FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects with Atriance in adults (which may affect more than 1 in 10 people) are infection, febrile neutropenia (low white blood cell counts with fever), neutropenia (low white blood cell counts), thrombocytopenia (low platelet counts), anaemia (low red blood cell counts), somnolence (sleepiness), peripheral neuropathy (damage to the nerves in the extremities), hypoaesthesia (a reduced sense of touch), paraesthesia (unusual sensations like pins and needles), dizziness, headache, dyspnoea (breathlessness), cough, diarrhoea, vomiting, constipation, nausea (feeling sick), myalgia (muscle pain), oedema (swelling), peripheral oedema (swelling in ankles and feet), pyrexia (fever), pain, tiredness and weakness.
Maltese: L-effetti sekondarji l-aktar komuni b'Atriance fl-adulti (li jistgħu jaffettwaw iktar minn persuna 1 minn kull 10) huma infezzjoni, newtropenja bid-deni (għadd baxx ta' ċelloli tad-demm bojod bid-deni), newtropenja (għadd baxx ta' ċelloli tad-demm bojod), tromboċitopenja (għadd baxx ta' pjastrini), anemija (għadd baxx ta' ċelloli tad-demm ħomor), ħedla (ngħas), newropatija periferali (ħsara għannervituri fl-estremitajiet), ipoestesija (sens imnaqqas ta' ħass), parestesija (sensazzjonijiet mhux tassoltu bħal effetti ta' tingiż), sturdament, uġigħ ta' ras, dispnea (qtugħ ta' nifs), sogħla, dijarea, rimettar, stitikezza, nawżja (dardir), mijalġja (uġigħ muskolari), edema (nefħa), edema periferali (nefħa fl-għekiesi u s-saqajn), piressija (deni), uġigħ, għejja u dgħjufija.
English: Atriance received a marketing authorisation valid throughout the EU on 22 August 2007.
Maltese: Atriance rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-22 ta' Awwissu 2007.
English: Other information about Atriance
Maltese: Informazzjoni oħra dwar Atriance
English: Atriance contains the active substance nelarabine.
Maltese: Atriance fih is-sustanza attiva nelarabina.
English: In adults and adolescents aged 16 years and over, the recommended starting dose is 1,500 mg per square metre of body surface area, given over two hours on days one, three and five, repeated every 21 days.
Maltese: Fl-adulti u l-adoloxxenti minn 16-il sena 'l fuq, id-doża inizjali rakkomandata hija 1,500 mg għal kull metru kwadru tal-erja tas-superfiċje tal-ġisem, mogħtija fuq sagħtejn fil-jiem wieħed, tlieta u ħamsa, ripetuta kull 21 jum.
English: Atriance is a cancer medicine used to treat patients with T-cell acute lymphoblastic leukaemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL).
Maltese: Atriance huwa mediċina kontra l-kanċer li tintuża għal kura ta' pazjenti li jbatu bil-lewkimja limfoblastika akuta taċ-ċellola T (T-ALL) L) jew bil-linfoma limfoblastika taċ-ċellola T (T-LBL).
English: Atriance has been authorised under ‘exceptional circumstances'.
Maltese: Atriance ġie awtorizzat taħt ‘ċirkostanzi ta' eċċezzjoni'.
English: In the body, this analogue takes the place of guanine and interferes with the enzymes involved in making new DNA, DNA polymerases.
Maltese: Fil-ġisem, dan l-analogu jieħu l-post tal-gwanina u jinterferixxi mal-enzimi involuti fil-formazzjoni ta' DNA ġdida, DNA polimerasi.
English: What information is still awaited for Atriance?
Maltese: Liema informazzjoni għadha mistennija għal Atriance?
English: What are the risks associated with Atriance?
Maltese: X'inhuma r-riskji assoċjati ma' Atriance?
English: Treatment may be delayed if other side effects occur.
Maltese: Il-kura tista' tiġi ttardjata jekk ikun hemm effetti sekondarji oħra.
English: This means that because the diseases are rare, it has not been possible to obtain complete information about Atriance.
Maltese: Dan ifisser li minħabba li l-mard huwa rari, ma kienx possibbli li tinkiseb informazzjoni kompluta dwar Atriance.
English: In T-ALL the abnormal cells are mainly in the blood and bone marrow, and in T-LBL they are mainly in the lymphatic system (lymph nodes or thymus gland).
Maltese: F'T-ALL, iċ-ċelloli anormali jinsabu l-aktar fid-demm u fil-mudullun talgħadam, filwaqt li f'T-LBL dawn jinsabu l-aktar fis-sistema limfatika (limfonodi jew il-glandola tattimu).
English: Because the guanine analogue accumulates in Tcells and lasts longer in these cells, Atriance slows down the growth and multiplication of the cells involved in T-ALL and T-LBL.
Maltese: Minħabba li l-analogu tal-gwanina jakkumula fit-T-cells u jdum iktar f'dawn iċ-ċelloli, Atriance inaqqas it-tkabbir u l-multiplikazzjoni taċ-ċelloli involuti fit-T-ALL u fit-T-LBL.
English: For the full list of side effects and restrictions of Atriance, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet ta' Atriance, ara l-fuljett ta' tagħrif.
English: As for all medicines, data on the use of Atriance are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Atriance hija ssorveljata kontinwament.
English: Patients receiving Atriance should be monitored regularly for changes in blood cell counts and should receive adequate hydration if they are at risk of tumour lysis syndrome (a complication due to the breakdown of cancer cells).
Maltese: Il-pazjenti li qed jirċievu Atriance għandhom jiġu mmonitorjati regolarment għal bidliet fl-għadd taċċelloli tad-demm u jingħataw idratazzjoni adegwata jekk ikunu f'riskju tas-sindromu tat-tumur ta' liżi (komplikazzjoni dovuta għat-tkissir taċ-ċelloli tal-kanċer).
English: Severe side effects affecting the brain and nervous system have also been reported in patients taking Atriance, including somnolence, convulsions, and peripheral neuropathy causing numbness, unusual sensations, weakness and even paralysis.
Maltese: Effetti sekondarji severi li jaffettwaw il-moħħ u s-sistema nervuża ġew irrapportati f'pazjenti li qegħdin jieħdu Atriance, fosthom ħedla, konvulżjonijiet, u newropatija periferali li tikkawża tirżiħ, sensazzjonijiet mhux tas-soltu, dgħjufija u anki paraliżi.
English: The active substance in Atriance, nelarabine, is a cytotoxic, a medicine that kills cells that are dividing, such as cancer cells.
Maltese: Is-sustanza attiva f'Atriance, in-nelabarina, hija ċitotossika, mediċina li toqtol iċ-ċelloli li jkunu qed jinqasmu, bħaċ-ċelloli tal-kanċer.
English: Atriance can only be obtained with a prescription and is given by drip into a vein under the supervision of a doctor who has experience in the use of thes type of medicine.
Maltese: Atriance jintuża meta l-kanċer ma jkunx irrisponda għal, jew ma baqax jirrispondi għal millinqas żewġ tipi ta' kimoterapija.
English: Since Atriance has been authorised under exceptional circumstances, the company that markets Atriance will provide yearly updates from a study on the effectiveness and safety of Atriance in children and young adults.
Maltese: Minħabba li Atriance ġie awtorizzat taħt ċirkostanzi ta' eċċezzjoni, il-kumpanija li tqiegħed Atriance fissuq se tipprovdi aġġornamenti ta' kull sena minn studju dwar l-effettività u s-sigurtà ta' Atriance fit-tfal u ż-żgħażagħ.
English: The first study involved 70 children and young adults below 21 years of age.
Maltese: L-ewwel studju kien jinvolvi 70 tifel u tifla u adulti żgħażagħ taħt il-21 sena.
English: Of those whose cancer had not responded (28) five (18%) had a complete response to treatment.
Maltese: Minn dawk li l-kanċer tagħhom ma kienx irrisponda (28) ħamsa (18 %) kellhom rispons sħiħ għall-kura.
English: It may harm them,
Maltese: Ġeneru Sesswali
English: Possible signs are listed in section 4, ‘Possible side effects'.
Maltese: Sinjali possibbli huma elenkati f'sezzjoni 4, “Effetti sekondarji possibbli”.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11 November 2016
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 11 ta' Novembru 2016
English: Insulin and sulphonylureas
Maltese: Insulina u sulfonylureas
English: Copovidone (K-value nominally 28) Crospovidone (Type B) Talc
Maltese: Copovidone (valur K nominali ta' 28) Crospovidone (Tip B) Talc
English: Diabetic ketoacidosis (DKA)
Maltese: Ketoaċidożi dijabetika (DKA)
English: , urticaria
Maltese: , urtikarja
English: HbA1c ( %) - 24 weeks
Maltese: HbA1c ( %) - 24 ġimgħa
English: Non-fatal MI N (%)
Maltese: MI mhux fatali N (%)
English: Common Common Rare
Maltese: Komuni Komuni Rari
English: (See sections 4.2, 4.4, 4.5 and 5.1 for available data on combinations studied)
Maltese: (Ara sezzjonijiet 4.2, 4.4, 4.5 u 5.1 għal tagħrif disponibbli dwar il-kombinazzjonijiet studjati)
English: Tablet core: mannitol (E421), pre-gelatinised starch (maize), maize starch, copovidone, crospovidone, talc and magnesium stearate.
Maltese: Qalba tal-pillola: mannitol (E421), pre-gelatinised starch (maize), maize starch, copovidone, crospovidone, talc u magnesium stearate.
English: Empagliflozin is a substrate of the human uptake transporters OAT3, OATP1B1, and OATP1B3, but not Organic Anion Transporter 1 (OAT1) and Organic Cation Transporter 2 (OCT2).
Maltese: Empagliflozin huwa sottostrat tat-trasportaturi tat-teħid uman OAT3, OATP1B1, u OATP1B3, imma mhux tat-Trasportatur Anjoniku Organiku 1 (OAT1) u t-Trasportatur Katajoniku Organiku 2 (OCT2).
English: The most serious adverse reactions were ketoacidosis (< 0.1%), pancreatitis (0.2%), hypersensitivity (0.6%), and hypoglycaemia (2.4%) (see section 4.4).
Maltese: Ir-reazzjonijiet avversi l-aktar serji kienu ketoaċidożi (< 0.1%), pankreatite (0.2%), sensittività eċċessiva (0.6%), u ipogliċemija (2.4%) (ara sezzjoni 4.4).
English: Linagliptin binds selectively to DPP-4 and exhibits a > 10,000-fold selectivity versus DPP-8 or DPP-9 activity in vitro.
Maltese: Linagliptin jeħel b'mod selettiv ma' DPP-4 u juri selettività ta' > 10,000 darba aktar kontra attività ta' DPP-8 jew DPP-9 in vitro.
English: CV Death N (%)
Maltese: Mewta CV N (%)
English: Empagliflozin is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP).
Maltese: Empagliflozin huwa sottostrat ta' P-glikoproteina (P-gp) u proteina ta' reżistenza għall-kanċer tas-sider (BCRP - breast cancer resistance protein).
English: Use of dipeptidyl peptidase-4 (DPP-4) inhibitors has been associated with a risk of developing acute pancreatitis.
Maltese: L-użu ta' impedituri ta' dipeptidyl peptidase-4 (DPP-4) ġie assoċjat ma' riskju li tiżviluppa pankreatite akuta.
English: Hypoglycaemias in the placebo-controlled studies (10.9 %; N=471) were mild (80 %; N=384), moderate (16.6 %; N=78) or severe (1.9 %; N=9) in intensity.
Maltese: Ipogliċemiji fl-istudji kkontrollati bi plaċebo (10.9%; N= 471) kienu ħfief (80%; N= 384), moderati (16.6%; N= 78) jew severi (1.9%; N= 9) fl-intensità tagħhom.
English: Systemic exposure of each metabolite was less than 10 % of total drug-related material.
Maltese: L-esponiment sistemiku ta' kull metabolit kien inqas minn 10% tal-materjal kollu marbut mal-mediċina.
English: In vitro assessment of linagliptin
Maltese: Evalwazzjoni in vitro ta' linagliptin
English: The incidence of confirmed hypoglycaemic events was low (< 1,5 %).
Maltese: L-inċidenza ta' avvenimenti ipogliċemiċi konfermati kienet baxxa (< 1,5%).
