumer safety and also agreed that the subcutaneous route should no longer be recommended for cattle and pigs since the depletion kinetics from the injection site remain unknown.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) talAġenzija kkonkluda li l-bilanċ ġenerali bejn il-benefiċċju u r-riskju tal-prodotti mediċinali veterinarji li fihom gentamicin li huma ppreżentati bħala soluzzjonijiet għall-injezzjoni huwa pożittiv u rrakkomanda emendi għall-perjodi ta' tiżmim tal-frat u l-ħnieżer biex tiġi pprovduta assigurazzjoni għas-sikurezza tal-konsumatur.
English: It is normally used as the sulfate salt.
Maltese: Normalment hu jintuża bħala l-melħ tas-sulfat.
English: Why were veterinary medicinal products containing gentamicin presented as solutions for injection reviewed?
Maltese: Għaliex il-prodotti mediċinali veterinarji li fihom gentamicin u li huma ppreżentati bħala soluzzjonijiet għall-injezzjoni ġew eżaminati?
English: The European Commission issued a decision on 27 February 2017.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni fis-27 ta' Frar 2017.
English: Further information on Dzuveo 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: Dzuveo contains the active substance sufentanil.
Maltese: Dzuveo fih is-sustanza attiva sufentanil.
English: Other information about Dzuveo
Maltese: Informazzjoni oħra dwar Dzuveo
English: The most serious side effects with sufentanil are severe breathing problems, which occur in around 6 people in 1,000.
Maltese: L-effetti sekondarji l-aktar serji b'sufentanil huma problemi severi fit-teħid tan-nifs, li jseħħu f'madwar 6 persuni minn kull 1,000.
English: In the first study in 163 patients who had undergone abdominal surgery, pain reduced by 26 points with Dzuveo compared with 13 points with placebo (a dummy treatment).
Maltese: Fl-ewwel studju f'163 pazjent li saritilhom kirurġija addominali, l-uġigħ tnaqqas b'26 punt b'Dzuveo meta mqabbel ma' 13-il punt bi plaċebo (kura finta).
English: Dzuveo should not be used for more than 48 hours.
Maltese: Dzuveo m'għandux jintuża għal aktar minn 48 siegħa.
English: What are the risks associated with Dzuveo?
Maltese: X'inhuma r-riskji assoċjati ma' Dzuveo?
English: In the second study in 101 patients after foot surgery, pain reduced by around 6 points with Dzuveo and increased by around 7 points with placebo.
Maltese: Fit-tieni studju f'madwar 101 pazjent wara kirurġija fis-sieq, l-uġigħ tnaqqas b'madwar 6 punti b'Dzuveo u żdied b'madwar 7 punti bi plaċebo.
English: This means that it is similar to a ‘reference medicine' (called Sufenta Forte) containing the same active substance.
Maltese: Dan ifisser li huwa simili għal ‘mediċina ta' referenza' (imsejħa Sufenta Forte) li fiha l-istess sustanza attiva.
English: As for all medicines, data on the use of Dzuveo are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Dzuveo hija ssorveljata kontinwament.
English: The difference between the products is that Dzuveo is available as sublingual tablets (tablets to be dissolved under the tongue) while the reference medicine is a solution for injection.
Maltese: Id-differenza bejn il-prodotti hija li Dzuveo jiġi bħala pilloli għal taħt l-ilsien (pilloli li għandhom jinħallu taħt l-ilsien) filwaqt li l-mediċina ta' referenza hija soluzzjoni għall-injezzjoni.
English: Dzuveo is available as 30 µg sublingual tablets.
Maltese: Dzuveo jiġi bħala 30 µg pilloli għal taħt l-ilsien.
English: Dzuveo is an opioid pain medicine used to treat moderate to severe pain in adults.
Maltese: Dzuveo huwa mediċina ta' opjojdi għall-uġigħ li tintuża biex tikkura wġigħ moderat sa sever fl-adulti.
English: For the full list of side effects and restrictions with Dzuveo, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u restrizzjonijiet bi Dzuveo, ara l-fuljett ta' tagħrif.
English: Studies show that Dzuveo is effective at reducing severe pain following surgeries.
Maltese: L-istudji juru li Dzuveo huwa effettiv biex inaqqas uġigħ sever wara l-kirurġiji.
English: Side effects reported with Dzuveo are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati bi Dzuveo huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Both studies used a pain rating scale known as SPID12 which tracks reduction in pain over 12 hours.
