FrancophonIA/ELRC3.0 huggingface dataset:
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere information om Cystadane findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: The recommended dose in children and adults is 100mg/kg/day divided in 2 dosesper day.
Danish: Den anbefalede dosis hos børn og voksne er 100 mg/kg/dag fordelt på 2 doser om dagen.
English: Late detection of homocystinuria in symptomatic state is responsible for residual morbidity due to irreversible damage to connective tissue (ophtalmological, skeletal) that cannot be corrected by further therapy.
Danish: Opdages homocysteinuria sent på det symptomatiske stadium, kan det medføre morbiditet som følge af irreversible skader på bindevævet (oftalmologisk, skelet), som ikke kan korrigeres med videre behandling.
English: If you notice side effects like headaches, vomiting or a change in your vision and you are of the homocystinuria subtype called CBS (cystathionine beta-synthase deficiency), please contact your doctor immediately, they could be signs of a swelling in the brain (cerebral oedema).
Danish: Hvis du har bemærket bivirkninger i form af hovedpine, opkastning eller ændringer af dit syn, og du tilhører undergruppen med homocystinuri, også kaldet CBS (cystathionin-beta-synthase-mangel), skal du straks kontakte din læge, idet det kan være tegn på hævelse i hjernen (cerebralt ødem).
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, ATC code: A16AA06.
Danish: Farmakoterapeutisk klassifikation: Fordøjelsesorganer og stofskifte, andre stofskiftesygdomme, ATCkode: A16AA06
English: What Cystadane contains - The active substance is betaine anhydrous.
Danish: Cystadane indeholder: - Det aktive stof er betain, vandfrit.
English: 180 g of oral powder.
Danish: 180 g oralt pulver.
English: Complete recovery was seen after treatment discontinuation (see section 4.4).
Danish: Fuld remission sås efter behandlingsophør (se pkt.
English: Cystadane should be used as supplement to other therapies such as vitamin B6 (pyridoxine), vitamin B12 (cobalamin), folate and a specific diet.
Danish: Cystadane bør benyttes som supplement to andre behandlinger som fx vitamin B6 (pyridoxin), vitamin B12 (cobalamin), folinsyre og en målrettet diæt.
English: 5 How to store Cystadane Contents of the pack and other information
Danish: Sådan opbevarer du Cystadane Pakningsstørrelser og yderligere oplysninger
English: Long-term carcinogenicity and reproductive toxicity studies have not been conducted on betaine anhydrous.
Danish: Der har ikke været udført karcinogenicitetsforsøg eller reproduktionstoksikologiske studier med betain, vandfri.
English: What Cystadane is and what it is used for What do you need to know before you take Cystadane How to take Cystadane
Danish: Oversigt over indlægssedlen Cystadanes virkning og hvad du skal bruge det til Det skal du vide, før du begynder at tage Cystadane Sådan skal du tage Cystadane Bivirkninger
English: Ask your pharmacist how to throw away medicines you no longer use.
Danish: Spørg på apoteket hvordan du skal aflevere medicinrester.
English: Other medicines and Cystadane
Danish: Brug af anden medicin sammen med Cystadane
English: The recommended total daily dose is 100 mg/kg/day given in 2 doses daily.
Danish: Den anbefalede totale daglige dosis er 100 mg/kg/dag fordelt på 2 daglige doser.
English: Description of selected adverse reactions *Uncommon cases of severe cerebral oedema and hypermethioninemia were reported within 2 weeks to 6 months of starting betaine anhydrous therapy in patients with CBS deficiency, with complete recovery after treatment discontinuation.
Danish: Beskrivelse af udvalgte bivirkninger *Der er rapporter om sjældne tilfælde af alvorligt cerebralt ødem og hypermethioninæmi i perioden mellem to uger til 6 måneder efter påbegyndelse af behandling med betain, vandfri til patienter med CBS-mangel.
English: Based on in vitro data, betaine anhydrous might interact with amino acids mixtures and medicinal products containing vigabatrin and GABA analogues.
Danish: Baseret på in vitro-data er det muligt, at betain, vandfri, interagerer med aminosyrerblandinger og lægemidler, der indeholder vigabatrin og GABA-analoger.
English: Data on a limited number of exposed pregnancies indicate no adverse event of betaine anhydrous on pregnancy or on the health of the foetus/newborn child. To date, no other relevant epidemiologic data are available.
Danish: Data om et begrænset antal eksponerede graviditeter viser, at betain, vandfri, ikke medfører uventede hændelser ved graviditet eller fostrets/det nyfødte barns sundhed.
English: What you need to know before you take Cystadane
Danish: Det skal du vide, før du begynder at tage Cystadane
English: The bottle should be lightly shaken before opening.
Danish: Flasken bør rystes let, før den åbnes.
English: Driving and using machines Cystadane has no or negligible influence on the ability to drive and use machines.
Danish: Trafik- og arbejdssikkerhed Cystadane påvirker ikke eller i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Each pack contains 1 bottle with 180 g of powder and three measuring spoons.
Danish: Hver pakning indeholder en flaske med 180 g pulver og tre måleskeer.
English: Mix the measured dose of powder with water, juice, milk, formula or food until completely dissolved and ingest immediately after mixing.
Danish: Pulveret blandes med vand, juice, mælk, opskrifter eller mad indtil det er helt opløst og indtages lige efter opblanding.
English: (age between 21 to 49 years), after a single oral dose of betaine anhydrous (50 mg/kg), absorption was rapid (tmax = 0.9 ± 0.3 hours and a Cmax = 0.9 ± 0.2 mM).
Danish: Hos raske voksne frivillige (mellem 21 og 49 år) var absorptionen hurtig (tmax = 0,9  0,3 timer og Cmax = 0,9  0,2 mM) efter en enkelt oral dosis betain, vandfri (50 mg/kg).
English: In order to reduce methionine levels, modification of diet as well as dose reduction of Cystadane or temporal interruption of Cystadane treatment should be considered.
Danish: Ændring af diæt samt nedtitrering af Cystadane eller midlertidig seponering af behandlingen med Cystadane bør overvejes for at reducere methionin-koncentrationen.
English: The use of this medicine will be supervised by a doctor experienced in the treatment of patients with homocystinuria.
Danish: Brugen af medicinen følges af en læge, der har erfaring med at behandle patienter med homocysteinuria.
English: Betaine anhydrous acts as a methyl group donor in the remethylation of homocysteine to methionine in patients with homocystinuria.
Danish: Betain, vandfri, virker som en methylgruppe-donor i remethyleringen af homocystein til methionin hos patienter med homocysteinuria.
English: Cystadane 1 g oral powder
Danish: Cystadane 1 g oralt pulver
English: • take a heaped spoonful of powder out of the bottle
Danish: • Tag en toppet måleskefuld fra flasken,
English: Betaine anhydrous has also been shown to increase plasma methionine and S-adenosyl methionine (SAM) levels in patients with MTHFR deficiency and cbl defects.
Danish: Det er også påvist, at betain, vandfri, øger plasmaniveauer af methionin og S-adenosylmethionin (SAM) hos patienter med MTHFR-mangel og cbl-defekter.
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Danish: Når lægemidlet er godkendt, er indberetning afformodede bivirkninger vigtig.
English: Three measuring spoons (green, blue, pink) dispense 100mg, 150mg or 1g of betaine anhydrous.
Danish: Tre måleskeer (grøn, blå, lyserød) dispenserer 100 mg, 150 mg eller 1 g betain, vandfri.
English: Elevated homocysteine plasma levels are associated with cardiovascular events (such as thrombosis), osteoporosis, skeletal abnormalities, and optic lens dislocation.