English: Glyxambi is available in PVC/PVDC/aluminium perforated unit dose blisters.
Maltese: Glyxambi huwa disponibbli f'folji tal-PVC/PVDC/aluminju perforati u f'doża waħda.
English: The absolute bioavailability of linagliptin is approximately 30 %.
Maltese: Il-bijodisponibilità assoluta ta' linagliptin hi ta' madwar 30%.
English: Linagliptin had no clinically relevant effect on the pharmacokinetics of metformin, glibenclamide, simvastatin, pioglitazone, warfarin, digoxin, empagliflozin or oral contraceptives providing in vivo evidence of a low propensity for causing drug interactions with substrates of CYP3A4, CYP2C9, CYP2C8, P-gp and organic cationic transporter (OCT).
Maltese: Linagliptin ma kellu l-ebda effett klinikament rilevanti fuq il-farmakokinetika ta' metformin, glibenclamide, simvastatin, pioglitazone, warfarin, digoxin, empagliflozin jew kontraċettivi orali u pprovda evidenza in vivo ta' propensità baxxa biex jikkawża interazzjonijiet bejn il-mediċini ma' substrati ta' CYP3A4, CYP2C9, CYP2C8, P-gp u t-trasportatur katajoniku organiku (OCT).
English: Approximately 19 % of the population had an eGFR of 45-60 mL/min/1.73 m2, 28 % of 30-45 mL/min/1.73 m2 and 15 % of <30 mL/min/1.73 m².
Maltese: Madwar 19% tal-popolazzjoni kellhom eGFR ta' 45-60 mL/min/1.73 m2, 28% ta' 30-45 mL/min/1.73 m2 u 15% ta' <30 mL/min/1.73 m².
English: Metformin + empagliflozin 25 mg Linagliptin 5 mg Placebo Linagliptin 5 mg Placebo
Maltese: Metformin + empagliflozin 25 mg Linagliptin 5 mg Plaċebo Linagliptin 5 mg Plaċebo
English: The steady state plasma AUCτ,ss and Cmax,ss concentrations of linagliptin were 153 nmol*hr/L and 12.9 nmol/L for linagliptin 5 mg once daily for 7 days.
Maltese: Il-konċentrazzjonijijiet AUCτ,ss u Cmax,ss fil-plażma fi stat fiss ta' linagliptin kienu 153 nmol*hr/L u 12.9 nmol/L għal linagliptin 5 mg darba kuljum għal 7 ijiem.
English: Baseline mean (SE)
Maltese: Linja bażi medja (SE)
English: In the EMPA-REG OUTCOME study, 10.1 % of the patients were reported with cardiac failure at baseline.
Maltese: Fl-istudju EMPA-REG OUTCOME, 10.1% tal-pazjenti ġew irrappurtati b'falliment kardijaku fil-linja bażi.
English: Mean percent increases from baseline for Glyxambi 10 mg/5 mg and 25 mg/5 mg versus placebo, respectively, were total cholesterol 3.2% and 4.6% versus 0.5%; HDL-cholesterol 8.5% and 6.2% versus 0.4%; LDL-cholesterol 5.8% and 11.0% versus 3.3%; triglycerides -0.5% and 3.3% versus 6.4 %.
Maltese: Żidiet fil-perċentwal tal-medja mil-linja bażi għal Glyxambi 10 mg/5 mg u 25 mg/5 mg kontra plaċebo, rispettivament, kienu kolesterol totali 3.2% u 4.6% kontra 0.5%; kolesterol HDL 8.5% u 6.2% kontra 0.4%; kolesterol LDL 5.8% u 11.0% kontra 3.3%; trigliċeridi -0.5% u 3.3% kontra 6.4%.
English: Linagliptin is an inhibitor of the enzyme DPP-4 an enzyme which is involved in the inactivation of the incretin hormones GLP-1 and GIP (glucagon-like peptide¬1, glucose-dependent insulinotropic polypeptide).
Maltese: Linagliptin hu impeditur tal-enzima DPP-4, enzima li hi involuta fl-inattivazzjoni tal-ormoni ta' incretin GLP-1 u GIP (peptide-1 jixbah lil glucagon, polypeptide insulinotropiku dipendenti fuq il-glukożju).
