FrancophonIA/ELRC3.0 huggingface dataset:
English: It must also not be used in patients with abnormal levels of calcium in their blood.
Danish: Daivobet må heller ikke anvendes hos patienter med unormale calciumniveauer i blodet.
English: For the full list, see the harmonised SmPC.
Danish: Den fuldstændige liste fremgår af det harmoniserede produktresumé.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Danish: På grundlag af de fremlagte oplysninger og den faglige drøftelse i udvalget var CHMP af den opfattelse, at produktresuméet, etiketteringen og indlægssedlen skulle harmoniseres inden for EU.
English: The Committee also harmonised other sections of the SmPC, including the sections on special warnings, pregnancy and lactation and undesirable effects.
Danish: Udvalget harmoniserede ligeledes andre punkter i produktresuméet, herunder punkterne om særlige advarsler, fertilitet, graviditet og amning samt bivirkninger.
English: 22 July 2010
Danish: 22. juli 2010
English: Daivobet must not be used in patients who have some types of psoriasis that is red and flaking off or filled with pus.
Danish: Daivobet må ikke anvendes hos patienter, der har visse typer psoriasis, som er rødt og skællende eller fydt med pus.
English: The CHMP agreed that Daivobet ointment is to be used for the treatment of adults with plaque psoriasis where it is possible to use a topical medicine.
Danish: CHMP vedtog, at Daivobet salve skulle bruges til behandling af voksne med plaque-psoriasis, når det er muligt at bruge et topisk lægemiddel.
English: Daivobet should not be used in patients who may be hypersensitive (allergic) to the active substances or to any other ingredient.
Danish: Daivobet bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for det aktive stof eller over for et eller flere af hjælpestofferne.
English: Daivobet is used to treat adults with psoriasis (a disease causing red, scaly patches on the skin).
Danish: Daivobet anvendes til behandling af voksne med psoriasis (en sygdom, der medfører røde, skællende pletter på huden).
English: For the gel, the recommended treatment period is four weeks for scalp psoriasis and eight weeks for non-scalp psoriasis.
Danish: For gelen er den anbefalede behandlingsperiode fire uger for psoriasis i hovedbunden og otte uger for psoriasis andre steder end i hovedbunden.
English: Calcipotriol, a substance derived from vitamin D, acts through receptors in the skin to prevent the multiplication of cells that cause the scaly patches in psoriasis.
Danish: Calcipotriol er et stof, der stammer fra D-vitamin, og som virker via receptorer i huden og hindrer den celledeling, der er årsag til de skællende pletter ved psoriasis.
English: Betamethasone is an anti-inflammatory medicine that helps to reduce the inflammation and itching that occur with psoriasis.
Danish: Betamethason er et betændelseshæmmende lægemiddel, som er med til at mindske den betændelse og kløe, der optræder i forbindelse med psoriasis.
English: Daivobet should be applied once a day on the affected areas of the skin.
Danish: Daivobet skal smøres på de berørte hudområder én gang om dagen.
English: Daivobet gel is for the treatment of psoriasis on the scalp or mild to moderate plaque psoriasis on other parts of the body.
Danish: Daivobet gel anvendes til behandling af psoriasis i hovedbunden eller mild til moderat plaque-psoriasis andre steder på kroppen.
English: 4.2 Posology and method of administration
Danish: 4.2 Dosering og indgivelsesvej
English: Company responses provided on: 16 June 2010 Opinion date:
Danish: Dato for virksomhedens svar:
English: Drink it straight away.
Danish: Drik den med det samme.
English: , increased appetite.
Danish: , øget appetit.
English: There are no adequate and well-controlled studies in pregnant women.
Danish: Der er ingen tilstrækkelige og velkontrollerede undersøgelser af gravide kvinder.
English: Place the tablet in your mouth.
Danish: Placér tabletten i din mund.
English: Tolerance developed to the CNS depression.
Danish: Der udvikledes tolerance overfor CNS depressionen.
English: With some drinks, the mixture may change colour and possibly become cloudy.
Danish: Med nogle drikkevarer kan blandingen ændre farve og måske blive uklar.
English: Increased total bilirubin
Danish: Forøget total bilirubin
English: In a study of Caucasians, Japanese, and Chinese subjects, there were no differences in the pharmacokinetic parameters among the three populations.
Danish: I en undersøgelse af kaukasiske, japanske og kinesiske individer fandtes ingen forskel i farmakokinetiske parametre i de tre populationsgrupper.
English: Restless legs syndrome
Danish: Restless legs-syndrom
English: Glucosuria Increased appetite
Danish: Glukosuri Øget appetit
English: No studies on the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget undersøgelser af virkninger på evnen til at føre motorkøretøj og betjene maskiner.
English: Alternatively, it may be dispersed in a full glass of water or other suitable beverage (orange juice, apple juice, milk or coffee) immediately before administration.
