FrancophonIA/ELRC3.0 huggingface dataset:
English: Invirase must not be used in patients who have severe problems with their liver, QT prolongation (an alteration of the electrical activity of the heart), abnormal levels of electrolytes in the blood (especially low potassium levels), bradycardia (slow heart rate) or heart failure (when the heart does not work as well as it should).
Danish: Invirase må ikke anvendes til patienter, som har svære leverproblemer, QT-forlængelse (en ændring af den elektriske aktivitet i hjertet), ændrede elektrolytmængder i blodet (især for lavt indhold af kalium i blodet), bradykardi (langsom hjerterytme) eller hjerteinsufficiens (når hjertet ikke fungerer så godt, som det skulle).
English: Invirase should only be used in combination with ritonavir (another antiviral medicine) and other antiviral medicines.
Danish: Invirase bør kun anvendes i kombination med ritonavir (et andet antiviralt lægemiddel) og andre antivirale lægemidler.
English: The active substance in Invirase, saquinavir, is a ‘protease inhibitor'.
Danish: Det aktive stof i Invirase, saquinavir, er en "proteasehæmmer".
English: The medicines were given in combination with ritonavir and two other HIV medicines.
Danish: Lægemidlerne blev anvendt i kombination med ritonavir og to andre HIVlægemidler.
English: The most common side effects when taking Invirase in combination with ritonavir (which may affect more than 1 patient in 10) are diarrhoea, nausea (feeling sick), increased levels of liver enzymes, cholesterol and triglycerides (a type of fat) in the blood, and decreased levels of platelets in the blood (components that help blood to clot).
Danish: De hyppigste bivirkninger ved Invirase i kombination med ritonavir (som kan forekomme hos mere end 1 ud af 10 patienter) er diarré, kvalme, forhøjede leverenzymer, kolesterol og triglycerider (en type fedtstoffer) i blodet og nedsat antal blodplader (som medvirker til blodets størkning).
English: In the first four studies, Invirase in combination with other HIV medicines, but without ritonavir, reduced the viral load and improved the immune system.
Danish: I de første fire studier reducerede Invirase i kombination med andre HIV-lægemidler (men uden ritonavir) virusbelastningen og forbedrede immunsystemet.
English: For patients already taking HIV medicines, the recommended dose of Invirase is 1,000 mg with 100 mg ritonavir twice daily.
Danish: For patienter, der i forvejen tager HIVmedicin, er den anbefalede dosis Invirase 1.000 mg med 100 mg ritonavir to gange dagligt.
English: What benefits of Invirase have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Invirase?
English: How is Invirase used?
Danish: Hvordan anvendes Invirase?
English: Invirase, taken in combination with other HIV medicines, reduces the viral load (the amount of HIV in the blood) and keeps it at a low level.
Danish: Når Invirase anvendes i kombination med andre HIV-lægemidler, mindsker det virusbelastningen (mængden af HIV i blodet) og holder den nede.
English: • midazolam taken by mouth, triazolam (used to relieve anxiety or difficulty sleeping);
Danish: • midazolam taget oralt, triazolam (mod angst eller søvnbesvær)
English: For patients who are not taking HIV medicines, Invirase is started at 500 mg twice daily with ritonavir 100 mg twice daily for the first 7 days of treatment, given in combination with other HIV medicines.
Danish: Patienter, der ikke får HIV-lægemidler, begynder med Invirase 500 mg to gange dagligt med ritonavir 100 mg to gange dagligt i de første 7 dages behandling, i kombination med andre HIV-lægemidler.
English: After 7 days, the recommended dose of Invirase is 1,000 mg twice daily with ritonavir 100 mg twice daily in combination with other HIV medicines.
Danish: Efter 7 dage er den anbefalede dosis af Invirase 1.000 mg to gange dagligt sammen med 100 mg ritonavir to gange dagligt i kombination med andre HIV-lægemidler.
English: Invirase is an antiviral medicine used to treat adults infected with the human immunodeficiency virus type 1 (HIV 1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Invirase er et lægemiddel mod virus og anvendes til behandling af voksne, som er smittet med HIV 1 (humant immundefektvirus type 1).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Invirase have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Invirase.
English: For the full list of side effects of Invirase, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Invirase fremgår af indlægssedlen.
English: • simvastatin, lovastatin (used to lower cholesterol);
Danish: • simvastatin og lovastatin (kolesterolsænkende midler)
English: How does Invirase work?
Danish: Hvordan virker Invirase?
English: Main outcomes of this study are presented in this table:
Danish: De vigtigste resultater fra dette studie vises i denne tabel:
English: Absolute bioavailability is estimated to be approximately 100%.
Danish: Den absolutte biotilgængelighed skønnes at være omkring 100 %.
English: Do not try to drive.
Danish: De må ikke selv prøve at køre.
English: You should not stop your treatment without discussing this with your doctor.
Danish: De må ikke standse Deres behandling uden at drøfte det med Deres læge.
English: The frequencies are arranged according to the following scheme:
Danish: Hyppighederne er ordnet efter følgende skema:
English: Date of first authorisation: 31 March 2016
Danish: Dato for første markedsføringstilladelse: 31. marts 2016
English: Children and adolescents Talk to your doctor about the following risks:
Danish: Børn og unge Tal med lægen om følgende risici:
English: You may become sleepy and could lose consciousness.
Danish: De bliver måske søvnig eller mister bevidstheden.
English: Steady state was achieved within 13 days.
Danish: Ligevægt blev opnået i løbet af 13 dage.
English: IF ANY OF THE FOLLOWING OCCUR, THE CHILD NEEDS URGENT MEDICAL ATTENTION:
Danish: HVIS EN AF FØLGENDE SITUATIONER OPSTÅR, SKAL BARNET OMGÅENDE HAVE LÆGEHJÆLP:
English: They occur during the first month of treatment and usually decrease with continued treatment.
Danish: De forekommer i løbet af den første behandlingsmåned og bliver sædvanligvis mindre ved fortsat behandling.
English: PC: SN:
Danish: PC: SN: NN:
English: Note: * All doses are once daily.
Danish: Bemærk: * Alle doser er én gang dagligt.
English: In addition there has been extensive post-marketing experience with zonisamide in Japan since 1989 and in the USA since 2000.
Danish: Yderligere er der indhøstet omfattende erfaringer efter markedsføringen af zonisamid i Japan fra 1989 og i USA fra 2000.
English: PP = Per Protocol Population; ITT = Intent To Treat Population *Primary endpoint
Danish: PP = pr. protokol-population, ITT = Intent To Treat-population *Primært endepunkt
English: There is inadequate information to assess the relationship, if any, between dose and duration of treatment and these events.
Danish: Der findes ikke tilstrækkelig information til at vurdere sammenhængen, hvis der er nogen, mellem dosis og behandlingsvarigheden og disse hændelser.
English: Most reports occurred during periods of warm weather.
Danish: De fleste tilfælde forekom i perioder med varmt vejr.
English: - if you are allergic to other sulfonamide medicines.
Danish: • hvis De er allergisk over for andre sulfonamid-lægemidler.
English: The effects at this dose level were reversible during the recovery period.
Danish: Virkningerne på dette dosisniveau var reversible i perioden med bedring.
English: Tell your doctor as this may need to be monitored.
Danish: Oplys dette til Deres læge, da det kan være nødvendigt at kontrollere det.
English: The dose should be titrated on the basis of clinical effect.
Danish: Dosis skal titreres på basis af klinisk virkning.
English: Subjects who were seizure-free for 26 weeks at a target dose level continued on this dose for another 26 weeks.
Danish: Personer, som ikke havde anfald i 26 uger på et måldosisniveau, fortsatte med denne dosis i endnu 26 uger.
English: The duration of low bicarbonate measurements was also long (median 188 days).
Danish: De lave hydrogencarbonatmålinger varede også længe (median 188 dage).
English: very rare not known cannot be estimated from the available data
Danish: Meget sjælden < 1/10.000 Ikke kendt kan ikke estimeres ud fra forhåndenværende data
English: Additional information on special populations
Danish: Yderligere information om specielle populationer:
English: The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for zonisamide.
Danish: Mekanismen for denne risiko er ikke kendt, og de tilgængelige data udelukker ikke muligheden for en øget risiko ved zonisamid.
English: All these effects and specifically weight loss may have deleterious implications for growth and development, and may lead to general deterioration of health.
Danish: Alle disse bivirkninger og specifikt vægttabet kan have skadelige konsekvenser for vækst og udvikling og kan medføre generel forringelse af helbredstilstanden.
English: • Body weight: You should monitor your child's weight every month and see your doctor as soon as possible if your child is not gaining enough weight.
Danish: • Legemsvægt: De skal kontrollere barnets vægt hver måned og kontakte lægens snarest muligt, hvis barnet ikke tager tilstrækkelig på.
English: The first-pass metabolism is believed to be negligible.
Danish: First-pass metabolismen menes at være negligeabel.
English: very common ≥ 1/10 common
Danish: Meget almindelig ≥ 1/10 Almindelig
English: General supportive care is indicated, including frequent monitoring of vital signs and close observation.
Danish: Almindelig understøttende behandling er indiceret herunder hyppig kontrol af vitale funktioner og tæt observation.
English: Your doctor may need to monitor or treat this.
Danish: Lægen skal eventuelt kontrollere eller behandle dette.
English: Read the package leaflet before use Oral use
Danish: Læs indlægssedlen inden brug Oral anvendelse
English: An updated RMP should be submitted:
Danish: En opdateret RMP skal fremsendes
English: - are pregnant or could become pregnant (see section ‘pregnancy, breast-feeding and fertility' for further information).
Danish: • De er gravid eller kan blive gravid (se punktet ”Graviditet, amning og frugtbarhed” for at få yderligere oplysninger).
English: Note: a. To ensure a therapeutic dose is maintained the weight of a child should be monitored and the dose reviewed as weight changes occur up to a weight of 55 kg.
Danish: Bemærk: a. For at sikre opretholdelse af en terapeutisk dosis skal barnets vægt monitoreres og dosis justeres i henhold til ændringer i vægten op til en vægt på 55 kg.
English: Sulfonamide reactions
Danish: Sulfonamidreaktioner
English: Some patients may respond to lower doses.
Danish: Nogle patienter kan respondere på lavere doser.
English: Zonisamide was not genotoxic and has no carcinogenic potential.
Danish: Zonisamid var ikke genotoksisk og har intet carcinogent potentiale.
English: If at any time you have these thoughts, immediately contact your doctor.
Danish: Hvis du på noget tidspunkt har sådanne tanker, skal du straks søge læge.
English: The incidence of marked decreases in weight of 20% or more was 0.7%.
Danish: Hyppigheden af markant vægttab på 20 % eller mere var 0,7 %.
English: Erythrocyte/plasma ratios are about 15 at low concentrations and about 3 at higher concentrations.
Danish: Erytrocyt/plasma ratio er omkring 15 ved lave koncentrationer og omkring 3 ved højere koncentrationer.
English: System Organ Class (MedDRA terminology)
Danish: Systemorganklasser (MedDRA terminologi)
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: Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge til råds, før De tager dette lægemiddel.
English: Symptoms may occur within hours to weeks of initiating therapy.
Danish: Symptomerne kan opstå inden for få timer eller i ugerne efter behandlingens start.
English: Usual Maintenance Dose
Danish: Sædvanlig vedligeholdelsesdosis
English: At this higher dose level, juvenile rats showed a decrease in growth, learning, and developmental parameters.
Danish: På dette højere dosisniveau var der hos unge rotter et fald i vækst, indlæring og udviklingsparametre.
English: Special patient groups
Danish: Specielle patientgrupper
English: The risk of birth defect is increased by factor 2 to 3 in the offspring of mothers treated with an antiepileptic medicinal product.
Danish: Risikoen for medfødt misdannelse øges med en faktor 2 til 3 for børn af mødre, der er behandlet med et antiepileptikum.
English: Some patients, especially those not taking CYP3A4-inducing agents, may respond to lower doses.
Danish: Nogle patienter, især dem der ikke tager CYP3A4-induktorer, kan respondere på lavere doser.
English: Be especially careful while driving or operating machinery if Zonisamide Mylan affects you in this way.
Danish: Vær særlig forsigtig, når De kører bil eller betjener maskiner, hvis Zonisamide Mylan påvirker Dem på denne måde.
English: Zonisamide Mylan may affect your concentration, ability to react/respond, and may make you feel sleepy, particularly at the beginning of your treatment or after your dose is increased.
Danish: Zonisamide Mylan kan påvirke Deres koncentration og Deres evne til at reagere/respondere og kan få Dem til at blive søvnig, især i begyndelsen af behandlingen eller efter, at Deres dosis er øget.
English: No clinically significant differences were observed in the pharmacokinetics between young (aged 21-40 years) and elderly (65-75 years).
Danish: Ældre: Der blev ikke observeret klinisk signifikante forskelle i farmakokinetikken mellem unge (i alderen 21 - 40 år) og ældre (65 - 75 år).
English: Generally, zonisamide-induced metabolic acidosis occurs early in treatment although cases can occur at any time during treatment.
Danish: Almindeligvis forekommer zonisamid-induceret metabolisk acidose tidligt i behandlingen, selv om der kan forekomme tilfælde på et hvilket som helst tidspunkt under behandlingen.
English: Suicide ideation and behaviour
Danish: Suicidale tanker og adfærd
English: - Do not take a double dose to make up for a forgotten dose.
Danish: • De må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Therefore, patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.
Danish: Patienterne bør derfor kontrolleres for tegn på suicidale tanker og adfærd, og passende behandling bør overvejes.
English: In some cases, the overdoses were asymptomatic, particularly where emesis or lavage was prompt.
Danish: I nogle tilfælde var overdoseringen asymptomatisk, specielt hvor opkastning og ventrikelskylning skete omgående.
English: You must only take Zonisamide Mylan during your pregnancy if your doctor tells you to. Research has shown an increased risk of birth defects in children of women taking anti-epileptic medicines.
Danish: De må kun tage Zonisamide Mylan under Deres graviditet, hvis Deres læge siger, at De skal gøre det. Forskning har vist en øget risiko for medfødte misdannelser hos børn af kvinder, der tager medicin mod epilepsi.
English: Do not give this medicine to children below the age of 6 years because it is not known for this age group whether the potential benefits are greater than the risks.
Danish: Giv ikke denne medicin til børn på under 6 år, da det ikke vides, om de mulige fordele opvejer risiciene i denne aldersgruppe.
English: Make sure you are fully informed about the risks and the benefits of using zonisamide for epilepsy during pregnancy.
Danish: Sørg for, at De har fået alle oplysninger om risici og fordele ved brug af zonisamid mod epilepsi under graviditet.
English: There are limited data from clinical studies in patients with a body weight of less than 20 kg.
Danish: Der findes kun begrænsede data fra kliniske studier hos patienter med legemsvægt under 20 kg.
English: Zonisamide exposure increases with time until steady state is achieved by approximately 8 weeks.
Danish: Eksponeringen for zonisamid øges med tiden, indtil steady state nås efter ca. 8 uger.
English: Example: A child who weighs 25 kg should take 25 mg once a day for the first week, and then increase the daily dose by 25 mg at the start of each week until a daily dose between 150 to 200 mg is reached.
Danish: Eksempel: Et barn, som vejer 25 kg, skal tage 25 mg én gang dagligt den første uge og derefter øge den daglige dosis med 25 mg i starten af hver uge, indtil der nås en daglig dosis på mellem 150 og 200 mg.
English: In addition, patients taking other medications associated with nephrolithiasis may be at increased risk.
Danish: Derudover kan patienter, der tager andre lægemidler associeret med nephrolithiasis, have en øget risiko.
English: It is not always possible to precisely achieve the calculated dose with the commercially available capsule strengths of zonisamide.
Danish: Det er ikke altid muligt præcist at opnå den beregnede dosis med de kommercielt tilgængelige kapselstyrker af zonisamid.
English: Parent drug and SMAP can additionally be glucuronidated.
Danish: Moderstof og SMAP kan yderligere blive glukoronideret.
English: - If you take Zonisamide Mylan twice a day, take half the daily dose in the morning and half in the evening.
Danish: • Hvis De tager Zonisamide Mylan to gange dagligt, skal De tage den ene halvdel af den daglige dosis om morgenen og den anden halvdel om aftenen.
English: 2D barcode carrying the unique identifier included
Danish: 2D-stregkode med det unikke id
English: At a higher dose level (2-3-fold systemic exposure compared to therapeutic exposure) renal histopathological effects were more severe and only partially reversible.
Danish: Ved et højere dosisniveau (systemisk eksponering på 2 - 3 gange i forhold til den terapeutiske eksponering) var de renale histopatologiske virkninger alvorligere og kun delvist reversible.
English: When a child is taking zonisamide:
Danish: Når et barn tager zonisamid:
English: Cognitive impairment in patients affected by epilepsy has been associated with the underlying pathology and/or the administration of anti-epileptic treatment.
Danish: Kognitiv svækkelse hos patienter med epilepsi har været forbundet med den underliggende patologi og/eller administration af antiepileptika.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Kravene til indsendelse af PSUR'er for dette lægemiddel fremgår af EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og alle efterfølgende opdateringer og offentliggjort på den europæiske webportal for lægemidler.
English: There have been cases of accidental and intentional overdose in adult and paediatric patients.
Danish: Der har været tilfælde med utilsigtet og forsætlig overdosering hos voksne og pædiatriske patienter.
