FrancophonIA/ELRC3.0 huggingface dataset:
English: Olanzapine administered with lithium or valproate resulted in increased levels (≥10%) of tremor, dry mouth, increased appetite, and weight gain.
Danish: Olanzapin administreret sammen med lithium eller valproat resulterede i øgede værdier (≥ 10 %) af rysten, mundtørhed, øget appetit og vægtstigning.
English: Your doctor or nurse will make it into a suspension that will be given as an injection using the vial of solvent for ZYPADHERA that comes as a clear, colourless to slightly yellow solution in a clear glass vial.
Danish: Din læge eller sygeplejerske vil tilberede det som en suspension ved at anvende hætteglasset med solvens til ZYPADHERA, der er en klar, farveløs til let gullig opløsning i et klart hætteglas af glas.
English: Common: Elevated cholesterol levels15
Danish: Almindelig: Forhøjede kolesterolniveauer15
English: Other very common side effects (may affect more than 1 in 10 people) include weight gain; and increases in levels of prolactin in the blood.
Danish: Andre meget almindelige bivirkninger (som forekommer hos flere end 1 ud af 10 patienter) omfatter vægtstigning og forhøjede niveauer af prolaktin i blodet.
English: In preclinical studies, olanzapine exhibited a range of receptor affinities (Ki; < 100 nM) for serotonin 5HT2A/2C, 5-HT3, 5-HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors M1-M5; α-1 adrenergic; and histamine H1 receptors.
Danish: I prækliniske studier udviste olanzapin affinitet (Ki; < 100 nM) til serotonin 5 HT2A/2C, 5 HT3, 5 HT6, dopamin D1, D2, D3, D4, D5, de kolinerge muskarine receptorer M1-M5, de α1-adrenerge receptorer og histamin H1-receptorerne.
English: Switching to other antipsychotic medicinal products There are no systematically collected data to specifically address switching patients from ZYPADHERA to other antipsychotic medicinal products.
Danish: Der er ingen systematisk indsamlede data, der specielt vedrører patienter, som skifter fra ZYPADHERA til andre antipsykotiske lægemidler.
English: However, systemic concentrations in these studies were generally less than that seen at effect levels in the oral studies; thus the information on oral olanzapine is provided below for reference.
Danish: De systemiske koncentrationer i disse forsøg var dog i almindelighed mindre end dem, som blev set ved effektniveauer i studier med oral olanzapin.
English: New-born infants exposed to antipsychotics (including olanzapine) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery.
Danish: Nyfødte, der har været eksponeret for antipsykotika (inklusive olanzapin) under tredje trimester af graviditeten, er i risiko for bivirkninger inkluderende ekstrapyramidale og/eller abstinenssymptomer, som kan variere i sværhedsgrad og varighed efter fødslen.
English: During pre-marketing clinical studies, reactions that presented with signs and symptoms consistent with olanzapine overdose, were reported in patients following an injection of ZYPADHERA.
Danish: Under præmarketing kliniske forsøg blev reaktioner, der præsenterede tegn og symptomer som ved overdosering med olanzapin, rapporteret hos patienter efter en injektion af ZYPADHERA.
English: In clinical trials with ZYPADHERA, the only adverse reaction reported at a statistically significantly higher rate in the ZYPADHERA group than in the placebo group was sedation (ZYPADHERA 8.2%, placebo 2.0%).
Danish: I kliniske forsøg med ZYPADHERA var den eneste bivirkning, som blev rapporteret med en statistisk signifikant højere frekvens i ZYPADHERAgruppen end i placebogruppen, sedation (ZYPADHERA 8.2 %, placebo 2.0 %).
English: 2 Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline.
Danish: 2Gennemsnitlig forøgelse i fastende lipidtal (total-kolesterol, LDL-kolesterol og triglycerider) var højere hos patienter uden tegn på lipiddysregulering ved baseline.
English: • Very rarely, medicines of this type may cause unusual movements mainly of the face or tongue or a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness.
Danish: • Medicin af denne type kan yderst sjældent forårsage usædvanlige bevægelser af især ansigt eller tunge eller en kombination af feber, hurtigere vejrtrækning, svedtendens, muskelstivhed og døsighed/søvnighed.
English: The use of olanzapine in the treatment of dopamine agonist associated psychosis in patients with Parkinson's disease is not recommended.
Danish: Anvendelse af olanzapin til behandling af psykose relateret til en dopaminagonist hos patienter med Parkinsons sygdom kan ikke anbefales.
English: Appropriate clinical monitoring is advisable in accordance with utilised antipsychotic guidelines, e.g. measuring of blood glucose at baseline, 12 weeks after starting olanzapine treatment and annually thereafter.
Danish: Passende klinisk monitorering tilrådes i henhold til anvendte antipsykotiske retningslinier, som f.eks. måling af blodsukker ved baseline, 12 uger efter start på olanzapinbehandling og derefter årligt.
English: All oral olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing risk factors.
Danish: Alle de patienter, som blev behandlet med oral olanzapin eller placebo og oplevede en cerebrovaskulær bivirkning, havde præeksisterende risikofaktorer.
English: If signs and symptoms of overdose consistent with post injection syndrome are observed, appropriate supportive measures should be taken (see section 4.4).
Danish: Hvis tegn og symptomer på overdosis, der svarer til postinjektionssyndrom, observeres, bør passende støtteforanstaltninger iværksættes (se pkt.
English: In a review of safety data from clinical trials and spontaneous postmarketing reports, injection site abscess was rarely (≥ 1/10,000 to < 1/1,000) reported.
Danish: I kliniske studier og spontane indberetninger efter markedsføring var absces på injektionsstedet sjældent rapporteret (≥ 1/10.000 til < 1/1.000).
English: Cytochromes P450-CYP1A2 and P450-CYP2D6 contribute to the formation of the N-desmethyl and 2-hydroxymethyl metabolites; both exhibited significantly less in vivo pharmacological activity than olanzapine in animal studies.
Danish: Cytokrom P450-CYP1A2 og P450-CYP2D6 bidrager til dannelsen af N-desmethyl og 2-hydroxymethyl metabolitter, der udviser signifikant mindre farmakologisk aktivitet in vivo end olanzapin i dyrestudier.
English: Failure to follow these instructions may result in a needle stick injury.
Danish: Hvis disse instruktioner ikke følges, er der fare for nålestikskade.
English: In plasma, olanzapine is bound to albumin and α1-acid glycoprotein.
Danish: Olanzapin er overvejende bundet til albumin og surt α1-glykoprotein i plasma.
English: Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is required after the introduction of concomitant olanzapine.
Danish: Terapeutisk monitorering af valproats plasmaniveauer indikerer ikke, at en justering af valproatdosis er nødvendig, når olanzapin gives sammen med valproat.
English: Children and adolescents ZYPADHERA is not for patients who are under 18 years.
Danish: Børn og unge ZYPADHERA er ikke beregnet til patienter under 18 år.
English: Volume of solvent to add (ml)
Danish: Mængde solvens til opløsning (ml)
English: The main findings found in repeat-dose toxicity studies (rat, dog), in a 2-year rat carcinogenicity study, and in toxicity to reproduction studies (rat, rabbit) were limited to injection site reactions for which no NOAEL could be determined.
Danish: De væsentligste fund i studier af toksicitet efter gentagne doser (rotter, hunde) i et 2-års karcinogenicitetstudie med rotter og i reproduktionstoksicitetsstudier (rotter og kaniner) var begrænset til reaktioner på injektionsstedet, for hvilke der ikke kunne bestemmes NOAEL (No Observed Adverse Effect Level).
English: 8 In clinical trials of up to 12 weeks, plasma prolactin concentrations exceeded the upper limit of normal range in approximately 30% of olanzapine treated patients with normal baseline prolactin value.
Danish: 8 I kliniske forsøg af op til 12 ugers varighed oversteg plasma-prolaktinkoncentrationen den øvre normalgrænseværdi hos ca. 30 % af de olanzapinbehandlede patienter med en normal baselineprolaktinværdi.
English: Fertility Effects on fertility are unknown (see section 5.3 for preclinical information)
Danish: Fertilitet Påvirkning af fertiliteten er ukendt (se pkt.
English: The predominant pharmacologic activity is from the parent, olanzapine.
Danish: Den dominerende farmakologiske aktivitet stammer fra det native olanzapin.
English: Animal behavioural studies with olanzapine indicated 5HT, dopamine, and cholinergic antagonism, consistent with the receptor-binding profile.
Danish: Dyreadfærdsstudier af olanzapin indikerede 5 HT, dopamin og kolinerg antagonisme i overensstemmelse med receptorbindingsprofilen.
English: Patients gaining ≥ 7 %, ≥ 15 % and ≥ 25% of their baseline body weight with long-term exposure (at least 48 weeks) were very common (64.4 %, 31.7 % and 12.3 % respectively).
Danish: Patienter med en vægtøgning på ≥7 %, ≥15 % og ≥ 25 % af deres kropsvægt ved baseline ved langvarig behandling (mindst 48 uger) var meget almindelig (henholdsvis 64,4 %, 31,7 % og 12,3 %).
English: Rare side effects (may affect up to 1 in 1000 people) with ZYPADHERA include injection site infection.
Danish: Sjældne bivirkninger (forekommer hos op til 1 ud af 1.000 patienter) ved ZYPADHERA omfatter infektion på injektionsstedet.
English: In the event of an injection site related adverse reaction occuring, appropriate measures to manage these events should be taken (see section
Danish: I de tilfælde, hvor en bivirkning relateret til injektionsstedet forekommer, bør der tages passende foranstaltninger til at behandle disse (se pkt.
English: Eli Lilly Danmark A/S Tlf: + 45 45 26 60 00
Danish: Danmark Eli Lilly Danmark A/S Tlf.: +45 45 26 60 00
English: This table confirms the final ZYPADHERA suspension volume to inject.
Danish: Denne tabel angiver den mængde ZYPADHERA suspension, som skal indsprøjtes.
English: The clinical consequences are likely to be limited, but clinical monitoring is recommended and an increase of olanzapine dose may be considered if necessary (see section 4.2).
Danish: De kliniske konsekvenser er sandsynligvis begrænsede, men klinisk overvågning anbefales og en øgning af olanzapindosis bør overvejes, hvis det er nødvendigt (se pkt.
English: If an overdose is suspected, close medical supervision and monitoring should continue until examination indicates that signs and symptoms have resolved.
Danish: Hvis der er mistanke om overdosering, bør tæt medicinsk tilsyn og overvågning fortsætte, indtil undersøgelser indikerer, at tegn og symptomer er forsvundet.
English: Patients treated with any antipsychoticmedicines, including ZYPADHERA, should be monitored regularly for lipids in accordance with utilised antipsychotic guidelines, e.g. at baseline, 12 weeks after starting olanzapine treatment and every 5 years thereafter.
Danish: Patienter, som behandles med antipsykotiske lægemidler, herunder ZYPADHERA, bør monitoreres regelmæssigt for lipider i henhold til anvendte antipsykotiske retningslinier, f.eks. ved baseline og 12 uger efter start på olanzapinbehandling, og derefter hvert 5. år.
English: Figure C: Vigorously shake vial
Danish: Figur C: Ryst hætteglasset kraftigt
English: Restless Legs Syndrome
Danish: Restless legssyndrom
English: • High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking ZYPADHERA.
Danish: • Højt sukker- og fedtindhold (triglycerider og kolesterol) i blodet er set hos patienter, som tager ZYPADHERA.
English: Other adverse reactions observed in patients treated with ZYPADHERA were similar to those seen with oral olanzapine.
Danish: Andre bivirkninger, som blev observeret hos patienter i behandling med ZYPADHERA, var de samme, som blev set med oral olanzapin.
English: 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 (see section 4.5).
Danish: 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 (se pkt.
English: Very common symptoms in overdose (>10% incidence) include tachycardia, agitation/aggressiveness, dysarthria, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma.
Danish: Meget almindelige symptomer på overdosering (forekomst > 10 %) inkluderer takykardi, agitation/aggressivitet, dysartri, forskellige ekstrapyramidale symptomer og nedsat bevidsthedsniveau, som varierer fra sedation til koma.
English: • excessive sleepiness
Danish: • Usædvanlig stor søvnighed
English: Table 1 Recommended dose scheme between oral olanzapine and ZYPADHERA Target oral olanzapine dose Recommended starting dose of ZYPADHERA
Danish: Tabel 1 Anbefalet doseringsskema mellem oral olanzapin og ZYPADHERA Mål for oral olanzapindosis Anbefalet startdosis af ZYPADHERA Vedligeholdelsesdosis efter behandling i 2 måneder med ZYPADHERA
English: Exacerbation was measured by worsening of items on the PANSS derived BPRS Positive scale and hospitalization due to worsening of positive psychotic symptoms.
Danish: Eksacerbationen blev bestemt som forværring af resultaterne fra BPRS, som er afledt af PANSS, og indlæggelse på grund af forværring af sikre psykotiske symptomer.
English: Patients should be advised not to drive or operate machinery for the remainder of the day after each injection due to the possibility of a post-injection syndrome event leading to symptoms consistent with olanzapine overdose (see section 4.4).
Danish: Patienterne bør rådes til ikke at køre eller betjene maskiner den resterende del af dagen efter hver injektion på grund af muligheden for, at en postinjektionssyndromhændelse kan medføre symptomer som ved overdosering med olanzapin (se pkt.
English: Immediately prior to leaving the health care facility, it should be confirmed that the patient is alert, oriented, and absent of any signs and symptoms of overdose.
Danish: Umiddelbart inden patienten forlader sundhedscenteret, bør det bekræftes, at patienten er bevidsthedsklar, kan orientere sig og er uden nogen tegn og symptomer på overdosering.
English: 300 mg/2 weeks
Danish: 300 mg/2 uger
English: Patients were randomized to receive injections of ZYPADHERA 405 mg every 4 weeks, 300 mg every 2 weeks, 210 mg every 2 weeks, or placebo every 2 weeks.
Danish: Patienterne blev randomiseret til at modtage injektioner med 405 mg ZYPADHERA hver 4. uge, 300 mg hver 2. uge, 210 mg hver 2. uge eller placebo hver 2. uge.
English: Discard the vials, syringe, used needles, extra needle and any unused solvent in accordance with appropriate clinical procedures.
Danish: Kasser hætteglas, sprøjter, brugte kanyler, den ekstra kanyle og ikke anvendt solvens i overensstemmelse med de relevante kliniske procedurer.
English: In most of these cases, a history of seizures or risk factors for seizures were reported.
Danish: I de fleste af disse tilfælde var tidligere krampeanfald eller risikofaktorer for krampeanfald rapporteret.
English: While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Danish: Selvom olanzapin udviste antikolinerg aktivitet in vitro, frembød kliniske studier en lav forekomst af dertil relaterede bivirkninger.
English: In renally impaired patients (creatinine clearance < 10 ml/min) versus healthy subjects, there was no significant difference in mean elimination half-life (37.7 versus 32.4 hours) or clearance (21.2 versus 25.0 l/hr).
Danish: Hos patienter med nedsat nyrefunktion (creatininclearance < 10 ml/min) versus raske forsøgspersoner var der ingen signifikant forskel i den gennemsnitlige halveringstid for elimination (37,7 versus 32,4 timer) eller clearance (21,2 versus 25,0 l/time).
English: Unsuspended powder appears as yellow, dry clumps clinging to the vial.
Danish: Ikke opslæmmet pulver viser sig som lysegule, tørre klumper, som klæber til hætteglasset.
English: As olanzapine may cause somnolence and dizziness, patients should be cautioned about operating machinery, including motor vehicles.
Danish: Da olanzapin kan forårsage døsighed og svimmelhed, bør patienterne tilrådes forsigtighed ved bilkørsel og maskinbetjening.
English: However, 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.
Danish: Der skal dog udvises forsigtighed, når olanzapin ordineres sammen med lægemidler, der vides at øge QTc-intervallet, specielt hos ældre patienter, hos patienter med medfødt langt QT-syndrom, hjerteinsufficiens, hjertehypertrofi, hypokaliæmi eller hypomagnesæmi.
English: Supplementation
Danish: Supplering
English: Total Positive and Negative Symptom Scores (PANSS) showed significant improvement from baseline (baseline mean Total PANSS Score 101) to endpoint (mean changes -22.57, -26.32, -22.49 respectively) with each dose of ZYPADHERA (405 mg every 4 weeks, 300 mg every 2 weeks, and 210 mg every 2 weeks) as compared to placebo (mean change -8.51).
Danish: Det samlede resultat af Positive and Negative Symptom Score (PANSS) viste signifikant bedring fra baseline (den gennemsnitlige totale PANSS var 101 ved baseline) til endpoint (de gennemsnitlige ændringer var henholdsvis - 22,57, -26,32,22,49) ved hver dosis ZYPADHERA (405 mg hver 4. uge, 300 mg hver 2. uge og 210 mg hver 2. uge) sammenlignet med placebo (gennemsnitændring -8,51).
English: Seat the needle firmly on the device with a push and a clockwise twist, then pull the needle cap straight away from the needle.
Danish: Sæt kanylen fast på udstyret med et tryk og et vrid i urets retning, træk derpå kanylehætten lige af kanylen.
English: In the same clinical trials, cerebrovascular adverse reactions (CVAEvents e.g., stroke, transient ischemic attack), including fatalities, were reported.
