FrancophonIA/ELRC3.0 huggingface dataset:
English: 12 months after the first revaccination
Danish: 5 måneder efter grundvaccination 12 måneder efter den første revaccination
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 2 år 6.4 Særlige opbevaringsforhold Opbevares ved 2-8°C, beskyttet mod lys.
English: SPECIAL WARNING(S), IF NECESSARY
Danish: SÆRLIG(E) ADVARSEL/ADVARSLER, OM NØDVENDIGT Læs indlægssedlen inden brug.
English: Veterinary medicinal product subject to prescription.
Danish: når de anvendes i et veterinærlægemiddel.
English: Phosphate buffer, traces of thiomersal, traces of formaldehyde
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Fortegnelse over hjælpestoffer Phosphatbuffer, spor af thiomersal, spor af formaldehyd 6.2 Væsentlige uforligeligheder Må ikke blandes med andre veterinære lægemidler.
English: 2 weeks after the primary vaccination course Duration of immunity: 5 months after the primary vaccination course
Danish: Immuniteten indtræder: 2 uger efter grundvaccination Immuniteten varer:
English: 42 months
Danish: 42 måneder Prequenza Te
English: 4.1 Target species
Danish: 4.1 Dyrearter, som lægemidlet er beregnet til Heste
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Danish: 4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til
English: ANNEX II A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: FREMSTILLER(E) AF DE(T) BIOLOGISK AKTIVE STOF(FER) OG FREMSTILLER(E) ANSVARLIG FOR BATCHFRIGIVELSE
English: MA (EU) number (Invented) name Strength Pharmaceutical form Route of administration
Danish: MF (EU)-nummer (Særnavn) Navn Styrke Lægemiddelform Administration
English: Content (concentration)
Danish: Emballage Indhold (Koncentration)
English: Alcohol should be avoided.
Danish: Alkohol bør undgås.
English: This difference was not statistically significant.
Danish: Forskellen var ikke statistisk signifikant.
English: Other symptoms may include:
Danish: Andre symptomer kan være:
English: Over 75% of patients were less than 13 years of age.
Danish: Mere end 75 % af patienterne var yngre end 13 år.
English: The duration of the long-term safety study was limited to 52 weeks.
Danish: Varigheden af langtidssikkerhedsstudiet var begrænset til 52 uger.
English: Patients should be closely monitored throughout this period.
Danish: Patienter skal monitoreres tæt gennem denne periode.
English: The absolute oral bioavailability of the tablet formulation is 87 %.
Danish: Den absolutte orale biotilgængelighed af tabletformuleringen er 87 %.
English: Recurrence prevention was not established.
Danish: Forebyggelse af tilbagefald blev ikke påvist.
English: It is especially important to mention the following to your doctor:
Danish: Det er især vigtigt at fortælle lægen, hvis du tager:
English: Patients with rare glucose-galactose malabsorption should not take this medicine.
Danish: Patiener med sjælden glucose-galactose malabsorption bør ikke tage dette lægemiddel.
English: • unusual movements (especially of the face or tongue) and reduced level of consciousness.
Danish: Usædvanlige bevægelser (især i ansigtet og med tungen) og nedsat bevidsthedsniveau.
English: The possibility of multiple medicinal product involvement should be considered.
Danish: Muligheden for, at flere lægemidler kan være involveret bør overvejes.
English: These symptoms can temporally deteriorate or can even arise after discontinuation of treatment.
Danish: Disse symptomer kan midlertidigt forværres og kan endda opstå efter behandlingsophør.
English: Tell your doctor if you experience any of these behaviours; he/she will discuss ways of managing or reducing the symptoms.
Danish: Fortæl din læge, hvis du oplever et sådant adfærdsmønster; han/hun vil diskutere måder til at håndtere eller mindske symptomerne.
English: Adjustments of daily dosage, including dose reduction should be considered on the basis of clinical status.
Danish: Justering af den daglige dosis, inklusive dosisreduktion, bør overvejes på baggrund af klinisk status.
English: If you cannot reach your doctor, go to the nearest hospital and take the pack with you.
Danish: Hvis du ikke kan få fat i lægen, skal du tage til det nærmeste hospital og medbringe medicinpakningen.
English: Consequently, the frequency of these adverse events is qualified as "not known”.
Danish: Hyppigheden af sådanne bivirkninger er derfor angivet som “ikke kendt”.
English: In patients with severe hepatic impairment, the data available are insufficient to establish recommendations.
