FrancophonIA/ELRC3.0 huggingface dataset:
English: In CHARM-Preserved, no statistically significant reduction was achieved in the composite endpoint of cardiovascular mortality or first CHF hospitalisation, HR 0.89 (95%CI: 0.77 to 1.03, p=0.118).
Danish: I CHARM-Preserved sås ingen statistisk signifikant reduktion i det kombinerede endepunkt, kardiovaskulær mortalitet eller første hospitalisering pga. hjerteinsufficiens, HR 0,89 (95 % konfidensinterval: 0,77-1,03; p =0,118).
English: Very rare Hyperkalaemia, hyponatraemia
Danish: Hyperkaliæmi, hyponatriæmi
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Atacand indeholder lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form for lactasemangel (Lapp lactase deficiency) eller glucose/galactosemalabsorption.
English: inhibitors such as enalapril, captopril, lisinopril or ramipril.
Danish: • Anden medicin mod forhøjet blodtryk, inklusive betablokkere, diazoxid og ACE-hæmmere så som enalapril, captopril, lisinopril eller ramipril.
English: the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Atacand and associated names (see Annex I).
Danish: - Produktresuméet, etiketteringen og indlægssedlen, som indehaveren af markedsføringstilladelsen har foreslået, er blevet vurderet på baggrund af den fremsendte dokumentation og udvalgets faglige drøftelse anbefaler CHMP at ændre markedsføringstilladelserne for Atacand og tilknyttede navne (se bilag I).
English: • The usual starting dose of Atacand is 4 mg once a day.
Danish: • Den sædvanlige startdosis Atacand er 4 mg én gang dagligt.
English: In CHARM-Alternative, the composite endpoint of cardiovascular mortality or first CHF hospitalisation was significantly reduced with candesartan in comparison with placebo, hazard ratio (HR) 0.77 (95%CI: 0.67 to 0.89, p< 0.001).
Danish: I CHARM-Alternative blev det sammensatte endepunkt, kardiovaskulær mortalitet eller første hospitalisering pga. kronisk hjerteinsufficiens, signifikant reduceret med candesartan sammenlignet med placebo, hazard ratio (HR) 0,77 (95 % konfidensinterval: 0,67-0,89; p<0,001).
English: The combination of an ACE inhibitor, a potassium-sparing diuretic (e.g. spironolactone) and Atacand is not recommended and should be considered only after careful evaluation of the potential benefits and risks (see sections 4.4, 4.8 and 5.1).
Danish: Kombination af en ACE-hæmmer, et kaliumbesparende diuretikum (for eksempel spironolacton) og Atacand anbefales ikke og bør kun overvejes efter omhyggelig evaluering af de mulige fordele og risici (se pkt.
English: Treatment of adult patients with heart failure and impaired left ventricular systolic function (left ventricular ejection fraction ≤ 40%) as add-on therapy to ACE inhibitors or when ACE inhibitors are not tolerated.
Danish: Behandling af voksne patienter med hjerteinsufficiens og systolisk dysfunktion i venstre ventrikel (venstre ventrikel ejektionsfraktion ≤ 40%) som tillægsbehandling til ACE-hæmmere, eller hvor ACE-hæmmere ikke tåles.
English: • Treatment of adult patients with heart failure and impaired left ventricular systolic function (left ventricular ejection fraction ≤ 40%) as add-on therapy to Angiotensin Converting Enzyme (ACE) inhibitors or when ACE inhibitors are not tolerated (see section 5.1).
Danish: • Behandling af voksne patienter med hjerteinsufficiens og nedsat systolisk funktion af venstre ventrikel (venstre ventrikels ejektionsfraktion (LVEF) ≤ 40 %) som tillægsbehandling til ACEhæmmer, eller når ACE-hæmmer ikke tåles (se pkt.
English: Finland AstraZeneca Oy Luomanportti 3
Danish: AstraZeneca Oy Luomanportti 3 FI-02200 Espoo Finland
English: - This medicine has been prescribed for you.
