FrancophonIA/ELRC3.0 huggingface dataset:
English: Cariprazine (dose range 3-6 mg, target dose 4.5 mg) was investigated compared to risperidone (dose range 3-6 mg, target dose 4 mg) in patients with persistent, predominant negative symptoms of schizophrenia (n=461).
Maltese: Cariprazine (firxa tad-doża ta' 3-6 mg, doża fil-mira ta' 4.5 mg) kien investigat mqabbel ma' risperidone (firxa tad-doża ta' 3-6 mg, doża fil-mira 4 mg) f'pazjenti b'sintomi negattivi predominanti, persistenti ta' skiżofrenija (n=461). 86% tal-pazjenti kellhom inqas minn 55 sena, 54% minnhom kienu rġiel.
English: - visual impairment.
Maltese: Mhux applikabbli.
English: A potentially fatal symptom complex referred to as neuroleptic malignant syndrome (NMS) has been reported in association with antipsychotic treatment.
Maltese: Kumpless ta' sintomi potenzjalment fatali msejjaħ sindrome newrolettiku malinn (NMS, neuroleptic malignant syndrome) kien irrappurtat b'rabta ma' kura b'antipsikotiċi.
English: Pruritus Rash
Maltese: Ħakk Raxx
English: With cariprazine no QT interval prolongation was detected compared to placebo in a clinical trial designed to assess QT prolongation (see section 5.1).
Maltese: B'cariprazine, l-ebda titwil fl-intervall tal-QT ma kien osservat mqabbel ma' plaċebo fi prova klinika maħsuba biex tevalwa t-titwil tal-QT (ara sezzjoni 5.1).
English: Each hard capsule contains cariprazine hydrochloride corresponding to 1.5 mg cariprazine.
Maltese: Kull kapsula iebsa fiha cariprazine hydrochloride li jikkorrispondi għal 1.5 mg cariprazine.
English: Safety and efficacy of cariprazine have not been evaluated in patients with severe renal impairment (CrCl < 30 mL/min).
Maltese: Is-sigurtà u l-effikaċja ta' cariprazine għadhom ma ġewx evalwati f'pazjenti b'indeboliment sever tal-kliewi (CrCl < 30 mL/min).
English: The primary endpoint was change from baseline to week 6 in the Positive and Negative Syndrome Scale (PANSS) total score and the secondary endpoint was change from baseline to week 6 in the Clinical Global Impressions-Severity (CGI-S) score in all acute schizophrenia studies.
Maltese: Il-punt finali primarju kien bidla mil-linja bażi sa Ġimgħa 6 fil-punteġġ totali tal-Iskala tas-Sindrome Pożittiv u Negattiv (PANSS, Positive and Negative Syndrome Scale) u l-punt finali sekondarju kien bidla mil-linja bażi sa Ġimgħa 6 fl-iskali ta' klassifikazzjoni tas-Severità tal-Impressjonijiet Globali
English: Therefore CYP2D6 inhibitors are unlikely to have a clinically relevant effect on cariprazine metabolism.
Maltese: Għalhekk, huwa improbabbli li l-inibituri ta' CYP2D6 se jkollhom effett klinikament sinifikanti fuq il-metaboliżmu ta' cariprazine.
English: 4Dystonia: Blepharospasm, Dystonia, Muscle tightness, Oromandibular dystonia, Torticollis, Trismus 5Other extrapyramidal diseases and abnormal movement disorders: Balance disorder, Bruxism, Drooling, Dysarthria, Gait deviation, Glabellar reflex abnormal, Hyporeflexia, Movement disorder, Restless legs syndrome, Salivary hypersecretion, Tongue movement disturbance 6Dyskinesia: Choreoathetosis, Dyskinesia, Grimacing, Oculogyric crisis, Protrusion tongue
Maltese: Disturb fil-bilanċ, Tgħażżiż tas-snien, Tlegħib, Disartrija, Devjazzjoni fil-mod kif persuna timxi, Rifless glabellari mhux normali, Nuqqas ta' riflessi, Disturb fil-moviment, Sindrome tas-Saqajn Bla Kwiet, Ipersekrezzjoni salivari, Disturb fil-moviment tal-ilsien 6Diskineżija:
English: During the long-term, open-label treatment period in, 3 patients (0.4%) had QTcB > 500 msec, one of whom also had QTcF > 500 msec. A > 60 msec increase from baseline was observed in 7 patients (1%) for QTcB and in 2 patients (0.3%) for QTcF.
