FrancophonIA/ELRC3.0 huggingface dataset:
English: Amoxil 250 mg powder for solution for injection or infusion United Kingdom - Amoxil
Maltese: 250 mg kapsuli Ir-Renju Unit - Amoxil
English: • Lyme disease (an infection spread by parasites called ticks): Isolated erythema migrans (early stage - red or pink circular rash): 4 g a day, Systemic manifestations (late stage - for more serious symptoms or when the disease spreads around your body): up to 6 g a day.
Maltese: Eritema migrans iżolata (stadju bikri - Raxx ċirkulari aħmar jew roża): 4 g kuljum, manifestazzjonijiet Sistemiċi (stadju avvanzat - għal sintomi aktar serji jew meta tinfirex il-marda ma' ġismek): sa 6 g kuljum.
English: • a skin reaction known as ‘erythema multiforme' where you may develop: itchy reddish purple patches on the skin especially on the palms of the hands or soles of the feet, ‘hive-like' raised swollen areas on the skin, tender areas on the surfaces of the mouth, eyes and genitals.
Maltese: • Reazzjoni tal-ġilda magħrufa bħala ‘eritema multiforme' fejn inti tista' tiżviluppa: irqajja ħomor fil-vjola fil-ġilda b'mod speċjali fuq il-pali ta' idejk jew fil-qiegħ ta' sieqek, partijiet minfuħin qishom duqqajs fuq il-ġilda, partijiet sensittivi fuq l-uċuħ tal-ħalq, l-għajnenjn u l-ġenitali.
English: The pharmacokinetic results for a study, in which an amoxicillin dose of 250 mg three times daily was administered in the fasting state to groups of healthy volunteers are presented below.
Maltese: Ir-riżultati farmakokinetiċi ta' studju, li fih ġiet amministrata doża ta' 250 mg amoxicillin tliet darbiet kuljum fl-istadju ta' sawm għal gruppi ta' voluntieri b'saħħithom huma ppreżentati hawn taħt.
English: 3 g powder for oral suspension (sachets) Paper/aluminium foil/copolymer film laminate sachets.
Maltese: Qratas b'laminat rita tal-karta/fojl tal-aluminju/kopolimer.
English: Escherichia coli
Maltese: Bacillus anthracis
English: • an excessive breakdown of red blood cells causing a type of anaemia.
Maltese: • tqassim eċċessiv ta-ċelluli tad-demm ħomor li jikkawżaw tip ta' anemija.
English: Asymptomatic bacteriuria in pregnancy Acute pyelonephritis Dental abscess with spreading cellulitis Acute cystitis
Maltese: 1 Enterobacteriaceae tat-tip selvaġġ huma kkategorizzati bħala suxxettibbli għall-aminopenicillins.
English: NAME OF THE MEDICINAL PRODUCT Amoxil and associated names (see Annex I) 125 mg/1.25 ml powder for oral suspension [See Annex I - To be completed nationally]
Maltese: Amoxil u ismijiet assoċjati (ara Anness I) 125 mg/1.25 ml trab għal sospensjoni orali [Ara Anness I - Li għandu jimtela fuq livell nazzjonali]
English: Amoxil 250 mg/5ml Powder for Oral Suspension is a white powder with yellowish grains filled into clear glass bottles with a nominal volume of 107 ml (for 40 ml or 60 ml presentations) or 147 ml (for 80 ml, 100 ml or 120 ml presentations).
Maltese: Amoxil 250 mg/5 ml Trab għal Sospensjoni Orali huwa trab bajdani b'vini fl-isfar li jimtela fi fliexken talħġieġ trasparenti b'volum nominali ta' 107 mL (għal preżentazzjonijiet ta' 40 mL jew 60 mL) jew 147 mL
English: Amoxil 250 mg powder for solution for injection or infusion is a white to off-white sterile powder filled into a clear glass 25 ml vial, with a chlorobutyl rubber stopper closure and a tamper evident sealing ring.
Maltese: Amoxil 250 mg trab għal soluzzjoni għal injezzjoni jew infużjoni huwa trab sterili abjad għal offwajt li jimtela f'kunjett tal-ħġieġ trasparenti ta' 25 ml, b'tapp tal-gomma chlorobutyl u b'siġill li jipprevjeni t tbagħbis.
