FrancophonIA/ELRC3.0 huggingface dataset:
English: Analyses of nocturnal hypoglycaemia in patients with type 1 diabetes showed a significantly lower risk of minor nocturnal hypoglycaemia (able to self-treat and confirmed by capillary blood glucose less than 2.8 mmol/l or 3.1 mmol/l if expressed as plasma glucose) than with NPH insulin, whereas no difference was seen in type 2 diabetes.
Maltese: Analiżi ta' ipogliċemija ta' matul il-lejl f'pazjenti b'dijabete ta' tip 1 uriet riskju ferm iktar baxx ta' ipogliċemija ta' matul il-lejl minuri (u kapaċi li jikkura lilu nnifsu u kkonfermat millglukosju fid-demm kapillari ta' inqas minn 2.8 mmol/l jew 3.1 mmol/l jekk espress bħala glukosju filplażma) milli bl-insulina NPH, filwaqt li l-ebda differenza ma ġiet innotata f'dijabete ta' tip 2.
English: The following substances may increase the patient's insulin requirements: Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone and danazol.
Maltese: Kontraċettivi li jittieħdu mill-ħalq, thiazides, glukokortikojdi, ormoni tat-tirojde, simpatomimetiċi, ormon tat-tkabbir u danazol.
English: INFORMATION IN BRAILLE Levemir InnoLet
Maltese: Levemir InnoLet It-teħid b'InnoLet
English: The overall percentage of treated patients expected to experience adverse reactions is estimated to be 12%.
Maltese: Il-perċentwal totali ta' pazjenti ttrattati li kien mistenni li jkollhom reazzjonijiet avversi huwa stmat li hu ta' 12%.
English: 1 x 3 ml pre-filled pen
Maltese: Penfill 1 x 3 ml skartoċċ
English: In clinical trials using basal bolus insulin therapy, the overall rates of hypoglycaemia with Levemir and NPH insulin were similar.
Maltese: Fi provi kliniċi bl-użu tat-terapija ta' l-insulina bażilari bolus, ir-rati totali ta' ipogliċemija ma' Levemir u linsulina NPH kienu simili.
English: Injection site reactions are seen more frequently during treatment with Levemir than with human insulin products.
Maltese: Reazzjonijiet fis-sit tal-injezzjon huma aktar frekwenti waqt il-kura b'Levemir milli bil-prodotti tal-insulina umana.
English: The requirements for submission of periodic safety reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tadDirettiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini
English: EU/1/04/278/013 5 pens of 3 ml
Maltese: EU/1/04/278/013 5 pinen ta' 3 ml
English: • Drink alcohol (see section 2 Drinking alcohol and taking Levemir).
Maltese: • Tixrob l-alkoħol (ara Tixrob l-alkoħol u tieħu NovoRapid f'sezzjoni 2)
English: No metabolic effects of ingested insulin detemir on the breast-fed newborn/infant are anticipated since insulin detemir, as a peptide, is digested into amino acids in the human gastrointestinal tract.
Maltese: Mhu mistenni ebda effett metaboliku minn insulin detemir li jittiekel mit-tarbija tat-twelid/tarbija li qiegħda tiġi mredda', minħabba li insulin detemir, bħala peptide, jitkisser f'aċidi aminiċi fil-passaġġ gastro-intestinali uman.
English: Activity profiles of Levemir in patients with type 1 diabetes
Maltese: Profili ta' attività ta' Levemir f'pazjenti b'dijabete ta' tip 1.
English: InnoLet.
Maltese: tintuża.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 01 June 2004
Maltese: Data tal-ewwel awtorizzazzjoni: 1 ta' Ġunju 2004
English: Time Since Insulin Injection (hours) Levemir ….. 0.2 U/kg 0.3 U/kg .
Maltese: 0.2 U/kg ______ 0.3 U/kg . . .0.4
English: Pack sizes of 1, 5 and 10 cartridges.
Maltese: Daqs tal-pakketti ta' 1, 5 u 10 skrataċ.
