natgillin/translations-raw huggingface dataset:
En enkelt dosis på 20 mg eller to doser på 10 mg med 12 timers interval anbefales til MF-patienter med trombocyttal >200.000/mm Efterfølgende doser (administreret som enkeltdosis eller to doser på 10 mg med 12 timers interval) skal kun administreres på hæmodialysedagen efter hver dialysesession.
A single dose of 20 mg or two doses of 10 mg given 12 hours apart is recommended for MF patients with platelet count of >200,000/mm Subsequent doses (single administration or two doses of 10 mg given 12 hours apart) should be administered only on haemodialysis days following each dialysis session.
Undgå at bruge fluconazol-doser højere end 200 mg dagligt samtidig med brug af ruxolitinib.
Avoid the concomitant use of ruxolitinib with fluconazole doses greater than 200 mg daily.
YDREKARTON TIL MULTIPAKNING
OUTER CARTON OF MULTIPACK
Samtidig brug af cytostatika og og ruxolitinib er ikke undersøgt.
The concomitant use of cytoreductive therapies and ruxolitinib has not been studied.
Til patienter med nedsat leverfunktion skal startdosis baseret på trombocyttal reduceres med ca. 50% til administration to gange daglig.
In patients with any hepatic impairment the recommended starting dose based on platelet count should be reduced by approximately 50% to be administered twice daily.
Efter en median opfølgningsperiode på 34,3 måneder i COMFORT-I var dødeligheden hos patienter randomiseret til ruxolitinib 27,1% mod 35,1% hos patienter, der var randomiseret til placebo: HR 0,687; 95% KI 0,459-1,029; p=0,0668.
In COMFORT-I, after a median follow-up of 34.3 months, the death rate in patients randomised to the ruxolitinib arm was 27.1% versus 35.1% in patients randomised to placebo; HR 0.687; 95% CI 0.459-1.029; p=0.0668.
Hos raske forsøgspersoner medførte administration af ruxolitinib (enkeltdosis 10 mg) sammen med fluconazol, som både er en CYP2C9- og en CYP3A4-hæmmer, i et ruxolitinib Cmax og AUC, som var henholdsvis 47% og 232% højere end med ruxolitinib alene.
In healthy subjects co-administration of ruxolitinib (10 mg single dose) with a dual CYP2C9 and CYP3A4 inhibitor, fluconazole, resulted in ruxolitinib Cmax and AUC that were higher by 47% and 232%, respectively, than with ruxolitinib alone.
Sådan virker Jakavi
How Jakavi works
Dosisjustering ved samtidig brug af potente CYP3A4-hæmmere eller fluconazol Når ruxolitinib administreres sammen med stærke CYP3A4-hæmmere eller hæmmere af både CYP2C9- og CYP3A4-enzymer (fx. fluconazol), skal ruxolitinib doseres i enheder, der er reduceret med ca. 50%, og administreres to gange dagligt (se pkt.
Dose adjustment with concomitant strong CYP3A4 inhibitors or fluconazole When ruxolitinib is administered with strong CYP3A4 inhibitors or dual inhibitors of CYP2C9 and CYP3A4 enzymes (e.g. fluconazole) the unit dose of ruxolitinib should be reduced by approximately 50%, to be administered twice daily (see section 4.5).
4 (<500/mm
c grade 4 (<500/mm
Hvis Jakavi skal administreres sammen med stærke CYP3A4-hæmmere eller både hæmmer CYP3A4og CYP2C9-enzymer (fx fluconazol), skal dosisenheden for Jakavi reduceres med ca. 50% og administreres to gange dagligt (se pkt.
If Jakavi is to be co-administered with strong CYP3A4 inhibitors or dual inhibitors of CYP3A4 and CYP2C9 enzymes (e.g. fluconazole), the unit dose of Jakavi should be reduced by approximately 50%, to be administered twice daily (for monitoring frequency see sections 4.2 and 4.5).
Den terminale eliminationshalveringstid blev forlænget hos patienter med nedsat leverfunktion sammenlignet med raske kontrolpersoner (4,1-5,0 timer mod 2,8 timer) En dosisreduktion på ca. 50% anbefales til patienter med nedsat leverfunktion (se pkt.
The terminal elimination half-life was prolonged in patients with hepatic impairment compared to healthy controls (4.1-5.0 hours versus 2.8 hours).