Maltese: Iż-żewġ studji użaw skala ta' klassifikazzjoni tal-uġigħ magħrufa bħala SPID12 li tirreġistra tnaqqis fl-uġigħ matul 12-il siegħa.
English: How is Dzuveo used?
Maltese: Kif jaħdem Dzuveo?
English: The active substance in Dzuveo, sufentanil, is an opioid that works by attaching to receptors (targets) in the brain known as μ-opioid receptors.
Maltese: Is-sustanza attiva f'Dzuveo, is-sufentanil, hija opjojde li taħdem billi teħel mar-riċetturi (miri) fil-moħħ magħrufa bħala riċetturi ta' μ-opjojde.
English: The side effects seen with Dzuveo are those expected with opioids, and are considered manageable.
Maltese: L-effetti sekondarji li dehru b'Dzuveo huma dawk mistennija bl-opjojdi, u jitqiesu bħala li jistgħu jiġu mmaniġġjati.
English: Patients should not eat or drink and should talk as little as possible for the 10 minutes after taking the tablet.
Maltese: Il-pazjenti m'għandhomx jieklu jew jixorbu u għandhom jitkellmu għal mill-inqas għall-10 minuti wara li jieħdu l-pillola.
English: Cabometyx is available as tablets (20, 40 and 60 mg).
Maltese: Cabometyx jiġi bħala pilloli (20, 40 u 60 mg).
English: Further information on Cabometyx can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/cabometyx.
Maltese: ema.europa.eu/en/medicines/human/EPAR/cabometyx.
English: Cabometyx received a marketing authorisation valid throughout the EU on 9 September 2016.
Maltese: Cabometyx ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fid-9 ta' Settembru 2016.
English: Cabometyx (cabozantinib)
Maltese: Cabometyx (kabozantinib)
English: The most common serious side effects (seen in more than 1 person in 100) with Cabometyx in patients with renal cell carcinoma are high blood pressure, diarrhoea, nausea (feeling sick), loss of appetite, tiredness, dehydration, hyponatraemia and hypomagnesaemia (low blood levels of sodium and magnesium), palmar-plantar erythrodysaesthesia syndrome (hand-foot syndrome, which involves rash and numbness on the palms and soles) and embolism (clot in a blood vessel).
Maltese: L-effetti sekondarji serji l-aktar komuni (li dehru f'aktar minn persuna waħda minn 100) b'Cabometyx f'pazjenti b'karċinoma taċ-ċelloli renali huma pressjoni għolja, dijarea, nawżja (tħossok ma tiflaħx), nuqqas ta' aptit, għeja, deidratazzjoni, iponatremja u ipomanjesemja (livelli ta' demm baxxi ta' sodju u manjeżju), sindromu tal-eritrodisesteżija palmar-plantar (sindromu tal-idejn u s-saqajn, li jinvolvi raxx u tnemnim fuq il-pali tal-idejn u l-qiegħ tas-saqajn) u emboliżmu (embolu f'vażu).
English: The active substance in Cabometyx, cabozantinib, is a ‘tyrosine kinase inhibitor'.
Maltese: Is-sustanza attiva f'Cabometyx, il-kabozantinib, hija “inibitur tat-tirożina kinażi”.
English: The study involved 157 patients, and compared Cabometyx with another cancer medicine, sunitinib.
Maltese: L-istudju involva 157 pazjent, u qabbel Cabometyx ma' mediċina oħra kontra l-kanċer, sunitinib.
English: In the study, Cabometyx was compared with the cancer medicine everolimus.
Maltese: Flistudju, Cabometyx tqabbel mal-mediċina kontra l-kanċer everolimus.
English: Other information about Cabometyx
Maltese: Informazzjoni oħra dwar Cabometyx
English: • hepatocellular carcinoma (a liver cancer).
Maltese: • karċinoma epatoċellulari (kanċer tal-fwied).
English: Cabometyx contains the active substance cabozantinib.
Maltese: Cabometyx fih is-sustanza attiva kabozantinib.
English: The recommended dose is 60 mg once a day.
Maltese: Id-doża rakkomandata hija ta' 60 mg darba kuljum.
English: The most common serious side effects (seen in more than 1 person in 100) with Cabometyx in patients with hepatocellular carcinoma are hepatic encephalopathy (harmful effects on the brain caused by liver damage), palmar-plantar erythrodysaesthesia syndrome, weakness and diarrhoea.
