FrancophonIA/ELRC3.0 huggingface dataset:
English: However, there was a wide variability in final outcome, i.e. in some patients the neuropathy resolved and some patients had persistent symptoms.
Danish: Hos nogle patienter forsvandt neuropatien, mens andre patienter havde vedvarende symptomer.
English: Mild thrombocytopen ia (platelets <100G/l)
Danish: Let trombocytopeni (trombocyttal <100x109/l)
English: A mean decrease less than 15% from baseline affecting white blood cell count has been observed (see section 4.8).
Danish: Et gennemsnitligt fald i antallet af hvide blodlegemer på mindre end 15 % i forhold til baseline er blevet observeret (se pkt.
English: A total of 1088 patients with RMS were randomised in TEMSO to receive 7 mg (n=366) or 14 mg (n=359) of teriflunomide or placebo (n= 363) for 108 weeks duration.
Danish: I TEMSO blev i alt 1.088 patienter med RMS randomiseret til 7 mg (n=366) eller 14 mg (n=359) teriflunomid eller placebo (n= 363) i 108 uger.
English: Teriflunomide is contraindicated in pregnancy (see section 4.3).
Danish: Teriflunomid er kontraindiceret under graviditet (se pkt.
English: Mild and moderate hepatic impairment had no impact on the pharmacokinetic of teriflunomide.
Danish: Let og moderat nedsat leverfunktion havde ingen indvirkning på teriflunomids farmakokinetik.
English: Pharmacokinetic interactions of other substances on teriflunomide
Danish: Teriflunomids farmakokinetiske interaktioner med andre stoffer - virkning på teriflunomid
English: Dyslipidaem ia
Danish: Ugedage Man Tir
English: Based on individual prediction of pharmacokinetic parameters using the PopPK model of teriflunomide in healthy volunteers and MS patients, median t1/2z was approximately 19 days after repeated doses of 14 mg. After a single intravenous administration, the total body clearance of teriflunomide is 30.5 ml/h.
Danish: Baseret på en individuel forudsigelse af de farmakokinetiske parametre ved hjælp af PopPK-modellen for teriflunomid hos raske frivillige og MS-patienter var den gennemsnitlige halveringstid (t1/2z) cirka 19 dage efter gentagne doser på 14 mg.
English: Elevation of blood pressure may occur during treatment with teriflunomide (see section 4.8).
Danish: Forhøjet blodtryk kan forekomme under behandling med AUBAGIO (se pkt.
English: Before starting treatment with teriflunomide the following should be assessed:
Danish: Før behandlingen med teriflunomid startes, skal følgende vurderes (se pkt.
English: Teriflunomide therapy should be discontinued if liver injury is suspected; consider discontinuing teriflunomide therapy if elevated liver enzymes (greater than 3-fold ULN) are confirmed.
Danish: Teriflunomid skal seponeres, hvis der er mistanke om leverskader, og seponering bør overvejes, hvis leverenzymstigning (> 3 gange den øvre normalgrænse (ULN)) bekræftes.
English: In placebo-controlled studies, no increase in serious infections was observed with teriflunomide (see section 4.8).
Danish: I placebokontrollerede studier observeredes alvorlige infektioner ikke hyppigere i teriflunomid-gruppen (se pkt.
English: Patients with severe active infection until resolution (see section 4.4).
Danish: Patienter med svær, aktiv infektion (se pkt.
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING WALLET
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN MELLEMLIGGENDE EMBALLAGE HYLSTER
English: A consistent treatment effect on relapses and time to 3-month sustained disability progression in a subgroup of patients in TEMSO (n 127) with high disease activity was observed.
Danish: I en undergruppe af patienter med høj sygdomsaktivitet i TEMSO (n=127) blev der observere konsistent behandlingseffekt på attakker og tid til 3 måneders vedvarende progression.
English: Women of childbearing potential must not take this medicine without using reliable contraceptive measures.
Danish: Kvinder i den fødedygtige alder må kun tagedette lægemiddel, hvis de bruger en effektiv præventionsmetode.
