natgillin/translations-raw huggingface dataset:
Depottablet Depottablet Depottablet Depottablet Depottablet Depottablet Depottablet Depottablet Depottablet Depottablet Depottablet Depottablet Depottablet Depottablet Depottablet Depottablet
Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet
Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
blister (PVC/ PCTFE/ alu) blister (PVC/ PCTFE/ alu) blister (PVC/ PCTFE/ alu) blister (hvid PVC/ PCTFE/ alu) blister (hvid PVC/ PCTFE/ alu) blister (hvid PVC/ PCTFE/ alu) blister (hvid PVC/ PCTFE/ alu) blister (hvid PVC/ PCTFE/ alu) blister (hvid PVC/ PCTFE/ alu) blister (OPA- Alu- PVC/ Alu) blister (OPA- Alu- PVC/ Alu) blister (OPA- Alu- PVC/ Alu) blister (OPA- Alu- PVC/ Alu) blister (OPA- Alu- PVC/ Alu) Flaske (HDPE/ PP) Flaske (HDPE/ PP)
blister (PVC/ PCTFE/ alu) blister (white PVC/ PCTFE/ alu) blister (OPA-Alu-PVC/ Alu) blister (PVC/ PCTFE/ alu) blister (PVC/ PCTFE/ alu) blister (PVC/ PCTFE/ alu) blister (PVC/ PCTFE/ alu) blister (PVC/ PCTFE/ alu) blister (PVC/ PCTFE/ alu) blister (white PVC/ PCTFE/ alu) blister (white PVC/ PCTFE/ alu) blister (white PVC/ PCTFE/ alu) blister (white PVC/ PCTFE/ alu) blister (white PVC/ PCTFE/ alu) blister (white PVC/ PCTFE/ alu) blister (OPA-Alu-PVC/ Alu) blister (OPA-Alu-PVC/ Alu) blister (OPA-Alu-PVC/ Alu) blister (OPA-Alu-PVC/ Alu) blister (OPA-Alu-PVC/ Alu) Bottle (HDPE/ PP) Bottle (HDPE/ PP)
49 tabletter 56 tabletter 98 tabletter 14 tabletter 28 tabletter 30 tabletter 49 tabletter 56 tabletter 98 tabletter 14 tabletter 28 tabletter 49 tabletter 56 tabletter 98 tabletter 30 tabletter 350 tabletter
14 tablets 14 tablets 14 tablets 14 tablets 28 tablets 30 tablets 49 tablets 56 tablets 98 tablets 14 tablets 28 tablets 30 tablets 49 tablets 56 tablets 98 tablets 14 tablets 28 tablets 49 tablets 56 tablets 98 tablets 30 tablets 350 tablets
INVEGA 1, 5 mg depottabletter
INVEGA 1.5 mg prolonged-release tablets
Hver depottablet indeholder 1, 5 mg paliperidon.
Each prolonged-release tablet contains 1.5 mg of paliperidone.
Kapselformede orange- brune tabletter med tre lag med teksten ” PAL 1, 5 ”
Trilayer capsule-shaped orange brown tablets printed with “ PAL 1.5”
INVEGA er indiceret til behandling af skizofreni.
INVEGA is indicated for the treatment of schizophrenia.
Voksne INVEGA er beregnet til oral indgift.
Adults INVEGA is for oral administration.
Den anbefalede dosis af INVEGA er 6 mg én gang dagligt administreret om morgenen.
The recommended dose of INVEGA is 6 mg once daily, administered in the morning.
5. 2).
The administration of INVEGA should be standardised in relation to food intake (see section 5.2).
Patienten bør instrueres i altid at indtage INVEGA enten i fastende tilstand eller sammen med morgenmaden og ikke skifte mellem indtagelse i fastende tilstand og sammen med føde.
The patient should be instructed to always take INVEGA in the fasting state or always take it together with breakfast and not to alternate between administration in the fasting state or in the fed state.
Initial dosistitrering er ikke nødvendigt.
Initial dose titration is not required.
Nogle patienter kan have gavn af en lavere eller højere dosis inden for det anbefalede område på 3- 12 mg én gang dagligt.
