FrancophonIA/ELRC3.0 huggingface dataset:
English: Converting patients from other levodopa/ dopa-decarboxylase (DDC) inhibitor (carbidopa or benserazide) immediate release medicinal products to Numient
Maltese: It-tneħħija ta' pazjenti minn prodotti mediċinali oħrajn li jerħu l-mediċina b'mod immedjat ta' levodopa /tal-inibitur ta' dopa-decarboxylase (DDC) (carbidopa jew benserazide) għal tpoġġija għal fuq Numient
English: Sporadic cases of a symptom complex resembling neuroleptic malignant syndrome (NMS) have been associated with dose reductions and withdrawal of levodopa/carbidopa containing medicinal products.
Maltese: Każijiet sporadiċi ta' sintomu kompless li jixbah is-sindromu newrolettiku malinn (SNM) ġew irrappurtati flimkien ma tnaqqis tad-doża jew irtirar tal-prodotti mediċinali levodopa/carbidopa.
English: This can cause muscle problems, fever and mental changes.
Maltese: Dan jista' jikkawża problemi fil-muskoli, deni u bidliet mentali.
English: Levodopa is a precursor of dopamine, and is given as dopamine replacement therapy in Parkinson's disease.
Maltese: Levodopa huwa prekursur tad-dopamina, u jingħata bħala terapija ta' sostituzzjoni tad-dopamina filmarda tal-Parkinsons.
English: Numient is a modified-release hard capsule.
Maltese: Inti għandek tibla' l-kapsula sħiħa.
English: Numient 145 mg/36.25 mg modified-release hard capsules
Maltese: Numient 145 mg/36.25 mg kapsuli ibsin li jerħu mediċina b'mod modifikat
English: There are no studies on the pharmacokinetics of levodopa and carbidopa in patients with hepatic impairment (see section 4.2).
Maltese: M'hemm l-ebda studji dwar il-farmakokinetika ta' levodopa u ta' carbidopa fil-pazjenti b'indebolimenti tal-fwied (ara sezzjoni 4.2).
English: The addition of carbidopa to levodopa reduces the peripheral effects (nausea, vomiting) due to decarboxylation of levodopa; however, carbidopa does not decrease the adverse reactions due to the central effects of levodopa.
Maltese: Iż-żieda ta' carbidopa għal levodopa jnaqqas l-effetti periferali (dardir, rimettar) minħabba d-decarbossilazzjoni ta' levodopa; madankollu, carbidopa ma jnaqqasx ir-reazzjonijiet avversi minħabba l-effetti ċentrali ta' levodopa.
English: There is a recognized drug-drug interaction of levodopa with type B MAO inhibitors which potentiates the effects of levodopa.
Maltese: Hemm interazzjoni rikonoxxuta bejn mediċina u oħra ta' levodopa tat-tip B mal-inibituri tal-MAO li ssaħħaħ l-effetti ta' levodopa.
English: Numient 95mg/23.75 mg modified-release hard capsules EU/1/15/1044/001 (25 modified-release hard capsules) EU/1/15/1044/002 (100 modified-release hard capsules) EU/1/15/1044/003 (240 modified-release hard capsules)
Maltese: Numient 95 mg/23.75 mg kapsuli ibsin li jerħu mediċina b'mod modifikat EU/1/15/1044/001 (25 kapsuli ibsin li jerħu mediċina b'mod modifikat) EU/1/15/1044/002 (100 kapsuli ibsin li jerħu mediċina b'mod modifikat) EU/1/15/1044/003 (240 kapsuli ibsin li jerħu mediċina b'mod modifikat)
English: Further, high protein meals may impair clinical response by decreasing the absorption of levodopa (see section 4.5).
Maltese: Barra minn hekk, ikliet b'ħafna proteini jistgħu jfixklu r-rispons kliniku billi jnaqqsu l-assorbiment ta' levodopa (ara sezzjoni 4.5).
English: Numient has not been studied in patients with renal impairment.
Maltese: Numient ma ġiex studjat fuq pazjenti b'indeboliment renali.
English: Renal and urinary disorders
Maltese: Żamma fis-sistema urinarja
English: 195 mg/48.75 mg modified-release hard capsule Yellow body and a blue cap of 24 x 8 mm imprinted with “IPX066” and “195” in blue ink.
Maltese: 195 mg/48.75 mg kapsula iebsa li terħi l-mediċina b'mod modifikat Parti safra u b'għatu blu ta' 24 × 8 mm stampati b' “IPX066” u “195” b'linka blu.
English: The terminal phase elimination half-life of carbidopa is approximately 2 hours.
Maltese: Il-half-life tal-eliminazzjoni tal-fażi terminali ta' carbidopa huwa ta' madwar sagħtejn.
English: Abdominal pain, constipation, diarrhoea, dry mouth, vomiting Hot flushes, excessive sweating, rash
Maltese: Uġigħ addominali, stitikezza, dijarea, ħalq xott, rimettar Fwawar, għaraq eċċessiv, raxx
English: A symptom complex resembling neuroleptic malignant syndrome and rhabdomyolysis may occur with levodopa/carbidopa medicinal products, although no cases have been identified in clinical studies with Numient.
Maltese: Sintomu kumpless li jixbah sindromu newroleptiku malinn u rabdomijoliżi jista' jseħħ bil-prodotti mediċinali ta' levodopa/carbidopa, għalkemm ebda każ ma kien identifikat fl-istudji kliniċi b'Numient.
English: Modified-release levodopa/carbidopa may be used together with other medicinal products for the treatment of Parkinson's disease.
Maltese: Levodopa/carbidopa li jerħi l-mediċina b'mod modifikat jista' jintuża flimkien ma' prodotti mediċinali oħra għat-trattament tal-marda ta' Parkinsons.
English: The terminal phase elimination half-life of levodopa, the active moiety of antiparkinsonian activity, is approximately 2 hours in the presence of carbidopa.
Maltese: Il-half-life tal-eliminazzjoni tal-fażi terminali ta' levodopa, il-moiety attiva talattività kontra l-parkinsons, hija ta' madwar sagħtejn fil-preżenza ta' carbidopa.
English: The dose of the modified-release levodopa/carbidopa capsule medicinal product may need to be decreased with concomitant use of COMT inhibitors.
Maltese: Id-doża tal-prodott mediċinali tal-kapsula levodopa/carbidopa li terħi l-mediċina b'mod modifikat jista' jkollha titnaqqas mal-użu konkomitanti tal-inibituri COMT.
English: The single dose pharmacokinetics in healthy adults following oral administration of 2 Numient 195 mg levodopa/48.75 mg carbidopa capsules is presented in Figure 1.
Maltese: Il-farmakokinetiċi ta' doża waħda f'adulti b'saħħithom wara l-għoti orali ta' 2 Numient 195 mg levodopa/48.75 mg kapsuli ta' carbidopa hija ppreżentata fil-Figura 1.
English: Following a single dose of Numient in patients with Parkinson's disease the plasma AUC and Cmax of levodopa was higher in females than males (on average, 37% for AUC and 35% for Cmax).
Maltese: Wara doża waħda ta' Numient f'pazjenti bil-marda tal-Parkinsons il-plażma AUC u Cmass ta' levodopa kien ogħla fin-nisa milli fl-irġiel (fuq medja, 37 % għal AUC u 35 % għal Ċmass).
English: Twisting and repetitive movements or abnormal posture caused by involuntary muscle contraction (dystonia), abnormal involuntary movements (dyskinesia), on and off phenomenon (the time when your medicine is working and then it begins to no longer work to control your symptoms), worsening of Parkinsons's disease, abnormal walking, dizziness, excessive drowsiness, prickling or tingling feeling in your arms and/or legs, tremor, headache
Maltese: Brim u movimenti ripetittivi jew pożizzjoni anormali kkawżati minn kontrazzjoni muskolari involontarju (distonja), movimenti involontarji mhux normali (diskinesija), fenomenu ‘on' u ‘off' (il-ħin meta l-mediċina tiegħek qed taħdem u mbagħad tibda ma taħdimx biex tikkontrolla s-sintomi tiegħek), aggravar tal-marda tal-Parkinsons, mixi anormali, sturdament, ngħas eċċessiv, sensazzjoni ta' tingiz jew tnemnim f'idejk u/jew f'saqajk, rogħda, uġigħ ta' ras Ritmu tal-qalb irregolari
English: Ethylcellulose
Maltese: Etilċelluloża
English: If any of this happens, contact your doctor immediately an eye condition called chronic wide angle glaucoma, because your dose may need to be adjusted and the pressure in your eyes may need to be monitored melanoma or suspicious skin lesion a heart attack, heart beat problems, circulation or breathing problems kidney or liver problems an ulcer in your gut (called ‘duodenal' or ‘peptic ulcer') an endocrine (hormone) disease bronchial asthma obsessive behaviour(s) convulsions low blood pressure or feeling dizzy when getting up new or increased abnormal body movements (dyskinesias)
Maltese: Jekk isseħħ xi waħda minn dawn, ikkuntattja lit-tabib tiegħek immedjatament kundizzjoni tal-għajn msejħa glawkoma kronika ta' anglu wiesgħa, għaliex id-doża tiegħek jista' jkollha bżonn tiġi aġġustata u l-pressjoni f'għajnejk jista' jkollha bżonn tiġi sorveljata. melanoma jew ferita suspettuża fil-ġilda attakk tal-qalb, problemi tal-ħbit tal-qalb, problemi ta' ċirkolazzjoni jew tan-nifs problemi fil-kliewi jew fil-fwied ulċera fl-imsaren tiegħek (imsejjaħ ‘duwodenali' jew ‘ulċera peptika') mard endokrinali (ormon) ażżma tal-bronki imġiba ossessiva konvulżjonijiet pressjoni tad-demm baxxa jew tħossok sturdut meta tqum movimenti tal-ġisem mhux normali li huma ġodda jew żdiedu (diskineżja)
English: In studies in advanced Parkinson's disease patients, there is limited data using doses above 2,450 mg of levodopa and 612.5 mg of carbidopa given as Numient.
Maltese: Fi studji dwar pazjenti fi stadju avvanzat talmarda tal-Parkinsons, hemm tagħrif limitat dwar l-użu tad-dożi ta' aktar minn 2,450 mg ta' levodopa u 612.5 mg ta' carbidopa mogħti bħala Numient.
English: How to take Numient
Maltese: Tiħux Numient:
English: Each capsule contains 95 mg of levodopa and 23.75 mg of carbidopa (as monohydrate) Each capsule contains 145 mg of levodopa and 36.25 mg of carbidopa (as monohydrate) Each capsule contains 195 mg of levodopa and 48.75 mg of carbidopa (as monohydrate) Each capsule contains 245 mg of levodopa and 61.25 mg of carbidopa (as monohydrate)
Maltese: U KWANTITATTIVA 95 mg/23.75 mg kapsuli ibsin li jerħu l-mediċina b'mod modifikat Kull kapsula iha 95 mg levodopa u 23.75 mg carbidopa (bħala monohydrate) 145 mg/36.25 mg kapsuli ibsin li jerħu l-mediċina b'mod modifikat Kull kapsula fiha 145 mg levodopa u 36.25 mg carbidopa (bħala monohydrate) 195 mg/48.75 mg kapsuli ibsin li jerħu l-mediċina b'mod modifikat Kull kapsula fiha 195 mg levodopa u 48.75 mg carbidopa (bħala monohydrate 245 mg/61.25 mg kapsuli ibsin li jerħu l-mediċina b'mod modifikat Kull kapsula fiha 245 mg levodopa u 61.25 mg carbidopa (bħala monohydrate Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: Numient is used to improve the symptoms of Parkinson's disease in adults.
