natgillin/translations-raw huggingface dataset:
33 meter efter behandlingen.
Before treatment with 100 mg sitaxentan sodium the average walking distance was between 343 and 394 metres, and this increased by about 33 metres after treatment.
Undersøgelserne viste, at en dosis på 50 mg ikke havde en relevant gavnlig virkning og en dosis på 300 mg ikke var mere virksom end en dosis på 100 mg.
The studies demonstrated that the 50 mg dose did not have a relevant benefit and the 300 mg dose did not show better efficacy than the 100 mg dose.
Den hyppigste bivirkning (som ses hos flere end 1 ud af 10 patienter) er hovedpine.
The most common side effect (seen in more than 1 patient in 10) is headache.
Andre almindelige bivirkninger (som kunne observeres hos mellem 1 til 10 patienter ud af 100) er perifere ødemer (hævelser af arme og bene) og nasal kongestion (næsetilstopning).
Other common side effects (between 1 and 10 patients in 100) are peripheral oedema (swelling of arms and legs), and nasal congestion (blocked nose).
Den fuldstændige liste over bivirkningerne ved Thelin fremgår af indlægssedlen.
For the full list of all side effects reported with Thelin, see the Package Leaflet.
Thelin må ikke anvendes af personer, der kan være overfølsomme over for sitaxentan sodium eller nogen af de øvrige indholdsstoffer eller som har alvorlige leverproblemer eller forhøjede niveauer for visse leverenzymer.
Thelin should not be used in people who may be hypersensitive (allergic) to sitaxentan sodium or any of the other ingredients, who have a serious liver problem or raised levels of some liver enzymes.
Patientens leverfunktion skal overvåges før og under behandling.
The patient ’ s liver function should be monitored before and during the treatment.
Thelin må ikke indtages sammen med cyclosporin A (et lægemiddel anvendt til behandling af psoriasis og ledgigt og til forebyggelse mod afstødelse af lever og nyretransplantater) og der bør udvises stor forsigtighed, hvis det indtages samtidig sammen med warfarin (et blodfortyndende middel).
Thelin should not be taken with cyclosporin A (a medicine used to treat psoriasis and rheumatoid arthritis, and to prevent rejection of liver or kidney transplant) and care should be taken when it is taken at the same time as warfarin (a medicine used to thin blood).
Kvinder, der tager Thelin, skal passe på ikke at blive gravide og derfor anvende effektiv antikonceptionsmetode.
Women taking Thelin should take care not to become pregnant, they need to use an effective contraception.
Det er ukendt, om sitaxentan udskilles i humanmælk, eller om det kan skade et ammende barn.
It is unknown whether or not sitaxentan is excreted into human milk or if it could harm a nursing baby.
Amning skal undgås, hvis man tager Thelin.
Breastfeeding should be avoided while using Thelin.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Thelin havde vist sig at være virksomt, og at virkningen var som forventet for denne klasse af lægemidler.
The Committee for Medicinal Products for Human Use (CHMP) concluded that Thelin had shown its effectiveness, and that this effectiveness was as expected for this class of medicines.
Udvalget besluttede, at fordelene ved Thelin er større end risiciene ved behandling af voksne patienter med primær pulmonal hypertension med henblik på at forbedre den fysiske kapacitet og pulmonal arteriel hypertension i forbindelse med bindevævssygdom.
They decided that Thelin’ s benefits are greater than its risks for the treatment of adult patients with pulmonary primary arterial hypertension to improve exercise capacity and pulmonary hypertension caused by connective tissue disease.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Thelin.
They recommended that Thelin be given marketing authorisation.
Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Thelin?
Which measures are being taken to ensure the safe use of Thelin?
Firmaet, som fremstiller Thelin, skal fremlægge oplysningsmateriale til læger og patienter (patientinformationskort).
The company that makes Thelin will provide educational information to doctors and patients (patient information card).
Firmaet skal også iværksætte et system til overvågning af bivirkninger, formodede bivirkninger sammen med andre lægemidler og resultater af enhver graviditet hos kvinder, der anvender lægemidlet).
The company will also set up a system to monitor side effects, suspected interactions with other medicines and outcome of any pregnancy that may happen in women using the medicine.
Europa- Kommissionen udstedte en markedsføringstilladelse for Thelin med gyldighed i hele Den Europæiske Union til Encysive (UK) Ltd den 10. 08. 2006.
The European Commission granted a marketing authorisation valid throughout the European Union for Thelin to Encysive (UK) Ltd on 10 August 2006.
Sammendraget af udtalelsen fra udvalget for lægemidler til sjældne sygdomme om Thelin kan ses her.
The summary of opinion of the Committee for Orphan Medicinal Products for Thelin is available here.
Den europæiske offentlige vurderingsrapport (EPAR) for Thelin kan ses i sin helhed her.
The full EPAR for Thelin can be found here.
Pakkestr.
Package size
Oralt Oralt Oralt Oralt Oralt
Oral use Oral use Oral use Oral use Oral use
blister (PVC/ Aclar/ alu) blister (PVC/ Aclar/ alu) blister (PVC/ Aclar/ alu) blister (PVC/ Aclar/ alu) flaske (HDPE)
blister (PVC/ Aclar/ alu) blister (PVC/ Aclar/ alu) blister (PVC/ Aclar/ alu) blister (PVC/ Aclar/ alu) bottle (HDPE)
14 tabletter 28 tabletter 56 tabletter 84 tabletter 28 tabletter
14 tablets 28 tablets 56 tablets 84 tablets 28 tablets
1 BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET, SOM SKALIMPLEMENTERES AF MEDLEMSLANDENE
1 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE ADDRESSED TO THE MEMBER STATES
EU- medlemslandene skal sikre at:
The EU Member States shall ensure that:
• Produktinformation • Lægens information om Thelin • Informationskort til patienten • Informationskort til patientens partner
The MAH must agree the details of a controlled distribution system with the National Competent Authorities and must implement such programme nationally to ensure that, prior to prescribing, all doctors who intend to prescribe Thelin are provided with a physician information pack containing the following: • Product information • Physician information about Thelin • Patient information card • Partner of patient information card
• At Thelin er teratogent o Brug af sikker kontraception hos kvinder i den fertile alder. o Mulig interaktion med orale kontraceptiva samt øget risiko for tromboemboli. o Nødvendigheden af at informere kvindelige patienter om risikoen for teratogenicitet, kontraception og om nødvendigt nødvendigheden af graviditetstests, samt om hvad de skal gøre, hvis de bliver gravide. o Henvisning af patienter, der bliver gravide, til en læge, der er specialist i eller har erfaring med teratologi samt dens diagnose, for evaluering og råd.
The physician information about Thelin should contain the following key elements: • That Thelin is teratogenic o Use of effective contraception in women of child bearing age o Possible interaction with oral contraceptives and increased risk of thromboembolism o Need to advise female patients about teratogenicity, contraception, if necessary the need for pregnancy testing and what to do if they become pregnant o Referral of patients who become pregnant to a physician specialised or experienced in teratology and its diagnosis for evaluation and advice
• At Thelin er hepatotoksisk o Nødvendigheden af leverfunktionstests før og i løbet af behandlingen. o Kontraindikation hos patienter med allerede eksisterende nedsat leverfunktion (Child - Pugh klasse A- C). o Nødvenligheden af tæt overvågning, hvis leverenzymerne er > 3 x den øvre normalgrænse (ULN). • > 3 ≤ 5 x ULN:
• That Thelin is hepatotoxic o Need for liver function tests prior to and during treatment o Contraindication in patients with pre-existing hepatic impairment (Child-Pugh Class A- C). o Need for close monitoring if liver enzymes measure > 3 × upper limit normal (ULN): > 3 and ≤ 5 × ULN:
Bekræft med ny levertest inden for 2 uger.
Confirm by another liver test within 2 weeks.
Ved bekræftelse, fortsæt med at monitorere aminotransferaser mindst hver fjortende dag.
