FrancophonIA/ELRC3.0 huggingface dataset:
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: Madanakollu, il-konċentrazzjonijiet tal-konjugati tas-sulfat ta' hydroxy-aripiprazole fil-bila umana fl-ogħla doża proposta, 30 mg kuljum, ma kinux aktar minn 6 % tal-konċentrazzjonijiet tal-bila li nstabet fix-xadini fl-istudju ta' 39 ġimgħa u huma inqas sew (6 %) mil-limiti ta' solubilità tagħhom in vitro.
English: 38 mm (1.5 inch) 22 gauge
Maltese: 38 mm (pulzier u nofs) 22 gejġ
English: 51 mm (2 inch) 21 gauge c) Slowly inject the recommended volume as a single intramuscular injection into the gluteal or deltoid muscle.
Maltese: 51 mm (2 pulzieri) 21 gejġ c) Bil-mod injetta l-volum irrakkomandat bħala injezzjoni waħda ġol-muskolu gluteali jew deltojde.
English: • triptans (such as sumatriptan and zolmitripitan) used for treating migraine.
Maltese: • triptans (bħal sumatriptan u zolmitripitan) użati għal trattament ta' emigranja.
English: Acute treatment of schizophrenia in adults
Maltese: Trattament akut għal skiżofrenja f'adulti
English: f) Slowly inject into the gluteal or deltoid muscle.
Maltese: f) Bil-mod injetta ġol-muskolu gluteali jew deltojde.
English: 0.8 ml e) Wipe the top of the vial of the reconstituted suspension with a sterile alcohol swab.
Maltese: 0.8 ml e) Imsaħ il-parti ta' fuq tal-kunjett tas-suspensjoni rrikostitwita b'imselħa sterili bl-alkoħol.
English: Hypersexuality Panic reaction Depression Affect lability Apathy
Maltese: Ipersesswalita` Reazzjoni ta' paniku Depressjoni Emozzjonijiet instabbli Apatija
English: Figure 1 Kaplan-Meier Product Limit Plot for Time to Exacerbation of Psychotic Symptoms/Impending Relapse
Maltese: Figura 1 Plot Kaplan-Meier tal-Limitu tal-Prodott għaż-Żmien biex iseħħ Taħrix ta' Sintomi Psikotiċi/Irkadar Imminenti
English: Neuroleptic malignant syndrome Grand mal convulsion Serotonin syndrome Speech disorder
Maltese: Konvulżjoni gran mal Sindromu tas-serotonin Disturb fid-diskors
English: Abilify Maintena contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics.
Maltese: Abilify Maintena fih is-sustanza attiva aripiprazole u jappartjeni għal grupp ta' mediċini msejħa antipsikotiċi.
English: • eye pain
Maltese: • vista doppja
English: LS Mean change (SE)
Maltese: Bidla medja f'LS (SE)
English: Electrocardiogram T wave amplitude decreased Electrocardiogram abnormal Electrocardiogram T wave inversion
Maltese: Tnaqqis fil-wisa' tal-mewġa T tal-elettrokardjogramma Elettrokardjogramma abnormali
English: - One 3 ml disposable syringe with luer lock tip.
Maltese: - Siringa waħda ta' 3 ml li tintuża u tintrema b'tarf luer lock.
English: Uncommon side effects (may affect up to 1 in 100 people):
Maltese: Effetti sekondarji mhux komuni (li jistgħu jaffettwaw sa persuna waħda minn kull 100):
English: Aripiprazole oral 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 orali ta' aripiprazole li jvarjaw minn 0.5 sa 30 mg li ġew amministrati darba kuljum lil individwi f'saħħithom għal ġimagħtejn ipproduċew tnaqqis marbut mad-doża fl-irbit ta' 11C-raclopride, li huwa riċettur ligand ta' D2/D3, mal-kawdat u l-putamen osservati permezz ta' tomografija ta' emissjonijiet ta' positron.
English: Gastrointesti nal disorders
Maltese: Disturbi gastrointestin ali
English: Anorexia Hyponatraemia
Maltese: Newtropenija Anemija
English: The recommended and starting dose is 400 mg unless your doctor decided to give you a lower starting or follow up dose (300 mg, 200 mg or 160 mg).
