FrancophonIA/ELRC3.0 huggingface dataset:
English: After a median follow-up of 32 weeks, the tritherapy with the three nucleosides ZDV/3TC/ABC was shown to be virologically inferior to the two other arms regardless of baseline viral load (< or > 100 000 copies/ml) with 26% of subjects on the ZDV/3TC/ABC arm, 16% on the ZDV/3TC/EFV arm and 13% on the 4 drug arm categorised as having virological failure (HIV RNA >200 copies/ml).
Danish: Ved en middelvurdering efter 32 uger blev 3-stofskombinationen af de tre nucleosider ZDV/3TC/ABC påvist at være virologisk inferiør til de to andre behandlingsregimer uanset baseline for den virale påvirkning (< eller > 100.000 kopier/ml).
English: Don't push too hard and squirt the liquid into the back of your throat, or you may choke Repeat steps 3 to 7 in the same way until you have taken your whole dose.
Danish: Du må ikke trykke for hårdt eller sprøjte opløsningen ned i halsen, da du risikerer kvælning.
English: What you need to know before you take Ziagen
Danish: Det skal du vide, før du begynder at tage Ziagen Tag ikke Ziagen:
English: This can be taken either as 300 mg (15 ml) twice a day or 600 mg (30 ml) once a day.
Danish: Denne dosis kan gives som enten 300 mg (15 ml) 2 gange daglig eller som 600 mg (30 ml) én gang daglig (se pkt.
English: If you notice any of these symptoms contact a doctor urgently.
Danish: Kontakt straks lægen, hvis du får nogle af disse symptomer.
English: None M184V alone 75 -0.74 Any one NRTI
Danish: M184V alene
English: Fever, lethargy, malaise, oedema, lymphadenopathy, hypotension, conjunctivitis, anaphylaxis
Danish: Feber, svær udmatning, utilpashed, ødem, lymfadenopati,
English: Many of the adverse reactions listed below occur commonly (nausea, vomiting, diarrhoea, fever, lethargy, rash) in patients with abacavir hypersensitivity.
Danish: En del af de bivirkninger, der er nævnt nedenfor, er almindelige hos patienter med overfølsomhed over for abacavir (kvalme, opkastning, diarré, feber, svær udmatning, udslæt).
English: The active substance in each Ziagen film-coated, scored tablet is 300 mg of abacavir (as sulfate).
Danish: Aktivt stof: Hver Ziagen filmovertrukken tablet med delekærv indeholder 300 mg abacavir (som sulfat).
English: This may be administered as either 150 mg (one half of a tablet) twice daily or 300 mg (one whole tablet) once daily.
Danish: Denne dosis kan gives som enten 150 mg (en halv tablet) 2 gange daglig eller 300 mg (en hel tablet) én gang daglig.
English: Ziagen oral solution contains 340 mg/ml of sorbitol.
Danish: Ziagen oral opløsning indeholder 340 mg/ml sorbitol og bør ikke anvendes til patienter med arvelig fructoseintolerans.
English: It is supplied in cartons containing a white polyethylene bottle, with a child resistant cap.
Danish: Ziagen oral opløsning leveres i æsker, der indeholder en hvid polyethylenflaske med børnesikret låg.
English: If the doctor thinks they may have been, you will then be told never again to take Ziagen, or any other medicine containing abacavir (e.g. Trizivir , Triumeq or Kivexa).
Danish: Hvis lægen mener, de kan være forårsaget af en overfølsomhedsreaktion, vil lægen råde dig til aldrig mere at tage Ziagen eller nogen anden medicin, som indeholder abacavir (f.eks. Triumeq, Trizivir eller Kivexa).
English: Renal disease Ziagen should not be administered to patients with end-stage renal disease (see section 5.2).
Danish: Nyresygdom Ziagen bør ikke gives til patienter med nyresvigt (se pkt.
English: Tablet Core
Danish: Tabletkerne:
English: Each ml of oral solution contains 20 mg of abacavir (as sulfate).
Danish: En ml oral opløsning indeholder 20 mg abacavir (som sulfat).
