FrancophonIA/ELRC3.0 huggingface dataset:
English: The age-specific PCR-corrected cure rates in the m-ITT populations are tabulated below for the Asian and African studies, respectively:
Danish: Den aldersspecifikke PCR-korrigerede helbredelseshyppighed i m-ITT-populationer er opstillet herunder for hhv. asiatiske og afrikanske undersøgelser:
English: Pharmacokinetic parameters observed for piperaquine in humans indicate that this active substance has a large volume of distribution (730 l/kg; CV 37.5%).
Danish: Farmakokinetiske parametre observeret for piperaquin hos mennesker indikerer, at dette aktive stof har et stort fordelingsvolumen (730 l/kg, CV 37,5 %).
English: There is the potential for reducing the rate of metabolism of other substrates of this enzyme, such as omeprazole, with consequent increase of their plasma concentration, and therefore, of their toxicity.
Danish: Der er potentiale for at reducere metaboliseringshastigheden af andre substrater for dette enzym, såsom omeprazol, med en resulterende forhøjelse af deres plasmakoncentration, og derfor af deres toksicitet.
English: - History of symptomatic cardiac arrhythmias or with clinically relevant bradycardia.
Danish: - Anamnese med symptomatiske kardiale arytmier eller med klinisk relevant bradykardi.
English: In a perinatal and postnatal development study (segment III) in female rats treated with 80 mg/kg, some animals had a delay of delivery inducing mortality of the neonates.
Danish: I en undersøgelse af perinatal og postnatal udvikling (segment III) hos hunrotter behandlet med 80 mg/kg, oplevede nogle dyr, at fødslen blev udsat, hvilket inducerede mortalitet af afkommet.
English: The exact mechanism of action of piperaquine is unknown, but it likely mirrors that of chloroquine, a close structural analogue.
Danish: Den nøjagtige virkningsmekanisme for piperaquin er ukendt, men afspejler sandsynligvis virkningsmekanisme ved chloroquin, som er en nært beslægtet strukturel analog.
English: The Physician Leaflet should contain the following key messages:
Danish: Lægebrochuren bør indeholde følgende nøgleinformation:
English: In a paediatric pharmacokinetic study, and based on very limited sampling, minor differences were observed for artenimol pharmacokinetics between the paediatric and adult populations.
Danish: I en pædiatrisk farmakokinetisk undersøgelse, og baseret på meget begrænset prøveudtagelse, blev der observeret mindre forskelle i artenimols farmakokinetik for pædiatriske og voksne populationer.
English: Influenza P. falciparum infection
Danish: Influenza P. falciparum infektion
English: 30.400 00071 Pomezia (Rome) Italy
Danish: 30,400 00071 Pomezia (Rom) Italien
English: Side effects in adults
Danish: Bivirkninger hos voksne
English: The mean QTcF prolongation compared to placebo decreased to 11.8 msec at 24 hours and to 7.5 msec at 48 hours.
Danish: Den gennemsnitlige QTcF-forlængelse sammenlignet med placebo faldt til 11,8 msek ved 24 timer og til 7,5 msek ved 48 timer.
English: Drug-drug interaction studies have only been performed in adults.
Danish: Der er kun udført lægemiddel-lægemiddel interaktionsstudier hos voksne.
English: A corresponding table for paediatric patients is presented in the specific section below.
Danish: En tilsvarende tabel for børn præsenteres i det specifikke afsnit.
English: Moreover, data obtained in animal studies show that fertility is unaffected by artenimol in both females and males.
Danish: Ydermere viser data fra dyreforsøg, at fertiliteten ikke er påvirket af artenimol hos både hunner og hanner.
English: Twenty-two of these patients were shown to be parasitic free at the last microscopic analysis of the blood sample; three patients did not complete parasitological blood analysis.
Danish: 22 af disse patienter viste sig at være parasitfri ved den sidste mikroskopiske analyse af blodprøven.
English: Artenimol causes embryolethality and teratogenicity in rats and rabbits.
Danish: Artenimol forårsagede embryoletalitet og teratogenicitet hos rotter og kaniner.
English: Food interaction
Danish: Fødevareinteraktion
English: In humans, piperaquine has a Tmax of approximately 5 hours following a single and repeated dose.
Danish: Hos mennesker har piperaquin en Tmax på ca. 5 timer efter enkeltdosis og gentagen dosis.
English: In humans, the potential neurotoxicity of orally administered artenimol can be considered highly unlikely, given the rapid clearance ofartenimol, and its short exposure (3 days of treatment for malaria patients).
Danish: Hos mennesker kan den potentielle neurotoksicitet af oralt indgivet artenimol anses for meget usandsynlig, set i forhold til den hurtige elimination af artenimol og korte eksponering (3 dages behandling for malariapatienter).
English: • That there is a potential risk of teratogenicity and so Eurartesim should not be used in the 1st trimester of pregnancy in situations where other suitable and effective anti-malarials are available.
Danish: • At der er en potentiel risiko for teratogenicitet, og Eurartesim derfor ikke bør anvendes i graviditetens 1. trimester, hvor andre hensigtsmæssige og effektive midler mod malaria er tilgængelige.
English: The primary end-point was PCR-corrected cure rate at Day 28.
Danish: Det primære endepunkt var den PCR-korrigerede helbredelseshyppighed ved Dag 28.
English: You or your child should not take a second course of Eurartesim within 2 months of the first course.
Danish: Du eller dit barn må ikke tage et andet forløb med Eurartesim inden for 2 måneder fra det første forløb.
English: This may reflect malaria-associated impairment of hepatic function, causing an increase in artenimol bioavailability (reduction of first hepatic effect) without affecting its apparent elimination half-life, which is absorption rate limited.
Danish: Dette kan afspejle den nedsatte leverfunktion forbundet med malaria, hvilket forårsager en forhøjet biotilgængelighed af artenimol (reduktion af den første levervirkning) uden at påvirke den tilsyneladende halveringstid for elimination, som er hastighedsbegrænset for absorption.
English: Therefore, Eurartesim should be taken with water only as described in section 4.2.
Danish: Eurartesim bør derfor kun tages sammen med vand som beskrevet i pkt.
English: In perinatal and postnatal studies in rats, piperaquine was associated with delivery complications.
Danish: I perinatale og postnatale forsøg med rotter var piperaquin forbundet med fødselskomplikationer.
English: • Inhibition of falciparum sarcoplasmic-endoplasmic reticulum calcium ATPase,
Danish: • Inhibition af falciparum sarkoplasmatisk-endoplasmatisk retikulum calcium ATPase.
English: − This medicine has been prescribed for you only.
Danish: - Lægen har ordineret dette lægemiddel til dig personligt.
English: There are only limited (n=3) amount of data from the use of artenimol/piperaquine during the 1st trimester of pregnancy.
Danish: Graviditet Der er utilstrækkelige data (n=3) fra anvendelse af artenimol/piperaquin i graviditetens 1. trimester.
English: However, the apparent clearance was faster (1.30 versus 1.14 l/h/kg) and the apparent total volume of distribution was lower in the paediatric population (623 versus 730 l/kg).
Danish: Den tilsyneladende elimination var imidlertid hurtigere (1,30 versus 1,14 l/t/kg) og det tilsyneladende fordelingsvolumen var lavere i den pædiatriske population (623 versus 730 l/kg).
English: Its endoperoxide bridge is thought to be essential for its antimalarial activity, causing free-radical damage to parasite membrane systems including:
Danish: Endoperoxidbroen menes at være essentiel for aktiviteten mod malaria, og forårsager skader fra frie radikaler til parasittens membransystemer, herunder:
English: Eurartesim are white film-coated tablets, embossed and with a break line along the middle.
Danish: Eurartesim tabletter er hvide filmovertrukne tabletter, præget og med en delekærv langs midten.
English: In vitro metabolism studies demonstrated that piperaquine is metabolised by human hepatocytes (approximately 85% of piperaquine remained after 2 hours incubation at 37°C).
Danish: Undersøgelser af in vitro metabolisme viste, at piperaquin i ringe grad metaboliseres af humane hepatocytter (ca. 85 % af piperaquin var tilbage efter 2 timers inkubering ved 37 °C).
English: This can cause a life-threatening abnormality of the heart rhythm.
Danish: Dette kan forårsage en unormal hjerterytme, der kan være livstruende.
English: When clinically appropriate, consideration should be given to obtaining an ECG from all patients before the last of the three daily doses is taken and approximately 4-6 hours after the last dose, since the risk of QTc interval prolongation may be greatest during this period (see section 5.2).
Danish: Når det er klinisk hensigtsmæssigt, skal det overvejes at optage et EKG hos alle patienter før den sidste af de tre daglige doser tages og ca. 4-6 timer efter den sidste dosis, da risikoen for forlængelse af QTc-intervallet kan være størst i løbet af denne periode (se pkt.
English: Dosing should be based on body weight as shown in the table below.
Danish: Dosering baseres på legemsvægt som vist i den nedenstående tabel:
English: In the European Safety Registry 25 patients weighing ≥ 100 kg (range 100 -121 kg) were treated with 4 tablets 320/40 mg PQP/artenimol for 3 days.
Danish: I den europæiske sikkerhedsregistrering blev 25 patienter, der vejede ≥ 100 kg (interval 100-121 kg), behandlet med 4 tabletter 320/40 mg PQP/artenimol i 3 dage.
English: Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or breastfeeding.
Danish: Spørg lægen eller apotekspersonalet til råds, før du tager nogen form for medicin i løbet af graviditeten eller mens du ammer.
English: PCR-corrected cure rate (m-ITT) Eurartesim AS + MQ A + L
Danish: PCR-korrigeret helbredelseshyppighed (m-ITT) Eurartesim AS + MQ A + L
English: The QTcF prolongation observed under fasting conditions lasted between 4 and 11 hours after the last dose was administered on Day 3.
Danish: QTcF-forlængelsen observeret under fastende betingelser varede fra 4-11 timer efter den sidste dosis var indgivet på dag 3.
English: In a randomised trial in which 767 adults and children with uncomplicated P. falciparum malaria were exposed to Eurartesim, 25% of subjects were judged to have experienced an adverse drug reaction
Danish: I en randomiseret undersøgelse, hvor 767 voksne og børn med ukompliceret P. falciparum malaria blev eksponeret for Eurartesim, blev 25 % af forsøgspersonerne bedømt til at have bivirkninger relateret til Euratesim.
English: You or your child must not take more than two courses within one year.
Danish: Du eller dit barn må ikke tage over to behandlingsforløb inden for et år.
English: Resistance to piperaquine (when used as monotherapy) has been reported.
Danish: Der er blevet rapporteret resistens over for piperaquin (når det anvendes som monoterapi).
English: Do not take this medicine after the expiry date which is stated on the package after ‘EXP'.
Danish: Tag ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: No reproduction toxicity studies have been performed with the combination of artenimol and piperaquine.
Danish: Der er ikke udført toksicitetsundersøgelser af reproduktion med kombinationen artenimol og piperaquin.
English: If you or your child gets a rash, swelling of the face, lips, tongue or throat with difficulty in swallowing or breathing, these may be signs of an allergic reaction.
Danish: Hvis dit barn får udslæt, hævelse af ansigt, læber, tunge eller hals med synke- eller vejrtrækningsbesvær, kan det være tegn på en allergisk reaktion.
English: Compared to placebo, the maximum mean increases in QTcF on Day 3 of dosing with Eurartesim were 45.2, 35.5 and 21.0 msec under respective dosing conditions.
Danish: Sammenlignet med placebo var de maksimale gennemsnitlige forhøjelser i QTcF på dag 3 for dosering med Eurartesim 45,2, 35,5 og 21,0 msek under de respektive doseringsbetingelser.
English: A course of Eurartesim lasts 3 consecutive days.
Danish: Et behandlingsforløb med Eurartesim varer i tre på hinanden følgende dage.
English: Effects on cardiac repolarization
Danish: Virkninger på hjertets repolarisation
English: Before the third dose of Eurartesim, in one of the two Phase III studies 3/767 patients (0.4%) were reported to have a QTcF value of >500 ms versus none in the comparator group.
Danish: Før indgift af tredje dosis af Eurartesim, blev det rapporteret, at 3/767 patienter (0,4 %) havde et QTcF-niveau på > 500 ms versus ingen patienter i sammenligningsgruppen.
English: Since piperaquine is present in the skin (about 9% in the non-pigmented rat and only 3% in the pigmented rat), slight phototoxic reactions (swelling and erythema) were observed 24 hours after oral treatment in mice exposed to UV radiation.
Danish: Da piperaquin forefindes i huden (ca. 9 % hos ikke-pigmenterede rotter og kun 3 % hos pigmenterede rotter), blev der observeret milde fototoksicitetsreaktioner (hævelse og erytem) 24 timer efter oral behandling hos mus eksponeret over for UV-stråling.
English: In females delivering normally the development, behaviour and growth of the surviving progeny was normal following exposure in utero or via milk.
Danish: Hundyr, som gennemgik en normal fødsel, oplevede normal udvikling, adfærd og vækst af det overlevende afkom efter eksponering in utero eller gennem mælken.
English: Reproductive studies with artemisinin derivatives have demonstrated teratogenic potential with an increased risk during early gestation (see section 5.3).
Danish: Reproduktionsstudier med artemisininderivater har vist teratogent potentiale med en forøget risiko under tidlig gestation (se pkt.
English: - Any predisposing cardiac conditions for arrhythmia such as severe hypertension, left ventricular hypertrophy (including hypertrophic cardiomyopathy) or congestive cardiac failure accompanied by reduced left ventricle ejection fraction.
Danish: - Alle prædisponerende hjertesygdomme for arythmi, såsom svær hypertension, venstre ventrikel hypertrofi (herunder hypertrofisk kardiomyopati) eller kronisk hjerteinsufficiens ledsaget af nedsat venstre ventrikel funktion.
English: Eurartesim treatment was compared with Artemether + Lumefantrine (A + L).
Danish: Eurartesim behandling blev sammenlignet med Artemeter + Lumefantrin (A + L).
English: You or your child should take each dose no less than 3 hours after the last food intake, and no food should be taken within 3 hours after each dose of Eurartesim.
Danish: Du eller dit barn skal tage hver dosis ikke senere end 3 timer efter sidste måltid, og intet måltid skal tages inden for 3 timer efter hver dosis Eurartesim.
English: No healthy subject dosed in fasting conditions showed a QTcF greater than 480 msec or an increase over baseline greater than 60 msec.
Danish: Ingen raske forsøgspersoner, der blev doseret under fastende betingelser, havde et QTcF længere end 480 msek, eller en forhøjelse fra baseline større end 60 msek.
English: Eurartesim treatment was compared with Artesunate + Mefloquine (AS + MQ).
Danish: Eurartesim behandling blev sammenlignet med Artesunat + Mefloquin (AS + MQ).
English: Data regarding artenimol excretion in humans are scarce.
Danish: Data angående udskillelsen af artenimol hos mennesker er begrænsede.
English: • Interference with parasite transport proteins
Danish: • Interferens med parasittens transportproteiner.
English: The most important nonclinical safety findings after repeated dosing were the infiltration of macrophages with intracytoplasmic basophilic granular material consistent with phospholipidosis and degenerative lesions in numerous organs and tissues.
Danish: De vigtigste ikke kliniske sikkerhedsfund efter gentagen dosering var infiltrationen af makrofager med intracytoplasmatisk basofilt granulært materiale i overensstemmelse med fosfolipidose og degenerative læsioner af flere organer og væv.
English: Caution is therefore, advised when Eurartesim is administered concomitantly with medicinal products metabolised by this enzyme that have a narrow therapeutic index, such as theophylline.
Danish: Der rådes derfor til forsigtighed, når Eurartesim indgives samtidigt med lægemidler, der metaboliseres af dette enzym og har et snævert terapeutisk indeks, såsom theophyllin.
English: • That Eurartesim has a potential to prolong the QTc interval that may lead to potentially lethal arrhythmias.
Danish: • At Eurartesim kan forlænge QTc-intervallet, hvilket kan føre til potentielt dødelige arytmier.
English: Literature data concerning chronic toxicity of piperaquine in dogs and monkeys indicate some hepatotoxicity and mild reversible depression of total white cell and neutrophil counts.
Danish: Data fra litteraturen angående piperaquins kroniske toksicitet hos hunde og aber indikerer nogen hepatotoksicitet og mild reversibel undertrykkelse af det totale antal hvide blodlegemer og neutrofiltal.
English: No effect on the metabolite profile of piperaquine in human hepatocytes was observed when piperaquine was co-incubated with artenimol.
Danish: Der blev ikke observeret nogen virkning på metabolitprofilen af piperaquin i humane hepatocytter, når piperaquin blev inkuberet sammen med artenimol.
English: In a second randomised trial, 1,038 children, aged between 6 months and 5 years, were exposed to Eurartesim and 71% were judged to have experienced an ADR.
Danish: I en anden randomiseret undersøgelse blev 1038 børn i alderen fra 6 måneder til 5 år eksponeret for Eurartesim og 71 % af forsøgspersonerne blev bedømt til at have oplevet en bivirkning.
English: Therefore, particular attention should be paid when medicinal products that have a narrow therapeutic index (e.g. antiretroviral medicinal products and cyclosporine) are co-administered with Eurartesim.
Danish: Derfor skal der tages særligt hensyn, når lægemidler, som har et snævert terapeutisk indeks (f.eks. antiretrovirale lægemidler og ciclosporin), indgives samtidigt med Euratesim.
English: Animal data suggest excretion of piperaquine into breast milk but no data are available in humans.
Danish: Data fra dyreforsøg tyder på udskillelse af piperaquin i brystmælken, men der foreligger ingen data for mennesker.
English: If the second dose is vomited, alternative antimalarial therapy should be instituted.
Danish: Hvis den anden dosis kastes op, skal alternativ behandling mod malaria påbegyndes.
English: A total of 6 (0.8%) subjects had serious ADRs in the study.
Danish: I alt 6 (0, 8 %) af forsøgspersonerne havde alvorlige bivirkninger i denne undersøgelse.
English: In the absence of carcinogenicity study data, and due to lack of clinical experience with repeated courses of treatment in humans, no more than two courses of Eurartesim should be given in a 12-month period (see sections 4.2 and 5.3).
Danish: Da der ikke foreligger undersøgelsesdata om karcinogenicitet og på grund af manglende klinisk erfaring med gentagne behandlingsforløb hos mennesker, bør flere end to behandlingsforløb med Eurartesim i løbet af en 12-måneders periode ikke gives (se pkt.
English: Do not give this medicine to infants under 6 months or below 5 kg in weight.
Danish: Denne medicin må ikke gives til spædbørn under 6 måneder eller med en vægt på under 5 kg.
English: Piperaquine has the potential to increase the rate of metabolism for CYP2E1 substrates resulting in a decrease in the plasma concentrations of substrates such as paracetamol or theophylline, and the anaesthetic gases enflurane, halothane and isoflurane.
Danish: Piperaquin har potentiale for at forøge metaboliseringshastigheden for CYP2E1-substrater, hvilket resulterer i en reduktion af plasmakoncentrationen af substrater såsom paracetamol eller theophyllin og de anæstesiologiske gasser enfluran, halothan og isofluran.
English: Pharmacokinetics in special patient populations No specific pharmacokinetic studies have been performed in patients with hepatic or renal insufficiency, or in elderly people.
Danish: Farmakokinetik hos specielle patientpopulationer Der er ikke udført specifikke farmakokinetiske undersøgelser af patienter med nedsat lever- eller nyrefunktion, eller af ældre personer.
English: A limited number of drug-drug pharmacokinetic interaction studies with Eurartesim have been performed in healthy adult subjects.
Danish: Et begrænset antal farmakokinetiske lægemiddel-lægemiddel interaktionsstudier med Eurartesim er udført hos raske, voksne personer.
English: • Inhibition of the transporters that efflux chloroquine from the parasite food vacuole
Danish: • Hæmning af transportørerne, som får chloroquin til at strømme ud af parasittens fødevakuole.
English: Central nervous system (CNS) toxicity
Danish: Toksicitet af centralnervesystemet (CNS)
English: The long half-life of piperaquine (about 22 days) should be kept in mind in the event that another antimalarial agent is started due to treatment failure or a new malaria infection (see below and sections 4.3 and 4.5).
Danish: Piperaquins lange halveringstid (omkring 22 dage) skal tages i betragtning, hvis et andet middel mod malaria startes på grund af behandlingssvigt eller en ny malariainfektion (se nedenfor og pkt.
English: The medicine can be taken by adults, adolescents, children and infants over 6 months old who weigh 5 kilograms or more.
Danish: Medicinen kan tages af voksne, unge, børn og spædbørn over 6 måneder, som vejer 5 kg eller derover.
English: This leaflet was last revised in month YYYY
Danish: Denne indlægsseddel blev senest ændret måned ÅÅÅÅ
English: Piperaquine was mainly metabolised by CYP3A4 and to a lesser extent by CYP2C9 and CYP2C19.
Danish: Piperaquin blev hovedsageligt metaboliseret af CYP3A4 og i en mindre udstrækning af CYP2C9 og CYP2C19.
English: − fluoroquinolones (e.g. moxifloxacin, sparfloxacin),
Danish: - Fluoroquinoloner (f.eks. moxifloxacin, sparfloxacin).
English: • Disruption of parasite mitochondrial function
Danish: • Forstyrrelse af parasittens mitokondrielle funktion.
English: The bulky bisquinolone structure may be important for activity against chloroquine-resistant strains, and may act through the following mechanisms:
Danish: Den voluminøse bisquinolon-struktur er formentlig vigtig for aktiviteten mod chloroquin-resistente stammer, og kan virke via den følgende mekanisme:
English: • That Eurartesim is contraindicated in patients with severe malaria according to WHO definition and in patients with a history of clinical conditions that may lead to QTc interval prolongation, and in patients taking drugs that are known to prolong the QTc interval.
Danish: • At Eurartesim er kontraindiceret hos patienter med svær malaria ifølge WHO-definitionen og hos patienter med tidligere kliniske tilstande, der kan føre til en forlængelse af QTc-intervallet, og hos patienter, der tager lægemidler, der er kendt for at forlænge QTc-intervallet.
English: The mean oral clearance for adult patients with malaria was 1.34 l/h/kg.
Danish: Den gennemsnitlige orale elimination for voksne patienter med malaria var 1,34 l/t/kg.
English: The effect on prolongation of the QTc interval was observed on Day 2, and had resolved by Day 7 (the next time point at which ECGs were performed).
Danish: Virkningen på forlængelse af QTc-intervallet blev observeret på dag 2, og var ikke længere tilstede ved dag 7 ( hvor der blev udført EKG).
English: The safety and efficacy of Eurartesim in infants aged less than 6 months and in children weighing less than 5 kg has not been established.
Danish: Eurartesims sikkerhed og virkning hos spædbørn i alderen under 6 måneder og hos børn, der vejer under 5 kg, er ikke klarlagt.
English: • If you or your child gets another attack of malaria, you may take a second course of Eurartesim within one year if your doctor thinks this is a suitable treatment.
Danish: • Hvis du eller dit barn igen får et malaria-anfald, kan du tage et andet behandlingsforløb med Eurartesim inden for et år, eller hvis lægen mener, at dette er hensigtsmæssig behandling.