FrancophonIA/ELRC3.0 huggingface dataset:
English: Overall, having considering the totality of the available evidence, the CHMP concluded that while a deviation from the current bioequivalence guideline is acknowledged, no potential serious risk to public health was identified, that extrapolation of the demonstrated bioequivalence from the 20 mg/5 ml strength to the 40 mg/5 ml strength is possible and that both strengths of the proposed product can therefore be considered bioequivalent to the reference product.
Danish: Efter gennemgang af al den foreliggende dokumentation konkluderede CHMP, at skønt det vedgås, at der er tale om en afvigelse fra den gældende bioækvivalensvejledning, kunne der ikke konstateres nogen potentiel alvorlig risiko for den offentlige sundhed, at den påviste bioækvivalens kan ekstrapoleres fra styrken 20 mg/5 ml til styrken 40 mg/5 ml, og at begge styrker af det ansøgte produkt derfor kan anses for at være bioækvivalente med referenceproduktet.
English: • the CHMP considered that both strengths of the proposed product can be considered bioequivalent to the reference product the CHMP has recommended the granting of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Simvastatin Vale and associated names (see Annex I).
Danish: • CHMP fandt, at begge styrker af det ansøgte produkt kan anses for at være bioækvivalente med referenceproduktet, anbefaler CHMP at der udstedes markedsføringstilladelser for Simvastatin Vale og tilknyttede navne (se bilag I).
English: While the CHMP agreed that there was a deviation from the CHMP Guideline on the Investigation of Bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1/ Corr), which states that for substances with linear pharmacokinetics, bioequivalence should in general be established with the highest strengths, it considered that this deviation should be considered in light of the available data and therefore assessed the Applicant dossier to determine the clinical relevance of the deviation.
Danish: CHMP vedgik, at der er tale om en afvigelse fra CHMP's vejledning for undersøgelse af bioækvivalens (“Guideline on the Investigation of Bioequivalence” (CPMP/EWP/QWP/1401/98 Rev. 1/ Corr)), der angiver, at bioækvivalens for stoffer med lineær farmakokinetik sædvanligvis skal fastlægges med de højeste styrker.
English: • the CHMP considered that the available data allowed extrapolation of the demonstrated bioequivalence from the 20 mg/5 ml strength to the 40 mg/5 ml strength
Danish: • CHMP fandt, at de foreliggende data tillod ekstrapolering af den påviste bioækvivalens fra styrken
English: Packaging Package size
Danish: Indgivelsesvej Emballage
English: Withdrawal period
Danish: Tilbageholdel sestid
English: However, Cystadane should not be used during pregnancy unless clearly necessary.
Danish: Dog bør Cystadane ikke anvendes under graviditet, medmindre det er klart nødvendigt.
English: Children and Adult
Danish: Børn og voksne
English: You will therefore need regular blood tests to determine the correct daily dose.
Danish: Du skal derfor have taget regelmæssige blodprøver for at bestemme den korrekte daglige dosis.
English: Date of first authorisation: 15 February 2007 Date of latest renewal: 21 November 2016
Danish: Dato for første markedsføringstilladelse: 15 februar 2007 Dato for seneste fornyelse: 21 november 2016
English: There is no evidence of development of tolerance.
Danish: Der er ingen tegn på udvikling af tolerance.
English: Do not stop the treatment without consulting your doctor.
Danish: Du må ikke holde op med behandlingen uden at rådføre dig med din læge.
English: After the first opening of the bottle, the medicine should be used within 3 months.
Danish: Efter første åbning af flasken skal lægemidlet bruges i løbet af 3 måneder.
English: - There is no other ingredient.
Danish: - Der er ikke andre indholdsstoffer.
English: Methionine levels should be closely monitored in these patients.
Danish: Methionin-niveauer skal overvåges nøje for disse patienter.
English: If you forget to take a dose take it as soon as you remember it and continue the next dose as planned.
Danish: Hvis du har glemt at tage en dosis, skal du tage den, så snart du kommer i tanke om det, og fortsætte med næste dosis efter planen.
English: Hypersensitivity to the active substance.
Danish: Overfølsomhed over for det aktive stof.
English: In that case your doctor will monitor your methionine level in your body and may review your diet.
Danish: I det tilfælde vil din læge overvåge methioninniveauet i din krop og muligvis gennemgå din diæt.
English: Do not store above 25C.
Danish: Må ikke opbevares over 25°C.
English: You should take Cystadane orally (by mouth).
Danish: Du skal tage Cystadane oralt (via munden).