Danish: - Lægen har ordineret Atacand til dig personligt.
English: The usual recommended initial dose of Atacand is 4 mg once daily.
Danish: Den normale anbefalede startdosis af Atacand er 4 mg én gang dagligt.
English: During dose titration of Atacand, monitoring of serum creatinine and potassium is recommended.
Danish: Under dosistitreringen af Atacand anbefales det at monitorere serum-kreatinin og serum-kalium regelmæssigt.
English: What Atacand is and what it is used for Before you take Atacand How to take Atacand Possible side effects How to store Atacand Further information
Danish: Det skal du vide, før du begynder at tage Atacand Sådan skal du tage Atacand Bivirkninger
English: In CHARM-Added, the composite endpoint of cardiovascular mortality or first CHF hospitalisation was significantly reduced with candesartan in comparison with placebo, HR 0.85 (95%CI: 0.75 to 0.96, p=0.011).
Danish: I CHARM-Added blev det kombinerede endepunkt, kardiovaskulær mortalitet eller første hospitalisering pga. kronisk hjerteinsufficiens, signifikant reduceret med candesartan sammenlignet med placebo, HR 0,85 (95 % konfidensinterval: 0,75-0,96; p=0,011).
English: Atacand 16, tabletten 16 mg 16 mg Tablet
Danish: Atacand 16, tabletten 16 mg 16 mg
English: Atacand 32, tabletten 32 mg 32 mg Tablet
Danish: Atacand 32, tabletten 32 mg 32 mg
English: In patients whose vascular tone and renal function depend predominantly on the activity of the reninangiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with other medicinal products that affect this system has been associated with acute hypotension, azotaemia, oliguria or, rarely, acute renal failure.
Danish: Hos patienter, hvis kartonus og nyrefunktion overvejende er afhængig af renin-angiotensin-aldosteronsystemet (for eksempel patienter med alvorlig hjerteinsufficiens eller underliggende nyresygdom, inkl.
English: indicates that a contraindication during the first trimester of pregnancy is not justified; the use of AIIRAs in the first trimester of pregnancy is not recommended.
Danish: Brug af angiotensin IIreceptorantagonister i graviditetens første trimester anbefales ikke.
English: Parapres 16 mg comprimidos
Danish: Parapres 16 mg comprimidos 16 mg
English: • treating adult heart failure patients with reduced heart muscle function, in addition to
Danish: • behandling af voksne patienter med hjertesvigt pga. nedsat hjertemuskelfunktion sammen med ACE-hæmmere, eller når ACE-hæmmere ikke kan anvendes.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER [Udfyldes nationalt]
English: MARKETING AUTHORISATION NUMBER(S)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) [Udfyldes nationalt]
English: The composite endpoint of all-cause mortality or first CHF hospitalisation was also significantly reduced with candesartan, HR 0.80 (95%CI: 0.70 to 0.92, p=0.001).
Danish: Det kombinerede endepunkt, mortalitet af alle årsager eller første hospitalisering pga. kronisk hjerteinsufficiens, blev også signifikant reduceret med candesartan, HR 0,80 (95 % konfidensinterval: 0,70-0,92; p=0,001).
English: The CHMP noted that there is plausible effect based on the pharmacologic action of the drug to affect the ability to drive thus this section was harmonised to reflect that ‘dizziness' and ‘weariness' can occur.
Danish: Dette afsnit blev harmoniseret, således at det afspejler, at der kan forekomme ”svimmelhed” og "træthed".
English: Your doctor may increase this dose to 16 mg once a day and further up to 32 mg once a day depending on blood pressure response.
Danish: Afhængigt af virkningen på dit blodtryk kan lægen øge dosis til 16 mg én gang dagligt og op til 32 mg én gang dagligt.
English: PHARMACEUTICAL FORM
Danish: Lægemiddelform Indgivelsesvej
English: Atacand 32 mg - Tabletten 32 mg Tablet
Danish: Atacand 32 mg - Tabletten 32 mg
English: The composite endpoint of all-cause mortality or first CHF hospitalisation was also significantly reduced with candesartan, HR 0.87 (95%CI: 0.78 to 0.98, p=0.021).
Danish: Det kombinerede endepunkt, mortalitet af alle årsager eller første hospitalisering pga. kronisk hjerteinsufficiens, blev også signifikant reduceret med candesartan, HR 0,87 (95 % konfidensinterval: 0,78-0,98; p=0,021).
English: SPECIAL STORAGE CONDITIONS
Danish: SÆRLIGE OPBEVARINGSBETINGELSER [Udfyldes nationalt]
English: The use of AIIRAs is contraindicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4).
Danish: 4.4) og er kontraindiceret i andet og tredje trimester (se pkt.
English: Atacand 16 mg - Tabletten 16 mg Tablet
Danish: Atacand 16 mg - Tabletten 16 mg
English: HOW TO TAKE ATACAND
Danish: SÅDAN SKAL DU TAGE ATACAND
English: Blopress 32 mg - Tabletten 32 mg Tablet
Danish: Blopress 32 mg - Tabletten 32 mg
English: Posology in hypertension
Danish: Dosering ved hypertension
English: Posology in heart failure
Danish: Dosering ved hjerteinsufficiens
English: Blopress 16 mg Tabletten 16 mg Tablet
Danish: Blopress 16 mg Tabletten 16 mg
English: Of candesartan patients 36.6% (95%CI: 33.7 to 39.7) and of placebo patients 42.7% (95%CI: 39.6 to 45.8) experienced this endpoint, absolute difference 6.0% (95%CI: 10.3 to 1.8).
Danish: 36,6 % af candesartan-patienterne (95 % konfidensinterval: 33,7-39,7) og 42,7 % af placebo-patienterne (95 % konfidensinterval: 39,6-45,8) oplevede dette endepunkt, absolut forskel 6,0 % (95 % konfidensinterval: 10,3-1,8).
English: Blopress 32 mg Tabletten 32 mg Tablet
Danish: Blopress 32 mg Tabletten 32 mg
English: Blopress 16 mg - Tabletten 16 mg Tablet
Danish: Blopress 16 mg - Tabletten 16 mg
English: Because no information is available regarding the use of Atacand during breastfeeding, Atacand is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Danish: Andre behandlinger med bedre fastlagte sikkerhedsprofiler under amning anbefales, især ved amning af nyfødte eller for tidligt fødte børn.
English: • Itching.
Danish: • Kløe.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN [Se Bilag I - Udfyldes nationalt]
English: Of candesartan patients 42.2% (95%CI: 39.5 to 45.0) and of placebo patients 46.1% (95%CI: 43.4 to 48.9) experienced this endpoint, absolute difference 3.9% (95%CI: 7.8 to 0.1).
Danish: 42,2 % af candesartan-patienterne (95 % konfidensinterval: 39,5-45,0) og 46,1 % af placebo-patienterne (95 % konfidensinterval: 43,4-48,9) oplevede dette endepunkt, absolut forskel 3,9 % (95 % konfidensinterval: 7,8-0,1).
English: In most of the MSs a dosage regimen up to a maximum of 32 mg dose was approved.
Danish: Den anbefalede startdosis og almindelige vedligeholdelsesdosis for candesartan er 8 mg. I de fleste medlemsstater var et dosisregime med en dosis på op til maksimalt 32 mg godkendt.
English: Parapres 32 mg comprimidos
Danish: Parapres 32 mg comprimidos 32 mg
English: The CHMP thus considered that although candesartan can be administered with other heart failure treatment (including ACE inhibitors, beta-blockers, diuretics and digitalis or a combination thereof), the association of an ACE inhibitor, a potassium-sparing diuretic and candesartan is not recommended.
Danish: betablokkere, diuretika og digitalis eller en kombination heraf), kan forbindelsen mellem en ACEhæmmer, et kaliumsparende diuretikum og candesartan ikke anbefales.
English: Of candesartan patients 33.0% (95%CI: 30.1 to 36.0) and of placebo patients 40.0% (95%CI: 37.0 to 43.1) experienced this endpoint, absolute difference 7.0% (95%CI: 11.2 to 2.8).
Danish: 33,0 % af candesartan-patienterne (95 % konfidensinterval: 30,1-36,0) og 44 % af placebo-patienterne (95 % konfidensinterval: 37,0-43,1) oplevede dette endepunkt, absolut forskel, 7,0 % (95 % konfidensinterval: 11,2-2,8).
English: Haemodialysis
Danish: Nyrearteriestenose
English: INFORMATION IN BRAILLE
Danish: INFORMATION I BRAILLE-SKRIFT [Udfyldes nationalt]
English: Of candesartan patients 37.9% (95%CI: 35.2 to 40.6) and of placebo patients 42.3% (95%CI: 39.6 to 45.1) experienced this endpoint, absolute difference 4.4% (95%CI: 8.2 to 0.6).
Danish: 37,9 % af candesartan-patienterne (95 % konfidensinterval: 35,2-40,6) og 42,3 % af placebo-patienterne (95 % konfidensinterval: 39,6-45,1) oplevede dette endepunkt, absolut forskel 4,4 % (95 % konfidensinterval: 8,2-0,6).
English: Atacand 16 mg comprimidos
Danish: Atacand 16 mg comprimidos 16 mg
English: However, in patients with renal impairment, periodic monitoring of serum potassium and creatinine levels is recommended.
Danish: Dog anbefales regelmæssig monitorering af serum-kalium og serum-kreatinin hos patienter med nedsat nyrefunktion.
English: BEFORE YOU TAKE ATACAND
Danish: Hvis du har glemt at tage Atacand
English: Blopress 16 mg comprimidos
Danish: Blopress 16 mg comprimidos 16 mg
English: Sweden AstraZeneca AB 151 85 Södertälje, Sweden
Danish: AstraZeneca AB 151 85 Södertälje, Sweden
English: GENERAL CLASSIFICATION FOR SUPPLY
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING [Udfyldes nationalt]
English: Atacand 32 mg comprimidos
Danish: Atacand 32 mg comprimidos 32 mg
English: In heart failure patients treated with Atacand, hyperkalaemia may occur.
Danish: Der kan opstå hyperkaliæmi hos patienter med hjerteinsufficiens, der behandles med Atacand.
English: Blopress 32 mg comprimidos
Danish: Blopress 32 mg comprimidos 32 mg
English: PACKAGE LEAFLET
Danish: MARKEDSFØRI
English: Whereas
Danish: Meget
English: For therapeutic doses of candesartan in humans, the hyperplasia/hypertrophy of the renal juxtaglomerular cells does not seem to have any relevance.
Danish: .3 Prækliniske sikkerhedsdata er juxtaglomerulære celler har nogen levans hos mennesker ved terapeutiske doser af candesartan.
English: This is usually achieved within a month.
Danish: Dette opnås sædvanligvis inden for en måned.
English: This summary was last updated in 10-2016
Danish: Dette sammendrag blev sidst ajourført i 10-2016.
English: It should be dissolved fully in water, juice, milk, formula or food immediately before being taken.
Danish: Det skal opløses fuldstændig i vand, juice, mælk, modermælkserstatning eller mad, umiddelbart før det indtages.
English: This helps to improve the symptoms of the disease.
Danish: Derved mindskes symptomerne på sygdommen.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Cystadane on 15 February 2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Cystadane den 15. februar 2007.
English: This causes a wide range of symptoms, including impaired vision, weak bones and circulatory problems.
Danish: Dette medfører en lang række symptomer, herunder nedsat syn, skrøbelige knogler og kredsløbsproblemer.
English: The aim of the treatment is to keep blood levels of homocysteine below 15 micromoles or as low as possible.
Danish: Målet for behandlingen er at holde blodets indhold af homocystein på under 15 mikromol eller så lavt som muligt.
English: This is a summary of the European public assessment report (EPAR) for Cystadane.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Cystadane.
English: The information from these studies was compared to published reports describing the outcome of untreated patients with the disease.
Danish: Oplysningerne fra disse undersøgelser blev sammenholdt med publicerede rapporter om forløbet hos ubehandlede patienter med sygdommen.
English: The Committee noted that Cystadane is not a substitute for other treatments.
Danish: Udvalget bemærkede, at Cystadane ikke erstatter andre behandlinger.
English: Other information about Cystadane
Danish: Andre oplysninger om Cystadane
English: For 140 patients, information was also provided on their symptoms, the dose and duration of treatment, and other medicines being taken.
Danish: For 140 patienter blev der desuden givet oplysninger om deres symptomer, dosis og behandlingsvarighed samt andre lægemidler taget samtidig.
English: Because the number of patients with homocystinuria is low, the disease is considered ‘rare', and Cystadane was designated an ‘orphan medicine' (a medicine used in rare diseases) on 9 July 2001.
Danish: Da antallet af patienter med homocystinuri er lavt, betragtes sygdommen som "sjælden", og Cystadane blev udpeget som "lægemiddel til sjældne sygdomme" den 9. juli 2001.
English: The standard dose of Cystadane is 100 mg per kilogram of body weight a day, divided into two equal doses.
Danish: Standarddosis af Cystadane er 100 mg pr. kilogram legemsvægt dagligt, fordelt på to lige store doser.
English: It is used with other treatments, such as vitamin B6 (pyridoxine), vitamin B12 (cobalamin), folate and a special diet.
Danish: Det anvendes sammen med andre behandlinger, såsom B6-vitamin (pyridoxin), B12-vitamin (kobalamin), folat og en særlig diæt.
English: The medicine was effective in patients with all three types of homocystinuria.
Danish: Lægemidlet var effektivt hos patienter med alle tre former for homocystinuri.
English: What measures are being taken to ensure the safe and effective use of Cystadane?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Cystadane?
English: Most patients were also taking vitamins B6 or B12, or folate.
Danish: Størstedelen af patienterne fik desuden B6-vitamin eller B12-vitamin eller folat.
English: Cystadane is supplied with 3 measuring spoons to measure 100 mg, 150 mg and 1 g of the powder.
Danish: Cystadane leveres med tre måleskeer til 100 mg, 150 mg og 1 g pulver.
English: The dose can be adjusted depending on the response to treatment (monitored by measuring the level of homocysteine in the blood).
Danish: Dosis kan korrigeres afhængig af behandlingens virkning (som overvåges ved at måle indholdet af homocystein i blodet).
English: This included 202 reports that described the effects of Cystadane, given at a variety of doses, on homocysteine levels in homocystinuria patients of various ages.
Danish: Oplysningerne omfattede 202 rapporter, der beskriver virkningerne af Cystadane, givet i forskellige doser, på homocysteinniveauet hos patienter i forskellige aldre med homocystinuri.
English: Betaine is a natural substance that is extracted from sugar beet.
Danish: Betain er et naturstof, der udvindes af sukkerroer.
English: What is Cystadane and what is it used for?
Danish: Hvad er Cystadane, og hvad anvendes det til?
English: Cystadane is a medicine used to treat homocystinuria, an inherited disease where the amino acid homocysteine cannot be broken down and therefore builds up in the body.
Danish: Cystadane er et lægemiddel, der anvendes til behandling af homocystinuri, som er en arvelig sygdom, hvor aminosyren homocystein ikke kan nedbrydes og derfor hober sig op i kroppen.
English: In particular, the company will monitor cases of cerebral oedema, which was seen in a small number of patients during the testing of the medicine.
Danish: Virksomheden skal navnlig overvåge tilfælde af hjerneødem, der blev iagttaget hos nogle få patienter under afprøvningen af lægemidlet.
English: Why is Cystadane approved?
Danish: Hvorfor blev Cystadane godkendt?
English: The full EPAR for Cystadane can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Cystadane findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Treatment with Cystadane should be supervised by a doctor who has experience in the treatment of patients with homocystinuria.
Danish: Behandlingen med Cystadane bør overvåges af en læge med erfaring i behandling af patienter med homocystinuri.
English: In homocystinuria, betaine reduces homocysteine levels in the blood by transforming homocysteine into the amino acid methionine.
Danish: Ved homocystinuri nedsætter betain homocysteinniveauet i blodet ved at omdanne homocystein til aminosyren methionin.
English: The company that makes Cystadane will set up a register of patients taking the medicine to monitor its safety.
Danish: Virksomheden, der fremstiller Cystadane, skal oprette et register over de patienter, der får lægemidlet, for at overvåge dets sikkerhed.
English: Patients taking Cystadane appeared to have greater reductions in homocysteine levels than untreated patients.
Danish: Hos patienter, der fik Cystadane, mindskedes homocysteinniveauet tilsyneladende mere end hos ubehandlede patienter.
English: The most common side effect when taking Cystadane (seen in more than 1 patient in 10) is elevated levels of methionine in the blood.
Danish: Den hyppigste bivirkning ved Cystadane (som optræder hos mere end 1 ud af 10 patienter) er forhøjet indhold af methionin i blodet.
English: This was associated with an improvement in symptoms affecting the cardiovascular system (heart and blood vessels) as well as an improvement in developmental problems in around three quarters of the patients taking Cystadane.
Danish: Dette var forbundet med bedring i symptomerne i hjerte-kar-systemet samt bedring med hensyn til de udviklingsmæssige problemer hos ca. tre fjerdedele af de patienter, der fik Cystadane.
English: What are the risks associated with Cystadane?
Danish: Hvilke risici er der forbundet med Cystadane?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, although there were few systematic studies of Cystadane, the medicine is useful when added to existing treatments for homocystinuria, such as vitamin supplementation and using a special diet.
Danish: Agenturets udvalget for Lægemidler til Mennesker (CHMP) besluttede, at lægemidlet, selvom der kun foreligger få systematiske undersøgelser af Cystadane, er et nyttigt supplement til de eksisterende behandlinger for homocystinuri, såsom vitamintilskud og særlig diæt.
English: Patients with symptoms of cerebral oedema, such as morning headaches with vomiting, or changes in vision, should speak to their doctor, as treatment with Cystadane may have to be interrupted.
Danish: Patienter med symptomer på hjerneødem, såsom morgenhovedpine med opkastning eller ændret syn, bør kontakte lægen, da det kan være nødvendigt at afbryde behandlingen med Cystadane.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Cystadane can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Cystadane findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The company presented information on Cystadane from the scientific literature.
Danish: Virksomheden har fremlagt oplysninger fra den videnskabelige litteratur om Cystadane.
English: It is not intended to provide practical advice on how to use Cystadane.
Danish: Det er ikke en praktisk vejledning i, hvordan Cystadane bør anvendes.
English: For more information about treatment with Cystadane, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Cystadane, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Cystadane is available as a powder to be taken by mouth.
Danish: Cystadane fås som et pulver til indtagelse gennem munden.
English: It recommended that Cystadane be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Cystadane.
English: Cystadane contains the active substance betaine anhydrous.
Danish: Cystadane indeholder det aktive stof betain, vandfrit.
English: Methionine levels should be monitored in patients taking Cystadane, as it might lead to cerebral oedema (swelling in the brain).
Danish: Indholdet af methionin bør overvåges hos patienter, der får Cystadane, da det kan medføre hjerneødem (hævelse i hjernen).