FrancophonIA/ELRC3.0 huggingface dataset:
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 webportal.
Danish: Kravene for fremsendelse af PSUR´er for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Artenimol administration may result in a slight decrease in CYP1A2 activity.
Danish: Indgivelse med artenimol kan resultere i en let reduktion i CYP1A2-aktivitet.
English: Tell your doctor or pharmacist if you or your child is taking, has recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du eller dit barn tager anden medicin, for nylig har taget anden medicin eller planlægger at tage anden medicin.
English: If you or your child is not able to do this, talk to your doctor or pharmacist.
Danish: Hvis du eller dit barn ikke er i stand til at gøre dette, skal I kontakte lægen eller apotekspersonalet.
English: Always take Eurartesim exactly as your doctor has told you to.
Danish: Tag altid Euratesim nøjagtigt efter lægens anvisning.
English: Due to its long elimination half-life, piperaquine accumulates after multiple dosing.
Danish: På grund af den lange halveringstid, akkumuleres piperaquin efter flere doser.
English: This increase in exposure to the antimalarial combination may result in an exacerbation of the effect on QTc (see section 4.4).
Danish: Denne øgede eksponering for kombinationen mod malaria kan føre til en forstærket virkning på QTc (se pkt.
English: QTc prolonged Tachycardia
Danish: QTc-forlængelse Takykardi
English: • The scope and use of the Contraindicated Conditions of Use and Contraindicated Concomitant Medication checklist
Danish: • Formålet for og anvendelsen af de kontraindicerede betingelser for brug og afkrydsningslisten for kontraindiceret samtidig medicin.
English: Artenimol was observed to have a small volume of distribution in humans (0.8 l/kg; CV 35.5%).
Danish: Artenimol blev observeret til at have et lille fordelingsvolumen hos mennesker (0,8 l/kg, CV 35,5 %).
English: Via Pontina Km 30.400 IT-00071 Pomezia (RM) Italy
Danish: Via Pontina Km 30.400 IT-00071 Pomezia (RM) Italien
English: What you need to know before you or your child takes Eurartesim Do not take Eurartesim if you or your child:
Danish: Det skal du vide, før du eller dit barn begynder at tage Eurartesim Tag ikke Eurartesim hvis du eller dit barn:
English: Eurartesim tablets are packaged in PVC/PVDC/aluminium blisters containing 3 tablets.
Danish: Eurartesim tabletter er pakket i blisters af PVC/PVDC/aluminium, som indeholder 3 tabletter.
English: Piperaquine did not induce malformation in rats and rabbits.
Danish: Piperaquin inducerede ikke misdannelse hos rotter og kaniner.
English: Each dose should be taken no less than 3 hours after the last food intake.
Danish: Hver dosis skal tages mindst 3 timer efter sidste fødeindtagelse.
English: artenimol is eliminated by metabolism (mainly glucuroconjugation).
Danish: Artenimol elimineres via metabolismen (hovedsageligt glukurokonjugation).
English: QT/QTc prolonged Heart rate irregular
Danish: QT-/QTc-forlængelse Uregelmæssig puls
English: Eurartesim tablets are packaged in PVC/PVDC/aluminium blisters containing 3, 6, 9 or 12 tablets.
Danish: Eurartesim-tabletter er pakket i blisters af PVC/PVDC/aluminium, som indeholder 3, 6, 9 eller 12 tabletter.
English: Stomatitis Nausea
Danish: Stomatitis Kvalme
English: Study DM040011 was conducted in African paediatric patients with uncomplicated P. falciparum malaria.
Danish: Undersøgelse DM040011 blev udført hos afrikanske pædiatriske patienter med ukompliceret P. falciparum malaria.
English: Eurartesim is indicated for the treatment of uncomplicated Plasmodium falciparum malaria in adults, adolescents, children and infants 6 months and over and weighing 5 kg or more.
Danish: Eurartesim er indiceret til behandling af ukompliceret Plasmodium falciparum malaria hos voksne, unge, børn og spædbørn med en alder over 6 måneder, med en minimumsvægt på 5 kg.
English: • That patients should be advised to contact their doctor about adverse events and that physicians/pharmacists should report suspected adverse reactions to Eurartesim, and in particular, those associated with a QT prolongation.
Danish: • At patienterne skal rådes til at kontakte lægen vedrørende uønskede hændelser, og at lægerne/apoteket skal indrapportere formodede bivirkninger ved Eurartesim og især bivirkninger forbundet med QT-forlængelse.
English: In healthy male volunteers under fasting conditions, mean Cmax and AUCINF of artenimol ranged between 180-252 ng/ml and 516-684 ng/ml*h, respectively.
Danish: Hos raske mandlige frivillige under fastende betingelser var gennemsnitlig Cmax og AUCINF af artenimol i intervallet mellem hhv. 180-252 ng/ml og 516-684 ng/ml*t.
English: These medicines include: mefloquine, halofantrine, lumefantrine, chloroquine or quinine
Danish: Disse former for medicin omfatter: mefloquin, halofantrin, lumefantrin, chloroquin eller quinin.
English: Chloroquine binds to toxic haeme (derived from the patient's haemoglobin) within the malaria parasite, preventing its detoxification via a polymerisation step.
Danish: Chloroquin bindes til den toksiske hæmgruppe (som stammer fra patientens hæmoglobin) i malariaparasitten, og forhindrer afgiftningen via et polymerisationstrin.
English: In the hERG test, the IC50 was 0.15 µmol for piperaquine and 7.7 µmol forartenimol.
Danish: I hERG-undersøgelsen var IC50 0,15 µmol for piperaquin og 7,7 µmol for artenimol.
English: • Interference with mitochondrial electron transport
Danish: • Interferens med mitokondriel elektrontransport.
English: Patients and caregivers should be advised to be vigilant for signs and symptoms of post-treatment haemolysis such as pallor, jaundice, dark-coloured urine, fever, fatigue, shortness of breath, dizziness and confusion.
Danish: Patienter og plejere skal informeres om at være opmærksomme på tegn og symptomer på hæmolyse efter behandling, såsom bleghed, gulsot, mørkfarvet urin, feber, træthed, stakåndethed, svimmelhed og forvirring.
English: • Certain non-sedating antihistamines (e.g. terfenadine, astemizole, mizolastine).
Danish: • Visse ikke-sederende antihistaminer (f.eks. terfenadin, astemizol, mizolastin).
English: The 160 mg/20 mg tablets have the letters ‘S' and ‘T' on one side and come in blisters containing 3 tablets.
Danish: 160 mg/20 mg tabletterne har bogstaverne ‘S' og ‘T' bogstav på den ene side, og kommer i blisters, der indeholder 3 tabletter.
English: The mean clearance (1.45 l/h/kg) was slightly faster in the paediatric patients than in the adult patients (1.34 l/h/kg), while the mean volume of distribution in the paediatric patients (0.705 l/kg) was lower than in the adults (0.801 l/kg).
Danish: Den gennemsnitlige elimination (1,45 l/t/kg) var lidt hurtigere hos pædiatriske patienter sammenlignet med voksne patienter (1,34 l/t/kg), mens det gennemsnitlige fordelingsvolumen hos pædiatriske patienter (0,705 l/kg) var lavere end hos voksne (0,801 l/kg).
English: Reactions such as cough, pyrexia, headache, P. falciparum infection, anaemia, asthenia, anorexia and the observed changes in blood cell parameters are consistent with those expected in patients with acute malaria.
Danish: Reaktioner såsom hoste, pyreksi, hovedpine, P. falciparum infektion, anæmi, asteni, anoreksi og de observerede ændringer i hæmatologi er ioverensstemmelse med de symptomer og fund som ses ved akut malaria.
English: Its clearance was found to be slightly lower in female than in male healthy volunteers.
Danish: Dets elimination fandtes af være lidt lavere hos kvindelige raske forsøgspersoner end hos mandlige.
English: The association of artenimol and piperaquine does not produce hERG inhibition greater than that of the single compounds.
Danish: Associationen mellem artenimol og piperaquin producerer ikke en større hERG-hæmning end af de enkelte stoffer.
English: Therefore, caution is advised when administering Eurartesim to these patients (see section 4.4).
Danish: Der rådes der til forsigtighed, når Eurartesim indgives til disse patienter (se pkt.
English: The following ADRs were observed at an incidence of ≥5.0%: Cough (32%), Pyrexia (22.4%), Influenza (16.0%), P. falciparum infection (14.1%), Diarrhoea (9.4%), Vomiting (5.5%) and Anorexia (5.2%).
Danish: De følgende bivirkninger blev observeret med en incidens på ≥5,0 % af forsøgspersonerne: Hoste (32 %), pyreksi (22,4 %), influenza (16,0 %), P. falciparum infektion (14,1 %), diarré (9,4 %), opkastning (5,5 %) og anoreksi (5,2 %).
English: Due to the potential for higher plasma concentrations of piperaquine to occur, caution is advised if Eurartesim is administered to patients with jaundice and/or with moderate or severe renal or hepatic insufficiency, and ECG and blood potassium monitoring are advised.
Danish: På grund af potentialet for, at der kan forekomme højere plasmakoncentrationer af piperaquin, rådes der til forsigtighed, hvis Eurartesim indgives til patienter med gulsot og /eller med moderat eller svært nedsat nyre- eller leverfunktion, og der rådes til overvågning med EKG ogn af kaliumniveauet i blodet.
English: EU/1/11/716/001 3 film-coated tablets EU/1/11/716/002 6 film-coated tablets EU/1/11/716/003 9 film-coated tablets EU/1/11/716/004 12 film-coated tablets
Danish: EU/1/11/716/001 3 filmovertrukne tabletter EU/1/11/716/002 6 filmovertrukne tabletter EU/1/11/716/003 9 filmovertrukne tabletter EU/1/11/716/004 12 filmovertrukne tabletter
English: No food should be taken within 3 hours after each dose.
Danish: Der må ikke indtages fødevarer inden for 3 timer efter hver dosis.
English: 36 to <75
Danish: 36 til <75
English: On the other hand, on the last day of Eurtartesim treatment, the piperaquine maximum plasma concentration was higher in female than in male healthy volunteers, the difference being in the order of 30 to 50%.
Danish: På den anden side var den maksimale plasmakoncentration på den sidste dag af behandling med Eurartesim højere hos kvindelige raske frivillige end hos de mandlige, forskellen var i størrelsesordenen 30 til 50 %.
English: If you or your child forgets to take the second dose of Eurartesim at the right time, take it as soon as you remember.
Danish: Hvis du eller dit barn har glemt at tage den tredje (sidste) dosis til det rigtige tidspunkt, skal du tage den så snart, du husker det.
English: How to take Eurartesim
Danish: Sådan skal du tage Eurartesim
English: Study DM040010 was conducted in Asian adult and paediatric patients with uncomplicated P. falciparum malaria.
Danish: Undersøgelse DM040010 blev udført blandt asiatiske voksne og pædiatriske patienter med ukompliceret P. falciparum malaria.
English: Contact your doctor immediately if you or your child develops one or more of the following symptoms after treatment with Eurartesim: pale skin, general weakness, headache, shortness of breath and rapid heartbeat; particularly with exercise, confusion, dizziness, or dark-coloured urine.
Danish: Kontakt straks lægen, hvis du eller dit barn får et eller flere af følgende symptomer efter behandling med Eurartesim: bleg hud, generel træthed, hovedpine, stakåndethed og hurtig hjerterytme (især ved fysisk anstrengelse), forvirring, svimmelhed eller mørkfarvet urin.
English: Skin and subcutaneous Tissue disorders
Danish: Hud og subkutane væv
English: Other medicines and Eurartesim
Danish: Brug af anden medicin sammen med Eurartesim
English: Artenimol is principally converted to α-artenimol-β-glucuronide (α-artenimol-G).
Danish: Artenimol konverteres hovedsageligt til α-artenimol-β-glukuronid (α-artenimol-G).
English: Therefore, particular caution is required if Eurartesim is administered to patients taking potent CYP3A4 inhibitors (e.g. some protease inhibitors [amprenavir, atazanavir, indinavir, nelfinavir, ritonavir], nefazodone or verapamil), and ECG monitoring should be considered due to the risk of higher plasma concentrations of piperaquine (see section 4.4).
Danish: Derfor kræves særlig hensyntagen, hvis Eurartesim indgives til patienter, som tager potente CYP3A4-hæmmere (f.eks. visse proteasehæmmere [amprenavir, atazanavir, indinavir, nelfinavir, ritonavir], nefazodon eller verapamil), og EKG-overvågning skal overvejes på grund af risikoen for øgede plasmakoncentrationer af piperaquin (se pkt.
English: Studies in human liver microsomes showed that artenimol was metabolised by the UDP-glucuronosyltransferase (UGT1A9 and UGT2B7) to α-artenimol-G with no cytochrome P450-mediated metabolism.
Danish: Undersøgelser af humane levermikrosomer viste, at artenimol blev metaboliseret af UDP-glukuronosyltransferase (UGT1A9 og UGT2B7) til α-artenimol-G uden en cytokrom P450-medieret metabolisme.
English: Exposure to piperaquine may also be increased when co-administered with mild or moderate CYP3A4-inhibitors (e.g. oral contraceptives).
Danish: Eksponeringen for piperaquin kan også være øget ved administration sammen med svage eller moderate CYP3A4-hæmmere (f.eks. oral kontraception).
English: The 320 mg/40 mg tablets have two 'σ' letters on one side and come in blisters containing 3, 6, 9 or 12
Danish: 320 mg/40 mg tabletterne har to bogstaver ‘σ' på den ene side, og kommer i blisters, der indeholder 3, 6, 9 eller 12 tabletter.
English: EU/1/11/716/005 3 film-coated tablets
Danish: EU/1/11/716/005 3-filmovertrukne tabletter
English: If this happens, talk to your doctor.
Danish: Tal med lægen hvis dette sker.
English: Both piperaquine and artenimol are highly bound to human plasma proteins: the protein binding observed in in vitro studies was 44-93% for artenimol and >99% for piperaquine.
Danish: Den observerede proteinbinding i in vitro-undersøgelser var 44-93 % for artenimol og >99 % for piperaquin.
English: - Taking medicinal products that are known to prolong the QTc interval.
Danish: - Indtagelse af lægemidler, der vides at forlænge QTc-intervallet.
English: Enzyme inducing medicinal products such as rifampicin, carbamazepine, phenytoin, phenobarbital, St. John's wort (Hypericum perforatum) are likely to lead to reduced piperaquine plasma concentrations.
Danish: Det er sandsynligt, at enzym-inducerende lægemidler, såsom rifampicin, carbamazepin, phenytoin, phenobarbital, perikon (Hypericum perforatum) kan føre til en reduceret plasmakoncentration af piperaquin.
English: In healthy volunteers, artenimol exposure was increased by 43% when administered with a high fat/high calorie meal.
Danish: Hos raske frivillige var eksponeringen for artenimol forøget med 43 % ved indgivelse sammen med et måltid med højt kalorieindhold.
English: Pharmacotherapeutic group: Antiprotozoals, antimalarials, artemisinin and derivatives, combinations, ATC code: P01BF05
Danish: Farmakoterapeutisk klassifikation: Antiprotozo-midler, malariamidler, artemisinin og derivater, kombinationer, ATC-kode: P01BF05
English: Malaria is caused by infection with a parasite called Plasmodium, spread by the bite of an infected mosquito.There are different types of Plasmodium parasite.
Danish: Malaria forårsages af en infektion med en parasit kaldet Plasmodium, som spredes via et stik fra en inficeret mosquito.
English: 5 to <7
Danish: 5 til <7
English: Based on animal data, Eurartesim is suspected to cause serious birth defects when administered during the first trimester of pregnancy (see sections 4.4 and 5.3).
Danish: Baseret på data fra dyreforsøg er Eurartesim under mistanke for at medføre alvorlige fødselsdefekter, når det indgives i graviditetens 1. trimester (se pkt.
English: 95% two-sided CI on the treatment difference (Eurartesim - Comparator); p-value
Danish: 95 % tosidet CI for behandlingsforskel (Eurartesim - Komparator), p-værdi
English: Analysis of cardiac adverse events in clinical trials showed that these were reported more frequently in Eurartesim treated patients than in those treated with comparator antimalarial (see section 4.8).
Danish: Ved analyse af kardielle uønskede hændelser blev disse rapporteret hyppigere hos patienter behandlet med Eurartesim end hos patienter, der blev behandlet med sammenlignende lægemidler mod malaria (se pkt.
English: 95 % two-sided CI on the treatment difference (EurartesimComparator); p-value
Danish: 95 % tosidet CI for behandlingsforskel (EurartesimKomparator), p-værdi
English: The most frequent ADRs observed at an incidence ≥1.0% were: Headache (3.9%), Electrocardiogram QTc Prolonged (3.4%), P. falciparum infection (3.0%), Anaemia (2.8%), Eosinophilia (1.7%), Haemoglobin decreased (1.7%), Sinus tachycardia (1.7%), Asthenia (1.6%), Haematocrit [decreased] (1.6%), Pyrexia (1.5%), Red Blood Cell Count decreased (1.4%).
Danish: De hyppigste bivirkninger, som blev observeret med en incidens på ≥1,0 %, var: Hovedpine (3,9 %), EKG QTc-forlængelse (3,4 %), P. falciparum infektion (3,0 %), anæmi (2,8 %), eosinofili (1,7 %), nedsat hæmoglobin (1,7 %), sinus takykardi (1,7 %), asteni (1,6 %), [nedsat] hæmatokrit (1,6 %), pyreksi (1,5 %), nedsat antal røde blodlegemer (1,4 %).
English: • Cisapride, droperidol, domperidone, bepridil, diphemanil, probucol, levomethadyl, methadone, vinca alkaloids, arsenic trioxide.
Danish: • Cisaprid, droperidol, domperidon, bepridil, diphemanil, probucol, levomethadyl, metadon, vinca alkaloider, arseniktrioxid.
English: Animal studies showed that radiolabelled piperaquine is excreted by the biliary route, while urinary excretion is negligible.
Danish: Dyreforsøg viste, at radioaktivt mærket piperaquin udskilles via galden, mens udskillelse i urin er ubetydelig.
English: In healthy volunteers, piperaquine exposure is increased approximately 3-fold when administered with a high fat/high calorie meal.
Danish: Hos raske frivillige forhøjedes eksponeringen over for piperaquin ca. 3 gange ved indgivelse sammen med et måltid med højt fedtindhold/højt kalorieindhold.
English: Artenimol pharmacokinetic parameters were found to be similar in healthy volunteers of Asian and Caucasian origin.
Danish: Artenimols farmakokinetiske parametre blev fundet til at være sammenlignelige hos raske frivillige af asiatisk og kaukasisk oprindelse.
English: Accordingly, Eurartesim should be administered with water no less than 3 hours after the last food intake, and no food should be taken within 3 hours after each dose (see section 4.2).
Danish: I overensstemmelse hermed bør Eurartesim indgives ikke senere end 3 timer efter sidste indtagelse af et måltid, og der bør ikke indtages et måltid inden for 3 timer efter den sidste dosis (se pkt.
English: From in vitro data, piperaquine undergoes a low level of metabolism by CYP2C19, and is also an inhibitor of this enzyme.
Danish: I følge in vitro-data gennemgår piperaquin CYP2C19-metabolisering på lavt niveau og er også en hæmmer af dette enzym.
English: - Recent treatment with medicinal products known to prolong the QTc interval that may still be circulating at the time that Eurartesim is commenced (e.g. mefloquine, halofantrine, lumefantrine, chloroquine, quinine and other antimalarial medicinal products) taking into account their elimination half-life.
Danish: - Nylig behandling med lægemidler, som vides at forlænge QTc-intervallet, og som har lang halveringstid vedpåbeyndelse af Euratesim (f.eks. mefloquin, halofantrin, lumefantrin, chloroquin, quinin og andre lægemidler mod malaria), under hensyntagen til deres halveringstid for elimination.
English: These adverse reactions were seen in animals at exposure levels similar to clinical exposure levels, and with possible relevance to clinical use.
Danish: Disse bivirkninger er set i dyrestudier efter eksponering for plasmakoncentrationer, der svarer til human-terapeutiske doser, og kan muligvis være klinisk relevante.
English: A second course of Eurartesim should not be given within 2 months after the first course due to the long elimination half-life of piperaquine (see sections 4.4 and 5.2).
Danish: Behandling med Eurartesim bør ikke gentages inden for 2 måneder efter første behandlingsforløb, på grund af den lange halveringstid for elimination af piperaquin (se pkt.
English: The mean oral clearance for adult patients with malaria was 2.09 l/h/kg, while in paediatric patients was 2.43 l/h/kg.
Danish: Den gennemsnitlige orale elimination for voksne patienter med malaria var 2,09 l/t/kg, mens den var 2,43 l/t/kg for pædiatriske patienter.
English: Piperaquine pharmacokinetic parameters were found to be similar in healthy volunteers of Asian and Caucasian origin.
Danish: Piperaquins farmakokinetiske parametre fandtes at være sammenlignelige hos raske frivillige af asiatisk og kaukasisk oprindelse.
English: In vitro drug-drug interaction studies revealed that artenimol is an inhibitor of CYP1A2; therefore, there is the potential for artenimol to increase plasma concentrations of CYP1A2 substrates (see section 4.5).
Danish: In vitro lægemiddel-lægemiddel interaktionsundersøgelser afslørede, at artenimol er en hæmmer for CYP1A2, derfor er der potentiale for, at artenimol forhøjer plasmakoncentrationerne af CYP1A2-substrater (se pkt.
English: White oblong biconvex film-coated tablet (dimension 11.5x5.5mm / thickness 4.4mm) with a break-line and marked on one side with the letters “S” and “T”.
Danish: Hvid, aflang, bikonveks filmovertrukket tablet (dimensioner 11,5 x 5 mm / tykkelse 4,4 mm) med en delekærv og præget på den ene side med bogstaverne “S” og “T”.
English: Piperaquine was found to be an inhibitor of CYP3A4 (also in a time-dependent way) and to a lesser extent of CYP2C19, while it stimulated the activity of CYP2E1.
Danish: Piperaquin fandtes at være en hæmmer af CYP3A4 (også i en tidsafhængig grad) og i en mindre udstrækning af CYP2C19, mens det stimulerede aktiviteten af CYP2E1.
English: A moderate increase of piperaquine plasma concentrations (<2-fold) was observed when co-administered with strong CYP3A4 inhibitors, resulting in a potential exacerbation of the effect on QTc prolongation (see section 4.5).
Danish: En moderat forhøjelse af piperaquin-plasmakoncentrationen (< 2 gange) blev observeret ved administration sammen med potente CYP3A4-hæmmere, hvilket fører til en mulig forstærket virkning på QTc-forlængelse (se pkt.
English: Email: antonietta.pazardjiklian@alfasigma.com
Danish: E-mail: antonietta.pazardjiklian@alfasigma.com
English: If you or your child forgets to take Eurartesim
Danish: Hvis du eller dit barn har glemt at tage Eurartesim
English: artenimol systemic exposure on the last day of treatment was higher in females than in males, the difference being within 30%.
Danish: Den systemiske eksponering for artenimol på den sidste behandlingsdag var højere hos kvinder end hos mænd.
English: Piperaquine is also a substrate of CYP3A4.
Danish: Piperaquin er også substrat for CYP3A4.
English: Respiratory tract infection Influenza
Danish: Luftvejsinfektion Influenza
English: The concurrent administration of oral Eurartesim with 7.5 mg oral midazolam, a CYP3A4 probe substrate, led to a modest increase (≤2-fold) in midazolam and its metabolites exposures in healthy adult subjects.
Danish: Samtidig administration af oral Eurartesim og 7,5 mg oral midazolam, et testsubstrat for CYP3A4, fører til en moderat forhøjelse (≤ 2 gange) af eksponeringen for midazolam og dets metabolitter hos raske, voksne personer.
English: 24 to <36
Danish: 24 til <36
English: In human studies, piperaquine was found to be a mild inhibitor of CYP3A4 enzyme while potent inhibitors of CYP3A4 activity caused mild inhibition of piperaquine metabolism (see section 4.5).
Danish: I studier med mennesker blev det observeret, at piperaquin var en svag hæmmer af CYP3A4-enzymet, mens potente hæmmere af CYP3A4-aktivitet førte til en svag hæmning af metaboliseringen af piperaquin (se pkt.
English: 7 to <13
Danish: 7 til <13
English: • The Physician Leaflet including the Contraindicated Conditions of Use and Contraindicated
Danish: • Lægebrochure, herunder kontraindicerede betingelser for brug og afkrydsningsliste for kontraindiceret samtidig medicin