Maltese: L-effetti sekondarji serji l-aktar komuni (li dehru f'aktar minn persuna waħda minn 100) b'Cabometyx f'pazjenti b'karċinoma epatoċellulari huma enċefalopatija epatika (effetti ta' ħsara fuq il-moħħ ikkawżati minn ħsara fil-fwied), sindromu ta' eritrodisesteżija palmar-plantar, dgħufija u dijarea.
English: What are the risks associated with Cabometyx?
Maltese: X'inhuma r-riskji assoċjati ma' Cabometyx?
English: It is used in patients who have been previously treated with a type of cancer medicine called ‘vascular endothelial growth factor (VEGF) inhibitor'.
Maltese: Din il-mediċina tintuża fuq pazjenti li ġew ikkurati preċedentament b'tip ta' mediċina kontra l-kanċer imsejħa "inibitur tal-fattur tattkabbir vaskulari endoteljali (VEGF, vascular endothelial growth factor)".
English: Cabometyx is a cancer medicine used to treat adults with:
Maltese: Cabometyx huwa mediċina kontra l-kanċer li tintuża fil-kura ta' adulti li jbatu minn:
English: Patients treated with Cabometyx lived on average for 10.2 months, compared with 8.0 months in patients who received placebo.
Maltese: Pazjenti kkurati b'Cabometyx għexu medja ta' 10.2 xhur meta mqabbla ma' 8.0 xhur għal pazjenti li rċevew plaċebo.
English: One main study involving 707 adults with hepatocellular carcinoma who had already been treated with sorafenib showed that Cabometyx was effective at prolonging how long patients lived (overall survival).
Maltese: Studju ewlieni li involva 707 adulti b'karċinoma epatoċellulari li kienu diġà ġew ikkurati b'sorafenib wera li Cabometyx kien effettiv biex itawwal kemm damu jgħixu l-pazjenti (sopravivenza ġenerali).
English: • advanced renal cell carcinoma (a kidney cancer).
Maltese: • karċinoma avvanzata taċ-ċellola renali (kanċer tal-kliewi).
English: For the full list of side effects and restrictions with Cabometyx, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Cabometyx, ara l-fuljett ta' tagħrif.
English: In addition, results indicated that patients treated with Cabometyx lived overall longer than patients treated with everolimus (an average of 21.4 months compared with 16.5 months).
Maltese: Barra minn hekk, ir-riżultati wrew li l-pazjenti kkurati b'Cabometyx għexu b'mod ġenerali aktar mill-pazjenti kkurati b'everolimus (medja ta' 21.4 xhur meta mqabbla ma' 16.5 xhur).
English: What measures are being taken to ensure the safe and effective use of Cabometyx?
Maltese: X'miżuri qed jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Cabometyx?
English: Patients treated with Cabometyx lived for an average of 8.6 months without their disease getting worse compared with 5.3 months in those treated with sunitinib.
Maltese: Il-pazjenti kkurati b'Cabometyx għexu medja ta' 8.6 xhur mingħajr ma l-marda tagħhom qalbet għall-agħar, meta mqabbla mal-5.3 xhur għal dawk il-pazjenti li ġew ikkurati b'sunitinib.
English: Patients treated with Cabometyx lived for an average of 7.4 months without their disease getting worse compared with 3.8 months in patients treated with everolimus.
Maltese: Il-pazjenti kkurati b'Cabometyx għexu medja ta' 7.4 xhur mingħajr ma l-marda tagħhom qalbet għall-agħar, meta mqabbla ma' 3.8 xhur għal pazjenti li ġew ikkurati b'everolimus.
English: In previously untreated patients with moderate or high risk disease, Cabometyx also provided clinically relevant benefit, delaying the progression of the cancer and the need for other treatments.
Maltese: F'pazjenti b'mard ta' riskju moderat jew għoli li ma kinux ikkurati preċedentament, Cabometyx ipprovda wkoll benefiċċju kliniku rilevanti, billi ttardja l-progressjoni talkanċer u l-bżonn ta' kuri oħra.
English: As for all medicines, data on the use of Cabometyx are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Cabometyx hija ssorveljata kontinwament.
English: Why is Cabometyx authorised in the EU?
Maltese: Għaliex Cabometyx huwa awtorizzat fl-UE?
English: One main study involving 658 adults with advanced renal cell carcinoma that had got worse despite treatment with a VEGF inhibitor showed that Cabometyx is effective at prolonging the time patients lived without their disease getting worse (progression-free survival).