Danish: Forhøjede homocystein-plasmaniveauer er associeret med kardiovakulære hændelser så som trombose, osteoporose, skeletforandringer og linsedislokation.
English: Gastrointestinal disorders like diarrhoea, nausea, vomiting, stomach discomfort and inflammation of the tongue may occur uncommonly (may affect up to 1 in 100 people).
Danish: Mave-tarm-lidelser som for eksempel diaré, kvalme, opkastning, maveubehag og betændelse i tungen kan forekomme, men er ikke almindelige (kan ramme op til 1 ud af 100 personer).
English: • shake the bottle lightly before opening
Danish: • Ryst flasken let før åbning,
English: Metabolism and nutrition disorders
Danish: Stofskiftesygdomme og ernæringsbetingede sygdomme
English: Betaine anhydrous supplementation was shown to improve the metabolic abnormalities in the cerebrospinal fluid of patients with homocystinuria.
Danish: Det er blevet påvist, at tilskud af betain, vandfri, forbedrer de metaboliske abnormiteter i cerebrospinalvæsken hos patienter med homocysteinuria.
English: With a slow elimination rate (mean half life = 14 h, mean total body clearance, CL/F, = 84 ml/h/kg),
Danish: Med en langsom eliminationsrate (gennemsnitlig halveringstid = 14 timer, gennemsnitlig total clearance fra kroppen, CL/F = 84 ml/t/kg), er den renale clearance ubetydelig (5% af den totale clearance fra kroppen), hvilket nærmer sig en biotilgængelighed på en 100%.
English: Unopened bottle: 3 years After the first opening: 3 months.
Danish: Uåbnet flaske: 3 år.
English: • pass the flat back of a knife over the top of the spoon
Danish: • Stryg en glat overflade, fx kanten af en kniv henover kanten af måleskeen,
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt frekvensgruppe er bivirkningerne opstillet med de alvorligste bivirkninger først.
English: Experience with betaine anhydrous therapy in patients with renal insufficiency or non-alcoholic hepatic steatosis has demonstrated no need to adapt the dose regimen of Cystadane.
Danish: Erfaring med behandling med betain, vandfri hos patienter med nedsat nyrefunktion eller leversteatose, som ikke skyldes alkohol, har vist at det ikke er nødvendigt at tilpasse den homocysteinsænkende effekt.
English: Shelf life after the first opening: 3 months.
Danish: Holdbarhed efter første åbning: 3 måneder.
English: As cerebral oedema has also been reported in patients with hypermethioninemia, secondary hypermethioninemia due to betaine anhydrous therapy has been postulated as a possible mechanism of action.
Danish: Eftersom der også er rapporter om cerebralt ødem hos patienter med hypermethioninæmi som følge af behandling med betain, vandfri, har det været foreslået som en mulig årsag til cerebralt ødem.
English: Do not pass it on to others.
Danish: Lad derfor være med at give Cystadane til andre.
English: - If you have any further questions, ask your doctor or your pharmacist.
Danish: Er du i tvivl så spørg lægen eller apoteket.
English: Betaine anhydrous was shown to lower plasma homocysteine levels in the three types of homocystinuria, i.e. CBS deficiency; MTHFR deficiency and cbl defect.
Danish: Det er påvist, at betain, vandfri, sænker plasma homocystein-niveauerne i tre typer af homocysteinuria, CBS- mangel, MTHFR-mangel, og cbl-deffekt.
English: Uncommon: urinary incontinence
Danish: Usædvanlig: Inkontinens.
English: What Cystadane looks like and contents of the pack Cystadane is a white crystalline free flowing powder.
Danish: Cystadane er et hvidt krystallinsk frit strømmende pulver.
English: This will give the following doses: small measure 100 mg, middle size measure 150 mg and large measure 1 g of betaine anhydrous.
Danish: Det giver følgende dosis: Den lille måleske giver 100 mg, den midterste måleske giver 150 mg og den store måleske giver 1 g betain, vandfri.
English: Gastrointestinal disorders like diarrhoea, glossitis, nausea, stomach discomfort, vomiting and dental disorders may occur uncommonly.
Danish: Mave-tarm-lidelser såsom diaré, glossitis, kvalme, maveubehag, opkastning og tandlidelser kan forekomme, men er ikke almindelige.
English: Complete recovery was seen after treatment discontinuation: - The plasma methionine concentrations should be kept below 1000 µM.
Danish: • Plasma methionin-koncentrationen skal holdes under 1000 M.
English: Medicinal product subject to restricted medical prescription (see annex I: Summary of Product Characteristics, section 4.2)
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé, pkt.
English: Uncommon cases of severe cerebral oedema associated with hypermethioninemia were reported with betaine anhydrous therapy in patients with CBS deficiency (see section 4.8).
Danish: Der er rapporter om sjældne tilfælde af alvorligt cerebralt ødem forbundet med hypermethioninæmi efter behandling med betain, vandfri til patienter med CBS-mangel (se pkt.
English: Monitoring plasma homocysteine levels has demonstrated that the onset of action of betaine anhydrous occurred within several days and that a steady-state response was achieved within one month.
Danish: Ved at måle plasma-homocystein-niveauet er det vist, at betain, vandfri, starter med at virke efter adskillige dage, og at den fulde effekt indtræder efter en måned.
English: In a few cases, increased plasma methionine levels were associated with cerebral oedema (see sections 4.4 and 4.8).
Danish: I enkelte tilfælde har øget plasmaniveauer af methionin været associeret med cerebralt ødem (se pkt.
English: In paediatric patients less than 10 years of age, the usual effective dose regimen is 100 mg/kg/day given in 2 doses daily; increasing the frequency above twice daily and/or the dose above 150 mg/kg/day does not improve the homocysteine-lowering effect.
Danish: Det forbedrer ikke den homocystein-sænkende effekt at øge antallet af doseringer til mere end to gange dagligt og/eller at øge dosis til mere end 150 mg/kg/dag.
English: How to store Cystadane
Danish: Sådan opbevarer du Cystadane
English: Lightly shake the bottle before opening.
Danish: Flasken rystes let før åbning.
English: This demonstrates that differences in betaine anhydrous kinetics are most probably due to betaine anhydrous depletion in untreated homocystinuria and are only meaningful for the initial treatment.
Danish: sandsynligvis skyldes mangel på betain, vandfri, hos patienter med ubehandlet homocysteinuria, og at forskellen kun har betydning for den initiale behandling.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Danish: Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant:
English: Check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen eller apoteket hvis der er noget, du er i tvivl om eller følger dig usikker på.
English: 1 g of oral powder contains 1 g of betaine anhydrous.
Danish: 1 g oralt pulver indeholder 1 g betain, vandfri.
English: Tél/Tel: +32 2 46101 36 Belgique
Danish: Tél/Tel: +32 2 46101 36
English: How to take Cystadane
Danish: Sådan skal du tage Cystadane
English: EXP Shelf life after the first opening: 3 months.
Danish: Udløbsdato: Holdbarhed efter første åbning: 3 måneder.
English: Symptoms of cerebral oedema include morning headaches with vomiting and/or visual changes High increases in plasma methionine levels in a range from 1,000 to 3,000 µM were noted in these patients.
Danish: Hos disse patienter blev der også observeret store stigninger af plasma-methionin på mellem 1000 og 3000 M.
English: Uncommon: diarrhoea, glossitis, nausea, stomach discomfort, vomiting Skin and subcutaneous tissue disorders Uncommon: hair loss, hives, skin odour abnormal Renal and urinary disorders
Danish: Sygdomme i hud og subkutane væv Usædvanlig: Hårtab, urticaria, unormal lugt fra huden.
English: Three measuring spoons are provided which dispense either 100 mg, 150 mg or 1 g of betaine anhydrous.
