FrancophonIA/ELRC3.0 huggingface dataset:
English: Levetiracetam 1,000 mg daily did not influence the pharmacokinetics of oral contraceptives (ethinylestradiol and levonorgestrel); endocrine parameters (luteinizing hormone and progesterone) were not modified.
Danish: Orale kontraceptiva og andre farmakokinetiske interaktioner Levetiracetam 1.000 mg dagligt påvirker ikke farmakokinetikken af orale kontraceptiva (ethinylestradiol og levonorgestrel); endokrine parametre (luteiniserende hormon og progesteron) blev ikke ændret.
English: If you stop taking Matever
Danish: Hvis De holder op med at tage Matever
English: Efficacy of levetiracetam as monotherapy was established in a double-blind, parallel group, noninferiority comparison to carbamazepine controlled release (CR) in 576 patients 16 years of age or older with newly or recently diagnosed epilepsy.
Danish: Levetiracetams virkning som monoterapi blev påvist i et dobbeltblindt, ækvivalensstudie med parallelle grupper med carbamazepin -depottabletter (CR) hos 576 patienter over 16 år med ny eller nyligt diagnosticeret epilepsi.
English: Matever 250 mg, 750 mg film-coated tablets contain E110 colouring agent which may cause allergic reactions.
Danish: Matever 250 mg, 750mg filmovertrukne tabletter indeholder farvestof E 110, som kan medføre allergiske reaktioner.
English: For children 6 years and above, an oral solution should be used for doses under 250 mg, for doses not multiple of 250 mg when dosing recommendation is not achievable by taking multiple tablets and for patients unable to swallow tablets.
Danish: For børn, der er 6 år og ældre, bør Matever oral opløsning anvendes ved doser under 250 mg, for doser, som ikke er delelig med 250 mg, når anbefalet dosis ikke kan opnås ved at tage flere tabletter og til patienter, som ikke er i stand til at synke tabletter.
English: The active substance, levetiracetam, is a pyrrolidone derivative (S-enantiomer of α-ethyl-2-oxo-1pyrrolidine acetamide), chemically unrelated to existing antiepileptic active substances.
Danish: Det aktive stof, levetiracetam er et pyrrolidon derivat (S-enantiomer af -ethyl-2-oxo-1-pyrrolidin acetamid), og er kemisk set ikke beslægtet med kendte antiepileptisk aktive stoffer.
English: In addition, the available dose strengths of the tablets are not appropriate for initial treatment in children weighing less than 25 kg, for patients unable to swallow tablets or for the administration of doses below 250 mg.
Danish: Desuden er de tilgængelige tabletstyrker ikke egnet til initialbehandling af børn, som vejer mindre end 25 kg, til patienter, som ikke er i stand til at synke tabletter, eller til administration af doser under 250 mg. I alle ovennævnte tilfælde skal en oral opløsning anvendes.
English: Matever concentrate for solution for infusion (Matever concentrate) is a clear, colorless, sterile liquid.
Danish: Matever 100 mg/ml koncentrat til infusionsvæsker, opløsning (Matever-koncentrat) er en klar, farveløs, steril væske.
English: The active substance, levetiracetam, is a pyrrolidone derivative (S-enantiomer of -ethyl-2-oxo-1pyrrolidine acetamide), chemically unrelated to existing antiepileptic active substances.
Danish: Det aktive stof, levetiracetam er et pyrrolidon derivat (S-enantiomer af-ethyl-2-oxo-1-pyrrolidin acetamid), og er kemisk set ikke beslægtet med kendte antiepileptisk aktive stoffer.
English: Steady-state is achieved after two days of a twice daily administration schedule.
Danish: Stabilt plasmaniveau (steady state) opnås inden for 2 dage med dosering 2 gange dagligt.
English: Film-coated tablet.
Danish: LÆGEMIDDELFORM Filmovertrukket tablet.
English: Contains sunset yellow FCF aluminum lake (E110).
Danish: Indeholder sunset yellow FCF (E110).
English: Sorbitan monooleate (E494) Titanium dioxide (E171) Vanillin.
Danish: Sorbitanmonooleat (E494) Titandioxid (E 171) Vanillin
English: One vial of Matever concentrate contains 500 mg levetiracetam (5 ml concentrate of 100 mg/ml).
Danish: Et hætteglas med Matever koncentrat indeholder 500 mg levetiracetam (5 ml koncentrat på 100 mg/ml).
English: Matever concentrate was found to be physically compatible and chemically stable when mixed with the following diluents for at least 24 hours and stored in PVC bags at controlled room temperature 1525°C.
Danish: Matever-koncentrat er fundet fysisk kompatibelt og kemisk stabilt i mindst 24 timer, når det fortyndes med følgende injektionsvæsker og opbevares i PVC beholdere ved kontrolleret stuetemperatur på 1525 °C.
English: The NOAEL was ≥ 1800 mg/kg/day for the F0 females, and for the survival, growth and development of the F1 offspring up to weaning (x 6 the MRHD on a mg/m basis).
Danish: NOAEL var ≥ 1.800 mg/kg/dag for F0-hunnerne samt for overlevelse, vækst og udvikling af F1-afkom indtil ophør af diegivning (6 x MRHD på basis af mg/m
English: An oral solution is the preferred formulation for use in infants and children under the age of 6 years.
Danish: En oral opløsning bør foretrækkes til spædbørn og børn under 6 år.
English: White opaque PVC/PE/PVDC-Aluminium foil blister in cardboard boxes.
Danish: Hvid, uigennemsigtig PVC / PE / PVDCaluminiumsfolie-blisterpakningipapæsker.
English: Matever 250 mg, 750 mg tablets contain Sunset Yellow FCF (E110) Sunset Yellow FCF (E110) colouring agent may cause allergic reactions.
Danish: Matever 250 mg, 750 mg filmovertrukne tabletter indeholder sunset yellow FCF (E110) Sunset yellow FCF (E 110) er et farvestof, som kan give allergiske reaktioner.
English: The other ingredients are: sodium acetate trihydrate, glacial acetic acid, sodium chloride, water for injections.
Danish: Øvrige indholdsstoffer: natriumacetat-trihydrat, eddikesyre, natriumchlorid, vand til injektionsvæsker.
English: Your total daily dose and frequency of administration remain identical.
Danish: Deres totale daglige dosis og antal indgivelser ændres ikke.
English: Tablet core: calcium hydrogen phosphate dihydrate, cellulose microcrystalline, crospovidone type A, hydroxypropylcellulose (L).
Danish: Tabletkerne: calciumhydrogenphosphatdihydrat, cellulose, mikrokrystallinsk, crospovidon (type A), hydroxypropylcellulose (L)
English: Amnesia, memory impairment, coordination abnormal/ataxia, paraesthesia, disturbance in attention
Danish: Amnesi, hukommelsessvækkelse, koordinationsforstyrrelser/ ataksi, paræstesi, opmærksomhedsforstyrrelser
English: 44.6 % of the levetiracetam treated patients and 19.6 % of the patients on placebo had a 50 % or greater reduction from baseline in the partial onset seizure frequency per week.
Danish: 44,6 % af de patienter, som fik levetiracetam, og 19,6 % af de patienter, som fik placebo, havde 50 % eller større reduktion i frekvensen af partielle anfald pr. uge, i forhold til baseline.
English: 5 ml glass vial (type I) with bromobutyl stoppers and sealed with an aluminium flip off cap. Each cartoncontains10 vials.
Danish: 5 ml hætteglas (type I) med bromobutyl prop, som er forseglet med en afrivelig hætte af aluminium.
English: Tél: +33 299 979 212 Hrvatska
Danish: Panpharma Tél: +33 299 979 212
English: Four embryo-fetal development studies were performed in rabbits covering doses of 200, 600, 800, 1200 and 1800 mg/kg/day.
Danish: Der blev udført fire embryo-føtale udviklingsstudier med doser på 200, 600, 800, 1.200 og 1.800 mg/kg/dag i kaniner.
English: Two embryo-fetal development (EFD) studies were performed in rats at 400, 1200 and 3600 mg/kg/day.
Danish: Der blev udført to embryo-føtale udviklingsstudier med 400, 1.200 og 3.600 mg/kg/dag i rotter.
