FrancophonIA/ELRC3.0 huggingface dataset:
English: The drug substance and the drug product have been appropriately described and generally satisfactory documentation has been provided.
Maltese: Is-sustanza mediċinali u l-prodott mediċinali ġew deskritti b'mod xieraq u ġeneralment ġiet ipprovduta dokumentazzjoni sodisfaċenti.
English: Topiramate resulted in no change in plasma concentrations of lamotrigine.
Maltese: Topiramate ma rriżulta f'ebda bidla fil-konċentrazzjonijiet ta' plasma ta' lamotrigine.
English: 12.5 mg/day (given as 25 mg on alternate days)
Maltese: 12.5 mg/kuljum (mogħtija f'25 mg darba iva u darba le)
English: 10 dispersible/chewable tablets 14 dispersible/chewable tablets 28 dispersible/chewable tablets 30 dispersible/chewable tablets 50 dispersible/chewable tablets 56 dispersible/chewable tablets
Maltese: 10 pilloli li jixterdu/jiġu mimgħuda li jixterdu 14 pilloli li jixterdu/jiġu mimgħuda li jixterdu 28 pilloli li jixterdu/jiġu mimgħuda li jixterdu 30 pilloli li jixterdu/jiġu mimgħuda li jixterdu 50 pilloli li jixterdu/jiġu mimgħuda
English: Week 2 Week 3 onwards *
Maltese: Ġimgħa 2 Ġimgħa 3 'l quddiem *
English: 400 mg/day 300 mg/day 200 mg/day
Maltese: 400 mg/kuljum 200 mg/kul jum
English: Adjunctive therapy WITH valproate (inhibitor of lamotrigine glucuronidation - see section 4.5): This dosage regimen should be used with valproate regardless of any other concomitant medicinal products
Maltese: B' valproate (impeditur ta' glukuronidazzjoni ta' lamotrigine -ara sezzjoni 4.5): Dan il-metodu ta' dożaġġ għandu jintuża ma' valproate ikunu x'ikunu lprodotti mediċinali li jittieħdu fl-istess ħin.
English: Withdrawal of medicinal products that do NOT significantly inhibit or induce lamotrigine glucuronidation (see section 4.5):
Maltese: Meta jitwaqqfu prodotti mediċinali li MHUMIEX impedituri jew indutturi sostanzjali ta' glukuronidazzjoni ta' lamotrigine (ara sezzjoni 4.5):
English: 50 mg/day (once a day)
Maltese: 50 mg/kuljum (darba kuljum)
English: Packs of 10, 14, 28, 30, 50 or 56 dispersible/chewable tablets.
Maltese: Pakketti ta' 10, 14, 28, 30, 50 jew 56 pilloli li jixterdu/jiġu mimgħuda.
English: Pale, yellowish-brown, multifaceted, super-elliptical tablet, marked “GSEC7” on one side and “25” on the other.
Maltese: Ta' kulur isfar-kannella mitfi, b'numru ta' faċċati, super-ellittiċi, immarkati “GSEC7” fuq naħa u “25” fuq loħra
English: Epidemiological studies involving in total approximately 2000 women exposed to lamotrigine monotherapy during pregnancy cannot exclude an increased risk for congenital malformations.
Maltese: Studji epidemjoloġi li kienu jinvolvu madwar 2000 mara li kienu fuq monoterapija b'lamotrigine waqt ittqala ma jeskludux riskju akbar ta' malformazzjonijiet konġenitali.
English: For AEDs where no such data are available, a similar association with suicide-related events cannot be excluded.
Maltese: F'AED fejn ma kienx hemm din id-dat disponibbli, ma tistax tiġi eskluża assoċjazzjoni simili ma' eventi relatati ma' suwiċidju.
English: Pale, yellowish-brown, multifaceted, super-elliptical tablet, marked “GSEE5” on one side and “100” on the other.
