FrancophonIA/ELRC3.0 huggingface dataset:
English: In the phase II pivotal study, muscle spasms, myalgia, myopathy and cases of CK elevations were observed.
Maltese: II, kienu osservati spażmi muskolari, mijalġja, mijopatija u każijiet ta' elevazzjonijiet tas-CK.
English: Sun Pharmaceutical Industries Europe B.V. Τηλ: +31 23 568 55 01
Maltese: Τηλ: +31 23 568 55 01
English: In these patients, increases in laboratory values of CK to grade 2 and higher severity had a median time to onset of 12.9 weeks (range 2 to 39 weeks) after initiating Odomzo therapy and a median time to resolution (to normalisation or grade 1) of 12 days (95% CI 8 to 14 days).
Maltese: F'dawn il-pazjenti, il-valuri tal-laboratorju tas-CK żdiedu fil-gravità għal grad 2 u aktar u dan seħħ fi żmien medju ta' 12.9 ġimgħat (medda ta' bejn ġimagħtejn u 39 ġimgħa) wara li tnediet it-terapija b'Odomzo u s-sintomi għaddew fi żmien medju ta' 12-il jum (għal-livell ta' normalizzazzjoni jew grad 1) (95% CI 8 sa 14-il jum).
English: This interaction is not expected to be clinically significant.
Maltese: Din linterazzjoni mhix mistennija tkun klinikament sinifikanti.
English: These effects observed at clinically relevant exposures include closure of bone growth plates, effects on growing teeth, effects on the male and female reproductive tract, atrophy of the hair follicles with alopecia, gastrointestinal toxicity with body weight loss and effects on lymph nodes.
Maltese: Dawn l-effetti osservati waqt espożizzjonijiet relevanti klinikament jinkludu l-għeluq tal-pjattaformi tat-tkabbir tal-għadam, effetti fuq it-tkabbir tassnien, effetti fuq il-passaġġ riproduttiv tal-irġiel u n-nisa, atrofija tal-follikali tax-xagħar b'alopeċja, tossiċità gastrointestinali b'telf tal-piż u effetti fuq l-għeqiedi limfatiċi. b'espożizzjonijiet 'il fuq sew mill-espożizzjoni klinika, organu tir ieħor kien il-fwied.
English: • muscle cramps, muscle pain, pain in the bones, ligaments and tendons
Maltese: • bugħawwiġ fil-muskoli, uġigħ fil-muskoli, uġigħ fl-għadam, fil-ligamenti u l-għerq (tendons)
English: • you must use 2 methods of contraception, one highly effective method and one barrier method (see the examples below) while you are taking Odomzo,
Maltese: • għandek tuża 2 metodi ta' kontraċezzjoni, metodu wieħed mill-aktar effettiv u metodu ta'
English: Patients with neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy) must be closely monitored due to an increased risk of muscle toxicity.
Maltese: Pazjenti b'disturbi newromuskolari (eż. mijopatiji infjammtorji, distrofija muskolari, sklerożi laterali amijotrofika, atrofija muskulari spinali) għandhom ikunu segwiti mill-qrib minħabba riskju li tiżdied it-tossiċità muskolari.
English: Tumour response was independent of Odomzo dose or plasma concentration in the dose range of 200 mg to 800 mg.
Maltese: Ir-rispons tat-tumur kien indipendenti mid-doża ta' Odomzo jew mill-konċentrazzjoni fil-plażma meta ngħatat doża ta' bejn 200 mg u 800 mg.
English: Odomzo contains lactose
Maltese: GĦAMLA KWALITATTIVA
English: Sun Pharmaceutical Industries Europe B.V. Sími: +31 23 568 55 01
Maltese: Sími: +31 23 568 55 01
English: For LaBCC, multiple punch biopsies were taken each time a response assessment was confounded by presence of lesion ulceration, cyst, and or scarring/fibrosis.
Maltese: Għal-laBCC, ittieħdu bijopsiji tat-tip “punch” kull darba li kien hemm konfużjoni tal-evalwazzjoni tar-rispons minħabba preżenza ta' ulċerazzjoni leżjonali, ċesta, u jew feriti/fibrożi.
English: Opaque pink hard capsule containing white to almost white powder with granules, with “NVR” imprinted in black ink on the cap and “SONIDEGIB 200MG” imprinted in black ink on the body.
Maltese: Kapsula iebsa ta' lewn roża opak li fiha trab abjad għal kważi abjad bil-frak, b'“NVR” stampati b'linka sewda fuq it-tapp u “SONIDEGIB 200MG” stampata b'linka sewda fuq il-qafas.
English: Among adverse drug reactions reported (Table 2), the frequency was greater in patients taking Odomzo 800 mg than in patients taking Odomzo 200 mg except for musculoskeletal pain, diarrhoea, abdominal pain, headache and pruritus.
Maltese: Fost ir-reazzjonijiet avversi rrappurtati (Tabella 2), il-frekwenza kienet akbar f'pazjenti mogħtija 800 mg Odomzo milli f'pazjenti mogħtija 200 mg Odomzo ħlief fejn jidħlu l-uġigħ muskoloskeletriku, id-dijarrea, l-uġigħ addominali, l-uġigħ ta' ras u l-ħakk.
English: • Methodology to collect information on the use of Odomzo and the compliance with the pregnancy pharmacovigilance programme and its effectiveness
Maltese: • Il-metodoloġija sabiex tinġabar l-informazzjoni dwar l-użu ta' Odomzo u l-osservanza tal programm ta' farmakoviġilanza tat-tqala u l-effettività tiegħu
English: Agents that may increase sonidegib plasma concentration
Maltese: Aġenti li jistgħu jnaqqsu l-konċentrazzjoni ta' sonidegib fil-plażma
English: It is not known whether SCC can be related to treatment with Odomzo.
Maltese: Ma ġiex stabbilit jekk is-cuSCC hix relatata mat-trattament b'Odomzo.
English: • pain
Maltese: • għeja
English: Please refer to these documents for further information.
Maltese: Sorsi oħra ta' informazzjoni
English: Sun Pharmaceutical Industries Europe B.V. Тел: +31 23 568 55 01
Maltese: Тел: +31 23 568 55 01
English: • Information for women of childbearing potential
Maltese: • Il-materjal edukattiv għall-pazjenti
English: Serum creatine phosphokinase (CK) increased
Maltese: L-aħjar rispons ġenerali, n (%) Rispons komplut
English: Women of childbearing potential must be able to comply with effective contraceptive measures.
Maltese: Nisa li jistgħu joħorġu tqal għandhom ikun kapaċi jimxu ma' miżuri għal kontraċezzjoni effettiva.
English: Embryofoetal death or severe birth defects
Maltese: Disturbi fis-sistema riproduttiva u fis-sider
English: • medicines such as methotrexate, mitoxantrone, irinotecan, or topotecan used to treat certain types of cancers or other diseases such as severe joint problems (rheumatoid arthritis) and psoriasis
Maltese: • mediċini bħalma huma methotrexate, mitoxantrone, irinotecan, jew topotecan użati biex jittrattaw ċerti tipi ta' kanċers jew mardiet oħrajn bħalma huma problemi gravi fil-ġogi (artrite rewmatojde) u psorajżi
English: Skin and subcutaneous tissue disorders Alopecia
Maltese: • mediċina msjeħa nefazodone użata biex tittratta d-dipressjoni
English: There was reduced fertility at low exposure in female rats.
Maltese: Kien hemm tnaqqis fil-fertilità minħabba espożizzjoni baxxa f'firien nisa.
English: • If renal function is not impaired and CK resolves to baseline, consider resuming treatment at 200 mg every other day.
Maltese: • Jekk il-funzjoni tal-kliewi ma tiddgħajjifx u s-CK jerġa' lura għal-linja bażi, ikkunsidra li tkompli bit-trattament billi tagħti 200 mg darba iva u darba le.
English: Therefore, therapeutic doses of Odomzo are not expected to cause clinically significant QTc prolongation.
Maltese: Għaldaqstant, id-dożi terapewtiċi ta' Odomzo mhumiex mistennija li jikkawżaw titwil sinjifikanti klinikament tal-QTc.
English: Sonidegib was shown to be foetotoxic in rabbits, as evidenced by abortion and/or complete resorption of foetuses and teratogenic resulting in severe malformations at very low exposure.
Maltese: Intwera li Sonidegib kien fetotossiku għall-fniek, kif evidenzjat permezz ta' abborti u/jew riassorbiment totali tal-feti u effetti teratoġeniċi li wasslu għal malformazzjonijiet gravi b'espożizzjoni mill-aktar baxxa.
English: Sun Pharmaceutical Industries Europe B.V. Tel: +31 23 568 55 01
Maltese: Tel.: +31 23 568 55 01
English: Odomzo must be taken at least two hours after a meal and at least one hour before the following meal to prevent increased risk of adverse events due to higher exposure of sonidegib when taken with a meal (see section 5.2).
Maltese: Odomzo għandu jittieħed mill-inqas sagħtejn wara l-ikel u mill-inqas siegħa qabel l-ikla li jkun imiss sabiex tkun evitata żieda fir-riskju ta' episodji avversi minħabba espożizzjoni ogħla għal sonidegib meta jittieħed mal-ikel (ara sezzjoni 5.2).
English: Patients with hepatic impairment No dose adjustment is necessary in patients with hepatic impairment (see section 5.2).
Maltese: Pazjenti b'indeboliment tal-fwied M'hemmx ħtieġa ta' aġġustament tad-doża f'pazjenti b'indeboliment tal-fwied (ara sezzjoni 5.2).
English: Vomiting
Maltese: Odomzo
English: In order to help healthcare providers and patients avoid embryonic and foetal exposure to Odomzo, the Marketing Authorisation Holder will provide educational materials (Odomzo Pregnancy Prevention Programme) to reinforce the potential risks associated with use of the medicinal product.
Maltese: Sabiex ngħinu lill-professjonisti fil-qasam tal-kura tas-saħħa u lill-pazjenti jevitaw li l-embrijuni u lfeti jkunu esposti għal Odomzo, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq se jipprovdi materjal edukattiv (Il-Programm ta' Prevenzjoni ta' Tqala ta' Odomzo) sabiex jissaħħu r-riskji li jista' jkun hemm b'rabta mal-użu tal-prodott mediċinali.
English: Prescriptions of Odomzo should be limited to 30 days of treatment, with continuation of treatment requiring a new prescription.
Maltese: Il-preskrizzjoni ta' Odomzo għandha tkun limitata għal 30 jum ta' trattament, u kull meta jkun hemm bżonn li jitkompla t-trattament trid tinħareġ riċetta ġdida.
English: In the phase II pivotal study, no reported cases of rhabdomyolysis were confirmed (defined as CK levels >10-fold above the pre-treatment or baseline level or >10x ULN if no baseline level reported plus a 1.5-fold increase in serum creatinine from the pre-treatment or baseline level).
Maltese: II, kien ikkonfermat li ma kienx hemm rapporti ta' każijiet ta' rabdomijoliżi (iddefiniti bħala livelli tas-CK >10 darbiet aktar mil-livell ta' qabel ma ngħata t-trattament jew tal-linja bażi jew >10x ULN jekk ma kienx irrappurtat il-livell tal-linja bażi flimkien ma' żieda ta' 1.5 drabi tal-kreatinina fis-serum mil-livell ta' qabel ma ngħata t-trattament jew tal-linja bażi).
English: Constipation
Maltese: Konstipazzjoni
English: Study CLDE225X2104 was a Phase I/II study of sonidegib in paediatric patients with recurrent or refractory medulloblastoma or other tumours potentially dependent on the Hedgehog (Hh) signalling pathway and adult patients with recurrent or refractory medulloblastoma.