English: Completed suicide, personality disorder, thinking abnormal, delirium
Danish: Selvmord , personlighedsforstyrrelse, abnorm tankegang, delirium
English: The possible side effects of an overdose of Matever are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma.
Danish: Bivirkningerne ved overdosering af Matever er søvnighed, uro, aggressiv adfærd, nedsat årvågenhed, vejrtrækningsbesvær og koma.
English: Levetiracetam efficacy was established in a 24-week double-blind, placebo-controlled study which included adults, adolescents and a limited number of children suffering from idiopathic generalized epilepsy with primary generalized tonic-clonic (PGTC) seizures in different syndromes (juvenile myoclonic epilepsy, juvenile absence epilepsy, childhood absence epilepsy, or epilepsy with Grand Mal seizures on awakening).
Danish: Levetiracetams virkning blev påvist i et 24 -ugers dobbeltblindt, placebokontrolleret studie, som omfattede voksne og unge samt et begrænset antal børn med idiopatisk generaliseret epilepsi med primært generaliserede tonisk-kloniske anfald (PGTC) i forskellige syndromer (juvenil myoklon epilepsi, juvenil absence epilepsi, børne-absence epilepsi eller epilepsi med Grand Mal anfald ved opvågning).
English: Each ml contains 3.81 mg sodium.
Danish: Hjælpestof som behandleren skal være opmærksom på Hver ml indeholder 3,81 mg natrium.
English: The NOAEL was < 200 mg/kg/day for the dams and 200 mg/kg/day for the fetuses (equal to the MRHD on a mg/m basis).
Danish: NOAEL var < 200 mg/kg/dag for hunnerne og 200 mg/kg/dag for fostrene (svarende til MRHD på basis af mg/m
English: In paediatric patients (1 month to less than 4 years of age), levetiracetam efficacy was established in a double-blind, placebo-controlled study, which included 116 patients and had a treatment duration of 5 days.
Danish: Levetiracetams virkning hos pædiatriske patienter (1 måned til under 4 år) blev påvist i et dobbelblindt, placebokontrolleret studie med 116 patienter og en behandlingsvarighed på 5 dage.
English: Following dialysis, a 250 to 500 mg supplemental dose is recommended.
Danish: Efter dialyse anbefales 250 mg til 500 mg som supplerende dosis.
English: The total daily dose and frequency of administration should be maintained.
Danish: Den totale daglige dosis og antal indgivelser bør være de sammme
English: Coating agent (white) consisting of: Hypromellose (E464) Lactose monohydrate Macrogol/PEG 4000
Danish: Coatingmiddel (hvid) bestående af: Hypromellose (E464) Lactosemonohydrat Macrogol /PEG 4000
English: • as an add-on to other antiepileptic medicines to treat: partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of age myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).
Danish: • som tillæg til andre lægemidler mod epilepsi til behandling af: partielle anfald med eller uden generalisering hos voksne, unge, børn og spædbørn over 1 måned myoklone anfald (korte, chok-lignende ryk i en muskel eller i en gruppe af muskler) hos voksne og unge over 12 år med juvenil myoklon epilepsi primært generaliserede tonisk-kloniske anfald (større anfald inklusiv bevidstløshed ) hos voksne og unge over 12 år med idiopatisk generaliseret epilepsi (den type epilepsi, som menes at være genetisk forårsaget)
English: A 10.5 mg/kg (0.105 ml/kg) loading dose is recommended on the first day of treatment with levetiracetam.
Danish: En 10,5 mg/kg (0,105 ml/kg) støddosis anbefales på den første behandlingsdag med levetiracetam.
English: Matever 1000 mg film-coated tablets contain lactose.
Danish: Matever 1000 mg filmovertrukne tabletter indeholder laktose.
English: A 15 mg/kg (0.15 ml/kg) loading dose is recommended on the first day of treatment with levetiracetam.
Danish: En 15 mg/kg (0,15 ml/kg) støddosis anbefales på den første behandlingsdag med levetiracetam.
English: The initial therapeutic dose is 500 mg twice daily.
Danish: Den initiale terapeutiske dosis er 500 mg to gange dagligt.
