FrancophonIA/ELRC3.0 huggingface dataset:
English: The inclusion criteria were pre-pubertal children with genetically diagnosed PWS, treated with Norditropin for at least 1 year in the centre.
Danish: Inklusionskriterierne var præpubertale børn, der var diagnosticeret med PWS og behandlet med Norditropin i mindst 1 år på centeret.
English: Taking into consideration the above mentioned data, the CHMP concluded that the provided study GHLiquid-1961 forming the basis for the application to extend the indication for Norditropin in children with PWS was uncontrolled, open-label and retrospective and not in accordance with the methodological standards for pivotal evidence.
Danish: På grundlag af ovenstående data konkluderede CHMP, at den forelagte undersøgelse GHLiquid1961, der var grundlag for ansøgningen om udvidelse af indikationen for Norditropin til børn med PWS, var ukontrolleret, åben og retrospektiv og ikke i overensstemmelse med de metodemæssige normer for hoveddokumentation.
English: This was a retrospective, observational, open-label, multicentre, multinational study in children with PWS treated with Norditropin off-label for short stature.
Danish: Denne undersøgelse var en retrospektiv, åben, multinational multicenter-observationsundersøgelse hos børn med PWS, der var blevet behandlet med Norditropin til den ikke godkendte indikation kort statur.
English: In the variation application dossier, the recommended dose from Novo Nordisk for the treatment of short stature and altered body composition in children with PWS was 0.025 to 0.035 mg/kg/day.
Danish: I dokumentationen til ændringsansøgningen var den af Novo Nordisk anbefalede dosis til behandling af lav højde og ændret kropssammensætning hos børn med PWS 0,025 til 0,035 mg/kg/dag.
English: Lean body mass increased by 9.1% from baseline to last observation.
Danish: Den fedtfri kropsmasse steg fra 9,1 % ved baseline til sidste observation.
English: • The Committee is also of the opinion that the particulars submitted in support of the application to extend the indications of Norditropin SimpleXx, Norditropin NordiFlex, Norditropin FlexPro and associated names do not comply with the requirements of a product authorised on the basis of Article 8(3) of Directive 2001/83/EC.
Danish: • udvalget var desuden af den opfattelse, at de forelagte oplysninger til støtte for ansøgningen om udvidelse af indikationerne for Norditropin SimpleXx, Norditropin NordiFlex, Norditropin FlexPro og relaterede navne ikke opfylder kravene for et produkt, der er godkendt på grundlag af artikel 8, stk. 3, i direktiv 2001/83/EF,
English: The mean HSDS for this subgroup was -0.6 at Year 1 and -0.4 at last observation.
Danish: Den gennemsnitlige HSDS for denne undergruppe var -0,6 ved år 1 og -0,4 ved sidste observation.
English: The primary objective of the study was to investigate changes in height standard deviation score (HSDS) in response to 1 year of Norditropin treatment in children with PWS (referenced to a PWS population).
Danish: Undersøgelsens primære formål var at undersøge ændringerne i standardafvigelsesscore for højde (HSDS) som respons på 1 års behandling med Norditropin hos børn med PWS (omtalt som en PWS-population).
English: The estimated gain in HSDS was 1.3 to last observation (approximately 6 years).
Danish: Den beregnede stigning i HSDS var 1,3 indtil sidste observation (ca. seks år).
English: Moreover, it was considered inappropriate for the MAH to refer to data from another GH product to claim the same indication since Norditropin was not authorised as a similar biological medicinal product.
Danish: Desuden blev det fundet upassende, at indehaveren af markedsføringstilladelsen henviste til data vedrørende et andet væksthormonprodukt for at påberåbe sig samme indikation, eftersom Norditropin ikke var godkendt som et tilsvarende biologisk lægemiddel.
English: The CHMP concluded that the rationale for the proposed dose (i.e. 0.035 mg/kg/day) is unclear.
Danish: CHMP konkluderede, at rationalet for den foreslåede dosis (dvs. 0,035 mg/kg/dag) er uklart.
English: The actual fat mass percentage was 38.2% at baseline, 28.1% at Year 1 and 27.1% at last observation.
Danish: Den faktiske fedtmasseprocent var 38,2 % ved baseline, 28,1 % ved år 1 og 27,1 % ved sidste observation.
English: • The Committee reviewed all available data submitted by the marketing authorisation holder, to support the safety and efficacy of Norditropin SimpleXx, Norditropin NordiFlex, Norditropin FlexPro and associated names in the applied indication “Improvement of growth and body composition in children with Prader-Willi syndrome (PWS) confirmed by appropriate genetic testing”.
Danish: • udvalget gennemgik alle foreliggende data, der var indsendt af indehaveren af markedsføringstilladelsen til støtte for sikkerheden og virkningen af Norditropin SimpleXx, Norditropin NordiFlex, Norditropin FlexPro og relaterede navne til indikationen ”Forbedring af vækst og krops sammensætning hos børn med Prader-Willis syndrom (PWS) verificeret ved passende genetisktestning”,
English: On 14 May 2010, the MAH submitted a type II variation via the MRP for Norditropin SimpleXx, Norditropin NordiFlex, Norditropin FlexPro and associated names (DK/H/0001/005-007 and 011016/II/078), to request an extension of the indications.
Danish: Den 14. maj 2010 indgav indehaveren af markedsføringstilladelsen en type II-ændringsansøgning gennem den gensidige anerkendelsesprocedure for Norditropin SimpleXx, Norditropin NordiFlex, Norditropin FlexPro og relaterede navne (DK/H/0001/005-007 og 011-016/II/078) med henblik på udvidelse af indikationerne.
English: The CHMP concluded that the rationale for the proposed dose (i.e. 0.035 mg/kg/day) is still unclear.
Danish: CHMP konkluderede, at rationalet for den foreslåede dosis (dvs. 0,035 mg/kg/dag) fortsat er uklart.
English: Body composition was improved, with an estimated mean increase in body mass of 9.9% and a corresponding reduction in fat mass of 9.9% after 1 year of Norditropin treatment.
Danish: Kropssammensætningen var efter 1 års behandling med Norditropin forbedret med en beregnet stigning i fedtfri kropsmasse på 9,9 % og en tilsvarende reduktion i fedtmasse på 9,9 %.
English: Data on final adult heights are not available.
Danish: Der foreligger ingen data om endelig voksenhøjde.
English: In this study the dose of Norditropin administered was chosen at the discretion of the physician and adjusted accordingly during the treatment period (the mean dose was 0.03 mg/kg/day).
Danish: I undersøgelsen blev dosis af Norditropin valgt efter lægens skøn og justeret i henhold dertil i løbet af behandlingsperioden (gennemsnitsdosis var 0,03 mg/kg/dag).
English: The actual lean body mass percentage was 61.8% at baseline, 71.9% at Year 1 and 72.9% at last observation.
Danish: Den faktiske fedtfri kropsmasseprocent var 61,8 % ved baseline, 71,9 % ved år 1 og 72,9 % ved sidste observation.
English: Hence, 35 of 41 (85%) children with PWS had a height within the reference range for normal children after Norditropin treatment.
Danish: Efter behandling med Norditropin havde således 35 ud af 41 (85 %) af børn med PWS en højde, der var inden for referenceområdet for normale børn.
English: Overall summary of the scientific evaluation of Norditropin SimpleXx, Norditropin NordiFlex, Norditropin FlexPro and associated names (see annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Norditropin SimpleXx, Norditropin NordiFlex, Norditropin FlexPro og relaterede navne (se bilag I)
English: Regarding safety, no new safety concern emerged from the submitted retrospective data.
Danish: Vedrørende sikkerheden gav de forelagte retrospektive data ikke anledning til nye betænkeligheder.
English: HSDS improved from a baseline mean of -1.8 to -1.2 after 1 year and to0.7 at last observation (approximately 6 years).
Danish: HSDS blev forbedret fra et gennemsnit på -1,8 ved baseline til -1,2 efter 1 år og til -0,7 ved sidste observation (ca. 6 år).
English: No data on final adult height were provided.
Danish: Der blev ikke forelagt data om endelig voksenhøjde.
English: The estimated gain in HSDS was 1.1 to last observation.
Danish: Den beregnede stigning i HSDS var 1,1 indtil sidste observation.
English: In addition, it is not considered acceptable to refer to the prospective data obtained with another GH product in order to claim the same indication with the same dose regimen, in view of the legal basis of the marketing authorisation of Norditropin, i.e.
Danish: Desuden anses det ikke for acceptabelt at henvise til prospektive data, som er opnået med et andet væksthormonprodukt, til påberåbelse af samme indikation med samme dosisregime, i betragtning af, at det retlige grundlag for markedsføringstilladelsen for Norditropin er artikel 8, stk. 3, i direktiv 2001/83/EF.
English: The most frequent probably/possibly related adverse events were scoliosis (in 8 children, 19.5%) and sleep apnoea (in 3 children, 7.3%).
Danish: De hyppigste bivirkninger med sammenhæng eller mulig sammenhæng med behandlingen var skoliose (hos 8 børn, 19,5 %) og søvnapnø (hos tre børn, 7,3 %).
English: the CHMP has recommended the refusal of the variation of the Marketing Authorisations for Norditropin SimpleXx, Norditropin NordiFlex, Norditropin FlexPro and associated names (see Annex I).
Danish: anbefalede CHMP afslag på ansøgningen om ændring af markedsføringstilladelserne for Norditropin SimpleXx, Norditropin NordiFlex, Norditropin FlexPro og relaterede navne (se bilag I).
English: In addition, not only improvement of growth but also improvement of body composition is part of the indication of Norditropin in PWS.
Danish: Desuden omfatter indikationen for Norditropin ved PWS ikke kun forbedret vækst, men også forbedret kropssammensætning.
English: HSDS improved from a baseline mean of -0.3 to 1.1 at last observation.
Danish: HSDS blevet forbedret fra et gennemsnit på -0,3 ved baseline til 1,1 ved sidste observation.
English: When standardised to the normal population, an estimated mean gain in HSDS of 0.7 was obtained after 1 year of Norditropin treatment in short children with PWS.
Danish: Ved standardisering i forhold til normalpopulationen fandtes en middelforøgelse i HSDS på 0,7 efter et års behandling med Norditropin af børn med lav højde med PWS.
English: When standardised to the PWS population, an estimated mean gain in HSDS of 0.9 was obtained after 1 year of Norditropin treatment in short children with PWS.
Danish: Ved standardisering i forhold til PWS-populationen fandtes en middelforøgelse i HSDS på 0,9 efter et års behandling med Norditropin af børn med lav højde med PWS.
English: No new safety concern emerged from the submitted retrospective data.
Danish: De forelagte retrospektive data giver ikke anledning til nye sikkerhedsmæssige betænkeligheder.
English: It is also considered that the data are unreliable and therefore the benefit risk balance of Norditropin SimpleXx, Norditropin NordiFlex, Norditropin FlexPro and associated names in the applied indication is unfavourable.
Danish: • udvalget anså de af indehaveren af markedsføringstilladelsen forelagte data, navnlig til støtte for virkningen, for at være begrænsede, da de er udledt af en retrospektiv, ikke-komparativ observationsundersøgelse; derudover fandt udvalget, at dataene er upålidelige, og at benefit/risk-forholdet for Norditropin SimpleXx, Norditropin NordiFlex, Norditropin FlexPro og relaterede navne til den ansøgte indikation er ugunstigt,
English: But even if this happens, it is unlikely to cause any problems.
Danish: Hvis det alligevel skulle ske, så vil det sandsynligvis ikke give problemer.
English: This makes it easier for the surgeon to do the operation.
Danish: Det gør det lettere for kirurgen at operere.
English: Gender: No gender differences were observed.
Danish: Køn: Der er ikke set nogen kønsforskelle.
English: Date of first authorisation: 25 July 2008 Date of latest renewal: 21 June 2013
Danish: Dato for første markedsføringstilladelse: 25. juli 2008 Dato for seneste fornyelse: 21. juni 2013
English: From a microbiological point of view, the diluted product should be used immediately.
Danish: Fra et mikrobiologisk synspunkt bør det fortyndede produkt anvendes med det samme.
English: In this situation the patient must be ventilated.
Danish: I sådanne situationer skal patienten ventileres.
English: In these studies a clear dose-response relationship was observed.
Danish: Der blev i disse studier set et tydeligt dosis-respons forhold.
English: This might cause you to move or cough at the end of the operation
Danish: Dette kan medføre, at du bevæger dig eller hoster ved slutningen af operationen
English: For oestrogens, the effect is expected to be lower.
Danish: For østrogener forventes effekten at være mindre.
English: Storage will be handled by healthcare professionals.
Danish: Opbevaringen vil blive varetaget af sundhedspersonalet.
English: An increased risk of bleeding cannot be excluded in patients:
Danish: En øget blødningsrisiko kan ikke udelukkes hos patienter:
English: A mass balance study demonstrated that > 90% of the dose was excreted within 24 hours.
Danish: Et massebalancestudie viste at > 90% af dosis blev udskilt inden 24 timer.
English: CV=coefficient of variation
Danish: CV = variationskoefficient
English: • how much the muscle relaxant medicine is still affecting you.
Danish: • hvor meget den muskelafslappende medicin stadig påvirker dig
English: • with pre-existing coagulopathies;
Danish: • med allerede eksisterende koagulopatier;
English: Information on healthy volunteers:
Danish: Information om raske frivillige:
English: Animal studies to evaluate fertility do not reveal harmful effects.
Danish: Dyrestudier til vurdering af fertiliteten viser ingen skadelige virkninger.
English: Special populations:
Danish: Specielle populationer:
English: Monitoring respiratory function during recovery:
Danish: Monitorering af den respiratoriske funktion under genopvågning:
English: Children and adolescents This medicine is not recommended for infants less than 2 years of age.
Danish: Børn og unge Dette lægemiddel bør ikke gives til små børn under 2 år.
English: • Return of muscle relaxation after the operation
Danish: • Tilbagevenden af muskelafslapning efter operationen
English: Minimum waiting time
Danish: Mindst ventetid
English: The recommended dose does not depend on the anaesthetic regimen.
Danish: Den anbefalede dosis afhænger ikke af anæstesiregimet.
English: Administration of the medicinal product which caused displacement should be stopped in case of an infusion.
Danish: Administration af det lægemiddel, som forårsagede fortrængelsen skal ophøre, hvis der er tale om infusion.
English: For immediate reversal:
Danish: For umiddelbar revertering:
English: Excretion via faeces or expired air was less than 0.02% of the dose.
Danish: Udskillelsen via fæces eller udåndet luft var mindre end 0,02% af dosis.
English: When you have some types of operations, your muscles must be completely relaxed.
Danish: Ved visse typer operationer skal dine muskler være helt afslappede.
English: Reports of suspected hypersensitivity were adjudicated by a blinded committee.
Danish: Indberetninger om formodet overfølsomhed blev bedømt af en blindet komité.
English: Adverse reactions (Preferred terms)
Danish: Bivirkninger (Foretrukne termer)
English: Bridion may affect other medicines or be affected by them.
Danish: Bridion kan påvirke andre lægemidler eller kan påvirkes af dem.
English: If more than 2.4 mL solution needs to be administered, this should be taken into consideration by patients on a controlled sodium diet.
Danish: Hvis der skal administreres mere end 2,4 ml, bør det tages med i overvejelserne hos patienter på en kontrolleret natriumdiæt.
English: → Tell your anaesthetist if this applies to you.
Danish: → Fortæl anæstesilægen, hvis dette gælder for dig.
English: • on coumarin derivates and at an INR above 3.5;
Danish: • i behandling med coumarinderivater og med en INR på over 3,5;
English: These limited mean aPTT and PT(INR) prolongations were of short duration (≤ 30 minutes).
Danish: Disse begrænsede gennemsnitlige aPTT- og PT(INR)-forlængelser var af kort varighed (≤ 30 minutter).
English: The pH is between 7 and 8 and osmolality is between 300 and 500 mOsm/kg.
Danish: pH er mellem 7 og 8, og osmolaliteten er mellem 300 og 500 mOsm/kg.
English: Mean Predicted PK parameters (CV%)
Danish: Gennemsnitlige forventede PK-parametre (CV%)
English: You may still be given Bridion, but you need to discuss it first.
Danish: Lægen kan stadig give dig Bridion, men det bør diskuteres først.
English: Limited data does not indicate differences in pharmacokinetic parameters in Black or African Americans.
Danish: Begrænsede data indikerer ikke forskelle i farmakokinetiske parametre hos sorte eller afroamerikanere.
English: Pharmacotherapeutic group: all other therapeutic products, antidotes, ATC code: V03AB35
Danish: Farmakoterapeutisk klassifikation: alle andre terapeutiske produkter, antidoter, ATC-kode: V03AB35
English: The usual dose is 2-4 mg per kg body weight.
Danish: Den sædvanlige dosis er 2-4 mg pr. kg legemsvægt.
English: • toremifene (used to treat breast cancer).
Danish: • toremifen (til behandling af brystkræft)
English: Because these medicines also make your breathing muscles relax, you need help to breathe (artificial ventilation) during and after your operation until you can breathe on your own again.
Danish: Da disse lægemidler også får dine vejrtrækningsmuskler til at slappe af, har du brug for hjælp til at trække vejret (kunstigt åndedræt) under og efter operationen indtil du selv kan trække vejret igen.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis produktet ikke anvendes med det samme, er opbevaringstider og -forhold før brug af produktet brugerens ansvar og vil normalt ikke være længere end 24 timer ved 2 °C til 8 °C, medmindre fortyndingen er foretaget under kontrollerede og validerede aseptiske forhold.
English: This is important as Bridion is removed from your body by the kidneys.
Danish: Dette er vigtigt, da Bridion fjernes fra kroppen via nyrerne.
English: Toremifene:
Danish: Toremifen:
English: Use in the paediatric population
Danish: Brug i den pædiatriske population
English: Based on these data, no clinically significant pharmacodynamic interaction with other medicinal products is expected, with exception of the following:
Danish: På baggrund af disse data, forventes ingen klinisk signifikante farmakodynamiske interaktioner med andre lægemidler, med undtagelse af følgende:
English: Patients with severe hepatic impairment should be treated with great caution.
Danish: Patienter med svær nedsat leverfunktion skal behandles med stor forsigtighed.
English: • if you are allergic to sugammadex or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for sugammadex eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: The same dose recommendations as for adults should be followed.
Danish: De anbefalede doseringer for voksne bør følges.
English: Demographics
Danish: Demografi
English: NL-5340 BH Oss The Netherlands
Danish: NL-5340 BH Oss Holland
English: In general, Bridion does not have an effect on laboratory tests.
Danish: Generelt har Bridion ikke indvirkning på laboratorieprøver.
English: Children and adolescents:
Danish: Børn og unge:
English: Bridion is used to speed up the recovery of your muscles after an operation to allow you to breathe on your own again earlier.
Danish: Bridion bruges til at vække musklerne hurtigere efter en operation for at du hurtigere kan komme til at trække vejret selv igen.
English: Volume of distribution at steady state (L)
Danish: Fordelingsvolumen ved steady state (liter)
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development.
Danish: Dyreforsøg viser ikke direkte eller indirekte skadelige virkninger for graviditet, embryoets/fostrets udvikling, fødslen eller den postnatale udvikling.
English: Other routine reversal situations have not been investigated and are therefore not recommended until further data become available.
Danish: Andre rutinemæssige reverteringssituationer er ikke blevet undersøgt og kan derfor ikke anbefales, før der foreligger yderligere data.
English: • Light anaesthesia - you may start to come out of deep sleep, so need more anaesthesia.
Danish: • Let bedøvelse - du kan begynde at komme ud af den dybe søvn, så du behøver mere bedøvelsesmiddel.
English: Talk to your doctor if your progesterone levels need to be tested on the same day you receive Bridion.
Danish: Tal med lægen, hvis dit progesteronniveau skal måles samme dag, som du får Bridion.
English: If these side effects occur while you are under anaesthesia, they will be seen and treated by your anaesthetist.
Danish: Hvis disse bivirkninger opstår, mens du er bedøvet, vil de blive set og behandlet af din anæstesilæge.
English: Manufacturer • N.V. Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands
Danish: Organon, Kloosterstraat 6, 5349 AB Oss, Holland
English: Patients on a controlled sodium diet:
Danish: Patienter på kontrolleret natriumdiæt:
English: Some medicines reduce the effect of Bridion → It is especially important that you tell your anaesthetist if you have recently taken:
Danish: Lægemidler, der nedsætter virkningen af Bridion → Det er især vigtigt, at du fortæller anæstesilægen, hvis du for nylig har taget:
English: Population pharmacokinetic analysis of adult and elderly patients showed no clinically relevant relationship of clearance and volume of distribution with body weight.
Danish: Populationsfarmakokinetisk analyse hos voksne og ældre patienter viste ikke klinisk relevante forhold af clearance og fordelingsvolumen med kropsvægten.
English: Treatment with anti-cholinergic agents such as atropine should be administered if clinically significant bradycardia is observed.
Danish: Behandling med antikolinerge lægemidler såsom atropin skal administreres, hvis klinisk signifikant bradykardi observeres.
English: The dose of Bridion for children is 2 mg/kg (children and adolescents between 2-17 years old).
Danish: Bridion-dosis for børn er 2 mg/kg (børn og unge mellem 2-17 år).
English: • fusidic acid (an antibiotic).
Danish: • fusidinsyre (antibiotikum)
English: Routine reversal:
Danish: Rutinemæssig revertering:
English: If such a situation is observed, the clinician is advised to consider the re-administration of the medicinal product, the administration of a therapeutically equivalent medicinal product (preferably from a different chemical class) and/or nonpharmacological interventions as appropriate.
Danish: Hvis dette opstår, anbefales det lægen at overveje genadministration af lægemidlet, administration af et terapeutisk lignende lægemiddel (her foretrækkes en anden kemisk klasse) og/eller en ikke-farmakologisk intervention.
English: The use of sugammadex in term newborn infants and infants is therefore not recommended until further data become available.
Danish: Brugen af sugammadex til nyfødte og spædbørn kan derfor ikke anbefales, før der foreligger yderligere data.
English: Renal function Creatinine clearance (mL/min)
Danish: Nyrefunktion Creatinin-clearance (ml/min)
English: Severe hypersensitivity reactions can be fatal.
Danish: Svære overfølsomhedsreaktioner kan være letale.
English: There is only limited experience with the use of sugammadex in infants (30 days to 2 years), and term newborn infants (less than 30 days) have not been studied.
Danish: Der er kun begrænset erfaring med sugammadex hos spædbørn (30 dage til 2 år), og hos nyfødte (yngre end 30 dage) er brugen ikke blevet undersøgt.
English: Sugammadex can be removed using haemodialysis with a high flux filter, but not with a low flux filter.
Danish: Sugammadex kan fjernes ved hæmodialyse ved brug af et højflux-filter, men ikke med et lavfluxfilter.