FrancophonIA/ELRC3.0 huggingface dataset:
English: This trial consisted of a screening phase and 3 treatment phases: Conversion Phase, Oral Stabilisation Phase, and Double-blind, Active-controlled Phase.
Maltese: Fażi ta' Konverżjoni, Fażi ta' Stabilizzazzjoni Orali, u Fażi Double-Blind, Ikkontrollata b'mod Attiv.
English: Each vial contains 300 mg aripiprazole.
Maltese: Kull kunjett fih 300 mg aripiprazole.
English: Completed suicide Suicide attempt Pathological gambling Impulse-control disorders Binge eating
Maltese: Logħob tal-ażżard patoloġiku u disturbi oħra tal- kontroll tal-impuls
English: Hyperglycaemia Hypercholesterolaemia Hyperinsulinaemia Hyperlipidaemia Hypertriglyceridaemia Appetite disorder
Maltese: Il-professjonisti dwar il-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V.
English: The toxicological profile for aripiprazole administered to experimental animals by intramuscular injection is generally similar to that seen following oral administration at comparable plasma levels.
Maltese: Il-profil tossikoloġiku għal aripiprazole mogħti b'injezzjoni ġol-muskoli lill-annimali f'esperimenti huwa ġeneralment simili għal dak li jidher wara l-għoti orali f'livelli kumparabbli tal-plażma.
English: Ketoconazole and other strong CYP3A4 inhibitors
Maltese: Ketoconazole u impedituri qawwija oħra ta' CYP3A4
English: The incidence of weight loss of ≥ 7 % from baseline to last visit was 10.2 % for Abilify Maintena and 4.5 % for oral aripiprazole tablets 10-30 mg. During the Doubleblind, Placebo-controlled Phase of the 52-week long-term trial, the incidence of weight gain of ≥ 7 % from baseline to last visit was 6.4 % for Abilify Maintena and 5.2 % for placebo.
Maltese: Waqt il-fażi double-blind tal-prova ikkontrollata b'mod attiv fuq tul ta' żmien ta' 52 ġimgħa, l-inċidenza ta' żieda fil-piż ta' ≥ 7 % mil-linja bażi sal-aħħar viżta kienet ta' 6.4 % għall-grupp ta' Abilify Maintena u 5.2 % għall-grupp tal-plaċebo.
English: An additional finding was cholelithiasis as a consequence of precipitation of sulphate conjugates of hydroxy-metabolites of aripiprazole in the bile of monkeys after repeated oral dosing at 25 to 125 mg/kg/day or approximately16 to 81 times the maximum recommended human dose based on mg/m2.
Maltese: Riżultat addizzjonali kien il-kolelitijasi bħala konsegwenza ta' preċipitazzjoni ta' konjugati tas-sulfat ta' metaboliti hydroxy ta' aripiprazole fil-bila ta' xadini wara dożaġġ orali ripetut b'25 sa
English: Abilify Maintena also showed statistically significant improvement in symptoms represented by CGIS score change from baseline to week 10.
Maltese: Abilify Maintena wkoll wera titjib statistikament sinifikanti f'sintomi rappreżentati bil-punteġġ CGIS mil-linja bażi sa ġimgħa 10.
English: Metabolism and nutrition disorders
Maltese: Disturbi fil-metaboliż mu u nnutrizzjoni
English: Less than doseproportional increases in aripiprazole and dehydro-aripiprazole concentrations and AUC parameters are observed after monthly Abilify Maintena injections of 300 mg to 400 mg.
Maltese: Żidiet li kienu inqas fi proporzjon mad-doża tal-konċentrazzjonijiet ta' aripiprazole u dehydroaripiprazole u l-parametri tal-AUC huma osservati wara injezzjonijiet kull xahar ta' Abilify Maintena ta' 300 mg sa 400 mg.
English: A single-dose study with oral administration of aripiprazole to 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: Fi studju b'doża waħda ta' għoti orali ta' aripiprazole lil individwi bi gradi differenti ta' ċirrożi tal-fwied (Klassijiet ta' Child-Pugh A, B u Ċ) ma ntwera l-ebda effett sinifikanti ta' indeboliment tal-fwied fuq il-farmakokinetika ta' aripiprazole u dehydro-aripiprazole, iżda l-istudju kien jinkludi biss 3 pazjenti b'ċirrożi tal-fwied ta' Klassi Ċ, li mhuwiex biżżejjed sabiex wieħed jagħmel konklużjonijiet fuq il-kapaċità metabolika tagħhom.
English: The 518 events included 291 serious events of which 31 events were fatal.
Maltese: Il-518-il każ kienu jinkludu 291 każ serju li minnhom 31 kienu fatali.
English: • sluggishness
Maltese: • letarġija
English: Other strong inhibitors of CYP2D6, such as fluoxetine and paroxetine, may be expected to have similar effects and similar dose reduction should, therefore, be applied (see section 4.2).
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 (ara sezzjoni 4.2).
English: Patients fulfilling the oral stabilisation requirement in the Oral Stabilisation Phase were assigned to receive, in a single-blind fashion, Abilify Maintena and began an Abilify Maintena Stabilisation Phase for a minimum of 12 weeks and a maximum of 36 weeks.
Maltese: Pazjenti li ssodisfaw ir-rekwiżit ta' stabilizzazzjoni orali fil-Fażi ta' Stabilizzazzjoni Orali kienu assenjati biex jirċievu, b'mod single-blind, Abilify Maintena u bdew Fażi ta' Stabilizzazzjoni fuq Abilify Maintena għal minimu ta' 12-il ġimgħa u massimu ta' 36 ġimgħa.
English: The aripiprazole Long-Acting Injectable 50 mg/25 mg dose was included as a low dose aripiprazole to test assay sensitivity for the non-inferiority design.
Maltese: Id-doża ta' 50 mg/25 mg ta' aripiprazole li Jiġi Injettat u Jaħdem fit-Tul kienet inkluża bħala grupp ta' aripiprazole b'doża baxxa sabiex tiġi ttestjata s-sensittività tal-assaġġ għad-disinn ta' non-inferjorità.
English: Step 2: Reconstitution of the powder a) Remove the solvent and powder vial caps and wipe the tops with a sterile alcohol swab.
Maltese: Stadju 2: Rikostituzzjoni tat-trab a) Neħħi l-għotjien tal-kunjetti tas-solvent u tat-trab u imsaħ il-partijiet ta' fuq b'imselħa sterili blalkoħol.
English: Strong CYP2D6 or strong CYP3A4 inhibitors
Maltese: Impedituri qawwija ta' CYP2D6 u impedituri qawwija ta' CYP3A4
English: - One 51 mm (2 inch) 21 gauge hypodermic safety needle with needle protection device.
Maltese: - Labra ipodermika waħda ta' sigurtà ta' 51 mm (2 pulzieri) 21 gejġ b'apparat ta' protezzjoni għal-labra.
English: Absorption of aripiprazole from the IM depot formulation was complete relative to the IM standard (immediate-release) formulation.
Maltese: L-assorbiment ta' aripiprazole mill-formulazzjoni depot IM kien sħiħ meta mqabbel mal-formulazzjoni standard IM (rilaxx immedjat).
English: Indicator line Plunger Rod b) Vertically shake the syringe vigorously for 20 seconds until the reconstituted suspension appears uniform.
Maltese: Indikattiva Virga tal planġer b) Waqt li tkun bil-wieqfa ħallat is-siringa sew għal 20 sekonda sakemm is-suspensjoni rerikostitwita tidher konsistenti.
English: Musculoskeletal stiffness
Maltese: Nixfa vulvovaġinali
English: CYP2D6 poor metabolisers
Maltese: Metabolizzaturi dgħajfa magħrufa ta' CYP2D6
English: Tardive dyskinesia Parkinsonism Movement disorder Psychomotor hyperactivity Restless legs syndrome Cogwheel rigidity Hypertonia
Maltese: Iperattività psikomotorja Sindromu ta' irrekwitezza tar-riġlejn
English: INSTRUCTIONS FOR HEALTH CARE PROFESSIONALS
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI
English: • mental disorder characterized by defective or lost contact with reality
Maltese: • disturb mentali kkaraterizzat minn realtà difettuża jew telf ta' kuntatt mar-realtà
English: Abilify Maintena is intended for adult patients with schizophrenia who are sufficiently stabilised during treatment with oral aripiprazole.
