FrancophonIA/ELRC3.0 huggingface dataset:
English: Weight changes
Danish: Vægtændring
English: No patients treated with cariprazine experienced QTc increases ≥ 60 msec from baseline, nor did any patient experience a QTc of > 500 msec in the study.
Danish: Ingen patienter i behandling med cariprazin oplevede en QTc-stigning ≥ 60 msek.
English: In the long-term , maintenance of effect study, during the open-label phase, > 60 msec increase of from baseline was observed in 12 patients (1.6%) for QTcB and in 4 patients (0.5%) for QTcF.
Danish: I det langvarige studie vedrørende fastholdelse af virkning blev der observeret > 60 msek stigning fra baseline hos 12 patienter (1,6 %) for QTcB og hos 4 patienter (0,5 %) for QTcF under den ikke-blindede fase.
English: Very common side effects (may affect more than 1 in 10 people)
Danish: Meget almindelige bivirkninger (kan forekomme hos mere end 1 ud af 10 personer)
English: Blood sodium abnormal Blood glucose increased Diabetes mellitus
Danish: Forhøjet blodglukose Diabetes mellitus
English: Brilliant blue FCF (E 133) Allura red AC (E 129) Titanium dioxide (E 171) Gelatin
Danish: Brilliant blue FCF (E133) Allura red AC (E129) Titandioxid (E171) Gelatine
English: In the short term studies the incidence of EPS was observed in 27%; 11.5%; 30.7% and 15.1% in patients treated with cariprazine, placebo, risperidone and aripiprazole respectively.
Danish: I de kortvarige studier blev forekomst af EPS observeret hos hhv. 27 %, 11,5 %, 30,7 % og 15,1 % af de patienter, der fik hhv. cariprazin, placebo, risperidon og aripiprazol.
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.
Danish: Eksponering (AUC og Cmax) for den totale aktive molekyledel (CAR+DCAR+DDCAR) faldt med hhv. 21-22 % og 13-15 % ved hhv. let eller moderat nedsat leverfunktion sammenlignet med raske personer, hvis der blev taget højde for ubundne + bundne koncentrationer.
English: Cardiovascular disorders
Danish: Kardiovaskulære lidelser
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.
Danish: I et multinationalt placebo-kontrolleret studie med faste doser på 1,5 mg, 3,0 mg og 4,5 mg cariprazin og 4,0 mg risperidon for analysefølsomhed viste alle cariprazin-doser og den aktive kontrol statistisk signifikant forbedring i både det primære og det sekundære endepunkt sammenlignet med placebo.
English: HIV infections (medicines containing cobicistat, indinavir, nelfinavir, ritonavir, saquinavir, efavirenz and etravirine) fungal infections (medicines containing itraconazole, posaconazole, voriconazole and fluconazole)
Danish: saquinavir, efavirenz eller etravirin) svampeinfektioner (lægemidler, som indeholder itraconazol, ketoconazol, posaconazol, voriconazol eller fluconazol)
English: Blood thyroid stimulating hormone decreased
Danish: Nedsat thyroideastimulerende hormon i blodet
English: In another multinational placebo controlled study using fixed doses of 3.0 mg, and 6.0 mg cariprazine and 10 mg aripiprazole for assay sensitivity, both cariprazine doses and the active-control showed statistically significant improvement in both primary as well as secondary endpoint compared to placebo.
Danish: I et andet multinationalt placebo-kontrolleret studie med faste doser på 3,0 mg og 6,0 mg cariprazin og 10 mg aripiprazol for analysefølsomhed viste begge cariprazin-doser og den aktive kontrol statistisk signifikant forbedring i både det primære og det sekundære endepunkt i forhold til placebo.
English: Ocular symptoms/cataract
Danish: Øjensymptomer/katarakt
English: In clinical trials, only a few, non-serious, QTprolongations have been reported with cariprazine (see section 4.8).
Danish: I kliniske forsøg er der kun rapporteret få, ikke alvorlige tilfælde af QT-forlængelse med cariprazin (se pkt.
English: 1Sleep disorders: Insomnia, Abnormal dreams/nightmare, Circadian rhythm sleep disorder, Dyssomnia, Hypersomnia, Initial insomnia, Middle insomnia, Nightmare, Sleep disorder, Somnambulism, Terminal insomnia
Danish: 1Søvnforstyrrelser: Insomni, unormale drømme/mareridt, døgnrytmerelateret søvnforstyrrelse, dyssomni, hypersomni, vanskelighed med at falde i søvn, vanskelighed med at opretholde søvn, mareridt, søvnforstyrrelse, søvngængeri, terminal insomni
English: Cartons contain 21, 28, 30, 49, 56, 60, 84, 90 or 98 hard capsules.
Danish: Pakningerne indeholder 21, 28, 30, 49, 56, 60, 84, 90 eller 98 hårde kapsler.
English: Reagila 1.5 mg hard capsules Reagila 3 mg hard capsules Reagila 4.5 mg hard capsules Reagila 6 mg hard capsules cariprazine
Danish: Reagila 1,5 mg hårde kapsler Reagila 3 mg hårde kapsler Reagila 4,5 mg hårde kapsler Reagila 6 mg hårde kapsler cariprazin
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.
Danish: Reagila 4,5 mg og Reagila 6 mg hårde kapsler fås i pakningsstørrelser med 21, 28, 30, 49, 56, 60, 84, 90 eller 98 hårde kapsler.
English: Visual acuity reduced
Danish: Akkommodationsforstyrrelse Nedsat synsevne
English: QT prolongation can develop in patients treated with antipsychotics.
Danish: Patienter i behandling med antipsykotika kan udvikle QT-forlængelse.
English: weakness, fever)
Danish: feber).
English: RECORDATI S.p.A. Tel: + 39 02 487871
Danish: Tel: + 39 02 487871
English: Cartons contain 7, 14, 21, 28, 30, 49, 56, 60, 84, 90 or 98 hard capsules.
Danish: Pakningerne indeholder 7, 14, 21, 28, 30, 49, 56, 60, 84, 90 eller 98 hårde kapsler.
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.
Danish: Reagila 1,5 mg og Reagila 3 mg hårde kapsler fås i pakningsstørrelser med 7, 14, 21, 28, 30, 49, 56, 60, 84, 90 eller 98 hårde kapsler.
English: Reagila 1.5 mg and Reagila 3 mg hard capsules
Danish: Reagila 1,5 mg og Reagila 3 mg hårde kapsler
English: How to take Reagila
Danish: Sådan skal du tage 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.
Danish: Akatisi blev rapporteret hos hhv. 13,6 %, 5,1 %, 9,3 % og 9,9 % af de patienter, der fik hhv. cariprazin, placebo, risperidon og aripiprazol.
English: Reagila 4.5 mg and Reagila 6 mg hard capsules
Danish: Reagila 4,5 mg og Reagila 6 mg hårde kapsler
English: Total PSP at Baseline Total PSP at Week 26 Total PSP CfB to Week 26 CfB= change from baseline
Danish: Total PSP CfB til uge 26
English: General disorders and administratio n site conditions
Danish: Hyppighed ikke kendt symptomer og reaktioner på administrationsstedet
English: Capsule shell (1.5 mg capsule)
Danish: Kapselskal (1,5 mg kapsel)
English: Reagila 1.5 mg hard capsules Reagila 3 mg hard capsules Reagila 4.5 mg hard capsules Reagila 6 mg hard capsules
Danish: Reagila 1,5 mg hårde kapsler Reagila 3 mg hårde kapsler Reagila 4,5 mg hårde kapsler Reagila 6 mg hårde kapsler
English: Printing ink (white: 4.5 mg capsule)
Danish: Trykfarve (hvid: 4,5 mg kapsel)
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).
Danish: Kvinder i den fødedygtige alder skal anvende meget sikker antikonception under brug af cariprazin og i mindst 10 uger efter seponering af behandlingen (se pkt.
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)
Danish: Aripiprazol 10 mg/dag 95,6 ± 9,0 -21,2 (1,4) RGH-MD-05 (n=439)
English: In clinical trials, glucose-related adverse reactions have been reported with cariprazine (see section 5.1).
Danish: Der er rapporteret om glukoserelaterede bivirkninger med cariprazin i kliniske forsøg (se pkt.
English: Reagila 6 mg hard capsules
Danish: Reagila 6 mg hårde kapsler
English: Akathisia, restlessness
Danish: Akatisi, rastløshed
English: Capsule shell (4.5 mg capsule)
Danish: Kapselskal (4,5 mg kapsel)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 13 July 2017
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Capsule shell (6 mg capsule)
Danish: Kapselskal (6 mg kapsel)
English: Parkinsonism was experienced in 5.2% and 7.4% in cariprazine and risperidone treated patients respectively.
Danish: Parkinsons sygdom forekom hos hhv. 5,2 % og 7,4 % af patienter behandlet med hhv. cariprazin og risperidon.
English: INFORMATION IN BRAILLE reagila 1.5 mg
Danish: INFORMATION I BRAILLESKRIFT reagila 1.5 mg
English: - decreased or increased sexual desire, erectile problems - eye irritation, high pressure in the eye, poor vision - focusing problems seeing at a distance to or seeing close-to - low blood pressure - abnormal ECG reading, abnormal nerve impulses in the heart - slow, irregular heart rate - hiccups - heartburn - thirst - pain when passing urine - abnormally frequent and large urinations - itching, rash - diabetes - the following can be seen in laboratory tests:
Danish: - depression - pludselig og omfattende forvirring - fornemmelse af, at det hele drejer rundt - ubehagelig unormal fornemmelse af berøring - sløvhed, manglende energi eller manglende interesse i at lave noget - ufrivillige bevægelser, normalt af tungen eller ansigt; dette kan opstå efter kort- eller langvarig brug - nedsat eller øget sexlyst, rejsningsproblemer - øjenirritation, højt tryk i øjet, nedsat synsevne, problemer med at skifte fokus mellem at se noget på afstand og tæt på - lavt blodtryk - unormalt EKG, unormale nerveimpulser i hjertet - langsom, uregelmæssig hjerterytme - hikke - halsbrand - tørst - smerter ved vandladning - unormalt hyppige og store vandladninger - kløe - udslæt - sukkersyge (diabetes) - følgende kan ses ved laboratorietest:
English: Dystonia was observed in 1.8%; 0.2%; 3.6% and 0.7% in patients on cariprazine, placebo, risperidone and aripiprazole, respectively.
Danish: Dystoni forekom hos hhv. 1,8 %, 0,2 %, 3,6 % og 0,7 % af de patienter, der fik hhv. cariprazin, placebo, risperidon og aripiprazol.
English: Allura red AC (E 129) Brilliant blue FCF (E 133) Titanium dioxide (E 171) Yellow iron oxide (E 172) Gelatin
Danish: Allura red AC (E129) Brilliant blue FCF (E133) Titandioxid (E171) Gul jernoxid (E172) Gelatine
English: Reagila 3 mg hard capsules
Danish: Reagila 3 mg hårde kapsler
English: If you are using hormonal contraceptives a so-called barrier method (e.g.condom or diaphragma) should also be used.
Danish: Hvis du bruger hormonbaseret prævention, skal du også bruge en såkaldt barrieremetode (f.eks. kondom eller pessar).
English: Parkinsonism was experienced in 13.6%; 5.7%; 22.1% and 5.3% in patients treated with cariprazine, placebo, risperidone and aripiprazole respectively.
Danish: Parkinsons sygdom forekom hos hhv. 13,6 %, 5,7 %, 22,1 % og 5,3 % af de patienter, der fik hhv. cariprazin, placebo, risperidon og aripiprazol.
English: Reagila 4.5 mg hard capsules
Danish: Reagila 4,5 mg hårde kapsler
English: What Reagila is and what it is used for What you need to know before you take Reagila How to take Reagila
Danish: Det skal du vide, før du begynder at tage Reagila Sådan skal du tage Reagila Bivirkninger
English: Capsule shell (3 mg capsule)
Danish: Kapselskal (3 mg kapsel)
English: INFORMATION IN BRAILLE reagila 4.5 mg
Danish: INFORMATION I BRAILLESKRIFT reagila 4.5 mg
English: Electrocardiog ram QT prolonged Electrocardiog ram T wave abnormal
Danish: Ledningsforstyrrelser Bradyarytmi QTforlængelse på elektrokardiogram Unormal T-tak på elektrokardiogram
English: In the preclinical studies of cariprazine lens opacity/cataract was detected in dogs (see sections 4.8 and 5.3).
Danish: I de prækliniske forsøg med cariprazin blev uklar linse/katarakt påvist hos hunde (se pkt.
English: Neuroleptic malignant syndrome extrapyramidal diseases and abnormal movement disorders5
Danish: Hyppighed ikke kendt sygdomme og forstyrrelser med unormale bevægelser5
English: INFORMATION IN BRAILLE reagila 6 mg
Danish: INFORMATION I BRAILLESKRIFT reagila 6 mg
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)
Danish: Cariprazin 4,5 mg/dag 96,7 ± 9,01 -23,77 (1,74) -10,48 (-15,41, -5,55) < 0,0001 Risperidon 4 mg/dag
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.
Danish: Under den langvarige, ikke-blindede behandlingsperiode havde 3 patienter (0,4 %) QTcB > 500 msek, hvoraf én også havde QTcF > 500 msek.
English: INFORMATION IN BRAILLE reagila 3 mg
Danish: INFORMATION I BRAILLESKRIFT reagila 3 mg
English: Reagila 1.5 mg: Each hard capsule contains cariprazine hydrochloride corresponding to 1.5 mg cariprazine.
Danish: Reagila 1,5 mg: Hver hård kapsel indeholder cariprazinhydrochlorid svarende til 1,5 mg cariprazin.
English: Adverse reactions are ranked by frequency, the most frequent first, using the following convention:
Danish: De hyppigste bivirkninger er anført først.
English: Weigth increase
Danish: Forhøjede leverenzymer
English: Development of cataracts was observed in cariprazine non-clinical studies (see section 5.3).
Danish: Der blev observeret udvikling af katarakt i prækliniske studier med cariprazin (se pkt.
English: Seizures and convulsions
Danish: Nyrer og urinveje
English: Reagila 4.5 mg: Each hard capsule contains cariprazine hydrochloride corresponding to 4.5 mg cariprazine.
Danish: Reagila 4,5 mg: Hver hård kapsel indeholder cariprazinhydrochlorid svarende til 4,5 mg cariprazin.
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.
Danish: Patienterne havde forskellige grader af nyrefunktion, herunder normal nyrefunktion (kreatininclearance (CrCl) ≥ 90 ml/min) samt let (CrCl
English: Reagila 6 mg: Each hard capsule contains cariprazine hydrochloride corresponding to 6 mg cariprazine.
Danish: Reagila 6 mg: Hver hård kapsel indeholder cariprazinhydrochlorid svarende til 6 mg cariprazin.
English: Reagila 3 mg: Each hard capsule contains cariprazine hydrochloride corresponding to 3 mg cariprazine.
Danish: Reagila 3 mg: Hver hård kapsel indeholder cariprazinhydrochlorid svarende til 3 mg cariprazin.
English: Each hard capsule contains cariprazine hydrochloride corresponding to 1.5 mg cariprazine.
Danish: Hver hård kapsel indeholder cariprazinhydrochlorid svarende til 1,5 mg cariprazin.
English: Use of cariprazine is not recommended in patients with severe renal impairment (see section 5.2).
Danish: Anvendelse af cariprazin til patienter med svært nedsat leverfunktion frarådes (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Reagila 1.5 mg hard capsules cariprazine
Danish: 1 LÆGEMIDLETS NAVN Reagila 1,5 mg hårde kapsler cariprazin
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1209/029-036
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/17/1209/029-036
English: NAME OF THE MEDICINAL PRODUCT Reagila 4.5 mg hard capsules cariprazine
Danish: 1 LÆGEMIDLETS NAVN Reagila 4,5 mg hårde kapsler cariprazin
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:
Danish: - angst - søvnighed, søvnproblemer, unormale drømme, mareridt, gå i søvne - svimmelhed - ufrivillige vridende bevægelser og mærkelige stillinger (dystoni) - overdreven tænderskæren eller spænding af kæben, savlen, vedvarende blinken ved banken på
English: Each hard capsule contains cariprazine hydrochloride corresponding to 4.5 mg cariprazine.
Danish: Hver hård kapsel indeholder cariprazinhydrochlorid svarende til 4,5 mg cariprazin.
English: Each hard capsule contains cariprazine hydrochloride corresponding to 6 mg cariprazine.
Danish: Hver hård kapsel indeholder cariprazinhydrochlorid svarende til 6 mg cariprazin.
English: NAME OF THE MEDICINAL PRODUCT Reagila 6 mg hard capsules cariprazine
Danish: 1 LÆGEMIDLETS NAVN Reagila 6 mg hårde kapsler cariprazin
English: Each hard capsule contains cariprazine hydrochloride corresponding to 3 mg cariprazine.
Danish: Hver hård kapsel indeholder cariprazinhydrochlorid svarende til 3 mg cariprazin.
English: Hypothyroidis m
Danish: Hypothyroidisme
English: NAME OF THE MEDICINAL PRODUCT Reagila 3 mg hard capsules cariprazine
Danish: 1 LÆGEMIDLETS NAVN Reagila 3 mg hårde kapsler cariprazin
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).
Danish: Reagila 1,5 mg hårde kapsler: prægelatiniseret (majs-) stivelse, magnesiumstearat, titandioxid (E171), gelatine, sort blæk (shellak, sort jernoxid (E172), propylenglycol, kaliumhydroxid).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains cariprazine hydrochloride corresponding to 1.5 mg cariprazine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder cariprazinhydrochlorid svarende til 1,5 mg cariprazin.
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.
Danish: Gradvis krydstitrering er ikke nødvendig ved skift fra cariprazin til et andet antipsykotikum.
English: Each hard capsule contains 0.0096 mg Allura red AC (E 129).
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver hård kapsel indeholder 0,0096 mg Allura red AC (E129).
English: CYP2D6 mediated pathway plays a minor role in the metabolism of cariprazine, the major pathway is via CYP3A4 (see section 5.2).
Danish: Den CYP2D6-medierede rute spiller en mindre rolle for metaboliseringen af cariprazin.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1209/021-028
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/17/1209/021-028
English: - Reagila 4.5 mg hard capsules: ‘Size 4' (approximately 14.3 mm in length) hard gelatin capsule with green opaque cap and green opaque body imprinted with “GR 4.5” on the capsule body with white ink.
Danish: - Reagila 4,5 mg hårde kapsler: Hård gelatinekapsel i str. 4 (ca. 14,3 mm lang) med grøn, uigennemsigtig overdel og grøn, uigennemsigtig underdel, præget med “GR 4.5” på kapslens underdel med hvidt blæk.
English: Each hard capsule contains 0.0008 mg Allura red AC (E 129).
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver hård kapsel indeholder 0,0008 mg Allura red AC (E129).
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.
Danish: - Reagila 1,5 mg hårde kapsler: Hård gelatinekapsel i str. 4 (ca. 14,3 mm lang) med hvid, uigennemsigtig overdel og hvid, uigennemsigtig underdel, præget med “GR 1.5” på kapslens underdel med sort blæk.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1209/001-040
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/17/1209/001-040
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains cariprazine hydrochloride corresponding to 4.5 mg cariprazine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder cariprazinhydrochlorid svarende til 4,5 mg cariprazin.
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.
Danish: - Reagila 3 mg hårde kapsler: Hård gelatinekapsel i str. 4 (ca. 14,3 mm lang) med grøn, uigennemsigtig overdel og hvid, uigennemsigtig underdel, præget med “GR 3” på kapslens underdel med sort blæk.
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).
Danish: Reagila 4,5 mg hårde kapsler: prægelatiniseret (majs-) stivelse, magnesiumstearat, Allura red AC (E129), Brilliant blue FCF (E133), titandioxid (E171), gul jernoxid (E172), gelatine, hvidt blæk (shellak, titandioxid (E171), propylenglycol, simeticon).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1209/011-020
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/17/1209/011-020
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1209/001-010
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/17/1209/001-010
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).
Danish: Reagila 6 mg hårde kapsler: prægelatiniseret (majs-) stivelse, magnesiumstearat, Brilliant blue FCF (E133), Allura red AC (E129), titandioxid (E171), gelatine, sort blæk (shellak, sort jernoxid (E172), propylenglycol, kaliumhydroxid).
English: - Reagila 6 mg hard capsules: ‘Size 3' (approximately 15.9 mm in length) hard gelatin capsule with purple opaque cap and white opaque body imprinted with “GR 6” on the capsule body with black ink.
Danish: - Reagila 6 mg hårde kapsler: Hård gelatinekapsel i str. 3 (ca. 15,9 mm lang) med lilla, uigennemsigtig overdel og hvid, uigennemsigtig underdel, præget med “GR 6” på kapslens underdel med sort blæk.
English: Nervous system disorders
Danish: Malignt neuroleptikasyndrom
English: Each hard capsule contains 0.0003 mg Allura red AC (E 129).
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver hård kapsel indeholder 0,0003 mg Allura red AC (E129).
English: Lens opacity/Cataract
Danish: Uklar linse/katarakt
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains cariprazine hydrochloride corresponding to 6 mg cariprazine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder cariprazinhydrochlorid svarende til 6 mg cariprazin.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains cariprazine hydrochloride corresponding to 3 mg cariprazine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder cariprazinhydrochlorid svarende til 3 mg cariprazin.
English: If you take more Reagila than you should
Danish: Hvis du har taget for meget Reagila