natgillin/translations-raw huggingface dataset:
I kliniske forsøg, af en varighed på et år eller kortere, er der kun sjældent indberettet behandlingsbetingede dyskinesier under behandling med aripiprazol.
59 Tardive Dyskinesia: in clinical trials of one year or less duration, there were uncommon reports of treatment emergent dyskinesia during treatment with aripiprazole.
60 Dysfagi: øsofagusdysmotilitet og aspiration er forbundet med anvendelse af antipsykotika inklusive ABILIFY.
60 Dysphagia: oesophageal dysmotility and aspiration have been associated with antipsychotic drug use, including ABILIFY.
Ligeledes var de geometriske middelværdier for dehydro- aripiprazol for Cmax og AUC efter samtidig brug af carbamazepin henholdsvis 69% og 71% lavere end ved behandling med aripiprazol alene.
61 of Cmax and AUC after carbamazepine co-administration were 69% and 71% lower, respectively, than those following treatment with aripiprazole alone.
61 Dosis af ABILIFY bør fordobles ved samtidig administration af ABILIFY og carbamazepin.
ABILIFY dose should be doubled when concomitant administration of ABILIFY occurs with carbamazepine.
62 Hjerte Ikke almindelige: takykardi * Nervesystemet Almindelige: ekstrapyramidale forstyrrelser, akathisia, tremor, svimmelhed, søvnighed, sedering, hovedpine Øjne Almindelige: sløret syn Mave- tarmkanalen Almindelige: dyspepsi, opkastning, kvalme, opstipation, hypersekretion af spyt Vaskulære sygdomme Ikke almindelige: ortostatisk hypotension * Almene symptomer og reaktioner på administrationsstedet Almindelige: træthed Psykiske forstyrrelser Almindelige: rastløshed, søvnløshed, ængstelse Ualmindelige: depression *
62 Cardiac disorders Uncommon: tachycardia* Nervous System disorders Common: extrapyramidal disorder, akathisia, tremor, dizziness, somnolence, sedation, headache Eye disorders Common: blurred vision Gastrointestinal disorders Common: dyspepsia, vomiting, nausea, constipation, salivary hypersecretion Vascular disorders Uncommon: orthostatic hypotension* General disorders and administration site conditions Common: fatigue Psychiatric disorders Common: restlessness, insomnia, anxiety Uncommon: depression*
leukopeni, neutropeni, thrombocytopeni 63
63 Nervous system disorders:
64 Medicinsk kul (50 g) administreret en time efter aripiprazol nedsatte aripiprazol Cmax med omkring 41% og AUC med omkring 51%; dette viser, at kul kan være effektivt i behandlingen af overdosering.
64 Activated charcoal (50 g), administered one hour after aripiprazole, decreased aripiprazole Cmax by about 41% and AUC by about 51%, suggesting that charcoal may be effective in the treatment of overdose.
65 maniske symptomer over 3 uger.
65 reduction of manic symptoms over 3 weeks.
66 Farmakokinetik i særlige patientgrupper
66 Pharmacokinetics in special patient groups
67 6.
67 6.
DATO FOR FØRSTE TILLADELSE/ FORNYELSE AF TILLADELSEN
68 Date of first authorisation:
69 1.
69 1.
6 mg aspartam (E951) per smeltetablet.
6 mg aspartame (E951) per orodispersible tablet
Smeltetablet Rund og lyserød, mærket med "A" over "643" på den ene side og ” 30 ” på den anden side.
Orodispersible tablet Round and pink, marked with "A" over "643" on one side and "30" on the other.
5. 2).
70 The orodispersible tablets may be used as an alternative to ABILIFY tablets for patients who have difficulty to swallow ABILIFY tablets (see also section 5.2).
I kliniske forsøg, af en varighed på et år eller kortere, er der kun sjældent indberettet behandlingsbetingede dyskinesier under behandling med aripiprazol.
71 Tardive Dyskinesia: in clinical trials of one year or less duration, there were uncommon reports of treatment emergent dyskinesia during treatment with aripiprazole.
72 Dysfagi: øsofagusdysmotilitet og aspiration er forbundet med anvendelse af antipsykotika inklusive ABILIFY.
72 Dysphagia: oesophageal dysmotility and aspiration have been associated with antipsychotic drug use, including ABILIFY.