English: 1 x 3 ml cartridge 5 x 3 ml cartridges 10 x 3 ml cartridges
Maltese: InnoLet 1 x 3 ml pinna mimlija għal-lest 5 x 3 ml pinen mimlijin għal-lest 10 x 3 ml pinen mimlijin għal-lest
English: If one SMPG measurement 3.1-4.0 mmol/l (56-72 mg/dl)
Maltese: 3.1-4.0 mmol/l (56-72 mg/dl)
English: Change in body weight from baseline (kg)
Maltese: Bidla fil-piż tal-ġisem milllinja bażi (kg)
English: Dose button
Maltese: Għatu talpinna
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/
English: Can be stored in a refrigerator (2°C to 8°C) Do not freeze
Maltese: Aħżen fi friġġ (2°C - 8°C)
English: Substances added to Levemir may cause degradation of insulin detemir, e.g. if the medicinal product contains thiols or sulphites.
Maltese: Sustanzi miżjuda ma' Levemir jistgħu jikkawżaw id-degradazzjoni ta' insulin detemir, eż. jekk il-prodott mediċinali fih thiols jew sulphites.
English: There was no clinically relevant difference in pharmacokinetics of Levemir between elderly and young patients.
Maltese: Ma kien hemm l-ebda differenza klinikament rilevanti fil-farmakokinetika ta' Levemir bejn pazjenti anzjani u dawk iżgħar.
English: The overall rates of maternal adverse events were similar for Levemir and NPH insulin treatment groups; however, a numerically higher frequency of serious adverse events in the mothers (61 (40%) vs. 49 (31%)) and in the newborn children (36 (24%) vs. 32 (20%)) was seen for Levemir compared to NPH insulin.
Maltese: Ir-rati totali ta' avvenimenti avversi materni kienu simili bejn il-gruppi ta' kura b'Levemir u b'NPH insulin madankollu kien hemm frekwenza numerikament ogħla ta' avvenimenti avversi serji fl-ommijiet (61 (40%) vs.
English: Intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy, while long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Maltese: L-intensifikazzjoni tat-terapija blinsulina, b'titjib f'daqqa fil-kontroll gliċemiku, tista' tkun assoċjata ma' retinopatija dijabetika li b'mod temporanju tmur għall-agħar waqt li titjib fil-kontroll gliċemiku fit-tul inaqqas ir-riskju tal-progressjoni tarretinopatija dijabetika.
English: The potency of insulin analogues, including insulin detemir, is expressed in units, whereas the potency of human insulin is expressed in international units.
Maltese: Il-qawwa tal-analogi tal-insulina inkluż l-insulin detemir hija rrappreżentata permezz ta' unitajiet, waqt li lqawwa tal-insulina umana hija rrappreżentata permezz ta' unitajiet internazzjonali.
English: Levemir + liraglutide + metformin n=160
Maltese: Għażla b'mod arbitrarju għal Liraglutide +
English: The most frequently reported adverse reaction during treatment is hypoglycaemia, please see section 4.8, Description of selected adverse reactions.
Maltese: Waqt il-kura, l-ipogliċemija hija r-reazzjoni avversa li ġiet irrapportata b'mod l-aktar frekwenti, jekk jogħġbok ara sezzjoni 4.8 Deskrizzjoni ta' reazzjonijiet avversi partikulari.
English: A 26-week, double blind, randomised clinical trial was conducted to investigate the efficacy and safety of adding liraglutide (1.8 mg) vs. placebo in patients with type 2 diabetes inadequately controlled on basal insulin with or without metformin.
Maltese: Saret prova klinika magħmula b'mod arbitrarju, double-blind u li damet 26 ġimgħa sabiex jiġu investigati leffikaċja u s-sigurtà taż-żieda ta' liraglutide (1.8 mg) kontra plaċebo f'pazjenti bid-dijabete tat-tip 2 li ma kinux ikkontrollati b'mod adegwat b'insulina bażilari flimkien jew mingħajr metformin.
English: No pharmacokinetic or pharmacodynamic interactions were observed between liraglutide and Levemir when administering a single dose of Levemir 0.5 units/kg with liraglutide 1.8 mg at steady state in patients with type 2 diabetes.
Maltese: Ma dehru ebda interazzjonijiet farmakokinetiċi jew farmakodinamiċi bejn liraglutide u Levemir meta, fl-istat fiss, ġiet mogħtija doża waħda ta' Levemir 0.5 ta' U/kg flimkien ma' liraglutide 1.8 mg f'pazjenti biddijabete tat-tip 2.
English: Levemir Penfill 100 units/ml solution for injection in cartridge.
Maltese: Levemir Penfill 100 unità/ml soluzzjoni għall-injezzjoni fi skartoċċ.
English: • Growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced influence on the body's metabolic processes)
Maltese: • Ormon tat-tkabbir (mediċina li tistimula t-tkabbir skeltrali u somatiku u għandha effett qawwi fuq il proċessi metaboliċi tal-ġisem)
English: Within-subject variability of the time action profile of Levemir and NPH insulin Pharmacodynamic Endpoint
Maltese: Varjabilità fis-suġġetti tal-profil tal-azzjoni mal-ħin ta' Levemir u tal-insulina NPH.
English: 1 pre-filled pen contains 3 ml equivalent to 300 units.
Maltese: Pinna mimlija għal-lest fiha 3 ml ekwivalenti għal 300 unità.
English: Levemir can be used in adolescents and children from the age of 1 year (see section 5.1).
Maltese: Levemir jista' jintuża fl-adolexxenti u fit-tfal mill-età ta' sena (ara sezzjoni 5.1).
English: Levemir contains less than 1 mmol sodium (23 mg) per dose, i.e. Levemir is essentially ‘sodium-free'.
Maltese: Kull doża ta' Levemir fiha inqas minn 1 mmol ta' sodium (23 mg), jiġifieri Levemir huwa bażikament ‘bla sodium'.
English: Your InnoLet is a simple, compact pre-filled pen able to deliver 1 to 50 units in increments of 1 unit.
Maltese: InnoLet tagħti minn 1- 50 unità f'inkrementi ta' unità 1.
English: Your FlexPen is a pre-filled dial-a-dose insulin pen.
Maltese: Qatra insulina se tidher fit-tarf tal-labra.
English: An apparent volume of distribution for Levemir (approximately 0.1 l/kg) indicates that a high fraction of insulin detemir is circulating in the blood.
Maltese: Volum apparenti ta' distribuzzjoni ta' Levemir (madwar 0.1 l/kg) jindika li porzjon għoli ta' insulin detemir qed jiċċirkola fid-demm.
English: You can carry it with you and keep it at room temperature (below 30°C) for up to 6 weeks.
Maltese: Tista' ġġorru miegħek u żżommu fit-temperatura tal-kamra (taħt 30ºC) sa perijodu ta' 6 ġimgħat.
English: Observed rates of minor hypoglycaemic episodes were similar and no severe hypoglycaemic episodes were observed in either group.
Maltese: Ir-rati osservati ta' episodji ħfief ta' ipogliċemija kieni simili u f'ebda grupp ma ġew osservati episodji severi ta' ipogliċemija.
English: The occurrence of generalised hypersensitivity reactions (including generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation and reduction in blood pressure) is very rare but can potentially be life threatening.
Maltese: Każijiet ta' reazzjonijiet ta' sensittività eċċessiva ġeneralizzata (li jinkludu raxx ġeneralizzat fil-ġilda, ħakk, għaraq, disturbi gastrointestinali, edima anġjonewrotika, diffikultà biex tieħu n-nifs, palpitazzjoni u tnaqqis fil-pressjoni tad-demm) huma rari ħafna iżda jistgħu potenzjalment ikunu ta' periklu għall-ħajja.
English: EU/1/04/278/015 1 pen of 3 ml and 7 NovoFine needles EU/1/04/278/016 1 pen of 3 ml and 7 NovoTwist needles
Maltese: EU/1/04/278/016 pinna ta' 3 ml u 7 labar NovoTwist
English: There was no clinically relevant difference in pharmacokinetics of Levemir between patients with renal or hepatic impairment and healthy subjects.
Maltese: Ma kien hemm l-ebda differenza klinikament rilevanti fil-farmakokinetika ta' Levemir bejn pazjenti b'indeboliment renali jew epatiku u individwi f'saħħithom.
English: Rare - Peripheral neuropathy (painful neuropathy)
Maltese: Komuni ħafna- Ipogliċemija* Disturbi fis-sistema nervuża Rari - Newropatija periferali (newropatija bl-uġigħ)
English: Levemir Penfill EU/1/04/278/001 EU/1/04/278/002 EU/1/04/278/003
Maltese: EU/1/04/278/001 EU/1/04/278/002 EU/1/04/278/003
English: Levemir 100 units/ml Solution for injection Insulin detemir SC use
Maltese: • Is-sustanza attiva hi insulin detemir Kull ml fih 100 unità ta' insulin detemir.
English: Levemir FlexTouch EU/1/04/278/012 EU/1/04/278/013 EU/1/04/278/014 EU/1/04/278/015 EU/1/04/278/016
Maltese: EU/1/04/278/012 EU/1/04/278/013 EU/1/04/278/014
English: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
Maltese: Novo Nordisk A/S,Novo Allé,DK-2880 Bagsværd, Id-Danimarka
English: Glycerol
Maltese: It-tqala
English: Signs of low blood sugar: Cold sweat; cool pale skin; headache; rapid heartbeat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
Maltese: Għaraq kiesaħ; ġilda kiesħa u pallida; uġigħ ta' ras; taħbit mgħaġġel talqalb, tħossok imqalla'; tħossok ħafna bil-ġuħ; tibdil temporanju fil-vista; ngħas, għeja u debbulizza mhux tas-soltu; nervożitá jew rogħda; tħossok ansjuż; tħossok konfuż; diffikultà fil-konċentrazzjoni.
English: Pen label Dose counter
Maltese: Kontatur tad-doża
English: Glucose must be given intravenously, if the patient does not respond to glucagon within 10 to 15 minutes.
Maltese: Il-glukosju għandu wkoll jingħata ġol-vina, jekk ilpazjent ma jirrispondix għal glucagon fi żmien 10 sa 15-il minuta.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (CARTRIDGE.
Maltese: Kontenut tal-pakkett u informazzjoni oħra).
English: Always make sure that a drop appears at the needle tip before you inject.
Maltese: Dan jista' jwassal li persuni jiġu infettati.
English: Insulin window
Maltese: Insulina
English: Levemir was non-inferior to NPH insulin as measured by HbA1c at gestational week (GW) 36, and the reduction in mean HbA1c through pregnancy was similar, see table 4.
Maltese: Levemir ma kienx inferjuri għal NPH insulin skont il-livelli ta' HbA1c fis-36 ġimgħa ta' ġestazzjoni (ĠĠ) u t-tnaqqis fil-medja tal-HbA1c minħabba t-tqala kien simili, ara tabella 4.
English: As with any insulin therapy, injection site reactions may occur and include pain, redness, hives, inflammation, bruising, swelling and itching.
Maltese: Bħalma ma jiġri fi kwalunkwe terapija bl-insulina, jistgħu jseħħu reazzjonijiet fis-sit ta' l-injezzjoni u dawn jinkludu wġigħ, ħmura, urtikarja, infjammazzjoni, tbenġil, nefħa u ħakk.
English: See also Serious allergic reaction above.
Maltese: Ara aktar 'il fuq Reazzjonijiet allerġiċi serji.
English: L. Lead the needle tip into the outer needle cap on a flat surface.
Maltese: Dejjem għandek tikkarga l-InnoLet qabel ma tinjetta.
English: Each cartridge contains 300 units of insulin detemir in 3 ml solution for injection.
Maltese: Kull skartoċċ fih 300 unità ta' insulin detemir f'soluzzjoni għall-injezzjoni ta' 3 ml.
English: INFORMATION IN BRAILLE Levemir FlexTouch
Maltese: Kif timmaniġġja Levemir FlexTouch
English: Hypoalbuminaemia
Maltese: Skartoċċ talinsulina
English: 1 pre-filled pen contains 3 ml equivalent to 300 units,
Maltese: Pinna mimlija għal-lest fiha 3 ml ekwivalenti għal 300 unità
English: Beta-blockers may mask the symptoms of hypoglycaemia.
Maltese: Sustanzi beta-blokkanti jistgħu jaħbu s-sintomi ta' ipogliċemija.
English: *Self-Monitored Plasma Glucose Adult type 2 diabetes simple self-titration guideline: Average pre-breakfast SMPG*
Maltese: *Monitoraġġ mill-pazjent stess tal-glukożju fil-plażma Linja gwida sempliċi għall-aġġustament fid-dożaġġ magħmul mill-pazjent stess għall-adulti biddijabete tat-tip 2:
English: Pregnancy
Maltese: Levemir
English: Pack sizes of 1 (with or without needles), 5 (without needles) and 10 (without needles) pre-filled pens of 3 ml.
Maltese: Daqs tal-pakketti ta' 1 (bil-labar jew mingħajr), 5 (mingħajr labar) u 10 (mingħajr labar) pinen mimlijin għallest.
English: Common - Injection site reactions
Maltese: Mhux komuni - Disturbi fir-rifrazzjoni
English: Insulin detemir is distributed more slowly to peripheral target tissues compared to NPH insulin.
Maltese: Jekk l-insulina tidher opaka, tużax il-pinna.
English: Octreotide and lanreotide (used for treatment of acromegaly, a rare hormonal disorder that usually occurs in middle-aged adults, caused by the pituitary gland producing excess growth hormone) may either increase or decrease your blood sugar level.
Maltese: Octreotide u lanreotide (użati għall-kura ta' l-akromegalija, disturb ormonali rari li normalment iseħħ f'adulti fl-età bejn 40 u 60 sena, ikkawżat minn produzzjoni eċċessiva ta' l-ormon ta' tkabbir mill-glandola pitwitarja) jistgħu kemm iżidulek kif ukoll inaqqsulek il-livell taz-zokkor fid-demm tiegħek.
English: INFORMATION IN BRAILLE Levemir FlexPen
Maltese: Kif timmaniġġja Levemir FlexPen
English: Levemir FlexTouch is a pre-filled, colour-coded, disposable pen containing insulin detemir.
Maltese: Levemir FlexTouch hija pinna mimlija għal-lest, b'kulur partikulari u li tintrema wara l-użu u li fiha insulin detemir.
English: There are no clinically relevant differences between genders in pharmacokinetic properties of Levemir.
Maltese: Bejn is-sessi ma kien hemm l-ebda differenza klinikament rilevanti fil-karatteristiċi farmakokinetiċi ta'
English: When Levemir is used in combination with oral antidiabetic medicinal products or when added to GLP-1 receptor agonists it is recommended to use Levemir once daily, initially at a dose of 0.10.2 units/kg or of 10 units in adult patients.
Maltese: Meta Levemir jintuża flimkien ma' prodotti mediċinali antidijabetiċi orali jew meta jiżdied ma' agonisti tarriċettur GLP-1, huwa rrikkmandat li Levemir jintuża darba kuljum, għall-bidu f'doża ta' 0.1-0.2 unitajiet/kg jew ta'10 unitajiet f'pazjenti adulti.
English: If it shows less than 80, the number shown is the number of units left in your pen.
Maltese: Jekk juri inqas minn 80, in-numru li jidher huwa n-numru ta' unitajiet li jkun fadal fil-pinna tiegħek.
English: This may lead to too high blood sugar level.
Maltese: Qatt m'għandek tuża labra mgħawġa jew bi ħsara.
English: Proportions of patients achieving HbA1c <7% targets
Maltese: Numru ta' pazjenti li laħqu ilmiri ta' HbA1c <7% (%)
English: Patients whose blood glucose control is greatly improved, e.g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia, and should be advised accordingly.
Maltese: Pazjenti li l-kontroll tal-glukosju fid-demm tagħhom jitjieb bil-kbir, eż. permezz ta' terapija bl-insulina intensifikata, jista' jkollhom bidla fis-sintomi normali ta' twissija tagħhom ta' ipogliċemija, u għandhom jingħataw parir kif xieraq.
English: I.
Maltese: E.
English: Levemir FlexPen is only suitable for subcutaneous injections.
Maltese: Levemir m'għandux jintuża f'pompi tal-infużjoni talinsulina.
English: After stabilisation of the patient's blood glucose, adjustment of the dose should be considered (see sections 4.8 and 4.9).
Maltese: Wara li l-livell talglukosju fid-demm tal-pazjent ikun ġie lura għan-normal, wieħed għandu jikkunsidra jaġġusta d-doża (ara sezzjonijiet 4.8 u 4.9).
English: FlexTouch.
Maltese: Tiffriżax.
English: ► If you suspect hypoglycaemia (low blood sugar) is starting, see a) Summary of serious and very common side effects in section 4.
Maltese: Sommarju ta' effetti sekondarji serji u komuni ħafna f'sezzjoni 4).
English: 2 units selected
Maltese: Isselezzjonati 2 unitajiet
English: The dose counter will show the exact number of units.
Maltese: Il-kontatur tad-doża se juri n-numru eżatt ta' unitajiet.
English: At the beginning of the insulin treatment, refraction anomalies and oedema may occur; these reactions are usually of transitory nature.
Maltese: Fil-bidu tal-kura bl-insulina jistgħu jseħħu, anomaliji fir-rifrazzjoni u edima; ħafna drabi dawn irreazzjonijiet huma ta' natura temporanja.
English: Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirements.
Maltese: Mard li jseħħ fl-istess żmien, speċjalment infezzjonijiet u kondizzjonijiet ta' deni, normalment iżidu lħtiġijiet ta' l-insulina tal-pazjent.
English: These reactions include pain, redness, hives, inflammation, bruising, swelling and itching at the injection site.
Maltese: Dawn ir-reazzjonijiet jinkludu wġigħ, ħmura, urtikarja, infjammazzjoni, tbenġil, tinfiħ u ħakk talġilda fil-parti injettata.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Id-Danimarka
English: (pulmonary embolism)
Maltese: (emboliżmu pulmonari)
English: • Female gender
Maltese: • Sess femminili
English: Alopecia rare
Maltese: Alopeċja rari
English: Niacin (nicotinic acid) ≥ 1 g/day
Maltese: Niacin (nicotinic acid) ≥ 1 g/kuljum
English: • muscle problems
Maltese: • problemi fil-muskoli
English: < PC: {number} [product code]
Maltese: <PC: {numru} [kodiċi tal-prodott]
English: Silicified microcrystalline cellulose (comprised of cellulose, microcrystalline and silica, colloidal anhydrous)
Maltese: Silicified microcrystalline cellulose (magħmul minn cellulose, microcrystalline u silica, colloidal anhydrous)
English: Mean (SD)
Maltese: Medju (SD)
English: Mylan Laboratories SAS, Route de Belleville - Lieu-dit Maillard, 01400 Châtillon-surChalaronne - France.
Maltese: Mylan Laboratories SAS, Route de Belleville - Lieu-dit Maillard, 01400 Châtillon-surChalaronne - Franza.
English: Myopathy**
Maltese: Mijopatija**
English: Mylan Laboratories SAS Route de Belleville - Lieu-dit Maillard 01400 Châtillon-sur-Chalaronne France
Maltese: Mylan Laboratories SAS Route de Belleville - Lieu-dit Maillard 01400 Châtillon-sur-Chalaronne Franza
English: LS (less square mean) SD (standard deviation)
Maltese: LS (medja tal-'less square') SD (devjazzjoni standard)
English: Veno-thromboembolic events
Maltese: Avvenimenti veno-tromboemboliċi
English: Thromboembolism (pulmonary embolism, deep vein thrombosis)*
Maltese: Tromboemboliżmu (emboliżmu pulmonari, trombożi profonda fil-vini)*
English: Adverse reactions (fenofibrate)
Maltese: Reazzjonijiet avversi (fenofibrate)
English: Gamma-glutamyltransferase increase rare
Maltese: Żieda fil-gamma-glutamyltransferase rari
English: Simva 40 (N=505) Mean (SD)
Maltese: Simva 40 (N=505) Medju (SD)
English: Simvastatin is a substrate of CYP 3A4 and of the efflux transporter BCRP.
Maltese: Simvastatin huwa substrat ta' CYP 3A4 u tat-trasportatur tal-effluss BCRP.
English: Interaction between simvastatin and fenofibrate
Maltese: Interazzjoni bejn simvastatin u fenofibrate
English: Fenofibric acid is strongly bound to plasma albumin (more than 99%).
Maltese: Fenofibric acid jintrabat sew mal-albumina fil-plasma (aktar minn 99%).
English: Gemfibrozil, Other statins and fibrates
Maltese: Gemfibrozil, statins u fibrati oħra
English: • dyspepsia
Maltese: • dispepsja
English: • anticoagulants such as warfarin, fluindione, phenprocoumone or acenocoumarol
Maltese: • antikoagulanti bħal warfarina, fluindione, phenprocoumone jew acenocoumarol
English: Poly (vinyl alcohol), partially hydrolysed (E1203) Titanium dioxide (E171)
Maltese: Poly (vinyl alcohol), parzjalment idrolizzat (E1203) Titanium dioxide (E171)
English: Alanine- aminotransferase increased
Maltese: Żieda fl-alanine- aminotransferase komuni
English: • diabetes mellitus
Maltese: • Dijabete mellitus
English: The C allele has a frequency of 18% in the European population.
Maltese: Is-C allele għandu frekwenza ta' 18% fil-popolazzjoni Ewropea.
English: • Concomitant administration of glecaprevir/ pibrentasvir (see section 4.5)
Maltese: • L-għoti konkomitanti ta' glecaprevir/pibrentasvir (ara sezzjoni 4.5)
English: Rash, pruritus, urticaria)
Maltese: Raxx, ħakk, urtikarja)