natgillin/translations-raw huggingface dataset:
Det er påvist, at probenecid (500 mg fire gange daglig), en substans som blokerer den tubulære sekretion i nyrerne, hæmmer renal udskillelse af den primære metabolit, men ikke af levetiracetam.
Probenecid (500 mg four times daily), a renal tubular secretion blocking agent, has been shown to inhibit the renal clearance of the primary metabolite but not of levetiracetam.
Levetiracetams påvirkning på probenecid var ikke undersøgt og virkningen af levetiracetam på andre lægemidler som udskilles ved aktiv sekretion f. eks.
The effect of levetiracetam on probenecid was not studied and the effect of levetiracetam on other actively secreted medicinal products, e. g.
Som med andre antiepileptika kan fysiologiske forandringer under graviditeten påvirke koncentrationen af levetiracetam.
As with other antiepileptic drugs, physiological changes during pregnancy may affect levetiracetam concentration.
Der er ikke lavet undersøgelser vedrørende påvirkningen af evnen til at føre bil eller betjene maskiner.
17 No studies on the effects on the ability to drive and use machines have been performed.
Da den individuelle følsomhed er forskellig, kan nogle patienter opleve træthed eller andre central nervesystems relaterede symptomer i begyndelsen af behandlingen eller ved øgning af dosis.
Due to possible different individual sensitivity, some patients might experience somnolence or other central nervous system related symptoms, especially at the beginning of treatment or following a dose increase.
17 49, 8% af patienterne i monoterapibehandling fik mindst én bivirkning relateret til lægemidlet.
In monotherapy 49.8% of the subjects experienced at least one drug related undesirable effect.
0, 0% af patienterne i Keppragruppen og 1, 0% af patienterne i placebogruppen oplevede alvorlige bivirkninger..
Serious undesirable effects were experienced in 0.0% of the patients in the Keppra group and 1.0% of the patients in the placebo group.
Bivirkninger rapporteret i kliniske afprøvninger (voksne og børn) eller fra erfaring efter markedsføring vises i nedenstående tabel med organklasse og frekvens.
Undesirable effects reported in clinical studies (adults and children) or from post-marketing experience are listed in the following table per System Organ Class and per frequency.
For kliniske afprøvninger er frekvensen defineret på følgende måde: meget almindelig (≥10); almindelig (≥1/ 100, < 1/ 10); usædvanlig (≥1/ 1000, < 1/ 100); sjælden (≥1/ 10000, < 1/ 1000; meget sjælden (< 1/ 10000), inklusive enkeltstående indberetninger:
For clinical trials, the frequency is defined as follows: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000), including isolated reports.
Meget almindelig: asteni/ træthed
Very common: asthenia/ fatigue.
Meget almindelig: somnolens Almindelig: amnesi, ataksi, krampe, svimmelhed, hovedpine, hyperkinesi, tremor, balanceforstyrrelser, koncentrationssvækkelse, hukommelsessvækkelse Erfaring efter markedsføring: paraesthesi
Post-marketing experience: paraesthesia
Almindelig: agitation, depression, emotionel labilitet/ humørsvingninger, fjendtlighed/ aggression, søvnløshed, nervøsitet/ irritabilitet, personlighedsforstyrrelse, abnorm tænkning Erfaring efter markedsføring: unormal adfærd, vrede, angst, forvirring, hallucinationer, psykotisk lidelse, selvmord, selvmordsforsøg og selvmordstanker
Common: agitation, depression, emotional lability / mood swings, hostility/ aggression, insomnia, nervousness/ irritability, personality disorders, thinking abnormal Post-marketing experience: abnormal behaviour, anger, anxiety, confusion, hallucination, psychotic disorder, suicide, suicide attempt and suicidal ideation
18 Erfaring efter markedsføring: vægttab
Post-marketing experience: weight loss
Almindelige: diplopi, sløret syn
Common: diplopia, vision blurred
Somnolens, agitation aggression, nedsat bevidsthed, repirationshæmning og coma blev set ved overdosering med Keppra.
19 Somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma were observed with Keppra overdoses.
19 Virkningsmekanismen for levetiracetam mangler stadig at blive fuldstændigt belyst, men den ser ud til at være forskellig fra mekanismerne hos andre antiepileptiske lægemidler.
The mechanism of action of levetiracetam still remains to be fully elucidated but appears to be different from the mechanisms of current antiepileptic medicinal products.
Effekten af levetiracetam hos pædiatriske patienter (4- 16 år) blev påvist i et dobbeltblindt placebokontrolleret forsøg med 198 patienter og en behandlingsvarighed på 14 uger.
20 In pediatric patients (4 to 16 years of age), levetiracetam efficacy was established in a double-blind, placebo-controlled study, which included 198 patients and had a treatment duration of 14 weeks.
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 udgangsniveau.
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.
Patienterne blev randomiseret til carbamazepin CR 400- 1200 mg/ dag eller levetiracetam 1000- 3000 mg/ dag, varigheden af behandlingen var op til 121 uger afhængigt af respons.
The patients were randomized to carbamazepine CR 400 – 1200 mg/ day or levetiracetam 1000 – 3000 mg/ day, the duration of the treatment was up to 121 weeks depending on the response.
20 I et forsøg, som afspejlede klinisk praksis, kunne samtidig antiepileptisk medicin seponeres hos et afgrænset antal patienter, som responderede på levetiracetam som tillægsbehandling (36 voksne patienter ud af 69).
In a study reflecting clinical practice, the concomitant antiepileptic medication could be withdrawn in a limited number of patients who responded to levetiracetam adjunctive therapy (36 adult patients out of 69).
58, 3% af de patienter som fik levetiracetam og 23, 3% af de patienter som fik placebo, havde mindst 50% reduktion i antal dage med myoklone anfald pr. uge.
58.3% of the levetiracetam treated patients and 23.3% of the patients on placebo had at least a 50% reduction in myoclonic seizure days per week.
Effekten af levetiracetam blev påvist i et 24 ugers dobbeltblindt placebokontrolleret forsøg, som omfattede voksne og unge samt et begrænset antal børn med idiopatisk generaliseret epilepsi med primære generaliserede toniske- kloniske anfald (PGTC) i forskellige syndromer (juvenil myoklon epilepsi, juvenil absence epilepsi, børne absence epilepsi eller epilepsi med Grand Mal anfald ved opvågning).
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).
Levetiracetam er en højt opløselig og permeabel substans.
21 Levetiracetam is a highly soluble and permeable compound.
Den farmakokinetiske profil er lineær med lille variation hos det enkelte indvidid og mellem individer.
The pharmacokinetic profile is linear with low intra- and inter-subject variability.
Signifikant korrelation mellem spyt og plasmakoncentrationer er blevet påvist hos voksne og børn (ratio af spyt/ plasmakoncentrationer strakte sig fra 1 til 1, 7 for henholdsvis orale tabletformuleringer og orale opløsningsformuleringer 4 timer efter dosering.
A significant correlation between saliva and plasma concentrations has been shown in adults and children (ratio of saliva/ plasma concentrations ranged from 1 to 1.7 for oral tablet formulation and after 4 hours post-dose for oral solution formulation).
21 Der foreligger ingen data vedrørende vævsfordeling hos mennesker.
No tissue distribution data are available in humans.
0, 5 til 0. 7 l/ kg, en værdi der ligger tæt påtotal volumen af kropsvæske.
The volume of distribution of levetiracetam is approximately 0.5 to 0.7 l/ kg, a value close to the total body water volume.
In vitro undersøgelser viste, at levetiracetam og dets primære metabolit ikke hæmmer de vigtigste human lever cytochrom P450 isoformer (CYP3A4, 2A6, 2C9, 2C19, 2D6, 2E1 og 1A2), glucuronyltransferase (UGT1A1 og UGT1A6) og epoxid hydroxylase aktiviteter Desuden påvirker levetiracetam ikke in vitro glukuronidering af valproatsyre.
In vitro, levetiracetam and its primary metabolite have been shown not to inhibit the major human liver cytochrome P450 isoforms (CYP3A4, 2A6, 2C9, 2C19, 2D6, 2E1 and 1A2), glucuronyl transferase (UGT1A1 and UGT1A6) and epoxide hydroxylase activities.
In vitro data og in vivo interaktionsdata med perorale antikonceptionsmidler, digoxin og warfarin viste, at der ikke kan forventes signifikant enzyminduktion in vivo.
The in vitro data and in vivo interaction data on oral contraceptives, digoxin and warfarin indicate that no significant enzyme
Efter indgivelse af en enkelt oral dosis (20 mg/ kg) til børn (6 til 12 år) med epilepsi, var halveringstiden for levetiracetam 6, 0 timer.
Following single oral dose administration (20 mg/ kg) to epileptic children (6 to 12 years), the half-life of levetiracetam was 6.0 hours.
22 og dosis proportionale øgninger blev observeret for peak plasma koncentrationer og AUC.
Linear and dose proportional increases were observed for peak plasma concentrations and area under the curve.
Farmakokinetiske reultater indikerer at halveringstiden var kortere (5, 3 timer) end for voksne (7, 2 timer), og tilsyneladende clearance er hurtigere (1, 5 ml/ min/ kg) end hos voksne (0, 96 ml/ min/ kg).
The pharmacokinetic results indicated that half-life was shorter (5.3 h) than for adults (7.2 h) and apparent clearance was faster (1.5 ml/ min/ kg) than for adults (0.96 ml/ min/ kg).
Hos personer med mild og moderat leverfunktionsnedsættelse fandtes der ikke nogen relevant ændring af clearance for levetiracetam.
23 In subjects with mild and moderate hepatic impairment, there was no relevant modification of the clearance of levetiracetam.
Croscarmellosenatrium
Sodium croscarmellose Macrogol 6000 Colloidal anhydrous silica Magnesium stearate
Filmovertræk:
Film-coating Opadry 85F32004:
Opadry 85F32004 Polyvinylalkohol delvis hydrolyseret Titandioxid (E 171) Macrogol 3350 Talcum Gul jernoxid (E 172)
Polyvinyl alcohol-part. hydrolyzed Titanium dioxide (E171) Macrogol 3350 Talc Iron oxide yellow (E172)
Keppra 500 mg filmovertrukne tabletter er pakket i aluminium/ PVC blister, indlagt i papæsker indeholdende 10, 20, 30, 50, 60, 100, 120 og 200 film- overtrukne tabletter.
24 Keppra 500 mg film-coated tablets are packaged in aluminium/ PVC blisters placed into cardboard boxes containing 10, 20, 30, 50, 60, 100, 120 and 200 film-coated tablets.
29. september 2000
29 September 2000 Date of last renewal:
Keppra 750 mg filmovertrukne tabletter.
Keppra 750 mg film-coated tablets.
Hver filmovertrukken tablet indeholder 750 mg levetiracetam Hjælpestof: farvestof E 110.
Each film-coated tablet contains 750 mg levetiracetam Excipient: colouring agent E110.
Orange aflang, med delekærv og graveret med koden “ ucb ” og ” 750 ” på den ene side.
Orange, oblong, scored and debossed with the code “ ucb” and “ 750” on one side.
Indikationen for Keppra er tillægsbehandling • af voksne og børn over 4 år med partiel epilepsi med eller uden sekundær generalisering. • af voksne og unge over 12 år med juvenil myoklon epilepsi med myoklone anfald. • af voksne og unge over 12 år med Idiopatisk Generaliseret Epilepsi med primære generaliserede toniske- kloniske anfald.
Keppra is indicated as adjunctive therapy • in the treatment of partial onset seizures with or without secondary generalisation in adults and children from 4 years of age with epilepsy. • in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy. • in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.
• Tillægsbehandling Voksne (≥ 18 år) og unge (12 til 17 år) som vejer 50 kg eller mere.
• Add-on therapy Adults (≥ 18 years) and adolescents (12 to 17 years) weighing 50 kg or more
Ældre (65 år og ældre)
26 Elderly (65 years and older)
Justering af dosis anbefales hos ældre patienter med nedsat nyrefunktion (se “ Patienter med nedsat nyrefunktion ” nedenfor).
Adjustment of the dose is recommended in elderly patients with compromised renal function (see “ Patients with renal impairment ” below).
Børn fra 4 til 11 år og unge (12 til 17 år) som vejer mindre end 50 kg:
Children aged 4 to 11 years and adolescents (12 to 17 years) weighing less than 50 kg
26 Den initiale, terapeutiske dosis er 10 mg/ kg to gange daglig.
The initial therapeutic dose is 10 mg/ kg twice daily.
Derefter justeres CLcr for legemets overfladearea (BSA) på følgende måde:
Then CLcr is adjusted for body surface area (BSA) as follows:
Dosisjustering for voksne patienter med nedsat nyrefunktion
27 Dosing adjustment for adult patients with impaired renal function
(5) En 750 mg støddosis anbefales ved første behandlingsdag med levetiracetam.
(1) A 750 mg loading dose is recommended on the first day of treatment with levetiracetam.
(6) Efter dialyse anbefales 250 mg til 500 mg som supplerende dosis.
(2) Following dialysis, a 250 to 500 mg supplemental dose is recommended.
27 Til børn med nedsat nyrefunktion skal levetiracetam dosis justeres i forhold til nyrefunktionen da levetiracetam clearance er afhængig af nyrefunktionen.
For children with renal impairment, levetiracetam dose needs to be adjusted based on the renal function as levetiracetam clearance is related to renal function.
I overensstemmelse med nuværende klinisk praksis anbefales det, at Keppra, hvis behandlingen skal afbrydes, seponeres gradvist (f. eks. for voksne: reduktion med 500 mg to gange daglig hver anden til fjerde uge); for børn: dosis bør ikke reduceres med mere end 10 mg/ kg to gange daglig hver anden uge).
500 mg decreases twice daily every two to four weeks; in children: dose decrease should not exceed 10 mg/ kg twice daily every two weeks).
Derfor bør patienterne overvåges for, om de får tegn på selvmordstanker og – adfærd, og passende behandling bør overvejes.
28 Therefore patients should be monitored for signs of depression and/ or suicidal ideation and behaviours and appropriate treatment should be considered.
Præ- marketing data fra kliniske undersøgelser udført på voksne tyder på, at Keppra ikke påvirker serum koncentrationerne af eksisterende antiepileptika (phenytoin, carbamazepin, valproat, phenobarbital, lamotrigin, gabapentin og primidon), og at disse antiepileptika ikke påvirker Keppra’ s farmakokinetik.
Pre-marketing data from clinical studies conducted in adults indicate that Keppra did not influence the serum concentrations of existing antiepileptic medicinal products (phenytoin, carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin and primidone) and that these antiepileptic medicinal products did not influence the pharmacokinetics of Keppra.
28 Retrospektiv vurdering af farmakokinetiske interaktioner hos børn og unge (4 til 17 år) med epilepsi bekræftede at samtidig behandling med oralt administreret levetiracetam ikke havde indflydelse på steady state serum koncentrationer af samtidigt administreret carbamazepin og valproat.
A retrospective assessment of pharmacokinetic interactions in children and adolescents with epilepsy (4 to 17 years) confirmed that adjunctive therapy with orally administered levetiracetam did not influence the steady-state serum concentrations of concomitantly administered carbamazepine and valproate.
Data tydede imidlertid på en 22% højere levetiracetam clearance hos børn, som tog enzyminducerende antiepileptiske lægemidler.
However, data suggested a 22% higher levetiracetam clearance in children taking enzyme- inducing antiepileptic medicinal products.
Da den individuelle følsomhed er forskellig, kan nogle patienter opleve træthed eller andre central nervesystems relaterede symptomer især i begyndelsen af behandlingen eller ved øgning af dosis.
Due to possible different individual sensitivity, some patients might experience somnolence or other central nervous system related symptoms, especially at the beginning of treatment or following a dose increase.
