FrancophonIA/ELRC3.0 huggingface dataset:
English: What measures are being taken to ensure the safe and effective use of Kolbam?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Kolbam?
English: What is Kolbam and what is it used for?
Danish: Hvad er Kolbam, og hvad anvendes det til?
English: Why is Kolbam approved?
Danish: Hvorfor er Kolbam blevet godkendt?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Kolbam's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Kolbam opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The efficacy of Kolbam for the authorised indications was established based on the results of this study.
Danish: Virkningen af Kolbam ved de godkendte indikationer kunne fastslås på grundlag af denne undersøgelses resultater.
English: The daily dose is chosen and adjusted during treatment for each patient depending on the patient's levels of bile acids in their blood and urine and their liver function.
Danish: Den daglige dosis vælges og tilpasses under behandlingen til den enkelte patient, afhængigt af patientens indhold af galdesyrer i blodet og i urinen og leverfunktion.
English: Because the number of patients with inborn errors in primary bile acid synthesis is low, the condition is considered ‘rare', and Kolbam was designated an ‘orphan medicine' (a medicine used in rare diseases) on 28 October 2009.
Danish: Da antallet af patienter med medfødte fejl i syntesen af primære galdesyrer er lavt, betragtes sygdommen som "sjælden", og Kolbam blev udpeget som "lægemiddel til sjældne sygdomme" den 28. oktober 2009.
English: Regarding its safety, the side effects appeared to be non-serious and reversible.
Danish: Vedrørende sikkerheden syntes bivirkningerne at være af mindre alvorlig karakter og forbigående.
English: For small children who cannot swallow capsules, the contents can be mixed in with infant formula, expressed breast milk, mashed potatoes or fruit puree.
Danish: Til små børn, som ikke kan synke kapsler, kan indholdet blandes i modermælkserstatning, udmalket modermælk, kartoffelmos eller frugtmos.
English: What are the risks associated with Kolbam?
Danish: Hvilke risici er der forbundet med Kolbam?
English: Kolbam cholic acid
Danish: Kolbam cholsyre
English: It is not intended to provide practical advice on how to use Kolbam.
Danish: Det er ikke en praktisk vejledning i, hvordan Kolbam bør anvendes.
English: Kolbam is a medicine that contains the active substance cholic acid.
Danish: Kolbam er et lægemiddel, der indeholder det aktive stof cholsyre.
English: The full EPAR and risk management plan summary for Kolbam can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Kolbam findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The most common side effects (which may affect up to 1 in 10 people) are peripheral neuropathy (nerve damage in the hands and feet), diarrhoea, nausea (feeling sick), acid reflux (stomach acid flowing up into the mouth), oesophagitis (inflammation of the food pipe), jaundice (yellowing of the skin and eyes), skin problems (lesions) and malaise (feeling unwell).
Danish: De almindeligste bivirkninger (som kan forekomme hos op til 1 ud af hver 10 personer) er nervebeskadigelse i hænder og fødder (perifer neuropati), diarré, kvalme, sure opstød (refluks), betændelse i spiserøret (esophagitis), gulsot af hud og øjne (ikterus), hudforandringer og utilpashed.
English: When primary bile acids are lacking, the body produces abnormal bile acids instead, which can damage the liver potentially leading to life-threatening liver failure.
Danish: Når primære galdesyrer mangler, producerer kroppen i stedet abnorme galdesyrer, som kan skade leveren og eventuelt medføre livstruende leversvigt.
English: Side effects with Kolbam are generally mild to moderate in severity and transitory.
Danish: Bivirkninger ved Kolbam er sædvanligvis lette til moderate og forbigående.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Kolbam can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Kolbam findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: In addition, the company that markets Kolbam will provide educational material with information on the correct and safe use of Kolbam to all doctors expected to prescribe this medicine.
Danish: Desuden skal den virksomhed, der markedsfører Kolbam, udlevere informationsmateriale om korrekt og sikker anvendelse af Kolbam til alle læger, der forventes at ordinere lægemidlet.
English: The main measures of effectiveness were changes in bile acid levels and liver function before and after treatment with Kolbam.
Danish: Det vigtigste mål for virkningen var ændringen i indholdet af galdesyrer og leverfunktionen før og efter behandling med Kolbam.
English: Kolbam can only be obtained with a prescription and treatment should be started and supervised by a doctor specialised in the diseases Kolbam is used to treat.
Danish: Kolbam fås kun på recept, og behandlingen bør iværksættes og overvåges af en læge med speciale i behandling af de sygdomme, som Kolbam anvendes til.
English: This helps to reduce the production of abnormal bile acids and contributes to the normal activity of bile in the digestive system, thereby relieving the symptoms of the condition.
Danish: Dette nedsætter produktionen af abnorme galdesyrer og fremmer galdens normale funktion i fordøjelsessystemet, hvorved sygdomssymptomerne mindskes.
English: Since Kolbam has been approved under exceptional circumstances, the company that markets Kolbam will monitor the benefits and safety of Kolbam from a patient registry and provide yearly updates.
Danish: Da Kolbam er godkendt under særlige betingelser, skal den virksomhed, der markedsfører Kolbam, overvåge fordelene og sikkerheden af Kolbam gennem et patientregister og indsende årlige ajourføringer.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Kolbam, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Kolbam, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: For more information about treatment with Kolbam, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Kolbam, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: This is a ‘primary bile acid', which is a main component of the bile (a fluid produced by the liver that helps to digest fats).
Danish: Dette er en "primær galdesyre", som er en hovedbestanddel i galden (den væske, der produceres af leveren og medvirker til fordøjelse af fedtstoffer).
English: The condition is known as ‘inborn errors in primary bile acid synthesis'.
Danish: Dette kaldes "medfødte fejl i syntesen af primære galdesyrer".
English: What information is still awaited for Kolbam?
Danish: Hvilke oplysninger afventes der stadig for Kolbam?
English: Cholic acid is one of the main primary bile acids produced by the liver.
Danish: Cholsyre er en af de vigtigste primære galdesyrer, der produceres af leveren.
English: The cholic acid contained in Kolbam replaces the patient's missing cholic acid.
Danish: Cholsyre i Kolbam erstatter patientens manglende cholsyre.
English: For the full list of all side effects and restrictions, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Kolbam fremgår af indlægssedlen.
English: Kolbam was investigated in one main study involving 52 patients with inborn errors in primary bile acid synthesis, including 7 patients who lack either sterol 27-hydroxylase, 2-methylacyl-CoA racemase or cholesterol 7α-hydroxylase.
Danish: Kolbam er undersøgt i én hovedundersøgelse med 52 patienter med medfødte fejl i syntesen af primære galdesyrer, herunder 7 patienter med mangel på enten sterol-27-hydroxylase, 2-methylacylCoA-racemase eller kolesterol-7-hydroxylase.
English: For practical information about using Kolbam, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Kolbam, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Kolbam is authorised for the life-long treatment of adults and children from one month of age who cannot produce enough primary bile acids such as cholic acid due to certain genetic abnormalities that result in a lack of the following liver enzymes: sterol 27-hydroxylase; 2-methylacyl-CoA racemase; or cholesterol 7α-hydroxylase.
Danish: Kolbam er godkendt til livslang behandling af voksne og børn fra 1-måneds-alderen, der ikke producerer tilstrækkeligt med primære galdesyrer såsom cholsyre på grund af visse genetiske abnormiteter, der medfører mangel på følgende leverenzymer: sterol-27-hydroxylase, 2-methylacylCoA-racemase eller kolesterol 7-hydroxylase.
English: The CHMP concluded that Kolbam has beneficial effects in patients with deficiencies in the following liver enzymes: sterol 27-hydroxylase; 2-methylacyl-CoA racemase; and cholesterol 7α-hydroxylase.
Danish: CHMP konkluderede, at Kolbam har gavnlig virkning hos patienter med mangel på følgende leverenzymer: sterol-27-hydroxylase, 2methylacyl-CoA-racemase og kolesterol-7-hydroxylase.
English: How is Kolbam used?
Danish: Hvordan anvendes Kolbam?
English: How does Kolbam work?
Danish: Hvordan virker Kolbam?
English: What benefits of Kolbam have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Kolbam?
English: Date of first authorisation: 17 December 2004 Date of latest renewal: 24 June 2009
Danish: Dato for første markedsføringstilladelse: 17. december 2004 Dato for seneste fornyelse: 24. juni 2009
English: Some patients who stop taking Xeristar suddenly have had symptoms such as:
Danish: Nogle patienter, som pludselig holdt op med at tage Xeristar, oplevede symptomer såsom:
English: Do not drive or use any tools or machines until you know how Xeristar affects you.
Danish: Du må ikke køre bil eller arbejde med værktøj eller maskiner, før du ved, hvordan Xeristar påvirker dig.
English: The corresponding figures for at least 50% pain reduction were 50% and 26% respectively.
Danish: De tilsvarende tal for mindst 50 % smertereduktion var henholdsvis 50 % og 26 %.
English: To help you remember to take Xeristar, you may find it easier to take it at the same times every day.
Danish: Det kan være lettere at huske at tage Xeristar, hvis du tager det på samme tidspunkt hver dag.
English: See section 4..
Danish: Se afsnit 4.
English: Food delays the time to reach the peak concentration from 6 to 10 hours and it marginally decreases the extent of absorption (approximately 11 %).
Danish: Fødeindtagelse udsætter tidspunktet for opnåelse af den maksimale koncentration fra 6 til 10 timer og mindsker omfanget af absorptionen marginalt (omtrent 11 %).
English: If your doctor thinks that you no longer need Xeristar he or she will ask you to reduce your dose over at least 2 weeks before stopping treatment altogether.
Danish: Hvis lægen mener, at du ikke længere behøver at tage Xeristar, vil lægen bede dig reducere dosis over mindst 2 uger, før du stopper behandlingen helt.
English: • Make sure your midwife and/or doctor knows you are on Xeristar.
Danish: • Du skal sikre dig, at din jordemoder og/eller læge ved, at du tager Xeristar.
English: Xeristar is for oral use.
Danish: Xeristar er til oral brug.
English: Other psychiatric conditions for which Xeristar is prescribed can also be associated with an increased risk of suicide-related events.
Danish: Andre psykiske tilstande, som Xeristar anvendes til, kan ligeledes være forbundet med en øget risiko for selvmordsrelaterede handlinger.
English: Xeristar is used in adults to treat:
Danish: Xeristar bruges hos voksne til behandling af:
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit risk profile or as the result of an important (pharmacovililance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Xeristar is indicated in adults.
Danish: Xeristar er indiceret til voksne.
English: Distribution: Duloxetine is approximately 96% bound to human plasma proteins.
Danish: Fordeling: Ca. 96 % af duloxetin er bundet til humane plasmaproteiner.
English: • diabetic neuropathic pain, depression, anxiety and urinary incontinence Using more than one of these medicines at the same time should be avoided.
Danish: • diabetisk neuropatisk smerte, depression, angst og stressinkontinens Brug af flere end et af disse lægemidler samtidig bør undgås.
English: Talk with your doctor about how long you should keep taking Xeristar.
Danish: Tal med din læge om, hvor længe du skal blive ved med at tage Xeristar.
English: The therapeutic benefit should be reassessed regularly (at least every three months) (see section 5.1).
Danish: Den terapeutiske effekt bør vurderes med jævne mellemrum (mindst hver tredje måned) (se pkt.5.1).
English: Care should be taken if you drink alcohol while you are being treated with Xeristar.
Danish: Du bør udvise forsigtighed, hvis du drikker alkohol, samtidig med, at du er i behandling med Xeristar.
English: Patients should be instructed that if they experience sedation or dizziness they should avoid potentially hazardous tasks such as driving or operating machinery.
Danish: Patienter bør informeres om, at hvis de oplever sedation eller svimmelhed, bør de undgå muligt farlige aktiviteter såsom bilkørsel og betjening af maskiner.
English: Check with your doctor if you are already taking other medicines containing duloxetine.
Danish: Spørg din læge, om du allerede tager andre lægemidler, der indeholder duloxetin.
English: Patients not demonstrating a pain reduction of 30% within 60 days of treatment were unlikely to reach this level during further treatment.
Danish: Det er usandsynligt, at patienter, som ikke opnåede en smertereduktion på 30 % indenfor 60 dage, skulle kunne opnå dette niveau af smertereduktion ved yderligere behandling.
English: • If you take Xeristar near the end of your pregnancy, your baby might have some symptoms when it is born.
Danish: • Hvis du tager Xeristar i slutningen af graviditeten, kan dit barn udvise visse symptomer når det bliver født.
English: The majority of cases have occurred either at birth or within a few days of birth.
Danish: De fleste tilfælde optrådte ved fødslen eller indenfor få dage efter fødslen.
English: Hallucinations Aggression and anger4
Danish: Hallucinationer Aggression og vrede4
English: Xeristar may be associated with sedation and dizziness.
Danish: Xeristar kan være forbundet med sedation og svimmelhed.
English: • excessive vaginal bleeding shortly after birth (postpartum haemorrhage)
Danish: • kraftig vaginal blødning kort efter fødslen (postpartum blødning)
English: No clinically significant differences were observed for QT, PR, QRS, or QTcB measurements between duloxetine-treated and placebo-treated patients.
Danish: Der blev ikke observeret nogen klinisk signifikante forskelle på QT, PR, QRS eller QTcB målinger mellem duloxetinbehandlede og placebo-behandlede patienter.
English: The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.
Danish: De samme forholdsregler som iagttages ved behandling af patienter med moderate til svære depressioner bør derfor tages ved behandling af patienter med andre psykiske sygdomme.
English: Taking a MAOI together with many prescription medicines, including Xeristar, can cause serious or even life-threatening side effects.
Danish: Hvis du tager en MAO-hæmmer sammen med en række forskellige receptpligtige lægemidler, heriblandt Xeristar, kan det medføre alvorlige og endda livstruende bivirkninger.
English: • coughing, wheezing and shortness of breath which may be accompanied by a high temperature
Danish: • hoste, hvæsende vejrtrækning og åndenød, som kan være ledsaget af en høj temperatur
English: Age: Pharmacokinetic differences have been identified between younger and elderly females (≥65 years) (AUC increases by about 25% and half-life is about 25% longer in the elderly), although the magnitude of these changes is not sufficient to justify adjustments to the dose.
Danish: Alder: Der er fundet farmakokinetiske forskelle mellem yngre og ældre kvinder (≥ 65 år) (AUCværdien forøges med ca. 25 %, og halveringstiden er ca. 25 % længere hos ældre) men omfanget af disse forandringer er ikke tilstrækkelige til at retfærdiggøre dosisjusteringer.
English: Xeristar should normally not be used for children and adolescents under 18 years.
Danish: Xeristar bør normalt ikke bruges til behandling af børn og unge under 18 år.
English: These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.
Danish: Disse tanker kan forstærkes især i starten af behandlingen med antidepresssiva, da det tager nogen tid før denne slags medicin virker, sædvanligvis omkring to uger, men af og til længere.
English: The antibiotic linezolid is a reversible non-selective MAOI and should not be given to patients treated with Xeristar (see section 4.4).
Danish: Det antibiotiske lægemiddel linezolid er en reversibel ikke-selektiv MAOI og bør ikke gives til patienter, der er i behandling med Xeristar (se afsnit 4.4).
English: Your doctor should decide whether you can take Xeristar with other medicines.
Danish: Din læge bør afgøre om Xeristar kan tages sammen med anden medicin.
English: Gender: Pharmacokinetic differences have been identified between males and females (apparent plasma clearance is approximately 50% lower in females).
Danish: Køn: Der er fundet farmakokinetiske forskelle mellem mænd og kvinder (den tilsyneladende plasmaclearance er omkring 50 % lavere hos kvinder).
English: The pharmacokinetics of duloxetine demonstrate large intersubject variability (generally 50-60%), partly due to gender, age, smoking status and CYP2D6 metaboliser status.
Danish: Duloxetins farmakokinetik viser stor variation mellem patienter (generelt 50-60 %), delvist på grund af køn, alder, ryger-/ikkerygerstatus og CYP2D6-metaboliseringsstatus.
English: Call your doctor or pharmacist immediately if you take more than the amount of Xeristar prescribed by your doctor.
Danish: Kontakt omgående lægen eller apoteket, hvis du har taget mere Xeristar, end lægen har ordineret.
English: Xeristar may cause a sensation of restlessness or an inability to sit or stand still.
Danish: Xeristar kan give en følelse af uro eller manglende evne til at sidde eller stå stille.
English: Based upon the overlap in the range of clearance, gender-based pharmacokinetic differences do not justify the recommendation for using a lower dose for female patients.
Danish: Det overlap, der er i de kønsbaserede farmakokinetiske forskelle i clearance-området, retfærdiggør ikke en anbefaling om lavere dosis til kvindelige patienter.
English: Xeristar should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
Danish: Xeristar bør kun bruges under graviditeten, hvis de potentielle behandlingsfordele opvejer de potentielle risici for fosteret.
English: Subsequently, over the four- to six-month extension period, patients on average trended toward recovery to their expected baseline weight percentile based on population data from age- and gender-matched peers.
Danish: I løbet af en efterfølgende 4-6 måneders forlængelsesperiode tenderede disse patienter i gennemsnit til at genvinde deres forventede baseline vægtpercentil baseret på populationsdata fra kønsmatchede jævnaldrende.
English: Duloxetine has a large volume of distribution and forced diuresis, haemoperfusion, and exchange perfusion are unlikely to be beneficial.
Danish: Duloxetin har stort fordelingsvolumen, og forceret diurese, hæmoperfusion og udskiftningstransfusion har sandsynligvis ingen gavnlig virkning.
English: • If you take Xeristar near the end of your pregnancy there is an increased risk of excessive vaginal bleeding shortly after birth, especially if you have a history of bleeding disorders.
Danish: • Hvis du tager Xeristar i slutningen af graviditeten, er der en øget risiko for kraftig vaginal blødning kort efter fødslen, især hvis du tidligere har haft blødningsforstyrrelser.
English: • Tell your doctor if you become pregnant, or you are trying to become pregnant, while you are taking Xeristar.
Danish: • Fortæl din læge, hvis du bliver gravid, eller hvis du prøver at blive gravid, mens du tager
English: Medicines like Xeristar (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4).
Danish: Lægemidler som Xeristar (såkaldte SSRI/SNRI'er) kan give symptomer på seksuel dysfunktion (se pkt.
English: Your doctor may continue to give you Xeristar when you are feeling better to prevent your depression or anxiety from returning.
Danish: Din læge kan vælge at fortsætte din behandling med Xeristar efter, at du har fået det bedre for at forebygge, at din depression eller angst skal vende tilbage.
English: Pregnancy There are no adequate data on the use of duloxetine in pregnant women.
Danish: Graviditet Data for anvendelse af duloxetin til gravide er utilstrækkelige.
English: Inducers of CYP1A2: Population pharmacokinetic analyses have shown that smokers have almost 50% lower plasma concentrations of duloxetine compared with non-smokers.
Danish: CYP1A2-induktorer: Befolkningsfarmakokinetiske analyser har vist, at rygere har næsten 50 % lavere plasmakoncentration af duloxetin sammenlignet med ikke-rygere.
English: You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Xeristar.
Danish: Du skal fortælle din læge, hvis et af ovenstående symptomer opstår eller forværres hos en patient under 18 år, som er i behandling med Xeristar.
English: The amount of duloxetine in breast milk is approximately 7 µg/day while on 40 mg twice daily dosing.
Danish: Mængden af duloxetin i human mælk er ca. 7 µg/dag under en dosering på 40 mg to gange dagligt.
English: The usual starting dose of Xeristar is 30 mg once a day after which most patients will receive 60 mg once a day, but your doctor will prescribe the dose that is right for you.
Danish: Den sædvanlige startdosis af Xeristar er 30 mg en gang dagligt, hvorefter de fleste patienter vil få 60 mg en gang dagligt, men din læge vil fastlægge den dosis, som passer til dig.
English: Xeristar starts to work in most people with depression or anxiety within two weeks of starting treatment, but it may take 2-4 weeks before you feel better.
Danish: Hos de fleste mennesker med depression eller angst begynder Xeristar at virke inden for de første to uger, men det kan vare 2-4 uger, før du får det bedre.
English: Compared with healthy subjects, the apparent plasma clearance of duloxetine was 79% lower, the apparent terminal half-life was 2.3 times longer, and the AUC was 3.7 times higher in patients with moderate liver disease.
Danish: Sammenlignet med raske patienter var den tilsyneladende plasma-clearance for duloxetin 79 % lavere, den tilsyneladende terminale halveringstid var 2,3 gange længere, og AUC var 3,7 gange højere hos patienter med moderat leversygdom.