FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety and efficacy of Kevzara in children up to 18 years of age have not been established.
Maltese: Is-sigurta u l-effikaċja ta' Kevzara fit-tfal li għandom sa 18-il sena ma ġewx determinati.
English: For recommended dose modifications based on transaminase elevations see section 4.2.
Maltese: Għall-modifikazzjonijiet fid-doża rrakkomandati abbażi tal-elevazzjonijiet tattransaminase ara sezzjoni 4.2.
English: Before you are given Kevzara, your doctor will check you for TB.
Maltese: Dan ser jippermetti identifikazzjoni ta' malajr ta' informazzjoni ġdida dwar is-sigurtà.
English: The contribution of these concomitant medications relative to Kevzara in the development of gastrointestinal perforations is not known (see section 4.4).
Maltese: Ilkontribuzzjoni ta' dawn il-medikazzjonijiet fl-istess waqt b'konnessjoni ma' Kevzara fl-iżvilupp ta' perforazzjonijiet gastrointestinali mhijiex magħrufa (ara sezzjoni 4.4).
English: Patients should be closely monitored for the development of signs and symptoms of tuberculosis including patients who tested negative for latent tuberculosis infection prior to initiating therapy.
Maltese: Il-pazjenti għadhom jiġu mmonitorjati mill-qrib għall-iżvilupp ta' sinjali u sintomi ta' tuberkulożi inkluż pazjenti li kellhom riżultat negattiv għat-test ta' infezzjoni moħbija tat-tuberkulożi qabel bdew it-terapija.
English: In the placebo-controlled population, the proportion of patients who discontinued treatment due to hypersensitivity reactions was higher among those treated with Kevzara (0.9% in 200 mg group, 0.5% in 150 mg group) than placebo (0.2%).
Maltese: Fil-popolazzjoni kkontrollata bi plaċebo, il-proporzjon ta' pazjenti li waqqfu t-trattament minħabba reazzjonijiet ta' sensittività eċċessiva kien ogħla fost dawk trattati b'Kevzara (0.9% fil-grupp ta'
English: For recommended dose modifications based on platelet counts see section
Maltese: Skala analoga viżwali (visual analogue scale)
English: The subsequent dose should be administered at the regularly scheduled time.
Maltese: Id-doża sussegwenti għandha tingħata fiż-żmien skedat regolari.
English: In an enhanced pre-/postnatal developmental toxicity study, pregnant Cynomolgus monkeys were administered sarilumab once-weekly intravenously from early gestation to natural birth (approximately 21 weeks) Maternal exposure up to approximately 83 times the human exposure based on AUC after subcutaneous doses of 200 mg every 2 weeks, did not cause any maternal or embryofetal effects.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni L-esponiment għal sarilumab ma kienx affettwat meta ngħata flimkien ma' MTX abbażi tal-analiżi farmakokinetika ta' popolazzjoni u fl-istudji ta' tqabbil.
English: In the placebo-controlled population, 0.2% of the patients treated with Kevzara 200 mg q2w + DMARD reported serious adverse events of hypersensitivity reactions, and none from Kevzara 150 mg q2w + DMARD group.
Maltese: irrappurtaw avvenimenti avversi serji ta' reazzjonijiet ta' sensittività eċċessiva, u l-ebda reazzjoni ma ġiet irrappurata mill-grupp ta' Kevzara 150 mg kull ġimagħtejn + DMARD.
English: International non-proprietary name (INN): fipronil
Maltese: Denominazzjoni internazzjonali komuni (INN): fipronil
English: 14 July 2014
Maltese: 14 ta' Lulju 2014
English: Fiprex is a veterinary medicinal product presented as a spot-on formulation containing fipronil as an active substance (pharmacotherapeutic group: ectoparasiticides for topical use).
Maltese: Fiprex huwa prodott mediċinali veterinarju ppreżentat bħala formulazzjoni topika li fiha fipronil bħala sustanza attiva (kategorija farmakoterapewtika: ektoparassitiċidi għall-użu topiku).
