FrancophonIA/ELRC3.0 huggingface dataset:
English: This is just in case any of them interfere with how Zebinix works or how Zebinix interferes with their effect.
Danish: Dette er vigtigt, hvis den anden medicin påvirker Zebinix's virkning, eller Zebinix påvirker den anden medicins virkning.
English: • Difficulty in concentration;
Danish: • nedsat koncentration
English: Package leaflet: Information for the user Zebinix 50 mg/ml oral suspension
Danish: Indlægsseddel: Information til brugeren Zebinix 50 mg/ml oral suspension
English: In vivo eslicarbazepine showed an inducing effect on the metabolism of medicinal products that are mainly eliminated by metabolism through CYP3A4 (e.g. Simvastatin).
Danish: In vivo udviste eslicarbazepin en inducerende virkning på metabolismen af lægemidler, der hovedsageligt metaboliseres via CYP3A4 (fx simvastatin).
English: Long-term safety data in the paediatric population obtained from open label extensions of the Phase III study was consistent with the known safety profile of the product with no new findings of concern.
Danish: I den åbne forlængelse til fase III-studiet var data vedrørende den langsigtede sikkerhed hos den pædiatriske populationi overensstemmelse med lægemidlets kendte sikkerhedsprofil, og der blev ikke observeret nye problematiske fund.
English: The oral suspension is packaged in amber glass bottles with HDPE child resistant closures containing 200 ml oral suspension, inside a cardboard box.
Danish: Den orale suspension er emballeret i gulbrune glasflasker med med børnesikrede lukninger af HDPE, der indeholder 200 ml oral suspension, i æsker.
English: Depending on the response to Zebinix, the dose may be increased by 10 mg per kg body weight, at intervals of one or two weeks, up to 30 mg per kg body weight.
Danish: Afhængig af responsen på Zebinix kan dosen øges med 10 mg pr. kg kropsvægt med intervaller på en eller to uger op til 30 mg pr. kg kropsvægt.
English: Administration of eslicarbazepine acetate 1,200 mg once daily to female subjects using a combined oral contraceptive showed an average decrease of 37% and 42% in systemic exposure to levonorgestrel and ethinylestradiol, respectively, most likely caused by an induction of CYP3A4.
Danish: Administration af eslicarbazepinacetat 1.200 mg en gang dagligt til kvindelige forsøgspersoner, som brugte et oralt kontraceptivum af kombinationstypen, viste et gennemsnitligt fald på henholdsvis 37 % og 42 % i systemisk eksponering for levonorgestrel og ethinylestradiol, sandsynligvis pga. induktion af CYP3A4.
English: Zebinix tablets may be taken with or without food.
Danish: Zebinix tabletter kan tages alene eller i forbindelse med et måltid.
English: A study in healthy subjects with eslicarbazepine acetate 1,200 mg once daily showed a minor average pharmacokinetic interaction (exposure of lamotrigine decreased 15%) between eslicarbazepine acetate and lamotrigine and consequently no dose adjustments are required.
Danish: Et studie med administration af eslicarbazepinacetat 1.200 mg en gang dagligt til raske forsøgspersoner viste en mindre gennemsnitlig farmakokinetisk interaktion (eksponering for lamotrigin faldt med 15 %) mellem eslicarbazepinacetat og lamotrigin, og dosisjustering er derfor ikke nødvendig.
English: The treatment effect observed during the 26-week evaluation period was maintained over 1 year of treatment with 64.7 % eslicarbazepine acetate subjects and 70.3 % carbamazepine controlled release subjects classified as seizure free (average risk difference -5.46%, 95% confidence interval: [-11.88; 0.97].
Danish: Behandlingseffekten, som blev observeret i den 26 ugers lange evalueringsperiode, blev opretholdt i 1 behandlingsår, idet 64,7 % af forsøgspersonerne, der fik eslicarbazepinacetat, og 70,3 % af forsøgspersonerne, der fik carbamazepin-depotformulering, blev klassificeret som anfaldsfri (gennemsnitlig risikoforskel -5,46 %, 95 % konfidensinterval: [-11,88; 0,97]).
English: Depending on how you respond to Zebinix, your dose may be increased to 1,200 mg once daily.
Danish: Afhængigt af hvordan De reagerer på Zebinix, kan dosis øges til 1.200 mg en gang dagligt.
English: In patients with CLCR <30 ml/min use is not recommended due to insufficient data.
Danish: Zebinix bør ikke anvendes til patienter med CLCR <30 ml/min pga. manglende dokumentation.
English: In the primary efficacy analysis, in which drop-outs were considered as non-responders, 71.1% subjects were classified as seizure free in the eslicarbazepine acetate group and 75.6% in the carbamazepine controlled release group during the 26 week evaluation period (average risk difference -4.28%, 95% confidence interval: [-10,30; 1,74].
Danish: I den primære effektanalyse, hvor patienter, der forlod studiet, blev betragtet som ikke-respondenter, blev 71,1 % af forsøgspersonerne i eslicarbazepinacetat-gruppen og 75,6% af forsøgspersonerne i gruppen med carbamazepin-depotformulering klassificeret som anfaldsfri i løbet af den 26 ugers lange evalueringsperiode (gennemsnitlig risikoforskel -4,28 %, 95 % konfidensinterval: [-10,30; 1,74]).
English: Studies in animals have shown impairment of fertility after treatment with eslicarbazepine acetate (see section 5.3).
Danish: Dyretudier har vist nedsat fertilitet efter behandling med eslicarbazepinacetat (se pkt.
English: • Feeling extremely sleepy;
Danish: • ekstrem søvnighed
English: • Hearing difficulty;
Danish: • problemer med hørelsen
English: 400 mg (or 10 mg/kg in children above 6 years) every other day for 2 weeks followed by a once daily dose of 400 mg (or 10 mg/kg in children above 6 years).
Danish: 400 mg (eller 10 mg/kg hos børn over 6 år) hver anden dag i to uger efterfulgt af en daglig dosis på 400 mg (eller 10 mg/kg hos børn over 6 år).
English: Class related adverse reactions
Danish: Klasserelaterede bivirkninger
English: Eslicarbazepine acetate was tested at doses of 400 mg (in -301 and -302 studies only), 800 mg and 1,200 mg, once daily.
Danish: Eslicarbazepinacetat blev undersøgt ved doser på 400 mg (kun i studierne -301 og -302), 800 mg og 1.200 mg en gang dagligt.
English: Other medicines and Zebinix
Danish: Brug af anden medicin sammen med Zebinix
English: Based on individual response, the dose of eslicarbazepine acetate may need to be increased if used concomitantly with carbamazepine.
Danish: Afhængigt af den enkelte patients respons skal dosis af eslicarbazepinacetat muligvis øges, hvis det anvendes sammen med carbamazepin.
English: • adjunctive therapy in adults, adolescents and children aged above 6 years with partial-onset seizures with or without secondary generalisation.
Danish: • supplerende antiepileptisk behandling til voksne, unge og børn over 6 år med fokale epileptiske anfald med eller uden sekundær generalisering.
English: Eisai B.V. Tél/Tel: + 31 (0) 900 575 3340
Danish: Tél/Tel: + 31 (0) 900 575 3340
English: A study in healthy subjects showed an average decrease of 50% in systemic exposure to simvastatin when co-administered with eslicarbazepine acetate 800 mg once daily, most likely caused by an induction of CYP3A4.
Danish: I et studie med raske forsøgspersoner sås en gennemsnitlig fald på 50 % i den systemiske eksponering for simvastatin, når det blev anvendt sammen med eslicarbazepinacetat 800 mg en gang dagligt, hvilket sandsynligvis skyldtes induktion af CYP3A4.
English: In a study in healthy subjects, concomitant administration of eslicarbazepine acetate 1,200 mg once daily and phenytoin resulted in an average decrease of 31-33% in exposure to the active metabolite, eslicarbazepine, most likely caused by an induction of glucuronidation, and an average increase of 31-35% in exposure to phenytoin, most likely caused by an inhibition of CYP2C19.
Danish: I et studie med raske forsøgspersoner medførte samtidig administration af eslicarbazepinacetat 1.200 mg en gang dagligt og phenytoin et gennemsnitligt fald på 31-33 % i eksponeringen for den aktive metabolit eslicarbazepin, der sandsynligvis skyldtes induktion af glukuronidering, og en gennemsnitlig stigning på 31-35 % i eksponeringen for phenytoin, sandsynligvis pga. hæmning af CYP2C19.
English: Glucuronidation is the major metabolic pathway for both eslicarbazepine and lamotrigine and, therefore, an interaction could be expected.
Danish: Metabolismen for både eslicarbazepin og lamotrigin finder især sted ved glukuronidering, hvorfor interaktion kunne forventes.
English: Dizziness; somnolence; vertigo; asthenia; gait disturbance; tremor; ataxia; balance disorder; vision blurred; diarrhoea; rash and hyponatraemia were less common in children than in adults.
Danish: Svimmelhed, døsighed, vertigo, asteni, gangforstyrrelse, tremor, ataksi, balanceforstyrrelse, uskarpt syn, diarré, udslæt og hyponatriæmi var mindre almindelig hos børn end hos voksne.
English: • Agitation;
Danish: • ophidselse
English: In the the double-blind period of the phase III study, the least square mean reduction in standardised seizure frequency with eslicarbazepine acetate (-18.1% versus baseline) was different to placebo (8.6% versus baseline) but not statistically significant (p=0.2490).
Danish: I den dobbeltblinde periode af fase III-studiet var mindste kvadraters-gennemsnitlige reduktion i standardiseret anfaldsfrekvens med eslicarbazepinacetat (-18,1 % versus baseline) forskellig fra placebo (-8,6 % versus baseline), men ikke statistisk signifikant (p = 0,2490).
English: Aluminium/Aluminium or PVC/Aluminium blisters placed into cardboard boxes containing 7, 14 or 28 tablets.
Danish: Aluminium/aluminium eller PVC/aluminium blisterkort i æsker med 7, 14 eller 28 tabletter.
English: BIAL - Portela & Cª , SA
Danish: BIAL - Portela & Cª, S.A.
English: Zebinix contains methyl parahydroxybenzoate (E218) and sulphites
Danish: Zebinix indeholder methylparahydroxybenzoat (E218) og sulfitter
English: Forty-two patients (50.6%) in the eslicarbazepine acetate group compared to 10 patients (25.0%) in the placebo group were responders (≥50% reduction of standardised seizure frequency), resulting in a significant difference (p=0.009).
Danish: 42 patienter (50,6 %) i eslicarbazepinacetat-gruppen sammenlignet med 10 patienter (25,0 %) i placebogruppen viste respons (≥ 50 % reduktion i standardiseret anfaldsfrekvens), hvilket resulterede i en signifikant forskel (p = 0,009).
English: • Muscle pain, pain in limbs, muscular weakness;
Danish: • muskelsmerter, smerter i arme og ben, muskelsvaghed
English: The most common adverse reactions reported, in placebo controlled adjunctive therapy studies with adult epileptic patients and in an active controlled monotherapy study comparing eslicarbazepine acetate with carbamazepine controlled release, were dizziness, somnolence, headache, and nausea.
Danish: De hyppigste bivirkninger, der blev rapporteret i placebokontrollerede studier med tillægsbehandling med voksne epilepsipatienter og i et aktivt kontrolleret monoterapistudie, der sammenlignede eslicarbazepinacetat med carbamazepin-depotformulering, var svimmelhed, døsighed, hovedpine og kvalme.
English: Eslicarbazepine acetate was tested at doses of 20 and 30 mg/kg/day, up to a maximum of 1,200 mg/day.
Danish: Eslicarbazepinacetat blev testet ved doser på 20 og 30 mg/kg/dag op til et maksimum på 1.200 mg/dag.
English: • Heart burn, stomach upset, abdominal pain, abdominal bloating and discomfort or dry mouth;
Danish: • halsbrand, urolig mave, mavesmerter, oppustethed og ubehag eller mundtørhed
English: Coordination abnormal, memory impairment, amnesia, hypersomnia, sedation, aphasia, dysaesthesia, dystonia, lethargy, parosmia, cerebellar syndrome, convulsion, peripheral neuropathy, nystagmus, speech disorder, dysarthria, burning sensation, paraesthesia, migraine
Danish: Koordinationsbesvær, svækket hukommelse, amnesi, hypersomni, sedation, afasi, dysæstesi, dystoni, apati, lugtforstyrrelser, cerebralt syndrom, kramper, perifer neuropati, nystagmus, taleforstyrrelser, dysartri, brændende fornemmelse, paræstesi, migræne
English: Based on individual response, the dose may be increased to 1,200 mg once daily.
Danish: Afhængig af den enkelte patients respons kan dosis øges til 1.200 mg en gang dagligt.
English: In a study in healthy subjects, concomitant administration of eslicarbazepine acetate 1,200 mg once daily and topiramate showed no significant change in exposure to eslicarbazepine but an 18% decrease in exposure to topiramate, most likely caused by a reduced bioavailability of topiramate.
Danish: I et studie med samtidig administration af eslicarbazepinacetat 1.200 mg en gang dagligt og topiramat til raske forsøgspersoner sås ingen signifikant ændring i eksponeringen for eslicarbazepin, mens der sås et 18 % fald i eksponeringen for topiramat, sandsynligvis pga. nedsat biotilgængelighed af topiramat.
English: The tablets have ‘ESL 400'engraved on one side and are scored on the other side, with a diameter of 11 mm.
Danish: Tabletterne har 'ESL 400' præget på den ene side og delekærv på den anden side med en diameter på 11 mm.
English: Amber glass bottles with HDPE child resistant closures containing 200 ml oral suspension, inside a cardboard box.
Danish: Gulbrune glasflasker med børnesikrede lukninger af HDPE, der indeholder 200 ml oral suspension, i æsker.
English: Remove the bottle, the oral syringe and the bottle adapter from the box Step 2.
Danish: Tag flasken, mundsprøjten og flaskeadapteren ud af æsken.
English: Take special care when taking Zebinix to avoid accidental injury, such as fall.
Danish: Vær ekstra forsigtig med at undgå uheld som for eksempel fald under behandlingen med Zebinix.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS ALU/ALU blister
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIPS ALU/ALU-blister
English: Epistaxis, chest pain
Danish: Epistaxis, smerter i brystet
English: Visual impairment, oscillopsia, binocular eye movement disorder, ocular hyperaemia
Danish: Nedsat syn, oscillopsi, forstyrrelser i binokulært syn, okulær hyperæmi
English: The efficacy of eslicarbazepine acetate as conversion to monotherapy was evaluated in 2 double-blind, randomized controlled studies in 365 adult patients with partial-onset seizures.
Danish: Eslicarbazepinacetats virkning ved konvertering til monoterapi er blevet undersøgt i 2 dobbeltblinde, randomiserede, kontrollerede studier med 365 voksne patienter med fokale epileptiske anfald.
English: Zebinix is for oral use.
Danish: Zebinix er til indtagelse gennem munden.
English: In children above 6 years, 36 patients (35.0%) in the eslicarbazepine acetate group compared to 29 patients (30.2%) in the placebo group were responders (p=0.4759) and the least square mean reduction in standardised seizure frequency was higher in the eslicarbazepine acetate group compared to placebo (-24.4% versus -10.5%); however, the difference of 13.9% was not statistically significant (p=0.1040).
Danish: Hos børn over 6 år viste 36 patienter (35,0 %) i eslicarbazepinacetat-gruppen respons sammenlignet med 29 patientet (30,2 %) i placebo-gruppen (p = 0,4759), og mindste kvadraters-gennemsnitlige reduktion i standardiseret anfaldsfrekvens var højere i eslicarbazepinacetat-gruppen sammenlignet med placebo (-24,4 % versus -10,5 %).
English: HPDE bottles carton and HPDE bottles of 60 tablets
Danish: Æske med HDPE-flasker og HDPE-flasker med 60 tabletter
English: Psychotic disorder, apathy, depression, nervousness, agitation, irritability, attention deficit/ hyperactivity disorder, confusional state, mood swings, crying, psychomotor retardation, anxiety
Danish: Psykose, apati, depression, nervøsitet, agitation, irritabilitet, nedsat opmærksomhed/hy peraktivitet, konfusion, stemningslabilitet, grådlabilitet, psykomotorisk retardering, angst
English: Malaise, chills, oedema peripheral
Danish: Utilpashed, kuldegysninger, perifere ødemer
English: The tablets are packaged in blisters in cardboard boxes containing 20, 30, 60 or 90 tablets or in multipacks containing 180 (2x90) tablets, and in HDPE bottles with child resistant closure in cardboard boxes containing 90 tablets.
Danish: Tabletterne er pakket i blisterkort i æsker med 20, 30, 60 eller 90 tabletter eller i multipakninger indeholdende 180 (2x90) tabletter, samt i HDPE-flasker med børnesikret lukning i æsker med 90 tabletter.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Box of 7, 14 or 28 tablets
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske med 7, 14 eller 28 tabletter
English: PVC/Aluminium blisters placed into cardboard boxes containing 20 or 60 tablets.
Danish: PVC/aluminium -blisterkort i æsker med 20 eller 60 tabletter.
English: EU/1/09/514/021 20 tablets - PVC/ALU blister EU/1/09/514/022 60 tablets - PVC/ALU blister
Danish: EU/1/09/514/021 20 tabletter - PVC/ALU-blisterkort EU/1/09/514/022 60 tabletter - PVC/ALU-blisterkort
English: The maximum dose is 1,200 mg once daily (see section 5.1).
Danish: Den maksimale dosis er 1.200 mg én gang dagligt (se pkt.
English: Table 1: Treatment emergent adverse reactions associated with Zebinix obtained clinical studies and post-marketing surveillance
Danish: Tabel 1: Behandlingsrelaterede bivirkninger, der er forbundet med Zebinix og observereti kliniske studier og ved overvågning efter markedsføring
English: If you are not sure if the medicines you are taking could have this effect, discuss with your doctor.
Danish: Tal med lægen om dette, hvis De er usikker på, om den medicin, De får, kan have denne virkning.
English: Zebinix may be taken with or without food.
Danish: Zebinix kan tages alene eller i forbindelse med et måltid.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS PVC/ALU blister
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIPS PVC/ALU-blister
English: Urinary tract infection
Danish: • urinvejsinfektion
English: • blistering or peeling of the skin and/or mucous membranes, rash, swallowing or breathing problems, swelling of your lips, face, eyelids, throat or tongue.
Danish: • blærer eller afskalning af hud og/eller slimhinder, udslæt, besvær med at synke eller trække vejret, hævelser i læber, ansigt, øjenlåg, hals eller tunge.
English: Forty-one patients (30.6%) in the eslicarbazepine acetate group compared to 40 patients (31.0%) in the placebo group were responders (≥50% reduction of standardised seizure frequency), resulting in a non-significant difference (p=0.9017).
Danish: 41 patienter (30,6 %) i eslicarbazepinacetat-gruppen viste respons sammenlignet med 40 patienter (31,0 %) i placebogruppen (≥ 50 % reduktion i standardiseret anfaldsfrekvens), hvilket resulterede i en ikke-signifikant forskel (p = 0,9017).
English: Table 1: Treatment emergent adverse reactions associated with Zebinix obtained from in clinical studies and post-marketing surveillance
Danish: Tabel 1: Behandlingsrelaterede bivirkninger, der er forbundet med Zebinix og observeret i kliniske studier og ved overvågning efter markedsføring
English: Toxic epidermal necrolysis, StevensJohnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), angioedema, urticaria
Danish: Toksisk epidermal nekrolyse, StevensJohnsons syndrom, lægemiddel reaktion med eosinofili og systemiske symptomer (DRESS), angioødem, urticaria
English: Therefore, women of childbearing potential must use adequate contraception during treatment with Zebinix, and up to the end of the current menstruation cycle after the treatment has been discontinued (see section 4.6).
Danish: Kvinder i den fertile alder skal derfor benytte tilstrækkelig kontraception under behandling med Zebinix og frem til afslutningen på den aktuelle menstruationscyklus efter endt behandling (se pkt.
English: Aluminium /Aluminium or PVC/Aluminium blisters placed into cardboard boxes containing 30 or 60 tablets.
Danish: Aluminium/aluminium eller PVC/aluminium blisterkort i æsker med 30 eller 60 tabletter.
English: • Anxiety.
Danish: • angst.
English: 20 tablets 60 tablets
Danish: 20 tabletter 60 tabletter
English: Do not use this medicine after the expiry date, which is stated on the blister, bottle and the carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på blisteren, flaske og æsken efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Children ≥60 kg
Danish: Børn med en kropsvægt ≥ 60 kg
English: Each ml of oral suspension contains 50 mg of eslicarbazepine acetate.
