FrancophonIA/ELRC3.0 huggingface dataset:
English: Because Modigraf contains granules, it allows for making fine adjustments in dosing and provides an alternative for young children and others unable to swallow capsules.
Danish: Da Modigraf indeholder granulat, er det muligt at finjustere dosis og udgør et alternativ til mindre børn og andre, som ikke kan sluge kapsler.
English: Modigraf is used in adults and children who have had a kidney, liver or heart transplant, to prevent rejection (when the immune system attacks the transplanted organ).
Danish: Modigraf anvendes til voksne og børn, som har fået en nyre-, lever- eller hjertetransplantation, til forebyggelse af afstødning (når immunsystemet angriber det transplanterede organ).
English: The CHMP decided that Modigraf's benefits are greater than its risks for prophylaxis of transplant rejection in kidney, liver and heart recipients, and in the treatment of rejection resistant to treatment with other immunosuppressive medicinal products.
Danish: CHMP fandt, at fordelene ved Modigraf opvejer risiciene ved forebyggelse af afstødning af transplantat hos modtagere af nyre, lever eller hjerte og ved behandling af afstødning, som ikke var modtagelig for behandling med andre immunsuppressive lægemidler.
English: Modigraf is similar to another tacrolimus-containing medicine, Prograf or Prograft, which is available as capsules.
Danish: Modigraf ligner et andet lægemiddel indeholdende tacrolimus, Prograf eller Prograft, som fås i kapsler.
English: What is the risk associated with Modigraf?
Danish: Hvilken risiko er der forbundet med Modigraf?
English: Modigraf was effective at preventing organ rejection in children who had had a liver transplant.
Danish: Modigraf var effektivt til forebyggelse af organafstødning hos børn, som havde fået en levertransplantation.
English: In the prevention of rejection, the dose of Modigraf to use depends on the type of transplant the patient has received.
Danish: Når Modigraf anvendes til forebyggelse af afstødning, afhænger dosis, der skal anvendes, af den type transplantat, patienten har fået.
English: When treating rejection, the same doses may be used in kidney and liver transplants.
Danish: Til behandling af afstødning kan der anvendes samme dosis ved nyre- og levertransplantation.
English: The main measure of effectiveness in this study was based on the number of patients who did not have organ rejection.
Danish: Det primære effektmål i denne undersøgelse var antallet af patienter, som ikke havde organafstødning.
English: Tacrolimus, the active substance in Modigraf, is an immunosuppressive agent.
Danish: Det aktive stof i Modigraf, tacrolimus, er et immunsuppressivt stof.
English: The main measure of effectiveness was based on the number of patients who did not have organ rejection.
Danish: Det primære effektmål var antallet af patienter, som ikke havde organafstødning.
English: Why has Modigraf been approved?
Danish: Hvorfor blev Modigraf godkendt?
English: What is Modigraf?
Danish: Hvad er Modigraf?
English: What benefit has Modigraf shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Modigraf?
English: What is Modigraf used for?
Danish: Hvad anvendes Modigraf til?
English: How has Modigraf been studied?
Danish: Hvordan blev Modigraf undersøgt?
English: How is Modigraf used?
Danish: Hvordan anvendes Modigraf?
English: The starting daily dose for heart transplant patients is 0.075 mg/kg for adults and 0.3 mg/kg for children.
Danish: Den daglige startdosis for hjertetransplanterede patienter er 0,075 mg pr. kg kropsvægt for voksne og 0,3 mg pr. kg kropsvægt for børn.
English: For heart transplants the dose is 0.15 mg/kg/day for adults and 0.2 to 0.3 mg/kg for children.
Danish: Ved hjertetransplantation er dosis 0,15 mg pr. kg kropsvægt for voksne og 0,2 til 0,3 mg/kg for børn.
English: How does Modigraf work?
Danish: Hvordan virker Modigraf?
English: In kidney transplant patients, the starting daily dose is 0.2 to 0.3 mg per kilogram body weight for adults and 0.3 mg/kg for children.
Danish: Hos nyretransplanterede patienter er startdosis 0,2 til 0,3 mg pr. kg kropsvægt dagligt for voksne og 0,3 mg pr. kg kropsvægt for børn.
English: In liver transplant patients, the starting daily dose is 0.1 to 0.2 mg/kg for adults and 0.3 mg/kg for children.
Danish: Hos levertransplanterede patienter er startdosis 0,1 til 0,2 mg pr. kg kropsvægt dagligt for voksne og 0,3 mg pr. kg kropsvægt for børn.
English: Patients should be closely monitored during this period.
Danish: Patienter bør følges nøje i denne periode.
