FrancophonIA/ELRC3.0 huggingface dataset:
English: In principle, it is important to achieve serum testosterone concentrations as low as possible for ADT to minimize stimulation of prostate cancer cells.
Maltese: Filprinċipju, huwa importanti li jinkisbu konċentrazzjonijiet ta' testosteron fis-serum baxxi kemm jista' jkun għal ADT biex tiġi minimizzata l-istimulazzjoni ta' ċelloli tal-kanċer tal-prostata.
English: Route of administration
Maltese: FIL-PAKKETT
English: The CHMP requests the inclusion, as proposed by the Applicant/MAH, of the five pharmacovigilance safety concerns in the Risk Management Plan as mentioned above.
Maltese: Is-CHMP titlob l-inklużjoni kif proposta mill-Applikant/MAH, talħames konsiderazzjonijiet dwar is-sigurtà tal-farmakoviġilanza fil-Pjan tal-Maniġment tar-Riskju kif imsemmi hawn fuq.
English: A distinction should be made between safety aspects of androgen suppression therapy in general and the (local) safety of this product.
Maltese: Trid issir distinzjoni bejn l-aspetti ta' sigurtà ta' terapija ta' soppressjoni ta' androġeni in ġenerali u s-sigurtà lokali ta' dan il-prodott.
English: SCIENTIFIC CONCLUSIONS
Maltese: KONKLUŻONIJIET XJENTIFIĊI
English: On the basis of these limited data, continued androgen suppression in men with androgenindependent prostate cancer (AIPC) is the current standard of care.
Maltese: Fuq il-bażi ta' dan it-tagħrif ristrett, soppressjoni mtennija ta' l-androġeni f'irġiel b'kanċer tal-prostata indipendenti mill-androġeni (AIPC) hija l-istandard ta' kura attwali.
English: Czech Republic AstraZeneca UK Limited 2 Kingdom Street
Maltese: AstraZeneca UK Limited 2 Kingdom Street
English: Luxembourg NV AstraZeneca SA Rue Egide Van Ophem 110
Maltese: NV AstraZeneca SA Rue Egide Van Ophem
English: W2 6BD London
Maltese: W2 6BD London Ir-Renju Unit
English: AstraZeneca A/S Arne Jacobsens Allé 13 Copenhagen S DK-2300
Maltese: AstraZeneca A/S Arne Jacobsens Alle 13 DK-2300 København S Id-Danimarka
English: AstraZeneca Österreich GmbH
Maltese: L-Awstrija AstraZeneca Österreich GmbH
English: Rua Humberto Madeira 7 - Queluz de Baixo Barcarena 2730-097 Portugal
Maltese: Queluz de Baixo 2730-097 Barcarena Il-Portugal
English: ASTRAZENECA 1, place Renault 92844 Rueil Malmaison Cedex FRANCE
Maltese: ASTRAZENECA 1, place Renault 92844
English: 2719 EE Zoetermeer The Netherlands cream; hydrophilic cutaneous use
Maltese: 2719 EE ZOETERMEER Il-Pajjiżi l-Baxxi krema; hydrophilic
English: AstraZeneca UK Limited 600 Capability Green Luton LU1 3LU United Kingdom
Maltese: L-Irlanda AstraZeneca UK Limited 600 Capability Green Luton LU1 3LU
English: AstraZeneca AB Sodertalje
Maltese: AstraZeneca AB
English: AstraZeneca GmbH Tinsdaler Weg 183 22876 Wedel Germany
Maltese: Il-Ġermanja AstraZeneca GmbH 22876 Wedel
English: EMLA 5 POUR CENT, crème
Maltese: POUR CENT, crème
English: Schwarzenbergplatz 7 A-1037 Wien Austria
Maltese: A-1037 Wien
English: 151 85 Gartunavagen Sweden
Maltese: SE-151 85 Sodertalje L-Isvezja
English: AstraZeneca AS Postboks 6050 Etterstad 0601 Oslo
Maltese: Etterstad 0601 OSLO
English: 1180 Bruxelles
Maltese: 1180 Brussel Il-Belġju
English: The Netherlands AstraZeneca B.V. Louis Pasteurlaan 5
Maltese: Louis Pasteurlaan 5
English: Luton LU1 3LU
Maltese: Il-Pajjiżi lBaxxi
English: AstraZeneca Oy Itsehallintokuja 4 02600 Espoo Finland
Maltese: Il-Finlandja AstraZeneca Oy Itsehallintokuja 4
