FrancophonIA/ELRC3.0 huggingface dataset:
English: The review was carried out by EMA's Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's opinion.
Maltese: Ir-rieżami sar mill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-EMA, responsabbli għal mistoqsijiet dwar mediċini għall-użu mill-bniedem, li adotta l-opinjoni tal-Aġenzija.
English: 1 The 6 and 4 years refer to the duration of time NDMA and NDEA are believed to have been present in valsartan from Zhejiang Huahai sartans because manufacturers had inadvertently used contaminated equipment or reagents in the manufacturing process.
Maltese: 1 Is-snin 6 u 4 jirreferu għat-tul ta' żmien li l-NDMA u l-NDEA huma maħsuba li kienu preżenti f'valsartan minn Zhejiang Huahai
English: The review estimated the highest possible cancer risk with these impurities.
Maltese: Ir-rieżami vvaluta l-ogħla riskju possibbli ta' kanċer b'dawn l-impuritajiet.
English: 2 International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) Guidance: M7(R1)
Maltese: 2 Il-Gwida tal-Kunsill Internazzjonali għall-Armonizzazzjoni ta' Rekwiżiti Tekniċi għal Farmaċewtiċi għall-Użu mill-Bniedem (ICH):
English: While the goal is to have no quantifiable nitrosamine impurities in sartans, interim limits have been set for NDMA and NDEA in line with current international guidelines.2
Maltese: Filwaqt li l-għan huwa li ma jkun hemm l-ebda impurità tan-nitrożammini fis-sartans, ġew stabbiliti limiti interim għall-NDMA u l-NDEA f'konformità mal-linji gwida internazzjonali attwali
English: Ref. EMEA/CHMP/512295/2008
Maltese: EMEA/CHMP/511848/2008
English: London, 24 September 2008 Doc.
Maltese: Londra, 24 ta' Settembru 2008 Dok. Ref.
English: Gemzar, 200 mg, 1000 mg, powder for solution for infusion, is a pyrimidine antagonist and is given in the management of solid tumours.
Maltese: Gemzar, 200 mg, 1000 mg, trab għal soluzzjoni għal infużjoni, huwa antagonista ta' pyrimidine u jingħata fit-trattament ta' tumuri solidi.
English: The Marketing Authorisation Holder provided supplementary information on 20 December 2007.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq ta informazzjoni supplimentari fl-20 ta' Diċembru 2007.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Gemzar International Non-Proprietary Name (INN): gemcitabine
Maltese: GĦALL-UŻU MILL-BNIEDEM (CHMP) OPINJONI WARA RIFERIMENT SKONT L-ARTIKOLU 30 GĦAL Gemzar Denominazzjoni Komuni Internazzjonali (DKI): gemcitabine
English: On 8 June 2007, the European Commission presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet including quality aspects of the medicinal product Gemzar.
Maltese: Fit-8 ta' Ġunju 2007, il-Kummissjoni Ewropea ippreżentat lill-EMEA riferment skont l-Artikolu 30 tadDirettiva 2001/83/KE, kif emendata, sabiex jiġu armonizzati s-Sommarji tal-Karatteristiċi tal-Prodott (SPC), it-Tikketta u l-Fuljett ta' Tagħrif awtorizzati fuq livell nazzjonali, inkluż aspetti ta' kwalità talprodott mediċinali Gemzar.
English: This medicinal product belongs to the list of products for SPC harmonisation.
Maltese: Dan il-prodott mediċinali jappartjeni għal-lista ta' prodotti għall-armonizzazzjoni tal-SPC.
English: It is indicated in bladder cancer, advanced non-small cell lung cancer, advanced pancreatic cancer, breast cancer and ovarian cancer.
Maltese: Huwa indikat fil-kanċer tal-bużżieqa tal-awrina, kanċer avvanzat talpulmun ta' ċelloli mhux żgħar, kanċer avvanzat tal-frixa, kanċer tas-sider u kanċer tal-ovarji.
English: The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) including quality aspects of Gemzar approved across EU Member States, mainly with respect to the approved indications, the posology, the contra-indications and the warnings.
Maltese: Il-bażi tar-riferiment kienet li kien hemm diverġenzi fis-Sommarji tal-Karatteristiċi tal-Prodott (SPC) inkluż l-aspetti ta' kwalità ta' Gemzar approvati madwar l-Istati Membri tal-UE l-iktar fir-rigward talindikazzjonijiet approvati, il-pożoloġija, il-kontra-indikazzjonijiet u t-twissijiet.
English: The CHMP gave a positive opinion on 26 June 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet including quality aspects for Gemzar.
Maltese: Is-CHMP ta opinjoni pożittiva fis-26 ta' Ġunju 2008 u rrakkomanda l-armonizzazzjoni tal-SPC, Tikketta u Fuljett ta' Tagħrif inkluż l-aspetti ta' kwalità għal Gemzar.
English: The procedure started on 21 June 2007.
Maltese: Il-proċedura bdiet fil-21 ta' Ġunju 2007.
English: During its June 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package leaflet including the quality aspects was acceptable and that they should be amended.
Maltese: Matul il-laqgħa tiegħu ta' Ġunju 2008, is-CHMP, fid-dawl tad-dejta ġenerali ippreżentata u taddiskussjoni xjentifika fi ħdan il-Kumitat, kien tal-opinjoni li l-proposta għall-armonizzazzjoni tal-SPC, itTikketta u l-Fuljett ta' Tagħrif kienet waħda aċċettabbli u li dawn għandhom jiġu emendati.
English: Oral use bottle (HDPE) 1 x 60 g granules
Maltese: 1 x 60 g granijiet
English: 33 mg/g Granules
Maltese: EU/1/01/200/003 Viread 33 mg/g Granijiet
English: The full EPAR for Karvezide 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: Karvezide irbesartan / hydrochlorothiazide
Maltese: Karvezide irbesartan/idroklorotijażide (hydrochlorothiazide)
English: This is a summary of the European public assessment report (EPAR) for Karvezide.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Karvezide.
English: The most common side effects with Karvezide (seen in between 1 and 10 patients in 100) are dizziness, nausea (feeling sick) or vomiting, abnormal urination, fatigue (tiredness), and increases in blood urea nitrogen (BUN, a breakdown product of protein), creatinine (a breakdown product of muscle) and creatine kinase (an enzyme found in muscles).
Maltese: L-iktar effett sekondarju komuni ma' Karvezide (li deher f'bejn pazjent wieħed u 10 minn kull 100) huma l-isturdament, dardir jew remettar, awrinar mhux normali, għeja, u żidiet fil-livelli ta' nitroġenu fl-urea tad-demm (BUN, prodott tat-tkissir tal-proteini), kreatinina (prodott tat-tkissir tal-muskoli) u kreatina kinażi (creatine kinase, enzim fil-muskoli).
English: The European Commission granted a marketing authorisation valid throughout the EU for Karvezide on 16 October 1998.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Karvezide fis16 ta' Ottubru 1998.
English: Karvezide contains two active substances, irbesartan and hydrochlorothiazide.
Maltese: Karvezide fih żewġ sustanzi attivi, l-irbesartan u l-idroklorotijażide.
English: Why has Karvezide been approved?
Maltese: Għaliex ġie approvat Karvezide?
English: Karvezide must also not be used in patients who have severe liver, kidney or bile problems, blood potassium levels that are too low or blood calcium levels that are too high.
Maltese: Karvezida lanqas ma għandux jintuża f'pazjenti li jkollhom problemi gravi fil-fwied, filkliewi jew fis-sistema biljari, livelli baxxi wisq ta' potassju, u livelli għoljin wisq ta' kalċju.
English: Karvezide is a medicine that contains two active substances, irbesartan and hydrochlorothiazide.
Maltese: Karvezide huwa mediċina li fiha żewġ sustanzi attivi, l-irbesartan u l-idroklorotijażide.
English: What is the risk associated with Karvezide?
Maltese: X'inhu r-riskju assoċjat ma' Karvezide?
English: Karvezide must not be used in people who are hypersensitive (allergic) to irbesartan, hydrochlorothiazide, sulfonamides, or any of the other ingredients.
Maltese: Karvezide ma għandux jintuża f'persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal irbesartan, għallidroklorotijażide, għas-sulfonamidi, jew għal kwalunkwe ingredjent ieħor.
English: What is Karvezide?
Maltese: X'inhu Karvezide?
English: Karvezide in combination with aliskiren-containing medicines (used to treat essential hypertension) must not be used in patients with diabetes, or moderate or severe kidney impairment.
Maltese: Karvezide ma għandux jintuża flimkien ma' mediċini li fihom l-aliskiren (użat fil-kura tal-ipertensjoni essenzjali) f'pazjenti bid-dijabete, jew insuffiċjenza moderata jew gravi fil-kliewi.
English: For the full list of all side effects reported with Karvezide, see the package leaflet.
Maltese: Għal-lista sħiħa ta' effetti sekondarji rrappurati ma' Karvezide, ara l-fuljett ta' tagħrif.
English: Karvezide may be added to some other treatments for hypertension.
Maltese: Karvezide jista' jiżdied ma' trattamenti oħra għall-ipertensjoni.
English: How has Karvezide been studied?
Maltese: Kif ġie studjat Karvezide?
English: The studies of Karvea/Aprovel used with hydrochlorothiazide as separate tablets were used to support the use of Karvezide.
Maltese: L-istudji ta' Karvea/Aprovel użat mal-idroklorotijażide bħala pilloli separati ntużaw b'appoġġ għall-użu ta' Karvezide.
English: The CHMP decided that Karvezide's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Karvezide huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Other information about Karvezide
Maltese: Kif jintuża Karvezide?
English: Ref. EMEA/403687/2009 EMEA/A-29/1094
Maltese: EMEA/403702/2009 EMEA/A-29/1094
English: Dr. Ondřej Slanař (Czech Republic)
Maltese: Ondřej Slanař (Repubblika Ċeka)
English: Dr. Karl Broich (Germany)
Maltese: Karl Broich (Ġermanja)
English: London, 4 June 2009 Doc.
Maltese: Londra, 4 ta' Ġunju 2009 Dok. ta' Ref.
English: Betavert N is a ‘generic medicine'.
Maltese: Betavert N huwa ‘mediċina ġenerika'.
English: What is Betavert N?
Maltese: X'inhu Betavert N?
English: Questions and answers on the referral for Betavert N tablets containing betahistine dihydrochloride (8 or 16 mg)
Maltese: Mistoqsija u tweġiba dwar ir-referenza għal Betavert N pilloli li fihom betaistina dikloridrat (betahistine dihydrochloride - 8 jew 16 mg)
English: The company wanted the authorisation to be recognised in Austria, Bulgaria, the Czech Republic, Hungary, Poland, Romania and Slovakia (the concerned Member States).
Maltese: Il-kumpanija xtaqet li lawtorizzazzjoni tkun rikonoxxuta mill-Awstrija, il-Bulgarija, ir-Repubblika Ċeka, l-Ungerija, ilPolonja, ir-Rumanija u s-Slovakkja (l-Istati Membri kkonċernati).
English: The active substance in Betavert N, betahistine, is an analogue of histamine, a naturally-occurring substance in the body that is involved in many processes.
Maltese: Is-sustanza attiva f'Betavert N, betaistina, hija analogu tal-istamina, sustanza li tiġi prodotta b'mod naturali fil-ġisem u li hija involuta f'bosta proċessi.
English: Hennig Arzneimittel GmbH & Co. KG submitted Betavert N for mutual recognition on the basis of the initial authorisation granted by Germany on 18 April 2007.
Maltese: KG ressqu Betavert N għal rikonoxximent reċiproku abbażi talawtorizzazzjoni inizjali li ngħatat mill-Ġermanja fit-18 ta' April 2007.
English: Company responses provided on: 11 February 2009 Opinion date:
Maltese: Tweġibiet tal-kumpaniji pprovduti fi: 11 ta' Frar 2009 Data tal-opinjoni:
English: This means that Betavert N is similar to a ‘reference medicine' already authorised in the European Union (EU) called Betaserc 8.
Maltese: Dan ifisser li Betavert N jixbah lil ‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) magħrufa bħala Betaserc 8.
English: Medicines are bioequivalent when they produce the same levels of active substance in the body.
Maltese: Il-mediċini huma bijoekwivalenti meta jipproduċu l-istess livelli ta' sustanza attiva fil-ġisem.
English: Why was Betavert N reviewed?
Maltese: Għaliex ġie rivedut Betavert N?
English: The grounds for the referral were concerns expressed by the Czech Republic that Betavert N had not been shown to be bioequivalent to Betaserc 8.
Maltese: Ir-raġunijiet għar-referenza kienu t-tħassib mir-Repubblika Ċeka li Betavert N ma kienx intwera li kien bijoekwivalenti għal Betaserc 8.
English: The CHMP therefore concluded that Betavert N could be considered a generic medicine of Betaserc 8, and the marketing authorisation for Betavert N should be granted in all concerned Member States.
Maltese: Għalhekk, is-CHMP kkonklulda li Betavert N jista' jiġi kkunsidrat bħala mediċina ġenerika ta' Betaserc 8 u l-awtorizzazzjoni għat-tqegħid fis-suq għal Betavert N għandha tingħata flIstati Membri kolla kkonċernati.
English: The European Medicines Agency (EMEA) has completed an arbitration procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Betavert N. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Betavert N outweigh its risks, and the marketing authorisation granted in Germany can be recognised in other Member States of the European Union.
Maltese: L-Aġenzija Ewropea għall-Mediċini (EMEA) temmet proċedura ta' arbitraġġ wara nuqqas ta' ftehim bejn l-Istati Membri tal-Unjoni Ewropew rigward l-awtorizzazzjoni tal-mediċina Betavert N.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP was of the opinion that bioequivalence between Betavert N and Betaserc 8 had been demonstrated.
Maltese: Abbażi tal-evalwazzjoni tad-dejta li hija disponibbli bħalissa u d-diskussjoni xjentifika fi ħdan ilKumitat, is-CHMP kien tal-opinjoni li kienet intweriet il-bijoekwivalenza bejn Betavert N u Betaserc 8.
English: Menière's disease is a disease where an accumulation of fluid in the inner ear causes a build-up of pressure.
Maltese: Din hija marda fejn l-akkumulu ta' fluwidu fil-parti interna tal-widna tikkawża akkumulu ta' pressjoni.
English: FAS: full analysis set.
Maltese: Sett sħiħ ta' analiżiFAS: full analysis set.
English: Cumulative Frequency (%)
Maltese: Frekwenza Kumulattiva (%)
English: CI=confidence interval.
Maltese: CI (confidence interval)=intervall ta' kunfidenza.
English: SD=standard deviation.
Maltese: SD (standard deviation)=devjazzjoni standard.
English: ***See section 4.4.
Maltese: ***Ara sezzjoni 4.4.
English: Baseline, kg (SD)
Maltese: Linja bażi, kg (SD)
English: Table 2 lists adverse reactions reported.
Maltese: Tabella 2 telenka reazzjonijiet avversi rrapurtati.
English: Placebo Liraglutide
Maltese: Plaċebo Liraglutide
English: Saxenda vs. placebo
Maltese: Saxenda vs. plaċebo
English: Cholelithiasis*** Cholecystitis***
Maltese: Kolelitijasi*** Koleċistite***
English: Pancreatitis*** Delayed gastric emptying****
Maltese: Pankreatite*** Tbattil gastriku mdewwem****
English: Apnoea-Hypopnoea Index (AHI)
Maltese: Indiċi Apnea-Ipopnea (AHI - Apnoea-Hypopnoea Index)
English: ****From controlled phase 2, 3a and 3b clinical trials.
Maltese: ****Minn provi kliniċi kkontrollati ta' fażi 2, 3a u 3b.
English: • ≥30 kg/m² (obese), or
Maltese: • ≥30 kg/m² (obeżi), jew
English: Table 2 Adverse reactions reported MedDRA system organ classes
Maltese: Tabella 2 Ir-reazzjonijiet avversi rrappuratati Klassi tas-sistemi u tal-organi MedDRA
English: Liraglutide is extensively bound to plasma protein (>98%).
Maltese: Liraglutide jintrabat b'mod estensiv mal-proteini fil-plażma (>98%).
English: Table 1 Dose escalation schedule Dose
Maltese: Tabella 1 Skeda ta' eskalazzjoni tad-doża Doża
English: HR: 0.87 95% CI 0.78; 0.97 p<0.001 for non-inferiority p=0.005 for superiority
Maltese: 95% CI 0.78; 0.97 p<0.001 għal mhux inferjuri p=0.005 għas-superjorità
English: • increase of pancreatic enzymes, such as lipase and amylase.
Maltese: • Żieda fl-enzimi pankreatiċi, bħal lipase u amylase.
English: Saxenda (N=1472) Placebo (N=738)
Maltese: Saxenda (N=1472) Plaċebo (N=738)
English: * p<0.05.
Maltese: * p<0.05. ** p<0.
English: Liraglutide significantly reduced the rate of major adverse cardiovascular events (primary endpoint events, MACE) vs. placebo (3.41 vs. 3.90 per 100 patient years of observation in the liraglutide and placebo groups, respectively) with a risk reduction of 13%, HR 0.87, [0.78, 0.97] [95% CI]) (p=0.005) (see figure 4).
Maltese: Liraglutide naqqas b'mod sinifikanti r-rata ta' avvenimenti avversi maġġuri kardjovaskulari (avvenimenti tal-għan primarju, MACE) vs plaċebo (3.41 vs. 3.90 għal kull 100 pazjent għal kull sena ta' osservazzjoni fil-gruppi ta' liraglutide u plaċebo,rispettivament) b'tnaqqis fir-riskju ta' 13%, HR 0.87, [0.78, 0.97] [95% CI]) (p=0.005) (ara figura 4).
English: Patients ≥65 years of age may experience more gastrointestinal effects when treated with Saxenda.
Maltese: Pazjenti ta' età ta' ≥65 sena jista' jkollhom aktar effetti gastrointestinali meta jiġu kkurati b'Saxenda.
English: Saxenda 6 mg/ml injection liraglutide
Maltese: Saxenda 6 mg/ml injezzjoni liraglutide
English: In clinical trials, 2.5% of patients treated with liraglutide developed anti-liraglutide antibodies.
Maltese: Fi provi kliniċi, 2.5% tal-pazjenti kkurati b'liraglutide żviluppaw antikorpi kontra liraglutide.
English: Systolic blood pressure, mmHg
Maltese: Pressjoni sistolika tad-demm, mmHg
English: Liraglutide exposure was lowered by 33%, 14%, 27% and 26%, respectively, in patients with mild (creatinine clearance, CrCl 50-80 ml/min), moderate (CrCl 30-50 ml/min) and severe (CrCl <30 ml/min) renal impairment and in end-stage renal disease requiring dialysis.
Maltese: L-espożizzjoni ta' liraglutide tbaxxiet bi 33%, 14%, 27% u 26%, rispettivament, f'pazjenti b'indeboliment tal-kliewi ħafif (tneħħija tal-kreatinina, CrCl 50-80 ml/min), moderat (CrCl 30-50 ml/min), u sever (CrCl <30 ml/min) u meta kien hemm mard tal-kliewi li wasal fl-aħħar stadju u li kien jeħtieġ id-dijalisi.
English: *human glucagon-like peptide-1 (GLP-1) analogue produced by recombinant DNA technology in Saccharomyces cerevisiae.
Maltese: * analogu ta' glucagon-like peptide-1 (GLP-1) uman magħmul minn teknoloġija tad-DNA rikombinanti f'Saccharomyces cerevisiae.
English: The duration of exposure was between 3.5 and 5 years.
Maltese: Iż-żmien ta' espożizzjoni kien ta' bejn 3.5 u 5 snin.
English: EU/1/15/992/001-003
Maltese: EU/1/15/992/003 5 x 3 ml
English: uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Maltese: Il-kategoriji ta' frekwenza huma definiti bħala: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000).
English: Acute renal failure Renal impairment
Maltese: Insuffiċjenza renali akuta Indeboliment renali
English: Interaction studies have been performed with 1.8 mg liraglutide.
Maltese: Studji ta' interazzjoni twettqu b'1.8 mg liraglutide.
English: Novo Nordisk A/S Hallas Allé 4400 Kalundborg Denmark
Maltese: 4400 Kalundborg
English: The liraglutide exposure in adolescents (age 12-17 years) was similar to that in adults with obesity.
Maltese: L-espożizzjoni ta' liraglutide fl-adolexxenti (età 12-17-il sena), kienet simili għal dik fl-adulti obeżi.
English: Date of first authorisation: 23 March 2015 Date of latest renewal:
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 23 Marzu 2015
English: FPG=fasting plasma glucose.
Maltese: FPG (fasting plasma glucose)=glucose fil-plażma fl-istat sajjem.
English: Saxenda is available in pack sizes containing 1, 3 or 5 pens.
Maltese: Saxenda hu disponibbli f'pakketti li jkun fihom 1, 3 jew 5 pinen.
English: Cartridge (type 1 glass) with a plunger (bromobutyl) and a laminate rubber sheet (bromobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene, polyacetal, polycarbonate and acrylonitrile butadiene styrene.
Maltese: Skartoċċ (ħġieġ ta' tip I), bi planġer (bromobutyl) u folja laminata tal-lastku (bromobutyl/polyisoprene) f'pinna mimlija għal-lest b'ħafna dożi u li tintrema wara li tintuża, magħmula minn polypropylene, polyacetal, polycarbonate u acrylonitrile butadiene styrene.
English: Overall, gastrointestinal reactions were the most frequently reported adverse reactions during treatment (67.9%) (see section ‘Description of selected adverse reactions').
Maltese: B'mod ġenerali, ir-reazzjonijiet gastrointestinali kienu l-aktar reazzjonijiet avversi rrappurtati b'mod frekwenti waqt it-trattament (67.9 %) (ara s-sezzjoni ‘Deskrizzjoni ta' reazzjonijiet avversi partikulari').
English: Excipients: disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid/sodium hydroxide (for pH adjustment), water for injections
Maltese: Eċċipjenti: disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid/sodium hydroxide (għal aġġustament tal-pH), ilma għall-injezzjonijiet
English: Major adverse cardiovascular events (MACE) were adjudicated by an external independent group of experts and defined as non-fatal myocardial infarction, non-fatal stroke and cardiovascular death.
Maltese: Avvenimenti kardjovaskulari avversi maġġuri (MACE - major adverse cardiovascular events) ġew aġġudikati minn grupp estern indipendenti ta' esperti u definiti bħala infart mijokardijaku mhux fatali, puplesija mhux fatali u mewt kardjovaskulari.
English: Novo Nordisk A/S Novo Allé 2880 Bagsværd Denmark
Maltese: 2880 Bagsværd Id-Danimarka
English: Liraglutide is an acylated human glucagon-like peptide-1 (GLP-1) analogue with 97% amino acid sequence homology to endogenous human GLP-1.
Maltese: Liraglutide hu analogu uman aċilat ta' peptide-1 li jixbaħ lil glucagon (GLP-1) b'omoloġija fissekwenza tal-amminoaċidi ta' GLP-1 endoġenu uman ta' 97%.
English: The Liraglutide Effect and Action in Diabetes Evaluation of Cardiovascular Outcomes Results (LEADER) trial included 9,340 patients with insufficiently controlled type 2 diabetes.
Maltese: Il-prova tal-Liraglutide Effect and Action in Diabetes Evaluation of Cardiovascular Outcomes Results (LEADER) kellha 9,340 pazjent bid-dijabete tat-tip 2 li ma kinitx ikkontrollata tajjeb.
English: Other medicines and Saxenda
Maltese: Mediċini oħra u Saxenda
English: Liraglutide lowered ethinylestradiol 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: Liraglutide binds to and activates the GLP-1 receptor (GLP-1R).
Maltese: Liraglutide jintrabat ma', u jattiva r riċettur GLP-1 (GLP-1R).
English: Clinical trials suggest that liraglutide improves and sustains beta-cell function, according to HOMA-B and the proinsulin-to-insulin ratio.
Maltese: Il-provi kliniċi jissuġġerixxu li liraglutide itejjeb u jsostni l-funzjoni taċ-ċelluli beta, skont HOMA-B, u l-proporzjon ta' proinsulina mal-insulina.
English: Please see section ‘Description of selected adverse reactions' for further information.
Maltese: Jekk jogħġbok ara s-sezzjoni ‘Deskrizzjoni ta' reazzjonijiet avversi partikulari' għal aktar informazzjoni.
English: Insomnia**
Maltese: Ipogliċemija*
English: Among patients not concomitantly treated with sulfonylurea, 15.7% of patients treated with Saxenda and 7.6% of patients treated with placebo reported documented symptomatic hypoglycaemic events (defined as plasma glucose ≤3.9 mmol/L accompanied by symptoms).
Maltese: Fost il-pazjenti li ma kinux ikkurati fl-istess ħin b'sulfonylurea, 15.7% tal-pazjenti kkurati b'Saxenda u 7.6% tal-pazjenti kkurati bi plaċebo, irrappurtaw avvenimenti dokumentati ta' ipogliċemija sintomatika (definita bħala glucose fil-plażma ta' ≤3.9 mmol/L akkompanjata minn sintomi).
English: Figure 4 Kaplan Meier plot of time to first MACE - FAS population
Maltese: Figura 4 Kaplan Meier graff taż-żmien għall-ewwel MACE - Popolazzjoni FAS Popolazzjoni pedjatrika