English: PHARMACEUTICAL FORM AND CONTENTS 2 sachets containing powder for oral suspension 14 sachets containing powder for oral suspension
Maltese: U KONTENUT 2 qratas li fihom trab għal sospensjoni orali 14-il qartas li fihom trab għal sospensjoni orali
English: 25 mg/kg stat and 12.5 mg/kg at the end of the dialysis, then 25 mg/kg/day
Maltese: Tfal taħt 40 kg 25 mg/kg stat u
English: Available in packs of 3, 6, 8, 10, 12, 16, 18, 20, 21, 24, 30, 32, 50, 100 and 500 capsules.
Maltese: Disponibbli f'pakketti ta' 3, 6, 8, 10, 12, 16, 18, 20, 21, 24, 30, 32,
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each sachet contains amoxicillin trihydrate equivalent to 3 g amoxicillin.
Maltese: Kull qartas fih amoxicillin trihydrate ekwivalenti għal 3 g amoxicillin.
English: The active substance in each capsule is 250 mg or 500 mg amoxicillin.
Maltese: X'fih Amoxil - Is-sustanza attiva f'kull kapsula hi 250 mg jew 500 mg amoxicillin.
English: Crystalluria (see sections 4.4 and 4.9 Overdose) * The incidence of these AEs was derived from clinical studies involving a total of approximately 6,000 adult and paediatric patients taking amoxicillin.
Maltese: *L-inċidenza ta' dawk l-Aes ħarġet minn studji kliniċili involvew total ta' bejn wieħed u ieħor 6,000 pazjenti adulti u tfal li jieħdu amoxicillin. #
English: If an allergic reaction occurs, amoxicillin therapy must be discontinued and appropriate alternative therapy instituted.
Maltese: Jekk isseħħ reazzjoni allerġika, it-terapija b'amoxicillin għandha titwaqqaf u tinbeda terapija alternattiva xierqa.
English: Amoxil 1 g Powder for Oral Suspension sachets contain a white powder with yellowish grains filled into paper/aluminium/polyethylene sachets.
Maltese: Il-qratas ta' Amoxil 1 g Trab għal Sospensjoni Orali fihom trab bajdani b'vini fl-isfar li jimtlew f'qratas talkarta/aluminju/polyethylene.
English: Amoxil 2 g powder for solution for injection or infusion is a white to off-white sterile powder filled into a clear glass 25 ml vial, with a chlorobutyl rubber stopper closure and a tamper evident sealing ring.
Maltese: Amoxil 2 g trab għal soluzzjoni għal injezzjoni jew infużjoni huwa trab sterili abjad għal abjad fl-isfar mimli f'kunjett tal-ħġieġ ċar ta' 25 ml, b'tapp tal-gimma tal-chlorobutyl u b'ċirku li jissiġilla li jagħmel kull tbagħbis evidenti.
English: 50 mg/kg orally, single dose 30 to 60 minutes before procedure
Maltese: 50 mg/kg b'mod orali, doża ta' darba 30 sa
English: How long will you need to take Amoxil for?
Maltese: Għal kemm għandek tieħu Amoxil?
English: Amoxil 500 mg/5 ml powder for oral suspension contains aspartame, maltodextrin and sodium benzoate
Maltese: Amoxil 500 mg/5 ml trab għal sospensjoni orali fih aspartame, maltodextrin u sodium benzoate • Aspartame (E951) huwa sors ta' fenilalanin.
English: • The expected pathogens and their likely susceptibility to antibacterial agents (see section 4.4)
Maltese: • Il-patoġeni msemmija u s-suxxettibilità probabbli tagħhom għall-aġenti antibatterjali (ara sezzjoni
English: 500 mg powder for oral suspension (sachets) Each sachet contains amoxicillin trihydrate equivalent to 500 mg amoxicillin.
Maltese: Kull doża ta' 5 ml ta' sospensjoni orali fiha amoxicillin trihydrate ekwivalenti għal 500 mg amoxicillin
English: Amoxil is for oral use.
Maltese: Għal uzu orali.
English: Belgium - Clamoxyl
Maltese: Il-Belġju - Clamoxyl
English: Adults and children ≥ 40 kg
Maltese: Adulti u tfal ta' aktar minn 40 kg
English: Reconstituted solutions of amoxicillin may be injected into the drip tubing over a period of 0.5 to 1 hour.
