natgillin/translations-raw huggingface dataset:
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.
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.
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.
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.
Serum-fosfor
Serum Phosphorus
Øvrige indholdsstoffer: L-histidin, D-sorbitol (E420), polysorbat 80, L-methionin, 10 % saltsyre og vand til injektionsvæsker.
The other ingredients are L-histidine, D-sorbitol (E420), polysorbate 80, L-methionine, 10%, hydrochloric acid, and water for injections.
Fastende serum-fosfat over normalområdet for alder på grund af risikoen for hyperfosfatæmi (se pkt.
Fasting serum phosphate above the normal range for age due to the risk of hyperphosphatemia (see section 4.4).
Score for rakitis-sværhedsgrad (RSS)
Rickets Severity Score (RSS)
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.
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.
Brug af anden medicin sammen med CRYSVITA Fortæl det altid til lægen, hvis du tager anden medicin eller har gjort det for nylig.
Other medicines and CRYSVITA Tell your doctor if you are taking, have recently taken, or might take any other medicines.
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.
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.
Burosumab udviser en tidsuafhængig farmakokinetik, som er lineær i forhold til dosen i det subkutane dosisinterval på 0,1 til 2,0 mg/kg.
Burosumab displays time-invariant pharmacokinetics that is linear to dose over the subcutaneous dose range of 0.1 to 2.0 mg/kg.
CRYSVITA leveres som en klar til let opaliserende, farveløs til svagt gul/brun injektionsvæske, opløsning i et lille hætteglas af glas.
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.
Dyreforsøg har påvist virkninger på reproduktionsorganerne hos hanner (se pkt.
Studies in animals have shown effects on male reproductive organs (see section 5.3).
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.
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.
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.
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.
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.
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.
CRYSVITA indeholder sorbitol Dette lægemiddel indeholder 45,91 mg sorbitol pr. hætteglas, svarende til 45,91 mg/ml.
CRYSVITA contains sorbitol This medicine contains 45.91 mg of sorbitol in each vial which is equivalent to 45.91 mg/ml.
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.
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.
Pakningsstørrelse med ét hætteglas.
Pack size of one vial.
Dette lægemiddel indeholder 45,91 mg sorbitol pr. hætteglas, svarende til 45,91 mg/ml.
This medicine contains 45.91 mg of sorbitol in each vial which is equivalent to 45.91 mg/ml.
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.
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.
Det skal du vide, før du begynder at bruge CRYSVITA
What you need to know before you use CRYSVITA
Indehaver af markedsføringstilladelsen Kyowa Kirin Holdings B.V.
Marketing Authorisation Holder Kyowa Kirin Holdings B.V. Bloemlaan 2
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).
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).
Fastende serum-fosfat skal måles 4 uger efter dosisjustering.
Fasting serum phosphate should be measured 4 weeks after dose adjustment.
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.
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.
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 %).
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%).
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.
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.
I toksikologistudier med gentagne doser af op til 40 ugers varighed hos cynomolgusaber blev der observeret mineralisering af rete testis/seminiferøse tubuli hos hanaber.
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.
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.
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.
Der rådes til periodiske målinger af paratyreoideahormon i serum.
Periodic measurement of serum parathyroid hormone is advised.
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.
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.
Burosumab skal injiceres i armen, abdomen, bagdelen eller låret.
Burosumab should be injected in the arm, abdomen, buttock or thigh.
Navn og adresse på den fremstiller (de fremstillere), der er ansvarlig(e) for batchfrigivelse Piramal Healthcare UK Limited
Name and address of the manufacturer(s) responsible for batch release
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.
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.
Burosumab forhøjede fosfatkoncentrationen i serum og forhøjede TmP/GFR (tubulær maksimal fosfat reabsorption pr. glomerulær filtrationshastighed).
Burosumab increased serum phosphate concentration and increased TmP/GFR).
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.
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.
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.
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.
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.
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.
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.
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).
Sådan skal du bruge CRYSVITA
How to use CRYSVITA
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.
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.
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.
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).
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 %).
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%).
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).
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).
Der blev observeret bivirkninger i prækliniske studier af normale dyr ved eksponeringer, der førte til fosfatkoncentrationer i serum over normalgrænsen.
Adverse reactions in non-clinical studies with normal animals were observed at exposures which resulted in serum phosphate concentration greater than normal limits.
Administrationen skal afbrydes hos alle patienter, der oplever svære reaktioner på injektionsstedet (se pkt.
Administration should be interrupted in any patient experiencing severe injection site reactions (see section 4.8) and appropriate medical therapy administered.
Inden for hver enkelt hyppighedsgruppe er bivirkningerne opstillet efter, hvor alvorlige de er, med de alvorligste bivirkninger anført først.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
CRYSVITA indeholder:
What CRYSVITA contains
10 mg KARTON
10 mg CARTON
30 mg KARTON
30 mg CARTON
20 mg KARTON
20 mg CARTON
• hurtig puls
• shortness of breath
Hyperfosfatæmi
Hyperphosphataemia
CRYSVITA 10 mg injektionsvæske, opløsning CRYSVITA 20 mg injektionsvæske, opløsning CRYSVITA 30 mg injektionsvæske, opløsning burosumab
CRYSVITA 10 mg solution for injection CRYSVITA 20 mg solution for injection CRYSVITA 30 mg solution for injection burosumab
Den negative ændring i RSS afspejler en bedring af rakitis påvist med røntgen.
The negative change in the Rickets Severity Score reflects resolution of the x-ray appearance of rickets.
Hætteglasset må ikke omrystes før brug.
Do not shake the vial before use.
Bivirkning
Effect Size
Klar til let opaliserende, farveløs til svagt brunlig-gullig opløsning.
Clear to slightly opalescent, colourless to pale brownish-yellowish solution.
Når behandlingen påbegyndes, skal den fastende fosfatkoncentration i serum være under referenceintervallet for alder (se pkt.
At initiation, fasting serum phosphate concentration should be below the reference range for age (see section 4.3).
Navn og adresse på fremstilleren (fremstillerne) af det (de) biologisk aktive stof(fer) Kyowa Kirin Co., Ltd.
Name and address of the manufacturer(s) of the biological active substance(s)
Sådan virker CRYSVITA
How CRYSVITA works
Du kan få hudreaktioner, hvor injektionen gives.
You may get skin reactions where the injection is given, see section 4 for more information.
Varighed af burosumab (uge)
Duration of Burosumab
• svedtendens.
• sweating.
Udslæt
Toothache
Basisk fosfataseaktivitet i serum
Serum alkaline phosphatase activity
Hvert hætteglas indeholder 20 mg burosumab i 1 ml opløsning.
Each vial contains 20 mg burosumab in 1 ml of solution.
Kontakt lægen, før du bruger CRYSVITA, hvis du er i tvivl.
If you are not sure, talk to your doctor before using CRYSVITA.
Dosisreduktion
Dose decrease
Det skal du vide, før du begynder at bruge CRYSVITA Sådan skal du bruge CRYSVITA Bivirkninger
What CRYSVITA is and what it is used for What you need to know before you use CRYSVITA How to use CRYSVITA
Hvert hætteglas indeholder 30 mg burosumab i 1 ml opløsning.
Each vial contains 30 mg burosumab in 1 ml of solution.
Hvert hætteglas indeholder 10 mg burosumab i 1 ml opløsning.
Each vial contains 10 mg burosumab in 1 ml of solution.
Ektopisk mineralisering, manifesteret ved nefrocalcinose, er blevet observeret hos patienter med XLH i behandling med oralt fosfor og D-vitaminanaloger.
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).
CRYSVITA 20 mg injektionsvæske, opløsning
CRYSVITA 20 mg solution for injection
CRYSVITA 20 mg injektionsvæske burosumab s.c.
CRYSVITA 20 mg injection burosumab
CRYSVITA 30 mg injektionsvæske burosumab s.c.
CRYSVITA 30 mg injection burosumab
Pædiatrisk farmakokinetik/farmakodynamik
Paediatric PK/PD
CRYSVITA 10 mg injektionsvæske, opløsning
CRYSVITA 10 mg solution for injection
CRYSVITA 30 mg injektionsvæske, opløsning
CRYSVITA 30 mg solution for injection
CRYSVITA 10 mg injektionsvæske burosumab s.c.
CRYSVITA 10 mg injection burosumab
Paratyreoideahormon i serum
Serum parathyroid hormone
Dosisforøgelse
Posology
Tandbyld
Tooth abscess
CRYSVITA 30 mg injektionsvæske, opløsning burosumab
CRYSVITA 30 mg solution for injection burosumab
CRYSVITA 20 mg injektionsvæske, opløsning burosumab
CRYSVITA 20 mg solution for injection burosumab
30 mg HÆTTEGLAS
30 mg VIAL
Den 24. april 2015 EMA/249807/2015 EMEA/H/C/004009
EMA/249807/2015 EMEA/H/C/004009
I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at tilbagetrækningen skyldtes, at der var konstateret problemer vedrørende GCP.
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.
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.
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.
Det betyder, at Duloxetine Sandoz er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Cymbalta.
This means that Duloxetine Sandoz is similar to a ‘reference medicine' already authorised in the European Union (EU) called Cymbalta.
Det virker ved at forhindre, at neurotransmitterne serotonin og noradrenalin genoptages i nervecellerne i hjernen og rygmarven.
It works by preventing the neurotransmitters serotonin and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Duloxetine Sandoz blev udviklet som et "generisk lægemiddel".
Duloxetine Sandoz was developed as a ‘generic medicine'.
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.
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.
Duloxetin blokerer for genoptagelsen af disse neurotransmittere, så der bliver en øget mængde af dem til rådighed til kommunikation mellem cellerne.
By blocking their re-uptake, duloxetine increases the amount of these neurotransmitters available for communication between the cells.
Da Duloxetine Sandoz er et generisk lægemiddel, havde virksomheden fremlagt undersøgelser, der skulle vise, at Duloxetine Sandoz er bioækvivalent med referencelægemidlet, Cymbalta.
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.
Duloxetine Sandoz forventedes anvendt til behandling af svær depression, smerter i lemmerne som følge af sukkersyge (diabetisk perifer neuropati) og langvarig angst eller nervøsitet over hverdagsproblemer (generaliseret angst).
Duloxetine Sandoz was to be used to treat major depression, pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes) and generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).
Duloxetine Sandoz er et lægemiddel, der indeholder det aktive stof duloxetin.
Duloxetine Sandoz is a medicine that contains the active substance duloxetine.
Hvad er Duloxetine Sandoz?
What is Duloxetine Sandoz?
Det aktive stof i Duloxetine Sandoz, duloxetin, hæmmer genoptagelsen af serotonin og noradrenalin.
The active substance in Duloxetine Sandoz, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Ved at blokere for deres genoptagelse i nervecellerne opnår man derfor bedring i depressionssymptomer og angst og i neuropatiske smerter.
mood and reducing the sensation of pain, blocking their re-uptake into nerve cells can improve the symptoms of depression, anxiety and neuropathic pain.
Hvad forventedes Duloxetine Sandoz anvendt til?
What was Duloxetine Sandoz expected to be used for?
Efter gennemgang af dataene var der i CHMP på tilbagetrækningstidspunktet nogen tvivl om, hvorvidt de to undersøgelser til påvisning af bioækvivalens mellem lægemidlet og referencelægemidlet var udført efter retningslinjerne for god klinisk praksis (GCP).
Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns about whether the two studies conducted to show bioequivalence between the medicine and the reference product had been carried out in accordance with guidelines for Good Clinical Practice (GCP) and was of the provisional opinion that Duloxetine Sandoz could not have been approved for the treatment of depression, diabetic nerve pain and generalised anxiety disorder.
Hvordan forventes Duloxetine Sandoz at virke?
How is Duloxetine Sandoz expected to work?
Disse neurotransmittere er med til at holde humøret oppe og mindske smertefornemmelsen.
Since these neurotransmitters are involved in maintaining high
BETINGELSER ELLER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
Indehaveren af markedsføringstilladelsen skal sikre, at pharmacovigilancesystemet, som beskrevet i version 3.0 i Modul 1.8.1 i ansøgningen om markedsføringstilladelse, er på plads og fungerer før og så længe produktet er markedsført.
The MAH must ensure that the system of pharmacovigilance, as described in version 3.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sådanne tilstande skal korrigeres før administration af Irbesartan BMS.
Such conditions should be corrected before the administration of Irbesartan BMS.