2, 4% af patienterne i Keppragruppen og 2, 0% af patienterne i placebogruppen fik alvorlige bivirkninger. De hyppigst rapporterede bivirkninger var
Serious undesirable effects were experienced in 2.4% of the patients in the Keppra and 2.0% of the patients in the placebo groups.
29 somnolens, asteni og svimmelhed.
The most commonly reported undesirable effects were somnolence, asthenia and dizziness.
49, 8% af patienterne i monoterapibehandling fik mindst én bivirkning relateret til lægemidlet.
In monotherapy 49.8% of the subjects experienced at least one drug related undesirable effect.
En undersøgelse udført med pædiatriske patienter (4- 16 år) med anfald af partiel type viste at 55, 4% af patienterne i Keppragruppen og 40, 2% af patientererne i placebogruppen oplevede bivirkninger.
A study conducted in paediatric patients (4 to 16 years) with partial onset seizures showed that 55.4% of the patients in the Keppra group and 40.2% of the patients in the placebo group experienced undesirable effects.
0, 0% af patienterne i Keppragruppen og 1, 0% af patienterne i placebogruppen oplevede alvorlige bivirkninger.
Serious undesirable effects were experienced in 0.0% of the patients in the Keppra group and 1.0% of the patients in the placebo group.
(≥1/ 10000, < 1/ 1000; meget sjælden (< 1/ 10000), inklusive enkeltstående indberetninger:
For clinical trials, the frequency is defined as follows: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000), including isolated reports.
Risikoen for anoreksi er større, når topiramat gives samtidig med levetiracetam.
The risk of anorexia is higher when topiramate is coadministered with levetiracetam.
Erfaring efter markedsføring: vægttab
Post-marketing experience: weight loss
Farvestoffet E 110 kan give allergiske reaktioner.
E 110 coloring agent may cause allergic reactions.
Symptomer
31 Symptoms
31 Virkningsmekanisme
Mechanism of action
Virkningsmekanismen for levetiracetam mangler stadig at blive fuldstændigt belyst, men den ser ud til at være forskellig fra mekanismerne hos andre antiepileptiske lægemidler.
The mechanism of action of levetiracetam still remains to be fully elucidated but appears to be different from the mechanisms of current antiepileptic medicinal products.
I en samlet analyse var den procentdel af patienterne, som opnåede 50% eller større reduktion fra baseline i frekvensen af partielle anfald pr. uge ved stabil dosis (12/ 14 uger) på 27, 7%, 31, 6% og 41, 3% for patienter, som fik hhv.
In a pooled analysis, the percentage of patients who achieved 50% or greater reduction from baseline in the partial onset seizure frequency per week at stable dose (12/ 14 weeks) was of 27.7%,
1000, 2000 eller 3000 mg levetiracetam og på 12, 6% hos patienter, som fik placebo.
32 31.6% and 41.3% for patients on 1000, 2000 or 3000 mg levetiracetam respectively and of 12.6% for patients on placebo.
Effekten af levetiracetam hos pædiatriske patienter (4- 16 år) blev påvist i et dobbeltblindt placebokontrolleret forsøg med 198 patienter og en behandlingsvarighed på 14 uger.
In pediatric patients (4 to 16 years of age), levetiracetam efficacy was established in a double-blind, placebo-controlled study, which included 198 patients and had a treatment duration of 14 weeks.
Ved fortsat langtidsbehandling var 11, 4% af patienterne anfaldsfrie i mindst 6 måneder og 7, 2% var anfaldsfrie i mindst 1 år.
With continued long-term treatment, 11.4% of the patients were seizure-free for at least 6 months and 7.2% were seizure-free for at least 1 year.
Mere end
Six-month seizure freedom was achieved in 73.0% of levetiracetam-treated patients and 72.8% of carbamazepine-CR treated patients; the adjusted absolute difference between treatments was 0.2% (95% CI: -7.8 8.2).
I et forsøg som afspejlede klinisk praksis, kunne samtidig antiepileptisk medicin seponeres hos et afgrænset antal patienter, som responderede på levetiracetam som tillægsbehandling (36 voksne patienter ud af 69).
In a study reflecting clinical practice, the concomitant antiepileptic medication could be withdrawn in a limited number of patients who responded to levetiracetam adjunctive therapy (36 adult patients out of 69).
58, 3% af de patienter som fik levetiracetam og 23, 3% af de patienter som fik placebo havde mindst 50% reduktion i antal dage med myoklone anfald pr. uge.
58.3% of the levetiracetam treated patients and 23.3% of the patients on placebo had at least a 50% reduction in myoclonic seizure days per week.
Ved fortsat langtidsbehandling var 28, 6% af patienterne fri for myoklone anfald i mindst 6 måneder og 21, 0% var fri for myoklone anfald i mindst 1 år.
With continued long-term treatment, 28.6% of the patients were free of myoclonic seizures for at least 6 months and 21.0% were free of myoclonic seizures for at least 1 year.
72, 2% af de patienter, som blev behandlet med levetiracetam, og 45, 2% af de patienter, som fik placebo, havde 50% eller større reduktion i frekvensen af PGTC anfald pr. uge.
With continued long-term treatment, 47.4% of
Ved fortsat langtidsbehandling var 47, 4% af patienterne fri for toniske- kloniske anfald i mindst 6 måneder og 31, 5% var fri for toniske- kloniske anfald i mindst 1 år.
33 the patients were free of tonic-clonic seizures for at least 6 months and 31.5% were free of tonic-clonic seizures for at least 1 year.
Signifikant korrelation mellem spyt og plasma koncentrationer er blevet påvist hos voksne og børn (ratio af spyt/ plasma koncentrationer strakte sig fra 1 til 1, 7 for henholdsvis orale tabletformuleringer og orale opløsningsformuleringer 4 timer efter dosering.
A significant correlation between saliva and plasma concentrations has been shown in adults and children (ratio of saliva/ plasma concentrations ranged from 1 to 1.7 for oral tablet formulation and after 4 hours post-dose for oral solution formulation).
33 Maksimale koncentrationer er (Cmax) er normalt 31 og 43 ug/ ml efter henholdsvis en enkelt dosis på 1000 mg og gentagen dosering 1000 mg 2 gange daglig.
Peak concentrations (Cmax) are typically 31 and 43 µg/ ml following a single 1,000 mg dose and repeated 1,000 mg twice daily dose, respectively.
Levetiracetam fremkaldte ikke enzyminduktion i dyrkede humane hepatocytter, og levetiracetam havde ingen eller lille effekt på CYP1A2, SULT1E1 eller UGT1A1.
34 In human hepatocytes in culture, levetiracetam had little or no effect on CYP1A2, SULT1E1 or UGT1A1.
34 Efter indgivelse af en enkelt oral dosis (20 mg/ kg) til børn (6- 12 år) med epilepsi, var halveringstiden for levetiracetam 6, 0 timer.
Following single oral dose administration (20 mg/ kg) to epileptic children (6 to 12 years), the half-life of levetiracetam was 6.0 hours.
Peak plasma koncentration blev observeret 0, 5 til 1, 0 timer efter dosering.
Peak plasma concentration was observed 0.5 to 1.0 hour after dosing.
Linear og dosis proportionale øgninger blev observeret for peak plasma koncentrationer og AUC.
Linear and dose proportional increases were observed for peak plasma concentrations and area under the curve.
Nedsat leverfunktion
35 Hepatic impairment
35 6. 1 Fortegnelse over hjælpestoffer
6.1 List of excipients
Croscarmellosenatrium Macrogol 6000 Silica, kolloid vandfri Magnesiumstearat
Magnesium stearate
Filmovertræk: Opadry 85F23452 Polyvinylalkohol delvis hydrolyseret Titandioxid (E 171) Macrogol 3350 Talcum Sunset yellow FCF (E 110) Rød jernoxid (E 172)
Polyvinyl alcohol-part. hydrolyzed Titanium dioxide (E171) Macrogol 3350 Talc Sunset yellow FCF aluminium lake (E110) Iron oxide red (E172)
Ingen.
36 No special precautions for storage.