FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: Ved moderat leverinsufficiens (cirrose, Child-Pugh Class A eller B) bør startdosis være 150 mg hver 4. uge og kun øges med forsigtighed.
English: Currently available data are described in sections 4.8 and 5.1 but no recommendation on a posology can be made.
Danish: 4.8 og 5.1, men der kan ikke gives nogen anbefalinger vedrørende dosering.
English: 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.
Danish: 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.
English: Speech disorder was also reported commonly.
Danish: Hyppigheden af taleforstyrrelser var ligeledes almindelig.
English: • Hypodermic Device Safety Information and Instructions for Use leaflet
Danish: • Hypodermic sikkerhedsinformation og brugsvejledning
English: Very rare side effects include serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
Danish: Meget sjældne bivirkninger omfatter alvorlige allergiske reaktioner såsom lægemiddelfremkaldt udslæt med eosinofili og systemiske symptomer (DRESS).
English: Caution should be exercised in patients who receive medicinal products that can induce hypotension or sedation.
Danish: Der skal udvises forsigtighed hos patienter, som får lægemidler, der kan inducere hypotension eller sedation.
English: • The use of ZYPADHERA in elderly patients with dementia (confusion and memory loss) is not recommended as it may have serious side effects.
Danish: • ZYPADHERA anbefales ikke til ældre patienter med demens (konfusion og hukommelsestab), da det kan have alvorlige bivirkninger.
English: Bradycardia QTc prolongation (see section 4.4)
Danish: Bradykardi QTc-forlængelse (se pkt.
English: Preclinical safety studies were performed using olanzapine pamoate monohydrate.
Danish: Præklinske sikkerhedsstudier blev udført ved at bruge olanzapin pamoatmonohydrat.
English: During the initial three months of treatment with ZYPADHERA, accumulation of olanzapine was observed but there was no additional accumulation during long-term use (12 months) in patients who were injected with up to 300 mg every two weeks.
Danish: I løbet af de første tre måneders behandling med ZYPADHERA blev der set akkumulering af olanzapin, men der var ingen yderligere akkumulering ved langtidsbehandling (12 måneder) hos de patienter, som fik op til 300 mg hver anden uge.
English: Fatal outcomes have been reported for acute oral overdoses as low as 450 mg but survival has also been reported following acute overdose of approximately 2 g of oral olanzapine.
Danish: Dødelig udgang er rapporteret efter akut oral overdosering med ned til 450 mg, men overlevelse er også rapporteret efter akut overdosering med ca. 2 g oral olanzapin.
English: These signs and symptoms can sometimes occur as a result of ZYPADHERA entering the bloodstream too quickly (a common side effect that may affect up to1 in10 people);
Danish: Disse tegn og symptomer kan i nogle tilfælde forekomme, hvis ZYPADHERA kommer for hurtigt ind i blodbanen (en almindelig bivirkning, som forekommer hos op til 1 ud af 10 patienter);
English: The magnitude of weight gain and the proportion of adolescent patients who had clinically significant weight gain were greater with long-term exposure (at least 24 weeks) than with short-term exposure.
Danish: Størrelsen af vægtstigningen og andelen af unge patienter, som havde en klinisk signifikant vægtstigning, var højere ved langvarig behandling (mindst 24 uger) end ved kortvarig behandling.
English: For instructions for use, see section 6.6.
Danish: Instruktion vedrørende brug se pkt.
English: No new toxic effect resulting from systemic exposure to olanzapine could be identified.
Danish: Der kunne ikke identificeres nogen nye toksiske virkninger ved systemisk eksponering for olanzapin.
English: Symptomatic treatment and monitoring of vital organ function should be instituted according to clinical presentation, including treatment of hypotension and circulatory collapse and support of respiratory function.
Danish: Symptomatisk behandling og overvågning af de vitale organers funktion bør indledes afhængig af den kliniske tilstand, inklusive behandling af hypotension og kredsløbssvigt samt understøttende behandling af den respiratoriske funktion.
English: ZYPADHERA belongs to a group of medicines called antipsychotics and is used to treat schizophrenia - a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.
Danish: ZYPADHERA tilhører en gruppe af lægemidler, der kaldes antipsykotika, og bruges til behandling af skizofreni - en sygdom med symptomer såsom at man hører, ser og mærker ting, som ikke eksisterer, er mistroisk, ualmindelig mistænksom og indesluttet.
English: Olanzapine was not mutagenic or clastogenic in a full range of standard tests, which included bacterial mutation tests and in vitro and oral in vivo mammalian tests.
Danish: Olanzapin var ikke mutagen eller clastogen i en række standardtests, der omfattede bakterielle mutationstests og in vitro og in vivo-tests på pattedyr.
English: Post-marketing reports of post-injection syndrome since the marketing authorization of ZYPADHERA are generally consistent with the experience seen in clinical studies.
Danish: Post-marketing indberetninger af postinjektionssyndrom efter markedsføringstilladelsen for ZYPADHERA stemmer generelt overens med erfaringerne fra kliniske studier.
English: Very common: Decreased total bilirubin, increased GGT, elevated plasma prolactin levels16.
Danish: Meget almindelig: Nedsat total bilirubin, forhøjet GGT, forhøjet plasma-prolaktin16.
English: 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), not known (cannot be estimated from the data available).
Danish: til < 1/10), ikke almindelig (≥1/1.000til < 1/100), sjælden (≥1/10.000til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Oral olanzapine was used as a flexible dose starting with 2.5 and ranging up to 20 mg/day.
Danish: Oral olanzapin blev brugt i en fleksibel dosis, som begyndte med 2,5 mg, og som gik op til 20 mg daglig.
English: Withdraw the pre-determined solvent volume (Step 2) into the syringe.
Danish: Træk den forudbestemte mængde solvens (Trin 2) op i sprøjten.
English: Weight should be monitored regularly, e.g. at baseline, 4, 8 and 12 weeks after starting olanzapine treatment and quarterly thereafter.
Danish: Vægt bør også monitoreres regelmæssigt, f.eks. ved baseline, 4, 8 og 12 uger efter start på olanzapinbehandling, og derefter kvartalsvist.
English: Water for injections Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment)
Danish: Vand til injektionsvæsker Saltsyre (pH justering) Natriumhydroxid (pH justering)
English: Shake the vial vigorously until the suspension appears smooth and is consistent in color and texture.
Danish: Ryst hætteglasset kraftigt, indtil suspensionen virker jævn og er ensartet i farve og struktur.
English: Clinically significant weight gain (≥ 7%) appears to occur more frequently in the adolescent population compared to adults with comparable exposures.
Danish: Klinisk signifikant vægtstigning (≥ 7 %) synes at forekomme hyppigere i den unge population sammenlignet med voksne patienter i tilsvarende behandling.
English: Olanzapine is an antipsychotic, antimanic and mood stabilising agent that demonstrates a broad pharmacologic profile across a number of receptor systems.
Danish: Olanzapin er et antipsykotisk, antimanisk og stemningsstabiliserende lægemiddelstof med en bred farmakologisk profil, der omfatter adskillige receptorsystemer.
English: Remove the needle, holding the vial upright to prevent any loss of solvent.
Danish: Fjern kanylen ved at holde hætteglasset opret for at undgå tab af solvens.
English: During treatment with oral olanzapine, adolescents gained significantly more weight compared with adults.
Danish: Under behandlingen med olanzapin tog de unge signifikant mere på i vægt sammenlignet med de voksne.
English: In adult patients who completed 9-12 months of therapy, the rate of increase in mean blood glucose slowed after approximately 6 months.
Danish: Hos voksne patienter, som fuldførte en 912 måneders behandling, faldt hastigheden, hvormed den gennemsnitlige blodglucoseværdi steg, efter omkring 6 måneder.
English: Patients should be treated initially with oral olanzapine before administering ZYPADHERA, to establish tolerability and response.
Danish: Patienten bør behandles initialt med oral olanzapin før administration af ZYPADHERA for at påvise tolerabilitet og respons.
English: ZYPADHERA contains the active substance olanzapine.
Danish: ZYPADHERA indeholder det aktive stof olanzapin.
English: In cytopenic dogs, there were no undesirable effects on progenitor and proliferating cells in the bone marrow.
Danish: Hos cytopeniske hunde var der ingen bivirkninger på stamceller og prolifererende celler i knoglemarven.
English: These results support efficacy for ZYPADHERA over 8 weeks of treatment and a drug effect that was observed as early as 1 week after starting treatment with ZYPADHERA.
Danish: Disse resultater underbygger virkningen af ZYPADHERA i løbet af 8 ugers behandling og en substansvirkning, som blev observeret så tidligt som første uge efter påbegyndt behandling med ZYPADHERA.