Danish: Hver ml oral suspension indeholder 50 mg eslicarbazepinacetat.
English: 30 tablets 60 tablets
Danish: 30 tabletter 60 tabletter
English: Blood pressure decreased, weight decreased, blood pressure increased, blood sodium decreased, blood chloride decreased, osteocalcin increased, haematocrit decreased, haemoglobin decreased, transaminases increased
Danish: Vægtstigning Blodtryksfald, vægttab, forhøjet blodtryk, fald i serumnatrium, nedsat indhold af chlorid i blodet, øget osteocalcin, fald i hæmatokritværdier, fald i hæmoglobinværdier, forhøjede aminotransferaser
English: • with other antiepileptic medicines (adjunctive therapy), in adult, adolescents and children patients above 6 years of age, who are experiencing seizures that affect one part of the brain (partial seizure).
Danish: • sammen med anden medicin mod epilepsi (supplerende behandlin)til voksne, unge og børn over 6 år, som får anfald, der påvirker en del af hjernen (fokale anfald).
English: Children with a body weight of 60 kg or more should be given the same dose as for adults.
Danish: Børn med en kropsvægt på 60 kg eller mere skal have samme dosis som til voksne.
English: zebinix 50 mg/ml (outer pack only)
Danish: zebinix 50 mg/ml (kun på den ydre emballage)
English: The tablets are packaged in blisters in cardboard boxes containing 20 or 60 tablets, and in HDPE bottles with child resistant closure in cardboard boxes containing 60 tablets.
Danish: Tabletterne er pakket i blisterkort i æsker med 20 eller 60 tabletter samt i HDPE-flasker med børnesikret lukning i æsker med 60 tabletter.
English: In the age group from 6 to 11 years of age, the most common adverse reactions observed in more than two patients treated with eslicarbazepine acetate were diplopia (9.5%), somnolence (7.4%), diziness (6.3%), convulsion (6.3%) and nausea (3.2%); in the age group from 12 to 18 years were somnolence (7.4%), vomiting (4.2%), diplopia (3.2%) and fatigue (3.2%).
Danish: I aldersgruppen fra 6 til 11 år var de mest almindelige bivirkninger, der blev observeret hos mere end to patienter behandlet med eslicarbazepinacetat, diplopi (9,5 %) døsighed (7,4 %), svimmelhed (6,3 %), kramper (6,3 %) og kvalme (3,2 %).
English: Myalgia, bone metabolism disorder, muscular weakness, pain in extremity
Danish: Myalgi, forstyrrelse i knoglemetabolismen, muskelsvaghed, ekstremitetssmerter
English: • with other antiepileptic medicines (adjunctive therapy), in adult, adolescents and children patients above 6 years of age, whoare experiencing seizures that affect one part of the brain (partial seizure).
Danish: • sammen med anden medicin mod epilepsi (supplerende behandling) til voksne, unge og børn over 6 år, som får anfald, der påvirker en del af hjernen (fokale anfald).
English: Do not use this medicine after the expiry date, which is stated on the bottle and the carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på flasken og æsken efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The other ingredients are xanthan gum (E415), macrogol-100 stearate, methyl parahydroxybenzoate (E218), saccharin sodium (E954), flavour tutti-frutti artificial (contains maltodextrin, propylene glycol, natural and artificial flavouring, and gum acacia (E414), masking flavour (contains propylene glycol, water and natural and artificial flavouring) and purified water.
Danish: • Øvrige indholdsstoffer: Xanthangummi (E145), macrogol-100-stearat, methylparahydroxybenzoat (E218), saccharinnatrium (E954), kunstigt smagsstof Tutti-Frutti
English: HDPE bottles with polypropylene child resistant closure, inside a cardboard box, containing 60 tablets.
Danish: HDPE-flasker med børnesikret lukning af polypropylen i æsker med 60 tabletter.
English: • Migraine;
Danish: • hovedpine
English: Children with a body weight of ≥60 kg Children with a body weight of 60 kg or more should be given the same dose as for adults.
Danish: Børn med en kropsvægt ≥ 60 kg Børn med en kropsvægt på 60 kg eller mere skal tage den samme dosis som voksne.