Maltese: Soluzzjonijiet rikostitwiti ta' amoxicillin jistgħu jiġu injettati fit-tubu tad-dripp fuq perjodu ta' 0.5 sa siegħa.
English: United Kingdom - Amoxil
Maltese: Ir-Renju Unit - Amoxil
English: For dispersible tablets and oral suspension formulations only
Maltese: Għal formulazzjonijiet orali biss
English: Infants and toddlers >3 months and children < 40 kg
Maltese: Adulti, anzjani u tfal li jiżnu ‘l fuq minn 40 kg
English: These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and in atopic individuals.
Maltese: Dawn ir-reazzjonijiet jistgħu jseħħu iktar f'individwi bi storja ta' sensittività eċċessiva għall-peniċillin u f'individwi atopiċi.
English: • low number of cells involved with blood clotting
Maltese: • numru baxx ta' ċelloli involuti fil-koagulazzjoni
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet dwar ir-rikostituzzjoni tal-prodott mediċinali qabel l-amministrazzjoni, ara sezzjoni 6.6.
English: Intravenous administration Vial
Maltese: Amministrazzjoni ġol-vina
English: 95%CI
Maltese: 95%CI valur p
English: Luxembourg/Luxemburg Recordati BVBA
Maltese: Luxembourg/Luxemburg Recordati
English: Treatment difference versus placebo (95% CI)
Maltese: Differenza tal-kura kontra plaċebo (95%
English: PANSS total (MMRM) RGH-MD-16 (n=711)
Maltese: RGH-MD-16 (n=711)
English: Table 2 Summary of results in study RGH-188-005
Maltese: Tabella 2 Sommarju tar-riżultati fl-istudju RGH-188-005
English: - The active substance is cariprazine.
Maltese: - Is-sustanza attiva hija cariprazine.
English: Richter Gedeon Nyrt.
Maltese: Magyarország Richter Gedeon Nyrt.
English: MedDRA System Organ Class
Maltese: Sistema talKlassifika tal-Organi
English: Risk of cerebrovascular accidents (CVA)
Maltese: Riskju ta' inċidenti ċerebrovaskulari (CVA, cerebrovascular accidents)
English: Capsule contents
Maltese: Kapsula iebsa
English: P-glycoprotein (P-gp) substrates
Maltese: Sottostrati ta' P-glycoprotein (P-gp)
English: The most commonly reported ocular adverse event was blurred vision (placebo: 1/683; 0.1%, cariprazine: 22/2048; 1.1%).
Maltese: L-avveniment avvers irrappurtat l-aktar komunement kien vista mċajpra (plaċebo: 1/683; 0.1%, cariprazine: 22/2048; 1.1%).
English: Akathisia, restlessness
Maltese: Akatiżija, irrekwitezza
English: Venous thromboembolism (VTE)
Maltese: Tromboemboliżmu venuż (VTE, venous thromboembolism)
English: Common (≥1/100 to
Maltese: (≥ 1/100 sa
English: ‘QR code to be included' + www.reagila.com
Maltese: ‘Il-kodiċi QR irid jiġi inkluż' + www.reagila.com
English: PANSS-FSNS at Baseline PANSS-FSNS at Week 26 PANSS-FSNS CfB to Week 26
Maltese: PANSS-FSNS fil-linja Bażi PANSS -FSNS f'Ġimgħa 26 CfB tal-PANSS-FSNS sa Ġimgħa 26
English: Allura red AC is a coloring agent, which may cause allergic reactions.
Maltese: Allura red AC huwa aġent tal-kulur, li jista' jikkawża reazzjonijiet allerġiċi.
English: Of the 2,844 patients 933 were female (see section 4.2).
Maltese: Mill-2,844 pazjent 933 kienu nisa (ara sezzjoni 4.2).
English: България ТП „Гедеон Рихтер АД”
Maltese: ТП „Гедеон Рихтер АД” Teл.:
English: DDCAR is further metabolised to HDDCAR by CYP3A4.
Maltese: DDCAR ikompli jiġi metabolizzat għal HDDCAR minn CYP3A4.
English: Cariprazine and its major active metabolites are not substrates of P-glycoprotein (P-gp), the organic anion transporting polypeptide 1B1 and 1B3 (OATP1B1 and OATP1B3), and the breast cancer resistance protein (BCRP).
Maltese: Cariprazine u l-metaboliti attivi ewlenin tiegħu mhumiex sottostrati ta' P-glycoprotein (P-gp), ilpolypeptide trasportatur tal-anjoni organiċi 1B1 u 1B3 (OATP1B1 u OATP1B3), u l-proteina tarreżistenza tal-kanċer tas-sider (BCRP, breast cancer resistance protein).
English: Casen Recordati S.L.
Maltese: RECORDATI S.p.A.
English: Results for the secondary outcome parameter (CGI) and additional endpoints were supportive of the primary endpoint.
Maltese: Irriżultati għall-parametru tar-riżultati sekondarju (CGI) u punti finali oħra, appoġġjaw il-punt finali primarju.
English: Česká republika Gedeon Richter Marketing ČR, s.r.o.
Maltese: Gedeon Richter Marketing ČR, s.r.o.
English: Cariprazine has two pharmacologically active metabolites with similar activites as cariprazine, desmethyl cariprazine (DCAR) and didesmethyl cariprazine (DDCAR).
Maltese: Cariprazine għandu żewġ metaboliti farmakoloġikament attivi b'attivitajiet simili bħal cariprazine, desmethyl cariprazine (DCAR) u didesmethyl cariprazine (DDCAR).
English: Cariprazine 1.5 mg/day 97.1 ± 9.13 -21.27 (1.77) -7.97 (-12.94, -3.01) 0.0017 Cariprazine 3 mg/day 97.2 ± 8.66 -21.45 (1.74) -8.16 (-13.09, -3.22) 0.0013 Cariprazine 4.5 mg/day 96.7 ± 9.01 -23.77 (1.74) -10.48 (-15.41, -5.55) < 0.0001 Risperidone 4 mg/day 98.1 ± 9.50 -29.27 (1.74) -15.98 (-20.91, -11.04) < 0.0001* RGH-MD-04 (n=604)
Maltese: 0017 Cariprazine 3 mg/jum 97.2 ± 8.66 -21.45 (1.74) -8.16 (-13.09, -3.22) 0.0013 Cariprazine 4.5 mg/jum 96.7 ± 9.01 -23.77 (1.74) -10.48 (-15.41, -5.55) < 0.0001 Risperidone 4 mg/jum 98.1 ± 9.50 -29.27 (1.74) -15.98 (-20.91, -11.04) < 0.0001* RGH-MD-04 (n=604)
English: Musculoskele tal and connective tissue disorders
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi
English: Reagila 3 mg, 4.5 mg, 6 mg hard capsules contain Allura red AC (E129).
Maltese: Reagila 3 mg, 4.5 mg, 6 mg kapsuli ibsin fihom Allura red AC (E129).
English: The metabolism of cariprazine involves demethylation (DCAR and DDCAR), hydroxylation (hydroxy cariprazine, HCAR) and a combination of demethylation and hydroxylation (hydroxy desmethyl cariprazine, HDCAR and hydroxy didesmethyl cariprazine, HDDCAR).
Maltese: Il-metaboliżmu ta' cariprazine jinvolvi d-demetilazzjoni (DCAR u DDCAR), l-idrossilazzjoni (hydroxy cariprazine, HCAR) u kombinazzjoni ta' demetilazzjoni u idrossilazzjoni (hydroxy desmethyl cariprazine, HDCAR u hydroxy didesmethyl cariprazine, HDDCAR).
English: Parkinson's disease
Maltese: Akatiżija Parkinsoniżmu
English: An additional metabolite, desdichlorophenyl piperazine cariprazine (DDCPPCAR) acid, is produced by dealkylation and subsequent oxidation of cariprazine.
Maltese: Metabolit addizzjonali, l-aċidu desdichlorophenyl piperazine cariprazine (DDCPPCAR), huwa prodott mid-dejalkilazzjoni u l-ossidazzjoni sussegwenti ta' cariprazine.
English: QR code to be included www.reagila.com
Maltese: Il-Kodiċi QR irid jiġi inkluż www.reagila.com
English: LIST OF EXCIPIENTS Also contains Allura red AC (E129).
Maltese: TA' EĊĊIPJENTI Fih ukoll Allura red AC (E129).
English: The exposure (AUC of total cariprazine) at the no-observed-adverse-effectlevel (NOAEL) for ocular toxicity is 4.2-fold the clinical AUC exposure at the maximal recommended human dose (MRHD) of 6 mg/day.
Maltese: L-esponiment (AUC ta' cariprazine totali) fil-livell bla effett ħażin osservat (NOAEL, no observed adverse effect level) għal tossiċità okulari kien 4.2 darbiet lesponiment AUC kliniku fid-doża massima rakkomandata fil-bnedmin (MRHD, maximal recommended human dose) ta' 6 mg/jum.
English: Pharmacotherapeutic group: Psycholeptics, other antipsychotics, ATC code: N05AX15
Maltese: Psikolettiċi, antipsikotiċi oħra, Kodiċi ATC:
English: Cariprazine and its major active metabolites are highly bound (96 to 97% for CAR, 94% to 97% for DCAR and 92% to 97% for DDCAR) to plasma proteins.
Maltese: Cariprazine u l-metaboliti attivi ewlenin tiegħu huma marbutin ħafna (96 sa 97% għal CAR, 94% sa 97% għal DCAR u 92% sa 97% għal
English: 21 hard capsules 28 hard capsules 30 hard capsules 49 hard capsules 56 hard capsules 60 hard capsules 84 hard capsules 90 hard capsules 98 hard capsules
Maltese: 21 kapsula iebsa 28 kapsula iebsa 30 kapsula iebsa 49 kapsula iebsa 56 kapsula iebsa 60 kapsula iebsa 84 kapsula iebsa 90 kapsula iebsa 98 kapsula iebsa
English: Gedeon Richter Slovakia, s.r.o.
Maltese: Slovenská republika Gedeon Richter Slovakia, s.r.o.
English: Elevated liver transaminases (ALT, AST) are frequently observed with antipsychotic treatment.
Maltese: Żidiet fit-transaminases tal-fwied (ALT, AST) kienu osservati frekwentement bil-kura b'antipsikotiċi.
English: Allura red AC (E 129) Brilliant blue FCF (E 133) Titanium dioxide (E 171) Yellow iron oxide (E 172) Gelatin
Maltese: Allura red AC (E 129) Brilliant blue FCF (E 133) Titanium dioxide (E 171) Yellow iron oxide (E 172)
English: Cases of venous thromboembolism have been reported with antipsychotic medicinal products.
Maltese: Każijiet ta' tromboemboliżmu venuż kienu rrappurtati bi prodotti mediċinali antipsikotiċi.
English: In clinical trials, glucose-related adverse reactions have been reported with cariprazine (see section 5.1).
Maltese: Fi provi kliniċi, kien hemm rapporti ta' reazzjonijiet avversi relatati mal-glukożju b'cariprazine (ara sezzjoni 5.1).
English: 7 hard capsules 14 hard capsules 21 hard capsules 28 hard capsules 30 hard capsules 49 hard capsules 56 hard capsules 60 hard capsules 84 hard capsules 90 hard capsules 98 hard capsules
Maltese: 7 kapsuli ibsin 14-il kapsula iebsa 21 kapsula iebsa 28 kapsula iebsa 30 kapsula iebsa 49 kapsula iebsa 56 kapsula iebsa 60 kapsula iebsa 84 kapsula iebsa 90 kapsula iebsa 98 kapsula iebsa
English: Accommodati on disorder
Maltese: Aċċessjonijiet u konvulżjonijiet
English: The total active moiety (CAR+DCAR+DDCAR) exposure (AUC and Cmax) decreased by 21-22% and 13-15% in mild or moderate hepatic impairment (HI), respectively, compared to healthy subjects if unbound + bound concentrations were considered, while for unbound total moiety a decrease of 1213% and an increase of 20-25% were calculated in mild HI patients and in moderate HI patients, respectively, after multiple dosing of cariprazine.
Maltese: L-esponiment (AUC u Cmax) tal-moiety attiv totali naqas b'21-22% u 13-15% f'indeboliment tal-fwied (HI, hepatic impairment) ħafif jew moderat, rispettivament, mqabbel ma' individwi b'saħħithom jekk ġew ikkunsidrati konċentrazzjonijiet mhux marbuta + marbuta, filwaqt li għal moiety totali mhux marbut ġew ikkakulati tnaqqis ta' 12-13% u żieda ta' 20-25% f'pazjenti b'HI ħafif u f'pazjenti b'HI moderat, rispettivament, wara diversi dożi ta' cariprazine.
English: Population pharmacokinetic modelling was performed using data from patients enrolled in the schizophrenia cariprazine clinical program with differing levels of renal function, including normal renal function (creatinine clearance (CrCl) ≥ 90 mL/min), as well as mild (CrCl 60 to 89 mL/min) and moderate (CrCl 30 to 59 mL/min) renal impairment.
Maltese: L-immudellar farmakokinetiku tal-popolazzjoni twettaq bl-użu ta' dejta minn pazjenti reġistrati filprogramm kliniku ta' cariprazine għall-iskiżofrenija b'livelli differenti ta' funzjoni tal-kliewi, inkluż funzjoni tal-kliewi normali (tneħħija ta' kreatinina (CrCl) ≥ 90 mL/min), kif ukoll indeboliment talkliewi ħafif (CrCl 60 sa 89 mL/min) u moderat (CrCl 30 sa 59 mL/min).
English: Rare (≥1/10,000 to
Maltese: (≥ 1/10,000 sa
English: Recordati Pharma GMBH Tel: + 49 731 70470 (Deutschland)
Maltese: Recordati Pharma GMBH Tel: + 49 731 70470
English: Akathisia was reported in 3.9% in patients treated with cariprazine, versus 2.0% in the placebo group.
Maltese: Akatiżija kienet irrapportata fi 3.9% ta' pazjenti kkurati b'cariprazine, kontra 2.0% fil-grupp tal-plaċebo.
English: The capsules are packed in transparent hard PVC/PE/PVDC blister heat-sealed with hard aluminium foil backing.
Maltese: Il-kapsuli huma ppakkjati f'folja tal-PVC/PE/PVDC trasparenti iebsa ssiġġillata bis-sħana b'fojl fuq wara tal-aluminju iebes.
English: Cariprazine is a P-gp inhibitor in vitro at its theoretical maximum intestinal concentration.
Maltese: Cariprazine huwa inibitur ta' P-gp in vitro fil-konċentrazzjoni massima teoretika tiegħu fl-imsaren.
English: Based on a population pharmacokinetic analysis, the apparent volume of distribution (V/F) was 916 L for cariprazine, 475 L for DCAR and 1,568 L for DDCAR, indicating extensive distribution of cariprazine and its major active metabolites.
Maltese: Fuq il-bażi ta' analiżi farmakokinetika tal-popolazzjoni, il-volum apparenti tad-distribuzzjoni (V/F) kien 916 L għal cariprazine, 475 L għal DCAR u 1,568 L għal DDCAR, li jindika distribuzzjoni estensiva ta' cariprazine u l-metaboliti attivi ewlenin tiegħu.
English: Dystonia was observed in 1.8%; 0.2%; 3.6% and 0.7% in patients on cariprazine, placebo, risperidone and aripiprazole, respectively.
Maltese: Distonija kienet osservata f'1.8%; 0.2%; 3.6% u 0.7% f'pazjenti fuq cariprazine, plaċebo, risperidone u aripiprazole, rispettivament.
English: Reagila 1.5 mg and Reagila 3 mg hard capsules are available in pack sizes containing 7, 14, 21, 28, 30, 49, 56, 60, 84, 90 or 98 hard capsules.
Maltese: Reagila 1.5 mg u Reagila 3 mg kapsuli ibsin huma disponibbli fid-daqsijiet tal-pakkett li fihom 7, 14, 21, 28, 30, 49, 56, 60, 84, 90 jew 98 kapsula iebsa.
English: Consumption of grapefruit juice should be avoided.
Maltese: Il-konsum tal-meraq tal-grejpfrut għandu jiġi evitat.
English: Other medicines and Reagila
Maltese: Mediċini oħra u Reagila
English: Akathisia was reported in 13.6%; 5.1%; 9.3% and 9.9% in patients treated with cariprazine, placebo, risperidone and aripiprazole respectively.
Maltese: Akatiżija kienet irrapportat fi 13.6%; 5.1%; 9.3% u 9.9% ta' pazjenti kkurati b'cariprazine, plaċebo, risperidone u aripiprazole rispettivament.
English: Cariprazine and its major active metabolites did not induce CYP1A2, CYP2B6 and CYP3A4 enzymes and were not inhibitors of CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP219, CYP2D6, CYP2E1 and CYP3A4 in vitro.
Maltese: Cariprazine u l-metaboliti attivi ewlenin tiegħu ma kinux indutturi tal-enzimi CYP1A2, CYP2B6 u CYP3A4 u ma kinux inibituri ta' CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP219, CYP2D6, CYP2E1 u CYP3A4 in vitro. Cariprazine u l-metaboliti attivi ewlenin tiegħu mhumiex inibituri tat-trasportaturi OATP1B1, OATP1B3, BCRP, it-trasportatur katajoniku organiku 2 (OCT2),
English: Persistent predominant negative symptoms were defined as symptoms lasting for a period of at least 6 months with high level of negative symptoms and low level of positive symptoms [(PANSS factor score for negative symptoms ≥ 24, a score of ≥ 4 on a minimum 2 of the 3 PANSS items (N1: flat affect, N4: avolition, and N6: poverty of speech) and PANSS factor score for positive symptoms ≤ 19].
Maltese: Sintomi negattivi predominanti persistenti kienu definiti bħala sintomi li jdumu għal perjodu ta' mhux inqas minn 6 xhur b'livell għoli ta' sintomi negattivi u livell baxx ta' sintomi pożittivi [(punteġġ ta' fatturi PANSS għal sintomi negattivi ta' ≥ 24, punteġġ ta' ≥ 4 fuq mhux inqas minn 2 mit-3 fatturi PANSS (N1: nuqqas ta' espressjoni ta' emozzjonijiet, N4: nuqqas ta' motivazzjoni, u N6: nuqqas ta' taħdit) u punteġġ ta' fatturi
English: Reagila 4.5 mg and Reagila 6 mg hard capsules are available in pack sizes containing 21, 28, 30, 49, 56, 60, 84, 90 or 98 hard capsules.
Maltese: Reagila 4.5 mg u Reagila 6 mg kapsuli ibsin huma disponibbli fid-daqsijiet tal-pakkett li fihom 21, 28, 30, 49, 56, 60, 84, 90 jew 98 kapsula iebsa.
English: Cariprazine 3 mg/day 96.1 ± 8.7 -20.2 (1.5) Cariprazine 6 mg/day 95.7 ± 9.4 -23.0 (1.5) Aripiprazole 10 mg/day 95.6 ± 9.0 -21.2 (1.4) RGH-MD-05 (n=439)
Maltese: Cariprazine 3 mg/jum 96.1 ± 8.7 -20.2 (1.5) Cariprazine 6 mg/jum 95.7 ± 9.4 -23.0 (1.5) Aripiprazole 10 mg/jum 95.6 ± 9.0
English: This analysis included 2,844 patients of different races, involving 536 patients between the ages of 50 and 65.
Maltese: Din l-analiżi kienet tinkludi 2,844 pazjent ta' razez differenti, u kienet tinvolvi 536 pazjent bejn l-etajiet ta' 50 u 65 sena.
English: Cariprazine has no appreciable affinity for cholinergic muscarinic receptors (IC50 > 1000 nM).
Maltese: Cariprazine ma għandu l-ebda affinità apprezzabbli għar-riċetturi muskariniċi kolinerġiċi (IC50 > 1000 nM).
English: Therefore, co-administration of cariprazine with strong or moderate inhibitors of CYP3A4 (e.g. boceprevir, clarithromycin, cobicistat, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole, diltiazem, erythromycin, fluconazole verapamil) is contraindicated (see section 4.3).
Maltese: Għalhekk, l-għoti flimkien ta' cariprazine ma' inibituri ta' CYP3A4 qawwija jew moderati (pereżempju boceprevir, clarithromycin, cobicistat, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole, diltiazem, erythromycin, fluconazole verapamil) huwa kontraindikat (ara sezzjoni 4.3).
English: Patients with secondary negative symptoms, such as moderate to severe depressive symptoms and clinically relevant parkinsonism (EPS) were excluded.
Maltese: Pazjenti b'sintomi negattivi sekondarji, bħal sintomi depressivi minn moderati għal severi u parkinsoniżmu klinikament rilevanti (EPS) kienu esklużi.
English: Anaemia Eosinophilia
Maltese: Anemija Eosinofilija
English: Parkinsonism was experienced in 7.8% and 1.0% in cariprazine and placebo group respectively.
Maltese: Parkinsoniżmu kien esperjenzat f'7.8% u 1.0% fil-grupp ikkurat b'cariprazine u plaċebo rispettivament.