English: • take the correct measuring spoon:
Danish: • Tag den korrekte måleske:
English: Your doctor may adapt the dose depending on your laboratory values.
Danish: Din læge kan tilpasse dosen i forhold til dine laboratorieværdier.
English: • cobalamin cofactor metabolism (cbl).
Danish: • cobalamin cofaktor metabolismen (cbl).
English: Frequencies are 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 (< 1/10,000).
Danish: Hyppigheder defineres som: Meget almindelig (1/10), almindelig (1/100 til <1/10), usædvanlig (1/1.000 til 1/100), sjælden (1/10.000 til 1/1.000) og meget sjælden (1/10.000).
English: Adjunctive treatment of homocystinuria, involving deficiencies or defects in:
Danish: Adjuverende behandling af homocystinuria, hvilket inkluderer mangler eller defekter i:
English: Fertility No data is available.
Danish: Fertilitet Der foreligger ingen data.
English: If methionine increases particularly above the first safety threshold of 700 µmol/L, patient should be monitored more frequently and compliance with diet should be checked.
Danish: Hvis methionin-koncentrationen stiger til over den første sikkerhedstærskel på 700 mol/l, skal patienten overvåges mere hyppigt og overholdelse af diæt skal kontrolleres.
English: The aim of treatment is to keep plasma levels of total homocysteine below 15 µM or as low as possible.
Danish: Målet med behandlingen er at holde plasma niveauerne af totalt homocystein under 15 M eller så lavt som muligt.
English: Reported adverse reactions are listed below, by system organ class and by frequency.
Danish: De rapporterede bivirkninger er opstillet nedenfor efter organklasse og hyppighed.
English: Methionine is present in regular food protein (e.g. meat, fish, milk, cheese, eggs).
Danish: Methionin findes i almindelige fødevarer (fx kød, fisk, mælk, ost og æg).
English: Your doctor will decide if you can use this medicine during pregnancy and breast-feeding.
Danish: Din læge vil afgøre, om du må bruge dette lægemiddel, mens du er gravid eller ammer.
English: A standard battery of genotoxicity test reveals no specific hazard for humans.
Danish: Standardtests med genotoksicitetstests har ikke afsløret nogen særlige farlige situationer for mennesker.
English: Keep the bottle tightly closed in order to protect from moisture.
Danish: Hold flasken godt lukket for at beskytte imod fugt.
English: HDPE bottles with a child resistant closure.
Danish: HDPE flasker med en børnesikret lukning.
English: Your treatment with Cystadane may need to be interrupted.
Danish: Det er muligt at din behandling med Cystadane skal stoppes.
English: Betaine anhydrous was rapidly distributed into a relatively large volume (V/F = 1.3 l/kg).
Danish: Betain, vandfri, blev hurtigt fordelt i et relativt stort volumen (V/F = 1,3 l/kg).
English: • 5,10-methylene-tetrahydrofolate reductase (MTHFR),
Danish: • 5,10-metylen-tetrahydrofolat reduktase (MTHFR),
English: • cystathionine beta-synthase (CBS),
Danish: • Cystationin beta-syntase (CBS),
English: Contact your doctor or pharmacist before stopping.
Danish: Kontakt din læge eller apoteket, inden du holder op.
English: As a result, plasma levels of homocysteine should decrease in these patients, to 20-30 % of pre-treatment levels.
Danish: Som et resultat heraf skulle plasmaniveauerne af homocystein falde til 20-30% af niveauet før behandlingen hos disse patienter.
English: In some patients doses above 200 mg/ kg/day were needed to reach therapeutic goals.
Danish: Hos visse patienter var der behov for doser over 200 mg/kg/dag for at nå de terapeutiske mål.
English: The most commonly side effect when taking Cystadane which may affect more than 1 in 10 people (frequency very common) is elevated levels of methionine in the blood.
Danish: Den mest almindelige bivirkning ved brug af Cystadane, som kan ramme mere end 1 ud af 10 personer (hyppighed meget almindelig), er forhøjede methioninniveauer i blodet.
English: Animal reproduction studies have not been conducted.
Danish: Der er ikke udført reproduktionsstudier på forsøgsdyr.
English: It is recommended to measure plasma methionine level at start of treatment and about annually or biannually thereafter.
Danish: Det anbefales at måle plasma methionin-koncentrationen ved behandlingsstart og årligt eller halvårligt derefter.
English: The steady-state response usually occurs within a month.
Danish: Den fulde effekt indtræder sædvanligvis i løbet af en måned.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede lægemiddelovervågningsaktiviteter og foranstaltninger, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2. i markedsføringstilladelsen, og enhver efterfølgende opdatering af RMP.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinier.
English: • take the correct number of spoonfuls of powder from the bottle
Danish: • Tag det korrekte antal skefulde fra flasken.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det til lægen, hvis du bruger anden medicin eller har brugt det for nylig eller måske vil gøre det.
English: However, the dose should be individually titrated according to plasma levels of homocysteine and methionine.
Danish: Dosen skal dog titreres individuelt i henhold til plasmaniveauerne af homocystein og methionin.
English: Methionine level can be related to swelling in the brain (cerebral swelling), which may affect up to 1 in 100 people (frequency uncommon).
Danish: Methioninniveauet kan være forbundet med hævelse i hjernen (cerebral hævelse), hvilket kan ramme op til 1 ud af 100 personer (hyppighed ikke almindelig).
English: At high doses, a CNS depressant effect and irritation of the gastrointestinal tract was seen in rats.
Danish: Ved høje doser sås en CNS-nedsættende effekt og irritation af den gastrointestinale kanal hos rotter.
English: Uncommon: agitation, irritability
Danish: Usædvanlig: Uro, irritabilitet.
English: Do not take Cystadane If you are allergic to betaine anhydrous.
Danish: Tag ikke Cystadane Hvis du er allergisk over for betain, vandfri.
English: Gastrointestinal disorders
Danish: Gastrointestinale sygdomme
English: Each carton contains one bottle and three measuring spoons.
Danish: Hver æske indeholder en flaske og tre måleskeer.
English: The most commonly reported adverse reaction during treatment is blood methionine increased.
Danish: Den mest almindeligt indberettede bivirkning under behandling er forhøjet blodmethionin.
English: Uncommon: anorexia
Danish: Usædvanlig: Anoreksi.
English: What Cystadane is and what it is used for
Danish: Cystadanes virkning og hvad du skal bruge det til
English: Each bottle contains 180 g of powder.
Danish: Hver flaske indeholder 180 g pulver.
English: During pregnancy, administering betaine anhydrous in addition to pyridoxine, folate, anticoagulant and diet under close monitoring of plasma homocysteine would be compatible with good maternal and foetal outcomes.
Danish: Under graviditet vil administration af betain, vandfri, i tillæg til pyridoxin, folinsyre, antikoagulantia og diæt under nøje overvågning af plasma homocystein være foreneligt med et godt resultat for moderen og fosteret.
English: • the powder left in the spoon is one spoonful
Danish: • Det pulver, der er tilbage i måleskeen giver en skefuld
English: If you are treated with Cystadane and with an amino-acid mixture and if you need to take other medicines at the same time, leave 30 minutes between the intake (see “section “Other medicines and Cystadane”).
Danish: Hvis du behandles med Cystadane og en aminosyreblanding og hvis du tager anden medicin samtidig skal du vente 30 minutter mellem at du tager dem (se afsnittet ”Brug af anden medicin sammen med Cystadane”).
English: Talk to your doctor or pharmacist before taking Cystadane.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Cystadane.
English: After a repeated dose regiment of 100 mg/kg/day for 5 days, the distribution half life was prolonged significantly (up to 36 h), indicating saturable transport and redistribution processes.
Danish: Efter et dosisregime med gentagne doser på 100 mg/kg/dag i 5 dage blev distributionshalveringstiden forlænget signifikant (med op til 36 timer), hvilket tyder på, at transport- og fordelingsprocesserne kan mættes.
English: It is presented in bottles with child resistant closures.
Danish: Det findes i flasker med en børnesikret lukning.
English: Caution should be exercised with up-titrating doses for patients with CBS deficiency due to the risk for hypermethioninaemia.
Danish: Der skal udvises forsigtighed ved optitrering af doser til patienter med CBS-mangel på grund af risikoen for hypermethioninæmi.
English: For storage conditions after first opening of the medicinal product, see section 6.3.
Danish: 6.3 vedrørende opbevaringsbetingelser efter første åbning af lægemidlet.
English: Therapeutic monitoring
Danish: Overvågning af behandlingen
English: Monitoring betaine plasma concentrations does not help to define the efficacy of treatment, since these concentrations do not directly correspond to the flux through the cytosolic betaine homocysteine methyl transferase pathway.
Danish: Overvågning af betain-plasmakoncentrationerne kan ikke bruges til at definere behandlingens effektivitet, idet koncentrationerne ikke direkte svarer til passagen gennem den cytosoliske betainhomocystein methyltransferase-pathway.
English: Because of lack of data, caution should be exercised when prescribing Cystadane to breast-feeding women.
Danish: På grund af de manglende data, bør der udvises forsigtighed, når Cystadane udskrives til ammende kvinder.
English: White crystalline free flowing powder.
Danish: Hvidt krystallinsk frit strømmende pulver.
English: In observational studies, clinical improvement (cardiovascular and neurodevelopmental) was reported by the treating physician in about 75% of patients taking betaine anhydrous.
Danish: I observationsstudier har der været rapporteret klinisk bedring (kardiovaskulær og neuronal udvikling) af den behandlende læge hos 75 % af patienterne, som tog betain, vandfri.
English: In CBS-deficient patients without dietary restriction of methionine, excessive accumulation of methionine has been observed.
Danish: Hos patienter med CBS-mangel uden diætrestriktioner med hensyn til methionin er der observeret overdreven akkumulering af methionin.
English: To measure the dose:
Danish: Dosen bestemmes ved at:
English: Very common: blood methionine increased*
Danish: Meget almindelig: Øget plasma methionin*.
English: Cystadane contains betaine anhydrous which is intended to be an adjunctive treatment of homocystinuria, an inherited (genetic) disease where the amino acid methionine cannot be broken down completely by the body.
Danish: Cystadane indeholder betain, vandfrit, der skal bruges som tillægsbehandling af homocysteinuria, en nedarvet (genetisk) sygdom, hvor aminosyren methionin ikke kan nedbrydes fuldstændigt af kroppen.
English: Nervous system disorders
Danish: Sygdomme i nervesystemet
English: 4.6 Fertility, pregnancy and lactation
Danish: 4.6 Graviditet og amning
English: If you take more Cystadane than you should If you accidentally take too much Cystadane, talk to a doctor or pharmacist immediately.
Danish: Hvis du har taget for meget Cystadane Hvis du kommer til at tage for meget Cystadane, skal du straks tale med din læge eller apoteket.
English: The pharmacokinetic data of homocystinuric patients on long-term betaine anhydrous supplementation are very similar to those of healthy volunteers.
Danish: De farmakokinetiske data fra homocysteinuriapatienter, der er på langvarigt tilskud af betain, vandfri, er meget lig de tilsvarende fra raske frivillige.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: If you experience morning headaches with vomiting and/or visual changes, contact immediately your doctor (they could be signs of a swelling in the brain).
Danish: Hvis du oplever morgenhovedpine med opkastning og/eller synsforandringer, skal du straks kontakte din læge (det kan være tegn på hævelse i hjernen).
English: It is not known whether betaine anhydrous is excreted in human milk (although its metabolic precursor, choline, occurs at high levels in human milk).
Danish: Det vides ikke, om betain, vandfri, udskilles i modermælken (selvom det metaboliske substrat, kolin, forekommer i store mængder i human mælk).
English: The extent of this effect was dependent on the absolute degree of hyperhomocysteinemia, being higher in severe hyperhomocysteinemia.
Danish: Effektgraden afhang af graden af homocysteinuria, og var højere i hyperhomocysteinuria.
English: Absorption The absolute bioavailability of betaine anhydrous has not been determined.
Danish: Den absolutte biotilgængelighed af betain, vandfri, er ikke blevet bestemt.
English: The available clinical data do not allow correlating posology and clinical efficacy.
Danish: De tilgængelige kliniske data gør det ikke muligt at korrelere dosering med den kliniske effekt.
English: Other uncommon side effects (may affect up to 1 in 100 people) may include decreased appetite (anorexia), agitation, irritability, hair loss, hives, skin odour abnormal, lack of control over passing urine (urinary incontinence).
Danish: Andre ikkealmindelige bivirkninger (kan ramme op til 1 ud af 100 personer) kan for eksempel være nedsat appetit (anoreksi), uro, irritabilitet, hårtab, nældefeber, unormal lugt fra huden, manglende blærekontrol (urininkontinens).
English: After a repeated dose regimen of 100 mg/kg/day for 5 days, the absorption kinetics did not change.
Danish: Efter et dosisregime med gentagne doser på 100 mg/kg/dag i 5 dage ændrede absorptionskinetikken sig ikke
English: In general, adverse reactions seen with betaine anhydrous therapy appeared to be not serious and are mainly related to the gastrointestinal system.
Danish: Generelt syntes de bivirkninger, der er set ved behandling med betain, vandfri, ikke at være alvorlige og er hovedsagelig relateret til mave-tarm-systemet.
English: Do not use this medicine after the expiry date which is stated on the bottle label and the carton after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen.
English: It is likely that due to the multiple nature of therapy (dietary, pharmaceutical, supportive) in these patients, there may be an element of overestimation in the clinical effects of betaine anhydrous treatment.
Danish: Det er muligt, at der på grund af de alsidige behandlingsformer til disse patienter (diæt, medicin og understøttende behandling) er en overvurderet kliniske effekt af behandling med betain, vandfri.
English: - If any symptoms of cerebral oedema like morning headaches with vomiting and/or visual changes appear, plasma methionine level and compliance to the diet should be checked and treatment with Cystadane interrupted.
Danish: • Hvis der opstår nogen symptomer på cerebralt ødem så som hovedpine om morgenen med kvalme og/eller synsforstyrrelser, skal plasma methionin-niveauet og overholdelse af diæten tjekkes og behandlingen med Cystadane afbrydes.
English: In most cases, adding betaine anhydrous resulted in a further reduction in plasma homocysteine level.
Danish: I de fleste tilfælde gjorde tilføjelsen af betain, vandfri, at plasma-homocystein-niveauet blev sænket yderligere.
English: If you are taking amino-acid mixture or medicines such as vigabatrin or Gaba analogues (medicine used to treat epilepsy), please tell your doctor as they might interact with your treatment with Cystadane.
Danish: Hvis du tager en aminosyreblanding eller medicin så som vigabatrin eller GABA-analoger (medicin, der bruges til behandling af epilepsi), skal du straks fortælle det til din læge, fordi de kan påvirke din behandling med Cystadane.
English: Cystadane has no or negligible influence on the ability to drive and use machines.
Danish: Cystadane påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: A. MANUFACTURERs RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE
English: To minimise the risk of potential drug interactions, it is advisable to leave 30 minutes between the intake of betaine anhydrous and amino acids mixtures and/or medicinal products containing vigabatrin and GABA analogues (see section 4.5).
Danish: For at minimere risikoen for potentielle lægemiddelinteraktioner, anbefales det, at man lader 30 minutter gå mellem indtagelsen af betain, vandfri, og af andre aminosyrerblandinger og/eller lægemidler, der indeholder vigabatrin og GABA-analoger (se pkt.
English: 180 g of oral powder and three measuring spoons.
Danish: 180 g oralt pulver og tre måleskeer.
English: If you stop taking Cystadane
Danish: Hvis du holder op med at tage Cystadane
English: It is recommended that a heaped measuring spoon is removed from the bottle and a flat surface e.g. base of a knife is drawn across the top of the measure.
Danish: Det anbefales at tage en toppet skefuld ud af flasken og at stryge en genstand med en glat overflade, fx en kniv, henover kanten af måleskeen.
English: Biotransformation Betaine anhydrous is a methyl group donor
Danish: Biotransformation Betain, vandfri er en methylgruppedonor.
English: The powder should be mixed with water, juice, milk, formula or food until completely dissolved and ingested immediately after mixing.
Danish: Pulveret bør blandes med vand, juice, mælk, kosttilskud eller mad, indtil det er helt opløst, og indtages lige efter opblanding.
English: Cystadane treatment should be supervised by a physician experienced in the treatment of patients with homocystinuria.
Danish: Cystadane behandling bør overvåges af en læge med erfaring i behandling af patienter med homocysteinuria.
English: If you forget to take Cystadane
Danish: Hvis du har glemt at tage Cystadane
English: - If symptoms of cerebral oedema recur after re-introduction of treatment then betaine anhydrous therapy should be discontinued indefinitely.
Danish: • Hvis der genopstår symptomer på cerebralt ødem efter at behandlingen er genintroduceret, så skal behandling med betain, vandfri, afbrydes permanent.
English: Most of these patients were also receiving other treatments such as vitamin B6 (pyridoxine), vitamin B12 (cobalamin) and folate with variable biochemical responses.
Danish: De fleste af disse patienter modtog også andre behandlinger så som B6 (pyroxin), B12 (cobalamin) og folinsyre med forskellige biokemiske responser.
English: The use of Cystadane together with other treatments such as vitamin B6, vitamin B12, folate and a specific diet aims to reduce the elevated homocysteine levels in your body.
Danish: Brug af Cystadane sammen med anden behandling som vitamin B6, vitamin B12, folinsyre og en speciel kost vil sænke et forhøjet indhold af homocystein i din krop.