FrancophonIA/ELRC3.0 huggingface dataset:
English: While no evidence was available to indicate that the pharmacokinetic and residue depletion behaviour following administration of the different nitroxinil containing products would be identical to that seen in the available study, the conservative approach adopted in the interpretation of the available data ensures that the resulting recommendation is valid for all nitroxinil containing products.
Maltese: Filwaqt li ma kien hemm l-ebda evidenza disponibbli biex tindika li l-imġiba farmakokinetika u tat-tnaqqis tar-residwi wara l-għoti tal-prodotti differenti li fihom nitroxinil sejra tkun identika għal dik osservata fl-istudju disponibbli, l-approċċ konservattiv adottat fl-interpretazzjoni taddejta disponibbli jiżgura li r-rakkomandazzjoni li tirriżulta hija valida għall-prodotti kollha li fihom nitroxinil.
English: Thesis.
Maltese: Teżi.
English: Tolomec Plus Clorsulon Ivermectin subcutaneous Cattle
Maltese: Tolomec Plus Klorsulon Ivermectin
English: Minimum safe time span
Maltese: Medda minima sigura ta' żmien
English: MERIAL's grounds for requesting a re-examination of the CVMP opinion focused on the fact that the results of a study using its marketed nitroxinil containing solution for injection indicate that by 71 days after administration of the product to dry cattle, residues in milk were at or below 20 µg/l, which the CVMP concluded to be a level of residues in milk that would not represent a consumer safety concern.
Maltese: Ir-raġunijiet ta' MERIAL għat-talba ta' eżaminazzjoni mill ġdid tal-opinjoni tas-CVMP iffokaw fuq il-fatt li r-riżultati ta' studju li uża soluzzjoni għal injezzjoni li fiha nitroxinil mqiegħda fis-suq minnha jindikaw li sa 71 jum wara l-għoti tal-prodott lill-baqar imnixxfin, ir-residwi fil-ħalib kienu ta' jew taħt l-20 µg/l, li s-CVMP ikkonkluda li kien livell ta' residwi fil-ħalib li ma jirrappreżentax tħassib għas-sigurtà talkonsumatur.
English: A pharmacokinetic study was provided in which 5 lactating cows were administered a single subcutaneous injection of clorsulon.
Maltese: Ġie pprovdut studju farmakokinetiku li fih 5 baqar li kienu qegħdin jaħilbu ngħataw injezzjoni unika ta' Klorsulon taħt il-ġilda.
English: 5 g/100ml intramuscular / subcutaneous
Maltese: 5 g/100ml intramuskulari / taħt il-ġilda
English: Assuming consumption of 1.5 l of milk per day and a marker to total residues ratio of 0.6, it is concluded that the concentration of triclabendazole in milk that can be considered safe is 10 µg/l.
Maltese: Jekk wieħed jassumi konsum ta' 1.5 litri ta' ħalib kuljum u proporzjon tal-markatur għar-residwi totali ta' 0.6, wieħed jikkonkludi li lkonċentrazzjoni ta' Triklabendażol fil-ħalib li tista' titqies sigura hija ta' 10 µg/l.
English: Consideration of realistic safe time spans
Maltese: Kunsiderazzjoni ta' meded realistiċi u siguri ta' żmien
English: Assuming consumption of 1.5 l of milk per day and a marker to total residues ratio of 0.3, it is concluded that the concentration of rafoxanide in milk that can be considered safe is 6 µg/l.
Maltese: Jekk wieħed jassumi konsum ta' 1.5 litri ta' ħalib kuljum u proporzjon tal-markatur għar-residwi totali ta' 0.3, wieħed jikkonkludi li l-konċentrazzjoni ta' rafoxanide fil-ħalib li tista' titqies sigura hija ta' 6 µg/l.
English: Intervet Production s.r.l.
Maltese: Intervet Production s.r.l. via Nettunense km 20300
English: The oral administration residue depletion study (study 1 above) demonstrated that milk from animals treated during the dry period between 45 and 56 days before calving may contain concentrations of closantel greater than 45 μg/l.
Maltese: L-istudju ta' tnaqqis tar-residwi wara għoti orali (studju 1 hawn fuq) wera li l-ħalib minn annimali kkurati matul il-perjodu xott bejn 45 u 56 jum qabel ma welldu jista' jkun fih konċentrazzjonijiet ta' Klożantel akbar minn 45 µg/l.
English: M. For products listed in Annex I containing triclabendazole and moxidectin as active substances and administered as pour-on to cattle:
Maltese: Għall-prodotti elenkati fl-Anness 1 li fihom Triklabendażol u moxidectin bħala sustanzi attivi u li jingħataw permezz ta' sustanza li titferra' lill-baqar:
English: Overall summary of the scientific evaluation of veterinary medicinal products containing active substances belonging to the class of flukicides for which no maximum residue limit has been established in milk and which are intended for use in ruminants producing milk for human consumption (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' prodotti mediċinali veterinarji li fihom sustanzi attivi li jappartjenu għall-klassi ta' flukicides li għalihom l-ebda limitu massimu ta' residwi ma ġie stabbilit fil-ħalib u li huma maħsuba għallużu fl-annimali li jixtarru li jipproduċu l-ħalib għall-konsum mill-bniedem (ara Anness I)
English: It is also noteworthy that the CVMP recommendation relating to the use of nitroxinil in cattle is meant to be applicable to all nitroxinil containing products including those with different formulations and strengths.
Maltese: Għandu jiġi nnotat ukoll li r-rakkomandazzjoni tas-CVMP dwar l-użu ta' nitroxinil fil-baqar hija maħsuba li tiġi applikata għall-prodotti kollha li fihom nitroxinil inkluż dawk b'formulazzjonijiet u qawwiet differenti.
English: IVOMEC PLUS Clorsulon Ivermectin subcutaneous Cattle
Maltese: IVOMEC PLUS Klorsulon Ivermectin
English: As the metabolism of clorsulon in milk has not been characterised, any estimation of a marker to total residues ratio should be conservative.
Maltese: Peress li lmetaboliżmu ta' Klorsulon fil-ħalib ma ġiex ikkaraterizzat, kull stima ta' proporzjon tal-markatur għarresidwi totali għandha tkun konservattiva.
English: Fasifree 10% Triclabendazole 100 mg/ml
Maltese: Fasifree 10% Triklabendażol
English: Fascinex 5% Triclabendazole 50 mg/ml
Maltese: Fascinex 5% Triklabendażol
English: Mectaject Plus Clorsulon Ivermectin subcutaneous Cattle
Maltese: Mectaject Plus Klorsulon Ivermectin
English: The marker residue established for tissues is the ‘sum of extractable residues which may be oxidised to ketotriclabendazole'.
Maltese: Ir-residwu markatur stabbilit għat-tessuti huwa s-‘somma ta' residwi li jistgħu jiġu estratti li jistgħu jiġu ossidizzati fi ketoTriklabendażol'.
English: Pharmacokinetic study in which 16 male cattle were administered single subcutaneous injections of one of two closantel formulations, at doses of 5 mg/kg bw.
Maltese: Studju 3. Studju farmakokinetiku li fih 16-il baqra maskili ngħataw injezzjoni unika taħt il-ġilda ta' waħda miż-żewġ formulazzjonijiet ta' Klożantel, f'dożi ta' 5 mg/kg tal-piż tal-ġisem.
English: However, it must be emphasised that these data are limited, with very few studies specifically addressing the depletion of residues of relevant substances in dry cattle/sheep/goats.
Maltese: Madankollu, għandu jiġi enfasizzat li din id-dejta hija limitata, bi ftit studji li speċifikament jindirizzaw it-tnaqqis ta' residwi ta' sustanzi rilevanti filbaqar/nagħaġ/mogħoż imnixxfin.
English: If no such data are available, the milk to plasma ratio could, in principle, be calculated on the basis of the pKa, degree of lipid solubility (ie the relative concentrations of ionised and unionised free drug), the degree of protein binding in plasma and milk, and assuming standard pH values for plasma and milk (Rasmussen, 1966).
Maltese: Jekk ma jkunx hemm dejta bħal din disponibbli, il-proporzjon tal-ħalib għall-plażma jista', fil-prinċipju, jiġi kkalkolat abbażi talpKa, il-grad tas-solubbiltà tal-lipidi (jiġifieri l-konċentrazzjonijiet relattivi tal-mediċina jonizzata u mhux jonizzata), il-grad ta' rbit mal-proteini fil-plażma u fil-ħalib, u bis-suppożizzjoni ta' valuri standard talpH għall-plażma u għall-ħalib (Rasmussen, 1966).
English: Fascicur 5% Triclabendazole 50 mg/ml
Maltese: Fascicur 5% Triklabendażol
English: Defining a safe concentration for nitroxinil in milk - cattle
Maltese: Id-definizzjoni ta' konċentrazzjoni sigura għall nitroxinil fil-ħalib - baqar
English: Fascinex 10% Triclabendazole 100 mg/ml
Maltese: Fascinex 10% Triklabendażol
English: The ‘SCLR' (Safe concentrations based on linear regression)4 method was used to extrapolate from the combined plasma depletion data available for the two formulations used in study 2.
Maltese: ġie użat biex issir estrapolazzjoni mid-dejta kkombinata dwar it-tnaqqis fil-plażma disponibbli għaż-żewġ formulazzjonijiet użati fl-istudju 2.
English: Czech Republic
Maltese: UNITED KINGDOM
English: Using the Time-To-Safe-Concentration (TTSC) method, the time point at which the 95th percentile of the treated population would have plasma closantel concentrations below 2250 μg/l with 95% confidence was calculated for each of the two formulations for which data were presented in study 3.
Maltese: Bl-użu tal-metodu taż-Żmien Għal Konċentrazzjoni Sigura (TTSC), ġie ikkalkolat il-punt fiż-żmien li fih il-95 perċentili tal-popolazzjoni kkurata jkollha konċentrazzjonijiet ta' Klorsulon fil-plażma taħt l-2250 µg/l b'kunfidenza ta' 95% għal kull wieħed mill-żewġ formulazzjonijiet li għalihom id-dejta kienet ippreżentata fl-istudju 3. Iż-żmien meħtieġ biex il-livelli ta' Klożantel fil-plażma jonqsu għal 2250 µg/l kien ikkalkolat li kien ta' 1780 siegħa (madwar 75 jum) għal formulazzjoni waħda u ta' 1931 siegħa (madwar 81 jum) għallformulazzjoni l-oħra.
English: However, as clorsulon was established as the marker residue in cattle tissues (CVMP Summary Report, 2008) and as the parent compound has been identified in bovine milk in a number of studies, clorsulon was also considered to be an appropriate marker residue for use in milk.
Maltese: Madankollu, peress li Klorsulon ġie stabbilit bħala r-residwu markatur fit-tessut tal-bovini (Rapport ta' Sinteżi tas-CVMP, 2008) u peress li l-kompost ġenitur kien ġie identifikat fil-ħalib tal-bovini f'għadd ta' studji, Klorsulon kien ikkunsidrat ukoll bħala residwu markatur xieraq għall-użu fil-ħalib.
English: Although 119 days was considered sufficient to allow for the depletion of residues of closantel to a safe concentration, as ivermectin was not within the scope of this referral and was therefore not evaluated, it was not possible to conclude whether 119 days would also allow residues of ivermectin to deplete to safe levels.
Maltese: Għalkemm 119-il jum kienu kkunsidrati biżżejjed biex jippermettu t-tnaqqis tar-residwi ta' Klożantel għal konċentrazzjoni sigura, peress li ivermectin ma kienx fil-kamp ta' applikazzjoni ta' dan riferiment u għalhekk ma ġiex evalwat, ma kienx possibbli li jiġi konkluż jekk il119-il jum jippermettux ukoll li r-residwi ta' ivermectin jonqsu għal livelli siguri.
English: E. For products listed in Annex I containing nitoxinil as sole active substance and administered subcutaneously to cattle:
Maltese: Għall-prodotti elenkati fl-Anness 1 li fihom nitoxinil bħala l-unika sustanza attiva u li jingħataw taħt il-ġilda lill-baqar:
English: Data are available on plasma closantel levels following oral administration (study 2 above) at the recommended dose.
Maltese: Hemm dejta disponibbli dwar il-livelli ta' Klożantel fil-plażma wara l-għoti orali (studju 2 hawn fuq) fid-doża rakkomandata.
English: The remaining 30% of the ADI corresponds to 27 µg triclabendazole residues.
Maltese: It-30% tal-ADI li fadal jikkorrispondi għal 70 µg ta' residwi ta' Triklabendażol.
English: Finally, the test for residues of nitroxinil in milk, which the marketing authorisation holder suggested could be used to ensure that residue levels remain below the safe level even following early calvings, has not been taken into account in this evaluation due to the lack of detailed information on the test in question.
Maltese: Fl-aħħarnett, it-test għal residwi ta' nitroxinil fil-ħalib, li d-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq issuġġerixxa li jista' jintuża biex jiġi żgurat li l-livelli ta' residwi jibqgħu taħt il-livell sigur anki wara twelid kmieni talgħoġġiela, ma kienx ġie kkunsidrat f'din l-evalwazzjoni minħabba n-nuqqas ta' informazzjoni ddettaljata dwar it-test inkwistjoni.