If confirmed, continue to monitor aminotransferases at least every 2 weeks.
Bekræft med ny levertest.
If the aminotransferase levels return to pre-treatment values, return to monthly liver testing. > 5 and ≤ 8 × ULN:
Ved bekræftelse skal behandlingen afbrydes, og aminotransferaseniveauer monitoreres mindst hver fjortende dag, indtil niveauerne normaliseres.
Confirm by another liver test; if confirmed, stop treatment and monitor aminotransferase levels at least every 2 weeks until levels have normalised.
Behandlingen skal afbrydes, og behandling med Thelin bør ikke genoptages.
If the aminotransferase levels return to pre-treatment values, reintroducing Thelin may be considered. > 8 x ULN: treatment must be stopped and reintroduction of Thelin is not to be considered.
2 • Thelins effekt på blødning o Interaktion med warfarin - og vitamin K- antagonister, der fører til en øget INR. o Behov for dosisreduktion af vitamin K- antagonister efter initiering af sitaxentanbehandling. o Start behandling med vitamin K- antagonister i reduceret dosis, hvis patienten er i behandling med sitaxentannatrium. o Behov for regelmæssig kontrol af INR. o Vær opmærksom på risikoen for hæmoragi og undersøg det, der er relevant o Forøget risiko for epistaxis og gingival blødning.
• Effect of Thelin on bleeding o Interaction with warfarin and vitamin K antagonists leading to an increased INR o Need to decrease established dose of vitamin K antagonist upon starting sitaxentan therapy o Start vitamin K antagonists treatment at a reduced dose if already on sitaxentan sodium o Need for regular monitoring of INR o Be aware of the potential for haemorrhage and investigate as appropriate o Increased risk of epistaxis and gingival bleeding
• At der er interaktion med ciclosporin, som kan medføre højere blodkoncentrationer af Thelin og således en øget risiko for bivirkninger.
2 • That there is an interaction with ciclosporin A which may lead to higher blood concentration of Thelin and hence an increased risk of adverse reactions.
• At sikkerhedsdatabasen for Thelin er begrænset, og at læger opfordres til at indskrive patienter i et overvågningsprogram med henblik på at øge kendskabet til forekomsten af væsentlige bivirkninger (ADR’ er).
• That the safety database of Thelin is limited and physicians are encouraged to enrol patients in a surveillance programme to increase knowledge about the incidence of important adverse drug reactions (ADRs).
Overvågningsprogrammet bør tilskynde læger til at indberette alvorlige bivirkninger og visse bestemte bivirkninger, som er nævnt nedenfor, øjeblikkeligt samt andre ikke- alvorlige bivirkninger med tre måneders intervaller.
The surveillance programme should prompt doctors to report serious ADRs and certain selected ADRs as below immediately and other non-serious ADRs at three monthly intervals.
Den indhentede information bør omfatte: o Anonymiserede patientoplysninger – alder, køn og ætiologi for PAH o Anden medicin o Årsager til ophør o Bivirkninger ○ Alle alvorlige bivirkninger ○ Stigning i leverenzymer til > 3 x ULN ○ Anæmi ○ Hæmoragi ○ Graviditet og udfald ○ Lungeødem (forbundet med veneokklusiv sygdom) ○ Formodede interaktioner ○ Uventede bivirkninger i henhold til produktresumé.
The information collected should include: o Anonymised patient details – age, sex and aetiology of PAH o Concomitant medications o Reason for discontinuation o ADRs o All serious ADRs o Increase in hepatic enzymes to > 3 × ULN o Anaemia o Haemorrhage o Pregnancy and outcome o Pulmonary oedema (associated with veno-occlusive disease) o Suspected interactions o Unexpected ADRs according to the SPC.
Informationskortet til patienten bør omfatte følgende information: • At Thelin er teratogent. • At kvinder i den fødedygtige alder skal bruge sikker prævention, og at de skal informere deres læge om mulig graviditet, før udskrivning af en ny recept. • Nødvendigheden af at kvindelige patienter kontakter deres behandlingslæge, straks efter at de får mistanke om, at de er gravide. • At Thelin er levertoksisk, og at de er nødt til at møde op til regelmæssig blodprøvetagning. • Nødvendigheden af at fortælle deres læge om alle uønskede hændelser. • Nødvendigheden af at fortælle deres læge, at de tager Thelin.
The Patient information card should include the following information • That Thelin is teratogenic • The need to ensure that women of child bearing age are using effective contraception and that patients should inform their doctors of any possibility of pregnancy before a new prescription is issued • The need for female patients to contact their treating doctor immediately if they suspect that they might be pregnant. • That Thelin is hepatotoxic and they will need to attend for regular blood tests • The need to tell their doctor about any adverse events • The need to tell their doctor that they are taking Thelin
Indeholder også 166, 3 mg lactosemonohydrat.
Also contains 166.3mg of lactose monohydrate.
Gule til orange, kapselformede filmovertrukne tabletter, præget med T- 100 på den ene side.
Film-coated tablet Capsule shaped yellow-to-orange film-coated tablets, debossed with T-100 on one side.
Behandling af patienter med pulmonal arteriel hypertension (PAH) klassificeret som WHO - funktionsklasse III for at forbedre fysisk funktionsevne.
Treatment of patients with pulmonary arterial hypertension (PAH) classified as WHO functional class III, to improve exercise capacity.
12 ugers yderligere behandling kan derfor overvejes.
However, a number of patients who showed no response by week 12 of treatment with Thelin responded favourably by week 24, so an additional 12 weeks of treatment may be considered.
4. 4).
Higher doses did not confer additional benefit sufficient to offset the increased risk of adverse reactions, particularly liver injury (see section 4.4).
Der er begrænset erfaring med pludselig afbrydelse af behandling med sitaxentannatrium.
Discontinuation of treatment There is limited experience with abrupt discontinuation of sitaxentan sodium.
4. 3).
Thelin is contraindicated in patients with elevated liver aminotransferases prior to initiation of treatment (> 3 x Upper Limit of Normal (ULN)) (see section 4.3).
2 Børn og unge (< 18 år):
2 Use in children and adolescents (< 18 years).
Effekten og sikkerheden af samtidig indgivelse af Thelin med andre behandlinger for PAH (f. eks. epoprostenol, sildenafil, iloprost) er ikke blevet undersøgt i kontrollerede kliniske forsøg.
The efficacy and safety of Thelin co-administration with other treatments for PAH (eg, epoprostenol, sildenafil, iloprost) has not been studied in controlled clinical trials.
Mildt til alvorligt nedsat leverfunktion (Child- Pugh klasse A- C).
Mild to severe hepatic impairment (Child-Pugh Class A-C).
Forhøjede aminotransferaser inden påbegyndelse af behandling (aspartat- aminotransferase (ASAT) og/ eller alanin- aminotransferase (ALAT) > 3 x ULN).
Elevated aminotransferases prior to initiation of treatment (aspartate aminotransferase (AST) and/ or alanine aminotransferase (ALT) > 3 x ULN).
4. 5).
Concomitant administration with ciclosporin A (see section 4.5).
4. 6)
Lactation (see section 4.6).
Thelins effekt som monoterapi er ikke blevet fastslået hos patienter med NYHA/ WHO - funktionsklasse IV PAH.
The efficacy of Thelin as monotherapy has not been established in patients with NYHA/ WHO functional class IV PAH.
4. 2).
Transfer to a therapy that is recommended at the severe stage of the disease (eg, epoprostenol) should be considered if the clinical condition deteriorates (see section 4.2).
Endothelinreceptor- antagonister er, som klasse, blevet forbundet med leverfunktionsabnormiteter.
Endothelin receptor antagonists, as a class, have been associated with liver function abnormalities.
Forhøjelserne udvikles som regel langsomt og er typisk asymptomatiske.
Elevations of AST and/ or ALT associated with Thelin occur both early and late in treatment, usually progress slowly, and are typically asymptomatic.
Ved fortsat sitaxentannatrium- behandling er forhøjelse af lever - aminotransferaser spontant reversible.
Liver aminotransferase elevations may reverse spontaneously while continuing treatment with sitaxentan sodium.
Da behandlingsrelaterede forhøjelse af ASAT og/ eller ALAT er en markør for potentielt alvorlige leverskader, skal lever- aminotransferaseniveauer måles, inden behandlingen påbegyndes og derefter månedligt.
Because treatment-associated elevations of AST and/ or ALT are a marker for potential serious liver injury, liver aminotransferase levels must be measured prior to initiation of treatment and subsequently at monthly intervals.
4. 3).
If AST and/ or ALT are > 3 x ULN prior to initiation of therapy, use of Thelin is contraindicated (see section 4.3).
Mekanismen ved levertoksicitet er ikke fuldt ud dokumenteret og kan variere mellem endothelin- antagonisterne.
The mechanism of liver toxicity is not fully documented and it might vary between endothelin antagonists.
4. 8).
Appropriate care should be exercised when initiating Sitaxentan in patients who discontinued other endothelin receptor antagonists due to liver enzyme abnormalities (see section 4.8).
Anbefalinger i tilfælde af ALAT/ ASAT forhøjelse, som opstår under behandling:
Recommendations in case of treatment-emergent ALT/ AST elevations:
Hvis ALAT - / ASAT- målinger stiger til følgende niveauer, bør der foretages ændringer af monitorering eller behandling:
If ALT/ AST measurements rise to the following levels then changes to the monitoring or treatment are given
> 3 og ≤ 5 × ULN:
3 > 3 and ≤  5 x ULN:
Bekræft med en ny levertest inden for 2 uger.
Confirm by another liver test within 2 weeks.
Ved bekræftelse, skal monitorering af aminotransferaser fortsættes mindst hver fjortende dag.
If confirmed, continue to monitor aminotransferases at least every 2 weeks.
Hvis aminotransferaseniveauerne returnerer til værdierne inden indledning af behandlingen, kan månedlige levertests genoptages.
If the aminotransferase levels return to pre-treatment values, return to monthly liver testing.
3 > 5 og ≤ 8 × ULN:
> 5 and ≤ 8 x ULN:
> 8 x ULN:
> 8 x ULN: treatment must be stopped and reintroduction of Thelin is not to be considered.
Hvis forhøjelse af transferase i leveren er ledsaget af kliniske symptomer på leverskader (såsom kvalme, opkastning, anoreksi, feber, mavesmerter, gulsot, eller usædvanlig apati eller træthed) eller af forhøjelse af total- bilirubin > 2 x ULN, skal behandlingen afbrydes, og behandling med Thelin bør ikke genoptages.
If liver transferase elevations are accompanied by clinical symptoms of liver injury (such as nausea, vomiting, anorexia, fever, abdominal pain, jaundice, or unusual lethargy or fatigue) or increases in total bilirubin > 2x ULN, treatment should be stopped and re-introduction of Thelin is not to be considered.
Kontrollen foregår derefter i henhold til ovenstående anbefalinger.
Aminotransferase levels must then be checked within 3 days after re-introduction, then again after a further 2 weeks, and thereafter according to the recommendations above.
Der er ikke blevet udført forsøg med patienter med præeksisterende nedsat leverfunktion.
Pre-existing liver impairment Studies in patients with pre-existing liver impairment have not been conducted.
4. 3).
Thelin is contraindicated in patients with elevated liver aminotransferases prior to initiation of treatment (> 3 x ULN, see section 4.3).
Der er forøget risiko for blødning med Thelin, fortrinsvis i form af epistaxis og gingival blødning.
Bleeding There is an increased risk of bleeding with Thelin, mainly in the form of epistaxis and gingival bleeding.
4. 5).
Vitamin K antagonists Thelin increases the plasma levels of Vitamin K antagonists such as warfarin, acenocoumarol and fenprocoumon (see section 4.5).
Graden af interaktion med potente OATP- hæmmere (f. eks. visser statiner, proteinasehæmmere, tuberkulostatika) er ukendt.
Drugs which inhibit Organic Anion Transporting Polypeptides (OATP) The extent of interaction with potent OATP inhibitors (e. g. some statins, proteinase inhibitors, tuberculostatics) is unknown.
4. 5).
As this could result in raised plasma levels of sitaxentan sodium, patients in need of the combination should be closely monitored for adverse events related to sitaxentan sodium (see section 4.5).
Thelin øger eksponering for østrogen, når det gives samtidigt med orale kontraceptiva (se pkt.
Oral contraceptive agents Thelin increases oestrogen exposure when given concomitantly with oral contraceptive agents (see Section 4.5).
Det gælder særligt for kvinder, som ryger.
Therefore, especially in women who smoke, there is an increased risk for thromboembolism.
Med den teoretisk højere risiko for tromboembolisme taget i betragtning, bør traditionel samtidig brug af vitamin K- antagonister overvejes.
Given a theoretical higher risk for thromboembolism, traditional concomitant use of vitamin K antagonists should be considered.
På grund af mulig teratogenicitet må Thelinbehandling ikke påbegyndes hos kvinder i den fertile alder, med mindre de anvender sikker kontraception under behandlingen.
Pregnancy Due to possible teratogenicity, Thelin must not be initiated in women of child-bearing potential unless they practise reliable contraception.
4. 6).
If necessary, pregnancy testing should be undertaken (see Section 4.6).
Der foreligger ingen data om brugen af Thelin hos patienter med pulmonal hypertension i forbindelse med pulmonal veneokklusiv sygdom.
4 Pulmonary veno-occlusive disease (PVOD) No data are available with Thelin in patients with pulmonary hypertension associated with pulmonary veno-occlusive disease.
Hvis
However, cases of life threatening pulmonary oedema have been reported with vasodilators (mainly prostacyclin) when used in those patients.
4 der forekommer tegn på lungeødem under Thelinbehandling hos patienter med pulmonal hypertension, bør muligheden for associeret veneokklusiv sygdom overvejes.
Consequently, should signs of pulmonary oedema occur when Thelin is administered in patients with pulmonary hypertension, the possibility of associated veno-occlusive disease should be considered.
4. 8).
Haemoglobin concentration Treatment with Thelin was associated with a dose-related decrease in haemoglobin (see section 4.8).
Thelintabletter indeholder lactosemonohydrat.
Excipients Thelin tablets contain lactose monohydrate.
Thelin bør derfor ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/ galactosemalabsorption.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Sitaxentannatrium metaboliseres i leveren af cytochrom P450 -, CYP2C9 - og CYP3A4/ 5- isoenzymer.
Sitaxentan sodium is metabolised in the liver by cytochrome P450 CYP2C9 and CYP3A4/ 5 isoenzymes.
Sitaxentannatrium er en hæmmer af CYP2C9 og i mindre grad af CYP2C19, CYP3A4/ 5 og CYP 2C8.
Sitaxentan sodium is an inhibitor of CYP2C9 and, to a lesser extent, CYP2C19, CYP3A4/ 5 and CYP2C8.
Sitaxentannatrium påvirker ikke p- glycoprotein- transportstoffet, men det er et substrat af OATP- transportproteiner.
Co-administration with drugs metabolized by CYP2C19 or CYP3A4/ 5 is not expected to result in clinically significant drug interactions.
Organisk anion- transport- polypeptid (OATP) - hæmmere:
Organic Anion Transporting Polypeptides (OATP) Inhibitors:
Brug af Thelin hos patienter, som får systemisk ciclosporin, er derfor kontraindiceret.
Co-administration with ciclosporin A, a potent OATP inhibitor, resulted in a 6-fold increase in Cmin and a 67% increase in AUC of sitaxentan therefore the use of Thelin in patients receiving systemic ciclosporin A is contraindicated (see section 4.3).