Some patients may benefit from lower or higher doses within the recommended range of 3 to 12 mg once daily.
Hvis en dosisjustering er indiceret, bør den kun finde sted efter klinisk revurdering.
Dosage adjustment, if indicated, should occur only after clinical reassessment.
Når øgning af dosis er indiceret, anbefales øgninger på 3 mg/ dag, og intervallet mellem øgning bør generelt være længere end 5 dage.
When dose increases are indicated, increments of 3 mg/ day are recommended and generally should occur at intervals of more than 5 days.
INVEGA skal sluges hele med væske og må ikke tygges, deles eller knuses.
INVEGA must be swallowed whole with liquid, and must not be chewed, divided, or crushed.
Det aktive stof er indkapslet i en ikke- absorberbar skal, som afgiver det aktive stof i kontrollerede mængder.
The active substance is contained within a non absorbable shell designed to release the active substance at a controlled rate.
Patienterne bør ikke blive bekymrede, hvis de opdager tabletlignende rester i afføringen.
The tablet shell, along with insoluble core components, is eliminated from the body; patients should not be concerned if they occasionally notice in their stool something that looks like a tablet.
Patienter med nedsat leverfunktion Dosisjustering er ikke nødvendigt hos patienter med let eller moderat nedsat leverfunktion.
Patients with hepatic impairment No dose adjustment is required in patients with mild or moderate hepatic impairment.
Patienter med nedsat nyrefunktion Til patienter med let nedsat nyrefunktion (kreatinin- clearance ≥ 50 og < 80 ml/ min.) er den anbefalede startdosis 3 mg én gang dagligt.
Patients with renal impairment For patients with mild renal impairment (creatinine clearance ≥ 50 to < 80 ml/ min), the recommended initial dose is 3 mg once daily.
Baseret på det kliniske respons og tolerancen kan dosis forhøjes til 6 mg én gang dagligt.
The dose may be increased to 6 mg once daily based on clinical response and tolerability.
Dosis kan dog øges til 3 mg én gang dagligt efter klinisk revurdering.
For patients with moderate to severe renal impairment (creatinine clearance ≥ 10 to < 50 ml/ min), the recommended initial dose of INVEGA is 1.5 mg every day, which may be increased to 3 mg once daily after clinical reassessment.
Eftersom INVEGA ikke er undersøgt hos patienter med kreatinin- clearance under 10 ml/ min., bør INVEGA ikke bruges til disse patienter.
As INVEGA has not been studied in patients with creatinine clearance below 10 ml/ min, use is not recommended in such patients.
2 Ældre Den anbefalede dosis til ældre med normal nyrefunktion (≥ 80 ml/ min.) er den samme som for voksne med normal nyrefunktion.
2 Elderly Dosing recommendations for elderly patients with normal renal function (≥ 80 ml/ min) are the same as for adults with normal renal function.
Eftersom ældre patienter kan have nedsat nyrefunktion, kan der dog være behov for dosisjustering alt efter nyrefunktionsstatus (se afsnittet "Patienter med nedsat nyrefunktion" ovenfor).
However, because elderly patients may have diminished renal function, dose adjustments may be required according to their renal function status (see Patients with Renal Impairment above).
4. 4).
INVEGA should be used with caution in elderly patients with dementia with risk factors for stroke (see section 4.4).
Børn Sikkerheden og effekten af INVEGA til patienter < 18 år er ikke undersøgt.
Paediatric population Safety and efficacy of INVEGA in patients < 18 years of age have not been studied.
Andre særlige befolkningsgrupper Der er ingen behov for dosisjustering af INVEGA på baggrund af køn, race eller rygning (se pkt.
Other special populations No dose adjustment for INVEGA is recommended based on gender, race, or smoking status.
4. 6 vedrørende graviditet og amning).
(For pregnant women and breast-feeding mothers, see section 4.6)
Skift til andre antipsykotika Der foreligger ingen systematisk indsamlede data, som specifikt vedrører skift af patienter fra INVEGA til andre antipsykotika.
Switching to other antipsychotic medicinal products There are no systematically collected data to specifically address switching patients from INVEGA to other antipsychotic medicinal products.
På grund af de forskellige antipsykotikas varierende farmakodynamiske og farmakokinetiske profiler skal medicinsk relevant skift til andre antipsykotika ske under lægeligt opsyn.
Due to different pharmacodynamic and pharmacokinetic profiles among antipsychotic medicinal products, supervision by a clinician is needed when switching to another antipsychotic product is considered medically appropriate.
Overfølsomhed over for det det aktive stof, over for risperidon eller over for et eller flere af hjælpestofferne.
Hypersensitivity to the active substance, risperidone, or to any of the excipients.
QT- interval Som ved andre antipsykotika bør der udvises forsigtighed, når INVEGA ordineres til patienter med kendt kardiovaskulær sygdom eller familiær disposition til forlængelse af QT- intervallet og ved samtidig brug af andre lægemidler, som menes at forlænge QT- intervallet.
QT interval As with other antipsychotics, caution should be exercised when INVEGA is prescribed in patients with known cardiovascular disease or family history of QT prolongation, and in concomitant use with other medicines thought to prolong the QT interval.
Malignt neuroleptikumsyndrom Malignt neuroleptikumsyndrom, som er karakteriseret ved hypertermi, muskelstivhed, autonome symptomer, ændret bevidsthed og forhøjet serum- kreatinfosfokinaseniveau, er rapporteret ved behandling med antipsykotika, herunder paliperidon.
Neuroleptic malignant syndrome Neuroleptic Malignant Syndrome (NMS), characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness, and elevated serum creatine phosphokinase levels has been reported to occur with antipsychotics, including paliperidone.
Yderligere kliniske tegn er bl. a. myoglobinuri (rabdomyolyse) og akut nyresvigt.
Additional clinical signs may include myoglobinuria (rhabdomyolysis) and acute renal failure.
Hvis en patient udvikler tegn eller symptomer på malignt neuroleptikumsyndrom, bør alle antipsykotika, herunder INVEGA, seponeres.
If a patient develops signs or symptoms indicative of NMS, all antipsychotics, including INVEGA, should be discontinued.
Tardiv dyskinesi Lægemidler med dopaminreceptorantagonistiske egenskaber er blevet forbundet med induktion af tardiv dyskinesi, som er karakteriseret ved ufrivillige, rytmiske bevægelser, især af tunge og/ eller ansigt.
Tardive dyskinesia Medicines with dopamine receptor antagonistic properties have been associated with the induction of tardive dyskinesia characterised by rhythmical, involuntary movements, predominantly of the tongue and/ or face.
Hyperglykæmi I kliniske forsøg med INVEGA er der i sjældne tilfælde rapporteret om glukoserelaterede bivirkninger, f. eks. blodglukosestigning.
Hyperglycemia Rare cases of glucose related adverse reactions, e. g., increase in blood glucose, have been reported in clinical trials with INVEGA.
Som ved andre antipsykotika tilrådes relevant klinisk monitorering af diabetespatienter og patienter med risiko for udvikling af diabetes mellitus.
As with other antipsychotics, appropriate clinical monitoring is advisable in diabetic patients and in patients with risk factors for the development of diabetes mellitus.
Ortostatisk hypotension Paliperidon kan inducere ortostatisk hypotension hos nogle patienter på grund af stoffets alfablokerende aktivitet.
Orthostatic hypotension Paliperidone may induce orthostatic hypotension in some patients based on its alpha-blocking activity.
På baggrund af opsummerede data fra tre placebokontrollerede 6- ugersforsøg med faste doser af INVEGA (3, 6, 9 og 12 mg), blev ortostatisk hypotension rapporteret hos 2, 5% af de patienter, som fik INVEGA, sammenlignet med 0, 8% af de patienter, som fik placebo.
Based on pooled data from the three, placebo-controlled, 6-week, fixed-dose trials with INVEGA (3, 6, 9, and 12 mg), orthostatic hypotension was reported by 2.5% of subjects treated with INVEGA compared with 0.8% of subjects treated with placebo.
INVEGA bør anvendes med forsigtighed til patienter med kendt kardiovaskulær sygdom (f. eks. hjerteinsufficiens, myokardieinfarkt eller
INVEGA should be used with caution in patients with known cardiovascular disease (e. g., heart failure, myocardial infarction or ischaemia, conduction abnormalities),
3 iskæmi eller ledningsforstyrrelser), cerebrovaskulær sygdom eller tilstande, som prædisponerer patienten for hypotension (f. eks. dehydrering og hypovolæmi).
3 cerebrovascular disease, or conditions that predispose the patient to hypotension (e. g., dehydration and hypovolemia).
Krampeanfald INVEGA bør anvendes med forsigtighed til patienter, hvis anamnese omfatter krampeanfald eller andre tilstande, som kan sænke krampetærskelen.
Seizures INVEGA should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.
Potentiale for gastrointestinal obstruktion Eftersom INVEGA- tabletterne ikke er deformerbare og ikke væsentligt ændrer form i mave- tarm- kanalen, bør INVEGA normalt ikke administreres til patienter med eksisterende svær gastrointestinal forsnævring (patologisk eller iatrogen) eller til patienter med dysfagi eller signifikant vanskelighed ved at sluge tabletter.
Potential for gastrointestinal obstruction Because the INVEGA tablet is non-deformable and does not appreciably change shape in the gastrointestinal tract, INVEGA should not ordinarily be administered to patients with preexisting severe gastrointestinal narrowing (pathologic or iatrogenic) or in patients with dysphagia or significant difficulty in swallowing tablets.
Der er rapporteret sjældne tilfælde af obstruktive symptomer hos patienter med kendt striktur i forbindelse med indtagelse af lægemidler i ikke- deformerbare depotformuleringer.
There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of medicines in non-deformable controlled-release formulations.
Tilstande med mindsket gastrointestinal transittid Tilstande, som kan føre til kortere gastrointestinal transittid, f. eks. sygdomme associeret med svær kronisk diaré, kan medføre nedsat absorption af paliperidon.
Conditions with decreased gastro-intestinal transit time Conditions leading to shorter gastrointestinal transit time, e. g., diseases associated with chronic severe diarrhoea, may result in a reduced absorption of paliperidone.
4. 2 og 5. 2).
Renal impairment The plasma concentrations of paliperidone are increased in patients with renal impairment and, therefore, dosage adjustment may be required in some patients (see section 4.2 and 5.2).
Der foreligger ingen data for patienter med en kreatinin- clearance under 10 ml/ min.
No data are available in patients with a creatinine clearance below 10 ml/ min.
Paliperidon må ikke anvendes til patienter med en kreatinin - clearance under 10 ml/ min.
Paliperidone should not be used in patients with creatinine clearance below 10 ml/ min.
Nedsat leverfunktion Der foreligger ingen data for patienter med svært nedsat leverfunktion (Child- Pugh- klasse C).
Hepatic impairment No data are available in patients with severe hepatic impairment (Child-Pugh class C).
Ældre patienter med demens INVEGA er ikke undersøgt hos ældre patienter med demens.
Elderly patients with dementia INVEGA has not been studied in elderly patients with dementia.
Så længe andet ikke er påvist, betragtes erfaringerne med risperidon også som værende gældende for paliperidon.
Hence, until data demonstrate otherwise the experience from risperidone is considered valid also for paliperidone.
Overordnet mortalitet I en meta- analyse af 17 kontrollerede kliniske forsøg havde ældre patienter med demens, som blev behandlet med andre atypiske antipsykotika, bl. a. risperidon, aripiprazol, olanzapin og quetiapin, øget mortalitetsrisiko i forhold til placebo.
Overall mortality In a meta-analysis of 17 controlled clinical trials, elderly patients with dementia treated with other atypical antipsychotics, including risperidone, aripiprazole, olanzapine, and quetiapine had an increased risk of mortality compared to placebo.
Blandt dem, der blev behandlet med risperidon var mortaliteten 4% i forhold til 3, 1% for dem, som fik placebo.
Among those treated with risperidone, the mortality was 4% compared with 3.1% for placebo.
Cerebrovaskulære bivirkninger Der er set en tilnærmelsesvis 3- fold forøgelse af risikoen for cerebrovaskulære bivirkninger i randomiserede, placebokontrollerede kliniske forsøg med patienter med demens, der behandles med visse atypiske antipsykotika, bl. a. risperidon, aripiprazol og olanzapin.
Cerebrovascular adverse reactions An approximately 3-fold increased risk of cerebrovascular adverse reactions have been seen in randomised placebo-controlled clinical trials in the dementia population with some atypical antipsychotics, including risperidone, aripiprazole, and olanzapine.
Parkinsons sygdom og demens med Lewy- legemer Risici og fordele bør afvejes ved ordination af antipsykotika, herunder INVEGA, til patienter med Parkinsons sygdom eller demens med Lewy- legemer, eftersom begge grupper kan have øget risiko for malignt neuroleptikumsyndrom samt øget sensitivitet for antipsykotika.
Parkinson’ s disease and dementia with Lewy bodies Physicians should weigh the risks versus the benefits when prescribing antipsychotic medicinal products, including INVEGA, to patients with Parkinson’ s Disease or Dementia with Lewy Bodies (DLB) since both groups may be at increased risk of Neuroleptic Malignant Syndrome as well as having an increased sensitivity to antipsychotics.
4 Priapisme Det er rapporteret, at lægemidler med alfaadrenergt blokerende virkning kan inducere priapisme.
4 Priapism Medicines with alpha-adrenergic blocking effects have been reported to induce priapism.
Selv om der ikke er rapporteret tilfælde af priapisme i kliniske forsøg med INVEGA, har paliperidon samme farmakologiske aktivitet og kan derfor være forbundet med denne risiko.
Although no cases of priapism have been reported in clinical trials with INVEGA, paliperidone shares this pharmacologic activity and, therefore, may be associated with this risk.
Regulering af legemstemperatur Antipsykotika er blevet forbundet med forstyrrelse af kroppens evne til at nedsætte sin kernetemperatur.
Body temperature regulation Disruption of the body’ s ability to reduce core body temperature has been attributed to antipsychotic medicines.
Der bør udvises forsigtighed ved ordination af INVEGA til patienter, som forventes at opleve forhold, der kan bidrage til en forøgelse af kroppens kernetemperatur, f. eks. kraftig fysisk aktivitet, eksponering for kraftig varme, samtidig indtagelse af lægemidler med antikolinerg aktivitet eller dehydrering.
Appropriate care is advised when prescribing INVEGA to patients who will be experiencing conditions which may contribute to an elevation in core body temperature, e. g., exercising strenuously, exposure to extreme heat, receiving concomitant medication with anticholinergic activity, or being subject to dehydration.
Antiemetisk effekt Der er observeret en antiemetisk effekt i de prækliniske forsøg med paliperidon.
Antiemetic effect An antiemetic effect was observed in preclinical studies with paliperidone.
Hvis denne effekt forekommer hos mennesker, kan den skjule tegn og symptomer på overdosering af visse lægemidler eller tilstande som intestinal obstruktion, Reyes syndrom og hjernetumor.
This effect, if it occurs in humans, may mask the signs and symptoms of overdosage with certain medicines or of conditions such as intestinal obstruction, Reye’ s syndrome, and brain tumour.
Der tilrådes forsigtighed ved ordination af INVEGA sammen med lægemidler, som vides at forlænge QT - intervallet, f. eks. antiarytmika klasse IA (f. eks. kinidin, disopyramid,) og klasse III (f. eks. amiodaron, sotalol), visse antihistaminer, andre antipsykotika, og visse malariamidler (f. eks. mefloquin).
Caution is advised when prescribing INVEGA with medicines known to prolong the QT interval, e. g., class IA antiarrhythmics (e. g., quinidine, disopyramide) and class III antiarrhythmics (e. g., amiodarone, sotalol), some antihistaminics, some other antipsychotics and some antimalarials (e. g., mefloquine).
INVEGAS potentielle indvirkning på andre lægemidler Paliperidon forventes ikke at forårsage klinisk vigtige farmakokinetiske interaktioner med lægemidler, som metaboliseres af cytokrom P450- isozymer.
Potential for INVEGA to affect other medicines Paliperidone is not expected to cause clinically important pharmacokinetic interactions with medicines that are metabolised by cytochrome P-450 isozymes.
4. 8) bør INVEGA anvendes med forsigtighed i kombination med andre centralt virkende lægemidler, f. eks. anxiolytika, antipsykotika, hypnotika, opiater etc. eller alkohol.
Given the primary CNS effects of paliperidone (see section 4.8), INVEGA should be used with caution in combination with other centrally acting medicines, e. g., anxiolytics, most antipsychotics, hypnotics, opiates, etc. or alcohol.
Hvis denne kombination anses for nødvendig, især i terminalfasen af Parkinsons sygdom, bør den laveste effektive dosis af hver behandling ordineres.
If this combination is deemed necessary, particularly in end-stage Parkinson’ s disease, the lowest effective dose of each treatment should be prescribed.
4. 4) ses en additiv effekt, når INVEGA indgives sammen med andre lægemidler med dette potentiale, f. eks. andre antipsykotika eller tricykliske antidepressiva.
Because of its potential for inducing orthostatic hypotension (see section 4.4), an additive effect may be observed when INVEGA is administered with other therapeutic agents that have this potential, e. g., other antipsychotics, tricyclics.
Der bør udvises forsigtighed, hvis paliperidon administreres samtidig med lægemidler, der vides at sænke krampetærsklen (f. eks. phenothiazin eller butyrophenon, tricykliske antidepressiva eller SSRI, tramadol, mefloqin ect.).
Caution is advised if paliperidone is combined with other medicines know to lower the seizure threshold (i. e., phenothiazines or butyrophenones, tricyclics or SSRIs, tramadol, mefloquine, etc.).
Andre lægemidlers potentielle indvirkning på INVEGA In vitro- forsøg indikerer, at CYP2D6 og CYP3A4 muligvis er minimalt involveret i metaboliseringen af paliperidon, men der er ingen indikationer, hverken in vitro eller in vivo, på, at disse isozymer spiller en signifikant rolle i metaboliseringen af paliperidon.
Potential for other medicines to affect INVEGA In vitro studies indicate that CYP2D6 and CYP3A4 may be minimally involved in paliperidone metabolism, but there are no indications in vitro nor in vivo that these isozymes play a significant role in the metabolism of paliperidone.
Samtidig indgift af INVEGA og paroxetin, en kraftig CYP2D6- inhibitor, har ikke vist nogen klinisk signifikant effekt på paliperidons farmakokinetiske egenskaber.
Concomitant administration of INVEGA with paroxetine, a potent CYP2D6 inhibitor, showed no clinically significant effect on the pharmacokinetics of paliperidone.
In vitro- forsøg har vist, at paliperidon er substrat for P- glycoprotein (P- gp).
In vitro studies have shown that paliperidone is a P-glycoprotein (P-gp) substrate.
Co- administration af INVEGA en gang daglig med carbamazepin 200 mg to gange daglig forårsagede et fald på omkring 37% i gennemsnitlig steady- state Cmax og AUCpaliperidon.
Co-administration of INVEGA once daily with carbamazepine 200 mg twice daily caused a decrease of approximately 37% in the mean steady-state Cmax and AUC of paliperidone.
Dette fald er i stor udstrækning forårsaget af en øgning i renal clearance af paliperidon med 35%, sandsynligvis som et resultat af induktion
This decrease is caused, to a substantial degree, by a 35% increase in renal clearance of paliperidone likely as a result of induction of renal P-gp by carbamazepine.
Ved start af behandling med carbamazepin skal doseringen af INVEGA re- evalueres og øges om nødvendigt.
On initiation of carbamazepine, the dose of INVEGA should 5 be re-evaluated and increased if necessary.