Maltese: Id-doża rrakkomandata u tal-bidu hi ta' 400 mg għajr meta t-tabib tiegħek jiddeċiedi li jagħtik doża tal-bidu jew sussegwenti aktar baxxa (300 mg, 200 mg jew 160 mg).
English: Alkaline phosphatase increased
Maltese: Żieda fl-alkaline phosphatase
English: In the Double-blind, Active-controlled Phase of the 38-week trial, from baseline to last visit there was a mean decrease in prolactin levels in Abilify Maintena (−0.33 ng/ml) compared with a mean increase in oral aripiprazole tablets 10-30 mg (0.79 ng/ml; p < 0.01).
Maltese: Prolaktin Fil-fażi double-blind ikkontrollata b'mod attiv tal-prova ta' 38 ġimgħa, mil-linja bażi sal-aħħar viżta kien hemm tnaqqis medju fil-livelli ta' prolactin fil-grupp ta' Abilify Maintena (−0.33 mg/ml) meta mqabbel ma' żieda medja fil-grupp ta' pilloli orali ta' aripiprazole ta' 10-30 mg (0.79 ng/ml; p < 0.01).
English: Dysgeusia
Maltese: Disfaġja
English: Blood bilirubin increased Aspartate aminotransferase increased
Maltese: Żieda fil-bilirubin tad-demm Żieda fl-aspartate aminotranferase
English: Single package containing:
Maltese: Pakkett multiplu:
English: This trial consisted of a screening phase and 4 treatment phases: Conversion, Oral Stabilisation, Abilify Maintena Stabilisation, and Double-blind Placebo-controlled.
Maltese: Konverżjoni, Stabilizzazzjoni Orali, Stabilizzazzjoni fuq Abilify Maintena, u Fażi Double-blind, ikkontrollata bi Plaċebo.
English: Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
Maltese: Sinjali oħra jistgħu jinkludu livelli ogħla ta' creatine phosphokinase, mijoglobinurja (rabdomijolisi) u insuffiċjenza renali akuta.
English: The safety profile was consistent with that known to Abilify Maintena.
Maltese: Il-profil ta' sigurtà kien konsistenti ma' dak magħruf dwar Abilify Maintena.
English: In trials in stable patients with schizophrenia, Abilify Maintena was associated with a higher frequency of EPS symptoms (18.4 %) than oral aripiprazole treatment (11.7 %).
Maltese: sintomi EPS (18.4 %) minn trattament b'aripiprazole orali (11.7 %).
English: • gait disturbance
Maltese: Disturbi vaskulari
English: There are a further 154 cumulative spontaneous reports of eye movement disorder, of which 22 were serious.
Maltese: Hemm 154 rapport spontanju kumulattiv ieħor ta' disturb fil-moviment tal-għajn, li minnhom 22 kienu serji.
English: • muscle rigidity, muscle spasms, muscle twitching, muscle tightness, mucle pain (myalgia), pain in extremity
Maltese: • riġidità fil-muskoli, spażmi fil-muskoli, kontrazzjoni fil-muskoli, ġbid fil-muskoli, uġigħ fil muskoli (mijalġja), uġigħ fil-periferiji
English: ARIP IMD 400/300 mg vs. ARIP 10-30 mg: p value 0.9920 ARIP IMD 400/300 mg vs. ARIP IMD 50/25 mg: p value < 0.0001
Maltese: ARIP 10-30 mg: valur p 0.9920 ARIP IMD 400/300 mg vs.
English: Based on population pharmacokinetic evaluation of Abilify Maintena, the total body clearance of aripiprazole was 3.71 L/h in extensive metabolisers of CYP2D6 and approximately 1.88 L/h (approximately 50 % lower) in poor metabolisers of CYP2D6 (for dose recommendation, see section 4.2).
Maltese: aripiprazole mill-ġisem kienet ta' 3.71 L/siegħa f'metabolizzaturi estensivi ta' CYP2D6 u madwar 1.88 L/siegħa (madwar 50 % inqas) f'metabolizzaturi dgħajfa ta' CYP2D6 (għal rakkomandazzjoni dwar id-doża, ara sezzjoni 4.2).
English: Based on in vitro studies, CYP3A4 and CYP2D6 enzymes are responsible for dehydrogenation and hydroxylation of aripiprazole, and N-dealkylation is catalysed by CYP3A4.
Maltese: Abbażi ta' studji in vitro, l-enzimi CYP3A4 u CYP2D6 huma responsabbli għal deidroġinazzjoni u idroksilazzjoni ta' aripiprazole, u N
English: Abilify Maintena contains less than 1 mmol sodium (23 mg) per dose.
Maltese: Abilify Maintena fih inqas minn 1 mmol ta' sodju (23 mg) f'kull doża.
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: Prolaktin Fi provi kliniċi bl-indikazzjonijiet approvati u wara t-tqegħid fis-suq, ġew osservati kemm żieda u tnaqqis ta' prolaktin fis-serum meta mqabbla mal-linja bażi b'aripiprazole (sezzjoni 5.1).
English: The 95 % CI (-5.26, 3.99) for the difference in the estimated proportion of patients experiencing impending relapse by end of Week 26 excluded the predefined non-inferiority margin, 11.5 %.
Maltese: Is-CI ta' 95 % (5.26, 3.99) għad-differenza fil-proporzjon ta' pazjenti stmati li jesperjenzaw rikaduta imminenti sa tmien il-Ġimgħa 26 kien jeskludi l-marġini ddefiniti minn qabel li ‘mhux inferjuri',
English: Oropharyngeal spasm Laryngospasm Aspiration pneumonia
Maltese: Spażmu orofarinġeali Laringospażmu
English: Compulsive shopping Poriomania
Maltese: Xiri kompulsiv Porjomanija
English: The incidence of Abilify Maintena patients with prolactin levels > 1 time the upper limit of normal range (ULN) at any assessment was 5.4 % compared with 3.5 % of the patients on oral aripiprazole tablets 10-30 mg.
Maltese: L-inċidenza ta' pazjenti fuq Abilify Maintena b'livelli ta' prolactin aktar minn darba ogħla mil-limitu ta' fuq tal-firxa normali (ULN - upper limit of normal) fi kwalunkwe stima kienet ta' 5.4 % meta mqabbla ma' 3.5 % għall-pazjenti fuq pilloli orali ta' aripiprazole ta' 10-30 mg.
English: Concomitant administration of Abilify Maintena and other inducers of CYP3A4 (such as rifampicin, rifabutin, phenytoin, phenobarbital, primidone, efavirenz, nevirapine and St. John's Wort) may be expected to have similar effects.
Maltese: (bħal rifampicin, rifabutin, phentoin, phenobarbital, primidone, efavirenz, nevirapine u St.
English: Nephrolithiasis Glycosuria
Maltese: Nefrolitijasi Glikosurja
English: Sudden unexplained death Cardiac arrest Torsades de pointes Ventricular arrhythmias QT prolongation
Maltese: Waqfien kardijaku Torsades de pointes Arritmiji ventrikulari
English: The incidence of weight loss of ≥ 7 % from baseline to last visit was 6.4 % for Abilify Maintena and 6.7 % for placebo.
Maltese: L-inċidenza ta' telf ta' piż ta' ≥ 7 % mil-linja bażi sal-aħħar viżta kienet ta' 6.4 % għal Abilify Maintena u 6.7 % għal plaċebo.
English: The efficacy of Abilify Maintena in acutely relapsed adult patients with schizophrenia was established in a short-term (12-week), randomised, double-blind, placebo-controlled trial (n = 339).
Maltese: L-effikaċja ta' Abilify Maintena f'pazjenti adulti li rkadew bi skiżofrenja b'mod akut ġiet stabbilita fi prova każwali, double-blind, bil-plaċebo bħala kontroll, ta' terminu qasir (12-il ġimgħa) (n = 339).
English: The Kaplan-Meier curves of the time from randomisation to impending relapse during the 38-week, Double-blind, Active-controlled Phase for Abilify Maintena, oral aripiprazole 10-30 mg, and aripiprazole Long-Acting Injectable 50 mg/25 mg are shown in Figure 1.
Maltese: Il-kurvi ta' Kaplan-Meier mill-ħin ta' għażla b'mod każwali sar-rikaduta imminenti matul il-Fażi Double-blind, Ikkontrollata b'mod attiv ta' 38 ġimgħa, għal Abilify Maintena, aripiprazole orali 10-30 mg, u aripiprazole 50 mg/25 mg li Jiġi Injettat u Jaħdem fit-Tul huma murija f'Figura 1.
English: It has been proposed that aripiprazole's efficacy in schizophrenia is mediated through a combination of partial agonism at dopamine D2 and serotonin 5-HT1A receptors and antagonism at serotonin 5-HT2A receptors.
Maltese: Ġie propost li l-effikaċja ta' aripiprazole fi skiżofrenija hija medjata minn kombinazzjoni ta' agoniżmu parzjali f'riċetturi D2 ta' dopamine u 5-HT1A ta' serotonin u antaġoniżmu f'riċetturi 5-HT2A ta' serotonin.
English: Oculogyric crisis: From post-marketing sources, there were 20 reports of oculogyric crisis during the interval (11 serious) and 244 reports cumulatively (92 serious).
Maltese: Minn sorsi ta' wara t-tqegħid fis-suq, kien hemm 20 rapport ta' kriżi tad-dawrien tal-ballun tal-għajn matul l-intervall (11 serji) u 244 rapport b'mod kumulattiv
English: The PSP is a validated clinician-rated scale that measures personal and social functioning in four domains: socially useful activities (e.g. work and study), personal and social relationships, self-care, and disturbing and aggressive behaviours.
Maltese: Il-PSP hi skala gradata u vvalidata minn tobba li tkejjel il-funzjonament personali u soċjali f'erba' oqsma: attivitajiet soċjalment utli (eż. xogħol u studju), relazzjonijiet personali u soċjali, kura personali, u imġiba inkwetanti u aggressiva.
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: The safety and efficacy of Abilify Maintena in the treatment of schizophrenia in patients 65 years of age or older has not been established (see section 4.4).
Maltese: Is-sigurtà u l-effikaċja ta' Abilify Maintena fit-trattament ta' skiżofrenija f'pazjenti ta' 65 sena jew aktar ma ġewx determinati (ara sezzjoni 4.4).
English: • frequent bowel movement
Maltese: • ippurgar frekwenti
English: • a combination of any of these symptoms: excessive sleepiness, dizziness, confusion, disorientation, difficulty talking, difficulty walking, muscle stiffness or shaking, fever, weakness, irritability, aggression, anxiety, increase in blood pressure, or seizures that can lead to unconsciousness.
Maltese: • kull kombinazzjoni minn dawn is-sintomi: ngħas eċċessiv, sturdament, konfużjoni, diżorjentament, diffikultà biex titkellem, diffikultà biex timxi, ebusija tal-muskoli jew rogħda, deni, dgħufija, irritabilità, aggressjoni, ansjetà, żieda fil-pressjoni, jew konvulżjonijiet li jistgħu jwasslu biex tintilef minn sensik.
English: Gluteal muscle administration
Maltese: Ebusija muskoloskeletri ka
English: Over-cap Tip-cap
Maltese: Għatu tat-tarf
English: The incidence of weight gain of ≥ 7 % from baseline to last visit (week 12) was 21.5 % for Abilify Maintena compared with the placebo group 8.5 %.
Maltese: L-inċidenza ta' żieda fil-piż ta' ≥ 7 % mil-linja bażi sal-aħħar vista (ġimgħa 12) kienet 21.5 % għal Abilify Maintena meta mqabbel mat-8.5 % tal grupp tal-plaċebo.
English: Further, the non-inferiority of Abilify Maintena compared to oral aripiprazole 10-30 mg is supported by the results of the analysis of the Positive and Negative Syndrome Scale score (PANSS).
Maltese: 10-30 mg hu sostnut mir-riżultati tal-analiżi tal-Iskala ta' Sindrome Pożittiv u Negattiv għall-Iskiżofrenija (PANSS - Positive and Negative Syndrome Scale Score).
English: This difference was not statistically significant.
Maltese: Din id-differenza ma kenitx statistikament sinifikanti.
English: The estimated relapse rate by end of Week 26 was 7.12 % for Abilify Maintena, and 7.76 % for oral aripiprazole tablets 10-30 mg, a difference of -0.64 %.
Maltese: u 7.76 % għal pilloli orali ta' aripiprazole 10-30 mg, differenza ta' −0.64 %.
English: Dose
Maltese: Azzjoni
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 (41 times highest recommended daily aripiprazole dose) with no fatalities.
Maltese: Fi provi kliniċi u mill-esperjenza ta' wara t-tqegħid fis-suq, doża eċċessiva akuta aċċidentali jew maħsuba ta' aripiprazole waħdu kienet identifikata f'pazjenti adulti b'dożi stmati rapportati sa 1,260 mg (41 darba aktar mill-ogħla doża ta' aripiprazole rakkomandata kuljum) mingħajr fatalitajiet.
English: The final efficacy analysis included 403 randomised patients and 80 exacerbations of psychotic symptoms/impending relapse events.
Maltese: L-analiżi ta' effikaċja finali kienet tinkludi 403 pazjenti magħżula b'mod każwali u 80 każ ta' taħrix ta' sintomi psikotiċi/rkadar imminenti.
English: Peripheral oedema
Maltese: Uġigħ fis-sider Edima periferali
English: How to store Abilify Maintena
Maltese: X'fih Abilify Maintena
English: • loss of appetite (anorexia), difficulty in swallowing
Maltese: • nuqqas t'aptit (anoreksja), diffikultà biex tibla'
English: MM/YYYY
Maltese: Waqgħat
English: During double-blind treatment, mean change in body weight from baseline to last visit was -0.2 kg for Abilify Maintena and -0.4 kg for placebo (p = 0.812).
Maltese: Matul it-trattament double-blind, il-bidla medja fil-piż tal-ġisem mil-linja bażi sal-aħħar viżta kienet ta' −0.2 kg għal Abilify Maintena u −0.4 kg għall-plaċebo (p = 0.812).
English: Deltoid
Maltese: Deltojde
English: In this PSUR, there are 15 spontaneous reports of oculogyric crisis (8 serious) in the interval and 223 cumulatively (78 serious) for the oral formulations, comparing to 5 spontaneous reports of oculogyric crisis (3 serious) in the interval and 21 cumulatively (14 serious) for the prolonged-release suspension for injection.
Maltese: F'dan il-PSUR, hemm 15-il rapport spontanju ta' kriżi tad-dawrien tal-ballun talgħajn (8 serji) fl-intervall u 223 b'mod kumulattiv (78 serji) għall-formulazzjonijiet orali, li jikkompara ma' 5 rapporti spontanji ta' kriżi tad-dawrien tal-ballun tal-għajn (3 serji) fl-intervall u 21 b'mod kumulattiv (14 serji) għas-sospensjoni li terħi l-mediċina bil-mod għall-injezzjoni.
English: Step 4: Injection procedure a) Detach the luer lock syringe containing the recommended volume of reconstituted Abilify Maintena suspension from the vial.
Maltese: Stadju 4: Proċedura tal-injezzjoni a) Aqla' minn mal-kunjett is-siringa luer lock li fiha l-volum irrakkomandat ta' suspensjoni rrikostitwita ta' Abilify Maintena.
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: Nuchal rigidity
Maltese: TAGĦRIF
English: Known CYP2D6 poor metabolisers
Maltese: F'metabolizzaturi batuti ta' CYP2D6,
English: Neutropenia has been reported in the clinical program with Abilify Maintena and typically started around day 16 after first injection, and lasted a median of 18 days.
Maltese: Newtropenija ġiet irrapportata fil-programm kliniku b'Abilify Maintena u b'mod tipiku bdiet madwar jum 16 wara l-ewwel injezzjoni, u damet medjan ta' 18-il jum.
English: • kidney stones, sugar (glucose) in urine
Maltese: • ġebel fil-kliewi, zokkor (glukosju) fl-awrina
English: In clinical trials aripiprazole has not been shown to induce clinically relevant weight gain (see section 4.8).
Maltese: Fi provi kliniċi, aripiprazole ma ntweriex li jqanqal żieda fil-piż rilevanti b'mod kliniku (ara sezzjoni 4.8).
English: After reconstitution each ml of suspension contains 200 mg aripiprazole.
Maltese: Wara r-rikostituzzjoni kull ml ta' suspensjoni fih 200 mg aripiprazole.
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 ħafna, ebusija fil-muskoli, bidla fl-istat mentali u evidenza ta' instabilità tas-sistema awtonomika (polz jew pressjoni mhux regolari, qalb tħabbat iktar mis-soltu, għaraq, u qalb ma tħabbatx b'mod regolari).
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 gruppi ta' età iżgħar.
English: Dose adjustments due to interactions with CYP2D6 and/or CYP3A4 inhibitors and/or CYP3A4 inducers
Maltese: Aġġustamenti fid-doża minħabba interazzjonijiet b'impedituri ta' CYP2D6 u/jew CYP3A4 u/jew indutturi ta' CYP3A4
English: In CYP2D6 poor metabolisers, concomitant use of strong inhibitors of CYP3A4 may result in higher plasma concentrations of aripiprazole compared to that in CYP2D6 extensive metabolisers (see section 4.2).
Maltese: aripiprazole fil-plażma meta mqabbel ma' dak ta' metabolizzaturi estensivi ta' CYP2D6 (ara sezzjoni 4.2).
English: - higher amounts of gamma-glutamyl transferase
Maltese: Żieda fl-alanine aminotransferase Żieda fil-gamma-glutamyl transferase
English: Table 1 PANSS Total Score - Change From Baseline to Week 38-LOCF: Randomised Efficacy Samplea, b
Maltese: Punteġġ Totali PANSS - Bidla mil-Linja Bażi sa Ġimgħa 38-LOCF Kampjun ta' Effikaċja Każwalia, b
English: In a clinical trial of oral aripiprazole 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 s-Cmax ta' aripiprazole b'63 % u 37 %, rispettivament.
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 oral 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 skiżofrenija jew disturb skiżoaffettiv, il-medji ġeometriċi tas-Cmax u l-AUC ta' aripiprazole kienu 68 % u 73 % inqas, rispettivament, meta mqabbla ma' meta aripiprazole orali (30 mg) ġie mogħti waħdu.
English: Patients treated with aripiprazole should be observed for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia and weakness) and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control (see section 4.8).
Maltese: Pazjenti kkurati b' aripiprazole, għandhom jiġu osservati għal sinjali u sintomi ta' ipergliċemija (bħal polidipsja, poliurja, polifaġja u dgħufija) u pazjenti b'dijabete mellitus jew fatturi ta' riskju għal dijabete mellitus għandhom jiġu monitorjati regolarment f'każ ta' kontroll ta' glukosju li jmur għall-agħar (ara sezzjoni 4.8).
English: Each vial contains 400 mg aripiprazole.
Maltese: Kull kunjett fih 400 mg aripiprazole.
English: Subjects with akathisia typically received anti-cholinergic medicines as treatment, primarily benzatropine mesilate and trihexyphenidyl.
Maltese: Individwi b'akatisja b'mod tipiku rċevew mediċini antikolinerġiċi bħala trattament, prinċipalment benzatropine mesilate u trihexphenidyl.
English: c) Use the luer lock syringe to remove the vial adapter from the package and discard the vial adapter package.
Maltese: c) Uża s-siringa luer lock biex tneħħi l-adapter tal-kunjett minn ġol-pakkett u armi l-pakkett tal-adapter tal-kunjett.
English: When used concomitantly with strong CYP3A4 inhibitors the dose should be reduced to 200 mg (see section 4.5).
Maltese: Meta jintuża fl-istess waqt ma' impedituri qawwija ta' CYP3A4 id-doża għandha titnaqqas għal 200 mg (ara sezzjoni 4.5).
English: Musculoskele tal and connective tissue disorders
Maltese: Disturbi muskolu skeletriċi u tat-tessuti konnettivi
English: • suicide attempt and suicide
Maltese: • attentat ta' suwiċidju u suwiċidju
English: Dry mouth Gastrooesophageal reflux disease
Maltese: Mard ta' rifluss gastroesofageali Dispepsja
English: After plunger rod is at complete stop, middle stopper will be at the indicator line.
Maltese: Wara li l-virga tal-planġer tkun waqfet kompletament, l-istopper tan-nofs ikun fil-linja indikattiva.
English: Developmental toxicity, including dose-dependent delayed foetal ossification and possible teratogenic effects, were observed in rats at doses resulting in sub-therapeutic exposures (based on AUC) and in rabbits at doses resulting in exposures approximately 3 and 11 times the mean steady-state AUC at the maximum recommended clinical dose.
Maltese: Tossiċità tal-iżvilupp, li tinkludi ossifikazzjoni mdewma fil-fetu u possibbiltà ta' effetti teratoġeniċi dipendenti mid-doża, kienu osservati fil-firien f'dożi li jirriżultaw minn esponimenti sottoterapewtiċi (abbażi tal-AUC) u fil-fniek f'dożi li jirriżultaw f'esponimenti ta' madwar 3 u 11-il darba il-medja tal-AUC fl-istat fiss bid-doża klinika massima rakkomandata.
English: Powder
Maltese: Piż