Maltese: Żieda ta' > 60 msec mil-linja bażi kienet osservata f'7 pazjenti (1%) għal QTcB u f'2 pazjenti (0.3%) għal QTcF.
English: You cannot take certain medicines together with Reagila (see section “Do not take Reagila”).
Maltese: Ma tistax tieħu ċertu mediċini flimkien ma' Reagila (ara s-sezzjoni “Tiħux Reagila”).
English: Reagila 6 mg: Each hard capsule contains cariprazine hydrochloride corresponding to 6 mg cariprazine.
Maltese: Reagila 6 mg: Kull kapsula iebsa fiha cariprazine hydrochloride li jikkorrispondi għal 6 mg cariprazine.
English: No effects on male fertility were noted at exposures up to 4.8 times the clinical exposure at the MRHD.
Maltese: L-ebda effett fuq il-fertilità talirġiel ma kien osservat f'esponimenti sa 4.8 darbiet l-esponiment kliniku fl-MRHD.
English: Tel.: + 48 (22)755 96 48
Maltese: GEDEON RICHTER POLSKA Sp. z o.o. Tel.: + 48 (22)755 96 48
English: Cariprazine caused bilateral cataract and secondary retinal changes (retinal detachment and cystic degeneration) in the dog.
Maltese: Cariprazine ikkawża katarretti bilaterali u bidliet sekondarji fir-retina (distakk tar-retina u deġenerazzjoni ċistika) fil-klieb.
English: Switching from other antipsychotics to cariprazine When switching from another antipsychotic to cariprazine gradual cross-titration should be considered, with gradual discontinuation of the previous treatment while cariprazine treatment is initiated.
Maltese: Meta taqleb minn antipsikotiku ieħor għal cariprazine għandek tikkunsidra t-titrazzjoni trasversali gradwali, bi twaqqif gradwali tal-kura preċedenti filwaqt li tinbeda l-kura b'cariprazine.
English: NAME OF THE MEDICINAL PRODUCT Reagila 1.5 mg hard capsules cariprazine
Maltese: Reagila 1.5 mg kapsuli ibsin cariprazine
English: Gastrointesti nal disorders
Maltese: Letarġija Disesteżija Diskineżija Diskineżija tardiva
English: Each hard capsule contains cariprazine hydrochloride corresponding to 4.5 mg cariprazine.
Maltese: Kull kapsula iebsa fiha cariprazine hydrochloride li jikkorrispondi għal 4.5 mg cariprazine.
English: Because cariprazine is not a substrate for CYP1A2, smoking is not expected to have an effect on the pharmacokinetics of cariprazine.
Maltese: Minħabba li cariprazine mhuwiex sottostrat għal CYP1A2, it-tipjip mhux mistenni li jkollu effett fuq il-farmakokinetika ta' cariprazine.
English: - if you experience a combination of fever, sweating, faster breathing, muscle stiffness and drowsiness or sleepiness (may be signs of neuroleptic malignant syndrome).
Maltese: - jekk tesperjenza kombinazzjoni ta' deni, tegħreq, nifs mgħaġġel, riġidità fil-muskoli u sturdament jew ngħas (jistgħu jkunu sintomi ta' sindrome malinn newrolettiku).
English: Cartons contain 21, 28, 30, 49, 56, 60, 84, 90 or 98 hard capsules.
Maltese: Il-kartun fihom 21, 28, 30, 49, 56, 60, 84, 90 jew 98 kapsula iebsa Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: Transparent hard PVC/PE/PVDC blister heat-sealed with hard aluminium foil backing packed in folded carton box.
Maltese: Folja tal-PVC/PE/PVDC trasparenti iebsa ssiġġillata bis-sħana b'fojl fuq wara tal-aluminju iebes ppakkjata f'kaxxa tal-kartun mitwija.
English: Efficacy in predominantly negative symptoms of schizophrenia The efficacy of cariprazine for the treatment of predominantly negative symptoms of schizophrenia was investigated in a 26-week, multi-centre, double-blind, and active-controlled clinical trial.
Maltese: L-effikaċja f'sintomi negattivi b'mod predominanti ta' skiżofrenija L-effikaċja ta' cariprazine għall-kura ta' sintomi negattivi b'mod predominanti ta' skiżofrenija kienet investigata fi prova klinika multiċentrika, double-blind, u kkontrollata b'mod attiv li damet 26 ġimgħa.
English: Blood pressure changes
Maltese: Depressjoni Tnaqqis fillibido
English: Reagila contains the active substance cariprazine and belongs to a group of medicines called antipsychotics.
Maltese: Reagila fih is-sustanza attiva cariprazine u jappartjeni għal grupp ta' mediċini li jissejħu antipsikotiċi.
English: Concomitant administration of strong or moderate CYP3A4 inhibitors (see section 4.5).
Maltese: L-għoti flimkien ta' indutturi ta' CYP3A4 qawwija jew moderati (ara sezzjoni 4.5).
English: Potential for other medicinal products to affect cariprazine
Maltese: Potenzjal li prodotti mediċinali oħra jaffettwaw cariprazine
English: dyskinesia
Maltese: Kontraċezzjoni
English: How to store Reagila
Maltese: X'fih Reagila
English: NAME OF THE MEDICINAL PRODUCT Reagila 4.5 mg hard capsules cariprazine
Maltese: Reagila 4.5 mg kapsuli ibsin cariprazine
English: Reagila is indicated for the treatment of schizophrenia in adult patients.
Maltese: Reagila huwa indikat għall-kura tal-iskiżofrenija f'pazjenti adulti.
English: The possibility of suicidality (suicidal ideation, suicide attempt and completed suicide) is inherent in psychotic illnesses and, generally, it is reported early after initiation or switch of antipsychotic therapy.
Maltese: Il-possibbiltà ta' suwiċidalità (ħsibijiet ta' suwiċidju, attentat ta' suwiċidju u suwiċidju komplut) hija inerenti f'mard psikotiku u, ġeneralment, din hija rrappurtata kmieni fi jew wara l-bidu jew mal-qlib ta' terapija antipsikotika.
English: Cariprazine and its major active metabolites are not inhibitors of transporters OATP1B1, OATP1B3, BCRP, organic cation transporter 2 (OCT2), and organic anion transporters 1 and 3 (OAT1 and OAT3) in vitro.
Maltese: u t-trasportaturi anjoniċi organiċi 1 u 3 (OAT1 u OAT3) in vitro.
English: Cariprazine 3 to 6 mg/day 96.3 ± 9.3 -22.8 (1.6) Cariprazine 6 to 9 mg/day 96.3 ± 9.0 -25.9 (1.7) CI = confidence interval; ITT = intent to treat; LS mean = least squares mean; PANSS = Positive and Negative Syndrome Scale.
Maltese: Cariprazine 3 sa 6 mg/jum 96.3 ± 9.3 -22.8 (1.6) Cariprazine 6 sa 9 mg/jum 96.3 ± 9.0
English: In the population PK analysis there were no clinically relevant differences in the PK parameters (AUC and Cmax of the sum of cariprazine and its major active metabolites) based on age, gender and race.
Maltese: Fl-analiżi tal-PK fil-popolazzjoni ma kien hemm l-ebda differenza klinikament rilevanti fil-parametri PK (AUC u Cmax tas-somma ta' cariprazine u l-metaboliti attivi ewlenin tiegħu) ibbażati fuq l-età, issess u r-razza.
English: 1Sleep disorders: Insomnia, Abnormal dreams/nightmare, Circadian rhythm sleep disorder, Dyssomnia, Hypersomnia, Initial insomnia, Middle insomnia, Nightmare, Sleep disorder, Somnambulism, Terminal insomnia
Maltese: Insomnija, Ħolm mhux normali/ħmar il-lejl, Disturb fl-irqad tar-ritmu Ċirkadjan, Dissomnija, Ipersomnija, Insomnija inizjali, Insomnija tan-nofs, Ħmar il-lejl, Disturb fl-irqad, Sonnambuliżmu, Insomnija terminali
English: Switching to another antipsychotic from cariprazine When switching to another antipsychotic from cariprazine, no gradual cross-titration is needed, the new antipsychotic should be initiated in its lowest dose while cariprazine is discontinued.
Maltese: Meta taqleb għal antipsikotiku ieħor minn cariprazine, l-ebda titrazzjoni trasversali gradwali ma hi meħtieġa, u l-antipsikotiku l-ġdid għandu jinbeda bid-doża l-aktar baxxa tiegħu filwaqt li jitwaqqaf cariprazine.
English: Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotics - Frequency unknown.
Maltese: Każijiet ta' tromboemboliżmu venuż, inklużi każijiet ta' emboliżmu pulmonari u każijiet ta' trombożi tal-vini fondi kienu rrappurtati b'antipsikotiċi - Frekwenza mhux magħrufa.
English: Change From Baseline to Week 6 in the PANSS Total Score in Studies of Acute Exacerbations of Schizophrenia-ITT Population
Maltese: Bidla mil-Linja Bażi sa Ġimgħa 6 fil-Punteġġ Totali PANSS fl-Istudji ta' Aggravamenti Akuti tal-Iskiżofrenija-Popolazzjoni ITT
English: Reagila 3 mg: Each hard capsule contains cariprazine hydrochloride corresponding to 3 mg cariprazine.
Maltese: Reagila 3 mg: Kull kapsula iebsa fiha cariprazine hydrochloride li jikkorrispondi għal 3 mg cariprazine.
English: In female rats, lower fertility and conception indices were observed at clinically relevant exposures based on mg/m2 body surface area.
Maltese: Fil-firien nisa, kienu osservati indiċijiet aktar baxxi ta' fertilità u konċepiment f'esponimenti klinikament rilevanti bbażati fuq mg/m2 tal-erja tal-wiċċ tal-ġisem.
English: NAME OF THE MEDICINAL PRODUCT Reagila 6 mg hard capsules cariprazine
Maltese: Reagila 6 mg kapsuli ibsin cariprazine
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Reagila 1.5 mg hard capsules
Maltese: U KWANTITATTIVA Reagila 1.5 mg kapsuli ibsin
English: Brilliant blue FCF (E 133) Allura red AC (E 129) Titanium dioxide (E 171) Gelatin
Maltese: Qoxra tal-kapsula (kapsula ta' 6 mg) Brilliant blue FCF (E 133) Allura red AC (E 129) Titanium dioxide (E 171)
English: Reagila 1.5 mg hard capsules: pregelatinized (maize) starch, magnesium stearate, titanium dioxide (E 171), gelatin, black ink (shellac, black iron oxide (E 172), propylene glycol, potassium hydroxide).
Maltese: Reagila 1.5 mg kapsuli ibsin: pregelatinized (maize) starch, magnesium stearate, titanium dioxide (E 171), gelatin, black ink (shellac, black iron oxide (E 172), propylene glycol, potassium hydroxide).
English: Each hard capsule contains cariprazine hydrochloride corresponding to 6 mg cariprazine.
Maltese: Kull kapsula iebsa fiha cariprazine hydrochloride li jikkorrispondi għal 6 mg cariprazine.
English: Each hard capsule contains cariprazine hydrochloride corresponding to 3 mg cariprazine.
Maltese: Kull kapsula iebsa fiha cariprazine hydrochloride li jikkorrispondi għal 3 mg cariprazine.
English: NAME OF THE MEDICINAL PRODUCT Reagila 3 mg hard capsules cariprazine
Maltese: Reagila 3 mg kapsuli ibsin cariprazine
English: Gastrooesopha geal reflux disease
Maltese: Żieda fl-aptit Dislipidemija
English: Elevated liver transaminases
Maltese: Żidiet fit-transaminases tal-fwied
English: ° increases in liver enzymes
Maltese: Żieda fl enzimi talfwied
English: - Reagila 1.5 mg hard capsules: ‘Size 4' (approximately 14.3 mm in length) hard gelatin capsule with white opaque cap and white opaque body imprinted with “GR 1.5” on the capsule body with black ink.
Maltese: - Reagila 1.5 mg kapsuli ibsin: Kapsula tal-ġelatina iebsa tad-Daqs 4 (madwar 14.3 mm fit-tul) b'għatu opak abjad u korp opak abjad li għandha stampat “GR 1.5” fuq il-korp tal-kapsula b'linka sewda.
English: Cartons contain 7, 14, 21, 28, 30, 49, 56, 60, 84, 90 or 98 hard capsules.
Maltese: Il-kartun fihom 7, 14, 21, 28, 30, 49, 56, 60, 84, 90 jew 98 kapsula iebsa Reagila 4.5 mg u Reagila 6 mg kapsuli ibsin
English: Blood creatine phosphokinase increased
Maltese: Żieda filphosphokinase tal-kreatinina fid-demm
English: The plasma concentration of total cariprazine decreases by 50% in ~1 week and greater than 90% decline in total cariprazine concentration occurs in ~3 weeks.
Maltese: Ilkonċentrazzjoni fil-plażma ta' cariprazine totali tonqos b'50% f'~ġimgħa waħda u jkun hemm tnaqqis ta' iżjed minn 90% fil-konċentrazzjoni ta' cariprazine totali f'~3 ġimgħat.
English: In case of severe extrapyramidal symptoms, anticholinergic medicinal products should be administered.
Maltese: Fil-każ ta' sintomi ekstrapiramidali severi, għandhom jingħataw prodotti mediċinali antikolinerġiċi.
English: The safety and efficacy of cariprazine in children and adolescents aged less than 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' cariprazine fit-tfal u adolexxenti li għandhom inqas minn 18-il sena għadhom ma ġewx determinati s'issa.
English: Vision blurred Eye irritation Intraocular pressure increased
Maltese: Vista mċajpra Irritazzjoni flgħajnejn
English: Akathisia and restlessness is a frequently occurring adverse reaction of antipsychotics.
Maltese: Akatiżja u irrekwitezza hija reazzjoni avversa li sseħħ b'mod frekwenti tal-antipsikotiċi.
English: Following multiple-dose administration, peak plasma concentrations for cariprazine and the major active metabolites generally occur at approximately 3-8 hours post dose.
Maltese: Wara l-għoti ta' dożi multipli, il-konċentrazzjonijiet massimi fil-plażma għal cariprazine u l-metaboliti attivi ewlenin iseħħu ġeneralment madwar 3-8 sigħat wara d-doża.
English: Additional signs may include myoglobinuria (rhabdomyolysis) and acute renal failure.
Maltese: Sinjali addizzjonali jistgħu jinkludu mijoglobinurija (rabdomajoliżi) u insuffiċjenza akuta tal-kliewi.
English: Photophobia Cataract
Maltese: Bidliet fil-piż
English: Akathisia is a movement disorder characterized by a feeling of inner restlessness and a compelling need to be in constant motion, as well as by actions such as rocking while standing or sitting, lifting the feet as if marching on the spot, and crossing and uncrossing the legs while sitting.
Maltese: Akatiżja huwa disturb fil-moviment ikkaratterizzat minn sensazzjoni ta' irrekwitezza interna u l-bżonn li wieħed ikun f'moviment kostanti, kif ukoll minn azzjonijiet bħal tbandil waqt li wieħed ikun bilwieqfa jew bilqiegħda, li wieħed jerfa' saqajh daqslikieku kien qed jimmarċja fuq il-post, u li wieħed isallab u jerġa' jiftaħ riġlejh waqt li jkun bilqiegħda.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1209/001-010
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/17/1209/001-010
English: Detailed and updated information on this medicine is available by scanning the QR code below and the outer carton with a smartphone.
Maltese: Informazzjoni dettaljata u aġġornata dwar din il-mediċina hija disponibbli mill-iskenjar tal-kodiċi QR hawn taħt u l-kartuna ta' barra bi smartphone.
English: The efficacy of cariprazine for the treatment of acute schizophrenia was studied in three multi-center, multinational, randomized, double-blind, placebo-controlled 6-week trials including 1,754 patients with the age of 18 to 60 years.
Maltese: L-effikaċja ta' cariprazine għall-kura tal-iskiżofrenija akuta kienet studjata fi tliet provi multiċentriċi, multinazzjonali, li fihom il-parteċipanti ntgħażlu b'mod każwali, double-blind, ikkontrollati bi plaċebo li damu 6 ġimgħat li kienu jinkludi 1,754 pazjent mill-età ta' 18 sa 60 sena.
English: Reagila 4.5 mg hard capsules: pregelatinized (maize) starch, magnesium stearate, allura red AC (E 129), brilliant blue FCF (E 133), titanium dioxide (E 171), yellow iron oxide (E 172), gelatin, white ink (shellac, titanium dioxide (E 171), propylene glycol, simeticone).
Maltese: Reagila 4.5 mg kapsuli ibsin: pregelatinized (maize) starch, magnesium stearate, allura red AC (E 129), brilliant blue FCF (E 133), titanium dioxide (E 171), yellow iron oxide (E 172), gelatin, white ink (shellac, titanium dioxide (E 171), propylene glycol, simeticone).
English: - anxiety - sleepiness, difficulty in sleeping, abnormal dreams, nightmare, sleepwalking - dizziness - involuntary twisting movements and strange postures - excessive teeth grinding or jaw clenching, drooling, persistent blinking in response to tapping of the forehead (an abnormal reflex), movement problems, tongue movement disturbance (these are called extrapyramidal symptoms) - blurred vision - high blood pressure - fast, irregular heartbeat - decreased or increased appetite - nausea, vomiting, constipation - weight increased - tiredness - the following can be seen in laboratory tests:
Maltese: (sonnambuliżmu) - sturdament - tgħawwiġ involontarju tal-ġisem u qagħda tal-ġisem stramba - theżżiż tas-snien eċċessiv jew tax-xedaq, tlegħib, teptip persistenti tal-għajnejn bħala rispons għal tektik fuq il-moħħ (rifluss mhux normali), problemi fil-moviment, disturb fil-moviment tal ilsien (dawn jissejħu sintomi ekstrapiramidali) - vista mċajpra pressjoni tad-demm għolja - taħbit tal-qalb mgħaġġel u irregolari - tnaqqis jew żieda fl-aptit - dardir, rimettar, stitikezza - żieda fil-piż - għeja - dawn li ġejjin jistgħu jiġu osservati fit-testijiet tal-laboratorju:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1209/001-040
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/17/1209/001-040
English: Administration of a single dose of 1.5 mg cariprazine with a high-fat meal (900 to 1,000 calories) did not significantly affect the Cmax or AUC of cariprazine (AUC0-∞ increased by 12%, Cmax decreased by < 5% under fed condition versus fasting).
Maltese: L-għoti ta' doża waħda ta' 1.5 mg cariprazine ma' ikla b'kontenut għoli ta' xaħam (900 sa 1,000 kalorija) ma kellux effett sinifikanti fuq is-Cmax jew l-AUC ta' cariprazine (l-AUC0-∞ żdiedet bi 12%, is-Cmax naqset b'< 5% wara l-ikel kontra l-istat sajjem).
English: Safety and efficacy of cariprazine have not been evaluated in patients with severe hepatic impairment (Child-Pugh score between 10 and 15).
Maltese: Is-sigurtà u l-effikaċja ta' cariprazine għadhom ma ġewx evalwati f'pazjenti b'indeboliment sever tal-fwied (punteġġ Child-Pugh ta' bejn 10 u 15).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1209/029-036
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/17/1209/029-036
English: Women of childbearing potential must use highly effective contraception while taking cariprazine and at least for 10 weeks after stopping treatment (see sections 4.5 and 4.6).
Maltese: Nisa li jistgħu joħorġu tqal għandhom jużaw kontraċettiv effettiv ħafna waqt li qed jieħdu cariprazine u għal mill-inqas 10 ġimgħat wara li jwaqqfu l-kura (ara sezzjonijiet 4.5 u 4.6).
English: Reagila 6 mg hard capsules: pregelatinized (maize) starch, magnesium stearate, brilliant blue FCF (E 133), allura red AC (E 129), titanium dioxide (E 171), gelatin, black ink (shellac, black iron oxide (E 172), propylene glycol, potassium hydroxide).
Maltese: Reagila 6 mg kapsuli ibsin: pregelatinized (maize) starch, magnesium stearate, brilliant blue FCF (E 133), allura red AC (E 129), titanium dioxide (E 171), gelatin, black ink (shellac, black iron oxide (E 172), propylene glycol, potassium hydroxide).
English: It is currently unknown if cariprazine may reduce the effectiveness of systemically acting hormonal contraceptives and therefore women using systemically acting hormonal contraceptives should add a barrier method (see section 4.5).
Maltese: Mhux magħruf jekk cariprazine jistax inaqqas l-effikaċja ta' kontraċettivi ormonali li jaġixxu b'mod sistmatiku u għalhekk nisa li jużaw kontraċettivi ormonali li jaġixxu b'mod sistematiku għandu jużaw ukoll metodu barroera (ara sezzjoni 4.5).
English: Rhabdomyoly sis
Maltese: TWISSIJA(IET) SPEĊJALI
English: Adverse drug reactions (ADRs) based upon pooled data from cariprazine schizophrenia studies are shown by system organ class and by preferred term.
Maltese: Reazzjonijiet avversi għall-mediċina (ADRs, adverse drug reactions) bbażati fuq dejta miġbura minn studji dwar l-iskiżofrenija b'cariprazine huma murija skont is-sistema ta' klassifika tal-organi u skont it-terminu preferut.
English: Neutropenia
Maltese: Ipotirojdiżmu
English: In the preclinical studies of cariprazine lens opacity/cataract was detected in dogs (see sections 4.8 and 5.3).
Maltese: Pazjenti għandhom ikollhom il-piż tagħhom immonitorjat regolarment (ara sezzjoni 4.8).
English: Reagila with food, drink and alcohol You should not drink grapefruit juice during treatment with Reagila.
Maltese: Reagila ma' ikel, xorb u alkoħol Ma għandekx tixrob meraq tal-grejpfrut matul il-kura b'Reagila.
English: Reagila 3 mg hard capsules: pregelatinized (maize) starch, magnesium stearate, allura red AC (E 129), brilliant blue FCF (E 133), titanium dioxide (E 171), yellow iron oxide (E 172), gelatin, black ink (shellac, black iron oxide (E 172), propylene glycol, potassium hydroxide).
Maltese: Reagila 3 mg kapsuli ibsin: pregelatinized (maize) starch, magnesium stearate, allura red AC (E 129), brilliant blue FCF (E 133), titanium dioxide (E 171), yellow iron oxide (E 172), gelatin, black ink (shellac, black iron oxide (E 172), propylene glycol, potassium hydroxide).
English: This patient experienced orthostasis and sedation.
Maltese: Dan il-pazjent kellu pressjoni baxxa ortostatika u sedazzjoni.
English: - Reagila 3 mg hard capsules: ‘Size 4' (approximately 14.3 mm in length) hard gelatin capsule with green opaque cap and white opaque body imprinted with “GR 3” on the capsule body with black ink.
Maltese: - Reagila 3 mg kapsuli ibsin Kapsula tal-ġelatina iebsa tad-Daqs 4 (madwar 14.3 mm fit-tul) b'għatu opak aħdar u korp opak abjad li għandha stampat “GR 3” fuq il-korp tal-kapsula b'linka sewda.
English: Stabilized patients were then randomised to receive fixed doses of 3 or 6 mg cariprazine (n=51) or placebo (n=51) in a double-blind manner for up to 72 weeks.
Maltese: Il-pazjenti stabbilizzati mbagħad intgħażlu b'mod każwali biex jirċievu dożi fissi ta' 3 jew 6 mg cariprazine (n=51) jew plaċebo (n=51) b'mod double-blind għal sa 72 ġimgħa.