FrancophonIA/ELRC3.0 huggingface dataset:
English: Certain ergot derivatives have been used to treat conditions usually affecting elderly patients, such as peripheral arterial occlusive disease (PAOD, where the body's large arteries become obstructed) causing pain when walking, and Raynaud's syndrome (where the blood supply is blocked to the extremities, usually the fingers and toes), as well as eyesight disturbances due to blood circulation problems.
Danish: Visse ergotderivater har været anvendt til behandling af sygdomme, sædvanligvis hos ældre patienter, såsom blokering af kroppens store arterier (perifer arteriel okklusiv sygdom (PAOD)), der medfører smerter ved gang, og Raynauds syndrom (med blokering af blodtilførslen til lemmerne, sædvanligvis fingre og tæer) samt synsforstyrrelser på grund af kredsløbsproblemer.
English: In its review, the CHMP considered all available data on the benefits and risks of ergot derivatives, including data from clinical studies, post-marketing safety reports and the published literature.
Danish: CHMP's gennemgang omfattede alle foreliggende data om fordele og risici ved ergotderivater, herunder data fra kliniske undersøgelser, indberetninger efter markedsføring og den publicerede litteratur.
English: • Medicines containing substances known as ergot derivatives can have serious side effects, called fibrosis and ergotism.
Danish: • Lægemidler indeholdende ergotderivater kan have alvorlige bivirkninger i form af fibrose og ergotisme.
English: As a result, they should no longer be used in the EU to treat a number of conditions involving blood circulation problems (that usually affect elderly patients) or problems with memory and sensation, or to prevent migraine headaches, as the risks outweigh the benefits.
Danish: Derfor bør de ikke længere anvendes i EU til behandling af en række sygdomme med kredsløbsproblemer (sædvanligvis hos ældre patienter), hukommelsesproblemer og nedsat følesans, eller til forebyggelse af migræne, da risiciene overstiger fordelene.
English: In some EU countries, certain ergot derivatives are also authorised for other indications not covered by the CHMP review, including other circulatory disorders, treatment of dementia (including Alzheimer's disease) and treatment of acute migraine.
Danish: I nogle EU-lande er visse ergotderivater desuden godkendt til andre indikationer, der ikke er omfattet af CHMP's gennemgang, herunder andre kredsløbsforstyrrelser, behandling af demens (herunder Alzheimers sygdom) og behandling af akut migræne.
English: Five ergot derivatives were considered in the CHMP review: dihydroergocristine, dihydroergotamine, dihydroergotoxine, nicergoline and the combination of dihydroergocryptine with caffeine.
Danish: CHMP's gennemgang omfattede 5 ergotderivater: dihydroergocristin, dihydroergotamin, dihydroergotoxin, nicergolin og en kombination af dihydroergocryptin med koffein.
English: They have also been used for treating chronic pathological cognitive and neurosensorial impairment (problems with memory and sensation) and for preventing migraine headaches.
Danish: De har desuden været anvendt til behandling af problemer med nedsat hukommelse og følesans (kronisk patologisk kognitiv og neurosensorisk funktionsnedsættelse) og til forebyggelse af migræne.
English: • Some ergot derivatives are approved in some EU Member States for use in other therapeutic indications, including other circulatory disorders, treatment of dementia (including Alzheimer's disease) and treatment of acute migraine.
Danish: • Nogle ergotderivater er i visse EU medlemsstater godkendt til andre terapeutiske indikationer, herunder andre kredsløbsforstyrrelser, behandling af demens (herunder Alzheimers sygdom) og behandling af akut migræne.
English: • Healthcare professionals should stop prescribing medicines containing dihydroergocristine, dihydroergotamine, dihydroergotoxine, nicergoline or a combination of dihydroergocryptine with caffeine, for any of the following indications:
Danish: • Der bør ikke længere ordineres lægemidler indeholdende dihydroergotamin, dihydroergotoxin, nicergolin eller en kombination af dihydroergocryptin med koffein til følgende indikationer:
English: Several cases of ergotism or symptoms potentially related to ergotism (including severe cases of symptoms of constriction of peripheral blood vessels) were also identified with the other ergot derivatives.
Danish: Med de øvrige ergotderivater blev der desuden fundet adskillige tilfælde af ergotisme og potentielt ergotismerelaterede symptomer (herunder tilfælde med svære symptomer på perifer vasokonstriktion).