English: In vitro assessment of empagliflozin
Maltese: Evalwazzjoni in vitro ta' empagliflozin
English: The mean age was 63 years, the mean HbA1c was 8.1 %, and 71.5 % were male.
Maltese: L-età medja kienet ta' 63 sena, l-HbA1c medju kien ta' 8.1 %, u 71.5 % kienu rġiel.
English: Film coating: hypromellose, mannitol (E421), talc, titanium dioxide (E171), macrogol 6000 and iron oxide yellow (E172).
Maltese: Kisja tar-rita: hypromellose, mannitol (E421), talc, titanium dioxide (E171), macrogol 6000 u iron oxide yellow (E172).
English: Urine glucose
Maltese: Glukożju fl-urina
English: Film coating: hypromellose, mannitol (E421), talc, titanium dioxide (E171), macrogol 6000 and iron oxide red (E172).
Maltese: Kisja tar-rita: hypromellose, mannitol (E421), talc, titanium dioxide (E171), macrogol 6000 u iron oxide red (E172).
English: Hypoglycaemia with empagliflozin
Maltese: Ipogliċemija b'empagliflozin
English: Pack sizes of 7 x 1, 10 x 1, 14 x 1, 28 x 1, 30 x 1, 60 x 1, 70 x 1, 90 x 1 and 100 x 1 film-coated tablets.
Maltese: Daqsijiet tal-pakkett huma ta' 7 x 1, 10 x 1, 14 x 1, 28 x 1, 30 x 1, 60 x 1, 70 x 1, 90 x 1 u 100 x 1 pillola miksija b'rita.
English: Necrotising fasciitis of the perineum (Fournier´s gangrene)
Maltese: Fasciitis nekrotika tal-perineum (Kankrena ta' Fournier)
English: Pharmacokinetic interactions
Maltese: Interazzjonijiet farmakokinetika
English: The frequency of reported nocturia was comparable between placebo and empagliflozin (< 1 %).
Maltese: Il-frekwenza ta' nokturja rapportata kienet komparabbli bejn plaċebo u empagliflozin (< 1%)
English: Improvement of surrogate markers of beta cell function including Homeostasis Model Assessment β (HOMA β) was noted.
Maltese: Kien innotat titjib fil-markaturi sostituti tal-funzjoni taċ-ċelluli beta li jinkludu l-Mudell Omeostatiku ta' Assessjar β (HOMA-β - Homeostasis Model Assessment-B).
English: Both incretin hormones are involved in the physiological regulation of glucose homeostasis.
Maltese: Iż-żewġ ormoni ta' incretin huma involuti fir-regolazzjoni fiżjoloġika tal-omeostażi tal-glukożju.
English: The intra-subject and inter-subject coefficients of variation for linagliptin AUC were small (12.6 % and 28.5 %, respectively).
Maltese: Il-koeffiċjenti ta' varjazzjoni fl-individwi nfishom u bejn l-individwi għall-AUC ta' linagliptin kienu żgħar (12.6% u 28.5%, rispettivament).
English: Empagliflozin cardiovascular outcome (EMPA-REG OUTCOME) study
Maltese: Studju dwar ir-riżultat kardjovaskulari ta' Empagliflozin (EMPA-REG OUTCOME)
English: Interaction studies suggest that the pharmacokinetics of empagliflozin were not influenced by coadministration with metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, verapamil, ramipril, simvastatin, torasemide and hydrochlorothiazide.
Maltese: Studji ta' interazzjoni jissuġġerixxu li l-farmakokinetika ta' empagliflozinma kinitx influwenzata bl-għoti flimkien ta' metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, verapamil, ramipril, simvastatin, torasemide u hydrochlorothiazide.
English: Approximately 19 % of the population had an eGFR <60 mL/min/1.73 m
Maltese: Madwar 19 % tal-popolazzjoni kellhom eGFR <60 mL/min/1.73 m
English: • other anti-diabetic medicines, such as insulin or a sulphonylurea.
Maltese: • mediċini kontra d-dijabete oħra, bħal insulina jew sulfonylurea.
English: (including pyelonephritis and urosepsis)
Maltese: (inklużi pajelonefrite u urosepsis)
English: The apparent steady-state volume of distribution was estimated to be 73.8 L based on the population pharmacokinetic analysis.
Maltese: Il-volum fi-istat fiss apparenti ta' distribuzzjoni kien stmat li hu 73.8 l skont l-analiżi farmakokinetika tal-popolazzjoni.
English: The mean age was 64 years, the mean HbA1c was 7.15 %, and 60 % were male.
Maltese: L-età medja kienet ta' 64 sena, HbA1c medja kienet ta' 7.15 %, u 60 % kienu rġiel.
English: Table 6 Major adverse cardiovascular events (MACE) and mortality by treatment group in the CAROLINA study
Maltese: Tabella 6 Avvenimenti avversi kardjovaskulari maġġuri (MACE - major adverse cardiovascular events) u mortalità skont il-grupp ta' trattament fl-istudju CAROLINA Linagliptin 5mg
English: Adverse reactions marked with an asterisk (*) are further discussed in section “Description of selected adverse reactions” below.
Maltese: Reazzjonijiet avversi mmarkati b'asterisk (*) huma diskussi fit-taqsima “Deskrizzjoni ta' reazzjonijiet avversi magħżula” hawn taħt.
English: • if you are taking other anti-diabetic medicines known as “sulphonylurea” (e.g. glimepiride, glipizide) and/or insulin.
Maltese: • jekk qed tieħu mediċini kontra d-dijabete oħra magħrufin bħala “sulfonylurea” (eż. glimepiride, glipizide) u/jew insulina.
English: Film coating Hypromellose 2910 Mannitol (E421) Talc
Maltese: Mannitol (E421) Talc
English: In analyses for albuminuria progression (change from normoalbuminuria to micro-or macroalbuminuria, or from microalbuminuria to macroalbuminuria) the estimated hazard ratio was 0.86 (95 % CI 0.78, 0.95) for linagliptin versus placebo.
Maltese: Fl-analiżi għall-progressjoni tal-albuminurja (bidla minn albuminurja normali għal mikro- jew makroalbuminurja, jew minn mikroalbuminurja għal makroalbuminurja) il-proporzjon ta' periklu stmat kien ta' 0.86 (CI ta' 95% 0.78, 0.95) għal linagliptin kontra l-plaċebo.
English: Linagliptin did not increase the risk of the combined endpoint of CV death, non-fatal myocardial infarction or non-fatal stroke (MACE-3) [HR=1.02; (95 % CI 0.89, 1.17); p=0.0002 for non inferiority], or the risk of combined endpoint of renal death, ESRD, 40% or more sustained decrease ineGFR [HR=1.04; (95 % CI 0.89, 1.22)].
Maltese: Linagliptin ma żiedx ir-riskju tal-punt finali kkombinat ta' mewt CV, infart mijokardijaku mhux fatali jew puplesija mhux fatali (MACE-3) [HR=1.02; (CI ta' 95% 0.89, 1.17); p=0.0002 għal nuqqas ta' inferjorità], jew ir-riskju tal-punt finali kkombinat ta' mewt tal-kliewi, ESRD, tnaqqis sostnut ta' 40% jew aktar fl-eGFR [HR=1.04; (CI ta' 95 % 0.89, 1.22)].
English: Coadministration of digoxin, a P-gp substrate, with empagliflozin resulted in a 6 % increase in AUC and 14 % increase in Cmax of digoxin.
Maltese: L-għoti flimkien ta' digoxin, sottostrat ta' P-gp, ma' empagliflozin irriżulta f'żieda ta' 6% fl-AUC u ta' 14% żieda f'Cmax ta' digoxin.
English: C] linagliptin oral 10 mg dose, approximately 5 % of the radioactivity was excreted in urine.
Maltese: C]-linagliptin orali ta' 10 mg, madwar 5% tar-radjuattività ġiet eliminata fl-awrina.
English: PVC/PVDC/aluminium perforated unit dose blisters.
Maltese: Folji tal-PVC/PVDC/aluminju perforati u f'doża waħda.
English: • Empagliflozin works by blocking a protein in the kidneys called sodium glucose co-transporter 2 (SGLT2).
Maltese: • Empagliflozin jaħdem billi jimblokka proteina fil-kliewi li tissejjaħ kotrasportatur-2 ta' Sodium-Glucose (SGLT2).
English: Inhibition of OATP1B1/1B3 transporters by co-administration with rifampicin resulted in a 75 % increase in Cmax and a 35 % increase in AUC of empagliflozin.
Maltese: L-impediment ta t-trasportaturi OATP1B1/1B3 bl-għoti flimkien ma' rifampicin irriżulta f'żieda ta' 75% fis-Cmax u żieda ta' 35% fl-AUC ta' empagliflozin.
English: No major metabolites of empagliflozin were detected in human plasma and the most abundant metabolites were three glucuronide conjugates (2-, 3-, and 6-O-glucuronide).
Maltese: Ma ġewx osservati metaboliti prinċipali ta' empagliflozin fil-plażma tal-bniedem u l-aktar metaboliti abundanti kienu tliet konjugati ta' glucuronide (2-, 3-, u 6-O glucorinide).
English: In vitro data suggest that the primary route of metabolism of empagliflozin in humans is glucuronidation by uridine 5'-diphosphoglucuronosyltransferases UGT1A3, UGT1A8, UGT1A9, and UGT2B7.
Maltese: Dejta in vitro tissuġġerixxi li r-rotta prinċipali ta' metaboliżmu ta' empagliflozin fil-bniedem hi glukuronidazzjoni permezz ta' uridine 5'-diphosphoglucuronosyltransferases UGT1A3, UGT1A8, UGT1A9, u UGT2B7.
English: Haematocrit increase was observed with empagliflozin treatment (see section 4.8).
Maltese: Bit-trattament ta' empagliflozin ġiet osservata żieda fl-ematokrit (ara sezzjoni 4.8).
English: Hypoglycaemia with linagliptin
Maltese: Ipogliċemija b'linagliptin
English: Other side effects while taking Glyxambi:
Maltese: Effetti sekondarji oħra waqt li qed tieħu Glyxambi:
English: • When eGFR is persistently below 45 mL/min/1.73 m2 or CrCl persistently below 45 mL/min, treatment should be discontinued (see sections 4.4, 4.8, 5.1, and 5.2).
Maltese: • Meta l-eGFR ikun b'mod persistenti taħt 45 mL/min/1.73 m jew is-CrCl ikun b'mod persistenti taħt 45 mL/min, it-trattament għandu jitwaqqaf (ara sezzjonijiet 4.4, 4.8, 5.1, u 5.2).
English: Each side of the tablet is 8 mm long.
Maltese: Kull naħa tal-pillola għandha tul ta' 8 mm.
English: Table 1 Adverse reactions System organ class
Maltese: Tabella 1 Reazzjonijiet avversi
English: The frequency of patients with major hypoglycaemic events was low (< 1 %) and similar for empagliflozin and placebo as monotherapy, as add-on to metformin +/- sulfonylurea, and as add-on to pioglitazone +/- metformin.
Maltese: Il-frekwenza ta' pazjenti b'ipogliċemija maġġuri kienet baxxa (< 1%) u simili għal empagliflozin u plaċebo bħala monoterapija, b'metformin+/- sulfonylurea bħala terapija aġġuntiva, u pioglitazone +/metformin bħala terapija aġġuntiva.
English: A total of 6979 patients were treated (linagliptin 5 mg: 3494, placebo: 3485) and followed for a median of 2.2 years.
Maltese: Total ta' 6979 pazjent kienu ttrattati (linagliptin 5 mg: 3494, plaċebo:
English: The steady state mean plasma area under the concentration-time curve (AUC) and Cmax were 1,870 nmol.h and 259 nmol/L with empagliflozin 10 mg and 4,740 nmol.h and 687 nmol/L with empagliflozin 25 mg once daily.
Maltese: Il-plażma fl-istat fiss medju tal-erja taħt il-kurva tal-ħin tal-konċentrazzjoni (AUC) u Cmax kienu ta' 1870 nmol/L u 259 nmoL/l b'empagliflozin 10 mg u 4740 nmol.h u 687 nmol/L b'empagliflozin 25 mg li jingħata darba kuljum.