Maltese: Abilify Maintena huwa maħsub għal pazjenti adulti bi skiżofrenija li huma stabilizzati biżżejjed waqt kura b'aripiprazole orali.
English: • a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness since this may be a sign of a condition called neuroleptic malignant syndrome (NMS).
Maltese: • kull kombinazzjoni ta' deni, teħid tan-nifs aktar mgħaġel, tegħreq, ebusija tal-muskoli u ħedla jew ngħas peress li dawn jistgħu jkunu sinjal ta' kondizzjoni magħrufa bħala sindromu newroletiku malinn (NMS -neuroleptic malignant syndrome).
English: The estimated proportion of patients experiencing impending relapse by end of Week 26 for Abilify Maintena was 7.12 %, which was statistically significantly lower than in aripiprazole Long-Acting Injectable 50 mg/25 mg (21.80 %; p = 0.0006).
Maltese: 50 mg/25 mg li Jiġi Injettat u Jaħdem fit-Tul (21.80 %; p = 0.0006).
English: Non-clinical safety data for orally administered aripiprazole reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Maltese: Tagħrif mhux kliniku dwar sigurtà għal aripiprazole mogħti b'mod orali bbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni, riskju ta' kanċer, tossiċità fuq ir-riproduzzjoni u l-iżvilupp.
English: a: Negative change in score indicates improvement.
Maltese: a: Bidla negattiva fil-punteġġ tindika titjib.
English: Abilify Maintena contains sodium
Maltese: Kif jidher Abilify Maintena u l-kontenut tal-pakkett
English: All the other formulations only state in section 4.8 that dystonia is a class effect of this medication.
Maltese: Il-formulazzjonijiet l-oħrajn kollha jiddikjaraw f'sezzjoni 4.8 li d-distonja hija effett tal-klassi ta' din il-mediċina.
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 kienu jinkludu letarġija, żieda fil-pressjoni, ħedla tan-ngħas, takikardija, dardir, rimettar u dijarea.
English: Based on results from trials with oral administration of aripiprazole, aripiprazole is widely distributed throughout the body with an apparent volume of distribution of 4.9 l/kg, indicating extensive extravascular distribution.
Maltese: Abbażi tar-riżultati minn provi wara għoti orali ta' aripiprazole, aripiprazole jinfirex sew madwar il-ġisem kollu b'volum apparenti ta' distribuzzjoni ta' 4.9 L/kg, li jindika distribuzzjoni ekstravaskulari estensiva.
English: The rate of death in oral aripiprazole-treated patients was 3.5 % compared to 1.7 % in placebo.
Maltese: Ir-rata ta' mewt f'pazjenti trattati b'aripiprazole orali kienet ta' 3.5 % meta mqabbla ma' 1.7 % fil-grupp tal-plaċebo.
English: Pain in extremity Arthralgia
Maltese: Uġigħ fil-partijiet periferiċi Artralġja
English: Jaundice
Maltese: Doża
English: Aripiprazole exhibited antagonist properties in animal models of dopaminergic hyperactivity and agonist properties of dopaminergic hypoactivity.
Maltese: Aripiprazole wera proprjetajiet antagonisti f'mudelli ta' annimali ta' attività dopaminerġika eċċessiva u proprjetajiet agonisti ta' ipoattività dopaminerġika.
English: Each single pack containing one vial of powder, 2 ml vial of solvent, one 3 ml luer lock syringe with pre-attached 38 mm (1.5 inch) 21 gauge, hypodermic safety needle with needle protection device, one 3 ml disposable syringe with luer lock tip, one vial adapter and three hypodermic safety needles: one 25 mm (1 inch) 23 gauge, one 38 mm (1.5 inch) 22 gauge and one 51 mm (2 inch) 21 gauge.
Maltese: Il-labra rrakkomandata għall-għoti gluteali għandha tkun labra ipodermika ta' sigurtà ta' 38 mm (pulzier u nofs), 22 gejġ; għal pazjenti obeżi (Indiċi tal-massa tal-ġisem (BMI) > 28 kg/m2), għandha tintuża labra ipodermika ta' sigurtà ta' 51 mm (2 pulzieri), 21 gejġ.
English: 400 mg vial:
Maltese: Kunjett ta' 400 mg:
English: Cases of serotonin syndrome have been reported in patients taking aripiprazole, and possible signs and symptoms for this condition can occur especially in cases of concomitant use with other serotonergic medicinal products, such as SSRI/SNRI, or with medicinal products that are known to increase aripiprazole concentrations (see section 4.8).
Maltese: Każijiet ta' sindromu ta' serotonin ġew rappurtati f'pazjenti li kienu qed jieħdu aripiprazole, u sinjali u sintomi possibbli għal din il-kundizzjoni jistgħu jseħħu speċjalment f'każijiet ta' użu flimkien ma' prodotti mediċinali serotoġeniċi oħra, bħal SSRI/SNRI, jew ma' prodotti mediċinali li huma magħrufa li jżidu l-konċentrazzjoniiet ta' 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: Abilify Maintena 400 mg Vial
Maltese: Abilify Maintena 400 mg/300 mg
English: • diabetic ketoacidosis (ketones in the blood and urine) or coma
Maltese: • ketoaċidosi dijabetika (ketones fid-demm u fl-awrina) jew koma
English: Patients taking 400 mg of Abilify Maintena
Maltese: Pazjenti li qed jieħdu 400 mg ta' Abilify Maintena
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 oral aripiprazole alone.
Maltese: Hekk ukoll, għal dehydro-aripiprazole, il-medji ġeometriċi tas-Cmax u l-AUC wara l-għoti ma' carbamazepine kienu 69 % u 71 % inqas, rispettivament, minn dawk ta' wara l-kura b'aripiprazole orali waħdu.
English: Table 2 PANSS Total Score - Change From Baseline to week 10: Randomised Efficacy Sample
Maltese: Tabella 2 Punteġġ Totali PANSS - Bidla mil-Linja
English: Abilify Maintena should not be used to manage acutely agitated or severely psychotic states when immediate symptom control is warranted.
Maltese: Abilify Maintena m'għandux jintuża sabiex jikkontrolla stati ta' aġitazzjoni akuta jew stati psikotiċi severi meta jkun meħtieġ kontroll immedjat tas-sintomi.
English: Trismus
Maltese: Rimettar
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton (without blue box) - component of multipack 300 mg
Maltese: Kartuna ta' barra (mingħajr il-kaxxa blu) - komponent ta' pakkett multiplu 300 mg
English: - One 25 mm (1 inch) 23 gauge hypodermic safety needle with needle protection device.
Maltese: - Labra ipodermika waħda ta' sigurtà ta' 25 mm (pulzier) 23 gejġ b'apparat ta' protezzjoni għal labra.
English: The incidences of the ADRs associated with aripiprazole therapy are tabulated below.
Maltese: L-inċidenzi ta' Reazzjonijiet Avversi tal-Mediċina (ADRs) assoċjati ma' terapija b'aripiprazole huma miġbura f'tabella hawn taħt.
English: Sluggishness
Maltese: Mijalġja
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 ittikkettata bis-[14C], bejn wieħed u ieħor 27 % tar-radjuattività li ngħatat inġabret mill-awrina u madwar 60 % mill-ippurgar.
English: Dyspepsia
Maltese: Distonja
English: Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe
Maltese: Abilify Maintena 300 mg trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod Abilify Maintena 400 mg trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod Abilify Maintena 300 mg trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod f'siringa mimlija għal-lest
English: - One vial adapter.
Maltese: - Adapter wieħed għall-kunjett.
English: Concomitant use of CYP3A4 inducers with Abilify Maintena should be avoided for more than 14 days because the blood levels of aripiprazole are decreased and may be below the effective levels (see section 4.5).
Maltese: 14-il jum peress li l-livelli ta' aripiprazole fid-demm jonqsu u jistgħu jkunu taħt il-livelli effettivi (ara sezzjoni 4.5).
English: The potentially medically serious signs and symptoms reported included somnolence, transient loss of consciousness and extrapyramidal symptoms.
Maltese: Is-sinjali u s-sintomi rrappurtati li possibbilment huma medikament serji kienu jinkludu ħedla tan-ngħas, telf temporanju mis-sensi u sintomi ekstrapiramidali.
English: • spontaneous flow of milk from the breasts (galactorrhoea)
Maltese: • influss ta' ħalib spontanju mis-sider (galaktorrea)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton (without blue box) - component of multipack 400 mg
Maltese: Kartuna ta' barra (mingħajr il-kaxxa blu) - komponent ta' pakkett multiplu 400 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton - Single pack 300 mg
Maltese: Kartuna ta' barra - Pakkett wieħed 300 mg
English: PANSS Total Score - Change From Baseline to Week 38-LOCF: Randomised Efficacy Samplea, b
Maltese: Bażi sal-Ġimgħa 38 LOCF: Kampjun ta' Effikaċja Każwalia, b
English: In patients who are known to be CYP2D6 poor metabolisers, the starting and maintenance dose should be 300 mg.
Maltese: F'pazjenti magħrufa li huma metabolizzaturi dgħajfa ta' CYP2D6, id-doża tal-bidu u ta' manteniment għandha tkun 300 mg.
English: In clinical trials, rare cases of NMS were reported during treatment with aripiprazole.
Maltese: ġew irrapportati xi każijiet rari ta' NMS waqt it-trattament b'aripiprazole.
English: Vision blurred Eye pain
Maltese: • uġigħ fis-sider
English: Akathisia was the most frequently observed symptom (8.2 %) and typically started around day 10 after first injection, and lasted a median of 56 days.
Maltese: Akatisja kienet l-aktar sintomu frekwenti osservat (8.2 %) u b'mod tipiku bdiet madwar jum 10 wara l-ewwel injezzjoni, u damet medjan ta' 56 jum.
English: Thus, superiority of Abilify Maintena over the aripiprazole Long-Acting Injectable 50 mg/25 mg was established and the validity of the trial design was confirmed.
Maltese: Abilify Maintena fuq aripiprazole 50 mg/25 mg li Jiġi Injettat u Jaħdem fit-Tul kienet stabbilita u l-validità tad-disinn tal-prova kien ikkonfermat.
English: Patients eligible for the Double-blind, Placebo-controlled Phase were randomly assigned in a 2:1 ratio to double-blind treatment with Abilify Maintena or placebo, respectively.
Maltese: Pazjenti eleġibbli għall-Fażi Double-blind, ikkontrollata bil-plaċebo kienu assenjati b'mod każwali fi proporzjon 2:1 għal trattament double-blind b'Abilify Maintena jew plaċebo rispettivament
English: Abilify Maintena comes as a pre-filled syringe.
Maltese: Abilify Maintena jista' jżid l-effett ta' mediċini użati biex ibaxxu l-pressjoni.
English: Temperature regulation disorder (e.g. hypothermia, pyrexia) Chest pain
Maltese: Disturb fir-regolazzjoni tat temperatura (eż ipotermja, deni)
English: Powder and solvent for prolonged-release suspension for injection Powder: white to off-white
Maltese: Trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod Trab: abjad għal offwajt
English: Patients taking 300 mg of Abilify Maintena
Maltese: Pazjenti li qed jieħdu 300 mg ta' Abilify Maintena
English: Diabetic hyperosmolar coma Diabetic ketoacidosis
Maltese: Koma iperosmolari dijabetika
English: Step 4: Procedures after injection
Maltese: Stadju 4: Proċeduri wara l-injezzjoni
English: - higher amounts of glycosylated haemoglobin
Maltese: Żieda fl-emoglobina glikosilata
English: Add 1.9 ml solvent to reconstitute the powder.
Maltese: Żid 1.9 ml ta' solvent biex tirrikostitwixxi t-trab.
English: Dystonia
Maltese: Indolenza
English: > 4 weeks and < 6 weeks
Maltese: > 4 ġimgħat u < 6 ġimgħat
English: Upon discontinuation of the CYP2D6 or CYP3A4 inhibitor, the dosage of aripiprazole should be increased to the dose prior to the initiation of the concomitant therapy.
Maltese: Mal-waqfien tal-impeditur ta' CYP2D6 jew CYP3A4, id dożaġġ ta'aripiprazole għandu jiżdied għad-doża ta' qabel il-bidu tat-terapija konkomitanti.
English: • involuntary loss of urine (incontinence)
Maltese: • taħrablek l-awrina (inkontinenza)
English: These included: dose-dependent adrenocortical toxicity in rats after 104 weeks of oral administration at approximately 3 to 10 times the mean steady-state AUC at the maximum recommended human dose and increased adrenocortical carcinomas and combined adrenocortical adenomas/carcinomas in female rats at approximately 10 times the mean steady-state AUC at the maximum recommended human dose.
Maltese: 3 sa 10 darbiet il-medja tal-AUC fl-istat fiss tad-doża massima rakkomandata għall-bniedem u żieda fil-karċinomi adrenokortikali u adenomi/karċinomi adrenokortiċi kkombinati f'firien nisa b'madwar
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton - Single pack 400 mg
Maltese: Kartuna ta' barra - Pakkett wieħed 400 mg
English: • difficulty swallowing
Maltese: • insuffiċjenza tal-fwied
English: Following multiple intramuscular doses, the plasma concentrations of aripiprazole gradually rise to a maximum plasma concentration at a median tmax of 7 days for the gluteal muscle and 4 days for the deltoid muscle.
Maltese: Wara dożi intramuskolari multipli, il-konċentrazzjonijiet ta' aripiprazole fil-plażma għolew b'mod gradwali għal konċentrazzjoni massima fil-plażma f'medjan tmax ta' sebat ijiem għall-muskolu gluteali u erbat ijiem għall-muskolu deltojde.
English: Aripiprazole is the predominant medicinal product moiety in systemic circulation.
Maltese: Aripiprazole huwa l-iżjed parti tal-prodott mediċinali li tinstab fiċ-ċirkolazzjoni sistemika.
English: The incidences of Abilify Maintena patients with prolactin levels > 1 time the upper limit of normal range (ULN) was 1.9 % compared to 7.1 % for placebo patients.
Maltese: kienu ta' 1.9 % meta mqabbla ma' 7.1 % għall-pazjenti fuq plaċebo.
English: The following symptoms may occur in new-born babies, of mothers that have received Abilify Maintena in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.
Maltese: Is-sintomi li ġejjin jistgħu jseħħu fi trabi tat-twelid, ta' ommijiet li rċivew Abilify Maintena fl-aħħar trimestru (l-aħħar tliet xhur tat-tqala tagħhom): tregħid, ebusija u/jew dgħufija tal-muskoli, ngħas, aġitazzjoni, problemi bin-nifs u diffikultà biex jinsqew.
English: Twist clockwise until snugly fitted.
Maltese: Tiġi Injettata u Taħdem fit-Tul
English: The SmPC for Abilify Maintena prolonged-release suspension for injection lists oculogyric crisis in section 4.8 and the PIL lists fixation of eye balls in one position as an uncommon side effect.
Maltese: Issuspensjoni tal-prodott rikostitwit għandha tidher bħala suspensjoni konsistenti u omoġenja li hi opaka u ta' kulur abjad ħalib.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer label (with blue box) - Multipack 300 mg
Maltese: Kartuna ta' barra (bil-kaxxa blu) - Pakkett multiplu 300 mg
English: Add 1.5 ml solvent to reconstitute the powder.
Maltese: Żid 1.5 ml ta' solvent biex tirrikostitwixxi t-trab.
English: Galactorrhoea Gynaecomastia Breast tenderness Vulvovaginal dryness
Maltese: Trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod
English: 300 mg vial:
Maltese: Kunjett ta' 300 mg:
English: - One 3 ml luer lock syringe with pre-attached 38 mm (1.5 inch) 21 gauge hypodermic safety needle with needle protection device.
Maltese: - Labra ipodermika waħda ta' sigurtà ta' 38 mm (pulzier u nofs) 22 gejġ b'apparat ta' protezzjoni għal-labra.
English: Although the causes of deaths were varied, most of the deaths appeared to be either cardiovascular (e.g. heart failure, sudden death) or infectious (e.g. pneumonia) in nature (see section 4.8).
Maltese: (eż. falliment tal-qalb, mewt zoptu) jew infettiva (eż. pnewmonja) (ara sezzjoni 4.8).