FrancophonIA/ELRC3.0 huggingface dataset:
English: In a phase 2 clinical trial investigating necitumumab in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone as the first-line therapy in patients with Stage IV metastatic squamous NSCLC, an increased rate of infections was observed early after start of treatment, which led to subsequent infectious complications such as pneumonia and/or sepsis.
Maltese: skwamuż metastatiku ta' Stadju IV, ġiet osservata żieda fir-rata ta' infezzjonijiet ftit wara li nbeda t trattament, li sussegwentement wassal għal komplikazzjonijiet infettivi bħal pulmonite u/jew sepsis.
English: • Permanently discontinue if patients experience Grade 3 skin induration/fibrosis.
Maltese: • Waqqaf b'mod permanenti jekk il-pazjenti jkollhom ebusija fil ġilda/fibrożi ta' Grad 3.
English: In the Portrazza+GC arm, 51 % of patients continued with single-agent Portrazza after completing chemotherapy.
Maltese: Fil-fergħa ta' Portrazza+GC, 51% tal-pazjenti komplew b'Portrazza waħdu wara li temmew il-kimoterapija.
English: Albumin-corrected hypocalcaemiac
Maltese: U EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: There are no data regarding necitumumab administration in patients with moderate or severe hepatic impairment (see section 5.2).
Maltese: Ma hemm l-ebda dejta dwar l-għoti ta' necitumumab f'pazjenti b'indeboliment moderat jew sever tal-fwied (ara sezzjoni 5.2).
English: Animal studies to assess fertility directly have not been conducted (see section 5.3).
Maltese: Ma sarux studji flannimali biex tiġi stmata l-fertilità b'mod dirett (ara sezzjoni 5.3).
English: Severe infusion-related reactions were reported in 0.4 % of patients.
Maltese: Reazzjonijiet severi marbuta mal-infużjoni ġew irrappurtati f'0.4% tal-pazjenit.
English: Administer via an infusion pump.
Maltese: Agħti permezz ta' pompa tal-infużjoni.
English: Necitumumab hinders other proteins from binding to the EGFR and thus prevents the cancer cell from growth and division.
Maltese: effikaċja klinika skont il-livell ta' espressjoni tal-proteina EGFR tat-tumur.
English: To administer using empty intravenous infusion containers Aseptically transfer 50 mL of necitumumab medicinal product into an empty intravenous container and add 200 mL of sodium chloride 9 mg/mL (0.9 %) solution for injection to the container to bring the total volume to 250 mL.
Maltese: B'mod asettiku ittrasferixxi 50 mL tal-prodott mediċinali necitumumab għal ġo kontenitur vojt għallinfużjoni fil-vina u żid 200 mL ta' soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/mL (0.9%)
English: • Decrease infusion rate by 50 % for the duration of infusion.b
Maltese: • Naqqas ir-rata tal-infużjoni b'50% għat-tul ta' żmien talinfużjoni.
English: There were no relevant differences in the distribution of demographics, disease characteristics, or the use of post-study systemic therapy between the subset of patients with detectable EGFR protein expression and the ITT population.
Maltese: Ma kien hemm l-ebda differenzi rilevanti fid-distribuzzjoni tad demografika, tal-karatteristiċi tal-marda, jew tal-użu ta' terapija sistemika wara l-istudju bejn is sottosett ta' pazjenti b'espressjoni tal-proteina EGFR li setgħet tiġi osservata u l-popolazzjoni ITT.
English: Necitumumab is a human IgG1 monoclonal antibody produced in murine (NS0) cells by recombinant DNA technology.
