FrancophonIA/ELRC3.0 huggingface dataset:
English: For [indication*] Use only once a week on ………………………………………………………………(include weekday of use in full) *[Indication] should be inserted by the MAHs in grouped terms, e.g. colitis, arthritis, psoriasis, where applicable.
Danish: Mod [indikation*] Må kun anvendes én gang ugentligt hver …………………………………………………………….. (skriv tydeligt hvilken ugedag lægemidlet skal tages) *[Indikation] skal indsættes af indehaverne af markedsføringstilladelserne i grupperede termer, f.eks. colitis, artritis, psoriasis, hvor det er relevant.
English: Tablet
Danish: 250 µg Tablet
English: 17 January 2014 EMA/40615/2014
Danish: Den 17. januar 2014 EMA/40615/2014
English: These medicines are therefore not affected by these recommendations.
Danish: Disse lægemidler er derfor ikke omfattet af disse anbefalinger.
English: Czech Republic, France, Greece, Hungary, Italy, Malta, Portugal and Spain.
Danish: Tjekkiet, Frankrig, Grækenland, Ungarn, Italien, Malta, Portugal og Spanien.
English: Women who might become pregnant must use contraception when taking these medicines.
Danish: Kvinder, der kan blive gravide, skal bruge prævention, når de tager disse lægemidler.
English: • Patients who have any questions should discuss them with their doctor or pharmacist.
Danish: • Patienter, der har spørgsmål, bør drøfte dem med lægen eller apotekspersonalet.
English: Educational materials for prescribers and patients will also be prepared.
Danish: Der vil desuden blive udarbejdet oplysningsmateriale til ordinerende læger og patienter.
English: The review of systemic thiocolchicoside-containing medicines was triggered on 15 February 2013 at the request of Italy, under Article 31 of Directive 2001/83/EC.
Danish: Gennemgangen af ikke-lokale (systemiske) lægemidler indeholdende thiocolchicosid blev indledt den 15. februar 2013 på anmodning af Italien i medfør af artikel 31 i direktiv 2001/83/EF.
English: When given intramuscularly, the maximum dose should be 4 mg every 12 hours, for up to 5 days.
Danish: Ved intramuskulær indgift er den maksimale dosis 4 mg hver 12. time i op til 5 dage.
English: Thiocolchicoside is authorised through national procedures in the Czech Republic, France, Greece, Hungary, Italy, Malta, Portugal and Spain.
Danish: Thiocolchicosid er godkendt ved nationale procedurer i Tjekkiet, Frankrig, Grækenland, Ungarn, Italien, Malta, Portugal og Spanien.
English: • Treatment should now only be given for 7 days by mouth or 5 days by injection into the muscle.
Danish: • Behandlingen bør nu kun vare i 7 dage ved indgift gennem munden eller i 5 dage ved injektion i en muskel.
English: It is thought to act on receptors in the nervous system that are involved in the regulation of muscle function.
Danish: Det menes at virke på de receptorer i nervesystemet, der medvirker i reguleringen af muskelfunktionen.
English: • The maximum recommended oral dose is 8 mg every 12 hours; treatment duration should be no more than 7 consecutive days.
Danish: • Den anbefalede maksimale orale dosis er 8 mg hver 12. time, og behandlingstiden bør ikke overstige 7 konsekutive dage.
English: The CHMP therefore recommended measures to ensure thiocolchicoside-containing medicines are used as safely as possible.
Danish: CHMP anbefalede derfor foranstaltninger, der skal sikre, at lægemidler indeholdende thiocolchicosid anvendes så risikofrit som muligt.
English: The Committee's recommendations were based on a review of available data from pre-clinical and clinical studies, published literature and post-marketing experience, and consultations with an expert working party on medicines safety.
Danish: CHMP's anbefalinger var baseret på en gennemgang af foreliggende data fra prækliniske og kliniske undersøgelser, den publicerede litteratur og erfaringer efter markedsføring samt drøftelser med en arbejdsgruppe af eksperter i lægemiddelsikkerhed.
English: On 21 November 2013 the European Medicines Agency's Committee on Human Medicinal Products (CHMP) recommended that the authorised uses for thiocolchicoside-containing medicines for use by mouth or injection should be restricted across the European Union (EU).
Danish: Den 21. november 2013 anbefalede Det Europæiske Lægemiddelagenturs Udvalg for Lægemidler til Mennesker (CHMP), at de godkendte anvendelser af lægemidler indeholdende thiocolchicosid til oral indgift og injektion begrænses i hele Den Europæiske Union (EU).
English: These include restricting the maximum dose and number of days of treatment when given by mouth or injection.
Danish: Disse består i begrænsning af maksimaldosis og antal behandlingsdage, når lægemidlet indgives gennem munden eller ved injektion.
English: • Prescribers will be sent a letter giving them further information on the restriction of indication of systemic thiocolchicoside.
Danish: • Ordinerende læger vil få tilsendt et brev med yderligere information om begrænsning i indikationen for systemisk thiocolchicosid.
English: In some countries it is also available as preparations to be applied to the skin, but these latter preparations are not affected by this review.
Danish: I nogle lande fås det desuden som hudpræparater, som dog ikke er omfattet af denne gennemgang.
English: As a result AIFA asked the CHMP to examine the safety profile of this medicine and consider what regulatory action might be appropriate.
Danish: AIFA anmodede derfor CHMP om at undersøge lægemidlets sikkerhedsprofil og tage stilling til, hvilke myndighedsindgreb der ville være hensigtsmæssige.
English: The Committee concluded that in the light of current evidence the benefit-risk for the medicine remained positive provided appropriate risk-mitigating measures were taken, including restricting the maximum dose and duration of use and contra-indicating use during pregnancy and lactation and in children.
Danish: Udvalget konkluderede på baggrund af den foreliggende evidens, at benefit/riskforholdet for lægemidlet fortsat var positivt under forudsætning af hensigtsmæssige risikobegrænsende foranstaltninger, herunder begrænsning af den maksimale dosis og anvendelsesvarighed samt kontraindikation under graviditet og amning og hos børn.
English: The Italian medicines regulatory authority therefore requested the CHMP to carry out a full assessment of the benefit-risk balance of systemic medicines containing thiocolchicoside, and issue an opinion on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across the European Union.
Danish: Den italienske lægemiddelstyrelse bad derfor CHMP om at foretage en fyldestgørende vurdering af forholdet mellem fordele og risici for systemiske lægemidler indeholdende thiocolchicosid og fremsætte en udtalelse om, hvorvidt markedsføringstilladelserne burde opretholdes, ændres, suspenderes eller inddrages i hele EU.
English: Thiocolchicoside metabolites were not associated with mutagenicity (changes to genes) or clastogenicity (structural damage to chromosomes).
Danish: Thiocolchicosids metabolitter var ikke forbundet med mutagenicitet (ændring i gener) eller klastogenicitet (strukturel kromosomskade).
English: • The current findings do not apply to topical preparations of thiocolchicoside.
Danish: • De nævnte resultater gælder ikke topikale præparater af thiocolchicosid.
English: It is available for use by mouth or by injection into the muscles.
Danish: Det indgives gennem munden eller ved injektion i muskler.
English: Patients who are taking thiocolchicoside for a long-term condition should have their treatment reviewed by their doctor at the next scheduled appointment.
Danish: Patienter, der tager thiocolchicosid i forbindelse med en langvarig sygdom, bør få deres behandling gennemgået af lægen ved næste planlagte konsultation.
English: In theory, long-term exposure might increase the risk of cancer although there is currently no evidence of this.
Danish: I teorien kan langvarig udsættelse for stoffet medføre øget kræftrisiko, men der er ingen iagttagelser heraf indtil nu.
English: • It is not recommended for longer-term treatment of chronic conditions.
Danish: • Det frarådes nu anvendt til længerevarende behandling af kroniske sygdomme.
English: Medicine only to be used at low doses for additional short-term relief of painful muscle contractures
Danish: Lægemidlet bør kun anvendes supplerende i lave doser til kortvarig lindring af smertefulde muskelkontrakturer
English: In theory it also increases the risk of cancer, although any significantly increased cancer risk would in general be dependent on long-term exposure to the causative substance.
Danish: Teoretisk øger det også kræftrisikoen, skønt nævneværdig øget kræftrisiko sædvanligvis forudsætter langvarig eksponering for det forårsagende stof.
English: The CHMP opinion was forwarded to the European Commission, which endorsed it and issued a final legally-binding decision, valid across the EU, on 17 January 2014.
Danish: CHMP's udtalelse blev overgivet til Europa-Kommissionen, som godkendte den og den 17. januar 2014 vedtog en endelig og retligt bindende beslutning med gyldighed i hele EU.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally-binding decision, valid across the EU, on 17 January 2014.
Danish: CHMP's udtalelse blev overgivet til Europa-Kommissionen, som den 17. januar 2014 vedtog en endelig og retligt bindende beslutning med gyldighed i hele EU.
English: The CHMP reviewed the evidence, including the opinions of experts in the field of medicines safety, and concluded that aneuploidy could occur with M2 at levels not much greater than those seen after recommended doses of thiocolchicoside taken by mouth.
Danish: CHMP gennemgik dokumentationen, herunder udtalelser fra eksperter inden for lægemiddelsikkerhed, og konkluderede, at der kunne optræde aneuploidi med M2 i koncentrationer, der ikke var meget større end de, der ses efter de anbefalede doser af thiocolchicosid ved indtagelse gennem munden.
English: Aneuploidy is a risk factor for harm to the developing fetus, reduced fertility in men and in theory could increase the risk of developing cancer.
Danish: Aneuploidi er en risikofaktor for fosterskade, nedsat frugtbarhed hos mænd og teoretisk også øget kræftrisiko.
English: • In order to minimise the amount of M2 produced in the body, and therefore any associated risks, medicines containing thiocolchicoside are now only recommended for short-term use as an addition to other treatment for pain due to permanent tightening of the muscles where there are problems with the spine, in adults and teenagers from 16 years of age.
Danish: • For at minimere den mængde M2, der produceres i kroppen, og alle tilknyttede risici, anbefales lægemidler indeholdende thiocolchicosid nu kun anvendt kortvarigt som tillægsbehandling til anden smertebehandling ved vedholdende muskelspændinger, der skyldes lidelser i rygsøjlen hos voksne og unge over 16 år.
English: In addition, the dose of thiocolchicoside by mouth or injection should be restricted.
Danish: Desuden bør dosis af thiocolchicosid til oral indgift og injektion begrænses.
English: • Thiocolchicoside-containing medicines are also available for application to the skin but these do not produce the same levels of M2 in the body and are not thought to affect the genetic material of cells.
Danish: • Lægemidler indeholdende thiocolchicosid findes også til brug på huden, men frembringer ikke samme mængder M2 i kroppen og menes derfor ikke at påvirke cellernes arvemateriale.
English: Preclinical studies indicated that the thiocolchicoside metabolite 3demethylthiocolchicine (M2, SL59.0955) may be associated with aneuploidy (abnormal chromosome number and loss of heterozygosity) in dividing cells, at levels of exposure not much greater than those achieved in the body with maximum recommended oral doses.
Danish: Prækliniske undersøgelser tydede på, at thiocolchicosids metabolit 3-demethylthiocolchicin (M2, SL59.0955) kan være forbundet med aneuploidi (abnormt kromosomantal og tab af heterozygositet) hos celler under deling ved et eksponeringsniveau, der ikke er ret meget højere end det, der fremkommer i kroppen ved de anbefalede maksimale orale doser.
English: • New evidence has shown that thiocolchicoside is broken down in the body into a substance called M2, which in sufficient amounts can affect the genetic material of the cells.
Danish: • Nye resultater har vist, at thiocolchicosid i kroppen nedbrydes til stoffet M2, som i tilstrækkelige mængder kan påvirke cellernes arvemateriale.
English: Thiocolchicoside is a muscle relaxant that has been authorised by national procedures in several EU Member States1 for use by mouth or injection into the muscles in the treatment of painful muscular disorders.
Danish: Thiocolchicosid er et muskelafslappende middel, der ved nationale procedurer i flere EUmedlemsstater1 er godkendt til oral indgift eller injektion i musklerne til behandling af smertefulde muskellidelser.
English: Aneuploidy is an established risk factor for teratogenicity, embryotoxicity or spontaneous abortion, and impaired male fertility.
Danish: Aneuploidi er en kendt faktor for teratogenicitet, embryotoksicitet og spontanabort samt nedsat fertilitet hos manden.
English: • Thiocolchicoside is a medicine used in some EU countries for conditions associated with muscle pain.
Danish: • Thiocolchicosid er et lægemiddel, der i nogle EU-lande anvendes til sygdomme, som er forbundet med muskelsmerter.
English: • Patients being treated with systemic thiocolchicoside should have their treatment reviewed at the next scheduled appointment, and appropriate alternative treatments should be considered.
Danish: • Patienter i behandling med systemisk thiocolchicosid bør få behandlingen gennemgået ved næste planlagte konsultation hos lægen, og der bør overvejes andre egnede behandlingsmuligheder.
English: The review of thiocolchicoside was triggered by the Italian medicines regulatory agency, AIFA, following new experimental evidence which suggested that thiocolchicoside was broken down in the body into a metabolite called M2 or SL59.0955 that could damage dividing cells, resulting in aneuploidy (an abnormal number or arrangement of chromosomes).
Danish: Gennemgangen af thiocolchicosid blev udløst af den italienske lægemiddelstyrelse, AIFA, efter at nye forsøgsdata viste, at thiocolchicosid i kroppen blev omdannet til nedbrydningsproduktet M2 eller SL59.0955, som kunne være skadeligt for celler under deling, der derved fik et unormalt antal eller arrangement af kromosomerne (aneuploidi).
English: • Medicines containing thiocolchicoside should not be used during pregnancy and lactation, nor in women of childbearing potential who are not taking appropriate contraceptive measures.
Danish: • Lægemidler indeholdende thiocolchicosid bør ikke anvendes under graviditet og amning eller hos kvinder, der er i den fødedygtige alder og ikke anvender tilstrækkelig antikonception.
English: This results in an abnormal number or arrangement of chromosomes, which can reduce fertility in men and, if it happens during pregnancy, can harm the developing baby in the womb.
Danish: Dette resulterer i et abnormt antal eller arrangement af kromosomerne, hvilket kan give nedsat frugtbarhed hos mænd og fosterskader ved udsættelse under graviditet.
English: • Systemic thiocolchicoside is recommended only as adjuvant treatment for acute muscle contractures in spinal pathology, for adults and adolescents from 16 years of age.
Danish: • Systemisk thiocolchicosid anbefales kun som adjuvant behandling af akutte muskelkontrakturer ved patologiske tilstande i columna hos voksne og unge over 16 år.
English: These medicines are now recommended only as an add-on treatment for painful muscle contractures (permanent tightening of the muscle tissue) resulting from spinal conditions in adults and adolescents 16 years of age or older.
Danish: Disse lægemidler anbefales nu kun som tillægsbehandling af smertefuld vedvarende muskelsammentrækning (kontrakturer) som følge af rygmarvslidelser hos voksne og unge over 16 år.
English: Thiocolchicoside is used as a muscle relaxant in the treatment of painful muscular conditions.
Danish: Thiocolchicosid anvendes som muskelafslappende middel til behandling af smertefulde muskelsygdomme.
English: Use is also contra-indicated in pregnancy and lactation or in women of childbearing potential not using contraception, as well as in children or for chronic (long-term) conditions.
Danish: Desuden må thiocolchicosid ikke anvendes under graviditet og amning eller hos kvinder, der er i den fødedygtige alder og ikke anvender prævention, hos børn eller til langvarige (kroniske) sygdomme.
English: This followed new evidence from experimental studies carried out by a marketing authorisation holder which suggested an effect on chromosomes by a metabolite of thiocolchicoside.
Danish: Dette fulgte efter, at indehaveren af markedsføringstilladelsen havde udført nye forsøg, der tydede på, at et nedbrydningsprodukt af thiocolchicosid påvirker kromosomerne.
English: Preparations for local application to the skin, which do not produce substantial levels of M2 in the body, are not affected by this review.
Danish: Denne gennemgang omfatter ikke præparater, der påføres lokalt på huden og ikke frembringer væsentlige mængder M2 i kroppen.
English: • Pharmacists should refer any patients who present a repeat prescription to their treating physician.
Danish: • Patienter, der på apoteket fremviser en fornyet recept, bør henvises til den behandlende læge.
English: • Medicines containing thiocolchicoside must never be taken if you are pregnant or breast-feeding.
Danish: • Hvis du er gravid eller ammer, må du aldrig tage lægemidler indeholdende thiocolchicosid.
English: Annex I List of the names, pharmaceutical forms, strength of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States
Danish: Bilag I Liste over navne, lægemiddelformer, lægemiddelstyrker, administrationsveje, indehavere af markedføringstilladelser i medlemsstaterne
English: Intravenous use Intrapleural use Intraperitoneal use
Danish: Intravenøs anvendelse, intrapleural anvendelse Intraperitoneal anvendelse
English: Concentrate for solution for infusion or solution for intrapleural or intraperitoneal use
Danish: Koncentrat til infusionsvæske, opløsning, eller opløsning til intrapleural eller intraperitoneal anvendelse
English: MEDA Pharma S.p.A. Viale Brenta 18 IT-20139
Danish: Felice Casati, 20 IT-20124
English: Slovenia
Danish: Sverige
English: The majority of the cases express non-serious and self-limiting conditions.
Danish: Størstedelen af disse tilfælde viser sig som ikke-alvorlige og selvbegrænsende tilstande.
English: The medicine should be taken after meals with a glass of water.
Danish: Lægemidlet skal tages efter måltider med et glas vand.
English: The safety profile of tolperisone containing tablets is supported by data on more than 12,000 patients.
Danish: Sikkerhedsprofilen for tabletter, der indeholder tolperison, understøttes af data fra mere end 12.000 patienter.
English: confusion (very rare), hyperhidrosis (rare)
Danish: konfusion (meget sjælden), hyperhidrose (sjælden)
English: Tolperisone does not influence the CNS effects of alcohol.
Danish: Tolperison har ingen indflydelse på alkohols virkning på CNS.
English: Insufficient food intake may decrease the bioavailability of tolperisone.
Danish: Utilstrækkelig fødeindtagelse kan nedsætte tolperisons biotilgængelighed.
English: In this case talk to your doctor before starting the treatment.
Danish: Hvis det er tilfældet, skal du tale med lægen, før du starter behandlingen.
English: 4.1 Therapeutic indications [the currently approved indications should be deleted and replaced by the following]
Danish: 4.1 Terapeutiske indikationer [de nuværende godkendte indikationer skal slettes og erstattes af følgende]
English: If you feel these symptoms stop taking this medicine immediately and contact your doctor or the nearest emergency department.
Danish: Hvis du bemærker disse symptomer, skal du straks stoppe med at tage dette lægemiddel og kontakte lægen eller den nærmeste skadestue.
English: Life-threatening hypersensitivity reactions are reported very rarely.
Danish: Livstruende overfølsomhedsreaktioner er rapporteret meget sjældent.
English: SUMMARY OF PRODUCT CHARACTERISTICS (TOLPERISONE-CONTAINING ORAL FORMULATIONS)
Danish: PRODUKTRESUME (ORALE FORMULERINGER INDEHOLDENDE TOLPERISON)
English: Annex III Relevant sections of the summary of product characteristics and package leaflet
Danish: BILAG III RELEVANTE AFSNIT AF PRODUKTRESUME OG INDLÆGSSEDDEL
English: Therefore the preparation can be combined with sedatives, hypnotics and tranquillisers.
Danish: Derfor kan det kombineres med sedativer, hypnotika og beroligende lægemidler.
English: Hypersensitivity reactions:
Danish: Overfølsomhedsreaktioner:
English: Rare side effects …increased sweating
Danish: Sjældne bivirkninger …øget svedtendens
English: Very rare side effects …confusion, severe allergic reaction (allergic shock)
Danish: Meget sjældne bivirkninger …konfusion, alvorlig allergisk reaktion (allergisk shock)
English: In vitro experiments in human liver microsomes and human hepatocytes did not suggest significant inhibition or induction of other CYP isoenzymes (CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP1A2, CYP3A4).
Danish: In vitro eksperimenter med humane lever-mikrosomer og humane hepatocytter tyder ikke på signifikant hæmning eller induktion af andre CYP-isoenzymer (CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP1A2, CYP3A4).
English: In post-marketing data, hypersensitivity reactions associated with tolperisone administration account for about 50-60% of the reported cases.
Danish: I data efter markedsføring af tolperison udgør overfølsomhedsreaktioner cirka 50-60% af de rapporterede tilfælde.
English: In the case of co-administration with other centrally acting muscle relaxants, the dose reduction of tolperisone should be considered.
Danish: Ved administration samtidigt med andre centralt virkende muskelrelaksantia bør reduktion af tolperisondosis overvejes.
English: Although tolperisone is a centrally acting compound, it does not induce sedation.
Danish: Selvom tolperison er en centralt virkende forbindelse så inducerer det ikke sedation.
English: High-fat meal increases the bioavailability of orally administered tolperisone by approx. 100% and increases the peak plasma concentration by approx. 45% as compared with fasting condition, delaying time to peak by approx. 30 minutes.
Danish: Meget fedtholdige måltider øger biotilgængeligheden af oralt administreret tolperison med cirka 100% og den maksimale plasmakoncentration med cirka 45% sammenlignet med fastende tilstand, hvor tiden til maksimum forsinkes med cirka 30 minutter.
English: Patients should be advised to remain vigilant for any symptoms compatible with hypersensitivity and to stop tolperisone and seek medical advice immediately if such symptoms occur.
Danish: Patienter skal informeres om fortsat at være opmærksomme på ethvert symptom, der er forligeligt med overfølsomhed, og om omgående at seponere tolperison og søge lægehjælp, hvis disse symptomer opstår.
English: The bioavailability of tolperisone is decreased when taken without food, therefore consistent administration in relation to meals is recommended (see also sections 4.2 and 5.2).
Danish: Tolperisons biotilgængelighed nedsættes, når det tages uden føde, derfor anbefales ensartet administration i forhold til måltider (se også pkt.
English: Although tolperisone is a centrally acting compound, its potential to cause sedation is low.
Danish: På trods af at tolperison virker centralt, er dets potentiale til at medføre sedation lavt.
English: PACKAGE LEAFLET (TOLPERISONE-CONTAINING ORAL FORMULATIONS) [the wording below should be inserted in the relevant sections]
Danish: INDLÆGSSEDDEL (ORALE FORMULERINGER INDEHOLDENDE TOLPERISON) [ordlyden nedenfor skal indsættes i de relevante afsnit]