English: No studies on the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke udført studier af virkningen på evnen til at føre motorkøretøj eller betjene maskiner.
English: Heat stroke requiring hospital treatment was diagnosed in some cases.
Danish: Hedeslag, der krævede hospitalsbehandling, blev diagnosticeret i visse tilfælde.
English: Zonisamide has been administered to over 1,200 patients in clinical studies, more than 400 of whom received zonisamide for at least 1 year.
Danish: Zonisamid er givet til 1.200 patienter i kliniske studier, hvoraf mere end 400 fik zonisamid i mindst 1 år.
English: Zonisamide Mylan is not recommended for children who are underweight or have a small appetite, and should be used with caution in those below 20 kg.
Danish: Zonisamide Mylan frarådes til børn, som er undervægtige eller har lille appetit, og skal bruges med forsigtighed til børn, som vejer under 20 kg.
English: If you feel that the effect of Zonisamide Mylan is too strong or too weak, talk to your doctor or pharmacist.
Danish: Hvis De mener, at virkningen af Zonisamide Mylan er for kraftig eller for svag, bør De tale med Deres læge eller apotek herom.
English: • Risk Management Plan (RMP)
Danish: • Risikostyringsplan
English: In addition there have been isolated cases of Sudden Unexplained Death in Epilepsy Patients (SUDEP) receiving zonisamide.
Danish: Desuden har der været isolerede tilfælde af pludselig uventet død hos epilepsipatienter (SUDEP), der har fået zonisamid.
English: Pharmacotherapeutic group: Antiepileptics, other antiepileptics, ATC code: N03AX15
Danish: Farmakoterapeutisk klassifikation: Antiepileptika, andre antiepileptika, ATC-kode: N03AX15
English: The apparent volume of distribution is about 1.1 - 1.7 l/kg in adults indicating that zonisamide is extensively distributed to tissues.
Danish: Det åbenbare fordelingsvolumen er omkring 1,1 - 1,7 l/kg hos voksne tydende på, at zonisamid i udstrakt grad fordeles til vævene.
English: A pooled analysis of safety data on 95 elderly subjects has shown a relatively higher reporting frequency of oedema peripheral and pruritus compared to the adult population.
Danish: En samlet analyse af sikkerhedsdata for 95 ældre personer har vist en relativt højere rapporteringshyppighed af perifert ødem og pruritus sammenlignet med den voksne population.
English: Patients of weight > 55 kg
Danish: Patienter, der vejer > 55 kg
English: Anhidrosis Erythema multiforme Stevens-Johnson syndrome
Danish: Erythema multiforme Stevens-Johnsons syndrom
English: Subjects were randomised to carbamazepine and zonisamide received treatment for a duration of up to 24 months depending on response.
Danish: Personerne blev randomiseret til carbamazepin eller zonisamid og fik behandling i op til 24 måneder afhængigt af respons.
English: The dose may be increased more slowly if you experience side effects, are elderly or if you suffer from kidney or liver problems.
Danish: Dosis kan øges langsommere, hvis De får bivirkninger, er ældre, eller hvis De har nyre- eller leverproblemer.
English: Fluctuation in serum or plasma concentrations over a dosing interval is low (< 30%).
Danish: Svingninger i serum- eller plasmakoncentrationer i løbet af et dosisinterval er små (< 30 %).
English: A study showed that babies born to mothers using zonisamide during pregnancy were smaller than expected for their age at birth, compared with babies born to mothers treated with lamotrigine monotherapy.
Danish: En undersøgelse har vist, at spædbørn, der er født af mødre, som har brugt zonisamid under graviditeten, var mindre end forventet for alderen ved fødslen sammenlignet med mødre, der kun blev behandlet med lamotrigin.
English: - Zonisamide Mylan can be taken once or twice daily, as instructed by your doctor.
Danish: • Zonisamide Mylan kan tages én eller to gange dagligt efter lægens anvisning.
English: When comparing the same dose level, subjects of higher total body weight appear to have lower steady-state serum concentrations, but this effect appears to be relatively modest.
Danish: Ved sammenligning af samme dosisniveau synes patienter med højere total legemsvægt af have lavere serumkoncentrationer ved steady-state, men denne virkning synes at være forholdsvis beskeden.
English: Symptoms include acute onset of decreased visual acuity and/or ocular pain.
Danish: Symptomer omfatter akut forringelse af synsstyrken og/eller smerter i øjet.
English: Rifampicin is a potent CYP3A4 inducer.
Danish: Rifampicin er et potent CYP3A4-inducerende stof.