FrancophonIA/ELRC3.0 huggingface dataset:
English: Their prescribing physician will provide training on the following elements: Precaution for storage
Maltese: It-tabib tagħhom li jagħti r-riċetta ser tipprovdi taħriġ dwar l-elementi li ġejjin: Prekawzjoni għal ħażna
English: The educational material for non Healthcare Professionals should include information on the following key elements:
Maltese: Il-materjal edukattiv għal persuni li mhumiex Professjonisti fil-Qasam tal-Kura tas-Saħħa għandu jinkludi informazzjoni dwar l-elementi ewlenin li ġejjin:
English: London, 23 January 2008 EMEA/CHMP/350278/2007
Maltese: Londra, 23 ta' Jannar 2008 EMEA/CHMP/350278/2007
English: The Rapporteur was Dr Hudson and Co-Rapporteur(s) was Dr Ljungberg.
Maltese: Ir-Rapporteur kien id-Dr Hudson u l-Korapporteur(s) kien id-Dr Ljungberg.
English: A positive opinion was adopted by consensus on 16 November 2006.
Maltese: Ġiet adottata opinjoni pożittiva, b'konsensus, fis-16 ta' Novembru 2006.
English: The Mutual Recognition Procedure started on 15 November 2005.
Maltese: Il-Proċedura ta' Rikonoxximent Reċiproku bdiet fil-15 ta' Novembru 2005.
English: Ciprofloxacin Nycomed and associated names, 2 mg/ml Solution for Infusion, is an antibiotic belonging to the quinolone family effective in vitro against a large number of Gram-negative aerobic bacteria as well as against some Gram-positive organisms.
Maltese: Ciprofloxacin Nycomed u d-denominazzjonijiet assoċjati, 2 mg/ml Soluzzjoni għal Infużjoni, huwa antibijotiku li jappartjeni għall-familja tal-kinoloni (quinolones), effikaċi in vitro, kontra numru kbir ta' batterji aerobiċi Gram-negattivi kif ukoll kontra xi organiżmi Gram-pożittivi.
English: Nycomed Danmark ApS submitted applications for mutual recognition of Ciprofloxacin Nycomed and associated names, 2 mg/ml Solution for Infusion, on the basis of the marketing authorisation granted by United Kingdom on 23 March 2005.
Maltese: Nycomed Danmark ApS ressqet applikazzjonijiet għar-rikonoxximent reċiproku ta' Ciprofloxacin Nycomed u ismijiet assoċjati, 2 mg/ml Soluzzjoni għal Infużjoni, fuq il-bażi ta' l-awtorizzazzjoni għattqegħid fis-suq mogħtija mir-Renju Unit fit-23 ta' Marzu 2005.
English: The Reference Member State was United Kingdom and the Concerned Member States were Denmark, Finland, Norway and Sweden.
Maltese: L-Istat Membru ta' Referenza kien ir-Renju Unit u l-Istati Membri Konċernati kienu d-Danimarka, il-Finlandja, in-Norveġja u l-Iżvezja.
English: During their 13-16 November 2006 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Ciprofloxacin Nycomed and associated names, that the objections raised by Norway and Sweden should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Maltese: Matul il-laqgħa tagħhom tat-13-16 ta' Novembru 2006, is-CHMP, fid-dawl tad-dejta kollha ppreżentata u fid-dawl tad-diskussjoni xejntifika fi ħdan il-Kumitat, kien ta' l-opinjoni li l-proporzjon bejn il-benefiċċju u rriskju kien wieħed favorevoli għal Ciprofloxacin Nycomed u denominazzjonijiet assoċjati, li lobjezzjonijiet imqajma min-Norveġja u mill-Iżvezja ma għandhomx jimpedixxu l-għoti ta' Awtorizzazzjoni għat-Tqegħid fis-Suq u li s-Sommarju tal-Karatteristiċi tal-Prodott, tikketta u fuljett ta' tagħrif ta' l-Istat Membru ta' Referenza għandhom jiġu emendati.
English: Further, as patients referred to parenteral treatment often are seriously ill, it was felt of importance that a maximum dosage of 1200 mg (400 mg three times daily) instead of 800 mg be permitted.
Maltese: Barra minn hekk, minħabba li pazjenti li ġew sottoposti għal trattament parenterali ta' spiss ikunu ma jifilħux serjament, inħass importanti li tkun permessa doża massima ta' 1200 mg (400 mg tliet darbiet kuljum) minflok 800 mg.
English: The proposed dosage regimen for complicated urinary tract infections (100 mg bid) was considered too low and should be changed to 200-400 mg twice daily.
Maltese: Irreġim propost tad-doża għal infezzjonijiet ikkumplikati fl-apparat urinarju (100 mg darbtejn kuljum) kien baxx wisq u għandu jinbidel għal 200-400 mg darbtejn kuljum.
English: The arbitration procedure started on 1 June 2006 with the adoption of a list of questions.
Maltese: Il-proċedura ta' arbitraġġ bdiet fl-1 ta' Ġunju 2006 bl-adozzjoni tal-lista ta' mistoqsijiet.
English: Significant differences were identified with regards to the approved posology for complicated urinary tract infections and the maximum daily dose for this generic intravenous ciprofloxacin product.
Maltese: Ġew identifikati differenzi sinifikanti fir-rigward tal-pożoloġija approvata għal infezzjonijiet ikkumplikati flapparat urinarju u d-doża massima ta' kuljum għal dan il-prodott ġeneriku abbażi ta' ciprofloxacin għall-użu intravenuż (fil-vina).
English: The Marketing Authorisation Holder provided written explanations on 21 September 2006.
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fisSuq ta spjegazzjonijiet bil-miktub fil-21 ta' Settembru 2006.
English: United Kingdom referred the reasons for disagreement to the EMEA on 5 May 2006.
Maltese: Ir-Renju Unit irrefera r-raġunijiet għan-nuqqas ta' ftehim lill-EMEA fil-5 ta' Mejju 2006.
English: International Non-Proprietary Name (INN): Ciprofloxacin
Maltese: Il-konklużjonijiet xjentifiċi huma pprovduti fl-Anness
English: On 21 June 2007 the CHMP, in order to focus and facilitate the translations of the specific amendments in the Summary of Product Characteristics, adopted a revised opinion with amended Annex II and Annex III, which was further reconsidered in October 2007.
Maltese: III emendati, li ġiet rikunsidrata aktar f'Ottubru 2007.
English: (see section 6.6).
Maltese: (ara sezzjoni 6.6)
English: ATC Code: A10A E04.
Maltese: A10A E04.
English: • Sulfonamide antibiotics.
Maltese: • L-antibijotiċi sulfonamide.
English: • Isoniazid - for tuberculosis.
Maltese: • Isoniazid - għat-tuberkulożi.
English: • The active substance is insulin glargine.
Maltese: • Is-sustanza attiva hi insulin glargine.
English: • Clozapine, olanzapine and phenothiazine derivatives - for mental health problems.
Maltese: • Clozapine, olanzapine u derivati ta' phenothiazine - għal problemi ta' saħħa mentali.
English: 58 units selected
Maltese: intgħażlu 58 unità
English: SoloStar pen:
Maltese: Pinna SoloStar:
English: • Danazol - for endometriosis.
Maltese: • Danazol - għall-endometrijożi.
English: EU/1/00/133/033 EU/1/00/133/034 EU/1/00/133/035 EU/1/00/133/036 EU/1/00/133/037 EU/1/00/133/038 EU/1/00/133/039 EU/1/00/133/040 EU/1/00/133/041
Maltese: EU/1/00/133/036 EU/1/00/133/037 EU/1/00/133/038 EU/1/00/133/039 EU/1/00/133/040
English: DoubleStar pen:
Maltese: Pinna DoubleStar:
English: • Monoamine oxidase inhibitors (MAOIs) - for depression.
Maltese: • Inibituri ta' monoamine oxidase (MAOIs - monoamine oxidase inhibitors) - għad-depressjoni.
English: Plunger*
Maltese: Planġer*
English: • Sugar (at least 20 grams).
Maltese: • Zokkor (mill-inqas 20 gramma).
English: SoloStar pen1 step=1 unit DoubleStar pen 1 step=2 units
Maltese: Pinna SoloStar Żieda 1= Unità 1 Pinna DoubleStar Żieda 1 = 2 unitajiet
English: • Fluoxetine - for depression.
Maltese: • Fluoxetine - għad-depressjoni.
English: Pharmacokinetic profiles were consistent with the pharmacodynamic activity of Toujeo.
Maltese: Il-profili farmakokinetiċi kienu konsistenti mal-attività farmakodinamika ta' Toujeo.
English: MedDRA system organ classes
Maltese: Klassijiet tassistemi u talorgani
English: Toujeo contains insulin called “insulin glargine”.
Maltese: Toujeo fih insulina msejħa “insulin glargine”.
English: [-0.144 to 0.083]
Maltese: [-0.144 sa 0.083]
English: • Muscular pain (myalgia).
Maltese: • Uġigħ fil-muskoli (mijalġja).
English: DoubleStar pen
Maltese: Pinna DoubleStar
English: Zinc chloride, metacresol, glycerol, hydrochloric acid / sodium hydroxide (for pH adjustment), water for injections.
Maltese: Zinc chloride, metacresol, glycerol, hydrochloric acid/sodium hydroxide (għal aġġustament tal-pH), ilma għall-injezzjonijiet.
English: This is a modified insulin, very similar to human insulin.
Maltese: Din hija insulina modifikata, simili ħafna għall-insulina umana.
English: Toujeo IGlar Toujeo IGlar Toujeo IGlar
Maltese: Meta tarmi l-pinna tiegħek
English: [-0.168 to 0.099]
Maltese: [-0.168 sa 0.099]
English: See also section 4.2 under “Method of administration”.
Maltese: Ara wkoll sezzjoni 4.2 taħt “Metodu ta' kif jingħata”.
English: • Your pen contains a total of 900 units of insulin.
Maltese: • Il-pinna tiegħek fiha total ta' 900 unità ta' insulina.
English: • The Toujeo SoloStar pen contains 450 units of Toujeo.
Maltese: • Il-pinna Toujeo SoloStar fiha 450 unità ta' Toujeo.
English: • Sympathomimetic medicines such as epinephrine (adrenaline), salbutamol and terbutaline - for asthma.
Maltese: • Mediċini simpatomimetiċi bħal epinephrine (adrenaline), salbutamol u terbutaline - għall-ażma.
English: Number of subjects treated (mITTa)
Maltese: Numru ta' individwi ttrattati (mITTa)
English: Toujeo SoloStar 30 months.
Maltese: Toujeo SoloStar 30 xahar.
English: Basal insulin dosec (U/kg)
Maltese: Doża tal-insulina tal-bażic (U/kg)
English: In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements (see section 4.8 and 5.1).
Maltese: Fl-anzjani, id-deterjorament progressiv tal-funzjoni tal-kliewi tista' twassal għal tnaqqis regolari filħtiġijiet tal-insulina (ara sezzjoni 4.8 u 5.1).
English: [-0.090 to 0.174]
Maltese: [-0.090 sa 0.174]
English: Toujeo 300 units/ml SoloStar injection Toujeo 300 units/ml DoubleStar injection insulin glargine
Maltese: Toujeo 300 unità/ml injezzjoni SoloStar Toujeo 300 unità/ml injezzjoni DoubleStar insulin glargine
English: • Lithium salts - for mental health problems.
Maltese: • Is-sustanzi ta' lithium - għal problemi ta' saħħa mentali.
English: Adjusted mean differenceb
Maltese: Differenza medja aġġustatab
English: No safety issues were identified with Toujeo with respect to adverse events and standard safety parameters.
Maltese: Ma ġew identifikati ebda kwistjonijiet ta' sigurtà b'Toujeo fir-rigward ta' avvenimenti avversi u parametri standard ta' sigurtà.
English: Visual impairment
Maltese: Indeboliment tal-vista
English: 60 units selected
Maltese: intgħażlu 60 unità
English: 1.5 ml (SoloStar) 3 ml (DoubleStar)
Maltese: 3 ml (DoubleStar)
English: Sanofisanofi A/S Tlf: +45 45 16 70 00
Maltese: Danmark Sanofisanofi A/S Tlf: +45 45 16 70 00
English: EU/1/00/133/033 1 pen (SoloStar) EU/1/00/133/034 3 pens (SoloStar) EU/1/00/133/035 5 pens (SoloStar) EU/1/00/133/036 10 pens (SoloStar) EU/1/00/133/037 1 pen (DoubleStar) EU/1/00/133/038 3 pens (DoubleStar) EU/1/00/133/041 10 pens (DoubleStar)
Maltese: EU/1/00/133/037 pinna 1 (DoubleStar) EU/1/00/133/038 3 pinen (DoubleStar) EU/1/00/133/038 10 pinen (DoubleStar)
English: • The Toujeo DoubleStar pen contains 900 units of Toujeo.
Maltese: • Il-pinna Toujeo DoubleStar fiha 900 unità ta' Toujeo.
English: • In a vein.
Maltese: • Ġo vina.
English: 1 step=2 units
Maltese: Żieda 1= 2 unitajiet
English: 1 step=1 unit
Maltese: Żieda 1=Unità 1
English: Elderly population (≥65 years old)
Maltese: Popolazzjoni anzjana (età ≥65 sena)
English: Incidence (%) of severea hypoglycaemia (n/Total N)
Maltese: Inċidenza (%) ta' ipogliċemija severaa (n/Total N)
English: • Somatropin - a growth hormone.
Maltese: • Somatropin - ormon tat-tkabbir.
English: Body weightd (kg)
Maltese: Piż tal-ġisemd (kg)
English: Packs of 1, 3, 6 (2 packs of 3), 9 (3 packs of 3) and 10 pre-filled pens.
Maltese: Pakketti ta' pinna 1, 3, 6 (2 pakketti ta' 3), 9 (3 pakketti ta' 3) u 10 pinen mimlijin għal-lest.
English: 450 units per pen (SoloStar pen) 900 units per pen (DoubleStar pen)
Maltese: 450 unità f'kull pinna (pinna SoloStar) 900 unità f'kull pinna (pinna DoubleStar)
English: • Protease inhibitors- for HIV.
Maltese: • Inibituri ta' protease - għall-HIV.
English: *RR: estimated risk ratio; [95% Confidence Interval]
Maltese: Toujeo- insulin glargine 100 unità/ml; [95% Confidence Interval]
English: 10 pens
Maltese: 10 pinen
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskoluskeletriċ i u tat-tessuti konnettivi
English: 5 pens
Maltese: 5 pinen
English: Toujeo with alcohol
Maltese: Toujeo ma' alkoħol
English: Packs of 1, 3, 5 and 10 pre-filled pens.
Maltese: Pakketti ta' pinna 1, 3, 5 u 10 pinen mimlijin għal-lest.
English: • Your pen contains a total of 450 units of insulin.
Maltese: • Il-pinna tiegħek fiha total ta' 450 unità ta' insulina.
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 għalliżvilupp tal-ipogliċemija, 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: EU/1/00/133/039 6 pens (2 packs of 3) EU/1/00/133/040 9 pens (3 packs of 3)
Maltese: EU/1/00/133/040 9 pinen (3 pakketti ta' 3)
English: This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol (23 mg) ta' sodium f'kull doża, i.e. tista' tgħid li hu ‘ħieles mis-sodium'.
English: The ORIGIN (Outcome Reduction with Initial Glargine INtervention) study was a multicenter, randomized, 2x2 factorial design study conducted in 12,537 participants at high cardiovascular (CV) risk with impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) (12% of participants) or type 2 diabetes mellitus (treated with ≤1 antidiabetic oral agent) (88% of participants).
Maltese: b'tifsila 2x2 factorial, fejn il-parteċipanti ġew assenjati b'mod arbitrarju, li sar fi 12,537 parteċipant b'riskju kardjovaskulari (CV - cardiovascular) għoli u b'indeboliment fil-kontroll tal-glukożju fl-istat ta' sawm (IFG - impaired fasting glucose) jew b'indeboliment fit-tolleranza għall-glukożju (IGTimpaired glucose tolerance) (12% tal-parteċipanti) jew bid-dijabete mellitus tat-tip 2 (ikkurata b'≤1 sustanza antidijabetika orali) (88% tal-parteċipanti).
English: 3 pens
Maltese: 3 pinen
English: Insulin glargine is a human insulin analogue designed to have a low solubility at neutral pH. At pH 4, insulin glargine is completely soluble.
Maltese: Insulin glargine hija analoga ta' insulina umana mfassla biex ikollha solubilità baxxa f'pH newtrali.
English: This means it is essentially ‘sodium-free'.
Maltese: ‘ħieles mis-sodium'.
English: Examples include:
Maltese: Trattament:
English: Each cartridge contains 1.5 ml solution.
Maltese: Kull skartoċċ fih 1.5 ml ta' soluzzjoni.
English: Tabulated list of adverse reactions The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing incidence (very common: ≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000; not known: cannot be estimated from the available data).
Maltese: Ir-reazzjonijiet avversi relatati li ġejjin minn investigazzjonijiet kliniċi huma elenkati taħt skont ilklassi tas-sistemi u tal-organi u skont l-inċidenza tagħhom b'dawk li għandhom l-ogħla inċidenza mniżżla l-ewwel segwiti minn dawk b'inċidenza inqas (komuni ħafna: ≥1/10; komuni: ≥1/100 sa <1/10; mhux komuni: ≥1/1,000 sa <1/100; rari:
English: After subcutaneous injection of insulin glargine, insulin glargine is rapidly metabolized at the carboxyl terminus of the Beta chain with formation of two active metabolites M1 (21A-Gly-insulin) and M2 (21A-Gly-des-30B-Thr-insulin).
Maltese: M1 (21A-Gly-insulin) u M2 (21A-Gly-des-30B-Thr-insulin).
English: Each pen contains 1.5 ml of solution, equivalent to 450 units.
Maltese: Kull pinna fiha 1.5 ml ta' soluzzjoni, ekwivalenti għal 450 unità.
English: In Toujeo clinical studies in adult patients, the incidence of allergic reactions was similar in Toujeo-treated patients (5.3%) and insulin glargine 100 units/ml-treated patients (4.5%).
Maltese: Fi studji kliniċi b'Toujeo f'pazjenti adulti, l-inċidenza ta' reazzjonijiet allerġiċi kienet simili f'pazjenti ttrattati b'Toujeo (5.3%) u pazjenti ttrattati b'insulin glargine 100 unità/ml (4.5%).
English: Switch between insulin glargine 100 units/ml and Toujeo
Maltese: Il-bidla bejn insulin glargine 100 unità/ml u Toujeo
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: somatropin, prodotti mediċinali simpatomimetiċi (eż. epinephrine [adrenaline], salbutamol, terbutaline), ormoni tat-tirojde, prodotti mediċinali antipsikotiċi atipiċi (eż clozapine u olanzapine) u inibituri tal-protease.
English: Table 1: Results from clinical trials in type 1 diabetes mellitus
Maltese: Tabella 1: Riżultati minn provi kliniċi f'dijabete mellitus tat-tip 1
English: Date of first authorisation: 27 June 2000 Date of latest renewal: 17 February 2015
Maltese: Data tal-aħħar tiġdid: 17 ta' Frar 2015
English: The percentage of patients reporting severe hypoglycaemia was lower in patients in the Toujeo group as compared to patients in the insulin glargine 100 units/mL group, 6% and 8.8% respectively.
Maltese: pazjenti li rrapportaw ipogliċemija severa kienu inqas fil-grupp ta' Toujeo meta mqabbel ma' pazjenti fil-grupp ta' insulin glargine 100 units/mL, 6% u 8.8% rispettivament.
English: The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism.
Maltese: Mekkaniżmu ta' azzjoni L-attività primarja tal-insulina, inkluża dik ta' insulin glargine, hija li tirregola l-metaboliżmu tal glukożju.
English: The following adverse reactions were observed during clinical studies conducted with Toujeo (see section 5.1) and during clinical experience with insulin glargine 100 units/ml.
Maltese: Ir-reazzjonijiet avversi li ġejjin ġew osservati waqt studji kliniċi li saru b'Toujeo (ara sezzjoni 5.1) u waqt esperjenza klinika b'insulin glargine 100 unità/ml.
English: STEP 2: Attach a new needle
Maltese: PASS 4: Agħżel id-doża
English: Toujeo dosed once daily showed similar reduction in HbA1c and FPG from baseline to week 26 compared to insulin glargine 100 units/mL.
Maltese: Toujeo b'doża ta' darba kuljum wera tnaqqis simili fl-HbA1c u FPG mil-linja bażi sa ġimgħa 26 meta mqabbel ma' insulin glargine 100 units/mL.
English: Multipack: 9 (3 packs of 3) pens
Maltese: Pakkett multiplu: 6 (2 pakketti ta' 3) pinen Pakkett multiplu: 9 (3 pakketti ta' 3) pinen
English: • Pentamidine - for some infections caused by parasites.
Maltese: • Pentamidine - għal xi infezzjonijiet ikkawżati mill-parassiti.
English: Insulin glargine is metabolised into 2 active metabolites M1 and M2 (see section 5.2).
Maltese: Insulin glargine huwa mmetabolizzat f'2 metaboliti attivi
English: • Thyroid hormones - for thyroid gland problems.
Maltese: • Ormoni tat-tirojde - għal problemi tal-glandola tat-tirojde.
English: • In an insulin infusion pump.
Maltese: • F'pompa tal-infużjoni tal-insulina.
English: It delivers doses of 1-80 units per injection, in steps of 1 unit.
Maltese: Tagħti dożi ta' 1-80 unità għal kull injezzjoni, f'żidiet ta' unità 1.
English: Packs of 1, 3, 6 (2 packs of 3), 9 (3 packs of 3) and 10 pens are available.
Maltese: Huma disponibbli pakketti ta' pinna waħda, 3, 6 (2 pakketti ta' 3), 9 (3 pakketti ta' 3) u 10 pinen.
English: Toujeo contains 3 times more insulin in 1 ml than standard insulin, which contains 100 unit/ml.
Maltese: F'millilitru 1 Toujeo hemm 3 darbiet aktar insulina minn insulina standard, li fiha 100 unità/ml.
English: Treatment of diabetes mellitus in adults, adolescents and children from the age of 6 years.
Maltese: Trattament ta' dijabete mellitus fl-adulti, fl-adolexxenti u tfal mill-età ta' 6 snin..
English: • The other ingredients are: zinc chloride, metacresol, glycerol, water for injections, and sodium hydroxide (see section 2 “Important information about some of the ingredients of Toujeo”) and hydrochloric acid (for pH adjustment).
Maltese: • Is-sustanzi l-oħra huma: zinc chloride, metacresol, glycerol, ilma għall-injezzjonijiet u sodium hydroxide (ara sezzjoni 2 “Informazzjoni importanti dwar xi wħud mis-sustanzi ta' Toujeo”) u hydrochloric acid (għal aġġustament tal-pH).
English: Pediatric population
Maltese: Popolazzjoni pedjatrika
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: Treatment in combination with Meal-time insulin analog+/-metformin
Maltese: Analogu tal-insulina waqt il-ħin tal-ikel+/metformin
English: Each pen contains 1.5 ml of solution for injection (equivalent to 450 units).
Maltese: Kull pinna fiha 1.5 ml ta' soluzzjoni għall-injezzjoni (ekwivalenti għal 450 unità).
English: • Detailed description of the modalities used for the self-administration of insulin glargine: - That insulin glargine 100 units/ml and insulin glargine 300 units/ml (Toujeo SoloStar and Toujeo
Maltese: - Li insulin glargine 100 unità/ml u insulin glargine 300 unità/ml (Toujeo SoloStar u Toujeo
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON Multipack (contains Blue Box)
Maltese: KARTUNA TA' BARRA Pakkett multiplu (fih il-Kaxxa Blu)
English: - That insulin glargine 300 units/ml is available in two different presentations: Toujeo SoloStar (1.5 mL prefilled pen/450 units) and Toujeo DoubleStar (3 mL prefilled pen/900 units).
Maltese: : Toujeo SoloStar (1.5 mL pinna mimlija għal-lest/450 unità) u Toujeo DoubleStar (3 mL pinna mimlija għal-lest/900 unità).
English: Insulin glargine 100 units/ml did not alter the relative risk for CV disease and CV mortality when compared to standard of care.
Maltese: Insulin glargine 100 unità/ml ma biddilx ir-riskju relattiv għal mard kardjovaskulari u mortalità kardjovaskulari meta mqabbel ma' kura standard.
English: Always perform a safety test
Maltese: Dejjem agħmel test ta' sigurtà
English: • Changes in taste (dysgeusia).
Maltese: • Tibdiliet fit-togħma (disgewzja).
English: Overall the incidence of hypoglycaemia in patients in any category was similar in both treatment groups, with 97.9% of patients in the Toujeo group and 98.2% in the insulin glargine 100 units/mL group reporting at least one event.
Maltese: B'mod ġenerali l-inċidenza ta' ipogliċemija f'pazjenti f'kwalunkwe kategorija kienet simili fiż-żewġ gruppi ta' trattament, b'97.9% tal-pazjenti fil-grupp ta' Toujeo u 98.2% fil-grupp ta' insulin glargine 100 units/mL li rrapportaw mill-inqas avveniment wieħed.
English: Please, also see section 2.
Maltese: Jekk jogħġbok, ara wkoll sezzjoni 2.
English: • Fibrates - for lowering high levels of blood fats.
Maltese: • Fibrati - biex ibaxxu livelli għoljin ta' xaħmijiet fid-demm.
English: At baseline, participants had a median HbA1c value of 6.4% and median on-treatment HbA1c values ranged from 5.9 to 6.4% in the insulin glargine 100 units/ml group, and 6.2% to 6.6% in the standard care group throughout the duration of follow-up.
Maltese: Fil-linja bażi, il-parteċipanti kellhom valur medjan ta' HbA1c ta' 6.4% u l-valuri medjani ta' HbA1c waqt il kura varjaw minn 5.9 sa 6.4% fil-grupp ta' insulin glargine 100 unità/ml u 6.2% sa 6.6% fil-grupp ta'