Danish: Hos patienter med svær leverinsufficiens er de tilgængelige data ikke tilstrækkelige til at fastlægge anbefalinger.
English: Some patients may benefit from a higher dose.
Danish: Nogle patienter kan have behov for højere dosis.
English: Pharmacokinetics in special patient groups
Danish: Farmakokinetik i særlige patientgrupper
English: The maximum daily dose should not exceed 30 mg.
Danish: Den maksimale daglige dosis bør ikke overstige 30 mg.
English: Dose adjustments due to interactions
Danish: Dosisjusteringer på grund af interaktioner
English: Thus, no dosage adjustment is required for smokers.
Danish: Dosisjustering er derfor ikke påkrævet hos rygere.
English: Contact your doctor or hospital immediately if you experience any of the above.
Danish: Kontakt lægen eller hospitalet med det samme, hvis du får nogen af ovenstående symptomer.
English: Impulse control disorders may result in harm to the patient and others if not recognised.
Danish: Manglende impulskontrol kan medføre skade på patienten og andre, hvis tilstanden ikke anerkendes.
English: This should be considered in cases where full alertness is required, e.g. when driving a car or handling machines.
Danish: Der skal tages hensyn til dette i situationer, der kræver fuld opmærksomhed, f.eks. ved bilkørsel eller betjening af maskiner.
English: However, the clinical relevance of this finding has not been established.
Danish: Den kliniske relevans af disse fund er dog ikke blevet etableret.
English: Talk to your doctor about the best way to feed your baby if you are taking this medicine.
Danish: Tal med lægen om, hvordan du bedst kan ernære dit barn, hvis du tager dette lægemiddel.
English: Photosensitivity reaction Alopecia
Danish: Fotosensibilitetsreaktion Alopeci
English: These trials included patients with or without psychotic features and with or without a rapid-cycling course.
Danish: Disse forsøg inkluderede patienter med eller uden psykotiske træk og med eller uden et hurtigt skiftende forløb (rapid cycling course).
English: The table is based on adverse events reported during clinical trials and/or postmarketing use.
Danish: Tabellen er baseret på bivirkninger rapporteret under kliniske studier og/eller efter markedsføringen.
English: Therefore, cardiovascular monitoring should be started immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias.
Danish: Kardiovaskulær overvågning bør derfor straks indledes og bør omfatte løbende elektrokardiografisk overvågning med henblik på eventuelle arytmier.
English: The recommended dose for adults is 15 mg once a day.
Danish: Den anbefalede dosis for voksne er 15 mg én gang dagligt.
English: The safety profile included weight gain and changes in prolactin levels.
Danish: Sikkerhedsprofilen omfattede vægtøgning og ændring i prolaktinniveauet.
English: NMS is a potentially fatal symptom complex associated with antipsychotics.
Danish: NMS er et potentielt letalt symptomkompleks forbundet med antipsykotika.
English: Elderly patients with dementia-related psychosis
Danish: Ældre patienter med demensrelaterede psykoser
English: Tell your doctor if you or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others.
Danish: Fortæl din læge, hvis du eller din familie/plejer bemærker, at du er ved at udvikle trang til at opføre dig på måder, der er usædvanlige for dig, og du ikke kan modstå trangen eller fristelsen til at udføre visse aktiviteter, der kan skade dig selv eller andre.
English: Consequently, newborn infants should be monitored carefully (see section 4.8).
Danish: Derfor bør nyfødte overvåges nøje (se pkt.
English: It should be noted that impulse-control symptoms can be associated with the underlying disorder; however, in some cases, urges were reported to have stopped when the dose was reduced or the medication was discontinued.
Danish: Det skal bemærkes, at symptomer på manglende impulskontrol kan være forbundet med den underliggende tilstand; i nogle tilfælde er adfærden ifølge rapporter dog ophørt, når dosen er blevet reduceret eller lægemidlet seponeret.
English: However, your doctor may prescribe a lower or higher dose to a maximum of 30 mg once a day.
Danish: Lægen kan dog have ordineret en lavere eller højere dosis, op til højst 30 mg én gang dagligt.
English: Interaction with receptors other than dopamine and serotonin subtypes may explain some of the other clinical effects of aripiprazole.
Danish: Interaktion med andre receptorer end dopamin- og serotonin-subtyper kan forklare nogle af de andre kliniske virkninger af aripiprazol.
English: Actual scores in rating scales used as secondary endpoints, including PANSS and the Montgomery-Asberg Depression Rating Scale showed a significant improvement over haloperidol.
Danish: Faktiske scorer på bedømmelsesskalaer anvendt som sekundære endepunkt, inklusive PANSS og Montgomery-Asberg Depression Rating Scale, viste en signifikant forbedring i forhold til haloperidol.
English: Dizziness and vision problems may occur during treatment with this medicine (see section 4).
Danish: Der kan forekomme svimmelhed og synsproblemer ved behandling med dette lægemiddel (se afsnit 4).
English: Caution should be taken, particularly if you are an elderly patient or have some debility.
Danish: Der skal udvises forsigtighed, især hvis du er ældre eller svækket.
English: Due to insufficient safety information in humans and concerns raised by animal reproductive studies, this medicinal product should not be used in pregnancy unless the expected benefit clearly justifies the potential risk to the foetus.
Danish: På grund af utilstrækkelige humane sikkerhedsdata, og forstyrrelser set ved reproduktionsforsøg hos dyr, bør dette lægemiddel ikke anvendes til gravide, medmindre de forventede fordele for kvinden klart opvejer den potentielle risiko for fostret.
English: Patients must be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with aripiprazole.
Danish: Patienterne skal rådes til at informere lægen, hvis de bliver gravide, eller planlægger at blive gravide, under behandling med aripiprazol.
English: 14 tablets 28 tablets 56 tablets 98 tablets 28 x 1 tablets
Danish: 14 tabletter 28 tabletter 56 tabletter 98 tabletter 28 x 1 tabletter
English: Increased mortality
Danish: Stigning i dødsfald
English: Among the patients included in the primary efficacy analysis, 139 patients had a current co-morbid diagnosis of ADHD.
Danish: Blandt patienterne, inkluderet i den primære effektanalyse, var 139 patienter diagnosticeret med ADHD som co- morbiditet.
English: The following side effects have been reported since the marketing of oral aripiprazole but the frequency for them to occur is not known:
Danish: Følgende bivirkninger er rapporteret efter markedsføringen af oralt aripiprazol, men hyppigheden er ikke kendt:
English: If your baby develops any of these symptoms you may need to contact your doctor.
Danish: Hvis dit barn får nogle af disse symptomer, bør du kontakte din læge.
English: Aripiprazole is excreted in human milk.
Danish: Aripiprazol udskilles i human mælk.
English: In these patients dosing should be managed cautiously.
Danish: Hos disse patienter bør dosering administreres med forsigtighed.
English: Animal studies could not exclude potential developmental toxicity (see section 5.3).
Danish: Dyreforsøg kan ikke udelukke potentiel udviklingstoksicitet (se pkt.
English: People with this condition may also feel depressed, guilty, anxious or tense.
Danish: Mennesker der har disse symptomer kan også føle sig deprimerede, have skyldfølelse, være angste og anspændte.
English: While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic medicinal products.
Danish: Symptomerne kan forekomme selv ved lave doser, men er imidlertid hyppigere og kraftigere med høj potens antipsykotika og ved højere doser af første generations antipsykotika.
English: In addition, reports of accidental overdose with aripiprazole alone (up to 195 mg) in children have been received with no fatalities.
Danish: Derudover er der rapporteret utilsigtet overdosering af aripiprazol alene (op til 195 mg) hos børn uden dødelighed.
English: Maternal toxicity occurred at doses similar to those eliciting developmental toxicity.
Danish: Der sås maternal toksicitet ved doser svarende til de, der medfører udviklingsmæssig toksicitet.
English: The highest nontumorigenic exposure in female rats was 7 times the human exposure at the recommended dose.
Danish: Den højeste ikke-tumorfremkaldende eksponering hos hunrotter var 7 gange den anbefalede humane dosis.
English: Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with aripiprazole and preventive measures undertaken.
Danish: Da patienter, i behandling med antipsykotika, ofte har sygdomsbetingede risikofaktorer for VTE, bør alle mulige risikofaktorer for VTE identificeres før og under behandling med aripiprazol, og forebyggende foranstaltninger iværksættes.
English: An elevated risk of acute dystonia is observed in males and younger age groups.
Danish: Der er observeret forhøjet risiko for akut dystoni hos mænd og yngre aldersgrupper.
English: The safety profile in a 26-week open-label extension trial was similar to that observed in the short-term, placebo-controlled trial.
Danish: Sikkerhedsprofilen i et 26-ugers åbent, forlænget forsøg var den samme som den, der blev observeret i det korte, placebokontrollerede forsøg.
English: Aripiprazole undergoes minimal pre-systemic metabolism.
Danish: Aripiprazol gennemgår minimal præ-systemisk metabolisme.
English: Prolactin levels were evaluated in all trials of all doses of aripiprazole (n = 28,242).
Danish: Prolaktin-niveauerne blev vurderet i alle studier og ved alle doser af aripiprazol (n = 28.242).
English: Compulsive shopping Poriomania
Danish: Kompulsiv trang til indkøb Poriomani
English: Additionally, aripiprazole and dehydroaripiprazole did not show potential for altering CYP1A2-mediated metabolism in vitro.
Danish: Derudover viste aripiprazol og dehydro-aripiprazol ikke potentiale til at ændre CYP1A2-medieret metabolisme in vitro.
English: Close supervision of high-risk patients should accompany antipsychotic treatment.
Danish: Høj-risikopatienter bør overvåges tæt under antipsykotisk behandling.
English: The total body clearance of aripiprazole is 0.7 ml/min/kg, which is primarily hepatic.
Danish: Total-clearance af aripiprazol er 0,7 ml/min/kg, primært hepatisk.
English: Suicidality
Danish: Suicidalitet
English: Less than 1 % of unchanged aripiprazole was excreted in the urine and approximately 18% was recovered unchanged in the faeces.
Danish: Mindre end 1 % uomdannet aripiprazol blev udskilt i urinen, og ca. 18 % blev genfundet uomdannet i fæces.
English: Caution should be taken when treating patients at higher risk and a lower starting dose should be considered (e.g. elderly or debilitated patients; see section 4.2).
Danish: Der skal udvises forsigtighed ved behandling af patienter med høj risiko og en lavere startdosis bør overvejes (f.eks. ældre eller svækkede patienter; se pkt.
English: Due to its α1-adrenergic receptor antagonism, aripiprazole has the potential to enhance the effect of certain antihypertensive medicinal products.
Danish: På grund af den α1-adrenerge receptorantagonisme, kan aripiprazol øge virkningen af visse antihypertensive lægemidler.
English: Aripiprazole was also studied in a placebo-controlled, long-term maintenance trial.
Danish: Aripiprazol blev også undersøgt i et placebokontrolleret, langvarigt vedligeholdelsesstudie.
English: Gender No dosage adjustment is required for female patients as compared to male patients (see section 5.2).
Danish: Køn Dosisjustering til kvindelige patienter i forhold til mandlige patienter er ikke påkrævet (se pkt.
English: Blood pressure-lowering medicines: Aripiprazole Mylan Pharma may increase the effect of medicines used to lower the blood pressure.
Danish: Blodtrykssænkende medicin: Aripiprazole Mylan Pharma kan forstærke virkningen af medicin, der bruges til at sænke blodtrykket.
English: Sudden unexplained death Torsades de pointes QT prolongation Ventricular arrhythmias Cardiac arrest Bradycardia
Danish: Pludselig, uforklarlig død Torsades de pointes QT-forlængelse Ventrikulære arytmier Hjertestop
English: Risk factors that may predispose patients to severe complications include obesity and family history of diabetes.
Danish: Risikofaktorer, der kan disponere patienterne for alvorlige komplikationer, omfatter overvægt og arvelig diabetes.
English: Be sure to tell your doctor if you take a medicine to keep your blood pressure under control.
Danish: Kontakt lægen, hvis du tager medicin for dit blodtryk.
English: Patients can experience increased urges, particularly for gambling, and the inability to control these urges while taking aripiprazole.
Danish: Patienter kan opleve forskellige former for øget trang, især til hasardspil, og manglende evne til at styre denne trang, når de tager aripiprazol.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: på anmodning fra Det Europæiske Lægemiddelagentur når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: However, elevated creatine phosphokinase and rhabdomyolysis, not necessarily in association with NMS, have also been reported.
Danish: Forhøjet kreatinfosfokinase og rabdomyolyse, der ikke nødvendigvis er forbundet med NMS, er dog også rapporteret.
English: Aripiprazole also exhibited moderate binding affinity for the serotonin reuptake site and no appreciable affinity for muscarinic receptors.
Danish: Aripiprazol viser også moderat bindingsaffinitet for serotonin-reuptake site og ingen væsentlig affinitet for muscarine receptorer.
English: Pharmacotherapeutic group: Psycholeptics, other antipsychotics, ATC code: N05AX12
Danish: Farmakoterapeutisk klassifikation: Psykoleptika, andre antipsykotika, ATC-kode: N05AX12
English: Oesophageal dysmotility and aspiration have been associated with the use of antipsychotics, including aripiprazole.
Danish: Øsofageal dysmotilitet og aspiration har været forbundet med brug af antipsykotika, herunder aripiprazol.
English: Aripiprazole Mylan Pharma with food, drink and alcohol This medicine can be taken regardless of meals.
Danish: Brug af Aripiprazole Mylan Pharma sammen med mad, drikke og alkohol Dette lægemiddel kan tages uafhængigt af måltider.
English: Management of overdose should concentrate on supportive therapy, maintaining an adequate airway, oxygenation and ventilation, and management of symptoms.
Danish: Håndtering af overdosering bør omfatte understøttende behandling, opretholdelse af frie luftveje, ilt og ventilering samt behandling af symptomerne.
English: Aripiprazole is well absorbed, with peak plasma concentrations occurring within 3-5 hours after dosing.
Danish: Aripiprazol absorberes godt, med maksimal plasmakoncentration inden for 3-5 timer efter administration.
English: Aripiprazole is extensively metabolised by the liver primarily by three biotransformation pathways: dehydrogenation, hydroxylation, and N-dealkylation.
Danish: Aripiprazol metaboliseres hovedsageligt i leveren via tre biotransformationsveje: dehydrogenering, hydroxylering og N-dealkylering.
English: Depression, Hypersexuality
Danish: Depression Hyperseksualitet
English: Stabilized patients were then randomised to continue the same mood stabilizer with double-blind aripiprazole or placebo.
Danish: Stabiliserede patienter blev herefter randomiseret til at fortsætte med at tage den samme stemningsstabilisator med dobbeltblind aripiprazol eller placebo.
English: In a post-hoc analysis, the improvement over placebo was more pronounced in the patients with associated co-morbidity of ADHD compared to the group without ADHD, where there was no difference from placebo.
Danish: I en post hoc-analyse var forbedringen versus placebo mere udtalt hos patienter med associeret ADHD som co-morbiditet sammenlignet med gruppen uden ADHD, hvor der ikke var nogen forskel sammenlignet med placebo.
English: Even if you feel better, do not alter or discontinue the daily dose of Aripiprazole Mylan Pharma without first consulting your doctor.
Danish: Selvom du føler du har det bedre, må du ikke ændre eller lade være med at tage den daglige dosis af Aripiprazole Mylan Pharma uden først at have kontaktet lægen.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 30 June 2015
Danish: Dato for første markedsføringstilladelse: 30. juni 2015 Dato for seneste fornyelse:
English: Try to take Aripiprazole Mylan Pharma at the same time each day.
Danish: Forsøg at tage Aripiprazole Mylan Pharma på samme tidspunkt hver dag.
English: In adults it also prevents this condition from returning in patients who have responded to the treatment with Aripiprazole Mylan Pharma.
Danish: Hos voksne forebygger det også, at tilstanden vender tilbage hos patienter, der har haft god effekt af behandling med Aripiprazole Mylan Pharma.
English: Serotonin syndrome
Danish: Serotoninsyndrom
English: Valproate and lithium
Danish: Valproat og litium
English: Thus, aripiprazole is unlikely to cause clinically important medicinal product interactions mediated by these enzymes.
Danish: Det er derfor ikke sandsynligt, at aripiprazol kan forårsage klinisk relevant lægemiddelinteraktion medieret ved disse enzymer.
English: At steady state, dehydro-aripiprazole, the active metabolite, represents about 40% of aripiprazole AUC in plasma.
Danish: Ved steady-state repræsenterer dehydro-aripiprazol, den aktive metabolit, omkring 40 % af aripiprazol AUC i plasma.
English: At therapeutic concentrations, aripiprazole and dehydro-aripiprazole are greater than 99 % bound to serum proteins, binding primarily to albumin.
Danish: Ved terapeutiske koncentrationer bindes aripiprazol og dehydro-aripiprazol mere end 99 % til serumproteiner, primært til albumin.
English: The dose may be gradually increased to the recommended dose for adolescents of 10 mg once a day.
Danish: Dosis kan gradvist øges til den anbefalede dosis for unge på 10 mg dagligt.
English: Aripiprazole may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls.
Danish: Aripiprazol kan medføre somnolens, postural hypotension, motorisk og sensorisk ustabilitet, som kan medføre fald.
English: Aripiprazole is effective in maintaining the clinical improvement during continuation therapy in adult patients who have shown an initial treatment response.
Danish: Aripiprazol er effektivt til at opretholde klinisk forbedring under fortsættelsesbehandling hos voksne patienter med respons på den indledende behandling.