FrancophonIA/ELRC3.0 huggingface dataset:
English: Frequencies are defined using the following convention: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (<1/10000), not known (cannot be estimated from the available data).
Danish: Frekvenserne er defineret ved hjælp af følgende konvention: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til <1/10), ikke almindelig (≥ 1/1000 til <1/100), sjælden (≥ 1/10.000 til <1/1000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The dose may be reduced (see section 3).
Danish: Dosis skal måske reduceres (se punkt 3).
English: These reactions occur usually at the beginning of the treatment and can occur after a single administration.
Danish: Disse reaktioner forekommer sædvanligvis i starten af behandlingen og kan forekomme efter en enkelt administration.
English: A symptomatic treatment and a continuous monitoring of the cardiovascular and respiratory functions should be carried out according to clinical status.
Danish: Symptomatisk behandling og kontinuerlig overvågning af de kardiovaskulære og respiratoriske funktioner skal udføres i henhold til klinisk status.
English: A large amount of data on pregnant women (more than 1000 exposed outcomes) indicates no malformative toxicity nor foetotoxicity.
Danish: En stor mængde data fra gravide kvinder (mere end 1.000 eksponeringer) viser ingen misdannelser eller føtotoksicitet.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Danish: BIVIRKNINGER Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: These may occur in children or young adults and particularly when high doses are used.
Danish: Disse kan forekomme hos børn og unge voksne, og især når der anvendes høje doser.
English: [Appropriate measuring device must be provided with the product, and instructions for use must be included in the SmPC]
Danish: [Egnede måleanordninger skal leveres sammen med produktet, og brugsanvisning skal indgå i produktresuméet]
English: Although the clinical significance is uncertain, patients should be monitored for adverse reactions.
Danish: Selv om den kliniske betydning er usikker, skal patienterne overvåges for bivirkninger.
English: This is because some medicines can affect the way {Tradename} works or {Tradename} can affect how other medicines work.
Danish: Dette skyldes, at visse lægemidler kan påvirke den måde, {Handelsnavn} virker, eller {Handelsnavn} kan påvirke virkningen af anden medicin.
English: Symptoms of Parkinson's disease may also be exacerbated by metoclopramide.
Danish: Symptomer på Parkinsons sygdom kan også blive forværret af metoclopramid.
English: It contains a medicine called “metoclopramide”.
Danish: Det indeholder et lægemiddelstof kaldet ”metoclopramid”.
English: Prolonged treatment with metoclopramide may cause tardive dyskinesia, potentially irreversible, especially in the elderly.
Danish: Langvarig behandling med metoclopramid kan forårsage tardiv dyskinesi, potentielt irreversibelt, især hos ældre patienter.
English: It will be given as a slow injection into a vein (over at least 3 minutes) or by injection into a muscle.
Danish: Det vil blive givet som en langsom injektion i en vene (over mindst 3 minutter) eller ved injektion i en muskel.
English: Metoclopramide should be avoided at the end of pregnancy.
Danish: Metoclopramid bør undgås i slutningen af graviditeten.
English: Anticholinergics and morphine derivatives
Danish: Antikolinergika og morphinderivater
English: If necessary, {Tradename} may be taken during pregnancy.
Danish: Om nødvendigt kan du <tage/få> {Handelsnavn} under graviditet.
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet
Danish: Bilag III Ændringer til relevante dele af produktresuméet og indlægssedlen
English: For all formulations
Danish: For alle formuleringer
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before being given this medicine.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apoteketspersonalet til råds, før du bruger dette lægemiddel.
English: Strong CYP2D6 inhibitors
Danish: Stærke CYP2D6-hæmmere
English: If metoclopramide is used, neonatal monitoring should be undertaken.
Danish: Hvis metoclopramid benyttes, skal der foretages neonatal monitorering.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion Alle administrationsveje
English: Metoclopramide increases cyclosporine bioavailability (Cmax by 46% and exposure by 22%).