English: 52.5 mg spot-on solution for cats; Fiprex S 75 mg spoton solution for dogs, Fiprex M 150 mg spot-on solution for dogs, Fiprex L 300 mg spot-on solution for dogs, Fiprex XL 412.5 mg spot-on solution for dogs
Maltese: Fiprex CAT 52.5 mg soluzzjoni topika għall-qtates; Fiprex S 75 mg soluzzjoni topika għall-klieb, Fiprex M 150 mg soluzzjoni topika għall-klieb, Fiprex L 300 mg soluzzjoni topika għall-klieb, Fiprex XL 412.5 mg soluzzjoni topika għall-klieb
English: On 9 April 2014, the CVMP adopted by majority a final opinion confirming the recommendation included in its opinion of 11 December 2013, that the granting of the marketing authorisations should be refused and the existing marketing authorisations should be suspended for Fiprex CAT 52.5 mg spot-on solution for cats, Fiprex S 75 mg spot-on solution for dogs, Fiprex M 150 mg spot-on solution for dogs, Fiprex L 300 mg spot-on solution for dogs and Fiprex XL 412.5 mg spot-on solution for dogs.
Maltese: Fid-9 ta' April 2014, is-CVMP adotta b'maġġoranza opinjoni finali li tikkonferma r-rakkomandazzjoni inkluża fl-opinjoni tiegħu tal-11 ta' Diċembru 2013, li l-għoti tal-awtorizzazzjonijiet għat-tqegħid fis-suq għandhom jiġu rifjutati u l-awtorizzazzjonijiet għat-tqegħid fis-suq eżistenti għandhom jiġu sospiżi għal Fiprex CAT 52.5 mg soluzzjoni topika għall-qtates, Fiprex S 75 mg soluzzjoni topika għall-klieb, Fiprex M 150 mg soluzzjoni topika għall-klieb, Fiprex L 300 mg soluzzjoni topika għall-klieb u Fiprex XL 412.5 mg soluzzjoni topika għall-klieb.
English: The legal basis of the applications was also Article 13a of Directive 2001/82/EC.
Maltese: Il-bażi legali talapplikazzjonijiet kienet ukoll l-Artikolu 13a tad-Direttiva 2001/82/KE.
English: The Committee appointed D. Murphy as rapporteur and J. Bureš as co-rapporteur.
Maltese: Bureš bħala ko-rapporteur.
English: Opinion following an Article 33(4)1 referral for Fiprex CAT
Maltese: Opinjoni wara riferiment skont l-Artikolu 33(4)
English: The mutual recognition procedures, CZ/V/0116/001/MR concerning the presentation for cats and CZ/V/0116/002-005/MR concerning the four presentations for dogs, started on 25 October 2012.
Maltese: Il-proċeduri ta' rikonoxximent reċiproku, CZ/V/0116/001/MR dwar il-preżentazzjoni għall-qtates u CZ/V/0116/002-005/MR dwar l-erba' preżentazzjonijiet għall-klieb, bdew fil-25 ta' Ottubru 2012.
English: Day 60 of the CMDv referral procedure was on 18 April 2013.
Maltese: Il-jum 60 tal-proċedura ta' riferiment tas-CMDv kien it-18 ta' April 2013.
English: were involved ( Austria, Belgium, Denmark, Greece, Ireland, Italy, the Netherlands, Spain, the Slovak Republic and the United Kingdom).
Maltese: L-Istat Membru ta' referenza għall-proċedura ta' rikonoxximent reċiproku kienet ir-Repubblika Ċeka u kienu involuti għaxar Stati Membri kkonċernati (l-Awstrija, il-Belġju, id-Danimarka, il-Greċja, l-Irlanda, l-Italja, il-Pajjiżi l-Baxxi, Spanja, ir-Repubblika Slovakka u r-Renju Unit).
English: The presentations for dogs have been nationally authorised in the Czech Republic since December 2011, and the presentation for cats has also been nationally authorised in the Czech Republic since May 2012.
Maltese: Il-preżentazzjonijiet għall-klieb ilhom awtorizzati nazzjonalment fir-Repubblika Ċeka minn Diċembru 2011 u l-preżentazzjoni għall-qtates ilha awtorizzata nazzjonalment fir-Repubblika Ċeka minn Mejju 2012.
