FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition to reports in clinical trials, worldwide voluntary reports of adverse reactions received for Bexsero since market introduction are included in the list.
Maltese: Flimkien mar-rapporti fil-provi kliniċi, rapporti minn madwar id-dinja kollha li saru b'mod volontarju dwar reazzjonijiet avversi li ġew riċevuti għal Bexsero minn meta tpoġġa fis-suq, huma inklużi fil-lista.
English: Not known: syncope or vasovagal responses to injection, meningeal irritation (signs of meningeal irritation, such as neck stiffness or photophobia, have been sporadically reported shortly after vaccination.
Maltese: Mhux magħrufa: sinkope jew risponsi vasovagali għall-injezzjoni, irritazzjoni meninġeali (sinjali ta' irritazzjoni meninġeali, bħal għebusija tal-għonq jew fotofobija, ġew irrappurtati sporadikament ftit wara t-tilqima.
English: Children and adolescents with complement deficiencies, asplenia, or splenic dysfunction
Maltese: Tfal u adolexxenti b'defiċjenzi tal-komplement, asplenja jew disfunzjoni tal-milsa
English: 35 to 47 months of age 4 to 7 years of age 8 to10 years of age fHbp
Maltese: 35 sa 47 xahar
English: Via Fiorentina 1 53100 Siena Italy.
Maltese: GSK Vaccines S.r.l. Via Fiorentina 1 53100
English: Common (these may affect up to 1 in 10 people) - skin rash (infants and children 2 to 10 years of age)
Maltese: Komuni (dawn jistgħu jaffettwaw sa persuna 1 minn kull 10 persuni) - raxx tal-ġilda (trabi u tfal ta' età minn sentejn sa 10 snin)
English: Summary of posology
Maltese: Immunoġeniċità f'popolazzjonijiet speċjali
English: Immunogenicity in infants and children
Maltese: Immunoġeniċità fit-trabi u tfal
English: MARKETING AUTHORISTION NUMBER(S)
Maltese: NUMRU(I)
English: The vaccine is given by deep intramuscular injection, preferably in the anterolateral aspect of the thigh in infants or in the deltoid muscle region of the upper arm in older subjects.
Maltese: Din it-tilqima tingħata permezz ta' injezzjoni profonda ġol-muskoli, preferibbilment fl-aspett anterolaterali tal-koxxa fi tfal żgħar jew fir-reġjun tal-muskolu deltojde tal-parti ta' fuq tad-driegħ f'individwi li jkollhom iktar żmien.
English: Not known: allergic reactions (including anaphylactic reactions)
Maltese: Mhux magħrufa: reazzjonijiet allerġiċi (li jinkludu reazzjonijiet anafilattiċi)
English: If you have any further questions on Bexsero, ask your doctor or nurse.
Maltese: Jekk ikollok aktar mistoqsijiet dwar Bexsero, staqsi lit-tabib jew l-infermier tiegħek.
English: Serum bactericidal antibody responses following a booster at 12 months after a primary series administered at 2, 3 and 4 or 2, 4 and 6 months of age, and persistence of bactericidal antibody one year after the booster
Maltese: 4 xhur u 6 xhur, u l-persistenza tal-antikorpi batteriċidjali sena wara d-doża booster
English: ATC Code: A10AE54.
Maltese: Kodiċi ATC: A10AE54.
English: Then press all the way in and hold.
Maltese: Oħroġ pinna ġdida mill-friġġ mill-inqas siegħa qabel tinjetta.
English: EU/1/16/1157/001 EU/1/16/1157/002 EU/1/16/1157/003 EU/1/16/1157/004 EU/1/16/1157/005 EU/1/16/1157/006
Maltese: EU/1/16/1157/001 EU/1/16/1157/002 EU/1/16/1157/003 EU/1/16/1157/004
English: uncommon: ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000).
Maltese: ≥1/10,000 sa <1/1,000; rari ħafna: <1/10,000).
English: [-2.246 to -1.682]
Maltese: [-2.246 sa -1.682]
English: (-3.89 to -2.77)
Maltese: (-3.89 sa -2.77)
English: INFORMATION IN BRAILLE Suliqua 10 - 40
Maltese: INFORMAZZJONI BIL-BRAILLE Suliqua 10 - 40
English: Store below 25°C.
Maltese: Aħżen f'temperatura taħt il- 25°C.
English: • Isoniazid, for tuberculosis.
Maltese: • Isoniazid, għat-tuberkulożi.
English: Industriepark Hochst 65926 Frankfurt am Main GERMANY
Maltese: Industriepark Hochst 65926 Frankfurt am Main
English: (-2.79 to -1.96)
Maltese: (-2.79 sa -1.96)
English: [12.2 to 24.0]
Maltese: [12.2 sa 24.0]
English: • Clozapine, olanzapine and phenothiazine derivatives, for mental health problems.
Maltese: • Clozapine, olanzapine u derivati ta' phenothiazine, għal problemi ta' saħħa mentali.
English: (-0.21 to 0.43)
Maltese: (-0.21 sa 0.43)
English: • Danazol, for endometriosis.
Maltese: • Danazol, għall-endometrijożi.
English: [-0.420 to 0.038]
Maltese: [-0.420 sa 0.038]
English: (-1.63 to -0.57)
Maltese: (-1.63 sa -0.57)
English: • The possible effects of changing to different time zones.
Maltese: • L-effetti possibbli ta' tibdil ta' żoni ta' ħin differenti.
English: Severe hypoglycaemia**
Maltese: Ipogliċemija severa**
English: [8.1 to 22.4]
Maltese: [8.1 sa 22.4]
English: • Sulfonamide antibiotics, to treat infections.
Maltese: • L-antibijotiċi sulfonamide, għat-trattament ta' infezzjonijiet.
English: The incidence of MACE was similar between LANTUS and standard care in ORIGIN [Hazard Ratio (95% CI) for MACE; 1.02 (0.94, 1.11)].
Maltese: L-inċidenza ta' MACE kienet simili bejn LANTUS u kura standard f'ORIGIN [Proporzjon ta' Periklu (95% CI) għal MACE; 1.02 (0.94, 1.11)].
English: • If you have poor eyesight, please see section 3.
Maltese: • Jekk għandek vista batuta, jekk jogħġbok ara sezzjoni 3.
English: [1.4 to 2.6]
Maltese: [1.4 sa 2.6]
English: [15.0 to 26.7]
Maltese: [15.0 sa 26.
English: Insulin glargine (100 units/ml)** ≥20 to <30 units
Maltese: Insulin glargine (100 unità/ml)** ≥20 sa <30 unità
English: • Fluoxetine, for depression.
Maltese: • Fluoxetine, għad-depressjoni.
English: Warfarin or other anticoagulants
Maltese: Warfarin jew antikoagulanti oħra
English: • Sympathomimetic medicines such as epinephrine (adrenaline), salbutamol and terbutaline, for asthma.
Maltese: • Mediċini simpatomimetiċi bħal epinephrine (adrenaline), salbutamol u terbutaline, għall-ażma.
English: Sanofi-Aventis Deutschland GmbH Industriepark Höchst - 65926 Frankfurt am Main Germany
Maltese: Sanofi-Aventis Deutschland GmbH Industriepark Höchst - 65926 Frankfurt am Main
English: Insulin glargine (100 units/ml)** ≥30 to ≤60 units
Maltese: Insulin glargine (100 unità/ml)** ≥30 sa ≤60 unità
English: [-1.9 to -0.9]
Maltese: [-1.9 sa -0.9]
English: [-1.8 to -0.9]
Maltese: [-1.8 sa -0.9]
English: Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens, phenothiazine derivatives, somatropin, sympathomimetic medicinal products (e.g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, atypical antipsychotic medicinal products (e.g. clozapine and olanzapine) and protease inhibitors.
Maltese: danazol, diazoxide, id-dijuretiċi, glucagon, isoniazid, estroġeni u proġestoġeni, id-derivati ta' phenothiazine, somatropin, prodotti mediċinali simpatomimetiċi (eż. epinephrine [adrenaline], salbutamol, terbutaline), l-ormoni tat-tirojde, prodotti mediċinali antipsikotiċi atipiċi (eż. clozapine u olanzapine) u inibituri tal-protease.
English: The AUC and Cmax of the active metabolite (ramiprilat) were not affected.
Maltese: L-AUC u s-Cmax tal-metabolit attiv (ramiprilat) ma ġewx affettwati.
English: 2 hour PPG (mmol/L)**
Maltese: PPG wara sagħtejn (mmol/L)**
English: Warfarin and other coumarin derivatives
Maltese: Warfarin u derivati oħra ta' coumarin
English: 30 dose steps (30 units/10 mcg)* * units insulin glargine (100 units/ml) / mcg lixisenatide
Maltese: (30 unità/10 mcg)* * unitajiet ta' insulin glargine (100 unità/ml) / mcg lixisenatide
English: 10 dose steps (10 units/5 mcg)*
Maltese: (10 unitajiet/5 mcg)*
English: *Insulin glargine is produced by recombinant DNA technology in Escherichia coli.
Maltese: *Insulin glargine huwa magħmul bit-teknoloġija rikombinanti tad-DNA ġo Escherichia coli.
English: The incidence of the primary endpoint was similar in the lixisenatide (13.4%) and placebo (13.2%) groups: the hazard ratio (HR) for lixisenatide versus placebo was 1.017, with an associated 2-sided 95% confidence interval (CI) of 0.886 to 1.168.
Maltese: L-inċidenza tal-iskop finali primarju kienet simili fil-gruppi ta' lixisenatide (13.4%) u tal-plaċebo (13.2%): il-proporzjon ta' periklu (HR, hazard ratio) għal lixisenatide versus il-plaċebo kien 1.017, b'confidence interval (CI) 95% 2-sided assoċjat ta' 0.886 sa 1.168.
English: 20 dose steps (20 units/10 mcg)*
Maltese: (20 unità/10 mcg)*
English: A metabolism study in diabetic patients who received insulin glargine alone indicates that insulin glargine is rapidly metabolised at the carboxyl terminus of the B chain to form two active metabolites, M1 (21A-Gly-insulin) and M2 (21A-Gly-des-30B-Thr-insulin).
Maltese: Studju dwar metaboliżmu f'pazjenti dijabetiċi li rċivew insulin glargine waħdu jindika li insulin glargine jiġi mmetabolizzat malajr fit-tarf li fih carboxyl tal-katina B biex jifforma żewġ metaboliti attivi, M1 (21A-Gly-insulin) u M2 (21A-Gly-des-30B-Thr-insulin).
English: ** If a different basal insulin was used:
Maltese: **Jekk intużat insulina tal-bażi differenti:
English: Metformin was a mandatory background therapy and 58% of patients received a second OAD at screening, being a sulfonylurea in 54% of patients.
Maltese: Metformin kien terapija obbligatorja flisfond u 58% tal-pazjenti rċivew OAD ieħor meta ġew eżaminati, li kien sulfonylurea f'54% talpazjenti.
English: In a pharmacokinetic study in elderly non-diabetic subjects, administration of lixisenatide 20 mcg resulted in a mean increase of lixisenatide AUC by 29% in the elderly population (11 subjects aged 65 to 74 years and 7 subjects aged ≥75 years) compared to 18 subjects aged 18 to 45 years, likely related to reduced renal function in the older age group.
Maltese: Fi studju farmakokinetiku f'individwi anzjani li ma kellhomx id-dijabete, l-għoti ta' 20 mcg lixisenatide wassal għal żieda medja fl-AUC ta' lixisenatide ta' 29% fil-popolazzjoni anzjana (11-il individwu ta' etajiet bejn 65 u 74 sena u 7 individwi b'età ≥ 75 sena) meta mqabbla ma' 18-il individwu b'etajiet minn 18 sa 45 sena, li x'aktarx kienet marbuta mat-tnaqqis fil-funzjoni talkliewi fil-grupp ta' età akbar.
English: Excipient(s) with known effects: Each ml contains 2.7 milligrams of metacresol.
Maltese: Kull ml fih 2.7 milligramma ta' metacresol.
English: Lixisenatide is a glucagon-like peptide (GLP1) receptor agonist.
Maltese: Lixisenatide huwa agonist tar-riċettur ta' peptide-1 li tixbah il-glucagon (GLP1).
English: DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION Date of first authorisation: 11 January 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 11 Jannar 2017
English: Exposure to insulin glargine following administration of the insulin glargine/lixisenatide combination was 86-88 % compared to administration of separate simultaneous injections of insulin glargine and lixisenatide.
Maltese: Esponiment għal insulin glargine wara l-għoti tal-kombinazzjoni ta' insulin glargine/lixisenatide kien ta' 86-88 % meta mqabbel mal-għoti ta' injezzjonijiet separati ta' insulin glargine u lixisenatide fl-istess waqt.
English: Number of subjects (mITT)
Maltese: NUMRU(I)
English: • The active substances are insulin glargine and lixisenatide.
Maltese: • Is-sustanzi attivi huma insulin glargine u lixisenatide.
English: • Monoamine oxidase inhibitors (MAOIs), for depression or Parkinson´s disease.
Maltese: • Inibituri ta' monoamine oxidase (MAOIs - monoamine oxidase inhibitors) għad-depressjoni jew għall-marda ta' Parkinson.
English: HbA1c (%)
Maltese: Numru ta' individwi (mITT) HbA1c (%)
English: Lixisenatide is a peptide and is not metabolised by cytochrome P450.
Maltese: Lixisenatide huwa peptide u mhuwiex immetabolizzat miċ-ċitokrom P450.
English: In patients treated with Suliqua, the incidence of related nausea, diarrhoea and vomiting was 8.4%, 2.2% and 2.2%, respectively.
Maltese: F'pazjenti ttrattati b'Suliqua, linċidenza ta' nawsja, dijarea u rimettar b'rabta mat-trattament kienet 8.4%, 2.2% u 2.2%, rispettivament.
English: 30-60 dose steps SoloStar
Maltese: 30-60 grad fuq l-iskala tad-doża SoloStar
English: Packs of 3, 5 and 10 pre-filled pens.
Maltese: Pakketti ta' 3, 5 u 10 pinen mimlijin għal-lest.
English: Use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions.
Maltese: L-użu ta' agonisti tar-riċettur GLP-1 jista' jkun assoċjat ma' reazzjonijiet gastrointestinali avversi.
English: Suliqua with alcohol
Maltese: Suliqua ma' alkoħol
English: Suliqua (30-60) pen contains insulin glargine and lixisenatide.
Maltese: Il-pinna Suliqua (30-60) fiha insulin glargine u lixisenatide.
English: When administered 1 or 4 hours after 10 mcg lixisenatide, Cmax of paracetamol was decreased by 29% and 31%, respectively and median tmax was delayed by 2.0 and 1.75 hours, respectively.
Maltese: Meta ngħata siegħa jew 4 sigħat wara 10 mcg ta' lixisenatide, is-Cmax ta' paracetamol tnaqqas b'29% u 31%, rispettivament u l-medjan ta' tmax kien imdewwem b'2.0 u 1.75 siegħa rispettivament.
English: After concomitant administration of warfarin 25 mg with repeated dosing of lixisenatide 20 mcg, there were no effects on AUC or INR (International Normalised Ratio) while Cmax was reduced by 19% and tmax was delayed by 7 hours.
Maltese: Wara li warfarin 25 mg ingħata flimkien ma' doża ripetuta ta' lixisenatide 20 mcg, ma kien hemm l ebda effetti fuq l-AUC jew l-INR (International Normalised Ratio) filwaqt li s-Cmax naqas b'19% u kien hemm dewmien ta' 7 sigħat għat-tmax.
English: 10-40 dose steps SoloStar
Maltese: 10-40 grad fuq l-iskala tad-doża SoloStar
English: • Lithium salts, for mental health problems.
Maltese: • Is-sustanzi ta' lithium, għal problemi ta' saħħa mentali.
English: Comparison versus lixisenatide [95% confidence interval]*
Maltese: Tqabbil versus lixisenatide [95% confidence interval]*
English: In subjects with mild (creatinine clearance calculated by the Cockcroft-Gault formula 60-90 ml/min), moderate (creatinine clearance 30-60 ml/min) and severe renal impairment (creatinine clearance 15-30 ml/min) AUC of lixisenatide was increased by 46%, 51% and 87%, respectively.
Maltese: F'individwi b'indeboliment ħafif (it-tneħħija tal-kreatinina kkalkulata bil-formula Cockcroft-Gault 60-90 ml/min), moderat (tneħħija tal-kreatinina 30-60 ml/min) u sever (tneħħija tal-kreatinina ta' 15-30 ml/min) tal-kliewi l-AUC ta' lixisenatide żdiedet b'46%, 51% u 87%, rispettivament.
English: Suliqua (10-40) pen contains insulin glargine and lixisenatide.
Maltese: Il-pinna Suliqua (10-40) fiha insulin glargine u lixisenatide.
English: Some (1.7%) patients taking insulin containing therapy, including Suliqua have experienced erythema, local edema, and pruritus at the site of injection.
Maltese: Xi (1.7%) pazjenti li jieħdu terapija li fiha l-insulina, inkluż Suliqua jkollhom eritema, edima lokali, u ħakk fil-post tal-injezzjoni.
English: • Somatropin, a growth hormone.
Maltese: • Somatropin, ormon għat-tkabbir fiżiku.
English: In controlled clinical trials in adults with insulin glargine (100 units/ml), subgroup analyses based on age, race, and gender did not show differences in safety and efficacy.
Maltese: Fi provi kliniċi kkontrollati fl-adulti b'insulin glargine (100 unità/ml), analiżi ta' sottogruppi abbażi tal-età, r-razza u s-sess tal-persuna ma wrew l-ebda differenzi fis-sigurtà u l-effikaċja.
English: • Keep your pen at room temperature, below 25°C.
Maltese: • Żomm il-pinna tiegħek f'temperatura ambjentali, inqas minn 25°C.
English: This could be a sign of of inflamed pancreas (acute pancreatitis).
Maltese: Dan jista' jkun sinjal ta' frixa infjammata (pankreatite akuta).
English: Previous therapy
Maltese: Terapija preċedenti
English: Age, Race, Gender and Body weight
Maltese: Età, Razza, Sess tal-persuna u Piż tal-ġisem
English: Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia include anti-hyperglycaemic medicinal products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates and sulfonamide antibiotics.
Maltese: Sustanzi li jistgħu jżidu l-effett tat-tnaqqis tal-glukożju fid-demm u jżidu s-suxxettibbiltà għallipogliċemija jinkludu prodotti mediċinali kontra l-ipergliċemija, inibituri tal-enzima li tikkonverti angiotensin (ACE - angiotensin converting enzyme), disopyramide, fibrati, fluoxetine, inibituri ta' monamine oxidase (MAO), pentoxifylline, propoxyphene, salicylates u l-antibijotiċi sulfonamide.
English: The therapeutic experience of Suliqua in patients ≥75 years of age is limited.
Maltese: L-esperjenza terapewtika ta' Suliqua f'pazjenti li għandhom ≥75 sena hija limitata.
English: Proportion difference vs. lixisenatide [95% confidence interval]*
Maltese: Differenza fil-proporzjon vs. lixisenatide [95% confidence interval]*
English: Patients in the Suliqua group reported a statistically significantly greater decrease in the average 7-point self-monitored plasma glucose (SMPG) profile from baseline to Week 30 (-3.35 mmol/L) compared to patients in the insulin glargine group (-2.66 mmol/L; difference -0.69 mmol/L) and patients in the lixisenatide group (-1.95 mmol/L; difference -1.40 mmol/L) (p<0.0001 for both comparisons).
Maltese: Il-pazjenti fil-grupp ta' Suliqua rrappurtaw tnaqqis b'mod sinifikanti ikbar fil-profil tal-medja ta' 7 punti ta' glukożju fil-plażma imkejjel mill-persuna nnifisha (SMPG, self-monitored plasma glucose) mil-linja bażi sa Ġimgħa 30 (-3.35 mmol/L) meta mqabbel ma' pazjenti fil-grupp ta' insulin glargine (-2.66 mmol/L; differenza -0.69 mmol/L) u pazjenti fil-grupp ta' lixisenatide (-1.95 mmol/L; differenza -1.40 mmol/L) (p<0.
English: • Protease inhibitors, for HIV.
Maltese: • Inibituri ta' protease, għall-HIV.
English: • Corticosteroids such as cortisone and prednisolone, for inflammation.
Maltese: • Il-kortikosterojdi bħal cortisone u prednisolone, għall-infjammazzjoni.
English: • Add-on to metformin [insulin naïve]
Maltese: • Terapija miżjuda ma' metformin [qatt ma ħadu insulina]
English: Suliqua has not been studied in combination with DPP-4 inhibitors, sulfonylureas, glinides, pioglitazone and SGLT-2 inhibitors.
Maltese: Suliqua ma ġiex studjat flimkien ma' inibituri ta' DPP-4, sulfonylureas, glinides, pioglitazone u inibituri ta' SGLT-2.
English: Do not use Suliqua:
Maltese: Tużax Suliqua:
English: AUC was comparable while there was a small decrease in Cmax of lixisenatide of 22-34% compared with separate simultaneous administration of insulin glargine and lixisenatide, which is not likely to be clinically significant.
Maltese: L-AUC kienet kumparabbli filwaqt li kien hemm tnaqqis żgħir ta' 22-34% fis-Cmax ta' lixisenatide meta mqabbel mal-għoti separat ta' insulin glargine u lixisenatide fl-istess waqt, li x'aktarx mhuwiex se jkun sisnifikanti b'mod kliniku.
English: 30-60 dose steps (1 dose step = 1 unit of insulin glargine + 0.33 micrograms of lixisenatide)
Maltese: 30-60 grad fuq l-iskala tad-doża (grad 1 fuq l-iskala tad-doża = unità 1 ta' insulin glargine + 0.33 mikrogramma ta' lixisenatide)
English: Allergic reactions (urticaria) possibly related with Suliqua have been reported in 0.3% of patients.
Maltese: Disturbi fis-sistema immuni Reazzjonijiet allerġiċi (urtikarja) possibilment marbuta ma' Suliqua ġew irrappurtati f'0.3% tal pazjenti.
English: The incidence of formation of antilixisenatide antibodies was approximately 43%.
Maltese: L-inċidenza talformazzjoni ta' antikorpi kontra lixisenatide kienet madwar 43%.
English: Other medicines and Suliqua
Maltese: Mediċini oħra u Suliqua
English: Important information about some of the ingredients of Suliqua This medicine contains less than 1 mmol (23 mg) sodium per dose.
Maltese: Din il-mediċina fiha inqas minn 1 mmol (23 mg) ta' sodium f'kull doża.
English: 5x 3 mL pens
Maltese: 5x 3 ml pinen
English: Patients [n (%)] reaching HbA1c <7% at week 30* Fasting plasma glucose (mmol/L) Baseline (mean)
Maltese: Pazjenti [n (%)] li kisbu HbA1c <7% f'ġimgħa 30*
English: The mean BMI at baseline was 31.7 kg/m2 with 63.4% of patients having a BMI ≥30 kg/m2.
Maltese: Il-medja tal-BMI fil-linja bażi kienet 31.7 kg/m2 b'63.4% tal-pazjenti li kellhom BMI ≥30 kg/m2.
English: LS difference versus glargine (mean) [95%CI]
Maltese: Differenza f'LS versus glargine (medja) [95%CI]
English: Number (%) of patients achieving HbA1c <7.0% with no body weight gain at week
Maltese: Numru (%) ta' pazjenti li kisbu HbA1c <7.0%
English: Places to inject
Maltese: Infezzjonijiet u infestazzjonijiet
English: Glycerol 85%
Maltese: Glycerol 85% Methionine Metacresol Zinc chloride
English: In the switch from basal insulin clinical study the starting dose was 20 dose steps (20 units insulin glargine and 10 mcg lixisenatide) or 30 dose steps, (30 units insulin glargine and 10 mcg lixisenatide), see section 4.2, depending on the previous insulin dose.
Maltese: Fl-istudju kliniku tal-bidla mill-insulina talbażi id-doża tal-bidu kienet 20 grad fuq l-iskala tad-doża (20 unità ta' insulin glargine u 10 mcg lixisenatide) jew 30 grad ta' doża, (30 unità ta' insulin glargine u 10 mcg lixisenatide), ara sezzjoni 4.2, skont kemm kienet id-doża preċedenti tal-insulina.
English: The mean BMI at baseline was 31.1 kg/m2 with 57.3% of patients having a BMI ≥30 kg/m2.
Maltese: Il-medja tal-BMI fil-linja bażi kienet 31.1 kg/m2 b'57.3% tal-pazjenti li kellhom BMI ≥30 kg/m2.
English: • Pentamidine, for some parasite infections.
Maltese: • Pentamidine, għal xi infezzjonijiet ikkawżati mill-parassiti.
English: 10-40 dose steps (1 dose step = 1 unit of insulin glargine + 0.5 micrograms of lixisenatide)
Maltese: 10-40 grad fuq l-iskala tad-doża (grad 1 fuq l-iskala tad-doża = unità 1 ta' insulin glargine + 0.5 mikrogramma ta' lixisenatide)
English: LS difference versus lixisenatide (mean) [95%CI]
Maltese: Differenza f'LS versus lixisenatide (medja) [95%CI]
English: For in use storage conditions, see section 6.3
Maltese: Għall-kundizzjonijiet ta' ħażna waqt l-użu, ara sezzjoni 6.3
English: When lixisenatide 20 mcg and atorvastatin 40 mg were co-administered in the morning for 6 days, the exposure to atorvastatin was not affected, while Cmax was decreased by 31% and tmax was delayed by 3.25 hours.
Maltese: Atorvastatin Meta lixisenatide 20 mcg u atorvastatin 40 mg ġew mogħtija flimkien fil-għodu għal 6 ijiem, l esponiment għal atorvastatin ma kienx affettwat, filwaqt li s-Cmax naqset b'31% u t-tmax ġie mdewwem bi 3.25 siegħa.
English: Dosage titration
Maltese: Titrazzjoni tad-doża
English: LIST OF EXCIPIENTS glycerol 85%, methionine, metacresol (see leaflet for further information), zinc chloride, concentrated hydrochloric acid and sodium hydroxide (for pH adjustment), water for injections.
Maltese: TA' EĊĊIPJENTI glycerol 85%, methionine, metacresol (ara l-fuljett għal-aktar informazzjoni), zinc chloride, hydrochloric acid konċentrat u sodium hydroxide (għal aġġustament tal-pH), ilma għall-injezzjonijiet.
English: 3x3 mL pens
Maltese: 3x3 ml pinen
English: LS difference versus lixisenatide (mean) [95%CI] (p-value)
Maltese: Differenza f'LS versus lixisenatide (medja) [95%CI] (valur p)
English: The Patient Guide shall contain the following key messages:
Maltese: Meta s-sinjali ta' ipogliċemija jistgħu jkunu inqas ċari:
English: The randomised type 2 diabetes population had the following characteristics: Mean age was 58.4 years with the majority (57.1%) being aged of 50 to 64 years, and 50.6 percent were male.
Maltese: Età medja ta' 58.4 snin bil-maġġoranza li kellhom (57.1%) minn 50 sa 64 sena, u 50.6 fil-mija kienu rġiel.
English: • Thyroid hormones, for thyroid gland problems.
Maltese: • Ormoni tat-tirojde, għal problemi tal-glandola tat-tirojde.
English: In approximately 93% of the patients, anti-insulin glargine antibodies showed cross-reactivity to human insulin.
Maltese: F'madwar 93% tal-pazjenti, antikorpi kontra insulin glargine wrew reattivita inkroċjata għall-insulina tal-bniedem.
English: 10x 3 mL pens
Maltese: 10x 3 ml pinen
English: In the Add-on to metformin clinical study the treatment was started at 10 dose steps (10 units insulin glargine and 5 mcg lixisenatide).
Maltese: Fl-istudju kliniku tat-Terapija miżjuda ma' metformin it-trattament inbeda b'10 gradi fuq l-iskala taddoża (10 unitajiet insulin glargine u 5 mcg lixisenatide).
English: Age has no clinically relevant effect on the pharmacokinetics of lixisenatide.
Maltese: L-età m'għandha l-ebda effett rilevanti b'mod kliniku fuq il-farmakokinetika ta' lixisenatide.