Jakavi 5 mg tabletter Jakavi 10 mg tabletter Jakavi 15 mg tabletter Jakavi 20 mg tabletter
Jakavi 5 mg tablets Jakavi 10 mg tablets Jakavi 15 mg tablets Jakavi 20 mg tablets
Den anbefalede dosis af ruxolitinib til PV er 10 mg oralt to gange dagligt.
The recommended starting dose of ruxolitinib in PV is 10 mg given orally twice daily.
Nogle er meget almindelige (kan forekomme hos mere end 1 ud af 10 patienter), nogle er almindelige (kan forekomme hos op til 1 ud af 10 patienter): - ethvert tegn på blødninger i hjernen, som fx pludselig ændret bevidsthedsniveau, vedvarende hovedpine, følelsesløshed, snurren, svaghed eller lammelse (almindelige) - ethvert tegn på blødning fra maven eller tarmen, som fx forbigående sort eller blodig afføring eller blodigt opkast (almindelige)
Some are very common (may affect more than 1 in 10 people), some are common (may affect up to 1 in 10 people): - any sign of bleeding in the brain, such as sudden altered level of consciousness, persistent headache, numbness, tingling, weakness or paralysis (common) - any sign of bleeding in the stomach or intestine, such as passing black or bloodstained stools, or vomiting blood (common) - unexpected bruising and/or bleeding, unusual tiredness, shortness of breath during exercise or at rest, unusually pale skin, or frequent infections (possible symptoms of blood disorders) (very common) - painful skin rash with blisters (possible symptoms of shingles (herpes zoster)) (common) - fever, chills or other symptoms of infections (very common) - low level of red blood cells (anaemia), low level of white blood cells (neutropenia) or low level of platelets (thrombocytopenia) (very common)
Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, før du begynder at tage Jakavi Sådan skal du tage Jakavi Bivirkninger
What Jakavi is and what it is used for What you need to know before you take Jakavi How to take Jakavi
I COMFORT-I (MF-patienter) var den gennemsnitlige stigning i systolisk blodtryk 0-2 mmHg fra baseline for ruxolitinib versus et fald på 2-5 mmHg i placebo-armen.
was 0-2 mmHg on ruxolitinib versus a decrease of 2-5 mmHg in the placebo arm.
Jakavi indeholder lactose.
Jakavi contains lactose.
Den anbefalede startdosis til PV- hæmodialysepatienter med nyresygdom i slutstadiet er en enkelt dosis på 10 mg eller to doser på 5 mg givet med 12 timers interval, administreret efter dialyse og kun på hæmodialysedagen.
The recommended starting dose for PV patients with ESRD on haemodialysis is a single dose of 10 mg or two doses of 5 mg given 12 hours apart, to be administered post-dialysis and only on the day of haemodialysis.
Jakavi 5 mg tabletter Jakavi 10 mg tabletter Jakavi 15 mg tabletter Jakavi 20 mg tabletter ruxolitinib
Jakavi 5 mg tablets Jakavi 10 mg tablets Jakavi 15 mg tablets Jakavi 20 mg tablets ruxolitinib
- Den sædvanlige startdosis ved myelofibrose er 15 mg to gange daglig eller 20 mg to gange daglig, afhængigt af dit blodcelletal.
- The recommended starting dose in myelofibrosis is 15 mg twice daily or 20 mg twice daily,
Du skal kun tage Jakavi på dialysedagen, og først når dialysen er afsluttet.
If you receive dialysis, take either one single dose or two separate doses of Jakavi only on dialysis days, after the dialysis has been completed.
Positiv (N=121) n (%)
Positive (N=121) n (%)
Sådan skal du tage Jakavi
How to take Jakavi
En af de ting, der er karakteristisk for myelofibrose, er at milten forstørres.
Enlargement of the spleen is one of the characteristics of myelofibrosis.
Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder 71,45 mg lactosemonohydrat.
Excipient with known effect Each tablet contains 71.45 mg lactose monohydrate.
Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder 285,80 mg lactosemonohydrat.
Excipient with known effect Each tablet contains 285.80 mg lactose monohydrate.
≥35% reduktion i miltvolumen Hæmatokritkontrol uden flebotomi
≥35% reduction in spleen volume
Behandlingsophør på grund af trombocytopeni skete hos 0,7% af de patienter, der fik ruxolitinib, og hos 0,9% af de patienter, der fik kontrolbehandlinger.
Discontinuation of treatment because of thrombocytopenia occurred in 0.7% of patients receiving ruxolitinib and 0.9%
Efter 24 uger
Time point After 24 weeks
4.3) og amning skal derfor stoppes, når behandling påbegyndes.
Jakavi must not be used during breast-feeding (see section 4.3) and breast-feeding should therefore be discontinued when treatment is started.
De opdaterede data viser, at 27,4% af patienterne, som blev behandlet med ruxolitinib, seponerede behandlingen på grund af bivirkninger.
With these updated data, therapy discontinuation due to adverse events was observed in 27.4% of patients treated with ruxolitinib.
Positiv (N=49) n (%)
Positive (N=49) n (%)
Hæmatokritkontrol blev opnået hos 60% af patienterne i Jakavi-armen sammenlignet med 18,8% af patienterne i BAT-armen.
Haematocrit control was achieved in 60% of patients in the Jakavi arm compared to 18.8% in the BAT arm and a ≥35% reduction in spleen volume was achieved in 40% of patients in the Jakavi arm compared to 0.9% in the BAT arm (Figure 1).
Positiv (N=110) n (%)
Positive (N=110) n (%)
Jakavi 20 mg tabletter
Jakavi 20 mg tablets
Positiv (N=113) n (%)
Positive (N=113) n (%)
Hypertriglyceridæmi b
Hypertriglyceridaemia b
- hvis du udvikler smertefuldt hududslæt med blærer (dette er tegn på helvedesild).
- if you develop painful skin rash with blisters (these are signs of shingles).
Mediantiden til udvikling af neutropeni grad 3 eller 4 var 12 uger i de kliniske fase 3-studier med MF. Under randomiseringsperioden blev doseringspause eller dosisreduktion på grund af neutropeni rapporteret for 1,0% af patienterne, og 0,3% af patienterne ophørte med behandlingen på grund af neutropeni.
During the randomised period, dose holding or reductions due to neutropenia were reported in 1.0% of patients, and 0.3% of patients discontinued treatment because of neutropenia.
Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder 142,90 mg lactosemonohydrat.
Excipient with known effect Each tablet contains 142.90 mg lactose monohydrate.
I kliniske studier seponerede 11,3% af patienterne Jakavi pga. bivirkninger uden hensyn til kausalitet.
In these clinical studies, discontinuation due to adverse events, regardless of causality, was observed in 11.3% of patients.
Blå mærker blev rapporteret hos 10,3% af patienterne i armen med ruxolitinib, 8,1% af patienterne i armen med bedste tilgængelige terapi i RESPONSEstudiet og 2,7% af patienterne i armen med bedste tilgængelige terapi i RESPONSE 2studiet.
Bruising was reported in 10.3% of patients treated with ruxolitinib, 8.1% of patients receiving best available therapy in RESPONSE
Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder 214,35 mg lactosemonohydrat.
Excipient with known effect Each tablet contains 214.35 mg lactose monohydrate.
Alle CTCAE-grader c
c grade 1
Negativ (N=35) n (%)
Negative (N=35) n (%)
- Hver Jakavi 20 mg tablet indeholder 20 mg ruxolitinib.
- Each 20 mg Jakavi tablet contains 20 mg of ruxolitinib.
- Hver Jakavi 15 mg tablet indeholder 15 mg ruxolitinib.
- Each 15 mg Jakavi tablet contains 15 mg of ruxolitinib.
Jakavi 10 mg tabletter
Jakavi 10 mg tablets
Jakavi 5 mg tabletter
Jakavi 5 mg tablets
Jakavi 20 mg tabletter Hver tablet indeholder 20 mg ruxolitinib (som fosfat).
Jakavi 20 mg tablets Each tablet contains 20 mg ruxolitinib (as phosphate).
Frekvensen hændelser af grad 3 eller 4 var omtrent den samme for patienter, der behandledes med ruxolitinib, som for patienter, der fik referencebehandlinger (4,7% mod 3,1%).
The frequency of grade 3-4 events was similar for patients treated with ruxolitinib or reference treatments
Brug af anden medicin sammen med Jakavi Fortæl altid lægen eller apoteketspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Jakavi 20 mg tabletter er hvide eller næsten hvide, aflange tabletter præget med ”NVR” på den ene side og ”L20” på den anden side.
Jakavi 20 mg tablets are white to almost white elongated tablets with “NVR” debossed on one side and “L20” debossed on the other side.
Jakavi 5 mg tabletter EU/1/12/773/004-006
Jakavi 5 mg tablets EU/1/12/773/004-006
Negativ (N=27) n (%)
Negative (N=27) n (%)
Tidspunkter
Time points
Jakavi 20 mg tabletter EU/1/12/773/010-012
Jakavi 20 mg tablets EU/1/12/773/010-012
Jakavi 10 mg tabletter EU/1/12/773/014-016
Jakavi 10 mg tablets EU/1/12/773/014-016
Negativ (N=40) n (%)
Negative (N=40) n (%)
Negativ (N=20) n (%)
Negative (N=20) n (%)
Jakavi 15 mg tabletter
Jakavi 15 mg tablets
DELPAKNING TIL MULTIPAKNING
INTERMEDIATE CARTON OF MULTIPACK
Jakavi 15 mg tabletter EU/1/12/773/007-009
Jakavi 15 mg tablets EU/1/12/773/007-009
- Hver Jakavi 10 mg tablet indeholder 10 mg ruxolitinib.
- Each 10 mg Jakavi tablet contains 10 mg of ruxolitinib.
De fleste af patienterne med blødningshændelser under behandlingen rapporterede blå mærker (65,3%).
Most of the patients with bleeding events during the treatment reported bruising
Hovedpine a
Headache a
Aflange, kurvede, hvide eller næsten hvide tabletter, på ca. 16,5 x 7,4 mm præget med ”NVR” på den ene side og ”L20” på den anden side.
Elongated curved white to almost white tablets of approximately 16.5 x 7.4 mm with “NVR” debossed one one side and “L20” debossed on the other side.
Runde, kurvede, hvide eller næsten hvide tabletter med ca. 9,3 mm i diameter præget med ”NVR” på den ene side og ”L10” på den anden side.
Round curved white to almost white tablets of approximately 9.3 mm in diameter with “NVR” debossed on one side and “L10” debossed on the other side.
Jakavi 5 mg tabletter Hver tablet indeholder 5 mg ruxolitinib (som fosfat).
Jakavi 5 mg tablets Each tablet contains 5 mg ruxolitinib (as phosphate).
Runde, kurvede, hvide eller næsten hvide tabletter med ca. 7,5 mm i diameter præget med ”NVR” på den ene side og ”L5” på den anden side.
Round curved white to almost white tablets of approximately 7.5 mm in diameter with “NVR” debossed on one side and “L5” debossed on the other side.
Ovale, kurvede, hvide eller næsten hvide tabletter, på ca. 15,0 x 7,0 mm præget med ”NVR” på den ene side og ”L15” præget på den anden side.
Ovaloid curved white to almost white tablets of approximately 15.0 x 7.0 mm with “NVR” debossed on one side and “L15” debossed on the other side.
Jakavi 10 mg tabletter Hver tablet indeholder 10 mg ruxolitinib (som fosfat).
Jakavi 10 mg tablets Each tablet contains 10 mg ruxolitinib (as phosphate).
Jakavi 15 mg tabletter Hver tablet indeholder 15 mg ruxolitinib (som fosfat).
Jakavi 15 mg tablets Each tablet contains 15 mg ruxolitinib (as phosphate).
Andelen af patienter, som opnåede fuldstændig hæmatologisk remission, var 23,6% i Jakavi-armen sammenlignet med 8,0% i BAT-armen (p=0,0013).
The proportion of patients achieving a complete haematological remission was 23.6% on Jakavi compared to 8.0% on BAT (p=0.0013) and the proportion of patients achieving a durable primary response at week 48 was 20% on Jakavi and 0.9% on BAT (p<0.0001).
Symptomer efter behandlingsophør
Cytoreductive therapies
Jakavi 20 mg tabletter ruxolitinib
Jakavi 20 mg tablets ruxolitinib
Jakavi 15 mg tabletter er hvide eller næsten hvide, ovale tabletter præget med ”NVR” på den ene side og ”L15” på den anden side.
Jakavi 15 mg tablets are white to almost white oval tablets with “NVR” debossed on one side and “L15” debossed on the other side.
Jakavi 10 mg tabletter er hvide eller næsten hvide, runde tabletter præget med ”NVR” på den ene side og ”L10” på den anden side.
Jakavi 10 mg tablets are white to almost white round tablets with “NVR” debossed on one side and “L10” debossed on the other side.
Medianværdien af Cmax for ruxolitinib og total eksponering (AUC) steg proportionalt over et enkeltdosisområde på 5-200 mg. Der var ingen klinisk relevant farmakokinetisk ændring af ruxolitinib efter administration sammen med indtagelse af et måltid med højt fedtindhold.
Mean ruxolitinib Cmax and total exposure (AUC) increased proportionally over a single dose range of 5-200 mg.
Vaskulære sygdomme Hypertension a
Vascular disorders Hypertensiona
Jakavi 5 mg tabletter ruxolitinib
Jakavi 5 mg tablets ruxolitinib
Jakavi 15 mg tabletter ruxolitinib
Jakavi 15 mg tablets ruxolitinib
Jakavi 10 mg tabletter ruxolitinib
Jakavi 10 mg tablets ruxolitinib
Hvis du har taget for meget Jakavi
If you take more Jakavi than you should
Før behandling med Jakavi påbegyndes, skal der foretages en komplet blodtælling inklusive en differentialtælling.
A complete blood cell count, including a white blood cell count differential, must be performed before initiating therapy with Jakavi.
Andre blødninger (inklusive næseblod, postprocedural blødning og hæmaturi)
Other bleeding (including epistaxis, post-procedural haemorrhage and haematuria)
Hver tablet indeholder 20 mg ruxolitinib (som fosfat).
Each tablet contains 20 mg ruxolitinib (as phosphate).
Hver tablet indeholder 5 mg ruxolitinib (som fosfat).
Each tablet contains 5 mg ruxolitinib (as phosphate).
Hver tablet indeholder 15 mg ruxolitinib (som fosfat).
Each tablet contains 15 mg ruxolitinib (as phosphate).
Hver tablet indeholder 10 mg ruxolitinib (som fosfat).
Each tablet contains 10 mg ruxolitinib (as phosphate).
Jakavi 5 mg tabletter er hvide eller næsten hvide, runde tabletter præget med ”NVR” på den ene side og ”L5” på den anden side.
What Jakavi looks like and contents of the pack Jakavi 5 mg tablets are white to almost white round tablets with “NVR” debossed on one side and “L5” debossed on the other side.
Bivirkninger
Withdrawal effects
De var milde eller moderate og var ikke vedvarende.
They were mild or moderate in severity and did not last.
Det betyder, at det svarer til et "referencelægemiddel", som indeholder det samme aktive stof.
This means that it is similar to a ‘reference medicine' containing the same active substance.
Undersøgelser har ikke desto mindre vist, at patienterne har gavn af lægemidlet uden at have væsentlige bivirkninger.
Nevertheless, studies have shown that the medicine benefits patients and has no significant side effects.
For små børn og børn, der ikke kan sluge kapsler, kan indholdet af kapslerne blandes i en natriumbikarbonatopløsning 8,4 %, så man opnår en væske.
For small children and children who cannot swallow capsules, the contents of the capsules can be mixed with sodium bicarbonate solution 8.4% to make a liquid.
Da der imidlertid er tale om en sjælden sygdom, er de tilgængelige data om brugen af lægemidlet stadig begrænsede.
However, due to the rarity of the disease, there are still limited data available on the use of the medicine.
Hos de fleste patienter sås også en lindring af sygdommens symptomer: Alle rapporterede om mindre forekomst af diarré, 89 % af patienterne opnåede bedre mentale evner, 60 % opnåede større mobilitet, og i henhold til to forskellige scorer havde 85 % og 77 % af patienterne fået det bedre psykisk.
Most patients also had improvements in symptoms of the disease: all reported an improvement in diarrhoea, 89% of patients showed an improvement in their mental ability, 60% of patients showed improvement in mobility, and 85% and 77% of patients showed psychiatric improvement based on two different scores.
Den daglige dosis fastsættes og justeres under behandlingen for hver enkelt patient, alt efter dennes alder, leverfunktion og galdesyreniveau i blod og urin.
The daily dose is chosen and adjusted during treatment for each patient depending on the patient's age, liver function and levels of bile acids in their blood and urine.
Blandt 23 patienter, hvis data om galdesyreniveau i blodet var tilgængelige, sås en reduktion hos alle (gennemsnitlig reduktion på 56-69 µmol/l).
Among 23 patients for whom data on blood levels of bile acids were available, all had reductions in their levels (average reduction of 56-69 µmol/l).
Chenodeoxycholic acid Leadiant fås som kapsler (250 mg), der tages 3 gange dagligt på nogenlunde samme tidspunkt hver dag.
Chenodeoxycholic acid Leadiant is available as capsules (250 mg) which are taken 3 times a day at approximately the same time every day.
Da Chenodeoxycholic acid Leadiant er godkendt under særlige omstændigheder, vil den virksomhed, der markedsfører lægemidlet, oprette et register til overvågning af lægemidlets fordele og sikkerhed.
Since Chenodeoxycholic acid Leadiant has been approved under exceptional circumstances, the company that markets this medicine will set up a registry to monitor the benefits and safety of the medicine.
Blandt 14 patienter, hvis data om galdesyreniveau i urinen var tilgængelige, sås en reduktion hos 79 % (11 ud af 14) i de seneste test.
Among 14 patients for whom data on urine levels of bile acids were available, 79% (11 out of 14) had reduced levels at their most recent test.
Derved nedsættes produktionen af unormale stoffer, og galdens normale aktivitet i fordøjelsessystemet fremmes, så sygdommens symptomer lindres.
This helps to reduce the production of abnormal substances and contributes to the normal activity of bile in the digestive system, thereby relieving the symptoms of the disease.
Udvalg for Lægemidler til Mennesker (CHMP) konkluderede derfor, at fordelene ved Chenodeoxycholic acid Leadiant opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Chenodeoxycholic acid Leadiant's benefits are greater than its risks and recommended that it be approved for use in the EU.
Dette er en "primær galdesyre", som er en hovedbestanddel i galden (den væske, der produceres af leveren og medvirker ved fordøjelsen af fedtstoffer).
This is a ‘primary bile acid', which is a main component of bile (a fluid produced by the liver that helps to digest fats).
Når der ingen galdesyre er, producerer kroppen i stedet anormale galdesyrer og andre stoffer, som ophober sig i kroppen og forvolder skade.
When primary bile acids are lacking, the body produces abnormal bile acids and other substances instead which accumulate throughout the body, causing damage.
Da antallet af patienter med denne sygdom er lavt, betragtes sygdommen som "sjælden", og Chenodeoxycholic acid Leadiant blev udpeget som "lægemiddel til sjældne sygdomme" den 16. december 2014.
Because the number of patients with this condition is low, the disease is considered ‘rare', and Chenodeoxycholic acid Leadiant was designated an ‘orphan medicine' (a medicine used in rare diseases) on 16 December 2014.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Chenodeoxycholic acid Leadiant den 10. april 2017.
The European Commission granted a marketing authorisation valid throughout the European Union for Chenodeoxycholic acid sigma-tau on 10 April 2017.
Den fuldstændige EPAR for Chenodeoxycholic acid Leadiant findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Chenodeoxycholic acid Leadiant can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Det skyldes, at det ikke har været muligt at indhente fyldestgørende oplysninger om Chenodeoxycholic acid Leadiant, fordi sygdommen er sjælden.
This is because it has not been possible to obtain complete information about Chenodeoxycholic acid Leadiant due to the rarity of the disease.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Chenodeoxycholic acid Leadiant.
This is a summary of the European public assessment report (EPAR) for Chenodeoxycholic acid Leadiant.
Chenodeoxycholsyre har været anvendt til behandling af cerebrotendinøs xantomatose i ca. 40 år, selvom det ikke var godkendt til denne anvendelse.
Chenodeoxycholic acid has been used to treat cerebrotendinous xanthomatosis for about 40 years, although it was not licensed for this use.
Lægemidlets navn blev ændret til Chenodeoxycholic acid Leadiant den 12. maj 2017.
The name of the product was changed to Chenodeoxycholic acid Leadiant on 12 May 2017.