English: In some EU Member States, ergot derivatives are also authorised for other indications such as treatment of dementia, including Alzheimer's disease, and treatment (as opposed to prevention) of acute migraine headache.
Danish: I nogle EU medlemsstater er ergotderivater desuden godkendt til andre anvendelser såsom behandling af demens, herunder Alzheimers sygdom, og behandling (men ikke forebyggelse) af akut migræne.
English: • You should make a non-urgent appointment with your doctor if you are taking a medicine containing any of these substances: dihydroergocristine, dihydroergotamine, dihydroergotoxine, nicergoline or a combination of dihydroergocryptine with caffeine.
Danish: • Hvis du tager et lægemiddel, der indeholder et af følgende stoffer, skal du få tid hos lægen til en ikke-hastende konsultation: dihydroergocristin, dihydroergotamin, dihydroergotoxin, nicergolin eller en kombination af dihydroergocryptin med koffein.
English: The varying affinity for serotoninergic receptors of the different ergot derivatives, and the therapeutic doses used, may explain the differences observed in reporting frequencies for the fibrotic reactions.
Danish: De iagttagne forskelle i indberetningshyppigheden af fibrotiske reaktioner kan forklares dels af de forskellige ergotderivaters forskellige affinitet for serotoninerge receptorer, dels de anvendte terapeutiske doser.
English: Ergot derivatives that are only indicated for these conditions will have their marketing authorisations suspended across the EU.
Danish: Markedsføringstilladelserne vil blive ophævet i hele EU for ergotderivater, der kun er godkendt til disse sygdomme.
English: The European Commission has already endorsed the CHMP opinion for 4 other ergot derivatives (dihydroergocristine, dihydroergotamine, nicergoline dihydroergocryptine), adopting a final legally binding decision on 27 September 2013.
Danish: Europa-Kommissionen vedtog CHMP's udtalelse for dihydroergocristin, dihydroergotamin, nicergolin og dihydroergocryptin den 27. september 2013, og CHMP's udtalelse for dihydroergotoxin den 18. december 2013.
English: The CHMP opinion on dihydroergotoxine will now be forwarded to the European Commission, which will issue a final decision in due course.
Danish: CHMP's anbefalinger blev forelagt Europa-Kommissionen, som har godkendt dem og truffet en endelig bindende beslutning med gyldighed i hele EU.
English: 1 vial + 1 pre-filled syringe + 2 injection needles + 2 alcohol swabs
Danish: 1 hætteglas + 1 fyldt injektionssprøjte + 2 kanyler + 2 spritsvampe
English: 7 vials + 7 pre-filled syringes + 14 injection needles + 14 alcohol swabs
Danish: 1 hætteglas + 1 fyldte injektionssprøjter + 14 kanyler + 14 spritsvampe
English: Strength Pharmaceutical form Route of administration
Danish: Særnavn Styrke Lægemiddelform Indgivelsesvej
English: It is available as tablets (500 mg) and capsules (250 mg).
Danish: Det fås som tabletter (500 mg) og kapsler (250 mg).
English: Other information about Myclausen:
Danish: Andre oplysninger om Myclausen:
English: This document is a summary of the European public assessment report (EPAR) for Myclausen.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Myclausen.
English: The European Commission granted a marketing authorisation valid throughout the EU for Myclausen on 7 October 2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Myclausen den 7. oktober 2010.
English: In children aged between two and 18 years, the dose of Myclausen is calculated depending on height and weight.
Danish: Hos børn mellem to og 18 år beregnes dosis af Myclausen på baggrund af barnets højde og vægt.
English: The full EPAR for Myclausen can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Myclausen findes på EMA's websted på ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It is used with ciclosporin and corticosteroids (other medicines used to prevent organ rejection).
Danish: Det anvendes sammen med ciclosporin og kortikosteroider (andre lægemidler, der bruges til at forhindre organafstødning).
English: This means that Myclausen is similar to a ‘reference medicine' already authorised in the European Union (EU) called Cellcept.
Danish: Det betyder, at Myclausen er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Cellcept.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Myclausen.
Danish: Det forklarer, hvordan Udvalget for Humanmedicinske Lægemidler (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Myclausen.
English: Myclausen treatment should be initiated and maintained by a qualified transplant specialist.
Danish: Behandling med Myclausen skal påbegyndes og fortsættes af en transplantationsspecialist.
English: For more information about treatment with Myclausen, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Myclausen, kan du læse indlægssedlen (også en del af EPAR) eller kontakte din læge eller dit apotek.
English: This makes them less effective at recognising and attacking the transplanted organ, lowering the risk of the organ being rejected.
Danish: Dette bevirker, at lymfocytterne bliver mindre effektive til at genkende og angribe det transplanterede organ, hvormed risikoen for, at organet afstødes, reduceres.
English: The full EPAR for the reference medicine can also be found on the Agency's website.
Danish: Den fuldstændige EPAR for referencelægemidlet findes ligeledes på EMA's websted.
English: This enzyme is important for the formation of DNA in cells, particularly in the lymphocytes (a type of white blood cell which is involved in the rejection of organ transplants).
Danish: Dette enzym spiller en vigtig rolle for DNA-dannelsen i cellerne, særlig i lymfocytterne (en type hvide blodlegemer, der er involveret i afstødningen af organtransplantater).
English: Myclausen mycophenolate mofetil
Danish: Myclausen mycophenolatmofetil
English: The Committee recommended that Myclausen be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Myclausen.
English: What are the benefit and risk of Myclausen?
Danish: Hvilke fordele og risici er der forbundet med Myclausen?
English: By preventing the production of new DNA, Myclausen reduces the rate at which the lymphocytes multiply.
Danish: Ved at forhindre, at der dannes nyt DNA, reducerer Myclausen den hastighed, hvormed lymfocytterne formerer sig.
English: Myclausen is used to prevent the body from rejecting a transplanted kidney, heart or liver.
Danish: Myclausen anvendes til at forhindre kroppen i at afstøde nyre-, hjerte- eller levertransplantater.
English: Myclausen is a ‘generic medicine'.
Danish: Myclausen er et generisk lægemiddel.
English: Because Myclausen is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Danish: Eftersom Myclausen er et generisk lægemiddel og er bioækvivalent med referencelægemidlet, anses dets risk-benefit-forhold for at være det samme som referencelægemidlets.
English: The CHMP concluded that, in accordance with EU requirements, Myclausen has been shown to have comparable quality and to be bioequivalent to Cellcept.
Danish: CHMP konkluderede, at det i overensstemmelse med EU-kravene er påvist, at Myclausens kvalitet svarer til Cellcepts, og at Myclausen er bioækvivalent med Cellcept.
English: Because Myclausen is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Cellcept.
Danish: Eftersom Myclausen er et generisk lægemiddel, har undersøgelserne hos patienter været begrænset til test for at fastslå, at det er bioækvivalent med referencelægemidlet, Cellcept.
English: The way that Myclausen should be given and the dose depend on the type of organ transplant.
Danish: Dosis og indgivelsesmåde afhænger af, hvilken type organtransplantation der skal udføres.
English: Myclausen is a medicine that contains the active substance mycophenolate mofetil.
Danish: Myclausen er et lægemiddel, der indeholder det aktive stof mycophenolatmofetil.
English: For more information, see the summary of product characteristics (also part of the EPAR).
Danish: Yderligere oplysninger fremgår af produktresuméet (også en del af EPAR).
English: Why has Myclausen been approved?
Danish: Hvorfor blev Myclausen godkendt?
English: For heart transplants, the recommended adult dose is 1.5 g twice a day, starting within five days following the transplant.
Danish: Den anbefalede dosis til voksne, der har fået en hjertetransplantation, er 1,5 g oralt to gange dagligt, og behandlingen påbegyndes inden for fem dage efter transplantationen.
English: In the body, it is converted into mycophenolic acid, which blocks an enzyme called ‘inosine monophosphate dehydrogenase'.
Danish: I kroppen omdannes mycophenolatmofetil til mycophenolsyre, som virker ved at blokere et enzym ved navn "inosinmonofosfatdehydrogenase".
English: The dose may need to be adjusted in patients with liver or kidney disease.
Danish: Hos patienter med lever- eller nyresygdomme kan det være nødvendigt at justere dosis.
English: Therefore, the CHMP's view was that, as for Cellcept, the benefit outweighs the identified risk.
Danish: CHMP var derfor af den opfattelse, at fordelene er større end de identificerede risici, ligesom det er tilfældet med Cellcept.
English: For kidney transplants, the recommended dose in adults is 1 g twice a day by mouth starting within 72 hours after the transplant.
Danish: Den anbefalede dosis til voksne, der har fået en nyretransplantation, er 1 g oralt to gange dagligt, og behandlingen påbegyndes inden for 72 timer efter transplantationen.
English: The active substance in Myclausen, mycophenolate mofetil, is an immunosuppressive medicine.
Danish: Det aktive stof i Myclausen, mycophenolatmofetil, er et lægemiddel, der anvendes til at undertrykke immunaktivitet.
English: What is Myclausen?
Danish: Hvad er Myclausen?
English: For liver transplants in adults, mycophenolate mofetil should be given as an infusion (drip into a vein) for the first four days after the transplant, before the patient is switched to Myclausen 1.5 g twice a day as soon as it can be tolerated.
Danish: Ved levertransplantation gives mycophenolatmofetil som infusion (drop i en vene) i de første fire dage efter transplantationen, og herefter skiftes til behandling med Myclausen 1,5 g to gange dagligt, så snart patienten kan tåle det. Myclausen anbefales ikke til børn efter en hjerte- eller levertransplantation, da der ikke foreligger oplysninger om lægemidlets virkning i denne patientgruppe.
English: What is Myclausen used for?
Danish: Hvad anvendes Myclausen til?
English: How has Myclausen been studied?
Danish: Hvordan blev Myclausen undersøgt?
English: How is Myclausen used?
Danish: Hvordan anvendes Myclausen?
English: How does Myclausen work?
Danish: Hvordan virker Myclausen?
English: 32 weeks 144 weeks
Danish: 32 uger 144 uger
English: When do these reactions happen?
Danish: Hvornår opstår disse reaktioner?
English: Let it dry completely before you use it again
Danish: Lad den tørre helt, inden du bruger den igen.
English: • if you are seriously overweight (especially if you are a woman)
Danish: • hvis du er svært overvægtig (særligt hvis du er kvinde)
English: No firm conclusion could be drawn due to the limited data derived from this study.
Danish: Ingen fast konklusion kunne drages ud fra de begrænsede data fra dette studie.
English: Week 0 (After ≥36 Weeks on Treatment)
Danish: Uge 0 (efter ≥36 ugers behandling)
English: ARROW PK Substudy Part 1
Danish: ARROW PK Substudie Del 1
English: Conclusions supported non-inferiority regardless of analysis method.
Danish: Konklusionerne understøttede non-inferioritet uanset analysemetode.
English: The duration of double-blind treatment was at least 48 weeks.
Danish: Varigheden af dobbeltblindet behandling var mindst 48 uger.
English: See sections 4.4 and 4.8.
Danish: Se section 4.4 og 4.8.
English: The dose depends on the child's body weight.
Danish: Dosis afhænger af barnets kropsvægt.
English: It is a potent selective inhibitor of HIV-1 and HIV-2.
Danish: Det er en potent selektiv hæmmer af hiv-1 og hiv-2.
English: • methadone used as a heroin substitute.
Danish: • Methadon, der anvendes som erstatning for heroin.
English: However, as there were only moderately experienced patients included in this study with an imbalance in baseline viral load between the arms, these results should be interpreted with caution.
Danish: Da der dog kun var moderat erfarne patienter inkluderet i dette studie, med en uligevægt i baseline viral load mellem armene, skal disse resultater tolkes med forsigtighed.
English: No safety concerns were observed in these subjects.
Danish: Ingen sikkerhedsproblemer blev observeret hos disse patienter.
English: Date of first authorisation: 8 July 1999 Date of latest renewal: 21 March 2014
Danish: Dato for første markedsføringstilladelse: 8. juli 1999 Dato for seneste fornyelse: 21 marts 2014
English: The malformative risk is unlikely in humans based on those data.
Danish: Den malformative risiko er usandsynlig hos mennesker, baseret på disse data.
English: While the carcinogenic potential in humans is unknown, these data suggest that a carcinogenic risk to humans is outweighed by the potential clinical benefit.
Danish: Mens det karcinogene potentiale hos mennesker er ukendt, indikerer disse data, at den karcinogene risiko hos mennesker opvejes af de potentielle kliniske fordele.
English: Additional information:
Danish: Yderligere oplysninger:
English: If the date of the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Danish: Hvis tidsfristen for en PSUR og for opdatering af en RMP er sammenfaldende, kan de fremsendes samtidig.
English: Like all medicines, this medicine can cause side effects, although not everyone gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, selvom ikke alle får bivirkninger.
English: If your child gets the symptoms described below it is essential that you follow the instructions given.
Danish: Hvis barnet får symptomerne nævnt nedenfor, er det vigtigt, at du følger de angivne instrukser.
English: Not everyone responds to treatment with Ziagen in the same way.
Danish: Ikke alle reagerer ens på behandlingen med Ziagen.
English: Plasma abacavir exposure has been shown to be the same for both formulations when administered at the same dose.
Danish: Eksponering af abacavir i plasma er blevet vist at være den samme for begge formuleringer, når den samme dosis administreres.
English: The safety and efficacy of Ziagen in a number of different multidrug combination regimens is still not completely assessed (particularly in combination with NNRTIs).
Danish: Sikkerheden og effekten af Ziagen i et antal forskellige multistof kombinationsregimer er stadig ikke fuldstændigt vurderet (specielt i kombination med NNRTI'er).
English: Food delayed absorption and decreased Cmax but did not affect overall plasma concentrations (AUC).
Danish: Fødeindtagelse forsinkede absorptionen og reducerede Cmax, men påvirkede ikke den totale plasmakoncentration (AUC).
English: Ziagen can be taken with or without food.
Danish: Ziagen kan tages med eller uden mad.
English: These symptoms are probably caused by the body's immune system becoming stronger, so that the body starts to fight these infections.
Danish: Disse symptomer opstår sandsynligvis, fordi kroppens immunsystem bliver stærkere, og kroppen begynder at bekæmpe disse infektioner.
English: Interaction with abacavir is possible but has not been studied.
Danish: Interaktion med abacavir er mulig, men er ikke undersøgt.
English: If you have taken Ziagen during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Danish: Hvis du har taget Ziagen under din graviditet, kan din læge bede om regelmæssige blodprøver og andre diagnostiske undersøgelser for at overvåge barnets udvikling.
English: This is consistent with the known activity of other nucleoside analogues.
Danish: Det svarer til den kendte aktivitet af andre nukleosidanaloger.
English: Abacavir is a NRTI.
Danish: Abacavir er en NRTI.
English: Do not drive or operate machines unless you are feeling well.
Danish: Kør ikke bil og betjen ikke maskiner, hvis du føler dig utilpas.
English: These may affect up to 1 in 1,000 people: • inflammation of the pancreas (pancreatitis)
Danish: Disse kan forekomme hos op til 1 ud af 1.000 personer: • betændelse i bugspytkirtlen (pankreatitis).
English: Abacavir is rapidly and well absorbed following oral administration.
Danish: Abacavir absorberes hurtigt og godt efter oral administration.
English: • phenytoin, for treating epilepsy.
Danish: • Phenytoin, til behandling af epilepsi.
English: Ziagen does not completely cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level.
Danish: Ziagen helbreder ikke hiv-infektionen, men nedsætter mængden af virus i kroppen og holder den på et lavt niveau.
English: • if you have ever had liver disease, including hepatitis B or C
Danish: • hvis du tidligere har haft en leversygdom, herunder hepatitis B eller C
English: 3 to 12 years (N=36)
Danish: 3 til 12 år (N=36)
English: Due to the high proportion of premature discontinuation (42% of patients discontinued randomised treatment by week 48), no definitive conclusion can be drawn regarding the equivalence between the treatment regimens at week 48.
Danish: På grund af den høje andel af tidligt ophør (42 % af patienterne var stoppet med randomiseret behandling senest i uge 48) kan der ikke drages nogen definitiv konklusion med hensyn til ækvivalensen mellem behandlingsregimerne ved uge 48.
English: The bottle is inverted and the correct volume withdrawn.
Danish: Flasken vendes på hovedet og den korrekte mængde trækkes ud.
English: The induction of drug metabolising enzymes cannot therefore be excluded.
Danish: Induktion af lægemiddelmetaboliserende enzymer kan derfor ikke udelukkes.
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFCTIVE USE OF THE MEDICINAL PRODUCT
Danish: BILAG II A. FREMSTILLER(E) ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: Sorbitol can have a mild laxative effect.
Danish: Sorbitol kan have en mild afførende virkning.
English: No studies on the effects on ability to drive and use machines have been performed.
Danish: Der er ikke foretaget studier af virkningen på evnen til at føre motorkøretøj og betjene maskiner.