Danish: I de samme kliniske forsøg blev cerebrovaskulære bivirkninger (f.eks. slagtilfælde, forbigående iskæmiske anfald), inklusive dem med dødelig udgang, rapporteret.
English: In placebocontrolled clinical trials (6-12 weeks duration) of elderly patients (mean age 78 years) with dementiarelated 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. 1.5%, respectively).
Danish: 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 %).
English: 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.
Danish: 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.
English: The combined 150 mg and 300 mg/2 week treatment group was non inferior to the 405 mg/4 week treatment group (exacerbation rates 10% for each group) at 24 weeks after randomisation.
Danish: Den kombinerede behandlingsgruppe med 150 mg og 300 mg/2 uger var ikke dårligere end behandlingsgruppen med 405 mg/4 uger (eksacerbationsrate på 10 % for hver gruppe) 24 uger efter randomiseringen.
English: • rapid beating of the heart, agitation/aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness.
Danish: • hurtigt hjerteslag, uro/aggressionspræget adfærd, talebesvær, usædvanlige bevægelser (særlig i ansigt og tunge) og nedsat bevidsthedstærskel.
English: 210 mg/2 weeks or 405 mg/4 weeks
Danish: 210 mg/2 uger eller 405 mg/4 uger
English: With long-term exposure (at least 24 weeks), 89.4 % gained ≥ 7 %, 55.3 % gained ≥ 15 % and 29.1 % gained ≥ 25% of their baseline body weight.
Danish: Ved langvarig behandling (mindst 24 uger) tog 89,4 % ≥7 % på, 55,3 % tog ≥15 % på og 29,1 % tog ≥ 25 % af deres kropsvægt ved baseline på.
English: The frequency terms listed are defined as follows: Very common (≥ 1/10), common (≥ 1/100 to < 1/10).
Danish: Hyppighederne er defineret som følger: Meget almindelig (≥1/10), almindelig (≥1/100 til < 1/10).
English: One vial of 3 ml solvent.
Danish: Et hætteglas med 3 ml solvens.
English: STEP 3: Reconstituting ZYPADHERA 1.
Danish: Trin 3: Rekonstitution af ZYPADHERA 1.
English: Elevated cholesterol levels2,3
Danish: Forhøjede kolesterolniveauer2,3
English: Visitwise mean change from baseline to endpoint in PANSS Total score indicated that by Day 3, patients in the 300 mg/2 weeks and 405 mg/4 weeks treatment groups had statistically significantly greater reductions in PANSS Total score compared to placebo (-8.6, -8.2, and -5.2, respectively).
Danish: I forhold til besøg indikerede den gennemsnitlige ændring i PANSS fra baseline til endpoint, at på dag 3 havde patienterne i behandlingsgrupperne 300 mg/2 uger og 405 mg/4 uger statistisk signifikant større reduktioner i PANSS sammenlignet med placebo (henholdsvis -8,6, -8,2 og -5,2).
English: • disorientation
Danish: • Desorientering
English: Olanzapine demonstrated a greater in vitro affinity for serotonin 5-HT2 than dopamine D2 receptors and greater 5HT2 than D2 activity in vivo, models.
Danish: Olanzapin udviste større affinitet til serotonin 5HT2- end til dopamin D2-receptorerne i in vitro-undersøgelser og større 5 HT2- end D2aktivitet i in vivo-modeller.
English: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Danish: Lægemiddelfre mkaldt udslæt med eosinofili og systemtiske symptomer (DRESS)
English: 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).
Danish: Patienterne bør mindes om, at de resten af dagen for injektionen rådes til at være opmærksomme på tegn og symptomer på overdosis sekundære til postinjektionsreaktioner, at kunne få assistance, hvis det er nødvendigt, og at de ikke bør køre eller betjene maskiner (se pkt.
English: The most commonly reported injection site related adverse reaction was pain.
Danish: Bivirkningsreaktioner relateret til injektionsstedet Den mest almindeligt rapporterede bivirkningsreaktion relateret til injektionsstedet var smerte.
English: DRESS appears initially as flu-like symptoms with a rash on the face and then with an extended rash, high temperature, enlarged lymph nodes, increased levels of liver enzymes seen on blood tests and an increase in a type of white blood cells (eosinophilia).
Danish: DRESS viser sig først ved influenzalignende symtomer og udslæt i ansigtet, og derefter ved udbredt udslæt, høj feber, hævede lymfekirtler, forhøjede leverenzymer målt ved blodprøver, samt en stigning i antallet af en bestemt type blodceller (eosinofili).