FrancophonIA/ELRC3.0 huggingface dataset:
English: Date of first authorisation: 04 March 2011 Date of latest renewal:16 December 2015
Danish: Dato for første markedsføringstilladelse: 4. marts 2011 Dato for seneste fornyelse: 16. december 2015
English: • low blood sugar
Danish: • lavt blodsukker
English: Overall mortality
Danish: Overordnet mortalitet
English: It should be noted that a broader spectrum of symptoms are included that do not necessarily have an extrapyramidal origin.
Danish: Det skal bemærkes, at der er medtaget et bredere spektrum af symptomer, som ikke nødvendigvis er af ekstrapyramidal oprindelse.
English: If you stop receiving your injections, you will lose the effects of the medicine.
Danish: Hvis du holder op med at få indsprøjtningerne, vil du miste virkningerne af medicinen.
English: Xeplion with alcohol Alcohol should be avoided.
Danish: Brug af Xeplion sammen med alkohol Alkohol bør undgås.
English: Xeplion should not be used during pregnancy unless clearly necessary.
Danish: Xeplion bør ikke anvendes under graviditeten, medmindre det er klart nødvendigt.
English: Shake the syringe vigorously for a minimum of 10 seconds to ensure a homogeneous suspension.
Danish: Ryst sprøjten kraftigt i minimum 10 sekunder for at sikre en homogen suspension.
English: The difference is unlikely to be of clinical relevance.
Danish: Det er usandsynligt, at forskellen har klinisk relevans.
English: For that reason, it is important to discuss with your doctor any of the following conditions which can potentially worsen during treatment with this medicine:
Danish: Det er derfor vigtigt, at du taler med lægen om følgende tilstande, som kan forværres under behandling med dette lægemiddel:
English: You should not stop using this medicine unless told to do so by your doctor as your symptoms may return.
Danish: Du bør ikke holde op med at bruge denne medicin, medmindre du får besked på det af lægen, da dine symptomer kan vende tilbage.
English: People with this disease may also feel depressed, anxious, guilty, or tense.
Danish: Personer med denne sygdom kan også føle sig deprimerede, angste, have skyldfølelse eller være anspændte.
English: Elderly Efficacy and safety in elderly > 65 years have not been established.
Danish: Ældre Sikkerhed og virkning hos ældre > 65 år er ikke klarlagt.
English: Occasionally abscess formation occurred.
Danish: Lejlighedsvist forekom abscesdannelse.
English: Approximately 80% of the administered radioactivity was recovered in urine and 11% in the faeces.
Danish: Ca. 80 % af den administrerede radioaktivitet blev genfundet i urin og 11 % i fæces.
English: The following terms and frequencies are applied: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (cannot be estimated from the available data).
Danish: Følgende termer og hyppigheder anvendes: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1000); meget sjælden (< 1/10.000); og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The suspension is pH neutral (approximately 7.0).
Danish: Suspensionen er pH-neutral (ca. 7,0).
English: If this combination is deemed necessary, particularly in end-stage Parkinson's disease, the lowest effective dose of each treatment should be prescribed.
Danish: Hvis en sådan kombination vurderes nødvendig, særligt ved Parkinsons sygdom i slutstadiet, bør der gives den laveste effektive dosis af hvert lægemiddel.
English: Acute treatment of schizophrenia
Danish: Akut behandling af skizofreni
English: This medicine can pass from mother to baby through breast milk and may harm the baby.
Danish: Dette lægemiddel kan videregives fra moderen til barnet gennem mælken og kan skade barnet.
English: One week following administration of a single oral dose of 1 mg immediate-release
Danish: Én uge efter administration af en enkelt oral dosis af 1 mg
English: Intraoperative Floppy Iris Syndrome
Danish: Intraoperativt floppy iris syndrom
English: Immediate medical treatment may be needed.
Danish: Du kan have behov for omgående behandling.
English: For example, a person with schizophrenia may hear voices or see things that are not there (called hallucinations), believe things that are not true (called delusions), or feel unusually suspicious of others.
Danish: For eksempel kan en person med skizofreni høre stemmer eller se ting, som ikke er der (hvilket kaldes hallucinationer), tro ting, som ikke er rigtige (hvilket kaldes vrangforestillinger), eller føle sig usædvanligt mistænksom over for andre.
English: Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring for possible arrhythmias.
Danish: Kardiovaskulær monitorering bør straks iværksættes og bør omfatte kontinuerlig elektrokardiografisk monitorering for mulige arytmier.
English: Use in patients who are in an acutely agitated or severely psychotic state
Danish: Brug til patienter, som er i en akut agiteret eller svært psykotisk tilstand
English: If you cannot keep your appointment with the doctor, make sure you call him right away so another appointment can be made as soon as possible.
Danish: Hvis du ikke kan overholde aftalen, skal du sørge for straks at ringe til lægen, så du kan lave en ny aftale så hurtigt som muligt.
English: If you stop using Xeplion
Danish: Hvis du holder op med at bruge Xeplion
English: • not moving or responding while awake (catatonia)
Danish: • ikke at bevæge sig eller reagere i vågen tilstand (katatoni)
English: The relevance of these tumour findings in rodents in terms of human risk is unknown.
Danish: Relevansen af disse tumorfund hos gnavere i relation til human risiko er ukendt.
English: Patients with severe neutropenia (absolute neutrophil count < 1 x 10
Danish: Hos patienter med svær neutropeni (absolut neutrofiltal < 1 x 10
English: For example, a person with schizophrenia may appear withdrawn and may not respond at all emotionally or may have trouble speaking in a clear and logical way.
Danish: For eksempel kan en person med skizofreni virke tilbageholdende og reagerer måske slet ikke følelsesmæssigt eller kan have svært ved at tale på en klar og logisk måde.
English: • priapism (a prolonged penile erection that may require surgical treatment)
Danish: • priapisme (forlænget erektion, som kan kræve kirurgisk behandling)
English: No in vivo data are available and the clinical relevance is unknown.
Danish: Der foreligger ingen in vivo-data, og den kliniske relevans er ukendt.
English: Because of the difference in median pharmacokinetic profiles between the two medicinal products, caution should be exercised when making a direct comparison of their pharmacokinetic properties.
Danish: På grund af forskellen i de mediane farmakokinetikprofiler mellem de to lægemidler skal man være forsigtig med at foretage en direkte sammenligning af deres farmakokinetiske egenskaber.
English: Select the appropriate needle.
Danish: Vælg den passende kanyle.
English: All medicines have side effects and some of the side effects of this medicine can worsen the symptoms of other medical conditions.
Danish: Alle lægemidler har bivirkninger, og nogle af bivirkningerne ved dette lægemiddel kan forværre symptomerne ved andre medicinske tilstande.
English: Administration should be made into the upper-outer quadrant of the gluteal area.
Danish: Administrationen bør ske i den øvre laterale kvadrant af glutealområdet.
English: The most commonly reported injection site related adverse reaction was pain.
Danish: Den hyppigst rapporterede bivirkning relateret til injektionsstedet var smerter.
English: The primary efficacy endpoint was defined as a decrease in Positive and Negative Syndrome Scale (PANSS) total scores as shown in the table below.
Danish: Det primære effektmål var defineret som et fald i den samlede PANSS-score (Positive And Negative Syndrome Scale), der er vist i tabellen nedenfor.
English: For instructions for use and handling of Xeplion, see package leaflet (information intended for medical or healthcare professionals).
Danish: For instruktioner om anvendelse og håndtering af Xeplion, se indlægssedlen (oplysninger tiltænkt læger og sundhedspersonale).
English: Depending on your symptoms, your doctor may increase or decrease the amount of medicine you receive by one dose level at the time of your scheduled monthly injection.
Danish: Afhængigt af dine symptomer kan lægen øge eller reducere den mængde af medicin, du får, med ét dosisniveau på tidspunktet for din planlagte månedlige indsprøjtning.
English: This should be considered in cases where full alertness is required, e.g., when driving a car or handling machines.
Danish: Dette skal du være opmærksom på i situationer, hvor fuld opmærksomhed er påkrævet, f.eks. ved bilkørsel og betjening af maskiner.
English: B-2340 Beerse Belgium
Danish: B-2340 Beerse Belgien
English: Patients should be informed to seek urgent medical care in case that priapism has not been resolved within 4 hours.
Danish: Patienter skal rådes til at søge akut lægehjælp, hvis priapismen ikke har fortaget sig i løbet af 4 timer.
English: After the injection is complete, use either thumb or finger of one hand (8a, 8b) or a flat surface (8c) to activate the needle protection system.
Danish: Efter at injektionen er gennemført, anvendes enten tommelfingeren eller en anden finger på den ene hånd (8a, 8b) eller en flad overflade (8c) til at aktivere kanylebeskyttelsessystemet.
English: • coma due to uncontrolled diabetes
Danish: • koma på grund af ukontrolleret diabetes
English: Therefore, you should not breastfeed when using this medicine.
Danish: Du må derfor ikke amme, når du bruger dette lægemiddel.
English: Nervous system disorders parkinsonism c,
Danish: Nervesystemet parkinsonisme c,
English: Negative means a lack of behaviours or feelings that are normally present.
Danish: Negative symptomer henviser til manglende adfærd eller følelser, som normalt er til stede.
English: Xeplion should then be continued at monthly intervals.
Danish: Der skal herefter fortsættes med Xeplion med månedlige intervaller.
English: No additional oral antipsychotic supplementation was needed during the acute treatment of schizophrenia with Xeplion.
Danish: Intet yderligere oralt antipsykotisk supplement var nødvendigt under den akutte behandling af skizofreni med Xeplion.
English: Do not use if the syringe is not visually free of foreign matter.
Danish: Må ikke anvendes, hvis sprøjten ikke er visuelt fri for fremmedlegemer.
English: This medicine is administered by your doctor or other health care professional.
Danish: Dette lægemiddel gives af din læge eller anden sundhedsperson.
English: Not known
Danish: Sjælden Ikke kendt
English: Appropriate clinical monitoring is advisable in accordance with utilised antipsychotic guidelines.
Danish: Passende klinisk monitorering tilrådes i henhold til de anvendte retningslinjer for brug af antipsykotika.
English: Administration should be in a single injection.
Danish: Administrationen skal foregå som en enkelt injektion.
English: This interaction has not been studied with Xeplion.
Danish: Denne interaktion er ikke undersøgt med Xeplion.
English: Xeplion contains a racemic mixture of (+)- and (-)-paliperidone.
Danish: Xeplion indeholder en racemisk blanding af (+)- og (-)-paliperidon.
English: Four metabolic pathways have been identified in vivo, none of which accounted for more than 6.5% of the dose: dealkylation, hydroxylation, dehydrogenation, and benzisoxazole scission.
Danish: Fire metaboliske metoder er blevet identificeret in vivo, hvoraf ingen tegnede sig for mere end 6,5 % af dosen: dealkylering, hydroxylering, dehydrogenering og benzisoxazol-spaltning.
English: If you have moderate or severe kidney problems this medicine should not be used.
Danish: Hvis du har moderate eller svære nyreproblemer, må du ikke bruge dette lægemiddel.
English: Xeplion can help alleviate the symptoms of your disease and stop your symptoms from coming back.
Danish: Xeplion kan være med til at lindre din sygdom og forhindre den i at komme igen.
English: Figure 1: Kaplan-Meier Plot of Time to Relapse - Interim Analysis (Intent-to-Treat Interim Analysis Set)
Danish: Figur 1: Kaplan-Meier-afbildning af tid til recidiv - interimanalyse (Intent-to-Treatinterimanalysesæt)
English: Since this medicine may reduce your urge to vomit, there is a chance that it may mask the body's normal response to ingestion of toxic substances or other medical conditions.
Danish: Da dette lægemiddel kan mindske din trang til at kaste op, er der en risiko for, at dette kan skjule kroppens normale reaktion på indtagelse af giftige stoffer eller andre medicinske tilstande.
English: The PSP is a validated clinician rated scale that measures personal and social functioning in four domains: socially useful activities (work and study), personal and social relationships, self-care and disturbing and aggressive behaviours.
Danish: PSP er en valideret klinisk gradinddelt skala, som måler, hvordan patienten fungerer personligt og socialt inden for fire domæner: socialt nyttige aktiviteter (arbejde og studie), personlige og sociale relationer, egenomsorg og forstyrrende og aggressive adfærdsmønstre.
English: Injury, poisoning and procedural complications fall
Danish: Traumer, forgiftninger og behandlingskomplikationer fald
English: • inability to reach orgasm
Danish: • manglende evne til at opnå orgasme
English: The PANSS is a validated multi-item inventory composed of five factors to evaluate positive symptoms, negative symptoms, disorganised thoughts, uncontrolled hostility/excitement and anxiety/depression.
Danish: PANSS er en valideret flerpunkts-liste, der består af fem faktorer til vurdering af positive symptomer, negative symptomer, disorganiserede tanker, ukontrolleret fjendtlighed/ophidselse og angst/depression.
English: • tremor (shaking)
Danish: • tremor (rysten)
English: The need for continuing existing extrapyramidal symptoms (EPS) medicine should be re-evaluated periodically.
Danish: Behovet for at fortsætte med eksisterende medicin mod ekstrapyramidale symptomer (EPS) skal regelmæssigt revurderes.
English: • life threatening complications of uncontrolled diabetes
Danish: • livstruende komplikationer ved ukontrolleret diabetes
English: Since this medicine can lower blood pressure, care should be taken when this medicine is used with other medicines that lower blood pressure.
Danish: Da dette lægemiddel kan sænke blodtrykket, skal du være forsigtig, når du bruger dette lægemiddel sammen med andre lægemidler, der også sænker blodtrykket.
English: Withdrawal of this medicine may be needed.
Danish: Det kan være nødvendigt at ophøre med dette lægemiddel.
English: EU/1/11/672/001 (25 mg) EU/1/11/672/002 (50 mg) EU/1/11/672/003 (75 mg) EU/1/11/672/004 (100 mg)
Danish: EU/1/11/672/001 (25 mg) EU/1/11/672/002 (50 mg) EU/1/11/672/003 (75 mg) EU/1/11/672/004 (100 mg) EU/1/11/672/005 (150 mg)
English: This medicine may cause an electrocardiogram (ECG) abnormality demonstrating a long time for an electrical impulse to travel through a certain part of the heart (known as “QT prolongation”).
Danish: Dette lægemiddel kan medføre et unormalt elektrokardiogram (EKG), der viser, at en elektrisk impuls er lang tid om at vandre gennem en bestemt del at hjertet (hvilket er kendt som “QT-forlængelse”).
English: Establish and maintain a clear airway and ensure adequate oxygenation and ventilation.
Danish: Der skal etableres og opretholdes frie luftveje og sørges for tilstrækkelig iltning og ventilation.
English: The third dose should be administered one month after the second initiation dose.
Danish: Den tredje dosis skal administreres én måned efter den anden startdosis.
English: Antiemetic effect
Danish: Antiemetisk virkning
English: The pharmacological activity of the (+)- and (-)-paliperidone enantiomers are qualitatively and quantitatively similar.
Danish: Den farmakologiske aktivitet af (+)- og (-)paliperidon-enantiomererne er kvalitativt og kvantitativt ens.
English: Body mass index (BMI)/body weight
Danish: BMI (kropsmasseindeks)/kropsvægt
English: This medicine may cause you to gain weight.
Danish: Dette lægemiddel kan medføre vægtstigning.
English: Care must be taken to avoid inadvertent injection of Xeplion into a blood vessel.
Danish: Der skal udvises forsigtighed for at undgå utilsigtet injektion af Xeplion i et blodkar.
English: Tardive dyskinesia/extrapyramidal symptoms
Danish: Tardiv dyskinesi/ekstrapyramidale symptomer
English: Caution is recommended if paliperidone is used in such patients.
Danish: Det anbefales, at der udvises forsigtighed, hvis paliperidon anvendes til sådanne patienter.
English: Elderly patients with dementia
Danish: Ældre patienter med demens
English: No data are available in patients with severe hepatic impairment (Child-Pugh class C).
Danish: Der foreligger ingen data for patienter med svært nedsat leverfunktion (Child-Pugh-klasse C).
English: Very common side effects: may affect more than 1 in 10 people • difficulty falling or staying asleep.
Danish: Meget almindelige bivirkninger: kan forekomme hos flere end 1 ud af 10 personer • problemer med at falde i søvn eller sove igennem.
English: Similarly, the third and subsequent injections after the initiation regimen are recommended to be given monthly.
Danish: Tilsvarende anbefales det, at den tredje og efterfølgende injektioner efter startregimet gives månedligt.
English: However, elderly patients with dementia, who are treated with other similar types of medicine, may have an increased risk of stroke or death (see section 4, possible side effects).
Danish: Ældre patienter med demens, som behandles med andre lignende typer medicin, kan dog have en øget risiko for at få et slagtilfælde eller dø (se afsnit 4, Bivirkninger).
English: It is recommended that the second initiation dose of Xeplion be given one week after the first dose.
Danish: Det anbefales, at den anden startdosis af Xeplion gives én uge efter den første dosis.
English: • leakage of milk from the breasts
Danish: • lækage af mælk fra brysterne
English: • diabetes or worsening of diabetes, increased insulin (a hormone that controls blood sugar levels)
Danish: • diabetes eller forværring af diabetes, forhøjet insulin (et hormon, som styrer blodsukkerniveauet) i blodet
English: Following administration of paliperidone palmitate the (+) and (-) enantiomers of paliperidone interconvert, reaching an AUC (+) to (-) ratio of approximately 1.6-1.8.
Danish: Efter administration af paliperidonpalmitat omdannes paliperidons (+)- og (-)-enantiomerer indbyrdes således, at der opnås et AUC (+) til (-)-forhold på ca. 1,6-1,8.
English: Tell your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth and face.
Danish: Fortæl straks din læge, hvis du oplever ufrivillige rytmiske bevægelser af tungen, munden eller ansigtet.
English: • decreased oxygen in parts of your body (because of decreased blood flow)
Danish: • nedsat iltforsyning til dele af kroppen (på grund af nedsat blodgennemstrømning)
English: • eye infection
Danish: • øjeninfektion
English: Xeplion contains sodium
Danish: Xeplion indeholder natrium
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 Xeplion and preventative measures undertaken.
Danish: Da patienter, der behandles med antipsykotika, ofte har erhvervede risikofaktorer for VTE, bør samtlige mulige risikofaktorer for VTE identificeres før og under behandlingen med Xeplion, og forebyggende foranstaltninger sættes i værk.
English: Therefore, patients should be advised not to drive or operate machines until their individual susceptibility to Xeplion is known.
Danish: Patienterne skal derfor rådes til ikke at køre og betjene maskiner, før det vides, hvordan de reagerer på Xeplion.
English: Potential for other medicines to affect Xeplion
Danish: Andre lægemidlers potentiale for påvirkning af Xeplion
English: Xeplion should be used with caution with medicines that increase the activity of the central nervous system (psychostimulants such as methylphenidate).
Danish: Xeplion bør anvendes med forsigtighed sammen med lægemidler, der øger aktiviteten i centralnervesystemet (psykostimulanser som f.eks. methylphenidat).
English: • abnormal coordination
Danish: • unormal koordination
English: Polyethylene glycol 4000
Danish: Polyethylenglycol 4000
English: In the case of acute overdose, the possibility of multiple drug involvement should be considered.
Danish: I tilfælde af akut overdosering skal muligheden for, at patienten har indtaget flere stoffer, tages i betragtning.
English: • loss of appetite resulting in malnutrition and low body weight
Danish: • appetitløshed og deraf følgende underernæring og lav kropsvægt
English: The release profile and dosing regimen of Xeplion results in sustained therapeutic concentrations.
Danish: Frigivelsesprofilen og dosisregimet for Xeplion resulterer i opretholdelse af terapeutiske koncentrationer.
English: Avoiding missed doses
Danish: Sådan undgås manglende doser
English: In general, recommended dosing of Xeplion for elderly patients with normal renal function is the same as for younger adult patients with normal renal function.
Danish: Generelt er den anbefalede dosering af Xeplion til ældre patienter med normal nyrefunktion den samme som til yngre voksne patienter med normal nyrefunktion.
English: The results of the other studies yielded statistically significant results in favour of Xeplion, except for the 50 mg dose in one study (see table below).
Danish: Resultaterne af de andre forsøg viste signifikant fordel for Xeplion, bortset fra 50 mg-dosen i et enkelt forsøg (se tabellen nedenfor).
English: Functioning was evaluated using the Personal and Social Performance (PSP) scale.
Danish: Hvor godt patienten fungerede, blev vurderet ved hjælp af PSP-skalaen (Personal and Social Performance).
English: Among those treated with risperidone, the mortality was 4% compared with 3.1% for placebo.
Danish: Mortaliteten var blandt dem, der blev behandlet med risperidon, og mortaliteten var 4 % sammenlignet med 3,1 % for placebo.
English: • are a man and experience prolonged or painful erection.
Danish: • er mand og får langvarig eller smertefuld rejsning.
English: Parkinson's disease and dementia with Lewy bodies
Danish: Parkinsons sygdom og Lewy body-demens
English: Adjustment of the maintenance dose may be made monthly.
Danish: Vedligeholdelsesdosen kan justeres en gang om måneden.
English: The suspension for injection is for single use only.
Danish: Suspensionen til injektion er udelukkende til engangsbrug.
English: Concomitant use of Xeplion with psychostimulants
Danish: Samtidig brug af Xeplion og psykostimulanser
English: Other injection site reactions were mostly mild in intensity and included induration (common), pruritus (uncommon) and nodules (rare).
Danish: Andre reaktioner på injektionsstedet var overvejende milde i intensitet og omfattede induration (almindelig), pruritus (ikke almindelig) og knuder (sjælden).
English: Subject evaluations of injection site pain based on a visual analogue scale tended to lessen in frequency and intensity over time in all Phase 2 and 3 studies with Xeplion.
Danish: Personevalueringer af smerter på injektionsstedet baseret på en visuel analog skala havde en tendens til at falde i frekvens og intensitet over tid i alle fase 2- og 3-forsøg med Xeplion.
English: If less than 6 weeks have elapsed since the last injection, then the previously stabilised dose should be administered as soon as possible, followed by injections at monthly intervals.
Danish: Hvis der er gået mindre end 6 uger siden den sidste injektion, skal den tidligere stabiliserede dosis administereres så hurtigt som muligt, efterfulgt af injektioner med månedlige intervaller.
English: The plasma protein binding of racemic paliperidone is 74%.
Danish: Plasmaproteinbindingen af racemisk paliperidon er 74 %.
English: • glaucoma (increased pressure within the eyeball)
Danish: • glaukom (øget tryk i øjet)
English: - if you are allergic to another antipsychotic medicine including the substance risperidone.
Danish: - Hvis du er allergisk over for et andet antipsykotisk lægemiddel, der indeholder stoffet risperidon.