FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety profile of lurasidone in children included in this short-term study is in general consistent with that observed when treated within the approved indication in adults, however, differences in frequency of the most commonly occurred adverse reactions have been observed in paediatric patients for nausea (very common), diarrhea (common) and decreased appetite (common), compared with adults (common, unknown, and uncommon, respectively).
Danish: Der er imidlertid observeret forskelle i hyppighed for de mest almindeligt forekommende bivirkninger hos pædiatriske patienter for kvalme (meget almindelig), diarré (almindelig) og nedsat appetit (almindelig) sammenlignet med voksne (henholdsvis almindelig, kendes ikke og ikke almindelig).
English: Kaplan-Meier estimates of the probability of relapse at Week 28 were 42.2% for lurasidone and 51.2%
Danish: Kaplan-Meier estimater for sandsynligheden for tilbagefald ved uge 28 var 42,2 % for lurasidon og
English: Co-administration of lurasidone and posaconazole (strong CYP3A4 inhibitor) resulted in an approximate 4-5 fold increase in lurasidone exposure.
Danish: Samtidig administration af lurasidon og posaconazol (stærk CYP3A4-hæmmer) resulterede i en stigning på omtrent 4-5 gange i eksponering over for lurasidon.
English: Neuroleptic Malignant Syndrome, characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated serum creatine phosphokinase levels, has been reported to occur lurasidone.
Danish: For lurasidon er der rapporteret om forekomst af malignt neuroleptikasyndrom, som er karakteriseret ved hypertermi, muskelrigiditet, autonom ustabilitet, ændret bevidsthedsniveau og forhøjet serumkreatinfosfokinase inklusive lurasidon.
English: Very common (may affect more than 1 in 10 people):
Danish: Meget almindelige bivirkninger (kan forekomme hos mere end 1 ud af 10 personer):
English: Baseline Mean (SD) LS Mean Change (SE) Treatment Difference vs. placebo
Danish: Baseline gennemsnit (SD) LS gennemsnitlig ændring (SE) Behandlingsforsel vs. placebo
English: If you notice any of these symptoms seek medical advice immediately.
Danish: Hvis du udvikler et eller flere af disse symptomer, bør du omgående søge lægehjælp.
English: • Latuda 18.5 mg film-coated tablets are white to off-white, film-coated round tablets debossed with “LA”
Danish: • Latuda 18,5 mg, filmovertrukne tabletter:hvide til råhvide, filmovertrukne tabletter præget med "LA"
English: Alcohol should be avoided when taking this medicine.
Danish: Du må ikke indtage alkohol, mens du er i behandling med denne medicin.
English: Lurasidone also exhibits partial agonism at the 5HT-1A receptor with a binding affinity of 6.38 nM. Lurasidone does not bind to histaminergic or muscarinic receptors.
Danish: Den blokerer også for α2c-adrenerge receptorer og α2a-adrenerge receptorer med en bindingsaffinitet til hhv. 10,8 og 40,7 nM. Lurasidon udviser også partiel agonisme på 5HT-1A-receptoren med en bindingsaffinitet på 6,38 nM. Lurasidon binder ikke til histaminerge eller muskarine receptorer.
English: • swelling beneath the skin surface (angioedema)
Danish: • hævelse under hudoverfladen (angioødem)
English: Lurasidone is contraindicated with strong CYP3A4 inhibitors (e.g. boceprevir, clarithromycin, cobicistat, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole) (see section 4.3).
Danish: Lurasidon er kontraindiceret ved samtidig administration af kraftige CYP3A4-hæmmere (f.eks. boceprevir, clarithromycin, cobicistat, indinavir, itraconazol, ketoconazol, nefazodon, nelfinavir, posaconazol, ritonavir, saquinavir,telaprevir, telithromycin, voriconazol) (se pkt.
English: Pale green, film-coated oval tablets of 12 mm x 7 mm debossed with ‘LD'
Danish: Lysegrønne, filmovertrukne, ovale tabletter på 12 x 7 mm, præget med "LD"
English: Iron oxide, Yellow (E 172) Indigotine (E 132)
Danish: Gul jernoxid (E 172) Indigotin (E 132) Carnaubavoks (E 903)
English: Lurasidone is an in vitro inhibitor of the efflux transporter BCRP and the clinical relevance of intestinal BCRP inhibition cannot be excluded.
Danish: Lurasidon er en in vitro-hæmmer af effluks-transportøren BCRP og den kliniske relevans af BCRP-hæmning i tarmkanalen kan ikke udelukkes.
English: Vomiting Dyspepsia Salivary hypersecretion Dry mouth Upper abdominal pain Stomach discomfort
Danish: Opkastninger Dyspepsi Øget spytsekretion Mundtørhed Øvre mavesmerter Mavepine/ubehag
English: No dose adjustment of lurasidone is required in patients with mild hepatic impairment.
Danish: Der er ikke behov for dosisjustering af lurasidon til patienter med let nedsat leverfunktion.
English: • Latuda 74 mg film-coated tablets are pale green, film-coated oval tablets debossed with “LD”.
Danish: • Latuda 74 mg, filmovertrukne tabletter:lysegrønne, filmovertrukne, ovale tabletter præget med "LD"
English: Lurasidone is an in vitro inhibitor of the efflux transporter P-gp and the clinical relevance of intestinal P-gp inhibition cannot be excluded.
Danish: Lurasidon er en in vitro-hæmmer af effluks-transportøren P-gp og den kliniske relevans af P-gp-hæmning i tarmkanalen kan ikke udelukkes.
English: Coadministration of lurasidone with the strong CYP3A4 inducer rifampicin resulted in a 6-fold decrease in exposure of lurasidone.
Danish: Samtidig administration af lurasidon og den kraftige CYP3A4-induktor rifampicin medførte en 6-foldig reduktion i lurasidon-eksponeringen.
English: • Latuda 37 mg film-coated tablets are white to off-white, film-coated round tablets debossed with “LB”
Danish: • Latuda 37 mg, filmovertrukne tabletter:hvide til råhvide, filmovertrukne tabletter præget med "LB"
English: In a long-term dog repeat-dose study, high serum prolactin levels were associated with effects on male and female reproductive tissues.
Danish: Høje prolaktinniveauer i serum i et studie af langvarige, gentagne doser hos hunde var forbundet med virkninger på reproduktivt væv hos hanner og hunner.
English: Renal impairment No dose adjustment of lurasidone is required in patients with mild renal impairment.
Danish: Der er ikke behov for dosisjustering af lurasidon til patienter med let nedsat nyrefunktion.
English: If you take more of this medicine than you should, contact your doctor immediately.
Danish: Hvis du har taget for meget Latuda, skal du straks kontakte din læge.
English: Via Vecchia del Pinocchio, 22 60100
Danish: Aziende Chimiche Riunite Angelini Francesco ACRAF SPA Via Vecchia del Pinocchio, 22 60100
English: Based on in vitro studies lurasidone is not a substrate of CYP1A1, CYP1A2, CYP2A6, CYP4A11, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP2E1 enzymes.
Danish: In vitro-studier viser, at lurasidon ikke er et substrat for CYP1A1-, CYP1A2-, CYP2A6-, CYP4A11-, CYP2B6-, CYP2C8-, CYP2C9-, CYP2C19-, CYP2D6- eller CYP2E1-enzymer.
English: Lurasidone is contraindicated with strong CYP3A4 inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifampicin, St John's wort (Hypericum perforatum)) (see section 4.3).
Danish: Lurasidon er kontraindiceret ved samtidig administration af kraftige CYP3A4-induktorer (f.eks. carbamazepin, phenobarbital, phenytoin, rifampicin, prikbladet perikon (Hypericum perforatum)) (se pkt.
English: White to off-white, film-coated round tablets of 8 mm debossed with ‘LB'
Danish: Hvide til råhvide, runde, filmovertrukne tabletter på 8 mm præget med "LB"
English: - Concomitant administration of strong CYP3A4 inhibitors (e.g. boceprevir, clarithromycin, cobicistat, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole) and strong CYP3A4 inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifampicin, St John's wort (Hypericum perforatum) (see section 4.5).
Danish: - Samtidig administration af kraftige CYP3A4-hæmmere (f.eks. boceprevir, clarithromycin, cobicistat, indinavir, itraconazol, ketoconazol, nefazodon, nelfinavir, posaconazol, ritonavir, saquinavir,telaprevir, telithromycin, voriconazol) og kraftige CYP3A4-induktorer (f.eks. carbamazepin, phenobarbital, phenytoin, rifampicin, prikbladet perikon (Hypericum perforatum)) (se pkt.
English: p-value (a) Olanzapine 15 mg in Study D1050231, quetiapine extended-release (XR) 600 mg in Study
Danish: Baseline, middel (SD) LS-middelændring (SE) Behandlingsforskel vs. placebo Estimat (SE) p-værdi (a) Olanzapin, 15 mg i Studie D1050231, quetiapin, depottabletter (XR), 600 mg i Studie D1050233.
English: 1499-040 Cruz Quebrada- Dafundo Tel: + 351 21 414 8300
Danish: 1499-040 Cruz Quebrada- Dafundo
English: Latuda 18.5 mg film-coated tablets
Danish: Latuda 18,5 mg filmovertrukne tabletter
English: In a long-term safety study clinically stable patients were treated using 37 - 111 mg lurasidone or risperidone 2 - 6 mg.
Danish: I et langvarigt sikkerhedsstudie blev klinisk stabile patienter behandlet med 37-111 mg lurasidon eller risperidon 2-6 mg. I dette studie var frekvensen for tilbagefald over en 12-måneders periode 20 % for lurasidon og 16 % for risperidon.
English: • Rhabdomyolysis which is the breakdown of muscle fibres that leads to the release of muscle fibre contents (myoglobin) into the bloodstream, seen as muscle pain, being sick, being confused, an abnormal heart rate and rhythm, and possibly dark urine
Danish: • Rabdomyolyse, som er nedbrydning af muskelfibrene, der fører til frigivelse af muskelfiberindhold (myoglobin) ind i blodbanen, viser sig ved muskelsmerter, utilpashed,
English: Contact your doctor if you have questions on this medicine.
Danish: Spørg lægen, hvis der er noget, du er i tvivl om.
English: • verapamil (to treat high blood pressure or chest pain).
Danish: • fluconazol (til behandling af svampeinfektioner) • verapamil (til behandling af forhøjet blodtryk eller brystsmerter).
English: If used in ESRD, clinical monitoring is advised.
Danish: Klinisk monitorering tilrådes ved behandling af patienter med ESRD.
English: White to off-white, film-coated round tablets of 6 mm debossed with ‘LA'
Danish: Hvide til råhvide, runde, filmovertrukne tabletter på 6 mm præget med "LA"
English: Latuda 18.5 mg tablets lurasidone
Danish: Latuda 18,5 mg, tabletter lurasidon
English: Hypromellose 2910 (E 464) Magnesium stearate (E 470b)
Danish: Mannitol (E 421) Stivelse, prægelatiniseret Croscarmellosenatrium (E468) Hypromellose 2910 (E 464) Magnesiumstearat (E 470b)
English: EU/1/14/913/016 28 x 1 film-coated tablets EU/1/14/913/017 30 x 1 film-coated tablets EU/1/14/913/018 56 x 1 film-coated tablets EU/1/14/913/019 60 x 1 film-coated tablets EU/1/14/913/020 90 x 1 film-coated tablets EU/1/14/913/021 98 x 1 film-coated tablets
Danish: EU/1/14/913/015 14 x 1 filmovertrukne tabletter EU/1/14/913/016 28 x 1 filmovertrukne tabletter EU/1/14/913/017 30 x 1 filmovertrukne tabletter EU/1/14/913/018 56 x 1 filmovertrukne tabletter EU/1/14/913/019 60 x 1 filmovertrukne tabletter EU/1/14/913/020 90 x 1 filmovertrukne tabletter EU/1/14/913/021 98 x 1 filmovertrukne tabletter
English: • newborn babies may show the following: agitation, increase or decreases in muscle tone, tremor,
Danish: • nyfødte børn kan udvise følgende:ophidselse, øget eller nedsat muskeltonus, rystelser, søvnighed, åndedrætsbesvær, besvær med at indtage føde
English: EU/1/14/913/002 28 x 1 film-coated tablets EU/1/14/913/003 30 x 1 film-coated tablets EU/1/14/913/004 56 x 1 film-coated tablets EU/1/14/913/005 60 x 1 film-coated tablets EU/1/14/913/006 90 x 1 film-coated tablets EU/1/14/913/007 98 x 1 film-coated tablets
Danish: EU/1/14/913/001 14 x 1 filmovertrukne tabletter EU/1/14/913/002 28 x 1 filmovertrukne tabletter EU/1/14/913/003 30 x 1 filmovertrukne tabletter EU/1/14/913/004 56 x 1 filmovertrukne tabletter EU/1/14/913/005 60 x 1 filmovertrukne tabletter EU/1/14/913/006 90 x 1 filmovertrukne tabletter EU/1/14/913/007 98 x 1 filmovertrukne tabletter
English: Rare (may affect up to 1 in 1,000 people):
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 personer):
English: Latuda film-coated tablets are available in pack sizes containing 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1,
Danish: Latuda, filmovertrukne tabletter, er tilgængelige i følgende pakningsstørrelser, som indeholder:14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 90 x 1 eller 98 x 1 filmovertrukne tabletter i aluminium/aluminium, perforeret enkeltdosisblister.
English: Very Common
Danish: Meget almindeli g
English: Each 18.5 mg tablet contains lurasidone hydrochloride equivalent to 18.6 mg lurasidone.
Danish: Hver 18,5 mg tablet indeholder lurasidonhydrochlorid svarende til 18,6 mg lurasidon.
English: Treatment Difference vs. placebo
Danish: LS gennemsnitlig ændring (SE) Behandlingsforsel vs. placebo
English: • weight gain
Danish: • Vægtforøgelse.
English: Rhabdomyolysis
Danish: Rhabdo-myolyse
English: Suicidal behaviour**** Panic attack**** Sleep disorder****
Danish: Panikanfald**** Søvnforstyrrelse r ****
English: Seizures
Danish: Sløvhed
English: 0.1 mg/kg/day lurasidone hydrochloride, respectively, or on early embryonic development at an oral dose of 15 mg/kg/day lurasidone hydrochloride.
Danish: Hos rotter havde lurasidon ingen indvirkning på reproduktionsevnen hos hanner og hunner ved orale doser på hhv. 150 og 0,1 mg/kg/dag lurasidonhydrochlorid eller den tidlige embryoudvikling ved en oral dosis på 15 mg/kg/dag lurasidonhydrochlorid.
English: You can also report side effects directly via the following website: www.mhra.gov.uk/yellowcard.
Danish: Du eller dine slægtninge kan også rapportere bivirkninger direkte til Lægemiddelstyrelsen via følgende hjemmeside: www.bogbivirkning.dk.
English: Latuda 74 mg film-coated tablets
Danish: Latuda 74 mg filmovertrukne tabletter
English: Latuda 37 mg film-coated tablets
Danish: Latuda 37 mg filmovertrukne tabletter
English: Treatment Difference vs. placebo Estimate (SE) p-value
Danish: LS-middelændring (SE) Behandlingsforskel vs. placebo Estimat (SE) p-værdi Studie D1050233
English: • nausea (feeling sick), vomiting (being sick)
Danish: • Kvalme (utilpashed), opkastning.
English: • fast heart beat
Danish: • hurtig hjerteslag
English: Latuda 74 mg tablets lurasidone
Danish: Latuda 74 mg, tabletter lurasidon
English: • gas (flatulence)
Danish: • luftafgang fra tarmen (flatulens)
English: Convulsion****
Danish: Panikanfald***
English: Possible side effects
Danish: 4 Bivirkninger
English: E-08034 Barcelona Tel: + 34 93 253 45 00
Danish: Tel: + 34 93 253 45 00
English: Latuda 18.5 mg film-coated tablets lurasidone
Danish: Latuda 18,5 mg, filmovertrukne tabletter lurasidon
English: Each 74 mg tablet contains lurasidone hydrochloride equivalent to 74.5 mg lurasidone.
Danish: Hver 74 mg tablet indeholder lurasidonhydrochlorid svarende til 74,5 mg lurasidon.
English: • a history of seizures (fits) or epilepsy
Danish: • tidligere har haft krampeanfald eller epilepsi.
English: Each 37 mg tablet contains lurasidone hydrochloride equivalent to 37.2 mg lurasidone.
Danish: Hver 37 mg tablet indeholder lurasidonhydrochlorid svarende til 37,2 mg lurasidon.
English: Tabulated summary of adverse reactions
Danish: Sammendrag af bivirkninger i tabelform
English: Latuda 37 mg tablets lurasidone
Danish: Latuda 37 mg, tabletter lurasidon
English: How to take Latuda
Danish: 3 Sådan skal du tage Latuda
English: Rare cases of glucose related adverse reactions, e.g. increase in blood glucose, have been reported in clinical trials with lurasidone.
Danish: I kliniske forsøg med lurasidon er der i sjældne tilfælde rapporteret om glukoserelaterede bivirkninger, f.eks. forhøjet blodglukose.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Danish: 2 ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER
English: Renal failure****
Danish: Nyresvigt****
English: Sudden death attributable to underlying cardiovascular disease observed during the clinical development programme**** *Somnolence includes adverse reaction terms: hypersomnia, hypersomnolence, sedation, and somnolence **Parkinsonism includes adverse reaction terms: bradykinesia, cogwheel rigidity, drooling, extrapyramidal disorder, hypokinesia, muscle rigidity, parkinsonism, psychomotor retardation, and tremor ***Dystonia includes adverse reaction terms: dystonia, oculogyric crisis, oromandibular dystonia, tongue spasm, torticollis, and trismus.
Danish: **Parkinsonisme omfatter bivirkningerne:bradykinesi, intermitterende stivhed (cogwheel), savlen, ekstrapyramidale symptomer, hypokinesi, muskelstivhed, parkinsonisme, psykomotorisk retardering og tremor.
English: Gait disturbance
Danish: Gangforstyrrelser
English: Flatulence
Danish: Angioødem
English: Uncommon (may affect up to 1 in 100 people):
Danish: Ikke almindelige bivirkninger (disse kan forekomme hos op til 1 ud af 100 personer):
English: Joint stiffness Myalgia Neck pain Back pain
Danish: Stive led Myalgi Nakkesmerter Rygsmerter
English: Each film-coated tablet contains lurasidone hydrochloride equivalent to 37.2 mg lurasidone.
Danish: Hver filmovertrukken tablet indeholder lurasidonhydrochlorid svarende til 37,2 mg lurasidon.
English: Each film-coated tablet contains lurasidone hydrochloride equivalent to18.6 mg lurasidone.
Danish: Hver filmovertrukken tablet indeholder lurasidonhydrochlorid svarende til 18,6 mg lurasidon.
English: magnesium stearate (E470b), titanium dioxide (E171), macrogol, yellow iron oxide (E172)
Danish: • Øvrige indholdsstoffer:mannitol, prægelatiniseret stivelse, croscarmellosenatrium, hypromellose, magnesiumstearat (E 470b), titaniumdioxid (E171), macrogol, gul jerndioxid (E172) (findes tabletter på 74 mg), indigotin (E132) (findes i tabletter på 74 mg) og carnaubavoks (E903).
English: Musculoskeletal and connective tissue disorders
Danish: Muskuloskeletal stivhed
English: Each film-coated tablet contains lurasidone hydrochloride equivalent to 74.5 mg lurasidone.
Danish: Hver filmovertrukken tablet indeholder lurasidonhydrochlorid svarende til 74,5 mg lurasidon.
English: Latuda 74 mg film-coated tablets lurasidone
Danish: Latuda 74 mg, filmovertrukne tabletter lurasidon
English: System Organ Class
Danish: • stiv kropsstilling
English: • rufinamide (to treat seizures).
Danish: • rufinamid (til behandling af krampeanfald).
English: Angelini S.p.A
Danish: A C R A F. S.p.A.
English: Latuda 37 mg film-coated tablets lurasidone
Danish: Latuda 37 mg, filmovertrukne tabletter lurasidon
English: • decreased kidney function
Danish: Nedsat nyrefunktion
English: What Latuda is and what it is used for What you need to know before you take Latuda How to take Latuda
Danish: Det skal du vide, før du begynder at tage Latuda 3.
English: • indigestion
Danish: • hedeture
English: • rigid posture
Danish: • rygsmerter
English: • hot flush
Danish: • ledsmerter
English: • problems walking
Danish: • potensproblemer
English: In this event, lurasidone should be discontinued.
Danish: Hvis de nævnte symptomer opstår, skal lurasidon seponeres.
English: Cardiac disorders
Danish: Tardivdyskinesi
English: Hepatic impairment
Danish: Hududslæt Kløe
English: If you take more Latuda than you should
Danish: Hvis du har taget for meget Latuda
English: N=121 N=116
Danish: N=116
English: Hepatobiliary disorders
Danish: Hyperprolaktinæmi
English: Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition and postnatal development (see section 5.3).
Danish: Data fra dyreforsøg er utilstrækkelige hvad angår reproduktionstoksicitet (se pkt.
English: • sweating
Danish: • svedafsondring
English: • pain when passing urine.
Danish: • inkontinens, smerte ved vandladning
English: Titanium dioxide (E 171)
Danish: Hypromellose 2910 (E 464) Titaniumdioxid (E 171) Macrogol 8000
English: • prednisone (to treat inflammatory disease)
Danish: • prednison (til behandling af betændelsestilstande)
English: (IC50>5.9 μM) of the enzymes cytochrome P450 (CYP)1A2, CYP2B6, CYP2C8, CYP2C9,
Danish: In vitro har lurasidon ikke udvist nogen, eller kun svag hæmning (direkte eller tidsafhængig) (IC50>5,9 μM) af enzymerne CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 og CYP3A4.
English: • dry mouth or excess saliva
Danish: • Mundtørhed eller øget spytproduktion.
English: EU/1/14/913/008 14 x 1 film-coated tablets EU/1/14/913/009 28 x 1 film-coated tablets
Danish: EU/1/14/913/008 14 x 1 filmovertrukne tabletter EU/1/14/913/009 28 x 1 filmovertrukne tabletter EU/1/14/913/010 30 x 1 filmovertrukne tabletter EU/1/14/913/011 56 x 1 filmovertrukne tabletter EU/1/14/913/012 60 x 1 filmovertrukne tabletter EU/1/14/913/013 90 x 1 filmovertrukne tabletter EU/1/14/913/014 98 x 1 filmovertrukne tabletter
English: Blood prolactin increased
Danish: Forhøjet prolaktin i blodet
English: MA (EU) Number Invented name Strength Pharmaceutical form Route of administration Immediate Packaging Package size
Danish: MF (EU)-nummer Særnavn Styrke Lægemiddelform Administration Emballage
English: 1 x 1 tablet (unit dose)
Danish: Oral anvendelse blister (alu/alu) 1 x 1 tablet (enkeltdosis)
English: Annex V
Danish: Bilag V
English: Implementation of the agreement by the Member States (submission of the variation by the Marketing Authorisation Holder):
Danish: Aftalen gennemføres i medlemsstaterne (ændringsansøgningen indsendes af indehaveren af markedsføringstilladelsen):
English: 20 February 2014
Danish: Den 20. februar 2015
English: November 2014 CMDh meeting
Danish: CMDh's møde i november 2014
English: The procedure started on 20 September 2007.
Danish: Proceduren blev indledt den 20. september 2007.
English: Ref. EMEA/CHMP/384879/2008
Danish: EMEA/CHMP/554674/2008
English: The Marketing Authorisation Holder provided supplementary information on 28 January 2008 and 28 April 2008.
Danish: Indehaveren af markedsføringstilladelsen fremsendte supplerende oplysninger den 28. januar 2008 og den 28. april 2008.
English: London, 8 October 2008 Doc.
Danish: London, den 8. oktober 2008 Ref. dok.
English: Risperdal Consta and associated names is an anti-psychotic, indicated for the maintenance treatment of schizophrenia in patients currently stabilised with oral antipsychotics.
Danish: Risperdal Consta og tilknyttede navne er et antipsykotikum, som er indiceret til vedligeholdelsesbehandling af skizofreni hos patienter, som er stabiliseret med orale antipsykotika.
English: The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Risperdal Consta and associated names approved across EU Member States, with respect to the indication, the special warnings and precautions for use and the interaction with other medicinal products and other forms of interaction.
Danish: Grundlaget for indbringelsen var, at der var afvigelser mellem de produktresuméer, der var godkendt for Risperdal Consta og tilknyttede navne i EU-medlemsstaterne, med hensyn til indikationen, de særlige advarsler og forsigtighedsregler vedrørende brugen og interaktionen med andre lægemidler og andre former for interaktion.
English: It is available as prolonged release powder and solvent for suspension for intramuscular use.
Danish: Det fås som depotinjektionsvæske, pulver og solvens til suspension, til intramuskulær anvendelse.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Risperdal Consta and associated names International Non-Proprietary Name (INN): risperidone
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 30 OM Risperdal Consta og tilknyttede navne Internationalt fællesnavn (INN): risperidon
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended SPC, Labelling and Package Leaflet in Annex III.
Danish: Listen over de pågældende lægemiddelnavne fremgår af bilag I. De faglige konklusioner findes i bilag II, og det ændrede produktresumé og den ændrede indlægsseddel og etikettering i bilag III.