English: Annex I List of the names, pharmaceutical form, strength of the medicinal products, route of administration, Marketing Authorisation Holders in the Member States
Maltese: mediċinali, mnejn jingħata, id-detenturi ta` l-awtorizzazzjoni għat tqegħid fis-suq fl-istati membri
English: Emla 5 % krēms
Maltese: EMLA 5
English: 28033 Madrid
Maltese: 02600 Espoo
English: ASTRAZENECA FARMACEUTICA SPAIN, S.A. Serrano Galvache 56
Maltese: Anness I Lista ta` l-ismijiet, għamla farmaċewtika, qawwa tal-prodott(i)
English: Edificio Roble
Maltese: Il-Greċja
English: Belgium NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Ukkel
Maltese: Il-Belġju NV AstraZeneca SA Egide Van Ophemstraat
English: The full EPAR for Advate 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: The European Commission granted a marketing authorisation valid throughout the EU for Advate on 2 March 2004.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Advate fit2 ta' Marzu 2004.
English: Other information about Advate
Maltese: Aktar informazzjoni dwar Advate
English: The effectiveness of Advate was rated as ‘excellent' or ‘good' in 86% of 510 new bleeding episodes.
Maltese: Leffikaċja ta' Advate ġiet ikklassifikata bħala “eċċellenti” jew “tajba” f'86% ta' 510 episodji ġodda ta' fsada.
English: Common side effects with Advate (affecting between 1 and 10 patients in 100) are headache and pyrexia (fever).
Maltese: Effetti sekondarji komuni b'Advate (li jaffettwaw bejn pazjent 1 u 10 minn 100) huma wġigħ ta' ras u piressija (deni).
English: It contains the active substance octocog alfa (human coagulation factor VIII).
Maltese: Jikkonsisti fissustanza attiva octocog alfa (fattur tal-koagulazzjoni VIII tal-bniedem).
English: Octocog alfa is made by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced that makes them able to produce it.
Maltese: L-octocog alfa tiġi prodotta permezz ta' metodu magħruf bħala ‘teknoloġija tad-DNA rikombinanti': din hija magħmula minn ċelloli li fihom ikun ġie introdott ġene (DNA) li jagħmilhom kapaċi jipproduċuha.
English: This is a summary of the European public assessment report (EPAR) for Advate.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Advate.
English: Because of this Advate has been compared with Recombinate to show that the two medicines are equivalent in one main study including 111 patients with haemophilia A.
Maltese: Minħabba dan, Advate tqabbel ma' Recombinate biex juri li ż-żewġ mediċini huma ekwivalenti fi studju ewlieni li inkluda 111-il pazjent bl-emofilja A.
English: Why is Advate approved?
Maltese: Għaliex ġie approvat Advate?
English: Three additional studies looked at the use of the medicine in the prevention of bleeding and in surgery in patients with severe or moderately severe haemophilia A, including one study in 53 children under the age of 6 years.
Maltese: Tliet studji addizzjonali ħarsu lejn l-użu tal-mediċina fil-prevenzjoni ta' fsada u f'kirurġija f'pazjenti b'emofilja A qawwija jew moderata, inkluż studju fuq 53 tifel u tifla ta' taħt is-6 snin.
English: The data provided on immune tolerance induction in patients with inhibitors were not considered sufficient to specifically approve the medicine for this use.
Maltese: Id-data pprovduta dwar l-istimulazzjoni ta' tolleranza immunitarja fil-pazjenti b'inibituri ma kinitx ikkunsidrata bħala suffiċjenti biex tapprova l-mediċina għal dan l-użu b'mod speċifiku.
English: The study went on to look at the number of bleeding episodes and rated Advate's effectiveness in stopping bleeding on a scale from ‘none' to ‘excellent' in 107 patients, all of whom received Advate.
Maltese: L-istudju ħares ukoll lejn in-numru ta' episodji ta' fsada u l-effikaċja ta' Advate biex iwaqqaf il-fsada ġiet ivvalutata fuq skala minn "xejn" għal "eċċellenti" f'107 pazjenti, li kollha ngħataw Advate.
English: Patients with haemophilia A lack factor VIII, and this causes blood clotting problems, such as bleeding in the joints, muscles or internal organs.
Maltese: Pazjenti bl-emofilja A għandhom nuqqas tal-fattur VIII, u dan jikkawża problemi fit-tagħqid tad-demm, bħal fsada fil-ġogi, fil-muskoli jew fl-organi interni.
English: Advate is similar to another medicine approved in the EU called Recombinate, but it is prepared differently so that there are no human- or animal-derived proteins in the medicine.
Maltese: Advate huwa simili għal mediċina oħra approvata fl-UE, imsejħa Recombinate, iżda huwa ppreparat b'mod differenti sabiex ma jkunx hemm proteini ġejjin mill-bniedem jew mill-annimali f'din il-mediċina.
English: In addition, 81% of these bleeding episodes required only a single treatment with Advate.
Maltese: Barra minn hekk, 81% ta' dawn l-episodji ta' fsada kienu jeħtieġu biss kura waħda ta' Advate.
English: The active substance in Advate, octocog alfa (human coagulation factor VIII), is a substance that helps the blood to clot.
Maltese: Is-sustanza attiva f'Advate, l-octocog alfa (fattur ta' koagulazzjoni VIII tal-bniedem), hija sustanza li tgħin lid-demm jagħqad.
English: Advate is a medicine used for the treatment and prevention of bleeding in patients of all ages with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII).
Maltese: Advate huwa mediċina li tintuża għall-kura u l-prevenzjoni ta' emorraġija f'pazjenti ta' kull età b'emofilja A (disturb ta' emorraġija li jintiret ikkawżat minn nuqqas ta' fattur VIII).
English: There is a risk with factor VIII medicines that some patients will develop inhibitors (antibodies) against factor VIII, causing the medicine to stop working and resulting in a loss of bleeding control.
Maltese: Hemm riskju li bil-mediċini tal-fattur VIII ċerti pazjenti jiżviluppaw inibituri (antikorpi) kontra lfattur VIII, fejn il-mediċina tieqaf tkun taħdem u dan jirriżulta f'telf tal-kontroll tal-fsada.
English: What are the risks associated with Advate?
Maltese: X'inhuma r-riskji assoċjati ma' Advate?
English: The dose and duration of treatment depend on whether Advate is used to treat or prevent bleeding or during surgery, as well as on the patient's factor VIII levels, the seriousness of the haemophilia, the extent and location of the bleeding and the patient's condition and bodyweight.
Maltese: Iddoża u d-durata tal-kura jiddependu minn jekk Advate jintużax għall-kura jew għall-prevenzjoni ta' fsada jew waqt il-kirurġija, kif ukoll mil-livelli tal-fattur VIII tal-pazjent, is-severità tal-emofilja, il-firxa u l-post tal-emorraġija u l-kundizzjoni u l-piż tal-ġisem tal-pazjent.
English: Advate is used to correct the factor VIII deficiency by replacing the missing factor VIII, giving temporary control of the bleeding disorder.
Maltese: Advate jintuża biex jikkoreġi d-defiċjenza tal-fattur VIII billi jissostitwixxi l-fattur VIII nieqes, filwaqt li jagħti kontroll temporanju tad-disturb tal-fsada.
English: Advate given at high dose has been studied to see whether it is effective in clearing antibodies against factor VIII from the blood (a process known as immune tolerance induction) so that treatment with factor VIII remains effective.
Maltese: Saru studji fuq Advate mogħti b'doża għolja biex isir magħruf jekk huwiex effikaċi fit-tneħħija tal-antikorpi kontra l-fattur VIII mid-demm (proċess magħruf bħala stimulazzjoni ta' tolleranza immunitarja) sabiex il-kura bil-fattur VIII tibqa' effikaċi.
English: Advate is available as a powder and solvent that are mixed together to make a solution for injection into a vein.
Maltese: Advate jiġi bħala trab u solvent li jitħalltu flimkien biex jagħmlu soluzzjoni għal injezzjoni ġol-vina.
English: For the full list of all side effects reported with Advate, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Advate, ara l-fuljett ta' tagħrif.
English: Some patients may develop factor VIII inhibitors, which are antibodies (proteins) that the body's immune system produces against factor VIII and which can cause the medicine to stop working resulting in a loss of bleeding control.
Maltese: Xi pazjenti jistgħu jiżviluppaw inibituri tal-fattur VIII, li huma antikorpi (proteini) li s-sistema immunitarja tal-ġisem tipproduċi kontra l-fattur VIII u li jistgħu jikkawżaw il-mediċina tieqaf taħdem u dan iwassal għal telf fil-kontroll tal-fsada.
English: Advate must not be used in people who are hypersensitive (allergic) to human coagulation factor VIII, to mouse or hamster protein, or to any of the other ingredients.
Maltese: Advate m'għandux jintuża minn persuni li huma ipersensittivi (allerġiċi) għall-fattur VIII tal-koagulazzjoni talbniedem, għal proteina tal-ġurdien jew tal-ħamster, jew għal kwalunkwe sustanza oħra tiegħu.
English: Advate can only be obtained with a prescription and treatment should be started by a doctor experienced in the treatment of haemophilia and with resuscitation equipment available in case of severe allergic reaction (anaphylaxis).
Maltese: L-Aġenzija ddeċidiet li l-benefiċċji ta' Advate huma akbar mir-riskji tiegħu u rrakkomandat li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: • Caution in use in the elderly in light of age related risks (in particular bladder cancer, fractures and heart failure).
Maltese: • Kawtela fl-użu fl-anzjani fid-dawl tar-riskji relatati ma' l-età (b'mod partikolari l-kanċer tal bużżieqa, ksur u insuffiċjenza tal-qalb).
English: The MAH shall provide an educational pack targeting all physicians who are expected to prescribe/use Pioglitazone.
Maltese: KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TAL-UŻU MINGĦAJR PERIKLU U EFFETTIV TAL-PRODOTT MEDIĊINALI LI JRIDU JIĠU IMPLIMENTATI
English: Date of first authorisation: 16 November 2015
Maltese: Data tal-ewwel awtorizzazzjoni: 16 ta' Novembru 2015
English: In active- and placebocontrolled clinical trials (dapagliflozin, N=5936, All control, N=3403), the frequency of rash was similar for dapagliflozin (1.4%) and all control (1.4%), respectively.
Maltese: Fi provi kliniċi attivi u kkontrollati bi plaċebo (dapagliflozin, N=5936, Kull kontroll, N=3403), il-frekwenza tar-raxx kienet simili għal dapagliflozin (1.4%) u kull kontroll (1.4%), rispettivament.
English: Posology Adults with normal renal function (glomerular filtration rate [GFR] ≥ 90 mL/min)
Maltese: Pożoloġija Adulti b'funzjoni renali normali (GFR≥ 90 mL/min)
English: The pack sizes are 14, 28, 56 and 60 film-coated tablets in non-perforated blisters, 60x1 film-coated tablets in perforated unit dose blisters and multipack containing 196 (2 packs of 98) film-coated tablets in non-perforated blisters.
Maltese: Id-daqsijiet tal-pakkett huma 14, 28, 56 u 60 pilloli miksijin b'rita f'folji mhux perforati, 60x1pilloli miksijin b'rita f'folji ta' doża waħda perforati u pakkett multiplu li fih 196(2pakketti ta' 98) pilloli miksijin b'rita f'folji mhux perforati.
English: They have “5/1000”
Maltese: Għandhom “5/1000”
English: Mean percent change from baseline for dapagliflozin 10 mg versus placebo, respectively, was: total cholesterol 2.5% versus 0.0%; HDL cholesterol 6.0% versus 2.7%; LDL cholesterol 2.9% versus -1.0%; triglycerides -2.7% versus -0.7%.
Maltese: Il-bidla medja perċentwali mil-linja bażi għal 10 mg dapagliflozin meta mqabbla ma' plaċebo, rispettivament, kienet: kolesterol totali 2.5% kontra 0.0%; kolesterol HDL 6.0% kontra 2.7%; kolesterol LDL 2.9% kontra -1.0%; trigliċeridi -2.7% kontra - 0.7%.
English: Glycaemic control in patients with moderate renal impairment CKD 3A (eGFR ≥ 45 to < 60 mL/min/1.73 m
Maltese: Kontroll gliċemiku f'pazjenti b'indeboliment moderat tal-kliewi CKD 3A (eGFR ≥ 45 sa < 60 mL/min/1.73 m
English: Ebymect 5 mg/850 mg film-coated tablets Polyvinyl alcohol (E1203) Macrogol 3350 (E1521) Talc (E553b)
Maltese: Ebymect 5 mg/850 mg pilloli miksijin b'rita Polyvinyl alcohol (E1203) Macrogol 3350 (E1521) Talc (E553b)
English: Mean eGFR was 85.2 mL/min/1.73 m of patients had eGFR < 60 mL/min/1.73 m2, and 30.3% of patients had micro- or macroalbuminuria (urine albumin to creatinine ratio [UACR] ≥ 30 to ≤ 300 mg/g or > 300 mg/g, respectively).
Maltese: L-eGFR medja kienet 85.2 mL/min/1.73 m2, 7.4% tal-pazjenti kellhom eGFR < 60 mL/min/1.73 m2, u 30.3% tal-pazjenti kellhom mikro- jew makroalbuminurja (proporzjon ta' albumina għal kreatinina fl-awrina [UACR] ≥ 30 sa ≤ 300 mg/g jew > 300 mg/g, rispettivament).
English: Metformin or metformin hydrochloride were part of the usual care in 69.4% and 64.0% of the patients for the dapagliflozin and placebo groups, respectively.
Maltese: Metformin jew metformin hydrochloride kienu parti mill-kura tas-soltu f'69.4 % u f'64.0 % tal-pazjenti għallgruppi ta' dapagliflozin u plaċebo, rispettivament.
English: After administration of a 50 mg C]-dapagliflozin dose, 96% was recovered, 75% in urine and 21% in faeces.
Maltese: C]-dapagliflozin, 96% kien irkuprat, 75% fl-awrina u 21% fl-ippurgar.
English: Subjects with mean daily insulin dose reduction of at least 10% (%)
Maltese: Individwi bi tnaqqis medju fid-doża tal-insulina ta' millinqas 10% kuljum (%)
English: HbA1c < 7% Adjusted for baseline
Maltese: HbA1c < 7% Aġġustat għallinja bażi
English: (95% CI) Subjects (%) achieving: HbA1c < 7% Adjusted for baseline Body weight (kg) Baseline (mean) Change from Baseline Difference from Placebo c
Maltese: (95% CI) Individwi (%) li kisbu: HbA1c < 7% Aġġustat għal-linja bażi Piż tal-ġisem (kg) Linja bażi (medja) Bidla mil-linja bażi Differenza minn Plaċebo c
English: Ebymect 5 mg/1,000 mg film-coated tablets Polyvinyl alcohol (E1203) Macrogol 3350 (E1521)
Maltese: Ebymect 5 mg/1000 mg pilloli miksijin b'rita Polyvinyl alcohol (E1203) Macrogol 3350 (E1521) Talc (E553b)
English: Talc (E553b) Titanium dioxide (E171) Iron oxide yellow (E172)
Maltese: Titanium dioxide (E171) Iron oxide yellow (E172)
English: hypersensitivity to the active substances or to any of the excipients listed in section 6.1; any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis); diabetic pre-coma; severe renal failure (GFR < 30 mL/min) (see sections 4.2, 4.4 and 5.2); acute conditions with the potential to alter renal function such as: - dehydration, - severe infection, - shock; acute or chronic disease which may cause tissue hypoxia such as: - cardiac or respiratory failure, - recent myocardial infarction, - shock; hepatic impairment (see sections 4.2, 4.4 and 5.2); acute alcohol intoxication, alcoholism (see section 4.5).
