FrancophonIA/ELRC3.0 huggingface dataset:
English: On 19 June 2012, following a re-examination, the CHMP confirmed its initial conclusions but decided to remove a requirement for a pharmacokinetic study with tranexamic acid.
Maltese: Fid-19 ta' Ġunju 2012, wara rieżami, is-CHMP ikkonferma l-konklużjonijiet inizjali tiegħu iżda ddeċieda li jneħħi l-ħtieġa għal studju farmakokinetiku bit-tranexamic acid.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of these medicines outweigh their risks and recommended that the EU-wide suspension of the marketing authorisation for aprotinin-containing medicines that has been in place since 2008 be lifted.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu millBniedem (CHMP) tal-Aġenzija kkonkluda li l-benefiċċji ta' dawn il-mediċini jisbqu r-riskji tagħhom u rrakkomanda li titneħħa s-sospensjoni madwar l-UE kollha tal-awtorizzazzjoni għat-tqegħid fis-suq talmediċini li fihom aprotinin li ilha fis-seħħ mill-2008.
English: The European Commission issued a decision for aprotinin on 18 September 2013.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni għal aprotinin fit-18 ta' Settembru 2013.
English: The amended prescribing information on aminocaproic acid for doctors can be found here.
Maltese: L-informazzjoni ta' preskrizzjoni emendata dwar l-aminocaproic acid, għat-tobba, tista' tinstab hawnhekk.
English: Diagonal 67-69 08019 Barcelona España
Maltese: Diagonal 67-69 08019 Barcelona Spanja
English: Rivium Westlaan 142 2909 LD, Capelle a/d Ijssel
Maltese: Westlaan 142, 2909 LD, Capelle a/d Ijssel
English: Via Valosa di Sopra, 9 20052 Monza - Italy
Maltese: Via Valosa di Sopra, 9 20052 Monza - L-Italja
English: HU - Hungary sanofi-aventis Zrt.
Maltese: HU - L-Ungerija sanofi-aventis Zrt.
English: TRANEXAMICO BIOINDUTRIA L.I.M.
Maltese: ACIDO TRANEXAMICO BIOINDUTRIA L.I.M.
English: D-10785 Berlin
Maltese: D-10785
English: Bioindutria Laboratorio Italiano Medicinali spa Via De Ambrosiis, 2 15067 Novi Ligure Alessandria Italy
Maltese: Bioindutria Laboratorio Italiano Medicinali spa Via De Ambrosiis, 2 15067 Novi Ligure Alessandria L-Italja
English: CONSTANTINOUPOLEOS STREET, P.O.BOX 51409, 3505 LEMESOS, CYPRUS
Maltese: CONSTANTINOUPOLEOS STREET, P.O.BOX 51409, 3505 LEMESOS, ĊIPRU
English: Pharmacia Ireland Ltd, 9 Riverwalk, National Digital Park,
Maltese: Pharmacia Ireland Ltd, 9 Riverwalk, National Digital Park, Citywest Business Campus,
English: Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
Maltese: Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, IdDanimarka
English: Pfizer Enterprises SARL Round-Point du Kirchberg 51, Avenue J.F.
Maltese: Pfizer Enterprises SARL Round-Point du Kirchberg 51, Avenue J.F. Kennedy L-1855
English: A. NIKOLAKOPOULOS A.E. GALATSIOU AVENUE 115, Athens 11146
Maltese: GALATSIOU AVENUE 115, Athens 11146
English: UK - United Kingdom Pharmacia Limited Walton Oaks, Dorking Road, Tadworth
Maltese: UK - Ir-Renju Unit Pharmacia Limited, Walton Oaks, Dorking Road, Tadworth, Surrey KT20 7NS
English: ES - Spain
Maltese: ES - Spanja
English: CZ - Czech Republic Sanofi-Aventis, s.r.o., Evropská 846/176a, 160 00
Maltese: Sanofi-Aventis, s.r.o., Evropská 846/176a, 160 00 Praha 6, IrRepubblika Ċeka
English: 1180 Brussels
Maltese: B- 1180 Bruxelles
English: FR - France
Maltese: FR - Franza
English: INJECTION
Maltese: INYECTABLE
English: AMCHAFIBRIN 500 mg SOLUCIÓN INYECTABLE
Maltese: AMCHAFIBRIN 500 mg SOLUCIÓN
English: ET - Estonia
Maltese: ET - L-Estonja
English: Sanofi Aventis France 1-13, bd Romain Rolland 75014 Paris
Maltese: France 1-13, bd Romain Rolland 75014
English: PL - Poland
Maltese: PL - Il-Polonja
English: IS - Iceland
Maltese: IS - L-Islanda
English: Pharmacia GmbH Linkstr.
Maltese: DE - Il-Ġermanja Pharmacia GmbH Linkstr. 10
English: IE - Ireland
Maltese: IE - L-Irlanda
English: Warszawskie Zakłady Farmaceutyczne POLFA S.A. 22/24 karolkowa st.
Maltese: 22/24 karolkowa st.
English: Sanofi-Aventis France Boulevard Romain Rolland 113, F-75014 Paris, France solution for infusion intravenous use
Maltese: Sanofi-Aventis France boulevard Romain Rolland 1-13, F-75014
English: 191 90 Sollentuna Sweden
Maltese: Pfizer AB , 191 90 Sollentuna, L-Isvezja
English: DK - Denmark
Maltese: DK - IdDanimarka
English: 01-207 Warsaw, Poland solution for infusion intravenous use
Maltese: 01-207 Warsaw, IlPolonja
English: Oy Leiras Finland Ab Paciuksenkatu 21 PL 1406
Maltese: FI - Il-Finlandja Oy Leiras Finland Ab Paciuksenkatu 21
English: NL - Netherlands
Maltese: NL - L-Olanda
English: Floridsdorfer Hauptstraße 1 A-1210 Wien
Maltese: Floridsdorfer Hauptstraße
English: Pfizer B.V.
Maltese: Pfizer B.V., Rivium
English: BE - Belgium Eumedica S.A. Winston Churchilllaan 67
Maltese: Eumedica SA 67, Avenue Winston Churchill
English: LU - Luxembourg Eumedica SA 67, Avenue Winston Churchill B- 1180 Bruxelles
Maltese: Winston Churchilllaan 67 1180 Brussels Il-Belġju
English: Avda.
Maltese: S.L. Avda.
English: FI - Finland
Maltese: Il-Finlandja
English: EL - Greece
Maltese: EL - Il-Greċja
English: BE - Belgium PFIZER S.A.N.V.
Maltese: PFIZER S.A.N.V.
English: Praha 6, Czech Republic
Maltese: Paris, Franza
English: IT - Italy
Maltese: IT - L-Italja
English: France
Maltese: Paris
English: CY - Cyprus
Maltese: CY - Ċipru
English: List of the invented names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states
Maltese: Lista tal-ismijiet, għamliet farmaċewtiċi, qawwa talprodotti mediċinali, mnejn jingħata, detenturi talawtorizzazzjoni għat-tqegħid fis-suq fl-istati membri
English: CYKLOKAPRON 100mg/ml
Maltese: Tranexamsyre "Pfizer" 100 mg/ml
English: Italy
Maltese: Ungerija
English: ROTTAPHARM S.L.
Maltese: Eumedica S.A.
English: 1045 Budapest, Hungary
Maltese: Budapest, L
English: 1324 Lysaker Norway
Maltese: NO - In-Norveġja Pfizer AS, Postboks 3, 1324 Lysaker In-Norveġja
English: Tranexamic acid containing medicinal products with Marketing Authorisation in the European Union
Maltese: Prodotti mediċinali li fihom tranexamic acid b'Awtorizzazzjoni għat-Tqegħid fis-Suq fl-Unjoni Ewropea
English: Schizophrenia
Maltese: Skiżofrenja
English: Invega paliperidone
Maltese: Invega paliperidon
English: The full EPAR for Invega can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal Invega jinstab fis-sit elettroniku tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Invega contains the active substance paliperidone.
Maltese: Invega fih is-sustanza attiva paliperidon.
English: This summary was last updated in 09-2017.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 09-2017.
English: Other information about Invega
Maltese: Informazzjoni oħra dwar Invega
English: Schizoaffective disorder
Maltese: Disturb skiżoaffettiv
English: The most frequent side effects with Invega in adults are headache, insomnia (difficulty sleeping), sleepiness, parkinsonism (effects similar to Parkinson's disease such as shaking, muscle stiffness and slow movement), dystonia (involuntary muscle contractions), tremor (shaking), dizziness, akathisia (restlessness), agitation, anxiety, depression, increased weight, nausea, vomiting, constipation, dyspepsia (heartburn), diarrhoea, dry mouth, tiredness, toothache, muscle and bone pain, back pain, asthenia (weakness), tachycardia (increased heart rate), high blood pressure, prolonged QT interval (an alteration of the electrical activity of the heart), upper respiratory tract infection (nose and throat infections) and cough.
Maltese: L-effetti sekondarji l-aktar komuni b'Invega fl-adulti huma wġigħ ta' ras, insomnja (diffikultà biex wieħed jorqod), ngħas, parkinsoniżmu (effetti simili għall-marda ta' Parkinson bħal tertir, ebusija tal-muskoli u moviment bil-mod), distonija (kontrazzjonijiet involontarji tal-muskoli), rogħda (tertir), sturdament, akatiżija (nuqqas ta' kwiet f'ġismek), aġitazzjoni, ansjetà, dipressjoni, żieda fil-piż, nawżja, remettar, stitikezza, dispepsja (ħruq ta' stonku), dijarea, ħalq xott, għeja, uġigħ fis-snien, uġigħ fil-muskoli u fl
English: In a third study of 334 previously treated patients, symptoms of depression came back in 15% (25 out of 164) of patients given paliperidone compared with 34% (57 out of 170) of patients given placebo.
Maltese: Fit-tielet studju ta' 334 pazjent li ġew ikkurati preċedentement, is-sintomi ta' dipressjoni reġgħu tfaċċaw fi 15 % (25 minn 164) tal-pazjenti li ngħataw paliperidone meta mqabbel ma' 34 % (57 minn 170) tal-pazjenti li ngħataw il-plaċebo.
English: Symptom scores fell by 19.9 points in those taking olanzapine.
Maltese: Il-punteġġi tas-sintomi naqsu b'19.9 punti f'dawk li kienu qed jieħdu olanzapine.
English: This is a summary of the European public assessment report (EPAR) for Invega.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Invega.
English: What are the risks associated with Invega?
Maltese: X'inhuma r-riskji assoċjati ma' Invega?
English: It is available as prolonged-release tablets (3, 6, 9 and 12 mg).
Maltese: Dan jiġi f'pilloli li jerħu l-mediċina bil-mod (3, 6, 9 u 12 mg).
English: In one of these studies, average symptom scores fell by between 17.9 and 23.3 points after 6 weeks in those taking Invega compared with a fall of 4.1 points with placebo.
Maltese: F'wieħed minn dawn l-istudji, il-medja tal-punteġġi tas-sintomi naqset b'bejn 17.9 u 23.3 punti wara 6 ġimgħat f'dawk li kienu qed jieħdu Invega meta mqabbla ma' tnaqqis ta' 4.1 punti bil-plaċebo.
English: Three short-term studies innvolving 1,692 adults showed that Invega is more effective than placebo (a dummy treatment) and as effective as another antipsychotic medicine olanzapine at reducing symptoms of schizophrenia (as measured by a standard rating scale).
Maltese: Tliet studji fuq perjodu qasir li involvew 1,692 adult urew li Invega huwa aktar effikaċi minn plaċebo (kura finta) u effikaċi daqs mediċina antipsikotika oħra olanzapine biex inaqqas is-sintomi tal-iskiżofrenja (kif imkejjel minn skala ta' klassifikazzjoni standard).
English: The two studies together involved a total of 614 patients.
Maltese: Iż-żewġ studji flimkien involvew total ta' 614-il pazjent.
English: Paliperidone acts mainly by blocking the receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin), which are involved in schizophrenia.
Maltese: Paliperidone jaġixxi prinċipalment billi jimblokka r-riċetturi għan-newrotrażmettituri dopamine u 5-hydroxytryptamine (imsejjaħ ukoll serotonin), li huma involuti fl-iskiżofrenja.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Invega on 25 June 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Invega fil-25 ta' Ġunju 2007.
English: Why is Invega approved?
Maltese: Għaliex ġie approvat Invega?
English: After assessing the symptoms, the doctor may adjust the dose to between 3 and 12 mg once a day in adults with schizophrenia and to between 6 and 12 mg once a day in patients with schizoaffective disorder.
Maltese: Wara li jiġu vvalutati s-sintomi, it-tabib jista' jaġġusta d-doża għal bejn 3 u 12 mg darba kuljum f'adulti bliskiżofrenja u għal bejn 6 u 12 mg darba kuljum f'pazjenti b'disturb skiżoaffettiv.
English: In an additional longer-term study involving 207 adults with schizophrenia who had initially been treated over 14 weeks, Invega was more effective than placebo in preventing new symptoms for up to 35 weeks.
Maltese: Fi studju addizzjonali fuq perjodu itwal li involva 207 adult bi skiżofrenja li għall-bidu ġew ikkurati matul 14-il ġimgħa, Invega kien aktar effikaċi minn plaċebo biex jipprevjeni sintomi ġodda sa 35 ġimgħa.
English: The active substance in Invega, paliperidone, is known as an ‘atypical' antipsychotic because it is different from the older antipsychotic medicines that have been available since the 1950s.
Maltese: Is-sustanza attiva f'Invega, paliperidon, hija magħrufa bħala antipsikotiku “atipiku” minħabba li hija differenti mill-mediċini antipsikotiċi aktar antiki li ilhom disponibbli sa mill-ħamsinijiet.
English: Studies have shown that Invega can reduce symptoms scores and prevent symptoms in patients with schizoaffective disorder.
Maltese: L-istudji wrew li Invega jista' jnaqqas il-punteġġi tas-sintomi u jipprevjeni s-sintomi f'pazjenti b'disturb skiżoaffettiv.
English: Side effects in adolescents are similar to those in adults, although some side effects may occur more frequently.
Maltese: L-effetti sekondarji fl-adolexxenti kienu simili għal dawk fl-adulti, għalkemm xi effetti sekondarji jistgħu jseħħu b'mod aktar frekwenti.
English: Paliperidone is an active breakdown product (metabolite) of risperidone, another atypical antipsychotic medicine that has been used in the treatment of schizophrenia since the 1990s.
Maltese: Paliperidone huwa prodott tat-tkissir attiv (metabolit) ta' risperidone, mediċina antipsikotika atipika oħra li ilha tintuża fil-kura tal-iskiżofrenja sa mis-snin disgħin.
English: In the brain, paliperidone attaches to several different receptors (targets) on nerve cells.
Maltese: Fil-moħħ, paliperidon jeħel ma' diversi riċetturi (miri) differenti fuq iċ-ċelloli tan-nervituri.
English: Invega is also used to treat adults with schizoaffective disorder.
Maltese: Invega jintuża wkoll biex jikkura adulti b'disturb skiżoaffettiv.
English: Invega is an antipsychotic medicine used in adults and adolescents from 15 years of age to treat schizophrenia, a mental illness with symptoms such as disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Maltese: Invega huwa mediċina antipsikotika li tintuża f'adulti u adolexxenti minn 15-il sena biex tikkura liskiżofrenja, marda mentali b'sintomi bħal ħsibijiet u taħdit diżorganizzati, alluċinazzjonijiet (is-smigħ u d-dehra ta' oġġetti li ma jkunux hemm), suspetti u delużjonijiet (konvinzjonijiet żbaljati).
English: How is Invega used?
Maltese: Kif jaħdem Invega?
English: In one study, patients who were given Invega had a fall in their symptom score for mania of between 27.4 and 30.6 after 6 weeks compared with 21.7 in patients who were given placebo.
Maltese: u 30.6 wara 6 ġimgħat meta mqabbel ma' 21.7 f'pazjenti li ngħataw il-plaċebo.
English: The recommended starting dose of Invega in adults is 6 mg once a day, taken in the morning; the starting dose in adolescents is 3 mg daily.
Maltese: Id-doża tal-bidu rakkomandata ta' Invega fl-adulti hija ta' 6 mg darba kuljum, li tittieħed filgħodu; iddoża tal-bidu fl-adolexxenti hija ta' 3 mg kuljum.
English: In another study, the fall in symptom score for mania after 6 weeks was 20.0 in the Invega group and 10.8 in the placebo group.
Maltese: Fi studju ieħor, it-tnaqqis fil-punteġġ tas-sintomi għall-manija wara 6 ġimgħat kien ta' 20.
English: Studies in adolescents have shown similar results with Invega to those seen in adults.
Maltese: L-istudji fl-adolexxenti wrew riżultati simili b'Invega għal dawk li dehru fl-adulti.
English: In adolescents with schizophrenia the maximum daily dose depends on the patient's body weight and should not be more than 6 mg in those who weigh less than 51 kg. For more information on the use of Invega, including the adjustment of doses in those with kidney disease and the elderly, see the summary of product characteristics (also part of the EPAR).
Maltese: F'adolexxenti bi skiżofrenja d-doża massima ta' kuljum tiddependi fuq il-piż tal-ġisem tal-pazjent u m'għandhiex tkun aktar minn 6 mg f'dawk li jiżnu inqas minn 51 kg.
English: EMA/463262/2015 EMEA/V/C/003866
Maltese: EMEA/463262/2015 EMEA/V/C/003866
English: Meloxicam
Maltese: Melossikam
English: Novaquin is a ‘generic medicine'.
Maltese: Novaquin huwa ‘mediċina ġenerika'.
English: The full EPAR for Novaquin can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: It contains the active substance meloxicam.
Maltese: Fih is-sustanza attiva l-melossikam.
English: This is a summary of the European public assessment report (EPAR) for Novaquin.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Novaquin.
English: Other information about Novaquin
Maltese: Informazzjoni oħra dwar Novaquin
English: Meloxicam acts by blocking an enzyme called cyclooxygenase which is involved in the production of prostaglandins.
Maltese: Il-melossikam jaġixxi billi jimblokka enzima msejħa cyclooxygenase li hija involuta fil-produzzjoni tal-prostaglandini.
English: What are the benefits and risks of Novaquin?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Novaquin?
English: Why is Novaquin approved?
Maltese: Għaliex ġie approvat Novaquin?
English: The European Commission granted a marketing authorisation valid throughout the EU for Novaquin on 8 September 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Novaquin valida fl-Unjoni Ewropea kollha fit-8 ta' Settembru 2015.
English: Novaquin contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Maltese: Novaquin fih is-sustanza l-melossikam li tappartjeni għall-klassi ta' mediċini msejħin mediċini antinfjammatorji nonsterojdali (NSAIDs).
English: Novaquin is a veterinary medicine used for the alleviation of inflammation and relief of pain and chronic musculoskeletal disorders (disorders affecting the muscle and bones) in horses.
Maltese: Novaquin huwa mediċina veterinarja li tintuża għat-tnaqqis ta' infjammazzjoni u għas-serħan milluġigħ u għal disturbi muskoloskeletali kroniċi (disturbi li jaffettwaw il-muskoli u l-għadam) fiż-żwiemel.
English: This means that Novaquin is similar to a ‘reference medicine' already authorised in the European Union (EU) called Metacam.
Maltese: Dan ifisser li Novaquin huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Europea (UE) li jisimha Metacam.
English: Novaquin is available as a 15 mg/ml oral suspension and can only be obtained with a prescription.
Maltese: Novaquin huwa disponibbli bħala sospensjoni orali ta' 15 mg/ml u jista' jinkiseb biss b'riċetta ta' tabib.
English: Because Novaquin is a generic medicine, studies in animals have been limited to tests to determine that it is bioequivalent to the reference medicine, Metacam.
Maltese: Minħabba li Novaquin huwa mediċina ġenerika, l-istudji fl-annimali kienu limitati għal testijiet biex tiġi ddeterminata l-bijoekwivalenza tiegħu għall-mediċina ta' referenza, Metacam.
English: It is either given with food or directly into the mouth at a dosage of 0.6 mg/kg bodyweight.
Maltese: Jingħata jew mal-ikel jew direttament fil-ħalq f'dożaġġ ta' 0.6 mg/kg tal-piż tal-ġisem.
English: As prostaglandins are substances that trigger inflammation, pain, exudation (fluid that leaks out of blood vessels during inflammation) and fever, meloxicam reduces these signs of disease.
Maltese: Minħabba li l-prostaglandini huma sustanzi li jiskattaw l-infjamazzjoni, l-uġigħ, it-tnixxija (fluwidu li joħroġ mill-vażijiet matul infjamazzjoni) u d-deni, il-melossikam tnaqqas dawn s-sintomi tal-marda.
English: This summary was last updated in July 2015.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'Lulju 2015.
English: How has Novaquin been studied?
Maltese: Kif ġie studjat Novaquin?
English: Because Novaquin is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Novaquin huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, ilbenefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: The Committee recommended that Novaquin be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Novaquin ikun approvat għall-użu fl-UE.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in accordance with EU requirements, Novaquin has been shown to have comparable quality and to be bioequivalent to Metacam.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija kkonkluda li, skont irrekwiżiti tal-UE, intwera li Novaquin għandu kwalità komparabbli u huwa bijoekwivalenti għal Metacam.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Novaquin, including the precautions to be followed by healthcare professionals and animal owners or keepers.
