FrancophonIA/ELRC3.0 huggingface dataset:
English: Inhaled corticosteroid (ICS) medicinal products are widely used in the treatment of COPD, as a monocomponent or in combination with a long-acting beta2 adrenergic agonist (LABA).
Maltese: Prodotti mediċinali kortikosterojdi li jittieħdu man-nifs (ICS, inhaled corticosteroid) jintużaw b'mod wiesa' fil-kura ta' COPD, bħala mono-komponenti jew f'kombinazzjoni ma' agonista adrenerġiku beta2 li jaġixxi fit-tul (LABA).
English: Overall, due to the variability in the clinical data and multiple uncertainties with study methodologies, there is no conclusive clinical evidence for intra-class differences in the magnitude of the risk among inhaled corticosteroid products.
Maltese: B'mod ġenerali, minħabba l-varjabbiltà fid-data klinika u inċertezzi multipli b'metodoloġiji ta' studju, ma hemm ebda evidenza klinika konklussiva għal differenzi bejn klassi u oħra fid-daqs tar-riskju fost prodotti kortikosterojdi li jittieħdu man-nifs.
English: Although a number of common criticisms can be levelled at the studies included in these meta-analyses, including difficulties with the accurate identification of pneumonia (particularly pre-TORCH studies), variations in participant populations and comparators, differential withdrawal rates, and trials not specifically powered to detect pneumonia, a consistent association between ICS use and increased risk of pneumonia in COPD patients was seen across the meta-analyses.
Maltese: Għalkemm għadd ta' kritika komuni jistgħu jiġu diretti għall-istudji inklużi f'dawn ilmetaanaliżi, inkluż diffikultajiet bl-identifikazzjoni preċiża ta' pulmonite (b'mod partikolari studji qabel TORCH), varjazzjonijiet fil-popolazzjoniijet tal-parteċipanti u komparaturi, rati ta' rtirar differenzjali, u provi mhux mgħammra speċifikament biex jikxfu pulmonite, assoċjazzjoni konsistenti bejn l-użu ta' ICS u riskju miżjud ta' pulmonite f'pazjenti b'COPD intwerew tul il-metaanaliżi.
English: Some evidence suggests an increased risk of pneumonia with increasing steroid dose.
Maltese: Xi evidenza tissuġġerixxi riskju miżjud ta' pulmonite aktar ma tiżdied id-doża ta' sterodji.
English: Results from older meta-analyses and from observational studies were also variable, with some suggesting an increased risk of pneumonia with fluticasone compared to budesonide and others finding no difference.
Maltese: Riżultati minn metaanaliżi u minn studji ta' osservazzjona iktar antiki kienu varjabbli wkoll, b'uħud jissuġġerixxu riskju miżjud ta' pulmonite bi fluticasone meta mqabbel ma' budesonide u oħrajn ma sabu ebda differenza.
English: • The PRAC was of the view that the increased risk of pneumonia should be included in the product information of all ICS-containing products indicated in the treatment of COPD, with a warning for healthcare professionals and patients to remain vigilant for the possible development of pneumonia in patients with COPD, taking into consideration the overlap of the symptoms of pneumonia with those of exacerbation of COPD.
Maltese: • Il-PRAC kien tal-fehma li riskju miżjud ta' pulmonite għandu jiġi inkluż fl-informazzjoni dwar ilprodott tal-prodotti kollha li fihom ICS indikati fil-kura ta' COPD, bi twissija għall-professjonisti tal-kura tas-saħħa u għall-pazjenti sabiex jibqgħu viġilanti għall-iżvilupp possibbli ta' pulmonite f'pazjenti b'COPD, filwaqt li tiġi kkunsidrata s-sovrapożizzjoni tas-sintomi ta' pulmonite ma'
English: The PRAC therefore concluded that pneumonia (in COPD patients) should be added as a common adverse drug reaction in the product information of all ICS-containing products and that for products with an existing Risk Management Plan, “increased risk of pneumonia in COPD patients” should be considered an Important Identified Risk.
Maltese: Għaldaqstant, il-PRAC ikkonkluda li l-pulmonite (f'pazjenti b'COPD) għandha tiżdied bħala reazzjoni avversa komuni għall-mediċina fl-informazzjoni dwar il-prodott tal-prodotti kollha li fihom ICS u li għal prodotti bi Pjan ta' Ġestjoni tar-Riskji eżistenti, "riskju miżjud ta' pulmonite f'pazjenti b'COPD" għandu jitqies bħala Riskju Identifikat Importanti.
English: • The PRAC concluded that the evidence provided supports a causal association between the use of ICS-containing products and an increased risk of pneumonia in COPD patients;
Maltese: • Il-PRAC ikkonkluda li l-evidenza pprovduta tappoġġa assoċjazzjoni kawżali bejn l-użu ta' prodotti li fihom ICS u riskju miżjud ta' pulmonite f'pazjenti b'COPD;
English: On 27 April 2015 the European Commission therefore triggered a referral under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, and requested the PRAC to assess the impact of the above concerns on the benefit-risk balance of ICS containing medicinal products indicated in the treatment of COPD and to issue a recommendation on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.
Maltese: Għaldaqstant, fis-27 ta' April 2015, il-Kummissjoni Ewropea tat bidu għal riferiment skont l-Artikolu 31 tad-Direttiva 2001/83/KE bħala riżultat tad-data dwar ilfarmakoviġilanza, u talbet lill-PRAC biex jevalwa l-impatt tat-tħassib imsemmi hawn fuq dwar il-bilanċ tal-benefiċċju-riskju ta' prodotti mediċinali li fihom ICS indikati fil-kura ta' COPD u biex joħroġ rakkomandazzjoni dwar jekk l-awtorizzazzjonijiet għat-tqegħid fis-suq rilevanti għandhomx jinżammu, jiġu varjati, sospiżi jew revokati.
English: • The PRAC reviewed the data submitted by the marketing authorisation holders in relation to the increased risk of pneumonia in patients with COPD in association with ICS-containing medicinal products;
Maltese: • Il-PRAC irrieżamina d-data sottomessa mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fir-rigward tar-riskju miżjud ta' pulmonite f'pazjenti b'COPD f'assoċjazzjoni ma' prodotti mediċinali li fihom ICS;
English: Due to a paucity of data regarding the potential effects of other classes of medication prescribed for COPD, no conclusions could be drawn regarding the influence of concomitant medications on the risk of pneumonia in COPD patients.
Maltese: Minħabba l-għadd żgħir ta' data dwar l-effetti potenzjali ta' klassijiet oħrajn ta' medikazzjoni preskritta għal COPD, ma tista' tinstilet ebda konklużjoni dwar l-influwenza ta' medikazzjonijiet konkomittanti fuq ir-riskju ta' pulmonite f'pazjenti b'COPD.
English: Estimates based on the data provided suggest a patient exposure in the tens of millions across ICS as a class.
Maltese: Stimi bbażati fuq id-data pprovduta jissuġġerixxu esponiment tal-pazjent fl-għexieren ta' miljuni tul l-ICS bħala klassi.
English: Episodes of acute worsening of these symptoms (exacerbations) often occur.
Maltese: Spiss iseħħu episodji ta' aggravar akut ta' dawn issintomi (taħrix).
English: • attenuated feline panleucopenia virus (PLI IV).
Maltese: • virus attenwat tal-panlewkopenja felina (PLI IV).
English: Feline viral rhinotracheitis, feline panleucopenia (live attenuated) and feline calicivirosis (inactivated) vaccine
Maltese: Tilqima kontra r-rinotrakeite virali felina, il-panlewkopenja felina (ħajja attenwata) u l-kaliċivirożi felina (inattivata)
English: The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RCP on 23 February 2005.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Purevax RCP fit-23 ta' Frar 2005.
English: Other information about Purevax RCP:
Maltese: Informazzjoni oħra dwar Purevax RCP:
English: The effectiveness of Purevax RCP has been studied in several trials in laboratory conditions where cats were vaccinated and infected with virulent herpesvirus, calicivirus or parvovirus.
Maltese: L-effikaċja ta' Purevax RCP ġiet studjata f'diversi provi f'kundizzjonijiet tal-laboratorju fejn qtates ġew imlaqqma u infettati bil-virus tal-erpete virulenti, bil-kaliċivirus jew bil-parvovirus.
English: Purevax RCP is a veterinary vaccine that contains:
Maltese: Purevax RCP huwa tilqima veterinarja li fiha:
English: Purevax RCP is used to vaccinate cats from the age of 8 weeks against:
Maltese: Purevax RCP jintuża għat-tilqim tal-qtates mill-età ta' 8 ġimgħat kontra:
English: Purevax RCP is a vaccine.
Maltese: Purevax RCP huwa vaċċin.
English: In the field study of basic vaccination there was an increase in antibodies against feline rhinotracheitis herpesvirus, calicivirus infection, and feline panleucopenia viruses.
Maltese: Fl-istudju fuq il-post tat-tilqim bażiku kien hemm żieda fl-antikorpi kontra l-virus tal-erpete tar-rinotrakeite felina, l-infezzjoni tal-kaliċivirus, u l-virusis tal-panlewkopenja felina.
English: For a full list of the side-effects reported with Purevax RCP, see the package leaflet.
Maltese: Għal-lista sħiħa ta' effetti sekondarji rrappurtati bi Purevax RCP, ara l-fuljett ta' tagħrif.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax RCP exceed the risks for the approved indications and recommended that Purevax RCP be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Purevax RCP huma akbar mir-riskji għall-kura tal-indikazzjoni approvata u rrakkomanda li Purevax RCP jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: What is Purevax RCP?
Maltese: X'inhu Purevax RCP?
English: In the study looking at booster vaccination, antibody levels against rhinotracheitis herpesvirus, calicivirus infection and feline panleucopenia remained stable at a high level or increased slightly.
Maltese: Fl-istudju li eżamina t-tilqima booster, il-livelli ta' antikorpi kontra l-virus tal-erpete tar-rinotrakeite, l-infezzjoni bil-kaliċivirus u l-panlewkopenja felina baqgħu stabbli f'livell għoli jew żdiedu bi ftit.
English: • feline panleucopenia (a serious illness causing bloody diarrhoea caused by a parvovirus).
Maltese: • panlewkopenja felina (marda serja li tikkawża dijarea bid-demm ikkawżata minn parvovirus).
English: Why has Purevax RCP been approved?
Maltese: Għaliex ġie approvat Purevax RCP?
English: What is the risk associated with Purevax RCP?
Maltese: X'inhuwa r-riskju assoċjati ma' Purevax RCP?
English: Purevax RCP contains small amounts of weakened or killed viruses that cause feline rhinotracheitis, calicivirosis and panleucopenia.
Maltese: Purevax RCP fih ammonti żgħar ta' virusis imdgħajfa jew maqtula li jikkawżaw ir-rinotrakeite virali, il-kaliċivirosi u l-panlewkopenja tal-qtates.
English: In laboratory conditions Purevax RCP was demonstrated to provide protection against the diseases listed above.
Maltese: Fil-kundizzjonijiet tal-laboratorju Purevax RCP intwera li jipprovdi protezzjoni kontra l-mard elenkat hawn fuq.
English: How has Purevax RCP been studied?
Maltese: Kif ġie studjat Purevax RCP?
English: This is a summary of the European public assessment report.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni.
English: EMA/764301/2014 EMEA/H/C/001027
Maltese: EMEA/H/C/001027
English: It is available as tablets (30 mg).
Maltese: Jiġi bħala pilloli (30 mg).
English: The full EPAR for ellaOne can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is less than the 5.5% of women who would have been expected to become pregnant if they had not taken any contraceptive.
Maltese: Dan huwa anqas mill-5.5% tan-nisa li kienu mistennija li joħorġu tqal li kieku ma ħadu l-ebda kontraċettiv.
English: Other information about ellaOne:
Maltese: Informazzjoni oħra dwar ellaOne:
English: EPAR summary for the public ellaOne ulipristal acetate
Maltese: Sommarju tal-EPAR għall-pubbliku ellaOne ulipristal aċetat
English: In one main study, ellaOne was given to 1,533 women (aged on average 24 years) who had requested emergency contraception between two and five days after unprotected sex or contraceptive failure.
Maltese: Fi studju wieħed prinċipali, ellaOne ngħata lil 1,533 mara (ta' età bħala medja ta' 24 sena) li kienu talbu kontraċezzjoni ta' emerġenza bejn jumejn u ħamest ijiem wara sess mhux protett jew kontraċettiv li ma ħadimx.
English: Of the women who completed the main study, 2.1% (26 out of 1,241) became pregnant.
Maltese: Min-nisa li temmew l-istudju prinċipali, 2.1% (26 minn 1,241) ħarġu tqal.
English: This document is a summary of the European public assessment report (EPAR) for ellaOne.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal ellaOne.
English: The most common side effects with ellaOne are headache, nausea (feeling sick), abdominal pain (stomach ache) and dysmenorrhea (period pains).
Maltese: L-effetti sekondarji l-aktar komuni b'ellaOne huma wġigħ ta' ras, nawżja (dardir), uġigħ addominali (uġigħ ta' stonku) u dysmenorrea (uġigħ tal-period.
English: The active substance in ellaOne, ulipristal acetate, acts as a progesterone receptor modulator.
Maltese: Is-sustanza attiva f'ellaOne, l-ulipristal aċetat, taġixxi bħala modulatur tar-reċettur tal-proġesteron.
English: EllaOne is a medicine that contains the active substance ulipristal acetate.
Maltese: EllaOne huwa mediċina li fiha s-sustanza attiva ulipristal aċetat.
English: An additional study compared ellaOne with levonorgestrel (another medicine used in emergency contraception).
Maltese: Studju addizzjonali qabbel ellaOne ma' levonorgestrel (mediċina oħra użata f'kontraċezzjoni ta' emerġenza).
English: What is ellaOne?
Maltese: X'inhu ellaOne?
English: This number was then compared with the number of women who would have been expected to become pregnant if they had not taken a contraceptive.
Maltese: Dan innumru wara tqabbel man-numru ta' nisa li kienu mistennija li joħorġu tqal kieku ma ħadux kontraċettiv.
English: The European Commission granted a marketing authorisation valid throughout the European Union for ellaOne on 15 May 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal ellaOne validu fl-Unjoni Ewropea kollha fil-15 ta' Mejju 2009.
English: A risk management plan has been developed to ensure that ellaOne is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiżgura li ellaOne jintuża bl-aktar mod sigur possibbli.
English: EllaOne is a female emergency contraceptive to be taken within 120 hours (five days) of unprotected sex or contraceptive failure (such as a tear in a condom during sex).
Maltese: EllaOne huwa kontraċettiv ta' emerġenza għan-nisa li għandu jittieħed fi żmien 120 siegħa (ħamest ijiem) ta' sess mhux protett jew kontraċettiv li ma ħadimx (bħal toqba f'kondom waqt is-sess).
English: EllaOne was effective as an emergency contraceptive, reducing the number of unintended pregnancies.
Maltese: EllaOne kien effettiv bħala kontraċettiv ta' emerġenza, billi naqqas in-numru ta' tqala mhux maħsuba.
English: Why has ellaOne been approved?
Maltese: Għaliex ġie approvat ellaOne?
English: The sex hormone progesterone plays a role in the timing of ovulation and in preparing the lining of womb to receive the fertilised egg.
Maltese: L-ormon sesswali proġesteron għandu rwol waqt l-ovulazzjoni u fit-tħejjija tal-inforra tal-ġuf biex jirċievi l-bajda fertilizzata.
English: For pregnancy to occur there has to be ovulation (release of eggs) followed by the fertilisation of the egg (fusion with a sperm) and implantation in the womb.
Maltese: Biex ikun hemm tqala jrid ikun hemm ovulazzjoni (ir-rilaxx tal-bajd) segwita bil-fertilizzazzjoni talbajda (il-fużjoni ma' sperma) u impjantazzjoni fil-ġuf.
English: EllaOne is taken as one tablet by mouth as soon as possible, but no later than 120 hours, after unprotected sex or contraceptive failure.
Maltese: EllaOne jittieħed bħala pillola mill-ħalq malajr kemm jista' jkun, iżda mhux aktar tard minn 120 siegħa, wara sess mhux protett jew kontraċettiv li ma ħadimx.
English: What is the risk associated with ellaOne?
Maltese: Għal xiex jintuża ellaOne?
English: This number was calculated from published pregnancy rates.
Maltese: Dan in-numru kien ikkalkulat minn rati ta' tqala ppubblikati.
English: The CHMP decided that ellaOne's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' ellaOne huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: How has ellaOne been studied?
Maltese: Kif ġie studjat ellaOne?
English: Deaths: AZA = 82, CCR = 113
Maltese: AZA = 82, CCR = 113
English: Date of latest renewal: 13 November 2013
Maltese: Data tal-aħħar tiġdid: 13 ta' Novembru, 2013
English: KEY: AZA = azacitidine; CCR = conventional care regimens; CI = confidence interval;
Maltese: KEY: AZA = azacitidine; CCR = (conventional care regimens) korsijiet ta' kura konvenzjonali; CI = (confidence interval) intervall tal-kunfidenza;
English: (% of recommended starting dose)
Maltese: (% tad-doża tal-bidu rakkomandata)
English: Health- Related Quality of Life (HRQoL) was assessed using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
Maltese: Health-Related Quality of Life (HRQoL) ġiet evalwata bl-użu tal-European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
English: Laboratory tests
Maltese: Testijiet tal-laboratorju
English: Total dose (mg) = Dose (mg/m2) x BSA (m2)
Maltese: Doża totali (mg) = Doża (mg/m2) x BSA (m2)
English: Dose mg/m2
Maltese: Doża mg/m2
English: Cardiac events
Maltese: Avvenimenti kardijaċi
English: • The active substance is azacitidine.
Maltese: • Is-sustanza attiva hi azacitidine.
English: Incompatibilities
Maltese: Inkompatibilitajiet
English: UNIQUE IDENTIFIER - 2D BARCODE 2 D bar code carrying the unique identifier 18.
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D Barcode 2D li jkollu l-identifikatur uniku inkluż 18.
English: • Painful skin ulceration (pyoderma gangrenosum).
Maltese: • Ulċerazzjoni tal-ġilda bl-uġigħ (pyoderma gangrenosum).
English: HR = hazard ratio
Maltese: HR = (hazard ratio) proporzjon tal-periklu
English: Vidaza contains the active substance ‘azacitidine'.
Maltese: Vidaza fih is-sustanza attiva msejħa ‘azacitidine'.
English: Pack size: 1 vial
Maltese: Daqs tal-pakkett: kunjett 1
English: Winthontlaan 6 N 3526 KV Utrecht Netherlands
Maltese: Winthontlaan 6 N 3526 KV Utrecht L-Olanda
English: Adult population (MDS, CMML and AML [20-30% marrow blasts])
Maltese: Popolazzjoni adulta (MDS, CMML u AML [20-30% blasts tal-mudullun])
English: For clinical management of infectious adverse reactions, see section 4.8 Infections.
Maltese: Għal immaniġġjar kliniku ta' reazzjonijiet avversi infettivi, ara sezzjoni 4.8 Infezzjonijiet.
English: • Allergic (hypersensitivity) reaction.
Maltese: • Reazzjoni allerġika (sensittività eċċessiva).
English: Necrotising fasciitis
Maltese: Faxxite nekrotizzanti
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/488/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/08/488/001
English: • chronic myelomonocytic leukaemia (CMML).
Maltese: • lewkimja majelomonoċitika kronika (CMML).
English: Haematological toxicity
Maltese: Tossiċità ematoloġika
English: Azacitidine becomes incorporated into the genetic material of cells (ribonucleic acid (RNA) and deoxyribonucleic acid (DNA)).
Maltese: Azacitidine jinkorpora ruħu fil-materjal ġenetiku taċ-ċelluli (ribonucleic acid (RNA) u deoxyribonucleic acid (DNA)).
English: Cardiac and pulmonary disease
Maltese: Mard kardijaku u pulmonari
English: Pericarditis is the most reported PT (n=35 cases) followed by endocarditis (n=10) and myocarditis (n=9).
Maltese: Perikardite hija l-aktar Terminu Preferut irrappurtat (n=35 każ) segwit minn endokardite (n=10) u mijokardite (n=9).
English: • acute myeloid leukaemia (AML).
Maltese: • lewkimja majelojde akuta (AML).
English: 2 vials
Maltese: 2 kunjetti
English: In studies to assess inhibition of a series of P450 isoenzymes (CYP 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4) azacitidine up to 100 μM did not produce inhibition.
Maltese: Fi studji biex jevalwaw l-inibizzjoni ta' serje ta' isoenzimi ta' P450 (CYP 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 u 3A4) azacitidine sa 100 μM ma pproduċiex inibizzjoni.
English: Azacitidine undergoes spontaneous hydrolysis and deamination mediated by cytidine deaminase.
Maltese: Azacitidine jgħaddi minn idrolisi spontanja u deaminazzjoni medjata minn cytidine deaminase.
English: The effects of hepatic impairment (see section 4.2), gender, age, or race on the pharmacokinetics of azacitidine have not been formally studied.
Maltese: L-effetti ta' indeboliment epatiku (ara sezzjoni 4.2), sess, età, jew razza fuq il-farmakokinetika ta' azacitidine ma kinux studjati formalment.
English: One vial contains 100 mg azacitidine.
Maltese: Kull kunjett fih 100 mg azacitidine.
English: muscle spasms, myalgia
Maltese: spażmi fil-muskoli, majalġja
English: Breast-feeding (see section 4.6).
Maltese: Treddigħ (ara sezzjoni 4.6).
English: The Cox PH model adjusted for pre-specified baseline prognostic factors defined a HR for Vidaza versus CCR of 0.80 (95% CI= 0.66, 0.99; p = 0.0355).
Maltese: Il-mudell ta' Cox PH aġġustat għal fatturi pronjostiċi fil-linja bażi speċifikati minn qabel, iddefinixxew HR għal Vidaza kontra CCR ta' 0.80 (95% CI= 0.66, 0.99; p = 0.0355).
English: Adult population with MDS, CMML and AML (20-30% marrow blasts)
Maltese: Popolazzjoni adulta b'MDS, CMML u AML (20-30% blasts tal-mudullun)
English: APPROPRIATE
Maltese: RESPONSABBLI
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 December 2008
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 17 ta' Diċembru, 2008
English: Hypersensitivity
Maltese: Sensittività eċċessiva
English: 67.5 mg
Maltese: 67.5 mg kunjett 1
English: Time (months) from Randomization
Maltese: Żmien (xhur) mir-Randomization
English: • AML with >30% marrow blasts according to the WHO classification.
Maltese: • AML bi >30% ta' blasts tal-mudullun skont il-klassifikazzjoni tal-WHO.
English: • chronic myelomonocytic leukaemia (CMML) with 10-29 % marrow blasts without myeloproliferative disorder,
Maltese: • lewkimja majelomonoċitika kronika (CMML) b'10-29% ta' blasts tal-mudullun mingħajr disturb majeloproliferattiv,
English: LIST OF EXCIPIENTS Also contains mannitol.
Maltese: TA' EĊĊIPJENTI Fih ukoll mannitol.
English: Immune system disorders hypersensitivity reactions
Maltese: Disturbi fis-sistema immuni reazzjonijiet minħabba sensittività eċċessiva
English: Pharmacotherapeutic group: Antineoplastic agents, pyrimidine analogues; ATC code: L01BC07
Maltese: Sustanzi antineoplastiċi, analogi ta' pyrimidine; Kodiċi ATC:
English: Other less frequently reported serious adverse reactions in the azacitidine treatment arm included sepsis (5.1%), anaemia (4.2%), neutropenic sepsis (3.0%), urinary tract infection (3.0%), thrombocytopenia (2.5%), neutropenia (2.1%), cellulitis (2.1%), dizziness (2.1%) and dyspnoea (2.1%).
Maltese: Reazzjonijiet avversi serji oħrajn irrappurtati b'mod inqas frekwenti fil-parti tal-istudju dwar il-kura b'azacitidine kienu jinkludu sepsis (5.1%), anemija (4.2%), sepsis newtropenika (3.0%), infezzjoni fl-apparat urinarju (3.0%), tromboċitopenija (2.5%), newtropenija (2.1% ), ċellulite (2.1%), sturdament (2.1%) u dispnea (2.1%).
English: • intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International
Maltese: • sindromi majelodisplastiċi (MDS) intermedji-2 u ta' riskju għoli skont l-International
English: Foetal abnormalities during organogenesis in rats included: CNS anomalies (exencephaly/encephalocele), limb anomalies (micromelia, club foot, syndactyly, oligodactyly) and others (microphthalmia, micrognathia, gastroschisis, oedema, and rib abnormalities).
Maltese: Anormalitajiet fetali matul l-organoġenesi fil-firien kienu jinkludu: anomaliji tas-Sistema Nervuża Ċentrali (CNS) (exencephaly/enċefaloċele), anomaliji fir-riġlejn jew fid-dirgħajn (mikromelija, saqajn mgħawġa, syndactyly, oligodactyly) u oħrajn (mikroftalmija, mikrognatija, gastroschisis, edema, u anormalitajiet fil-kustilji).