Maltese: Studju ewlieni wieħed li fih ħadu sehem 658 adult b'karċinoma avvanzata taċ-ċellola renali li ggravat minkejja l-kura b'inibitur VEGF wera li Cabometyx huwa effettiv biex itawwal iż-żmien li l-pazjenti għexu mingħajr ma l-marda tagħhom qalbet għall-agħar (sopravivenza mingħajr progressjoni).
English: In hepatocellular carcinoma, Cabometyx was shown to prolong survival in patients who had been treated with sorafenib.
Maltese: Jintuża waħdu f'pazjenti li jkunu ġew ikkurati preċedentament bil-mediċina kontra l-kanċer sorafenib;
English: In the study, Cabometyx was compared with placebo (a dummy treatment).
Maltese: Flistudju, Cabometyx tqabbel ma' plaċebo (kura finta).
English: The side effects of Cabometyx are similar to other tyrosine kinase inhibitors, and they are considered manageable.
Maltese: L-effetti sekondarji ta' Cabometyx huma simili għal inibituri oħrajn tat-tirożina kinażi u huma kkunsidrati maniġġabbli.
English: How does Cabometyx work?
Maltese: Kif jaħdem Cabometyx?
English: Side effects reported with Cabometyx are carefully evaluated and any necessary action taken to protect patients.
Maltese: Leffetti sekondarji rrappurtati b'Cabometyx huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti..
English: • The Committee considered the referral under Article 31 of Directive 2001/83/EC, as amended, for dexrazoxane-containing medicinal products;
Maltese: • Il-Kumitat ikkunsidra r-riferiment skont l-Artikolu 31 tad-Direttiva 2001/83/KE, kif emendata, għall-prodotti mediċinali li fihom dexrazoxane;
English: A significantly increased risk of other toxicities compared to controls were also reported in the study in paediatric patients with Hodgkin's disease and included grade 4 neutropenia, grade 3/4 thrombocytopenia, grade 3/4 sepsis and grade 3/4 pulmonary toxicity.
Maltese: Ġiet irrapportata wkoll żieda sinifikanti fir-riskju ta' tossiċitajiet oħra meta mqabbla ma' kontrolli fl-istudju fuq pazjenti pedjatriċi bil-marda ta' Hodgkin u kienu jinkludu newtropenja ta' grad 4, tromboċitopenja ta' grad 3/4, sepsis ta' grad 3/4 u tossiċità pulmonari ta' grad 3/4.
English: AML was also identified as an uncommonly reported adverse reaction.
Maltese: AML ġiet identifikata wkoll bħala reazzjoni avversa rari rrapportata.
English: During the evaluation of a periodic safety update report (PSUR), concerns were raised regarding an increase risk of second malignancies neoplasms (SMN), in particular acute myelogenous leukaemia (AML)/myelodyspastic syndrome (MDS) and solid tumours in paediatric patients observed in studies reported in the literature.
Maltese: Matul l-evalwazzjoni ta' rapport perjodiku ta' aġġornament dwar is-sigurtà (PSUR), kien hemm xi tħassib fir-rigward ta' żieda fir-riskju ta' neoplażmi malinni sekondarji (SMN), b'mod partikolari lewkimja akuta majeloġenuża (AML)/sindromu majelodisplastiku (MDS) u tumuri solidi f'pazjenti pedjatriċi osservati fi studji rrapportati fir-riċensjoni.
English: In addition, a signal of increased risk of solid tumours was noted.
Maltese: Barra minn hekk, kien innotat sinjal ta' żieda fir-riskju ta' tumuri solidi.
English: Following the consultation of the Scientific Advisory Group (SAG) on oncology, the CHMP agreed that the therapeutic indication should be restricted to adult breast cancer patients who had received a prior cumulative dose of 300 mg/m2 of doxorubicin or a prior cumulative dose of 540 mg/m2 of epirubicin when further anthracycline treatment is required.
Maltese: Wara l-konsultazzjoni tal-Grupp Konsultattiv Xjentifiku (SAG) dwar l-onkoloġija, is-CHMP qabel li l-indikazzjoni terapewtika għandha tiġi ristretta għal pazjenti adulti bil-kanċer tas-sider li fil-passat kienu rċevew doża kumulattiva ta' 300 mg/m2 ta' doxorubicin jew doża kumulattiva preċedenti ta' 540 mg/m2 ta' epirubicin meta hija meħtieġa kura addizzjonali b'anthracycline.
English: An increased risk of myelosuppression and infection was also observed in paediatric patients.
Maltese: Ġiet osservata wkoll żieda fir-riskju ta' majelosoppressjoni u infezzjoni f'pazjenti pedjatriċi.