Maltese: IgG1 uman magħmul f'ċelluli tal-ġrieden (NS0)
English: Common (may affect up to 1 in 10 people) - headache - coughing up blood (haemoptysis) - nosebleed (epistaxis) - strange tastes; metallic taste (dysgeusia) - eye inflammation (conjunctivitis) - blood clots in the arteries - urinary tract infection (bladder and/or kidneys) - pain when passing urine (dysuria) - difficulty in swallowing (dysphagia) - muscle spasms - inflammation of veins in the legs (phlebitis) - allergic reactions - pain in your mouth and throat (oropharyngeal pain)
Maltese: Portrazza jintuża flimkien ma' mediċini oħra kontra l-kanċer għat-trattament ta' adulti b'ċerti tipi ta' kanċer tal-pulmun fi stadju avvanzat (kanċer taċ-ċelluli skwamużi mhux żgħar tal-pulmun), fejn iċċelluli tal-kanċer tagħhom għandhom il-proteina EGFR fuq is-superfiċje tagħhom.
English: There was no relationship between immunogenicity and IRRs or treatment emergent adverse events.
Maltese: Portrazza jista' jżid dan ir-riskju.
English: There are no data on the effect of necitumumab on human fertility.
Maltese: Ma hemm l-ebda dejta dwar l-effett ta' necitumumab fuq il-fertilita umana.
English: Common Headache Common Dysgeusia
Maltese: Infezzjoni flapparat talawrina
English: Sodium restricted diet
Maltese: Dieta b'ammont ristrett ta' sodium
English: In a clinical trial in advanced non-squamous NSCLC, venous thromboembolic events (VTEs) were reported in approximately 11 % of patients treated with necitumumab in combination with pemetrexed and cisplatin (versus 8 % in the pemetrexed and cisplatin alone arm) and mainly presented as pulmonary embolism and deep vein thrombosis.
Maltese: pemetrexed u cisplatin (versus 8% fil-fergħa ta' pemetrexed u cisplatin waħedhom) u dehru l-aktar bħala emboliżmu fil-pulmuni u trombożi fil-vini fil-fond.
English: a Grade per NCI-CTCAE, Version 3.0 b Once the infusion rate has been reduced for a Grade 1 or 2 hypersensitivity/infusion-related reaction, it is recommended that the lower infusion rate be utilized for all subsequent infusions.
Maltese: a Grad skont NCI-CTCAE, Verżjoni 3.0 b Ladarba r-rata tal-infużjoni tkun ġiet imnaqsa minħabba reazzjoni ta' Grad 1 jew 2 ta'
English: To administer using empty intravenous infusion containers Aseptically transfer 50 mL of necitumumab medicine into an empty intravenous container and add 200 mL of sterile sodium chloride 9 mg/mL (0.9%) solution for injection to the container to bring the total volume to 250 mL.
Maltese: Biex tagħti billi tuża kontenituri vojta għall-infużjoni fil-vina B'mod asettiku ittrasferixxi 50 mL tal-mediċina necitumumab għal ġo kontenitur vojt għal infużjoni fil-vina u żid 200 mL ta' soluzzjoni għall-injezzjoni sterili ta' sodium chloride 9 mg/mL (0.9%) fil kontenitur biex iġġib il-volum totali għal 250 mL.
English: There is no known antidote for necitumumab overdose.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: The risk of fertility impairment is unknown.
Maltese: Mhux magħruf ir-riskju ta' indeboliment talfertilità.
English: In patients who have experienced a previous Grade 1-2 hypersensitivity or infusion-related reaction to Portrazza, premedication with a corticosteroid and an antipyretic in addition to an antihistamine is recommended.
Maltese: sensittività eċċessiva jew marbuta mal-infużjoni għal Portrazza, hija rrakkomandata premedikazzjoni b'kortikosterojd u mediċina kontra d-deni flimkien ma' antiistamina.
English: • If symptoms do not worsen at 600 mg for another treatment cycle, the dose may be further increased to 800 mg.
Maltese: • Jekk is-sintomi ma jmorrux għall-agħar b'600 mg għal ċiklu ieħor ta' trattament, id-doża tista' tkompli tiżdied 800 mg.
