FrancophonIA/ELRC3.0 huggingface dataset:
English: Schizophrenia in adolescents aged 15 years and older In a short-term placebo-controlled clinical trial involving 302 adolescents (13 - 17 years) with schizophrenia, the frequency and type of adverse reactions were similar to those in adults except for the following reactions that were reported more frequently in adolescents receiving aripiprazole than in adults receiving aripiprazole (and more frequently than placebo): Somnolence/sedation and extrapyramidal disorder were reported very commonly (≥ 1/10), and dry mouth, increased appetite, and orthostatic hypotension were reported commonly (≥ 1/100, < 1/10).
Maltese: Skizofrenja f'adolexxenti li għandhom 15-il sena jew aktar Fi prova klinika li damet żmien qasir, ikkontrollata bil-plaċebo, li kienet tinvolvi 302 adolexxenti (minn 13-17-il sena) li kellhom skizofrenja, il-frekwenza u t-tip ta' reazzjonijiet avversi kienu simili għal dawk fl-adulti, ħlief għal dawn ir-reazzjonijiet li ġejjin li kienu rrappurtati b'mod iktar frekwenti fl-adolexxenti li kienu qed jirċievu aripiprazole milli fl-adulti li kienu qed jirċievu aripiprazole (u iktar b'mod frekwenti mill-plaċebo): Ngħas/sedazzjoni u disturb ekstrapiramidali kienu rrappurtati b'mod komuni ħafna (≥ 1/10), u ħalq xott, żieda fl-aptit, u pressjoni tad-demm baxxa meta wieħed ikun bilwieqfa kienu rrappurtati b'mod komuni (≥ 1/100, < 1/10).
English: The most common treatment-emergent adverse events among patients receiving 30 mg were extrapyramidal disorder (28.3%), somnolence (27.3%), headache (23.2%), and nausea (14.1%).
Maltese: L-aktar każijiet avversi komuni li joħorġu mit-trattament fost pazjenti li qed jirċievu 30 mg kienu disturb ekstrapiramidali (28.3 %), ħedla (27.3 %), uġigħ ta' ras (23.2 %), u dardir (14.1 %).
English: • trembling,
Maltese: • rimettar,
English: In another 12-week trial, the incidence of EPS was 26.6% for patients treated with aripiprazole and 17.6% for those treated with lithium.
Maltese: Fi prova oħra ta' 12-il ġimgħa, l-inċidenza ta' EPS kienet ta' 26.6 % għal pazjenti kkurati b'aripiprazole u 17.6 % għal dawk ikkurati b'litju.
English: • light-headedness,
Maltese: • tegħreq iżżejjed,
English: In clinical trials for the approved indications and post-marketing, both increase and decrease in serum prolactin as compared to baseline was observed with aripiprazole (see section 5.1).
Maltese: Fi provi kliniċi bl-indikazzjonijiet approvati u wara t-tqegħid fis-suq, ġew osservati kemm żieda u kemm tnaqqis ta' prolaktin fis-serum meta mqabbla mal-linja bażi b'aripiprazole (sezzjoni 5.1).
English: In the adolescent (13 - 17 years) schizophrenia population with aripiprazole exposure of 5 to 30 mg up to 72 months, incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 25.6% and 45.0%, respectively.
Maltese: Fil-popolazzjoni ta' adolexxenti (13-17-il sena) bi skizofrenja b'esponiment għal aripiprazole ta' 5 sa 30 mg għal 72 xahar, l-inċidenza ta' livelli baxxi ta' prolactin fis-serum f'nisa (< 3 ng/ml) u rġiel (< 2 ng/ml) kienu ta' 25.6 % u 45.0 % rispettivament.
English: PHARMACEUTICAL FORM AND CONTENTS Orodispersible tablet
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT
English: Additionally, aripiprazole and dehydroaripiprazole did not show potential for altering CYP1A2-mediated metabolism in vitro.
Maltese: Ukoll, aripiprazole u dehydro-aripiprazole ma wrewx li jistgħu jibdlu lmetaboliżmu effettwat minn CYP1A2 in vitro.
English: In a sub-analysis of the adolescent patients between the ages of 15 to 17 years, representing 74% of the total enrolled population, maintenance of effect was observed over the 26-week open-label extension trial.
Maltese: F'sottoanaliżi ta' pazjenti adolexxenti bejn l-etajiet ta' 15 sa 17-il sena, li jirrappreżentaw 74 % tal-popolazzjoni totali rreġistrata, iż-żamma tal-effett kienet osservata matul il-prova ta' estensjoni open-label, li damet 26 ġimgħa.
English: • cardiovascular diseases (diseases of the heart and circulation), family history of cardiovascular disease, stroke or “mini” stroke, abnormal blood pressure
Maltese: • mard kardjovaskulari (mard tal-qalb u taċ-ċirkolazzjoni), storja ta' mard kardjovaskulari fil-familja, puplesija jew attakk ħafif ta' puplesija, pressjoni mhux normali
English: The rate of death in aripiprazoletreated patients was 3.5% compared to 1.7% in the placebo group.
Maltese: Ir-rata ta' mwiet f'pazjenti fuq kura b'aripirazole kienet 3.5 % imqabbla ma' 1.7 % fil-grupp ta' plaċebo.
English: Aripiprazole Zentiva is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older (see section 5.1).
Maltese: Aripiprazole Zentiva huwa indikat għal trattament sa 12-il ġimgħa ta' episodji manijaċi minn moderati sa severi f'Disturb Bipolari I f'adolexxenti b'età ta' 13-il sena jew aktar (ara sezzjoni 5.1).
English: At steady state, dehydro-aripiprazole, the active metabolite, represents about 40% of aripiprazole AUC in plasma.
Maltese: Fi stat stabbli, dehydro-aripiprazole, il-prodott tal-metaboliżmu attiv, jagħmel madwar 40 % ta' l-AUC ta' aripiprazole fil-plasma.
English: Aripiprazole Zentiva 30 mg tablets EU/1/15/1009/016
Maltese: Aripiprazole Zentiva 30 mg pilloli EU/1/15/1009/016
English: Other medicines and Aripiprazole Zentiva
Maltese: Mediċini oħra u Aripiprazole Zentiva
English: Aripiprazole did not impair fertility in reproductive toxicity studies.
Maltese: Aripiprazole ma naqqasx il-fertilità fi studji dwar tossiċità fuq is-sistema riproduttiva.
English: Lactose monohydrate Microcrystalline cellulose Crospovidone Hydroxypropyl cellulose Silica colloidal anhydrous Croscarmellose sodium Magnesium stearate
Maltese: Lactose monohydrate Microcrystalline cellulose Crospovidone Hydroxypropyl cellulose
English: Activated charcoal (50 g), administered one hour after aripiprazole, decreased aripiprazole Cmax by about 41% and AUC by about 51%, suggesting that charcoal may be effective in the treatment of overdose.
Maltese: Faħam attivat (50 g), li ngħata siegħa wara aripiprazole, naqqas is-Cmax ta' aripiprazole b'madwar 41% u l-AUC b'madwar 51%, li jissuġġerixxi li l-faħam jista' jkun effettiv fit-trattament ta' doża eċċessiva.
English: Diabetes mellitus Hyperglycaemia
Maltese: Silica colloidal anhydrous
English: Excipient with known effect: each orodispersible tablet contains 37 mg of lactose (as monohydrate) and 1.31 mg of sodium.
Maltese: Eċċipjent b'effett magħruf: kull pillola li tinħall fil-ħalq fiha 37 mg ta' lactose (bħala monohydrate) u ta' 1.31 mg sodium.
English: In a 6-week placebo-controlled trial involving 302 schizophrenic adolescent patients (13 - 17 years), presenting with positive or negative symptoms, aripiprazole was associated with statistically significantly greater improvements in psychotic symptoms compared to placebo.
Maltese: Fi prova klinika li damet 6 ġimgħat, ikkontrollata bil-plaċebo, li kienet tinvolvi 302 pazjenti adolexxenti skizofreniċi (minn 13 sa 17-il sena) li kellhom sintomi pożittivi jew negattivi, aripiprazole kien assoċjat ma' titjib li kien statistikament ħafna akbar f'sintomi psikotiċi meta mqabbel malplaċebo.
English: Aripiprazole Zentiva 30 mg tablets
Maltese: Aripiprazole Zentiva 30 mg pilloli aripiprazole
English: Tardive dyskinesia Dystonia
Maltese: Diskajneżja tardiva Distonja
English: Sudden unexplained death Torsades de pointes QT prolongation Ventricular arrhythmias Cardiac arrest Bradycardia
Maltese: Arritmiji ventrikulari Waqfien kardijaku Bradikardija
English: However, the estimation of the HR for the younger (13 - 14 years) group was not precise, reflecting the smaller number of subjects in that group (aripiprazole, n = 29; placebo, n = 12), and the confidence interval for this estimation (ranging from 0.151 to 1.628) did not allow conclusions to be drawn on the presence of a treatment effect.
Maltese: Madanakollu, l-istima ta' HR għall-grupp ta' etajiet iżgħar ma kienx preċiż, li jirrifletti l-għadd iżgħar ta' individwi f'dak il-grupp (aripiprazole, n = 29; plaċebo, n = 12), u l-intervall ta' kunfidenza għal din l-istima (li tvarja minn 0.151 sa 1.628) ma ppermettietx li jsiru konklużjonijiet fuq l-preżenza tal-effett tat-trattament.
English: Following concomitant administration of carbamazepine, a strong inducer of CYP3A4, and oral aripiprazole to patients with schizophrenia or schizoaffective disorder, the geometric means of Cmax and AUC for aripiprazole were 68% and 73% lower, respectively, compared to when aripiprazole (30 mg) was administered alone.
Maltese: Wara l-għoti fl-istess waqt ta' carbamazepine, induttur qawwi ta' CYP3A4, u aripiprazole orali lil pazjenti bi skizofrenja jew disturb skizoaffettiv, il-medji ġeometriċi tas-Cmax u l-AUC ta' aripriprazole kienu ta' 68 % u 73 % inqas, rispettivament, meta mqabbla ma' meta aripiprazole (30 mg) ġie mogħti waħdu.
English: • agitation,
Maltese: • konvulżjoni,
English: Additional side effects in children and adolescents Adolescents aged 13 years and older experienced side effects that were similar in frequency and type to those in adults except that sleepiness, uncontrollable twitching or jerking movements, restlessness, and tiredness were very common (may affect more than 1 in 10 people) and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle twitching, uncontrolled movements of the limbs, and feeling dizzy, especially when getting up from a lying or sitting position, were common (may affect up to 1 in 10 people).
Maltese: Effetti sekondarji addizzjonali fit-tfal u l-adolexxenti Adolexxenti li kellhom 13-il sena jew aktar, kellhom effetti sekondarji li kienu simili fil-frekwenza u fit-tip għal dawk fl-adulti, ħlief li l-irqad, ġbid involontarju tal-muskoli jew movimenti bl-iskossi li ma setgħux jiġu kkontrollati, nuqqas ta' kwiet fil-ġisem u l-għeja kienu komuni ħafna (jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) u l-uġigħ fil-parti ta' fuq tal-addome, ħalq xott, żieda fir-rata ta' taħbit tal-qalb, żieda fil-piż, żieda fl-aptit, kontrazzjonijiet tal-muskoli, movimenti mhux ikkontrollati tad-dirgħajn u tar-riġlejn, u s-sensazzjoni ta' sturdament, speċjalment meta tqum bilwieqfa meta tkun mimdud/a jew bilqiegħda, kienu komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10).
English: • baldness,
Maltese: • ebusija,
English: - Keep this leaflet.
Maltese: Stat ta' tipjip
English: EU/1/15/1009/011 EU/1/15/1009/012 EU/1/15/1009/013 EU/1/15/1009/014 EU/1/15/1009/015
Maltese: EU/1/15/1009/011 EU/1/15/1009/012 EU/1/15/1009/013 EU/1/15/1009/014
English: EU/1/15/1009/001 EU/1/15/1009/002 EU/1/15/1009/003 EU/1/15/1009/004 EU/1/15/1009/005
Maltese: EU/1/15/1009/001 EU/1/15/1009/002 EU/1/15/1009/003 EU/1/15/1009/004
English: In a long term 26-week placebo-controlled trial, the incidence of EPS was 19% for aripiprazole-treated patients and 13.1% for placebo-treated patients.
Maltese: Fi studju fit-tul ta' 26 ġimgħa kkontrollat minn plaċebo, linċidenza ta' EPS kienet 19 % għall-pazjenti kkurati b'aripiprazole u 13.1 % għall-pazjenti kkurati bilplaċebo.
English: Aripiprazole Zentiva 10 mg tablets
Maltese: Pilloli Aripiprazole Zentiva 10 mg
English: INFORMATION IN BRAILLE Aripiprazole Zentiva 30 mg tablets
Maltese: INFORMAZZJONI BIL-BRAILLE Aripiprazole Zentiva 30 mg pilloli
English: In the paediatric bipolar population (10 - 17 years) with exposure up to 30 weeks, incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 28.0% and 53.3%, respectively.
Maltese: Fil-popolazzjoni bipolari pedjatrika (10-17-il sena) b'esponiment sa 30 ġimgħa, l-inċidenza ta' livelli baxxi ta' prolactin fis-serum fin-nisa (< 3 ng/ml) u fl-irġiel (< 2 ng/ml) kienet 28.0 % u 53.3 % rispettivament.
English: Aripiprazole Zentiva 10 mg tablets EU/1/15/1009/006
Maltese: Aripiprazole Zentiva 10 mg pilloli EU/1/15/1009/006
English: Aripiprazole Zentiva 15 mg tablets EU/1/15/1009/011
Maltese: Aripiprazole Zentiva 15 mg pilloli EU/1/15/1009/011
English: Class effect - Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment.
Maltese: Effetti tal-klassi - Sintomi ta' distonja, kontrazzjonijiet anormali fit-tul ta' gruppi ta' muskoli, jistgħu jseħħu f'individwi suxxettibbli matul l-ewwel ftit jiem ta' kura.
English: Less than 1% of unchanged aripiprazole was excreted in the urine and approximately 18% was recovered unchanged in the faeces.
Maltese: Inqas minn 1 % ta' aripiprazole mhux imbiddel tneħħa fl-awrina u bejn wieħed u ieħor 18 % inġabar mhux mibdul flippurgar.
English: In three short-term (4 to 6 weeks) placebo-controlled trials involving 1,228 schizophrenic adult patients, presenting with positive or negative symptoms, aripiprazole was associated with statistically significantly greater improvements in psychotic symptoms compared to placebo.
Maltese: Fi tliet provi kliniċi fuq medda qasira (4 sa 6 ġimgħat) ikkontrollati minn plaċebo li fihom kienu involuti 1,228 pazjent adult skiżofreniku li wrew sintomi pożittivi jew negattivi, aripiprazole orali kien assoċjat ma' titjib statistikament sinifikanti akbar fis-sintomi psikotiċi meta mqabbla mal-plaċebo.
English: Aripiprazole Zentiva 15 mg tablets
Maltese: Aripiprazole Zentiva 15 mg pilloli aripiprazole
English: Aripiprazole Zentiva 5 mg tablets EU/1/15/1009/001
Maltese: Aripiprazole Zentiva 5 mg pilloli EU/1/15/1009/001
English: In a clinical trial in healthy subjects, a strong inhibitor of CYP3A4 (ketoconazole) increased aripiprazole AUC and Cmax by 63% and 37%, respectively.
Maltese: (ketoconazole) żied l-AUC u sCmax ta' aripiprazole b'63% u 37 % rispettivament.
English: Tics associated with Tourette's disorder
Maltese: Tikks assoċjati mad-disturb ta' Tourette:
English: Aripiprazole Zentiva 15 mg orodispersible tablets are white to off-white round flat bevel edged tablets debossed ‘15' on one side and plain on the other side with diameter approx. 8 mm.
