FrancophonIA/ELRC3.0 huggingface dataset:
English: It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors in various types of immune cell.
Maltese: Din taħdem simili għall-ormoni corticosteroid li jokkorru b'mod naturali, billi tnaqqas l-attività tas-sistema immunitarja permezz tattwaħħal ta' riċetturi f'tipi varji ta' ċelloli immunitarji.
English: Alisade was compared with placebo (a dummy treatment) in six main studies involving almost 2,500 patients.
Maltese: Alisade tqabbel ma' plaċebo (trattament finta) f'sitt studji ewlenin li involvew 2,500 pazjent.
English: The first four studies looked at Alisade used in patients aged 12 years or over: three were short-term studies lasting two weeks and involved a total of 886 patients with seasonal allergic rhinitis (hay fever), while the fourth lasted four weeks and involved 302 patients with perennial (nonseasonal) allergies, such as allergies to animals.
Maltese: Tliet studji qosra li damu tliet ġimgħat involvew total ta' 886 pazjent b'rinite allerġika staġjonali (riħ tal-ħuxlief), filwaqt li rraba' studju dam erba' ġimgħat u involva 302 pazjenti b'allerġiji (mhux staġjonali) perenni, bħalma huma l-allerġiji għall-annimali.
English: Why has Alisade been approved?
Maltese: Għaliex ġie approvat Alisade?
English: How has Alisade been studied?
Maltese: Kif ġie studjat Alisade?
English: Alisade is a nasal spray that contains the active substance fluticasone furoate.
Maltese: Alisade huwa sprejj li jintuża fl-imnieħer li fih is-sustanza attiva fluticasone furoate.
English: The most common side effect with Alisade (seen in more than 1 patient in 10) is epistaxis (nosebleeds).
Maltese: L-aktar effett sekondarju komuni b'Alisade (li deher f'iktar minn pazjent 1 minn 10) hu epistasi (fġir mill-imnieħer).
English: What is Alisade?
Maltese: X'inhu Alisade?
English: Alisade is used to treat the symptoms of allergic rhinitis.
Maltese: Alisade jintuża fit-trattament ta' sintomi ta' rinite allerġika.
English: The name of the medicine was changed to Alisade on 25 March 2009.
Maltese: L-isem tal-mediċina nbidel għal Alisade fil-25 ta' Marzu 2009.
English: This authorisation was based on the authorisation granted to Avamys in January 2008 (‘informed consent').
Maltese: Din l-awtorizzazzjoni kienet ibbażata fuq l-awtorizzazzjoni mogħtija lil Avamys f'Jannar 2008 (‘kunsens infurmat').
English: However, it was not possible to determine if Alisade worked in children below the age of six years, because there were too few children below this age included the studies.
Maltese: Madanakollu, ma kienx possibbli jkun magħruf jekk Alisade ħadimx fit-tfal taħt is-sitt snin, minħabba li kien hemm ftit wisq tfal ta' din l-età inklużi flistudju.
English: In the study of perennial allergic rhinitis, Alisade had reduced scores by 3.6 points after four weeks, compared with a reduction of 2.8 points with placebo.
Maltese: Fl-istudju tar-rinite allerġika perenni, Alisade naqqas l-iskor ta' punti minn 3.6 wara erba' ġimgħat, meta mqabbel ma' tnaqqis ta' 2.8 bi plaċebo.
English: The other two studies were carried out in children aged between two and 11 years: the first involved 558 children with perennial allergic rhinitis and the second involved 554 children with seasonal allergic rhinitis.
Maltese: Iż-żewġ studji l-oħra ffukaw fuq it-tfal ta' bejn is-sentejn u l-ħdax-il sena: l-ewwel wieħed involva 558 tifel u tifla b'rinite allerġika perenni u t-tieni studju involva 554 tifel u tifla b'rinite allerġika staġjonali.
English: The lowest effective dose that keeps symptoms controlled should be used.
Maltese: Għandha tintuża l-inqas doża effettiva li tikkontrolla s-sintomi.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Alisade's benefits are greater than its risks for the treatment of the symptoms of allergic rhinitis in patients aged six years or over.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Alisade huma akbar mir-riskji għat-trattament tas-sintomi ta' rinite allerġika f'pazjenti minn sitt snin 'il fuq.
English: For the full list of all side effects reported with Alisade, see the Package Leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati b'Alisade, ara lFuljett ta' Tagħrif.
English: This is generally mild or moderate and tends to affect adults who have used Alisade for more than six weeks.
Maltese: Dan ġeneralment ikun ħafif jew moderat u hemm tendenza li jaffettwa l-adulti li użaw Alisade għal iktar minn sitt ġimgħat.
English: Alisade was more effective than placebo at reducing symptoms of allergic rhinitis in patients aged six years and over.
Maltese: Sabiex jinkseb l-aħjar riżultat mill-mediċina, din għandha tintuża regolarment u fl-istess ħin kuljum.
English: What benefit has Alisade shown during the studies?
Maltese: Liema benefiċċju wera Alisade waqt l-istudji mwettqa?
English: This leads to a reduction the release of substances that are involved in the inflammation process, such as histamine, reducing the symptoms of allergy.
Maltese: Dan iwassal għal tnaqqis fir-rilaxx ta' sustanzi li huma involuti fil-proċess ta' fjammazzjoni, bħalma huma l-istamine, u tnaqqas is-sintomi ta' allerġija.
English: What is the risk associated with Alisade?
Maltese: Għalxiex jintuża Alisade?
English: It is often accompanied by symptoms affecting the eyes, such as irritation, watering or redness.
Maltese: Din hija l-infjammazzjoni tal-imnifsejn ikkawżata minn allerġija, u twassal għal riħ, imnieħer miżdud, irritazzjoni u għatis.
English: The effects of Alisade were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Alisade kienu ttestjati l-ewwel f'mudelli sperimentali qabel ġew studjati fil-bniedem.
English: What is Alendronic Acid/Colecalciferol Mylan?
Maltese: X'inhu Alendronic Acid/Colecalciferol Mylan?
English: On 27 May 2016, Mylan SAS officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Alendronic Acid/Colecalciferol Mylan, for the treatment of postmenopausal osteoporosis in women at risk of vitamin D deficiency.
Maltese: Fis-27 ta' Mejju 2016, Mylan SAS għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li tirtira l-applikazzjoni tagħha għall-awtorizzazzjoni għat-tqegħid fis-suq għal Alendronic Acid/Colecalciferol Mylan, għall-kura tal-osteoporożi ta' wara l-menopawża f'nisa f'riskju ta' defiċjenża tal-vitamin D.
English: Alendronic Acid/Colecalciferol Mylan is a medicine that contains two active substances: alendronic acid and colecalciferol.
Maltese: Alendronic Acid/Colecalciferol Mylan huwa mediċina li fiha żewġ sustanzi attivi: alendronic acid u colecalciferol.
English: EMA/354096/2016
Maltese: (alendronic acid u colecalciferol) EMA/354096/2016
English: Alendronic Acid/Colecalciferol Mylan was developed as a ‘generic medicine'.
Maltese: Alendronic Acid/Colecalciferol Mylan ġie żviluppat bħala ‘mediċina ġenerika'.
English: It was expected to reduce the risk of fractures (broken bones) in the spine and the hip.
Maltese: Kien mistenni li jnaqqas ir-riskju ta' fratturi (ksur tal-għadam) fis-sinsla tad-dahar u filġenbejn.
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 Alendronic Acid/Colecalciferol Mylan could not have been approved for the treatment of postmenopausal osteoporosis in women at risk of vitamin D insufficiency.
Maltese: Fuq il-bażi tar-reviżjoni tad-dejta, fiż-żmien tal-irtirar, is-CHMP kellu xi tħassib u kien tal-idea provviżorja li Alendronic Acid/Colecalciferol Mylan ma setax jiġi approvat għall-kura ta' osteoporożi wara l-menopawża fin-nisa li huma f'riskju ta' insuffiċjenza tal-vitamina D.
English: Alendronic Acid/Colecalciferol Mylan is expected to work in the same way as the reference medicine, Fosavance.
Maltese: Alendronic Acid/Colecalciferol Mylan huwa mistenni li jaħdem bl-istess mod bħall-mediċina ta' referenza, Fosavance.
English: Because Alendronic Acid/Colecalciferol Mylan is a generic medicine, the company had presented results of a study to determine that Alendronic Acid/Colecalciferol Mylan is bioequivalent to the reference medicine, Fosavance.
Maltese: Peress li Alendronic Acid/Colecalciferol Mylan huwa mediċina ġenerika, il-kumpanija kienet ippreżentat ir-riżultati ta' studju biex tiddetermina li Alendronic Acid/Colecalciferol Mylan huwa bijoekwivalenti għall-mediċina ta' referenza, Fosavance.
English: Alendronic acid reduces the loss of bone tissue and colecalciferol, also known as vitamin D3, increases the absorption of calcium and formation of bone.
Maltese: Aċidu alendroniku jnaqqas it-telf tat-tessut tal-għadam u colecalciferol, magħruf ukoll bħala l-vitamina D3, iżid l-assorbiment tal-kalċju u l-formazzjoni tal-għadam.
English: The CHMP also considered that data from the study do not convincingly establish that Alendronic Acid/Colecalciferol Mylan is sufficiently similar to the reference medicine, Fosavance.
Maltese: Is-CHMP ikkunsidra wkoll li d-dejta millistudju ma tistabbilixxix b'mod konvinċenti li Alendronic Acid/Colecalciferol Mylan hu simili biżejjed għall-mediċina ta' referenza Fosavance.
English: For more information on generic medicines, see the question-andanswer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini ġeneriċi, ara ddokument ta' mistoqsijiet u tweġibiet hawnhekk
English: Alendronic Acid/Colecalciferol Mylan was to be used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of insufficient vitamin-D levels.
Maltese: Alendronic Acid/Colecalciferol Mylan kellu jintuża fil-kura tal-osteoporożi (marda li tagħmel l-għadam fraġli) f'nisa li jkunu għaddew mill-menopawża u li hemm ir-riskju li ma jkollhomx biżżejjed livelli talvitamina D.
English: 15 September 2017 EMA/599030/2017 EMEA/H/C/003847
Maltese: 15 ta' Settembru 2017 EMA/599030/2017 EMEA/H/C/003847
English: The company that applied for authorisation is Helsinn Birex Pharmaceuticals Ltd.
Maltese: Il-kumpanija li applikat għal awtorizzazzjoni hija Helsinn Birex Pharmaceuticals Ltd.
English: Refusal of the marketing authorisation for Adlumiz (anamorelin hydrochloride) EMA/599030/2017
Maltese: Rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq ta' Adlumiz (anamorelin hydrochloride) EMA/599030/2017
English: Adlumiz is a medicine that contains the active substance anamorelin hydrochloride.
Maltese: Adlumiz huwa mediċina li fiha s-sustanza attiva anamorelin hydrochloride.
English: What is Adlumiz?
Maltese: X'inhu Adlumiz?
English: On 18 May 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Adlumiz, intended for the treatment of anorexia, cachexia or unintended weight loss in patients with non-small cell lung cancer.
Maltese: Fit-18 ta' Mejju 2017, il-Kumitat għal Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, u rrakkomanda r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq għall-prodott mediċinali Adlumiz, maħsub għat-trattament tal-anoressija, il-cachexia jew telf ta' piż mhux maħsub f'pazjenti b'kanċer taċ-ċelluli mhux żgħar tal-pulmun.
English: After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the marketing authorisation on 14 September 2017.
Maltese: Wara li kkunsidra r-raġunijet għal din it-talba, is-CHMP reġa' eżamina l-opinjoni inizjali u kkonferma r-rifjut tal-awtorizzazzjoni għattqegħid fis-suq fl-14 ta' Settembru 2017.
English: Adlumiz was expected to be used to treat anorexia (loss of appetite), cachexia (a form of muscle wasting with significant weight loss) or unintended weight loss in patients with a type of lung cancer called non-small cell lung cancer.
Maltese: Adlumiz kien mistenni li jintuża biex jikkura l-anoressija (telf ta' aptit), il-cachexia (forma ta' degredazzjoni tal-muskoli b'telf sinifikanti fil-piż) jew telf fil-piż mhux maħsub f'pazjenti b'tip ta' kanċer tal-pulmun magħruf bħala kanċer taċ-ċelloli mhux żgħar tal-pulmun.
English: It was to be available as 100 mg tablets to be taken by mouth.
Maltese: Dan kellu jiġi bħala pilloli ta' 100 mg sabiex jittieħdu mill-ħalq.
English: What was Adlumiz expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Adlumiz?
English: Refusal of the marketing authorisation for Adlumiz (anamorelin hydrochloride)
Maltese: (anamorelin hydrochloride)
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes in Europe with Adlumiz.
Maltese: Il-kumpanija għarrfet lis-CHMP li fil-preżent m'hemm ebda prova klinika jew programm ta' użu ta' kompassjoni fl-Ewropa b'Adlumiz.
English: This meant that a thorough evaluation of potential risks with Adlumiz was not possible.
Maltese: Dan kien ifisser li evalwazzjoni bir-reqqa tar-riskji potenzjali b'Adlumiz ma kinitx possibbli.
English: Patients were given either Adlumiz or placebo (a dummy treatment) and the main measures of effectiveness were changes in lean body mass (body weight excluding fat) and hand grip strength.
Maltese: Il-pazjenti ngħataw jew Adlumiz jew inkella plaċebo (kura finta) u l-miżuri ewlenin tal-effettività kienu bidliet fil-massa talġisem mingħajr xaħam (il-piż tal-ġisem mingħajr xaħam) u s-saħħa tal-qabda tal-id.
English: 7 ml (50 mg/ml) 1 vial
Maltese: Kunjett (ħġieġ) 7 ml (50 mg/ml)
English: EU/1/19/1376/001
Maltese: EU/1/19/1376/001 LIBTAYO 350 mg Konċentrat għal soluzzjoni għall-infużjoni
English: Intravenous use Vial (glass)
Maltese: Numru tal-MA (EU) Isem (ivvintat)
English: Pack size
Maltese: Użu minn ġolvini
English: Route of Administration
Maltese: kunjett 1
English: London, 22 August 2007 EMEA/CHMP/248862/2007
Maltese: Londra, 22 ta' Awwissu 2007 EMEA/CHMP/248862/2007
English: OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR
Maltese: OPINJONI SKOND L-ARTIKOLU 29(4)1 REFERENZA GĦAL
English: The Rapporteur was Dr Frits Lekkerkerker and Co-Rapporteur was Dr Gonzalo Calvo Rojas.
Maltese: IrRapporteur kien Dr. Frits Lekkerkerker u l-Ko-Rapporteur(s) kien Dr Gonzalo Calvo Rojas.
English: International Non-Proprietary Name (INN): cefuroxime (as axetil)
Maltese: Denominazzjoni Komuni Internazzjonali (INN- Internatinal Non-proprietary Name ): cefuroxime (bħal axetil)
English: Cefuroximaxetil and associated names
Maltese: Cefuroximaxetil u ismijiet assoċjati
English: - upper respiratory tract infections: acute otitis media, sinusitis, tonsillitis and pharyngitis - acute bronchitis, acute exacerbations of chronic bronchitis - lower uncomplicated urinary tract infections: cystitis - skin and soft tissue infections: furunculosis, pyoderma and impetigo - uncomplicated gonorrhoea: urethritis and cervicitis - treatment of early stage Lyme disease (stadium I) and subsequent prevention of late complications in adults and children above 12 years of age.
Maltese: Otitis media akuta (infezzjoni tal-widna minn ġewwa, sinusitis, tonsillitis u farinġitis - bronkite akuta, tqanqiliet akuti ta' bonkite kronika - infezzjonijiet ħfaf tal-parti ta' isfel tal-passaġġ ta' l-awrina: Ċistitis (infezzjoni tal-borża ta' l-awrina) - Infezzjonijiet tal-ġilda u tat-tessut artab: furunculosis, pyoderma u impetigo - Gonorrea ħafifa:
English: The Reference Member State was the Netherlands and the Concerned Member States were Estonia, Greece, Portugal and Spain.
Maltese: L-Istat Membru ta' Referenza kien l-Olanda u l-Istati Membri Konċernati kienu lEstonja, il-Greċja, il-Portugall u Spanja.
English: Cefuroximaxetil and associated names, 125 mg, 250 mg and 500 mg, coated tablets is a cephalosporin (βlactam group of antibiotics), indicated for the treatment of mild to moderately severe infections caused by micro-organisms susceptible to cefuroxime, such as:
Maltese: Cefuroximaxetil u ismijiet asso ċjati, 125mg, 250 mg u 500 mg, pilloli miksija b'rita huma cephalosporin (antibijotiċi tal-grupp β-lactam), indikati għat-trattament ta' infezzjonijiet ħfaf sa kemmxejn severi li huma kkawwżati minn mikro-organiżmi suxxettibbli għaċ-cefuroxime, bħal:
English: Significant difference was identified with regard to the indication “uncomplicated gonorrhoea: urethritis and cervicitis”.
Maltese: Differenza sinifikanti ġiet identifikata rigward l-indikazzjoni ta' “gonorrea ħafifa: Urethritis u Cervicitis”.
English: Sandoz B.V. submitted applications for mutual recognition of Cefuroximaxetil and associated names, 125 mg, 250 mg and 500 mg, coated tablets on the basis of the marketing authorisation granted by the Netherlands on 1 October 2004.
Maltese: Sandoz B.V. issottomettiet applikazzjonijet għar-rikonoxximent reċiproku taċ-Cefuroximaxetil u ismijiet assoċjati, 125mg, 250mg u 500 mg, pilloli miksija b'rita abbażi ta' l-awtorizzazzjoni għat-tqegħid fis-suq mogħtija mill-Olanda fl-1 ta' Ottubru 2004.
English: The repeat-use Mutual Recognition Procedure started on 17 May 2006.
Maltese: L-użu ripetut tal-Proċedura ta' Rikonoxximent Reċiproku beda fis-17 ta' Mejju 2006.
English: An opinion was adopted by consensus on 26 April 2007.
Maltese: Ġiet adottata opinjoni pożittiva permezz ta' kunsens fis-26 ta' April 2007.
English: The Marketing Authorisation Holder provided written explanations on 15 January 2007.
Maltese: Il-Pussessur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq ta' spjegazzjonijiet bil-miktub fid-15 ta' Jannar 2007.
English: Spain referred the reasons for disagreement to the EMEA on 25 September 2006.
Maltese: Spanja rreferiet għar-raġunijiet ta' nuqqas ta' qbil lill-EMEA fil-25 ta' Settembru 2006.
English: During their April 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the objections raised by Spain could be agreed and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Maltese: Matul il-laqgħa ta' April 2007, is-CHMP, fid-dawl tad-dejta gobali sottomessa u d-diskussjoni xjentifika fi ħdan il-Kumitat, kien ta' l-opinjoni li l-oġġezzjonijiet imqajjma minn Spanja jistgħu jiġu ffissati u li Sommarju tal-Karatteristiċi tal-Prodotti, l-ittikkettjar u l-fuljett ta' tagħrif ta' l-Istat Membru ta' Referenza għandhom jiġu emendati.
English: This refers to the safety and efficacy of cefuroximaxetil in uncomplicated gonorrhoea and riskbenefit balance for this sought indication and this was considered to be a serious public health concern.
Maltese: Dan jirreferi għas-sigurtà u l-effikaċja taċ-cefuroximaxetil f'gonorrea ħafifa u bilanċ tar-riskju u l-benefiċċju għal din l-indikazzjoni imfittxija u dan kien ikkonsidrat bħala konċern serju għas-saħħa pubblika.
English: Roche Eesti OÜ Lõõtsa 2, 11415 Tallinn
Maltese: Roche Eesti OÜ Lõõtsa 2, 11415
English: Czech Republic Roche s.r.o., Dukelských hrdinů 52
Maltese: Ir-Repubblika Ċeka Roche s.r.o., Dukelských hrdinů 52
English: Roche Latvija SIA G. Astras 8b Riga, LV-1082 Latvia
Maltese: Astras 8b Riga, LV-1082 Latvia
English: 5x1 ml and 5x3 ml
Maltese: 5x1 ml u 5x3 ml
English: Slovak Republic F.Hoffmann-La Roche Ltd. Basel, Switzerland
Maltese: F.Hoffmann-La Roche Ltd.
English: UAB “Roche Lietuva” J. Jasinskio 16b, LT-01112 Vilnius
Maltese: Jasinskio 16b, LT-01112 Vilnius
English: United Kingdom Roche Products Limited, 6 Falcon Way, Shire Park Welwyn Garden City
Maltese: Roche Products Limited, 6 Falcon Way, Shire Park Welwyn Garden City AL7 1TW
English: 1ml contains 1mg granisetron (hydrochloride) 1mg contains 9mg sodium chloride = 3.54 mg sodium
Maltese: 1ml fih 1mg granisetron (hydrochloride) 1mg fiha 9mg sodium chloride = 3.54 mg sodium
English: 3ml contains 3mg granisetron (hydrochloride) 3ml contains 27mg sodium chloride = 10.62 mg sodium
Maltese: 3ml fihom 3mg granisetron (hydrochloride) 3ml fihom 27mg sodium chloride = 10.
