FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with moderate to severe renal impairment (Creatinine clearance 15-60 ml/min), the dose should be reduced by 50% (see section 5.2).
Danish: Hos patienter med moderat til svært nedsat nyrefunktion (kreatininclearance 15-60 ml/min) skal dosis reduceres med 50 % (se pkt.
English: mainly with concomitant administration of high doses of sulphur-releasing medicinal products
Danish: 4.4) Sulfhæmoglobinæmi, især ved samtidig administration af svovl-frigivende lægemidler i høje doser.
English: - Use in children less than 1 year of age due to an increased risk of extrapyramidal disorders (see section 4.4)
Danish: - Børn under 1 år på grund af øget risiko for ekstrapyramidale forstyrrelser (se pkt.
English: If you are not sure, talk to your doctor, pharmacist or nurse before you take Tradename.
Danish: Hvis du er i tvivl, så spørg lægen, apotekspersonalet eller sundhedspersonalet, før du bruger {Handelsnavn}.
English: Appropriate additional information regarding posologies adaptation should be implemented in the SmPC depending on the strength of the formulations
Danish: Passende yderligere oplysninger om tilpasning af dosis skal implementeres i indlægssedlen afhængigt af formuleringernes styrke
English: For the prevention of nausea and vomiting that may occur after surgery prevention: a single dose of 10mg is recommended.
Danish: Forebyggelse af kvalme og opkastning efter operation: en enkelt dosis på 10 mg anbefales.
English: The treatment should not exceed 48 hours for treatment of nausea and vomiting that has occurred after surgery.
Danish: Behandlingsvarigheden må ikke overskride 48 timer ved behandling af kvalme og opkastning efter operation.
English: Uncommon Bradycardia, particularly with intravenous formulation
Danish: Bradykardi, specielt ved intravenøs administration.
English: For rectal formulation - you have recently experienced inflammation and/or bleeding from your back passage (anus/rectum) - you are below 18 years of age.
Danish: - hvis du for nylig har haft en betændelseslignende tilstand (inflammation) og/eller blødning fra endetarmsåbningen - hvis du er under 18 år
English: Treatment should not exceed 3 months because of the risk of tardive dyskinesia (see section 4.8).
Danish: Behandling må ikke overskride 3 måneder på grund af risikoen for tardiv dyskinesi (se pkt.
English: - high fever, high blood pressure, convulsions, sweating, production of saliva.
Danish: Høj feber, højt blodtryk, kramper, svedeture, savlen.
English: - Symptomatic treatment of nausea and vomiting, including acute migraine induced nausea and vomiting.
Danish: - Symptomatisk behandling af kvalme og opkastning, herunder kvalme og opkastning forårsaget af akut migræne.
English: Metoclopramide should be discontinued immediately in the event of extrapyramidal symptoms.
Danish: Metoclopramid skal seponeres øjeblikkeligt i tilfælde af ekstrapyramidale symptomer.
English: The recommended dose is 30mg once daily.
Danish: Den anbefalede dosis er 30 mg én gang dagligt.
English: Extrapyramidal disorders, drowsiness, decreased level of consciousness, confusion, hallucination, and cardio-respiratory arrest may occur.
Danish: Ekstrapyramidale forstyrrelser, døsighed, nedsat bevidsthedsniveau, konfusion, hallucinationer og hjerte/respirationsstop kan forekomme.
English: Talk to your doctor if you have liver problems.
Danish: Tal med din læge, hvis du har nedsat leverfunktion.
English: 5.2 Pharmacokinetic properties
Danish: 5.2 Farmakokinetiske egenskaber Alle administrationsveje
English: Common Extrapyramidal disorders (particularly in children and young adults and/or when the recommended dose is exceeded, even following administration of a single dose of the drug) (see section 4.4), Parkinsonism, Akathisia
Danish: Ekstrapyramidale forstyrrrelser (især hos børn og unge voksne og/eller når den anbefalede dosis overskrides, selv efter administration af en enkelt dosis af lægemidlet) (se pkt.