English: Written explanations were provided by the marketing authorisation holder on 10 September 2013 and 21 October 2013.
Maltese: Spjegazzjonijiet bil-miktub ġew ipprovduti mid-detentur talawtorizzazzjoni għat-tqegħid fis-suq fl-10 ta' Settembru 2013 u fil-21 ta' Ottubru 2013.
English: for up to 28 days after administration, for the control of Flea Allergy Dermatitis, as well as for treatment and prevention of tick (Ixodes spp., Rhipicephalus sanguineus and Dermacentor reticulatus) infestations between 7 and 21 days after administration.
Maltese: Fiprex għall-klieb huwa indikat għall-kura u l-prevenzjoni ta' infestazzjonijiet tal-briegħed (Ctenocephalides spp.) sa 28 jum wara li jingħata, għall-kontroll ta' Dermatite Allerġika għall-Briegħed, kif ukoll għallkura u l-prevenzjoni ta' infestazzjonijiet tal-qurdien (Ixodes spp., Rhipicephalus sanguineus u Dermacentor reticulatus) bejn 7 u 21 jum wara li jingħata.
English: On 20 December 2013, Vet-Agro Trading Sp. z o.o.
Maltese: Fl-20 ta' Diċembru 2013, Vet-Agro Trading Sp. z o.o. innotifika lill-Aġenzija bl-intenzjoni tagħhom li jitolbu eżami mill-ġdid tal-opinjoni tas-CVMP tal-11 ta' Diċembru 2013.
English: During its meeting of 14-16 January 2014 the CVMP appointed R. Breathnach as rapporteur and B. Zemann as the co-rapporteur for the re-examination procedure.
Maltese: Matul il-laqgħa tiegħu tal-14-16 ta' Jannar 2014, is-CVMP ħatar lil R. Breathnach bħala rapporteur u lil B.
English: On day 90 of the mutual recognition procedure these issues remained unsolved and therefore a referral procedure under Article 33(1) of Directive 2001/82/EC to the veterinary coordination group for the mutual recognition and decentralised procedures (CMDv) was started on 18 February 2013.
Maltese: Fil-jum 90 tal-proċedura ta' rikonoxximent reċiproku dawn il-kwistjonijiet baqgħu mhux solvuti, u għalhekk fit-18 ta' Frar 2013 inbdiet proċedura ta' riferiment skont l-Artikolu 33(1) tadDirettiva 2001/82/KE lill-grupp veterinarju ta' koordinazzjoni għar-rikonoxximent reċiproku u lproċeduri deċentralizzati (CMDv).
English: The detailed grounds for the re-examination request were submitted by Vet-Agro Trading Sp. z o.o.
Maltese: Aktar tard fl2012 id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq, Vet-Agro Trading Sp. z o.o., ippreżenta
English: On 29 April 2013, the reference Member State, the Czech Republic, notified the European Medicines Agency that the CMD(v) had failed to reach an agreement and referred the matter to the CVMP pursuant to Article 33(4) of Directive 2001/82/EC.
Maltese: Fid-29 ta' April 2013, l-Istat Membru ta' referenza, ir-Repubblika Ċeka, innotifika lill-Aġenzija Ewropea għall-Mediċini li s-CMD(v) kien naqas milli jilħaq ftehim u rrefera l-kwistjoni lis-CVMP skont lArtikolu 33(4) tad-Direttiva 2001/82/KE.
English: Based on the evaluation of the available data, the CVMP concluded that Fiprex does not pose a risk in terms of target animal safety.
Maltese: Abbażi tal-valutazzjoni tad-dejta disponibbli, is-CVMP ikkonkluda li Fiprex ma joħloqx riskju f'termini ta' sigurtà għall-annimal fil-mira.
English: Page 2/2
Maltese: III.
English: infestations for up to 28 days, as well as for the control of Flea Allergy Dermatitis.
Maltese: Fiprex għall-qtates huwa indikat għall-kura u l-prevenzjoni ta' infestazzjonijiet tal-briegħed (Ctenocephalides spp.) sa 28 jum, kif ukoll għall-kontroll ta' Dermatite Allerġika għall-Briegħed.
English: The CVMP therefore adopted by majority a negative opinion recommending the refusal of the granting of the marketing authorisations and the suspension of the existing marketing authorisations for the aforementioned veterinary medicinal products.
Maltese: Għalhekk is-CVMP adotta b'maġġoranza opinjoni negattiva u rrakkomanda r-rifjut tal-awtorizzazzjonijiet għat-tqegħid fissuq u s-sospensjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq eżistenti għall-imsemmija prodotti mediċinali veterinarji.
English: Cluj-Napoca, Judeţul Cluj
Maltese: Cluj-Napoca, Judeţul Cluj România
English: Sodium starch glycolate (Type B) Tartaric acid
Maltese: Sodium starch glycolate (Tip B) Tartaric acid
English: Ranbaxy UK Ltd a Sun Pharma Company Millington Road 11
Maltese: United Kingdom Ranbaxy UK Ltd a Sun Pharma Company Millington Road 11
English: TMZ + concomitant RT n=288*
Maltese: TMZ + RT flimkien n=288*
English: - The active substance is temozolomide.
Maltese: - Is-sustanza attiva hi temozolomide.
English: SUN Pharma logo
Maltese: FIS-SUQ Logo SUN Pharma
English: common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000).
Maltese: Mhux komuni (≥ 1/1,000 to < 1/100); Rari (≥1/10,000 sa <1/1,000);
English: 5x1 hard capsule 20x1 hard capsule
Maltese: 5x1 kapsuli ibsin 20x1 kapsula ibsin
English: Date of first authorization: 13 July 2011 Date of latest renewal: 21 April 2016
Maltese: Data tal-aħħar tiġdid: 21 ta' April, 2016
English: Temozolomide SUN may cause permanent infertility.
Maltese: Temozolomide SUN jista' jikkawża infertilità permanenti.
English: Nederland/Pays-Bas/Niederlande/Нидерландия/Nizozemsko/ Nederlandene/Holland/Ολλανδία/Nizozemska/The Netherlands/Holland/
Maltese: Nederland/Pays-Bas/Niederlande/Нидерландия/Nizozemsko/ Nederlandene/Holland/Ολλανδία/Nizozemska/The Netherlands/Holland/ Ολλανδία/Nīderlande/Nyderlandai/Pays-Bas/Niederlande/Hollandia/
English: Erythema multiforme, erythroderma, urticaria, exanthema
Maltese: Erythema multiforme, eritroderma, urtikarja,
English: Terapia S.A. Str. Fabricii nr 124
Maltese: Fabricii nr 124
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) għallpopolazzjoni intent-to-treat (ITT) n=162.
English: Tolerance to TMZ is similar to adults.
Maltese: Ittolleranza għal TMZ hija simili għall-adulti.
English: Herpes simplex, herpes zoster, influenza-like symptoms
Maltese: Herpes simplex, herpes zoster, sintomi bħal ta' l-influwenza
English: 929 & 140 mg
Maltese: 929 u 140 mg
English: TMZ demonstrates low protein binding (10 % to 20 %), and thus it is not expected to interact with highly protein-bound substances.
Maltese: TMZ jeħel b'mod ħafif mal-proteini (10 % sa 20 %), u għalhekk mhux mistenni li jinteraġixxi ma' sustanzi li jeħlu ħafna mal-proteini.
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: Pharmacotherapeutic group: Antineoplastic agents, other alkylating agents, ATC code: L01A X03.
Maltese: Aġenti antineoplastiċi - alkylating agents oħra, kodiċi ATC L01A
English: Excipient with known effect Each hard capsule contains 163.441 mg of lactose.
Maltese: Eċċipjent b'effett magħruf Kull kapsula iebsa fiha 163.441 mg ta' lactose.
English: Neutropenia or lymphopenia (grade 3-4), thrombocytopenia (grade 3-4)
Maltese: Newtropenija jew limfopenija (grad 3-4), tromboċitopenija (grad 3-4)
English: 930 & 180 mg
Maltese: 930 u 180 mg
English: Allergic reactions, including anaphylaxis, angioedema
Maltese: Reazzjonijiet allerġiċi, inkluża anafilassi, anġjoedima
English: 890 & 5 mg
Maltese: 890 u 5 mg
English: The hazard ratio (HR) for overall survival was 1.59 (95 % CI for HR=1.33-1.91) with a log-rank p < 0.0001 in favour of the TMZ arm.
Maltese: Il-proporzjon tal-periklu (HR) għas-sopravivenza ġenerali kienet ta' 1.59 (95 % CI għal HR=1.331.91) b'log rank p < 0.0001 favur il-fergħa ta' TMZ.
English: Embolism pulmonary, oedema, oedema peripheral
Maltese: Emboliżmu fil-pulmun, edima, edima periferali
English: For the 20 capsules packs, 4 blisters of 5 capsules will be included in a carton.
Maltese: Għall-pakketti ta' 20 kapsula, 4 folji ta' 5 kapsuli se jkunu inklużi f'kartuna.
English: There is limited information in patients over 3 years of age who have taken Temozolomide SUN.
Maltese: Hemm informazzjoni limitata f'pazjenti li għandhom 'l fuq minn 3 snin li ħadu Temozolomide SUN.
English: TMZ is spontaneously hydrolyzed at physiologic pH primarily to the active species, 3-methyl-(triazen1-yl)imidazole-4-carboxamide (MTIC).
Maltese: TMZ huwa idrolizzat b'mod spontanju fil-pH fiżjoloġika għall-ispeċi attiva, 3-methyl-(triazen-1yl)imidazole-4-carboxamide (MTIC).
English: cytomegalovirus infection, infection reactivation such as cytomegalovirus, hepatitis B virus†, meningoencephalitis herpetic†, sepsis†
Maltese: infezzjoni b'cytomegalovirus, attivazzjoni mill-ġdid ta' infezzjonijiet bħal cytomegalovirus, u virus talepatite B†, meningoenċefalite ħerpetika†, sepsis†
English: Excipient with known effect Each hard capsule contains 127.121 mg of lactose.
Maltese: Kull kapsula iebsa fiha 127.121 mg ta' lactose.
English: Excipient with known effect Each hard capsule contains 30.97 mg of lactose.
Maltese: Kull kapsula iebsa fiha 30.97 mg ta' lactose.
English: In the randomised active-controlled trial, the PFS at 6 months was significantly greater for TMZ than for procarbazine (21 % vs 8 %, respectively - chi-square p=0.008) with median PFS of 2.89 and 1.88 months respectively (log rank p=0.0063).
Maltese: Fil-prova randomised ikkontrollata b'mod attiv, l-PFS ma' 6 xhur kien akbar b'mod sinifikanti għal TMZ milli għal procarbazine (21 % vs 8 %, rispettivament - chi-square p=0.008) bil-PFS medjan ta' 2.89 u 1.88 xhur rispettivament (log rank p=0.0063).
English: Excipient with known effect Each hard capsule contains 90.801 mg of lactose.
Maltese: Kull kapsula iebsa fiha 90.801 mg ta' lactose.
English: Temozolomide SUN contains lactose (a kind of sugar).
Maltese: Temozolomide SUN fih lactose (tip ta' zokkor).
English: 893 & 250 mg
Maltese: 893 u 250 mg
English: Hemiplegia, ataxia, coordination abnormal, gait abnormal, hyperesthesia, sensory disturbance
Maltese: Emipleġja, atassja, koordinament anormali, mixja mhux normali, iperesteżija, disturbi sensorjali
English: Figure 1 Kaplan-Meier curves for overall survival (intent-to-treat population)
Maltese: Kaplan-Meier għas-sopravivenza ġenerali (popolazzjoni intent-to-treat)
English: Vaginal haemorrhage, menorrhagia, amenorrhea, vaginitis, breast pain
Maltese: Emorraġija vaġinali, menorraġja, amenorreja, vaġinite, uġigħ fissider
English: The major route of 14C elimination is renal.
Maltese: Il-mod ewlieni ta' l-eliminazzjoni ta' 14C huwa dak renali.
English: 891 & 20 mg
Maltese: 891 u 20 mg
English: Rare (may affect up to 1 in 1,000 people): cough, infections including pneumonia.
Maltese: Rari (jistgħu jaffettwaw sa persuna waħda minn kull 1,000): sogħla, infezzjonijiet fosthom pulmonite.
English: Abdominal distension, fecal incontinence, gastrointestinal disorder (NOS), gastroenteritis, haemorrhoids
Maltese: Nefħa addominali, inkontinenza ta' l-ippurgar, disturbi gastrointestinali (NOS), gastroenterite, emorrojdi
English: These reactions were usually Grade 1 or 2 (0-5 episodes of vomiting in 24 hours) and were either self-limiting or readily controlled with standard anti-emetic therapy.
Maltese: Dawn ir-reazzjonijet kienu normalment Grad 1 jew 2 (0-5 episodji ta' rimettar f'24 siegħa) u jew waqfu waħidhom jew kienu kontrollati b'terapija kontra t-tqalligħ standard.
English: 892 & 100 mg
Maltese: 892 u 100 mg
English: Grade 3 or 4 thrombocytopenia and neutropenia occurred in 19 % and 17 % respectively, of patients treated for malignant glioma.
Maltese: Tromboċitopenija u newtropenija ta' Grad 3 jew 4 seħħew f'19 % u 17 % rispettivament, talpazjenti kkurati għal glijoma malinna.
English: MTIC is spontaneously hydrolyzed to 5-amino-imidazole-4carboxamide (AIC), a known intermediate in purine and nucleic acid biosynthesis, and to methylhydrazine, which is believed to be the active alkylating species.
Maltese: MTIC huwa idrolizzat b'mod spontanju għal 5-aminoimidazole-4-carboxamide (AIC), intermedju magħruf fil-bijosintesi ta' purine u aċidi nuklejiċi, u għal methylhydrazine, li hu maħsub li jkun l-ispeċi alkylating attiva.
English: Aluminium/aluminium unit dose blisters, consisting of an OPA [Oriented Poly Amide] / Aluminium / PVC [Polyvinyl chloride] forming film and peelable Aluminium lidding foil with heat seal laquer.
Maltese: F'folji tal-unità tad-doża tal-aluminju/aluminju, li jikkonsistu f'forming film tal-OPA [polyamide orjentat] / Aluminju / PVC [Polyvinyl chloride] forming film u lidding foil tal-Aluminju li jista' jitqaxxar b'heat sealer laquer.
English: In a study of 288 subjects with newly-diagnosed glioblastoma multiforme, Grade 4 neutropenia occurred in 3 % of female vs 0 % of male subjects and Grade 4 thrombocytopenia in 1 % of female vs 0 % of male subjects in the first cycle of therapy.
Maltese: Fi studju b'288 individwu bi glioblastoma multiforme li għadha kif ġiet iddijanjostikata, newtropenija ta' Grad 4 seħħet fi 3 % tan-nisa vs 0 % tal-irġiel u tromboċitopenija ta' Grad 4 seħħet f'1 % tan-nisa vs 0 % tal-irġiel fl-ewwel ċiklu tat-terapija.
English: Grade 3 or Grade 4 thrombocyte abnormalities, including thrombocytopenic events were observed in 14 % of the patients who received TMZ.
Maltese: Anormalitajiet ta' Grad 3 jew ta Grad 4, fit-tromboċiti, inkluż effetti tromboċitopeniċi dehru f'14 % tal-pazjenti li ingħataw TMZ.
English: Data on clinical efficacy in patients with glioblastoma multiforme (Karnofsky performance status [KPS] ≥ 70), progressive or recurrent after surgery and RT, were based on two clinical trials with oral TMZ.
Maltese: Dejta dwar l-effikaċja klinika f'pazjenti bi glioblastoma multiforme (Status ta'-prestazzjoni ta' Karnofsky [KPS] ≥ 70), progressiva jew rikorrenti wara operazzjoni u RT, kienet ibbażata fuq żewġ provi kliniċi b'TMZ orali.