Maltese: - sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fissezzjoni 6.1 - kull tip ta' aċidożi metabolika akuta (bħal aċidożi lattika, ketoaċidożi dijabetika); - stat dijabetiku ta' qabel il-koma; - insuffiċjenza renali severa (GFR <30 mL/min) (ara sezzjonijiet 4.4 u 5.2); - kundizzjonijiet akuti li potenzjalment jistgħu jbiddlu l-funzjoni tal-kliewi bħalma huma: - deidratazzjoni, - infezzjoni severa, - xokk; - mard akut jew kroniku li jista' jikkawża ipoksja tat-tessut bħalma huwa: - insuffiċjenza kardijaka jew respiratorja, - infart mijokardijaku reċenti, - xokk; - indeboliment tal-fwied (ara sezzjonijiet 4.2, 4.4 u 5.2); - intossifikazzjoni akuta bl-alkoħol, alkoħoliżmu (ara sezzjoni 4.5).
English: on one side and “1069” on the other side.
Maltese: fuq naħa u “1069” fuq in-naħa l-oħra.
English: In addition, dapagliflozin reduced the new onset of sustained albuminuria (hazard ratio 0.79 [95% CI 0.72, 0.87]) and led to greater regression of macroalbuminuria (hazard ratio 1.82 [95% CI 1.51, 2.20]) compared with placebo.
Maltese: Barra minn hekk, dapagliflozin naqqas il-bidu ġdid ta' albuminurja sostnuta (proporzjon ta' periklu 0.79 [95% CI 0.72, 0.87]) u wassal għal rigressjoni akbar ta' makroalbuminurja (proporzjon ta' periklu 1.82 [95% CI 1.51, 2.20]) meta mqabbel ma' plaċebo.
English: Patients with baseline HbA1c ≥ 9%
Maltese: HbA1c ≥ 9 %
English: • Ebymect 5 mg/850 mg are 9.5 x 20 mm oval, brown film-coated tablets.
Maltese: • Ebymect 5 mg/850 mg huma 9.5 x 20 mm pilloli miksijin b'rita ovali, kannella.
English: Vulvovaginitis, balanitis and related genital infections In the 13-study safety pool, vulvovaginitis, balanitis and related genital infections were reported in 5.5% and 0.6% of subjects who received dapagliflozin 10 mg and placebo, respectively.
Maltese: Vulvovaginitis, balanite u infezzjonijiet ġenitali relatati Fil-ġabra ta' 13-il studju ta' sigurtà, vulvovaġinite, balanite u infezzjonijiet ġenitali kienu rrappurtati f'5.5% u f'0.6% tal-individwi li rċievew dapagliflozin 10 mg u plaċebo, rispettivament.
English: Subjects (%) achieving:
Maltese: Patients with events (%)
English: Rare cases of diabetic ketoacidosis (DKA), including life-threatening and fatal cases, have been reported in patients treated with sodium-glucose co-transporter 2 (SGLT2) inhibitors, including dapagliflozin.
Maltese: Każijiet rari ta' ketoaċidożi dijabetika (DKA), inklużi każijiet ta' theddida għall-ħajja u fatali, ġew irrapportati, ikkurati b'inibituri ta' kotrasportatur 2 tas-sodium-glucose (SGLT2), inkluż dapagliflozin.
English: Vulvovaginitis , balanitis and related genital infections
Maltese: Vulvovaginite, balanite u infezzjonijiet ġenitali relatati
English: In patients at increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months.
Maltese: F'pazjenti b'riskju akbar ta' aktar progressjoni ta' indeboliment renali u flanzjani, il-funzjoni renali għandha tiġi evalwata b'mod aktar frekwenti, eż. kull 3-6 xhur.
English: • For renal function with GFR levels < 60 mL/min and in elderly patients, at least 2 to 4 times per year.
Maltese: • Għal funzjoni renali b'livelli < 60 mL/min u f'pazjenti anzjani, tal-anqas darbtejn sa erba' darbiet fissena.
English: Ebymect should not be initiated in patients with GFR < 60 mL/min and should be discontinued at GFR persistently below 45 mL/min (see section 4.2).
Maltese: Ebymect m'għandux jinbeda f'pazjenti b'GFR < 60 ml/min u għandu jitwaqqaf f'GFR li tkun b'mod persistenti taħt 45 mL/min ( ara sezzjoni 4.2).
English: In a cardiovascular outcomes study (DECLARE), dapagliflozin as adjunct to standard care therapy reduced cardiovascular and renal events in patients with type 2 diabetes.
Maltese: Fi studju tal-eżiti kardjovaskulari (DECLARE), dapagliflozin bħala żieda ma' terapija ta' kura standard naqqas l-avvenimenti kardjovaskulari u renali f'pazjenti bid-djiabete tat-tip 2.
English: Maximum daily dose is 3000 mg.
Maltese: Id-doża massima ta' kuljum hija ta' 3000 mg.
English: Add-on combination therapy
Maltese: Terapija kkombinata miżjuda
English: Diabetic ketoacidosis b,k,l
Maltese: Ketoaċidożi dijabetika b,
English: Reported by the investigator as possibly related, probably related or related to study treatment and reported in ≥ 0.2% of subjects and ≥ 0.1% more and at least 3 more subjects treated with dapagliflozin 10 mg compared to placebo.
Maltese: Irrapportati mill-investigaturi bħala possibbilment relatati, probabbilment relatati jew relatati mal-kura tal-istudju u rrapportati f'≥ 0.2% tal-individwi u ≥ 0.1% iktar u mill-inqas 3 individwi iktar ittrattati b'10 mg dapagliflozin meta mqabbla ma' plaċebo.
English: Reported in ≥ 2% of subjects and ≥ 1% more and at least 3 more subjects treated with dapagliflozin 10 mg compared to placebo.
Maltese: Irrapportati f'≥ 2 % tal-individwi u ≥ 1% aktar u għallinqas 3 individwi aktar ikkurati b'10 mg dapagliflozin meta mqabbel ma' plaċebo.
English: Ebymect combines two anti-hyperglycaemic medicinal products with different and complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: dapagliflozin, a SGLT2 inhibitor, and metformin hydrochloride, a member of the biguanide class.
Maltese: Ebymect jgħaqqad żewġ prodotti mediċinali għal kontra l-ipergliċemija b'mekkaniżmi ta' azzjoni differenti u kumplimentari biex itejjeb il-kontroll gliċemiku f'pazjenti bid-dijabete tat-tip 2: dapagliflozin, impeditur ta' SGLT2, u metformin hydrochloride, membru tal-klassi biguanide.
English: Cardiac failure There is no experience in clinical studies with dapagliflozin in NYHA class IV.
Maltese: M'hemmx esperjenza ta' studji kliniċi b'dapagliflozin fl-NYHA klassi IV.
English: film-coating: polyvinyl alcohol (E1203), macrogol 3350 (E1521), talc (E553b), titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172) (only Ebymect 5 mg/850 mg).
Maltese: • Is-sustanzi l-oħra huma: qalba tal-pillola: hydroxypropyl cellulose (E463), microcrystalline cellulose (E460(i)), magnesium stearate (E470b), sodium starch glycolate. kisja b'rita: polyvinyl alcohol (E1203), macrogol 3350 (E1521), talc (E553b), titanium dioxide (E171), iron oxides (E172).