English: How to take {Tradename}
Danish: SÅDAN SKAL DU BRUGE {HANDELSNAVN}
English: Common Diarrhoea
Danish: • Diarré
English: Methaemoglobinemia
Danish: Methæmoglobinæmi
English: {Tradename} if”) - anticholinergics (medicines used to relieve stomach cramps or spasms) - morphine derivatives (medicines used to treat severe pain) - sedative medicines - any medicines used to treat mental health problems - digoxin (medicine used to treat heart failure) - cyclosporine (medicine used to treat certain problems with the immune system) - mivacurium and suxamethonium (medicines used to relax muscles)
Danish: Disse lægemidler omfatter følgende: levodopa eller anden medicin til behandling af Parkinsons sygdom (se ovenfor under ”Brug ikke {Handelsnavn} hvis”) antikolinergika (medicin mod spasmer og kramper i maven) morphinlignende stoffer (medicin til at behandle svære smerter) sløvende medicin al medicin, som anvendes til behandling af mentale problemer digoxin (medicin mod hjerteproblemer) ciclosporin (medicin som anvendes ved visse problemer med immunsystemet) mivacurium og suxamethonium (muskelafslappende medicin) fluoxetin og paroxetin (medicin ved depression)
English: Talk to your doctor if you have kidney problems.
Danish: Tal med din læge, hvis du har nedsat nyrefunktion.
English: You should not take this medicine for more than 5 days to prevent delayed nausea and vomiting that may occur after chemotherapy.
Danish: Du må ikke <tage/få> denne medicin i mere end 5 dage til forebyggelse af forsinket kvalme og opkastning efter kemoterapi.
English: The dose should be reduced if you have moderate or severe kidney problems.
Danish: Dosis skal reduceres, hvis du har moderat til svært nedsat nyrefunktion.
English: Serotonergic drugs
Danish: Serotonerge lægemidler
English: Neuroleptic malignant syndrome has been reported with metoclopramide in combination with neuroleptics as well as with metoclopramide monotherapy (see section 4.8).
Danish: Malignt neuroleptikasyndrom er rapporteret med metoclopramid i kombination med neuroleptika og med metoclopramidmonoterapi (se pkt.
English: For all formulations - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Gastrointestinal haemorrhage, mechanical obstruction or gastro-intestinal perforation for which the stimulation of gastrointestinal motility constitutes a risk - Confirmed or suspected pheochromocytoma, due to the risk of severe hypertension episodes - History of neuroleptic or metoclopramide-induced tardive dyskinesia - Epilepsy (increased crises frequency and intensity) - Parkinson's disease - Combination with levodopa or dopaminergic agonists (see section 4.5) - Known history of methaemoglobinaemia with metoclopramide or of NADH cytochrome-b5
Danish: - Gastrointestinal blødning, mekanisk obstruktion eller gastrointestinal perforation, hvor stimulering af gastrointestinal motilitet udgør en risiko - Bekræftet eller mistænkt fæokromocytom på grund af risikoen for svære hypertensive episoder - Tidligere tilfælde af neuroleptisk eller metoclopramid-induceret tardiv dyskinesi - Epilepsi (øget krisehyppighed og intensitet) - Parkinsons sygdom - Kombination med levodopa eller dopaminerge agonister (se pkt.
English: General disorders and administra- tion site conditions Common Asthenia
Danish: Almene symptomer og reaktioner på administrationsstedet Almindelig
English: Not known Tardive dyskinesia which may be persistent, during or after prolonged treatment, particularly in elderly patients (see section 4.4), Neuroleptic malignant syndrome (see section 4.4)
Danish: Tardiv dyskinesi, som kan være persisterende, under eller efter langvarig behandling, især hos ældre patienter (se pkt.
English: Dosing table Age
Danish: Doseringstabel Alder
English: In patients with renal impairment or with severe hepatic impairment, a dose reduction is recommended (see section 4.2).