Maltese: Ta' kulur isfar-kannella mitfi, b'numru ta' faċċati, super-ellittiċi, immarkati “GSEE5” fuq naħa u “100” fuq l-oħra
English: In another study, single oral doses of 600 mg carbamazepine significantly impaired fine visual motor co-ordination and eye movements, while increasing both body sway and heart rate, whereas results with lamotrigine at doses of 150 mg and 300 mg did not differ from placebo.
Maltese: Fi studju ieħor, dożi orali waħedhom ta' 600 mg carbamazepine ikkawżaw indeboliment sinifikanti filkoordinament tal-mutur viżwali u l-movimenti ta' l-għajnejn, waqt li żiedu kemm it-tbandil tal-ġisem u kemm it-taħbit tal-qalb, filwaqt li riżultati b'dożi ta' 150 mg u 300 mg lamotrigine ma wrewx differenza minn plaċebo.
English: tiredness.
Maltese: Awstrija
English: Adjunctive therapy WITHOUT valproate and WITH inducers of lamotrigine glucuronidation (see section 4.5):
Maltese: MINGĦAJR valproate u B'indutturi ta' glukuronidazzjoni ta' lamotrigine (ara sezzjoni 4.5):
English: Approximately half of these cases have been reported as Stevens-Johnson syndrome (1 in 1000).
Maltese: Madwar nofs dawn il-każi ġew rappurtati bħala sindrome Stevens-Johnson (1 minn kull 1000).
English: Medicines to treat depression and other mental health problems increase the risk of suicidal thoughts and behaviour in children and adolescents aged under 18 years.
Maltese: Mediċini għad-depressjoni u għal mard ieħor mentali iżidu r-riskju ta' ħsibijiet u mġiba ta' suwiċidju fit-tfal u adolexxenti taħt it-18-il sena.
English: • a severe skin reaction, starting with a painful red area, developing into large blisters then peeling of layers of skin (toxic epidermal necrolysis)
Maltese: • reazzjoni qawwija fil-ġilda, li tibda bi ħmura w uġigħ f'xi partijiet, u li tiżviluppa f'nuffati kbar u mbagħad qxur li jaqgħu mill-ġilda (nekroliżi tossika tal-ġilda)
English: Discontinuation of Lamictal in patients with bipolar disorder In clinical trials, there was no increase in the incidence, severity or type of adverse reactions following abrupt termination of lamotrigine versus placebo.
Maltese: Fi provi kliniċi, ma kien hemm ebda żjieda fl-inċidenza, severita' jew tipi ta' reazzjonijiet avversi wara ttwaqqif f'salt ta' lamotrigine kontra plaċebo.
English: The efficacy and safety of adjunctive therapy in partial seizures in patients aged 1 to 24 months has been evaluated in a small double-blind placebo-controlled withdrawal study.
Maltese: L-effikaċja u sigurta' ta' terapija aġġuntiva f'aċċessjonijiet parzjali f'pazjenti ta' eta' minn 1 sa 24 xahar ġiet evalwata fi studju żgħir, double-blind, ikkontrollat bi plaċebo, irtirat.
English: 100 mg/day Maintain this dose (100 mg/day)
Maltese: Żomm din id-doża (100 mg/kuljum)
English: They are marked ‘GS CL2' on one side; and ‘5' on the other.
Maltese: Huma mmarkati ‘GS CL2' fuq naħa waħda; u ‘5' fuq in-naħa l-oħra.
English: - Clinical aspects
Maltese: - Aspetti kliniċi
English: There are reports in the literature that severe convulsive seizures including status epilepticus may lead to rhabdomyolysis, multiorgan dysfunction and disseminated intravascular coagulation, sometimes with fatal outcome.
Maltese: Fil-letteratura jeżistu rapporti li jgħidu li attakki qawwija konvulsivi inkluż l-istatus epilepticus jistgħu iwasslu għal rabdomilosi, disfunzjoni multiorganika u tixrid ta' koagulazzjoni tad-demm fil-vini, xi drabi b'konsegwenzi fatali.
English: 1 − 10 mg/kg/day (once a day or two divided doses)
Maltese: 1 - 10 mg/kg/kuljum (darba kuljum jew żewġ dożi maqsuma)
English: Some patients may experience severe seizures, which may cause serious health problems.
Maltese: Xi pazjenti jista' jkollhom aċċessjonijiet qawwija, li jistgħu jikkaġunaw problemi serji ta' saħħa.
English: Each pack contains blisters of 14, 21, 30, 42, 50, 56 or 100 tablets.
Maltese: Kull pakkett fih strxxi ta' 14, 21, 30, 42, 50, 56 jew 100 pilloli.
English: pain, back pain.
Maltese: dardir, remettar.
English: Each pack contains blisters of 10, 30, 50, 56, 60, 90, 100 or 200 tablets.
Maltese: Kull pakkett fih strixxi ta' 10, 30, 50, 56, 60, 90, 100 jew 200 pilloli.
English: • Swallow your tablets whole.
Maltese: • Ibla' l-pilloli sħaħ.
English: During monotherapy clinical trials: Uncommon:
Maltese: Matul esperjenza oħra klinika:
English: Starter pack 21 dispersible/chewable tablets, valproate add-on therapy Starter pack 42 dispersible/chewable tablets, monotherapy
Maltese: Pakkett tal-bidu 21 pillola li jixterdu/jiġu mimgħuda valproate terapija add-on Pakkett tal-bidu 42 pillola li jixterdu/jiġu mimgħuda valproate terapija add-on
English: • feeling dizzy
Maltese: • ħalq xott
English: White to off-white multi-faceted, super-elliptical, tablet with a blackcurrant odour, marked “GSCL5” on one side “25” on the other.
Maltese: Pillola bajda jew tagħti fl-abjad, b'numru ta' faċċati, super-ellittika,u b'riħa ta' ribes, immarkata “GSCL5” fuq naħa u “25” fuq l-oħra.
English: Therapy with multiple AEDs is associated with a higher risk of congenital malformations than monotherapy and therefore monotherapy should be used whenever possible.
Maltese: Terapija b'numru ta' AEDs hi assoċjata ma' riskju akbar ta' malformazzjonijiet konġenitali minn monoterapija u għalhekk meta possibbli għandha tintuża monoterapija.
English: Lamotrigine reduced foetal folic acid levels in rats.
Maltese: Sa ċertu punt lamotrigine jinduċi l-metaboliżmu tiegħu stess u dan jiddependi mid-doża.
English: 25 mg tablets:
Maltese: Pilloli ta' 25 mg:
English: If you are taking Lamictal for epilepsy
Maltese: Prekawzjonijiet konnessi ma' l-epilessija
English: 200 mg tablets:
Maltese: Pilloli ta' 200 mg :
English: arthralgia.
Maltese: dijareja
English: Pale, yellowish-brown, multifaceted, super-elliptical tablet, marked “GSEE1” on one side and “50” on the other.
Maltese: Ta' kulur isfar-kannella mitfi, b'numru ta' faċċati, super-ellittiċi, immarkati “GSEE1” fuq naħa u “50” fuq loħra
English: • olanzapine, used to treat mental health problems
Maltese: • olanzapine, li jintuża fil-kura ta' problemi ta' saħħa mentali
English: White to off-white multi-faceted, super-elliptical, tablet with a blackcurrant odour, marked “GSCX7” on one side and “50” on the other.
Maltese: Pillola bajda jew tagħti fl-abjad, b'numru ta' faċċati, super-ellittika u b'riħa ta' ribes, immarkata “GSCX7” fuq naħa u “50” fuq l-oħra.
English: 1 − 5 mg/kg/day (once a day or two divided doses)
Maltese: 1 − 5 mg/kg/kuljum (darba kuljum jew żewġ dożi maqsuma)
English: The pharmacokinetics of lamotrigine in this age group do not differ significantly from a non-elderly adult population (see section 5.2).
Maltese: Il-farmakokinetiċi ta' lamotrigine f'dan il-grupp mhumiex wisq differenti minn dawk ta' popolazzjoni adulta mhux tant anzjana (ara sezzjoni
English: Clearance of lamotrigine is primarily metabolic with subsequent elimination of glucuronide-conjugated material in urine.
Maltese: It-tneħħija ta' lamotrigine hi primarjament metabolika bl-eliminazzjoni sussegwenti ta' materjal konjugat bi glukuronid flawrina.
English: * Other oral contraceptive and HRT treatments have not been studied, though they may similarly affect lamotrigine pharmacokinetic parameters (see sections 4.2 and 4.4).
Maltese: *Trattamenti orali oħra kontraċettivi jew HRT ma ġewx studjati, għalkemm dawn jistgħu bl-istess mod jaffettwaw il-parametri tal-farmakokinetiċi ta' lamotrigine (ara sezzjonijiet 4.2 u 4.4).
English: There is a suggestion in the data that responses in combination with enzyme inducers is less than in combination with non-enzyme inducing antiepileptic agents.
Maltese: Hemm ħjiel fid-data li risponsi meta użat flimkien ma' enzyme inducers huwa anqas minn meta jintuża flimkien ma' aġenti anti-epileptiċi li ma humiex enzyme inducers.
English: “After epileptic control has been achieved during adjunctive therapy, concomitant antiepileptic drugs (AEDs) may be withdrawn and patients continued on {Tradename} monotherapy”.
Maltese: "Wara li jkun intlaħaq kontroll epilettiku waqt it-terapija aġġuntiva, mediċini antiepilettiċi konkomitanti (AEDs) ikunu jistgħu jiġu rtirati u l-pazjenti jitkomplew fuq monoterapija bi {Isem kummerċjali}".
English: 150 mg/day
Maltese: 150 mg/kulju m
English: • lithium, used to treat mental health problems
Maltese: • litju, li jintuża fil-kura ta' problemi ta' saħħa mentali
English: It inhibits sustained repetitive firing of neurones and inhibits release of glutamate (the neurotransmitter which plays a key role in the generation of epileptic seizures).
Maltese: Hu jinibixxi l-isparar repetitiv ta' newroni u jimpedixxi l-ħruġ ta' glutamat (in-newrotrasmettitur li għandu parti importanti ħafna fil-ġenerazzjoni ta' attakki epilettiċi).
English: • a combination of lopinavir and ritonavir, used to treat Human Immunodeficiency Virus
Maltese: • taħlita ta' lopinavir u ritonavir, li tintuża fil-kura ta' l-infezzjoni mill-Virus ta' l
English: Medicinal products that do not significantly inhibit or induce glucuronidation of lamotrigine
Maltese: Prodotti mediċinali li mhumiex impedituri jew indutturi sinifikanti talglukuronidazzjoni ta' lamotrigine
English: Each pack contains blisters of 14, 30, 42, 56, 90 or 100 tablets.
Maltese: Kull pakkett fih strxxi ta' 14, 30, 42, 56, 90 jew 100 pilloli.
English: The CHMP, taking into consideration the assessment of the studies and the recommendation of the SAG concluded that lamotrigine should be used for the prevention of depressive episode in patients with Bipolar I disorder who experience predominantly depressive episodes.
Maltese: Is-CHMP, wara li kkunsidra l-valutazzjoni ta' l-istudji u r-rakkomandazzjonijiet ta' l-SAG u kkonkluda li lamotriġina għandu jintuża għall-prevenzjoni ta' episodji depressivi f'pazjenti li jbatu minn disturb bipolari tat-tip I li jkunu jesperjenzaw primarjament episodji depressivi.
English: These data indicate that lamotrigine does not influence the pharmacokinetics of levetiracetam and that levetiracetam does not influence the pharmacokinetics of lamotrigine.
Maltese: Dan id-dożaġġ għandu jintuża ma' prodotti mediċinali oħra li mhumiex impedituri jew indutturi ta' glukuronidazzjoni ta' lamotrigine
English: Lamotrigine caused a dose-related inhibition of the hERG channel tail current in human embryonic kidney cells.
Maltese: Lamotrigine ikkawża inibizzjoni relatata mad-dożi ta' l-hERG channel tail current fiċ-ċelluli embrijoniċi tal-kliewi fil-bniedem.
English: Lamictal and associated names (see Annex I) 200 mg tablets.
Maltese: Lamictal u ismijiet assoċjati (ara Anness I), pilloli ta' 200 mg (Ara Anness I - Biex timtela mill-pajjiż partikolari) Lamotrigine
English: In juvenile rats, an effect on learning in the Biel maze test, a slight delay in balanopreputial separation and vaginal patency and a decreased postnatal body weight gain in F1 animals were observed at exposures approximately two-times higher than the therapeutic exposures in human adults.
Maltese: Il-bilanċ bejn il-benefiċċji u r-riskji ta' trattament aġġuntiv tal-kriżijiet parzjali u ġeneralizzati fl-adulti u ladolexxenti minn 13-il sena 'l fuq, kien konfermat bħala wieħed pożittiv.
English: Each pack contains blisters of 30, 56 or 100 tablets.
Maltese: Kull pakkett fih strixxi ta' 30, 56 jew 100 pilloli.
English: The safety profile of lamotrigine in children aged 1 month to 2 years was similar to that in older children except that clinically significant worsening of seizures (>=50%) was reported more often in children under 2 years of age (26%) as compared to older children (14%).
Maltese: Il-profil ta' sigurta' ta' lamotrigine fit-tfal minn xahar sa sentejn kienet simili għal dak fi tfal akbar barra li żvilupp klinikament sinifikanti għall-agħar ta' aċċessjonijiet (>=50%) kienet rappurtata aktar spiss fi tfal taħt is-sentejn (26%) meta mqabbla ma' tfal akbar (14%).
English: It is recommended that from the time that the hormonal contraceptive is started, the lamotrigine dose is increased by 50 to 100 mg/day every week, according to the individual clinical response.
Maltese: Hu rakkomandat li malli tinbeda l-kontraċezzjoni ormonali, id-doża ta' lamotrigine tiżdied b'50 jew 100 mg/kuljum kull ġimgħa, skond ir-riżultati kliniċi ta' l-individwu.
English: The predicted serum concentration levels in children of 2 to 26 months were in general in the same range as those in older children, though higher Cmax levels are likely to be observed in some children with a body weight below 10 kg.
Maltese: Il-livelli ta' konċentrazzjoni fis-serum previsti fi tfal ta' bejn 2 u 26 xahar kienu in ġenerali fl-istess skala ta' dawk fi tfal akbar, għalkemm livelli ta' Cmax aktar għolja huma aktar possibli li jkunu osservati f'xi tfal b'piż tal-ġisem ta' anqas minn 10kg.
English: Monotherapy with lamotrigine OR adjunctive therapy WITHOUT valproate and WITHOUT inducers of lamotrigine glucuronidation (see section 4.5):
Maltese: Żjieda ta' prodotti mediċinali li MHUMIEX impedituri jew indutturi sostanzjali ta' glukuronidazzjoni ta' lamotrigine (ara sezzjoni 4.5):
English: Therefore in patients receiving concomitant therapy with oxcarbazepine, the treatment regimen for lamotrigine adjunctive therapy without valproate and without inducers of lamotrigine glucuronidation should be used (see section 4.2).
Maltese: Għalhekk f'pazjenti li jirċievu kura flimkien ma' oxycarbazepine, għandha tintuża is-sistema ta' kura għal terapija aġġuntiva b'lamotrigine ,mingħajr valproate u mingħajr inducers ta' glukorinidzzjoni ta' lamotrigine (ara s-sezzjoni 4.2).
English: General disorders and administration site conditions During bipolar disorder clinical trials: Common:
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Waqt provi kliniċi dwar mard bi-polari:
English: Multiple oral doses of bupropion had no statistically significant effects on the single dose pharmacokinetics of lamotrigine in 12 subjects and had only a slight increase in the AUC of lamotrigine glucuronide.
Maltese: L-għoti ta' ħafna dożi ta' bupropion ma' kellu ebda effett sinifikanti ta' statistika fuq il-farmakokinetiċi ta' doża waħda ta' lamotrigine fi 12-il persuna u wera biss żjieda żgħira fl-AUC tal-glukuronid ta' lamotrigine.
English: Other information about Tredaptive:
Maltese: Informazzjoni oħra dwar Tredaptive:
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) TREDAPTIVE EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) TREDAPTIVE Sommarju ta' l-EPAR għall-pubbliku
English: The second study showed that the LDL cholesterol levels were further reduced when Tredaptive was taken with simvastatin (48% reduction), compared with Tredaptive alone (17% reduction) or simvastatin alone (37% reduction).
Maltese: It-tieni studju wera li l-livelli ta' kolesterol LDL tnaqqsu iktar meta Tredaptive ittieħed flimkien ma' simvastatin (tnaqqis ta' 48%), milli meta Tredaptive ittieħed waħdu (tnaqqis ta' 17%) jew ma' simvastatin waħdu (tnaqqis ta' 37%).
English: What is the risk associated with Tredaptive?
Maltese: X'inhu r-riskju assoċjat ma' Tredaptive?
English: The second study compared the combination of Tredaptive and simvastatin (a statin) with Tredaptive alone or simvastatin alone in 1,398 patients.
Maltese: It-tieni studju qabbel il-kombinazzjoni ta' Tredaptive u simvastatin (statin) ma' Tredaptive waħdu jew simvastatin waħdu f'1,398 pazjent.
English: The first study compared the effectiveness of Tredaptive with that of nicotinic acid alone or placebo (a dummy treatment) in reducing the levels of LDL cholesterol in a total of 1,613 patients.
Maltese: Lewwel studju qabbel l-effikaċja ta' Tredaptive ma' dik ta' l-aċidu nikotiniku waħdu jew plaċebo (trattament finta) fit-tnaqqis tal-livelli ta' kolesterol LDL f'total ta' 1,613-il pazjent.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tredaptive to Merck Sharp & Dohme Ltd. on 3 July 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq madwar l-Unjoni Ewropea, għal Tredaptive lil Merck Sharp & Dohme Ltd. fl-3 ta' Lulju 2008.
English: The two active substances in Tredaptive, nicotinic acid and laropiprant, have different modes of action.
Maltese: Iż-żewġ sustanzi attivi fi Tredaptive, l-aċidu nikotiniku u laropiprant, għandhom modi differenti ta' azzjoni.
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk tixtieq aktar informazzjoni abbażi tar-rakkomandazzjonijiet ta' CHMP, aqra dDiskussjoni Xjentifika (ukoll parti mill-EPAR).
English: In the first study, LDL cholesterol levels were reduced by 19% in patients taking Tredaptive, compared with 1% in those taking placebo.
Maltese: Fl-ewwel studju, il-livelli ta' kolesterol LDL tnaqqsu b'19% fil-pazjenti li kienu qed jieħdu Tredaptive, meta mqabbla ma' 1% f'dawk li kienu qed jieħdu plaċebo.
English: Patients with combined mixed dyslipidaemia have high blood levels of ‘bad' LDL cholesterol and triglycerides (a type of fat), and low levels of ‘good' HDL cholesterol.
Maltese: Il-pazjenti b'dislipidemija mħallta kombinata jkollhom livelli għoljin ta' kolesterol LDL ‘ħażin' u ta' trigliċeridi (tip ta' xaħam), u livelli baxxi ta' kolesterol HDL ‘tajjeb' fiddemm.
English: Tredaptive is a medicine containing two active substances: nicotinic acid (also known as niacin or vitamin B3) and laropiprant.
Maltese: Tredaptive huwa mediċina li fiha żewġ sustanzi attivi: l-aċidu nikotiniku (magħruf ukoll bħala niacin jew vitamina
English: What is Tredaptive?
Maltese: X'inhu Tredaptive?
English: They included a total of 2,349 patients who were taking either Tredaptive or nicotinic acid.
Maltese: F'dawn b'kollox ħadu sehem 2,349 pazjent li kienu qegħdin jieħdu Tredaptive jew aċidu nikotiniku.
English: Tredaptive is normally given together with a statin (the standard medicine used to reduce cholesterol) when the effectiveness of a statin taken alone is inadequate.
Maltese: Tredaptive normalment jingħata flimkien ma' statin (il-mediċina standard użata għat-tnaqqis talkolesterol) meta l-effikaċja ta' statin meħud waħdu ma jkunx adegwat.
English: Tredaptive was effective in reducing the blood levels of LDL cholesterol.
Maltese: Tredaptive kien effettiv fit-tnaqqis tal-livelli ta' kolesterol LDL fid-demm.
English: How has Tredaptive been studied?
Maltese: Kif ġie studjat Tredaptive?
English: Primary hypercholesterolaemia is when the levels of cholesterol in the blood are high.
Maltese: Primarju jfisser li l-livell għoli ta' kolesterol ma jkollux kawża identifikabbli.
English: Tredaptive is used in addition to diet and exercise in patients with dyslipidaemia (abnormally high levels of fat in the blood), particularly ‘combined mixed dyslipidaemia' and ‘primary hypercholesterolaemia'.
Maltese: Tredaptive jintuża flimkien mad-dieta u l-eżerċizzju f'pazjenti b'dislipidemija (livelli għoljin b'mod mhux normali ta' xaħam fid-demm), b'mod partikolari ‘dislipidemija mħallta kombinata' u ‘livell għoli primarju ta' kolesterol'.
English: What benefit has Tredaptive shown during the studies?
Maltese: Liema benefiċċju wera Tredaptive waqt l-istudji mwettqa?
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Tredaptive's benefits are greater than its risks for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia and in patients with primary hypercholesterolaemia.
Maltese: Il-Kumitat għal Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Tredaptive huma ikbar mir-riskji tiegħu għat-trattament tad-dislipidemija, b'mod partikolari f'pazjenti b'dislipidemija mħallta kombinata u f‘pazjenti b'livell għoli primarju ta' kolesterol fid-demm.
English: How is Tredaptive used?
Maltese: Għalxiex jintuża Tredaptive?
English: In the first and third studies, fewer patients taking Tredaptive reported moderate, severe or extreme flushing than patients taking nicotinic acid alone.
Maltese: Fl-ewwel u t-tielet studji, inqas pazjenti li kienu qegħdin jieħdu Tredaptive rrappurtaw ħmura fil-wiċċ moderata, severa jew estrema meta mqabbla ma' pazjenti li kienu qed jieħdu l-aċidu nikotiniku biss.
English: It should also not be used in patients who have problems with their liver, an active stomach ulcer or bleeding from an artery.
Maltese: Lanqas ma għandu jintuża f'pazjenti bi problemi fil-fwied, b'ulċera attiva fl-istonku jew bi fsada minn arterja.
English: The effects of Tredaptive were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Tredaptive għall-ewwel ġew ittestjati f'mudelli sperimentali qabel ma ġew studjati fuq ilbniedem.
English: Ranbaxy (Poland) Sp. Z. o. o. ul.
Maltese: Ranbaxy (Poland) Sp. Z. o. o.
English: MedDRA system organ class (SOC)
Maltese: Organi MedDRA (SOC)
English: - Allergic reactions.
Maltese: - Reazzjonijiet allergiċi.
English: Hyde Park, Hayes 3
Maltese: Hyde Park, Hayes 3 5th Floor
English: Ranbaxy Pharmacie Generiques 11-15, Quai de Dion Bouton 92800 Puteaux
Maltese: Ranbaxy Pharmacie Generiques 11-15, Quai de Dion Bouton
English: Atosiban SUN contains atosiban.
Maltese: Atosiban SUN fih atosiban.