Ligeledes var de geometriske middelværdier for dehydro- aripiprazol for Cmax og AUC efter samtidig brug af carbamazepin henholdsvis 69% og 71% lavere end ved behandling med aripiprazol alene.
73 of Cmax and AUC after carbamazepine co-administration were 69% and 71% lower, respectively, than those following treatment with aripiprazole alone.
73 Dosis af ABILIFY bør fordobles ved samtidig administration af ABILIFY og carbamazepin.
ABILIFY dose should be doubled when concomitant administration of ABILIFY occurs with carbamazepine.
74 Hjerte Ikke almindelige: takykardi * Nervesystemet Almindelige: ekstrapyramidale forstyrrelser, akathisia, tremor, svimmelhed, søvnighed, sedering, hovedpine Øjne Almindelige: sløret syn Mave- tarmkanalen Almindelige: dyspepsi, opkastning, kvalme, opstipation, hypersekretion af spyt Vaskulære sygdomme Ikke almindelige: ortostatisk hypotension * Almene symptomer og reaktioner på administrationsstedet Almindelige: træthed Psykiske forstyrrelser Almindelige: rastløshed, søvnløshed, ængstelse Ualmindelige: depression *
74 Cardiac disorders Uncommon: tachycardia* Nervous System disorders Common: extrapyramidal disorder, akathisia, tremor, dizziness, somnolence, sedation, headache Eye disorders Common: blurred vision Gastrointestinal disorders Common: dyspepsia, vomiting, nausea, constipation, salivary hypersecretion Vascular disorders Uncommon: orthostatic hypotension* General disorders and administration site conditions Common: fatigue Psychiatric disorders Common: restlessness, insomnia, anxiety Uncommon: depression*
leukopeni, neutropeni, thrombocytopeni 75
leukopenia, neutropenia, thrombocytopenia
Nervesystemet:
75 Nervous system disorders:
76 Medicinsk kul (50 g) administreret en time efter aripiprazol nedsatte aripiprazol Cmax med omkring 41% og AUC med omkring 51%; dette viser, at kul kan være effektivt i behandlingen af overdosering.
76 Activated charcoal (50 g), administered one hour after aripiprazole, decreased aripiprazole Cmax by about 41% and AUC by about 51%, suggesting that charcoal may be effective in the treatment of overdose.
77 maniske symptomer over 3 uger.
77 reduction of manic symptoms over 3 weeks.
78 Farmakokinetik i særlige patientgrupper
78 Pharmacokinetics in special patient groups
DATO FOR FØRSTE TILLADELSE/ FORNYELSE AF TILLADELSEN
80 Date of first authorisation:
ABILIFY 1 mg/ ml oral opløsning
ABILIFY 1 mg/ ml oral solution
200 mg fructose per ml 400 mg saccharose per ml 1, 8 mg methylparahydroxybenzoat (E218) per ml 0, 2 mg propylparahydroxybenzoat (E216) per ml
200 mg fructose per ml 400 mg sucrose per ml 1.8 mg methyl parahydroxybenzoate (E218) per ml 0.2 mg propyl parahydroxybenzoate (E216) per ml
Oral opløsning Klar, farveløs til lysegul væske.
Oral solution Clear, colourless to light yellow liquid.
5. 2).
ABILIFY oral solution may be used as an alternative to ABILIFY tablets for patients who have difficulty swallowing ABILIFY tablets (see section 5.2).
Den anbefalede startdosis for ABILIFY er 10 eller 15 mg/ dag (dvs.
The recommended starting dose for ABILIFY is 10 or 15 mg/ day (i. e.
10 eller 15 ml opløsning/ dag) med en vedligeholdelsesdosis på 15 mg/ dag, administreret som en enkelt daglig dosis uden hensyntagen til måltider.
10 or 15 ml solution/ day) with a maintenance dose of 15 mg/ day administered on a once-a-day schedule without regard to meals.
Et kalibreret målebæger og en 2 ml kalibreret pipette er inkluderet i pakningen.
A calibrated measuring cup and a 2 ml calibrated dropper are included in the carton.
ABILIFY er effektiv i dosisområdet 10- 30 mg/ dag (dvs.
ABILIFY is effective in a dose range of 10 to 30 mg/ day (i. e.
10- 30 ml opløsning/ dag).
10 to 30 ml solution/ day).
Den anbefalede startdosis for ABILIFY er 15 mg (dvs.
The recommended starting dose for ABILIFY is 15 mg (i. e.
5. 1).
15 ml solution/ day) administered on a once-a-day schedule without regard to meals as monotherapy or combination therapy (see section 5.1).
Den maksimale daglige dosis bør ikke overstige 30 mg (dvs.
The maximum daily dose should not exceed 30 mg (i. e.
30 ml. opløsning/ dag).
30 ml solution/ day).
82 Til forebyggelse af recidiv af maniske episoder hos patienter, der har været behandlet med aripiprazol, fortsættes behandlingen i samme dosis.
82 For preventing recurrence of manic episodes in patients who have been receiving aripiprazole, continue therapy at the same dose.
Hos disse patienter bør dosering administ reres med forsigtighed.
In these patients dosing should be managed cautiously.
5. 2).
Gender: no dosage adjustment is required for female patients as compared to male patients (see sections 4.4 and 5.2).
I kliniske forsøg, af en varighed på et år eller kortere, er der kun sjældent indberettet behandlingsbetingede dyskinesier under behandling med aripiprazol.
83 Tardive dyskinesia: in clinical trials of one year or less duration, there were uncommon reports of treatment emergent dyskinesia during treatment with aripiprazole.
Neuroleptisk Malignt Syndrom (NMS):
Neuroleptic malignant syndrome (NMS):
Der er indberettet hyperglykæmi, i nogle tilfælde udtalt og relateret til ketoacidose eller hyperosmolær koma eller død, hos patienter i behandling med atypiske antipsykotika, inklusive ABILIFY.
Hyperglycaemia and diabetes mellitus: hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotic agents, including ABILIFY.
84 Dysfagi: øsofagusdysmotilitet og aspiration er forbundet med anvendelse af antipsykotika inklusive ABILIFY.
84 Dysphagia: oesophageal dysmotility and aspiration have been associated with antipsychotic drug use, including ABILIFY.
Intolerans:
Intolerance:
Den orale opløsning indeholder fructose.
The oral solution contains fructose.
Patienter med sjældne, arvelige problemer med fructoseintolerans, bør ikke anvende dette lægemiddel.
Patients with rare hereditary problems of fructose intolerance should not take this medicinal product.
Den orale opløsning indeholder saccharose.
The oral solution contains sucrose.
Patienter med sjældne, arvelige problemer med fructoseintolerans, glucose- galactose malabsorption eller sucrase- isomaltaseinsufficiens bør ikke anvende den orale opløsning.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take the oral solution.
Ved samtidig anvendelse af svage CYP3A4 - (fx diltiazem eller escitalopram) eller CYP2D6- hæmmere og ABILIFY, kan beskeden stigning i koncentrationen af aripiprazol forventes.
85 When weak inhibitors of CYP3A4 (e. g., diltiazem or escitalopram) or CYP2D6 are used concomitantly with ABILIFY, modest increases in aripiprazole concentrations might be expected.
85 Efter samtidig behandling med carbamazepin, en potent induktor af CYP3A4, var de geometriske middelværdier for Cmax og AUC for aripiprazol henholdsvis 68% og 73% lavere end, hvis aripiprazol (30 mg) blev givet alene.
Following concomitant administration of carbamazepine, a potent inducer of CYP3A4, the geometric means of Cmax and AUC for aripiprazole were 68% and 73% lower, respectively, compared to when aripiprazole (30 mg) was administered alone.
Følgende bivirkninger optrådte hyppigere (≥1/ 100) end placebo eller blev identificeret som muligvis medicinsk relevante bivirkningsreaktioner (*):
The following undesirable effects occurred more often (≥ 1/ 100) than placebo, or were identified as possibly medically relevant adverse reactions (*):
86 Hjerte Ikke almindelige: takykardi * Nervesystemet Almindelige: ekstrapyramidale forstyrrelser, akathisia, tremor, svimmelhed, søvnighed, sedering, hovedpine Øjne Almindelige: sløret syn Mave- tarmkanalen Almindelige: dyspepsi, opkastning, kvalme, opstipation, hypersekretion af spyt Vaskulære sygdomme Ikke almindelige: ortostatisk hypotension * Almene symptomer og reaktioner på administrationsstedet Almindelige: træthed Psykiske forstyrrelser Almindelige: rastløshed, søvnløshed, ængstelse Ualmindelige: depression *
86 Cardiac disorders Uncommon: tachycardia* Nervous System disorders Common: extrapyramidal disorder, akathisia, tremor, dizziness, somnolence, sedation, headache Eye disorders Common: blurred vision Gastrointestinal disorders Common: dyspepsia, vomiting, nausea, constipation, salivary hypersecretion Vascular disorders Uncommon: orthostatic hypotension* General disorders and administration site conditions Common: fatigue Psychiatric disorders Common: restlessness, insomnia, anxiety Uncommon: depression*
I et andet 12- ugers forsøg var forekomsten af EPS 26, 6% for aripiprazol- behandlede patienter og 17, 6% for lithium- behandlede patienter.
In another 12-week trial, the incidence of EPS was 26.6% for patients treated with aripiprazole and 17.6% for those treated with lithium.
I den længerevarende 26- ugers vedligeholdelsesfase i et placebokontrolleret forsøg, var forekomsten af EPS 18, 2% for aripiprazolbehandlede patienter og 15, 7% for placebobehandlede patienter.
In the long term 26-week maintenance phase of a placebo-controlled trial, the incidence of EPS was 18.2% for aripiprazole-treated patients and 15.7% for placebo-treated patients.
Hyppighed af disse bivirkninger betragtes som ukendt (kan ikke estimeres ud fra foreliggende data).
The frequency of these events is considered not known (cannot be estimated from the available data).
leukopeni, neutropeni, thrombocytopeni 87
87 Nervous system disorders:
88 Medicinsk kul (50 g) administreret en time efter aripiprazol nedsatte aripiprazol Cmax med omkring 41% og AUC med omkring 51%; dette viser, at kul kan være effektivt i behandlingen af overdosering.
88 Activated charcoal (50 g), administered one hour after aripiprazole, decreased aripiprazole Cmax by about 41% and AUC by about 51%, suggesting that charcoal may be effective in the treatment of overdose.
I et 26- ugers, kontrolleret, dobbeltblindt, multinationalt forsøg med olanzapin til behandling af skizofreni, som inkluderede 314 patienter, og hvor det primære endpoint var vægtstigning, fandtes signifikant færre patienter at have 7% eller yderligere vægtstigning i forhold til baseline (dvs en stigning på mindst 5, 6 kg for en middel- baselinevægt på ∼80, 5 kg) med aripripazol (N= 18 eller 13% af de evaluérbare patienter) sammenlignet med olanzapin (N= 45 eller 33% af de evaluérbare patienter).
In a 26-week, olanzapine-controlled, double-blind, multi-national study of schizophrenia which included 314 patients and where the primary end-point was weight gain, significantly less patients had at least 7% weight gain over baseline (i. e. a gain of at least 5.6 kg for a mean baseline weight of ~80.5 kg) on aripiprazole (N = 18, or 13% of evaluable patients), compared to olanzapine (N = 45, or 33% of evaluable patients).
I to, 3- ugers placebokontrollerede enkeltstofforsøg med fleksible doser til patienter med manisk eller blandet episode af bipolar lidelse type 1, viste aripiprazol bedre effekt end placebo til reduktion af de
In two 3-week, flexible-dose, placebo-controlled monotherapy trials involving patients with a manic or mixed episode of Bipolar I Disorder, aripiprazole demonstrated superior efficacy to placebo in
89 maniske symptomer over 3 uger.
89 reduction of manic symptoms over 3 weeks.
Oral opløsning Aripiprazol absorberes godt, når det administreres peroralt som opløsning.
Aripiprazole is well absorbed when administered orally as the solution.
Ved ækvivalente doser var maksimal plasmakoncentrationen af aripiprazol (Cmax) for opløsningen noget højere end for tabletterne, men den systemiske optagelse (AUC) var ækvivalent.
At equivalent doses, the peak plasma concentrations of aripiprazole (Cmax) from the solution were somewhat higher but the systemic
90 opløsning med 30 mg aripiprazol som tabletter hos raske forsøgspersoner, var forholdet mellem opløsning versus tabletter af den gennemsnitlige Cmax værdi 122% (N = 30).
In a relative bioavailability study comparing the pharmacokinetics of 30 mg aripiprazole as the oral solution to 30 mg aripiprazole tablets in healthy subjects, the solution to the tablet ratio of geometric mean Cmax values was 122% (N = 30).
Enkeltdosis - farmakokinetik for aripiprazol var lineær og dosisproportionel.
The single- dose pharmacokinetics of aripiprazole were linear and dose-proportional.
Der er hos rotter observeret udviklingsmæssig toksicitet, inklusive dosisafhængig, forsinket føtal ossifikation og
Developmental toxicity, including dose-dependent delayed foetal ossification and possible teratogenic effects, were
91 mulig teratogen effekt ved doser som resulterede i sub- terapeutisk optagelse (baseret på AUC), og i kaniner ved doser, der resulterede i optagelser henholdsvis 3 og 11 gange middel- steady- state AUC ved maksimal, anbefalet klinisk dosis.
91 observed in rats at doses resulting in subtherapeutic exposures (based on AUC) and in rabbits at doses resulting in exposures 3 and 11 times the mean steady-state AUC at the maximum recommended clinical dose.
Dinatriumedetat Fructose Glycerin Mælkesyre Methylparahydroxybenzoat (E218) Propylenglykol Propylparahydroxybenzoat (E216) Natriumhydroxid Saccharose Renset vand
Disodium edetate Fructose Glycerin Lactic acid Methyl parahydroxybenzoate (E218) Propylene glycol Propyl parahydroxybenzoate (E216) Sodium hydroxide Sucrose Purified water
Efter åbning:
3 years After first opening:
Hver pakning indeholder en flaske og både et kalibreret polypropylen- målebæger og en kalibreret polypropylen low- density polyethylen pipette.
Each carton contains 1 bottle and both a calibrated polypropylene measuring cup and a calibrated polypropylene low-density polyethylene dropper.
92 8.
92 8.
93 1.
93 1.
ABILIFY 7, 5 mg/ ml injektionsvæske, opløsning
ABILIFY 7.5 mg/ ml solution for injection
Hver ml indeholder 7, 5 mg aripiprazol.
Each ml contains 7.5 mg of aripiprazole.
Et hætteglas indeholder 9, 75 mg aripiprazol.
A vial contains 9.75 mg aripiprazole.
Klar, farveløs, vandig opløsning.
Solution for injection Clear, colourless, aqueous solution.
ABILIFY injektionsvæske, opløsning er indiceret til hurtig kontrol af agitation og adfærdsforstyrrelser hos patienter med skizofreni eller patienter med maniske episoder ved bipolar lidelse type I, når oral behandling ikke er hensigtsmæssig.
ABILIFY solution for injection is indicated for the rapid control of agitation and disturbed behaviours in patients with schizophrenia or in patients with manic episodes in Bipolar I Disorder, when oral therapy is not appropriate.
Behandling med aripiprazol injektionsvæske, opløsning skal seponeres så hurtigt som klinisk muligt, og brug af oral aripiprazol påbegyndes.
Treatment with aripiprazole solution for injection should be discontinued as soon as clinically appropriate and the use of oral aripiprazole should be initiated.
Det anbefales at injicere i deltoid eller dybt i gluteus og at undgå områder med fedtaflejringer, for at øge absorptionen samt at minimere forskelle i absorptionen.
To enhance absorption and minimise variability, injection into the deltoid or deep within the gluteus maximus muscle, avoiding adipose regions, is recommended.
5. 1).
ABILIFY solution for injection is ready to use and intended for short-term use only (see section 5.1).
Den anbefalede startdosis for aripiprazol injektionsvæske, opløsning er 9, 75 mg (1, 3 ml), administreret som enkelt intramuskulær injektion.
The recommended initial dose for aripiprazole solution for injection is 9.75 mg (1.3 ml), administered as a single intramuscular injection.
Effektivt dosisområde for aripiprazol injektionsvæske, opløsning er 5- 15 mg som enkeltinjektion.
The effective dose range of aripiprazole solution for injection is 5.25-15 mg as a single injection.
Der kan gives lavere dosis, 5, 25 mg (0, 7 ml), på baggrund af individuel klinisk status, hvor andre medicinske produkter, der allerede administreres i forbindelse med vedligeholdelses - eller akut behandling også indgår i overvejelserne (se afsnit 4. 5).
A lower dose of 5.25 mg (0.7 ml) may be given, on the basis of individual clinical status, which should also include consideration of medicinal products already administered either for maintenance or acute treatment (see section 4.5).
Yderligere injektion kan administreres 2 timer efter første injektion, på baggrund af individuel klinisk status; der bør ikke gives mere end 3 injektioner i løbet af en 24- timers periode.
A second injection may be administered 2 hours after the first injection, on the basis of individual clinical status and no more than three injections should be given in any 24-hour period.
Maksimal daglig dosis af aripiprazol er 30 mg (inkluderende alle formuleringer af aripiprazol).
The maximum daily dose of aripiprazole is 30 mg (including all formulations of aripiprazole).
Den
In patients with severe hepatic impairment, the data available are insufficient to
Virkningen af ABILIFY ved behandling af skizofreni hos patienter på 65 år eller derover er ikke undersøgt.
Elderly: the effectiveness of ABILIFY solution for injection in patients who are 65 years of age or older has not been established.
Effekt af aripiprazol injektionsvæske, opløsning hos patienter med agitation og adfærdsforstyrrelser er ikke undersøgt i andre sammenhænge end skizofreni og maniske episoder ved bipolar lidelse type I.
The efficacy of aripiprazole solution for injection in patients with agitation and disturbed behaviours has not been established related to conditions other than schizophrenia and manic episodes in Bipolar I Disorder.
4. 5).
If parenteral benzodiazepine therapy is deemed necessary in addition to aripiprazole solution for injection, patients should be monitored for excessive sedation and for orthostatic hypotension (see section 4.5).
Patienter der behandles med aripiprazol injektionsvæske, opløsning skal observeres for ortostatisk hypotension.
Patients receiving aripiprazole solution for injection should be observed for orthostatic hypotension.
Sikkerheden og effekten af aripiprazol injektionsvæske, opløsning er ikke evalueret hos patienter med alkohol - eller medicinforgiftning (hverken med ordinerede eller ulovlige midler).
The safety and efficacy of aripiprazole solution for injection has not been evaluated in patients with alcohol or medicinal product intoxication (either with prescribed or illicit medicinal products).
Aripiprazol bør anvendes med forsigtighed til patienter med kendt kardiovaskulær sygdom (anamnestisk myokardieinfarkt eller iskæmisk hjertesygdom, hjertesvigt eller ledningsforstyrrelser), cerebrovaskulær sygdom, tilstande som disponerer for hypotension
Aripiprazole should be used with caution in patients with known cardiovascular disease (history of myocardial infarction or ischaemic heart disease, heart failure, or
95 (dehydrering, hypovolæmi og behandling med antihypertensiva) eller hypertension, accelereret såvel som malign.
95 conduction abnormalities), cerebrovascular disease, conditions which would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medications) or hypertension, including accelerated or malignant.
96 vægtstigning hos patienter behandlet med ABILIFY.
96 Weight gain: weight gain is commonly seen in schizophrenic and bipolar mania patients due to co- morbidities, use of antipsychotics known to cause weight gain, poorly managed life-style, and might lead to severe complications.
Øsofagusdysmotilitet og aspiration er forbundet med anvendelse af antipsykotika inklusive ABILIFY.
Dysphagia: oesophageal dysmotility and aspiration have been associated with antipsychotic drug use, including ABILIFY.
Lorazepam injektionsvæske, opløsning havde ingen effekt på farmakokinetik af aripiprazol injektionsvæske, opløsning ved samtidig administration.
The administration of lorazepam solution for injection had no effect on the pharmacokinetics of aripiprazole solution for injection when administered concomitantly.
Ved afbrydelse af behandling med CYP2D6 - eller 3A4- hæmmer, bør dosis af ABILIFY øges til niveauet inden start af den samtidige behandling.
97 Upon discontinuation of the CYP2D6 or 3A4 inhibitor, the dosage of ABILIFY should be increased to the level prior to the initiation of the concomitant therapy.