Maltese: Numient huwa użat biex itejjeb is-sintomi tal-marda tal-Parkinsons fl-adulti.
English: Convulsions, sudden onset of sleep (see section 4.4), trismus, restless legs syndrome
Maltese: Konvulżjonijiet, irqad li jiġi f'daqqa (ara sezzjoni 4.4), trismus, sindromu tar-riġlejn li ma jkollhomx kwiet
English: The primary efficacy endpoint was the mean change from baseline of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (activities of daily living) score plus Part III motor score at week 30 or early termination.
Maltese: L-endpoint primarju effikaċi kien il-bidla medja mil-linja bażi tal-iSkala Unifikata tal-Ikklassifikar talMarda tal-Parkinsons (UPDRS -) Parti II (attivitajiet tal-ħajja ta' kuljum) punteġġ plus Parti III f'ħin tal-mutur fit-30 ġimgħa jew terminazzjoni bikrija.
English: Periodic evaluation of hepatic, haematopoietic, cardiovascular and renal function is recommended during extended therapy.
Maltese: Evalwazzjoni perjodika tal-funzjonament tal-fwied, ematopojetika, kardjovaskulari u renali hu rakkomandat matul il-kura estiża.
English: Common
Maltese: Linka
English: Nausea
Maltese: Glawkoma
English: Levodopa/carbidopa can cause orthostatic hypotension.
Maltese: Levodopa/carbidopa tista' tikkawża pressjoni baxxa ortostatika.
English: One bottle containing 25, 100 or 240 modified-release hard capsules.
Maltese: Flixkun wieħed fih 25, 100 jew 240 kapsuli li terħi mediċina b'mod modifikat Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: Numient can be taken concomitantly with the recommended dose of an MAO inhibitor, which is selective for MAO inhibitor type B such as selegiline and rasagiline.
Maltese: Numient jista' jittieħed flimkien ma' doża rakkomandata ta' inibitur MAO, li huwa selettiv għallinibitur MAO tat-tip B bħal selegiline u rasagiline.
English: Numient 195 mg/48.75 mg modified-release hard capsules
Maltese: Numient 195 mg/48.75 mg kapsuli ibsin li jerħu mediċina b'mod modifikat
English: The initial total daily dose of Numient described in Table 1 above may need to be decreased by approximately 30% for patients converting specifically from levodopa/DDC inhibitor modified-release medicinal products to Numient.
Maltese: It-total tad-doża inizjali ta' kuljum ta' Numient deskritta f'Tabella 1 hawn fuq jeħtieġ li titnaqqas b'madwar 30 % għal pazjenti li jkunu qed jitneħħew b'mod speċifiku minn prodotti mediċinali li jerħu l-mediċina b'mod modifikat ta' levodopa/inibitur ta' DDC u jitpoġġew għal fuq Numient.
English: EU/1/15/1044/010 (25 modified-release hard capsules) EU/1/15/1044/011 (100 modified-release hard capsules) EU/1/15/1044/012 (240 modified-release hard capsules)
Maltese: (25 kapsuli ibsin li jerħu mediċina b'mod modifikat) EU/1/15/1044/011 (100 kapsuli ibsin li jerħu mediċina b'mod modifikat) EU/1/15/1044/012 (240 kapsuli ibsin li jerħu mediċina b'mod modifikat)
English: Numient 95 mg/23.75 mg modified-release hard capsules
Maltese: Numient 95 mg/23.75 mg kapsuli ibsin li jerħu mediċina b'mod modifikat
English: Breast-feeding should be discontinued during treatment with Numient.
Maltese: In-nisa ma għandhomx jreddgħu waqt it-trattament bin-Nutrient.
English: Each 195 mg/48.75 mg modified-release hard capsule contains 195 mg levodopa and 48.75 mg carbidopa (as monohydrate)
Maltese: Kull kapsula fiha 195 mg ta' levodopa u 48.75 mg ta' carbidopa (bħala monohydrate)
English: Outcomes Study arms
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Each 245 mg/61.25 mg modified-release hard capsule contains 245 mg levodopa and 61.25 mg carbidopa (as monohydrate)
Maltese: Kull kapsula fiha 245 mg ta' levodopa u 61.25 mg ta' carbidopa (bħala monohydrate).
English: Patients were not allowed to receive supplemental levodopa/carbidopa or catechol-O-methyl transferase (COMT) inhibitor medicinal products during the trial.
Maltese: Il-pazjenti ma tħallewx jirċievu prodotti mediċinali supplimentali ta' levodopa/carbidopa jew tal-inibitur catechol-O-methyl transferase (COMT) matul ilprova.
English: Carbidopa does not cross the blood-brain barrier at clinically relevant doses.
Maltese: Carbidopa ma jaqsamx il-barriera bejn id-demm u l-moħħ f'dożi klinikament rilevanti.
English: Dyskinesias
Maltese: Prijapriżmu
English: Dosing of concomitant antiParkinson medicinal products was kept stable.
Maltese: Il-prodotti mediċinali konkomitanti kontra l-Parkinson inżammu stabbli matul l-istudju.
English: Unchanged levodopa accounts for less than 10% of the total urinary excretion.
Maltese: Levodopa mhux mibdul jagħmel inqas minn 10 % mit-total tattneħħija tal-awrina.
English: Initial dose and titration in levodopa-naïve patients
Maltese: Doża tal-bidu u titrazzjoni f'pażjenti li huma ‘levodopa-naïve'
English: The starting dose is one capsule containing 95 mg of levodopa and 23.75 mg carbidopa three times daily (TID) for the first three days; this may be increased to a dose of one modified-release hard capsule containing 145 mg of levodopa and 36.25 mg carbidopa three times daily from Day 4 of treatment.
Maltese: Id-doża tal-bidu hija kapsula waħda li fiha 95 mg ta' levodopa u 23.75 mg carbidopa tliet darbiet kuljum (TID) għall-ewwel tlett ijiem; dan jista' jiżdied għal doża ta' kapsula waħda li terħi l-mediċina b'mod modifikat, iebsa, li fiha 145 mg ta' levodopa u 36.25 mg carbidopa tliet darbiet kuljum mirraba' jum ta' trattament.
English: Renal impairment
Maltese: Renju Unit
English: There are no studies on the pharmacokinetics of levodopa and carbidopa when administered as Numient in children.
Maltese: M'hemmx studji dwar il-farmakokinetika ta' levodopa u ta' carbidopa meta mogħti bħala Numient littfal.
English: A lower dose of levodopa can be used when it is coadministered with carbidopa, reducing the incidence and severity of peripheral side effects.
Maltese: Doża iktar baxxa ta' levodopa tista' tintuża meta tkun ko-amministrata b'carbidopa, b'hekk tnaqqas l-inċidenza u s-severità tal-effetti sekondarji periferali.
English: Each 145 mg/36.25 mg modified-release hard capsule contains 145 mg levodopa and 36.25 mg carbidopa (as monohydrate)
Maltese: Kull kapsula fiha 145 mg ta' levodopa u 36.25 mg ta' carbidopa (bħala monohydrate)
English: The combination may be associated with severe orthostatic hypotension.
Maltese: Il-kombinazzjoni tista' tkun assoċjata ma' pressjoni baxxa ortostatika severa.
English: Following this dose conversion, 91 study patients (mean age: 64.1 years; 75% male patients) were randomized to receive Numient followed by prestudy LCE or vice versa.
Maltese: Wara dan il-qlib fid-dożi, 91 pazjent tal-istudju (età medja: 64.1 snin; 75 % pazjenti rġiel) kienu rrandomizzati biex jirċievu Numient segwit minn LCE qabel l-istudju jew viċi-versa.
English: Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating, and dopamine dysregulation syndrome can occur in patients treated with dopamine agonists and/or other dopaminergic treatments containing levodopa.
