natgillin/translations-raw huggingface dataset:
EU/1/11/706/012 10 filmovertrukne tabletter EU/1/11/706/013 30 filmovertrukne tabletter EU/1/11/706/014 100 filmovertrukne tabletter EU/1/11/706/015 130 filmovertrukne tabletter EU/1/11/706/016 175 filmovertrukne tabletter EU/1/11/706/017 250 filmovertrukne tabletter
EU/1/11/706/012 10 film-coated tablets EU/1/11/706/013 30 film-coated tablets EU/1/11/706/014 100 film-coated tablets EU/1/11/706/015 130 film-coated tablets EU/1/11/706/016 175 film-coated tablets EU/1/11/706/017 250 film-coated tablets
EU/1/11/706/018 10 filmovertrukne tabletter EU/1/11/706/019 30 filmovertrukne tabletter EU/1/11/706/020 100 filmovertrukne tabletter EU/1/11/706/021 130 filmovertrukne tabletter EU/1/11/706/022 175 filmovertrukne tabletter
EU/1/11/706/018 10 film-coated tablets EU/1/11/706/019 30 film-coated tablets EU/1/11/706/020 100 film-coated tablets EU/1/11/706/021 130 film-coated tablets EU/1/11/706/022 175 film-coated tablets
Levodopa/Carbidopa/Entacapone Orion indeholder saccharose (2,3 mg/tablet).
Levodopa/Carbidopa/Entacapone Orion contains sucrose (2.3 mg/tablet).
Hvis dette er tilfældet, bør du kontakte din læge, fordi der kan være behov for at justere dosis af din medicin mod Parkinsons sygdom - får diarré: Du anbefales at kontrollere din vægt for at undgå muligt overdrevent vægttab.
In such a case your doctor may need to adjust your other antiparkinson medicines, especially levodopa, to give sufficient control of your symptoms.
Levodopa/Carbidopa/Entacapone Orion indeholder saccharose (1,9 mg/tablet).
Levodopa/Carbidopa/Entacapone Orion contains sucrose (1.9 mg/tablet).
Levodopa/Carbidopa/Entacapone Orion 75 mg/18,75 mg/200 mg filmovertrukne tabletter Levodopa/carbidopa/entacapon
Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
- Øvrige indholdsstoffer i tabletkernen: croscarmellosenatrium, magnesiumstearat, majsstivelse,
- The other ingredients in the tablet core are croscarmellose sodium, magnesium stearate, maize starch, mannitol (E421) and povidone (E1201).
Sådan skal du tage Levodopa/Carbidopa/Entacapone Orion
How to take Levodopa/Carbidopa/Entacapone Orion
Levodopa/Carbidopa/Entacapone Orion 175 mg/43,75 mg/200 mg filmovertrukne tabletter levodopa/carbidopa/entacapon
Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Levodopa/Carbidopa/Entacapone Orion 175 mg/43,75 mg/200 mg filmovertrukne tabletter Levodopa/carbidopa/entacapon
Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Levodopa/Carbidopa/Entacapone Orion indeholder saccharose (1,4 mg/tablet).
Levodopa/Carbidopa/Entacapone Orion contains sucrose (1.4 mg/tablet).
Levodopa/Carbidopa/Entacapone Orion 50 mg/12,5 mg/200 mg filmovertrukne tabletter levodopa/carbidopa/entacapon
Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Levodopa/Carbidopa/Entacapone Orion indeholder saccharose (1,2 mg/tablet).
Levodopa/Carbidopa/Entacapone Orion contains sucrose (1.2 mg/tablet).
Levodopa/Carbidopa/Entacapone Orion indeholder saccharose (1,6 mg/tablet).
Levodopa/Carbidopa/Entacapone Orion contains sucrose (1.6 mg/tablet).
