FrancophonIA/ELRC3.0 huggingface dataset:
English: In the intention to treat analysis, 939 events were observed in the clopidogrel group and 1,020 events with ASA (relative risk reduction (RRR) 8.7%, [95% CI: 0.2 to 16.4]; p = 0.045), which corresponds, for every 1,000 patients treated for 2 years, to 10 [CI: 0 to 20] additional patients being prevented from experiencing a new ischaemic event.
Maltese: Fl-analiżi ta' lintenzjoni tal-kura, ġew osservati 939 avveniment fil-grupp ta' clopidogrel u 1 020 avveniment b'ASA (tnaqqis tar-riskju relattiv (RRR) ta' 8.7%, [95% CI: minn 0.2 għal 16.4]; p = 0.
English: Thrombotic Thrombocytopenic Purpura (TTP) has been reported very rarely following the use of clopidogrel, sometimes after a short exposure.
Maltese: Ġiet irrapurtata Purpura Trombotika Tromboċitopenika (TTP) b'mod rari ħafna wara l-użu ta' clopidrogel, xi kultant wara espożizzjoni qasira.
English: Other side effects reported with Clopidogrel BMS are: Common side effects (affects 1 to 10 patients in 100): Diarrhoea, abdominal pain, indigestion or
Maltese: Effetti sekondarji komuni (jaffettwaw minn 1 sa 10 pazjenti minn kull 100):
English: Dose scale
Maltese: Skala tad doża
English: Mixtard 30 vial, Penfill and FlexPen:
Maltese: Mixtard 30 kunjett, Penfill u FlexPen:
English: Mixtard 30 vial (100 international units/ml) EU/1/02/231/003
Maltese: Mixtard 30 vial (100 unità internazzjonali/ml) EU/1/02/231/003
English: Residual scale
Maltese: Skala ta' residwu
English: Mixtard 30 vial (40 international units/ml)/Mixtard 30 vial (100 international units/ml) Vial (type 1 glass) closed with a disc (bromobutyl/polyisoprene rubber) and a protective tamper-proof plastic cap containing 10 ml of suspension.
Maltese: Mixtard 30 f'kunjett (40 unità internazzjonali/ml)/Mixtard 30 f'kunjett (100 unità internazzjonali/ml) Kunjett (tal-ħġieġ ta'tip 1) magħluq b'disk (gomma tal-bromobutyl/polyisoprene) u b'għatu protettiv tal-plastik li jingħalaq b'sikurezza u li fih suspensjoni ta' 10 ml.
English: Mixtard with alcohol
Maltese: Mixtard mal-alkoħol
English: Mixtard contains sodium
Maltese: Mixtard fih sodium
English: Mixtard 30 vial (40 international units/ml) EU/1/02/231/001
Maltese: Mixtard 30 f'kunjett (40 unità internazzjonali/ml) EU/1/02/231/001
English: Suspension for injection 1 x 3 ml pre-filled pen 5 x 3 ml pre-filled pens 10 x 3 ml pre-filled pens
Maltese: U KONTENUT Suspensjoni għall-injezzjoni 1 x 3 ml pinna mimlija għal-lest 5 x 3 ml pinen mimlijin għal-lest
English: Animal reproduction studies with human insulin have not revealed any adverse effects on fertility.
Maltese: Fertilità Studji ta' riproduzzjoni fl-annimali bl-insulina umana ma wrew ebda effett avvers fuq il-fertilità.
English: Other medicines and Mixtard
Maltese: Mediċini oħra u Mixtard
English: Mixtard 30 vial (40 international units/ml)/Mixtard 30 vial (100 international units/ml)
Maltese: Mixtard 30 f'kunjett (40 unità internazzjonali/ml)/Mixtard 30 f'kunjett (100 unità internazzjonali/ml)
English: EU/1/02/231/036 5 packs of 1 x 10 ml vial
Maltese: EU/1/02/231/036 5 pakketti ta' kunjett 1 x 10 ml
English: Mixtard is a mixture consisting of 50% soluble human insulin and 50% isophane human insulin.
Maltese: Mixtard huwa taħlita li tikkonsisti minn 50 % ta' insulina umana li tinħall u 50 % ta' insulina umana isophane.
English: Mixtard is a mixture consisting of 30% soluble human insulin and 70% isophane human insulin.
Maltese: Mixtard huwa taħlita li tikkonsisti minn 30 % ta' insulina umana li tinħall u 70 % ta' insulina umana isophane.
