FrancophonIA/ELRC3.0 huggingface dataset:
English: No QT interval prolongation was detected following supratherapeutic doses (9 mg/day or 18 mg/day).
Maltese: L-ebda titwil tal-intervall tal-QT ma kien osservat wara dożi supraterapewtiċi (9 mg/jum jew 18 mg/jum).
English: RECORDATI S.p.A. Tel: + 39 02 487871
Maltese: Tel: + 39 02 487871
English: The most frequently reported ADRs with cariprazine in the dose range (1.5-6 mg) were akathisia (19%) and parkinsonism (17.5%).
Maltese: L-aktar reazzjonijiet avversi għall-mediċina rappurtati ta' spiss b'cariprazine fil-firxa tad-doża (1.5-6 mg) kienu akatiżija (19%) u parkinsoniżmu (17.5%).
English: - a history of seizures (fits) or epilepsy.
Maltese: - storja ta' aċċessjonijiet jew epilessija.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 13 July 2017
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI 13 ta 'Lulju, 2017
English: INFORMATION IN BRAILLE reagila 1.5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE reagila 1.5 mg
English: Total PSP at Baseline Total PSP at Week 26 Total PSP CfB to Week 26 CfB= change from baseline
Maltese: CfB tal-PSP totali sa Ġimgħa 26 CfB= bidla mil-linja bażi
English: (See section “Pregnancy and breastfeeding”).
Maltese: (Ara s-sezzjoni “Tqala u treddigħ”).
English: Co-administration of cariprazine with strong and moderate inducers of CYP3A4 may result in a significant decrease in total cariprazine exposure, therefore the co-administration of cariprazine and strong or moderate CYP3A4 inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifampicin, St. John's wort (Hypericum perforatum), bosentan, efavirenz, etravirine, modafinil, nafcillin) is contraindicated (see section 4.3).
Maltese: L-għoti flimkien ta' cariprazine ma' indutturi ta' CYP3A4 qawwija u moderati jista' jwassal għal tnaqqis sinifikanti fl-esponiment totali ta' cariprazine, għalhekk l-għoti flimkien ta' cariprazine u indutturi ta' CYP3A4 qawwija jew moderati (pereżempju carbamazepine, phenobarbital, phenytoin, rifampicin, St John's wort (Hypericum perforatum), bosentan, efavirenz, etravirine, modafinil, nafcillin) huwa kontraindikat (ara sezzjoni 4.3).
English: However, a statistically significant difference (p< 0.001) in favour of cariprazine over risperidone was observed from Week 10 onward (Table 2).
Maltese: Madankollu, differenza statistikament sinifikanti (p< 0.001) favur cariprazine fuq risperidone kienet osservata minn Ġimgħa 10 'il quddiem (Tabella 2).
English: Cariprazine has not been evaluated in patients with severe hepatic impairment (Child-Pugh Class C) (see section 4.2).
Maltese: Cariprazine ma ġiex evalwat f'pazjenti b'indeboliment sever tal-fwied (Child-Pugh Klassi Ċ) (ara sezzjoni 4.2).
English: The same information is also available on the following URL: www.reagila.com
Maltese: L-istess informazzjoni hija disponibbli wkoll fuq il-URL li ġej: www.reagila.com
English: Printing ink (black: 1.5 mg, 3 mg and 6 mg capsules)
Maltese: Linka tal-istampar (sewda: kapsuli ta' 1.5 mg, 3 mg u 6 mg)
English: A 2-part study (a single dose of 1 mg cariprazine [Part A] and a daily dose of 0.5 mg cariprazine for 14 days [Part B] was conducted in patients with varying degrees of impaired hepatic function (ChildPugh Classes A and B).
Maltese: Studju f'żewġ partijiet (doża waħda ta' 1 mg cariprazine [Parti A] u doża ta' kuljum ta' 0.5 mg cariprazine għal 14-il ġurnata [Parti B] twettaq f'pazjenti b'gradi differenti ta' funzjoni indebolita talfwied (Child-Pugh Klassijiet A u B).
English: In dogs, reversible hypertrophy/hyperplasia and vacuolation/vesiculation of the adrenal gland cortex were observed with a NOAEL 4.2 times the clinical exposure at the MRHD.
