FrancophonIA/ELRC3.0 huggingface dataset:
English: Kidney and liver problems Please talk with your surgeon before the start of treatment if you have liver or kidney disease.
Danish: Nyre- og leverproblemer Hvis du har lever- eller nyresygdom, skal du inden behandlingens start tale med kirurgen.
English: How Holoclar is given
Danish: Sådan får du Holoclar
English: The recommended dose of Holoclar is 79,000 - 316,000 cells/cm², corresponding to 1 cm² of product/cm² of defect.
Danish: Den anbefalede dosis Holoclar er 79.000 - 316.000 celler/cm², svarende til 1 cm² produkt/cm² defekt.
English: Keep the steel primary container tightly closed in order to protect from bacterial, fungal and viral contamination
Danish: Hold den primære beholder af stål tæt tillukket for at beskytte indholdet mod bakteriel-, fungal- og viral kontaminering
English: Educational material for healthcare professionals to provide training on the appropriate use of the product and to minimise risks, addressing the key elements of: - Patient selection - Traceability of patients and use of identifiers - Biopsy, implant and follow up care - Contraindicated use of eye drops containing benzalkonium chloride - Risk of glaucoma and blepharitis - Encouraging enrolment in the registry - Reporting suspected side effects
Danish: Følgende yderligere risikominimeringsforanstaltninger er nødvendige for den sikre og effektive anvendelse af præparatet: Undervisningsmaterialet til sundhedspersonalet skal give oplysninger om den korrekte anvendelse af præparatet og skal for at minimere risiciomfattefølgende væsentlige elementer: - Udvælgelse af patienter - Sporbarhed af patienter og brug afidentifikatorer - Biopsi, implantat og opfølgningsbehandling - Kontraindiceret brug af øjendråber, der indeholderbenzalkoniumchlorid - Risiko for glaukom og blepharitis - Opmuntring af optagelse i registret - Indberetning af formodede bivirkninger Undervisningsmaterialet skal også inkludere både en undervisningsmanual og et undervisningsprogram, som vil omfatte verificering af lægers forståelse af den givne undervisning.
English: Each container contains 3.8 cm2 of autologous human corneal epithelium attached on a fibrin support and covered with transport medium.
Danish: Hver beholder indeholder 3,8 cm2 autologt humant corneaepitel fastgjort på et fibrint underlag og dækket af transportmedium.
English: Keep the steel primary container tightly closed to protect from bacterial, fungal and viral contamination.
Danish: Hold den primære beholder af stål tæt tillukket for at beskytte indholdet mod bakteriel-, fungal- og viral kontaminering.
English: What Holoclar looks like and contents of the pack Holoclar is a layer of cells for implantation into your eye.
Danish: Holoclar er et lag celler til implantation i dit øje.
English: The sealed bag is put in a non-sterile, thermally insulated box for organ transportation with a temperature monitor.
Danish: Til sidst anbringes den forseglede pose i en usteril, termisk isoleret transportkasse til organtransport med en temperaturmåler.
English: After surgery, you will be prescribed a course of medicines to ensure full healing: antibiotics to reduce the chance of an infection and steroids to reduce swelling and irritation.
Danish: Antibiotika for at reducere risikoen for en infektion og steroider for at reducere hævelse og irritation.
English: PHARMACEUTICAL FORM AND CONTENTS Living tissue equivalent.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Vævskultur, levende.
English: Infections and infestations
Danish: Infektionerogparasitæresygdomme
English: PHARMACEUTICAL FORM Living tissue equivalent.
Danish: LÆGEMIDDELFORM Vævskultur, levende.
English: Immunohistochemical analysis of cornea taken from patients receiving keratoplasty after Holoclar treatment demonstrated that the transplanted stem cells establish a normal layer of stratified corneal epithelium, which do not migrate or invade basal ocular structures.
Danish: Typen af- og den beregnede kliniske anvendelse af Holoclar er således, at konventionelle farmakokinetiske studier om absorption, biotransformation og elimination ikke er relevante.Immunhistokemiskanalyse af cornea taget fra patienters corneatransplantation efter Holoclar-behandling viste, at de transplanterede stamceller etablerer et normalt lag af stratificeret corneaepitel, som ikke migrerer eller invaderer basale okulære strukturer.
English: - If you have any further questions, ask your surgeon.
Danish: - Spørg kirurgen, hvis der er mere, du vil vide.
English: For information on the preparation and handling of Holoclar, please refer to section 6.6.
Danish: For instruktioner om klargøring og håndtering af Holoclar se pkt.
English: In such a case, please contact your surgeon.
Danish: Sker det, skal du kontakte din læge.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING ZIPPED SEALABLE BAG
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE LUKKET FORSEGLET POSE
English: The surgical nature of the underlying procedure for the implantation of Holoclar has a major influence on the ability to drive and use machines.
Danish: Holoclar påvirker i væsentlig grad evnen til at føre motorkøretøj og betjene maskiner på grund af indgrebet i forbindelse med implantationen.
English: Very common
Danish: Ikkealmindelig
English: For relevant safety information, physicians should consult the SmPC of these medicinal products.
Danish: Lægen bedes konsultere disse lægemidlers produktresuméer for relevante sikkerhedsoplysninger.
English: Ask your surgeon if you have any further questions about the treatment with Holoclar.
Danish: Spørg kirurgen, hvis der er noget, du er i tvivl om.
English: Posology
Danish: Hornhinde
English: Conjunctival haemorrhage, eye haemorrhage, corneal epithelium defect, eye pain, glaucoma/intraocular pressure increased, ulcerative keratitis
Danish: Almindelig i øjet, glaukom/øget intraokulørt tryk, ulcerativkeratitis Conjunctivaladhæsion, conjunctivalhyperæmi, ødemi cornea, perforation af cornea, øjenirritation, fotofobi.
English: • Eye pain
Danish: • Øjensmerter
English: Reporting of suspected adverse reactions
Danish: Indberetning om formodede bivirkninger
English: No recommendation on posology can be made (see sections 4.8 and 5.1).
Danish: Der kan ikke gives nogen anbefalinger vedrørende dosering(se pkt.
English: NAME OF THE MEDICINAL PRODUCT Holoclar 79,000 - 316,000 cells/cm2 living tissue equivalent.
Danish: LÆGEMIDLETS NAVN Holoclar 79.000 - 316.000 celler/cm2 vævskultur, levende.
English: General disorders and administration site conditions Metaplasia of the implant
Danish: Almene symptomer og reaktioner på administrationsstedet
English: The picture shows where the limbus is in your eye.
Danish: Billedetviser, hvorlimbusbefinder sig iøjet.
English: • Uneven eyelids
Danish: • Ujævneøjenlåg
English: Pharmacotherapeutic group: Ophthalmologicals, other ophthalmologicals, ATC code: S01XA19 Mechanism of action and pharmacodynamic effects The mechanism of action of Holoclar is the replacement of corneal epithelium and lost limbal stem cells in patients in which the limbus has been destroyed by ocular burns.
Danish: Holoclars virkningsmekanisme er udskiftningen af corneaepitel og mistedelimbale stamceller hos patienter, i hvilke limbus er blevet ødelagt pga. okulære forbrændinger.
English: Conjunctival adhesion, conjunctival hyperaemia, corneal oedema, corneal
Danish: Farmakoterapeutisk klassifikation: Ophthalmologica, andre ophthalmologiske midler, ATC-kode: S01XA19
English: • worsening of existing neurological conditions.
Danish: • forværring af eksisterende neurologiske tilstande.
English: In small children this can be 4 to 6 times per day.
Danish: Dette kan for små børn være 4 til 6 gange om dagen.
English: Make sure that there are at least 3 hours between two doses.
Danish: Der skal være mindst 3 timer mellem to doser.
English: Your doctor will tell you the amount of granules you should take.
Danish: Din læge vil fortælle dig, hvor meget granulat du skal tage.
English: Date of first authorisation: 31 July 2013 Date of latest renewal: 23 March 2018
Danish: Dato for første markedsføringstilladelse: 31 juli 2013 Dato for seneste fornyelse: 23 marts 2018
English: You should take a dose as soon as possible with your next meal.
Danish: Du skal tage en dosis så hurtigt som muligt sammen med dit næste måltid.
English: You must follow this diet carefully.
Danish: Du skal følge denne diæt nøje.
English: The patient recovered within 48 hours after symptomatic treatment.
Danish: Patienten blev rask i løbet af 48 timer efter symptomatisk behandling.
English: It is important that the diagnosis is made early and treatment is initiated immediately to improve the survival and the clinical outcome.
Danish: Det er vigtigt, at diagnosen stilles tidligt, og at behandlingen indsættes straks for at forbedre overlevelsen og det kliniske udfald.
English: The effect of food on absorption is unknown.
Danish: Fødeindtagelsens betydning for absorptionen er ukendt.
English: It is especially important to tell your doctor if you are taking medicines containing:
Danish: Det er især vigtigt, at du fortæller det til din læge, hvis du tager medicin, som indeholder:
English: The total daily dose should be divided into equal amounts and given with each meal or feeding (e.g. 4-6 times per day in small children).
Danish: Den totale daglige dosis bør deles i lige store mængder, som gives ved hvert måltid eller madning (f.eks. 4-6 gange dagligt til små børn).
English: The elimination half-life was estimated to be 0.8 hours.
Danish: Halveringstiden blev skønnet til at være 0,8 time.
English: This will keep the granules from producing any taste.
Danish: Derved undgås, at granulatet afgiver smag.
English: This should be taken into account in patients with diabetes mellitus.
Danish: Dette bør tages i betragtning hos patienter med diabetes mellitus.
English: Adverse reactions mainly involved the reproductive and gastrointestinal system.
Danish: Uønskede hændelser involverede hovedsagelig det reproduktive og det gastrointestinale system.
English: You will need to take this medicine and to follow a diet throughout your life.
Danish: Du skal tage dette lægemiddel og holde diæt hele livet.
English: The safety and efficacy of doses in excess of 20 g/day have not been established.
Danish: Sikkerheden og effekten ved doser over 20 g/dag er ikke undersøgt.
English: Content of clinically important electrolytes
Danish: Indhold af klinisk vigtige elektrolytter
English: Common depression, irritability
Danish: Almindelig depression, irritabilitet
English: Nitrogen is a building block of proteins, which are an essential part of the food we eat.
Danish: Kvælstof er en af byggestenene i proteiner og er en væsentlig del af den kost vi spiser.
English: If you are sexually active and your period stops altogether, do not assume that this is caused by PHEBURANE.
Danish: Hvis du er seksuelt aktiv, og dine menstruationer standser helt, må du ikke antage, at det skyldes PHEBURANE.
English: If caloric supplementation is indicated, a protein-free product is recommended.
Danish: Hvis kalorietilskud er påkrævet, anbefales et proteinfrit produkt.
English: Talk to your doctor or pharmacist if you need 3 or more grams daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.
Danish: Fortæl det til din læge eller apotekspersonalet, hvis du har brug for 3 gram eller mere pr. dag i en længere periode, især hvis du er blevet rådet til at følge en diæt med lavt indhold af salt (natrium).
English: You should take PHEBURANE with each meal or feeding.
Danish: Du skal tage PHEBURANE sammen med hvert måltid eller madning.
English: These medicines may change the effect of PHEBURANE and you will need more frequent blood tests.
Danish: Disse lægemidler kan ændre virkningen af PHEBURANE, og du vil have behov for hyppigere at få taget blodprøver.
English: • are pregnant.
Danish: • hvis du er gravid
English: (see section 4.6).
Danish: (angivet i afsnit 6)
English: • valproate (an antiepileptic medicine),
Danish: • valproat (et antiepileptisk lægemiddel)
English: The elimination half-life was estimated to be 1.3 and 2.4 hours, respectively.
Danish: Halveringstiden blev skønnet til at være henholdsvis 1,3 og 2,4 timer.
English: Patients with neonatal-onset disease had a high incidence of mental retardation.
Danish: Patienter med den neonatalt indsættende sygdom havde en høj hyppighed af mental retardering.
English: She recovered following dose reduction except for recurrent pancreatitis episodes that eventually prompted treatment discontinuation.
Danish: Hun kom sig, efter at dosis blev reduceret, med undtagelse af tilbagevendende episoder af pankreatitis, der slutteligt førte til, at behandlingen blev seponeret.
English: Very common side effects (may affect more than 1 in 10 people): irregular menstrual periods and stopping of menstrual periods in fertile women.
Danish: Meget almindelige bivirkninger (kan forekomme hos mere end 1 ud af hver 10 behandlede): Uregelmæssige menstruation og ophør af menstruation hos fødedygtige kvinder.
English: Only use this measuring spoon to measure out the dose.
Danish: Brug kun denne måleske til at afmåle dosis.
English: Very common amenorrhea, irregular menstruation
Danish: Meget almindelig amenoré, uregelmæssig menstruation
English: More frequent monitoring of plasma ammonia levels is advised when these medicinal products have to be used.
Danish: En hyppigere kontrol af plasmakoncentrationen af ammoniak tilrådes, når disse præparater skal anvendes.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Danish: Undersøgelser hos dyr har vist reproduktiv toksicitet (se pkt.
English: • 9.9 - 13.0 g/m2/day in children weighing more than 20 kg, adolescents and adults.
Danish: • 9,9-13,0 g/m2/dag til børn, som vejer mere end 20 kg, samt unge og voksne.
English: If you mix them with food, it is important that you take it immediately.
Danish: Hvis du blander granulatet med mad, er det vigtigt at tage det straks.
English: Cerebral synapse maturation was retarded and the number of functioning nerve terminals in the cerebrum was reduced, which resulted in impaired brain growth.
Danish: Modningen af hjernesynapse var retarderet og antallet af fungerende nerveterminaler i storhjernen var reduceret, hvilket resulterede i svækket hjernevækst.
English: • suffer from congestive heart failure (a type of heart disease where the heart cannot pump enough blood around the body) or a decrease in your kidney function.
Danish: • hvis du lider af kongestivt hjertesvigt (en hjertesygdom, hvor hjertet ikke kan pumpe tilstrækkeligt med blod rundt i kroppen) eller nedsat nyrefunktion
English: Distribution The volume of distribution of phenylbutyrate is 0.2 l/kg.
Danish: Distribution Distributionsvolumen for phenylbutyrat er 0,2 l/kg.
English: As the body breaks down protein after eating, waste nitrogen, in the form of ammonia, accumulates because the body cannot eliminate it. Ammonia is especially toxic for the brain and leads, in severe cases, to reduced levels of consciousness and to coma.
Danish: Da kroppen nedbryder protein, efter at man har indtaget det, vil kvælstof ophobes i form af ammoniak, fordi kroppen ikke kan udskille det. Ammoniak er specielt giftigt for hjernen, og fører i alvorlige tilfælde til bevidsthedsforstyrrelser og koma.
English: If you are a woman who could get pregnant, you must use reliable contraception, during treatment with PHEBURANE.
Danish: Hvis du er kvinde, og du kan blive gravid, skal du bruge en sikker form for svangerskabsforebyggelse under behandlingen med PHEBURANE.
English: You should take PHEBURANE by mouth.
Danish: Du skal tage PHEBURANE gennem munden.
English: Talk to your doctor for the details.
Danish: Tal med lægen herom.
English: The mean time to peak concentration was 3.55 and 3.23 hours, respectively, and the mean peak concentration was 45.3 and 62.8 μg/ml, respectively.
Danish: Den gennemsnitlige tid til maksimumkoncentration var henholdsvis 3,55 og 3,23 timer, og de gennemsnitlige maksimumkoncentrationer var henholdsvis 45,3 og 62,8 µg/ml.
English: The maximum daily dose of this medicinal product is equivalent to 125% of the WHO recommended maximum daily intake for sodium.
Danish: Den maksimale daglige dosis af dette lægemiddel er ækvivalent med 125% af WHO's maksimalt anbefalede daglige indtag af natrium.
English: The daily dose should be individually adjusted according to the patient's protein tolerance and the daily dietary protein intake needed to promote growth and development.
Danish: Den daglige dosis bør justeres individuelt svarende til patientens proteintolerance og den daglige indtagelse af kostprotein, som er nødvendig for at fremme vækst og udvikling.
English: If you experience any of these symptoms, you should immediately contact your doctor or the nearest hospital emergency department for supportive treatment.
Danish: Hvis du oplever et af de nævnte symptomer, bør du straks kontakte din læge eller skadestuen på nærmeste hospital for at få understøttende behandling.
English: • Even on therapy, acute hyperammonaemic encephalopathy may occur in a number of patients.
Danish: • Selv under behandling kan akut hyperammonæmisk encefalopati opstå hos nogle patienter.
English: <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: 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).
English: Do not use PHEBURANE if you are pregnant, because this medicine can harm your unborn baby.
Danish: Tag ikke PHEBURANE, hvis du er gravid, da denne medicin kan skade det ufødte barn.
English: PHEBURANE may be required life-long unless orthotropic liver transplantation is elected.
Danish: Livslang behandling med PHEBURANE kan være nødvendig, medmindre der vælges ortotrop levertransplantation.
English: Plasma glutamine should be maintained at levels less than 1,000 μmol/L.
Danish: Plasmaglutamin skal holdes på koncentrationer under 1 000 µmol/l.
English: In case of mixture of the granules with solid foods or liquid it is important that it is taken immediately after mixing.
Danish: Når granulatet blandes med fast føde eller væske, er det vigtigt, at det indtages straks efter opblanding.
English: In the table below all adverse reactions are listed below, by system organ class and by frequency.
Danish: I nedenstående tabel er uønskede hændelser inddelt efter systemorganklasse og hyppighed.
English: Phenylacetate is also hydrolysed by esterases in liver and blood.
Danish: Phenylacetat bliver desuden hydrolyseret af esteraser i lever og blod.
English: • disorientation,
Danish: • desorientering
English: • Pour granules directly into the spoon as shown by the picture (on the outer carton and at the end of/page 2 of this leaflet)
Danish: • Hæld granulatet direkte i skeen som vist på tegningen (på yderkartonen og nederst på side 2 af denne indlægsseddel).
English: Repeated dosing with phenylacetate showed evidence of an induction of clearance.
Danish: Gentagen indgift med phenylacetat viste tegn på fremkaldelse af clearance.
English: • 450 - 600 mg/kg/day in neonates, infants and children weighing less than 20 kg
Danish: • 450-600 mg/kg/dag til børn, som vejer mindre end 20 kg.
English: • sleepiness, tiredness, light-headedness and less frequently confusion,
Danish: • søvnighed, træthed, svimmelhed og mindre hyppigt forvirring
English: One case of overdose occurred in a 5-month old infant with an accidental single dose of 10 g (1370 mg/kg).
Danish: Et enkelt tilfælde af overdosering indtraf hos et 5 måneders gammelt spædbarn med en utilsigtet enkelt dosis på 10 g (1 370 mg/kg).
English: Contains sodium and sucrose.
Danish: Indeholder natrium og saccharose.
English: Common renal tubular acidosis
Danish: Almindelig renal tubulær acidose
English: There are no or limited amount of data from the use of sodium phenylbutyrate in pregnant women.
Danish: Der findes ingen eller kun begrænsede data vedrørende brugen af natriumphenylbutyrat hos gravide kvinder.
English: The patient developed diarrhea, irritability and metabolic acidosis with hypokalaemia.
Danish: Patienten udviklede diaré, irritabilitet og metabolisk acidose med hypokalæmi.
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product.
Danish: Patienter med sjældne arvelige sygdomme med fruktoseintolerans, glukose-galaktosemalabsorption eller sukrase-isomaltase-insufficiens bør ikke anvende dette lægemiddel.
English: It is indicated in all patients with neonatal-onset disease (complete enzyme deficiencies, presenting within the first 28 days of life).
Danish: Det er indiceret til alle patienter med neonatalt indsættende sygdom (komplet enzymmangel, som viser sig inden for 28 dage post partum).
English: In patients diagnosed during gestation and treated prior to any episode of hyperammonaemic encephalopathy, survival was 100 %, but even in these patients, many subsequently demonstrated cognitive impairment or other neurologic deficits.
Danish: Hos patienter, som blev diagnosticeret under svangerskabet og behandlet, før der forekom anfald af hyperammonæmisk encefalopati, var overlevelsen 100 %, men selv hos disse patienter viste de fleste i efterforløbet kognitiv svækkelse eller andre neurologiske defekter.
English: • Tap the spoon once on a table to give a horizontal level of granules and continue filling if necessary
Danish: • Bank skeen mod bordet, så overfladen af granulatet bliver vandret, og fyld efter om nødvendigt.
English: CARTON AND BOTTLE LABEL
Danish: KARTON OG ETIKET TIL FLASKE
English: Reversal of pre-existing neurologic impairment is not likely to occur with treatment, and neurologic deterioration may continue in some patients.
Danish: Eksisterende neurologisk funktionsnedsættelse kan ikke forventes ophævet ved behandling, og hos nogle patienter må forventes neurologisk forværring.
English: PHEBURANE helps the body to eliminate waste nitrogen, reducing the amount of ammonia in your body.
Danish: PHEBURANE hjælper kroppen med at fjerne de kvælstofholdige affaldsstoffer og dermed reducere mængden af ammoniak i kroppen.
English: These rare disorders are due to a deficiency of certain liver enzymes which are necessary to eliminate waste nitrogen in the form of ammonia.
Danish: Disse sjældne sygdomme skyldes mangel på visse leverenzymer, som er nødvendige til udskillelse af kvælstofholdige affaldsstoffer i form af ammoniak.
English: This may be due to the lipophilicity of sodium phenylbutyrate and consequent differences in volume of distribution.
Danish: Dette kan skyldes lipofiliciteten af natriumphenylbutyrat og en deraf betinget forskel i distributionsvolumen.
English: Manifestations of neurotoxicity were predominantly somnolence, fatigue and light-headedness.
Danish: Neurotoksicitet var fortrinsvis manifesteret ved somnolens, træthed og svimmelhed.
English: There have been published reports of hyperammonaemia being induced by haloperidol and by valproate.
Danish: Der er publiceret rapporter om hyperammoniæmi, som var udløst af haloperidol og valproat.
English: If this happens you will develop symptoms such as feeling sick (nausea), being sick (vomiting), confusion and will need to get urgent medical help.
Danish: Hvis det sker, vil du få symptomer i form af kvalme, opkastning og forvirring, og du skal have øjeblikkelig lægehjælp.
English: Approximately 80 - 100 % of the medicinal product is excreted by the kidneys within 24 hours as the conjugated product, phenylacetylglutamine.
Danish: Cirka 80-100 % af medicinen udskilles af nyrerne inden for 24 timer som det konjugerede produkt phenylacetylglutamin.