FrancophonIA/ELRC3.0 huggingface dataset:
English: • signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding,
Maltese: • sinjali u sintomi li għandhom x'jaqsmu ma'disturbi tad-demm bħal deni persistenti, tbenġil,
English: 40 mg every other week
Maltese: 40 mg.
English: In the open-label extension for RA study V, ACR response rates were maintained when followed for up to 10 years.
Maltese: Fl-estensjoni open-label għal studju RA V, rati ta' rispons ACR ġew miżmuma meta kienu segwiti sa 10 snin.
English: PHARMACEUTICAL FORM
Maltese: GĦAMLA FARMAĊEWTIKA
English: After doses of 0.5 mg / kg (~40 mg), clearances ranged from 11 to 15 ml / hour, the distribution volume (Vss) ranged from 5 to 6 litres and the mean terminal phase half-life was approximately two weeks.
Maltese: kien 5.6 ± 5.6 µg/ml (102 %CV) meta adalimumab ma kienx użat flimkien ma' methotrexate u 10.
English: In period A, patients received placebo or adalimumab at an initial dose of 160 mg at week 0 and 80 mg at week 2 and 40 mg every week starting at week 4 to week 11.
Maltese: F'perjodu A, pazjenti rċevew plaċebo jew adalimumab b'doża inizjali ta' 160 mg f'ġimgħa 0, 80 mg f'ġimgħa 2, u 40 mg kull ġimgħa li tibda f'ġimgħa 4 sa ġimgħa 11.
English: Hefiya is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
Maltese: Hefiya huwa intenzjonat għall-kura ta' psorjasi tal-plakka moderata sa severa fl-adulti.
English: Adalimumab was studied in 9,506 patients in pivotal controlled and open label trials for up to 60 months or more.
Maltese: Adalimumab ġie studjat f'9,506 pazjent fi provi pivitali kkontrollati u open-label li damu sejrin sa 60 xahar jew aktar.
English: Hefiya is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and / or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs.
Maltese: Hefiya huwa indikat għall-kura ta' adulti li jbatu minn infjammazzjoni tal-vertebri li jirriżulta fil-vertebri jitwaħħlu flimkien (ankylosing spondylitis), li kellhom rispons inadegwat meta ngħataw kura konvenzjonali.
English: Table 26 paediatric CD study PCDAI clinical remission and response standard dose 40 / 20 mg eow N = 93
Maltese: Tabella 26 studju ta' CD fit-tfal qlib għall-aħjar fl-istat kliniku u rispons kliniku tal-PCDAI
English: week 26
Maltese: Tabella 25
English: ≥30% reduction in skin painb
Maltese: ≥30% tnaqqis fl-uġigħ fil-ġildab
English: Of 342 subjects originally randomized to adalimumab monotherapy or adalimumab / methotrexate combination therapy who entered the open-label extension study, 171 subjects completed 10 years of adalimumab treatment.
Maltese: Ir-rispons għaż-żewġ sezzjonijiet ta' kura mhux ikkombinata kien simili (p = 0.447). Minn 342 suġġetti li oriġinarjament kienu magħżula b'mod każwali għal monoterapija b'adalimumab jew terapija kkombinata b'adalimumab / methotrexate li daħlu fl-istudju ta' estensjoni open-label, 171 suġġetti temmew 10 snin ta' kondizzjoni b'adalimumab.
English: • neurological infections (including viral meningitis);
Maltese: • infezzjonijiet newroloġiċi (li jinkludu meninġite virali);
English: The recommended Hefiya dose for patients with plaque psoriasis from 4 to 17 years of age is based on body weight (table 3).
Maltese: Id-doża rrakkomandata ta' Hefiya f'pazjenti bil-psorjasi tal-plakka mill-età ta' 4 sa 17-il sena hija bbażata fuq il-piż tal- ġisem (tabella 3).
English: Limited information from the published literature indicates that adalimumab is excreted in breast milk at very low concentrations with the presence of adalimumab in human milk at concentrations of 0.1 % to 1 % of the maternal serum level.
Maltese: Informazzjoni limitata mil-litteratura ppubblikata tindika li adalimumab joħroġ mal-ħalib tas-sider talbniedem f'konċentrazzjonijiet baxxi ħafna bil-preżenza ta' adalimumab fil-ħalib tal-bniedem f'konċentrazzjonijiet ta' 0.1% sa 1% tal-livell tas-serum maternali.
English: Multipack containing 6 (3 packs of 2) pre-filled syringes in a blister Packs of 1 and 2 pre-filled pens
Maltese: Pakkett multiplu li fih 6 (3 pakketti ta' 2) pinen mimlijin għal-lest
English: Date
Maltese: Data
English: Conditions
Maltese: Kondizzjonijiet
English: 31 July 2016
Maltese: 31 ta' Lulju 2016
English: • same data lock point (31st of December of each year),
Maltese: • l-istess data lock point (31 ta' Diċembru ta' kull sena),
English: 31 March 2014 and annually thereafter
Maltese: 31 ta' Marzu 2014 u kull sena wara dan
English: Final study report by:
Maltese: Rapport finali tal-istudju sa:
English: • same exposure definition (expressed in 100,000 patients treated - daily dose of 100 mg equivalents),
Maltese: • l-istess definizzjoni ta' espożizzjoni (espressa f'100,000 pazjent li rċevew kura - doża ta' kuljum f'ekwivalenti ta' 100 mg),
English: • and use the severity classification according to Ring and Messmer classification.
Maltese: • u jużaw il-klassifika ta' severità skont il-klassifika ta' Ring u Messmer.
English: • same event definition (use of the specific PT “Hypersensitivity” and the narrow and broad scope SMQs for “Anaphylactic reactions and angioedema”: the MAHs should confirm their coding convention for capturing symptoms and diagnosis as MedDRA terms)
Maltese: • l-istess definizzjoni ta' avveniment (l-użu tal-PT speċifiku “Sensittività eċċessiva” u l-kamp ta' applikazzjoni dejjaq u wiesa ta' SMQs għal “Reazzjonijiet anafilattiċi u angjoedema”: il-MAHs għandhom jikkonfermaw ilkonvenzjoni tal-kodifikazzjoni tagħhom biex jaqbdu ssintomi u d-dijanjosi bħala termini MedDRA)
English: For products without an RMP, a RMP should be submitted.
Maltese: Għallprodotti mingħajr RMP, RMP għandu jiġi ppreżentat.
English: Annex IV Conditions to the marketing authorisations
Maltese: Anness IV
English: Within 30 days following EC decision
Maltese: Fi żmien 30 jum middeċiżjoni tal-KE
English: The MAHs should submit annual cumulative reviews of hypersensitivity case reports, all fatal cases and all pregnancy cases, together with usage data yearly.
Maltese: Il-MAHs għandhom jissottomettu reviżjonijiet kumulattivi annwali tar-rapporti ta' każijiet ta' sensittività eċċessiva, il-każijiet fatali kollha u l-każijiet kollha ta' tqala, flimkien ma' dejta dwar l-użu kull sena.
English: The MAHs should update the risk management plan (RMP) for products with an existing RMP to include the additional risk minimisation measures and the additional pharmacovigilance activities agreed as part of this procedure.
Maltese: Il-MAHs għandhom jaġġornaw il-pjan għall-ġestjoni tar-riskju (RMP) għal prodotti b'RMP eżistenti biex jiġu nklużi l-miżuri addizzjonali għall-minimizzazzjoni tar-riskji u l-attivitajiet addizzjonali ta' farmakoviġilanza miftiehma bħala parti minn din il-proċedura.
English: National competent authorities of Member State(s) coordinated by reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Maltese: L-awtoritajiet nazzjonali kompetenti tal-Istat(i) Membru(i) ikkoordinati mill-Istat(i) Membru(i) ta' referenza jekk applikabbli, għandhom jiżguraw li l-kondizzjonijiet li ġejjin ikunu sodisfatti mill-MAH(s):
English: The MAHs should circulate the agreed DHPC in coordination with the NCAs according to the action plan agreed by CHMP.
Maltese: Il-MAHs għandhom jiċċirkolaw id-DHPC miftiehma f'koordinazzjoni mal-NCAs skont il-pjan ta' azzjoni miftiehem mis-CHMP.
English: This will highlight the risks and warnings on hypersensitivity reactions (by e.g. a checklist, to be implemented at national level).
Maltese: Dan se jenfasizza r-riskji u t-twissijiet dwar reazzjonijiet ta' sensittività eċċessiva (eż/ permezz ta' lista ta' kontroll, li għandha tiġi implimentata fuq livell nazzjonali).
English: The MAH(s) should provide within the risk management plan educational material for prescribers and patients.
Maltese: Il-MAH(s) għandu(hom) jipprovdi(u) fil-pjan għall-ġestjoni tar-riskju materjal edukattiv għal minn jippreskrivi u għall-pazjenti.
English: EMA/460814/2013 EMEA/H/C/002542
Maltese: 26 ta' Lulju 2013 EMA/460814/2013 EMEA/H/C/002542
English: What is Xeljanz?
Maltese: X'inhu Xeljanz?
English: The company that applied for authorisation is Pfizer Limited.
Maltese: Il-kumpanija li applikat għall-awtorizzazzjoni hija Pfizer Limited.
English: Xeljanz is a medicine that contains the active substance tofacitinib.
Maltese: Xeljanz huwa mediċina li fiha s-sustanza attiva tofaċitinib.
English: It was to be available as tablets (5 mg).
Maltese: Kellu jkun disponibbli bħala pilloli (5 mg).
English: The active substance in Xeljanz, tofacitinib, is an immunosuppressant (a medicine that reduces the activity of the immune system) that works by blocking the action of enzymes known as Janus kinases.
Maltese: Is-sustanza attiva f'Xeljanz, it-tofaċitinib, hija immunosuppressiva, (mediċina li tnaqqas l-attività tassistema immunitarja) li taħdem billi timblokka l-azzjoni ta' enzimi magħrufa bħala kinażi ta' Janus.
English: What was Xeljanz expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża Xeljanz?
English: Xeljanz was expected to be used in the treatment of moderate to severe active rheumatoid arthritis (an immune system disease causing damage and inflammation in the joints).
Maltese: Xeljanz kien mistenni li jintuża għall-kura ta' artrite idjopatika attiva moderata sa severa (marda tassistema immunitarja li tikkawża ħsara u infjammazzjoni fil-ġogi).
English: On 25 April 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Xeljanz, intended for the treatment of rheumatoid arthritis.
Maltese: Fil-25 ta' April 2003, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, fejn irrakkomanda r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq għall-prodott mediċinali Xeljanz, maħsub għall-kura tal-artrite idjopatika.
English: The CHMP had major concerns about the overall safety profile of Xeljanz.
Maltese: Is-CHMP kellu tħassib serju dwar il-profil ta' sigurtà ġenerali ta' Xeljanz.
English: Biological DMARDs are medicines that target specific proteins in the immune system.
Maltese: DMARDs bijoloġiċi huma mediċini li jimmiraw lejn proteini speċifiċi fis-sistema immunitarja.
English: These studies compared Xeljanz (in a dose of 5 or 10 mg twice daily) with placebo (a dummy treatment), either alone or as an addition to other background medicines (DMARDs).
Maltese: Dawn l-istudju qabblu Xeljanz (b'doża ta' 5 jew 10 mg darbtejn kuljum) ma' plaċebo (trattament finta), jew waħedha jew flimkien ma' mediċini ta' sfond oħra (DMARDs).
English: However, the studies were not sufficient to show a consistent reduction in disease activity and structural damage to joints, particularly at the lower 5-mg dose of Xeljanz and in the target population of patients in whom treatment with at least two other DMARDs has been unsuccessful.
Maltese: Madankollu, l-istudji ma kinux suffiċjenti biex jindikaw tnaqqis konsistenti fl-attività talmarda u l-ħsara strutturali fil-ġogi, b'mod partikolari bid-doża aktar baxxa ta' 5-mg ta' Xeljanz u filpopolazzjoni fil-mira ta' pazjenti fejn il-kura b'tal anqas żewġ DMARDs oħra ma rnexxietx.
English: In April 2013, the Committee considered that, taken together, the data from the five main studies showed that treatment with Xeljanz resulted in an improvement in the signs and symptoms of rheumatoid arthritis and the physical function of patients.
Maltese: F'April 2013, il-Kumitat ikkunsidra li, meta wieħed janalizza b'mod konġunt id-dejta tal-ħames studji ewlenin, il-kura b'Xeljanz irriżultat f'titjib fis-sinjali u s-sintomi ta' artrite idjopatika u l-funzjoni fiżika tal-pazjenti.
English: These safety concerns also included a risk of other severe side effects including certain cancers, gastro-intestinal perforations (holes in the wall of the gut), liver damage and problems with increased lipid (fat) levels in the blood.
Maltese: Dan it-tħassib dwar is-sigurtà kien jinkludi wkoll effetti kollaterali severi oħra inklużi ċerti kanċers, perforazzjonijiet gastro-intestinali (toqob fil-ħajt tal-musrana), ħsara fil-fwied u problemi minħabba żieda fil-livelli tal-lipidi (xaħam) fid-demm.
English: There were significant and unresolved concerns about the risk and type of serious infections seen with tofacitinib, which are related to the immunosuppressant action of the medicine.
Maltese: Kien hemm tħassib sinifikanti u mhux solvut dwar ir-riskju u t-tip ta' infezzjonijiet serji li rriżultaw b'tofaċitinib, li huma relatati malazzjoni immunosuppressiva tal-mediċina.
English: Therefore, in April 2013 the CHMP was of the opinion that the benefits of Xeljanz did not outweigh its risks and recommended that it be refused marketing authorisation.
Maltese: Għalhekk, f'April 2013, is-CHMP kien tal-opinjoni li l-benefiċċji ta' Xeljanz ma kinux jaqbżu r-riskji tiegħu u rrakkomanda li tiġi rrifjutata l-awtorizzazzjoni għat-tqegħid fis-suq.
English: The effects of Xeljanz were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Xeljanz inizjalment ġew ittestjati fuq mudelli sperimentali qabel ma ġew studjati filbnedmin.
English: They are produced by a method known as ‘recombinant DNA technology': they are made by cells that have received a gene (DNA) that makes them able to produce the medicine.
Maltese: Dawn huma prodotti minn metodu magħruf bħala “teknoloġija tad-DNA rikombinanti”:
English: 26 July 2013
Maltese: EMA/460814/2013
English: However, the lack of robust evidence on prevention of structural damage with Xeljanz in the proposed dose and population still contributed to the Committee's view that the benefits of treatment did not outweigh significant and unresolved concerns about safety.
Maltese: Madankollu, in-nuqqas ta' evidenza b'saħħitha dwar il-prevenzjoni ta' ħsara stutturali b'Xeljanz bid-doża u fil-popolazzjoni proposta xorta waħda kkontribwixxa għall-opinjoni tal-Kumitat li l-benefiċċji tal-kura ma kinux jaqbżu t-tħassib sinifikanti u mhux solvut dwar is-sigurtà.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 25 July 2013.
Maltese: Wara li kkunsidra r-raġunijiet għal din it-talba, is-CHMP eżamina mill-ġdid l-opinjoni inizjali, u kkonferma r-rifjut tal-awtorizzazzjoni għat-tqegħid fissuq fil-25 ta' Lulju 2013.
English: The main measures of effectiveness were changes in patient scores for signs and symptoms of disease, physical function of the patient, structural damage to joints and disease activity; these were measured after 3 or 6 months, depending on the study.
Maltese: Il-kejl ewlieni tal-effikaċja kienu l-bidliet fil-punteġġi tal-pazjenti għas-sinjali u s-sintomi tal-marda, il-funzjoni fiżika tal-pazjent, il-ħsara strutturali fil-ġogi u l-l-attività tal-marda; dawn ġew imkejla wara 3 xhur jew 6 xhur, skont l-istudju.
English: It was not clear that these risks could be managed successfully in medical practice.
Maltese: Ma kienx ċar jekk dawn ir-riskji setgħux jiġu mmaniġġati b'suċċess fil-prattika medika.
English: The applicant requested a re-examination of the opinion.
Maltese: L-applikant talab eżaminazzjoni mill-ġdid tal-opinjoni.
English: See section 4.
Maltese: Ara taqsima 4.
English: Pancreatitis (including necrotising pancreatitis)
Maltese: (including necrotising pancreatitis)
English: Important information
Maltese: Informazzjoni importanti
English: Insulin glargine4
Maltese: Insulina glargine4
English: Ethnic origin
Maltese: Oriġini etnika
English: 6.2 Incompatibilities
Maltese: .2 Inkompatibbilitajiet
English: MedDRA system organ classes
Maltese: Sistema talklassifika tal organi MedDRA
English: Hazard Ratio (95% CI)
Maltese: (95% CI)
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Maltese: 6.1 Lista ta' eċċipjenti
English: ATC code: A10BJ02
Maltese: A10BJ02
English: - The active substance is liraglutide.
Maltese: - Is-sustanza attiva hi liraglutide.
English: 1 pen 2 pens 3 pens 5 pens 10 pens
Maltese: pinna 1 2 pinen 3 pinen 5 pinen 10 pinen
English: Placebo Victoza
Maltese: Plaċebo Victoza
English: ≤5.5 mmol/l (≤100 mg/dl) Target
Maltese: ≤ 5.5 mmol/l (≤100 mg/dl) Il-Mira
English: Liraglutide was superior in preventing MACE vs placebo (Figure 1).
Maltese: Liraglutide kien superjuri fil-prevenzjoni ta' MACE vs plaċebo (Figura 1).
English: Primary endpoint - MACE Components of MACE:
Maltese: L-għan primarju - MACE Komponenti tal-MACE:
English: The duration of observation was a minimum of 3.5 years and up to a maximum of 5 years.
Maltese: L-osservazzjoni damet minimu ta' 3.5 snin u sa massimu ta' 5 snin.
English: • Microvascular evaluation
Maltese: • Evalwazzjoni mikrovaskulari
English: Oral contraceptives
Maltese: Kontraċettivi orali
English: Warfarin and other coumarin derivatives
Maltese: Warfarin u derivattivi oħra ta' coumarin
English: Novo Nordisk A/S Novo Allé DK-2880 Bagsværd Denmark
Maltese: DK-2880 Bagsværd Id-Danimarka
English: Summary of the safety profile
Maltese: Sommarju tal-profil ta' sigurtà
English: • Abdominal discomfort
Maltese: • Skonfort addominali
English: Acute pancreatitis
Maltese: Pankreatite akuta
English: Liraglutide is extensively bound to plasma proteins (>98%).
Maltese: Liraglutide jintrabat b'mod estensiv mal-proteini fil-plażma (>98%).
English: • Gastro-oesophageal reflux disease (GORD).
Maltese: • Mard tar-rifluss gastro-esofagali (GORD).
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Maltese: Mediċini http://www.ema.europa.eu
English: Add-on to SGLT2i5 ± metformin (≥1500 mg/day)
Maltese: Żieda ma' SGLT2i5 ± metformin (≥1500 mg/jum)
English: Insulin
Maltese: Insulina
English: Victoza 6 mg/ml injection Liraglutide
Maltese: Victoza 6 mg/ml injezzjoni Liraglutide
English: • Immunogenicity
Maltese: • Immunoġeniċità
English: • Sulfonylurea (such as glimepiride or glibenclamide) or insulin.
Maltese: • Sulfonylurea (bħal glimepiride jew glibenclamide) jew insulina.
English: • Inflamed stomach (gastritis).
Maltese: • Stonku infjammat (gastrite).
English: For further instructions on administration, see section 6.6.
Maltese: Għal aktar istruzzjonijiet dwar l-għoti, ara taqsima 6.6.
English: Acute pancreatitis has been observed with the use of GLP-1 receptor agonists.
Maltese: Ġiet osservata pankreatite akuta bl-użu ta' agonisti tar-riċetturi ta' GLP-1.
English: Two minor plasma metabolites were detected (≤9% and ≤5% of total plasma radioactivity exposure).
Maltese: Fil-plażma ġew ukoll osservati żewġ metaboliti minuri (≤9% u ≤5% tal-espożizzjoni totali ta' radjuattività fil-plażma).
English: Victoza is available in packs containing 1, 2, 3, 5 or 10 pens.
Maltese: Victoza hu disponibbli f'pakketti li jkun fihom 1, 2, 3, 5 jew 10 pinen.
English: Nervous system disorders
Maltese: Disturbi fissistema nervuża
English: Patients (%) achieving
Maltese: Pazjenti (%)
English: Figure 2: Forest plot of analyses of individual cardiovascular event types - FAS population
Maltese: Figura 2: Skema Forest ta' analiżi tat-tipi individwali ta' avvenimenti kardjovaskulariPopolazzjoni FAS
English: Gastrointestinal adverse reactions
Maltese: Reazzjonijiet avversi gastrointestinali
English: • Increase of pancreatic enzymes (such as lipase and amylase).
Maltese: • Żieda fl-enzimi pankreatiċi (bħal lipase u amylase).
English: UNIQUE IDENTIFIER - 2D BARCODE
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D barcode 2D li jkollu l-identifikatur uniku inkluż.>
English: • Warfarin or other oral anti-coagulation medicines.
Maltese: • Warfarin jew mediċini oħra kontra l-koagulazzjoni.
English: Victoza contains the active substance liraglutide.
Maltese: Victoza fih is-sustanza attiva liraglutide.
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista kompluta ta' eċċipjenti, ara taqsima 6.1.
English: The mean age was 64 years and the mean BMI was 32.5 kg/m².
Maltese: L-età medja kienet ta' 64 sena u l-medja tal-BMI kienet ta' 32.5 kg/m².
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); not known (cannot be estimated from the available data).
Maltese: 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), mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: Liraglutide is not a substitute for insulin.
Maltese: Liraglutide mhuwiex sostitut għall-insulina.
English: Date of first authorisation: 30 June 2009 Date of last renewal: 11 April 2014
Maltese: Data tal-aħħar tiġdid: 11 April 2014
English: Add-on to glimepiride (4 mg/day)
Maltese: Żieda ma' glimepiride (4 mg/jum)
English: The analysis of time to first microvascular event for liraglutide vs placebo had a HR of 0.84 [0.73, 0.97].
Maltese: L-analiżi taż-żmien sal-ewwel avveniment mikrovaskulari għal liraglutide vs plaċebo kellu HR ta' 0.84 [0.73, 0.97].
English: • Diarrhoea.
Maltese: • Dijarea.
English: >5.5 and <6.7 mmol/l (>100 and <120 mg/dl) 0-2 IUa ≥6.7 mmol/l (≥120 mg/dl)
Maltese: M'hemmx bżonn ta' aġġustament > 5.5 u ≤ 6.7 mmol/ (> 100 u <120 mg/dl) 0-2 UIa
English: The treatment difference in HbA1c was 1.3% after additional 26 weeks of open label extension, confirming the sustained glycaemic control with Victoza.
Maltese: Id differenza fit-trattament fl-HbA1c kien ta' 1.3% wara 26 ġimgħa oħra ta' estensjoni open label, li jikkonferma l-kontroll gliċemiku sostnut ta' Victoza.
English: Figure 1: Kaplan Meier plot of time to first MACE - FAS population
Maltese: Figura 1 Skema Kaplan Meier taż-żmien għall-ewwel MACE - Popolazzjoni FAS
English: Placebo
Maltese: Plaċebo
English: When combining liraglutide with metformin, 20.7% of patients reported at least one episode of nausea, and 12.6% of patients reported at least one episode of diarrhoea.
Maltese: Meta ħadu liraglutide flimkien ma' metformin, 20.7% tal-pazjenti rrappurtaw mill-inqas episodju wieħed ta' nawseja, u 12.6% tal-pazjenti rrappurtaw mill-inqas episodju wieħed ta' dijarea.
English: Liraglutide lowered ethinyloestradiol and levonorgestrel Cmax by 12 and 13%, respectively, following administration of a single dose of an oral contraceptive product.
Maltese: Liraglutide baxxa s-Cmax ta' ethinyloestradiol u levonorgestrel bi 12 u 13%, rispettivament, wara lgħoti ta' doża waħda ta' prodott kontraċettiv orali.
English: In the LEADER trial, microvascular events comprised nephropathy and retinopathy outcomes.
Maltese: Fil-prova LEADER, l-avvenimenti mikrovaskulari kienu jinkludu inċidenti nefropatiċi u retinopatiċi.
English: • Allergic reactions like pruritus (itching) and urticaria (a type of skin rash)
Maltese: • Reazzjonijiet allerġiċi bħal pruritus (ħakk) u urtikarja (tip ta' raxx fil-ġilda)
English: Table 1 lists adverse reactions reported in long-term phase 3a controlled trials, the LEADER trial (a long-term cardiovascular outcome trial) and spontaneous (post-marketing) reports.
Maltese: Tabella 1 telenka reazzjonijiet avversi rrapurtati fi provi kkontrollati fit-tul ta' Fażi 3a, il-prova LEADER (prova dwar l-effett kardjovaskulari wara użu fit-tul) u rapporti spontanji (wara t-tqegħid fis-suq).
English: Patients at risk
Maltese: Pazjenti f'riskju
English: Very rare
Maltese: Rari ħafna
English: To improve gastro-intestinal tolerability, the starting dose is 0.6 mg liraglutide daily.
Maltese: Biex ittejjeb it-tollerabilità gastro-intestinali, fil-bidu d-doża għandha tkun ta' 0.6 mg liraglutide kuljum.
English: Table 2 Liraglutide clinical phase 3 trials in monotherapy (52 weeks) and in combination with oral antidiabetics (26 weeks)
Maltese: Tabella 2 Provi kliniċi ta' fażi 3 b'liraglutide f'monoterapija (52 ġimgħa) u flimkien ma' antidijabetiċi orali (26 ġimgħa)
English: Favours Victoza Favours Placebo
Maltese: Jiffavorixxi Plaċebo
English: Gastrointestinal adverse events were more frequently reported with liraglutide treatment (43.6% vs 37.1%).
Maltese: Avvenimenti avversi gastrointestinali ġew irrapportatati b'mod aktar frekwenti bit-trattament ta' liraglutide (43.6% vs