Maltese: Fis-sommarju tal-karatteristiċi tal-prodott u l-fuljett ta' tagħrif ġiet inkluża informazzjoni rigward issigurtà ta' Novaquin, fosthom il-prekawzjonijiet xierqa li jridu jiġu segwiti mill-professjonisti fil-kura tas-saħħa u mis-sidien tal-annimali jew dawk li jieħdu ħsiebhom.
English: The precautions are the same as for the reference medicine since Novaquin is a generic medicine.
Maltese: Il-prekawzjonijiet huma bħal dawk tal-mediċina ta' referenza minħabba li Novaquin huwa mediċina ġenerika.
English: de la Industria, 30 28108 Alcobendas, Madrid Spain
Maltese: de la Industria, 30 28108 Alcobendas, Madrid Spanja
English: - The active substance is abemaciclib.
Maltese: - Is-sustanza attiva hi abemaciclib.
English: Toxicitya, b
Maltese: Tossiċitàa, b
English: a NCI CTCAE ULN = upper limit of normal
Maltese: a NCI CTCAE ULN = limitu ta' fuq tan-normal
English: Frequency Preferred term
Maltese: Klassi tas-sistemi u tal-organi Frekwenza Terminu preferut
English: Grade 3 or 4 a NCI CTCAE
Maltese: Grad 3 jew 4 a NCI CTCAE
English: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, The Netherlands.
Maltese: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, L-Olanda.
English: Excipients: lactose.
Maltese: TA' EĊĊIPJENTI Eċċipjenti: lactose.
English: Alanine aminotransferase increased Aspartate aminotransferase increased a
Maltese: Żieda fl-alanine aminotransferase Żieda fl-aspartate aminotransferase a
English: Grade 1 (>ULN-3.0 x ULN) Grade 2 (>3.0-5.0 x ULN)
Maltese: Grad 1 (>ULN-3.0 x ULN) Grad 2 (>3.0-5.0 x ULN)
English: Infections/infestations
Maltese: Infezzjonijiet/infestazzjonijiet
English: Gastrointestinal disorders
Maltese: Disturbi gastrointestiali
English: Lilly Hungária Kft. Tel: + 36 1 328 5100
Maltese: Magyarország Lilly Hungária Kft. Tel: + 36 1 328 5100
English: Tablet core croscarmellose sodium lactose monohydrate microcrystalline cellulose colloidal hydrated silica sodium stearyl fumarate
Maltese: Qalba tal-pillola croscarmellose sodium lactose monohydrate microcrystalline cellulose colloidal hydrated silica sodium stearyl fumarate
English: • Tablet core: colloidal hydrated silica, croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, sodium stearyl fumarate.
Maltese: • Il-qalba tal-pillola: colloidal hydrated silica, croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, sodium stearyl fumarate.
English: The HR was 0.854 (95% CI: 0.598, 1.221), p=0.3886.
Maltese: L-HR kien 0.854 (95% CI: 0.598, 1.221), p=0.3886.
English: Adverse reactions reported in phase 3 studies of abemaciclib in combination with endocrine therapy (N=768)
Maltese: Reazzjonijiet avversi rrappurtati fi studji ta' fażi 3 ta' abemaciclib flimkien ma' terapija endokrinali (N=768)
English: Increased aminotransferases
Maltese: Żieda fl-aminotransferases
English: Abemaciclib is a potent and selective inhibitor of cyclin-dependent kinases 4 and 6 (CDK4 and CDK6), and most active against Cyclin D1/CDK4 in enzymatic assays.
Maltese: Abemaciclib huwa inibitur potenti u selettiv ta' kinases 4 u 6 (CDK4 u CDK6) dipendenti mis-cyclin, u huwa attiv l-aktar kontra Cyclin D1/CDK4 f'analiżi enzimatiċi.
English: Eli Lilly Benelux S.A./N.V.
Maltese: Luxembourg/Luxemburg Eli Lilly Benelux S.A./N.V.
English: Grade 4 (>20.0 x ULN)
Maltese: Grad 4 (>20.0
English: The HR was 1.057 (95% CI: 0.683, 1.633), p=0.8017.
Maltese: L-HR kien 1.057 (95% CI: 0.683, 1.633), p=0.8017.
English: Date of first authorisation: 27 September 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 27 Settembru 2018
English: Verzenios plus fulvestrant
Maltese: Verzenios flimkien ma' fulvestrant