English: •Lactated Ringer's injection
Danish: • Ringer lactat injektionsvæske
English: Other medicines and Matever
Danish: Brug af anden medicin sammen med Matever
English: Aluminium/ PVC/PE/PVDC blister
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP Aluminium/ PVC/PE/PVDC blister
English: Coating agent (yellow) consisting of: Hydroxypropylcellulose (E463) Hypromellose (E464) Propylene glycol (E1520) Quinoline yellow aluminium lake (E104) Sorbic acid (E200)
Danish: Coatingmiddel (gul) bestående af: Hydroxypropylcellulose (E463) Hypromellose (E464) Propylenglycol (E1520) Quinolingul Aluminium Lake (E104) Sorbinsyre (E200)
English: Coating agent (blue) consisting of: Hypromellose (E464) Titanium dioxide (E171) Talc
Danish: Coatingmiddel (blå) bestående af:Hypromellose (E464) Titandioxid (E 171)
English: The NOAEL (No Observed Adverse Effect Level) was 3600 mg/kg/day for pregnant female rats (x 12 the MRHD on a mg/m basis) and 1200 mg/kg/day for fetuses.
Danish: NOAEL (No Observed Adverse Effect Level) var 3.600 mg/kg/dag for drægtige hunrotter (12 x MRHD (Maximum Recommended Human Dose) på basis af mg/m2) og 1.200 mg/kg/dag for fostre.
English: Matever 250 mg film-coated tablets Matever 500 mg film-coated tablets Matever 750 mg film-coated tablets Matever 1000 mg film-coated tablets
Danish: Matever 250 mg filmovertrukne tabletter Matever 500 mg filmovertrukne tabletter Matever 750 mg filmovertrukne tabletter Matever 1000 mg filmovertrukne tabletter
English: Following dialysis, a 3.5 to 7 mg/kg (0.035 to 0.07 ml/kg) supplemental dose is recommended.
Danish: Efter dialyse anbefales 3,5 til 7 mg/kg (0,035 til 0,07 ml/kg) som supplerende dosis.
English: Matever 250 mg film-coated tablets Matever 500 mg film-coated tablets Matever 750 mg film-coated tablets Matever 1000 mg film-coated tablets levetiracetam
Danish: Matever 250 mg filmovertrukne tabletter Matever 500 mg filmovertrukne tabletter Matever 750 mg filmovertrukne tabletter Matever 1000 mg filmovertrukne tabletter levetiracetam
English: Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis);
Danish: Johnson syndrom) og en mere alvorlig form, der forårsager afskalning af hud på mere end 30 %
English: Dose in children (4 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg: General dose: between 20 mg per kg bodyweight and 60 mg per kg bodyweight each day.
Danish: Dosis til børn og unge (4 til 17 år), som vejer under 50 kg Normaldosis: mellem 20 mg og 60 mg pr. kg legemsvægt dagligt.
English: Intermediate packaging containing 100 tablets for multipack of 200 (2 x 100) tablets [without Blue Box]
Danish: Indre pakning der indeholder 100 filmovertrukne tabletter til multipakning med 200 (2 x 100) filmovertrukne tabletter [UDEN BLÅ BOKS]
English: • amnesia (loss of memory),memory impairment (forgetfulness), abnormal coordination/ataxia
Danish: • amnesi (hukommelsestab), hukommelsessvækkelse (glemsomhed), koordinationsbesvær,
English: As with all antiepileptic medicinal products, sudden discontinuation of levetiracetam should be avoided as this may lead to breakthrough seizures that could have serious consequences for the woman and the unborn child. Monotherapy should be preferred whenever possible because therapy with multiple antiepileptic medicinal products AEDs could be associated with a higher risk of congenital malformations than monotherapy, depending on the associated antiepileptics.
Danish: Hvis det er muligt så foretrækkes monoterapi, da behandling med flere antiepileptika (AED'er) kunne være forbundet med højere risiko for medfødte misdannelser end behandling med monoterapi, afhængigt af de pågældende antiepileptika.
English: • skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens
Danish: • hududslæt, der kan danne blærer, og som ligner små skydeskiver (mørk plet i midten omgivet af et blegere område, med en mørk ring om kanten) (erythema multiforme), et udbredt udslæt med blærer og skællende hud, især omkring munden, næsen, øjnene og kønsdelene (Stevens
English: Peak plasma concentrations (Cmax) are achieved at 1.3 hours after dosing.
