FrancophonIA/ELRC3.0 huggingface dataset:
English: No such increase for tmax was observed when atorvastatin was administered in the evening and lixisenatide in the morning but the AUC and Cmax of atorvastatin were increased by 27% and 66%, respectively.
Maltese: Din iż-żieda fit-tmax ma ġietx osservata meta atorvastatin ingħata filgħaxija u lixisenatide filgħodu iżda l-AUC u s-Cmax ta' atorvastatin żdiedu b'27% u 66% rispettivament.
English: Hypoglycaemia was the most frequently reported observed adverse reaction during treatment with Suliqua (see section 4.8).
Maltese: L-ipogliċemija kienet l-aktar reazzjoni avversa osservata rrappurtata waqt it-trattament b'Suliqua (ara sezzjoni 4.8).
English: In each of the active-controlled trials, treatment with Suliqua produced clinically and statistically significant improvements in hemoglobin A1c (HbA1c).
Maltese: F'kull wieħed mill-provi kkontrollati b'mod attiv, trattament b'Suliqua pproduċa titjib sinifikanti b'mod kliniku u statistiku fl-emoglobina A1c (HbA1c, hemoglobin A1c).
English: • You are taking or have stopped taking certain other medicines (see section 2, "Other medicines and Suliqua").
Maltese: • Inti qed tieħu jew għadek kemm waqaft tieħu ċerti mediċini oħra (ara sezzjoni 2, "Mediċini oħra u Suliqua ").
English: • in a vein.
Maltese: • ġo vina.
English: In in vitro studies, lixisenatide did not affect the activity of cytochrome P450 isozymes or human transporters tested.
Maltese: Fi studji in vitro, lixisenatide ma affettwax l-attività tal-isoenzimi taċ-ċitokrom P450 jew tat-trasportaturi umani li ġew ittestjati.
English: • Suliqua 100 units/ml + 33 micrograms/ml pre-filled pen delivers dose steps from 30-60 units of insulin glargine in combination with 10-20 mcg lixisenatide (Suliqua (30-60) pen).
Maltese: • Pinna Suliqua 100 unità/ml + 33 mikrogramma/ml mimlija għal-lest tagħti gradi fuq l-iskala ta' dożi minn 30-60 unità ta' insulin glargine flimkien ma' 10-20 mcg lixisenatide (pinna ta' Suliqua (30-60)).
English: MACE was defined as the composite of CV death, nonfatal myocardial infarction and nonfatal stroke.
Maltese: MACE kien iddefinit bħala magħmul mill-elementi ta' mewt kardjovaskulari, infart mijokardijaku mhux fatali, u puplesija mhux fatali.
English: • You are recovering from an injury, operation or other stress.
Maltese: • Inti qed tirkupra minn korriment, operazzjoni jew stress ieħor.
English: Plunger* Dose window Dose pointer
Maltese: Planġer* Tieqa tad-doża Indikatur tad-doża
English: The ELIXA study was a randomised, double-blind, placebo-controlled, multinational study that evaluated cardiovascular (CV) outcomes during treatment with lixisenatide in patients (n=6068) with type 2 diabetes mellitus after a recent Acute Coronary Syndrome.
Maltese: Lixisenatide L-istudju ELIXA kien studju arbitrarju, ikkontrollat bil-plaċebo, multinazzjonali, fejn la l investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża li evalwa r-riżultati kardjovaskulari (CV, cardiovascular) waqt trattament b'lixisenatide f'pazjenti (n=6068) bid-dijabete mellitus tat-tip 2 wara Sindrom Koronarju Akut reċenti.
English: Administration of the oral contraceptive 1 hour or 4 hours after lixisenatide did not affect AUC and t1/2 of ethinylestradiol and levonorgestrel, whereas Cmax of ethinylestradiol was decreased by 52% and 39%, respectively and Cmax of levonorgestrel was decreased by 46% and 20%, respectively and median tmax was delayed by 1 to 3 hours.
Maltese: ethinylestradiol u levonorgestrel, filwaqt li s-Cmax ta' ethinylestradiol naqas bi 52% u 39%, rispettivament u s-Cmax ta' levonorgestrel naqas b'46% u 20%, rispettivament u l-medja tat-tmax kellha dewmien minn siegħa sa 3 sigħat.
English: Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.
Maltese: L-insulina tinibixxi l-lipoliżi u l-proteoliżi, u ttejjeb is-sintesi tal-proteini.
English: The apparent volume of distribution of lixisenatide after subcutaneous administration of insulin glargine/lixisenatide combinations (Vz/F) is approximately 100 L. The apparent volume of distribution of insulin glargine after subcutaneous administration of the insulin glargine/lixisenatide combinations (Vss/F) is approximately 1700 L.
Maltese: Il-volum apparenti ta' distibuzzjoni ta' insulin glargine wara għoti ta' kombinazzjonijiet ta' insulin glargine/lixisenatide (Vss/F) taħt il-ġilda huwa madwar 1700 L.
English: • Your healthcare professional will explain the design and features of your Suliqua pen, including how the dose counter of the pre-filled pen device shows the number of dose steps to be injected.
Maltese: • Il-professjonist fil-kura tas-saħħa tiegħek se jispjegalek id-disinn u l-karatteristiċi tal-pinna Suliqua tiegħek, inkluż kif il-kontatur tad-doża tal-apparat tal-pinna mimlija għal-lestjuri nnumru ta' inkrimenti fid-doża li għandhom jiġu injettati.including how the dose counter of the pre-filled pen device shows the number of dose steps to be injected.
English: Proportion difference vs. insulin glargine [95% confidence interval] (p-value)
Maltese: Differenza vs. insulin glargine [95% confidence interval] (valur p)
English: At screening 64.4% of patients were receiving insulin glargine as basal insulin and 95.0% received at least 1 concomitant OAD.
Maltese: Fiż-żmien tal-eżami 64.4% tal-pazjenti kienu qed jirċievu insulin glargine bħala l-insulina tal-bażi u flimkien magħha 95.0% kienu qed jirċievu mill-inqas OAD wieħed.
English: As a peptide, lixisenatide is eliminated through glomerular filtration, followed by tubular reabsorption and subsequent metabolic degradation, resulting in smaller peptides and amino acids, which are reintroduced in the protein metabolism.
Maltese: Bħala peptide, lixisenatide jiġi eliminat permezz ta' filtrazzjoni mill-glomeruli, segwit minn assorbiment mill-ġdid mit-tubuli u sussegwentement degradazzjoni metabolika, li jwassal għal peptidi u aċidi amminiċi iżgħar, li jiġu introdotti mill-ġdid fil-metaboliżmu tal-proteina.
English: • Suliqua 100 units/ml + 50 micrograms/ml pre-filled pen delivers dose steps from 10-40 units of insulin glargine in combination with 5-20 mcg lixisenatide (Suliqua (10-40) pen).
Maltese: • Pinna Suliqua 100 unità/ml + 50 mikrogramma/ml mimlija għal-lest tagħti gradi fuq l-iskala ta' dożi minn 10-40 unità ta' insulin glargine flimkien ma' 5-20 mcg lixisenatide (pinna ta' Suliqua (10-40)).
English: • Only use needles that are compatible for use with Suliqua pen (see “Instructions for Use”).
Maltese: • Uża biss labar li huma kompatibbli mal-pinna Suliqua (ara “Istruzzjonijiet dwar l-Użu”).
English: HbA1c (%) Baseline (mean; post run-in phase) End of study (mean) LS change from baseline (mean) Difference vs. insulin glargine [95% confidence interval] (p-value) Difference vs. lixisenatide [95% confidence interval] (p-value) Number of Patients (%) reaching HbA1c <7% at week 30* Fasting plasma glucose (mmol/L) Baseline (mean) End of study (mean) LS change from baseline (mean) LS difference versus glargine (mean) [95%CI] (p-value)
Maltese: F'analiżi speċifikata minn qabel ta' dan l-iskop finali primarju, id-differenzi osservati kienu konsistenti rigward HbA1c fil-linja bażi (<8% jew ≥8%) jew l-użu ta' OAD fil-linja bażi (metformin waħdu jew metformin ma' OAD ieħor).
English: Paediatric population There is no relevant use of Suliqua in the paediatric population.
Maltese: Popolazzjoni pedjatrika Mhemm l-ebda użu rilevanti ta' Suliqua fil-popolazzjoni pedjatrika.
English: Patients should be informed of the characteristic symptoms of acute pancreatitis: persistent, severe abdominal pain.
Maltese: Il-pazjenti għandhom ikunu infurmati bis-sintomi tipiċi ta' pankreatite akuta: uġigħ addominali persistenti u sever.
English: Following administration of a single dose of an oral contraceptive medicinal product (ethinylestradiol 0.03 mg/levonorgestrel 0.15 mg) 1 hour before or 11 hours after 10 mcg lixisenatide, the Cmax, AUC, t1/2 and tmax of ethinylestradiol and levonorgestrel were unchanged.
Maltese: 0.03 mg/levonorgestrel 0.15 mg) siegħa qabel jew 11-il siegħa wara 10 mcg lixisenatide, is-Cmax, lAUC, t-t1/2 u t-tmax ta' ethinylestradiol u levonorgestrel ma nbidlux.
English: Hypoglycaemia (low blood sugar levels)
Maltese: Ipogliċemija (livelli baxxi ta' zokkor fid-demm)
English: Suliqua 100 units/ml + 50 micrograms/ml pre-filled pen:
Maltese: Suliqua 100 unità/ml + 50 mikrogramma/ml pinna mimlija għal-lest:
English: Studies with lixisenatide in animals have shown reproductive toxicity (see section 5.3).
Maltese: Studji b'lixisenatide fl-annimali urew effett tossiku fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: Add-on to metformin [insulin naïve]
Maltese: Terapija miżjuda ma' metformin [qatt ma ħadu insulina]
English: Suliqua (10-40) pen
Maltese: Pinna Suliqua (10
English: At Week 30, Suliqua provided statistically significant improvement in HbA1c (p-value <0.0001) compared to the individual components.
Maltese: F'ġimgħa 30, Suliqua pprovda titjib sinifikanti b'mod statistiku fl-HbA1c (valurp <0.
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: sanofi-aventis groupe
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq: sanofi-aventis groupe
English: Suliqua is an injectable diabetes medicine that contains two active substances:
Maltese: Suliqua huwa mediċina li tiġi injettata għad-dijabete li fiha żewġ sustanzi attivi:
English: After 30 weeks of treatment with Suliqua in two phase 3 trials, the incidence of formation of antiinsulin glargine antibodies was 21.0% and 26.2%.
Maltese: antikorpi kontra insulin glargine kienet 21.0% and 26.
English: This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially 'sodium-free'.
Maltese: Eċċipjenti Dan il-prodott mediċinali fih inqas minn 1 mmol (23 mg) ta' sodium f'kull doża, i.e. huwa essenzjalment ‘ħieles mis-sodium'.
English: The safety and effectiveness of Suliqua on glycaemic control were evaluated in two randomised clinical studies in patients with type 2 diabetes mellitus:
Maltese: Effikaċja klinika u sigurtà Is-sigurtà u l-effikaċja ta' Suliqua fuq il-konroll gliċemiku ġew evalwati f'żewġ studji kliniċi arbitrarji f'pazjenti b'dijabete mellitus tat-tip 2:
English: After concomitant administration of lixisenatide 20 mcg and ramipril 5 mg during 6 days, the AUC of ramipril was increased by 21% while the Cmax was decreased by 63%.
Maltese: Wara l-għoti ta' lixisenatide 20 mcg flimkien ma' ramipril 5 mg għal 6 ijiem, l-AUC ta' ramipril żdied b'21% filwaqt li s-Cmax naqas bi 63%.
English: • The other ingredients are: glycerol 85%, methionine, metacresol, zinc chloride, concentrated hydrochloric acid and sodium hydroxide (for pH adjustment) and water for injections.
Maltese: • Is-sustanzi l-oħra huma: glycerol 85%, methionine, metacresol, zinc chloride, hydrochloric acid ikkonċentrat u sodium hydroxide (għall-aġġustment tal-pH) u ilma għall-injezzjonijiet.
English: Reaching lower HbA1c levels and achieving greater HbA1c reduction did not increase rates of hypoglycaemia with combination treatment versus insulin glargine alone (see section 4.8).
Maltese: ipogliċemija bit-trattament ta' kombinazzjoni versus insulin glargine waħdu (ara sezzjoni 4.8).
English: The most frequently reported adverse reactions during treatment with Suliqua were hypoglycaemia and gastrointestinal adverse reactions (see section 'Description of selected adverse reactions' below).
Maltese: L-aktar reazzjonijet avversi rrappurtati b mod frekwenti waqt trattament b'Suliqua kienu ipogliċemija u reazzjonijiet avversi gastrointestinali (ara s-sezzjoni ‘Deskrizzjoni ta' għażla ta' reazzjonijiet avversi hawn taħt).
English: Zinc chloride
Maltese: X'fih Suliqua
English: • Fibrates, for lowering high levels of blood fats.
Maltese: • Fibrati, biex ibaxxu livelli għoljin ta' xaħmijiet fid-demm.
English: This pen is peach coloured with an orange injection button.
Maltese: Din il-pinna hija ta' lewn peach b'buttuna tal-injezzjoni oranġjo.
English: The impact of the combination of insulin glargine and lixisenatide on the pharmacodynamics of lixisenatide has not been studied in phase 1 studies.
Maltese: L-impatt tal-kombinazzjoni ta' insulin glargine u lixisenatide fuq il farmakodinamika ta' lixisenatide ma ġietx studjata fi studji ta' fażi 1.
English: Use of glucagon-like peptide-1 (GLP-1) receptor agonists has been associated with a risk of developing acute pancreatitis.
Maltese: Pankreatite akuta L-użu ta' agonisti tar-riċetturi ta' peptide-1 li tixbah il-glukagon (GLP-1, glucagon-like peptide-1) ġie assoċjat ma' riskju ta' żvilupp ta' pankreatite akuta.
English: Elderly (≥65 years old)
Maltese: Anzjani (għandhom ≥65 sena)
English: Suliqua 100 units/ml + 50 microgram/ml solution for injection in a pre-filled pen Each pre-filled pen contains 300 units of insulin glargine* and 150 micrograms lixisenatide in 3 ml solution.
Maltese: Suliqua 100 unità/ml + 50 mikrogramma/ml soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest Kull pinna mimlija għal-lest fiha 300 unità ta' insulin glargine* u 150 mikrogramma lixisenatide f'soluzzjoni ta' 3 ml.
English: • The other ingredients are: 85% glycerol, methionine, metacresol, zinc chloride, concentrated hydrochloric acid, and sodium hydroxide (for pH adjustement) and water for injections.
Maltese: • Is-sustanzi l-oħra huma: 85% glycerol, methionine, metacresol, zinc chloride, hydrochloric acid ikkonċentrat u sodium hydroxide (għall-aġġustment tal-pH) u ilma għall-injezzjonijiet.
English: Dizziness
Maltese: Nażofarinġite
English: The Suliqua 100 units/ml + 33 microgams/ml pre-filled SoloStar pen:
Maltese: Suliqua 100 unità/ml + 33 mikrogramma/ml pinna mimlija għal-lest:
English: Suliqua is available in two pens, providing different dosing options, i.e. Suliqua (10-40) pen, Suliqua (30-60) pen respectively.
Maltese: .2 Pożoloġija u metodu ta' kif għandu jingħata Suliqua huwa disponibbli f'żewġ pinen, li jipprovdu għażla għall-għoti tad-dożi differenti, i.e. pinna ta' Suliqua (10-40), pinna ta' Suliqua (30-60) rispettivament.
English: Lixisenatide has a low level (55%) of binding to human proteins.
Maltese: Lixisenatide għandu livell baxx (55%) ta' rbit mal-proteini tal-bniedem.
English: At the end of the run-in period, patients with an HbA1c between 7 and 10% , FPG ≤7.77 mmol/L and insulin glargine daily dose of 20 to 50 units, were randomised to either Suliqua (n=367) or insulin glargine (n=369).
Maltese: Fl-aħħar tal-perjodu ta' qabel l-istudju kliniku, pazjenti b'HbA1c bejn 7 u 10% , FPG ≤7.77 mmol/L u doża kuljum ta' insulin glargine ta' bejn 20 u 50 unità, intagħżlu b'mod arbitrarju biex jingħataw
English: • Switch from basal insulin
Maltese: • Bidla mill-insulina tal-bażi
English: During this run-in phase metformin treatment was optimised and any other OADs were discontinued.
Maltese: it-trattament b'metformin ġie ottimizzat u kwalunkwe OADs oħra twaqqfu.
English: Figure - Mean HbA1c (%) at start of screening, at randomization, Each Time Point (Completers) and at Week 30 - mITT population
Maltese: Figura - Medja ta' HbA1c(%) fil-bidu tal-eżami, fil-punt tal-għażla arbitrarja, f'Kull Punt ta' Ħin (Dawk li temmew l-istudju) u f'Ġimgħa 30 - popolazzjoni mITT
English: This difference is not considered clinically relevant.
Maltese: Din iddifferenza ma kinitx meqjusa bħala rilevanti b'mod kliniku.
English: Suliqua").
Maltese: Użu”).
English: Neither status for anti-insulin glargine antibodies nor for anti-lixisenatide antibodies had a clinically relevant impact on safety or efficacy.
Maltese: L-ebda stat kemm ta' antikorpi kontra insulin glargine u lanqas ta' antikorpi kontra lixisenatide ma kellu impatt rilevanti kliniku fuq is-sigurtà jew l-effikaċja.
English: The main reasons for not entering the randomized phase were FPG value >13.9 mmol/L and HbA1c value <7% or >10% at the end of the run-in phase
Maltese: Ir raġunijiet prinċipali għalfejn ma ddaħlux fil-fażi arbitrarja kienu valur ta' FPG >13.9 mmol/L u valur ta' HbA1c <7% jew >10% fit-tmiem tal-fażi ta' qabel il-prova klinika.
English: Patients with type 2 diabetes, treated with metformin alone or metformin and a second OAD treatment that could be a sulfonylurea or a glinide or a sodium-glucose co-transporter-2 (SGLT-2) inhibitor or a dipeptidyl peptidase-4 (DPP-4) inhibitor, and who were not adequately controlled with this treatment (HbA1c range 7.5% to 10% for patients previously treated with metformin alone and 7.0% to 9% for patients previously treated with metformin and a second oral anti-diabetic treatment) entered a run-in period for 4 weeks.
Maltese: Pazjenti b'dijabete mellitus tat-tip 2, ttrattati b'metformin waħdu jew b'metformin u trattament OAD ieħor li seta' kien sulfonylurea jew glinide jew inibitur tal-kotrasportatur-2 tas-sodium-glucose (SGLT-2, sodium-glucose co-transporter-2) jew inibitur dipeptidyl ta' peptidase-4 (DPP-4, dipeptidyl peptidase-4), u li ma kinux ikkontrollati b'mod xieraq b'dan it-trattament (firxa ta' HbA1c minn 7.5% sa 10% għall-pazjenti li qabel kienu ttrattati b'metformin waħdu u minn 7.0% sa 9% għall-pazjenti li qabel kienu ttrattati b'metformin u trattament ieħor mill-ħalq kontra d-dijabete) iddaħħlu fl-istudju għal perjodu ta' 4 ġimgħat qabel il-bidu tal-prova klinika.
English: Animal studies with lixisenatide or insulin glargine do not indicate direct harmful effects with respect to fertility.
Maltese: Studji fl-annimali b'lixisenatide jew insulin glargine ma urewx effetti tossiċi diretti rigward ilfertilità.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Suliqua 100 units/mL +33 mcg/mL solution for injection insulin glargine + lixisenatide
Maltese: Suliqua 100 unità/ml +33 mcg/ml injezzjoni insulin glargine + lixisenatide
English: Rubber seal
Maltese: Siġill tal-lastku
English: Proportion difference versus insulin glargine [95% confidence interval] (p-value)
Maltese: Differenza fil-proporzjon versus insulin glargine [95% confidence interval] (valur p)
English: • Suliqua is available in two pre filled pens containing different strengths of lixisenatide, and different dose ranges: Both pre filled pens contain insulin glargine in a strength of 100 units/ml Suliqua 10-40 pen allows daily doses between 10 and 40 dose steps of Suliqua to be given (strength: insulin glargine 100 units/ml and lixisenatide 50 mcg/ml; dose range: 10 to 40 units of insulin glargine in combination with 5 to 20 mcg lixisenatide) Suliqua 30-60 pen allows daily doses between 30 and 60 dose steps of Suliqua to be given (strength: insulin glargine 100 units/ml and lixisenatide 33 mcg/ml; dose range: 30 to 60 units insulin glargine in combination with 10 to 20 mcg lixisenatide)
Maltese: Iż-żewġ pinen mimlijin għal-lest fihom insulin glargine b'qawwa ta' 100 unità/ml Il-pinna Suliqua 10-40 tħallik tagħti dożi ta' kuljum ta' Suliqua ta' bejn 10 u 40 inkriment fid-doża (qawwa: insulin glargine 100 unità/ml u lixisenatide 50 mcg/ml; marġni tad-doża: 10 sa 40 unità ta' insulin glargine flimkien ma' 5 sa 20 mcg lixisenatide)
English: The following table describes the rate of documented symptomatic hypoglycaemia (≤3.9 mmol/L) and severe hypoglycaemia for both Suliqua and the comparator.
Maltese: It-tabella li jmiss tiddeskrivi r-rata ta' ipogliċemija ddokumentata (≤3.9 mmol/L) bis-sintomi u ipogliċemija severa kemm għal Suliqua kif ukoll għall-kumparatur.
English: Each mL contains 100 units of insulin glargine and 33 micrograms lixisenatide.
Maltese: Kull ml fih 100 unità ta' insulin glargine u 33 mikrogramma lixisenatide.
English: • Tiredness
Maltese: • Rimettar • Dijarea
English: Animal data do not indicate reproductive toxicity with insulin glargine.
Maltese: Dejta fl-annimali ma turix effett tossiku fuq is-sistema riproduttiva b'insulin glargine.
English: LS change from baseline (mean) Difference versus insulin glargine [95% confidence interval]
Maltese: Differenza versus insulin glargine [95% confidence interval]
English: The maximum daily dose is 60 units insulin glargine and 20 mcg lixisenatide corresponding to 60 dose steps.
Maltese: Id-doża massima ta' kuljum hija 60 unità insulin glargine u 20 mcg lixisenatide li huma ekwivalenti għal 60 grad fuq l-iskala tad-doża.
English: Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen Insulin glargine + lixisenatide
Maltese: Suliqua 100 unità/ml + 50 mcg/ml injezzjoni insulin glargine + lixisenatide
English: • Suliqua is available in two pre-filled pens containing two different strengths of lixisenatide, and different dose ranges: Both pre-filled pens contain insulin glargine in a strength of 100 units/ml Suliqua 10-40 pen allows daily doses between 10 and 40 dose steps of Suliqua to be given (strength: insulin glargine 100 units/ml and lixisenatide 50 mcg/ml; dose range: 10 to 40 units of insulin glargine in combination with 5 to 20 mcg lixisenatide) Suliqua 30-60 pen allows daily doses between 30 and 60 dose steps of Suliqua to be given (strength: insulin glargine 100 units/ml and lixisenatide 33 mcg/ml; dose range: 30 to 60 units insulin glargine in combination with 10 to 20 mcg lixisenatide)
Maltese: Il-pinna Suliqua 30-60 tħallik tagħti dożi ta' kuljum ta' Suliqua ta' bejn 30 u 60 inkriment fid-doża (qawwa: insulin glargine 100 unità/ml u lixisenatide 33 mcg/ml; marġni tad-doża: 30 sa 60 unità ta' insulin glargine flimkien ma' 10 sa 20 mcg lixisenatide)
English: • Each dose step of Suliqua you dial contains 1 unit of insulin glargine and 0.33 micrograms of lixisenatide.
Maltese: • Kull grad fuq l-iskala tad-doża ta' Suliqua li ddawar fih unità 1 ta' insulin glargine u 0.33 mikrogramma ta' lixisenatide.
English: Any other OADs were discontinued.
Maltese: Kwalunkwe OADs oħra twaqqfu.
English: • Medicines to relieve pain and lower fever, such as pentoxifylline, propoxyphene and salicylates
Maltese: • Mediċini li jtaffu l-uġigħ u jniżżlu d-deni, bħal pentoxifylline, propoxyphene u salicylates (bħal acetylsalicylic acid).
English: Other signs include: headaches, feeling very hungry, feeling sick (nausea) or being sick (vomiting), feeling tired, sleepy, restless, sleeping problems, aggressive behaviour, difficulty concentrating, slow reactions, depression, feeling confused, difficulty speaking (sometimes total loss of speech), changes in your sight, trembling, being unable to move (paralysis), tingling in the hands or arms, feeling numb and tingling often around the mouth, feeling dizzy, loss of self-control, being unable to look after yourself, fits, passing out.
Maltese: Sinjali oħra jinkludu: uġigħ ta' ras, tħossok bil-ġuħ ħafna, tħossok imdardar (nawsja) jew tirremetti, tħossok għajjien, bi ngħas, bla kwiet, ikollok problemi bl-irqad, komportament aggressiv, diffikultà biex tikkonċentra, reazzjonijiet bil-mod, depressjoni, tħossok konfuż, issib diffikultà biex titkellem (xi drabi anke telf totali tat-taħdit), bidliet fil-vista tiegħek, rogħda, ma tkunx tista' tiċċaqlaq (paraliżi), tingiż fl-idejn jew fid-dirgħajn, tħoss titrix jew tingiż ħafna drabi madwar il-ħalq, tħossok stordut, telf ta' kontroll fuqek innifsek, ma tkunx tista' tieħu ħsieb lilek innifsek, aċċessjonijiet, tintilef minn sensik.
English: The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing frequency (very common: ≥1/10; common: ≥1/100 to <1/10;
Maltese: Ir-reazzjonijiet avversi relatati li ġejjin minn investigazzjonijiet kliniċi huma elenkati taħt skont ilklassi tas-sistemi u tal-organi u skont il-frekwenza tagħhom b'dawk li għandhom l-ogħla frekwenza mniżżla l-ewwel segwiti minn dawk bi frekwenza inqas (komuni ħafna: ≥1/10; komuni: ≥1/100 sa <1/10; mhux komuni: ≥1/1,000 sa <1/100; rari:
English: The combination of insulin glargine and lixisenatide has no impact on the pharmacodynamics of of insulin glargine.
Maltese: Il-kombinazzjoni ta' insulin glargine u lixisenatide m'għandha l-ebda impatt fuq il-farmakodinamika ta' insulin glargine.
English: Hypoglycaemia is also more likely to happen if:
Maltese: Tgħallem injetta:
English: Each ml contains 100 units of insulin glargine and 33 micrograms lixisenatide.
Maltese: Kull ml fih 100 unità insulin glargine u 33 mikrogramma lixisenatide.