Maltese: Fil-klieb, ipertrofija/iperplasija riversibbli u vakwolazzjoni/vesikulazzjoni talkortiċi tal-glandola adrenali kienu osservati b'NOAEL ta' 4.2 darbiet l-esponiment kliniku fl-MRHD.
English: During the schizophrenia clinical development program of cariprazine, few cataract cases were reported, characterized with minor lens opacities with no visual impairment (13/3192; 0.4%).
Maltese: Matul il-programm ta' żvilupp kliniku ta' cariprazine dwar l-iskiżofrenija, ftit każijiet ta' katarretti ġew irrappurtati, ikkaratterizzati minn opaċitajiet żgħar tal-lenti b'ebda indeboliment tal-vista (13/3192; 0.4%).
English: Recordati AB Tel: +46 8 545 80 230
Maltese: Tel: +46 8 545 80 230
English: Parkinsonism was experienced in 13.6%; 5.7%; 22.1% and 5.3% in patients treated with cariprazine, placebo, risperidone and aripiprazole respectively.
Maltese: Parkinsoniżmu kien esperjenzat fi 13.6%; 5.7%; 22.1% u 5.3% f'pazjenti kkurati b'cariprazine, plaċebo, risperidone u aripiprazole rispettivament.
English: The metabolites of HCAR, HDCAR, and HDDCAR are subsequently biotransformed to their corresponding sulfate and glucuronide conjugates.
Maltese: Il-metaboliti ta' HCAR, HDCAR, u HDDCAR jiġu bijotrasformati sussegwentement fil-konjugati korrispondenti tagħhom ta' sulfate u glucoronide.
English: INFORMATION IN BRAILLE reagila 6 mg
Maltese: INFORMAZZJONI BIL-BRAILLE reagila 6 mg
English: Capsule shell (3 mg capsule)
Maltese: Qoxra tal-kapsula (kapsula ta' 3 mg)
English: INFORMATION IN BRAILLE reagila 4.5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE reagila 4.5 mg
English: Reagila 1.5 mg hard capsules Reagila 3 mg hard capsules Reagila 4.5 mg hard capsules Reagila 6 mg hard capsules cariprazine
Maltese: Reagila 1.5 mg kapsuli ibsin Reagila 3 mg kapsuli ibsin Reagila 4.5 mg kapsuli ibsin Reagila 6 mg kapsuli ibsin cariprazine
English: Respiratory, thoracic and mediastinal disorders
Maltese: Disturbi respiratorji, toraċiċi u
English: Reagila 3 mg, 4.5 mg and 6 mg hard capsules contain Allura red AC (E 129), which may cause allergic reactions.
Maltese: Reagila 3 mg, 4.5 mg u 6 mg kapsuli ibsin fihom Allura red AC (E 129), li jista' jikkawża reazzjonijiet allerġiċi.
English: The effective (functional) half-life is ~ 2 days for cariprazine and DCAR, 8 days for DDCAR and is ~1 week for total cariprazine.
Maltese: Il-half-life (funzjonali) terminali hija ~ jumejn għal cariprazine u DCAR, 8 ijiem għal DDCAR u hija ~ ġimgħa waħda għal cariprazine totali.
English: Drug withdrawal syndrome neonatal (see section 4.6)
Maltese: Sindrome ta' twaqqif talmediċina tattwelid (ara sezzjoni 4.6)
English: Capsule shell (4.5 mg capsule)
Maltese: Qoxra tal-kapsula (kapsula ta' 4.5 mg)
English: atstovybė Lietuvoje
Maltese: atstovybė Lietuvoje Tel:
English: 2Akathisia: Akathisia, Psychomotor hyperactivity, Restlessness 3Parkinsonism: Akinesia, Bradykinesia, Bradyphrenia, Cogwheel rigidity, Extrapyramidal disorder, Gait disturbance, Hypokinesia, Joint stiffness, Tremor, Masked facies, Muscle rigidity, Musculoskeletal stiffness, Nuchal rigidity, Parkinsonism
Maltese: Akatiżija, Iperattività psikomotorja, Irrekwitezza 3Parkinsoniżmu: Akineżija, Bradikineżija, Bradifrenija, Riġidità ta' Cogwheel, Disturb ekstrapiramidali, Disturbi fil-mod kif persuna timxi, Ipokineżija, Ebusija fil-ġogi, Rogħda, Ebusija fil-muskoli, Ebusija muskuloskeletrika, Ebusija f'raqbet l-għonq, Parkinsoniżmu
English: Ocular symptoms/cataract
Maltese: Sintomi okulari/katarretti
English: Reagila 1.5 mg and Reagila 3 mg hard capsules
Maltese: Reagila 1.5 mg u Reagila 3 mg kapsuli ibsin
English: - depression - sudden and severe confusion - spinning sensation - unpleasant, abnormal sense of touch - drowsiness, lack of energy or a lack of interest in doing things - involuntary movements, most commonly of the tongue or face.
Maltese: - depressjoni - konfużjoni f'daqqa u severa - tħoss kollox idur - sensazzjoni spjaċevoli u mhux normali mal-mess - ħedla, nuqqas ta' enerġija jew nuqqas ta' interess biex tagħmel l-affarijiet - movimenti involontarji, bl-aktar komuni li huma tal-ilsien jew tal-wiċċ.
English: INFORMATION IN BRAILLE reagila 3 mg
Maltese: INFORMAZZJONI BIL-BRAILLE reagila 3 mg
English: Inflammation was observed in the lungs of dogs dosed for 1 year with a NOAEL at AUC exposures 2.7 (males) and 1.7 (females) times the clinical exposure at the MRHD.
Maltese: Infjammazzjoni kienet osservata fil-pulmun tal-klieb mogħtija doża għal sena b'NOAEL f'esponimenti AUC ta' 2.7 (irġiel) u 1.7 (nisa) darbiet l-esponiment kliniku fl-MRHD.
English: Tel: + 34 91 659 15 50
Maltese: Casen Recordati S.L. Tel: + 34 91 659 15 50
English: Reagila 1.5 mg hard capsules Reagila 3 mg hard capsules Reagila 4.5 mg hard capsules Reagila 6 mg hard capsules
Maltese: Reagila 1.5 mg kapsuli ibsin Reagila 3 mg kapsuli ibsin Reagila 4.5 mg kapsuli ibsin Reagila 6 mg kapsuli ibsin
English: In the open-label phase of the study during 20 weeks cariprazine treatment 9.0% of patients developed potentially clinically significant (PCS) weight gain (defined as increase ≥ 7%) while during the double-blind phase, 9.8 % of the patients who continued with cariprazine treatment had PCS weight gain versus 7.1% of the patients who were randomized to placebo after the 20 week open-label cariprazine treatment.
Maltese: Fil-fażi open-label tal-istudju matul 20 ġimgħa ta' kura b'cariprazine, 9.0% tal-pazjenti żviluppaw żieda fil-piż li seta' kien klinikament sinifikanti (PCS, potentially clinically significant) (definita bħala żieda ta' ≥ 7%), filwaqt li matul il-fażi double-blind, 9.8% tal-pazjenti li komplew bilkura b'cariprazine kellhom żieda fil-piż PCS kontra 7.1% tal-pazjenti li kienu magħżula b'mod każwali għal plaċebo wara l-kura b'cariprazine open-label ta' 20 ġimgħa.
English: In the negative symptom study, the mean change of body weight was -0.3 kg for cariprazine and +0.6 kg for risperidone and PCS weight gain was observed in 6% of the cariprazine group while 7.4% of the risperidone group.
Maltese: Fl-istudju dwar is-sintomi negattivi, il-bidla medja fil-piż tal-ġisem kienet ta' -0.3 kg għal cariprazine u +0.6 kg għal risperidone, u żieda fil-piż PCS kienet osservata f'6% tal-grupp ta' cariprazine, kontra 7.4% tal-grupp ta' risperidone.
English: Metabolism of cariprazine and its major active metabolites, desmethyl cariprazine (DCAR) and didesmethyl cariprazine (DDCAR), is mediated mainly by CYP3A4 with a minor contribution of CYP2D6.
Maltese: Il-metaboliżmu ta' cariprazine u l-metaboliti attivi ewlenin tiegħu, desmethyl cariprazine (DCAR) u didesmethyl cariprazine (DDCAR), huwa medjat l-aktar b'CYP3A4 b'kontribuzzjoni żgħira ta' CYP2D6.
English: Both cariprazine- and risperidone-treated patient groups have shown statistically significant improvement in the change from baseline for the primary efficacy parameter, PANSS factor score for negative symptoms (PANSS-FSNS) (p< 0.001).
Maltese: PANSS għal sintomi negattivi (PANSS-FSNS, PANSS factor score for negative symptoms) (p< 0.001).
English: DCAR and DDCAR were not inhibitors of transporter P-gp although cariprazine was a P-gp inhibitor in the intestine (see section 4.5).
Maltese: DCAR u DDCAR ma kinux inibituri tat-trasportatur P-gp, għalkemm cariprazine kien inibitur ta' P-gp fl-imsaren (ara sezzjoni 4.5).
English: Cushing's syndrome - when the body produces an excess of cortisol (medicines containing ketoconazole) depression (herbal therapy containing St. John's wort (Hypericum perforatum) and medicines containing nefazodone) epilepsy and seizures (medicines containing carbamazepine, phenobarbital and phenytoin) heart disease (medicines containing diltiazem and verapamil) sleepiness (medicines containing modafinil) high blood pressure in the lungs (medicines containing bosentan).
Maltese: saquinavir, efavirenz u etravirine) infezzjonijiet fungali (mediċini li fihom itraconazole, posaconazole, voriconazole u fluconazole) sindrome ta' Cushing - meta l-ġisem jipproduċi cortisol żejjed (mediċini li fihom ketoconazole) depressjoni terapija li tuża l-ħxejjex li fiha St John's wort (Hypericum perforatum) u mediċini li fihom nefazodone) epilessija u aċċessjonijiet (mediċini li fihom carbamazepine, phenobarbital u phenytoin) mard tal-qalb (mediċini li fihom diltiazem u verapamil) ngħas (mediċini li fihom modafinil) pressjoni tad-demm għolja fil-pulmun (mediċini li fihom bosentan).
English: Reagila 4.5 mg hard capsules
Maltese: Reagila 4.5 mg kapsuli ibsin
English: There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress or feeding disorder.
Maltese: Kien hemm rapporti ta' aġitazzjoni, ipertonija, ipotonija, rogħda, ngħas, diffikultà respiratorja jew disturbi alimentari.
English: Reagila 1.5 mg: Each hard capsule contains cariprazine hydrochloride corresponding to 1.5 mg cariprazine.
Maltese: Reagila 1.5 mg: Kull kapsula iebsa fiha cariprazine hydrochloride li jikkorrispondi għal 1.5 mg cariprazine.
English: MARKETING AUTHORISATION HOLDER Gedeon Richter Plc.
Maltese: FIS-SUQ Gedeon Richter Plc.
English: In a third multinational placebo controlled study using fixed/flexible doses of 3.0-6.0 mg and 6.0-9.0 mg cariprazine, both cariprazine doses groups showed statistically significant improvement in both primary as well as secondary endpoint compared to placebo.
Maltese: Fit-tielet studju multinazzjonali kkontrollat bi plaċebo li uża dożi fissi/flessibbli ta' 3.06.0 mg u 6.t-9.0 mg cariprazine, iż-żewġ gruppi tad-dożi ta' cariprazine wrew titjib statistikament sinifikanti fil-punt finali primarju kif ukoll dak sekondarju mqabblin mal-plaċebo.
English: Akathisia was reported in 10.0% in patients treated with cariprazine and 5.2% in the risperidone group.
Maltese: Akatiżija kienet irrappurtata f'10.0% ta' pazjenti kkurati b'cariprazine u 5.2% fil-grupp ikkurat b'risperidone.
English: An increased risk cannot be excluded for other antipsychotics or other patient populations.
Maltese: Ma jistax jiġi eskluż riskju miżjud għal antipsikotiċi oħra jew popolazzjonijiet oħra ta' pazjenti.
English: DCAR is further metabolized by CYP3A4 and to a lesser extent by CYP2D6 into DDCAR and HDCAR.
Maltese: DCAR ikompli jiġi metabolizzat minn CYP3A4 u, sa livell inqas, minn CYP2D6 f'DDCAR u HDCAR.
English: In the cariprazine clinical studies the incidence of ALT, AST elevation ADRs occurred in 2.2% of cariprazine-, 1.6% of risperidone- and 0.4% of placebo-treated patients.
Maltese: Fl-istudji kliniċi b'cariprazine l-inċidenza ta' ADRs ta' żidiet fl-ALT u AST seħħet fi 2.2% ta' pazjenti kkurati b'cariprazine, 1.6% b'risperidone u 0.4% bi plaċebo.
English: In a multinational placebo controlled study using fixed doses of 1.5 mg, 3.0 mg and 4.5 mg cariprazine and 4.0 mg risperidone for assay sensitivity, all cariprazine doses and the active-control showed statistically significant improvement in both primary as well as secondary endpoint compared to placebo.
Maltese: Fi studju multinazzjonali kkontrollat bi plaċebo li uża dożi fissi ta' 1.5 mg, 3.0 mg u 4.5 mg cariprazine u 4.0 mg ta' risperidone għassensittività tal-assaġġ, id-dożi kollha ta' cariprazine u l-kontroll attiv urew titjib statistikament sinifikanti kemm fil-punt finali primarju kif ukoll dak sekondarju mqabblin ma' plaċebo.
English: Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, elevated serum creatine phosphokinase levels, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia).
Maltese: Manifestazzjonijiet kliniċi ta' NMS huma deni għoli, ebusija tal-muskoli, żieda fil-livelli tal-phosphokinase tal-kreatinina fis-serum, stat mentali alterat u evidenza ta' instabbiltà awtomatika (polz jew pressjoni tad-demm irregolari, takikardija, dijaforesi u taħbit tal-qalb irregolari).
English: Cariprazine is metabolized by CYP3A4 and, to a lesser extent, by CYP2D6, to DCAR and HCAR.
Maltese: Cariprazine huwa metabolizzat minn CYP3A4 u, sa livell inqas, minn CYP2D6 għal DCAR u HCAR.
English: In rabbits, cariprazine caused maternal toxicity, but no foetal toxicity at exposures 5.8 times the clinical exposure at the MRHD.
Maltese: Fil-fniek, cariprazine ikkawża tossiċità għallomm, iżda l-ebda tossiċità għall-fetu f'esponimenti ta' 5.8 darbiet l-esponiment kliniku fl-MRHD.
English: Parkinsonism was experienced in 5.2% and 7.4% in cariprazine and risperidone treated patients respectively.
Maltese: Parkinsoniżmu kien esperjenzat f'5.2% u 7.4% ta' pazjenti kkurati b'cariprazine u risperidone rispettivament.
English: Sími: +46 8 545 80 230 (Svíþjóð)
Maltese: +46 8 545 80 230 (Svíþjóð)
English: However, a statistically significant difference (p=0.002) in favour of cariprazine over risperidone was observed from Week 14 onward (Table 2).
Maltese: Madankollu, differenza statistikament sinifikanti favur cariprazine fuq risperidone kienet osservata minn Ġimgħa 14 'il quddiem (Tabella 2).
English: It is currently unknown whether cariprazine may reduce the effectiveness of systemically acting hormonal contraceptives, and therefore women using systemically acting hormonal contraceptives should add a second barrier method.
Maltese: Mhux magħruf jekk cariprazine jistax inaqqas l-effikaċja ta' kontraċettivi ormonali li jaġixxu b'mod sistematiku, u għalhekk nisa li jużaw kontraċettivi ormonali li jaġixxu b'mod sistematiku għandhom iżidu tieni metodu barriera.
English: Reagila 6 mg hard capsules
Maltese: Reagila 6 mg kapsuli ibsin
English: Alcohol should be avoided when taking Reagila.
Maltese: L-alkoħol għandu jiġi evitat meta tieħu Reagila.
English: (Rare side effect) - combination of fever, sweating, muscle stiffness, and drowsiness or sleepiness.
Maltese: (Effett sekondarju rari) - kombinazzjoni ta' deni, tegħreq, riġidità fil-muskoli u ħedla jew ngħas.
English: However the therapeutic effect of cariprazine may be mediated through a combination of partial agonist activity at dopamine D3, D2 (Ki values of 0.085-0.3 nM versus 0.49-0.71 nM respectively) and serotonin 5-HT1A receptors (Ki values of 1.4-2.6 nM), and antagonist activity at serotonin 5-HT2B, 5-HT2A and histamine H1 receptors (Ki values of 0.58-1.1 nM, 18.8 nM and 23.3 nM, respectively).
Maltese: 4-2.6 nM), u attività antagonista fir-riċetturi ta' serotonin 5-HT2B, 5-HT2A u ta' histamine H1 (valuri Ki ta' 0.58-1.1 nM, 18.8 nM u 23.3 nM, rispettivament). Cariprazine għandu affinità baxxa għar-riċetturi ta' serotonin 5-HT2C u adrenerġiċi α1 (valuri Ki ta' 134 nM u 155 nM, rispettivament).
English: Dysuria Pollakisuria
Maltese: Disturbi flakkomodazzjoni viżwali
English: No dose adjustment is required in patients with mild to moderate renal impairment (Creatinine Clearance (CrCl) ≥ 30 mL/min and < 89 mL/min).
Maltese: L-ebda aġġustament fid-doża ma hu meħtieġ f'pazjenti b'indeboliment tal-kliewi minn ħafif għal moderat (Tneħħija ta' Kreatinina (CrCl) ≥ 30 mL/min u < 89 mL/min).
English: Each hard capsule contains 0.0096 mg Allura red AC (E 129).
Maltese: Kull kapsula iebsa fiha 0.0096 mg Allura red AC (E 129).
English: Both cariprazine- and risperidone-treated patient groups have shown statistically significant improvement in the change from baseline for the secondary efficacy parameter, Personal and Social Performance (PSP) total score (p< 0.001).
Maltese: Kemm il-grupp ta' pazjenti kkurati b'cariprazine kif ukoll dak b'risperidone wrew titjib statistikament sinifikanti fil-bidla mil-linja bażi għall-parametru tal-effikaċja sekondarja, il-punteġġ totali tal-Prestazzjoni Personali u Soċjali (PSP, Personal and Social Performance) (p< 0.001).
English: The two major active metabolites, desmethyl cariprazine and didesmethyl cariprazine have a similar in vitro receptor binding and functional activity profile as the parent drug.
Maltese: Iż-żewġ metaboliti attivi ewlenin, desmethyl cariprazine u didesmethyl cariprazine għandhom irbit mar-riċetturi in vitro u profil ta' attività funzjonali simili bħall-mediċina prinċipali.
English: After repeated administration plasma exposure of cariprazine and its two major active metabolites, desmethyl cariprazine (DCAR) and didesmethyl cariprazine (DDCAR), increases proportionally over the therapeutic dose range of 1.5 to 6 mg.
Maltese: Wara l-għoti ripetut, l-esponiment fil-plażma ta' cariprazine u ż-żewġ metaboliti attivi ewlenin tiegħu, desmethyl cariprazine (DCAR) u didesmethyl cariprazine (DDCAR), jiżdied b'mod proporzjonali fuq il-firxa tad-doża terapewtika ta' 1.5 sa 6 mg.
English: By the end of the trial 49.0% of placebo-treated patients versus 21.6% of cariprazine-treated patients had a relapse of schizophrenic symptoms.
Maltese: Sal-aħħar tal-prova 49.0% talpazjenti kkurati bi plaċebo kontra 21.6% tal-pazjenti kkurati b'cariprazine kellhom rikaduta tassintomi skiżofreniċi.
English: Each hard capsule contains 0.0008 mg Allura red AC (E 129).
Maltese: Kull kapsula iebsa fiha 0.0008 mg Allura red AC (E 129).
English: Reagila 4.5 mg: Each hard capsule contains cariprazine hydrochloride corresponding to 4.5 mg cariprazine.
Maltese: Reagila 4.5 mg:Kull kapsula iebsa fiha cariprazine hydrochloride li jikkorrispondi għal 4.5 mg cariprazine.
English: In vivo non-clinical studies demonstrated that cariprazine occupies D3 receptors to a similar extent as D2 receptors at pharmacologically effective doses.
Maltese: Studji mhux kliniċi in vivo wrew li cariprazine jokkupa r-riċetturi D3 sa livell simili bħar-riċetturi D2 fid-dożi farmakoloġikament effettivi.
English: Suicidal behaviour Delirium Depression Libido decreased Libido increased Erectile dysfunction
Maltese: Żieda fil-libido Disfunzjoni erettili
English: Hypertrophy of the adrenal gland cortex was observed at 4.1 times the clinical exposure at the MRHD in rats (females only) and at clinically relevant total cariprazine plasma concentrations in mice.
Maltese: Ipertrofija tal-kortiċi tal-glandola adrenali kienet osservata f'4.1 darbiet l-esponiment kliniku flMRHD fil-firien (nisa biss) u f'konċentrazzjonijiet fil-plażma ta' cariprazine totali klinikament rilevanti fil-ġrieden.
English: In elderly patients above 65 years of age data are limited.
Maltese: Id-dejta hija limitata għal pazjenti anzjani li għandhom iżjed minn 65 sena.
English: Compared to healthy subjects, patients with either mild or moderate hepatic impairment had up to approximately 25% higher exposure (Cmax and AUC) for cariprazine and up to approximately 45% lower exposure for the major active metabolites, desmethyl cariprazine and didesmethyl cariprazine, following the single dose of 1 mg cariprazine or 0.5 mg cariprazine for 14 days.
Maltese: Mqabbla ma' individwi b'saħħithom, pazjenti b'indeboliment tal-fwied ħafif jew moderat kellhom esponiment ogħla ta' sa madwar 25% (Cmax u AUC) għal cariprazine u esponiment aktar baxx ta' madwar 45% għall-metaboliti attivi ewlenin, desmethyl cariprazine u didesmethyl cariprazine, wara d-doża waħda ta' 1 mg cariprazine jew 0.5 mg cariprazine għal 14-il ġurnata.
English: In the negative symptom study EPS was reported in 14.3% in the cariprazine group and 11.7% in the risperidone treated patients.
Maltese: Fl-istudju dwar sintomi negattivi l-EPS kienet irrappurtata f'14.3% fil-grupp ikkurat b'cariprazine u 11.7% fil-pazjenti kkurati b'risperidone.
English: During the double-blind treatment period, > 60 msec increases from baseline in QTcB were observed in 3 cariprazine-treated patients (3.1%) and 2 placebo-treated patients (2%).
Maltese: Matul il-perjodu tal-kura double-blind, żidiet ta' > 60 msec mil-linja bażi kienu osservati fi 3 pazjenti kkurati b'cariprazine (3.1%) u f'2 pazjenti kkurati bi plaċebo (2%).
English: There is no specific antidote to cariprazine.
Maltese: Ma hemm l-ebda antidotu speċifiku għal cariprazine.
English: Reagila 3 mg hard capsules
Maltese: Reagila 3 mg kapsuli ibsin
English: Totally, 751 patients with acute symptoms of schizophrenia received cariprazine 3-9 mg/day for 20 weeks, of whom 337 received cariprazine in the dose-range of 3 or 6 mg/day.
Maltese: Globalment, 751 pazjent b'sintomi akuti taliskiżofrenija rċevew cariprazine 3-9 mg/jum għal 20 ġimgħa, li minnhom 337 rċivew cariprazine filmedda tad-doża ta' 3 jew 6 mg/jum.
English: Phospholipidosis was observed in the lungs of rats, dogs, and mice (with or without inflammation) and in the adrenal gland cortex of dogs at clinically relevant exposures.
Maltese: Fosfolipidożi kienet osservata fil-pulmun tal-firien, klieb u ġrieden (b'infjammazzjoni jew mingħajr) u fil-kortiċi tal-glandola adrenali tal-klieb f'esponimenti klinikament rilevanti.
English: Each hard capsule contains 0.0003 mg Allura red AC (E 129).
Maltese: Kull kapsula iebsa fiha 0.0003 mg Allura red AC (E 129).
English: Potential for cariprazine to affect other medicinal products
Maltese: Potenzjal li cariprazine jaffettwa prodotti mediċinali oħra