English: EU/1/02/231/037 5 packs of 1 x 10 ml vial
Maltese: EU/1/02/231/037 5 pakketti ta' kunjett 1 x 10 ml
English: Mixtard is a mixture consisting of 40% soluble human insulin and 60% isophane human insulin.
Maltese: Mixtard huwa taħlita li tikkonsisti minn 40 % ta' insulina umana li tinħall u 60 % ta' insulina umana isophane.
English: Disodium phosphate dihydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Protamine sulfate
Maltese: Sodium hydroxide (għall-aġġustament tal-pH) Hydrochloric acid (għall-aġġustament tal-pH)
English: 1 vial contains 10 ml equivalent to 400 international units.
Maltese: Kunjett fih 10 ml ekwivalenti għal 400 unità internazzjonali.
English: Mixtard 30 FlexPen EU/1/02/231/033 EU/1/02/231/034 EU/1/02/231/035
Maltese: Mixtard 30 FlexPen EU/1/02/231/033 EU/1/02/231/034
English: Pack sizes of 1 and 5 vials of 10 ml or a multipack of 5 packs of 1 x 10 ml vial.
Maltese: Daqsijiet ta' pakketti ta' 1 u 5 kunjetti ta' 10 ml jew pakkett multiplu ta' 5 pakketti ta' kunjett ta' 1 x 10 ml.
English: Mixtard 30 FlexPen 100 IU/ml Suspension for injection Insulin human
Maltese: Mixtard 30 FlexPen 100 UI/ml Suspensjoni għall-injezzjoni Insulina umana
English: Mixtard Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Maltese: Mixtard Penfill hu magħmul biex jintuża ma' sistemi ta' għoti ta' insulina NovoNordisk u labar NovoFine jew NovoTwist.
English: Mixtard 30 vial (40 international units/ml)
Maltese: Mixtard 30 f'kunjett (40 unità internazzjonali/ml)
English: EU/1/02/231/033 1 pen of 3 ml EU/1/02/231/034 5 pens of 3 ml EU/1/02/231/035 10 pens of 3 ml
Maltese: EU/1/02/231/033 Pinna 1 ta' 3 ml EU/1/02/231/034 5pinen ta' 3 ml EU/1/02/231/035 10 pinen ta' 3 ml
English: Mixtard 50 contains less than 1 mmol sodium (23 mg) per dose, i.e. Mixtard 50 is essentially ‘sodiumfree'.
Maltese: Mixtard 50 fih inqas minn mmol 1 ta' sodium (23 mg) għal kull doża, i.e Mixtard 50 huwa essenzjalment ‘bla sodium'.
English: - If the second and third characters are S6 or ZF, the manufacturer is Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark.
Maltese: - Jekk it-tieni u t-tielet karattri huma S6 jew ZF, il-manifattur huwa Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Id-Danimarka.
English: ► Mixtard Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Maltese: ► L-iskrataċ ta' Mixtard Penfill huma magħmula biex jintużaw mas-sistemi tal-għoti tal-insulina Novo Nordisk u mal-labar NovoFine jew NovoTwist.
English: Mixtard 30 contains less than 1 mmol sodium (23 mg) per dose, i.e. Mixtard 30 is essentially ‘sodiumfree'.
Maltese: Mixtard 30 fih inqas minn mmol 1 ta' sodium (23 mg) għal kull doża, i.e Mixtard 30 huwa essenzjalment ‘bla sodium'.
English: Mixtard 40 Penfill 100 IU/ml Suspension for injection Insulin human
Maltese: Mixtard 40 Penfill 100 UI/ml Suspensjoni għall-injezzjoni Insulina umana
English: EU/1/02/231/030 1 pen of 3 ml EU/1/02/231/031 5 pens of 3 ml EU/1/02/231/032 10 pens of 3 ml
Maltese: EU/1/02/231/030 Pinna 1 ta' 3 ml EU/1/02/231/031 5pinen ta' 3 ml EU/1/02/231/032 10 pinen ta' 3 ml
English: • Drink alcohol, see Mixtard with alcohol in section 2.
Maltese: • Tixrob l-alkoħol (ara Mixtard mal-alkoħol f'sezzjoni 2)
English: Mixtard 40 contains less than 1 mmol sodium (23 mg) per dose, i.e. Mixtard 40 is essentially ‘sodiumfree'.
Maltese: Mixtard 40 fih inqas minn mmol 1 ta' sodium (23 mg) għal kull doża, i.e Mixtard 40 huwa essenzjalment ‘bla sodium'.
English: Fertility
Maltese: Pożoloġija
English: Mixtard is a dual-acting human insulin.
Maltese: Mixtard hu insulina umana li taħdem b'żewġ modi.
English: Mixtard is a dual-acting insulin.
Maltese: Mixtard li ġie ffriżat m'għandux jintuża.
English: Renal and hepatic impairment
Maltese: Phenol Disodium phosphate dihydrate
English: Suspension for injection 1 x 3 ml cartridge 5 x 3 ml cartridges 10 x 3 ml cartridges
Maltese: U KONTENUT Suspensjoni għall-injezzjoni 1 x 3 ml skartoċċ
English: Detailed information on this medicine is available on the European Medicines Agency website 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: 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 fil-kura tal-akromegalija, disturb ormonali rari li ħafna drabi jseħħ f'adulti ta' mezza età, ikkawżat mill-glandola pitwitarja li tipproduċi ammont żejjed mill-ormon tat tkabbir) jistgħu jew iżidu jew inaqqsu l-livell taz-zokkor fid-demm tiegħek.
English: EU/1/02/231/001 1 vial of 10 ml EU/1/02/231/002 5 vials of 10 ml
Maltese: EU/1/02/231/001 kunjett 1 ta' 10 ml EU/1/02/231/002 5 kunjetti ta' 10 ml
English: Suspension for injection 1 vial of 10 ml 5 vials of 10 ml
Maltese: Suspensjoni għall-injezzjoni Kunjett 1 ta' 10 ml
English: Mixtard 30 Penfill 100 international units/ml suspension for injection in cartridge.
Maltese: Mixtard 30 Penfill 100 unità internazzjonali/ml suspensjoni għall-injezzjoni f'skartoċċ.
English: EU/1/02/231/003 1 vial of 10 ml EU/1/02/231/004 5 vials of 10 ml
Maltese: EU/1/02/231/003 kunjett 1 ta' 10 ml EU/1/02/231/004 5 kunjetti ta' 10 ml
English: Contents of the pack and other information What Mixtard 30 contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Mixtard 30
English: Contents of the pack and other information What Mixtard 40 contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Mixtard 40
English: Mixtard 40 Penfill 100 international units/ml suspension for injection in cartridge.
Maltese: Mixtard 40 Penfill 100 unità internazzjonali/ml suspensjoni għall-injezzjoni f'skartoċċ.
English: EU/1/02/231/011 1 cartridge of 3 ml EU/1/02/231/012 5 cartridges of 3 ml EU/1/02/231/013 10 cartridges of 3 ml
Maltese: EU/1/02/231/011…skartoċċ 1 ta' 3 ml EU/1/02/231/012 5 skartoċċi ta' 3 ml EU/1/02/231/013 10 skartoċċi ta' 3 ml
English: Contents of the pack and other information What Mixtard 50 contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Mixtard 50
English: 1 vial contains 10 ml equivalent to 1,000 international units.
Maltese: Kunjett fih 10 ml ekwivalenti għal 1,000 UI .
English: Making the injection
Maltese: insuffiċjenza kardijaka.
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: Żieda fil-qawwa tat-terapija bl-insulina b'titjib f'daqqa fil-kontroll gliċemiku jista' jwassal li b'mod temporanju r-retinopatija dijabetika tmur għall-agħar, waqt li titjib fit-tul tal-kontroll gliċemiku jnaqqas ir-riskju tal-iżvilupp tar retinopatija dijabetika.
English: Package leaflet: Information for the user Mixtard 30 Penfill 100 IU/ml (international units/ml) suspension for injection in cartridge human insulin
Maltese: Informazzjoni għall-utent Mixtard 30 Penfill 100 UI/ml (unità internazzjonali/ml) suspensjoni għall-injezzjoni f'skartoċċ insulina umana
English: ► If you suspect hypoglycaemia (low blood sugar) is starting, see Summary of serious and very common side effects in section 4.
Maltese: Sommarju ta' effetti sekondarji serji u komuni ħafna f'sezzjioni 4.
English: Package leaflet: Information for the user Mixtard 40 Penfill 100 IU/ml (international units/ml) suspension for injection in cartridge human insulin
Maltese: Informazzjoni għall-utent Mixtard 40 Penfill 100 UI/ml (unità internazzjonali/ml) suspensjoni għall-injezzjoni f'skartoċċ insulina umana
English: 1 ml suspension contains 100 IU insulin human (30% as soluble insulin and 70% as isophane insulin) (equivalent to 3.5 mg),
Maltese: UI ta' insulina umana (30 % bħala insulin li tinħall u 70 % bħala insulina isophane) (ekwivalenti għal
English: Insulin cartridge Glass ball
Maltese: Zinc chloride Glycerol Metacresol
English: Mixtard 30 100 international units/ml suspension for injection in vial.
Maltese: Mixtard 30 100 unità internazzjonali/ml suspensjoni għall-injezzjoni f'kunjett.
English: Mixtard 30 40 international units/ml suspension for injection in vial.
Maltese: Mixtard 30 40 unità internazzjonali/ml suspensjoni għall-injezzjoni f'kunjett.
English: How to store Mixtard
Maltese: Qabel ma tuża Mixtard
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Maltese: Rappurtar ta' reazzjonijiet avversi suspettati Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: Mixtard 30 vial (100 international units/ml)
Maltese: Mixtard 30 Penfill 100 UI/ml
English: The expiry date refers to the last day of that month.
Maltese: DATA TA' REVIŻJONI TA' TEST
English: Mixtard FlexPen is a pre-filled pen designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. FlexPen delivers 1-60 units in increments of 1 unit.
Maltese: Il-FlexPen hi magħmula biex tintuża mal-labar NovoFine jew NovoTwist li jintużaw darba biss u li għandhom tul ta' mhux iżjed minn 8 mm.
English: EU/1/02/231/014 1 cartridge of 3 ml EU/1/02/231/015 5 cartridges of 3 ml EU/1/02/231/016 10 cartridges of 3 ml
Maltese: EU/1/02/231/015 5 skartoċċi ta' 3 ml EU/1/02/231/016 10 skartoċċi ta' 3 ml
English: Lipodystrophy
Maltese: Skartoċċ
English: Mixtard 30 FlexPen is a pre-filled disposable pen containing a mixture of fast-acting and long-acting human insulin in the ratio 30/70.
Maltese: Mixtard 30 FlexPen hija pinna mimlija għal-lest li tintuża darba biss u li fiha taħlita ta' insulina umana li taħdem kemm malajr u kemm fit-tul fil-proporzjoni ta' 30/70.
English: EU/1/02/231/017 1 cartridge of 3 ml EU/1/02/231/018 5 cartridges of 3 ml EU/1/02/231/019 10 cartridges of 3 ml
Maltese: EU/1/02/231/018 5 skartoċċi ta' 3 ml EU/1/02/231/019 10 skartoċċi ta' 3 ml
English: ► Mixtard FlexPen is only suitable for injecting under the skin.
Maltese: ► Mixtard FlexPen huwa tajjeb biss għall-injezzjonijiet minn taħt il-ġilda.
English: Mixtard 30 FlexPen 100 international units/ml suspension for injection in pre-filled pen.
Maltese: Mixtard 30 FlexPen 100 unità internazzjonali/ml suspensjoni għall-injezzjoni f'pinna mimlija għallest.
English: Renal or hepatic impairment may reduce the patient's insulin requirements.
Maltese: Indeboliment renali u epatiku L-indeboliment renali jew epatiku jista' jnaqqas il-ħtieġa tal-pazjent għall-insulina.
English: Package leaflet: Information for the user Mixtard 30 40 IU/ml (international units/ml) suspension for injection in vial human insulin
Maltese: Informazzjoni għall-utent Mixtard 30 40 UI/ml (unità internazzjonali/ml) suspensjoni għall-injezzjoni f'kunjett insulina umana
English: Package leaflet: Information for the user Mixtard 30 100 IU/ml (international units/ml) suspension for injection in vial human insulin
Maltese: Informazzjoni għall-utent Mixtard 30 100 UI/ml (unità internazzjonali/ml) suspensjoni għall-injezzjoni f'kunjett insulina umana
English: Mixtard vials are for use with insulin syringes with the corresponding unit scale.
Maltese: Jekk ma jkunx fadal biżżejjed insulina, uża wieħed ġdid.
English: Mixtard vials are for use with insulin syringes with a corresponding unit scale.
Maltese: Il-kunjetti ta' Mixtard huma għall-użu ma' siringi tal-insulina bi skala korrispondenti ta' unitajiet.
English: Each prefilled pen contains 300 IU of human insulin in 3 ml suspension for injection.
Maltese: Kull skartoċċ fih 300 UI ta' insulina umana f'3 ml ta' suspensjoni għall-injezzjoni.
English: The full EPAR for Ebixa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Ebixa was compared with placebo (a dummy treatment) over 24 to 28 weeks.
Maltese: Ebixa tqabbel ma' plaċebo (trattament finta) tul 24 sa 28 ġimgħa.
English: This is a summary of the European public assessment report (EPAR) for Ebixa.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Ebixa.
English: The most common side effects with Ebixa (seen in between 1 and 10 patients in 100) are somnolence (sleepiness), dizziness, hypertension (high blood pressure), dyspnoea (difficulty breathing), constipation, headache and drug hypersensitivity (allergy to the medicine).
Maltese: L-effetti sekondarji l-aktar komuni b'Ebixa (li dehru f'bejn 1 u 10 pazjenti minn kull 100) huma ħedla tan-ngħas, sturdament, ipertensjoni (pressjoni għolja tad-demm), dispnea (diffikultà fin-nifs), stitikezza, uġigħ ta' ras u ipersensittività għall-mediċina (allerġija għall-mediċina).
English: The first study involved 252 patients with moderately severe to severe disease, while the other two involved a total of 873 patients with mild to moderate disease.
Maltese: L-ewwel studju involva 252 pazjent b'mard moderat sa gravi, filwaqt li t-tnejn l-oħra involvew total ta' 873 pazjent bil-marda fi stadju ħafif sa moderat.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ebixa on 15 May 2002.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Ebixa fil-15 ta' Mejju 2002.
English: The active substance in Ebixa, memantine hydrochloride, is an antidementia medicine.
Maltese: Is-sustanza attiva f'Ebixa, il-memantina idroklorika, hija mediċina li taġixxi kontra d-dimenzja.
English: Ebixa is a medicine that contains the active substance memantine hydrochloride.
Maltese: Ebixa huwa mediċina li fih is-sustanza attiva memantina idroklorika.
English: Ebixa is used to treat patients with moderate to severe Alzheimer's disease.
Maltese: Ebixa jintuża għat-trattament ta' pazjenti bil-marda ta' Alzheimer moderata sa gravi.
English: Why has Ebixa been approved?
Maltese: Għaliex ġie approvat Ebixa?
English: Ebixa has been studied in three main studies including a total of 1,125 patients with Alzheimer's disease, some of whom had taken other medicines for their disease in the past.
Maltese: Ebixa ġie studjat fi tliet studji prinċipali li inkludew total ta' 1,125 pazjent bil-marda ta' Alzheimer, li xi wħud minnhom kienu ħadu mediċini oħrajn għal din il-marda fil-passat.
English: Ebixa was also studied in three additional studies including a total of 1,186 patients with mild to severe disease.
Maltese: Ebixa ġie studjat ukoll fi tliet studji addizzjonali li kienu jinvolvu total ta' 1,186 pazjent bil-marda fi stadju ħafif sa gravi.
English: Neurotransmitters are chemicals in the nervous system that allow nerve cells to communicate with one another.
Maltese: In-newrotrasmettituri huma sustanzi kimiċi fis-sistema nervuża li jippermettu li ċelluli tan-nervituri jikkomunikaw ma' xulxin.
English: What is the risk associated with Ebixa?
Maltese: X'inhuwa r-riskju assoċjati ma' Ebixa?
English: The main measures of effectiveness were the change in symptoms in three main areas: functional (the degree of disability), cognitive (the ability to think, learn and remember) and global (a combination of several areas including general function, cognitive symptoms, behaviour and the ability to carry out everyday activities).
Maltese: Il-kejl ewlieni tal-effikaċja kien il-bidla tas-sintomi fi tliet oqsma prinċipali: funzjonali (ilgrad ta' diżabbiltà), konjittiv (il-kapaċità tal-ħsieb, it-tagħlim u l-memorja) u globali (kombinazzjoni ta' diversi oqsma inklużi l-funzjoni ġenerali, is-sintomi konjittivi, l-imġiba u l-kapaċità li wieħed iwettaq lattivitajiet ta' kuljum).
English: In the study of moderately severe to severe disease, patients taking Ebixa had fewer symptoms than those taking placebo after 28 weeks, as measured on both global and functional scores.
Maltese: Fl-istudju fejn ilmarda kienet moderata sa gravi, il-pazjenti li ħadu Ebixa kellhom inqas sintomi minn dawk li ħadu plaċebo wara 28 ġimgħa, kif ġie mkejjel kemm b'punteġġ globali kif ukoll funzjonali.
English: How has Ebixa been studied?
Maltese: Kif ġie studjat Ebixa?
English: What is Ebixa?
Maltese: Kif jintuża Ebixa?
English: Memantine works by blocking special types of receptor called NMDA receptors to which the neurotransmitter glutamate normally attaches.
Maltese: NMDA li normalment jeħel magħhom in-newrotrasmettitur glutamat.
English: By blocking NMDA receptors, memantine improves the transmission of signals in the brain and reduces the symptoms of Alzheimer's disease.
Maltese: Permezz tal-imblukkar tar-riċetturi NMDA, il-memantina ttejjeb it-trażmissjoni ta' sinjali fil-moħħ u tnaqqas is-sintomi tal-marda ta' Alzheimer.
English: Ebixa is also available as an oral solution, which is supplied with a pump that delivers 5 mg memantine hydrochloride with each activation.
Maltese: Ebixa huwa disponibbli wkoll bħala soluzzjoni orali, li hija mogħtija permezz ta' pompa li tagħti 5 mg ta' memantina idroklorika ma' kull attivazzjoni.
English: To prevent side effects, the dose of Ebixa is gradually increased over the first three weeks of treatment: during the first week, the dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg. From week four onwards, the recommended maintenance dose is 20 mg once a day.
Maltese: Bil-għan li jiġu prevenuti effetti sekondarji, id-doża ta' Ebixa tiżdied gradwalment matul l-ewwel tliet ġimgħat tat-trattament: matul l-ewwel ġimgħa, iddoża hija 5 mg; fit-tieni ġimgħa, titla' għal 10 mg; u matul it-tielet ġimgħa, għal 15 mg.
English: The CHMP decided that Ebixa's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Ebixa huma akbar mir-riskji tiegħu u għaldaqstant irrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Ebixa was more effective than placebo at controlling the symptoms of Alzheimer's disease.
Maltese: Ebixa kien iktar effikaċi mill-plaċebo fil-kontroll tas-sintomi tal-marda ta' Alzheimer.
English: For the full list of all side effects reported with Ebixa, see the package leaflet.
Maltese: Għal-lista sħiħa taleffetti sekondarji kollha rrapportati b'Ebixa, ara l-fuljett ta' tagħrif.
English: In the two studies of mild to moderate disease, patients on Ebixa had less severe symptoms after 24 weeks, as measured on the global and cognitive scores.
Maltese: Fiż-żewġ studji fejn il-marda kienet ħafifa sa moderata, il-pazjenti li ħadu Ebixa kellhom sintomi inqas gravi wara 24 ġimgħa, kif imkejjel skont il-punteġġ globali u konjittiv.
English: However, when these results were considered along with those of the three additional studies, it was noted that the effect of Ebixa was smaller in patients with mild disease.
Maltese: Madankollu, meta dawn ir-riżultati tqiesu ma' dawk tat-tliet studji addizzjonali, kien innotat li l-effett ta' Ebixa kien iżgħar fil-pazjenti li kellhom ilmarda moderata.
English: Alzheimer's disease is a type of dementia (a brain disorder) that gradually affects memory, intellectual ability and behaviour.
Maltese: Il-marda ta' Alzheimer hija tip ta' dimenzja (diżordni fil-moħħ) li taffettwa gradwalment il-memorja, il-kapaċità intellettwali u l-imġiba.
English: Changes in the way glutamate transmits signals within the brain have been linked to the memory loss seen in Alzheimer's disease.
Maltese: Tibdil fil-mod ta' kif il-glutamat jittrasmetti sinjali fil-moħħ ġew konnessi mat-telf tal-memorja misjuba fil-marda ta' Alzheimer.
English: The full EPAR and risk management plan summary for Synjardy can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Synjardy
Maltese: Informazzjoni oħra dwar Synjardy
English: Why is Synjardy approved?
Maltese: Għaliex ġie approvat Synjardy?
English: • liver impairment, or problems with alcoholism or alcohol intoxication.
Maltese: • indeboliment tal-fwied, jew problemi bl-alkoħoliżmu jew intossikazzjoni bl-alkoħol.
English: Synjardy empagliflozin / metformin
Maltese: Sommarju tal-EPAR għall-pubbliku empagliflozin / metformina
English: Synjardy is used:
Maltese: Synjardy jintuża:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Synjardy on 27 May 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Synjardy fis-27 ta ᾽ Mejju 2015.