FrancophonIA/ELRC3.0 huggingface dataset:
English: Subsequent doses (single dose of 20 mg or two doses of 10 mg given 12 hours apart in MF patients; single dose of 10 mg or two doses of 5 mg given 12 hours apart in PV patients) should be administered only on haemodialysis days following each dialysis session.
Danish: Efterfølgende doser (enkeltdosis på 20 mg eller to doser på 10 mg med 12 timers interval til MF-patienter; enkeltdosis på 10 mg eller to doser på 5 mg med 12 timers interval til PV-patienter) skal kun administreres på hæmodialysedagen efter hver dialysesession.
English: c grade 3 (<1,000 - 500/mm
Danish: 3 (<1.000-500/mm
English: Cellulose, microcrystalline Magnesium stearate Silica, colloidal anhydrous Sodium starch glycolate (Type A) Povidone K30
Danish: Kolloid vandfri silica Natriumstivelseglycolat (type A) Povidon K30
English: In healthy subjects co-administration of ruxolitinib (10 mg single dose) with erythromycin 500 mg twice daily for four days resulted in ruxolitinib Cmax and AUC that were higher by 8% and 27%, respectively, than with ruxolitinib alone.
Danish: Hos sunde forsøgspersoner medførte samtidig administration af ruxolitinib (enkeltdosis på 10 mg) med erythromycin 500 mg to gange dagligt i fire dage ruxolitinib Cmax og AUC, som var henholdsvis 8% og 27% højere end med ruxolitinib alene.
English: Long-term safety was evaluated using data from two phase 3 studies including data from patients initially randomised to ruxolitinib (n=184; exposure 0.03 to 43.5 months, median exposure 18.9 months) and patients who received ruxolitinib after crossing over from control treatments (n=149; exposure: 0.2 to 33.5 months, median exposure 12.0 months): With longer exposure, the cumulative frequency of adverse events increased but no new safety findings emerged.
Danish: Langtidssikkerhed blev evalueret på baggrund af data fra to fase 3-studier, som inkluderede data fra patienter, som initielt var randomiseret til ruxolitinib (n=184; eksponering 0,03 til 43,5 måneder, medianeksponering 18,9 måneder) og patienter, som fik ruxolitinib efter at krydse over fra kontrolbehandling (n=149; eksponering: 0,2 til 33,5 måneder, medianeksponering 12,0 måneder).
English: - Cimetidine, a medicine to treat heartburn.
Danish: - Cimetidin, medicin som bruges til behandling af halsbrand.
English: The rate of herpes zoster was similar in PV (4.3%)
Danish: Hyppigheden af herpes zoster var sammenlignelig hos PV-patienter (4,3%) og hos MF-patienter (4,0%).
English: 14 tablets 56 tablets
Danish: 14 tabletter 56 tabletter
English: Additional dose modifications should be made with careful monitoring of safety and efficacy (see sections 4.2 and 5.2).
Danish: Yderligere dosisjusteringer skal ske under nøje monitorering af sikkerhed og effekt (se pkt.
English: c grade 4 (<25,000/mm
Danish: 4 (<25.000/mm
English: In COMFORT-I, after a median follow-up of 61.7 months, the death rate in patients randomised to the ruxolitinib arm was 44.5% (69 of 155 patients) versus 53.2% (82 of 154) in patients randomised to placebo.
Danish: Efter en median opfølgningsperiode på 61,7 måneder i COMFORT-I var dødeligheden hos patienter randomiseret til ruxolitinib 44,5% (69 ud af 155 patienter) mod 53,2% (82 ud af 154 patienter) hos patienter, der var randomiseret til placebo.
English: 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.
Danish: 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.
English: Avoid the concomitant use of ruxolitinib with fluconazole doses greater than 200 mg daily.
Danish: Undgå at bruge fluconazol-doser højere end 200 mg dagligt samtidig med brug af ruxolitinib.
English: OUTER CARTON OF MULTIPACK
Danish: YDREKARTON TIL MULTIPAKNING
English: The concomitant use of cytoreductive therapies and ruxolitinib has not been studied.
Danish: Samtidig brug af cytostatika og og ruxolitinib er ikke undersøgt.
English: 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.
Danish: Til patienter med nedsat leverfunktion skal startdosis baseret på trombocyttal reduceres med ca. 50% til administration to gange daglig.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: How Jakavi works
Danish: Sådan virker Jakavi
English: 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).
Danish: 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.
English: c grade 4 (<500/mm
Danish: 4 (<500/mm
English: 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).
Danish: 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.
English: 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).
Danish: 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.
English: Jakavi 5 mg tablets Jakavi 10 mg tablets Jakavi 15 mg tablets Jakavi 20 mg tablets
Danish: Jakavi 5 mg tabletter Jakavi 10 mg tabletter Jakavi 15 mg tabletter Jakavi 20 mg tabletter
English: The recommended starting dose of ruxolitinib in PV is 10 mg given orally twice daily.
Danish: Den anbefalede dosis af ruxolitinib til PV er 10 mg oralt to gange dagligt.
English: 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)
Danish: 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)
English: What Jakavi is and what it is used for What you need to know before you take Jakavi How to take Jakavi
Danish: Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, før du begynder at tage Jakavi Sådan skal du tage Jakavi Bivirkninger
English: was 0-2 mmHg on ruxolitinib versus a decrease of 2-5 mmHg in the placebo arm.
Danish: 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.
English: Jakavi contains lactose.
Danish: Jakavi indeholder lactose.
English: 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.
Danish: 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.
English: Jakavi 5 mg tablets Jakavi 10 mg tablets Jakavi 15 mg tablets Jakavi 20 mg tablets ruxolitinib
Danish: Jakavi 5 mg tabletter Jakavi 10 mg tabletter Jakavi 15 mg tabletter Jakavi 20 mg tabletter ruxolitinib
English: - The recommended starting dose in myelofibrosis is 15 mg twice daily or 20 mg twice daily,
Danish: - Den sædvanlige startdosis ved myelofibrose er 15 mg to gange daglig eller 20 mg to gange daglig, afhængigt af dit blodcelletal.
English: 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.
Danish: Du skal kun tage Jakavi på dialysedagen, og først når dialysen er afsluttet.
English: Positive (N=121) n (%)
Danish: Positiv (N=121) n (%)
English: How to take Jakavi
Danish: Sådan skal du tage Jakavi
English: Enlargement of the spleen is one of the characteristics of myelofibrosis.
Danish: En af de ting, der er karakteristisk for myelofibrose, er at milten forstørres.
English: Excipient with known effect Each tablet contains 71.45 mg lactose monohydrate.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder 71,45 mg lactosemonohydrat.
English: Excipient with known effect Each tablet contains 285.80 mg lactose monohydrate.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder 285,80 mg lactosemonohydrat.
English: ≥35% reduction in spleen volume
Danish: ≥35% reduktion i miltvolumen Hæmatokritkontrol uden flebotomi
English: Discontinuation of treatment because of thrombocytopenia occurred in 0.7% of patients receiving ruxolitinib and 0.9%
Danish: 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.
English: Time point After 24 weeks
Danish: Efter 24 uger
English: Jakavi must not be used during breast-feeding (see section 4.3) and breast-feeding should therefore be discontinued when treatment is started.
Danish: 4.3) og amning skal derfor stoppes, når behandling påbegyndes.
English: With these updated data, therapy discontinuation due to adverse events was observed in 27.4% of patients treated with ruxolitinib.
Danish: De opdaterede data viser, at 27,4% af patienterne, som blev behandlet med ruxolitinib, seponerede behandlingen på grund af bivirkninger.
English: Positive (N=49) n (%)
Danish: Positiv (N=49) n (%)
English: 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).
Danish: Hæmatokritkontrol blev opnået hos 60% af patienterne i Jakavi-armen sammenlignet med 18,8% af patienterne i BAT-armen.
English: Positive (N=110) n (%)
Danish: Positiv (N=110) n (%)
English: Jakavi 20 mg tablets
Danish: Jakavi 20 mg tabletter
English: Positive (N=113) n (%)
Danish: Positiv (N=113) n (%)
English: Hypertriglyceridaemia b
Danish: Hypertriglyceridæmi b
English: - if you develop painful skin rash with blisters (these are signs of shingles).
Danish: - hvis du udvikler smertefuldt hududslæt med blærer (dette er tegn på helvedesild).
English: 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.
Danish: 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.
English: Excipient with known effect Each tablet contains 142.90 mg lactose monohydrate.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder 142,90 mg lactosemonohydrat.
English: In these clinical studies, discontinuation due to adverse events, regardless of causality, was observed in 11.3% of patients.
Danish: I kliniske studier seponerede 11,3% af patienterne Jakavi pga. bivirkninger uden hensyn til kausalitet.
English: Bruising was reported in 10.3% of patients treated with ruxolitinib, 8.1% of patients receiving best available therapy in RESPONSE
Danish: 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.
English: Excipient with known effect Each tablet contains 214.35 mg lactose monohydrate.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder 214,35 mg lactosemonohydrat.
English: c grade 1
Danish: Alle CTCAE-grader c
English: Negative (N=35) n (%)
Danish: Negativ (N=35) n (%)
English: - Each 20 mg Jakavi tablet contains 20 mg of ruxolitinib.
Danish: - Hver Jakavi 20 mg tablet indeholder 20 mg ruxolitinib.
English: - Each 15 mg Jakavi tablet contains 15 mg of ruxolitinib.
Danish: - Hver Jakavi 15 mg tablet indeholder 15 mg ruxolitinib.
English: Jakavi 10 mg tablets
Danish: Jakavi 10 mg tabletter
English: Jakavi 5 mg tablets
Danish: Jakavi 5 mg tabletter
English: Jakavi 20 mg tablets Each tablet contains 20 mg ruxolitinib (as phosphate).
Danish: Jakavi 20 mg tabletter Hver tablet indeholder 20 mg ruxolitinib (som fosfat).
English: The frequency of grade 3-4 events was similar for patients treated with ruxolitinib or reference treatments
Danish: 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%).
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Jakavi Fortæl altid lægen eller apoteketspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Jakavi 20 mg tablets are white to almost white elongated tablets with “NVR” debossed on one side and “L20” debossed on the other side.
Danish: Jakavi 20 mg tabletter er hvide eller næsten hvide, aflange tabletter præget med ”NVR” på den ene side og ”L20” på den anden side.
English: Jakavi 5 mg tablets EU/1/12/773/004-006
Danish: Jakavi 5 mg tabletter EU/1/12/773/004-006
English: Negative (N=27) n (%)
Danish: Negativ (N=27) n (%)
English: Time points
Danish: Tidspunkter
English: Jakavi 20 mg tablets EU/1/12/773/010-012
Danish: Jakavi 20 mg tabletter EU/1/12/773/010-012
English: Jakavi 10 mg tablets EU/1/12/773/014-016
Danish: Jakavi 10 mg tabletter EU/1/12/773/014-016
English: Negative (N=40) n (%)
Danish: Negativ (N=40) n (%)
English: Negative (N=20) n (%)
Danish: Negativ (N=20) n (%)
English: Jakavi 15 mg tablets
Danish: Jakavi 15 mg tabletter
English: INTERMEDIATE CARTON OF MULTIPACK
Danish: DELPAKNING TIL MULTIPAKNING
English: Jakavi 15 mg tablets EU/1/12/773/007-009
Danish: Jakavi 15 mg tabletter EU/1/12/773/007-009
English: - Each 10 mg Jakavi tablet contains 10 mg of ruxolitinib.
Danish: - Hver Jakavi 10 mg tablet indeholder 10 mg ruxolitinib.
English: Most of the patients with bleeding events during the treatment reported bruising
Danish: De fleste af patienterne med blødningshændelser under behandlingen rapporterede blå mærker (65,3%).
English: Headache a
Danish: Hovedpine a
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Jakavi 5 mg tablets Each tablet contains 5 mg ruxolitinib (as phosphate).
Danish: Jakavi 5 mg tabletter Hver tablet indeholder 5 mg ruxolitinib (som fosfat).
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Jakavi 10 mg tablets Each tablet contains 10 mg ruxolitinib (as phosphate).
Danish: Jakavi 10 mg tabletter Hver tablet indeholder 10 mg ruxolitinib (som fosfat).
English: Jakavi 15 mg tablets Each tablet contains 15 mg ruxolitinib (as phosphate).
Danish: Jakavi 15 mg tabletter Hver tablet indeholder 15 mg ruxolitinib (som fosfat).
English: 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).
Danish: Andelen af patienter, som opnåede fuldstændig hæmatologisk remission, var 23,6% i Jakavi-armen sammenlignet med 8,0% i BAT-armen (p=0,0013).
English: Cytoreductive therapies
Danish: Symptomer efter behandlingsophør
English: Jakavi 20 mg tablets ruxolitinib
Danish: Jakavi 20 mg tabletter ruxolitinib
English: Jakavi 15 mg tablets are white to almost white oval tablets with “NVR” debossed on one side and “L15” debossed on the other side.
Danish: Jakavi 15 mg tabletter er hvide eller næsten hvide, ovale tabletter præget med ”NVR” på den ene side og ”L15” på den anden side.
English: Jakavi 10 mg tablets are white to almost white round tablets with “NVR” debossed on one side and “L10” debossed on the other side.
Danish: Jakavi 10 mg tabletter er hvide eller næsten hvide, runde tabletter præget med ”NVR” på den ene side og ”L10” på den anden side.
English: Mean ruxolitinib Cmax and total exposure (AUC) increased proportionally over a single dose range of 5-200 mg.
Danish: 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.
English: Vascular disorders Hypertensiona
Danish: Vaskulære sygdomme Hypertension a
English: Jakavi 5 mg tablets ruxolitinib
Danish: Jakavi 5 mg tabletter ruxolitinib
English: Jakavi 15 mg tablets ruxolitinib
Danish: Jakavi 15 mg tabletter ruxolitinib
English: Jakavi 10 mg tablets ruxolitinib
Danish: Jakavi 10 mg tabletter ruxolitinib
English: If you take more Jakavi than you should
Danish: Hvis du har taget for meget Jakavi
English: A complete blood cell count, including a white blood cell count differential, must be performed before initiating therapy with Jakavi.
Danish: Før behandling med Jakavi påbegyndes, skal der foretages en komplet blodtælling inklusive en differentialtælling.
English: Other bleeding (including epistaxis, post-procedural haemorrhage and haematuria)
Danish: Andre blødninger (inklusive næseblod, postprocedural blødning og hæmaturi)
English: Each tablet contains 20 mg ruxolitinib (as phosphate).
Danish: Hver tablet indeholder 20 mg ruxolitinib (som fosfat).
English: Each tablet contains 5 mg ruxolitinib (as phosphate).
Danish: Hver tablet indeholder 5 mg ruxolitinib (som fosfat).
English: Each tablet contains 15 mg ruxolitinib (as phosphate).
Danish: Hver tablet indeholder 15 mg ruxolitinib (som fosfat).
English: Each tablet contains 10 mg ruxolitinib (as phosphate).
Danish: Hver tablet indeholder 10 mg ruxolitinib (som fosfat).
English: 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.
Danish: Jakavi 5 mg tabletter er hvide eller næsten hvide, runde tabletter præget med ”NVR” på den ene side og ”L5” på den anden side.
English: Withdrawal effects
Danish: Bivirkninger
English: They were mild or moderate in severity and did not last.
Danish: De var milde eller moderate og var ikke vedvarende.
English: This means that it is similar to a ‘reference medicine' containing the same active substance.
Danish: Det betyder, at det svarer til et "referencelægemiddel", som indeholder det samme aktive stof.
English: Nevertheless, studies have shown that the medicine benefits patients and has no significant side effects.
Danish: Undersøgelser har ikke desto mindre vist, at patienterne har gavn af lægemidlet uden at have væsentlige bivirkninger.
English: 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.
Danish: 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.
English: However, due to the rarity of the disease, there are still limited data available on the use of the medicine.
Danish: Da der imidlertid er tale om en sjælden sygdom, er de tilgængelige data om brugen af lægemidlet stadig begrænsede.
English: 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.
Danish: 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.