English: Triclaben 10% Triclabendazole 100 mg/ml
Maltese: Triclaben 10% Triklabendażol
English: 30 mg/ml
Maltese: 12 g/100 ml
English: Both the immature and mature flukes are harmful to the target species, and each flukicide has varying efficacy against different ages of fluke.
Maltese: Kemm il-parassiti immaturi u maturi huma ta' ħsara għall-ispeċi fil-mira, u kull flukicide għandu effikaċja differenti kontra etajiet differenti ta' parassiti.
English: The only available residue study (study 1) demonstrates that milk from animals whose dry period lasted at least 71 days did not contain nitroxinil at levels above 20 μg/l.
Maltese: L-uniku studju disponibbli tar-residwi (studju 1) juri li l-ħalib minn annimali li l-perjodu niexef dam mill-anqas 71 jum ma kienx fih nitroxinil f'livelli ogħla minn 20 µg/l.
English: Fascicur 10% Triclabendazole 100 mg/ml
Maltese: Fascicur 10% Triklabendażol
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Maltese: Is-Sommarju tal-karateristiċi tal-prodott, tabellar, u fuljett ta' tagħrif huma l-verzjonijiet finali ottentuti waqt il-proċedura tal-grupp Koordinazzjoni.
English: Note: This SmPC, labelling and packages leaflet is the version valid at the time of Commission decision.
Maltese: Nota: Din SPC, tabellar, u fuljett ta' tagħrif huwa il-verżjoni valida fil-ħin tad-deċiżjoni tallKummissjoni.
English: Summary of product characteristics, labelling and package leaflet
Maltese: Sommarju tal-karateristiċi tal-prodott, tabellar, fuljett ta' tagħrif
English: After the Commission decision the Member State competent authorities, in liaison with the reference Member State, will update the product information as required.
Maltese: Wara id- deċiżjoni tall-Kummissjoni l-awtoritajiet kompetenti ta' l-istat membru, flimkien ma' l-istat membru ta' referenza, jaġġorna l-informazzjoni fuq il-prodott kif inhu meħtieġ.
English: Therefore, this SmPC, labelling and package leaflet may not necessarily represent the current text.
Maltese: B'hekk, din l-SPC, tabellar, u fuljett ta' tagħrif mhux bilfors jirrapreżenta t-test kurrenti.
English: The Mutual Recognition Procedure (UK/V/0145/001/II/007) started on 30 January 2009.
Maltese: Il-Proċedura ta' Rikonoxximent Reċiproku (UK/V/0145/001/II/007) bdiet fit-30 ta' Jannar 2009.
English: referral for Porcilis
Maltese: Porcilis PRRS
English: PRRS
Maltese: III.
English: Porcilis PRRS is an immunological veterinary medicinal product containing the Porcine Reproductive and Respiratory Syndrome (PRRS) virus.
Maltese: Porcillis PRRS huwa prodott mediċinali veterinarju immunoloġiku li fih il-virus tas-Sindromu Respiratorju u Riproduttiv tal-Majjali (PRRS).
English: Article 6(12) of Commission Regulation (EC) No 1084/2003.
Maltese: L-Artikolu 6(12) tar-Regolament tal-Kummissjoni (KE) Nru 1084/2003.
English: The application was submitted in the framework of Article 6 of Commission Regulation (EC) No 1084/2003, where the Reference Member State was the United Kingdom and the Concerned Member States were Austria, Belgium, Germany, Greece, Spain, France, Ireland, Italy, Luxembourg, the Netherlands and Portugal.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq Intervet International B.V. issottometta applikazzjoni għal varjazzjoni ta' Tip II soġġetta għall-Proċedura ta' Rikonoxximent Reċiproku għal Porcillis PRRS fir-rigward ta' għoti fl-istess ħin ma' Porcillis M Hyo. L-applikazzjoni ġiet sottomessa skont il-qafas tal-Artikolu 6 tar-Regolament tal-Kummissjoni (KE) Nru 1084/2003, fejn l-Istat Membru ta' Referenza kien ir-Renju Unit u l-Istati Membri Kkonċernati kienu l-Awstrija, il-Belġju, il-Ġermanja, il-Greċja, Spanja, Franza, l-Irlanda, l-Italja, il-Lussemburgu, l-Olanda u l-Portugall.
English: Written explanations were provided by the marketing authorisation holder on 15 January 2010 and supplementary information was submitted on 20 April
Maltese: Ġew ipprovduti spjegazzjonijiet bil-miktub mid-detentur talawtorizzazzjoni għat-tqegħid fis-suq fil-15 ta' Jannar 2010 u fl-20 ta' April 2010 ġiet ippreżentata informazzjoni supplimentari.
English: On 2 October 2009 the United Kingdom, referred the matter to the Agency under Article 39 of Directive 2001/82/EC as amended by reference to Article 6(12) of Regulation (EC) No 1084/2003 due to concerns raised by Spain relating to the quality and efficacy of the simultaneous administration of Porcilis PRRS with Porcilis M Hyo.
Maltese: Fit-2 ta' Ottubru 2009, ir-Renju Unit, irrefera l-kwistjoni lill-Aġenzija skont l-Artikolu 39 tad-Direttiva 2001/82/KE kif emendata permezz ta' referenza għall-Artikolu 6(12) tar-Regolament (KE) Nru 1084/2003 minħabba tħassib imqajjem minn Spanja dwar il-kwalità u l-effikaċja ta' għoti fl-istess ħin ta' Porcillis PRRS ma' Porcillis M Hyo.
English: Based on the rapporteurs' assessment of the currently available data, the CVMP adopted, on 19 May 2010, an opinion recommending that the variation application applied for the veterinary medicinal product Porcilis PRRS satisfies the criteria for approval.
Maltese: Fuq il-bażi tal-istima li għamlu r-rapporteurs tad-data disponibbli dak il-ħin, fid-19 ta' Mejju 2010, isCVMP adotta opinjoni li tirrakkomanda li l-applikazzjoni għall-varjazzjoni applikata għall-prodott mediċinali veterinarju Porcillis PRRS tissodisfa l-kriterji għall-approvazzjoni.
English: Further information on Steglujan 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: • patients who are already taking ertugliflozin and sitagliptin as separate tablets.
Maltese: • pazjenti li diġà qegħdin jieħdu ertugliflozin u sitagliptin bħala pilloli separati.
English: HbA1c levels fell by between 0.8 and 0.9 points, compared with a fall of 0.1 with placebo.
Maltese: Il-livelli ta' HbA1c naqsu b'bejn 0.8 u 0.9 punti, meta mqabbel ma' tnaqqis ta' 0.1 bil-plaċebo.
English: Other information about Steglujan
Maltese: Informazzjoni oħra dwar Steglujan
English: Steglujan is available as tablets in 2 strengths of ertugliflozin and sitagliptin (5 mg/100 mg and 15 mg/100 mg) and can only be obtained with a prescription.
Maltese: Steglujan jiġi bħala pilloli f'2 qawwiet ta' ertugliflozin u sitagliptin (5 mg/100 mg u 15 mg/100 mg) u jista' jinkiseb biss b'riċetta ta' tabib.
English: Steglujan contains the active substances ertugliflozin and sitagliptin.
Maltese: Steglujan fih is-sustanzi attivi ertugliflozin u sitagliptin.
English: This study found that adding Steglujan to diet and exercise was much more effective than placebo, with HbA1c levels falling by between 1.6 and 1.7 points with the combination of ertugliflozin and sitagliptin compared with a fall of 0.4 points with placebo.
Maltese: Dan l-istudju sab li ż-żieda ta' Steglujan mad-dieta u mal-eżerċizzju kienet ħafna aktar effettiva mill-plaċebo, bil-livelli ta' HbA1c li naqsu b'bejn 1.6 u 1.7 punti bil-kombinazzjoni ta' ertugliflozin u sitagliptin meta mqabbel ma' tnaqqis ta' 0.4 punti bil-plaċebo.
English: Treatment with the combination of ertugliflozin and sitagliptin lowered HbA1c levels by up to 1.5 percentage points, compared with reductions of up to 1.1 for ertugliflozin and for sitagliptin on their own.
Maltese: Il-kura bil-kombinazzjoni ta' ertugliflozin u sitagliptin baxxiet il-livelli ta' HbA1c b'sa 1.5 punti perċentwali, meta mqabbel ma' tnaqqis sa 1.1 għal ertugliflozin u għal sitagliptin waħidhom.
English: At the start of the studies, patients' HbA1c was above 7.0%.
Maltese: Fil-bidu tal-istudji, HbA1c tal-pazjenti kienu ‘l fuq minn 7.0 %.
English: The recommended starting dose is one 5 mg/100 mg tablet taken once a day.
Maltese: Id-doża rakkomandata tal-bidu hija pillola waħda ta' 5 mg/100 mg darba kuljum.