English: drug reaction with eosinophilia and systemic symptoms (DRESS)
Maltese: reazzjoni għall-Mediċina b'esinofilja u sintomi sistemiċi (DRESS)
English: Each one lasts 28 days.
Maltese: Ċiklu ta' kura jikkonsisti minn 28 jum.
English: Excipient with known effect Each hard capsule contains 18.16 mg of lactose.
Maltese: Kull kapsula iebsa fiha 18.16 mg ta' lactose.
English: toxic epidermal necrolysis, Stevens-Johnson syndrome
Maltese: nekrolisi tossika tal-ġilda, sindrome ta' Stevens
English: Prior to dosing, the following laboratory parameters must be met: ANC ≥ 1.5 x 109/l and platelet count ≥ 100 x 109/l.
Maltese: ANC ≥ 1.5 x 109/l u għadd tal-plejtlets ≥ 100 x 109/l.
English: Hearing impairment
Maltese: Disturbi vaskulari
English: Yellow iron oxide (E172)
Maltese: Red iron oxide (E172)
English: Excipient with known effect Each hard capsule contains 227.001 mg of lactose.
Maltese: Kull kapsula fiha 227,001 mg ta' lactose.
English: How to store Temozolomide SUN
Maltese: Tiħux Temozolomide SUN
English: - as you should be observed closely for the development of a serious form of chest infection called Pneumocystis jirovecii pneumonia (PCP).
Maltese: - ser tiġi osservat mill-qrib għall-iżvilupp ta' forma serja ta' pnewmonja msejħa pnewmonja Pneumocystis jirovecii (PCP).
English: Pneumonia, sinusitis, upper respiratory infection, bronchitis
Maltese: Pulmonite, sinusite, infezzjoni fil-parti ta' fuq tal-apparat respiratorju, bronkite
English: Following oral administration, approximately 5 % to 10 % of the dose is recovered unchanged in the urine over 24 hours, and the remainder excreted as temozolomide acid, 5-aminoimidazole-4carboxamide (AIC) or unidentified polar metabolites.
Maltese: Wara għoti orali, madwar 5 % sa 10 % tad-doża tiġi rkuprata mhux mibdula fl-awrina fuq medda ta' 24 siegħa, u l-bqija tiġi eliminata bħala aċidu temozolomide, 5-aminoimidazole-4carboxamide (AIC) jew metaboliti polari li ma ġewx identifikati.
English: Very rare cases of lung side effects have been observed with Temozolomide SUN.
Maltese: Każijiet rari ħafna ta' effetti sekondarji fil-pulmun ġew osservati b'Temozolomide SUN.
English: Muscle weakness, arthralgia Muscle weakness, arthralgia, musculoskeletal pain, myalgia
Maltese: Dgħjufija fil-muskoli, artralġja Dgħjufija fil-muskoli, artralġja, uġigħ muskolu-skeletrali, mijalġja
English: An overdose of 10,000 mg (total dose in a single cycle, over 5 days) was taken by one patient and the adverse reactions reported were pancytopenia, pyrexia, multiorgan failure and death.
Maltese: Doża eċċessiva ta' 10,000 mg (doża totali f'ċiklu wieħed, matul 5 ijiem) ittieħdet minn pazjent u rreazzjonijiet avversi rrappurtati kienu panċitopenija, deni, kollass ta' diversi organi u mewt.
English: One was a non-comparative trial in 138 patients (29 % received prior chemotherapy), and the other was a randomised active-controlled trial of TMZ vs procarbazine in a total of 225 patients (67 % received prior treatment with nitrosourea based chemotherapy).
Maltese: Waħda kienet prova mhux komparattiva f'138 pazjent (29 % kienu rċevew il- kemoterapija qabel), u l-oħra kienet prova randomized kontrollata b'mod attiv ta' TMZ vs procarbazine f'total ta' 225 pazjent (67 % kienu rċivew trattament qabel bil-kemoterapija bbażata fuq nitrosourea).