Danish: Metoclopramid øger biotilgængeligheden af ciclosporin (Cmax med 46 % og eksponeringen med 22 %).
English: Adverse reactions listed by System Organ Class.
Danish: Bivirkninger er anført efter systemorganklasse.
English: Metoclopramide can be used during pregnancy if clinically needed.
Danish: Metoclopramid kan anvendes under graviditet, hvis det er klinisk nødvendigt.
English: This may affect your vision and also interfere with your ability to drive and use machines.
Danish: Dette kan påvirke dit syn og også din evne til at køre bil og betjene maskiner.
English: The following wording should be included in the SmPC of the marketing authorisations to be varied, as relevant:
Danish: Følgende ordlyd skal medtages i produktresuméet for de markedsføringstilladelser, der skal ændres, hvor det er relevant:
English: All indications (adult patients)
Danish: Alle indikationer (voksne)
English: Systeme Organ Class
Danish: Systemorganklasse
English: In such cases, metoclopramide should be immediately and permanently discontinued and appropriate measures initiated (such as treatment with methylene blue).
Danish: I sådanne tilfælde skal metoclopramid seponeres øjeblikkeligt og permanent og passende foranstaltninger indledes (såsom behandling med methylthionin).
English: Device / instruction for use
Danish: Udstyr /brugsanvisning
English: 30mg strength
Danish: 30mg
English: The use of metoclopramide with serotonergic drugs such as SSRIs may increase the risk of serotonin syndrome.
Danish: Anvendelse af metoclopramid sammen med serotonerge lægemidler såsom SSRI'er kan øge risikoen for serotoninsyndrom.
English: In patients with cirrhosis of the liver, accumulation of metoclopramide has been observed, associated with a 50% reduction in plasma clearance.
Danish: Hos patienter med levercirrose er akkumulation af metoclopramid observeret, i forbindelse med 50 % reduktion i plasmaclearance.
English: Combination to be taken into account Due to the prokinetic effect of metoclopramide, the absorption of certain drugs may be modified.
Danish: Kombination, hvor der skal tages hensyn På grund af metoclopramids prokinetiske virkning kan absorptionen af visse lægemidler ændres.
English: Your doctor will decide whether or not you should be given this medicine.
Danish: Din læge vil beslutte, hvorvidt du kan <tage/få> denne medicin.
English: Stop the treatment and talk straight away to your doctor, pharmacist or nurse if you experience one of the following signs while having this medicine: - uncontrollable movements (often involving head or neck).
Danish: Stop behandlingen og kontakt læge, apotekspersonalet eller sundhedspersonalet med det samme, hvis du oplever et af følgende symptomer, når du bruger denne medicin: Ukontrollerbare bevægelser (involverer ofte hovedet eller halsen).
English: Uncontrollable movements (extrapyramidal disorders) may occur in children and young adults.
Danish: Ufrivillige bevægelser (ekstrapyramidale forstyrrelser) kan forekomme hos børn og unge voksne.
English: [To be completed nationally, if necessary]
Danish: Yderligere erklæringer vedrørende hjælpestoffer [Udfyldes nationalt, hvis nødvendigt]
English: Intravenous doses should be administered as a slow bolus (at least over 3 minutes).
Danish: Intravenøse doser skal indgives som langsom bolus (over mindst 3 minutter).
English: Endocrine disorders*
Danish: Det endokrine system*
English: If you forget to take {Tradename} Do not take a double dose to make up for a forgotten dose.
Danish: Du må ikke tage en dobbeltdosis som erstatning for en glemt dosis.
English: Metoclopramide may decrease digoxin bioavailability.
Danish: Metoclopramid kan nedsætte biotilgængeligheden af digoxin.
English: Careful monitoring of digoxin plasma concentration is required.
Danish: Omhyggelig monitorering af digoxins plasmakoncentration er påkrævet.
English: The solution can be administered intravenously or intramuscularly.
Danish: Injektionsvæsken kan administreres intravenøst eller intramuskulært.
English: Careful monitoring of cyclosporine plasma concentration is required.
Danish: Omhyggelig monitorering af ciclosporins plasmakoncentration er påkrævet.
English: Combination to be avoided Alcohol potentiates the sedative effect of metoclopramide.
Danish: Kombination, der skal undgås Alkohol forstærker den sedative effekt af metoclopramid.
English: Adverse reactions in the breast-fed baby cannot be excluded.
Danish: Bivirkninger hos det ammede barn kan ikke udelukkes.
English: {Tradename} is not recommended if you are breast-feeding because metoclopramide passes into breast milk and may affect your baby.
Danish: Du må ikke <tage/få> {Handelsnavn}, hvis du ammer, fordi metoclopramid passerer over i mælken og kan påvirke dit barn.
English: Do not give {Tradename} to a child less than 1 year of age (see below “Children and adolescents”).
Danish: Du må ikke bruge {Handelsnavn} til et barn under 1 år (se under ”Børn og unge”).
English: This medicine must not be used in children below 1 year of age because of the increased risk of the uncontrollable movements (see above “Do not take {Tradename} if”).
Danish: Dette lægemiddel må ikke anvendes til børn under 1 år på grund af den øgede risiko for ukontrollerede bevægelser (se ovenfor under ”Brug ikke {Handelsnavn}”)
English: Metoclopramide exposure levels are increased when co-administered with strong CYP2D6 inhibitors such as fluoxetine and paroxetine.
Danish: Metoclopramids eksponeringsniveau øges ved samtidig administration af stærke CYP2D6-hæmmere såsom fluoxetin og paroxetin.
English: Metoclopramide may cause drowsiness, dizziness, dyskinesia and dystonias which could affect the vision and also interfere with the ability to drive and operate machinery.
Danish: Metoclopramid kan forårsage døsighed, svimmelhed, dyskinesi og dystoni, som kan påvirke synet og også interferere med evnen til at føre motorkøretøj og betjene maskiner.
English: In elderly patients a dose reduction should be considered, based on renal and hepatic function and overall frailty.
Danish: Hos ældre patienter skal dosisreduktion overvejes, baseret på nyre- og leverfunktion og generel svaghed.
English: Other pharmaceutical forms/strengths may be more appropriate for administration.
Danish: Andre lægemiddelformer/styrker kan være mere egnede til behandling af denne population.
English: Metoclopramide is excreted in breast milk at low level.
Danish: Metoclopramid udskilles i mælk i lav grad.
English: Metoclopramide injection may prolong the duration of neuromuscular block (through inhibition of plasma cholinesterase).
Danish: Metoclopramidinjektion kan forlænge varigheden af neuromuskulær blokade (ved hæmning af plasma-kolinesterase).
English: For prevention of PONV a single dose of 10mg is recommended.
Danish: Til forebyggelse af PONV anbefales en enkelt dosis på 10 mg.
English: * Endocrine disorders during prolonged treatment in relation with hyperprolactinaemia (amenorrhoea, galactorrhoea, gynaecomastia).
Danish: * Endokrine forstyrrelser under langvarig behandling i relation til hyperprolaktinæmi (amenoré, galaktoré, gynækomasti).
English: Intravenous doses should be administered as a slow bolus (at least over 3 minutes) in order to reduce the risk of adverse effects (e.g. hypotension, akathisia).
Danish: Intravenøse doser skal indgives som langsom bolus (over mindst 3 minutter) for at reducere risikoen for bivirkninger (f.eks. hypotension, akatisi).
English: - Itching or skin rashes, swelling of the face, lips or throat, difficulty in breathing.
Danish: Kløe eller hududslæt, hævelse af ansigtet, læber eller hals, åndedrætsbesvær.
English: - you have bleeding, obstruction or a tear in your stomach or gut.
Danish: - hvis du har blødning, forsnævringer eller hul i maven eller tarmen.
English: Alcohol should not be consumed during treatment with metoclopramide because it increases the sedative effect of {Tradename}.
Danish: Alkohol må ikke indtages under behandling med metoclopramid, fordi det øger den sløvende effekt af {Handelsnavn}.
English: Discontinuation of metoclopramide in breastfeeding women should be considered.
Danish: Seponering af metoclopramid hos ammende kvinder skal overvejes.
English: Metoclopramide can be used in combination with oral analgesics to improve the absorption of analgesics in acute migraine.
Danish: Metoclopramid kan anvendes i kombination med orale analgetika for at forbedre absorptionen af analgetika ved akut migræne.
English: In adults patients
Danish: Ældre patienter
English: Extrapyramidal disorders may occur, particularly in children and young adults, and/or when high doses are used.
Danish: Ekstrapyramidale forstyrrelser kan forekomme, især hos børn og unge voksne og/eller ved anvendelse af høje doser.
English: Due to pharmacological properties (as other neuroleptics), in case of metoclopramide administration at the end of pregnancy, extrapyramidal syndrome in newborn cannot be excluded.
Danish: På grund af de farmakologiske egenskaber (som andre antipsykotika) kan ekstrapyramidalt syndrom hos nyfødte ikke udelukkes, hvis metoclopramid administreres sidst i graviditeten.
English: Metoclopramide should be discontinued immediately in the event of symptoms of neuroleptic malignant syndrome and appropriate treatment should be initiated.
Danish: Metoclopramid skal seponeres øjeblikkeligt i tilfælde af symptomer på malignt neuroleptikasyndrom og passende behandling initieres.
English: The clearance of metoclopramide is reduced by up to 70% in patients with severe renal impairment, while the plasma elimination half-life is increased (approximately 10 hours for a creatinine clearance of 10-50 mL/minute and 15 hours for a creatinine clearance <10 mL/minute).
Danish: Nedsat nyrefunktion Metoclopramids clearance er reduceret med op til 70 % hos patienter med svær nyreinsufficiens og plasmahalveringstiden øget (ca. 10 timer ved kreatininclearance 10-50 ml/minut og 15 timer ved kreatininclearance < 10 ml/minut).
English: Special care should be exercised in patients with underlying neurological conditions and in patients being treated with other centrally-acting drugs (see section 4.3)
Danish: Særlig forsigtighed skal udvises hos patienter med underliggende neurologiske tilstande samt hos patienter, der behandles med andre centralt virkende lægemidler (se pkt.
English: 4.7 Effects on ability to drive and use machines
Danish: 4.7 Virkninger på evnen til at føre motorkøretøj og betjene maskiner Alle administrationsveje
English: You may experience uncontrollable movements (extrapyramidal disorders), feel drowsy, have some troubles of consciousness, be confused, have hallucination and heart problems.
Danish: Du kan opleve ukontrollerbare bevægelser (ekstrapyramidale forstyrrelser), føle dig døsig, have problemer med bevidstheden, være forvirret, have hallucinationer og hjerteproblemer.
English: Anticholinergics and morphine derivatives may have both a mutual antagonism with metoclopramide on the digestive tract motility.
Danish: Antikolinergika og morphinderivater kan begge have en gensidig antagonisme med metoclopramid på mave-tarmkanalens motilitet.
English: You may feel drowsy, dizzy or have uncontrollable twitching, jerking or writhing movements and unusual muscle tone causing distortion of the body after taking {Tradename}.
Danish: Du kan føle dig døsig, svimmel eller få ukontrollerbare trækninger, ryk eller vridende bevægelser og usædvanlig muskeltonus, der medfører vridning af kroppen efter indtagelse af {Handelsnavn}.