Danish: Dosisreduktion anbefales hos patienter med nedsat nyrefunktion eller med svært nedsat leverfunktion (se pkt 4.2).
English: Metoclopramide is contraindicated in children aged less than 1 year (see section 4.3).
Danish: Pædiatrisk population Metoclopramid er kontraindiceret til børn under 1 år (se pkt.
English: Uncommon Dystonia, Dyskinesia, Depressed level of consciousness
Danish: Dystoni, dyskinesi, nedsat bevidsthedsniveau.
English: Neurological Disorders
Danish: Neurologiske sygdomme
English: Therefore metoclopramide is not recommended during breastfeeding.
Danish: Derfor frarådes metoclopramid under amning.
English: Other medicines and {Tradename} For all routes of administration
Danish: Brug af anden medicin sammen med {Handelsnavn} For alle administrationsveje
English: Uncommon Amenorrhoea, Hyperprolactinaemia, Rare
Danish: Amenoré, hyperprolaktinæmi.
English: Adults with kidney problems
Danish: Voksne med nedsat nyrefunktion
English: <Other pharmaceutical forms/strengths may be more appropriate for administration to this/these population(s)> <This formulation is not suitable for administration to this/these population(s)>
Danish: Passende yderligere oplysninger om tilpasning af dosis skal implementeres i indlægssedlen afhængigt af formuleringerne: <Andre lægemiddelformer/styrker kan være mere egnede til behandling af denne/disse population(er)> <Denne formulering er ikke egnet til behandling af denne/disse population(er)>
English: Parenteral route
Danish: Parenteral administration
English: Blood and lymphatic system disorders Not known Methaemoglobinaemia, which could be related to NADH cytochrome b5 reductase deficiency, particularly in neonates (see section 4.4)
Danish: Methæmoglobinæmi, som kan være relateret til NADHcytokrom-b5-reduktasemangel, især hos nyfødte (se pkt.
English: Hepatic impairment: In patients with severe hepatic impairment, the dose should be reduced by 50% (see section 5.2).
Danish: Nedsat leverfunktion Hos patienter med svært nedsat leverfunktion skal dosis reduceres med 50 % (se pkt.
English: Adult population
Danish: Ældre personer
English: Talk to your doctor, pharmacist or nurse before taking {Tradename} if: - you have a history of abnormal heart beats (QT interval prolongation) or any other heart problems - you have problems with the levels of salts in your blood, such as potassium, sodium and magnesium.
Danish: Advarsler og forsigtighedsregler For alle formuleringer Tal med din læge, apotekspersonalet eller sundhedspersonalet før du bruger {Handelsnavn}, hvis: - du har eller har haft unormal hjerterytme (forlænget QT-interval) eller andre hjerteproblemer - hvis du har problemer med saltbalancen i blodet, såsom kalium, natrium og magnesium - hvis du tager anden medicin, som er kendt for at påvirke hjerterytmen (pulsen) - hvis du har neurologiske (hjerne-) problemer - hvis du har lever- eller nyreproblemer.
English: Older people The dose may need to be reduced depending on kidney problems, liver problems and overall health.
Danish: Dosisreduktion kan være nødvendig, afhængigt af nyre- og leverfunktion og generel svaghed.
English: The treatment should not exceed 5 days for prevention of delayed nausea and vomiting that may occur after chemotherapy.
Danish: Behandlingsvarigheden må ikke overskride 5 dage ved forebyggende behandling af forsinket kvalme og opkastning efter kemoterapi.
English: Adult population {Tradename} is indicated in adults for: - Prevention of post operative nausea and vomiting (PONV) - Symptomatic treatment of nausea and vomiting, including acute migraine induced nausea and vomiting - Prevention of radiotherapy induced nausea and vomiting (RINV).
Danish: Voksne {Handelsnavn} er indiceret til voksne til: - Forebyggelse af postoperativ kvalme og opkastning (PONV) - Symptomatisk behandling af kvalme og opkastning, herunder kvalme og opkastning forårsaget af akut migræne - Forebyggelse af kvalme og opkastning (RINV) i forbindelse med strålebehandling.