Danish: Den absolutte orale biotilgængelighed er næsten Maksimale plasmakoncentrationer (Cmax) opnås 1,3 time efter indtagelse.
English: It is therefore recommended to adjust the maintenance daily dose of Matever, based on creatinine clearance in patients with moderate and severe renal impairment (see section 4.2).
Danish: Hos patienter med moderat og udtalt nyrefunktionsnedsættelse anbefales det derfor at justere daglig vedligeholdelsesdosis af Matever i forhold til kreatininclearance (se pkt.
English: Following dialysis, a 5 to 10 mg/kg (0.05 to 0.10 ml/kg) supplemental dose is recommended.
Danish: Efter dialyse anbefales 5 til 10 mg/kg (0,05 til 0,10 ml/kg) som supplerende dosis.
English: Titanium dioxide (E171).
Danish: Titandioxid (E 171)
English: Children and adolescents • Matever is not indicated in children and adolescents below 16 years on its own (monotherapy).
Danish: Børn og unge Matever, som eneste lægemiddel (monoterapi), er ikke indiceret til børn og unge under 16 år.
English: Dose recommendations for children and adolescents:
Danish: Dosisanbefalinger til børn og unge: Vægt
English: • Dose in infants (1 month to 23 months), children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:
Danish: • Dosis til spædbørn (1 måned til 23 måneder), børn (2 år til 11 år) og unge (12 år til 17 år), som vejer under 50 kg:
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Danish: De kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu/ http://www.ema.europa.eu.
English: 500 mg tablet: quinoline yellow aluminium lake (E104) 750 mg tablet: indigo carmine aluminum lake (E132), sunset yellow FCF aluminum lake (E110) 1000 mg tablet: (no additional colourant).
Danish: 250 mg tablet: indigotin I (E 132), sunset yellow FCF (E 110), quinolingul Aluminium Lake (E104) 500 mg tablet: quinolingul Aluminium Lake (E104) , 750 mg tablet: indigotinI (E 132), sunset yellow FCF (E 110), 1.000 mg tablet: ikke tilsat farvestoffer.
English: Pharmathen S.A., 6 Dervenakion Str., 15351 Pallini, Attiki, Greece
Danish: Pharmathen S.A, 6 DervenakionStr., 15351 Pallini, Attiki, Grækenland.
English: Add-on therapy for adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more
Danish: Tillægsbehandling til voksne (≥18 år) og unge (12 til 17 år) som vejer 50 kg eller mere
English: Dose Withdrawal Volume
Danish: Udtrækningsvolumen Volumen af fortynding svæske
English: What you need to know before you take Matever
Danish: Det skal De vide, før De begynder at tage Matever
English: Serum Creatinine (mg/dl) ks= 0.55 in Children to less than 13 years and in adolescent female; ks= 0.7 in adolescent male
Danish: ks= 0,55 hos børn under 13 år og hos unge kvinder; ks= 0,7 hos unge drenge
English: The CLcr in ml/min/1.73 m may be estimated from serum creatinine (mg/dl) determination, for young adolescents and children using the following formula (Schwartz formula):
Danish: CLcr i ml/min/1,73 m kan hos unge teenagere og børn beregnes ud fra serum-kreatinin (mg/dl) ved at anvende følgende formel (Schwartz formel):
English: A dose of 20 mg/kg/day titrating to 40 mg/kg/day for infants one month to less than six months and a dose of 25 mg/kg/day titrating to 50 mg/kg/day for infants and children 6 months to less than 4 years old, was use in this study.
Danish: I dette studie fik patienterne en daglig dosis oral opløsning på 20 mg/kg, 25 mg/kg, 40 mg/kg eller 50 mg/kg baseret på en titreringsplan i forhold til deres alder. Der blev anvendt en dosis på 20 mg/kg/dag titreret til 40 mg/kg/dag for spædbørn fra 1 måned op til 6 måneder og en dosis på 25 mg/kg/dag titreret til 50 mg/kg/dag for spædbørn og børn fra 6 måneder op til 4 år i dette studie.
English: The CLcr in ml/min/1.73 m may be estimated from serum creatinine (mg/dl) determination, for young adolescents, children and infants, using the following formula (Schwartz formula):
Danish: CLcr i ml/min/1,73 m kan hos unge teenagere, børn og spædbørn beregnes ud fra serum-kreatinin (mg/dl) ved at anvende følgende formel (Schwartz formel):
English: Matever 100 mg/ml concentrate for solution for infusion levetiracetam
Danish: Matever 100 mg/ml koncentrat til infusionsvæske, opløsning levetiracetam
English: Contains glacial acetic acid, water for injections, sodium acetate trihydrate, sodium chloride - see leaflet for further information.
Danish: Indeholder eddikesyre, vand til injektionsvæsker, natriumacetat-trihydrat, natriumchlorid.
English: The recommended dose must be diluted in at least 100 ml of a compatible diluent and infused over 15 minutes.
Danish: Matever er til intravenøs anvendelse.Den anbefalede dosis skal fortyndes med mindst 100 ml forenelig fortyndingsvæske og infunderes i løbet af 15 minutter .
English: Matever is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy.
Danish: Indikationen for Matever er monoterapibehandling af voksne og unge over 16 år, som for nyligt har fået stillet diagnosen partiel epilepsi med eller uden sekundær generalisering.
English: 100 film-coated tablets.
Danish: 100 filmovertrukne tabletter.
English: • Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more: General dose: between 1,000 mg and 3,000 mg each day.
Danish: • Dosis til voksne og unge (12 til 17 år), som vejer 50 kg eller mere: Den sædvanlige dosis er mellem 1.000 mg og 3.000 mg dagligt.
English: The safety and efficacy of Matever in children and adolescents below 16 years as monotherapy treatment have not been established.
Danish: Matevers sikkerhed og virkning som monoterapibehandling hos børn og unge under 16 år er ikke klarlagt.
English: Suicide attempt, suicidal ideation, psychotic disorder, abnormal behaviour, hallucination, anger, confusional state, panic attack, affect lability/mood swings, agitation
Danish: Selvmordsforsøg, selvmordstanker,psykose, unormal adfærd hallucinationer, vrede, konfusion, panikanfald, affektlabilitet/humørsving ninger, agitation
English: België/Belgique/Belgien Pharmathen S.A.
Danish: België/Belgique/Belgien
English: Depression, hostility/ aggression, anxiety, insomnia, nervousness/irritability
Danish: Depression, fjendtlighed/aggress ion, angst, insomni, nervøsitet/ irritabilitet
English: Neonatal and juvenile animal studies in rats and dogs demonstrated that there were no adverse reactions seen in any of the standard developmental or maturation endpoints at doses up to 1800 mg/kg/day (x 6 - 17 the MRHD on a mg/m basis).
Danish: Neonatale og juvenile dyrestudier med rotter og hunde demonstrerede, at der med doser op til 1.800 mg/kg/dag (6-17 x MRHD på basis af mg/m2) ikke var uønskede virkninger på standardudvikling og modningsmålepunkter.
English: Pancytopenia,neutropen ia, agranulocytosis
Danish: Trombocytopeni, leukopeni Pancytopeni, neutropeni, agranulocytose
English: 6, Dervenakion EL-15351 Pallini Attiki Greece
Danish: 6, Dervenakion str., 153 51 Pallini Attiki, Grækenland
English: Each film-coated tablet contains 0.08 mg sunset yellow FCF aluminum lake (E110).
Danish: Hjælpestof som behandleren skal være opmærksom på Hver filmovertrukken tablet indeholder 0,08 mg sunset yellow FCF (E110).
English: Film-coating: hypromellose (E464), titanium dioxide (E171), hydroxypropyl cellulose (E463), propylene glycol (E1520), sorbic acid (E200), sorbitan monooleate (E494), vanillin, colourants*.
Danish: Film-coating: hydroxypropylcellulose (E463), hypromellose (E464), propylenglycol (E1520), sorbinsyre (E200), sorbitanmonooleat (E494), titandioxid (E 171), vanillin, farvestoffer*.
English: 1500 mg 15 ml (three 5 ml vials) 100 ml
Danish: 1.500 mg 15 ml (tre 5 ml hætteglas) 100 ml
English: OTHER SPECIALWARNING(S), IF NECESSARY
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER