natgillin/translations-raw huggingface dataset:
97 Ved samtidig anvendelse af svage CYP3A4 - (fx diltiazem eller escitalopram) eller CYP2D6- hæmmere og ABILIFY, kan beskeden stigning i koncentrationen af aripiprazol forventes.
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.
Aripiprazol injektionsvæske, opløsning havde ingen effekt på farmakokinetik af lorazepam injektionsvæske, opløsning ved samtidig administration.
The administration of aripiprazole solution for injection had no effect on the pharmacokinetics of lorazepam solution for injection when administered concomitantly.
98 4. 8 Bivirkninger
98 4.8 Undesirable effects
5. 1):
The following undesirable effects occurred more often (≥ 1/ 100) than placebo, or were identified as possibly medically relevant adverse reactions (*) in clinical trials with aripiprazole solution for injection (see section 5.1):
Hyppigheden anført nedenfor defineres i henhold til følgende konventioner: almindelig (≥ 1/ 100, < 1/ 10); ikke almindelig (≥ 1/ 1000, < 1/ 100)
The frequency listed below is defined using the following convention: common (≥ 1/ 100, < 1/ 10) and uncommon (≥ 1/ 1,000, < 1/ 100).
Hjerte Ikke almindelige: takykardi * Nervesystemet Almindelige: somnolens, svimmelhed, hovedpine, akatisi Mave- tarmkanalen Almindelige: kvalme, opkastning Ikke almindelige: tør mund * Vaskulære sygdomme Ikke almindelige: ortostatisk hypotension *, øget diastolisk blodtryk * Almene symptomer og reaktioner på administrationsstedet Ikke almindelige: træthed *
Cardiac disorders Uncommon: tachycardia* Nervous system disorders Common: somnolence, dizziness, headache, akathisia Gastrointestinal disorders Common: nausea, vomiting Uncommon: dry mouth* Vascular disorders Uncommon: orthostatic hypotension*, increased diastolic blood pressure* General disorders and administration site conditions Uncommon: fatigue*
5. 1):
The following undesirable effects occurred more often (≥ 1/ 100) than placebo, or were identified as possibly medically relevant adverse reactions (*) in clinical trials with oral formulations of aripiprazole (see section 5.1):
Hjerte Ikke almindelige: takykardi * Nervesystemet Almindelige: ekstrapyramidal forstyrrelse, akathisia, tremor, svimmelhed, somnolens, sedering, hovedpine Øjne Almindelige: sløret syn Mave- tarmkanalen Almindelige: dyspepsi, opkastning, kvalme, obstipation, hypersekretion af spyt Vaskulære sygdomme Ikke almindelige: ortostatisk hypotension * Almene symptomer og reaktioner på administrationsstedet Almindelige: træthed Psykiske forstyrrelser Almindelige: rastløshed, søvnløshed, ængstelse Ikke almindelige: depression *
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 den længerevarende 26- ugers vedligeholdelsesfase i et placebokontrolleret forsøg, var forekomsten af EPS 18, 2% for aripiprazol- behandlede patienter og 15, 7% for placebo- behandlede 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.
99 I placebokontrollerede forsøg var forekomsten af akathisia hos bipolære patienter 12, 1% med aripiprazol og 3, 2% med placebo.
In placebo-controlled trials, the incidence of akathisia in bipolar patients was 12.1% with aripiprazole and 3.2% with placebo.
Sammenligning af aripiprazol og placebo hos den gruppe af patienter, der oplevede potentielt klinisk signifikante ændringer i rutinemæssige laboratorieprøver viste ingen medicinsk vigtige forskelle.
99 Comparisons between aripiprazole and placebo in the proportions of patients experiencing potentially clinically significant changes in routine laboratory parameters revealed no medically important differences.
100 aspartat- aminotransferase (ASAT), forhøjet gammaglutamyltransferase (GGT), forhøjet alkalinfosfatase
100
Det er foreslået, at aripiprazols virkning på skizofreni og bipolar lidelse type I medieres gennem en kombination af partiel agonisme på dopamin D2 - og serotonin 5- HT1a- receptorer samt antagonisme på serotonin 5- HT2a- receptorer.
It has been proposed that aripiprazole’ s efficacy in schizophrenia and Bipolar I Disorder is mediated through a combination of partial agonism at dopamine D2 and serotonin 5HT1a receptors and antagonism of serotonin 5HT2a receptors.
Yderligere information om kliniske undersøgelser:
101 Further information on clinical trials:
Agitation ved skizofreni og bipolar lidelse type I med aripiprazol injektionsvæske, opløsning:
Agitation in schizophrenia and Bipolar I Disorder with aripiprazole solution for injection:
I 2 korterevarende (24- timers) placebo- kontrollerede forsøg med 554 skizofrene patienter med agitation
In two short- term (24-hour) placebo-controlled trials involving 554 schizophrenic patients presenting with agitation and disturbed behaviours, aripiprazole solution for injection was associated with statistically significant greater improvements in agitation/ behavioural symptoms compared to placebo and was similar to haloperidol.
I ét kortvarigt (24- timers) placebokontrolleret forsøg med 291 patienter med bipolar lidelse og agitation samt adfærdsforstyrrelser, var aripiprazol opløsning til injektion forbundet med statistisk signifikante større forbedringer i agitations - / adfærdssymptomerne sammenlignet med placebo og forbedringer svarende til referencearmen med lorazepam.
In one short-term (24-hour) placebo-controlled trial involving 291 patients with bipolar disorder presenting with agitation and disturbed behaviours, aripiprazole solution for injection was associated with statistically significant greater improvements in agitation/ behavioural symptoms compared to placebo and was similar to the reference arm lorazepam.
Den observerede gennemsnitlige forbedring fra baseline i affektkomponent- scoren i PANSS ved det primære 2- timers endpoint var 5, 8 for placebo, 9, 6 for lorazepam og 8, 7 for aripiprazol.
The observed mean improvement from baseline on the PANSS Excitement Component score at the primary 2-hour endpoint was 5.8 for placebo, 9.6 for lorazepam, and 8.7 for aripiprazole.
I subgruppe- analyser af patienter med blandede episoder og patienter med svær agitation sås effektmønstre svarende til den overordnede population, men statistisk signifikans kunne ikke fastslås på grund af reduceret populationsstørrelse.
In subpopulation analyses on patients with mixed episodes or on patients with severe agitation, a similar pattern of efficacy to the overall population was observed but statistical significance could not be established due to a reduced sample size.
Skizofreni med oral aripiprazol:
Schizophrenia with oral aripiprazole:
I tre kortere varende (4- 6 uger), placebokontrollerede undersøgelser med 1228 skizofrene patienter med positive eller negative symptomer var aripiprazol forbundet med statistisk signifikant, større forbedring i psykotiske symptomer sammenlignet med placebo.
In three short-term (4 to 6 weeks) placebo-controlled trials involving 1,228 schizophrenic patients, presenting with positive or negative symptoms, oral aripiprazole was associated with statistically significantly greater improvements in psychotic symptoms compared to placebo.
I et kontrolleret forsøg med haloperidol var andelen af responderende patienter, der opretholdt respons på lægemidlet efter 52 uger, den samme i begge grupper (aripiprazol 77% og haloperidol 73%).
In a haloperidol-controlled trial, the proportion of responder patients maintaining response to medicinal product at 52-weeks was similar in both groups (oral aripiprazole 77% and haloperidol 73%).
Andelen af patienter, der gennemførte forsøget, var signifikant højere for patienter i behandling med aripiprazol (43%) end med halperidol (30%).
The overall completion rate was significantly higher for patients on oral aripiprazole (43%) than for oral haloperidol (30%).
I et 26- ugers, placebokontrolleret forsøg med stabiliserede patienter med kronisk skizofreni var aripiprazol forbundet med en signifikant større reduktion i tilbagefaldsraten; 34% i aripiprazolgruppen og 57% i placebo.
In a 26-week, placebo-controlled trial in stabilised patients with chronic schizophrenia, oral aripiprazole had significantly greater reduction in relapse rate, 34% in oral aripiprazole group and 57% in placebo.
Vægtændring: aripiprazol er i kliniske forsøg ikke vist at forårsage klinisk relevante vægtstigninger.
Weight gain: in clinical trials oral aripiprazole has not been shown to induce clinically relevant weight gain.
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 oral aripiprazole (N= 18, or 13% of evaluable patients), compared to oral olanzapine (N= 45, or 33% of evaluable patients).
Maniske episoder ved bipolar lidelse type 1 med oral aripiprazol:
Manic episodes in Bipolar I Disorder with oral aripiprazole:
Tillæg af aripiprazol forbedrede reduktionen af de maniske symptomer i forhold til enkeltstofbehandling med lithium eller valproat.
In a 6-week, placebo-controlled trial involving patients with a manic or mixed episode of Bipolar I Disorder, with or without psychotic features, who were partially non-responsive to lithium or valproate monotherapy for 2 weeks at therapeutic serum levels, the addition of aripiprazole as adjunctive therapy resulted in superior efficacy in reduction of manic symptoms than lithium or valproate monotherapy.
Aripiprazol havde ikke bedre effekt end placebo ved forebyggelse af recidiv af depression.
102 In a 26-week, placebo-controlled trial, followed by a 74-week extension, in manic patients who achieved remission on aripiprazole during a stabilization phase prior to randomization, aripiprazole demonstrated superiority over placebo in preventing bipolar recurrence, primarily in preventing recurrence into mania but failed to demonstrate superiority over placebo in preventing recurrence into depression.
Aripiprazol injektionsvæske, opløsning administreret intramuskulært som enkeltdosis til raske frivillige absorberes godt og har en absolut biotilgængelighed på 100%.
Aripiprazole solution for injection administered intramuscularly as a single-dose to healthy subjects is well absorbed and has an absolute bioavailability of 100%.
AUC for aripiprazol er i de første 2 timer efter en intramuskulær injektion 90% større end AUC efter samme dosis i tabletform; den systemiske optagelse er umiddelbart den samme for de 2 formuleringer.
The aripiprazole AUC in the first 2 hours after an intramuscular injection was 90% greater than the AUC after the same dose as a tablet; systemic exposure was generally similar between the 2 formulations.
I 2 forsøg med raske frivillige var median- tid til maksimal plasmakoncentration 1 og 3 timer efter administration.
In 2 studies in healthy subjects the median times to the peak plasma concentrations were 1 and 3 hours after dosing.
Nyrelidelse:
103 Renal Disease:
103 aripiprazol og dehydro- aripiprazol, men undersøgelsen omfattede kun 3 patienter med klasse C levercirrhose, hvilket er utilstrækkelig basis for en konklusion vedrørende metabolisk kapacitet.
A single-dose study in subjects with varying degrees of liver cirrhosis (Child-Pugh Classes A, B, and C) did not reveal a significant effect of hepatic impairment on the pharmacokinetics of aripiprazole and dehydro-aripiprazole, but the study included only 3 patients with Class C liver cirrhosis, which is insufficient to draw conclusions on their metabolic capacity.
Administration af aripiprazol injektionsvæske, opløsning var veltolereret og medførte ikke toksicitet i målorganer hos rotter eller aber efter gentagen dosering medførende systemisk optagelse (AUC), henholdsvis 15 og 5 gange højere end den humane optagelse ved maksimal anbefalet dosis på 30 mg intramuskulært.
Administration of aripiprazole solution for injection was well tolerated and produced no direct target organ toxicity in rats or monkeys after repeated dosing at systemic exposures (AUC) that were 15 and 5 times, respectively, human exposure at the maximum recommended human dose of 30 mg intramuscular.
De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet og reproduktionstoksicitet.
Non-clinical safety data revealed no special hazard for humans based on conventional oral aripiprazole studies of safety pharmacology, repeat-dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction.
Derudover sås cholelithiasis som følge af udfældning af sulfatkonjugater af hydroxymetabolitter af aripiprazol i galden hos aber efter gentagne orale doser på 25- 125 mg/ kg/ dag (1- 3 gange middel - steady- state AUC ved den maksimale, anbefalede kliniske dosis eller 16- 81 gange den anbefalede, humane dosis baseret på mg/ m2).
An additional finding was cholelithiasis as a consequence of precipitation of sulphate conjugates of hydroxy metabolites of aripiprazole in the bile of monkeys after repeated oral dosing at 25 to 125 mg/ kg/ day (1 to 3 times the mean steady-state AUC at the maximum recommended clinical dose 2 or 16 to 81 times the maximum recommended human dose based on mg/ m).
Sulfobutylether β- cyclodextrin (SBECD) Vinsyre Natriumhydroxid Vand til injektionsvæsker
Sulfobutylether β -cyclodextrin (SBECD) Tartaric acid Sodium hydroxide Water for injection
104 6. 3 Opbevaringstid
104 6.2 Incompatibilities
Produktet skal anvendes umiddelbart efter åbning og eventuelle rester smides ud.
18 months Use product immediately after opening and discard any unused amount.
Hver karton indeholder ét type I hætteglas til éngangsbrug med gummibutylstopper og aluminiumforsegling, der kan vippes af..
Each carton contains one single-use type I glass vial with a rubber butyl stopper and a "flip-off" aluminium seal.
105 BILAG II
105 ANNEX II
BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
B CONDITIONS OF THE MARKETING AUTHORISATION
FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
106 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Contrada Fontana del Ceraso I- 03012 Anagni- Frosinone Italien
Bristol-Myers Squibb Srl Contrada Fontana Del Ceraso I-03012 Anagni-Frosinone Italy
Otsuka Pharmaceuticals Europe Ltd forpligter sig at fremskaffe sikkerhedsrapporter (PSUR) med 6 måneders mellemrum medmindre CHMP ændrer bestemmelsen.
Otsuka Pharmaceutical Europe Ltd commits to provide a PSUR at 6 monthly intervals unless otherwise decided by the CHMP.
Pharmacovigilance system Indehaveren af markedsføringstilladelsen skal sikre, at pharmacovigilancesystemet, som står beskrevet i version 2. 1 i Modul 1. 8. 1 i ansøgningen om markedsføringstilladelse, er på plads og fungerer før og efter produktet er markedsført.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 1.0 presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Risk Management Plan Indehaveren af markedsføringstilladelsen er forpligtet til at udføre undersøgelser og yderligere pharmacovigilance- aktiviteter som beskrevet i Pharmacovigilanceplanen i overensstemmelse med version 2. 1 af Risk Management Planen (RMP), der er beskrevet i Modul 1. 8. 2 i ansøgningen om markedsføringstilladelse samt alle efterfølgende RMP- opdateringer, der er vedtaget af CHMP.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
I henhold til CHMP Guideline for Risk Management Systemet for lægemidler til human brug bør den opdaterede RMP indsendes samtidig med den næste sikkerhedsopdateringsrapport (PSUR).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Desuden bør en opdateret RMP indsendes når der modtages ny information, der kan have indvirkning på den gældende sikkerhedsspecifikation, Pharmacovigilanceplan eller risikominimeringsaktiviteterne senest 60 dage efter at en vigtig milepæl (pharmacovigilance eller risikominimering) er nået ved anmodning fra EMEA
In addition, an updated RMP should be submitted When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached At the request of the EMEA
107 BILAG III
107 ANNEX III
109 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
109 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
ANGIVELSE AF AKTIVT STOF/ AKTIVE STOFFER
STATEMENT OF ACTIVE SUBSTANCE
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ( E)
METHOD AND ROUTE(S) OF ADMINISTRATION
EU/ 1/ 04/ 276/ 001 14 x 1 tabletter EU/ 1/ 04/ 276/ 002 28 x 1 tabletter EU/ 1/ 04/ 276/ 003 49 x 1 tabletter EU/ 1/ 04/ 276/ 004 56 x 1 tabletter EU/ 1/ 04/ 276/ 005 98 x 1 tabletter
EU/ 1/ 04/ 276/ 001 14 x 1 tablets EU/ 1/ 04/ 276/ 002 28 x 1 tablets EU/ 1/ 04/ 276/ 003 49 x 1 tablets EU/ 1/ 04/ 276/ 004 56 x 1 tablets EU/ 1/ 04/ 276/ 005 98 x 1 tablets
INFORMATION I BRAILLE- SKRIFT
INFORMATION IN BRAILLE
111 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
111 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
112 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
112 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
EU/ 1/ 04/ 276/ 006 14 x 1 tabletter EU/ 1/ 04/ 276/ 007 28 x 1 tabletter EU/ 1/ 04/ 276/ 008 49 x 1 tabletter EU/ 1/ 04/ 276/ 009 56 x 1 tabletter EU/ 1/ 04/ 276/ 010 98 x 1 tabletter
EU/ 1/ 04/ 276/ 006 14 x 1 tablets EU/ 1/ 04/ 276/ 007 28 x 1 tablets EU/ 1/ 04/ 276/ 008 49 x 1 tablets EU/ 1/ 04/ 276/ 009 56 x 1 tablets EU/ 1/ 04/ 276/ 010 98 x 1 tablets
114 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
114 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
115 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
115 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
EU/ 1/ 04/ 276/ 011 14 x 1 tabletter EU/ 1/ 04/ 276/ 012 28 x 1 tabletter EU/ 1/ 04/ 276/ 013 49 x 1 tabletter EU/ 1/ 04/ 276/ 014 56 x 1 tabletter EU/ 1/ 04/ 276/ 015 98 x 1 tabletter
EU/ 1/ 04/ 276/ 011 14 x 1 tablets EU/ 1/ 04/ 276/ 012 28 x 1 tablets EU/ 1/ 04/ 276/ 013 49 x 1 tablets EU/ 1/ 04/ 276/ 014 56 x 1 tablets EU/ 1/ 04/ 276/ 015 98 x 1 tablets
117 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
117 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
118 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
118 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
EU/ 1/ 04/ 276/ 016 14 x 1 tabletter EU/ 1/ 04/ 276/ 017 28 x 1 tabletter EU/ 1/ 04/ 276/ 018 49 x 1 tabletter EU/ 1/ 04/ 276/ 019 56 x 1 tabletter EU/ 1/ 04/ 276/ 020 98 x 1 tabletter
EU/ 1/ 04/ 276/ 016 14 x 1 tablets EU/ 1/ 04/ 276/ 017 28 x 1 tablets EU/ 1/ 04/ 276/ 018 49 x 1 tablets EU/ 1/ 04/ 276/ 019 56 x 1 tablets EU/ 1/ 04/ 276/ 020 98 x 1 tablets
120 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
120 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
121 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
121 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
14 x 1 smeltetabletter 28 x 1 smeltetabletter 49 x 1 smeltetabletter
14 x 1 orodispersible tablets 28 x 1 orodispersible tablets 49 x 1 orodispersible tablets
122 9.
122 9.
EU/ 1/ 04/ 276/ 024 14 x 1 smeltetabletter EU/ 1/ 04/ 276/ 025 28 x 1 smeltetabletter EU/ 1/ 04/ 276/ 026 49 x 1 smeltetabletter
EU/ 1/ 04/ 276/ 024 14 x 1 orodispersible tablets EU/ 1/ 04/ 276/ 025 28 x 1 orodispersible tablets EU/ 1/ 04/ 276/ 026 49 x 1 orodispersible tablets
123 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
123 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
124 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
124 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
EU/ 1/ 04/ 276/ 027 14 x 1 smeltetabletter EU/ 1/ 04/ 276/ 028 28 x 1 smeltetabletter EU/ 1/ 04/ 276/ 029 49 x 1 smeltetabletter
EU/ 1/ 04/ 276/ 027 14 x 1 orodispersible tablets EU/ 1/ 04/ 276/ 028 28 x 1 orodispersible tablets EU/ 1/ 04/ 276/ 029 49 x 1 orodispersible tablets
126 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
126 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
127 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
127 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
128 9.
128 9.
EU/ 1/ 04/ 276/ 030 14 x 1 smeltetabletter EU/ 1/ 04/ 276/ 031 28 x 1 smeltetabletter EU/ 1/ 04/ 276/ 032 49 x 1 smeltetabletter
EU/ 1/ 04/ 276/ 030 14 x 1 orodispersible tablets EU/ 1/ 04/ 276/ 031 28 x 1 orodispersible tablets EU/ 1/ 04/ 276/ 032 49 x 1 orodispersible tablets
129 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
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130 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE
130 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
ABILIFY 1 mg/ ml oral opløsning aripiprazol
ABILIFY 1 mg/ ml oral solution aripiprazole
50 ml oral opløsning 150 ml oral opløsning 480 ml oral opløsning
50 ml oral solution 150 ml oral solution 480 ml oral solution
EU/ 1/ 04/ 276/ 033 - 50 ml flaske EU/ 1/ 04/ 276/ 034 - 150 ml flaske EU/ 1/ 04/ 276/ 035 - 480 ml flaske
EU/ 1/ 04/ 276/ 033 - 50 ml bottle EU/ 1/ 04/ 276/ 034 - 150 ml bottle EU/ 1/ 04/ 276/ 035 - 480 ml bottle
132 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
132 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
ABILIFY 7, 5 mg/ ml injektionvæske, opløsning aripiprazol
ABILIFY 7.5 mg/ ml solution for injection aripiprazole
Et hætteglas giver 9, 75 mg per 1, 3 ml.
A vial provides 9.75 mg in 1.3 ml
Indeholder også sulfobutylether b- cyclodextrin, vinsyre, natriumhydroxid og vand til injektionsvæsker.
Also contains sulfobutylether b-cyclodextrin, tartaric acid, sodium hydroxide, and water for injection.
133 10.
133 10.
FREMSTILLERENS BATCHNUMMER
MANUFACTURER’ S BATCH NUMBER
Da ABILIFY 7, 5 mg/ ml opløsning til injektion udelukkende er beregnet til administration ved sundhedspersonale, vil der ikke blive inkluderet information i Braille- skrift
As ABILIFY 7.5 mg/ ml solution for injection is only intended for administration by health care professionals, no information will be included in Braille.
134 MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
134 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
HÆTTEGLAS- ETIKET
VIAL LABEL
LÆGEMIDLETS NAVN, STYRKE OG/ ELLER ADMINISTRATIONSVEJ( E)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
ABILIFY 7, 5 mg/ ml injektionvæske, opløsning aripiprazol Intramuskulær anvendelse
ABILIFY 7.5 mg/ ml solution for injection aripiprazole Intramuscular use
135 B.
135 B.
136 INDLÆGSSEDDEL:
136 PACKAGE LEAFLET:
INFORMATION TIL BRUGEREN
INFORMATION FOR THE USER
Lægen har ordineret ABILIFY til dig personligt.
This medicine has been prescribed for you.
Virkning og anvendelse2. Det skal du vide, før du begynder at tage ABILIFY 3.
What ABILIFY is and what it is used for 2.