FrancophonIA/ELRC3.0 huggingface dataset:
English: 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Maltese: .6 Prekawzjonijiet speċjali għar-rimi tal-prodotti mediċinali veterinarji mhux użata jew materjal ieħor għar-rimi li huwa derivat minn dawn il-prodotti
English: None
Maltese: Te
English: Cardboard box(es) with 1, 5 or 10 pre-filled syringes with needles.
Maltese: Kaxxa(i) tal- kartun b' 1, 5 jew 10 siringi tal-ħ[ie[ bil-labar, mimlija għall-lest.
English: Allow the vaccine to reach room temperature before use.
Maltese: }alli t-temperatura tal-vaċċin tilħaq t-temperatura tal-kamra qabel l-użu.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label.
Maltese: Tużax wara d-data ta l-iskadenza li hemm fuq it-tikketta.
English: The first revaccination is given not later than 17 months after the primary vaccination course.
Maltese: L-ewwel revaċċinazzjoni tingħata mhux aktar tard minn 17-il xahar wara l-ewwel kors vaċċinazzjoni.
English: The active substance being a principle of biological origin intended to produce active immunity is not in the scope of Regulation (EC) 470/2009.
Maltese: DIKJARAZZJONI TA' L-MRLs Peress li is-sustanza attiva hija fil-prinċipju ta' oriġni bijoloġika u maħsuba sabiex tipproduċi immunitaċ attiva m' hijiex fl-iskop tar-Regolazzjoni (EC)470/2009
English: Not all pack sizes may be marketed.
Maltese: Mhux id-daqsijiet kollha tal-pakketti jistgħu qegħdin fis-suq.
English: MA (EU) number (Invented) name Strength Pharmaceutical form Route of administration
Maltese: Numru ta' l-EU Isem (ivvintat) Qawwa Għamla farmaċewtika
English: Alcohol should be avoided.
Maltese: Alkoħol għandu jiġi evitat.
English: • The active substance is aripiprazole.
Maltese: • Is-sustanza attiva hi aripiprazole.
English: 14 tablets 28 tablets 56 tablets 98 tablets 28 x 1 tablets
Maltese: 14 pilloli 28 pilloli 56 pilloli 98 pilloli 28 × 1 pilloli
English: Sodium content
Maltese: Kontenut Sodium
English: Valproate and lithium
Maltese: Valproate u lithium
English: Aripiprazole undergoes minimal pre-systemic metabolism.
Maltese: Aripiprazole ikollu metaboliżmu pre-sistematiku minimu.
English: Serotonin syndrome
Maltese: Sindromu ta' serotonin
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Tablet core
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti
English: • diabetes mellitus,
Maltese: • dijabete mellitus,
English: Mylan S.A.S, 117, Allée des Parcs, 69800 Saint-Priest, France
Maltese: Mylan S.A.S, 117, Allée des Parcs, 69800
English: Quinidine and other CYP2D6 inhibitors
Maltese: Quinidine u impedituri oħra ta' CYP2D6
English: • depression,
Maltese: • depressjoni,
English: • loss of appetite (anorexia),
Maltese: • telf ta' aptit (anoreksja),
English: • nervousness,
Maltese: • nervożità,
English: The absolute oral bioavailability of the tablet formulation is 87 %.
Maltese: Ilbijodisponibbilità orali assoluta tal-formolazzjoni tal-pillola hija ta' 87%.
English: • involuntary loss of urine (incontinence),
Maltese: • telf involontarju ta' awrina (inkontinenza),
English: • SSRI s (such as paroxetine and fluoxetine) used for depression, OCD, panic and anxiety
Maltese: • SSRIs (bħal paroxetine u fluoxetine) użati għal depressjoni, OCD, paniku u ansjetà
English: Pharmathen International S.A., Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Greece or
Maltese: Pharmathen International S.A Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Greece
English: Lipid parameters
Maltese: Parametri tal-lipidi
English: Each tablet of 5, 10, 15, 30 mg containing 5, 10, 15, 30 mg of aripiprazole respectively.
Maltese: Kull pillola ta' 5, 10, 15, 30 mg fihom 5, 10, 15, 30 mg ta' aripiprazole rispettivament.
English: Carbamazepine and other CYP3A4 inducers
Maltese: Carbamazepine u sensibilizzaturi ta' CYP3A4
English: • double vision,
Maltese: • vista doppja,
English: Neuroleptic Malignant Syndrome (NMS)
Maltese: Sindromu Newrolettiku malinn (NMS)
English: • anticonvulsants used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital)
Maltese: • antikonvulsanti użati biex jittrattaw l-epilessija (bħal carbamazepine, phenytoin, phenobarbital)
English: • feeling aggressive,
Maltese: • tħossok aggressiv,
English: • abdominal discomfort,
Maltese: • skonfort addominali,
English: The AUC and Cmax of dehydro-aripiprazole, the active metabolite, decreased by 32 % and 47 %, respectively.
Maltese: L-AUC u Cmax ta' dehydro-aripiprazole, is-sustanza metabolika attiva, tnaqqsu bejn 32% u 47%.
English: The following adverse reactions had a possible dose response relationship; extrapyramidal disorder (incidences were 10 mg, 9.1 %, 30 mg, 28.8 %, placebo, 1.7 %,); and akathisia (incidences were 10 mg, 12.1 %, 30 mg, 20.3 %, placebo, 1.7 %).
Maltese: Dawn ir-reazzjonijiet avversi kellhom relazzjoni possibbli mar-rispons tad-doża; disturb ekstrapiramidali (l-inċidenzi kienu 10 mg, 9.1%, 30 mg, 28.8%, plaċebo, 1.7%); u akatisija (l-inċidenzi kienu 10 mg, 12.1%, 30 mg, 20.
English: The point estimate of the hazard ratio (HR) was 0.461 (95% confidence interval, 0.242-0.879) in the full population.
Maltese: Il-punt ta' stima tal-proporzjon ta' periklu (HR - hazard ratio) kien globalment (individwi kollha) 0.461 (95% tal-intervall ta' kunfidenza, 0.242 - 0.879) fil-popolazzjoni sħiħa.
English: • antifungal medicines (such as ketoconazole, itraconazole)
Maltese: • mediċini ta' kontra l-moffa (bħal ketoconazole, itraconazole)
English: In three placebo-controlled trials (n = 938; mean age: 82.4 years; range: 56-99 years) of aripiprazole in elderly patients with psychosis associated with Alzheimer's disease, patients treated with aripiprazole were at increased risk of death compared to placebo.
Maltese: Fi tliet provi kontrollati minn plaċebo (n = 938; età medja: 82.4 snin; medda: 56 - 99 sena) ta' aripiprazole f'pazjenti anzjani bil-psikosi assoċjat mal-marda Alzheimer, pazjenti kkurati b'aripiprazole kellhom riskju ogħla ta' mewt imqabbla mal-plaċebo.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 30 June 2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 30 Ġunju 2015
English: In the same trials, cerebrovascular adverse reactions (e.g. stroke, transient ischaemic attack), including fatalities, were reported in patients (mean age: 84 years; range: 78-88 years).
Maltese: Fl-istess provi, kienu rrapurtati reazzjonijiet avversi ċerebrovaskulari (eż. puplesija, attakk għaddieni iskemiku), inklużi uħud fatali, f'pazjenti (età medja: 84 sena; medda: 78 - 88 sena).
English: • certain antibiotics used to treat tuberculosis (rifabutin, rifampicin)
Maltese: • ċerti antibijotiċi użati biex jittrattaw it-tuberkolosi (rifabutin, rifampicin)
English: Oesophageal dysmotility and aspiration have been associated with the use of antipsychotics, including aripiprazole.
Maltese: Dismotilità tal-esofagu u aspirazzjoni ġew assoċjati mal użu ta' antipsikotiċi, li jinkludi aripiprazole.
English: The AUC and Cmax of dehydroaripiprazole increased by 77 % and 43 %, respectively.
Maltese: L-AUC u Cmax ta' dehydro-aripiprazole żdiedu b' 77% u 43% rispettivament.
English: Ketoconazole and other CYP3A4 inhibitors
Maltese: Ketoconazole u impedituri oħra ta' CYP3A4
English: Croscarmellose Sodium Magnesium stearate
Maltese: Croscarmellose Sodium
English: Schizophrenia in adolescents
Maltese: Tfal u adolexxenti
English: • tricyclic's (such as clomipramine and amitriptyline) used for depressive illness
Maltese: • triċikliċi (bħal clomipramine u amitriptyline) użati għal mard depressiv
English: Consequently, the frequency of these adverse events is qualified as "not known”.
Maltese: Konsegwentement, il-frekwenza ta' dawn l-avvenimenti avversi huma kklassifikati bħala “mhux magħrufa”.
English: Leukopenia Neutropenia Thrombocytopenia
Maltese: Lewkopenija Newtropenija Tromboċitopenija
English: Four mood stabilizer subgroups were assessed in the randomised phase: aripiprazole + lithium; aripiprazole + valproate; placebo + lithium; placebo + valproate.
Maltese: Erba' sottogruppi ta' stabbilizzaturi tal-burdata kienu assessjati fil-fażi li fiha l-pazjenti ntagħażlu b'mod każwali: aripiprazole + lithium; aripiprazole + valproate, plaċebo + lithium; plaċebo + valproate.
English: Pregnancy, puerperium and perinatal conditions
Maltese: Tqala, puerperium u kundizzjonijiet perinatali
English: In clinical studies, 10-30 mg/day doses of aripiprazole had no significant effect on the metabolism of substrates of CYP2D6 (dextromethorphan/3-methoxymorphinan ratio), CYP2C9 (warfarin), CYP2C19 (omeprazole), and CYP3A4 (dextromethorphan).
Maltese: Fi studji kliniċi, dożi t'aripiprazole ta' 10 - 30 mg/jum ma kellhom l-ebda effett ta' importanza fuq ilmetaboliżmu tas-sustanzi li jaħdmu fuqhom is-CYP2D6 (dextromethorphan/3-methoxymorphinan ratio), CYP2C9 (warfarin), CYP2C19 (omeprazole), u CYP3A4
English: Depression, Hypersexuality
Maltese: Depressjoni Ipersesswalità
English: They are supplied in PA/Alu/PVC-Aluminium foil perforated blisters packed in cardboard box containing 14, 28, 56 or 98 tablets and 28 x 1 tablets (unit dose).
Maltese: Huma fornuti fi PA fojl / Alu / PVC-Aluminium folji mtaqqbin ppakkjati f'kaxxa tal-kartun li fiha 14, 28, 56 jew 98, 28 × 1 pillola.
English: • medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide)
Maltese: • mediċini li jikkoreġu r-ritmu tal-qalb (bħal quinidine, amiodarone, flecainide)
English: It has been proposed that aripiprazole's efficacy in schizophrenia and Bipolar I Disorder is mediated through a combination of partial agonism at dopamine D2 and serotonin 5-HT1A receptors and antagonism of serotonin 5-HT2A receptors.
Maltese: Ġie propost li l-effikaċja ta' aripiprazole fuq is-skiżofrenja u Disturb Bipolari I hija medjatur bejn taħlita ta' agoniżmu parzjali tar-reċetturi dopamina D2 u serotonina 5-HT1A, u antagoniżmu tarreċetturi serotonina 5-HT2A.
English: Aripiprazole Mylan Pharma 5 mg tablets Aripiprazole Mylan Pharma 10 mg tablets Aripiprazole Mylan Pharma 15 mg tablets Aripiprazole Mylan Pharma 30 mg tablets
Maltese: Aripiprazole Mylan Pharma 5 mg pilloli Aripiprazole Mylan Pharma 10 mg pilloli Aripiprazole Mylan Pharma 15 mg pilloli Aripiprazole Mylan Pharma 30 mg pilloli
English: Тел: +359 2 44 55 400
Maltese: Майлан ЕООД Тел: +359 2 44 55 400
English: Pharmacotherapeutic group: Psycholeptics, other antipsychotics, ATC code: N05AX12
Maltese: Psikolettiċi, antipsikotiċi oħrajn, Kodiċi ATC:
English: All ADRs are listed by system organ class and frequency; very common (≥ 1 /10), common (≥ 1/100 to< 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Maltese: L-ADRs kollha huma elenkati skont is-sistema tal-klassifika tal-organi u l-frekwenza: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Pancreatitis Dysphagia
Maltese: Pankreatite Disfaġija
English: Other extrapyramidal symptoms
Maltese: Disturbi extrapiramidali
English: Aripiprazole demonstrated statistically superior efficacy compared to placebo on the Aberrant Behaviour Checklist Irritability subscale.
Maltese: Aripiprazole wera effikaċja statistikament superjuri meta mqabbel mal-plaċebo fuq is-sottoskala tal-Irritabilità tal-Lista tal-Iċċekkjar tal-Imġiba Aberranti.
English: Crystalline Maltose
Maltese: Fih maltosju.
English: • muscle pain,
Maltese: • uġigħ fil-muskoli,
English: The potentially medically important signs and symptoms observed included lethargy, increased blood pressure, somnolence, tachycardia, nausea, vomiting and diarrhoea.
Maltese: Is-sinjali u sintomi osservati li possibbilment huma medikament importanti jinkludu letarġija, żieda fil-pressjoni tad-demm, ħedla ta' rqad, tatikardija, nawsja, remettar u dijarea.
English: In a 52-week, placebo-controlled trial, in patients with a current manic or mixed episode of Bipolar I Disorder who achieved sustained remission (Y-MRS and MADRS total scores ≤ 12) on aripiprazole (10 mg/day to 30 mg/day) adjunctive to lithium or valproate for 12 consecutive weeks, adjunctive aripiprazole demonstrated superiority over placebo with a 46 % decreased risk (hazard ratio of 0.54) in preventing bipolar recurrence and a 65 % decreased risk (hazard ratio of 0.35) in preventing recurrence into mania over adjunctive placebo but failed to demonstrate superiority over placebo in preventing recurrence into depression.
Maltese: Fi prova li damet sejra għal 52 ġimgħa, bil-plaċebo bħala kontroll, f'pazjenti li attwalment kellhom episodju manijaku jew episodju mħawwad ta' Disturb Bipolari I li kisbu waqfienfejqan sostnut (punteġġi totali ta' ≤ 12 għal Y-MRS u MADRS) b'aripiprazole (10 mg/kuljum sa 30 mg/kuljum) bħala mediċina addizzjonaliaġġuntiv mal-għal lithiumju jew valproate għal 12-il ġimgħa konsekuttiva, l-għoti ta' aripiprazole bħala mediċina addizzjonaliaġġuntiv wera superjorità fuq il-plaċebo b'riskju mnaqqas ta' 46% (proporzjon ta' periklu ta' 0.54) fil-prevenzjoni ta' sabiex ixejjen ir-rikorrenza bipolari u riskju mnaqqas ta' 65% (proporzjon ta' periklu ta' 0.35) fil-prevenzjoni ta'sabiex ixejjen rikorrenza għal rikorrenza ta' manija meta mqabbel mal-plaċebo li ngħata bħala mediċina addizzjonali, aġġuntiv imma naqas li juri superjorità fuq il-plaċebo fil-prevenzjoni ta' biex ixejjen ir-rikorrenza għal dipressjoni.
English: Aspiration pneumonia Laryngospasm Oropharyngeal spasm
Maltese: Pnewmonja ta' aspirazzjoni Laringospażmu Spażmu orofarinġeali
English: Cases of venous thromboembolism (VTE) have been reported with antipsychotic medicinal products.