Levodopa/Carbidopa/Entacapone Orion 150 mg/37,5 mg/200 mg filmovertrukne tabletter levodopa/carbidopa/entacapon
Levodopa/Carbidopa/Entacapone Orion 150 mg/37.5 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Levodopa/Carbidopa/Entacapone Orion 125 mg/31,25 mg/200 mg filmovertrukne tabletter Levodopa/carbidopa/entacapon
Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg filmovertrukne tabletter Levodopa/carbidopa/entacapon
Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg filmovertrukne tabletter levodopa/carbidopa/entacapon
Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg filmovertrukne tabletter Levodopa/carbidopa/entacapon
Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Meget almindelig: Dyskinesi* Almindelig:
Nervous system disorders Very common:
Levodopa/Carbidopa/Entacapone Orion 150 mg/37,5 mg/200 mg filmovertrukne tabletter.
Ten tablets of Levodopa/Carbidopa/Entacapone Orion 150 mg/37.5 mg/200 mg equals 375 mg of carbidopa a day.
12 (3 x 4) fyldte penne (multipakning)
1 ml (125 mg/ml) 12 (4 x 3) pre-filled pens (multipack)
4 fyldte penne
1 ml (125 mg/ml) 4 pre-filled pens
Denne dosis bør betragtes som en maksimal dosis for alle patienter.
This dose should be considered as a maximal dose for all patients.
Dato for første markedsføringstilladelse: 24. august 2017
Date of first authorisation: 24 August 2017
Opfølgning skal foretages af Deres læge hver 6. måned.
Follow-up by your doctor should be performed every 6 months.
Der foreligger ikke information om specifik behandling af overdosering.
No information about specific treatment of overdose is available.
Disse stoffer ophobes i kroppen.
These substances are accumulated in your body.
Det kliniske studie var åbent og ukontrolleret.
The clinical study was open-labelled and uncontrolled.
Studiet indikerer, at administration én gang dagligt er sikkert og effektivt hos patienter i alle aldre.
The study indicates that once daily administration is safe and efficacious across all ages of patients.
Data fra et studie anvendt som historisk kontrol (van Spronsen et al., 1994) viste følgende sandsynligheder for overlevelse.
Data from a study used as a historical control (van Spronsen et al., 1994) showed the following survival probability.
Kontakt Deres læge, hvis De planlægger at blive gravid.
Please contact your doctor if you plan to become pregnant.
Kapslerne er pakket i plasticflasker.
The capsules are packaged in plastic bottles.
Glem ikke at mærke flasken med datoen for, hvornår den fjernes fra køleskabet.
Do not forget to mark the date on the bottle, when removed from the refrigerator.
De må ikke ændre dosis eller stoppe behandlingen uden at have talt med Deres læge.
Do not change the dose or stop the treatment without talking to your doctor.
Opbevares i den originale beholder for at beskytte mod lys.
Store in the original bottle in order to protect from light.
2 mg/kg legemsvægt/dag kan være nødvendig baseret på evalueringen af alle biokemiske parametre.
A dose of 2 mg/kg body weight/day may be needed based on the evaluation of all biochemical parameters.
Øvrige indholdsstoffer:
- The other ingredients are:
Under behandlingen vil der blive taget blodprøver, for at Deres læge kan kontrollere, om behandlingen er tilstrækkelig, og for at sikre, at der ikke er nogen mulige bivirkninger, der medfører sygdomme i blodet.
During the treatment, blood samples will be drawn in order for your doctor to check whether the treatment is adequate and to make sure that there are no possible side effects causing blood disorders.
Sandsynlighed for fravær af HCC (95 % konfidensinterval)
Probability of no HCC (95% confidence interval) at
Hvis det biokemiske respons er tilfredsstillende, bør dosis kun justeres i henhold til øgning i legemsvægt.
If the biochemical response is satisfactory, the dose should be adjusted only according to body weight gain.
Tilgængelige data fra en klinisk studie indikerer, at hos mere end 90 % af patienterne blev succinylacetone i urinen normaliseret under den første uges behandling.
Available data from a clinical study indicates that in more than 90% of the patients urine succinylacetone was normalized during the first week of treatment.
NTBC-studiet (N=250)
NTBC study (N=250)
Opfølgningsbesøg bør foretages hver 6. måned; kortere interval mellem hvert besøg anbefales hvis der optræder bivirkninger.
Monitoring visits should be performed every 6 months; shorter intervals between visits are recommended in case of adverse events.
Hver flaske indeholder 60 kapsler.
Each bottle contains 60 capsules.
Behandlingen af alle sygdommens genotyper bør startes så hurtigt som muligt for at øge den totale overlevelse og undgå komplikationer, såsom leversvigt, levercancer og nyresygdomme.
Treatment of all genotypes of the disease should be initiated as early as possible to increase overall survival and avoid complications such as liver failure, liver cancer and renal disease.
Clearance og halveringstid blev bestemt til at være henholdsvis 0,0956 l/kg legemsvægt/dag og 52,1 timer.
The clearance and half-life were determined to be 0.0956 l/kg body weight/day and 52.1 hours respectively.
Der fås andre lægemiddelformer til pædiatriske patienter, som har problemer med at sluge kapsler.
Other pharmaceutical forms are available for paediatric patients who have difficulties swallowing capsules.
Ud fra de kliniske studier og data efter markedsføringen er der ikke noget, der tyder på, at sikkerhedsprofilen er forskellig i forskellige undergrupper af den pædiatriske population eller forskellig fra sikkerhedsprofilen hos voksne patienter.
From clinical study and post marketing data there are no indications that the safety profile is different in different subsets of the paediatric population or different from the safety profile in adult patients.
Der foreligger imidlertid begrænsede data for patienter med legemsvægt < 20 kg.
Data is, however, limited in patients with body weight <20 kg.
Doseringshyppigheden i studiet var to gange dagligt.
The dosing frequency in the study was twice daily.
Hvis De oplever bivirkninger, anbefales kortere intervaller.
If you experience any side effects, shorter intervals are recommended.
De skal følge en speciel diæt, når De tager lægemidlet, fordi tyrosin forbliver i kroppen.
You must follow a special diet while you are taking this medicine, because tyrosine will remain in your body.
111 Power Rd, Unit G.07, Chiswick London, W4 5PY, Det Forenede Kongerige
111 Power Rd, Unit G.07, Chiswick London, W4 5PY, United Kingdom
Dato for udtagning fra køleskab:
Date when removed from refrigerator:
Hvis De imidlertid oplever bivirkninger, der påvirker synet, bør De ikke køre bil eller betjene maskiner, før synet igen er normalt (se punkt 4 ”Bivirkninger”).
However, if you experience side effects affecting your vision you should not drive or use machines until your vision is back to normal (see section 4 “Possible side effects”).
Øjenlågsbetændelse (blepharitis) er en ikke almindelig bivirkning (kan ramme op til 1 ud af 100 personer).
Inflammation of the eyelid (blepharitis) is an uncommon side effect (may affect up to 1 in 100 people).
Det anbefales at administrere dosis én gang dagligt.
It is recommended to administer the dose once daily.
7 Grimes Gate, Diseworth Leicestershire, DE74 2QD Det Forenede Kongerige
7 Grimes Gate, Diseworth Leicestershire, DE74 2QD United Kingdom
Der foreligger ikke tilstrækkelige data fra anvendelse af nitisinon til gravide kvinder.
There are no adequate data from the use of nitisinone in pregnant women.
Hvis De har indtryk af, at lægemidlet ikke virker korrekt, så tal med Deres læge.
If you have the impression that the medicine is not working properly, talk to your doctor.
Hvis De bliver gravid, bør De straks kontakte Deres læge.
If you become pregnant you should contact your doctor immediately.
I kliniske studier var granulocytopeni kun ikke almindeligt alvorlig (<0,5 x 109/l) og ikke associeret med infektioner.
In clinical studies, granulocytopenia was only uncommonly severe (<0.5x109/L) and not associated with infections.
Dosis af nitisinon bør justeres individuelt.
The dose of nitisinone should be adjusted individually.
Hyppigheden defineres som meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Frequency is defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare
Hver æske indeholder en flaske.
Each carton pack contains one bottle.
MedDRA-systemorganklasse Hyppighed
MedDRA system organ class Frequency
Lægen vil justere dosis individuelt.
Your doctor will adjust the dose individually.
Sikkerheden ved lægemidlet er ikke blevet undersøgt hos gravide og ammende kvinder.
The safety of this medicine has not been studied in pregnant and breast-feeding women.
Hvis De har taget mere af dette lægemiddel, end De bør, skal De kontakte Deres læge eller apotek så hurtigt som muligt.
If you have taken more of this medicine than you should, contact your doctor or pharmacist as soon as possible.
Øgning i koncentrationen af serum alfa-føtoprotein kan være et tegn på utilstrækkelig behandling.
Increase in serum alpha-fetoprotein concentration may be a sign of inadequate treatment.
Dosisanbefalingen i mg/kg legemsvægt er den samme hos børn og voksne.
The dose recommendation in mg/kg body weight is the same in children and adults.
En populationsfarmakokinetisk analyse af en population er blevet gennemført på en gruppe på 207 HT-1 patienter.
Population pharmacokinetic analysis has been conducted on a group of 207 HT-1 patients.
Deres lever vil blive kontrolleret med regelmæssige mellemrum, fordi sygdommen påvirker leveren.
Your liver will be checked at regular intervals because the disease affects the liver.
Sandsynlighederne for overlevelse efter 2, 4 og 6 års behandling med nitisinon er opsummeret i nedenstående tabel.
Survival probabilities after 2, 4 and 6 years of treatment with nitisinone are summarized in the table below.
I et internationalt studie af patienter med HT-1, hvor kostrestriktioner var eneste behandling, blev det fundet, at HCC var blevet diagnosticeret hos 18 % af alle patienter i alderen 2 år og derover.
In an international survey of patients with HT-1 on treatment with dietary restriction alone, it was found that HCC had been diagnosed in 18% of all patients aged 2 years and above.
Der blev ikke observeret mutagen, men svag klastogen aktivitet i in vitro studier.
No mutagenic but a weak clastogenic activity was observed in in vitro studies.
Monitorering af plasma-tyrosin-niveauerne
Monitoring of plasma tyrosine levels
Dyrestudier har vist postnatale bivirkninger via eksponering over for nitisinon i mælk.
Animal studies have shown adverse postnatal effects via exposure of nitisinone in milk.
Der var ingen klinisk vigtige forskelle i bivirkninger eller andre sikkerhedsvurderinger mellem dosering én og to gange dagligt.
There were no clinically important differences in AEs or other safety assessments between once and twice daily dosing.
Nitisinon viste ikke karcinogenicitet i et 26-ugers karcinogenicitetsstudie hos transgene mus (TgrasH2).
Nitisinone did not show carcinogenic potential in a 26-week carcinogenicity study in transgenic mice (TgrasH2).
Det er ukendt, om nitisinon udskilles i human mælk.
It is unknown whether nitisinone is excreted in human breast milk.
Det anbefales, at en undersøgelse af øjnene med en spaltelampe udføres, inden der indledes behandling med nitisinon, og derefter regelmæssigt, mindst én gang årligt.
It is recommended that a slit-lamp examination of the eyes is performed before initiation of nitisinone treatment and thereafter regularly, at least once a year.
Nitisinone MDK bør ikke anvendes under graviditeten, medmindre kvindens kliniske tilstand kræver behandling med nitisinon.
Nitisinone MDK should not be used during pregnancy unless the clinical condition of the woman requires treatment with nitisinone.
Ingen patienter havde detekterbart niveau af succinylacetone (SA) ved slutningen af behandlingsperioden med dosering én gang dagligt.
No patient had detectable succinylacetone (SA) levels at the end of the once-daily treatment period.
Nitisinon har imidlertid været givet samtidig med mad under indsamling af effekt- og sikkerhedsdata.
However, nitisinone has been co-administered with food during the generation of efficacy and safety data.
Man fandt ud af, at tidlig indledning af behandling resulterede i en yderligere nedsat risiko for udvikling af hepatocellulært karcinom.
It was found that the early initiation of treatment resulted in a further reduced risk for the development of hepatocellular carcinoma.
Patienter med øgende alfa-føtoprotein eller tegn på knuder i leveren bør altid evalueres for hepatisk malignitet.
Patients with increasing alpha-fetoprotein or signs of nodules in the liver should always be evaluated for hepatic malignancy.
Det anbefales også at monitorere koncentrationen af serum alfa-føtoprotein.
It is recommended to also monitor serum alpha-fetoprotein concentrations.
Hvis De har problemer med at synke kapslerne, kan De åbne kapslen og blande pulveret med en lille smule vand eller diætpulver lige inden indtagelse.
If you have problems with swallowing the capsules, you may open the capsule and mix the powder with a small amount of water or formula diet just before you take it.
Nitisinone MDK blokerer nedbrydningen af tyrosin og de skadelige stoffer dannes derfor ikke.
Nitisinone MDK blocks the breakdown of tyrosine and the harmful substances are not formed.
Nitisinone MDK kan påvirke virkningen af andre lægemidler såsom: - Lægemidler mod epilepsi (såsom phenytoin) - Lægemidler mod blodpropper (såsom warfarin)
Nitisinone MDK may interfere with the effect of other medicines, such as: - Medicines for epilepsy (such as phenytoin) - Medicines against blood clotting (such as warfarin)
Det bør fastslås, om patienten følger sit kostprogram, og plasma-tyrosinkoncentrationen bør måles.
It should be established that the patient is adhering to his/her dietary regimen and the plasma tyrosine concentration should be measured.
Det anbefales ikke at sænke plasmatyrosinkoncentrationen ved reduktion eller afbrydelse af nitisinon, da den metaboliske defekt kan resultere i forværring af patientens kliniske tilstand.
It is not recommended to lower the plasma tyrosine concentration by reduction or discontinuation of nitisinone, since the metabolic defect may result in deterioration of the patient's clinical condition.
Der er ikke udført formelle studier af absorption, fordeling, metabolisme og elimination med nitisinon.
Formal absorption, distribution, metabolism and elimination studies have not been performed with nitisinone.
Udover de ovenfor nævnte tests kan det imidlertid i forbindelse med indledning af behandlingen, efter skift fra dosering to gange dagligt til én gang dagligt, eller hvis der optræder forværring, være nødvendigt at følge alle tilgængelige biokemiske parametre nøjere (dvs. plasma-succinylacetone, urin5-aminolevulinsyre (ALA) og erytrocyt-porfobilinogen (PBG)-syntaseaktivitet).
However, in addition to the tests above, during the initiation of therapy, switch from twice daily to once daily dosing or if there is a deterioration, it may be necessary to follow more closely all available biochemical parameters (i.e. plasma succinylacetone, urine 5-aminolevulinate (ALA) and erythrocyte porphobilinogen (PBG)-synthase activity).
Anvendelse sammen med andre lægemidler
Concomitant use with other medicinal products
Hvis De får røde øjne eller andre tegn på påvirkninger på øjnene,skal De straks kontakte Deres læge for en øjenundersøgelse.
If you get red eyes or any other signs of effects on the eyes, contact your doctor immediately for an eye examination.
Hvis synet er påvirket, bør patienten ikke føre motorkøretøj eller betjene maskiner, indtil reaktionen forbedres.
If the vision is affected the patient should not drive or use machines until the event has subsided.
2, 4 og 6 års sandsynligheden for, at HCC ikke udvikles under nitisinonbehandling for patienter på 24 måneder og derunder ved behandlingsstart, og for patienter over 24 måneder ved behandlingsstart vises i følgende tabel:
The 2-, 4-, and 6-year probability of no occurrence of HCC during nitisinone treatment for patients aged 24 months or younger at the start of treatment and for those older than 24 months at the start of treatment is shown in the following table:
Fertilitet Der foreligger ingen data vedrørende nitisinons indvirkning på fertilitet.
Fertility There are no data on nitisinone affecting fertility.
Hvis succinylacetone stadig kan måles i urinen én måned efter start på behandling med nitisinon, bør dosis af nitisinon øges til 1,5 mg/kg legemsvægt/dag.
If urine succinylacetone is still detectable one month after the start of nitisinone treatment, the nitisinone dose should be increased to 1.5 mg/kg body weight/day.
Hos 10 raske, mandlige frivillige var, efter administration af en enkelt dosis nitisinon kapsler (1 mg/kg legemsvægt), den terminale halveringstid (median) af nitisinon i plasma 54 timer (spændende fra 39 til 86 timer).
In 10 healthy male volunteers, after administration of a single dose of nitisinone capsules (1 mg/kg body weight) the terminal half-life (median) of nitisinone in plasma was 54 hours (ranging from 39 to 86 hours).
En kost med mere begrænset tyrosin og fenylalanin bør implementeres i tilfælde af, at niveauet af plasma-tyrosin er over 500 mikromol/L.
A more restricted tyrosine and phenylalanine diet should be implemented in case the plasma tyrosine level is above 500 micromol/L.
Lægemidlet anvendes til behandling af en sjælden sygdom, der kaldes arvelig tyrosinæmi type 1 hos voksne, unge og børn (i alle aldersgrupper).
This medicine is used for treatment of a rare disease called hereditary tyrosinemia type 1 in adults, adolescents and children (in any age range).
Der er ingen specifikke dosisanbefalinger for ældre patienter eller patienter med nedsat nyre- eller leverfunktion.
There are no specific dose recommendations for elderly or patients that have renal or hepatic impairment.
Kapslens indhold Prægelatiniseret stivelse (majs)
Capsule content ˗ Pregelatinised starch (maize)
Der er ikke udført formelle studier om fødevareinteraktioner med Nitisinone MDK hårde kapsler.
No formal food interactions studies have been performed with Nitisinone MDK hard capsules.
Nitisinon hæmmer ikke CYP 2D6, da metoprolol AUC∞ ikke blev påvirket af administrationen af nitisinon.
Nitisinone does not inhibit CYP2D6 since metoprolol AUC∞ was not affected by the administration of nitisinone.
60 kapsler
60 capsules
Sikkerhedsprofilen baserer sig hovedsageligt på den pædiatriske population, eftersom nitisinonbehandling bør iværksættes, så snart diagnosen arvelig tyrosinæmi type 1 (HT-1) er blevet stillet.
The safety profile is mainly based on the paediatric population since nitisinone treatment should be started as soon as the diagnosis of hereditary tyrosinemia type 1 (HT-1) has been established.
- hvis De er allergisk over for nitisinon eller et af de øvrige indholdsstoffer i Nitisinone MDK (angivet i punkt 6).
- if you are allergic to nitisinone or any of the other ingredients of this medicine (listed in section 6).
6 år
6 years
Forhøjede tyrosinniveauer
Elevated tyrosine levels
Da der imidlertid kun foreligger begrænsede data for patienter med en legemsvægt < 20 kg, anbefales det at dele den totale daglige dosis på to daglige doser hos denne patientpopulation.
However, due to the limited data in patients with body weight <20 kg, it is recommended to divide the total daily dose into two daily administrations in this patient population.
Eksfoliativ dermatitis kan forekomme ikke almindeligt.
Exfoliative dermatitis may occur uncommonly.
Succinylacetone skulle ikke kunne måles i urin eller plasma, når dosis af nitisinon er korrekt justeret.
Succinylacetone should not be detectable in urine or plasma when the nitisinone dose is properly adjusted.
Hos patienter med HT1, omdannes disse mellemprodukter til de toksiske metabolitter succinylacetone og succinylacetoacetat.
In patients with HT1, these intermediates are converted to the toxic metabolites succinylacetone and succinylacetoacetate.
Kapslen indeholder et hvidt til cremefarvet pulver.
The capsule contains a white to off-white powder.