Danish: Alternativt kan den dispergeres i et helt glas vand eller anden egnet væske (appelsinjuice, æblejuice, mælk eller kaffe) umiddelbart før administration.
English: Do not handle the tablets with wet hands as the tablets may break up.
Danish: Håndter ikke tabletterne med våde hænder, da tabletterne kn knække.
English: 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 starting dose.
Danish: Når mere end én parameter, som kan føre til nedsat metabolisering, er til stede (kvinder, ældre, ikke-rygere), bør det overvejes at reducere startdosis.
English: Dyskinesia6
Danish: Dyskinesi6
English: Adolescents (ages 13 to 17 years): The pharmacokinetics of olanzapine are similar between adolescents and adults.
Danish: Unge (alder 13-17 år): Farmakokinetikken af olanzapin er den samme hos unge og voksne.
English: • medicines for Parkinson's disease.
Danish: • Medicin for Parkinsons sygdom.
English: Dose escalation, when indicated, should be conservative in such patients.
Danish: Optrapning af dosis, når indiceret, bør hos sådanne patienter foretages med forsigtighed.
English: Activated charcoal reduces the bioavailability of oral olanzapine by 50 to 60% and should be taken at least 2 hours before or after olanzapine.
Danish: Aktivt kul reducerer biotilgængeligheden af oral olanzapin med 50 til 60 % og bør tages mindst 2 timer før eller efter olanzapin.
English: In cases of moderate hepatic insufficiency (cirrhosis, Child-Pugh Class A or B), the starting dose should be 5 mg and only increased with caution.
Danish: I tilfælde af moderat leverinsufficiens (cirrhosis, Child-Pugh klasse A eller B) bør startdosis være 5 mg og bør kun øges med forsigtighed.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Very common: Sedation (including: hypersomnia, lethargy, somnolence).
Danish: Meget almindelig: Sedation (inklusive: hypersomni, letargi, somnolens).
English: Based on the results of studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
Danish: På baggrund af resultater fra undersøgelser af mus og rotter blev det konkluderet, at olanzapin ikke er karcinogent.
English: Clinically significant weight gain (≥ 7%) appears to occur more frequently in the adolescent population compared to adults with comparable exposures.
Danish: Klinisk signifikant vægtøgning (≥ 7 %) synes at forekomme hyppigst i den unge population sammenlignet med ældre med sammenlignelig eksponering.
English: In studies up to 3 months duration in mice and up to 1 year in rats and dogs, the predominant effects were CNS depression, anticholinergic effects, and peripheral haematological disorders.
Danish: I undersøgelser af op til 3 måneders varighed af mus og op til 1 års varighed af rotter og hunde var CNS depression, antikolinerge effekter og perifere hæmatologiske forstyrrelser de dominerende effekter.
English: • Periodic Safety update Reports
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
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 lægemiddelreaktion med eosinofili og systemiske symptomer (DRESS).
English: • Tell the doctor if you or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots.
Danish: • Fortæl det til lægen, hvis du eller nogen i din familie tidligere har haft blodpropper, da denne type medicin kan være forbundet med dannelse af blodpropper
English: Dystonia (including oculogyration) 11
Danish: Dystoni (inklusive okulogyration)11
English: Elevated plasma prolactin levels were reported in 47.4% of adolescent patients.
Danish: 16 Forhøjede plasmaprolaktinniveauer blev rapporteret hos 47,4 % af de unge patienter.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Graviditet og amning Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel.
English: and 98 tablets.
Danish: 98 tabletter.
English: Adults Olanzapine is indicated for the treatment of schizophrenia.
Danish: Voksne Olanzapin er indiceret til behandling af skizofreni.
English: You can also place the tablet in a full glass or cup of water, orange juice, apple juice, milk or or coffee and stir.
Danish: Du kan også placere tabletten i et helt glas vand, appelsinjuice, æblejuice, mælk eller kaffe og rør rundt.
English: • If you have been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye).
Danish: • hvis du tidligere har fået at vide, at du har en bestemt slags glaukom (grøn stær) med øget tryk i øjet.
English: In two of two placebo and two of three comparator controlled trials with over 2,900 schizophrenic patients presenting with both positive and negative symptoms, olanzapine was associated with statistically significantly greater improvements in negative as well as positive symptoms.
Danish: I 2 ud af 2 placebo- og 2 ud af 3 komparatorkontrollerede undersøgelser af mere end 2.900 skizofrene patienter med både positive og negative symptomer blev olanzapin forbundet med statistisk signifikante større forbedringer af negative såvel som af positive symptomer.
English: However, olanzapine (5-20 mg) demonstrated a comparable safety profile in female (n = 467) as in male patients (n = 869).
Danish: Olanzapin (5-20 mg) udviste imidlertid en sammenlignelig sikkerhedsprofil hos kvindelige (n=467) som hos mandlige patienter (n=869).
English: The recommended starting dose is 10 mg/day.
Danish: Den anbefalede startdosis er 10 mg/dag.
English: Photosensitivity reaction Alopecia
Danish: Lysfølsomhedsreaktion Alopeci
English: Hypromellose Hydroxypropylcellulose Macrogol 8000
Danish: Tabletovertræk Hypromellose Hydroxypropylcellulose Macrogol 8000
English: Children and adolescents Olanzapine Apotex is not for patients who are under 18 years.
Danish: Børn og unge Olanzapin Apotex er ikke beregnet til patienter under 18 år.
English: In patients with Parkinson's disease Olanzapine Apotex may worsen the symptoms.
Danish: Hos patienter med Parkinsons sygdom kan Olanzapin Apotex forværre symptomerne.
English: Clinically significant weight gain was observed across all baseline Body Mass Index (BMI) categories.
Danish: Klinisk signifikant vægtøgning blev observeret på tværs af alle baseline bodymassindex (BMI) kategorier.
English: Consider referral to a dietician or help with a diet plan if necessary.
Danish: Henvisning til en diætist eller hjælp med at lægge en kostplan bør om nødvendigt overvejes.
English: The mean increase in olanzapine Cmax following fluvoxamine was 54 % in female non-smokers and 77 % in male smokers.
Danish: Den gennemsnitlige øgning af olanzapin Cmax efter fluvoxamin var 54 % hos kvindelige ikke-rygere og 77 % hos mandlige rygere.
English: Olanzapine
Danish: Olanzapin
English: Removal of the intact orodispersible tablet from the mouth is difficult.
Danish: Det er svært at fjerne den intakte smeltetablet fra munden igen.
English: Pharmacotherapeutic group: psycholeptics, diazepines, oxazepines, thiazepines and oxepines, ATC code N05A H03.
Danish: Farmakoterapeutisk klassifikation: Psykoleptika, diazepiner, oxazepiner, thiazepiner og oxepiner, ATC-kode: N05A H03
English: Do not use epinephrine, dopamine, or other sympathomimetic agents with beta-agonist activity since beta stimulation may worsen hypotension.
Danish: Brug ikke adrenalin, dopamin eller andre sympatomimetiske midler med beta-agonist aktivitet, da beta-stimulation kan forværre hypotension.
English: The frequency terms listed are defined as follows: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: You should not be given this medicine when breast-feeding, as small amounts of OlanzapineApotex can pass into breast milk
Danish: Du bør ikke få denne medicin, mens du ammer, da små mængder Olanzapin Apotex kan overføres til modermælken.
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 9-12 måneders behandling, aftog hyppigheden i stigning af middelblodglucose efter ca. 4-6 måneder.
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 forhåndenværende data).
English: Olanzapine Apotex tablets break easily, so you should handle the tablets carefully.
Danish: Olanzapin Apotex tabletter knækker let, så du bør håndtere tabletterne forsigtigt.
English: In a study in breast-feeding, healthy women, olanzapine was excreted in breast milk.
Danish: I en undersøgelse af raske, ammende kvinder blev olanzapin udskilt i modermælken.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe er bivirkningerne opført efter faldende grad af alvorlighed.
English: Risk factors that may predispose this patient population to increased mortality include age > 65 years, dysphagia, sedation, malnutrition and dehydration, pulmonary conditions (e.g., pneumonia, with or without aspiration), or concomitant use of benzodiazepines.
Danish: Risikofaktorer, som kan prædisponere denne patientpopulation til øget mortalitet, inkluderer alder > 65 år, dysfagi, sedation, fejlernæring og dehydrering, pulmonale tilstande (f.eks. pneumoni, med eller uden aspiration) eller samtidig brug af benzodiazepiner.
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 in blood tests and an increase in a type of white blood cell (eosinophilia).
Danish: DRESS forekommer indledningsvis som influenzalignende symptomer med et udslæt i ansigtet og derefter med et udstrakt udslæt, høj temperatur, forstørrede lymfekirtler, øgede niveauer af leverenzymer, der ses i blodprøver, og en øgning i en type af hvide blodlegemer (eosinofili).
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 hændelser i relation til olanzapinbehandling.
English: Olanzapine does not inhibit the main CYP450 isoenzymes in vitro (e.g. 1A2, 2D6, 2C9, 2C19, 3A4).
Danish: Olanzapin inhiberer ikke de vigtigste CYP450 isoenzymer in vitro (f.eks. 1A2, 2D6, 2C9, 2C19, 3A4).
English: Caution should be used if olanzapine is being administered concomitantly with medicinal products known to increase QTc interval (see section 4.4).
Danish: Der skal udvises forsigtighed, hvis olanzapin administreres samtidig med lægemidler, som øger QTc-intervallet (se pkt.
English: Estrous cycles were affected at doses of 1.1 mg/kg (3 times the maximum human dose) and reproduction parameters were influenced in rats given 3 mg/kg (9 times the maximum human dose).
Danish: Østralperioder blev påvirket ved doser på 1,1 mg/kg (3 gange maksimal human dosis), og reproduktionsparametre påvirkedes hos rotter, der fik 3 mg/kg (9 gange maksimal human dosis).
English: • If you are allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk (overfølsom) over for olanzapin eller et af de øvrige indholdsstoffer i Olanzapin Apotex (angivet i punkt 6).
English: If you notice any of these symptoms seek medical advice immediately;
Danish: Hvis du bemærker nogle af disse symptomer, skal du omgående søge læge.
English: • The use of Olanzapine Apotex in elderly patients with dementia is not recommended as it may have serious side effects.
Danish: • Olanzapin Apotex anbefales ikke til ældre, demente patienter, da det kan have alvorlige bivirkninger
English: Parkinsonism
Danish: Parkinsonisme
English: Mean infant exposure (mg/kg) at steady state was estimated to be 1.8% of the maternal olanzapine dose (mg/kg).
Danish: Den gennemsnitlige dosis, som barnet blev udsat for (mg/kg), blev ved steady state bestemt til at være 1,8 % af moderens olanzapindosis (mg/kg).
English: Since the orodispersible tablet is fragile, it should be taken immediately on opening the blister.
Danish: Da smeltetabletten er skrøbelig, bør den tages umiddelbart efter, at den er trykket ud af blisterkortet.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på kartonen og blisterpakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
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 kortvatige kliniske forsøg med unge patienter.
English: Metabolism and nutrition disorders Very common: Weight gain13, elevated triglyceride levels14, increased appetite.
Danish: Metabolisme og ernæring Meget almindelig: Øget vægt13, forhøjede triglyceridniveauer14, øget appetit.
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) forebyggende mod tilbagefald hos patienter med bipolær sygdom blev forbundet med en stigning på ≥ 7 % af baseline legemsvægt hos 39,9 % af patienterne.
English: Olanzapine Apotex orodispersible tablet should be placed in the mouth, where it will rapidly disperse in saliva, so it can be easily swallowed.
Danish: Olanzapin Apotex smeltetablet bør placeres i munden, hvor den hurtigt vil dispergeres i spyttet, så den let kan synkes.
English: All olanzapine- and placebo-treated patients who experienced a cerebrovascular event had preexisting risk factors.
Danish: Alle de olanzapin- og placebobehandlede patienter,som oplevede en cerebrovaskulær hændelse, havde præeksisterende risikofaktorer.
English: This leaflet was last revised in {month XXXX}.
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}.
English: Preventing recurrence in bipolar disorder:
Danish: Forebyggelse af tilbagefald i bipolær lidelse.
English: You should swallow the Olanzapine Apotex tablets whole with water.
Danish: Du bør synke Olanzapin Apotex tabletterne hele med vand.
English: 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: 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 baseline-prolaktinværdi.
English: The concomitant administration of activated charcoal was shown to reduce the oral bioavailability of olanzapine by 50 to 60%.
Danish: Samtidig administration af aktivt kul har vist at nedsætte den perorale biotilgængelighed af olanzapin med 50-60 %.
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 undersøgelser en lav forekomst af dertil relaterede hændelser.
English: Metabolism and nutrition disorders Very common: Weight gain
Danish: Metabolisme og ernæring Meget almindelig: Øget vægt
English: In these trials, patients were initially required to be stable on the lowest effective dose of anti- Parkinsonian medicinal products (dopamine agonist) and to remain on the same antiParkinsonian medicinal products and dosages throughout the study.
Danish: I disse forsøg skulle patienterne initialt være stabiliserede på den lavest effektive dosis af antiparkinsonbehandling (dopaminagonist) og skulle forblive på den samme antiparkinsonbehandling og dosering under hele forsøget.
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 undersøgelser af op til 1 års varighed var olanzapin forbundet med en statistisk lavere forekomst af behandlingsrelateret dyskinesi.
English: In clinical studies, the average olanzapine exposure was approximately 27% higher in adolescents.
Danish: Den gennemsnitlige eksponering med olanzapin var i kliniske forsøg ca. 27 % højere hos unge.
English: • carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - it may be necessary to change your Olanzapine Apotex dose.
Danish: • Carbamazepin (mod epilepsi og stemningsforstyrrelser), fluvoxamin (mod depression) eller ciprofloxacin (mod infektion), da det kan blive nødvendigt at ændre din Olanzapin Apotex-dosis
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 baseline legemsvægt hos 17,4 % af patienterne ved akut behandling (op til 6 uger).