natgillin/translations-raw huggingface dataset:
Det bør sikres, at patienten er bevidsthedsklar, kan orientere sig og er uden nogen tegn og symptomer på overdosis.
It should be confirmed that the patient is alert, oriented, and absent of any signs and symptoms of overdose.
4. 4).
If an overdose is suspected, close medical supervision and monitoring should continue until examination indicates that signs and symptoms have resolved (See section 4.4.).
6. 6.
For Instructions for Use, see section 6.6.
ZYPADHERA 210 mg pulver og solvens til depotinjektionsvæske, suspension må ikke forveksles med olanzapin 10 mg pulver til injektionsvæske, opløsning.
Do not confuse ZYPADHERA 210 mg powder and solvent for prolonged release suspension for injection with olanzapine 10 mg powder for solution for injection.
2 Tabel 1 Anbefalet doseringsskema mellem oral olanzapin og ZYPADHERA
2 Table 1
Mål for oral olanzapindosis Anbefalet startdosis af ZYPADHERA Vedligeholdelsesdosis efter behandling i 2 måneder med ZYPADHERA 10 mg/ dag 15 mg/ dag 20 mg/ dag
Recommended dose scheme between oral olanzapine and ZYPADHERA
210 mg/ 2 uger eller 405 mg/ 4 uger 300 mg/ 2 uger 300 mg/ 2 uger
Target Oral Dose 10 mg/ day 15 mg/ day 20 mg/ day
150 mg/ 2 uger eller 300 mg/ 4 uger 210 mg/ 2 uger eller 405 mg/ 4 uger 300 mg/ 2 uger
Olanzapine Recommended Starting Dose of Maintenance Dose after 2 Months of ZYPADHERA ZYPADHERA Treatment 210 mg/ 2 weeks or 405 mg/ 4 weeks 150 mg/ 2 weeks or 300 mg/ 4 weeks 300 mg/ 2 weeks 210 mg/ 2 weeks or 405 mg/ 4 weeks 300 mg/ 2 weeks 300 mg/ 2 weeks
Patienten bør monitoreres omhyggeligt for tegn på tilbagefald i de første en til to måneder af behandlingen.
Dose Adjustment Patients should be monitored carefully for signs of relapse during the first one to two months of treatment.
Under antipsykotisk behandling kan bedring i patientens kliniske tilstand vare fra flere dage til nogle uger.
During antipsychotic treatment, improvement in the patient’ s clinical condition may take several days to some weeks.
Under behandling kan dosis efterfølgende justeres på basis af den individuelle kliniske status.
During treatment dosage may subsequently be adjusted on the basis of individual clinical status.
Efter klinisk revurdering kan dosis justeres inden for området 150 mg til 300 mg hver 2. uge eller 300 mg til 450 mg hver 4. uge.
After clinical reassessment dosage may be adjusted within the range 150 mg to 300 mg every 2 weeks or 300 to 405 mg every 4 weeks.
Supplering Det var ikke tilladt at supplere med oral olanzapin i de dobbeltblindede kliniske studier.
Supplementation Supplementation with oral olanzapine was not authorised in double-blind clinical studies.
Hvis der er klinisk indikation for supplering med oral olanzapin, så bør den totale dosis af olanzapin fra begge lægemiddelformer ikke overstige den tilsvarende maksimale dosis for oral olanzapin på 20 mg/ dag.
If oral olanzapine supplementation is clinically indicated, then the combined total dose of olanzapine from both formulations should not exceed the corresponding maximum oral olanzapine dose of 20 mg/ day.
Skift til andre antipsykotiske lægemidler Der er ingen systematisk indsamlede data, der specielt vedrører patienter, som skifter fra ZYPADHERA til andre antipsykotiske lægemidler.
Switching to other antipsychotic medicinal products There are no systematically collected data to specifically address switching patients from ZYPADHERA to other antipsychotic medicinal products.
Ældre patienter ZYPADHERA er ikke systematisk undersøgt hos ældre patienter (> 65 år).
Elderly patients ZYPADHERA has not been systematically studied in elderly patients (> 65 years).
ZYPADHERA bør ikke anvendes til behandling af den ældre population, før et veltålt og effektivt dosisregime for brug af oral olanzapin er fastsat.
ZYPADHERA is not recommended for treatment in the elderly population unless a well-tolerated and effective dosage regimen using oral olanzapine has been established.
En lavere begyndelsesdosis (150 mg hver 4. uge) er ikke rutinemæssigt indiceret, men bør overvejes til patienter på 65 år og derover, når kliniske faktorer berettiger dertil.
A lower starting dose (150 mg/ 4 weeks) is not routinely indicated, but should be considered for those 65 and over when clinical factors warrant.
4. 4).
ZYPADHERA is not recommended to be started in patients > 75 years (see section 4.4).
Patienter med nedsat nyre - og/ eller leverfunktion ZYPADHERA bør ikke anvendes, før et veltålt og effektivt dosisregime for brug af oral olanzapin er fastsat til disse patienter.
Patients with renal and/ or hepatic impairment Unless a well-tolerated and effective dosage regimen using oral olanzapine has been established in such patients, ZYPADHERA should not be used.
Ved moderat leverinsufficiens (cirrhose, Child- Pugh Class A eller B) bør startdosis være 150 mg hver 4. uge og kun øges med forsigtighed.
In cases of moderate hepatic insufficiency (cirrhosis, Child- Pugh Class A or B), the starting dose should be 150 mg every 4 weeks and only increased with caution.
Køn Det er ikke nødvendigt rutinemæssigt at ændre begyndelsesdosis og dosisforløb hos kvinder i forhold til mænd.
Gender The starting dose and dose range need not be routinely altered for female patients relative to male patients.
Rygere Det er ikke nødvendigt rutinemæssigt at ændre begyndelsesdosis og dosisforløb hos ikke- rygere i forhold til rygere.
Smokers The starting dose and dose range need not be routinely altered for non-smokers relative to smokers.
Når mere end en parameter, som kan føre til nedsat metabolisme, er til stede (kvinder, ældre, ikke - rygere), bør det overvejes at reducere dosis.
When more than one factor is present which might result in slower metabolism (female gender, geriatric age, non-smoking status), consideration should be given to decreasing the dose.
3 Børn ZYPADHERA bør ikke anvendes til børn og unge under 18 år p. g. a. manglende dokumentation for sikkerhed og virkning.
3 ZYPADHERA is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
6. 6).
Special care must be taken to apply appropriate injection technique to avoid inadvertent intravascular or subcutaneous injection (see section 6.6).
Postinjektionssyndrom Under de præmarketing kliniske forsøg blev tilfælde, der viste sig med tegn og symptomer som ved overdosering med olanzapin, rapporteret hos patienter efter en injektion af ZYPADHERA.
Post-injection syndrome During pre-marketing clinical studies, events that presented with signs and symptoms consistent with olanzapine overdose, were reported in patients following an injection of ZYPADHERA.
Disse tilfælde opstod ved < 0, 1% af injektionerne og hos omkring 1, 4% af patienterne.
These events occurred in < 0.1% of injections and approximately 1.4% of patients.
De fleste af disse patienter udviklede symptomer på sedation (fra mild sedation til koma) og/ eller delirium (herunder forvirring, desorientering, ophidselse/ uro, angst og anden kognitiv svækkelse).
Most of these patients have developed symptoms of sedation (ranging from mild in severity up to coma) and/ or delirium (including confusion, disorientation, agitation, anxiety and other cognitive impairment).
Andre bemærkede symptomer inkluderer ekstrapyramidale symptomer, dysartri, ataksi, aggression, svimmelhed, svaghed, hypertension eller mulig krampe.
Other symptoms noted include extrapyramidal symptoms, dysarthria, ataxia, aggression, dizziness, weakness, hypertension and convulsion.
I de fleste tilfælde havde de initiale tegn og symptomer relateret til dette tilfælde vist sig inden for 1 time efter injektionen, og i alle tilfælde blev fuldstændig bedring rapporteret inden for 24- 72 timer efter injektionen.
In most cases, initial signs and symptoms related to this event have appeared within 1 hour following injection, and in all cases full recovery was reported to have occurred within 24 – 72 hours after injection.
Tilfælde forekom sjældent (< 1 af 1. 000 injektioner) mellem 1 og 3 timer, og meget sjældent (< 1 af 10. 000 injektioner) efter 3 timer.
Events occurred rarely (< 1 in 1,000 injections) between 1 and 3 hours, and very rarely (< 1 in 10,000 injections) after 3 hours.
Patienterne bør underrettes om denne potentielle risiko og behovet for at blive observeret i 3 timer i et sundhedscenter, hver gang ZYPADHERA bliver administreret.
Patients should be advised about this potential risk and the need to be observed for 3 hours in a healthcare facility each time ZYPADHERA is administered.
Før indgivelse af injektionen skal sundhedspersonalet sikre sig, at patienten ikke vil tage alene til sit bestemmelsessted.
Prior to giving the injection, the healthcare professional should determine that the patient will not travel alone to their destination.
Det bør bekræftes, at patienten er bevidsthedsklar, kan orientere sig og er uden nogen tegn og symptomer på overdosis.
It should be confirmed that the patient is alert, oriented, and absent of any signs and symptoms of overdose.
Hvis der er mistanke om overdosis, bør tæt medicinsk tilsyn og overvågning fortsætte, indtil undersøgelser indikerer, at tegn og symptomer er forsvundet.
If an overdose is suspected, close medical supervision and monitoring should continue until examination indicates that signs and symptoms have resolved.
4. 7).
For the remainder of the day after injection, patients should be advised to be vigilant for signs and symptoms of overdose secondary to post injection adverse reactions, be able to obtain assistance if needed and should not drive or operate machinery (see section 4.7).
Hvis det er påkrævet at give benzodiazepiner parenteralt til behandling af postinjektionsreaktioner, tilrådes omhyggelig vurdering af den klinisk status for udtalt sedation og kardiorespiratorisk depression.
If parenteral benzodiazepines are essential for management of post injection adverse reactions, careful evaluation of clinical status for excessive sedation and cardiorespiratory depression is recommended.
4. 5)
(see section 4.5)
Bivirkningsreaktioner relateret til injektionsstedet Den mest almindeligt rapporterede bivirkningsreaktion relateret til injektionsstedet var smerte.
Injection Site Related Adverse Events The most commonly reported injection site related adverse event was pain.
Hovedparten af disse tilfælde blev rapporteret til at være af ” mild ” til ” moderat ” alvorlighed.
The majority of these events was reported to be of “ mild” to “ moderate” severity.
I de tilfælde hvor en bivirkningsreaktion relateret til injektionsstedet forekommer, bør der tages passende foranstaltninger til at behandle disse tilfælde.
In the event of an injection site related adverse event occuring, appropriate measures to manage these events should be taken.
4. 8)
(see section 4.8)
4 Demensrelaterede psykoser og/ eller adfærdsforstyrrelser Olanzapin er ikke godkendt til behandling af demensrelateret psykose og/ eller adfærdsforstyrrelse, og bør ikke anvendes til denne særlige patientgruppe på grund af øget mortalitet og risiko for cerebrovaskulære hændelser.
Dementia-related psychosis and/ or behavioural disturbances Olanzapine is not approved for the treatment of dementia-related psychosis and/ or behavioural disturbances and is not recommended for use in this particular group of patients because of an increase
I placebokontrollerede kliniske forsøg (af 6- 12 ugers varighed) med ældre patienter (gennemsnitlig alder 78 år) med demensrelateret psykose og/ eller adfærdsforstyrrelser var der en dobbelt så høj forekomst af dødsfald hos de oralt olanzapinbehandlede patienter i forhold til de placebobehandlede patienter (henholdsvis 3, 5% og 1, 5%).
In placebo-controlled clinical trials (6-12 weeks duration) of elderly patients (mean age 78 years) with dementia-related psychosis and/ or disturbed behaviours, there was a 2-fold increase in the incidence of death in oral olanzapine-treated patients compared to patients treated with placebo (3.5% vs.
Den højere forekomst af dødsfald var ikke relateret til olanzapindosis (gennemsnitlig daglig dosis 4, 4 mg) eller behandlingsvarighed.
The higher incidence of death was not associated with olanzapine dose (mean daily dose 4.4 mg) or duration of treatment.
Der var en tre gange så høj forekomst af cerebrovaskulære hændelser hos de patienter, som blev behandlet med oral olanzapin, sammenlignet med de patienter, som blev behandlet med placebo (henholdsvis 1, 3% og 0, 4%).
There was a 3-fold increase in CVAE in patients treated with oral olanzapine compared to patients treated with placebo (1.3% vs.
Alle de patienter, som blev behandlet med oral olanzapin eller placebo og oplevede en cerebrovaskulær hændelse, havde præeksisterende risikofaktorer.
All oral olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing risk factors.
Parkinsons sygdom Anvendelse af olanzapin til behandling af psykose relateret til en dopaminagonist hos patienter med Parkinsons sygdom kan ikke anbefales.
Parkinson's disease The use of olanzapine in the treatment of dopamine agonist associated psychosis in patients with Parkinson's disease is not recommended.
4. 8), og oral olanzapin var ikke mere effektivt end placebo til behandling af psykotiske symptomer.
In clinical trials, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo (see section 4.8), and oral olanzapine was not more effective than placebo in the treatment of psychotic symptoms.
Oral olanzapin blev initieret på 2, 5 mg/ dag og titreret til maksimalt 15 mg/ dag, baseret på lægens vurdering.
Oral olanzapine was started at 2.5 mg/ day and titrated to a maximum of 15 mg/ day based on investigator judgement.
Malignt neuroleptikasyndrom (NMS) NMS er en potentielt livstruende tilstand, som er forbundet med antipsykotiske lægemidler.
Neuroleptic Malignant Syndrome (NMS) NMS is a potentially life-threatening condition associated with antipsychotic medicinal products.
Yderligere symptomer kan inkludere forhøjet kreatinfosfokinase, myoglobulinuri (rhabdomyolyse) og akut nyresvigt.
Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
Hensigtsmæssig klinisk monitorering tilrådes i henhold til anvendte antipsykotiske retningslinier.
Appropriate clinical monitoring is advisable in accordance with utilised antipsychotic guidelines.
Patienter med diabetes mellitus eller patienter med risikofaktorer for udvikling af diabetes mellitus bør monitoreres regelmæssigt for forværring af blodglucosekontrol.
Patients treated with any antipsychotic agents, including ZYPADHERA, should be observed for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia, and weakness) and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control.
Vægt bør også monitoreres regelmæssigt.
Weight should be monitored regularly.
4. 8).
Lipid alterations Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebo- controlled clinical trials (see section 4.8).
5 henhold til normal klinisk praksis, specielt hos patienter med dyslipidæmi og hos patienter med risikofaktorer for udvikling af lipidforstyrrelser.
Lipid alterations should be managed as clinically appropriate, particularly in dyslipidemic patients and in patients with risk factors for the development of lipids disorders.
Patienter, som behandles med antipsykotiske lægemidler, herunder ZYPADHERA, bør monitoreres regelmæssigt for lipider i henhold til anvendte antipsykotiske retningslinier.
Patients treated with any antipsychotic agents, including ZYPADHERA, should be monitored regularly for lipids in accordance with utilised antipsychotic guidelines.
Antikolinerg aktivitet Selvom olanzapin udviste antikolinerg aktivitet in vitro, frembød kliniske undersøgelser en lav forekomst af dertil relaterede hændelser.
5 Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Neutropeni Der bør udvises forsigtighed hos patienter med lavt leukocyt - og/ eller neutrofiltal uanset årsag, hos patienter, som får medicin, der er kendt for at medføre neutropeni, hos patienter med tidligere medicin- induceret knoglemarvsdepression/ toksicitet, hos patienter med knoglemarvsdepression forårsaget af samtidig sygdom, strålebehandling eller kemoterapi og hos patienter med hypereosinofile tilstande eller myeloproliferativ sygdom.
Neutropenia Caution should be exercised in patients with low leukocyte and/ or neutrophil counts for any reason, in patients receiving medicines known to cause neutropenia, in patients with a history of drug-induced bone marrow depression/ toxicity, in patients with bone marrow depression caused by concomitant illness, radiation therapy or chemotherapy and in patients with hypereosinophilic conditions or with myeloproliferative disease.
Ophør med behandling Akutte symptomer såsom perspiration, søvnløshed, rysten, angst, kvalme eller opkastning er rapporteret meget sjældent (< 0, 01%), når oral olanzapin stoppes pludseligt.
Discontinuation of treatment Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported very rarely (< 0.01%) when oral olanzapine is stopped abruptly.
QTc- forlængelse blev defineret som Fridericia korrigeret QT [QTcF] ≥500 millisekunder [msek] på et hvilket som helst tidspunkt post- baseline hos patienter med baseline QTcF < 500 msek.
QT interval In clinical trials with oral olanzapine, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] ≥ 500 milliseconds [msec] at any time post baseline in patients with baseline QTcF < 500 msec) were uncommon (0.1% to 1%) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo.
I kliniske forsøg med olanzapinpulver til opløsning til injektionsvæske, eller ZYPADHERA blev olanzapin ikke associeret med en vedvarende øgning af absolut QT eller af QTc- intervaller.
In clinical trials with olanzapine powder for solution for injection or ZYPADHERA, olanzapine was not associated with a persistent increase in absolute QT or in QTc intervals.
Som med ethvert andet antipsykotisk middel skal der dog udvises forsigtighed, når olanzapin ordineres sammen med lægemidler, der er kendt for at øge QTc- intervallet, specielt hos ældre patienter, hos patienter hvor syndrom med lang QT er medfødt, hjerteinsufficiens, hjertehypertrofi, hypokaliæmi eller hypomagnesæmi.
However, as with other antipsychotics, caution should be exercised when olanzapine is prescribed with medicines known to increase QTc interval, especially in the elderly, in patients with congenital long QT syndrome, congestive heart failure, heart hypertrophy, hypokalaemia or hypomagnesaemia.
6 Almindelig CNS- aktivitet Som følge af olanzapins primære effekt på centralnervesystemet bør der udvises forsigtighed, når stoffet anvendes i kombination med andre centralt virkende lægemidler og alkohol.
General CNS activity Given the primary CNS effects of olanzapine, caution should be used when it is taken in combination with other centrally acting medicines and alcohol.
Da olanzapin udviser in vitro- dopaminantagonisme, kan det hæmme effekten af direkte eller indirekte dopaminagonister.
As it exhibits in vitro dopamine antagonism, olanzapine may antagonize the effects of direct and indirect dopamine agonists.
Tardiv dyskinesi I sammenlignende undersøgelser af op til 1 års varighed var olanzapin forbundet med en statistisk signifikant lavere forekomst af behandlingsrelateret dyskinesi.
6 Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
Anvendelse til børn og unge under 18 år Olanzapin er ikke indiceret til behandling af børn og unge.
Use in children and adolescents under 18 years of age Olanzapine is not indicated for use in the treatment of children and adolescents.
Studier med patienter på 13- 17 år viste forskellige bivirkninger, herunder vægtøgning, ændringer i metaboliske parametre og stigninger i prolaktinniveauer.
Studies in patients aged 13-17 years showed various adverse reactions, including weight gain, changes in metabolic parameters and increases in prolactin levels.
4. 8 og 5. 1).
Long-term outcomes associated with these events have not been studied and remain unknown (see sections 4.8 and 5.1).
Brug til ældre patienter (> 75 år) Der er ingen tilgængelige data vedrørende brugen af ZYPADHERA til patienter > 75 år.
Use in elderly patients (> 75 years) No information on the use of ZYPADHERA in patients > 75 years is available.
Potentielle interaktioner, der kan påvirke olanzapin Da olanzapin metaboliseres af CYP1A2, kan substanser, som specifikt inducerer eller inhiberer dette isoenzym, påvirke farmakokinetikken af olanzapin.
Potential interactions affecting olanzapine Since olanzapine is metabolised by CYP1A2, substances that can specifically induce or inhibit this isoenzyme may affect the pharmacokinetics of olanzapine.
Induktion af CYP1A2 Olanzapins metabolisering kan induceres ved rygning eller af carbamazepin, hvilket kan medføre reducerede olanzapinkoncentrationer.
Induction of CYP1A2 The metabolism of olanzapine may be induced by smoking and carbamazepine, which may lead to reduced olanzapine concentrations.
7 henholdsvis 52% og 108%.
The mean increase in olanzapine AUC was 52% and 108% respectively.
En lavere startdosis af olanzapin bør overvejes hos de patienter, som anvender fluvoxamin eller andre CYP1A2- inhibitorer, såsom ciprofloxacin.
A lower starting dose of olanzapine should be considered in patients who are using fluvoxamine or any other CYP1A2 inhibitors, such as ciprofloxacin.
Der er ikke fundet tegn på, at fluoxetin (en CYP2D6- inhibitor), enkeltdoser af antacida (aluminium, magnesium) eller cimetidin påvirker olanzapins farmakokinetik signifikant.
Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine.
Olanzapin inhiberer ikke de vigtigste CYP450- isoenzymer in vitro (f. eks.
Olanzapine does not inhibit the main CYP450 isoenzymes in vitro (e. g.
Derfor forventes ingen særlig interaktion, hvilket bekræftes af in vivo- studier, hvor der ikke blev fundet inhibition af metaboliseringen af følgende aktive substanser: tricykliske antidepressiva (hovedsageligt CYP2D6), warfarin (CYP2C9), theophyllin (CYP1A2) eller diazepam (CYP3A4 og 2C19).
Thus no particular interaction is expected as verified through in vivo studies where no inhibition of metabolism of the following active substances was found: tricyclic antidepressant (representing
Almindelig CNS- aktivitet Der skal udvises forsigtighed hos patienter, som indtager alkohol eller får lægemidler, der kan undertrykke centralnervesystemet.
General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
4. 4).
QTc interval Caution should be used if olanzapine is being administered concomitantly with medicinal products known to increase QTc interval (see section 4.4).
Der er meget sjældent modtaget spontane indberetninger af tremor, hypertoni, letargi og søvnighed hos børn af mødre, som har taget olanzapin i tredje trimester.
Spontaneous reports have been very rarely received on tremor, hypertonia, lethargy and sleepiness, in infants born to mothers who had used olanzapine during the 3rd trimester.
I en undersøgelse af oral olanzapin hos ammende, raske kvinder blev olanzapin udskilt i modermælken.
In a study of oral olanzapine in breast-feeding, healthy women, olanzapine was excreted in breast milk.
Patienten bør frarådes at amme, hvis hun er i behandling med olanzapin.
Patients should be advised not to breast-feed an infant if they are taking olanzapine.
Da olanzapin kan forårsage somnolens og svimmelhed, bør patienterne tilrådes forsigtighed ved bilkørsel og maskinbetjening.
As olanzapine may cause somnolence and dizziness, patients should be cautioned about operating machinery, including motor vehicles.