English: Gammaglutamyltransfer ase (GGT) increaseb, Aspartate aminotransferas
Danish: Forhøjet gammaglutamyltransferase (GGT)b, Forhøjet aspartataminotransferaseb
English: Severe skin reactions Cases of severe skin reactions have been reported with teriflunomide post-marketing (see section 4.4).
Danish: Alvorlige hudreaktioner Efter markedsføringen er der rapporteret tilfælde om alvorlige hudreaktioner med teriflunomid (se pkt.
English: The risk of male-mediated embryo-foetal toxicity through teriflunomide treatment is considered low (see section 5.3).
Danish: Risikoen for embryoføtal toksicitet på grund af mandlig partner i behandling med teriflunomid betragtes som lav (se pkt.
English: Therefore, when warfarin is co-administered with teriflunomide, close INR follow-up and monitoring is recommended.
Danish: Derfor anbefales tæt opfølgning og monitorering af INR, når warfarin administreres samtidigt med teriflunomid.
English: - cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections - indometacin, ketoprofen for pain or inflammation - furosemide for heart disease - cimetidine for reducing gastric acid - zidovudine for HIV infection - rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol) - sulfasalazine for inflammatory bowel disease or rheumatoid arthritis - cholestyramine for high cholesterol or relief from itching in liver disease - activated charcoal to reduce absorption of medicines or other substances
Danish: tyndere) for at undgå blodpropper - p-piller (indeholdende ethinylestradiol og levonorgestrel) - cefaclor, benzylpenicillin eller ciprofloxacin mod infektioner - indomethacin eller ketoprofen mod smerter eller gigt - furosemid mod hjertelidelser - cimetidin for at nedsætte produktionen af mavesyre - zidovudin mod hiv - rosuvastin, simvastatin, atorvastatin, pravastatin mod forhøjet kolesterol (hyperkolesterolæmi) - sulfasalazin mod inflammatorisk tarmsygdom eller leddegigt (reumatoid artrit) - colestyramin mod forhøjet kolesterol eller mod kløe ved leversygdom - aktivt kul for at reducere optagelsen af medicin eller andre stoffer
English: Severe renal impairment had no impact on the pharmacokinetic of teriflunomide.
Danish: Alvorligt nedsat nyrefunktion havde ingen indvirkning på teriflunomids farmakokinetik.
English: In particular, tell your doctor or pharmacist if you are taking any of the following: - leflunomide, methotrexate and other medicines that affect the immune system (often called immunosuppressants or immunomodulators) - rifampicin (a medicine used to treat tuberculosis and other infections) - carbamazepine, phenobarbital, phenytoin for epilepsy - St John's wort (a herbal medicine for depression) - repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes - daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer - duloxetine for depression, urinary incontinenece or in kidney disease in diabetics - alosetron for the management of severe diarrhea - theophylline for asthma - tizanidine, a muscle relaxant - warfarin, an anticoagulant used to make the blood thinner (i.e. more fluid) in order to avoid blood clots - oral contraceptives (containing ethinylestradiol and levonorgestrel)
Danish: Du skal især fortælle det til lægen eller på apoteket, hvis du tager nogle af følgende: - leflunomid, methotrexat eller andre lægemidler, der påvirker immunsystemet (ofte kaldet immununsuppressiva eller immunmodulatorer) - rifampicin mod tuberkulose og andre infektioner - carbamazepin, phenobarbital, phenytoin mod epilepsi - perikon - et naturlægemiddel mod depression - repaglinid, pioglitazon, nateglinid eller rosiglitazon mod sukkersyge - daunorubicin, doxorubicin, paclitaxel eller topotecan mod kræft - duloxetin mod depression, ufrivillig vandladning (urininkontinens) eller nyresygdom ved sukkersyge
English: Repeated doses of teriflunomide decreased mean Cmax and AUC of caffeine (CYP1A2 substrate) by 18% and 55%, respectively, suggesting that teriflunomide may be a weak inducer of CYP1A2 in vivo.
Danish: Virkningen af teriflunomid på CYP1A2-substrat: caffein Gentagne doser teriflunomid gav et fald i middel-caffein-Cmax og -AUC på henholdsvis 18 % og 55 %, hvilket tyder på, at teriflunomid kan være en svag CYP1A2-induktor in vivo.
English: Breast-feeding women (see section 4.6).
Danish: Ammende kvinder (se pkt.
English: Effect of teriflunomide on CYP2C8 substrate: repaglinide There was an increase in mean repaglinide Cmax and AUC (1.7- and 2.4-fold, respectively), following repeated doses of teriflunomide, suggesting that teriflunomide is an inhibitor of CYP2C8 in vivo.
Danish: Virkningen af teriflunomid på CYP2C8-substrat: repaglinid Der var en stigning i middel-repaglinid-Cmax og -AUC (henholdsvis 1,7 og 2,4 gange) efter gentagne doser teriflunomid, hvilket tyder på, at teriflunomid hæmmer CYP2C8 in vivo.
English: Effect of teriflunomide on organic anion transporter 3 (OAT3) substrates There was an increase in mean cefaclor Cmax and AUC (1.43- and 1.54-fold, respectively), following repeated doses of teriflunomide, suggesting that teriflunomide is an inhibitor of OAT3 in vivo.
Danish: Virkningen af teriflunomid på organisk aniontransporter 3- (OAT3-) substrater Der var en stigning i middel-cefaclor-Cmax og -AUC (henholdsvis 1,43 og 1,54 gange) efter gentagne doser teriflunomid, hvilket tyder på, at teriflunomid hæmmer OAT3 in vivo.
English: - if you are allergic to teriflunomide or any of the other ingredients of this medicine (listed in section 6), - if you have severe liver problems, - if you are pregnant, think you may be pregnant, or are breast-feeding, - if you suffer from a serious problem which affects your immune system e.g. acquired immunodeficiency syndrome (AIDS), - if you have a serious problem with your bone marrow, or if you have low numbers of red or white cells in your blood or a reduced number of blood platelets, - if you are suffering from a serious infection, - if you have severe kidney problems which require dialysis, - if you have very low levels of proteins in your blood (hypoproteinaemia), If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Danish: (AIDS) - hvis du har alvorlige problemer med rygmarven, eller hvis du har et lavt antal røde eller hvide blodlegemer eller et nedsat antal blodplader - hvis du lider af en alvorlig infektion - hvis du har en alvorlig nyresygdom, som kræver dialyse - hvis du har en meget lav koncentration af proteiner i blodet (hypoproteinæmi) Spørg lægen eller apotekspersonalet, før du tager dette lægmiddel, hvis der er noget, du er i tvivl om.
English: Uncommon (may affect up to 1 in 100 people) - Decrease in the number of blood platelets (mild thrombocytopenia) - Increased feeling or sensitivity, especially in the skin; stabbing or throbbing pain along one or more nerves, problems in the nerves of the arms or legs (peripheral neuropathy) - Nail disorders - Post-traumatic pain
Danish: Ikke almindelige (kan forekomme hos op til 1 ud af 100 personer) - Nedsat antal blodplader (mild trombocytopeni) - Øget følsomhed særligt i huden, jagende eller dunkende smerter langs en eller flere nerver,
English: The recommended dose is one film-coated tablet (14 mg) daily.
Danish: Den sædvanlige dosis er 1 tablet på 14 mg dagligt.
English: Over 21 days, 60.1% of the administered dose is excreted via feces (37.5%) and urine (22.6%).
Danish: (37,5 %) og urin (22,6 %).
English: AUBAGIO 14 mg tablets teriflunomide
Danish: AUBAGIO 14 mg tabletter teriflunomid
English: Blood pressure elevation should be appropriately managed before and during treatment with teriflunomide.
Danish: Forhøjet blodtryk skal behandles passende før og under behandlingen med AUBAGIO.
English: Haematological effects
Danish: Hæmatologiske virkninger
English: Change relative to placebo (CI95%) Number of unique active lesions /scan Change relative to placebo (CI95%)  p<0.0001  p<0.001  p<0.01  p<0.05 compared to placebo (1) BOD: burden of disease: total lesion volume (T2 and T1 hypointense) in ml
Danish: p<0.05 sammenlignet med placebo (1) BOD: Sygdomsbyrde (Burden of Disease): samlet læsionsvolumen (T2 and T1 hypointense) i ml
English: • For women of child-bearing potential o to emphasise the need for effective contraception during treatment with teriflunomide o to stop treatment with teriflunomide immediately if they suspect they might be pregnant and also to contact their doctor immediately
Danish: o at stoppe behandlingen med teriflunomid straks, hvis de har mistanke om at være gravid, og kontakte deres læge med det samme.
English: For further information on the laboratory testing please contact your doctor.
Danish: Spørg lægen, hvis du vil have yderligere oplysninger om laboratorieprøverne.
English: The patient must be advised that if there is any delay in onset of menses or any other reason to suspect pregnancy, they must notify the physician immediately for pregnancy testing, and if positive, the physician and patient must discuss the risk to the pregnancy.
Danish: Patienten skal informeres om omgående at kontakte lægen, hvis menstruationen er forsinket, eller der er andre tegn på graviditet, så en graviditetstest kan udføres.
English: Musculoskeletal pain,
Danish: Karpaltunnelsyndrom,
English: Teriflunomide is contraindicated in patients with severe hepatic impairment (see section 4.3).
Danish: Teriflunomid er kontraindiceret til patienter med alvorligt nedsat leverfunktion (se pkt.
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING PROTECTIVE SLEEVE CONTAINING WALLET
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN MELLEMLIGGENDE EMBALLAGE HYLSTER MED BLISTERKORT
English: Gastrointestinal disorders
Danish: Viral gastroenteritis,
English: AUBAGIO is for oral use.
Danish: AUBAGIO er beregnet til at blive taget gennem munden (oral anvendelse).
English: Your doctor may do blood tests to check your white blood cells if you think you have an infection.
Danish: Hvis du tror, du har en infektion, vil lægen muligvis tage blodprøver for at kontrollere de hvide blodlegemer.
English: Hypoproteinaemia
Danish: Hypoproteinæmi
English: cysts and polyps) There does not appear to be an increased risk of malignancy with teriflunomide in the clinical trial experience.
Danish: Benigne, maligne og uspecificerede neoplasmer (herunder cyster og polypper) På baggrund af erfaringen fra de kliniske forsøg synes der ikke at være en øget risiko for malignitet med teriflunomid.
English: Myalgia, Arthralgia
Danish: Muskel- og knoglesmerter, Myalgi, Arthralgi
English: Tell your doctor immediately, if you notice any of the following serious side effects: - allergic reactions which might include symptoms of rash, hives, swelling of lips, tongue or face or sudden difficulty breathing.
Danish: - Allergiske reaktioner der kan have symptomer som udslæt, nældefeber, hævede læber, tunge eller ansigt eller pludseligt åndedrætsbesvær.
English: Hazard ratio (CI95%) 6-month Sustained Disability Progression week
Danish: Relativ risiko (95 % KI) 6-måneders vedvarende progression uge 108
English: Pain, Astheniaa
Danish: Smerter, Astenia
English: Alanine aminotransfer ase (ALT) increaseb
Danish: Lever og galdeveje Forhøjet alaninaminotransferase (ALT)b
English: No dosage adjustment is necessary for patients with mild and moderate hepatic impairment.
Danish: Dosisjustering er ikke nødvendig til patienter med let og moderat nedsat leverfunktion.
English: AUBAGIO 14 mg film-coated tablets teriflunomide
Danish: AUBAGIO 14 mg filmovertrukne tabletter teriflunomid
English: Polska sanofi-aventis Sp. z o.o.
Danish: Sanofi-aventis Sp. z o.o.
English: Method of administration
Danish: Anvendelsesmåde
English: AUBAGIO 14 mg film-coated tablets
Danish: AUBAGIO 14 mg filmovertrukne tabletter
English: The majority of patients had relapsing-remitting multiple sclerosis (91.5%), but a subgroup of patients had secondary progressive (4.7%) or progressive relapsing multiple sclerosis (3.9%).
Danish: Størstedelen af patienterne havde recidiverenderemitterende multipel sklerose (91,5 %), men en undergruppe havde sekundær progressiv (4,7%) eller progressiv recidiverende multipel sklerose (3,9 %).Det gennemsnitslige antal attakker i året inden studiestart var 1,4, og 36,2 % af patienterne havde gadolinium-forstærkede læsioner ved baseline.
English: Hazard ratio (CI95%) 3-month Sustained Disability Progression week
Danish: Relativ risiko (95 % KI) 3-måneders vedvarende progression uge 108
English: Tell your doctor if you plan to become pregnant after stopping treatment with AUBAGIO, as you need to ensure that most of this medicine has left your body before trying to become pregnant.
Danish: Fortæl det til din læge, hvis du planlægger at blive gravid efter behandlingen med AUBAGIO.
English: Median time to reach maximum plasma concentrations occurs between 1 to 4 hours post-dose following repeated oral administration of teriflunomide, with high bioavailability (approximately 100%).
Danish: Efter gentagen oral administration af teriflunomid var mediantiden til at nå maksimal plasmakoncentration mellem 1 til 4 timer efter dosering.
English: France sanofi-aventis France Tél: 0 800 222 555
Danish: Tél : 0 800 222 555
English: Tablet coating hypromellose titanium dioxide (E171) talc macrogol 8000 indigo carmine aluminum lake (E132)
Danish: Indigocarmin-aluminiumpigment (E132)
English: - severe skin reactions which might include symptoms of skin rash, blistering, or ulcers in your mouth - severe infections or sepsis (a potentially life-threatening type of infection) which might include symptoms of high fever, shaking, chills, reduced urine flow, or confusion - serious liver disease which might include symptoms of yellowing of your skin or the whites of your eyes, darker urine than normal, unexplained nausea and vomiting, or abdominal pain - inflammation of the lungs which might include symptoms of shortness of breath or persistent cough - inflammation of the pancreas which might include symptoms of severe pain in the upper abdominal area that may also be felt in your back, nausea, or vomiting
Danish: der er mørkere end normalt, uforklarlig kvalme eller opkastning eller mavesmerter - Lungebetændelse der kan have symptomer som åndenød eller vedvarende hoste - Betændelse i bugspytkirtlen der kan have symptomer som svære smerter i den øvre maveregion, som også kan mærkes på ryggen, kvalme eller opkastning
English: ALT >3 ULN and TBILI >2 ULN
Danish: ALAT >3 ULN og total-bilirubin >2 ULN 5/994 (0,5 %)
English: Tue
Danish: Lør
English: How to take AUBAGIO
Danish: Sådan skal du tage AUBAGIO
English: Therefore no dose adjustment is anticipated in mild, moderate and severe renal-impaired patients.
Danish: Derfor forventes dosisjustering ikke at være nødvendig hos patienter med let, moderat eller alvorligt nedsat nyrefunktion.
English: Breast-feeding
Danish: Teriflunomid
English: Common (may affect up to 1 in 10 people) - Influenza, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat and discomfort when swallowing, cystitis, gastroenteritis viral, oral herpes, tooth infection, laryngitis, fungal infection of the foot - Laboratory values: a decrease in the number of red blood cells (anaemia), changes in liver and white blood cell test results (see section 2), as well as elevations in a muscle enzyme (creatine phosphokinase) have been observed.
Danish: Almindelige (kan forekomme hos op til 1 ud af 10 personer) - Influenza, infektion i de øvre luftveje, urinvejsinfektion, bronkitis, bihulebetændelse, ondt i halsen og ubehag, når der skal synkes, blærebetændelse, mave-tarminfektion forårsaget af virus, forkølelsessår, tandinfektion, strubekatar, fodsvamp
English: Teriflunomide is contraindicated during breast-feeding (see section 4.3).
Danish: Teriflunomid er kontraindiceret under amning (se pkt.
English: Teriflunomide is contraindicated in this population (see section 4.3).
Danish: Derfor frarådes brugen af teriflunomid i denne population (se pkt.
English: - you have high blood pressure (hypertension) whether it is controlled with medicines or not.
Danish: - Hvis du har forhøjet blodtryk (hypertension), uanset om dette behandles med medicin eller ej. Aubagio kan forårsage en stigning i blodtrykket.
English: - Feeling your heartbeat - Increase in blood pressure - Being sick (vomiting), toothache, upper abdominal pain - Rash, acne - Pain of the tendons, joints, bones, muscle pain (musculoskeletal pain), - Needing to urinate more often than usual - Heavy periods - Pain - Lack of energy or feeling weak (asthenia) - Weight loss
Danish: - Lette allergiske reaktioner - Angstfølelse - Prikkende, snurrende fornemmelse i huden, følelse af svaghed, følelsesløshed, snurrende fornemmelse eller smerter over lænden (iskias), følelsesløse, brændende, prikkende eller smertende hænder og fingre (karpaltunnelsyndrom) - Følelse af hjertebanken - Forhøjet blodtryk - Opkastning, tandpine, smerter i den øverste del af maven - Udslæt, akne - Smerter i sener, led, knogler eller muskler - Hyppigere vandladning - Kraftig menstruation - Smerter - Manglende energi eller følelse af kraftesløshed (asteni) - Vægttab
English: In placebo-controlled studies the following was established: - systolic blood pressure was >140 mm Hg in 19.9% of patients receiving 14 mg/day teriflunomide as compared to 15.5% receiving placebo; - systolic blood pressure was >160 mm Hg in 3.8% of patients receiving 14 mg/day teriflunomide as compared to 2.0% receiving placebo; - diastolic blood pressure was >90 mm Hg in 21.4% of patients receiving 14 mg/day teriflunomide as compared to 13.6% receiving placebo.
Danish: I placebokontrollerede studier fandtes følgende: - systolisk blodtryk var >140 mmHg hos 19,9 % af de patienter, der fik 14 mg teriflunomid/dag,
English: However, also following either of the accelerated elimination procedures, verification by 2 separate tests at an interval of at least 14 days and a waiting period of one-and-a-half months between the first occurrence of a plasma concentration below 0.02 mg/l and fertilisation is required.
Danish: Endvidere er en venteperiode på 1½ måned fra første gang, der registreres en plasmakoncentration på under 0,02 mg/l, og indtil befrugtning nødvendig.
English: Elevations of liver enzymes have been observed in patients receiving teriflunomide (see section 4.8).
Danish: Forhøjede leverenzymer er blevet observeret hos patienter, der fik AUBAGIO (se pkt.
English: However, teriflunomide is contraindicated in patients with severe hepatic impairment (see sections 4.2 and 4.3).
Danish: Teriflunomid er derimod kontraindiceret til patienter med alvorligt nedsat leverfunktion (se pkt.
English: Sun
Danish: Søn
English: Fri
Danish: Fre
English: Diarrhoea, Nausea
Danish: Mave-tarm-kanalen Diarre, Kvalme
English: Menorrhagia
Danish: Amning
English: • cholestyramine 8 g is administered 3 times daily for a period of 11 days, or cholestyramine 4 g three times a day can be used, if cholestyramine 8 g three times a day is not well tolerated,
Danish: • colestyramin 8 g administreres 3 gange dagligt i en periode på 11 dage.
English: • Risk of hepatic effects o liver function tests are needed prior to treatment and periodically during treatment o To educate the patient about the signs and symptoms of liver disease and the need to report to their HCP if they experience any of them
Danish: o Informerere patienten om tegn og symptomer ved leversygdom og nødvendigheden af at fortælle det til sundhedspersonalet, hvis patienten oplever tegn på leversygdom.
English: Thu
Danish: Tor
English: Vomiting, Toothache
Danish: Nyrer og urinveje