English: Close medical supervision and monitoring should continue until the patient recovers.
Danish: Omhyggelig medicinsk kontrol og overvågning bør fortsætte, indtil patienten kommer sig.
English: Date of latest renewal: 12 September 2006
Danish: Dato for første tilladelse: 3. februar 2000 Dato for seneste fornyelse: 12. september 2006
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af at der er nået en vigtig milepæl (lægemiddelovervågning eller risikominimering).
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 dette lægemiddel (angivet i afsnit 6).
English: In cases where dose increments of 2.5 mg are considered necessary, ZYPREXA coated tablets should be used.
Danish: I tilfælde, hvor dosisstigninger på 2,5 mg er nødvendige, bør ZYPREXA overtrukne tabletter anvendes.
English: It will dissolve directly in your mouth, so that it can be easily swallowed.
Danish: Den vil blive opløst med det samme i munden, så du let kan synke den.
English: Generally, delayed type reactions such as contact dermatitis may occur, but rarely immediate reactions with bronchospasm may occur.
Danish: Generelt kan senreaktioner, såsom kontaktdermatitis, forekomme, men akutte reaktioner med bronchospasme forekommer sjældent.
English: These preservatives are known to cause urticaria.
Danish: Disse konserveringsmidler kan medføre urticaria.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Lilly S.A., Avda.
Danish: A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE Navn og adresse på fremstilleren ansvarlig for batchfrigivelse Lilly S.A., Avda.
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 hos i den unge population sammenlignet med ældre med sammenlignelig eksponering.
English: This may occur immediately or some time after you take ZYPREXA VELOTAB.
Danish: Dette kan komme straks eller noget tid efter, at du har taget ZYPREXA VELOTAB.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede lægemiddelovervågningsaktiviteter og foranstaltninger, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende opdatering af RMP.
English: May be harmful for people with phenylketonuria.
Danish: Kan være skadelig for mennesker med phenylketonuri.
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 vægtøgning og andelen af unge patienter, som havde klinisk signifikant vægtøgning, var større end langvarig eksponering (mindst 24 uger) end ved kortvarig eksponering.
English: You should not be given this medicine when breast-feeding, as small amounts of ZYPREXA VELOTAB can pass into breast milk.
Danish: Du bør ikke få denne medicin, mens du ammer, da små mængder ZYPREXA VELOTAB kan overføres til modermælken.
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: Yellow, round, freeze dried, rapid-dispersing preparation to be placed in the mouth or alternatively to be dispersed in water or other suitable beverage for administration.
Danish: Et gult og rundt frysetørret, hurtigt dispergerende præparat, der ved administration placeres i munden eller alternativt dispergeres i vand eller anden egnet væske.
English: Weight should be monitored regularly, e.g. at baseline, 4, 8 and 12 weeks after starting olanzapine treatment and quarterly thereafter.
Danish: Vægten bør kontrolleres regelmæssigt, f.eks. ved baseline, 4, 8 og 12 uger efter start på olanzapinbehandling, og derefter kvartalsvist
English: • The use of ZYPREXA VELOTAB in elderly patients with dementia is not recommended as it may have serious side effects.
Danish: • ZYPREXA VELOTAB anbefales ikke til ældre, demente patienter, da det kan have alvorlige bivirkninger
English: Hold the blister strip at the edges and separate one blister cell from the rest of the strip by gently tearing along the perforations around it.
Danish: Hold blisterkortet i kanterne og adskil en blisterlomme fra resten af blisterkortet ved forsigtigt at rive langs perforeringen rundt om blisterlommen.
English: Hepatitis (including hepatocellular, cholestatic or mixed liver injury)11
Danish: Hepatitis (inklusive hepatocellulær, kolestatisk eller blandet leverskade) 11
English: Very common: Sedation (including: hypersomnia, lethargy, somnolence).
Danish: Meget almindelig: Sedation (inklusiv: hypersomni, letargi, døsighed).
English: You should take your ZYPREXA VELOTAB tablets once a day following the advice of your doctor.
Danish: Du bør tage ZYPREXA VELOTAB tabletter én gang dagligt efter din læges anvisning.
English: You can also place the tablet in a full glass or cup of water, orange juice, apple juice, milk or coffee, and stir.
Danish: Du kan også lægge tabletten i et glas vand, appelsinjuice, æblejuice eller mælk eller i en kop kaffe.
English: The frequency terms listed are defined as follows: Very common (≥ 1/10), common (≥ 1/100 to
Danish: Hyppighederne er defineret som følgende: Meget almindelig (≥1/10), almindelig (≥ 1/100
English: ZYPREXA VELOTAB tablets break easily, so you should handle the tablets carefully.
Danish: ZYPREXA VELOTAB tabletter knækker let, så du bør tage forsigtigt på tabletterne.
English: It is important that you carry on taking ZYPREXA VELOTAB for as long as your doctor tells you.
Danish: Det er vigtigt, at du fortsætter med at tage ZYPREXA VELOTAB, så længe din læge beder dig om det.
English: • Schizophrenia, a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.
Danish: • Skizofreni, en lidelse med symptomer såsom, at man hører, ser og mærker ting, som ikke eksisterer, mistro, ualmindelig mistænksomhed og indesluttethed.
English: Talk to your doctor or pharmacist before you take ZYPREXA VELOTAB
Danish: Kontakt lægen eller apotekspersonalet, før du tager ZYPREXA VELOTAB
English: In patients with Parkinson's disease ZYPREXA VELOTAB may worsen the symptoms.
Danish: Hos patienter med Parkinsons sygdom kan ZYPREXA VELOTAB forværre symptomerne.
English: Restless Legs
Danish: Restless legs-syndrom
English: Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
Danish: Der skal udvises forsigtighed hos patienter, som indtager alkohol eller får lægemidler, der kan undertrykke centralnervesystemet og alkohol.
English: Manufacturer Lilly S.A., Avda.
Danish: Lilly S.A., Avda.
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: • Weight gain has been seen in patients taking ZYPREXA VELOTAB.
Danish: • Vægtstigning er set hos patienter, som tager ZYPREXA VELOTAB.
English: Do not handle the tablets with wet hands as the tablets may break up.
Danish: Tag ikke på tabletterne med våde hænder, da de i så fald let vil gå i stykker.
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: Patienterne med vægtøgning på ≥7 %, ≥15 % og ≥25 % af deres baseline kropsvægt ved langvarig eksponering (mindst 48 uger) var meget almindelig (henholdsvis 64,4 %, 31,7 % og 12,3 %).
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 øget vægt.
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: 8I 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: Gently push the tablet out.
Danish: Tryk forsigtigt tabletten ud.
English: • carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - it may be necessary to change your ZYPREXA VELOTAB dose.
Danish: • Carbamazepin (mod epilepsi og stemningsforstyrrelser), fluvoxamin (mod depression) eller ciprofloxacin (mod infektion), da det kan blive nødvendigt at ændre din ZYPREXA VELOTAB
English: However, the incidence of death was higher in olanzapine-treated than in placebotreated patients independent of these risk factors.
Danish: Forekomsten af dødsfald var dog højere hos olanzapinbehandlede patienter end hos patienter, behandlet med placebo, uafhængig af disse risikofaktorer.
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).
English: Olanzapine orodispersible tablets may be used as an alternative to olanzapine coated tablets.
Danish: Olanzapin smeltetabletter kan anvendes som et alternativ til olanzapin overtrukne tabletter.
English: ZYPREXA VELOTAB orodispersible tablet should be placed in the mouth, where it will rapidly disperse in saliva, so it can be easily swallowed.
Danish: ZYPREXA VELOTAB smeltetablet bør placeres i munden, hvor den hurtigt vil dispergeres i spyttet, så den let kan synkes.
English: In preclinical studies, olanzapine exhibited a range of receptor affinities (Ki < 100 nM) for serotonin 5 HT2A/2C, 5 HT3, 5 HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors M1-M5; α1 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, kolinerge muskarine receptorer M1-M5, α1-adrenerge og histamin H1 receptorer.
English: Very common side effects (may affect more than 1 in 10 people) include weight gain; sleepiness; and increases in levels of prolactin in the blood.
Danish: Meget almindelige bivirkninger (forekommer hos flere end 1 ud af 10 patienter) omfatter vægtstigning; søvnighed og forhøjede niveauer af prolaktin i blodet.
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 data available).
Danish: 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: If this happens after you have been given ZYPREXA VELOTAB tell your doctor.
Danish: Hvis dette forekommer, når du har taget ZYPREXA VELOTAB, skal du fortælle det til lægen.
English: Reversible neutropenia, thrombocytopenia, or anaemia developed in a few dogs treated with 8 or 10 mg/kg/day (total olanzapine exposure [area under the curve] is 12- to 15-fold greater than that of a man given a 12-mg dose).
Danish: Reversibel neutropeni, trombocytopeni eller anæmi udvikledes hos enkelte hunde, som blev behandlet med 8 eller 10 mg/kg/dag (total olanzapin dosis [arealet under kurven] var 12-15 gange højere end human dosis på 12 mg).
English: The following symptoms may occur in newborn babies, of mothers that have used ZYPREXA VELOTAB 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 ZYPREXA VELOTAB i sidste trimester (de sidste tre måneder af graviditeten): rystelser, muskelstivhed og/eller svaghed, søvnighed, ophidselse, vejrtrækningsbesvær og besvær med at indtage føde.
English: In addition, a Single Photon Emission Computed Tomography (SPECT) imaging study in schizophrenic patients revealed that olanzapine-responsive patients had lower striatal D2 occupancy than some other antipsychoticand risperidone-responsive patients, while being comparable to clozapine-responsive patients.
Danish: Single Photon Emission Computed Tomography (SPECT) undersøgelse af skizofrene patienter, at olanzapinresponderende patienter havde en lavere striatal D2-binding end visse andre antipsykotikaog risperidonresponderende patienter, hvorimod det var sammenligneligt med clozapinresponderende patienter.
English: Olanzapine orodispersible tablet is bioequivalent to olanzapine coated tablets, with a similar rate and extent of absorption.
Danish: Olanzapin smeltetabletter er bioækvivalente med olanzapin overtrukne tabletter, med en lignende absorptionshastighed og grad af absorption.
English: • unusual movement (a common side effect that may affect up to 1 in 10 people) mainly of the face or tongue;
Danish: • Unormale bevægelser (en almindelig bivirkning, som forekommer hos op til 1 ud af 10 patienter) særligt i ansigtet eller tungen (grimasser).
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 receptorbindings-profilen.
English: There is a risk of feeling drowsy when you are given ZYPREXA VELOTAB.
Danish: Der er risiko for døsighed, når du får ZYPREXA VELOTAB.
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 eksponering (mindst 24 uger) tog 89,4 % ≥7 % på i vægt, 55,3 % tog ≥15 % på i vægt og 29,1% tog ≥25 % af deres baseline kropsvægt på.
English: Children and adolescents ZYPREXA VELOTAB is not for patients who are under 18 years.
Danish: ZYPREXA VELOTAB er ikke beregnet til patienter under 18 år.
English: 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 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 adfærdsforstyrrelse var der en dobbelt så høj forekomst af dødsfald hos de olanzapinbehandlede patienter i forhold til de placebobehandlede patienter (henholdsvis 3,5 % og 1,5 %).
English: • High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking ZYPREXA VELOTAB.
Danish: • Højt sukker- og fedtindhold (triglycerider og kolesterol) i blodet er set hos patienter, som tager ZYPREXA VELOTAB.
English: Lilly Portugal Produtos Farmacêuticos, Lda Tel: + 351 21 412 66 00
Danish: Portugal Lilly Portugal Produtos Farmacêuticos,Lda Tel: + 351 21 412 66 00
English: 6 In clinical trials, the incidence of Parkinsonism and dystonia in olanzapine-treated patients was numerically higher, but not statistically significantly different from placebo.
Danish: 6I kliniske forsøg var forekomsten af parkinsonisme og dystoni hos olanzapin-behandlede patienter numerisk højere men ikke statistisk signifikant forskellig fra placebo.
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: Forsøg med patienter i alderen 13 - 17 år gav forskellige bivirkninger, inklusive vægtøgning, ændringer i metaboliske parametre og stigning i prolaktinværdier (se pkt.
English: ZYPREXA VELOTAB belongs to a group of medicines called antipsychotics and is used to treat the following conditions:
Danish: ZYPREXA VELOTAB tilhører en gruppe af lægemidler, der kaldes antipsykotika.
English: Aluminium blister strips in cartons of 28, 35, 56, 70 or 98 orodispersible tablets per carton.
Danish: 6.5 Emballagetype og pakningsstørrelser Aluminium blisterkort i kartoner a 28, 35, 56, 70 eller 98 smeltetabletter pr. karton.
English: Patients treated with any antipsychotic medicines, including ZYPREXA VELOTAB, 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, der behandles med antipsykotika herunder ZYPREXA VELOTAB, bør have kontrolleret lipider regelmæssigt i henhold til de anvendte antipsykotiske vejledninger, f.eks. ved baseline og 12 uger efter start på olanzapinbehandling, og derefter hvert 5. år.
English: Each ZYPREXA VELOTAB orodispersible tablet contains either 5 mg, 10 mg, 15 mg or 20 mg of the active substance.
Danish: Hver ZYPREXA VELOTAB smeltetablet indeholder enten 5 mg, 10 mg, 15 mg eller 20 mg af det aktive stof.
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, hos patienter med knoglemarvsdepression forårsaget af samtidig sygdom, strålebehandling eller kemoterapi, og hos patienter med hypereosinofile tilstande eller myeloproliferativ sygdom.