FrancophonIA/ELRC3.0 huggingface dataset:
English: Results from studies comparing Toujeo and insulin glargine 100 units/ml did not indicate any difference in term of development of anti-insulin antibodies, on efficacy, safety or dose of basal insulin between Toujeo and insulin glargine 100 units/ml.
Maltese: Ir-riżultati minn studji li qabblu Toujeo ma' insulin glargine 100 unità/ml ma wrew l-ebda differenza f'dak li għandu x'jaqsam mal-iżvilupp ta' antikorpi kontra l-insulina, mal-effikaċja, mas-sigurtà jew mad-doża tal-insulina tal-bażi bejn Toujeo u insulin glargine 100 unità/ml.
English: In Toujeo clinical studies in adult patients, the incidence of injection site reactions was similar in Toujeo-treated patients (2.5%) and insulin glargine 100 units/ml-treated patients (2.8%).
Maltese: Fi studji kliniċi ta' Toujeo f'pazjenti adulti, l-inċidenza ta' reazzjonijiet fis-sit tal injezzjoni kienet simili f'pazjenti ttrattati b'Toujeo (2.5%) u pazjenti ttrattati b'insulin glargine 100 unità/ml (2.8%).
English: Improvement in HbA1C was not affected by, gender, ethnicity, age, diabetes duration (<10 years and ≥10 years), HbA1c value at baseline (<8% or ≥8%) or baseline body mass index (BMI).
Maltese: Titjib fl-HbA1c ma kienx affettwat, mis-sess, mill-etniċità, mill-età, minn kemm ilha d-dijabete (<10 snin u ≥10 snin), mill-valur ta' HbA1c fil-linja bażi (<8% jew ≥8%) jew mill-indiċi tal-massa talġisem fil-linja bażi (BMI - body mass index).
English: Very rare: may affect up to 1 in 10,000 people
Maltese: Rari ħafna: jistgħu jaffettwaw sa persuna 1 minnn kull 10,000
English: Table 3 - Summary of the hypoglycaemic episodes of the clinical study in patients with type 1 and type 2 diabetes mellitus
Maltese: Tabella 3 - Sommarju tal-episodji ta' ipogliċemija tal-istudju kliniku f'pazjenti b'dijabete mellitus tattip 1 u tat-tip 2 Popolazzjoni dijabetika
English: • Toujeo is injected under the skin (subcutaneous use or “SC”).
Maltese: • Toujeo jiġi injettat taħt il-ġilda (użu taħt il-ġilda jew “SC - subcutaneous use”).
English: The superiority of Toujeo over insulin glargine 100 units/ml in lowering the risk of confirmed nocturnal hypoglycaemia was shown in patients with type 2 diabetes treated with basal insulin in combination with either non-insulin anti-hyperglycaemic medicinal product (18% risk reduction) or mealtime insulin (21% risk reduction) during the period from week 9 to end of study period.
Maltese: Is-superjorità ta' Toujeo fuq insulin glargine 100 unità/ml fit-tnaqqis tar-riskju ta' ipogliċemija kkonfermata matul il-lejl intweriet f'pazjenti b'dijabete tat-tip 2 ittrattati b'insulina tal-bażi flimkien ma' prodott mediċinali kontra l-ipergliċemija li mhuwiex insulina (tnaqqis fir-riskju ta' 18%) jew inkella b'insulina waqt il-ħin tal-ikel (tnaqqis fir-riskju ta' 21%) waqt il-perjodu mill-ġimgħa 9 salaħħar tal-perjodu tal-istudju.
English: • Keep eating enough carbohydrates.
Maltese: • Ibqa' kul biżżejjed karboidrati.
English: 0.04 [-0.098 to 0.185]
Maltese: [-0.098 sa 0.185]
English: • Corticosteroids such as cortisone - for inflammation.
Maltese: • Il-kortikosterojdi bħal cortisone - għall-infjammazzjoni.
English: SoloStar pen
Maltese: Lipoipertro fija
English: It delivers doses of 2-160 units per injection, in steps of 2 units.
Maltese: Tagħti dożi ta' 2-160 unità għal kull injezzjoni, f'żidiet ta' 2 unitajiet.
English: Cutaneous amyloidosis
Maltese: taħt il-ġilda
English: Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany
Maltese: Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Il-Ġermanja
English: Diabetic population
Maltese: Popolazzjoni dijabetika
English: Injection button
Maltese: Buttuna tal-injezzjoni
English: b Confirmed hypoglycaemia: Any severe hypoglycaemia and/or hypoglycaemia confirmed by plasma glucose value ≤3.9 mmol/l.
Maltese: glukożju fil-plażma ≤3.9 mmol/l.
English: Each DoubleStar pen contains 3 ml of solution for injection (equivalent to 900 units).
Maltese: Kull pinna DoubleStar fiha 3 ml ta' soluzzjoni għall-injezzjoni (ekwivalenti għal 900 unità).
English: Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Germany.
Maltese: Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main,
English: 29 units selected
Maltese: intgħażlu 30 unità intgħażlu 29 unità
English: Taking into account the PRAC Assessment Report on the PSUR(s) for insulin glargine, the scientific conclusions of CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal insulin glargine, il konklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: The rates of severe hypoglycaemia (affected participants per 100 participant years of exposure) were 1.05 for insulin glargine 100 units/ml and 0.30 for standard care group and the rates of confirmed non-severe hypoglycaemia were 7.71 for insulin glargine 100 units/ml and 2.44 for standard care group.
Maltese: ipogliċemija kkonfermata li ma kinitx severa kienu ta' 7.71 għal insulin glargine 100 unità/ml u 2.44
English: Effects of insulin glargine 100 units/ml (once daily) on diabetic retinopathy were evaluated in an open-label 5 year NPH-controlled study (NPH given bid) in 1024 type 2 diabetic patients in which progression of retinopathy by 3 or more steps on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale was investigated by fundus photography.
Maltese: L-effetti ta' insulin glargine 100 unità/ml (darba kuljum) fuq retinopatija tad-dijabete ġew evalwati f'1,024 pazjent dijabetiku tat-tip 2 fi studju ta' ħames snin, fejn kemm l-investigatur kif ukoll il pazjenti kienu jafu x'mediċini kienu qed jintużaw, b'NPH bħala kontroll (NPH ingħata darbtejn kuljum) fejn il-progress tar-retinopatija bi tlett gradi jew aktar fuq l-iskala tal-iStudju Dwar Kura Bikrija ta' Retinopatija tad-Dijabete (ETDRS - Early Treatment Diabetic Retinopathy Study) kien investigat b'ritratt tal-fundus.
English: Insulin inhibits lipolysis in the adipocyte, inhibits proteolysis and enhances protein synthesis.
Maltese: tinibixxi l-proteoliżi u ttejjeb is-sinteżi tal-proteini.
English: Each SoloStar pen delivers 1-80 units in steps of 1 unit.
Maltese: Kull pinna SoloStar tagħti 1-80 unità f'żidiet ta' unità 1
English: IGlar: Insulin glargine 100 units/ml a mITT: Modified intention-to-treat b Treatment difference: Toujeo- insulin glargine 100 units/ml; [95% Confidence Interval] c Change from baseline to Month 6 (observed case) d Change from baseline to Last main 6-month on-treatment value
Maltese: c Ipogliċemija bil-lejl: Episodju li seħħ bejn 00:00 (nofsillejl) u s-05:59 d Perjodu ta' trattament ta' 6 xhur *RR: proporzjon stmat ta' riskju (estimated risk ratio); [95% Confidence Interval]
English: Each pen contains 3 ml of solution, equivalent to 900 units.
Maltese: Kull pinna fiha 3 ml ta' soluzzjoni, ekwivalenti għal 900 unità.
English: - That dose adjustment is needed when patients are switched from one to the other strength: After titration, on average a 10-18% higher basal insulin dose are needed to achieve target ranges for plasma glucose levels when using the 300 units/ml formulation compared to the 100 units/ml formulation.
Maltese: - Li hemm bżonn ta' aġġustament fid-doża meta il-pazjenti jinqalbu minn qawwa waħda għal oħra: o Wara t-titrazzjoni, bħala medja jkun hemm bżonn ta' 10-18% ta' żieda fid-doża talinsulina tal-bażi biex tikseb il-marġni ta' miri ta' livelli tal-glukosju fil-plażma meta tuża l-formulazzjoni ta' 300 unità/ml meta mqabbel mal-formulazzjoni ta' 100 unità/ml.
English: When given intravenously the elimination half-life of insulin glargine and human insulin were comparable.
Maltese: Meta jingħata minn ġol-vini, il-half-life ta' eliminazzjoni ta' insulin glargine u tal-insulina umana kienu simili.
English: The half-life of Toujeo after subcutaneous injection is 18-19 hours independent of dose.
Maltese: Il-half-life ta' Toujeo wara injezzjoni taħt il-ġilda hija ta' 18-19-il siegħa indipendenti mid-doża.
English: Each pen contains 1.5 ml of solution for injection, equivalent to 450 units.
Maltese: Pinna SoloStar Kull pinna fiha 1.5 ml ta' soluzzjoni għall-injezzjoni, ekwivalenti għal 450 unità.
English: Toujeo DoubleStar 24 months.
Maltese: Toujeo DoubleStar 24 xahar
English: Prior to launch of Toujeo 300 units/ml in each Member State the MAH must agree the content and format of the educational programme, including communication media, distribution modalities, and any other aspects, with the National Competent Authority.
Maltese: Qabel ma Toujeo 300 unità/ml jitqiegħed fis-suq ta' kull Stat Membru, l-MAH għandu jaqbel mal-Awtorità Nazzjonali Kompetenti dwar il-kontenut u l-format tal-programm edukattiv, inkluż il-midja ta' komunikazzjoni, il-mod ta' distribuzzjoni u f'kwalunkwe aspett ieħor.
English: Participants were randomized (1:1) to receive insulin glargine 100 units/ml (n=6264), titrated to reach FPG ≤95 mg/dl (5.3 mM), or standard care (n=6273).
Maltese: (1:1) biex jew jirċievu insulin glargine 100 unità/ml (n=6,264), li ġie titrat biex jilħaq FPG ≤95 mg/dl
English: Overall, these effects on hypoglycaemia risk were consistently observed whatever the age, gender, BMI and duration of diabetes (<10 years and ≥10 years) in Toujeo-treated patients compared to insulin glargine 100 units/ml-treated patients.
Maltese: B'mod globali, dawn l-effetti fuq ir-riskju ta' ipogliċemija kienu osservati b'mod konsistenti kienu x'kienu l-età, is-sess, il-BMI u t-tul ta' żmien bid-dijabete (<10 snin u ≥10 snin) f'pazjenti ttrattati b'Toujeo meta mqabbla ma' pazjenti ttrattati b'insulin glargine 100 unità/ml.
English: How to store Toujeo
Maltese: X'fih Toujeo
English: The MAH shall ensure that in each Member State where Toujeo 300 units/ml is marketed, all healthcare professionals (HCPs) who are expected to prescribe or dispense Toujeo 300 units/ml, as well as all patients or their carers who are expected to use Toujeo 300 units/ml, are provided with educational material to address the risk(s) of Medication error (switching between 100 units/ml and 300 units/ml without dose adjustment).
Maltese: il-professjonisti fil-kura tas-saħħa (HCPs) kollha li huma mistennija li jiktbu jew jagħtu Toujeo 300 unità/ml, kif ukoll kull wieħed mill-pazjenti jew dawk li se jieħdu ħsiebhom li huma mistennija li jużaw Toujeo 300 unità/ml, li jiġu pprovduti b'materjal edukattiv li jindirizza r riskji ta' żbalji ta' Medikazzjoni (il-bidla bejn 100 unità/ml u 300 unità/ml mingħajr aġġustament fid-doża).
English: Figure 1: Activity profile at steady state in patients with type 1 diabetes in a 36-hour euglycaemic clamp study
Maltese: Figura 1: Profil ta' attività fl-istat fiss f'pazjenti b'dijabete tat-tip 1 fl-istudju ta' 36 siegħa fejn il-livell taz-zokkor fid-demm inżamm kostanti (euglycaemic clamp)
English: Similarly, nocturnal hypoglycaemia was comparable in the Toujeo and insulin glargine 100 units/mL treatment groups.
Maltese: B'mod simili, l-ipogliċemija ta' matul illejl kienet simili fil-gruppi ta' trattament ta' Toujeo u insulin glargine 100 units/mL.
English: Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections.
Maltese: Hydrochloric acid (għal aġġustament tal-pH)
English: Do not inject insulin.
Maltese: 1 Tinjettax insulina.
English: Beta-blockers
Maltese: Imblokkaturi tar-riċetturi beta
English: Even numbers are shown in line with the dose pointer:
Maltese: Meta s-sinjali ta' ipogliċemija jistgħu jkunu inqas ċari:
English: Each ml contains 300 units insulin glargine* (equivalent to 10.91 mg).
Maltese: U KWANTITATTIVA Kull ml fih 300 unità ta' insulin glargine* (ekwivalenti għal 10.
English: Take about 10 to 20 grams sugar straight away - such as glucose, sugar cubes or a sugary-drink.
Maltese: Ħu madwar 10 sa 20 grammi ta' zokkor minnufih - bħal glukożju, dadi taz zokkor jew xarba biz-zokkor.
English: Each ml contains 300 units (10.91 mg) insulin glargine.
Maltese: 91 mg) insulin glargine.
English: • Angiotensin converting enzyme (ACE) inhibitors - for heart problems or high blood pressure.
Maltese: • Inibituri tal-enzima li tikkonverti anġjotensin (ACE - angiotensin converting enzyme) - għal problemi tal-qalb jew pressjoni għolja tad-demm.
English: The overall efficacy and safety of Toujeo (insulin glargine 300 units/ml) once-daily on glycaemic control was compared to that of once-daily insulin glargine 100 units/ml in open-label, randomised, active-control, parallel studies of up to 26 weeks of duration, including 546 patients with type 1 diabetes mellitus and 2,474 patients with type 2 diabetes mellitus (Table 1 and 2).
Maltese: 300 unità/ml) mogħti darba kuljum tqabblu ma' dawk ta' insulin glargine 100 unità/ml mogħti darba kuljum fi studji paralelli, kkontrollati b'mod attiv, li damu għaddejjin sa 26 ġimgħa u kienu jinkludu
English: Each pen contains 3 ml of solution for injection, equivalent to 900 units.
Maltese: Kull pinna fiha 3 ml ta' soluzzjoni għall-injezzjoni, ekwivalenti għal 900 unità.
English: Toujeo must not be drawn from the cartridge of the Toujeo SoloStar pre-filled pen or Toujeo DoubleStar pre-filled pen into a syringe or severe overdose can result (see section 4.4, 4.9 and 6.6).
Maltese: Toujeo m'għandux jinġibed mill-iskartoċċ ta' ġol-pinna Toujeo SoloStar mimlija għal-lest jew ta' ġolpinna Toujeo DoubleStar mimlija għal-lest għal ġo siringa għax inkella tista' tingħata doża eċċessiva severa (ara sezzjoni 4.4, 4.9 u 6.6).
English: The end of the observation period was 36 hours.
Maltese: It-tmiem tal-perjodu ta' osservazzjoni kien 36 siegħa.
English: The dose selector adjusts in steps of 2 units.
Maltese: Kull linja hija ugwali għal 2 unitajiet.
English: IGF-1 receptor binding: The affinity of insulin glargine for the human IGF-1 receptor is approximately 5 to 8-fold greater than that of human insulin (but approximately 70 to 80-fold lower than the one of IGF-1), whereas M1 and M2 bind the IGF-1 receptor with slightly lower affinity compared to human insulin.
Maltese: Il-konċentrazzjoni terapewtika kollha tal-insulina (insulin glargine u l-metaboliti tiegħu) li nstabet f'pazjenti dijabetiċi tat-tip 1 kienet ħafna inqas milli hemm bżonn sabiex tintlaħaq nofs l-okkupazzjoni massima tar-riċettur ta' IGF-1 u l-attivazzjoni sussegwenti tas-sensiela ta' reazzjonijiet mitoġeniċi proliferattivi mibdija mir-riċettur ta' IGF-1.
English: Table 2: Results from clinical trials in type 2 diabetes mellitus
Maltese: Tabella 2: Riżultati minn provi kliniċi f'dijabete mellitus tat-tip 2 26 ġimgħa ta' trattament
English: At the last on-treatment visit, there was a mean increase in body weight from baseline of 1.4 kg in the insulin glargine 100 units/ml group and a mean decrease of 0.8 kg in the standard care group.
Maltese: Waqt l-aħħar viżta ta' matul il-kura, kien hemm medja ta' żieda fil-piż tal-ġisem ta' 1.4 kg mil-linja bażi fil-grupp ta' insulin glargine 100 unità/ml u medja ta' tnaqqis ta' 0.8 kg fil-grupp ta' kura standard.
English: Lipohypertrophy Lipoatrophy
Maltese: Kontenitur tal-iskartoċċ
English: Each ml of the solution contains 300 units of insulin glargine (equivalent to 10.91 mg).
Maltese: Kull millilitru ta' soluzzjoni fih 300 unità ta' insulin glargine (ekwivalenti għal 10.
English: Toujeo can be used in adolescents and children from the age of 6 years based on the same principles as for adult patients (see sections 5.1and 5.2).
Maltese: pazjenti adulti (ara sezzjonijiet 5.1 u 5.2).
English: Other medicines and Toujeo
Maltese: Mediċini oħra u Toujeo
English: Insulin administration may cause insulin antibodies to form.
Maltese: L-għoti tal-insulina jista' jikkawża l-formazzjoni ta' antikorpi.
English: Non-insulin antihyperglycaemic medicinal products
Maltese: Prodotti mediċinali kontra l-ipergliċemija li mhumiex insulina
English: 900 units per pen
Maltese: 900 unità f'kull pinna
English: MARKETING AUTHORISATION HOLDER
Maltese: Ċ KONDIZZJONIJIET U REKWIŻITI
English: To reduce the risk of hypoglycaemia, patients who are changing their basal insulin regimen from an insulin regimen with once daily Toujeo (insulin glargine 300 units/ml) to a once daily regimen with insulin glargine 100 units/ml should reduce their dose by 20%;
Maltese: Sabiex tnaqqas ir-riskju ta' ipogliċemija, il-pazjenti li qed ibidlu l-iskeda tal-insulina tal-bażi tagħhom minn skeda ta' insulina b'Toujeo 300 unità/ml (insulin glargine 300 unità/ml) għal skeda ta' darba kuljum b'insulin glargine 100 unità/ml għandhom inaqqsu d-doża tagħhom b'20%;
English: Hypoglycaemia
Maltese: Immaniġġar
English: - Keep this leaflet.
Maltese: F'każ ta' labra mblukkata,
English: Before injecting Toujeo
Maltese: Qabel tinjetta Toujeo
English: The Marketing Authorisation Holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: • Pjan tal-ġestjoni tar-riskju (RMP) Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza ddettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 talAwtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: See “Pioglitazone used together with insulin”.
Maltese: Ara “Meta Pioglitazone jintuża flimkien mal-insulina”.
English: • Beta-blockers or clonidine - for high blood pressure.
Maltese: • Imblokkaturi tar-riċetturi beta jew clonidine - għall-pressjoni tad-demm għolja.
English: • You are taking or have stopped taking certain other medicines (see section 2, "Other medicines and Toujeo").
Maltese: • Inti qed tieħu jew għadek kemm waqaft tieħu ċerti mediċini oħra (ara sezzjoni 2, "Mediċini oħra u Toujeo").
English: 26 weeks of treatment Patients previously treated with basal insulin
Maltese: 26 ġimgħa ta' trattament Pazjenti li qabel kienu ttrattati b'insulina tal-bażi
English: Toujeo is for subcutaneous use only.
Maltese: Toujeo huwa soluzzjoni ċara u mingħajr kulur.
English: Please, consult your doctor for further information.
Maltese: Jekk jogħġbok ikkonsulta lit-tabib tiegħek għal aktar informazzjoni.
English: Entire study periodd
Maltese: Postijiet fejn tinjetta
English: Tell a doctor straight away if you notice signs of a severe allergic reaction.
Maltese: Għid tabib minnufih jekk tinnota sinjali ta' reazzjoni allerġika severa.
English: Each DoubleStar pen contains 3 ml of solution for injection, equivalent to 900 units.
Maltese: Kull pinna DoubleStar fiha 3 ml ta' soluzzjoni għall injezzjoni, ekwivalenti għal 900 unità.
English: Signs in your brain 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: (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 pharmacokinetic and pharmacodynamic findings indicate that the effect of the subcutaneous injection with insulin glargine is principally based on exposure to M1. Insulin glargine and the metabolite M2 were not detectable in the vast majority of subjects and, when they were detectable their concentration was independent of the administered dose and formulation of insulin glargine.
Maltese: Fil-parti l-kbira tal-individwi, insulin glargine u l-metabolit M2 ma nstabux u meta nstabu, il-konċentrazzjoni tagħhom kienet indipendenti mid-doża u mill-formulazzjoni ta' insulin glargine li ngħatat.
English: If this happens: - change the needle (see STEP 6 and STEP 2), - then repeat the safety test (STEP 3A and STEP 3 B).
Maltese: - ibdel il-labra (ara PASS 6 u PASS 2), - imbagħad irrepeti t-test ta' sigurtà (PASS 3).
English: Cartridge (type 1 colourless glass) with a grey plunger (bromobutyl rubber) and a flanged cap (aluminium) with a stopper (laminate of isoprene and bromobutyl rubber).The cartridge is sealed in a disposable pen injector.
Maltese: Skartoċċ (ħġieġ bla kulur tat-tip 1) bi planġer griż (gomma bromobutyl) u għatu flanġ (tal-aluminju)
English: Based on the results from clinical studies, the safety profile of Toujeo in elderly patients and in patients with renal impairment was similar to that of the overall population (see section 5.1).
Maltese: Abbażi ta' riżultati minn studji kliniċi, il-profil ta' sigurtà ta' Toujeo f'pazjenti anzjani u f'pazjenti b'indeboliment tal-kliewi kien simili għal dak tal-popolazzjoni ġenerali (ara sezzjoni 5.1).
English: • Serious low blood sugar may cause brain damage and may be life-threatening.
Maltese: • Kwalunkwe riskji ta' saħħa fil-pajjiżi li inti se żżur.
English: Read this first Toujeo SoloStar contains 300 units/ml insulin glargine in a 1.5 ml disposable prefilled pen
Maltese: Aqra din l-ewwel Toujeo SoloStar fih 300 unità/ml insulin glargine f'pinna mimlija għal-lest ta' 1.5 ml li tintrema wara li tintuża - Qatt terġa' tuża l-labar mill-ġdid.
English: Rubber seal
Maltese: Għatu tal-pinna
English: • Oestrogens and progestogens - such as in the contraceptive pill for birth control.
Maltese: • Estroġeni u proġestoġeni - bħal pillola kontraċettiva għall-kontroll tat-tqala.
English: Hyperglycaemia (high blood sugar levels)
Maltese: Ipergliċemija (livelli għoljin ta' zokkor fid-demm)
English: In patients with type 2 diabetes mellitus, Toujeo can also be given together with other anti-hyperglycaemic medicinal products.
Maltese: F'pazjenti b'dijabete mellitus tat-tip 2, Toujeo jista' jingħata wkoll flimkien ma' prodotti mediċinali oħra kontra l-ipergliċemija.
English: Medication errors prevention
Maltese: TAL-PRODOTT MEDIĊINALI
English: • Disopyramide - for some heart problems.
Maltese: • Disopyramide - għal xi problemi tal-qalb.
English: Insulin scale Insulin name
Maltese: Siġill tal-lastku Skala tal-insulina nsulin scale
English: - When switching from insulin glargine 100 units/ml to Toujeo, this can be done on a unit-to-unit basis, but a higher Toujeo dose (approximately 10-18%) may be needed to achieve target ranges for plasma glucose levels.
Maltese: - Meta tibdel minn insulin glargine 100 unità/ml għal Toujeo, dan jista' jsir fuq bażi ta' unità għal unità, iżda jista' jkollok bżonn ta' doża ogħla ta' Toujeo (madwar 10-18 %) sabiex tikseb ilmarġni tal-miri għal-livelli tal-glukosju fid-demm.
English: In patients with type 1 diabetes, the incidence of hypoglycaemia was similar in patients treated with Toujeo compared to insulin glargine 100 units/ml-treated patients (Table 3).
Maltese: F'pazjenti b'dijabete tat-tip 1, l-inċidenza ta' ipogliċemija kienet simili f'pazjenti trattati b'Toujeo meta mqabbla ma' pazjenti ttrattati b'insulin glargine 100 unità/ml (Tabella 3).
English: Mean dose of insulin glargine 100 units/ml by study end was 0.42 U/kg.
Maltese: Insulin glargine (100 unità/ml) 0.4
English: Combination of Toujeo with pioglitazone
Maltese: X'inhu Toujeo u għalxiex jintuża
English: Paediatric population Population pharmacokinetic analysis was conducted for Toujeo based on concentration data of its main metabolite M1 using data from 75 pediatric subjects (6 to <18 years of age) with type 1 diabetes.
Maltese: L-analiżi farmakokinetika tal-popolazzjoni għal Toujeo saret skont it-tagħrif ta' konċentrazzjoni talmetabolit prinċipali tiegħu M1 bl-użu ta' dejta minn 75 suġġett pedjatriku (6 sa <18-il sena ta' età)
English: The Toujeo DoubleStar pre-filled pen can provide a dose of 2 to 160 units per injection, in steps of 2 units.
Maltese: Bil-pinna Toujeo DoubleStar mimlija għal-lest, tista' tiġi injettata doża minn 2-160 unità f'kull injezzjoni, b'żidiet ta' 2 unitajiet.
English: These measures will help protect the environment.
Maltese: A Ħu labra ġdida u qaxxar is-siġill protettiv.
English: • Skin changes at the injection site:
Maltese: • Reazzjonijiet fil-ġilda u reazzjonijiet allerġiċi fil-post tal-injezzjoni:
English: Patients previously treated with basal insulin
Maltese: Pazjenti li qatt ma kienu ħadu insulina qabel