English: Grade ≥ 3
Maltese: ANNESS III
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 ºC, or up to 4 hours at 9 ºC to 25 ºC.
Maltese: Jekk ma tintużax immedjatament, il-ħinijiet u l-kondizzjonijiet qabel u waqt l-użu huma r-responsabbiltà ta' min ikun qed jużah, u s-soltu ma jkunux aktar minn 24 siegħa f'temperatura ta' 2 sa 8°C jew sa mhux aktar minn 4 sigħat f'temperatura ta' 9 ºC sa 25 ºC.
English: Based on the results of the population pharmacokinetic analysis, there was no impact of renal function as assessed by creatinine clearance [CrCl] on the pharmacokinetics of necitumumab.
Maltese: Abbażi tar-riżultati ta' analiżi farmakokinetika ta' popolazzjoni, ma kien hemm l-ebda impatt mill-funzjoni tal-kliewi kif stmat mit-tneħħija tal-kreatinina [CrCl - creatinine clearance] fuq il-farmakokinetika ta' necitumumab.
English: Key elements of the physician educational material: o Importance of assessing the risks before starting treatment with necitumumab o Description of thromboembolic events including incidence rates from clinical trials o Advice that patients and physicians should be aware of signs and symptoms of thromboembolism.
Maltese: o L-importanza li jiġu evalwati r-riskji qabel ma jinbeda t-trattament b'necitumumab o Deskrizzjoni tal-avvenimenti tromboemboliċi inklużi r-rati tal-inċidenza mill-provi kliniċi o Parir li l-pazjenti u l-ispeċjalisti għandhom jkunu jafu dwar is-sinjali u s-sintomi ta'
English: For management and dose adjustments, see section 4.2.
Maltese: Għal immaniġġjar u aġġustamenti fid-doża, ara sezzjoni 4.2.
English: Toxicity in the elderly or in patients with ECOG PS 2
Maltese: Tossiċità fl-anzjani jew f'pazjenti b'PS ta' ECOG ta' 2
English: The important side effects of Portrazza are skin reactions and blood clots in the veins.
Maltese: L-effetti sekondarji importanti ta' Portrazza huma reazzjonijiet fil-ġilda u tagħqid tad-demm fil-vini.
English: If symptoms worsen at 400 mg, permanently discontinue.
Maltese: Jekk is-sintomi jmorru għall-agħar b'400 mg, waqqaf b'mod permanenti.
English: Infusion-related reactions were reported in 1.5 % of patients and mainly present as chills, fever or dyspnoea.
Maltese: Reazzjonijiet marbuta mal-infużjoni ġew irrappurtati f'1.5% tal-pazjenti u dehru l-aktar bħala tkexkix ta' bard, deni jew qtugħ ta' nifs.
English: However, no adverse effects on male or female reproductive organs were observed in monkeys treated for 26 weeks with necitumumab.
Maltese: Madankollu, ma kienu osservati l-ebda effetti avversi fuq l-organi ta' riproduzzjoni maskili jew femminili ta' xadini ttrattati għal-26 ġimgħa b'necitumumab.
English: 11 January 2019
Maltese: 11 ta' Jannar 2019
English: The review of Paclitaxel Hetero was initiated at the request of Portugal under Article 29 of Directive 2001/83/EC.
Maltese: Ir-rieżami ta' Paclitaxel Hetero inbeda fuq talba tal-Portugall, skont l-Artikolu 29 tadDirettiva 2001/83/KE.
English: What is Paclitaxel Hetero?
Maltese: X'inhu Paclitaxel Hetero?
English: In particular, the company did not provide direct comparative data with the reference medicine, which is normally required for medicines formulated in micelles.
Maltese: B'mod partikolari, il-kumpanija ma pprovdietx data komparattiva diretta mal-mediċina ta' referenza, li normalment tkun meħtieġa għal mediċini fformulati f'miċelli.
English: It was to be available as a concentrate for solution for infusion (6 mg/ml) for the treatment of breast cancer, cancer of the ovaries, non-small cell lung cancer and Kaposi's sarcoma (a cancer of the blood vessels) in patients with acquired immune deficiency syndrome (AIDS).
Maltese: Dan kellu jiġi bħala konċentrat għal soluzzjoni għall-infużjoni (6 mg/ml) għall-kura ta' kanċer tas-sider, kanċer tal-ovarji, kanċer talpulmun mhux b'ċelloli żgħar u sarkoma ta' Kaposi (kanċer tal-vażi) f'pazjenti b'sindrome ta' defiċjenza immuni akkwiżita (AIDS).
English: Paclitaxel Hetero is a medicine that contains the active substance paclitaxel.
Maltese: Paclitaxel Hetero huwa mediċina li fiha s-sustanza attiva paclitaxel.
English: On 18 October 2018, the European Medicines Agency (EMA) completed a review of Paclitaxel Hetero following a disagreement among EU Member States regarding its authorisation.
Maltese: Fit-18 ta' Ottubru 2018, l-Aġenzija Ewropea għall-Mediċini (EMA) lestiet rieżami ta' Paclitaxel Hetero wara nuqqas ta' qbil fost l-Istati Membri tal-UE dwar l-awtorizzazzjoni tiegħu.
English: Viladecans (Barcelona) submitted Paclitaxel Hetero to the Portuguese medicines agency for a decentralised procedure.
Maltese: Hetero Europe S.L. Viladecans (Barċellona) ippreżentat Paclitaxel Hetero lill-aġenzija tal-mediċini Portugiża għal proċedura deċentralizzata.
English: Paclitaxel Hetero was developed as a generic medicine.
Maltese: Paclitaxel Hetero ġie żviluppat bħala “mediċina ġenerika”.
English: The European Commission issued an EU-wide legally binding decision on 11 January 2019.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni legalment vinkolanti mal-UE kollha fil-11 ta' Jannar 2019.
English: Instead, it submitted indirect comparative data and a study which compared blood levels of paclitaxel in Paclitaxel Hetero with those of another generic paclitaxel medicine, which was not considered sufficient by the Netherlands.
Maltese: Minflok, din ippreżentat data komparattiva indiretta u studju li qabbel il-livelli fid-demm ta' paclitaxel f'Paclitaxel Hetero ma' dawk ta' mediċina ġenerika oħra ta' paclitaxel, li ma tqisitx biżżejjed min-Netherlands.
English: However, the Member States were not able to reach an agreement and the Portuguese agency referred the matter to EMA for arbitration on 2 November 2017.
Maltese: Madankollu, l-Istati Membri ma setgħux jaslu għal qbil u l-aġenzija Portugiża rreferiet il-kwistjoni lillEMA għal arbitraġġ fit-2 ta' Novembru 2017.
English: The grounds for the referral were concerns raised by the Netherlands that the data submitted to support the application were not sufficient to show that Paclitaxel Hetero is ‘bioequivalent' to Taxol.
Maltese: Ir-raġunijiet għal referenza kienu tħassib li qam min-Netherlands li d-data ppreżentata biex tappoġġja l-applikazzjoni ma kinitx biżżejjed biex turi li Paclitaxel Hetero huwa “bijoekwivalenti” għal Taxol.
English: The Agency concluded that the benefits of Paclitaxel Hetero do not outweigh its risks, and the marketing authorisation cannot be granted in Portugal or in other Member States of the EU (Germany, the Netherlands and the UK).
Maltese: kumpanija applikat għal awtorizzazzjoni għat-tqegħid fis-suq (“l-Istati Membri kkonċernati”, f'dan ilkaż il-Ġermanja, in-Netherlands u r-Renju Unit).
English: Based on the evaluation of the currently available data, the Agency concluded that they were not sufficient to show that Paclitaxel Hetero is ‘bioequivalent' to Taxol and that their active substances behave in the same way in the body.
Maltese: Abbażi tal-evalwazzjoni tad-data disponibbli bħalissa, l-Aġenzija kkonkludiet li din ma kinitx biżżejjed biex turi li Paclitaxel Hetero huwa “bijoekwivalenti” għal Taxol u li s-sustanzi attivi tiegħu jġibu ruħhom bl-istess mod fil-ġisem.
English: Paclitaxel belongs to the group of cancer medicines known as the ‘taxanes'.
Maltese: Paclitaxel jappartjeni għall-grupp ta' mediċini tal-kanċer magħruf bħala “tassani”.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Portugal) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States where the company has applied for a marketing authorisation (the ‘concerned Member States', in this instance Germany, the Netherlands and the UK).
Maltese: Din hija proċedura fejn Stat Membru wieħed (“l-Istat Membru ta' referenza”, f'dan il-każ ir-Renju Unit) jivvaluta mediċina bl-għan li tingħata lawtorizzazzjoni għat-tqegħid fis-suq li tkun valida f'dan il-pajjiż kif ukoll fi Stati Membri oħrajn fejn il
English: This means that Paclitaxel Hetero was developed to contain the same active substance and work in the same way as a ‘reference medicine' already authorised in EU called Taxol.
Maltese: Dan ifisser li Paclitaxel Hetero ġie żviluppat biex ikun fih l-istess sustanza attiva u jaħdem bl-istess mod bħal “mediċina ta' referenza” diġà awtorizzata fl-UE li jisimha Taxol.
English: The paclitaxel in Paclitaxel Hetero and in Taxol is contained in tiny particles called micelles, to help it dissolve in the solution.
Maltese: Il-paclitaxel f'Paclitaxel Hetero u f'Taxol jiġi fformulat f'partiċelli żgħar imsejħa miċelli, biex jgħinuh jinħall fis-soluzzjoni.
English: - The active substance is etoposide phophate.
Maltese: - Is-sustanza attiva hi etoposide phophate.
English: This may take between 30 to 60 minutes.
Maltese: Dan jista' jieħu bejn 30 sa 60 minuta.
English: • convulsions (seizure)
Maltese: • konvulżjonijiet (aċċessjonijiet)
English: UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.>
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D <barcode 2D li jkollu lidentifikatur uniku inkluż.> 18.
English: • 0.9 % sodium chloride solution.
Maltese: • soluzzjoni ta' 0.9 % sodium chloride.
English: Leucopenia and severe leucopenia (less than 1,000 cells/mm3) were observed in 91% and 17%, respectively, for etoposide phosphate.
Maltese: Lewkopenija u lewkopenija severa (inqas minn 1,000 ċellula/mm3) ġew osservati f'91% u 17%, rispettivament, għal etoposide phosphate.
English: In vitro, etoposide is highly protein bound (97%) to human plasma proteins.
Maltese: In vitro, etoposide jeħel ħafna mal-proteini (97%) mal-proteini tal-plażma tal-bniedem.
English: Etoposide phosphate is metabolised in vivo into the active substance etoposide by a process of dephosphorylation.
Maltese: Etoposide phosphate jiġi metabolizzat in vivo fis-sustanza attiva etoposide permezz ta' proċess ta' defosforilazzjoni.
English: Testicular cancer
Maltese: Kanċer testikulari
English: In clinical studies in which ETOPOPHOS and associated names was administered as a single agent at a total dose of ≥450 mg/m2 the most frequent adverse reactions of any severity were leucopenia (91%), neutropenia (88%), anaemia (72%) thrombocytopenia (23%), asthenia (39%), nausea and/or vomiting (37%), alopecia (33%) and chills and/or fever (24%).
Maltese: Fi studji kliniċi li fihom ETOPOPHOS u ismijiet assoċjati ingħataw bħala sustanza waħidha f'doża totali ta' ≥450 mg/m2, l-aktar reazzjonijiet avversi frekwenti ta' kwalunkwe severità kienu lewkopenija (91%), newtropenija (88%), anemija (72%) tromboċitopenija (23%), astenija (39%), dardir u/jew rimettar (37%), alopeċja ( 33%) u tertir u/jew deni (24%).
English: These adverse reactions are presented by system organ class and frequency, which is defined by the following categories: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1, 000, <1/100), rare (≥1/10, 000, <1/1,000), not known (cannot be estimated from the available data).
Maltese: Dawn ir-reazzjonijiet avversi huma ppreżentati skont is-sistema tal-klassifika tal-organi u l-frekwenza, li hi definita mill-kategoriji li ġejjin:komuni ħafna (≥1/10), komuni (≥1/100, <1/10), mhux komuni (≥1/1, 000, <1/100), rari (≥1/10, 000, <1/1,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: 3) were seen in 23% and 9% respectively, for etoposide phosphate.
Maltese: 9%, rispettivament, għal etoposide phosphate.
English: • 5% glucose solution or,
Maltese: • soluzzjoni ta' 5% glucose jew,
English: • 5% glucose solution or
Maltese: • soluzzjoni ta' 5% glucose jew
English: Infections and infestations common infection
Maltese: Infezzjonijiet u infestazzjonijiet komuni infezzjoni
English: Sodium citrate
Maltese: 6.1 Lista ta' eċċipjenti Sodium citrate
English: Etoposide phosphate is administered by slow intravenous infusion (usually over a 30 to 60 minute period) (see section 4.4).
Maltese: Etoposide phosphate jingħata permezz ta' infużjoni ġol-vini bil-mod (normalment fuq perjodu 30 sa 60 minuta) (ara sezzjoni 4.4).
English: - testicular cancer - small cell lung cancer - cancer of the blood (acute myeloid leukaemia) - tumour in the lymphatic system (Hodgkin's lymphoma, non-Hodgkin's lymphoma) - reproductive system cancers (gestational trophoblastic neoplasia and ovarian cancer)
Maltese: - kanċer testikulari - kanċer tal-pulmun ta' ċelluli mhux żgħar - kanċer tad-demm (lewkimja majelojde akuta) - tumur fis-sistema limfatika (limfoma ta' Hodgkin, limfoma mhux ta' Hodgkin) - kanċers tas-sistema riproduttiva (neoplażija trofoblastika waqt it-tqala u kanċer fl-ovarji)
English: Anaphylactic reactions (see section 4.4), manifested by chills, tachycardia, bronchospasm, dyspnoea, diaphoresis, pyrexia, pruritus, hypertension or hypotension, syncope, nausea, and vomiting have been reported to occur in 3% (7 of 245 patients treated with ETOPOPHOS and associated names in 7 clinical studies) of patients treated with ETOPOPHOS and associated names.
Maltese: Reazzjonijiet anafilattiċi (ara sezzjoni 4.4), li tidher bħala tertir, takikardija, bronkospażmu, qtugħ ta' nifs, dijaforeżi, deni, ħakk, pressjoni għolja jew pressjoni baxxa, sinkope, dardir, u rimettar, ġew irrappurtati li jseħħu fi 3% (7 minn 245 pazjent ikkurati b'ETOPOPHOS u ismijiet assoċjati f'7 studji kliniċi) ta' pazjenti kkurati b'ETOPOPHOS u ismijiet assoċjati.
English: Frequency Adverse Reaction (MedDRA Terms)
Maltese: Sistema tal-Klassifika tal-Organi Frekwenza Reazzjoni avversa (Termini MedDRA)
English: ETOPOPHOS and associated names 1000 mg is intended to be handled by pharmaceutical staff in central hospital units for the preparation of cytostatics.
Maltese: ETOPOPHOS u ismijiet assoċjati 1000 mg huma maħsuba biex jiġu mmaniġġjati minn staff farmaċewtiku f'taqsimiet ta' sptarijiet ċentrali għall-preparazzjoni ta' ċitostatiċi.
English: As etoposide phosphate is converted in vivo to etoposide by phosphorylation, caution should be exercised when administering etoposide phosphate with drugs that are known to inhibit phosphatase activity as such combination may reduce efficacy of etoposide phosphate.
Maltese: Billi etoposide phosphate jiġi konvertitin vivo għal etoposide permezz ta' fosforilazzjoni, għandu jkun hekk kawtela meta jingħata etoposide phosphate ma' mediċini li huma magħrufa li jinibixxu l-attività tal-phosphatase, għax din il-kombinazzjoni tista' tnaqqas l-effikaċja ta' etoposide phosphate.
English: Reversible alopecia, sometimes progressing to total baldness, was observed in up to 44% of patients treated with etoposide phosphate.
Maltese: Alopeċja riversibbli, li xi kultant tiggrava għal twaqqigħ tax-xagħar totali, ġiet osservata f'sa 44% talpazjenti kkurati b'etoposide phosphate.
English: • bleeding Rare side effects (affecting between 1 in 1,000 and 1 in 10,000 people)
Maltese: • ħruġ ta' demm Effetti sekondarji rari (li jaffettwaw bejn 1 u 1,000 u 1 minn kull 10,000 persuna)
English: Keep this medicine out of the sight and reach of children.
Maltese: mediċini kimoterapewtiċi oħra.
English: The mean volumes of distribution at steady state range from 18 to 29 liters .
Maltese: Il-volumi medji tad-distribuzzjoni fl-istat fiss ivarjaw minn 18 sa 29 liru.
English: Hepatobiliary disorders very common alanine aminotransferase increased, alkaline phosphatase increased, aspartate amino transferase increased, bilirubin increased, hepatotoxicity
Maltese: Disturbi fil-fwied u fil-marrara komuni ħafna żieda f'alanine aminotransferase, żieda f'alkaline phosphatase, żieda f'amino aspartate transferase, żieda fil-bilirubina,
English: This will yield a reconstituted stock solution containing 20 mg/ml or 10 mg/ml etoposide.
Maltese: Dan se jipproduċi soluzzjoni stock rikostitwita (reconstituted stock solution) fih 20 mg/mL jew 10 mg/mL ta' etoposide.
English: Gastrointestinal disorders very common abdominal pain, anorexia, constipation, nausea and vomiting common diarrhoea, mucositis (including stomatitis and esophagitis)
Maltese: Disturbi gastro-intestinali komuni ħafna uġigħ addominali, anoressija, stitikezza, dardir u rimettar komuni dijarea, mukożite (li tinklude stomatite u esofaġite)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 113.6 mg etoposide phosphate equivalent to 100 mg etoposide.
Maltese: Kull kunjett fih 113.6 mg ta' etoposide phosphate ekwivalenti għal 100 mg ta' etoposide.
English: Each vial contains 1136 mg etoposide phosphate equivalent to 1000 mg etoposide.
Maltese: Kull kunjett fih 1136 mg ta' etoposide phosphate ekwivalenti għal 1000 mg ta' etoposide.
English: Etoposide has been shown to be teratogenic in mice and rats (see section 5.3).
Maltese: Intwera li etoposide li hu teratoġeniku fil-ġrieden u l-firien (ara sezzjoni 5.3).
English: - cancer of the blood (acute myeloid leukaemia) - tumour in the lymphatic system (Hodgkin's lymphoma, non-Hodgkin's lymphoma)
Maltese: - kanċer tad-demm (lewkimja majelojde akuta) - tumur fis-sistema limfatika (limfoma ta' Hodgkin, limfoma mhux ta' Hodgkin)
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC: {number}
Maltese: IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM < PC: