FrancophonIA/ELRC3.0 huggingface dataset:
English: Grand mal convulsion Serotonin syndrome Speech disorder
Maltese: Sindrome Malinn Newrolettiku (NMS) Puplesija grand mal Is-sindrome ta' serotonin
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 skiżofreniċi (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 mal-plaċebo.
English: Dizziness and vision problems may occur during treatment with this medicine (see section 4).
Maltese: Problemi ta' sturdament u vista jistgħu jseħħu waqt it-trattament b'din il-mediċina (ara sezzjoni 4).
English: Do not take Aripiprazole Mylan Pharma
Maltese: Tiħux Aripiprazole Mylan Pharma
English: In another long-term 26-week controlled trial, the incidence of EPS was 14.8 % for aripiprazole-treated patients and 15.1 % for olanzapine-treated patients.
Maltese: Fi studju ieħor ikkontrollat fit-tul ta' 26 ġimgħa, l-inċidenza ta' EPS kienet 14.8% f'pazjenti kkurati b'aripiprazole u 15.
English: In paediatric clinical trials of aripiprazole akathisia and Parkinsonism were observed.
Maltese: Fi provi kliniċi pedjatriċi ta' aripiprazole, ġew osservati akatisja u Parkinsoniżmu.
English: Irritability associated with autistic disorder: the safety and efficacy of aripiprazole in children and adolescents aged below 18 years have not yet been established.
Maltese: Irritabilità marbuta ma' disturb awtistiku: is-sigurtà u effikaċja ta' aripiprazole fit-tfal u adolexxenti taħt l-età ta' 18-il sena ma ġewx determinati s'issa.
English: • high blood pressure,
Maltese: • pressjoni għolja,
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 adulti skiżofreniku li wrew sintomi pożittivi jew negattivi, aripiprazole orali kien assoċjat ma' titjib statistikament sinifikanti akbar fis-sintomi psikotiċi meta mqabbla mal-plaċebo.
English: The efficacy of aripiprazole in paediatric subjects with Tourette's syndrome (aripiprazole: n = 32, placebo: n = 29) was also evaluated over a flexible dose range of 2 mg/day to 20 mg/day and a starting dose of 2 mg, in a 10 week, randomised, double blind, placebo-controlled study conducted in SouthKorea.
Maltese: n = 29) kienet valutata fuq firxa ta' dożi flessibbli bejn 2 mg/jum sa 20 mg/jum u b'doża inizjali ta' 2 mg, fi studju każwali, double-blind, bil-plaċebo bħala kontroll li dam sejjer 10 ġimgħat fil-Korea t'Isfel.
English: Urinary incontinence Urinary retention
Maltese: Inkontinenza urinarja Żamma ta' l-awrina
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: 6% għal pazjenti ttrattati b'aripiprazole u 17.6% għal dawk ittrattati b'litju.
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, l-inċidenza ta' EPS kienet 19% għall-pazjenti ikkurati b'aripiprazole u 13.1% għall-pazjenti ikkurati bil-plaċebo.
English: Aripiprazole Mylan Pharma 15 mg tablets Yellow, round and biconvex tablets of 10.1 mm in diameter, engraved with “15” on one side
Maltese: Aripiprazole Mylan Pharma 15 mg pilloli Isfar, tondi u bikonvessi pilloli ta ‘10.1 mm dijametru, imnaqqxa b' “15” fuq naħa waħda
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: The maximum daily dose should not exceed 30 mg.
Maltese: Id-doża massima ta' kuljum ma għandhiex taqbeż 30 mg.
English: Syncope
Maltese: Diplopja
English: Population pharmacokinetic evaluation has revealed no evidence of clinically significant effects from smoking on the pharmacokinetics of aripiprazole.
Maltese: Studju farmakokinetiku tal-popolazzjoni ma wera l-ebda evidenza klinikament sinifikanti minn tipjip fuq il-farmakokinetika ta' aripiprazole
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 fl-ippurgar.
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 (greater than 1 in 10 patients) 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 (greater than 1 in 100 patients).
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, kontrazzjonijiet jew movimenti bl-iskossi li ma setgħux jiġu kkontrollati, ma kellhomx kwiet f'ġisimhom u għeja kienu komuni ħafna (aktar minn 1 f'kull 10 pazjenti) u wġigħ 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 tas-saqajn, u sensazzjoni ta' sturdament, speċjalment meta tqum bilwieqfa meta tkun mimdud/a jew bilqiegħda, kienu komuni (aktar minn 1 f'kull 100 pazjenti).
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 skiżofrenja jew disturb skiżoaffettiv, 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: Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
Maltese: Sinjali oħra jistgħu jkunu livell għoli ta' ‘creatine phosphokinase', myoglobulin flawrina (rabdomajoliżi), u mard tal-kliewi akut.
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% talpopolazzjoni totali rreġistrata, iż-żamma tal-effett kienet osservata matul il-prova ta' estensjoni openlabel, li damet 26 ġimgħa.
English: • increased blood levels of the hormone prolactin,
Maltese: • żieda fil-livelli tal-ormon prolactin fid-demm,
English: Pharmacokinetics in special patient groups
Maltese: Farmakokinetiċi fi gruppi ta' pazjenti speċjali
English: • skin rash,
Maltese: • raxx tal-ġilda,
English: • The other ingredients for 15 mg are crystalline maltose, microcrystalline cellulose, pregelatinised starch, croscarmellose sodium, iron oxide yellow (E172) and magnesium stearate.
Maltese: • Is-sustanzi l-oħra għal 15 mg huma maltosju kristallin, microcrystalline cellulose, lamtu ġelatinizzat minn qabel, croscarmellose sodium, isfar ossidu tal-ħadid (E172) u magnesium stearate.
English: Hypersensitivity reactions, characterised by allergic symptoms, may occur with aripiprazole (see section 4.8).
Maltese: Reazzjonijiet ta' sensittività eċċessiva, ikkaratterizzati b'sintomi allerġiċi, jistgħu jseħħu b'aripiprazole (ara sezzjoni 4.8).
English: NMS is a potentially fatal symptom complex associated with antipsychotics.
Maltese: NMS huwa grupp ta' sintomi li jista' jwassal għall-mewt, assoċjat ma' antipsikotiċi.
English: Tics associated with Tourette's disorder: the safety and efficacy of aripiprazole in children and adolescents 6 to 18 years of age have not yet been established.
Maltese: Tikks assoċjati mad-disturb ta' Tourette: is-sigurtà u l-effikaċja ta' aripiprazole fit-tfal u adolexxenti bejn 6 snin u 18-il sena ma ġewx determinati s'issa.
English: Tics associated with Tourette's disorder in paediatric patients (see section 4.2) The efficacy of aripiprazole was studied in paediatric subjects with Tourette's disorder (aripiprazole: n = 99, placebo: n = 44) in a randomised, double-blind, placebo controlled, 8 week study using a fixed dose weight-based treatment group design over the dose range of 5 mg/day to 20 mg/day and a starting dose of 2 mg.
Maltese: n = 44) fi studju każwali, double-blind, bil-plaċebo bħala kontroll, ta' 8 ġimgħat fejn ġie użat grupp ta' trattament b'doża fissa abbażi tal-piż fuq firxa ta' dożi ta' bejn 5 mg/jum sa 20 mg/jum b'doża inizjali ta' 2 mg.
English: In the pooled adolescent schizophrenia population (13-17 years) with exposure up to 2 years, incidence of low serum prolactin levels in females (<3 ng/ml) and males (<2 ng/ml) was 29.5 % and 48.3 %, respectively.
Maltese: Fil-popolazzjoni miġbura ta' adolexxenti (13 - 17-il sena) li jbatu bl-iskiżofrenja li kellhom espożizzjoni sa sentejn, l-inċidenza ta' livelli baxxi ta' prolactin fis-serum fin-nisa (< 3 ng/ml) u flirġiel (< 2 ng/ml) kienet ta' 29.5% u ta' 48.3% respettivament.
English: INFORMATION IN BRAILLE Aripiprazole Mylan Pharma 5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Aripiprazole Mylan Pharma 5 mg
English: A single-dose study in subjects with varying degrees of liver cirrhosis (Child-Pugh Classes A, B, and C) did not reveal a significant effect of hepatic impairment on the pharmacokinetics of aripiprazole and dehydro-aripiprazole, but the study included only 3 patients with Class C liver cirrhosis, which is insufficient to draw conclusions on their metabolic capacity.
Maltese: Studji ta' pazjenti b'mard tal-fwied (Child-Pugh Klassi A, B u C) li ngħataw doża waħda ma wrew l-ebda effett tal-mard tal-fwied fuq il-farmakokinetiċi ta' aripiprazole u dehydro-aripiprazole iżda l-istudju li inkluda 3 pazjenti biss b'ċirrożi tal-fwied Klassi C, huwa insuffiċjenti biex joħroġ b'konklużjonijiet fuq il-kapaċitajiet metaboliċi tagħhom.
English: The potentially medically serious signs and symptoms reported included somnolence, transient loss of consciousness and extrapyramidal symptoms.
Maltese: Is-sinjali u sintomi rapurtati li possibbilment huma medikament importanti kienu jinkludu ħedla ta' rqad, telf temporanju ta' koxjenza u sintomi ekstrapiramidali.
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) skiżofreniċi u bipolari ttrattati 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: • shaking and blurred vision,
Maltese: • rogħda u vista mċajpra,
English: QT prolongation
Maltese: Titwil tal QT
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 filfamilja, puplesija jew attakk ħafif ta' puplesija, pressjoni mhux normali
English: What Aripiprazole Mylan Pharma look like and contents of the pack Aripiprazole Mylan Pharma 5 mg tablets are blue, round and biconvex of 6.1 mm in diameter, engraved with ‘5' on one side.
Maltese: Kif jidher Aripiprazole Mylan Pharma u l-kontenut tal-pakkett Pilloli Aripiprazole Mylan Pharma 5 mg huma blu, tondi u bikonvessi tal 6.1 mm fid-dijametru, imnaqqxa bil “5” fuq naħa waħda.
English: Aripiprazole Mylan Pharma 30 mg tablets EU/1/15/1005/010
Maltese: Aripiprazole Mylan Pharma 30 mg pilloli EU/1/15/1005/010
English: Vision blurred Diplopia
Maltese: .8 Effetti mhux mixtieqa
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 a single oral dose of [14C]-labelled aripiprazole, approximately 27% of the administered radioactivity was recovered in the urine and approximately 60 % in the faeces.
Maltese: Wara li ngħatat doża waħda mill-ħalq ta' aripiprazole mmarkata bl-[14C], bejn wieħed u ieħor 27% tar radjoattività li ngħatat ħarġet fl-awrina u madwar 60% ma' l-ippurgar.
English: EU/1/15/1005/004 EU/1/15/1005/005 EU/1/15/1005/006 EU/1/15/1005/015 EU/1/15/1005/016
Maltese: EU/1/15/1005/005 EU/1/15/1005/006 EU/1/15/1005/015 EU/1/15/1005/016
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Mylan Pharma 30 mg tablets aripiprazole
Maltese: Airpiprazole Mylan Pharma 30 mg pilloli aripiprazole
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'.
Maltese: Din il-mediċina fiha inqas minn 1 mmol sodium (23 mg) għal kull pillola, jiġifieri essenzjalment jiġifieri essenzjalment ‘ ħieles mis-sodium'.
English: Other strong inhibitors of CYP2D6, such as fluoxetine and paroxetine, may be expected to have similar effects and similar dose reductions should therefore be applied.
Maltese: Impedituri qawwija oħra ta' CYP2D6, bħal fluoxetine u paroxetine jistgħu jkunu mistennija li jkollhom effetti bħal dawn u għalhekk tnaqqis fid-doża simili għandu jiġi applikat.
English: • chest pain,
Maltese: • ħass ħażin,
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 bejn wieħed u ieħor b' 41% u l-AUC bejn wieħed u ieħor b' 51%, li jissuġġerixxi li l-faħam jista jkun effettiv għallkura ta' doża eċċessiva.
English: An elevated risk of acute dystonia is observed in males and younger age groups.
Maltese: Riskju għoli ta' distonja akuta kien osservat fl-irġiel u fi grupp ta' età iżgħar.
English: Microcrystalline cellulose Pregelatinised starch
Maltese: Il-qalba tal-pillola maltosju kristallinMicrocrystalline cellulose lamtu ġelatinizzat minn qabel Magnesium stearate
English: • sleepiness,
Maltese: • ebusija,
English: Sudden unexplained death Torsades de pointes QT prolongation Ventricular arrhythmias Cardiac arrest Bradycardia
Maltese: Mewt għall-għarrieda inspjegabbli Torsades de pointes Titwil tal-QT Arritmiji ventrikulari Waqfien tal-qalb Bradikardija
English: INFORMATION IN BRAILLE Aripiprazole Mylan Pharma 15 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Aripiprazole Mylan Pharma 15 mg
English: Stiffness
Maltese: Pożoloġija
English: EU/1/15/1005/010 EU/1/15/1005/011 EU/1/15/1005/012 EU/1/15/1005/019 EU/1/15/1005/020
Maltese: EU/1/15/1005/11 EU/1/15/1005/12 EU/1/15/1005/19 EU/1/15/1005/20
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 kienux 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: Over 75% of patients were less than 13 years of age.
Maltese: Aktar minn 75% tal-pazjenti kellhom inqas minn 13-il sena.
English: Aripiprazole Mylan Pharma tablets contain less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Maltese: Il-pilloli Aripiprazole Mylan Pharma fihom inqas minn 1 mmol sodium (23 mg), għal kull pillola, jiġifieri essenzjalment ‘ ħieles mis-sodium'.
English: INFORMATION IN BRAILLE Aripiprazole Mylan Pharma 30 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Aripirprazole Mylan Pharma 30 mg
English: Aripiprazole group showed an improvement of 14.97 on TTS-YGTSS change from baseline to week 10 as compared with an improvement of 9.62 in the placebo group.
Maltese: Il-grupp ta' aripiprazole wera titjib ta' 14.97 fuq il-bidla TTS-YGTSS mil-linja bażi sa Ġimgħa 10 meta mqabbel ma' titjib ta' 9.62 fil-grupp tal-plaċebo.
English: Aripiprazole Mylan Pharma 10 mg tablets EU/1/15/1005/004
Maltese: Aripiprazole Mylan Pharma 10 mg pilloli EU/1/15/1005/004
English: Aripiprazole Mylan Pharma 5 mg tablets Blue round and biconvex tablets of 6.1 mm in diameter, engraved with “5” on one side
Maltese: Aripiprazole Mylan Pharma 5 mg pilloli Blue tondi u bikonvessi pilloli ta ‘6.1 mm dijametru, imnaqqxa b' “5” fuq naħa waħda.
English: Akathisia
Maltese: Stitikezza
English: Aripiprazole Mylan Pharma 15 mg tablets EU/1/15/1005/007
Maltese: Aripiprazole Mylan Pharma 15 mg pilloli EU/1/15/1005/007
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 l-aktar ma' l-albumina.
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 (1317-il sena) bi skiżofrenja 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.
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 (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: Weight gain should be monitored in adolescent patients with bipolar mania.
Maltese: Iż-żieda fil-piż għandha tiġi mmonitorjata f'pazjenti adolexxenti b'manija bipolari.
English: The incidence of hypoprolactinaemia or decreased serum prolactin in patients treated with aripiprazole was 0.4 %, compared with 0.02 % for patients treated with placebo.
Maltese: L inċidenza ta' ipoprolaktinemija jew tnaqqis ta' prolaktin fis-serum f'pazjenti trattati b'aripiprazole kien ta' 0.4% meta mqabbel ma' 0.02% għal pazjenti trattati bi plaċebo.
English: INFORMATION IN BRAILLE Aripiprazole Mylan Pharma 10 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Aripiprazole Mylan Pharma10 mg
English: • stiffness,
Maltese: • aġitazzjoni,
English: Aripiprazole Mylan Pharma 5 mg tablets EU/1/15/1005/001
Maltese: Aripiprazole Mylan Pharma 5 mg pilloli EU/1/15/1005/001
English: Jaundice
Maltese: Dijarea
English: Aripiprazole Mylan Pharma 10 mg tablets Pink, round and biconvex tablets of 8.1 mm in diameter, engraved with “10” on one side
Maltese: Aripiprazole Mylan Pharma 10 mg pilloli Roża, tonda u pilloli żewġ naħat ta ‘8.1 mm dijametru, imnaqqxa b' “10” fuq naħa waħda.
English: Prolactin
Maltese: Rimettar
English: When the CYP3A4 or CYP2D6 inhibitor is withdrawn from the combination therapy, aripiprazole dose should then be increased (see section 4.5).
Maltese: Meta ma jibqax jingħata l-impeditur ta' CYP3A4 jew CYP2D6, id-doża ta' aripiprazole għandha tiżdied (ara sezzjoni 4.5).
English: Drug withdrawal syndrome neonatal (see section 4.6)
Maltese: Sindrome ta' meta wieħed jieqaf jieħu l-mediċina fi trabi tattwelid (ara sezzjoni 4.6).
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: Therefore, aripiprazole is not recommended for use in patients below 13 years of age (see sections 4.8 and 5.1).
Maltese: Għalhekk aripiprazole mhux rakkomandat għal użu f'pazjenti taħt it-13-il sena (ara sezzjonijiet 4.8 u 5.1).
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' l-ossifikazzjoni 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.
English: Hyperhidrosis
Maltese: Iperprolaktinemija
English: Aripiprazole Mylan Pharma is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.
Maltese: Aripiprazole Mylan Pharma hu indikat għal trattament ta' skiżofrenja fl-adulti u fl-adolexxenti minn età ta' 15-il sena jew aktar.
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: • triptans, tramadol and tryptophan used for conditions including depression, generalised anxiety disorder, obsessive compulsive disorder (OCD) and social phobia as well as migraine and pain
Maltese: • triptans, tramadol u tryptophan użati għal kundizzjonijiet li jinkludu depressjoni, disturb ta'
English: How to store Aripiprazole Mylan Pharma
Maltese: Mediċini oħra u Aripiprazole Mylan Pharma
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: Diabetes mellitus
Maltese: TAL-PRODOTT MEDIĊINALI