FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Danish: Særlige forsigtighedsregler for anvendelse til dyr Sikkerheden ved veterinærlægemidlet er ikke blevet fastslået under drægtighed og laktation.
English: Administer orally once daily at 0.63 mg mitratapide/kg bodyweight (1 ml of the product per 8 kg) given for 2 periods of 21 days with 14 days without treatment in between.
Danish: Gives peroralt én gang daglig som 0,63 mg mitratapid/kg legemsvægt (1 ml af produktet pr. 8 kg) i 2 perioder på 21 dage med 14 dages mellemrum uden behandling.
English: The usual dose is once daily 0.63 mg mitratapide/kg bodyweight (1 ml of the product per 8 kg).
Danish: Den sædvanlige dosis er 0,63 mg mitratapid/kg legemsvæg (1 ml af produktet pr. 8 kg) én gang daglig.
English: At the end of a three week dosing period, mitratapide attains average steady-state concentrations of 0.0068 g/ml, the sulphoxide metabolites 0.0089 g/ml and 0.0167 g/ml, respectively, the sulphone 0.0471 g/ml.
Danish: I slutningen af den tre ugers doseringsperiode når mitratapid gennemsnitlige steady-state koncentrationer på 0,0068 µg/ml, sulfoxidmetaboliterne henholdsvis 0,0089 µg/ml og 0,0167 µg/ml, sulfon 0,0471 µg/ml.
English: 6.5 Nature and composition of immediate packaging 55, 120 or 210 ml amber glass bottle (type III) with a child resistant polypropylene closure and dosing pipette.
Danish: 55, 120 eller 210 ml ravfarvet glasflaske (type III) med børnesikret polypropylenlukning og doseringspipette.
English: To be supplied only on veterinary prescription.
Danish: Må kun udleveres efter veterinærrecept
English: Yarvitan is indicated as an aid in the management of overweight and obesity in adult dogs.
Danish: Yarvitan er indikeret til hjælp i behandlingen af overvægt og fedme hos voksne hunde.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE
English: Once opened, use within 3 months.
Danish: Efter åbning anvendes inden 3 måneder.
English: • up to 36 kg for the 55 ml bottle
Danish: • op til 36 kg for 55 ml flasken
English: In case vomiting, diarrhoea, softening stools repeatedly occurs or in case the dog stops eating for two consecutive days, stop the administration of Yarvitan to your dog and seek the advice of your veterinary surgeon as soon as possible.
Danish: I tilfælde af, at opkastning, diaré, bløde afføringer gentagne gange forekommer, eller i tilfælde af, at hunden holder op med at spise i to på hinanden følgende dage, stoppes indgivelsen af Yarvitan til Deres hund, og De skal kontakte Deres dyrlæge så snart som muligt.
English: • If you have further questions, please ask your veterinary surgeon or your pharmacist
Danish: • Kontakt Deres dyrlæge eller apotek, hvis De har yderligere spørgsmål
English: INDICATION(S) As an aid in the management of overweight and obesity in adult dogs.
Danish: INDIKATION(ER) Som en hjælp i behandlingen af overvægt og fedme hos voksne hunde
English: Where treatment is interrupted due to vomiting, it is recommended that when treatment is resumed, the product should be administered after a meal.
Danish: Er behandlingen blevet afbrudt på grund af opkastning, anbefales det at give produktet efter et måltid, når behandlingen genoptages..
English: • up to 48 kg for the 210 ml bottle
Danish: • op til 48 kg for 210 ml flasken
English: Do not use in dogs during pregnancy and lactation.
Danish: Må ikke anvendes til hunde under drægtighed og laktation.
English: In order to avoid rebound weight gain, it is necessary to continue the feeding for maintenance regimen after the end of treatment with the product.
Danish: For at undgå efterfølgende vægtøgning er det nødvendigt at fortsætte fodringen efter et vedligeholdelsesregime med produktet efter afslutningen af behandlingen.
English: PACKAGE SIZE 55 ml:  10 kg BW 120 ml:  22 kg BW 210 ml:  40 kg BW
Danish: PAKNINGSSTØRRELSE 55 ml: ≤ 10 kg legemsvægt 120 ml: ≤ 22 kg legemsvægt 210 ml: ≤ 40 kg legemsvægt
English: Name and address of the manufacturer(s) responsible for batch release
Danish: Navn og adresse på fremstilleren af de(t) ansvarlig for batchfrigivelse
English: Do not use in dogs with impaired liver function.
Danish: Bør ikke anvedes til hunde med nedsat leverfunktion.
English: • up to 36 kg for the 120 ml bottle
Danish: • op til 36 kg for 120 ml flasken
English: In most of the cases, these side effects are mild and do not last very long.
Danish: I de fleste tilfælde er disse bivirkninger lette og forbigående.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Peroral brug.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Yarvitan 5 mg/ml oral solution for dogs Mitratapide
Danish: VETERINÆRLÆGEMIDLETS NAVN Yarvitan 5 mg/ml peroral opløsning til hunde Mitratapid
English: MARKETING AUTHORISATION NUMBER(S) EU/0/00/000/001
Danish: MARKEDSFØRINGSTILLADELSENSNUMMER (NUMRE) EU/0/00/000/001
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Yarvitan 5 mg/ml oral solution for dogs
Danish: VETERINÆRLÆGEMIDLETS NAVN Yarvitan 5 mg/ml peroral opløsning til hunde
English: MARKETING AUTHORISATION NUMBER(S) EU/0/00/000/002
Danish: MARKEDSFØRINGSTILLADELSENSNUMMER (NUMRE) EU/0/00/000/002
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Mitratapide 5 mg/ml
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER Mitratapid 5 mg/ml
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Mitratapide 5 mg/ml
Danish: ANGIVELSE AF DET AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER Mitratapid 5 mg/ml
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Mitratapide 5 mg/ml
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) Mitratapid 5 mg/ml
English: Typically, these findings normalised, or appeared to be reversing, within two weeks following the end of treatment.
Danish: så disse fund typisk ud til at bedre sig, eller de normaliseredes helt.
English: Pack sizes - amber glass bottles containing : 55ml:  10 kg bodyweight, 120ml:  22 kg bodyweight, 210ml:  40 kg bodyweight.
Danish: Pakningsstørrelser - ravfarvede glasflasker indeholdende: 55 ml: ≤ 10 kg legemsvægt.
English: Macrogol 400
Danish: Butyleret hydroxyanisol Macrogol 400
English: Excretion is rapid and mainly via the faeces.
Danish: Udskillelsen er hurtig og foregår
English: ROUTE(S) OF ADMINISTRATION Oral use.
Danish: INDGIVELSESVEJ(E) Peroral brug.
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF LÆGEMIDLER ELLER AFFALD FRA SÅDANNE
English: EU field trial
Danish: EU feltafprøvning
English: Excipient(s):
Danish: EXP (MM/ÅÅÅÅ)
English: MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER AF DE(T) BIOLOGISK AKTIVE STOF(FER) OG INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: 4.2 Indications for use, specifying the target species
Danish: 4.1 Dyrearter, som lægemidlet er beregnet til Hunde.
English: In case an adverse reaction repeatedly occurs or in case the dog stops eating for two consecutive days, treatment should be interrupted and the advice of a veterinarian should be sought.
Danish: Afbryd behandlingen og søg råd hos en dyrlæge, hvis en bivirkning forekommer gentagne gange, eller hvis hunden intet har ædt i to på hinanden følgende dage.
English: This is called ‘myeloablation'.
Danish: Dette kaldes »myeloablation«.
English: These substances are ‘cytotoxic'.
Danish: Disse stoffer er »cytotoksiske«.
English: Busulfan is used before transplantation to destroy abnormal cells and the patient's existing bloodmaking cells.
Danish: Busulfan anvendes før transplantationen for at ødelægge abnorme celler og patientens eksisterende bloddannende celler.
English: The full EPAR and risk management plan summary for Busulfan Fresenius Kabi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Busulfan Fresenius Kabi findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This type of transplant is used in patients who need to replace their blood-making cells, because they have a blood disorder (such as a rare type of anaemia) or a cancer of the blood.
Danish: Denne type transplantat anvendes hos patienter med behov for udskiftning af de bloddannende celler på grund af en blodsygdom (f.eks. en sjælden form for blodmangel) eller blodkræft.
English: Cyclophosphamide, melphalan or fludarabine are used to suppress the immune system, so that the body's natural defences are decreased.
Danish: Cyclophosphamid, melphalan eller fludarabin anvendes til at dæmpe immunsystemet, så kroppens naturlige forsvar nedsættes.
English: This means that they kill cells, especially cells that develop rapidly, such as cancer or progenitor (‘stem') cells (cells that make other types of cell).
Danish: Det vil sige, at de dræber celler, navnlig hurtigvoksende celler som kræftceller eller progenitorceller (stamceller, der frembringer andre typer celler).
English: It is used in adults and children as part of a ‘conditioning' (preparative) treatment before transplantation of haematopoietic progenitor cells (the cells that make blood cells).
Danish: Det anvendes til voksne og børn som en del af en »konditionerende« (forberedende) behandling før transplantation af bloddannende progenitorceller (stamceller, der danner røde blodlegemer).
English: The company provided data from the published literature on busulfan.
Danish: Virksomheden fremlagde data fra faglitteraturen om busulfan.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Busulfan Fresenius Kabi on 22 September 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Busulfan Fresenius Kabi den 22. september 2014.
English: This is a summary of the European public assessment report (EPAR) for Busulfan Fresenius Kabi.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Busulfan Fresenius Kabi.
English: This means that Busulfan Fresenius Kabi is similar to a ‘reference medicine' already authorised in the European Union (EU) called Busilvex.
Danish: Det betyder, at Busulfan Fresenius Kabi er identisk med et »referencelægemiddel«, som allerede er godkendt i Den Europæiske Union (EU), og som hedder Busilvex.
English: Busulfan Fresenius Kabi can only be obtained with a prescription and should only be used by a doctor who has experience in treatments given before transplantation.
Danish: Busulfan Fresenius Kabi udleveres kun efter recept og bør kun anvendes af en læge med erfaring i behandling før transplantation.
English: This helps the transplanted cells to ‘engraft' (when they start to grow and produce normal blood cells).
Danish: Dette gør det lettere for de transplanterede celler at »slå an«, dvs. begynde at vokse og producere normale blodceller.
English: Therefore, the CHMP's view was that, as for Busilvex, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Busilvex.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Busulfan Fresenius Kabi has been shown to be comparable to Busilvex.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Busulfan Fresenius Kabi er sammenligneligt med Busilvex.
English: The medicine is available as a concentrate to be made up into a solution for central intravenous infusion (drip into a central vein in the chest).
Danish: Lægemidlet leveres som et koncentrat, som bruges til at fremstille en opløsning, der efter fortynding indgives med drop i en central vene i brysthulen (central intravenøs infusion).
English: The Committee recommended that Busulfan Fresenius Kabi be approved for use in the EU.
Danish: Udvalget anbefalede, at Busulfan Fresenius Kabi godkendes til anvendelse i EU.
English: A risk management plan has been developed to ensure that Busulfan Fresenius Kabi is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Busulfan Fresenius Kabi anvendes så sikkert som muligt.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Busulfan Fresenius Kabi, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Busulfan Fresenius Kabi, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: When used in combination with fludarabine, the recommended dose of Busulfan Fresenius Kabi is 3.2 mg per kilogram given once a day as a three-hour infusion immediately after fludarabine, for 2 or 3 consecutive days.
Danish: Når det anvendes i kombination med fludarabin, er den anbefalede dosis af Busulfan Fresenius Kabi 3,2 mg pr.kg en gang dagligt som en tre timers infusion umiddelbart efter fludarabin, i 2-3 på hinanden følgende dage.
English: When used in combination with cyclophosphamide or melphalan the recommended dose of Busulfan Fresenius Kabi in adults is 0.8 mg per kilogram body weight.
Danish: Når det anvendes i kombination med cyclophosphamid eller melphalan er den anbefalede dosis af Busulfan Fresenius Kabi til voksne 0,8 mg pr. kg legemsvægt.
English: For a conventional conditioning treatment, Busulfan Fresenius Kabi is given before treatment with a second medicine, cyclophosphamide in adults, and either cyclophosphamide or melphalan in children.
Danish: I forbindelse med konventionel konditionerende behandling gives Busulfan Fresenius Kabi inden behandlingen sammen med et andet lægemiddel, nemlig cyclophosphamid til voksne og enten cyclophosphamid eller melphalan til børn.
English: No additional studies were needed as Busulfan Fresenius Kabi is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Busilvex.
Danish: Der krævedes ingen supplerende undersøgelser, eftersom Busulfan Fresenius Kabi er et generisk lægemiddel, der indgives ved infusion og indeholder det samme aktive stof som referencelægemidlet Busilvex.
English: Because Busulfan Fresenius Kabi is given by infusion and contains the same active substance as the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Busulfan Fresenius Kabi gives ved infusion og indeholder samme aktive stof som referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: In adult patients who are eligible for a ‘reduced-intensity' conditioning regimen, Busulfan Fresenius Kabi is given right after treatment with another medicine, fludarabine.
Danish: Til voksne, der egner sig til en konditionerende behandling med reduceret intensitet, gives Busulfan Fresenius Kabi lige efter behandlingen sammen med et andet lægemiddel, fludarabin.
English: Busulfan Fresenius Kabi is a ‘generic medicine'.
Danish: Busulfan Fresenius Kabi er et »generisk lægemiddel«.
English: For more information about treatment with Busulfan Fresenius Kabi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Busulfan Fresenius Kabi, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Busulfan Fresenius Kabi is a medicine that contains the active substance busulfan.
Danish: Busulfan Fresenius Kabi er et lægemiddel, der indeholder det aktive stof busulfan.
English: What measures are being taken to ensure the safe and effective use of Busulfan Fresenius Kabi?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Busulfan Fresenius Kabi?
English: Other information about Busulfan Fresenius Kabi
Danish: Andre oplysninger om Busulfan Fresenius Kabi
English: For practical information about using Busulfan Fresenius Kabi, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Busulfan Fresenius Kabi, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: It is not intended to provide practical advice on how to use Busulfan Fresenius Kabi.
Danish: Det er ikke en praktisk vejledning i, hvordan Busulfan Fresenius Kabi bør anvendes.
English: The active substance in Busulfan Fresenius Kabi, busulfan, belongs to a group of medicines called ‘alkylating agents'.
Danish: Det aktive stof i Busulfan Fresenius Kabi, busulfan, tilhører lægemiddelgruppen »alkylerende midler«.
English: What is Busulfan Fresenius Kabi and what is it used for?
Danish: Hvad er Busulfan Fresenius Kabi, og hvad anvendes det til?
English: What are the benefits and risks of Busulfan Fresenius Kabi?
Danish: Hvilken fordel og risiko er der forbundet med Busulfan Fresenius Kabi?
English: Why is Busulfan Fresenius Kabi approved?
Danish: Hvorfor blev Busulfan Fresenius Kabi godkendt?
English: Before receiving Busulfan Fresenius Kabi, patients are given anticonvulsive medicines (to prevent seizures) and anti-emetic medicines (to prevent vomiting).
Danish: Inden Busulfan Fresenius Kabi gives, får patienten et krampestillende lægemiddel og et middel til forebyggelse af opkastning.
English: In children up to 17 years of age, the recommended dose of Busulfan Fresenius Kabi varies between 0.8 and 1.2 mg per kilogram depending on the weight of the child. Each infusion lasts for two hours and it is given to the patient every six hours on four consecutive days before treatment with cyclophosphamide or melphalan and the transplant.
Danish: Hver infusion varer i to timer og gives til patienten hver sjette time i fire på hinanden følgende dage inden behandlingen med cyclophosphamid eller melphalan og transplantationen.
English: How has Busulfan Fresenius Kabi been studied?
Danish: Hvordan blev Busulfan Fresenius Kabi undersøgt?
English: How is Busulfan Fresenius Kabi used?
Danish: Hvordan anvendes Busulfan Fresenius Kabi?
English: How does Busulfan Fresenius Kabi work?
Danish: Hvordan virker Busulfan Fresenius Kabi?
English: In children over 1 year of age and ≥ 10 kg
Danish: Til børn over 1 år og ≥ 10 kg
English: Special populations: all formulations
Danish: Særlige populationer: alle formuleringer
English: In addition, H2 receptor antagonists have a more immediate effect.
Danish: Desuden har H2receptorantagonister en hurtigere virkning.
English: In line with the indication, this product should not be used in children.
Danish: I overensstemmelse med indikationen bør dette lægemiddel ikke anvendes til børn.
English: Regarding Section 4.1, the CHMP adopted the following harmonised indication:
Danish: Vedrørende afsnit 4.1 vedtog CHMP følgende harmoniserede indikation:
English: For the elderly (>65 years old), no dose adjustment is needed.
Danish: For ældre (>65 år) er dosisjustering ikke nødvendig.
English: The conditions of the Marketing Authorisations are described in Annex IV.
Danish: Betingelserne for markedsføringstilladelserne er beskrevet i bilag IV.
English: The intravenous indications were largely harmonised already.
Danish: De intravenøse indikationer er stort set allerede harmoniserede.
English: Such ulcers are also associated with a high frequency of potentially fatal complications.
Danish: Sådanne ulcera er også forbundet med en høj frekvens af potentielt dødelige komplikationer.
English: Identified or suspected adverse drug reactions are listed in this sections.
Danish: Identificerede eller mistænkte lægemiddelbivirkninger er opført i disse afsnit.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF LOSEC AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF LOSEC OG TILKNYTTEDE NAVNE (SE BILAG I)
English: The latest guidelines include symptoms as the most important part for the diagnosis of GERD.
Danish: De seneste retningslinjer inkluderer symptomer som det vigtigste element ved diagnosticering af GERD.
English: Patients are also told not to take omeprazole as a preventive medication.
Danish: Patienter bliver også informeret om ikke at tage omeprazol som forebyggende medicin.
English: Alternatively, patients can suck the capsule and swallow the pellets with water.
Danish: Alternativt kan patienter sutte på kapslen og sluge pillerne med vand.
English: None have been found to be dose-related and the reactions are classified according to frequency.
Danish: Ingen af dem har vist sig at være dosisrelaterede, og reaktionerne er klassificeret efter hyppighed.
English: The mention of erosions was therefore deleted from the indication.
Danish: Erosioner blev derfor slettet fra indikationen.
English: Powder for infusion and powder for injection
Danish: Pulver til infusion og pulver til injektion
English: These are based on established data and are currently confirmed as the most efficacious combinations, and are intended to allow treatment alternatives according to local needs and clinical practice.
Danish: De er baseret på vedtagen dokumentation, er aktuelt bekræftet som de mest effektive kombinationer og er beregnet til at give mulighed for behandlingsalternativer i henhold til lokale behov og klinisk praksis.
English: Although this food interaction is not likely to be of any clinical relevance, it warrants the recommendation that Losec should preferably be taken without food.
Danish: Selvom denne interaktion med mad sandsynligvis ikke vil have nogen klinisk relevans, giver den anledning til at anbefale, at Losec helst skal tages uden mad.
English: This indication is not generally accepted and the use of PPIs in the treatment of chemical pneumonia is not advocated in the various guidance on treatment/prevention of this pneumonia.
Danish: Denne indikation er ikke generelt accepteret, og brug af PPI'er ved behandling af kemisk pneumoni er ikke anbefalet i de forskellige retningslinjer for behandling/forebyggelse af denne type pneumoni.
English: PPIs are also effective for primary prevention of NSAID-associated ulcers.
Danish: PPI'er er også effektive til primær forebyggelse af NSAID-associeret ulcus.
English: Gastric ulcers in elderly patients may be located more proximally in the stomach than in younger patients.
Danish: Gastrisk ulcus hos ældre patienter kan opstå mere proksimalt i maven end hos yngre patienter.
English: Since such ulcers are difficult to treat and are associated with more frequent and more serious complications, preventing relapse is a reasonable course of action.
Danish: Da disse ulcera er vanskelige at behandle og forbundet med hyppigere forekommende og mere alvorlige komplikationer, er det en rimelig fremgangsmåde at forebygge tilbagefald.
English: The SPC also provides guidance on dose adjustments and practical advice on the administration of the formulations.
Danish: Produktresuméet indeholder også vejledning om dosisjusteringer og praktiske råd om administration af formuleringerne.
English: The statement “symptomatic treatment”, provides some guidance to the physician on how to handle an overdose.
Danish: Erklæringen om ”symptomatisk behandling” giver lægen visse retningslinjer for håndtering af en overdosis.
English: The use of endoscopy and/or x-ray in case of acid related ulcers is no longer necessary according to current practice and these techniques are therefore omitted.
Danish: Brug af endoskopi og/eller røntgen i tilfælde af syrerelateret ulcus er ikke længere nødvendig i henhold til aktuel praksis, og disse teknikker er derfor udeladt.
English: However, peptic ulcers and erosions are different clinical entities.
Danish: Peptisk ulcus og erosioner er imidlertid forskellige kliniske enheder.
English: The CHMP agreed on the following indications in paediatric patients, in line with the outcome of the EU work-sharing assessment of paediatric data:
Danish: CHMP accepterede følgende indikationer hos pædiatriske patienter i overensstemmelse med resultatet af EU-arbejdsdelingsvurderingen af pædiatriske data: