FrancophonIA/ELRC3.0 huggingface dataset:
English: ANNEX II A MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BILAG II A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: Therefore Eurartesim must not be used in the 1st trimester of pregnancy if your doctor can give you an alternative medicine.
Danish: Eurartesim må derfor ikke anvendes i graviditetens 1. trimester, hvis din læge kan give dig en alternativ medicin.
English: The elimination half-life of artenimol is approximately 1 hour.
Danish: Halveringstiden for elimination af artenimol er ca. 1 time.
English: Risk factors may include young age (children under 5 years old) and previous treatment with IV artesunate.
Danish: Risikofaktorer kan indbefatte lav alder (børn under 5 år) og tidligere behandling med i.v.-artesunat.
English: The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe or use Eurartesim are provided with a healthcare profession educational pack containing the following:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle læger, som forventes at ordinere eller anvende Eurartesim, får udleveret en uddannelsespakke til sundhedspersonale, der indeholder følgende:
English: • is in the 1st trimester of pregnancy or breastfeeding (see below);
Danish: • er i graviditetens 1. trimester eller ammer (se nedenfor),
English: For patients unable to swallow the tablets, such as infants and young children, Eurartesim may be crushed and mixed with water.
Danish: For patienter, der ikke er i stand til at sluge tabletterne, såsom spædbørn og små børn, kan Eurartesim knuses og blandes med vand.
English: If a dose is missed, it should be taken as soon as realised and then the recommended regimen continued until the full course of treatment has been completed.
Danish: Hvis en dosis springes over, skal denne tages så snart det opdages, og den anbefalede behandling skal fortsætte indtil hele behandlingsforløbet er gennemført.
English: The results for the primary endpoint in the modified intent to treat (m-ITT) populations (defined as all randomised patients who received at least one dose of the study treatment, with the exclusion of those patients lost to follow up for unknown reasons) were as follows:
Danish: Resultaterne for det primære endepunkt i de modificerede intent to treat (m-ITT)populationer (defineret som alle randomiserede patienter, som fik mindst en dosis , med eksklusion af de patienter, der blev tabt for opfølgning af ukendte årsager) var følgende:
English: The elimination half-life of piperaquine is around 22 days for adult patients and around 20 days for paediatric patients.
Danish: Halveringstiden for elimination for piperaquin er omkring 22 dage for voksne patienter, og omkring 20 dage for pædiatriske patienter.
English: In each case the results confirmed that Eurartesim was not inferior to the comparator medicinal product.
Danish: I hvert tilfælde bekræftede resultaterne, at Eurartesim ikke var ringere end komparator-lægemidlet.
English: You should not breast-feed your baby while taking this medicine because the medicine may pass through breast milk to your baby.
Danish: Du bør ikke amme dit barn mens du tager denne medicin, da medicinen kan overføres til dit barn via brystmælken.
English: You should take the Eurartesim tablets with water only.
Danish: Du bør kun tage Eurartesim tabletter sammen med vand.
English: The ADRs noted for Eurartesim were generally mild in severity, and the majority were non-serious.
Danish: De registrerede bivirkninger for Eurartesim var generelt milde i alvorlighedsgrad, og hovedparten var ikke alvorlige.
English: Total number of tablets for treatment
Danish: Totalt antal tabletter til behandling
English: Some medicines can affect the way Eurartesim works and your doctor may decide that Eurartesim is not suitable or that extra checks are needed while you or your child is taking the medicines which could cause possible interactions.
Danish: Nogle former for medicin kan påvirke den måde, Eurartesim virker på, og din læge kan beslutte, at Eurartesim ikke er hensigtsmæssigt, eller at yderligere kontroller er nødvendige, mens du eller dit barn tager medicin, som kan give mulige interaktioner.
English: There is no data on a second course of treatment.
Danish: Der foreligger ingen data om et yderligere behandlingsforløb.
English: In both studies, the true treatment failure rate was below the 5% efficacy threshold set by WHO.
Danish: I begge undersøgelser var den reelle hyppighed af behandlingssvigt under den WHO fastsatte 5 % tærskelværdi for effekt.
English: It is used to treat uncomplicated malaria when use of a medicine given by mouth is appropriate.
Danish: Det anvendes til at behandle ukompliceret malaria, når det er hensigtsmæssigt at give medicin via munden.
English: Any effects are unlikely to persist beyond 24 hours after the last intake of artenimol.
Danish: Det er ikke sandsynligt, at virkningerne varer længere end 24 timer efter den sidste indtagelse af artenimol.
English: The efficacy and safety of Eurartesim have been assessed in two large randomised, open-label clinical trials:
Danish: Sikkerhed og virkning af Eurartesim er blevet vurderet i to store åbne randomiserede kliniske undersøgelser:
English: The most important potential cardiac effect was related to cardiac conduction.
Danish: Den vigtigste potentielle kardiale virkning var relateret til kardial konduktion.
English: The systemic exposure to artenimol was slightly lower following the last dose of Eurartesim (lower than after the first dose by up to 15%).
Danish: Den systemiske eksponering over for artenimol var lidt lavere efter den sidste dosis Eurartesim (lavere end efter den første dosis med op til 15 %).
English: • 30 minutes of taking Eurartesim, the whole dose must be taken again.
Danish: • 30 minutter af indtagelsen af Eurartesim, skal hele dosis tages igen.
English: Effects on blood pressure and on PR and QRS duration were observed at high piperaquine doses.
Danish: Virkning på blodtryk og længden af PR og QRS blev observeret ved høje doser af piperaquin.
English: • is taking or has taken any other medicines for the treatment of malaria (other than those mentioned above);
Danish: • tager eller har taget anden medicin til behandling af malaria (udover dem, der er nævnt ovenfor),
English: If you find out that you are pregnant within one month from taking Eurartesim, please inform your doctor.
Danish: Hvis du finder ud af, at du er gravid, inden for én måned, efter du har taget Eurartesim, bedes du informere din læge.
English: Via Ragazzi del '99, n. 5 40133 Bologna Italy
Danish: Via Ragazzi del '99, n. 5 40133 Bologna Italien
English: If you are taking folate supplements to prevent possible neural tube birth defects, you can continue taking them at the same time as Eurartesim.
Danish: Hvis du tager folattilskud for at forhindre mulige neuralrørsdefekter, kan du fortsætte med at tage dem samtidigt med Eurartesim.
English: • If you or your child is infected more than twice in a year, your doctor will prescribe an alternative treatment.
Danish: • Hvis du eller dit barn inficeres mere end to gange på et år, vil lægen ordinere en alternativ behandling.
English: For the medicine to work effectively, you or your child should take the tablets as instructed and should complete the 3 days course of treatment.
Danish: For at medicinen virker effektivt, skal du eller dit barn tage tabletterne som anvist, og I skal gennemføre det 3-dages behandlingsforløb.
English: - Electrolyte disturbances, particularly hypokalaemia, hypocalcaemia or hypomagnesaemia.
Danish: - Elektrolytforstyrrelser, især hypokaliæmi, hypocalcæmi eller hypomagnesæmi.
English: Your doctor may suggest special monitoring for you or your child because doses higher than those recommended may have an unwanted, severe effect on the heart (see also section 4).
Danish: Din læge kan foreslå, at du eller dit barn overvåges særligt, da doser over de anbefalede kan have uønskede, alvorlige virkninger på hjertet (se også pkt.
English: Clinical studies of Eurartesim did not include patients aged 65 years and over, therefore no dosing recommendation can be made.
Danish: Kliniske undersøgelser med Eurartesim omfattede ikke patienter i alderen 65 år og derover, derfor kan der ikke gives nogen dosisanbefaling.
English: However, there was no delay in neonatal development following exposure in utero or via milk (see section 5.3).
Danish: Der var dog ikke nogen forsinket neonatal udvikling efter eksponering in utero eller gennem mælken (se pkt.
English: Therefore, ECG monitoring during the following 24-48 hours should be applied for patients found to have a prolongation to this extent.
Danish: Derfor skal der udføres EKG-overvågning i de følgende 24-48 timer for patienter, hvor en forlængelse af denne størrelsesorden er påvist.
English: You should not take Eurartesim with grapefruit juice due to possible interactions.
Danish: Eurartesim må ikke tages sammen med grapefrugt juice på grund af mulige interaktioner.
English: Therefore the assessment of the potential for drug-drug interactions to occur is based on either in vivo or in vitro studies.
Danish: Derfor er vurderingen af potentialet for, at lægemiddel-lægemiddel interaktioner kan forekomme, baseret på enten in vivo- eller in vitro-studier.
English: medicines used to treat infections.
Danish: medicin, der anvendes til at behandle infektioner.
English: However, it is reported in the literature that the excretion of unchanged active substance in human urine and faeces is negligible for artemisinin derivatives.
Danish: Det rapporteres imidlertid i litteraturen, at udskillelsen af uændret aktivt stof i human urin og fæces er ubetydelig for artemisinin-derivater.
English: The mean oral clearance was slightly higher for paediatric patients, however the differences were minor in magnitude (<20%).
Danish: Den gennemsnitlige orale elimination var lidt højere for pædiatriske patienter, men forskellene var imidlertid af en mindre størrelsesorden (<20 %).
English: No single type of ADR occurred at an incidence of ≥5%.
Danish: Der forekom ingen enkelt type af bivirkninger med en incidens på ≥5 %.
English: Artenimol is able to reach high concentrations within the parasitized erythrocytes.
Danish: Artenimol er i stand til at opnå høje koncentrationer i de parasitinficerede erytrocytter.
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 benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Therefore, they may be more sensitive to the effects of QTc-prolonging medications such as Eurartesim so that special caution is required.
Danish: Derfor kan de være mere følsomme over for virkningen af QTc-forlængende medicin, såsom Eurartesim, hvorfor der kræves speciel forsigtighed.
English: Women taking Eurartesim should not breast-feed during their treatment.
Danish: Kvinder, der tager Eurartesim, bør ikke amme under behandlingen.
English: If the tablets are difficult to swallow, you can crush and mix them with water; drink the mixture immediately.
Danish: Hvis der er besværligt at sluge tabletterne, kan du knuse dem og blande dem med vand, Drik straks blandingen.
English: In clinical trials, nine patients received double the cumulative intended dose of Eurartesim.
Danish: I kliniske undersøgelser fik ni patienter den dobbelt kumulative tilsigtede dosis Eurartesim.
English: The safety of Eurartesim has been evaluated in two phase III open-label studies involving 1,239 paediatric patients up to 18 years and 566 adult patients >18 years treated with Eurartesim.
Danish: Sikkerheden af Eurartesim er blevet evalueret i to åbne fase III-undersøgelser af 1239 pædiatriske patienter op til 18 år og 566 voksne patienter >18 år behandlet med Eurartesim.
English: >1 to ≤ 2 years >2 to ≤5 years
Danish: >1 til ≤2 år >2 til ≤5 år
English: These patients should not receive another dose of Eurartesim and alternative antimalarial therapy should be instituted.
Danish: Disse patienter må ikke få yderligere dosis af Eurartesim, og alternativ behandling af malaria skal igangsættes.
English: The primary end-point was the PCR-corrected cure rate at Day 63.
Danish: Det primære endepunkt var den PCR-korrigerede helbredelsesrate på Dag 63.
English: Eurartesim should be taken orally with water and without food.
Danish: Euratesim skal tages oralt sammen med vand og uden føde.
English: Examples are listed in the section “Other medicines and Eurartesim”.
Danish: Eksempler findes i afsnittet “Brug af anden medicin sammen med Eurartesim”.
English: Eurartesim kills the Plasmodium falciparum parasite.
Danish: Eurartesim dræber parasitten Plasmodium falciparum.
English: Tablet strength and number of tablets per dose
Danish: Tabletstyrke og antal tabletter pr. dosis
English: Delayed haemolytic anaemia has been observed up to one month following use of IV artesunate and oral artemisinin-based combination treatment (ACT) including reports involving Eurartesim.
Danish: Forsinket hæmolytisk anæmi er observeret op til én måned efter anvendelse af i.v.-artesunat og oral artemisininbaseret kombinationsbehandling (ACT), herunder rapporter, der involverer Eurartesim.
English: If you or your child takes more than the recommended dose, tell your doctor.
Danish: Hvis du eller dit barn har taget mere end den anbefalede dosis, skal du fortælle det til lægen.
English: Sometimes a problem with your red blood cells, called haemolytic anaemia can occur after receiving malaria treatment.
Danish: Der kan undertiden opstå et problem med de røde blodlegemer, som kaldes hæmolytisk anæmi, efter malariabehandling.
English: There was no evidence of artenimol-induced lesions in the specific nuclei in rats or dogs, even at lethal dose.
Danish: Der var ikke evidens for artenimol-inducerede læsioner i de specifikke kerner hos rotter eller hunde, selv ved en dødelig dosis.
English: The safety profile of these patients did not differ from that of patients receiving the recommended dose, with no patient reporting SAEs.
Danish: Sikkerhedsprofilen for disse patienter var ikke forskellig fra profilen hos patienter, der fik den anbefalede dosis, og ingen patienter rapporteret nogen alvorlige uønskede hændelser.
English: • That piperaquine absorption is increased in the presence of food, therefore to reduce this risk of QTc interval prolongation, the patients should be advised to take the tablets with water, without food, no less than three hours after the last food intake.
Danish: • At absorptionen af piperaquin forøges under tilstedeværende af fødevarer; for at reducere denne risiko for QTc-forlængelse skal patienterne derfor rådes til at tage tabletterne sammen med vand, uden føde, højst 3 timer efter den sidste indtagelse af fødevarer.
English: This pharmacokinetic effect is accompanied by an increased effect on prolongation of the QT interval.
Danish: Denne farmakokinetiske virkning ledsages af en forøget virkning på forlængelse af QT-intervallet.
English: QTc intervals of more than 500 ms are associated with a pronounced risk for potentially life-threatening ventricular tachyarrhythmias.
Danish: QTc-intervaller på over 500 msek er forbundet med en udtalt risiko for potentielt livstruende ventrikel takyarytmier.
English: Based on animal data Eurartesim is suspected to harm the unborn child when used during the first three months of pregnancy.
Danish: Baseret på data fra dyreforsøg er Eurartesim under mistanke for at skade det ufødte barn, hvis det anvendes i løbet af de første 3 måneder af graviditeten.
English: You can drive or use machines after taking Eurartesim once you have recovered from your illness.
Danish: Du kan føre motorkøretøj eller betjene maskiner efter du tager Eurartesim, når du er over din sygdom.
English: If you notice anything different about your or your child's heart rhythm or have symptoms (such as palpitations or irregular heart beat) you should contact your doctor as soon as possible and before the next dose is due.
Danish: Hvis du bemærker noget anderledes ved dit eller dit barns hjerterytme eller hvis I har symptomer (såsom hjertebanken eller uregelmæssigt hjerteslag), skal du snarest muligt kontakte lægen, og før næste dosis skal indgives.
English: The potential for Eurartesim to prolong the QTc interval was investigated in parallel groups of healthy volunteers who took each dose with high (~1000 Kcal) or low (~400 Kcal) fat/calorie meals or in fasting conditions.
Danish: Eurartesims potentiale til at forlænge QTc-intervallet blev undersøgt blandt parallelle grupper med raske frivillige, som tog hver dosis sammen med måltider med højt (~1000 Kcal) eller lavt (~400 Kcal) kalorieindhold, eller under fastende betingelser.
English: Pharmacokinetic profiles of artenimol and piperaquine have been investigated in animal models and in different human populations (healthy volunteers, adult patients and paediatric patients).
Danish: De farmakokinetiske profiler af artenimol og piperaquin er blevet undersøgt i dyremodeller, og hos forskellige humane populationer (raske frivillige, voksne patienter og pædiatriske patienter).
English: A total of 15 (1.5%) subjects had serious ADRs in the study.
Danish: I alt 15 (1,5 %) af forsøgspersonerne havde alvorlige bivirkninger i denne undersøgelse.
English: If you or your child vomit also the second dose, do not take or give your child another dose.
Danish: Hvis du eller dit barn også kaster den anden dosis op, skal du ikke tage eller give dit barn en til dosis.
English: • has liver or kidney problems;
Danish: • har problemer med lever- eller nyrer,
English: The main consequence of this interaction could be a reduction of efficacy of the co-administered medicinal products.
Danish: Den primære følge af denne interaktion kunne være en reduktion i virkningen af samtidigt indgivne lægemidler.
English: Artenimol bioavailability appears to be higher in malaria patients than in healthy volunteers, possibly because malaria per se has an effect on artenimol disposition.
Danish: Den resulterende biotilgængelighed af artenimol forekommer højere hos malariapatienter end hos raske frivillige, muligvis på grund af, at malaria i sig selv har en virkning på dispositionen af artenimol.
English: A heart problem, called QT prolongation, can occur while taking Eurartesim and for some days after taking the last dose.
Danish: Et hjerteproblem, som kaldes QT-forlængelse, kan forekomme hos patienter, der tager Eurartesim, og i nogle dage efter indtagelse af den sidste dosis.
English: Your doctor may take electrical recordings of the heart (electrocardiogram, ECG) while you or your child is being treated and after the last dose is given.
Danish: Din læge kan optage den elektriske aktivitet af hjertet (elektrokardiogram, EKG) under behandlingen af dig eller dit barn, og efter den sidste dosis.
English: Tell your doctor if you are in the 1st trimester of pregnancy, think you may be pregnant or become pregnant, or if you are breast-feeding.
Danish: Fortæl det til lægen, hvis du er i graviditetens 1. trimester, har mistanke om, at du er gravid eller bliver gravid, eller hvis du ammer.
English: P. falciparum infection
Danish: P. falciparum infektion
English: Piperaquine, a highly lipophilic compound, is slowly absorbed.
Danish: Piperaquin, et meget lipofilt stof, absorberes langsomt.
English: Eurartesim should not be taken with grapefruit juice as it is likely to lead to increased piperaquine plasma concentrations.
Danish: Euratesim bør ikke tages sammen med grapefrugt juice, da dette sandsynligvis fører til forhøjede plasmakoncentrationer af piperaquin.
English: The number of subjects with QTcF greater than 480 msec after dosing with low fat meals was 3/64, while 10/64 had QTcF values over this threshold after dosing with high fat meals.
Danish: Antallet af forsøgspersoner med QTcF over 480 msek efter dosering sammen med måltider med lavt fedtindhold var 3/64, mens 10/64 havde QTcF-værdier over denne tærskelværdi efter dosering sammen med måltider med højt fedtindhold.
English: Artenimol and piperaquine were not genotoxic/clastogenic based on in vitro and in vivo testing.
Danish: Artenimol og piperaquin var ikke genotoksiske/klastogene baseret på in vitro og in vivo testing.
English: No subject had a QTcF value greater than 500 msec in any of the dosing conditions.
Danish: Ingen forsøgspersoner havde en QTcF-værdi over 500 msek under nogen af doseringsbetingelserne.
English: Consideration should be given to official guidance on the appropriate use of antimalarial medicinal products.
Danish: Ved anvendelse skal der tages hensyn til officielle retningslinjer for anvendelse af lægemidler mod malaria.
English: Adverse event data collected in clinical trials suggest that Eurartesim has no influence on the ability to drive and operate machines once the patient has recovered from the acute infection.
Danish: Data over uønskede hændelser, som blev indsamlet i kliniske undersøgelser, tyder på, at Eurartesim ikke påvirker evnen til at føre motorkøretøj og betjene maskiner, efter patienten er i bedring fra den akutte infektion.
English: Eurartesim should be administered over three consecutive days for a total of three doses taken at the same time each day.
Danish: Eurartesim indgives i tre på hinanden følgende dage med i alt tre doser, som indtages på samme tidspunkt hver dag.
English: The same comparison showed that piperaquine absorption rate constant and terminal half-life in children were predominantly similar to those seen in adults.
Danish: Den samme sammeligning viste, at piperaquins hastighedskonstanter for absorption og terminal halveringstid hos børn var overvejende sammenlignelige med parametre for voksne.
English: Talk to your doctor or pharmacist before taking this medicine if you or your child:
Danish: Kontakt lægen eller apotekspersonalet, før I tager denne medicin, hvis du eller dit barn:
English: If any of the above applies to you or your child or if you are unsure, tell your doctor or pharmacist before taking or giving Eurartesim.
Danish: Hvis noget af det ovenstående gælder for dig eller dit barn, eller du er i tvivl, skal du fortælle det til lægen eller apotekspersonalet, før du tager eller giver Eurartesim.
English: • has a malaria infection caused by a parasite other than Plasmodium falciparum;
Danish: • har en malariainfektion, som er forårsaget af en anden parasit end Plasmodium falciparum,
English: The piperaquine major metabolites were a carboxyl acid cleavage product, and a mono-N-oxidated product.
Danish: De hovedsagelige metabolitter for piperaquin var et carboxylsyre kløvningsprodukt og et mono-N-oxideret produkt.
English: Piperaquine is a bisquinoline, and this class has shown good antimalarial activity against chloroquineresistant Plasmodium strains in vitro.
Danish: Piperaquin er et bisquinolin og denne klasse har udvist god aktivitet mod malaria forårsaget af chloroquin-resistente Plasmodium stammer in vitro.
English: A large amount of data (more than 3000 exposed outcomes) from the use of artenimol/piperaquine during the 2nd and 3rd trimester indicate no fetotoxicity.
Danish: En stor mængde data (mere end 3000 eksponerede udfald) fra anvendelse af artenimol/piperaquin i det 2. og 3. trimester indikerer ingen føtal toksicitet.
English: • The need to counsel patients on important risks associated with Eurartesim therapy and appropriate precautions when using the medicine.
Danish: • Behovet for at rådgive patienterne om vigtige risici i forbindelse med Eurartesim-behandlingen og hensigtsmæssige forholdsregler, når denne medicin anvendes.