Danish: Der følger tre måleskeer med, og de svarer til hhv. 1 g, 150 mg og 100 mg betain, vandfri.
English: Marketing Authorisation Holder Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du General de Gaulle F-92 800 Puteaux France
Danish: Indehaveren af markedsføringstilladelsen Recordati Rare Diseases Immeuble “Le Wilson” 70, Avenue du General de Gaulle F-92 800 Puteaux
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
Danish: MINDSTEKRAV TIL OPLYSNINGER, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: 1 g of powder contains 1 g of betaine anhydrous.
Danish: 1 g pulver indeholder 1 g betain, vandfri.
English: Recordati Rare Diseases Immeuble "Le Wilson" 70, avenue du Général de Gaulle F-92800 Puteaux France
Danish: Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F-92800 Puteaux Frankrig
English: Recordati Rare Diseases Immeuble “Le Wilson” 70, Avenue du General de Gaulle F-92 800 Puteaux France
Danish: Recordati Rare Diseases Immeuble “Le Wilson” 70, Avenue du General de Gaulle F-92 800 Puteaux Frankrig
English: Cystadane 1 g oral powder Betaine anhydrous
Danish: Cystadane 1 g oralt pulver Betain, vandfri
English: Hepatic or renal impairment
Danish: Sygdomme i nyre og urinveje
English: Uncommon: brain oedema*
Danish: Usædvanlig: Ødem i hjernen*.
English: It is converted into homocysteine which is then normally converted into cysteine during digestion.
Danish: I kroppen kan det først ændres til stoffet homocystein og derefter til stoffet cystein.
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret Cystadane til dig personligt.
English: Homocystinuria is a disease caused by the accumulation of homocysteine which is not converted to cysteine and is characterised by formation of clots in the veins, bone weakness, and skeletal and crystalline lens abnormalities.
Danish: De typiske tegn på homocysteinuria er blodpropper i årene, skøre knogler, ændringer af skelettet og i øjets linse.
English: 6.6 Special precautions for disposal
Danish: 6.6 Regler for destruktion <og anden håndtering >
English: This overview was last updated in October 2019.
Danish: Denne oversigt blev sidst ajourført i oktober 2019.
English: The contents of one tube are given into each infected ear.
Danish: Indholdet i en tube indgives i hvert inficeret øre.
English: Other information about Neptra
Danish: Andre oplysninger om Neptra
English: The inside of the ear should be cleaned and dry before treatment.
Danish: Indersiden af øret skal renses og tørres inden behandlingen.
English: Avoid swallowing the product or accidentally transferring it from hand to mouth.
Danish: Undgå at sluge produktet eller utilsigtet at overføre det fra hånden til munden.
English: A single treatment is required however the full effect may only be seen 28 days later.
Danish: Der kræves kun en enkelt behandling, men det kan tage op til 28 dage, inden den fulde virkning opnås.
English: Neptra received a marketing authorisation valid throughout the EU on 10 December 2019.
Danish: Neptra fik en markedsføringstilladelse med gyldighed i hele EU den 10/12/2019.
English: Further information on Neptra can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/neptra.
Danish: Yderligere oplysninger om Neptra findes på agenturets websted under: ema.europa.eu/medicines/veterinary/EPAR/Neptra.
English: The European Medicines Agency decided that Neptra's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Neptra opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: In case of accidental eye exposure, the eyes should be flushed thoroughly with water for 10 to 15 minutes.
Danish: Ved utilsigtet øjeneksponering skylles øjnene grundigt med vand i 10-15 minutter.
English: This was more effective than the control group of 27 dogs, which received a placebo (dummy treatment) and for which the reduction was 49%.
Danish: Dette var mere effektivt end kontrolgruppen med 27 hunde, som fik placebo (en uvirksom behandling), og hvor reduktionen var på 49 %.