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to restricted medical prescription.
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING Receptpligtigt lægemiddel med begrænset udlevering.
English: Special care must be taken to apply appropriate injection technique to avoid inadvertent intravascular or subcutaneous injection (see section 6.6).
Danish: Der skal udvises særlig forsigtighed med brug af hensigtsmæssig injektionsteknik for at undgå utilsigtet intravaskulær eller subkutan injektion (se pkt.
English: In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
Danish: I sammenlignende studier af op til 1 års varighed var olanzapin forbundet med en statistisk signifikant lavere forekomst af behandlingsrelateret dyskinesi.
English: • carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - it may be necessary to change your ZYPADHERA dose.
Danish: • Carbamazepin (mod epilepsi og stemningsforstyrrelser), fluvoxamin ( mod depression) eller ciprofloxacin (mod infektion) - det kan blive nødvendigt at ændre din dosis af ZYPADHERA.
English: As a routine precaution, if you are over 65 years your doctor may monitor your blood pressure.
Danish: Hvis du er over 65 år, bør du som rutinemæssig foranstaltning have målt dit blodtryk hos din læge.
English: The metabolism of olanzapine may be induced by smoking and carbamazepine, which may lead to reduced olanzapine concentrations.
Danish: Olanzapins metabolisering kan induceres ved rygning eller af carbamazepin, hvilket kan medføre reducerede olanzapinkoncentrationer.
English: In a study of oral olanzapine in breast-feeding, healthy women, olanzapine was excreted in breast milk.
Danish: I et studie af oral olanzapin hos ammende, raske kvinder blev olanzapin udskilt i mælken.
English: Perform a one-handed technique by GENTLY pressing the sheath against a flat surface.
Danish: Udfør enhåndsteknikken ved at presse hylsteret LET mod en flad overflade.
English: Age > 75 years and vascular/mixed type dementia were identified as risk factors for CVAE in association with olanzapine treatment.
Danish: Alder >75 år og vaskulær/blandet demens blev identificeret som risikofaktorer for cerebrovaskulære bivirkninger i relation til olanzapinbehandling.
English: Solvent: clear, colourless to slightly yellow solution.
Danish: Solvens: klar, farveløs til svagt gullig væske.
English: After a single IM injection with ZYPADHERA the slow dissolution of the olanzapine pamoate salt in muscle tissue begins immediately and provides a slow continuous release of olanzapine for more than four weeks.
Danish: Efter en enkelt intramuskulær injektion med ZYPADHERA begynder den langsomme frigivelse af olanzapinpamoatsaltet fra muskelvævet straks og giver en langsom, kontinuerlig frigivelse af olanzapin i mere end fire uger.
English: Olanzapine plasma clearance after oral olanzapine is lower in females (18.9 l/hr) versus males (27.3 l/hr), and in non-smokers (18.6 l/hr) versus smokers (27.7 l/hr).
Danish: Olanzapins plasmaclearance efter oral indgift af olanzapin er lavere hos kvinder (18,9 l/time) end hos mænd (27,3 l/time) og hos ikke-rygere (18,6 l/time) end hos rygere (27,7 l/time).
English: Electrophysiological studies demonstrated that olanzapine selectively reduced the firing of mesolimbic (A10) dopaminergic neurons, while having little effect on the striatal (A9) pathways involved in motor function.
Danish: Elektrofysiologiske undersøgelser viste, at olanzapin selektivt reducerede ”firing” ved de mesolimbiske (A10) dopaminerge neuroner, hvorimod det kun havde lille påvirkning af de striatale (A9) baner for motorisk funktion.
English: Olanzapine reduced a conditioned avoidance response, a test indicative of antipsychotic activity, at doses below those producing catalepsy, an effect indicative of motor side-effects.
Danish: Olanzapin hæmmede et klassisk betinget respons (conditioned avoidance response), en test, der indikerer antipsykotisk aktivitet, ved lavere doser end de, der frembringer katalepsi, en effekt, der indikerer motoriske bivirkninger.
English: If you are already taking antidepressants, medicines for anxiety or to help you sleep (tranquillisers), you may feel drowsy if ZYPADHERA is given.
Danish: Hvis du allerede tager medicin mod depression, medicin mod angst eller søvnløshed (sovemedicin) kan du føle dig døsig, hvis du får ZYPADHERA.
English: The following table summarises the adverse reactions reported with a greater frequency in adolescent patients (aged 13-17 years) than in adult patients or adverse reactions only identified during short-term clinical trials in adolescent patients.
Danish: Den følgende tabel opsummerer de bivirkninger, som blev rapporteret med større frekvens hos unge patienter (alder 13 - 17 år) end hos voksne patienter, eller bivirkninger som kun blev identificeret i kortvarige kliniske forsøg med unge patienter.
English: Use in patients who are in an acutely agitated or severely psychotic state ZYPADHERA should not be used to treat patients with schizophrenia who are in an acutely agitated or severely psychotic state such that immediate symptom control is warranted.
Danish: Brug til patienter som er i en akut agiteret eller svært psykotisk tilstand ZYPADHERA bør ikke anvendes til behandling af patienter med skizofreni, som er i en akut agiteret eller svært psykotisk tilstand, hvor øjeblikkelig symptomkontrol er påkrævet.
English: The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/LDL/HDL cholesterol or triglycerides increased over time.
Danish: Andelen af patienter, som havde klinisk signifikante bivirkninger i form af vægtstigning, glucose, total/LDL/HDL kolesterol eller triglycerider, steg over tid.
English: A lower starting dose of olanzapine should be considered in patients who are using fluvoxamine or any other CYP1A2 inhibitors, such as ciprofloxacin.
Danish: En lavere startdosis af olanzapin bør overvejes hos de patienter, som anvender fluvoxamin eller andre CYP1A2-inhibitorer, såsom ciprofloxacin.
English: If this happens after you have been given ZYPADHERA, tell your doctor or nurse immediately.
Danish: Hvis dette sker efter du har fået ZYPADHERA, skal du omgående kontakte din læge eller sygeplejerske.
English: ZYPADHERA with alcohol
Danish: Brug af ZYPADHERA sammen med alkohol
English: Olanzapine is not indicated for use in the treatment of children and adolescents.
Danish: Olanzapin er ikke indiceret til behandling af børn og unge.
English: Attach the selected 50 mm or 38 mm safety needle to the syringe prior to injection.
Danish: Sæt den valgte 50 mm eller 38 mm sikkerhedskanyle på sprøjten forud for indsprøjtning.
English: 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.
Danish: 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.
English: General CNS activity
Danish: Almindelig CNS-aktivitet
English: Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported rarely (≥0.01% and <0.1%) when oral olanzapine is stopped abruptly.
Danish: Akutte symptomer såsom perspiration, søvnløshed, rysten, angst, kvalme eller opkastning er rapporteret sjældent (≥ 0,01 % og < 0,1 %), når oral olanzapin stoppes pludseligt.
English: • Weight gain has been seen in patients taking ZYPADHERA.
Danish: • Vægtstigning er set hos patienter, som tager ZYPADHERA.
English: Press the needle into the sheath using a one-handed technique.
Danish: Pres kanylen ind i hylsteret ved brug af en enhåndsteknik.
English: • an allergy (hypersensitivity) to olanzapine or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for olanzapin eller et af de øvrige indholdsstoffer (angivet i afsnit 6).
English: Visually check the vial for clumps.
Danish: Kontroller visuelt hætteglasset for klumper.
English: 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.
Danish: 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.
English: Remove by grasping the Luer hub of the needle protection device with thumb and forefinger, keeping the free fingers clear of the end of the device containing the needle point (Fig. 3).
Danish: Fjernes ved at gribe om Luer-spidsen på kanylebeskyttelsesudstyret med tommelfinger og pegefinger og ved at holde de frie fingre klar af udstyrsenden, som indeholder kanylespidsen (Fig. 3).
English: In clinical trials with ZYPADHERA the incidence of injection site related adverse reactions was approximately 8%.
Danish: I kliniske forsøg med ZYPADHERA var incidensen af bivirkninger relateret til injektionsstedet omkring 8 %.
English: The second, a long term study in clinically stable patients (n=1065) (baseline mean Total PANSS Score 54.33 to 57.75) who were initially treated with oral olanzapine for 4 to 8 weeks and then switched to continue on oral olanzapine or to ZYPADHERA for 24 weeks.
Danish: Det andet var et langtidsstudie med klinisk stabile patienter (n=1065) (gennemsnitlig, total PANSS var 54,33 til 57,75 ved baseline), som initialt blev behandlet med oral olanzapin i 4 til 8 uger og derpå skiftet til at fortsætte med oral olanzapin eller til ZYPADHERA i 24 uger.
English: Long-term olanzapine treatment (up to 12 months) for recurrence prevention in patients with bipolar disorder was associated with an increase of ≥7% from baseline body weight in 39.9% of patients.
Danish: Langvarig olanzapinbehandling (op til 12 måneder) som forebyggelse mod tilbagefald hos patienter med bipolar sygdom blev forbundet med en stigning på ≥7 % af legemsvægt ved baseline hos 39,9 % af patienterne.
English: Potential for olanzapine to affect other medicinal products Olanzapine may antagonise the effects of direct and indirect dopamine agonists.
Danish: Olanzapins potentielle indvirkning på andre lægemidler Olanzapin kan antagonisere effekten af direkte og indirekte dopaminagonister.
English: Carmellose sodium Mannitol
Danish: Carmellosenatrium Mannitol
English: During treatment with olanzapine in combination with lithium or divalproex, an increase of ≥ 7% from baseline body weight occurred in 17.4% of patients during acute treatment (up to 6 weeks).
Danish: Under behandling med olanzapin sammen med lithium eller valproat forekom en stigning på ≥ 7 % af legemsvægt ved baseline hos 17,4 % af patienterne ved akut behandling (op til 6 uger).
English: However, the incidence of death was higher in oral olanzapine-treated than in placebo-treated patients independent of these risk factors.
Danish: Forekomsten af dødsfald var dog højere hos oralt olanzapinbehandlede patienter end hos de patienter som blev behandlet med placebo, uafhængig af disse risikofaktorer.
English: • muscle stiffness or shaking
Danish: • Muskelstivhed eller rysten
English: • Two 19-gauge, 50 mm Hypodermic safety needles
Danish: • To 19-gauge, 50 mm Hypodermic sikkerhedskanyler
English: After insertion of the needle, aspirate for several seconds to ensure no blood appears.
Danish: Aspirer i nogle sekunder efter indføring af kanylen for at sikre, at der ikke kommer blod til syne.
English: Pharmacotherapeutic group: psycholeptics, diazepines, oxazepines, thiazepines and oxepines, ATC code N05A H03.
Danish: Farmakoterapeutisk klassifikation: Psykoleptika, diazepiner, oxazepiner, thiazepiner og oxepiner, ATC-kode: N05AH03
English: The following symptoms may occur in newborn babies, of mothers that have used ZYPAHDERA in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.
Danish: Følgende symptomer kan forekomme hos nyfødte af mødre, som har taget ZYPADHERA i sidste trimester (de sidste tre måneder af graviditeten): rystelser, muskelstivhed og/eller svaghed, søvnighed, ophidselse, vejrtrækningsbesvær og besvær med at indtage føde.
English: Date of latest renewal: 26/08/2013
Danish: Dato for første markedsføringstilladelse: 19.11.2008 Dato for seneste fornyelse: 26.08.2013
English: • a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness (the frequency of this side effect cannot be estimated from the available data).
Danish: • En kombination af feber, hurtigt åndedræt, svedtendens, muskelstivhed og sløvhed eller søvnighed (hyppigheden af denne bivirkning kan ikke estimeres ud fra tilgængelige data).
English: Withdraw air to equalize the pressure in the vial.
Danish: Træk luft ud for at udligne trykket i hætteglasset.
English: Studies in patients aged 13-17 years showed various adverse reactions, including weight gain, changes in metabolic parameters and increases in prolactin levels (see sections 4.8 and 5.1).
Danish: Studier med patienter på 13-17 år viste forskellige bivirkninger, herunder vægtøgning, ændringer i metaboliske parametre og stigninger i prolaktinniveauer (se pkt.
English: The combination of the release profile and the dosage regimen (IM injection every two or four weeks) result in sustained olanzapine plasma concentrations.
Danish: Kombinationen af frigivelsesprofilen og doseringsregimet (i. m. injektion hver anden til fjerde uge) medfører vedvarende plasmakoncentrationer af olanzapin.
English: 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 mostly CYP2D6 pathway), warfarin (CYP2C9), theophylline (CYP1A2) or diazepam (CYP3A4 and 2C19).
Danish: 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).
English: The safety and efficacy of ZYPADHERA in children and adolescents below 18 years has not been established.
Danish: ZYPADHERAs sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.