English: In PENTA 15 study, the geometric mean plasma abacavir AUC(0-24) (95% CI) of the four subjects under 12 months of age who switch from a twice daily to a once daily regimen (see section 5.1) are 15.9 (8.86, 28.5) µg.h/ml in the once-daily dosing and 12.7 (6.52, 24.6) µg.h/ml in the twice-daily dosing.
Danish: I PENTA 15-studiet er abacavirs geometriske gennemsnits-AUC (0 - 24) (95 % CI) i plasma for de fire patienter under 12 måneder, som skiftede fra 2 daglige doser til én daglig dosis (se pkt.
English: Alternatively, for patients who are unable to swallow tablets, the tablet(s) may be crushed and added to a small amount of semi-solid food or liquid, all of which should be consumed immediately (see section 5.2).
Danish: Eventuelt kan patienter med synkebesvær knuse tabletterne og opblande dem i en lille mængde væske eller halvflydende føde.
English: Ziagen should not be administered to patients with end-stage renal disease (see section 5.2).
Danish: Ziagen bør ikke anvendes til patienter med nyresvigt (se pkt.
English: This may be administered as either one 150 mg (one half of a tablet) taken in the morning and 300 mg (one whole tablet) taken in the evening, or 450 mg (one and a half tablets) taken once daily.
Danish: Denne dosis kan gives som enten 150 mg (en halv tablet) om morgenen og 300 mg (en hel tablet) om aftenen eller som 450 mg (en og en halv tablet) én gang daglig.
English: What Ziagen is and what it is used for What you need to know before you take Ziagen How to take Ziagen
Danish: Det skal du vide, før du begynder at tage Ziagen Sådan skal du tage Ziagen Bivirkninger
English: Carefully read all the information about hypersensitivity reactions in Section 4 of this leaflet.
Danish: Læs alle oplysningerne om overfølsomhedsreaktioner grundigt under punkt 4 i denne indlægsseddel.
English: Ziagen is not recommended in patients with moderate or severe hepatic impairment (see sections 4.2 and 5.2).
Danish: Ziagen anbefales ikke til patienter med moderat til svært nedsat leverfunktion (se pkt.
English: Ziagen contains abacavir (which is also an active substance in medicines such as Kivexa, Triumeq and Trizivir).
Danish: Ziagen indeholder abacavir (der også er et aktivt stof i medicin som Kivexa, Triumeq og Trizivir).
English: Film-coated tablet (tablets)
Danish: BLISTERFOLIE TEKST - TABLETTER
English: • After stopping treatment with Ziagen for reasons of a suspected HSR, Ziagen or any other medicinal product containing abacavir (e.g. Kivexa, Trizivir, Triumeq) must never be reinitiated.
Danish: Ziagen eller andre lægemidler, som indeholder abacavir (f.eks. Kivexa, Trizivir, Triumeq), aldrig genoptages.
English: Some medicines interact with Ziagen
Danish: Nogle lægemidler kan påvirke virkningen af Ziagen og omvendt
English: This may be administered as either 300 mg (one tablet) twice daily or 600 mg (two tablets) once daily (see sections 4.4 and 5.1).
Danish: Denne dosis kan gives som enten 300 mg (en tablet) 2 gange daglig eller som 600 mg (to tabletter) én gang daglig (se pkt.
English: • if you have severe kidney disease Talk to your doctor if any of these apply to you.
Danish: Tal med lægen, hvis noget af ovenstående gælder for dig.
English: Remove the bottle cap. Keep it safely.
Danish: Tag sprøjten ud af flasken, og vask den grundigt i rent vand.
English: Changes in laboratory chemistries
Danish: Afvigende laboratoriefund
English: Ziagen contains abacavir (which is also an active substance in Trizivir , Triumeq and Kivexa).
Danish: Ziagen indeholder abacavir (der også er et aktivt stof i medicin som Trizivir, Triumeq og Kivexa).
English: This can be given as 150 mg (half of a tablet) twice daily, or 300 mg (one whole tablet) once a day as advised by your doctor.
Danish: Denne dosis kan gives enten som 150 mg (en halv tablet) 2 gange daglig eller som 300 mg (en hel tablet) én gang daglig.
English: Once-Versus Twice-Daily Comparison GLS Mean Ratio (90% Cl)
Danish: Sammenligning af en versus 2 daglige doser Geometrisk gennemsnitsratio beregnet efter mindste kvadraters metode (90 % CI)
English: The active substance in Ziagen oral solution is 20 mg of abacavir (as sulfate) in each ml of the solution.
Danish: Aktivt stof: En ml Ziagen oral opløsning indeholder 20 mg abacavir (som sulfat).
English: CONTACT YOUR DOCTOR IMMEDIATELY for advice on whether you should stop taking Ziagen if: you get a skin rash OR you get one or more symptoms from at least TWO of the following groups
Danish: 1 Hvis du får udslæt, ELLER 2 Hvis du får symptomer fra mindst to af følgende grupper:
English: If you take more Ziagen than you should
Danish: Hvis du har taget for meget Ziagen
English: Very rarely, patients who have taken medicines containing abacavir in the past without any symptoms of hypersensitivity have developed a hypersensitivity reaction when they start taking these medicines again.
Danish: I meget sjældne tilfælde er disse reaktioner opstået hos personer, der genoptog behandling med abacavir, og som ikke havde haft nogen symptomer på overfølsomhed, før de stoppede med at tage medicinen.
English: mutation 82 -0.72
Danish: Polysorbat 80
English: There have been reports of mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally to nucleoside analogues ; these have predominantly concerned treatment with regimens containing zidovudine.The main adverse reactions reported are haematological disorders (anaemia, neutropenia) and metabolic disorders (hyperlactatemia, hyperlipasemia).
Danish: De hyppigst rapporterede bivirkninger er hæmatologiske forstyrrelser (anæmi, neutropeni) og metaboliske forstyrrelser (hyperlaktatæmi, hyperlipasæmi).
English: Patients co-infected with chronic hepatitis B or C virus
Danish: Patienter co-inficeret med kronisk hepatitis B eller C Patienter med kronisk hepatitis B eller C behandlet med antiretroviral kombinationsbehandling, har større risiko for alvorlige og potentielt letale leverbivirkninger.
English: Flupirtine-containing medicines have been authorised since the 1980s and are currently available in the following EU Member States: Bulgaria, Estonia, Germany, Hungary, Italy, Latvia, Lithuania, Poland, Portugal, Romania and Slovakia.
Danish: Lægemidler indeholdende flupirtin har været godkendt siden midten af 1980'erne og er på nuværende tidspunkt på markedet i følgende EU-medlemsstater: Bulgarien, Estland, Tyskland, Ungarn, Italien, Letland, Litauen, Polen, Portugal, Rumænien og Slovakiet.
English: The review of flupirtine-containing medicines was initiated in March 2013 at the request of Germany, under Article 107i of Directive 2001/83/EC.
Danish: Gennemgangen af lægemidler indeholdende flupirtin blev indledt i marts 2013 på anmodning af Tyskland i henhold til artikel 107i i direktiv 2001/83/EF.
English: The other dosages and pharmaceutical forms are only available in Germany.
Danish: De øvrige styrker og lægemiddelformer markedsføres kun i Tyskland.
English: 28 June 2013 EMA/384191/2013
Danish: Den 13. september 2013 EMA/563900/2013
English: It followed the procedural steps laid out in Article 107i of Directive 2001/83, also known as the urgent Union procedure.
Danish: Den fulgte proceduren i artikel 107i af direktiv 2001/83, der også kaldes EU-hasteproceduren.
English: Based on the findings of this review, healthcare professionals in the EU are advised of the following updated recommendations:
Danish: På grundlag af denne gennemgang bedes sundhedspersoner i EU være opmærksomme på følgende opdaterede anbefalinger:
English: Subsequently, multiple other actions such as muscle relaxation were identified.
Danish: Senere blev der fundet flere andre virkninger såsom muskelafslappende virkning.
English: In particular, there was a lack of efficacy data on the use of flupirtine for longer than 8 weeks.
Danish: Navnlig savnedes der oplysninger om virkning ved anvendelse af flupirtin i længere tid end otte uger.
English: The 100-mg immediate-release capsules are available in the 11 EU Member States listed above.
Danish: 100 mg kapsler med hurtig udløsning er på markedet i de 11 ovennævnte EU-medlemsstater.
English: Flupirtine is available as 100-mg immediate-release capsules, 400-mg extended-release tablets, 75mg and 150-mg suppositories and as a solution for injection (100 mg).
Danish: Flupirtin leveres som 100 mg kapsler med hurtig udløsning, 400 mg depottabletter, 75 mg og 150 mg suppositorier samt injektionsvæske (100 mg).
English: The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Danish: CMDh er et organ, der repræsenterer EU's medlemsstater, og som har ansvar for at sikre harmoniserede sikkerhedsnormer i hele EU for lægemidler, der godkendes ved nationale procedurer.
English: Doctors using the injectable flupirtine should also follow relevant advice to minimise risk to patients.
Danish: Læger, der anvender injektionspræparater med flupirtin, bør desuden følge relevante råd om minimering af risikoen for patienterne.
English: • Healthcare professionals should review the treatment of patients taking flupirtine taking into account the recommendations above.
Danish: • Sundhedspersoner bør gennemgå behandlingen af patienter i behandling med flupirtin under hensyntagen til ovenstående anbefalinger.
English: • You should not take flupiritine as a long-term treatment for chronic pain.
Danish: • Du skal ikke tage flupirtin som langtidsbehandling af kroniske smerter.
English: • The duration of treatment with flupirtine should not exceed 2 weeks and patients' liver function should be checked after each full week of treatment.
Danish: • Behandlingsvarigheden med flupirtin bør ikke overstige to uger, og patienternes leverfunktion bør kontrolleres efter hver hel uges behandling.
English: The PRAC recommendations were sent to the CMDh, which adopted a final position.
Danish: PRAC's anbefalinger blev overgivet til CMDh, som vedtog et endeligt standpunkt.
English: Flupirtine works as a ‘selective neuronal-potassium-channel opener'.
Danish: Flupirtin virker som en “selektiv neuronal kaliumkanalåbner”.
English: If you are taking flupirtine, your treatment should not last longer than 2 weeks.
Danish: Hvis du får flupirtin, må din behandling ikke vare længere end to uger.
English: The PRAC concluded that the benefits of injectable flupirtine continue to outweigh their risks when used in this way.
Danish: PRAC konkluderede, at fordelene ved flupirtin som injektionspræparat fortsat opvejer risiciene, når det anvendes på denne måde.
English: • Because flupirtine may have effects on the liver in some patients, your doctor will test your liver function during treatment and stop treatment if there are any signs of liver problems.
Danish: • Da flupirtin hos nogle patienter kan have virkning på leveren, vil din læge teste din leverfunktion under behandlingen og stoppe behandlingen, hvis der er tegn på leverproblemer.
English: In addition to oral medicines and suppositories, this review also covered injectable flupirtine medicines which were being given as a single injection for pain following surgery.
Danish: Foruden orale lægemidler og suppositorier omfattede gennemgangen også injektionspræparater af flupirtin, der blev givet som en enkelt injektion mod smerter efter operation.
English: The CMDh agreed with the PRAC's conclusions and has endorsed the PRAC's recommendations on the use of flupirtine-containing medicines.
Danish: CMDh tilsluttede sig PRAC's konklusioner og vedtog PRAC's anbefalinger om anvendelse af lægemidler indeholdende flupirtin.
English: If you have been taking flupirtine for longer than 2 weeks you will need to get your treatment reviewed by your doctor or pharmacists.
Danish: Hvis du har taget flupirtin længere end to uger, skal du få din behandling gennemgået af lægen eller apotekspersonalet.
English: A review of the safety data from the EU adverse reaction database revealed 330 cases of adverse liver events suspected to be linked to flupirtine.
Danish: En gennemgang af sikkerhedsdata fra EU's bivirkningsdatabase viste 330 tilfælde af uønskede leverhændelser med formodet sammenhæng med flupirtin.
English: Flupirtine is a non-opioid painkiller that has been used to treat pain, such as pain associated with muscle tension, cancer pain, menstrual pain and pain following orthopaedic surgery or injuries.
Danish: Flupirtin er et smertestillende middel af ikke-opioid type og er blevet anvendt til smertebehandling såsom smerter ved muskelspændinger, cancersmerter, menstruationssmerter og smerter efter ortopædkirurgiske operationer og skader.
English: This means that it opens specific pores on the surface of nerve cells called potassium channels.
Danish: Det vil sige, at det åbner kaliumkanalerne, der er særlige porer på overfladen af nervecellerne.
English: The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) has endorsed by majority new recommendations to restrict the use of oral flupirtine medicines and suppositories.
Danish: Den 26. juni 2013 vedtog koordinationsgruppen vedrørende gensidig anerkendelse og decentraliserede godkendelsesprocedurer - human (CMDh) ved en flertalsafgørelse nye anbefalinger om begrænsning af anvendelsen af flupirtinholdige lægemidler, der leveres til oral anvendelse og som suppositorier.
English: In addition, patients' liver function should be checked after each full week of treatment and treatment should be stopped if the patient has any signs of liver problems.
Danish: Derudover bør patienternes leverfunktion overvåges efter hver hel uges behandling, og behandlingen bør stoppes, hvis patienten viser tegn på leverproblemer.
English: Flupirtine was first introduced as an alternative painkiller to opioids and NSAIDs.
Danish: Flupirtin blev først indført som et smertestillende middel, der var et alternativ til opioider og NSAID.
English: The recommendations follow a review by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) which looked into reported liver problems with flupirtine, ranging from high liver-enzyme levels to liver failure.
Danish: Anbefalingerne følger EMA's Udvalg for Risikovurdering inden for Lægemiddelovervågning (PRAC), som gennemgik leverproblemerne med flupirtin, der spænder fra forhøjede leverenzymer til leversvigt.
English: With regard to the evidence of efficacy, the review highlighted a lack of sufficient data on the benefits of flupirtine in chronic pain.
Danish: Vedrørende dokumentationen for virkning viste gennemgangen, at der savnedes tilstrækkelige oplysninger om fordelene ved flupirtin til behandling af kroniske smerter.
English: No cases of liver failure or liver transplantation were reported in patients who took the medicine for 2 weeks or less.
Danish: Der blev ikke indberettet tilfælde af leversvigt eller levertransplantationer hos patienter, som tog lægemidlet i op til to uger.
English: The PRAC also reviewed the available data on the benefits of flupirtine and concluded that, while there were data from studies in the treatment of acute pain, there were insufficient data to support its use in the treatment of long-term pain.
Danish: PRAC gennemgik desuden de foreliggende data om de gavnlige virkninger af flupirtin og konkluderede, at der forelå data fra undersøgelser om behandling af akutte smerter, men at der ikke var tilstrækkelige data til at underbygge anvendelse til behandling af langvarige smerter.
English: These medicines should now only be used for treating acute (short-term) pain in adults who cannot use other painkillers, such as non-steroidal anti-inflammatory drug (NSAIDs) and weak opioids, and treatment should not last longer than 2 weeks.
Danish: Disse lægemidler bør kun anvendes til kortvarig (akut) behandling af smerter hos voksne, som ikke kan anvende andre smertestillende midler såsom nonsteroide antiinflammatoriske lægemidler (NSAID) og svage opioider, og behandlingen bør højst vare to uger.
English: As the CMDh position was adopted by majority it will be sent to the European Commission, which will take a legally binding position throughout the EU.
Danish: Eftersom CMDh vedtog dette standpunkt ved en flertalsafgørelse, blev det overgivet til EuropaKommissionen, som godkendte det og vedtog en retligt bindende beslutning, der er gyldig i hele EU.
English: The events ranged from asymptomatic increases in liver enzymes to liver failure.
Danish: Hændelserne spændte fra asymptomatiske forhøjelser af leverenzymer til leversvigt.
English: • Treatment must be stopped in any patient with abnormal liver function tests results or symptoms of liver disease.
Danish: • Behandlingen skal seponeres hos alle patienter med abnorm leverfunktionstest eller symptomer på leversygdom.
English: The PRAC evaluated the available data on liver safety, noting that there were no cases of liver failure or liver transplantation reported in patients who took the medicine for 2 weeks or less.
Danish: PRAC vurderede de foreliggende data om leversikkerhed og konstaterede, at der ikke var registreret tilfælde af leversvigt eller levertransplantation hos patienter, der fik lægemidlet i op til to uger.
English: Flupirtine must also not be used in patients with pre-existing liver disease or alcohol abuse problems or in patients taking other medicines known to cause liver problems.
Danish: Flupirtin må heller ikke anvendes hos patienter, der i forvejen har leversygdom eller alkoholmisbrug, eller som får andre lægemidler, der vides at forårsage leverproblemer.
English: • Oral flupirtine medicines and suppositories should only be used to treat adults with acute pain and only if treatment with other painkillers (such as NSAIDs and weak opioids) is contraindicated.
Danish: • Flupirtin i form af orale lægemidler og suppositorier bør kun anvendes til behandling af akutte smerter hos voksne, og kun når andre analgetika (såsom NSAID og svage opioider) er kontraindiceret.
English: A review of these data was first conducted by the PRAC.
Danish: Disse data blev først gennemgået af Udvalget for Risikovurdering inden for Lægemiddelovervågning (PRAC).
English: • If you are being treated with flupirtine and have any questions or concerns about your treatment,
Danish: • Hvis du er i behandling med flupirtin, og du har spørgsmål eller betænkeligheder vedrørende din behandling, skal du tale med lægen eller med apotekspersonalet.
English: • Flupirtine must not be used in patients with pre-existing liver disease or alcohol abuse problems or in patients taking other medicines known to cause liver problems.
Danish: • Flupirtin må ikke anvendes hos patienter med eksisterende leversygdom eller alkoholmisbrug eller ved samtidig anvendelse af andre lægemidler, der vides at forårsage leverproblemer.
English: The CMDh position will now be sent to the European Commission, which will take a legally binding decision to be valid throughout the EU.
Danish: CMDh's udtalelse blev overgivet til Europa-Kommissionen, som godkendte den og den 5. september 2013 vedtog en endelig beslutning, der er retligt bindende i hele EU.
English: Restrictions in the use of flupirtine-containing medicinesCMDh endorses PRAC recommendation
Danish: Begrænsninger i anvendelsen af lægemidler indeholdende flupirtin
English: • Oral flupirtine medicines and suppositories should only be used to treat acute (short-term) pain in adults who cannot use other painkillers (such as NSAIDs and weak opioids).
Danish: (akutte) smerter hos voksne, der ikke tåler andre smertestillende midler (såsom NSAID og svage opioider).
English: Strength Pharmaceutical form
Danish: MF (EU)-nummer (Særnavn) Navn Styrke Lægemiddelform Administration Emballage Pakningsstørrelse
English: 31 October 2013
Danish: Den 31. oktober 2013
English: The European Commission issued a decision on 31 October 2013.
Danish: Europa-Kommissionen traf en beslutning den 31. oktober 2013.
English: They are also used to treat autoimmune diseases.
Danish: De anvendes desuden til behandling af autoimmune sygdomme.
English: The package leaflet was amended accordingly.
Danish: Indlægssedlen blev ændret tilsvarende.
English: Both medicines contain the active substance ciclosporin.
Danish: Begge lægemidler indeholder det aktive stof ciclosporin.
English: The companies that market these medicines are Novartis group of companies and associated companies.
Danish: Disse lægemidler markedsføres af virksomheder i Novartis-koncernen og tilknyttede virksomheder.
English: In addition, the capsules and oral solutions may also be used to treat the following autoimmune diseases:
Danish: Desuden kan kapsler og orale opløsninger anvendes til behandling af følgende autoimmune sygdomme: