FrancophonIA/ELRC3.0 huggingface dataset:
English: • The PRAC also concluded that in case of mild and/or self-limiting infections, the benefit of quinolones and fluoroquinolones treatment does not outweigh the overall risk related to the use of these medicinal products including serious risk of long-lasting, disabling and potentially irreversible adverse drug reactions.
Maltese: • Il-PRAC ikkonkluda wkoll li fil-każ ta' infezzjonijiet ħfief u/jew awtolimitanti, il-benefiċċju talkura bil-kinoloni u bil-fluworokinoloni ma jegħlibx ir-riskju ġenerali relatat mal-użu ta' dawn ilprodotti mediċinali inkluż ir-riskju serju ta' reazzjonijiet avversi fit-tul, debilitanti u potenzjalment irriversibbli għall-mediċina.
English: • Prevention of traveller's diarrhoea Preoperative preparations for chronic cholesteatomatous otitis and chronic otitis spreading to bone Septicaemia Selective decontamination of gastrointestinal tract in patients with compromised immune system Prevention of exacerbations in women with recurring urinary tract
Maltese: • Barra minn hekk, il-PRAC irrakkomanda tibdil għall-informazzjoni dwar il-prodott inkluż lindikazzjoni u twissijiet u prekawzjonijiet ulterjuri dwar l-użu relatati mar-reazzjonijiet avversi fit-tul, debilitanti u potenzjalment irriversibbli għall-mediċina.
English: • Simple uncomplicated acute cystitis
Maltese: • Ċistite akuta mhux ikkomplikata sempliċi
English: However, lack of symptoms relief and risk of complications (specifically pyelonephritis) have been found to be higher in non-antibiotic group.
Maltese: Madankollu, in-nuqqas ta' taffija tas-sintomi u r-riskju ta' komplikazzjonijiet (b'mod partikolari pajelonefrite) instabu li huma ogħla fil-grupp li ma ngħatax antibijotiċi.
English: It is also noted that these substances are not mentioned in any clinical guidelines and their place in the therapeutic armamentarium of urinary / genital / gastro-intestinal infections is not justified anymore.
Maltese: Ta' min jinnota wkoll li dawn is-sustanzi ma jissemmew f'ebda linja gwida klinika u posthom fil-lista ta' mediċini disponibbli għat-tobba (armamentarium) għal infezzjonijiet urinarji/ġenitali/gastrointestinali ma għadux ġustifikat.
English: Urethritis and cervicitis
Maltese: Konklużjonijiet xjentifiċi
English: Category 3: deletion of indications
Maltese: Kategorija 3: tneħħija ta' indikazzjonijiet
English: • The PRAC concluded that for patients with a serious infection that is susceptible to these antibiotics fluoroquinolones remain an important treatment option despite the very rare risk of long-lasting, disabling and potentially irreversible adverse reactions.
Maltese: • Il-PRAC ikkonkluda li għal pazjenti b'infezzjoni serja li hija suxxettibbli għal dawn l-antibijotiċi, il-fluworokinoloni jibqgħu għażla ta' kura importanti minkejja r-riskju rari ħafna ta' reazzjonijiet avversi fit-tul, debilitanti u potenzjalment irriversibbli.
English: Based on the increasing resistance of pathogenic microorganisms to (fluoro)quinolones, the association of (fluoro)quinolones with C. difficile-associated diarrhoea, their other well-known risks in addition to the risk of rare, nevertheless persistent and disabling ADRs, the benefit/risk balance of (fluoro)quinolones in the prophylaxis of travellers´ diarrhoea is considered negative.
Maltese: Difficile,, ir-riskji l-oħra magħrufa sew tagħhom flimkien mar-riskju ta' ADRs rari, madankollu persistenti u debilitanti, il-bilanċ bejn il-benefiċċju u r-riskju tal(fluworo)kinoloni fil-profilassi tad-dijarea tal-vjaġġaturi huwa meqjus negattiv.
English: No updated data (e.g. in relation to the current prevalence of resistance in Enterobacterales and other Gram-negative bacteria) are available regarding the antimicrobial activity of pefloxacin, as no clinical breakpoints were defined by EUCAST.
Maltese: Ma hemm l-ebda data aġġornata disponibbli (eż. fir-rigward tal-prevalenza attwali tar-reżistenza f'Enterobacteriales u f'batterji Gram-negattivi oħrajn) fir-rigward talattività antimikrobika ta' pefloksaċina, peress li l-EUCAST ma ddefinixxa l-ebda valur kritiku kliniku.
English: Uncomplicated cystitis
Maltese: Ċistite mhux ikkomplikata
English: Indication heading Vaginal infections Meningitis
Maltese: Infezzjoni f'pazjenti immunokompromessi
English: Taking into consideration the risk of long-lasting, disabling and potentially irreversible ADRs the benefit-risk balance of (fluoro)quinolones in the indication of prevention of exacerbations in women with recurring urinary tract infection is considered negative.
Maltese: Meta wieħed iqis ir-riskju ta' ADRs fit-tul, debilitanti u potenzjalment irriversibbli, il-bilanċ bejn il-benefiċċju u r-riskju ta' (fluworo)kinoloni fl-indikazzjoni tal-prevenzjoni ta' aggravar f'nisa b'infezzjonijiet urinarji rikorrenti huwa meqjus negattiv.
English: Malignant external otitis
Maltese: Otite esterna malinna
English: In majority of cases, otitis externa is caused by bacterial infection (Dibb 1991; Rosenfeld et al. 2014), however, also other causative agents such as fungal infection or non-infectious dermatologic processes should be considered.
Maltese: Rosenfeld et al. 2014), madankollu, għandhom jiġu kkunsidrati wkoll aġenti kawżattivi oħra bħal infezzjoni fungali jew proċessi dermatoloġiċi mhux infettivi.
English: Infective endocarditis is a severe and life-threatening disease associated with high mortality.
Maltese: L-endokardite infettiva hija marda severa u ta' periklu għall-ħajja assoċjata ma' mortalità għolja.
English: Generally, the most bronchial infections are of viral origin.
Maltese: Ġeneralment, il-maġġoranza tal-infezzjonijiet tal-bronki huma ta' oriġini virali.
English: The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for pefloxacin, lomefloxacin, ciprofloxacin, levofloxacin, ofloxacin, moxifloxacin, norfloxacin, prulifloxacin, rufloxacin.
Maltese: Il-PRAC ikkonkluda wkoll li l-bilanċ bejn il-benefiċċju u r-riskju tal-prodotti mediċinali li ġejjin li fihom il-kinoloni, l-aċidu nalidiksiku, l-aċidu pipemidiku, iċ-ċinoksaċina u l-flumekina ma għadux aktar favorevoli u għandhom jiġu sospiżi.
English: Indication heading
Maltese: Intestatura tal-indikazzjoni
English: • The PRAC concluded that some of the serious adverse drug reactions associated with the use of quinolones and fluoroquinolones could very rarely be long-lasting, disabling and potentially irreversible and that these risks are a class effect.
Maltese: • Il-PRAC ikkonkluda li wħud mir-reazzjonijiet avversi serji għall-mediċini assoċjati mal-użu talkinoloni u tal-fluworokinoloni, rarament jistgħu jkunu dejjiema, debilitanti u potenzjalment irriversibbli u li dawn ir-riskji huma effett tal-klassi.
English: The benefit of systemic antibiotic prophylaxis in general in the clean-contaminated ear surgery is currently not sufficiently substantiated and the benefit over topical antibiotics is not proven.
Maltese: Il-benefiċċju ta' profilassi b'antibijotiċi sistemiċi inġenerali f'kirurġija tal-widnejn f'każijiet fejn minkejja nuqqas ta' sinjali ta' infezzjoni hemm riskju kbir ta' infezzjoni (clean-contaminated) attwalment mhuwiex sostanzjat biżżejjed u l-benefiċċju fuq antibijotiċi topiċi ma ġiex ippruvat.
English: Indeed, due to their chemical structure and the related pharmacodynamic and pharmacokinetic profile (very narrow range of antibacterial activity, high minimal inhibitory concentrations) their benefit is limited based on the current available data.
Maltese: Tabilħaqq, minħabba l-istruttura kimika tagħhom u l-profil farmakodinamiku u farmakokinetiku relatat (firxa dejqa ħafna ta' attività antibatterika, konċentrazzjonijiet inibitorji minimi għoljin), abbażi tad-data attwalment disponibbli, il-benefiċċju tagħhom huwa limitat.
English: Based on the efficacy data, current treatment guideline, known risks related to the use of (fluoro)quinolones including disabling ADRs the PRAC considered that benefit-risk balance of (fluoro)quinolones in vaginitis is negative.
Maltese: ADRs debilitanti, il-PRAC qies li lbilanċ bejn il-benefiċċju u r-riskju ta' (fluworo)kinoloni) f'vaġinite huwa negattiv.
English: In addition, the PRAC considered the views of patient organisations, patients, families and carers, and the views of healthcare professionals in a public hearing.
Maltese: Barra minn hekk, il-PRAC qies il-fehmiet tal-organizzazzjonijiet tal-pazjenti, tal-pazjenti, tal-familji u ta' dawk li jieħdu ħsiebhom, u l-fehmiet tal-professjonisti fil-qasam tal-kura tas-saħħa waqt seduta pubblika.
English: Pharmaceutical Form
Maltese: 30 pillola
English: Name Strength Pharmaceutical Form Route of Administration
Maltese: Għamla farmaċewtika
English: The full EPAR for Stivarga 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: Stivarga is available as tablets (40 mg).
Maltese: Stivarga huwa disponibbli bħala pilloli (40 mg).
English: The active substance in Stivarga, regorafenib, is a ‘protein kinase inhibitor'.
Maltese: Is-sustanza attiva fi Stivarga, regorafenib, hija “inibitur ta' proteina kinażi”.
English: Other information about Stivarga
Maltese: Informazzjoni oħra dwar Stivarga
English: • hepatocellular carcinoma (HCC, a cancer of the liver).
Maltese: • karċinoma epatoċellulari (HCC, kanċer tal-fwied).
English: This is a summary of the European public assessment report (EPAR) for Stivarga.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta᾽ valutazzjoni (EPAR) għal Stivarga.
English: Why is Stivarga approved?
Maltese: Għaliex ġiet approvat Stivarga?
English: Stivarga is a cancer medicine that contains the active substance regorafenib.
Maltese: Stivarga huwa mediċina kontra l-kanċer li fih is-sustanza attiva regorafenib.
English: The most common side effects with Stivarga (which may affect more than 3 in 10 people) are pain, weakness, tiredness, loss of appetite and eating less, hand-foot syndrome (rash and numbness affecting the palms and soles), diarrhoea, infection and hypertension (high blood pressure).
Maltese: L-effetti sekondarji l-aktar komuni bi Stivarga (li jistgħu jaffettwaw aktar minn 3 persuni minn kull 10) huma uġigħ, dgħjufija, għeja, nuqqas ta' aptit u tnaqqis fit-teħid tal-ikel, is-sindrome tal-idejn u ssaqajn (raxx u tnemnim li jaffettwaw il-pali tal-idejn u l-qiegħ tas-saqajn), dijarea, infezzjoni u ipertensjoni (pressjoni tad-demm għolja).
English: The side effects of Stivarga are manageable.
Maltese: L-effetti sekondarji ta' Stivarga jistgħu jiġu mmaniġġjati.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Stivarga on 26 August 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Stivarga fis-26 ta' Awwissu 2013.
English: The most serious side effects are severe liver injury, bleeding, gastrointestinal perforation (development of a hole in the wall of the gut) and infection.
Maltese: L-effetti sekondarji l-aktar serji huma korriment sever talfwied, fsada, perforazzjoni gastrointestinali (żvilupp ta' toqba fil-ħajt tal-musrana) u infezzjoni.
English: In a main study involving 760 patients with metastatic colorectal cancer which had progressed after standard therapy, Stivarga was compared with placebo (a dummy treatment) and the main measure of effectiveness was overall survival (the length of time that patients lived).
Maltese: Fi studju ewlieni wieħed li fih ħadu sehem 760 pazjent b'kanċer metastatiku kolorettali li kien avvanza wara terapija standard, Stivarga tqabbel ma' plaċebo (kura finta) u l-kejl ewlieni tal-effikaċja kien issopravivenza globali (it-tul ta' żmien li l-pazjenti għexu).
English: What are the risks associated with Stivarga?
Maltese: X'inhuma r-riskji assoċjati ma' Stivarga?
English: It is taken in 4-week treatment cycles at a recommended starting dose of 160 mg (4 tablets) once every day for three weeks, followed by a week without taking the medicine.
Maltese: Jittieħed f'ċikli ta' kura ta' 4 ġimgħat f'doża rakkomandata tal-bidu ta' 160 mg (4 pilloli) darba kuljum għal tliet ġimgħat, segwit minn ġimgħa mingħajr il-mediċina.
English: However, given the side effects, the CHMP considered it important to find ways to identify any subgroups of patients who are more likely to respond to Stivarga.
Maltese: Il-kumpanija li tqiegħed Stivarga fis-suq se twettaq studji biex tfittex modi biex jiġu identifikati pazjenti li huma aktar probabbli li jirrispondu għall-kura.
English: The study showed that Stivarga increased the length of time that patients lived overall, with patients treated with Stivarga living for 10.6 months on average, compared with 7.8 months for those given placebo.
Maltese: L-istudju wera li Stivarga żied it-tul ta' żmien li b'mod ġenerali għexu l-pazjenti, bil-pazjenti kkurati bi Stivarga jgħixu medja ta' 10.6 xhur, meta mqabbla ma' 7.8 xhur għal dawk li ngħataw plaċebo.
English: The study showed that Stivarga improved survival, with treated patients living for 6.4 months on average, compared with 5 months for those given placebo.
Maltese: L-istudju wera li Stivarga tejjeb issopravivenza, b'pazjenti li rċevew kura jgħixu medja ta' 6.4 xhur, meta mqabbla ma' 5 xhur għal dawk li ngħataw plaċebo.
English: For colorectal cancer, these include chemotherapy based on medicines called fluoropyrimidines and treatment with other cancer medicines known as anti-VEGF and anti-EGFR therapies.
Maltese: Għall-kanċer kolorettali, dawn jinkludu kimoterapija bbażata fuq mediċini li jissejħu fluoropiramidini u l-kura b'mediċini oħra tal-kanċer magħrufa bħala terapjiji kontra l-VEGF u kontra lEGFR.
English: • gastrointestinal stromal tumour (GIST, a cancer of the stomach and bowel) that has spread or cannot be surgically removed;
Maltese: • tumur stromali gastrointestinali (GIST, kanċer fl-istonku u fil-musrana) li jkun infirex jew li ma jistax jitneħħa b'intervent kirurġiku;
English: In another main study, Stivarga was compared with placebo in 199 patients with GIST that had spread or was inoperable and who were also given best supportive care.
Maltese: Fi studju ewlieni ieħor, Stivarga tqabbel ma' plaċebo f'199 pazjent b'GIST li kien infirex jew li kien inoperabbli u li ngħataw ukoll l-aqwa kura ta' appoġġ.
English: In a main study involving 573 patients with HCC that had worsened after treatment with sorafenib, Stivarga was compared with placebo and the main measure of effectiveness was overall survival.
Maltese: Fi studju ewlieni wieħed li fih ħadu sehem 573 pazjent b'HCC li kien mar għall-agħar wara kura b'sorafenib, Stivarga tqabbel ma' plaċebo u l-kejl ewlieni tal-effikaċja kien is-sopravivenza globali.
English: Patients with GIST should have tried treatment with imatinib and sunitinib and patients with HCC should have tried sorafenib before starting treatment with Stivarga.
Maltese: Dan jispjega kif l-Aġenzija vvalutat il-mediċina biex tirrakkomanda l-awtorizzazzjoni tagħha fl-UE u lkondizzjonijiet ta' użu tagħha.
English: What measures are being taken to ensure the safe and effective use of Stivarga?
Maltese: X' miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Stivarga?
English: For the full list of all restrictions and side effects with Stivarga, see the package leaflet.
Maltese: Għal-lista sħiħa tar-restrizzjonijiet u tal-effetti sekondarji kollha b' Stivarga, ara l-fuljett ta' tagħrif.
English: • colorectal cancer (cancer of the bowel and rectum) that has spread to other parts of the body;
Maltese: • kanċer kolorettali (kanċer tal-musrana u r-rektum) li jkun infirex f'partijiet oħra tal-ġisem;
English: The European Medicines Agency decided that Stivarga's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li l-benefiċċji ta' Stivarga huma akbar mir-riskji tiegħu u rrakkomandat li jkun approvat għall-użu fl-UE.
English: Patients treated with Stivarga lived on average for 4.8 months without their disease getting worse compared with 0.9 months for patients taking placebo and supportive care.
Maltese: Il-pazjenti li ħadu l-kura bi Stivarga għexu medja ta' 4.8 xhur mingħajr ma l-marda tagħhom marret għall-agħar meta mqabbla ma' 0.9 xhur għall-pazjenti li ħadu plaċebo u kura ta' appoġġ.
English: EMA/335824/2014 EMEA/V/C/003680
Maltese: EMEA/V/C/003680
English: Versican Plus L4 is a veterinary vaccine that contains inactivated (killed) strains of Leptospira bacteria (Icterohaemorrhagiae, Canicola, Bratislava and Grippotyphosa).
Maltese: Versican Plus L4 huwa vaċċin veterinarju li fih ir-razez inattivati (maqtulin) ta' Leptospira bacteria (Icterohaemorrhagiae, Canicola, Bratislava u Grippotyphosa).
English: The effectiveness of Versican Plus L4 was investigated in a field study involving 129 dogs.
Maltese: L-effikaċja ta' Versican Plus L4 ġiet investigata fi studju fuq il-post li involva 129 kelb.
English: The field study showed that after vaccination with Versican Plus L4 the percentage of dogs with protective levels of antibodies for leptospira ranged from 59 to 96%.
Maltese: L-istudju fuq il-post wera li wara t-tilqima b'Versican Plus L4, il-perċentwal ta' klieb b'livelli protettivi ta' antikorpi għal leptospira varja minn 59 għal 96%.
English: Other information about Versican Plus L4:
Maltese: Informazzjoni oħra dwar Versican Plus L4:
English: Versican Plus L4 is used to protect dogs against leptospirosis, a bacterial disease that may be transmitted via infected urine and result in bleeding, hepatitis (inflammation of the liver) and jaundice or nephritis (kidney inflammation).
Maltese: Versican Plus L4 jintuża biex jipproteġi lil klieb kontra leptospirożi, marda batterjali li tista' tiġi trażmessa permezz ta' awrina infettata u tirriżulta fi fsada, epatite (infjammazzjoni tal-fwied) u suffejra jew nefrite (infjammazzjoni tal-kliewi).
English: The most common side effect (seen in more than 1 in 100 dogs) with Versican Plus L4 is a short lived swelling of up to 5 cm which may occur at the injection site after vaccination.
Maltese: L-effett sekondarju l-aktar komuni (li deher f'aktar minn kelb 1 minn kull 100) b'Versican Plus L4 kien nefħa għal żmien qasir ta' massimu ta' 5 cm li tista' sseħħ fis-sit tal-injezzjoni wara t-tilqima.
English: Versican Plus L4 is available as a suspension for injection.
Maltese: Versican Plus L4 jiġi bħala sospensjoni għal injezzjoni.
English: Versican Plus L4 contains an adjuvant (aluminium hydroxide) to enhance the immune response.
Maltese: Versican Plus L4 fih aġġuvant (aluminium hydroxide) biex itejjeb ir-rispons immunitarju.
English: Versican Plus L4 is a vaccine.
Maltese: Versican Plus L4 huwa vaċċin.
English: What is the risk associated with Versican Plus L4?
Maltese: X'inhu r-riskju assoċjat ma' Versican Plus L4?
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Versican Plus L4 exceed the risks for the approved indication and recommended that Versican Plus L4 be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Versican Plus L4 huma akbar mir-riskji għall-indikazzjoni approvata u rrakkomanda li Versican Plus L4 jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Versican Plus L4 on 31 July 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Versican Plus L4 fil-31 ta' Lulju 2014.
English: What is Versican Plus L4?
Maltese: X'inhu Versican Plus L4?
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Maltese: Il-bilanċ bejn il-benefiċċju-riskju jista' jinstab fil-modulu taddiskussjoni xjentifika ta' dan l-EPAR.
English: Why has Versican Plus L4 been approved?
Maltese: Għaliex ġie approvat Versican Plus L4?
English: The strains of Leptospira bacteria in Versican Plus L4 are killed (inactivated) so that they do not cause disease.
Maltese: Ir-razez tal-batterji ta' Leptospira f'Versican Plus L4 jinqatlu (jiġu inattivati) sabiex ma jikkawżawx il-marda.
English: ≥ 40 to < 50
Maltese: ≥ 40 sa < 50
English: * Medical Dictionary for Regulatory Activities (MedDRA) version 19.1.
Maltese: * Dizzjunarju Mediku għall-Attivitajiet Regolatorji (MedDRA) verżjoni 19.1.
English: Category
Maltese: Kategorija
English: Patients' MELD scores ranged from < 10 (37.5%), 10 to 14 (46.3%) and from > 14 to < 24 (16.2%), and included patients with CTP Class A (56.4%), Class B (38.1%), and Class C (5.6%).
Maltese: Il-punteġġi MELD tal-pazjenti varjaw minn < 10 (37.5%), 10 sa 14 (46.3%) u minn > 14 sa < 24 (16.2%), u inkludew pazjenti b'CTP Klassi A (56.4%), Klassi B (38.1%), u Klassi C (5.6%).
English: System organ class (MedDRA terminology*)
Maltese: (Terminoloġija ta' MedDRA*)
English: b Cochran-Mantel-Haenszel Test. c Wilcoxon Rank Sum Test.
Maltese: b Test Cochran-Mantel-Haenszel.
English: Date of first authorisation: 20 June 2019
Maltese: Data tal-ewwel awtorizzazzjoni: 20 ta 'Ġunju 2019
English: Thrombotic/thromboembolic events
Maltese: Avvenimenti trombotiċi/tromboemboliċi
English: Macrogol 3350 (E1521) Titanium dioxide (E171) Iron oxide yellow (E172)
Maltese: Macrogol 3350 (E1521) Titanium dioxide (E171)
English: Avatrombopag is not a substrate for OATP1B1, OATP1B3, OCT2, OAT1, and OAT3.
Maltese: Avatrombopag mhuwiex substrat għal OATP1B1, OATP1B3, OCT2, OAT1, u OAT3.
English: Pharmacotherapeutic group: Antihemorrhagics, other systemic hemostatics, ATC code: B02BX08
Maltese: Antiemorraġiċi, emostatiċi sistemiċi oħra, Kodiċi ATC: B02BX08 Mekkaniżmu ta' azzjoni
English: Lactose monohydrate Microcrystalline cellulose (E460(i)) Crospovidone type B (E1202) Silica, colloidal anhydrous (E551) Magnesium stearate (E470b)
Maltese: Lactose monohydrate Microcrystalline cellulose (E460(i)) Crospovidone tip B (E1202) Silica, colloidal anhydrous (E551) Magnesium stearate (E470b)
English: Racial or Ethnic Groups
Maltese: Gruppi ta' Razza jew Etniċi
English: - The active substance is avatrombopag.
Maltese: - Is-sustanza attiva hi avatrombopag.
English: Frequencies are defined as: very common (≥ 1/10); 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: Il-frekwenzi huma definiti bħala: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000).
English: Each film-coated tablet contains 120.8 mg of lactose monohydrate.
Maltese: Kull pillola miksija b'rita fiha 120.8 mg ta' lactose monohydrate.
English: Film coating: poly(vinyl alcohol) [E1203]; talc [E553b]; macrogol 3350 [E1521]; titanium dioxide [E171]; iron oxide yellow [E172].
Maltese: Kisja tar-rita: poly(vinyl alcohol) [E1203]; talc [E553b]; macrogol 3350 [E1521]; titanium dioxide [E171]; iron oxide yellow [E172].
English: Of the 88% of drug-related material in the faeces, 77% was identified as parent (34%) and the 4-hydroxy metabolite (44%).
Maltese: Mit-88% tal-materjal relatat mal-mediċina fl-ippurgar, 77% kien identifikat bħala l-ġenitur (34%) u l-metabolit 4-hydroxy (44%).
English: Doptelet 20 mg tablets avatrombopag
Maltese: Doptelet 20 mg pilloli avatrombopag
English: Platelet count (x109/L)
Maltese: Għadd tal-plejtlits (x109/L)
English: Adverse reactions are classified by Preferred Term and System Organ Class, and by frequency.
Maltese: Ir-reazzjonijiet avversi huma kklassifikati bit-Terminu Preferut u bis-Sistema tal-Klassifika tal-Organi,
English: Avatrombopag is a substrate for P-glycoprotein (P-gp) mediated transport (see Table 3).
Maltese: Avatrombopag huwa substrat għat-trasport medjat ta' P-glycoprotein (P-gp) (ara Tabella 3).
English: Tablet core: lactose monohydrate (see section 2 “Doptelet contains lactose”); microcrystalline cellulose [E460(i)]; crospovidone type B [E1202]; silica, colloidal anhydrous [E551]; magnesium stearate [E470b].
Maltese: Qalba tal-pillola: lactose monohydrate (ara sezzjoni 2 “Doptelet fih il-lactose”); microcrystalline cellulose [E460(i)]; crospovidone tip B [E1202]; silica, colloidal anhydrous [E551]; magnesium stearate [E470b].
English: Doptelet contains lactose (a type of sugar).
Maltese: Doptelet fih il-lactose (tip ta' zokkor).