FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Viramune's benefits are greater than its risks in combination with other antiviral medicinal products for the treatment of HIV-1 infected adults, adolescents, and children of any age.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Viramune opvejede de risici, der er forbundet med stoffet i kombination med andre antivirale lægemidler til behandling af hiv1-smittede voksne, unge og børn i alle aldre.
English: For the full list of all side effects reported with Viramune, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Viramune fremgår af indlægssedlen.
English: The studies compared Viramune, taken in combination with zidovudine and didanosine (other antiviral medicines), with other antiviral medicines.
Danish: I undersøgelserne blev Viramune, taget i kombination med zidovudin og didanosin (andre antivirale lægemidler), sammenlignet med andre antivirale lægemidler.
English: They also showed that patients can be safely switched from immediate- to prolonged-release tablets.
Danish: De viste også, at det er sikkert for patienterne at skifte fra tabletter med umiddelbar frigivelse til depottabletter.
English: What is Viramune?
Danish: Hvad er Viramune?
English: Why has Viramune been approved?
Danish: Hvorfor blev Viramune godkendt?
English: The dose should then be increased to the standard dose of 200 mg twice a day using immediate release tablets or oral suspension or to the standard dose of 400mg once a day using the prolonged-release tablets are prescribed.
Danish: Dosis bør så sættes op til standarddosis på 200 mg to gange dagligt i form af tabletter med umiddelbar frigivelse eller oral suspension eller til standarddosis på 400 mg én gang dagligt i form af depottabletter.
English: To support the use of the prolonged-release tablets, the company conducted studies to show that the immediate- and prolonged-release tablets both had adequate drug levels, and the same effect on the viral load in the body.Studies were also done to show successful switching from immediate-release tablets, twice daily to prolonged-release tablets, once daily.
Danish: Til støtte for anvendelsen af depottabletter foretog virksomheden undersøgelser for at påvise, at både tabletter med umiddelbar frigivelse og depottabletter havde passende lægemiddelniveauer, og at de havde samme virkning på den virale belastning i kroppen.
English: What is Viramune used for?
Danish: Hvad anvendes Viramune til?
English: How has Viramune been studied?
Danish: Hvordan blev Viramune undersøgt?
English: What benefit has Viramune shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Viramune?
English: How is Viramune used?
Danish: Hvordan anvendes Viramune?
English: How does Viramune work?
Danish: Hvordan virker Viramune?
English: The carcinogenic potential was not evaluated.
Danish: Det karcinogene potentiale blev ikke evalueret.
English: This has been shown in studies in animals and in laboratory studies.
Danish: Dette er blevet påvist i studier med dyr og i laboratorieundersøgelser.
English: This medicine is a muscle relaxant.
Danish: Dette lægemiddel er et muskelafslappende middel.
English: Method of administration [To be completed nationally]
Danish: Administration [Udfyldes nationalt]
English: Therefore, the potential hazards for the embryo and foetus are unknown.
Danish: Derfor er de potentielle farer for embryoner og fostre ukendte.
English: There are limited data on the use of thiocolchicoside in pregnant women.
Danish: Der er begrænsede data fra anvendelse af thiocolchicosid til gravide kvinder.
English: What you need to know before you take X
Danish: Det skal du vide, før du begynder at tage x
English: You should not use this medicine at higher dose or for longer than 7 days (for oral forms)/5 days (for IM forms).
Danish: Du må ikke tage lægemidlet i højere doser eller i mere end 7 dage (for orale formuleringer)/5 dage (for i.mformuleringer).
English: Your doctor will inform you about all measures relating to an effective contraception and about the potential risk of a pregnancy.
Danish: Lægen vil informere dig om alle foranstaltninger vedrørende effektiv prævention og om den mulige risiko ved en graviditet.
English: The dose without toxic effect was 3 mg/kg/day.
Danish: Dosis uden toksisk effekt var 3 mg/kg/dag.
English: Furthermore, minor abnormalities have been observed (supernumerary ribs, retarded ossification).
Danish: Desuden er mindre abnormiteter blevet observeret (ekstra ribben, forsinket ossifikation).
English: Patients should be carefully informed about the potential risk of a possible pregnancy and about effective contraception measures to be followed.
Danish: Patienter skal nøje informeres om den potentielle risiko for en eventuel graviditet samt om tiltag vedrørende effektiv prævention, der skal overholdes.
English: The treatment duration is limited to 5 consecutive days.
Danish: Behandlingsvarigheden er begrænset til 5 på hinanden følgende dage.
English: - After oral administration, total radioactivity is mainly excreted in feces (79%) while urinary excretion represents only 20%.
Danish: - Efter oral indgift udskilles den samlede radioaktivitet primært i fæces (79 %), mens kun 20 % udskilles i urinen.
English: The treatment duration is limited to 7 consecutive days.
Danish: Behandlingsvarigheden er begrænset til 7 på hinanden følgende dage.
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflets
Danish: BILAG III Ændringer i relevante afsnit af produktresumeet, etiketteringen og indlægssedlen
English: [This wording should be inserted]
Danish: [Denne ordlyd skal indsættes]
English: It is used in adults and adolescents from 16 years onwards as an adjuvant treatment for painful muscular contractions.
Danish: Det anvendes til voksne og unge fra 16 år og opefter som en supplerende behandling ved smertefulde muskelsammentrækninger.
English: Studies in animals have shown teratogenic effects (see section 5.3).
Danish: Dyrestudier har vist teratogene virkninger (se pkt.
English: It is to be used for acute conditions related to spinal column.
Danish: Det skal bruges til akutte lidelser, der er relateret til rygsøjlen.
English: The corresponding values of AUC are respectively 283 and 417 ng.h/mL.
Danish: De tilsvarende værdier for AUC er henholdsvis 283 og 417 ng∙t/ml.
English: Paediatric population <Invented name> should not be used in children and adolescents under 16 years of age because of safety concerns (see section 5.3).
Danish: Pædiatrisk population <Særnavn> bør ikke anvendes til børn og unge under 16 år på grund af problemstillinger vedrørende sikkerhed (se pkt.
English: For both metabolites, maximum plasma concentrations occur 1hour after thiocolchicoside administration.
Danish: For begge metabolitter nås maksimale plasmakoncentrationer en time efter indgift af thiocolchicosid.
English: 4.6 Fertility, pregnancy and lactation [the currently approved wording should be deleted and replaced by the following]
Danish: 4.6 Fertilitet, graviditet og amning [den nuværende godkendte ordlyd skal slettes og erstattes af følgende]
English: This is based on laboratory studies (see section 2 “Warnings and precautions”).
Danish: Dette er fundet i laboratorieforsøg (se punkt 2 "Advarsler og forsigtighedsregler").
English: This is because the medicine passes into your breast-milk.
Danish: Dette skyldes, at lægemidlet udskilles i mælken.
English: In the rabbit, thiocolchicoside showed maternotoxicity starting from 24 mg/kg/day.
Danish: Hos kaniner viste thiocolchicosid maternal toksicitet startende ved 24 mg/kg/dag.
English: 4 mg [up to 30] hard capsules [up to 30] tablets
Danish: 4 mg [op til 30] hårde kapsler [op til 30] tabletter
English: - After oral administration, no thiocolchicoside is detected in plasma.
Danish: - Efter oral indgift er der ikke påvist thiocolchicosid i plasma.
English: Do not take this medicine if: - you are pregnant, might become pregnant or think you may be pregnant - you are a woman of childbearing potential not using contraception
Danish: Tag ikke dette lægemiddel, hvis: - du er gravid, planlægger at blive gravid eller har mistanke om, at du kan være gravid - du er en kvinde, der kan blive gravid, og ikke bruger prævention.
English: This medicine should not be used for long-term treatment (see section 2 “Warnings and precautions”).
Danish: Lægemidlet må ikke anvendes til langtidsbehandling (se punkt 2 "Advarsler og forsigtighedsregler").
English: No data are available for the inactive metabolite SL59.0955.
Danish: Der foreligger ingen data for den inaktive metabolit SL59.0955.
English: In humans, this type of damage to cells is a risk factor for cancer, harm to the unborn child, and impairment of male fertility.
Danish: Hos mennesker udgør denne type skader på celler en risikofaktor for kræft, skader på det ufødte barn og forringelse af mænds frugtbarhed.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for capsules, hard /tablets/orodispersible tablets and solution for injection
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Den udvendige karton til kapsler, hårde/ tabletter/smeltetabletter og injektionsvæske, opløsning
English: Strictly respect the doses and duration of treatment detailed in section 3.
Danish: Du skal overholde de doser og den behandlingsvarighed, der er beskrevet i punkt 3.
English: This medicine might cause problems to the male fertility due to potential damage to sperm cells (abnormal number of chromosomes).
Danish: Dette lægemiddel kan forårsage problemer med mænds frugtbarhed på grund af mulige skader på sædcellerne (unormalt antal kromosomer).
English: Thiocolchicoside profile has been assessed in vitro, and in vivo following parenteral and oral administration.
Danish: Thiocolchicosidprofilen er blevet vurderet in vitro og in vivo efter parenteral og oral indgift.
English: This is because one of the products formed in your body when taking thiocolchicoside at high doses might cause damage to some cells (abnormal number of chromosomes).
Danish: Dette skyldes, at et af de nedbrydningsprodukter, der dannes i kroppen, når du tager thiocolchicosid, kan forårsage skader på nogle celler (unormalt antal kromosomer) ved høje doser.
English: Thiocolchicoside was well tolerated following oral administration for periods of up to 6 months in both the rat and the non-human primate when administered at repeated doses of less than or equal to 2 mg/kg/day in the rat and less or equal to 2.5 mg/kg/day in non-human primate, and by the intramuscular route in the primate at repeated doses up to 0.5 mg/kg/day for 4 weeks.
Danish: Thiocolchicosid var veltolereret efter oral indgift i perioder på op til 6 måneder hos både rotter og nonhumane primater, når det blev indgivet i gentagne doser på mindre end eller lig med 2 mg/kg/dag til rotter og mindre end eller lig med 2,5 mg/kg/dag i non-humane primater, og ved intramuskulær indgift til primaterne ved gentagne doser på op til 0,5 mg/kg/dag i 4 uger.
English: Distribution The apparent volume of distribution of thiocolchicoside is estimated around 42.7 L after an IM administration of 8 mg. No data are available for both metabolites.
Danish: Den tilsyneladende fordelingsvolumen for thiocolchicosid er anslået til omkring 42,7 l efter i.m.injektion af 8 mg. Der foreligger ingen data for de to metabolitter.
English: [the currently approved indications should be deleted and replaced by the following]
Danish: [den nuværende godkendte ordlyd skal slettes og erstattes af følgende]
English: SL59.0955 is also demethylated into didemethyl-thiocolchicine.
Danish: SL59.0955 demetyleres også til didemethyl-thiocolchicin.
English: 4 mg/2 ml [up to 10] vials/ampoules
Danish: 4 mg/2 ml [op til 10] hætteglas/ampuller
English: How to take X [the currently approved wording should be deleted and replaced by the following]
Danish: Sådan skal du tage X [den nuværende godkendte ordlyd skal slettes og erstattes af følgende]
English: In the rat, an oral dose of 12 mg/kg/day of thiocolchicoside caused major malformations along with foetotoxicity (retarded growth, embryo death, impairment of sex distribution rate).
Danish: Hos rotter forårsagede en oral dosis thiocolchicosid på 12 mg/kg/dag alvorlige misdannelser sammen med føtotoksicitet (retarderet vækst, tab af embryon, påvirket kønsfordeling).
English: <Invented name> is contraindicated during pregnancy and in women of childbearing potential not using contraception (see section 4.3).
Danish: <Særnavn> er kontraindiceret under graviditet samt til kvinder i den fertile alder, som ikke bruger prævention (se pkt.
English: You can also report side effects directly via {the national reporting system listed in Appendix V}*.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen via {det nationale rapporteringssystem anført i Appendiks V}*.
English: This step mainly occurs by intestinal metabolism explaining the lack of circulating unchanged thiocolchicoside by this route of administration.
Danish: Dette trin forekommer hovedsageligt ved metabolisering i tarmen, hvilket forklarer manglen på cirkulerende, uomdannet thiocolchicosid efter oral indgift.
English: After oral administration of thiocolchicoside, the SL18.0740 metabolite is eliminated with an apparent t1/2 ranging from 3.2 to 7 hours and the metabolite SL59.0955 has a t1/2 averaging 0.8h.
Danish: Efter oral indgift af thiocolchicosid elimineres SL18.0740-metabolitten med en tilsyneladende t1/2, der spænder fra 3,2 til 7 timer, og metabolitten SL59.0955 har en t1/2 på gennemsnitligt 0,8 timer.
English: At high doses, thiocolchicoside induced emesis in dog, diarrhoea in rat and convulsions in both rodents and non-rodents after acute administration by oral route.
Danish: Ved høje doser inducerede thiocolchicosid emesis hos hunde, diarré hos rotter og kramper hos både gnavere og ikke-gnavere efter akut oral indgift.
English: SL18.0740 and SL59.0955 are found in urine and feces while the didemethyl-thiocolchicine is only recovered in feces.
Danish: SL18.0740 og SL59.0955 findes i urin og fæces, mens didemethyl-thiocolchicin kun genfindes i fæces.
English: For SL59.0955 these values are much lower: Cmax around 13 ng/mL and AUC ranging from 15.5 ng.h/mL (until 3h) to 39.7 ng.h/mL (until 24h).
Danish: De tilsvarende værdier for SL59.0955 er meget lavere: Cmax omkring 13 ng/ml og AUCværdier, der spænder fra 15,5 ng∙t/ml (indtil 3 timer) til 39,7 ng∙t/ml (indtil 24 timer).
English: Aneuploidy is considered as a risk factor for teratogenicity, embryo/foeto-toxicity, spontaneous abortion, and impaired male fertility and a potential risk factor for cancer.
Danish: Aneuploidi betragtes som en risikofaktor for teratogenicitet, embryon-/fostertoksicitet, spontan abort, nedsat fertilitet hos hanner og en potentiel risikofaktor for kræft.
English: If you accidentally take more X than you should talk to your doctor, pharmacist or nurse.
Danish: Hvis du ved et uheld har taget mere X, end du skal, skal du kontakte lægen, apotekspersonalet eller sundhedspersonalet.
English: Do not give this medicine to children and adolescents below 16 years old because of safety concerns.
Danish: Børn og unge Af sikkerhedshensyn må dette lægemiddel ikke gives til børn og unge under 16 år.
English: Aneuploidy is a modification in the number of chromosomes and loss of heterozygosity, which is recognized as a risk factor for teratogenicity, embryotoxicity/ spontaneous abortion, impaired male fertility, when impacting germ cells and a potential risk factor for cancer when impacting somatic cells.
Danish: Aneuploidi er en modifikation i antallet af kromosomer og tab af heterozygositet, hvilket er anerkendt som en risikofaktor for teratogenicitet, embryo-toksicitet/spontan abort, nedsat fertilitet hos hanner, når kønsceller er påvirkede, samt en potentiel kræftrisikofaktor, når somatiske celler er påvirkede.
English: SL59.0955 is then glucuroconjugated into SL18.0740 which has equipotent pharmacological activity to thiocolchicoside and thus supports the pharmacological activity after oral administration of thiocolchicoside.
Danish: Derefter konjugeres SL59.0955 med glukuronsyre til SL18.0740, som har farmakologisk aktivitet ækvipotent til thiocolchicosid og dermed understøtter den farmakologiske aktivitet efter oral indgift af thiocolchicosid.
English: The aneugenic effect of SL18.0740 was observed at concentrations in the in vitro test and at AUC plasma exposures in the in vivo test higher (more than 10 fold based on AUC) than those observed in human plasma at therapeutic doses.
Danish: Den aneugene effekt af SL18.0740 blev observeret ved koncentrationer i in vitro testen og ved AUC-plasmaeksponeringer i in vivo-testen, der er højere (mere end 10 gange baseret på AUC) end dem, der observeres i humant plasma ved terapeutiske doser.
English: After repeated administration, thiocolchicoside induced gastro-intestinal disorders (enteritis, emesis) by oral route and emesis by IM route.
Danish: Efter gentagen indgift inducerede thiocolchicosid gastrointestinale forstyrrelser (enteritis, emesis) efter oral indgift og emesis ved i.m.-indgift.
English: After a single oral dose of 8 mg of thiocolchicoside the Cmax and AUC of SL18.0740 are about 60 ng/mL and 130 ng.h/mL respectively.
Danish: Efter en enkelt oral dosis på 8 mg thiocolchicosid er Cmax og AUC for SL18.0740 henholdsvis ca. 60 ng/ml og 130 ng.h/ml.
English: Thiocolchicoside and its metabolites exert aneugenic activity at different concentration levels, which is recognised as a risk factor for impairment of human fertility.
Danish: Thiocolchicosid og dets metabolitter udøver aneugen aktivitet ved forskellige koncentrationsniveauer, hvilket er anerkendt som en risikofaktor for forringelse af fertiliteten hos mennesker.
English: Elimination - After IM administration the apparent t1/2 of thiocolchicoside is 1.5h and the plasma clearance 19.2 L/h.
Danish: Elimination - Efter i.m.-administration er den tilsyneladende t1/2 for thiocolchicosid 1,5 time og plasmaclearance 19,2 l/time.
English: Please discuss with your doctor if you have further questions.
Danish: Spørg lægen, hvis der er noget, du er i tvivl om.
English: No unchanged thiocolchicoside is excreted either in urine or feces.
Danish: Uomdannet thiocolchicosid udskilles hverken i urin eller fæces.
English: In a fertility study performed in rats, no impairment of fertility was seen at doses up to 12 mg/kg, i.e. at dose levels inducing no clinical effect.
Danish: I et fertilitetsstudie udført med rotter blev der ikke observeret nogen forringelse af fertiliteten ved doser på op til 12 mg/kg, dvs. ved dosisniveauer, der ikke inducerer nogen klinisk effekt.
English: 8 mg [up to 14] hard capsules [up to14] orodispersible tablets
Danish: 8 mg [op til 14] hårde kapsler [op til 14] smeltetabletter
English: Biotransformation After oral administration, thiocolchicoside is first metabolized in the aglycon 3demethyltiocolchicine or SL59.0955.
Danish: Efter oral indgift metaboliseres thiocolchicosid først til aglykonet 3-demethyltiocolchicin eller SL59.0955.
English: Thiocolchicoside and its metabolites exert aneugenic activity at different concentration levels, which is a risk factor for impairment of human fertility (see section 5.3).
Danish: Thiocolchicosid og dets metabolitter udøver aneugen aktivitet ved forskellige koncentrationsniveauer, hvilket er en risikofaktor for forringelse af fertiliteten hos mennesker (se pkt.
English: In a fertility study performed in rats, no impairment of fertility was seen at doses up to 12 mg/kg/day, i.e. at dose levels inducing no clinical effect.
Danish: I et fertilitetsstudie udført med rotter blev der ikke observeret nogen forringelse af fertiliteten ved doser på op til 12 mg/kg/dag, dvs. ved dosisniveauer, der ikke inducerer en klinisk effekt.
English: The presence of the aglycon metabolite (3-demethylthiocolchicine-SL59.0955) after intramuscular administration has never been assessed, therefore its formation using this route of administration can not be excluded.
Danish: Det er aldrig blevet undersøgt, om aglykon-metabolitten (3-demethylthiocolchicin - SL59.0955) er til stede efter intramuskulær indgift, derfor kan dannelse af 3-demethylthiocolchicin efter denne administrationsmåde ikke udelukkes.
English: Absorption - After IM administration, thiocolchicoside Cmax occur in 30 min and .reach values of 113 ng/mL after a 4 mg dose and 175 ng/mL after a 8 mg dose.
Danish: Absorption - Efter i.m.-administration nås thiocolchicosid-Cmax efter 30 min og når værdier på 113 ng/ml efter en dosis på 4 mg og 175 ng/ml efter en dosis på 8 mg.
English: This is because this medicine may harm your unborn child. Do not take this medicine if you are breast-feeding.
Danish: Dette skyldes, at dette lægemiddel kan skade dit ufødte barn.
English: As a precautionary measure, use of the product at doses exceeding the recommended dose or long-term use should be avoided (see section 4.2).
Danish: Som en forebyggende foranstaltning skal doser over den anbefalede dosis eller langvarig brug af præparatet undgås (se pkt.
English: The pharmacologically active metabolite SL18.0740 is also observed at lower concentrations with a Cmax of 11.7 ng/mL occurring 5 h post dose and an AUC of 83 ng.h/mL.
Danish: Den farmakologisk aktive metabolit SL18.0740 er også observeret ved lavere koncentrationer med Cmax på 11,7 ng/ml 5 timer efter dosering og en AUC på 83 ng∙t/ml.
English: 4.4 Special warnings and precautions for use
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen [ordlyden nedenfor skal indsættes]
English: The aglycon metabolite (3-demethylthiocolchicine-SL59.0955) formed mainly after oral administration induced in vitro chromosomal damage (in vitro micronucleus test on human lymphocytes) and in vivo chromosomal damage (in vivo oral micronucleus test in rat bone marrow administred orally).
Danish: Aglykon-metabolitten (3-demethylthiocolchicin - SL59.0955), der hovedsageligt dannes efter oral administration, inducerede in vitro kromosomskader (in vitro mikrokernetest på humane lymfocytter) og in vivo kromosomskader (in vivo mikrokernetest i knoglemarv hos rotter indgivet oralt).
English: Only two metabolites are observed: The pharmacologically active metabolite SL18.0740 and an inactive metabolite SL59.0955.
Danish: Den farmakologisk aktive metabolit SL18.0740 og en inaktiv metabolit SL59.0955.
English: Thiocolchicoside itself did not induce gene mutation in bacteria (Ames test), in vitro chromosomal damage (chromosome aberration test in human lymphocytes) and in vivo chromosomal damage (in vivo micronucleus in mouse bone marrow administered intraperitoneally).
Danish: Thiocolchicosid inducerede i sig selv ikke genmutation i bakterier (Ames-test), in vitro kromosomskader (kromosomafvigelsestest i humane lymfocytter) og in vivo kromosomskade (in vivo mikrokerne i knoglemarven hos mus indgivet intraperitonealt).
English: The aneugenic effect of SL59.0955 was observed at concentrations in the in vitro test and at exposures in the in vivo test close to those observed in human plasma at therapeutic doses of 8 mg twice daily per os. Aneugenic effect in dividing cells may result in aneuploid cells.
Danish: Den aneugene effekt af SL59.0955 blev observeret ved koncentrationer i in vitro testen og ved eksponeringer i in vivo testen tæt på dem, der blev observeret i humant plasma ved terapeutiske doser på 8 mg to gange dagligt oralt.
English: Contents of the pack and other information [the currently approved wording should be deleted and replaced by the following] 30 tablets/capsules for the 4mg dose and 14 tablets/capsules for the 8mg dose.
Danish: Pakningsstørrelser og yderligere oplysninger [den nuværende godkendte ordlyd skal slettes og erstattes af følgende] 30 tabletter / kapsler på 4 mg og 14 tabletter / kapsler på 8 mg. 10 hætteglas / ampuller for 4 mg / 2 ml dosis.
English: Since it passes into the mother's milk, the use of thiocolchicoside is contraindicated during breastfeeding (see section 4.3).
Danish: Amning Da thiocolchicosid udskilles i mælken, er brugen af det kontraindiceret under amning (se pkt.