FrancophonIA/ELRC3.0 huggingface dataset:
English: Vepesid is marketed in 16 EU member States (Austria, Belgium, Croatia, Denmark, Estonia, Finland, Germany, Ireland, Italy, Luxembourg, the Netherlands, Romania, Slovenia, Spain, Sweden and the United Kingdom) as well as in Norway.
Maltese: Vepesid huwa kkummerċjalizzat f'16-il Stat Membru tal-UE (l-Awstrija, il-Belġju, il-Kroazja, idDanimarka, l-Estonja, il-Finlandja, il-Ġermanja, l-Irlanda, l-Italja, il-Lussemburgu, in-Netherlands, irRumanija, is-Slovenja, Spanja, l-Iżvezja u r-Renju Unit) kif ukoll fin-Norveġja.
English: The areas of the SmPC harmonised include:
Maltese: Il-partijiet armonizzati tal-SmPC jinkludu:
English: Other sections of the SmPC harmonised include section 4.4 (special warnings and precautions), section 4.6 (fertility, pregnancy and lactation) and section 4.8 (undesirable effects).
Maltese: Sezzjonijiet oħra tal-SmPC li ġew armonizzati jinkludu s-sezzjoni 4.4 (twissijiet speċjali u prekawzjonijiet), is-sezzjoni 4.6 (fertilità, tqala u treddigħ) u s-sezzjoni 4.8 (effetti mhux mixtieqa).
English: EMA/251790/2017 Rev. 1 EMEA/H/A-30/1425
Maltese: 1 EMEA/H/A-30/1425
English: On 21 April 2017, the European Medicines Agency completed a review of Vepesid.
Maltese: Fil-21 ta' April 2017, l-Aġenzija Ewropea għall-Mediċini temmet rieżami ta' Vepesid.
English: Vepesid is a cancer medicine used to treat: testicular cancer, lung cancer, ovarian cancer and cancers of the blood (Hodgkin's and non-Hodgkin's lymphoma and acute myeloid leukaemia).
Maltese: Vepesid huwa mediċina kontra l-kanċer li tintuża għall-kura ta': kanċer testikolari, kanċer tal-pulmun, kanċer tal-ovarji u kanċer tad-demm (linfoma ta' Hodgkin u mhux ta' Hodgkin u lewkimja majelojde akuta).
English: 4.2 Posology and method of administration
Maltese: .2 Pożolo ġija u metodu ta
English: The usual dose of Vepesid is 100 to 200 mg per m2 of body surface area for 5 days in a row or 200 mg/m2/day on days 1, 3 and 5 every 3 to 4 weeks.
Maltese: Id-doża tas-soltu ta' Vepesid hija ta' 100 sa 200 mg għal kull m2 tal-erja tas-superfiċje tal-ġisem għal 5 tijiem wara xulxin jew 200 mg/m2/kuljum fl-ewwel, fit-tielet u fil-ħames jum kull 3 sa 4 ġimgħat.
English: It is also available in the EU under the trade name Vepesid K. The company that markets these medicines is Bristol-Myers Squibb.
Maltese: Il-kumpanija li tqiegħed dawn il-mediċini fis-suq hija Bristol-Myers Squibb.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Vepesid in the European Union (EU).
Maltese: ġenzija kkonkluda li he armonizzazzjoni tal-informazzjoni tal-preskrizzjoni għal Vepesid fl-Unjoni Ewropea (UE).
English: The dose of Vepesid is based on the recommended dose for the intravenous etoposide medicines, with a 100 mg oral dose being comparable to a 75 mg intravenous one.
Maltese: Id-doża ta' Vepesid hija bbażata fuq id-doża rrakkomandata għall-mediċini etoposide fil-vini, b'doża orali ta' 100 mg li hija komparabbli ma' waħda fil-vina ta' 75 mg.
English: The European Commission issued a decision on this opinion on 26/6/17.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni dwar din l-opinjoni fl-26/6/17.
English: On 14 October 2015, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Vepesid in the EU.
Maltese: Fl-14 ta' Ottubru 2015, il-Kummissjoni Ewropea rriferiet il-kwistjoni lis-CHMP sabiex jarmonizza lawtorizzazzjonijiet għat-tqegħid fis-suq għal Vepesid fl-UE.
English: • small-cell lung cancer;
Maltese: • kanċer tal-pulmun b'ċelloli żgħar;
English: • Hodgkin's lymphoma as second-line treatment;
Maltese: • Linfoma ta' Hodgkin bħala trattament tat-tieni linja;
English: • non-epithelial ovarian cancer.
Maltese: • kanċer mhux epiteljali tal-ovarji.
English: Vepesid contains the active substance etoposide and is available as capsules to be taken by mouth.
Maltese: Vepesid fih is-sustanza attiva etoposide u huwa disponibbli bħala kapsuli li għandhom jittieħdu millħalq.
English: • acute myeloid leukaemia that is resistant to treatment or has come back;
Maltese: • lewkimja majelojde akuta li hija reżistenti għall-kura jew li tkun reġgħet tfaċċat;
English: Vepesid was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Maltese: Vepesid ġie identifikat bħala li jeħtieġ armonizzazzjoni mill-Grupp ta' Koordinazzjoni għal Proċedura tar-Rikonoxximent Reċiproku u l-Proċedura Deċentralizzata - Bniedem (CMDh).
English: Vepesid is authorised in the EU via national procedures.
Maltese: Vepesid huwa awtorizzat fl-UE permezz ta
English: The CHMP recommended that Vepesid should be used in combination with other cancer treatments to treat the following cancers in adults:
Maltese: Is-CHMP irrakkomanda li Vepesid għandu jintuża f'kombinazzjoni ma' trattamenti oħra tal-kanċer għallkura tal-kanċers li ġejjin:
English: Vepesid capsules should be taken on an empty stomach.
Maltese: Għaliex ġie rieżaminat Vepesid?
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Maltese: Membri fil-mod ta' kif tista' tintuża l-mediċina, kif jidher fid-differenzi fis-sommarji tal-karatteristiċi talprodott (SmPCs), it-tikkettar u l-fuljetti ta' tagħrif fil-pajjiżi fejn il-mediċina titqiegħed fis-suq.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs and package leaflets should be harmonised across the EU.
Maltese: Fid-dawl tad-data sottomessa u d-diskussjoni xjentifika fil-Kumitat, is-CHMP kien tal-fehma li l-SmPCs u l-fuljetti ta' tagħrif għandhom jiġu armonizzati fl-UE kollha.
English: Grades 3 and 4*
Maltese: Gradi 3 u 4*
English: (see sections 4.2 and 4.8).
Maltese: (ara sezzjoni 4.4).
English: * WHO Criteria
Maltese: * Kriterji WHO
English: Confusional state, Depression
Maltese: Stat ta' konfużjoni, Depressjoni
English: • Medroxyprogesterone acetate depot
Maltese: • Depot Medroxyprogesterone acetate depot
English: MP - T
Maltese: MP MP-T
English: Melphalan c,d,e
Maltese: Thalidomidea,b Melphalanċ,d,e
English: Educational materials
Maltese: Materjal edukattiv
English: (For description of symptoms see section 4 “Possible side effects”).
Maltese: (Għal deskrizzjoni tas-sintomi ara sezzjoni 4 “Effetti sekondarji possibbli”).
English: The plasma protein binding of the (+)-(R) and (-)-(S) enantiomers was found to be 55 % and 65 % respectively.
Maltese: L-irbit bejn plażma-protejina ta' (+)-(R) u (-)-(S) enantiomers instabu li huma 55 % u 65 % rispettivament.
English: • Convulsions.
Maltese: • Konvulżjonijiet.
English: Cardiac failure, Bradycardia
Maltese: Insuffiċjenza kardijaka, Bradikardija
English: • The active substance is thalidomide.
Maltese: • Is-sustanza attiva hi thalidomide.
English: • Tubal sterilisation
Maltese: • Sterilizzazzjoni tubali
English: Amenorrhea
Maltese: Amenorreja
English: Thalidomide has a chiral centre and is used clinically as a racemate of (+)-(R)- and (-)-(S)-thalidomide.
Maltese: Thalidomide għandu ċentru kirali u jiġi użat klinikament bħala racemate ta' (+)-(R)- u (-)-(S)-thalidomide.
English: Thalidomide shows immunomodulatory, anti-inflammatory and potential anti-neoplastic activities.
Maltese: Thalidomide juri attivitajiet immunomodulatorji, anti-infjammatorji u anti-neo-plastiċi potenzjali.
English: • Sexual dysfunction, for example impotence.
Maltese: • Nuqqas ta' ħajra sesswali, pereżempju impotenza.
English: The median overall survival (OS) was 51.6 ± 4.5 and 33.2 ± 3.2 months in the MPT and MP groups, respectively (97.5 % CI 0.42 to 0.84).
Maltese: Is-sopravivenza totali medjana kien ta' 51.6 ± 4.5 u 33.2 ± 3.2 xhur fil-gruppi MPT u MP, rispettivament (97.5 % CI 0.42 sa 0.84).
English: o The capsule shell contains gelatin and titanium dioxide (E171).
Maltese: o Il-qoxra tal-kapsula fiha ġelatina u titanium dioxide (E171).
English: • Premature ovarian failure confirmed by a specialist gynaecologist.
Maltese: • Ċediment ovarju prematur ikkonfermat minn ginekoloġista.
English: Teratogenic effects
Maltese: Effetti teratoġeniċi:
English: Figure 1: Overall survival according to treatment
Maltese: Figura 1: Sopravivenza globali skont it-trattament
English: Celgene Europe B.V.
Maltese: Celgene Distribution B.V.
English: > 75 < 1,500 but
Maltese: > 75 < 1,500 iżda
English: UNIQUE IDENTIFIER - 2D BARCODE
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D barcode 2D li jkollu l-identifikatur uniku inkluż
English: This 18 month difference was statistically significant with a hazard ratio of reduction of risk of death in the MPT arm of 0.59, 97.5 % confidence interval of 0.42-0.84 and p-value of < 0.001 (see Figure 1).
Maltese: Din id-differenza ta' 18-il xahar kienet statistikament sinifikanti bi proporzjon ta' periklu tat-tnaqqis tar-riskju tal-mewt fid-driegħ ta' MPT ta' 0.59, intervall ta' kunfidenza ta' 97.5 % ta' 0.42-0.84 u valur-p ta' < 0.001 (ara Figura 1).
English: Gastrointestinal perforation
Maltese: Disturbi gastrointestinali
English: EU/1/08/443/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/08/443/001
English: Capsule contents Starch, pregelatinised Magnesium stearate
Maltese: o Il-kontenut tal-kapsula fih pregelatinised starch u magnesium stearate.
English: Melphalan and prednisone were dosed at 0.25 mg/kg/day and 2 mg/kg/day respectively on days 1 to 4 of each 6 weeks cycle.
Maltese: Melphalan u prednisone kienu dożati f'0.25 mg/kg/kuljum u 2 mg/kg/kuljum rispettivament fil-jiem 1 sa 4 ta' kull ċiklu ta' sitt ġimgħat.
English: Extremely intense and serious skin reactions.
Maltese: Reazzjonijiet tal-ġilda intensi u serji ħafna.
English: • The need for effective contraception
Maltese: • Il-bżonn ta' kontraċettiv effettiv
English: • slow the heart rate (induce bradycardia, such as anticholinesterases and beta blockers).
Maltese: • ibaxxu r-rata ta' taħbit tal-qalb (bradikardija indotta, bħal anti-cholinesterases u imblokkaturi beta).
English: • XY genotype, Turner's syndrome, uterine agenesis.
Maltese: • Ġenotip XY, sindromu ta' Turner, aġenesi fl-utru.
English: OR < 100,000 but
Maltese: JEW < 100,000 iżda
English: There is minimal cytochrome P450 catalysed hepatic metabolism of thalidomide.
Maltese: Hemm metaboliżmu epatiku minimu kkatalizzat permezz ta' cytochrome P450 fuq thalidomide.
English: ≤ 75 < 1,500 but
Maltese: ≤ 75 < 1,500 iżda
English: The recommended dose is 200 mg (4 x 50 mg capsules) a day for adults aged 75 years and under or 100 mg (2 x 50 mg capsules) a day for adults aged over 75 years.
Maltese: Id-doża rakkomandata hija ta' 200 mg (4 kapsuli x 50 mg) kuljum għal adulti li jkollhom 75 sena u anqas jew 100 mg (2 x 50 mg kapsuli) kuljum għal adulti li jkollhom iktar minn 75 sena.
English: Table 4: Comparison of haematological disorders for the melphalan, prednisone (MP) and melphalan, prednisone, thalidomide (MPT) combinations in study IFM 99-06 (see section 5.1) n (% of patients)
Maltese: Tabella 4: Tqabbil bejn id-disturbi ematoloġiċi għal kombinazzjonijiet ta' melphalan, prednisone (MP) u melphalan, prednisone, thalidomide (MPT) fl-istudju IFM 99-06 (ara sezzjoni 5.1) n (% ta' pazjenti) MP (n=193)
English: Celgene Europe B.V. Winthontlaan 6 N 3526 KV Utrecht Netherlands
Maltese: Celgene Europe B.V. Winthontlaan 6 N 3526 KV Utrecht L-Olanda
English: When provided, antiovary antibodies were negative and prolactin level was within the normal range.
Maltese: Meta pprovduti, antikorpi antiovarji kienu negattivi u l-livell ta' prolactin kien fil-medda normali.
English: Black iron oxide (E172) Propylene glycol
Maltese: Black iron oxide (E172)
English: • Post-marketing and compliance assessment (as applicable to a Member State)
Maltese: • Evalwazzjoni ta' wara t-tqegħid fis-suq u konformità (kif applikabbli għal Stat Membru)
English: Very Common Peripheral oedema Common
Maltese: Komuni Ħafna Edema periferali
English: o The printing ink is composed of shellac, black iron oxide (E172) and propylene glycol.
Maltese: o L-inka tal-istampar hi magħmula minn xellak, black iron oxide (E172) u propylene glycol.
English: Pharmacotherapeutic group: immunosuppressants, other immunosuppressants, ATC code: L04AX02.
Maltese: Kategorija farmakoterapewtika: immunosoppressanti, immunosoppressanti oħrajn, Kodiċi ATC:
English: System Organ Class
Maltese: Klassi tas-Sistemi u tal-Organi
English: Platelet Count (/µL)
Maltese: Għadd tal-Plejtlits (/µL)
English: • Decreased or abnormal sensation (dysaesthesia).
Maltese: • Tnaqqis fis-sensazzjoni jew sensazzjoni mhux normali (disastesija).
English: Thalidomide Celgene is prescribed and dispensed according to the Thalidomide Celgene Pregnancy Prevention Programme (see section 4.4).
Maltese: Thalidomide Celgene jingħata b'riċetta u jiġi mogħti skont il-Programm ta' Prevenzjoni ta' Tqala ta' Thalidomide Celgene (ara sezzjoni 4.4).
English: • Additional risk minimisation measures 1.
Maltese: • Miżuri addizzjonali għall-minimizzazzjoni tar-riskji
English: • you have or have ever had previous viral infection, particularly varicella zoster, hepatitis B infection, or HIV.
Maltese: • għandek jew qatt kellek infezzjoni virali fil-passat, partikularment varicella zoster, infezzjoni bil-virus tal-epatite B, jew HIV.
English: Dose delay, reduction or discontinuation, dependent upon the NCI CTC (National Cancer Institute Common Toxicity Criteria) grade, may be necessary.
Maltese: Jista' jkun meħtieġ li d-doża tingħata aktar tard, titnaqqas jew titwaqqaf għal kollox skont il-grad ta' NCI CTC (National Cancer Institute Common Toxicity Criteria).
English: The mean elimination half-life of thalidomide in plasma following single oral doses between 50 mg and 400 mg was 5.5 to 7.3 hours.
Maltese: Il-half-life ta' l-eliminazzjoni medja ta' thalidomide fil-plażma wara dożi orali singoli ta' bejn 50 mg u 400 mg kienet ta' bejn 5.5 sa 7.3 siegħat.
English: In humans, thalidomide is a proven teratogen.
Maltese: Fil-bniedem, thalidomide huwa teratoġen ipprovat.
English: However, reports following relatively shortterm use also exist.
Maltese: Madankollu, rapporti wara perijodu relattivament qasir jeżistu wkoll.
English: Total systemic exposure (AUC) is proportional to dose at single-dose conditions.
Maltese: L-espożizzjoni sistematika totali (AUC) hija proporzjonali għad-doża f'kondizzjonijiet ta' doża waħda.
English: Neutropenia, Leukopenia, Anaemia, Lymphopenia, Thrombocytopenia
Maltese: Komuni Ħafna Newtropenija, Lewkopenija, Anemija, Limfopenija, Tromboċitopenija
English: Date of first authorisation: 16 April 2008 Date of latest renewal: 08 February 2018
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 16 ta' April 2008
English: Survival time median ± se (month)
Maltese: Sewqan u tħaddim ta' magni
English: Thalidomide is a poor substrate for cytochrome P450 isoenzymes and therefore clinically important interactions with medicinal products that are inhibitors and/or inducers of this enzyme system are unlikely.
Maltese: Thalidomide huwa substrat ħafif għal isoenżimi ta' cytochrome P450 u għalhekk interazzjonijiet klinikament importanti ma' prodotti mediċinali li huma impedituri u/jew jistimulaw din is-sistema enżimatika huma improbabbli.
English: Venous and arterial thromboembolic events
Maltese: Avvenimenti tromboemboliċi venużi u arterjali
English: The adverse reaction profile reported in patients > 75 years of age treated with thalidomide 100 mg once daily was similar to the adverse reaction profile observed in patients ≤ 75 years of age treated with thalidomide 200 mg once daily (see Table 3).
Maltese: Il-profil tar-reazzjonijiet avversi rrappurtat f'pazjenti li kellhom > 75 ikkurati b'thalidomide 100 mg darba kuljum kien simili għall-profil tar-reazzjonijiet avversi osservat f'pazjenti li kellhom ≤ 75 sena kkurati b'thalidomide 200 mg darba kuljum (ara Tabella 3).
English: In plasma, unchanged thalidomide represents 80 % of the circulatory components.
Maltese: Fil-plażma, thalidomide mhux mibdul jirrappreżenta 80 % tal-komponenti ċirkolatorji.
English: Posterior reversible encephalopathy syndrome (PRES)/ Reversible posterior leukoencephalopathy syndrome (RPLS)
Maltese: Sindrome ta' enċefalopatija riversibbli posterjuri (PRES)/Sindrome ta' lewkoenċefalopatija posterjuri riversibbli (RPLS - Reversible posterior leukoencephalopathy syndrome) Każijiet ta' PRES/RPLS ġew irrappurtati.
English: †, Abnormal coordination
Maltese: Konvulżjonijiet†, Koordinazzjoni anormali
English: Increase of sedative effects of other medicinal products Thalidomide has sedative properties, thus may enhance the sedation induced by anxiolytics, hypnotics, antipsychotics, H1 antihistamines, opiate derivatives, barbiturates and alcohol.
Maltese: Żieda fl-effetti sedattivi ta' prodotti mediċinali oħra Thalidomide għandu karatteristiċi sedattivi, u għalhekk jista' jħarrax l-induzzjoni sedattiva b'ansjolitiċi, ipnotiċi, antipsikotiċi, H1 antiistamini, derivati ta' opijati, barbiturati u alkoħol.
English: • Inflammation and swelling of the tubes in your lungs (bronchitis).
Maltese: • Infjammazzjoni u nefħa fit-tubi tal-pulmuni tiegħek (bronkite).
English: Table 1: Starting doses for thalidomide in combination with melphalan and prednisone Age (years)
Maltese: Tabella 1: Dożi tal-bidu għal thalidomide flimkien ma' melphalan u prednisone Età (snin)
English: Peripheral neuropathy
Maltese: Newropatija periferali
English: The maximum daily melphalan dose is 20 mg in patients > 75 years of age (see Table 1).
Maltese: Id-doża massima ta' kuljum ta' melphalan hi ta' 20 mg f'pazjenti li jkollhom > 75 sena (ara Tabella 1).
English: • She should be capable of complying with effective contraceptive measures
Maltese: • Għandha tkun kapaċi tikkonforma mal-miżuri ta' kontraċezzjoni effettiva
English: In this study the age range of patients was 65-75 years, with 41 % (183/447) of patients 70 years old or older.
Maltese: F'dan l-istudju l-età tal-pazjenti kienet tvarja bejn 65-75 sena, b'41 % (183/447) tal-pazjenti ikollhom 70 sena jew aktar.
English: • are used for contraception.
Maltese: • jintużaw għal kontraċezzjoni.
English: Allergic reactions (hypersensitivity, angioedema, urticaria)
Maltese: Mhux Magħrufa Reazzjonijiet allerġiċi (sensittività eċċessiva, anġjoedema, urtikarja)†
English: Thalidomide is metabolised almost exclusively by non-enzymatic hydrolysis.
Maltese: Thalidomide jiġi metabolizzat kważi esklussivament minn idrolisi mhux enzimatika.
English: Eighteen cases of overdose have been reported in the literature concerning doses up to 14.4 grams.
Maltese: Tmintax-il każ ta' doża eċċessiva ġew rapportati fil-letteratura medika dwar dożi sa 14.4 grammi.
English: Severe infections (e.g. fatal sepsis including septic shock)
Maltese: Infezzjonijiet severi (eż. sepsis fatali li tinkludi xokk settiku)†,
English: The median dose of thalidomide was 217 mg and > 40 % of patients received 9 cycles.
Maltese: Id-doża medjana ta' thalidomide kienet ta' 217 mg u > 40 % tal-pazjenti rċevew 9 ċikli.
English: In one 2-year-old child who took 700 mg, there was an abnormal plantar response in addition to drowsiness and irritability.
Maltese: F'tifel ta' sentejn li ħa 700 mg, kien hemm rispons plantari mhux normali flimkien ma' ngħas u irritabilità.
English: Unchanged thalidomide was a minor component (< 3 % of the dose) in urine.
Maltese: Thalidomide mhux mibdul kien komponent minuri (< 3 % tad-doża) fl-awrina.
English: The most commonly observed adverse reactions associated with the use of thalidomide in combination with melphalan and prednisone are: neutropenia, leukopenia, constipation, somnolence, paraesthesia, peripheral neuropathy, anaemia, lymphopenia, thrombocytopenia, dizziness, dysaesthesia, tremor and peripheral oedema.
Maltese: L-aktar reazzjonijiet avversi komuni osservati assoċjati ma' l-użu ta' thalidomide f'kombinazzjoni ma' melphalan u prednisone huma: newtropenja, lewkopenja, stitikezza, ngħas, parestesija, newropatija periferali, anemija, limfopenja, tromboċitopenja, stordament, disaestesija, tertir, u edema periferali.
English: The recommended dose of thalidomide is 200 mg orally per day.
Maltese: Id-doża rakkomandata ta' thalidomide hija ta' 200 mg oralment kuljum.
English: In addition to thalidomide, hydrolytic products N-(o-carboxybenzoyl) glutarimide and phthaloyl isoglutamine formed via non-enzymatic processes are also present in plasma and in majority in urine.
Maltese: Flimkien ma' thalidomide, prodotti idrolitiċi N-(o-carboxybenzoyl) glutarimide u phthaloyl isoglutamine iffurmati permezz ta' proċessi mhux enzimatiċi huma wkoll preżenti fil-plażma u fil-maġġoranza fl-awrina.
English: White opaque capsules marked “Thalidomide Celgene 50 mg”.
Maltese: Kapsuli opaki mmarkati b'“Thalidomide Celgene 50 mg”.
English: PC:
Maltese: * ANC:
English: The incidence of neutropenia grade 3 or 4 reported as adverse reactions was higher in multiple myeloma patients receiving MPT (Melphalan, Prednisone, Thalidomide) than in those receiving MP (Melphalan, Prednisone): 42.7 % versus 29.5 % respectively (study IFM 99-06).
Maltese: L-inċidenza ta' newtropenija ta' grad 3 jew 4 irrappurtata bħala reazzjonijiet avversi kienet ogħla f'pazjenti ta' majeloma multipla li kienu qed jirċievu MPT (Melphalan, Prednisone, Thalidomide) minn f'dawk li kienu qed jirċievu MP (Melphalan, Prednisone): 42.7 % kontra 29.5 % rispettivament (studju IFM 99-06).
English: Data from in vitro studies and clinical trials suggest that the immunomodulatory, anti-inflammatory and anti-neoplastic effects of thalidomide may be related to suppression of excessive tumour necrosis factor-alpha (TNF-) production, down-modulation of selected cell surface adhesion molecules involved in leukocyte migration and anti-angiogenic activity.
Maltese: Tagħrif minn studji in vitro u provi kliniċi jissuġerixxu li l-effetti immunomodulatorji, anti-infjammatorji u anti-neoplastiċi ta' thalidomide jistgħu ikunu relatati mat-trażżin fil-produzzjoni eċċessiva tal-fattur ta' nekrosi tumurili-alfa (TNF-), ibaxxi modulazzjoni ta' molekoli ta' adeżjoni fis-superfiċje ta' ċelluli magħżula involuti fil-migrazzjoni ta' lewkoċiti u attività anti-anġjoġenika.
English: • There should be 3 types of treatment initiation forms and/or equivalent tool:
Maltese: • Għandu jkun hemm 3 tipi ta' formoli biex jinbeda t-trattament u/jew għodda ekwivalenti:
English: The melphalan recommended starting dose is 0.1 to 0.2 mg/kg daily according to bone marrow reserve along with a further 50 % dose reduction for moderate (creatinine clearance: ≥ 30 but < 50 mL/minute) or severe (CrCl: < 30 mL/minute) renal insufficiency.
Maltese: Id-doża tal-bidu rakkomandata ta' melphalan hi ta' 0.1 sa 0.2 mg/kg kuljum skont ir-riżerva tal-mudullun fil-linja bażi flimkien ma' tnaqqis addizzjonali tad-doża ta' 50 % għal insuffiċjenza renali moderata (tneħħija tal-kreatinina: ≥ 30 iżda < 50 mL/minuta) jew severa (CrCl: < 30 mL/minuta).
English: Viral infections, including herpes zoster and hepatitis B virus reactivation
Maltese: Infezzjonijiet virali, li jinkludu herpes zoster u l-attivazzjoni mill-ġdid tal-virus tal-epatite B†
English: Symptoms include paraesthesia, dysaesthesia, discomfort, abnormal co-ordination or weakness.
Maltese: Is-sintomi jinkludu paretesija, disestesija, skomfort, koordinazzjoni annormali u debbolezza.
English: Time from randomization ( month )
Maltese: Żmien mir-randomization (xhur)
English: A clear mechanism by which thalidomide can induce amenorrhea is not elucidated.
Maltese: Mekkaniżmu ċar li bih thalidomide jista' jinduċi l-amenorreja ma jistax jiġi spjegat.
English: A cumulative search of DRESS cases with thalidomide from spontaneous sources and clinical trials retrieved 8 cases among which 4 cases were assessed as probable or possible drug reaction with eosinophilia and systemic symptoms (DRESS) as per Regiscar criteria.
Maltese: Tiftixa kumulattiva tal-każijiet ta' DRESS b'thalidomide minn sorsi spontanji u provi kliniċi sabet 8 każijiet fost 4 każijiet li kienu evalwati bħal reazzjoni tal-mediċina b'eosinofilja u sintomi sistemiċi (DRESS) probabbli jew possibbli skont il-kriterji ta' Regiscar.