FrancophonIA/ELRC3.0 huggingface dataset:
English: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom - Zinnat Germany - Elobact
Danish: Belgien, Bulgarien, Cypern, Danmark, Estland, Finland, Frankrig, Holland, Irland, Island, Italien, Letland, Litauen, Luxembourg, Malta, Polen, Rumænien, Slovakiet, Slovenien, Spanien, Storbritannien, Sverige, Tjekkiet, Tyskland, Ungarn, Østrig - Zinnat Tyskland - Elobact
English: Candida overgrowth
Danish: Candidaovervækst
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION {DD month YYYY} [To be completed nationally]
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Patients with known hypersensitivity to cephalosporin antibiotics.
Danish: 6.1. atienter med verificeret overfølsomhed over for cefalosporiner.
English: Austria, Bulgaria, Czech Republic, Denmark, Estonia, France, Germany, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, Netherlands, Poland, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom - Zinnat
Danish: Belgien, Bulgarien, Danmark, Estland, Frankrig, Holland, Irland, Island, Italien, Letland, Litauen, Luxembourg, Malta, Polen, Rumænien, Slovakiet, Slovenien, Spanien, Storbritannien, Sverige, Tjekkiet, Tyskland, Ungarn, Østrig - Zinnat
English: Oral anticoagulants
Danish: Blodfortyndende medicin (orale antikoagulantia).
English: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Romania, Slovakia, Slovenia, Spain, United Kingdom - Zinnat
Danish: Belgien, Bulgarien, Cypern, Danmark, Estland, Frankrig, Holland, Irland, Italien, Letland, Litauen, Luxembourg, Malta, Polen, Rumænien, Slovakiet, Slovenien, Spanien, Storbritannien, Tjekkiet, Tyskland, Ungarn, Østrig - Zinnat
English: Remove the cap and the heat-seal membrane.
Danish: Fjern hætten og forseglingen.
English: 90 to 180
Danish: på 125
English: 250 mg granules for oral suspension Austria, Italy, Spain, United Kingdom - Zinnat Italy - Oraxim
Danish: Belgien, Italien, Luxembourg, Spanien, Storbritannien, Østrig - Zinnat Italien - Oraxim
English: 2 pre-filled pens
Danish: 2 fyldte penne
English: 6 (3 x 2) prefilled pens (multipack)
Danish: 6 (3 x 2) fyldte penne (multipakning)
English: Initiation pack: 1 pre-filled syringe (63 µg) + 1 pre-filled syringe (94 µg)
Danish: Startpakke: 1 fyldt sprøjte (63µg) + 1 fyldt sprøjte (94µg)
English: Initiation pack: 1 pre-filled pen (63 µg) + 1 pre-filled pen (94 µg)
Danish: Startpakke: 1 fyldt pen (63µg) + 1 fyldt pen (9µg)
English: 20 December 2013 EMA/13239/2014 Corr. 1
Danish: Den 20. december 2013 EMA/13239/2014 Corr. 1
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: Detailed recommendations for patients and healthcare professionals are available below.
Danish: Detaljerede anbefalinger for patienter og sundhedspersoner er givet nedenfor.
English: Changes aim mainly to reduce the risk of neurological side effects
Danish: Ændringerne har hovedsagelig til formål at nedsætte risikoen for neurologiske bivirkninger
English: The review of metoclopramide-containing medicines was initiated in December 2011 at the request of France, under Article 31 of Directive 2001/83/EC.
Danish: Gennemgangen af lægemidler indeholdende metoclopramid blev indledt i december 2011 på anmodning af Frankrig i henhold til artikel 31 i direktiv 2001/83/EF.
English: • Extrapyramidal disorders constituted nearly half of all spontaneously reported adverse effects in a manufacturer database (1749 cases out of 4005, up to December 2011).
Danish: • Ekstrapyramidale forstyrrelser udgjorde næsten halvdelen af alle spontant indberettede bivirkninger i en fremstillers database (1 749 tilfælde ud af 4 005 indtil december 2011).
English: Use is contraindicated in children under 1 year of age.
Danish: Det er kontraindiceret til børn under 1 år.
English: The product information has been amended appropriately, and prescribers sent further communication at a national level.
Danish: Produktinformationen er ændret tilsvarende, og de ordinerende læger har på nationalt plan fået tilsendt yderligere information.
English: • Intravenous formulations with concentrations above 5 mg/ml and suppositories containing 20 mg will also be withdrawn.
Danish: • Intravenøse formuleringer med koncentration over 5 mg/ml og suppositorier indeholdende 20 mg skal ligeledes trækkes tilbage.
English: There have also been very rare cases of serious effects on the heart or circulation, particularly after injection.
Danish: Der har desuden været meget sjældne tilfælde af alvorlige bivirkninger fra hjertet eller kredsløbet, navnlig efter injektion.
English: Metoclopramide-containing medicines have been authorised by national procedures in all the Member States of the EU and have been available for many years under different trade names.
Danish: Lægemidler indeholdende metoclopramid har været godkendt ved nationale procedurer i alle EU's medlemsstater og har været på markedet i mange år under forskellige handelsnavne.
English: • Metoclopramide should no longer be used in children under 1 year old.
Danish: • Metoclopramid bør ikke længere anvendes til børn under 1 år.
English: • Intravenous doses should be administered as a slow bolus over at least 3 minutes to reduce the risk of adverse effects.
Danish: • Intravenøse doser bør administreres som en langsom bolus over mindst 3 minutter for at mindske risikoen for bivirkninger.
English: Following this assessment and the issuing of the CHMP's original opinion, one of the companies producing metoclopramide-containing medicines exercised its legal right to ask for a re-examination of the opinion, which was duly carried out.
Danish: Efter denne gennemgang og afgivelsen af CHMP's oprindelige udtalelse gjorde en af de virksomheder, der fremstiller lægemidler indeholdende metoclopramid, sin ret gældende til at anmode om en fornyet overvejelse af udtalelsen, hvilket fandt sted behørigt.
English: ANSM asked the CHMP to review the benefits and risks of these medicines in all age groups and to recommend consistent indications across the EU.
Danish: ANSM anmodede CHMP om at gennemgå fordele og risici ved disse lægemidler hos alle aldersgrupper og anbefale ensartede indikationer i hele EU.
English: There were also a significant number of reports of overdose in children, particularly with oral liquid formulations.
Danish: Der var desuden et betydeligt antal indberetninger om overdosering hos børn, navnlig med orale flydende formuleringer.
English: The reporting rate for these disorders was calculated to be 6 times higher in children than in adults, although it was not possible to accurately account for usage patterns in different age-groups.
Danish: Indberetningsfrekvensen for disse forstyrrelser blev beregnet til at være seks gange højere hos børn end hos voksne, skønt der ikke kunne redegøres nøjagtigt for anvendelsesmønstret hos forskellige aldersgrupper.
English: • Patients who are currently taking regular metoclopramide should have their treatment reviewed at a routine (non-urgent) medical appointment.
Danish: • Patienter, der på nuværende tidspunkt er i løbende behandling med metoclopramid, bør få behandlingen gennemgået ved en rutinemæssig (ikke-hastende) konsultation hos lægen.
English: • The recommended maximum dose of the medicine has been lowered in adults to a total of 30 mg a day, and some high dose products will be removed from the market as they will no longer be needed.
Danish: • Den anbefalede maksimale dosis af lægemidlet hos voksne er nedsat til i alt højst 30 mg dagligt, og visse højdosispræparater skal tages af markedet, da der ikke længere er behov for dem.
English: Evidence to support a role as an adjunct in surgical and radiological procedures was also lacking.
Danish: Ligeledes savnes evidens for en rolle som supplement ved kirurgiske og radiologiske procedurer.
English: • In other longer lasting conditions, the benefits of this medicine do not outweigh the risks of side effects.
Danish: • Til andre længerevarende sygdomme overstiger lægemidlets fordele ikke risiciene for bivirkninger.
English: The evidence indicated that these risks outweighed the benefits of metoclopramide in conditions requiring long-term treatment.
Danish: Dokumentationen viste, at disse risici oversteg fordelene ved metoclopramid til sygdomme, der kræver langvarig behandling.
English: Elderly patients seemed to be more at risk of potentially irreversible tardive dyskinesia after longer term treatment.
Danish: Ældre patienter syntes at have større risiko for potentielt irreversibel tardiv dyskinesi efter langvarig behandling.
English: This followed a re-examination, at the request of a marketing authorisation holder, of the opinion originally given by the Committee on 26 July 2013.
Danish: Forinden havde udvalget på anmodning af en markedsføringstilladelsesindehaver foretaget en fornyet overvejelse af sin oprindelige udtalelse af 26. juli 2013.
English: Such oral liquids have been associated with overdose in children.
Danish: Sådanne orale væsker har været forbundet med overdosering hos børn.
English: A dosing table for use in children will be included in the product information.
Danish: I produktinformationen vil der blive indsat en doseringstabel for børn.
English: On 24 October the European Medicines Agency's Committee on Medicinal Products for Human Use (CHMP) confirmed previously recommended changes to the use of metoclopramide-containing medicines in the European Union (EU), including restricting the dose and duration of use of these medicines to minimise the known risks of potentially serious neurological (brain and nerve) side effects.
Danish: Den 24. oktober bekræftede Det Europæiske Lægemiddelagenturs Udvalg for Lægemidler til Mennesker (CHMP) de tidligere anbefalede ændringer i anvendelsen af lægemidler indeholdende metoclopramid i EU, heriblandt at dosis og anvendelsesvarighed for disse lægemidler begrænses for at minimere de kendte risici for potentielt alvorlige bivirkninger fra hjernen og nerverne (neurologiske bivirkninger).
English: In children the recommended dose is 0.1 to 0.15 mg per kg body weight, repeated up to three times daily.
Danish: Hos børn er den anbefalede dosis 0,1-0,15 mg/kg legemsvægt, der gentages op til tre gange dagligt.
English: • For adults and children the maximum dose in 24 hours is 0.5 mg per kg body weight; in adults, the usual dose of conventional formulations (all routes) is 10 mg up to 3 times daily.
Danish: • Til voksne og børn er maksimumdosis i løbet af 24 timer 0,5 mg/kg legemsvægt; hos voksne er den sædvanlige dosis af sædvanlige formuleringer (alle administrationsveje) 10 mg op til tre gange dagligt.
English: It is given by injection, by mouth, or as suppositories.
Danish: Det indgives ved injektion, gennem munden eller som stikpiller.
English: This included published studies and meta-analyses on the efficacy of metoclopramide and analyses of reports of suspected adverse reactions.
Danish: Dette omfattede publicerede undersøgelser og metaanalyser om virkningen af metoclopramid samt analyser af indberetninger af formodede bivirkninger.
English: • If you are taking metoclopramide (especially for long-term conditions) you will have your treatment reviewed by your doctor at your next scheduled appointment, and in some cases you may be recommended a different treatment.
Danish: • Hvis du får metoclopramid (navnlig ved længerevarende sygdomme), skal du få din behandling gennemgået af lægen ved næste planlagte konsultation, hvor lægen kan tænkes at ville anbefale et behandlingsskift.
English: Given the known risk of neurological and other adverse effects, particularly in children and young people, the Committee concluded that the indications for metoclopramide should be restricted to those involving short-term use, at a maximum dose of 0.5 mg per kg body weight daily, and where there is sufficient evidence of efficacy.
Danish: På baggrund af den kendte risiko for neurologiske og andre bivirkninger, navnlig hos børn og unge, konkluderede udvalget, at indikationerne for metoclopramid bør begrænses til korttidsanvendelse med en maksimal dosis på 0,5 mg/kg legemsvægt dagligt og til indikationer med tilstrækkelig evidens for virkning.
English: Following the re-examination, the final CHMP recommendation was then sent to the European Commission, which adopted it with an EU-wide legally binding decision on 20 December 2013.
Danish: Efter den fornyede overvejelse blev CHMP's endelige anbefaling overgivet til Europa-Kommissionen, som den 20. december 2013 vedtog den ved en retligt bindende afgørelse for hele EU.
English: • Oral liquid formulations have been particularly associated with overdose in children.
Danish: • Orale flydende formuleringer har specielt været sat i forbindelse med overdosering hos børn.
English: There was also some evidence suggestive of a role in radiotherapy-induced nausea and vomiting, although again it seemed to be less effective than the 5-HT3 antagonists.
Danish: Der var desuden nogen evidens for en rolle ved stråleterapiinduceret kvalme og opkastning, men igen syntes effektiviteten at være ringere end af 5-HT3-antagonister.
English: The French medicines agency therefore asked the CHMP to carry out an assessment of the benefit-risk balance in all populations, especially in children and the elderly.
Danish: Den franske lægemiddelstyrelse bad derfor CHMP om at foretage en vurdering af benefit/risk-forholdet for alle patientgrupper, navnlig børn og ældre.
English: The CHMP recommendation was then sent to the European Commission, which adopted it with a final legally binding decision, valid throughout the European Union (EU), on 20 December 2013.
Danish: CHMP's udtalelse blev overgivet til Europa-Kommissionen, som godkendte den og vedtog en endelig afgørelse med gyldighed i hele EU den 20. december 2013.
English: The original review of metoclopramide was carried out at the request of the French medicines regulatory agency (ANSM), following continued safety concerns over side effects and concerns over efficacy.
Danish: Den oprindelige gennemgang af metoclopramid blev udført på anmodning af den franske lægemiddelstyrelse (ANSM), efter at der fortsat var betænkelighed ved bivirkningerne og ved den terapeutiske virkning.
English: The risk of acute (short-term) neurological effects is higher in children, although tardive dyskinesia is reported more often in the elderly, and the risk is increased at high doses or with long-term treatment.
Danish: Risikoen for kortvarige (akutte) neurologiske virkninger er højere hos børn, skønt tardiv dyskinesi er beskrevet oftere hos ældre, og risikoen øges ved høje doser og ved langvarig behandling.
English: The evidence for intravenous metoclopramide in post-operative nausea and vomiting suggests it is as effective as other licensed treatments.
Danish: Evidensen vedrørende intravenøs anvendelse af metoclopramid ved postoperativ kvalme og opkastning tyder på, at det er lige så effektivt som andre godkendte behandlinger.
English: • In order to minimise the risks of neurological and other adverse reactions, metoclopramide is now only licensed for short-term use (up to 5 days).
Danish: • For at minimere risiciene for bl.a. neurologiske bivirkninger er metoclopramid nu kun godkendt til kortvarig anvendelse (op til fem dage).
English: It also stimulates the movement of the stomach and upper part of the bowel, speeding passage through the gut.
Danish: Det stimulerer desuden bevægelserne i mavesækken og den øverste del af tarmen og fremmer tarmpassagen.
English: During the re-examination the Committee confirmed its recommendation that metoclopramide should only be authorised for short-term use (up to 5 days), that it should not be used in children below 1 year of age and that in children over 1 year of age it should only be used as a second-choice treatment (after other treatments have been considered or tried) for the prevention of delayed nausea and vomiting after chemotherapy and for the treatment of post-operative nausea and vomiting.
Danish: Ved den fornyede overvejelse bekræftede udvalget sin anbefaling om, at metoclopramid kun burde godkendes til kortvarig anvendelse (op til fem dage), at det ikke burde anvendes til børn under 1 år, og at det til børn over 1 år kun burde anvendes som andetvalg (efter at anden behandling havde været overvejet eller forsøgt) til forebyggelse af forsinket kvalme og opkastning efter kemoterapi og til behandling af kvalme og opkastning efter operationer.
English: The Agency's recommendations are based on a review of the benefit-risk of metoclopramide-containing products in all indications and populations.
Danish: Agenturets anbefalinger er baseret på en gennemgang af benefit/risk-forholdet for præparater indeholdende metoclopramid til alle indikationer og populationer.
English: • The evidence also indicated efficacy in nausea and vomiting associated with acute migraine, but seemed to indicate that doses above 10 mg do not result in increased efficacy.
Danish: • Evidensen viste også virkning mod kvalme og opkastning ved akut migræne, men doser over 10 mg giver tilsyneladende ikke øget virkning.
English: • For both adults and children, metoclopramide should only be used for a maximum of 5 days.
Danish: • Hos både voksne og børn bør metoclopramid ikke anvendes længere end fem dage.
English: However, the CHMP concluded that although liquid dose forms had some benefits, such as easier adjustment of doses in patients with reduced kidney or liver function, the 1 mg/ml solution could be used in situations where a liquid dosage form was appropriate, and the Committee was not convinced the proposed restrictions would be sufficient to reduce the risk of error and overdose in children.
Danish: CHMP konkluderede imidlertid, at skønt de flydende formuleringer havde visse fordele såsom lettere dosisjustering hos patienter med nedsat nyre- eller leverfunktion, kunne opløsningen i styrken 1 mg/ml anvendes i situationer, hvor en flydende formulering er hensigtsmæssig, og udvalget var ikke overbevist om, at de foreslåede begrænsninger ville være tilstrækkelige til at nedsætte risikoen for fejl- og overdosering af børn.
English: In addition, the maximum recommended doses in adults and children should be restricted, and higher strength formulations, including oral liquids in strengths above 1 mg/ml, removed from the market.
Danish: Desuden burde der indføres begrænsning af de anbefalede maksimale doser til voksne og børn, og formuleringer af højere styrke burde tages af markedet, herunder orale væsker med styrke over 1 mg/ml.
English: Other nervous system side effects may occur when metoclopramide is used for prolonged periods and may occur more often in the elderly.
Danish: Andre bivirkninger fra nervesystemet kan forekomme ved mere langvarig anvendelse af metoclopramid og er hyppigere hos ældre.
English: It should no longer be used in chronic conditions such as gastroparesis, dyspepsia and gastro-oesophageal reflux disease, nor as an adjunct in surgical and radiological procedures.
Danish: Det bør ikke længere anvendes ved kroniske tilstande såsom gastroparese, dyspepsi og gastroøsofageal reflukssygdom eller som supplement ved kirurgiske og radiologiske procedurer.
English: Therefore, it should no longer be used to treat conditions such as indigestion, heartburn and acid reflux, or chronic (long-term) disorders due to slow emptying of the stomach.
Danish: Det bør derfor ikke længere anvendes til behandling af tilstande såsom fordøjelsesbesvær, halsbrand og sure opstød (refluks) eller langvarige (kroniske) sygdomme forårsaget af langsom tømning af mavesækken.
English: It is authorised for a variety of indications, which differ between EU Member States and is available in different formulations including as an injection (to be given into a vein or muscle), as tablets and oral liquids to be taken by mouth and as suppositories.
Danish: Det er godkendt til en række anvendelser, der afviger mellem EU-medlemsstaterne, og det fås i forskellige formuleringer, herunder som injektionspræparat (til indsprøjtning i en vene eller en muskel), som tabletter og orale væsker til indtagelse gennem munden samt som stikpiller.
English: • There was no evidence of consistent benefit in gastroparesis, gastro-oesophageal reflux disease and dyspepsia, all of which are chronic conditions requiring prolonged treatment which puts patients at risk of chronic neurological side effects.
Danish: • Der var ingen samstemmende evidens for gavnlig virkning ved gastroparese, gastroøsofageal reflukssygdom eller dyspepsi, som alle er kroniske tilstande, der kræver langvarig behandling med risiko for kroniske neurologiske bivirkninger.
English: Oral liquids containing more than 1 mg/ml will be withdrawn from the market, and oral doses of remaining formulations should be administered using an appropriately designed graduated oral syringe to ensure accuracy.
Danish: Orale væsker med en styrke over 1 mg/ml skal tages af markedet, og oral dosis af de tilbageværende formuleringer bør kun gives ved hjælp af en passende udformet oral sprøjte med målestreger for at sikre nøjagtigheden.
English: The effects of metoclopramide on gut motility may be of benefit when given orally with analgesics in this acute setting.
Danish: Virkningen af metoclopramid på tarmmotiliteten kan være en fordel ved oral indgift sammen med analgetika i akutte situationer.
English: • Given very rare reports of serious cardiovascular reactions associated with metoclopramide, particularly via the intravenous route, special care should be taken in populations likely to be at increased risk, including the elderly, patients with cardiac conduction disturbances, uncorrected electrolyte imbalance or bradycardia, and those taking other drugs known to prolong QT interval.
Danish: • På baggrund af meget sjældne indberetninger om alvorlige kardiovaskulære reaktioner knyttet til metoclopramid, navnlig ved intravenøs indgift, bør der udvises særlig forsigtighed hos populationer med forhøjet risiko, herunder ældre, patienter med ledningsforstyrrelser i hjertet, ukorrigeret elektrolytubalance eller bradykardi samt patienter, som tager andre lægemidler, der forlænger QTintervallet.
English: • Recommended use in children is therefore now restricted to prevention of nausea and vomiting that occurs in the days after treatment with anticancer medicines, or to treat nausea and vomiting after surgery, and only when other treatments do not work or cannot be used.
Danish: • Derfor er den anbefalede anvendelse til børn nu begrænset til forebyggelse af kvalme og opkastning i dagene efter behandling med kræftmedicin samt kvalme og opkastning efter operationer, og kun når andre behandlinger ikke virker eller ikke kan anvendes.
English: The review confirmed the well-known risks of neurological effects such as short-term extrapyramidal disorders, a group of involuntary movement disorders that may include muscle spasms (often involving the head and neck) and tardive dyskinesia (uncontrollable movements such as grimacing and twitching).
Danish: Gennemgangen bekræftede de velkendte risici i form af neurologiske virkninger såsom kortvarige ufrivillige bevægelsesforstyrrelser, der kan være ledsaget af muskelspasmer, ofte af hoved og hals (ekstrapyramidale symptomer), og ukontrollerede bevægelser såsom grimasser og trækninger (tardiv dyskinesi).
English: • Cardiovascular reaction reports associated with metoclopramide appeared to be very rare, and mainly associated with intravenous formulations given to patients with underlying risks for cardiac disease; they included hypotension, shock, syncope, bradycardia or atrioventricular block, and cardiac arrest.
Danish: • Indberetninger om kardiovaskulære reaktioner i forbindelse med metoclopramid syntes at være meget sjældne og hovedsagelig knyttet til intravenøse formuleringer, der gives til patienter med underliggende risici for hjertesygdom; de omfattede hypotension, shock, synkope, bradykardi eller atrioventrikulært blok samt hjertestop.