English: It does this by blocking a protein in the kidneys (called SGLT2) that normally takes glucose back into the blood from the kidneys.
Maltese: Dan tagħmlu billi timblokka proteina fil-kliewi (imsejħa SGLT2) li normalment tieħu l-glukożju lura fid-demm mill-kliewi.
English: Steglujan is a medicine used to control blood glucose (sugar) levels in adults with type 2 diabetes.
Maltese: Steglujan huwa mediċina li tintuża biex tikkontrolla l-livelli tal-glukożju (taz-zokkor) fid-demm f'adulti b'dijabete tat-tip 2.
English: Regarding safety, this was considered in line with that of other medicines of the same class.
Maltese: Fir-rigward tas-sigurtà, din tqieset li hija konformi ma' dik ta' mediċini oħra tal-istess klassi.
English: These hormones stimulate the pancreas to produce insulin.
Maltese: Dawn l-ormoni jistimulaw il-frixa biex tipproduċi l-insulina.
English: Three main studies, involving 1,987 patients showed that Steglujan was effective at lowering blood glucose levels in patients with type 2 diabetes, as measured by the decrease in blood levels of HbA1c (a measure of blood glucose) after 6 months of treatment.
Maltese: Tliet studji ewlenin, li involvew 1,987 pazjent urew li Steglujan kien effettiv biex ibaxxi l-livelli talglukożju fid-demm f'pazjenti b'dijabete tat-tip 2, kif imkejjel minn tnaqqis fil-livelli ta' HbA1c fid-demm (kejl tal-glukożju fid-demm) wara 6 xhur ta' kura.
English: The most common side effects with Steglujan (which may affect more than 1 in 10 people) are fungal infections of the vagina and other infections of the female reproductive system.
Maltese: L-effetti sekondarji l-aktar komuni b'Steglujan (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma infezzjonijiet fungali tal-vaġina u infezzjonijiet oħra tas-sistema riproduttiva tal-mara.
English: What are the risks associated with Steglujan?
Maltese: X'inhuma r-riskji assoċjati ma' Steglujan?
English: The second study found that adding ertugliflozin to a combination of sitagliptin and metformin was more effective than placebo (a dummy treatment).
Maltese: It-tieni studju sab li ż-żieda ta' ertugliflozin għal kombinazzjoni ta' sitagliptin u metformina kienet aktar effettiva mill-plaċebo (kura finta).
English: For the full list of side effects and restrictions with Steglujan, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u restrizzjonijiet bi Steglujan, ara l-fuljett ta' tagħrif.
English: The two active substances in Steglujan work in different ways to lower glucose levels:
Maltese: Iż-żewġ sustanzi attivi f'Steglujan jaħdmu b'modi differenti biex ibaxxu l-livelli tal-glukożju:
English: How does Steglujan work?
Maltese: Kif jintuża Steglujan?
English: The first study, in patients who were all taking metformin, compared the combination of ertugliflozin and sitagliptin with ertugliflozin or sitagliptin on their own.
Maltese: L-ewwel studju, f'pazjenti li kollha kienu qegħdin jieħdu metmorfina, qabbel il-kombinazzjoni ta' ertugliflozin u sitagliptin ma' ertugliflozin jew sitagliptin waħidhom.
English: As for all medicines, data on the use of Steglujan is continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Steglujan hija ssorveljata kontinwament.
English: • patients whose blood glucose levels are not satisfactorily controlled with the diabetes medicines metformin and/or a sulphonylurea, in combination with either ertugliflozin or sitagliptin;
Maltese: • pazjenti li l-livelli tal-glukożju fid-demm tagħhom ma jiġux ikkontrollati b'mod sodisfaċenti bil mediċini tad-dijabete metformina u/jew sulfonilurea, flimkien ma' jew ertugliflozin jew sitagliptin;
English: Sitagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Maltese: Billi l-azzjoni tal-ormoni ta' inkretin tittawwal, dan jagħmel lill-frixa tipproduċi aktar insulina meta l-livelli tal-glukożju fid-demm ikunu għoljin.
English: Why is Steglujan authorised in the EU?
Maltese: Għaliex Steglujan ġie awtorizzat fl-EU?
English: In patients whose blood sugar needs further control, the dose can be increased to one 15 mg/100 mg tablet once a day.
Maltese: F'pazjenti li z-zokkor fid-demm tagħhom jeħtieġ aktar kontroll, id-doża tista' tiżdied għal pillola waħda ta' 15 mg/100 mg darba kuljum.