Maltese: Pazjenti u dawk li jieħdu ħsiebhom għandhom ikunu jafu li s-sintomi ta' mġiba ta' disturbi fil-kontroll tal-impuls jinkludu logħob tal-ażżard patoloġiku, żieda fil-libido, ipersesswalità, infieq jew xiri kompulsiv, li tiekol aktar milli suppost jew li tiekol b'mod kompulsiv, u sintomu ta' disregulazzjoni tad-dopamine jista' jseħħ f'pazjenti kkurati b'agonisti tad-dopamine u/jew trattamenti dopaminerġiċi oħrajn li fihom levodopa.
English: Serious events of gastrointestinal haemorrhage (uncommon) and of allergic oedema (uncommon) were reported in the clinical studies with Numient.
Maltese: Avvenimenti serji ta' emorraġija gastro-intestinali (mhux komuni) jew ta' edema allerġika (mhux komuni) kienu rrappurtati fl-istudji kliniċi b'Numient.
English: Numient 145 mg/36.25 mg modified-release hard capsules EU/1/15/1044/004 (25 modified-release hard capsules) EU/1/15/1044/005 (100 modified-release hard capsules) EU/1/15/1044/006 (240 modified-release hard capsules)
Maltese: Numient 145 mg/36.25 mg kapsuli ibsin li jerħu mediċina b'mod modifikat EU/1/15/1044/004
English: Therefore, patients must be monitored carefully when the dose of levodopa/carbidopa is reduced abruptly or discontinued, especially if the patient is receiving antipsychotics (see section 4.2).
Maltese: Għalhekk, il-pazjenti għandhom ikunu monitorjati b'attenzjoni meta d-doża ta' levodopa/carbidopa hija mnaqqsa f'daqqa jew imwaqqfa, speċjalment jekk il-pazjent ikun qed jirċievi antipsikotiċi (ara sezzjoni 4.2).
English: EU/1/15/1044/004 (25 modified-release hard capsules) EU/1/15/1044/005 (100 modified-release hard capsules) EU/1/15/1044/006 (240 modified-release hard capsules)
Maltese: (25 kapsuli ibsin li jerħu mediċina b'mod modifikat) EU/1/15/1044/005 (100 kapsuli ibsin li jerħu mediċina b'mod modifikat) EU/1/15/1044/006 (240 kapsuli ibsin li jerħu mediċina b'mod modifikat)
English: Abbreviations: CGI-C: clinical global impression of change from baseline; CI: confidence interval; IR: immediate release; LCE: Levodopa/Carbidopa/Entacapone; L-dopa†: Levodopa/Carbidopa; LS: least squares; PD: Parkinson's disease; SD: standard deviation; N/A: not available; hrs: hours; yrs: years.
Maltese: Ebda effetti ma dehru fuq l-organi riproduttivi tal-irġiel u tan-nisa fi studji tossikoloġiċi b'doża ripetuta fil-ġrieden, firien jew xadini b'levodopa waħdu, jew flimkien ma' carbidopa.
English: When converting patients from levodopa/DDC inhibitor medicinal products to Numient, the dose should be adjusted to maintain sufficient symptomatic control.
Maltese: Meta l-pazjenti huma mneħħija minn prodotti mediċinali ta' levodopa/ta' inibitur DDC u poġġuti għal fuq Numient, id-doża għandha tiġi aġġustata sabiex iżomm kontroll simptomatiku suffiċjenti.
English: The ADVANCE-PD study was a 22-week study consisting of a 3-week dose adjustment of pre-study immediate release levodopa/carbidopa treatment prior to a 6-week conversion to Numient.
Maltese: L-istudju ADVANCE-PD kien studju ta' 22 ġimgħa li jikkonsisti minn aġġustament fid-doża ta' 3 ġimgħat tal-kura b'levodopa/carbidopa li jerħiu l-mediċina b'mod immedjat qabel il-qlib ta' 6 ġimgħat għal Numient.
English: In the pharmacokinetic studies conducted in patients following a single dose of Numient, systemic exposure to levodopa generally increased with increasing age with AUC values being, on average, approximately 15% higher in elderly (≥65 years) than younger subjects (<65 years).
Maltese: Fl-istudji farmakokinetiċi li saru fuq pazjenti wara doża waħda ta'Numient, esponiment sistematiku għal levodopa ġeneralment żdiedu biż-żieda fl-età bil-valuri AUC ikunu, bħala medja, madwar 15 % ogħla fl-anzjani (≥ 65 sena) milli f'individwi żgħar (< 65 sena).
English: Sporadic cases of a symptom complex resembling NMS have been reported in association with dose reductions or withdrawal of levodopa/carbidopa medicinal products.
Maltese: Każi rari ta' sintomu kumpless li tixbaħ sindromu newroleptikuu malinn (SNM) ġew assoċjati ma' tnaqqis fid-doża u l-irtirar ta' prodotti mediċinali li fihom levodopa/carbidopa.
English: Concomitant use of antipsychotics should be monitored carefully for worsening of Parkinson's motor symptoms especially when D2-receptor antagonists are used (see section
Maltese: Użu konkomitanti tal-antipsikotiċi għandhom ikunu sorveljati bir-reqqa għall-aggravar tas-sintomi tal-moviment tal-Parkinsons speċjalment meta l-antagonisti tar-riċettur D2 huma użati (ara sezzjoni 4.5).
English: The full EPAR for Komboglyze 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: Saxagliptin is a dipeptidyl peptidase 4 (DPP4) inhibitor.
Maltese: Is-saxagliptin hija inibitur tad-dipeptidil peptidażi 4 (DPP4).
English: EPAR summary for the public saxagliptin / metformin
Maltese: Sommarju tal-EPAR għall-pubbliku saxagliptin / metformina
English: Komboglyze is available as tablets (2.5 mg/850 mg and 2.5 mg/1,000 mg) and can only be obtained with a prescription.
Maltese: Komboglyze jiġi bħala pilloli (2.5 mg/850 mg u 2.5 mg/ 1,000 mg) u jista' jinkiseb biss b' riċetta ta' tabib.
English: Other information about Komboglyze
Maltese: Informazzjoni oħra dwar Komboglyze
English: This is a summary of the European public assessment report (EPAR) for Komboglyze.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Komboglyze.
English: Komboglyze contains the active substances saxagliptin and metformin.
Maltese: Komboglyze fih is-sustanzi attivi saxagliptin u metformina.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Komboglyze on 24 November 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Komboglyze fl-24 ta' Novembru 2011.
English: The most common side effects seen with saxagliptin used together with metformin (seen in between 1 and 10 patients in 100) are upper respiratory infection (nose and throat infection), urinary tract infection (infection of the structures that carry urine such as the bladder), gastroenteritis (diarrhoea and vomiting), sinusitis (inflammation of the sinuses), nasopharyngitis (inflammation of the nose and throat), headache and vomiting.
Maltese: L-effetti sekondarji l-aktar komuni bis-saxagliptin flimkien mal-metformina (li dehru f' bejn 1 u 10 pazjenti minn kull 100) huma infezzjoni fil-parti ta' fuq tal-apparat respiratorju (infezzjoni tal-imnieħer u tal-griżmejn), infezzjoni fl-apparat tal-awrina (infezzjoni tal-istrutturi li jġorru l-awrina bħall-bużżieqa talawrina), gastroenterite (dijarea u rimettar), sinusite (infjammazzjoni tas-sinus), nażofarinġite (infjammazzjoni tal-imnieħer u tal-griżmejn), uġigħ ta' ras u rimettar.
English: Why has Komboglyze been approved?
Maltese: Għaliex ġie approvat Komboglyze?
English: Saxagliptin has been authorised in the EU as Onglyza since 2009.
Maltese: Is-saxagliptin ilu awtorizzat fl-UE bħala Onglyza sa mill-2009.