Maltese: Każijiet ta' tromboemboliżmu venuż (VTE) kienu rrappurtati b'mediċini antipsikotiċi.
English: Manic episodes in Bipolar I Disorder
Maltese: Episodji manijaċi f'Disturb Bipolari I
English: Kaplan-Meier relapse rates at week 16 were 35% for aripiprazole and 52% for placebo; the hazard ratio for relapse within 16 weeks (aripiprazole/placebo) was 0.57 (non-statistically significant difference).
Maltese: Ir-rati ta' rikaduta Kaplan-Meier f'ġimgħa 16 kienu ta' 35% għal aripiprazole u ta' 52% għal plaċebo; ilproporzjon ta' periklu ta' rikaduta fi żmien 16-il ġimgħa (aripiprazole/plaċebo) kien ta' 0.57 (differenza mhux statistikament sinifikanti).
English: Aripiprazole Mylan Pharma 5 mg tablets Aripiprazole Mylan Pharma 10 mg tablets Aripiprazole Mylan Pharma 15 mg tablets Aripiprazole Mylan Pharma 30 mg tablets aripiprazole
Maltese: Aripiprazole Mylan Pharma 5 mg pilloli Aripiprazole Mylan Pharma 10 mg pilloli Aripiprazole Mylan Pharma 15 mg pilloli Aripiprazole Mylan Pharma 30 mg pilloli aripiprazole
English: • rapid heartbeat, agitation/aggressiveness, problems with speech.
Maltese: • taħbit mgħaġġel tal-qalb, aġitazzjoni/aggressività, problemi fit-taħdit.
English: Aripiprazole Mylan Pharma is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment (see section 5.1).
Maltese: Aripiprazole Mylan Pharma hu indikat għal trattament ta' episodji manijaċi minn moderati sa severi f'Disturb Bipolari I u għall-prevenzjoni ta' episodju manijaku ġdid f'adulti li esperjenzaw episodji predominantament manijaċi u li l-episodji manijaċi tagħhom irrispondew għal trattament ta' aripiprazole (ara sezzjoni 5.1).
English: In a pooled analysis on lipid parameters from placebo controlled clinical trials in adults, aripiprazole has not been shown to induce clinically relevant alterations in levels of total cholesterol, triglycerides, HDL and LDL.
Maltese: F'analiżi miġbura fuq parametri tal-lipidi minn provi kliniċi kkontrollati bil-plaċebo f'persuni adulti, ma ntweriex li aripiprazole jikkaġuna tibdil rilevanti kliniku fil-livelli ta' kolesterol totali, trigliċeridi, HDL u LDL.
English: • abnormal muscle breakdown which can lead to kidney problems,
Maltese: • distruzzjoni mhu normali tal-muskoli li tista' twassal għall-problemi tal-kliewi,
English: Other strong inhibitors of CYP3A4, such as itraconazole and HIV protease inhibitors, may be expected to have similar effects and similar dose reductions should therefore be applied (see section 4.2).
Maltese: Impedituri qawwija oħra ta' CYP3A4, bħal itraconazole u impedituri tal-protease ta' HIV huma mistennija li jkollhom effetti simili u tnaqqis simili fid-doża għandu, għalhekk jiġi applikat (ara sezzjoni 4.2).
English: In a clinical trial in healthy subjects, a strong inhibitor of CYP2D6 (quinidine) increased aripiprazole AUC by 107 %, while Cmax was unchanged.
Maltese: Fi studju kliniku f'pazjenti b'saħħithom, impeditur qawwi tas-CYP2D6 (quinidine) żied l-AUC ta' aripiprazole b' 107% waqt li Cmax ma tbiddilx.
English: Rhabdomyolysis Myalgia
Maltese: Rabdomijolosi Mijalġija Ebusija
English: Population pharmacokinetic evaluation showed no evidence of race-related differences on the pharmacokinetics of aripiprazole.
Maltese: Evalwazzjoni farmakokinetika tal popolazzjoni ma wriet l ebda evidenza ta' differenza marbuta ma' razza fuq il farmakokinetika ta' aripiprazole.
English: • speech disorder,
Maltese: • disturbi fid-diskors,
English: Venous thromboembolism (including pulmonary embolism and deep vein thrombosis) Hypertension
Maltese: Tromboemboliżmu talvini (li jinkludu emboliżmu pulmonari u trombożi tal-vini profondi)
English: Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia).
Maltese: Klinikament NMS jista' juri deni għoli, muskoli jibbiesu, stat mentali mibdul u evidenza ta' instabilità tas-sistema autonomika (polz mhux regolari jew pressjoni mhux normali, qalb tħabbat iktar mis-soltu, għaraq, u qalb ma tħabbatx regolari).
English: Overall, 1.3 % of aripiprazole-treated patients reported cerebrovascular adverse reactions compared with 0.6 % of placebo-treated patients in these trials.
Maltese: Bħala total, 1.3% ta' pazjenti kkurati b'aripiprazole irrapurtaw reazzjonijiet avversi ċerebrovaskulari mqabbla ma' 0.6% ta' pazjenti kkurati bil-plaċebo f'dawn il-provi.
English: • other anti-depressants (such as venlafaxine and tryptophan) used in major depression
Maltese: • antidipressanti oħra (bħal venlafaxine u trytophan) użati għal depressjoni maġġuri
English: Aripiprazole doses ranging from 0.5 to 30 mg administered once a day to healthy subjects for 2 weeks produced a dose-dependent reduction in the binding of 11C-raclopride, a D2/D3 receptor ligand, to the caudate and putamen detected by positron emission tomography.
Maltese: Dożi ta' aripiprazole li jvarjaw minn 0.5 sa 30 mg mogħtija darba kuljum għal ġimgħatejn lil nies b'saħħithom ipproduċew tnaqqis ta' dipendanza fuq id-droga fl-irbit ta' 11C-raclopride, reċettur li jgħaqqad D2/D3, caudate u l-putamen osservati bit-tomografija bl-emisssjoni positronika.
English: • triptans (such as sumatriptan and zolmitripitan) used for treating migraine
Maltese: • triptans (bħal sumatriptan u zolmitripitan) użati għal trattament ta' emigranja
English: In clinical trials aripiprazole has not been shown to induce clinically relevant weight gain in adults (see section 5.1).
Maltese: Fi provi kliniċi aripiprazole ma deherx li jwassal għal żieda fil-piż klinikament relevanti f'adulti (ara sezzjoni 5.1).
English: In subgroup analyses the point estimate of the HR was 0.495 for subjects 13 to 14 years of age compared to 0.454 for subjects 15 to 17 years of age.
Maltese: F'analiżi tassottogrupp il-punt ta' stima tal-HR kien 0.495 għal individwi ta' bejn 13 sa 14-il sena meta mqabbel ma' 0.454 fost dawk ta' 15 sa 17-il sena.
English: The safety profile in a 26-week open-label extension trial was similar to that observed in the short-term, placebo-controlled trial.
Maltese: Il-profil tas-sigurtà fil-prova ta' estensjoni open-label, li damet 26 ġimgħa, kien simili għal dak osservat fil-prova li damet żmien qasir, ikkontrollata bil-plaċebo.
English: Elevations of CPK (Creatine Phosphokinase), generally transient and asymptomatic, were observed in 3.5 % of aripiprazole treated patients as compared to 2.0 % of patients who received placebo.
Maltese: Elevazzjonijiet ta' CPK (Kreatina Fosfokinejż), ġeneralment li tgħaddi u asintomatika, kienu osservati f'3.5% tal-pazjenti ikkurati b'aripiprazole meta mqabbla ma' 2.0% talpazjenti li rċevew plaċebo.
English: Aripiprazole is effective in a dose range of 10 to 30 mg/day.
Maltese: Aripiprazole hu effettiv f'medda ta' dożi ta' 10 sa 30 mg/kuljum.
English: The Kaplan-Meier rates for recurrence to any mood episode for the adjunctive treatment arm were 16 % in aripiprazole + lithium and 18 % in aripiprazole + valproate compared to 45 % in placebo + lithium and 19 % in placebo + valproate.
Maltese: Ir-rati ta' Kaplan-Meier għal kull rikorrenza ta' kwalunkwe episodju ta' burdata fil-parti tal-istudju d-driegħ tal-kura fejn ingħatat mediċina addizzjonalit-trattament aġġuntiv kienu 16% f'aripiprazole + lithium u 18% f'aripiprazole + valproate meta mqabblal ma' 45% fi tal-plaċebo + lithium u 19% fi talplaċebo + valproate.
English: In the pooled trials, the incidence of low serum prolactin levels in females (<3 ng/ml) and males (<2 ng/ml) in aripiprazole-treated patients was 27/46 (58.7%) and 258/298 (86.6%), respectively.
Maltese: Fil-provi miġbura, l-inċidenza tal-livelli baxx ta' prolactin fis-serum fin-nisa (< 3 ng/ml) u fl-irġiel (< 2 ng/ml) f'pazjenti kkurati b'aripiprazole kienet 27/46 (58.7%) u 258/298 (86.6%), rispettivament.
English: Aripiprazole Mylan Pharma tablets contain maltose.
Maltese: Il-pilloli Aripiprazole Mylan Pharma fihom maltosju.
English: Cerebrovascular adverse reactions
Maltese: Reazzjonijiet avversi ċerebrovaskulari
English: There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder.
Maltese: Kien hemm rapporti ta' aġitazzjoni, ipertonja, ipotonja, rogħda, ħedla, distress respiratorju, jew disturb fit-tmigħ.
English: Tardive dyskinesia
Maltese: Disturbi vaskulari
English: In contrast the 95 % confidence interval for the HR in the older subgroup (aripiprazole, n = 69; placebo, n = 36) was 0.242 to 0.879 and hence a treatment effect could be concluded in the older patients.
Maltese: Bil-kuntrarju l-intervall tal-kunfidenza ta' 95% għall-HR fis-sottogrupp ta' etajiet akbar (aripiprazole, n = 69; plaċebo, n = 36) kien 0.242 sa 0.879 u għalhekk l-effett ta' trattament seta jiġi konkluż f'pazjenti akbar fl-età.
English: Patients were 7 - 17 years of age and presented an average score of 30 on Total Tic Score on the Yale Global Tic Severity Scale (TTS-YGTSS) at baseline.
Maltese: Il-pazjenti kienu bejn 7 snin - 17-il sena u kienu ppreżentati b'punteġġ medju ta' 30 fit-Total Tic Score fil-Global Tic Severity Scale (TTS-YGTSS) fil-linja bażi.
English: Actual scores in rating scales used as secondary endpoints, including PANSS and the Montgomery-Asberg Depression Rating Scale showed a significant improvement over haloperidol.
Maltese: Il-punteġġ attwali fl-iskali tal-klassifika użati bħala endpoints sekondarji, li jinkludu PANSS u il-Montgomery-Asberg Depression Rating Scale urew titjib sinifikanti fuq haloperidol.
English: Common Uncommon
Maltese: Mhux komuni
English: In a 26-week, placebo-controlled trial in adult stabilised patients with chronic schizophrenia, aripiprazole had significantly greater reduction in relapse rate, 34 % in aripiprazole group and 57 % in placebo.
Maltese: Fi provi ta' 26 ġimgħa kkontrollati bil-plaċebo f' pazjenti adulti stabbilizzati, bi skiżofrenja kronika, aripiprazole orali kellu tnaqqis sinifikament akbar fir-rata ta' pazjenti li rkadew, 34% fil-grupp ta' aripiprazole orali u 57% fil-plaċebo.
English: • uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia),
Maltese: • movimenti inkontrollabbli tal-ħalq, ilsien u r-riġlejn/dirgħajn (diskinesija tardiva),