Maltese: Analiżi farmakokinetika fost il-popolazzjoni wriet li indeboliment tal-kliewi ħafif jew moderat ma kellux effett sinjifikanti fuq it-tneħħija apparenti (CL/F) ta' sonidegib, li jissuġġerixxi li l-aġġustament taddoża mhuwiex meħtieġ f'pazjenti b'indeboliment tal-kliewi (ara sezzjoni 5.2).
English: Frequency all grades 200 mg
Maltese: 200 mg
English: Carcinogenicity studies have not been performed with sonidegib, but sonidegib was not genotoxic in studies conducted in vitro and in vivo.
Maltese: Ma sarux studji karċinoġenetiċi b'sonidegib, imma sonidegib ma kienx ġenotossiku waqt studji magħmulin in vitro u in vivo.
English: Tel:+40 264 50 15 00
Maltese: Terapia S.A. Tel:+40 264 50
English: A moderate meal taken 1 hour after the administration of Odomzo 200 mg provided similar exposures compared to the fasted state.
Maltese: Ikla moderata meħuda sa siegħa wara l-għoti ta' Odomzo 200 mg waslet għal espożizzjonijiet simili mqabbel mal-istat ta' sawm.
English: In the pivotal study, 29.1% of patients discontinued due to adverse events, which were mostly mild or moderate (see section 4.8).
Maltese: Fl-istudju pivotali, 29.1% tal-pazjenti twaqqfu minħabba reazzjonijiet avversi, li fil-biċċa l-kbira tagħhom kienu ħfief jew moderati (ara sezzjoni 4.8).
English: Log-Rank Test
Maltese: Test Log-Rank
English: P-value Treatment differenceb (95 % CI)
Maltese: Valur-p Differenza fit-trattamentb (95 % CI)
English: - The active substance is aripiprazole.
Maltese: - Is-sustanza attiva hi aripiprazole.
English: Personal and social functioning were evaluated using the Personal and Social Performance (PSP) scale.
Maltese: (Personal and Social Performance scale, PSP).
English: Oral aripiprazole
Maltese: Aripiprazole orali
English: Ventricular extrasystoles Bradycardia
Maltese: Ekstrasistoli ventrikulari Bradikardija
English: a Data were analysed using a mixed model repeated measures (MMRM) approach.
Maltese: Id-dejta kienet analizzata permezz ta' mudell imħallat ta' miżuri ripetuti (mixed model repeated measures, MMRM).
English: paroxetine, St. John's Wort)
Maltese: (bħal fluoxetine, paroxetine, St John's Wort)
English: • muscle problems
Maltese: • problemi muskolari
English: Oral aripiprazole 10-30 mg/day (n = 266)
Maltese: Aripiprazole orali 10-30 mg/jum (n = 266)
English: H. Lundbeck A/S Ottiliavej 9, 2500 Valby Denmark
Maltese: H. Lundbeck A/S Ottiliavej 9, 2500 Valby Id-Danimarka
English: • reduced sexual interest (libido is decreased)
Maltese: • tnaqqis fl-interess sesswali (libido mnaqqas)
English: Extrapyramidal Symptoms (EPS)
Maltese: Sintomi ekstrapiramidali (EPS - Extrapyramidal Symptoms):
English: In three placebo-controlled trials of oral aripiprazole in elderly patients with psychosis associated with Alzheimer's disease (n = 938; mean age: 82.4 years; range: 56-99 years), patients treated with aripiprazole were at an increased risk of death compared to placebo.
Maltese: Fi tliet provi ta' aripiprazole orali kkontrollati bi plaċebo f'pazjenti anzjani bi psikożi assoċjata mal-marda ta' Alzheimer (n = 938; età medja: 82.4 snin; firxa: 56-99 sena), pazjenti kkurati b'aripiprazole kienu f'riskju akbar ta' mewt meta mqabbla mal-plaċebo.
English: b Difference (Abilify Maintena minus placebo) in least squares mean change from baseline.
Maltese: b Differenza (Abilify Maintena mingħajr plaċebo) fil-bidla tal-anqas kwadri medji (least squares mean change) mil-linja bażi.
English: Neuroleptic Malignant Syndrome (NMS)
Maltese: Sindrome Newroleptiku Malinn (NMS)
English: Cases of venous thromboembolism (VTE) have been reported with antipsychotic medicinal products.
Maltese: Każijiet ta' tromboemboliżmu fil-vini (VTE - venous thromboembolism) ġew irrapportati bi prodotti mediċinali antipsikotiċi.
English: • nervousness
Maltese: • nervożità
English: 25 mm (1 inch) 23 gauge
Maltese: 25 mm (pulzier) 23 gejġ
English: Gluteal
Maltese: Gluteali
English: deltoid gluteal
Maltese: deltojde gluteali
English: Oesophageal dysmotility and aspiration have been associated with the use of aripiprazole.
Maltese: Dismotilità esofaġali u aspirazzjoni ġew assoċjati mal-użu ta' aripiprazole.
English: Aripiprazole exhibits high binding affinity in vitro for dopamine D2 and D3, serotonin 5-HT1A and 5-HT2A receptors and has moderate affinity for dopamine D4, serotonin 5-HT2C and 5-HT7, alpha-1 adrenergic, and histamine H1 receptors.
Maltese: Aripiprazole juri affinità qawwija għal irbit in vitro ma' riċetturi D2 u D3 ta' dopamine, 5-HT1A u 5-HT2A ta' serotonin u għandu affinità moderata għal riċetturi D4 ta' dopamine, 5-HT2C u 5-HT7 ta' serotonin, alfa-1 adrenerġiċi u H1 tal-istamina.
English: Multipack Bundle pack of 3 single packs.
Maltese: Pakkett multiplu Pakkett magħmul minn tliet pakketti singoli.
English: The AUC and Cmax of dehydroaripiprazole, the active metabolite, decreased by 32 % and 47 %, respectively.
Maltese: L-AUC u s-Cmax ta' dehydro-aripiprazole, il-metabolit attiv, tnaqqset bi 32 % u 47 %, rispettivament.
English: Potential for other medicinal products to affect aripiprazole
Maltese: Possibbiltà li prodotti mediċinali oħra jaffettwaw aripiprazole
English: Parkinsonism events followed in frequency of 6.9 % for Abilify Maintena, 4.15 % for oral aripiprazole 10-30 mg tablets and 3.0 % for placebo, respectively.
Maltese: Każijiet ta' parkinsoniżmu segwew fil-frekwenza ta' 6.9 % għal Abilify Maintena, 4.15 % tal-pilloliorali aripiprazole ta' 10-30 mg u 3.0 % għal plaċebo, rispettivament).
English: Alcohol should be avoided.
Maltese: Abilify Maintena ma' alkoħol Alkoħol għandu jiġi evitat.
English: 87 cases had medical history of confounding risk factors such as balance disorders, loss of consciousness, syncope, somnolence, extrapyramidal disorder, femoral fracture, alcohol abuse, bundle branch block, osteoporosis, knee arthroplasty, spinal fusion surgery, road traffic accident, fall, transient ischemic attack, cerebrovascular accident, head injury and dementia with Lewy bodies and concomitant therapy with risperidone, quetiapine fumarate, clonazepam, Latuda, valium was a confounding factor in 172 cases.
Maltese: 87 każ kellhom storja medika ta' fatturi ta' riskju konfondenti bħal disturbi tal-bilanċ, telf ta' sensi, sinkope, ħedla, disturb ekstrapiramidali, ksur femorali, abbuż t'alkoħol, imblokk tal-fergħa tal-faxxa (bundle branch block), osterporożi, artroplastija tal-irkoppa, kirurġija ta' fużjoni spinali, inċident tat-traffiku, waqgħa, attakk iskemiku temporanju (riħ ta' puplesija), inċident ċerebrovaskulari, ġerħa fir-ras u dimenzja b'korpi ta' Lewy u terapija konkomitanti b'risperidone, quetiapone fumarate, clonazepam, Latuda, valium ikun fattur ta' tfixkil f'172 każ.
English: All ADRs are listed by system organ class and frequency; very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000)
Maltese: (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Single pack
Maltese: Pakkett multiplu
English: Step 3: Preparation prior to injection a) Remove the cover, but not the adapter from the package.
Maltese: Stadju 3: Preparazzjoni qabel l-injezzjoni a) Neħħi l-għatu, imma mhux l-adapter minn ġol-pakkett.
English: • movement problems
Maltese: • problemi ta' moviment
English: Powder Carmellose sodium, mannitol, sodium dihydrogen phosphate monohydrate, sodium hydroxide
Maltese: Trab Carmellose sodium, mannitol, sodium dihydrogen phosphate monohydrate, sodium hydroxide
English: Akathisia was the most frequently observed EPS symptom (Abilify Maintena 11.4 % and placebo group 3.5 %).
Maltese: Akatisija kienet l-aktar sintomu ta' EPS osservat ta' spiss (Abilify Maintena 11.4 % u grupp tal-plaċebo 3.5 %).
English: • gastroesophageal reflux disease.
Maltese: • mard tar-refluss gastroesofaġeali.
English: Mean baseline (SD)
Maltese: Linja bażi medja (SD)
English: After administration of multiple dose of 400 mg or 300 mg of Abilify Maintena, the mean aripiprazole terminal elimination half-life is respectively 46.5 and 29.9 days presumably due to absorption ratelimited kinetics.
Maltese: Wara għoti ta' diversi dożi ta' 400 mg jew 300 mg ta' Abilify Maintena, il-half-life terminali medja ta' eliminazzjoni ta' aripiprazole kienet ta' 46.5 jiem u 29.9 jiem rispettivament preżumibbilment minħabba kinetiċi limitati mir-rata ta' assorbiment.
English: Pharmacotherapeutic group: Psycholeptics, other antipsychotics, ATC code: N05AX12
Maltese: Psikolettiċi, antipsikotiċi oħra, Kodiċi ATC:
English: Date of first authorisation: 15 November 2013 Date of latest renewal: 27 August 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 15 ta' Novembru 2013
English: The primary endpoint (change in PANSS total score from baseline to week 10) showed superiority of Abilify Maintena (n = 167) over placebo (n = 172).
Maltese: L-punt aħħari primarju (bidla fil-punteġġ totali ta' PANSS minn linja bażi sa ġimgħa 10) wera superjorità ta' Abilify Maintena (n = 167) fuq il-plaċebo (n = 172).
English: There was a statistically significant treatment difference in favour of Abilify Maintena 400 mg/300 mg compared to placebo at week 10 (+7.1, p < 0.0001, 95 % CI: 4.1, 10.1 using an ANCOVA model (LOCF)).
Maltese: Kien hemm differenza statistikament sinifikanti favur Abilify Maintena 400 mg/300 mg meta mqabbla ma' plaċebo f'ġimgħa 10 (+7.1, p < 0.0001, 95 % CI: 4.1, 10.
English: Less often substances such as propranolol and benzodiazepines (clonazepam and diazepam) were administered to control akathisia.
Maltese: Inqas ta' spiss sustanzi bħal propranolol u benzodiazepines (clonazepam u diazepam) ġew amministrati biex jikkontrollaw akatisja.
English: In the same trials with oral aripiprazole, cerebrovascular adverse reactions (e.g. stroke, transient ischaemic attack), including fatalities, were reported in patients (mean age: 84 years; range: 78-88 years).
Maltese: Fl-istess provi b'aripiprazole orali, reazzjonijiet ċerebrovaskulari avversi (eż. puplesija, attakk iskemiku temporanju), li jinkludu fatalitajiet, kienu rapportati f'pazjenti (età medja: 84 sena; firxa 78-88 sena).
English: The AUC and Cmax of dehydroaripiprazole increased by 77 % and 43 %, respectively.
Maltese: L-AUC u s-Cmax ta' dehydro-aripiprazole żdiedu b'77 % u 43 % rispettivament.
English: After multiple dose administration of Abilify Maintena, dehydro-aripiprazole, the active metabolite, represents about 29.1-32.5 % of aripiprazole AUC in plasma.
Maltese: Wara diversi dożi mogħtija ta' Abilify Maintena, dehydro aripiprazole, il-metabolit attiv, jirrapreżenta madwar 29.1-32.5 % tal-AUC ta' aripiprazole fil-plażma.
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 iktar minn 99 % mal-proteini tas-serum, u jintrabtu l-aktar mal-albumina.
English: • state of indifference with lack of emotion, feelings of emotional and mental discomfort
Maltese: • stat ta' indifferenza b'nuqqas ta' emozzjoni, sensazzjoni ta' skonfort emozzjonali u mentali
English: The safety and efficacy of Abilify Maintena in children and adolescents aged 0-17 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Abilify Maintena fi tfal u adolexxenti minn età ta' 0-17-il sena ma ġewx determinati s'issa.
English: Abilify Maintena is indicated for maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.
Maltese: Abilify Maintena hu indikat għal trattament ta' manteniment ta' skiżofrenija f'pazjenti adulti stabilizzati b'aripiprazole orali.
English: The most frequently observed adverse drug reactions (ADRs) reported in ≥ 5 % of patients in two double-blind, long-term trials of Abilify Maintena were weight increased (9.0 %), akathisia (7.9 %), insomnia (5.8 %), and injection site pain (5.1 %).
Maltese: Sommarju tal-profil tas-sigurtà L-aktar reazzjonijiet avversi tal-mediċina (ADRs - Adverse Drug Reactions) osservati b'mod frekwenti rrapportati f'≥ 5 % tal-pazjenti f'żewġ provi kliniċi double-blind, fuq tul ta' żmien, ta' Abilify Maintena kienu żieda fil-piż (9.0 %), akatisja (7.9 %), nuqqas ta' rqad (5.8 %), u uġigħ fis-sit tal-injezzjoni (5.1 %).
English: Carbamazepine and other CYP3A4 inducers
Maltese: Carbamazepine u indutturi oħra ta' CYP3A4
English: Abilify Maintena 300 mg injection aripiprazole
Maltese: Abilify Maintena 300 mg injezzjoni aripiprazole
English: Mean baseline (SD) Mean change (SD) P-value
Maltese: Bidla medja (SD) Valur-p
English: Chemical and physical in-use stability has been demonstrated for 4 hours at 25 °C.
Maltese: L-istabilità kimika u fiżika waqt l-użu intweriet għal 4 sigħat f'temperatura ta' 25 °C.
English: Abilify Maintena 400 mg injection aripiprazole
Maltese: Abilify Maintena 400 mg injezzjoni aripiprazole
English: NOTE: ARIP IMD 400/300 mg = Abilify Maintena;ARIP 10-30 mg = oral aripiprazole; ARIP IMD 50/25 mg = Long-acting Injectable
Maltese: NOTA: ARIP IMD 400/300 mg = Abilify Maintena ARIP 10-30 mg = aripiprazole orali; ARIP IMD = IM depot 50/25 mg = Sustanza li
English: Overall, 1.3 % of oral aripiprazole-treated patients reported cerebrovascular adverse reactions compared with 0.6 % of placebo-treated patients in these trials.
Maltese: Globalment, 1.3 % ta' pazjenti kkurati b'aripiprazole orali rrapportaw reazzjonijiet ċerebrovaskulari avversi meta mqabbla ma' 0.6 % ta' pazjenti kkurati bi plaċebo f'dawn il-provi.