English: Your doctor may perform blood tests to check your blood pigment levels.
Danish: Din læge kan tage blodprøver for at teste for methæmoglobinæmi.
English: For all routes of administration
Danish: For alle administrationsveje
English: These signs usually occur at the beginning of treatment and may even occur after one single administration.
Danish: Disse symptomer opstår som regel i starten af behandlingen og kan endda opstå efter en enkelt dosis.
English: Children and adolescents Metoclopramide must not be used in children aged less than 1 year (see section 2).
Danish: Metoclopramid må ikke anvendes til børn under 1 år (se punkt 2).
English: In patients with end stage renal disease (Creatinine clearance ≤ 15 ml/min), the daily dose should be reduced by 75%.
Danish: Hos patienter med nyresygdom i slutstadiet (kreatininclearance ≤ 15 ml/min) skal den daglige dosis reduceres med 75 %.
English: The following reactions, sometimes associated, occur more frequently when high doses are used: - Extrapyramidal symptoms: acute dystonia and dyskinesia, parkinsonian syndrome, akathisia, even following administration of a single dose of the medicinal product, particularly in children and young adults (see section 4.4).
Danish: Følgende reaktioner, nogle gange forbundet, forekommer hyppigere, når der er anvendt høje doser: - Ekstrapyramidale symptomer: akut dystoni og dyskinesi, parkinsonsyndrom, akatisi, selv efter administration af en enkelt dosis af lægemidlet, især hos børn og unge voksne (se pkt.
English: Contraindicated combination Levodopa or dopaminergic agonists and metoclopramide have a mutual antagonism (see section 4.3).
Danish: Kontraindiceret kombination Levodopa / dopaminerge agonister og metoclopramid udviser gensidig antagonisme (se pkt.
English: These may be signs of a condition called neuroleptic malignant syndrome.
Danish: Dette kan være tegn på en tilstand, der kaldes malignt neuroleptikasyndrom.
English: It works on a part of your brain that prevents you from feeling sick (nausea) or being sick (vomiting).
Danish: Det virker et sted i din hjerne og forhindrer dig i at få kvalme og kaste op.
English: The dose should be reduced if you have severe liver problems.
Danish: Dosis skal reduceres, hvis du har svært nedsat leverfunktion.
English: The maximum treatment duration is 48 hours for treatment of established post operative nausea and vomiting (PONV).
Danish: Den maksimale behandlingsvarighed er 48 timer ved behandling af manifest postoperativ kvalme og opkastning (PONV).
English: Convulsion especially in epileptic patients
Danish: Kramper, især hos epilepsipatienter.
English: Special care should be taken when administering metoclopramide, particularly via the intravenous route to the elderly population, to patients with cardiac conduction disturbances (including QT prolongation), patients with uncorrected electrolyte imbalance, bradycardia and those taking other drugs known to prolong QT interval.
Danish: Særlig forsigtighed skal udvises, når der gives metoclopramid, især intravenøst, til ældre, til patienter med ledningsforstyrrelser (herunder QT-forlængelse), ukorrigerede elektrolytforstyrrelser eller bradykardi og til patienter, der tager andre lægemidler, der vides at forlænge QT-intervallet.
English: Metoclopramide-containing products
Danish: Metoclopramidholdige produkter
English: Do not exceed 3-month treatment because of the risk of involuntary muscle spasms.
Danish: Behandlingsvarigheden må ikke overskride 3 måneder på grund af risikoen for ufrivillige muskelspasmer.
English: In case of extrapyramidal symptoms related or not to overdose, the treatment is only symptomatic (benzodiazepines in children and/or anticholinergic anti-parkinsonian medicinal products in adults).
Danish: I tilfælde af ekstrapyramidale symptomer, relateret eller ikke relateret til overdosering, er behandlingen udelukkende symptomatisk (benzodiazepiner hos børn og/eller antikolinerge antiparkinsonmidler hos voksne).
English: Central nervous system depressants (morphine derivatives, anxiolytics, sedative H1 antihistamines, sedative antidepressants, barbiturates, clonidine and related) Sedative effects of Central Nervous System depressants and metoclopramide are potentiated.
Danish: CNS-supprimerende stoffer (morphinderivater, anxiolytika, sedative H1-antihistaminer, sederende antidepressiva, barbiturater, clonidin og beslægtede) Den sedative effekt af CNS-supprimerende stoffer og metoclopramid forstærkes.
English: For rectal formulations
Danish: Rektal formulering
English: Metoclopramide may have an additive effect with other neuroleptics on the occurrence of extrapyramidal disorders.
Danish: Metoclopramid kan have en additiv effekt sammen med andre neuroleptika på forekomsten af ekstrapyramidale forstyrrelser.
English: - Drowsiness, decreased level of consciousness, confusion, hallucination.
Danish: - Døsighed, nedsat bevidsthedsniveau, konfusion, hallucinationer.
English: Methemoglobinemia which could be related to NADH cytochrome b5 reductase deficiency has been reported.
Danish: Methæmoglobinæmi, som kan være relateret til NADH-cytokrom-b5-reduktasemangel, er rapporteret.
English: Very common (may affect more than 1 in 10 people) feeling drowsy.
Danish: Meget almindelig (forekommer hos flere end 1 ud af 10 patienter) • Døsighed
English: These effects are generally completely reversible after treatment discontinuation, but may require a symptomatic treatment (benzodiazepines in children and/or anticholinergic anti-Parkinsonian medicinal products in adults).
Danish: Disse er generelt fuldstændig reversible efter behandlingsophør, men kan kræve symptomatisk behandling (benzodiazepiner hos børn og/eller antikolinerge antiparkinsonmidler hos voksne).
English: There have been reports of serious cardiovascular undesirable effects including cases of circulatory collapse, severe bradycardia, cardiac arrest and QT prolongation following administration of metoclopramide by injection, particularly via the intravenous route (see section 4.8).
Danish: Der er rapporteret om alvorlige kardiovaskulære bivirkninger, herunder tilfælde af kredsløbskollaps, svær bradykardi, hjertestop og QT-forlængelse efter administration af metoclopramid ved injektion, især ved intravenøs administration (se pkt.
English: Prevention of delayed chemotherapy induced nausea and vomiting (CINV) (paediatric patients aged 118 years)
Danish: Forebyggelse af forsinket kemoterapiinduceret kvalme og opkastning (CINV) (pædiatriske patienter i alderen 1-18 år)
English: The maximum treatment duration is 5 days for prevention of delayed chemotherapy induced nausea and vomiting (CINV).
Danish: Den maksimale behandlingsvarighed er 5 dage ved forebyggelse af forsinket kemoterapiinduceret kvalme og opkastning (CINV).
English: All routes of administration
Danish: Alle administrationsveje
English: Not known Shock, syncope after injectable use Acute hypertension in patients with phaeochromocytoma (see section 4.3)
Danish: Shock, synkope (efter intravenøs administration), akut hypertension hos patienter med fæokromocytom (se pkt.
English: All routes of administration at the exception prolonged release preparations
Danish: Alle administrationsveje med undtagelse af formuleringer med forlænget afgift Administrationsmetode:
English: For the treatment of nausea and vomiting including nausea and vomiting which may occur with a migraine and for the prevention of nausea and vomiting caused by radiotherapy: the recommended single dose is 10 mg, repeated up to 3 times daily.
Danish: Behandling af kvalme og opkastning, herunder kvalme og opkastning i forbindelse med migræne, og forebyggelse af kvalme og opkastning forårsaget af strålebehandling: Den anbefalede enkeltdosis er 10 mg, givet op til 3 gange dagligt.
English: For immediate release oral formulations
Danish: For formuleringer med umiddelbar afgift