FrancophonIA/ELRC3.0 huggingface dataset:
English: Fasting serum phosphate should also be measured 4 weeks after any dose adjustment.
Danish: Fastende serum-fosfat skal også måles 4 uger efter enhver dosisjustering.
English: Excipients: L-histidine, D- sorbitol E420, polysorbate 80, L-methionine, hydrochloric acid, 10%, and water for injections.
Danish: Hjælpestoffer: L-histidin, D-sorbitol E420, polysorbat 80, L-methionin, saltsyre, 10 %, og vand til injektionsvæsker.
English: Baseline Mean (SD)
Danish: Gennemsnit ved baseline (SD)
English: The positive change in the RGI-C score reflects resolution of the x-ray appearance of rickets.
Danish: Den positive ændring i RGI-C-scoren afspejler en bedring af rakitis påvist med røntgen.
English: Twenty six of 52 patients received burosumab every two weeks (Q2W) at an average dose (min, max) of 0.73 (0.3, 1.5), 0.98 (0.4, 2.0) and 1.04 (0.4, 2.0) mg/kg at weeks 16, 40 and 60 respectively, and up to a maximum dose of 2.0 mg/kg.
Danish: 26 ud af 52 patienter fik burosumab hver 2. uge (Q2W) med en gennemsnitlig dosis (min; max) på 0,73 (0,3; 1,5), 0,98 (0,4; 2,0) og 1,04 (0,4; 2,0) mg/kg ved hhv. uge 16, 40 og 60 og op til en maksimal dosis på 2,0 mg/kg.
English: Ectopic mineralisation of multiple tissues and organs (e.g. kidney, heart, lung, and aorta), and associated secondary consequences (e.g. nephrocalcinosis) in some cases, due to hyperphosphataemia, was observed in normal animals at doses of burosumab that resulted in serum phosphate concentrations in animals greater than approximately 2.58 mmol/L.
Danish: Ektopisk mineralisering af flere væv og organer (f.eks. nyre, hjerte, lunge og aorta) og i nogle tilfælde forbundne sekundære følger (f.eks. nefrocalcinose) på grund af hyperfosfatæmi blev observeret hos normale dyr ved doser af burosumab, der førte til fosfatkoncentrationer i dyrenes serum på over ca. 2,58 mmol/l.
English: Serum Phosphorus
Danish: Serum-fosfor
English: The other ingredients are L-histidine, D-sorbitol (E420), polysorbate 80, L-methionine, 10%, hydrochloric acid, and water for injections.
Danish: Øvrige indholdsstoffer: L-histidin, D-sorbitol (E420), polysorbat 80, L-methionin, 10 % saltsyre og vand til injektionsvæsker.
English: Fasting serum phosphate above the normal range for age due to the risk of hyperphosphatemia (see section 4.4).
Danish: Fastende serum-fosfat over normalområdet for alder på grund af risikoen for hyperfosfatæmi (se pkt.
English: Rickets Severity Score (RSS)
Danish: Score for rakitis-sværhedsgrad (RSS)
English: With the subcutaneous route of administration, a direct PK-PD relationship between serum burosumab concentrations and increases in serum phosphate concentration is observed and well described by an Emax/EC50 model.
Danish: Med den subkutane administrationsmetode observeres et direkte farmakokinetisk-farmakodynamisk forhold mellem koncentrationerne af burosumab i serum og stigninger i fosfatkoncentrationen i serum, som kan beskrives godt med en Emax/EC50-model.
English: Other medicines and CRYSVITA Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Danish: Brug af anden medicin sammen med CRYSVITA Fortæl det altid til lægen, hvis du tager anden medicin eller har gjort det for nylig.
English: All patients had radiographic evidence of rickets at baseline and twelve patients had received oral phosphate and vitamin D analogues for a mean (SD) duration of 16.7 (14.4) months.
Danish: Alle patienter havde radiografisk evidens for rakitis ved baseline, og 12 patienter havde fået oralt fosfat og D-vitaminanaloger i gennemsnitligt (SD) 16,7 (14,4) måneder.
English: Burosumab displays time-invariant pharmacokinetics that is linear to dose over the subcutaneous dose range of 0.1 to 2.0 mg/kg.
Danish: Burosumab udviser en tidsuafhængig farmakokinetik, som er lineær i forhold til dosen i det subkutane dosisinterval på 0,1 til 2,0 mg/kg.
English: What CRYSVITA looks like and contents of the pack CRYSVITA comes as a clear to slightly opalescent, colourless to pale yellow/brown solution for injection in a small glass vial.
Danish: CRYSVITA leveres som en klar til let opaliserende, farveløs til svagt gul/brun injektionsvæske, opløsning i et lille hætteglas af glas.
English: Studies in animals have shown effects on male reproductive organs (see section 5.3).
Danish: Dyreforsøg har påvist virkninger på reproduktionsorganerne hos hanner (se pkt.
English: To decrease the risk for ectopic mineralisation, it is recommended that fasting serum phosphate is targeted in the lower end of the normal reference range for age.
Danish: For at nedsætte risikoen for ektopisk mineralisering anbefales det, at målet for fastende serum-fosfat er i den lave ende af det normale referenceinterval for alderen.
English: Burosumab has been administered in paediatric clinical trials without dose limiting toxicity using doses up to 2.0 mg/kg body weight with a maximal dose of 90 mg every two weeks.
Danish: Burosumab er blevet administreret i pædiatriske kliniske studier uden dosisbegrænsende toksicitet ved doser på op til 2,0 mg/kg legemsvægt med en maksimal dosis på 90 mg hver 2. uge.
English: Anti-drug antibodies (ADA) have been detected in a small percentage of patients receiving burosumab who had also tested positive for ADA prior to dosing; no adverse events or loss of efficacy was associated with these findings.
Danish: Der er detekteret antistoffer mod lægemidlet (anti-drug antibodies, ADA) hos en lille procentdel af patienter, der fik burosumab samt testede positive for ADA før doseringen.
English: CRYSVITA contains sorbitol This medicine contains 45.91 mg of sorbitol in each vial which is equivalent to 45.91 mg/ml.
Danish: CRYSVITA indeholder sorbitol Dette lægemiddel indeholder 45,91 mg sorbitol pr. hætteglas, svarende til 45,91 mg/ml.
English: In paediatric Study UX023-CL201, 52 paediatric patients aged 5 to 12 years (mean 8.5 years; SD 1.87) with XLH were treated for 64 weeks.
Danish: I det pædiatriske studie UX023-CL201 blev 52 pædiatriske patienter i alderen 5 til 12 år (gennemsnit 8,5 år; SD 1,87) med XLH behandlet i 64 uger.
English: Pack size of one vial.
Danish: Pakningsstørrelse med ét hætteglas.
English: This medicine contains 45.91 mg of sorbitol in each vial which is equivalent to 45.91 mg/ml.
Danish: Dette lægemiddel indeholder 45,91 mg sorbitol pr. hætteglas, svarende til 45,91 mg/ml.
English: Nearly all patients had radiographic evidence of rickets at baseline and had received prior oral phosphate and vitamin D analogues for a mean (SD) duration of 7 (2.4) years.
Danish: Næsten alle patienter havde radiografisk evidens på rakitis ved baseline og havde tidligere fået oralt fosfat og D-vitaminanaloger i gennemsnitligt (SD) 7 (2,4) år.
English: What you need to know before you use CRYSVITA
Danish: Det skal du vide, før du begynder at bruge CRYSVITA
English: Marketing Authorisation Holder Kyowa Kirin Holdings B.V. Bloemlaan 2
Danish: Indehaver af markedsføringstilladelsen Kyowa Kirin Holdings B.V.
English: After 40 weeks of treatment with burosumab, mean total RSS improved from 2.92 (1.367) at baseline to 1.19 (0.522), corresponding to a change from baseline in LS mean (SE) change of -1.73 (0.132) (p<0.0001).
Danish: Efter 40 ugers behandling med burosumab var den gennemsnitlige totale RSS forbedret fra 2,92 (1,367) ved baseline til 1,19 (0,522) svarende til en ændring fra baseline i LS gennemsnit (SE) på -1,73 (0,132) (p<0,0001).
English: Fasting serum phosphate should be measured 4 weeks after dose adjustment.
Danish: Fastende serum-fosfat skal måles 4 uger efter dosisjustering.
English: The severity of paediatric rickets in Study UX023-CL201 was measured using the RSS, a radiographic scoring method developed originally to assess the severity of nutritional rickets in the wrists and knees based on the degree of metaphyseal fraying, concavity, and the proportion of the growth plate affected.
Danish: Score for rakitis-sværhedsgrad (rickets severity score, RSS) Sværhedsgraden af pædiatrisk rakitis i studie UX023-CL201 blev målt ved brug af RSS, en metode til radiografisk scoring, der oprindeligt blev udviklet til at vurdere sværhedsgraden af ernæringsrelateret rakitis i håndled og knæ baseret på graden af metafysær slitage, konkavitet og andelen af påvirket vækstplade.
English: Bone-derived serum alkaline phosphatase content was 165 (52) μg/L [mean (SD)] at Baseline and 115 (31) μg/L at Week 64 (mean change: -28.5%).
Danish: Knoglederiveret basisk fosfataseindhold i serum var 165 (52) μg/l [gennemsnit (SD)] ved baseline og 115 (31) μg/l ved uge 64 (gennemsnitlig ændring: -28,5 %).
English: In Study UX023-CL205, mean (SD) fasting serum phosphate concentration increased from 0.81 (0.092) mmol/L at baseline to 1.12 (0.158) mmol/L at Week 40.
Danish: I studie UX023-CL205 steg den gennemsnitlige (SD) fastende fosfatkoncentration i serum fra 0,81 (0,092) mmol/l ved baseline til 1,12 (0,158) mmol/l ved uge 40.
English: In repeat-dose toxicology studies of up to 40 weeks duration in cynomolgus monkeys, mineralisation of the rete testis/seminiferous tubules was observed in male monkeys; however, no changes were observed in semen analysis.
Danish: I toksikologistudier med gentagne doser af op til 40 ugers varighed hos cynomolgusaber blev der observeret mineralisering af rete testis/seminiferøse tubuli hos hanaber.
English: In the reproductive and developmental toxicology study performed in pregnant cynomolgus monkeys, moderate mineralisation of the placenta was seen in pregnant animals given 30 mg/kg of burosumab and occurred in animals with peak serum phosphate concentration greater than approximately 2.58 mmol/L.
Danish: I studiet af reproduktions- og udviklingstoksikologi, der blev udført hos drægtige cynomolgusaber, blev der observeret moderat mineralisering af placenta hos drægtige dyr, der fik burosumab 30 mg/kg, og det opstod hos dyr med maksimale fosfatkoncentrationer i serum, der var over ca. 2,58 mmol/l.
English: Periodic measurement of serum parathyroid hormone is advised.
Danish: Der rådes til periodiske målinger af paratyreoideahormon i serum.
English: In paediatric Study UX023-CL205, burosumab was evaluated in 13 XLH patients, aged 1 to 4 years (mean 2.9 years; SD 1.1) for 40 weeks.
Danish: I det pædiatriske studie UX023-CL205 blev burosumab evalueret hos 13 XLH-patienter i alderen 1 til 4 år (gennemsnit 2,9, SD 1,1) i 40 uger.
English: Burosumab should be injected in the arm, abdomen, buttock or thigh.
Danish: Burosumab skal injiceres i armen, abdomen, bagdelen eller låret.
English: Name and address of the manufacturer(s) responsible for batch release
Danish: Navn og adresse på den fremstiller (de fremstillere), der er ansvarlig(e) for batchfrigivelse Piramal Healthcare UK Limited
English: In the group that received burosumab every 2 weeks, mean (SD) serum phosphate concentration increased from 0.77 (0.13) mmol/L at baseline, to 1.07 (0.13) mmol/L at Week 40 and was maintained to Week 64 at 1.08 (0.14) mmol/L.
Danish: I gruppen, der fik burosumab hver 2. uge, steg den gennemsnitlige (SD) fosfatkoncentration i serum fra 0,77 (0,13) mmol/l ved baseline til 1,07 (0,13) mmol/l ved uge 40, som blev opretholdt til uge 64 med 1,08 (0,14) mmol/l.
English: Burosumab increased serum phosphate concentration and increased TmP/GFR).
Danish: Burosumab forhøjede fosfatkoncentrationen i serum og forhøjede TmP/GFR (tubulær maksimal fosfat reabsorption pr. glomerulær filtrationshastighed).
English: In order to confirm the efficacy and safety of Crysvita in the treatment of X-linked Hypophosphataemia (XLH) in children between 1 and 4 years old, the MAH should submit the updated results of study UX023-CL205, an open-label, phase 2 study to assess the safety, pharmacodynamics, and efficacy of KRN23 in paediatric patients with XLH.
Danish: For at bekræfte Crysvitas virkning og sikkerhed til behandling af X-bundet hypofosfatæmi (XLH) hos børn i alderen fra 1 til 4 år, skal indehaveren af markedsføringstilladelsen indsende de opdaterede resultater fra studie UX023-CL205, et åbent fase II-studie til at vurdere sikkerhed, farmakodynamik og virkning af KRN23 hos pædiatriske patienter med XLH.
English: Radiographic Global Impression of Change (RGI-C) As a complement to the RSS system to assess the severity of paediatric rickets in Study UX023CL201, the RGI-C is a relative rating scale that compares a patient's rickets before and after treatment utilising a 7-point ordinal scale to evaluate change in the same abnormalities rated in the RSS.
Danish: Som et supplement til RSS-systemet til at vurdere sværhedsgraden af pædiatrisk rakitis i studie UX023CL201 er RGI-C en relativ vurderingsskala, der sammenligner patientens rakitis før eller efter behandling ved anvendelse af en 7-punkts ordinalskala til at evaluere ændringer i de samme anomalier vurderet i RSS.
English: In order to confirm the efficacy and safety of Crysvita in the treatment of X-linked Hypophosphataemia (XLH) in children between 1 and 12 years old, the MAH should conduct and submit the results of study UX023-CL301, a randomized, open-label, phase 3 Study to assess efficacy, safety and pharmacodynamics of the anti-FGF23 antibody, KRN23, versus oral phosphate and active vitamin D in paediatric patients with XLH.
Danish: For at bekræfte Crysvitas virkning og sikkerhed til behandling af X-bundet hypofosfatæmi (XLH) hos børn i alderen fra 1 til 12 år, skal indehaveren af markedsføringstilladelsen udføre og indsende resultaterne fra studie UX023-CL301, et randomiseret, åbent, fase III-studie til at vurdere virkning, sikkerhed og farmakodynamik af anti-FGF23-antistoffet, KRN23 versus oralt fosfat og aktivt Dvitamin hos pædiatriske patienter med XLH.
English: In preclinical studies, ectopic mineralisation has been observed in normal animals, most frequently in the kidney, given burosumab at doses that resulted in serum phosphate concentrations greater than 2.58 mmol/L (see section 5.3).
Danish: I prækliniske studier er ektopisk mineralisering blevet observeret, hyppigst i nyrerne, hos normale dyr, som fik burosumab ved doser, der førte til fosfatkoncentrationer i serum på over 2,58 mmol/l (se pkt.
English: How to use CRYSVITA
Danish: Sådan skal du bruge CRYSVITA
English: Radiographic Global Impression of Change (RGI-C) After 40 weeks of treatment with burosumab, the LS mean (SE) RGI-C Global score was +2.33 (0.08) in all 13 patients (p < 0.0001) demonstrating healing of rickets.
Danish: Efter 40 ugers behandling med burosumab var LS gennemsnit (SE) RGI-C global score +2,33 (0,08) hos alle 13 patienter (p<0,0001), hvilket viste en heling af rakitis.
English: To decrease the risk for ectopic mineralisation, it is recommended that fasting serum phosphate is targeted in the lower end of the normal reference range for age (see section 4.4).
Danish: For at nedsætte risikoen for ektopisk mineralisering anbefales det, at målet for fastende serum-fosfat er i den lavere ende af det normale referenceinterval for alder (se pkt.
English: Mean (SD) serum total alkaline phosphatase activity was 549 (193.8) U/L at baseline and decreased to 335 (87.6) U/L at Week 40 (mean change: -36.3%).
Danish: Gennemsnitlig (SD) total basisk fosfataseaktivitet i serum var 549 (193,8) E/l ved baseline og faldt til 335 (87,6) E/l ved uge 40 (gennemsnitlig ændring: -36,3 %).
English: Mean (SD) serum total alkaline phosphatase activity was 459 (105) U/L at baseline and decreased to 369 (76) U/L at Week 64 (-19.6%, p < 0.0001).
Danish: Gennemsnitlig (SD) total basisk fosfataseaktivitet i serum var 459 (105) E/l ved baseline og faldt til 369 (76) E/l ved uge 64 (-19,6 %, p <0,0001).
English: Adverse reactions in non-clinical studies with normal animals were observed at exposures which resulted in serum phosphate concentration greater than normal limits.
Danish: Der blev observeret bivirkninger i prækliniske studier af normale dyr ved eksponeringer, der førte til fosfatkoncentrationer i serum over normalgrænsen.
English: Administration should be interrupted in any patient experiencing severe injection site reactions (see section 4.8) and appropriate medical therapy administered.
Danish: Administrationen skal afbrydes hos alle patienter, der oplever svære reaktioner på injektionsstedet (se pkt.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt hyppighedsgruppe er bivirkningerne opstillet efter, hvor alvorlige de er, med de alvorligste bivirkninger anført først.
English: What CRYSVITA contains
Danish: CRYSVITA indeholder:
English: Kyowa Kirin Co., Ltd. Takasaki Plant 100-1 Hagiwara-machi Takasaki
Danish: 100-1 Hagiwara-machi
English: 10 mg CARTON
Danish: 10 mg KARTON
English: 30 mg CARTON
Danish: 30 mg KARTON
English: 20 mg CARTON
Danish: 20 mg KARTON
English: • shortness of breath
Danish: • hurtig puls
English: Hyperphosphataemia
Danish: Hyperfosfatæmi
English: CRYSVITA 10 mg solution for injection CRYSVITA 20 mg solution for injection CRYSVITA 30 mg solution for injection burosumab
Danish: CRYSVITA 10 mg injektionsvæske, opløsning CRYSVITA 20 mg injektionsvæske, opløsning CRYSVITA 30 mg injektionsvæske, opløsning burosumab
English: The negative change in the Rickets Severity Score reflects resolution of the x-ray appearance of rickets.
Danish: Den negative ændring i RSS afspejler en bedring af rakitis påvist med røntgen.
English: Do not shake the vial before use.
Danish: Hætteglasset må ikke omrystes før brug.
English: Effect Size
Danish: Bivirkning
English: Clear to slightly opalescent, colourless to pale brownish-yellowish solution.
Danish: Klar til let opaliserende, farveløs til svagt brunlig-gullig opløsning.
English: At initiation, fasting serum phosphate concentration should be below the reference range for age (see section 4.3).
Danish: Når behandlingen påbegyndes, skal den fastende fosfatkoncentration i serum være under referenceintervallet for alder (se pkt.
English: Name and address of the manufacturer(s) of the biological active substance(s)
Danish: Navn og adresse på fremstilleren (fremstillerne) af det (de) biologisk aktive stof(fer) Kyowa Kirin Co., Ltd.
English: How CRYSVITA works
Danish: Sådan virker CRYSVITA
English: You may get skin reactions where the injection is given, see section 4 for more information.
Danish: Du kan få hudreaktioner, hvor injektionen gives.
English: Duration of Burosumab
Danish: Varighed af burosumab (uge)
English: • sweating.
Danish: • svedtendens.
English: Toothache
Danish: Udslæt
English: Serum alkaline phosphatase activity
Danish: Basisk fosfataseaktivitet i serum
English: Each vial contains 20 mg burosumab in 1 ml of solution.
Danish: Hvert hætteglas indeholder 20 mg burosumab i 1 ml opløsning.
English: If you are not sure, talk to your doctor before using CRYSVITA.
Danish: Kontakt lægen, før du bruger CRYSVITA, hvis du er i tvivl.
English: Dose decrease
Danish: Dosisreduktion
English: What CRYSVITA is and what it is used for What you need to know before you use CRYSVITA How to use CRYSVITA
Danish: Det skal du vide, før du begynder at bruge CRYSVITA Sådan skal du bruge CRYSVITA Bivirkninger
English: Study UX023-CL201
Danish: Studie UX023-CL201
English: Study UX023-CL205
Danish: Studie UX023-CL205
English: Each vial contains 30 mg burosumab in 1 ml of solution.
Danish: Hvert hætteglas indeholder 30 mg burosumab i 1 ml opløsning.
English: Each vial contains 10 mg burosumab in 1 ml of solution.
Danish: Hvert hætteglas indeholder 10 mg burosumab i 1 ml opløsning.
English: Ectopic mineralisation, as manifested by nephrocalcinosis, has been observed in patients with XLH treated with oral phosphorous and vitamin D analogues; these medicinal products should be stopped at least 1 week prior to initiating burosumab treatment (see section 4.2).
Danish: Ektopisk mineralisering, manifesteret ved nefrocalcinose, er blevet observeret hos patienter med XLH i behandling med oralt fosfor og D-vitaminanaloger.
English: Northumberland Morpeth
Danish: Northumberland
English: CRYSVITA 20 mg solution for injection
Danish: CRYSVITA 20 mg injektionsvæske, opløsning
English: CRYSVITA 20 mg injection burosumab
Danish: CRYSVITA 20 mg injektionsvæske burosumab s.c.
English: CRYSVITA 30 mg injection burosumab
Danish: CRYSVITA 30 mg injektionsvæske burosumab s.c.
English: Paediatric PK/PD
Danish: Pædiatrisk farmakokinetik/farmakodynamik
English: CRYSVITA 10 mg solution for injection
Danish: CRYSVITA 10 mg injektionsvæske, opløsning
English: CRYSVITA 30 mg solution for injection
Danish: CRYSVITA 30 mg injektionsvæske, opløsning
English: CRYSVITA 10 mg injection burosumab
Danish: CRYSVITA 10 mg injektionsvæske burosumab s.c.
English: Serum parathyroid hormone
Danish: Paratyreoideahormon i serum
English: +1.56 (0.1) (p<0.0001)
Danish: +1,56 (0,1) (p<0,0001) +1,58 (0,1) (p<0,0001)
English: +1.66 (0.1) (p<0.0001)
Danish: +1,66 (0,1) (p<0,0001) +1,47 (0,1) (p<0,0001)
English: 64 -1.00 (0.1) (p<0.0001)
Danish: -1,00 (0,1) (p<0,0001) -0,84 (0,1) (p<0,0001)
English: Posology
Danish: Dosisforøgelse
English: Tooth abscess
Danish: Tandbyld
English: CRYSVITA 30 mg solution for injection burosumab
Danish: CRYSVITA 30 mg injektionsvæske, opløsning burosumab
English: CRYSVITA 20 mg solution for injection burosumab
Danish: CRYSVITA 20 mg injektionsvæske, opløsning burosumab
English: 30 mg VIAL
Danish: 30 mg HÆTTEGLAS
English: EMA/249807/2015 EMEA/H/C/004009
Danish: Den 24. april 2015 EMA/249807/2015 EMEA/H/C/004009
English: In its letter notifying the Agency of the withdrawal of application, the company stated that it was withdrawing its application because of the identification of GCP issues.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at tilbagetrækningen skyldtes, at der var konstateret problemer vedrørende GCP.
English: It was to be available as gastroresistant capsules (capsules whose contents are not broken down in the stomach and release the medicine in the intestine) containing 30 or 60 mg of duloxetine.
Danish: Det var meningen, at det skulle kunne fås som kapsler, hvis indhold ikke nedbrydes i maven, men frigives i tarmen (enterokapsler) med 30 eller 60 mg duloxetin.
English: This means that Duloxetine Sandoz is similar to a ‘reference medicine' already authorised in the European Union (EU) called Cymbalta.
Danish: Det betyder, at Duloxetine Sandoz er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Cymbalta.
English: It works by preventing the neurotransmitters serotonin and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Danish: Det virker ved at forhindre, at neurotransmitterne serotonin og noradrenalin genoptages i nervecellerne i hjernen og rygmarven.
English: Duloxetine Sandoz was developed as a ‘generic medicine'.
Danish: Duloxetine Sandoz blev udviklet som et "generisk lægemiddel".
English: On 08 April 2015, Sandoz GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Duloxetine Sandoz, for the treatment of depression, diabetic nerve pain and generalised anxiety disorder.
Danish: Den 8. april 2015 meddelte Laboratories Sandoz GmbH officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning tilbage om markedsføringstilladelse for Duloxetine Sandoz til behandling af depression, diabetiske nervesmerter og generaliseret angst.
English: By blocking their re-uptake, duloxetine increases the amount of these neurotransmitters available for communication between the cells.
Danish: Duloxetin blokerer for genoptagelsen af disse neurotransmittere, så der bliver en øget mængde af dem til rådighed til kommunikation mellem cellerne.
English: Because Duloxetine Sandoz is a generic medicine, the company had presented results of tests to determine that Duloxetine Sandoz is bioequivalent to the reference medicine, Cymbalta.
Danish: Da Duloxetine Sandoz er et generisk lægemiddel, havde virksomheden fremlagt undersøgelser, der skulle vise, at Duloxetine Sandoz er bioækvivalent med referencelægemidlet, Cymbalta.