English: An overview of Neptra and why it is authorised in the EU
Danish: En oversigt over Neptra, og hvorfor det er godkendt i EU
English: Why is Neptra authorised in the EU?
Danish: Hvorfor er Neptra godkendt i EU?
English: What are the risks associated with Neptra?
Danish: Hvilke risici er der forbundet med Neptra?
English: Neptra may be harmful after swallowing.
Danish: Neptra kan være skadeligt efter indtagelse.
English: Neptra can cause serious eye irritation if it accidentally gets into the eyes when the dog shakes its head during or just after application.
Danish: Neptra kan forårsage alvorlig øjenirritation, hvis det ved et uheld kommer i øjnene, når hunden ryster sit hoved i løbet af eller lige efter påføring.
English: The third active substance, mometasone, is a corticosteroid, a medicine that reduces inflammation and pain associated with the infection.
Danish: Det tredje aktive stof, mometason, er et kortikosteroid, et lægemiddel, der mindsker inflammation og smerter i forbindelse med infektionen.
English: Florfenicol is an antibiotic which works by blocking the production of proteins, which are essential components of bacterial cell walls.
Danish: Florfenicol er et antibiotikum, der virker ved at blokere produktionen af proteiner, som er vigtige bestanddele i bakteriernes cellevægge.
English: What is Neptra and what is it used for?
Danish: Hvad er Neptra, og hvad anvendes det til?
English: In case of accidental skin contact, exposed skin should be thoroughly washed with water.
Danish: I tilfælde af utilsigtet hudkontakt skal den eksponerede hud vaskes grundigt med vand.
English: Two of the active substances in Neptra, florfenicol and terbinafine, act against possible causes of infection.
Danish: To af de aktive stoffer i Neptra, florfenicol og terbinafin, modvirker infektionens mulige årsager.
English: The medicine is available as ear drops and can only be obtained with a prescription.
Danish: Lægemidlet fås som øredråber og fås kun på recept.
English: It is therefore recommended that this medicine is applied only by veterinarians or under their close supervision and that measures are taken to reduce the risk (e.g. wearing safety glasses during treatment, massaging the ear canal well after application to ensure even distribution of product, restraining the dog after application).
Danish: Det anbefales derfor, at lægemidlet kun anvendes af dyrlæger eller under deres nøje overvågning, og at der træffes foranstaltninger for at mindske risikoen (f.eks. ved at bære sikkerhedsbriller under behandling, massere øregangen godt efter påføring for at sikre en jævn fordeling af produktet samt fastholde hunden efter anvendelse).
English: Neptra (florfenicol / terbinafine / mometasone)
Danish: Neptra (florfenicol / terbinafin / mometason)
English: Although no potential for skin irritation was indicated by studies, skin contact should be avoided.
Danish: Selv om studiet ikke har påvist nogen risiko for hudirritation, bør kontakt med huden undgås.
English: For more information about using Neptra, see the package leaflet or contact your veterinarian or pharmacist.
Danish: Hvis du ønsker flere oplysninger om anvendelsen af Neptra, kan du læse indlægssedlen eller kontakte din dyrlæge eller apoteket.
English: In a field study in Europe involving dogs with ear infections with both Staphylococcus pseudintermedius and Malassezia pachydermatitis 43 Neptra treated dogs had their signs of infection reduced by 71% after 28 days which was as effective as the comparator group of 45 dogs, treated with another veterinary medicine authorised for ear infections, for which the reduction was 74%.
Danish: I et feltstudie, der blev gennemført i Europa, hos hunde med øreinfektioner forårsaget af både Staphylococcus pseudintermedius og Malassezia pachydermatitis blev tegnene på infektion mindsket med 71 % hos 43 hunde behandlet med Neptra efter 28 dage, hvilket var lige så effektivt som i sammenligningsgruppen med 45 hunde, som blev behandlet med et andet veterinærlægemiddel til øreinfektioner, og hvor reduktionen var 74 %.