FrancophonIA/ELRC3.0 huggingface dataset:
English: Foscan is used to relieve the symptoms of advanced head and neck squamous cell carcinoma (a type of cancer that starts in the cells lining the mouth, nose, throat or ear).
Maltese: Foscan jintuża biex itaffi s-sintomi ta' karċinoma b'ċelluli squamous tar-ras u tal-għonq (tip ta' kanċer li jibda miċ-ċelluli li jiksu l-ħalq, l-imnieħer, il-gerżuma jew il-widna).
English: Offene multizentrische Studie über ein Jahr.
Maltese: Offene multizentrische Studie über ein Jahr. Fortschr.
English: Flupirtine-containing medicinal products are currently approved in 11 Member States (MSs) of the Union on prescription only: Bulgaria, Estonia, Germany, Hungary, Italy, Latvia, Lithuania, Poland, Portugal, Romania and Slovak Republic.
Maltese: Prodotti mediċinali li fihom flupirtine huma attwalment approvati fi 11-il Stat Membru (MSs) tal-Unjoni b'riċetta ta' tabib biss: il-Bulgarija, l-Estonja, il-Ġermanja, l-Ungerija, l-Italja, il-Latvja, il-Litwanja, ilPolonja, il-Portugall, ir-Rumanija u r-Repubblika Slovakka.
English: Open study over 12 months, single blind subsequent observation period of 14 days (including an „Additional evaluation about a group of very old patients > 80 years“) Degussa-Report No. D-09998 / 75 057 C, (for publication see also below)
Maltese: Open study over 12 months, single blind subsequent observation period of 14 days (including an „Additional evaluation about a group of very old patients > 80 years“) Degussa-Report No.
English: However, three published studies1,2,3 reported elevated transaminases in 3%, 31% and 58.6% respectively, of the patients treated with flupirtine.
Maltese: Madankollu, tliet studji ppubblikati1,2,3 rrapportaw żieda fit-transaminażi fi 3%, 31% u 58.6% rispettivament, tal-pazjenti li rċevew kura bi flupirtine.
English: Uberall MA, Mueller-Schwefe GH, Terhaag B. Efficacy and safety of flupirtine modified release for the management of moderate to severe chronic low back pain: results of SUPREME, a prospective randomized, double-blind, placebo- and active-controlled parallel-group phase IV study.
Maltese: Efficacy and safety of flupirtine modified release for the management of moderate to severe chronic low back pain: results of SUPREME, a prospective randomized, double-blind, placebo- and active-controlled parallel-group phase IV study.
English: Flupirtine is a ‘selective neuronal potassium channel opener' (SNEPCO) that acts by reducing the excessive electrical activity that leads to many pain states.
Maltese: Flupirtine huwa ‘selective neuronal potassium channel opener' (SNEPCO) li jaġixxi billi jnaqqas l-attività elettrika eċċessiva li twassal għal ħafna stati ta' uġigħ.
English: The WHO defined daily dose (DDD) for flupirtine oral is 400 mg.
Maltese: Id-doża definita ta' kuljum tad-WHO (DDD) għal flupirtine orali hija ta' 400 mg.
English: 1 Li C, Ni J, Wang Z et al. Analgesic efficacy and tolerability of flupirtine vs. tramadol in patients with subacute low back pain: a double-blind multicentre trial.
Maltese: Analgesic efficacy and tolerability of flupirtine vs. tramadol in patients with subacute low back pain: a double-blind multicentre trial.
English: Herrmann WM: Investigation of the long-term tolerability of the analgesic flupirtine in patients who require analgesics regularly over a long period of time.
Maltese: Investigation of the long-term tolerability of the analgesic flupirtine in patients who require analgesics regularly over a long period of time.
English: [All pharmaceutical forms]
Maltese: Twissijiet u prekawzjonijiet [Forom farmaċewtiċi kollha]
English: Flupirtine is available as 100 mg immediate release capsules, 400 mg modified release tablet, 75 mg and 150 mg suppositories and as solution for injection (100 mg).
Maltese: Flupirtine huwa disponibbli bħala kapsuli b'rilaxx immedjat ta' 100 mg, pillola b'rilaxx modifikat ta' 400 mg, suppożitorji ta' 75 mg u 150 mg u bħala soluzzjoni għal injezzjoni (100 mg).
English: • The PRAC considered the procedure under Article 107i of Directive 2001/83/EC, for flupirtine containing medicinal products.
Maltese: • Il-PRAC ikkunsidra l-proċedura taħt l-Artikolu 107i tad-Direttiva 2001/83/KE, għal prodotti mediċinali li fihom flupirtine.
English: Herrmann WM: Final report: Investigation of the long-term tolerability of the analgesic flupirtine in patients who require analgesics regularly over long periods of time.
Maltese: Investigation of the long-term tolerability of the analgesic flupirtine in patients who require analgesics regularly over long periods of time.
English: It also acts as functional N-methyl-Daspartate (NMDA) receptor antagonist.
Maltese: Jaġixxi wkoll bħala antagonist funzjonali tarriċettur N-methyl-D-aspartate (NMDA).
English: Patient exposure to flupirtine was greater in Germany and has increased steadily from 7,9 million DDD in 2001 to 28,1 million DDD in 2011.
Maltese: L-esponiment tal-pazjent għal flupirtine kienet akbar fil-Ġermanja u żdiedet b'mod stabbli minn DDD ta' 7,9 miljuni fl-2001 għal DDD ta' 28,1 miljun fl-2011.
English: During the period of 1999 to March 2013 a total of 136 reports of flupirtine drug induced liver injury (DILI, hepatic necrosis, liver failure including fatal cases) have been identified in spontaneous reporting and literature including 15 cases with fatal outcome.
Maltese: Matul il-perjodu tal-1999 sa Marzu 2013 kienu identifikati total ta' 136 rapport ta' ħsara fil-fwied minħabba l-mediċina flupirtine (DILI, nekrożi epatika, insuffiċjenza tal-fwied inkluż każijiet fatali) f'rapportar spontanju u fil-letteratura nkluż 15-il każ b'eżitu fatali.
English: A total of 570 serious (421) and non-serious (149) flupirtine hepatic case reports have been reported up to 28 March 2013, accordingly to the market leader MAH's safety database.
Maltese: Sat-28 ta' Marzu 2013 ġie rrapportat total ta' 570 rapport ta' każijiet epatiċi serji (421) u mhux serju (149) bi flupirtine, kif xieraq lid-dejtabejż dwar is-sigurtà tal-MAH mexxej tas-suq.
English: • The PRAC considered that flupirtine containing medicinal products only show very limited efficacy in the management of chronic pain.
Maltese: • Il-PRAC ikkunsidra li prodotti mediċinali li fihom flupirtine juru biss effikaċja limitata ħafna filġestjoni ta' uġigħ kroniku.
English: The reporting rate for hepatic cases with flupirtine (regardless of causality) is of 15,2 cases/100 000 patients years (based on a patient exposure of 893, 000 patients year).
Maltese: Ir-rata ta' rappurtar għal każijiet epatiċi bi flupirtine (irrispettivament mill-kawżalità) hija ta' 15,2 każijiet/100 000 pazjent snin (abbażi ta' esponiment tal-pazjent ta' 893, 000 pazjent fis-sena).
English: It is authorised in the European Union since 1984 as an alternative analgesic to opioids and NonSteroidal Anti-Inflammatory Drugs (NSAIDs) for the treatment of acute and chronic pain (such as painful muscle tenseness, tension headaches, cancer pain, dysmenorrhoea and pain following trauma or orthopaedic surgery or injuries).
Maltese: Ilu awtorizzat fl-Unjoni Ewropea sa mill-1984 bħala analġesiku alternattiv għall-opjojdi u Mediċini AntiInfjammatorji Mhux Sterojdi (NSAIDs) għall-kura ta' uġigħ akut u kroniku (bħal tensjoni muskolari bluġigħ, uġigħ ta' rasijiet minħabba tensjoni, uġigħ tal-kanċer, dismenorrea u uġigħ wara trawma jew kirurġija ortopedika jew korrimenti).
English: The CMDh considered the below PRAC recommendation dated 13 June 2013 with regards to the flupirtine containing medicinal products.
Maltese: Is-CMDh ikkunsidra r-rakkomandazzjoni tal-PRAC ta' hawn taħt datata t-13 ta' Ġunju 2013 fir-rigward tal-prodotti mediċinali li fihom flupirtine.
English: Degussa-Report No. D-09998 / 75 101
Maltese: D-09998 / 75 057 C, (għall-pubblikazzjoni ara wkoll taħt)
English: The German National Competent Authority (BfArM) identified a growing number of hepatotoxicity reactions (probably idiosyncratic) reported in association with flupirtine.
Maltese: L-Awtorità Nazzjonali Kompetenti Ġermaniża (BfArM) identifikat għadd dejjem jikber ta' reazzjonijiet ta' epatotossiċità (probabbilment idjosinkratiċi) irrapportati f'rabta ma' flupirtine.
English: • The PRAC reviewed all available data from clinical and non-clinical studies, epidemiological studies, spontaneous reports and published literature on the safety and efficacy of flupirtine containing medicinal products, as well as stakeholders' submissions in particular with regards to the risk of hepatotoxicity.
Maltese: • Il-PRAC irreveda d-dejta kollha disponibbli minn studji kliniċi u mhux kliniċi, studji epidemjoloġiċi, rapporti spontanji u letteratura ppubblikata dwar is-sigurtà u l-effikaċja ta' prodotti mediċinali li fihom flupirtine, kif ukoll is-sottomissjonijiet tal-partijiet interessati b'mod partikolari fir-rigward tar-riskju ta' epatotossiċità.
English: Based on the above safety concerns and further to consideration of the current evidence of efficacy of flupirtine in the treatment of chronic and acute pain, the BfArM considered the benefit-risk not to be favourable in the treatment of chronic pain and potential favourable in acute pain subject to effective implementation of risk minimisation measures (e.g. limited duration of treatment, closely liver monitoring) and therefore on 28 February 2013 initiated an urgent union procedure under Article 107i of Directive 2001/83/EC.
Maltese: Abbażi tat-tħassib dwar is-sigurtà ta' hawn fuq u wara kunsiderazzjoni tal-evidenza attwali tal-effikaċja ta' flupirtine fil-kura ta' uġigħ kroniku u akut, il-BfArM ikkunsidrat li l-benefiċċju-riskju ma kienx favorevoli fil-kura ta' uġigħ kroniku u potenzjalment favorevoli f'uġigħ akut soġġett għallimplimentazzjoni effettiva ta' miżuri għall-minimizzazzjoni tar-riskji (eż. tul limitat ta' kura, monitoraġġ tal-fwied mill-qrib) u għalhekk fit-28 ta' Frar 2013 bdiet proċedura urġenti tal-unjoni taħt lArtikolu 107i tad-Direttiva 2001/83/KE.
English: Most cases were reports of increased liver enzymes, jaundice, hepatitis or hepatic failure.
Maltese: Ħafna millkażijiet kienu rapporti ta' żieda fl-enzimi tal-fwied, suffejra, epatite jew insuffiċjenza epatika.
English: Cases possible related to flupirtine treatment, and with re-challenge reported, had reoccurrence or worsening of the symptoms in 93% of the cases.
Maltese: Każijiet possibbilment relatati ma' kura bi flupirtine, u bl-għoti mill-ġdid irrapportati, kellhom aggravar tas-sintomi jew is-sintomi reġgħu feġġew mill-ġdid fi 93% tal-każijiet.