English: 1ml contains 1mg granisetron (hydrochloride)
Maltese: 1ml fih 1mg granisetron (hydrochloride)
English: 1ml contains 1mg granisetron (hydrochloride
Maltese: 1ml fih1mg granisetron (hydrochloride
English: Roche (Hungary) Ltd H-2040 Budaörs Edison u. 1.
Maltese: Roche (Hungary) Ltd H-2040
English: 1mg/ml (1ml and 3ml)
Maltese: 1mg/ml (1ml u 3ml)
English: Slovak Republic Roche Slovensko s.r.o.
Maltese: Roche Slovensko s.r.o. Cintorínska 3/A Bratislava
English: 3 mg = 3 ml, oplossing voor injectie 1 mg/ml
Maltese: Kytril i.v. 3 mg = 3 ml, oplossing voor injectie 1 mg/ml
English: 100 74 Stockholm Sweden
Maltese: 1070 Bruxelles
English: 1 mg = 1 ml, oplossing voor injectie 1 mg/ml
Maltese: Kytril i.v. 1 mg = 1 ml, oplossing voor injectie 1 mg/ml
English: Germany
Maltese: Greece
English: Bratislava
Maltese: Ir-Rumanija
English: The full EPAR for Valdoxan 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: Valdoxan agomelatine
Maltese: Valdoxan agomelatina
English: However, the second study showed that symptoms returned in 21% of the patients taking Valdoxan over 24 weeks (34 out of 165), compared with 41% of the patients taking placebo (72 out of 174).
Maltese: Madankollu, it-tieni studju wera li s-sintomi rritornaw f'21% tal-pazjenti li kienu qed jieħdu Valdoxan tul 24 ġimgħa (34 minn 165), meta mqabbel ma' 41% tal-pazjenti li kienu qed jieħdu l-plaċebo (72 minn 174).
English: The active substance in Valdoxan, agomelatine, is an antidepressant.
Maltese: Is-sustanza attiva f'Valdoxan, l-agomelatina, hija antidepressiv.
English: This is a summary of the European public assessment report (EPAR) for Valdoxan.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Valdoxan.
English: Valdoxan contains the active substance agomelatine.
Maltese: Valdoxan fih is-sustanza attiva agomelatina.
English: Valdoxan has been compared with placebo (a dummy treatment) in five main short-term studies involving a total of 1,893 adults with major depression.
Maltese: Valdoxan tqabbel ma' plaċebo (kura finta) f'ħames studji qosra prinċipali li involvew total ta' 1,893 adult b'dipressjoni qawwija.
English: Why is Valdoxan approved?
Maltese: Għaliex ġie approvat Valdoxan ?
English: The main measure of effectiveness in these five studies was the change in symptoms after six weeks, as measured on a standard scale for depression called the Hamilton Depression Rating Scale (HAM D).
Maltese: Il-kejl ewlieni tal-effikaċja f'dawn il-ħames studji kien il-bidla fis-sintomi wara sitt ġimgħat, kif imkejla fuq skala standard għal dipressjoni magħrufa bħala Hamilton Depression Rating Scale (HAM D - Skala Hamilton għall-Kejl tad-Dipressjoni).
English: Valdoxan can only be obtained with a prescription and is available as tablets (25 mg).
Maltese: Valdoxan jista' jinkiseb biss b'riċetta ta' tabib u jiġi bħala pilloli (25 mg).
English: It must also not be used in patients who are taking medicines that slow down the breakdown of Valdoxan in the body, such as fluvoxamine (another antidepressant) and ciprofloxacin (an antibiotic).
Maltese: Lanqas m'għandu jintuża f'pazjenti li qed jieħdu mediċini li jdewmu l-assorbiment ta' Valdoxan fil-ġisem, bħalma huma l-fluwoksamina (antidepressiv ieħor) u ċċiprofloksaċina (antibijotiku).
English: Two other main studies compared the ability of Valdoxan and placebo to prevent symptoms returning in 706 patients whose depression had already been controlled with Valdoxan.
Maltese: Żewġ studji prinċipali oħra qabblu l-abbiltà ta' Valdoxan u l-plaċebo biex jipprevjenu s-sintomi milli jirritornaw f'706 pazjenti li d-dipressjoni tagħhom kienet diġà ġiet ikkontrollata b'Valdoxan.
English: What are the risks associated with Valdoxan?
Maltese: X'inhuma r-riskji assoċjati ma' Valdoxan ?