FrancophonIA/ELRC3.0 huggingface dataset:
English: Since renal elimination plays a minor role in the clearance of Skilarence from plasma, it is unlikely that renal impairment would affect the pharmacokinetic characteristics, and so a need for dose adjustment in patients with mild to moderate renal impairment is not expected (see sections 4.2 and
Maltese: Peress li l-eliminazzjoni renali għandha rwol kbir fl-ikklirjar ta' Skilarence mill-plażma, mhuwiex probabbli li indeboliment renali jaffettwa l-karatteristiċi farmakokinetiċi u b'hekk mhuwiex mistenni li jkun hemm bżonn ta' aġġustament tad-doża f'pazjenti b'indeboliment renali ħafif sa moderat (ara sezzjonijiet 4.2 u 5.2).
English: Fanconi syndrome is a rare but serious kidney disorder which may occur with Skilarence.
Maltese: Is-sindrome ta' Fanconi hu disturb fil-kliewi rari iżda serju li jista' jsir bi Skilarence.
English: Patients who develop lymphopenia should be monitored for signs and symptoms of opportunistic infections, particularly for symptoms indicative of PML.
Maltese: Fil-każ ta' doża eċċessiva hija indikata kura sintomatika.
English: However, there was an increased number of foetuses with the variations “supernumerary liver lobe” and “abnormal iliac alignment” at maternally toxic doses.
Maltese: Madankollu, kien hemm numru ikbar ta' feti bil-varjazzjonijiet “lobu tal-fwied supernumerari” u “allinjament ilijaku anormali” b'dożi tossiċi għall-omm.
English: - Other medicines used to treat psoriasis, such as methotrexate, retinoids, psoralens, ciclosporin, or other immunosuppressants or cytostatics (medicines that affect the immune system).
Maltese: - Mediċini oħrajn użati għall-kura tal-psorijażi, bħal methotrexate, retinoids, psoralens, ciclosporin, jew immunosuppressanti jew ċitostatiċi oħrajn (mediċini li jaffettwaw is-sistema immuni).
English: You may not need the maximum dose of 720 mg per day.
Maltese: Jista' jkun li ma jkollokx bżonn id-doża massima ta' 720 mg kuljum.
English: *Additional adverse reactions reported with Fumaderm, a related medicinal product containing dimethyl fumarate along with other fumaric acid esters.
Maltese: *Reazzjonijiet allerġiċi addizzjonali rrappurtati b'Fumaderm, bi prodott mediċinali relatat li jkun fih dimethyl fumarate flimkien ma' esteri tal-aċidu fumariku oħrajn.
English: Prior and concomitant treatment with immunosuppressive or immunomodulating therapies Limited data are available on the efficacy and safety of Skilarence in patients who have been previously treated with other immunosuppressive or immunomodulating therapies.
Maltese: Hemm dejta limitata disponibbli dwar l-effikaċja u s-sigurtà ta' Skilarence f'pazjenti li qabel ġew ikkurati b'terapiji immunosuppressivi jew immunomodulatorji oħrajn.
English: Renal findings in dogs included minimal to moderate tubular hypertrophy, increased incidence and severity of tubular vacuolation and minimal to slight tubular degeneration, which were considered toxicologically relevant.
Maltese: Issejbiet renali fil-klieb kienu jinkludu ipertrofija tubulari minima sa moderata, żieda fl-inċidenza u sseverità tal-vakuolazzjoni tubulari u deġenerazzjoni tubulari minima sa ħafifa, li tqiesu tossikoloġikament relevanti.
English: Total daily dose
Maltese: Total f'ġurnata doża
English: The objectives of the educational programme are to inform health care professionals about the risk of serious infections, mainly opportunistic infections such as progressive multifocal leukoencephalopathy (PML), and to provide guidance on the monitoring of lymphocyte and leukocyte count abnormalities.
Maltese: L-objettivi tal-programm edukattiv huma li jinforma lill-professjonisti tal-kura tas-saħħa dwar ir-riskju ta' infezzjonijiet serji, prinċipalment infezzjonijiet opportunistiċi bħal lewkoenċefalopatija multifokali progressivi (progressive multifocal leukoencephalopathy, PML), u li jipprovdi gwida dwar ilmonitoraġġ tal-anormalitajiet tal-għadd tal-linfoċiti u l-lewkoċiti.
English: Rebound (defined as worsening of ≥125% of baseline PASI value) was assessed after 2 months off treatment and was shown not to be a clinical concern with fumaric acid esters, as it was documented in very few patients (Skilarence 1.1% and active comparator 2.2%, compared to 9.3% in the placebo group).
Maltese: Ġiet ivvalutata r-rikorrenza (definita bħala l-iggravar ta' ≥125 % tal-valur PASI fil-linja bażi) wara xahrejn mingħajr kura u ntwera li din mhijiex ta' tħassib kliniku b'esteri tal-aċidu fumariku, kif ġie ddokumentat f'verament ftit pazjenti (Skilarence 1.1 % u kumparatur attiv 2.2 %, meta mqabbel ma' 9.3 % fil-grupp tal-plaċebo).
English: How to store Skilarence
Maltese: DATA TA' SKADENZA
English: Abdominal distension* Abdominal pain Nausea
Maltese: Distensjoni fl-addome* Uġigħ fl-addome Dardir
English: Rare side effects (may affect up to 1 in 1,000 people): - allergic skin reaction
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa persuna f'1,000): - reazzjoni allerġika tal-ġilda
English: Dimethyl fumarate does not show any binding affinity to serum proteins which may further contribute to its rapid elimination from the circulation.
Maltese: Dimethyl fumarate ma juri ebda affinità ta' legar ma' proteini tas-seru li jistgħu jkomplu jikkontribwixxu għalleliminazzjoni rapida tiegħu fiċ-ċirkulazzjoni.
English: - constipation - gas (flatulence), stomach discomfort, indigestion - decreased appetite - headache - feeling tired - weakness - feeling hot - abnormal sensations of the skin, such as itching, burning, stinging, tickling or tingling - pink or red blotches on the skin (erythema)
Maltese: Madankollu, jekk int ikollok ħmura u jkollok kwalunkwe wieħed missinjali li ġejjin: - tħarħir, diffikultà biex tieħu nifs jew qtugħ ta' nifs, - nefħa fil-wiċċ, fix-xofftejn, fl-ħalq jew fl-ilsien waqqaf Skilarence u ċempel tabib minnufih.
English: Very common Very common Very common Very common Common Common Common Common
Maltese: Komuni ħafna Komuni ħafna Komuni ħafna Komuni ħafna Komuni Komuni Komuni Komuni Komuni
English: The most serious side effects that may occur with Skilarence are allergic or hypersensitivity reactions; kidney failure or a kidney disease called Fanconi syndrome; or a severe brain infection called progressive multifocal leukoencephalopathy (PML).
Maltese: L-aktar effetti sekondarji serji li jistgħu jseħħu bi Skilarence huma reazzjonijiet allerġiċi jew ta' sensittività eċċessiva; insuffiċjenza renali jew marda tal-kliewi li tissejjaħ sindrome ta' Fanconi; jew infezzjoni severa fil-moħħ li tissejjaħ lewkoenċefalopatija multifokali progressiva (PML).
English: Uncommon side effects (may affect up to 1 in 100 people): - dizziness - excess protein in the urine (proteinuria) - increase in serum creatinine (a substance in the blood used for measuring how well your kidneys are working)
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna f'100): - sturdament - proteina eċċessiva fl-urina (proteinurja) - żieda fil-kreatinina fis-seru (sustanza fid-demm li tintuża biex tkejjel kemm qed jaħdmu tajjeb il-kliewi tiegħek)
English: The efficacy of oral contraceptives may be reduced and the use of an alternative barrier contraceptive method is recommended to prevent possible failure of contraception (see the prescribing information of the oral contraceptive).
Maltese: L-effikaċja tal-kontraċettivi orali tista' titnaqqas u huwa rakkomandat l-użu ta' metodu kontraċettiv ta' lqugħ alternattiv sabiex jipprevjeni l-possibbiltà li l-kontraċettiv ma jaħdimx (ara l-informazzjoni tal-preskrizzjoni talkontraċettiv orali).
English: The kidney was identified as a major target organ of toxicity in non-clinical studies.
Maltese: Il-kilwa ġiet identifikata bħala organiku primarjament fil-mira tat-tossiċità fi studji mhux kliniċi.
English: In vitro studies have shown that hydrolysis of dimethyl fumarate to monomethyl fumarate occurs rapidly at pH 8 (pH in the small intestine), but not at pH 1 (pH in the stomach).
Maltese: L-istudju in vitro wrew li l-idroliżi ta' dimethyl fumarate għal monomethyl fumarate sseħħ malajr f'pH 8 (pH fl-intestina ż-żgħira), iżda mhux f'pH 1 (pH fl-istonku).
English: Blood sampling for safety clinical laboratory tests at follow-up visits was only performed in case of abnormalities at the preceeding visit.
Maltese: Il-kampjunar tad-demm għal testijiet tal-laboratorji kliniċi tas-sigurtà fil-visti ta' segwitu twettaq biss f'każ ta' anormalitajiet fil-vista preċedenti.
English: Consumption of large quantities of strong alcoholic drinks (more than 30% alcohol by volume) should be avoided because it may lead to increased dissolution rates of Skilarence and, therefore, may increase the frequency of gastrointestinal adverse reactions.
Maltese: Għandu jiġi evitat il-konsum ta' kwantitajiet kbar ta' xarbiet alkoħoliċi qawwija (aktar minn volum ta' alkoħol ta' 30 %) għax dan jista' jwassal għal rati ta' tidwib miżjuda ta' Skilarence, u għalhekk, jista' jżid il-frekwenza ta' reazzjonijiet avversi gastrointestinali.
English: Dizziness*
Maltese: Sturdament*
English: PGA score clear or almost clear, n (%) p-value a a
Maltese: Punteġġ tal-PGA kklirjat jew kważi kklirjat, n (%) valur-p a a
English: In patients experiencing diarrhoea during Skilarence treatment, the effect of oral contraceptives may be reduced and additional barrier methods of contraception may be necessary (see section 4.5).
Maltese: F'pazjenti li jesperjenzaw dijarea waqt kura bi Skilarence, l-effett tal-kontraċettivi orali jista' jonqos u jistgħu jkunu neċessarji metodi ta' kontraċezzjoni ta' lqugħ addizzjonali (ara sezzjoni 4.5).
English: In the third week, Skilarence 30 mg is taken three times daily (1 tablet in the morning, 1 at midday, and 1 in the evening).
Maltese: Fit-tielet ġimgħa, Skilarence 30 mg jittieħed tliet darbiet kuljum (pillola waħda filgħodu, waħda f'nofsinhar u waħda filgħaxija).
English: The risk of vaccination should be weighed against the benefit.
Maltese: Ir-riskju ta' tilqim għandu jiġi mwieżen kontra l-benefiċċju.
English: Dose
Maltese: Remettar
English: Treatment should not be initiated if leukopenia below 3.0x10
Maltese: Il-kura ma għandhiex tinbeda jekk tiġi identifikata lewkopenija taħt 3.0x10
English: Each gastro-resistant tablet contains 120 mg dimethyl fumarate.
Maltese: Kull pillola gastroreżistenti fiha 120 mg dimethyl fumarate.
English: Lymphopenia
Maltese: Linfopenija
English: Summary of clinical efficacy after 16 weeks treatment in Study 1102 Assessment
Maltese: Sommarju tal-effikaċja klinika wara 16-il ġimgħa kura fl-Istudju 1102 Valutazzjoni
English: The anti-inflammatory and immunomodulating effects of dimethyl fumarate and its metabolite monomethyl fumarate are not fully elucidated but are thought to be mainly due to the interaction with the intracellular reduced glutathione of cells directly involved in the pathogenesis of psoriasis.
Maltese: L-effetti antiinfjammatorji u immunomodulatorji tal-dimethyl fumarate u l-metabolit tiegħu monomethyl fumarate mhumiex mifhuma għal kollox iżda huwa masħub li huma dovuti l-iktar għallinterazzjoni mal-glutatjon imnaqqas intraċellulari taċ-ċelloli direttament involuti fil-patoġenesi talpsorijażi.
English: Skilarence contains lactose.
Maltese: Skilarence fih il-lattożju.
English: Very rare side effects (may affect up to 1 in 10,000 people): - acute lymphatic leukaemia (a type of blood cancer) - decrease in all types of blood cells (pancytopenia)
Maltese: Effetti sekondarji rari ħafna (jistgħu jaffettwaw sa persuna f'10,000): - lewkimja linfatika akuta (tip ta' kanċer fid-demm) - tnaqqis fit-tipi kollha ta' ċelloli tad-demm (panċitopenija)
English: Dimethyl fumarate works on cells of the immune system (the body's natural defences).
Maltese: Dimethyl fumarate taħdem fuq iċ-ċelluli tas-sistema immuni (id-difiżi naturali tal-ġisem).
English: The biotransformation of dimethyl fumarate does not involve cytochrome P450 isoenzymes.
Maltese: Hemm dejta limitata mill-użu ta' dimethyl fumarate f'nisa tqal.
English: Each gastro-resistant tablet contains 30 mg dimethyl fumarate.
Maltese: Kull pillola gastroreżistenti fiha 30 mg dimethyl fumarate.
English: If you notice you are passing more urine, are more thirsty and drinking more than normal, your muscles seem weaker, you break a bone, or just have aches and pains, talk to your doctor as soon as possible so that this can be investigated further.
Maltese: Jekk tinnota li qed tgħaddi aktar awrina, qed tkun aktar bl-għatx jew qed tixrob aktar min-normal, il-muskoli tiegħek jidhru aktar dgħajfa, tikser għadma, jew sempliċiment għandek uġigħ, kellem lit-tabib tiegħek malajr kemm jista' jkun sabiex dan ikun jista' jiġi investigat aktar.
English: A part of the total dimethyl fumarate is hydrolysed by esterases and the alkaline milieu of the small intestine, while the remainder enters the portal vein blood.
Maltese: Parti minn dimethyl fumarate totali tiġi idrolizzata mill-esterasi u l-milieu alkalin tal-intestin iż-żgħir, filwaqt li l-bqija tidħol fiddemm tal-vina portali.
English: Dosage modifications may also be necessary if abnormalities in laboratory parameters are observed (see section 4.4).
Maltese: Jista' jkun hemm bżonn li jsiru modifiki fid-dożaġġ anki jekk jiġu osservati anormalitajiet filparametri tal-laboratorju (ara sezzjoni 4.4).
English: Evening of dimethyl fumarate
Maltese: Id-doża totali f'ġurnata (mg) ta' dimethyl fumarate
English: In the clinical study a total of 20.8% of patients receiving Skilarence experienced flushing, which was mild in the majority of cases (see section 4.4).
Maltese: Fl-istudju kliniku, total ta' 20.8 % tal-pazjenti li kienu qed jirċevu Skilarence esperjenzaw fwawar li fil-maġġoranza tal-każijiet kienu ħfief (ara sezzjoni 4.4).
English: In particular, in the clinical study there was a slight decrease in mean lymphocyte counts starting between weeks 3 and 5 and reaching a maximum in week 12 where approximately one third of patients had lymphocyte values below 1.0x10
Maltese: B'mod partikolari, fl-istudju kliniku kien hemm tnaqqis żgħir fl-għadd medju ta' linfoċiti li jibda bejn ġimgħat 3 u 5 u jilħaq massimu f'ġimgħa 12 fejn madwar terz tal-pazjenti kellhom valuri ta' limfoċiti taħt 1.0x10
English: Avoid strong alcoholic drinks (more than 50 ml of spirits containing more than 30% alcohol by volume) during treatment with Skilarence, as alcohol can interact with this medicine.
Maltese: Evita xarbiet alkoħoliċi qawwija (aktar minn 50 ml ta' spirti li jkun fihom aktar minn volum ta' 30 % ta' alkoħol) waqt il-kura bi Skilarence, peress li l-alkoħol jista' jinteraġixxi ma' din il-mediċina.
English: Clinical studies of Skilarence did not include sufficient numbers of patients aged 65 years and above to determine whether they respond differently compared to patients under 65 years (see section 5.2).
Maltese: L-istudji kliniċi ta' Skilarence ma kienx fihom numri kbar biżżejjed ta' pazjenti li għandhom 65 sena jew aktar biex jiġi stabbilit jekk ikollhomx rispons differenti meta mqabbel ma' pazjenti li għandhom inqas minn 65 sena (ara sezzjoni 5.2).
English: For the total leukocyte count, a decline became apparent at week 12 of treatment; it slowly increased again at week 16 (end of treatment); and 12 months after stopping treatment all patients had values above 3.0x10
Maltese: Għall-għadd totali ta' lewkoċiti, tnaqqis sar apparenti f'ġimgħa 12 tal-kura; dan żdied bil-mod f'ġimgħa 16 (tmiem il-kura); u 12-il xahar wara t-twaqqif tal-kura, il-pazjenti kollha kellhom valuri ta' 'l fuq minn 3.0x10
English: Patients began treatment with tablets containing 30 mg/day dimethyl fumarate or placebo, titrating up to a maximum of 720 mg/day in both active treatment arms as described in section 4.2.
Maltese: Il-pazjenti bdew il-kura bil-pilloli li fihom 30 mg/jum dimethyl fumarate jew bi plaċebo, b'titrazzjoni sa massimu ta' 720 mg/jum fiż-żewġ fergħat ta' kura attiva kif deskritt fis-sezzjoni 4.2.
English: The portion of dimethyl fumarate that reacts with glutathione, forming a glutathione-adduct, is metabolised further to its mercapturic acid, which is excreted in the urine.
Maltese: Il-porzjon ta' dimethyl fumarate li jirreaġixxi mal-glutatjon, li jifforma addott tal-glutatjon, jiġi metabolizzat iktar għall-aċidu merkapturiku tiegħu, li jitneħħa mal-urina.
English: 9/L, then treatment must be stopped immediately.
Maltese: 9/L , il-kura mbagħad għandha titwaqqaf immedjatament.
English: - Severe hepatic or renal impairment.
Maltese: − Indeboliment epatiku jew renali sever.
English: Hepatic enzymes increased Serum creatinine increased*
Maltese: Żieda fl-enzimi epatiċi Żieda fil-kreatinina fis-seru*
English: OTHER
Maltese: b
English: Most patients had moderate psoriasis based on Psoriasis Area and Severity Index (PASI) and Physician's Global Assessment (PGA) scores at baseline: the mean PASI score at baseline was 16.35 and 60% of patients scored as moderate on the PGA.
Maltese: Ħafna mill-pazjenti kellhom psorijażi moderata bbażata fuq ilpunteġġi tal-Indiċi tal-Erja u S-Severità tal-Psorijażi (PASI) u tal-Valutazzjoni Globali tat-Tabib (PGA) fix-xenarju bażi: il-punteġġ PASI medjan fix-xenarju bażi kien ta' 16.35 u 60% tal-pazjenti rriżultaw moderati fuq il-PGA. Il-maġġoranza tal-pazjenti rrapportat effett “kbir ħafna” jew “enormi” tal-psorijażi fuq ħajjitha fuq il-bażi tal-Indiċi tal-Kwalità tal-Ħajja Dermatoloġika (DLQI), b'punteġġ medjan tad-DLQI ta' 11.5.
English: Common side effects (may affect up to 1 in 10 people): - increase in all white blood cells (leukocytosis) - increase in specific white blood cells called eosinophils - increase in certain enzymes in the blood (used for checking the health of your liver) - being sick
Maltese: Effetti sekondarji komuni ħafna (jistgħu jaffettwaw iktar minn persuna f'10): - tnaqqis f'ċelloli bojod tad-demm imsejħin linfoċiti (linfopenija) - tnaqqis f'ċelloli bojod tad-demm kollha (lewkopenija) - ħmura tal-wiċċ jew tal-ġisem (vampati)
English: Skilarence contains lactose
Maltese: Skilarence fih il-lattożju
English: EMA/440995/2017 EMEA/H/C/003934
Maltese: 1-antitrypsin) EMA/440995/2017
English: What is Infinia?
Maltese: X'inhu Infinia?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21 July 2017
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21 ta' Lulju 2017 EMA/440995/2017 EMEA/H/C/003934
English: The active substance in Infinia, alpha-1-antitrypsin, is a protein in the blood which protects lung tissue from damage.
Maltese: Is-sustanza attiva f'Infinia, ll-alpha-1-antitrypsin, hija proteina fid-demm li tipproteġi t-tessut talpulmun mill-ħsara.
English: Infinia was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 16 November 2004 for the treatment of emphysema due to congenital alpha-1-antitrypsin deficiency.
Maltese: Infinia kien ikklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fis16 ta' Novembru 2004 għall-kura ta' emfiżema minħabba defiċjenza konġenitali ta' alpha-1-antitrypsin.
English: Infinia is a medicine containing the active substance alpha-1-antitrypsin (also known as alpha1proteinase inhibitor).
Maltese: Infinia huwa mediċina li fih is-sustanza attiva alpha-1-antitrypsin (magħrufa wkoll bħala inibitur ta' alpha1-proteinase).
English: On 21 June 2017, Kamada BioPharma Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Infinia, for the treatment of adults with lung disease due to congenital deficiency of alpha-1antitrypsin.
Maltese: Fil-21 ta' Ġunju 2017, Kamada BioPharma Limited għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni tagħha għall-awtorizzazzjoni għat-tqegħid fis-suq għal Infinia, għall-kura ta' adulti b'marda tal-pulmun minħabba defiċjenza konġenitali ta' alpha-1-antitrypsin.
English: What was Infinia expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Infinia?
English: The company presented results of a main study in 168 patients looking at the effects of the medicine on exacerbations (sudden worsening of symptoms) of the disease.
Maltese: Il-kumpanija ppreżentat riżultati ta' studju ewlieni f'168 pazjent li jħares lejn l-effetti tal-mediċina fuq l-aggravar (aggravar f'daqqa tas-sintomi) tal-marda.
English: Other medicines containing alpha-1-antitrypsin are authorised in the EU for the same disease but are given as an infusion (drip) into a vein.
Maltese: Mediċini oħra li fihom alpha-1-antitrypsin huma awtorizzati fl-UE għall-istess marda iżda jingħataw bħala infużjoni (dripp) ġo vina.
English: Withdrawal of the marketing authorisation application for Infinia (alpha-1-antitrypsin)
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għattqegħid fis-suq għal Infinia (alpha-1-antitrypsin)
English: The medicine was expected to be used for treating lung disease in adults with congenital (inborn) deficiency of alpha-1-antitrypsin.
Maltese: Il-mediċina kienet mistennija li tintuża biex tikkura marda tal-pulmun fl-adulti b'defiċjenza konġenitali (li titwieled biha) ta' alpha-1-antitrypsin.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Infinia could not have been approved for the treatment of adults with lung disease due to congenital deficiency of alpha-1-antitrypsin.
Maltese: Abbażi tar-rieżami tad-data, fiż-żmien tal-irtirar, is-CHMP kellu xi tħassib u kien tal-fehma provviżorja li Infinia ma setax jiġi approvat għall-kura ta' adulti b'marda tal-pulmun minħabba defiċjenza konġenitali ta' alpha-1-antitrypsin.
English: There were also concerns that patients taking Infinia may produce antibodies against it which could reduce its effects or make patients more prone to allergic reactions.
Maltese: Kien hemm ukoll tħassib li l-pazjenti li jkunu qed jieħdu Infinia jistgħu jipproduċu antikorpi kontriha li jistgħu jnaqqsu l-effetti tagħha jew jagħmlu lill-pazjenti aktar suxxettibbli għal reazzjonijiet allerġiċi.
English: In addition, there were concerns about the tolerability and safety profile of the medicine, since patients who were taking Infinia had to stop treatment due to side effects more often than patients taking placebo.
Maltese: Barra minn hekk, kien hemm tħassib dwar il-profil tat-tollerabbiltà u tas-sigurtà tal-mediċina, peress li lpazjenti li kienu qed jieħdu Infinia kellhom iwaqqfu l-kura minħabba effetti sekondarji aktar ta' spiss minn ta' pazjenti li kienu qed jieħdu l-plaċebo.
English: Zoely is a contraceptive pill.
Maltese: Zoely huwa pillola kontraċettiva.
English: The full EPAR for Zoely 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: Zoely nomegestrol acetate / estradiol
Maltese: Zoely aċetat tan-nomegestrolu / estradijolu
English: Other information about Zoely
Maltese: Informazzjoni oħra dwar Zoely
English: Zoely was investigated in two main studies involving a total of 4,433 women aged 18 to 50 years old.
Maltese: Zoely kien investigat f'żewġ studji ewlenin li fihom ħadu sehem total ta' 4,433 mara bejn it-18 u l-50 sena.
English: Zoely is a medicine available as 24 white ‘active' tablets that contain the active substances nomegestrol acetate (2.5 mg) and estradiol (1.5 mg), and four yellow ‘inactive' (placebo) tablets that do not contain any active substance.
Maltese: Zoely huwa mediċina li tiġi bħala 24 pillola bajda ‘attiva' li fiha s-sustanzi attivi aċetat tan-nomegestrolu (2.5 mg) u estradijolu (1.5 mg), u erba' pilloli sofor ‘inattivi' (plaċebo) li ma fihom l-ebda s-sustanza attiva.
English: In women aged 18 to 35, the Pearl Index was around 0.4 with Zoely and 0.8 with the comparator medicine in the first study, and around 1.2 with Zoely and 1.9 with the comparator medicine in the second study.
Maltese: F'nisa ta' bejn it-18 u l-35 sena, l-Indiċi Pearl kien ta' madwar 0.4 b'Zoely u ta' 0.8 bil-mediċina komparatur fl-ewwel studju, u madwar 1.2 b'Zoely u 1.9 bil-mediċina komparatur fit-tieni studju.
English: This is a summary of the European public assessment report (EPAR) for Zoely.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Zoely.