English: Overall summary of the scientific evaluation of flupirtine containing medicinal products by PRAC
Maltese: Sommarju ġenerali tal-valutazzjoni xjentifika ta' prodotti mediċinali li fihom flupirtine mill-PRAC
English: The maximum daily dose should not exceed 600 mg.
Maltese: Id-doża massima ta' kuljum m'għandhiex taqbeż is-600 mg.
English: The time to onset of liver failure observed in spontaneous reporting was 25 % for each of the cases after 2-3 weeks, after 3-8 weeks, after 8-13 weeks and after >13 weeks (information on time to onset was available in 35 cases of the total 49 cases).
Maltese: Iż-żmien għall-bidu tal-insuffiċjenza tal-fwied osservat f'rapportar spontanju kien ta' 25 % għal kull wieħed mill-każijiet wara 2-3 ġimgħat, wara 3-8 ġimgħat, wara 8-13-il ġimgħa u wara >13-il ġimgħa (informazzjoni dwar iż-żmien għall-bidu kienet disponibbli f'35 każ mit-total ta' 49 każ).
English: The PRAC, as a consequence, concluded that pursuant to Article 116 of Directive 2001/83/EC the riskbenefit balance for flupirtine containing medicinal products in the management of chronic pain is not favourable.
Maltese: Il-PRAC, bħala konsegwenza, ikkonkluda li skont l-Artikolu 116 tad-Direttiva 2001/83/KE, il-bilanċ tarriskju-benefiċċju għal prodotti mediċinali li fihom flupirtine fil-ġestjoni ta' uġigħ kroniku mhuwiex favorevoli.
English: Risk minimisation measures
Maltese: Miżuri għall-minimizzazzjoni tar-riskji
English: As part of the risk minimisation measures the PRAC recommended amendments to the product information for all flupirtine containing medicinal products.
Maltese: Bħala parti mill-miżuri għall-minimizzazzjoni tar-riskji, il-PRAC irrakkomanda emendi fl-informazzjoni dwar il-prodott għall-prodotti mediċinali kollha li fihom flupirtine.
English: The 100 mg immediate release capsules are available in all MSs.
Maltese: Il-kapsuli b'rilaxx immedjat ta' 100 mg huma disponibbli fl-MSs kollha.
English: Fortschr.
Maltese: IV.
English: The PRAC reviewed the data submitted by the marketing authorisation holders and other stakeholders from clinical and non-clinical studies, epidemiological studies, spontaneous reports and published literature.
Maltese: Il-PRAC irreveda d-dejta sottomessa mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq u minn partijiet interessati oħra, studji epidemjoloġiċi, rapporti spontanji u letteratura ppubblikata minn studji kliniċi u mhux kliniċi.
English: Liver transplantation or fatal cases resulting from liver failure were seen after 3-5 weeks of treatment in 25% of the cases and the remaining after 60 days of treatment (information is only available from 8 cases of the total of 15 fatal cases).
Maltese: Trapjanti talfwied jew każijiet fatali bħala riżultat ta' insuffiċjenza tal-fwied dehru wara 3-5 ġimgħat ta' kura f'25% tal-każijiet u l-bqija wara 60 jum ta' kura (informazzjoni hija disponibbli biss minn 8 każijiet mit-total ta' 15-il każ fatali).
English: The PRAC also noted that according to the current scientific knowledge including the Note for Guidance on clinical investigation of medicinal products for treatment of nociceptive pain (CPMP/EWP/612/00) clinical data of at least 3 months for the treatment of mild to moderately severe chronic back pain is required.
Maltese: Il-PRAC innota wkoll li skont it-tagħrif xjentifiku attwali, inkluż in-Nota għal Gwida dwar linvestigazzjoni klinika ta' prodotti mediċinali għall-kura ta' uġigħ nociceptive (CPMP/EWP/612/00) hemm il-ħtieġa ta' dejta klinika ta' mill-anqas 3 xhur għall-kura ta' uġigħ kroniku ħafif sa moderatament sever fid-dahar.
English: Overall, 11.8 million patients have been treated with flupirtine containing medicinal products since
Maltese: B'kollox, sa mill-1999, 11.8 miljun pazjent irċevew kura bi prodotti mediċinali li fihom flupirtine.
English: Furthermore the PRAC agreed on additional pharmacovigilance activities and risk minimisation measures.
Maltese: Barra minn hekk il-PRAC qabel dwar attivitajiet addizzjonali ta' farmakoviġilanza u miżuri għall-minimizzazzjoni tarriskji.
English: The PRAC considers that there is sufficient evidence on efficacy in the acute (nociceptive) pain indication (mild, moderate and severe).
Maltese: Il-PRAC iqis li hemm biżżejjed evidenza dwar l-effikaċja flindikazzjoni ta' uġigħ akut (nociceptive) (ħafif, moderat u sever).
English: The PRAC concluded that the benefit-risk balance for flupirtine containing medicinal products remains favourable in the treatment of acute pain subject to the agreed restrictions, contraindications, warnings, other changes to the product information and additional risk minimisation measures.
Maltese: Il-PRAC ikkonkluda li l-bilanċ tal-benefiċċju-riskju għal prodotti mediċinali li fihom flupirtine jibqa' favorevoli fil-kura ta' uġigħ akut soġġett għar-restrizzjonijiet, kontraindikazzjonijiet, twissijiet, tibdil ieħor lill-informazzjoni dwar il-prodott u miżuri addizzjonali għall-minimizzazzjoni tar-riskji maqbula.
English: The 400 mg modified release tablets, although only authorised in Germany, is the most prescribed formulation in the Union since 2007.
Maltese: Il-pilloli b'rilaxx modifikat ta' 400 mg, għalkemm awtorizzati fil-Ġermanja biss, huma l-aktar formulazzjoni preskritta fl-Unjoni sa mill-2007.
English: A total of 330 hepatic and biliary disorders were reported post-marketing, of which 49 involved liver failure and 15 had a fatal outcome or resulted in liver transplantation.
Maltese: Total ta' 330 disturb tal-fwied u tal-marrara ġie rrapportat wara t-tqegħid fis-suq, li minnhom 49 kienu jinvolvu insuffiċjenza tal-fwied u 15 kellhom eżitu fatali jew irriżultaw fi trapjant tal-fwied.
English: The CMDh having considered the PRAC recommendation dated 13 June 2013 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC reached a position on the variation to the terms of the marketing authorisations of flupirtine containing medicinal products for which the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III and subject to the conditions set out in Annex IV.
Maltese: Is-CMDh wara li kkunsidra r-rakkomandazzjoni tal-PRAC datata t-13 ta' Ġunju 2013 skont lArtikolu 107k(1) u (2) tad-Direttiva 2001/83/KE laħaq pożizzjoni dwar il-varjazzjoni għat-termini talawtorizzazzjonijiet għat-tqegħid fis-suq ta' prodotti mediċinali li fihom flupirtine li għalihom issezzjonijiet rilevanti tas-sommarju tal-karatteristiċi tal-prodott u l-fuljett ta' tagħrif huma stabbiliti flAnness
English: The PRAC concluded that the risk-benefit balance of flupirtine containing medicinal product(s) in the treatment of acute pain remains favourable subject to the restrictions, warnings, other changes to the product information, additional pharmacovigilance activities and additional risk minimisation measures agreed.
Maltese: Il-PRAC ikkonkluda li l-bilanċ tar-riskju-benefiċċju ta' prodott(i) mediċinali li fih(om) flupirtine fil-kura ta' uġigħ akut jibqa' favorevoli soġġett għar-restrizzjonijiet, twissijiet, tibdil ieħor lill-informazzjoni dwar il-prodott, attivitajiet addizzjonali ta' farmakoviġilanza u miżuri addizzjonali għall-minimizzazzjoni tar-riskji maqbula.
English: The PRAC noted that based on clinical and histological features, the hepatotoxicity of flupirtine may be immune-mediated and that hepatotoxicity associated with flupirtine treatment may be type B or idiosyncratic adverse drug reaction.
Maltese: Il-PRAC innota li abbażi tal-karatteristiċi kliniċi u istoloġiċi, l-epatotossiċità ta' flupirtine tista' tkun medjata mis-sistema immunitarja u li l-epatotossiċità assoċjata mal-kura bi flupirtine tista' tkun reazzjoni avversa tal-mediċina tat-tip B jew idjosinkratika.
English: The exact wording recommended by the PRAC to relevant sections of the Summary of Product Characteristics (SmPC) and Package Leaflet (PIL) are found in Annex III of this recommendation.
Maltese: Il-formulazzjoni eżatta rakkomandata mill-PRAC lis-sezzjonijiet rilevanti tas-Sommarju tal-Karatteristiċi tal-Prodott (SmPC) u l-Fuljett ta' Tagħrif (PIL) jinsabu fl-Anness III ta' din ir-rakkomandazzjoni.
English: However, the CMDh considered that changes were necessary to the wording proposed in section 2 of the PL, in order to accurately reflect the PRAC recommended amendments to the SmPC section 4.3 “contraindications”.
Maltese: Madankollu, is-CMDh ikkunsidra li kien hemm il-ħtieġa ta' tibdil lillkitba proposta fis-sezzjoni 2 tal-PL, sabiex l-emendi rakkomandati mill-PRAC lis-sezzjoni 4.3 tal-SmPC “kontraindikazzjonijiet” jiġu riflessi b'mod preċiż.
English: [Oral pharmaceutical forms and suppositories] Do not <take><use><Product name> if you: suffer from pre-existing liver disease suffer from alcoholism concomitantly use other medicinal products known to cause drug induced liver injury.
Maltese: [Forom farmaċewtiċi orali u suppożitorji] M'għandekx <tieħu><tuża><Isem tal-Prodott > jekk inti: tbati minn mard pre-eżistenti tal-fwied tbati mill-alkoħoliżmu tuża b'mod konkomitanti prodotti mediċinali oħra magħrufa li jikkawżaw ħsara fil-fwied minħabba l-mediċina.
English: The PRAC in accordance with Article 107j(3) of Directive 2001/83/EC, recommended by a majority that a. the marketing authorisation holders should sponsor a post-authorisation safety study together with the follow up evaluation of the results of that study, as well as a drug utilisation study (see Annex IV - Conditions of marketing Authorisations); b. the marketing authorisation holders should implement risk minimisation measures; c. the marketing authorisations of flupirtine containing medicinal products (see Annex I) should be varied (in accordance with changes to the product information as set out in Annex III).
Maltese: Skont l-Artikolu 107j(3) tad-Direttiva 2001/83/KE, il- PRAC irrakkomanda b'maġġoranza li a. id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq għandhom jisponsorjaw studju dwar issigurtà wara l-awtorizzazzjoni flimkien mal-valutazzjoni ta' segwitu tar-riżultati ta' dak listudju, kif ukoll studju dwar l-użu tal-mediċina (ara Anness IV - Kondizzjonijiet talAwtorizzazzjonijiet għat-Tqegħid fis-Suq);
English: For the treatment of acute pain, the PRAC recommended that the benefit still outweighs the hepatotoxicity risk when treatment with other analgesics (e.g. non-steroidal anti-inflammatory drugs, weak opioids) is contraindicated.
Maltese: Għall-kura ta' uġigħ akut, il-PRAC irrakkomanda li l-benefiċċju għadu akbar minn ir-riskju ta' epatotossiċità meta kura b'analġesiċi oħra (eż. mediċini anti-infjammatorji mhux sterojdi, opjojdi ħfief) tkun kontraindikata.
English: In view of the hepatotoxicity and very limited efficacy PRAC concluded that the benefit/risk for flupirtine containing medicinal products in the management of chronic pain is no longer favourable.
Maltese: Fid-dawl tal-epatotossiċità u l-effikaċja limitata ħafna, il-PRAC ikkonkluda li benefiċċju/riskju għal prodotti mediċinali li fihom flupirtine fil-ġestjoni ta' uġigħ kroniku m'għadux favorevoli.
English: Data from the literature as well as data from randomised clinical trials,,, showed an increment of markers for hepato-biliary impairment associated with the treatment of flupirtine.
Maltese: Dejta mil-letteratura kif ukoll dejta minn provi kliniċi każwali1,2,3,4 urew żieda fil-markaturi għal indeboliment epato-biljari assoċjati mal-kura ta' flupirtine.
English: Teva Gyógyszergyár Zrt
Maltese: Teva Gyógyszergyár Zrt Tel.:
English: CTC Grade 4b a:
Maltese: CTC Grad 4b a:
English: Temozolomide Teva may cause permanent infertility.
Maltese: Temozolomide Teva jista' jikkawża infertilità permanenti.
English: Dose levels include 100 mg/m², 150 mg/m², and 200 mg/m².
Maltese: Il-livelli tad-doża jinkludu 100 mg/m², 150 mg/m², u 200 mg/m².
English: TMZ Dose (mg/m²/day)
Maltese: (mg/m²/jum)
English: The active substance is temozolomide.
Maltese: Is-sustanza attiva hi temozolomide.
English: TMZ dose levels are listed in Table 2.
Maltese: Livelli tad-doża ta' TMZ huma elenkati f'Tabella 2.
English: Doses of 500, 750, 1,000, and 1,250 mg/m² (total dose per cycle over 5 days) have been evaluated clinically in patients.
Maltese: .9 Doża eċċessiva Dożi ta' 500, 750, 1,000, u 1,250 mg/m² (doża totali kull ċiklu matul 5 ijiem) ġew evalwati klinikament f'pazjenti.
English: Temozolomide Teva contains lactose
Maltese: Temozolomide Teva fih lactose
English: Response rate, based on the central reviewer assessment, was 35% (13 CR and 43 PR) for the intent-to-treat population (ITT) n=162.
Maltese: Ir-rata ta' rispons, ibbażata fuq il-valutazzjoni tal-verifikatur ċentrali, kienet ta' 35% (13 CR u 43 PR) għall popolazzjoni intent-to-treat (ITT) n=162 .
English: Herpes simplex, Herpes zoster, influenza-like symptoms
Maltese: Herpes simplex, herpes zoster,
English: Haupt Pharma Amareg GmbH Donaustaufer Straβe 378 93055 Regensburg Germany
Maltese: Haupt Pharma Amareg GmbH Donaustaufer Straβe 378
English: Lymphopenia, petechiae
Maltese: Limfopenija, petekje
English: Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100) ); Rare (≥1/10,000 to <1/1,000);
Maltese: Mhux komuni (≥ 1/1,000 sa < 1/100); Rari (≥1/10,000 sa
English: Black iron oxide (E172) Propylene Glycol Ammonium hydroxide (E527)
Maltese: Iron oxide iswed (E172) Propylene Glycol Ammonium hydroxide (E527)
English: There were higher rates of Grade 4 neutropenia (ANC < 0.5 x 109/l), 12% vs 5%, and thrombocytopenia (< 20 x 109/l), 9% vs 3%, in women vs men in the first cycle of therapy.
Maltese: Kien hemm rati ogħla ta' newtropenija ta' Grad 4 (ANC < 0.5 x 109/l), 12% vs 5%, u tromboċitopenija (< 20 x 109/l), 9% vs 3% fin-nisa vs l irġiel fl-ewwel ċiklu tat-terapija.
English: 2031GA Haarlem Netherlands
Maltese: 2031GA HaarlemL-Olanda
English: interstitial pneumonitis/pneumonitis, pulmonary fibrosis, respiratory failure†
Maltese: pulmonite tal-interstizju/pulmonite, fibrożi tal pulmuni, insuffiċjenza respiratorja†