Maltese: Pilloli Aripiprazole Zentiva 15 mg li jinħallu fil-ħalq Pilloli tondi minn bojod sa ofwajt b'xifer ċatt iċċanfrat b'‘15' imnaqqxa fuq naħa waħda u bla marki fuq in-naħa l-oħra b'dijametru ta' madwar 8 mm.
English: INFORMATION IN BRAILLE Aripiprazole Zentiva 10 mg tablets
Maltese: INFORMAZZJONI BIL-BRAILLE Aripiprazole Zentiva 10 mg pilloli
English: Aripiprazole Zentiva is effective in a dose range of 10 to 30 mg/day.
Maltese: Aripiprazole Zentiva hu effettiv b'firxa ta' dożi minn 10 sa 30 mg/kuljum.
English: Doses higher than 10 mg/day should therefore only be used in exceptional cases and with close clinical monitoring (see sections 4.4, 4.8 and 5.1).
Maltese: Għalhekk dożi ogħla minn 10 mg/kuljum għandhom jintużaw biss f'każijiet eċċezzjonali u b'monitoraġġ kliniku mill-qrib (ara sezzjonijiet 4.4, 4.8 u 5.1).
English: Pack size: 14, 28 or 49 orodispersible tablets Not all pack sizes may be marketed.
Maltese: Daqs tal-pakkett: 14, 28 jew 49 pillola li tinħall fil-ħalq Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: Aripiprazole Zentiva 5 mg tablets
Maltese: Pilloli Aripiprazole Zentiva 5 mg
English: In a 26week, olanzapine-controlled, double-blind, multi-national study of schizophrenia which included 314 adult patients and where the primary end-point was weight gain, significantly less patients had at least 7% weight gain over baseline (i.e. a gain of at least 5.6 kg for a mean baseline weight of ~80.5 kg)
Maltese: Fi studju ta' 26 ġimgħa multi-nazzjonali double-blind fuq l-iskizofrenja ikkontrollat bl-olanzapine li inkluda 314 pazjent adult u fejn l-end-point primarju kien iż-żieda fil-piż, inqas pazjenti kellhom millinqas żieda ta' 7 % fil-piż fuq il-linja bażi b'mod sinifikattiv (i.e. żieda ta' mill-inqas ta' 5.6 kg għallpunt medjan tal-linja bażi tal-piż - 80.5 kg) fuq aripiprazole (n = 18, jew 13 % tal-pazjenti evalwabbli), mqabbla ma' olanzapine orali (n = 45, jew 33 % tal-pazjenti evalwabbli).
English: Over 75% of patients were less than 13 years of age.
Maltese: Aktar minn 75 % tal-pazjenti kellhom inqas minn 13-il sena.
English: INFORMATION IN BRAILLE Aripiprazole Zentiva 5 mg tablets
Maltese: INFORMAZZJONI BIL-BRAILLE Aripiprazole Zentiva 5 mg pilloli
English: In clinical trials and post-marketing experience, accidental or intentional acute overdose of aripiprazole alone was identified in adult patients with reported estimated doses up to 1,260 mg with no fatalities.
Maltese: Fi provi kliniċi u esperjenza ta' wara t-tqegħid fis-suq, ġie identifikat teħid aċċidentali jew intenzjonat ta' doża eċċessiva ta' aripiprazole waħdu f'pazjenti adulti bid-dożi rrappurtati stmati li kienu sa 1,260 mg mingħajr ebda fatalità.
English: Pregnancy, puerperium and perinatal conditions
Maltese: Disturbi fis-sistema riproduttiva u fissider
English: What Aripiprazole Zentiva contains
Maltese: Tiħux Aripiprazole Zentiva :
English: Aripiprazole Zentiva contains the active substance aripiprazole and belong to a group of medicines called antipsychotics.
Maltese: Aripiprazole Zentiva fih is-sustanza attiva aripiprazole u jappartjeni għal grupp ta' mediċini msejħa antipsikotiċi.
English: What Aripiprazole Zentiva looks like and contents of the pack Aripiprazole Zentiva 10 mg orodispersible tablets are white to off-white round tablets debossed ‘10' on one side and snap break line on other side with diameter approx. 7 mm.
Maltese: Kif jidher Aripiprazole Zentiva u l-kontenut tal-pakkett Il-pilloli Aripiprazole Zentiva 10 mg li jinħallu fil-ħalq huma pilloli tondi minn bojod sa ofwajt b'‘10' imnaqqxa fuq naħa waħda u b'linja li taqsam il-pillola fuq in-naħa l-oħra b'dijametru ta' madwar 7 mm.
English: Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older The recommended dose for Aripiprazole Zentiva is 10 mg/day administered on a once-a-day schedule without regard to meals.
Maltese: Episodji manijaċi f'Disturb Bipolari I f'adolexxenti b'età ta' 13-il sena jew aktar Id-doża rrakkomandata għal Aripiprazole Zentiva hi ta' 10 mg/kuljum mogħtija bi skeda ta' darba kuljum mingħajr ma jitqies il-ħin tal-ikel.
English: Similarly, for dehydro-aripiprazole the geometric means of Cmax and AUC after carbamazepine co-administration were 69% and 71% lower, respectively, than those following treatment with aripiprazole alone.
Maltese: Hekk ukoll, għad-dehydro-aripiprazole, il-medji ġeometriċi tas-Cmax u l-AUC wara l-għoti ta' carbamazepine kienu ta' 69 % u 71 % inqas, rispettivament, minn dawk ta' wara l-kura b'aripiprazole orali waħdu.
English: At therapeutic concentrations, aripiprazole and dehydro-aripiprazole are greater than 99% bound to serum proteins, binding primarily to albumin.
Maltese: F'konċentrazzjonijiet terapewtiċi, aripiprazole u dehydro-aripiprazole jintrabtu b'iktar minn 99 % mal-protejini tad-demm, u jintrabtu laktar ma' l-albumina.
English: • Acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating,
Maltese: • konfużjoni akuta, konvulżjonijiet (epilessija), koma, kombinazzjoni ta' deni, tieħu n-nifs aktar malajr, tegħreq
English: Aripiprazole Zentiva 15 mg tablets are white to off-white round flat bevel edged uncoated tablets with ‘15' debossed on one side and plain on the other side with diameter approx. 8.8 mm.
Maltese: Il-pilloli Aripiprazole Zentiva 15 mg huma pilloli tondi mhux miksija minn bojod sa ofwajt b'xifer ċatt iċċanfrat b'‘15' imnaqqxa fuq naħa waħda u bla marki fuq in-naħa l-oħra b'dijametru ta' madwar 8.8 mm.
English: However, the concentrations of the sulphate conjugates of hydroxy aripiprazole in human bile at the highest dose proposed, 30 mg per day, were no more than 6% of the bile concentrations found in the monkeys in the 39-week study and are well below (6%) their limits of in vitro solubility.
Maltese: Iżda l-konċentrazzjoni tal-konjugi sulfatizzati ta' idroxi aripiprazole fil-bile tal-bniedem fl-ogħla doża proposta, dik ta' 30 mg kuljum, ma kinux iktar minn 6 % tal-konċentrazzjoni fil-bile li nstabet fixxadini fl-istudju li dam 39 ġimgħa u huwa ħafna inqas (6 %) mill-limiti li taħthom jinħallu in vitro.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Aripiprazole Zentiva 5 mg tablets
Maltese: U KWANTITATTIVA Pilloli Aripiprazole Zentiva 5 mg
English: Venous thromboembolism (including pulmonary embolism and deep vein thrombosis)
Maltese: Tromboemboliżmu fil-vini (li jinkludi emboliżmu fil-pulmuni u trombożi fil-vini tal-fond) Ipertensjoni
English: Upon discontinuation of the CYP2D6 or CYP3A4 inhibitor, the dosage of aripiprazole should be increased to the level prior to the initiation of the concomitant therapy.
Maltese: Mal-waqfien tal-impeditur ta' CYP2D6 jew CYP3A4, id-dożaġġ ta' aripiprazole għandu jiżdied għaddoża ta' qabel il-bidu tat-terapija konkomitanti.
English: Adjunctive aripiprazole demonstrated superiority over placebo on the secondary outcome measure, CGI-BP Severity of Illness score (mania).
Maltese: Dan il-prodott mediċinali jista' jinbeda b'doża baxxa bis-soluzzjoni (likwidu) orali.
English: Aripiprazole Zentiva 30 mg orodispersible tablets are white to off-white round tablets debossed ‘30' on one side and snap break line on the other side with diameter approx. 10.2 mm.
Maltese: Pilloli Aripiprazole Zentiva 30 mg li jinħallu fil-ħalq Pilloli tondi minn bojod sa ofwajt b'‘30' imnaqqxa fuq naħa waħda u b'linja li taqsam il-pillola fuq innaħa l-oħra b'dijametru ta' madwar 10.2 mm.
English: INFORMATION IN BRAILLE Aripiprazole Zentiva 15 mg tablets
Maltese: INFORMAZZJONI BIL-BRAILLE Aripiprazole Zentiva 15 mg pilloli
English: What Aripiprazole Zentiva looks like and contents of the pack Aripiprazole Zentiva 5 mg are white to off-white round flat bevel edged uncoated tablets with ‘5' debossed on one side and plain on the other side with diameter approx. 6 mm.
Maltese: Kif jidher Aripiprazole Zentiva u l-kontenut tal-pakkett Il-pilloli Aripiprazole Zentiva 5 mg huma pilloli tondi mhux miksija minn bojod sa ofwajt b'xifer ċatt iċċanfrat b'‘5' imnaqqxa fuq naħa waħda u bla marki fuq in-naħa l-oħra b'dijametru ta' madwar 6 mm.
English: Extrapyramidal symptoms were mainly reported during the stabilisation phase in 17% of patients, with tremor accounting for 6.5%.
Maltese: Sintomi ekstrapiramidali ġew irrappurtati primarjament matul il-fażi ta' stabbilizzazzjoni fi 17 % tal-pazjenti, bir-rogħda li kienet tammonta għal 6.5 %.
English: • serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness,
Maltese: • sindromu ta' serotonin (reazzjoni li tista' tikkawża sensazzjonijiet ta' ferħ kbir, ħedla,
English: In two long term trials with adolescent (13 - 17 years) schizophrenia and bipolar patients treated with aripiprazole, incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 37.0 % and 59.4 %, respectively.
Maltese: F'żewġ provi b'terminu ta' żmien twil b'pazjenti adolexxenti (13-17-il sena) skizofreniċi u bipolari kkurati b'aripiprazole, l-inċidenza ta' livelli baxxi ta' prolactin fis-serum fin-nisa (< 3 ng/ml) u flirġiel (< 2 ng/ml) kienet 37.0% u 59.4, rispettivament.
English: • allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching, hives),
Maltese: • reazzjoni allerġika (eż. nefħa fil-ħalq, ilsien, wiċċ u gerżuma, ħakk, urtikarja),
English: Aripiprazole Zentiva contains lactose
Maltese: X'fih Aripiprazole Zentiva
English: Allergic reaction (e.g. anaphylactic reaction, angioedema including swollen tongue, tongue oedema, face oedema, pruritus, or urticaria)
Maltese: Reazzjoni allerġika (eż. reazzjoni anafilattika, anġjoedima li tinkludi lsien minfuħ, edima fl-ilsien, edima fil-wiċċ, ħakk, jew urtikarja)
English: Developmental toxicity, including dose-dependent delayed foetal ossification and possible teratogenic effects, were observed in rats at doses resulting in subtherapeutic exposures (based on AUC) and in rabbits at doses resulting in exposures 3 and 11 times the mean steady-state AUC at the maximum recommended clinical dose.
Maltese: Effett tossiku fuq l-iżvilupp, li jinkludu, tardjar ta' lossifikazzjoni tal-fetu skond id-doża u effetti teratoġeniċi possibli ġew osservati f'firien b'dożi li jirriżultaw f'espożizzjonijiet taħt il-livelli terapewtiċi (ibbażati fuq l-AUC) u fi fniek b'dożi li jirriżultaw f'espożizzjonijiet ta' 3 u 11-il darba iktar mill-medja ta' l-AUC fi stat stabbli fid-doża massima klinika rakkomandata.