English: - Recent history of proctitis or rectal bleeding
Danish: For rektale formuleringer - Nylig proctitis eller rektal blødning - Børn under 18 år
English: The maximum dose in 24 hours is 0.5 mg/kg body weight.
Danish: Den maksimale dosis på 24 timer er 0,5 mg/kg legemsvægt.
English: - you are taking levodopa (a medicine for Parkinson's disease) or dopaminergic agonists (see below “Other medicines and Tradename”) - you have ever had an abnormal blood pigment levels (methaemoglobinemia) or NADH cytochromeb5 deficiency
Danish: - hvis du har haft ufrivillige langsomme muskelkramper (tardiv dyskinesi), når du er blevet behandlet med medicin - hvis du har epilepsi - hvis du har Parkinsons sygdom - hvis du tager levodopa (medicin for Parkinsons sygdom) eller dopaminerge agonister (se under ”Brug af anden medicin sammen med {Handelsnavn}”) - hvis du har haft methæmoglobinæmi eller NADH-cytokrom-b5-mangel eller NADHcytokrom-b5-mangel
English: The product information shall be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Danish: CHMP anbefaler derfor i overensstemmelse med artikel 116 i direktiv 2001/83/EF:
English: {Tradename} is indicated in children (aged 1-18 years) if other treatment does not work or cannot be used to prevent delayed nausea and vomiting that may occur after chemotherapy
Danish: Pædiatrisk population {Handelsnavn} anvendes til børn (i alderen 1-18 år), hvis anden behandling ikke virker eller ikke kan anvendes til at forebygge forsinket kvalme og opkastning efter kemoterapi.
English: The recommended dose is 0.1 to 0.15 mg/kg body weight, repeated up to three times daily by oral route.
Danish: Den anbefalede dosis er 0,1 til 0,15 mg/kg legemsvægt, administreret op til tre gange dagligt ved oral administration.
English: Common: Hypotension, particularly with intravenous formulation
Danish: Hypotension (specielt efter intravenøs administration).
English: Adult population {Tradename} is indicated in adults for: - Prevention of delayed chemotherapy induced nausea and vomiting (CINV) - Prevention of radiotherapy induced nausea and vomiting (RINV).
Danish: Voksne {Handelsnavn} er indiceret til voksne til: - Forebyggelse af forsinket kemoterapiinduceret kvalme og opkastning (CINV) - Forebyggelse af kvalme og opkastning (RINV) i forbindelse med strålebehandling.
English: Paediatric population {Tradename} is indicated in children (aged 1-18 years) for: - Prevention of delayed chemotherapy induced nausea and vomiting (CINV) as a second line option - Treatment of established post operative nausea and vomiting (PONV) as a second line option Oral route
Danish: Pædiatrisk population {Handelsnavn} er indiceret til børn (i alderen 1-18 år) til: - Forebyggelse af forsinket kemoterapiinduceret kvalme og opkastning (CINV) som andenvalgsbehandling - Behandling af manifest postoperativ kvalme og opkastning (PONV) som andenvalgsbehandling
English: Sinus arrest particularly with intravenous formulation; Electrocardiogram QT prolonged; Torsade de Pointes;
Danish: 4.4); AV-blok, sinusarrest, især ved intravenøs administration; QT-forlængelse; Torsades de pointes.
English: - you are allergic to metoclopramide or any of the other ingredients of this medicine (listed in section 6).
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT FÅ {HANDELSNAVN} Du må ikke få {Handelsnavn}: - hvis du er allergisk over for metoclopramid eller et af de øvrige indholdsstoffer i {handelsnavn} (angivet i punkt 6).
English: Treatment must be discontinued if clinical signs of tardive dyskinesia appear.
Danish: 4.8), og metoclopramid skal seponeres, hvis der opstår kliniske tegn på tardiv dyskinesi.
English: For formulations which cannot be used to administer a 5mg dose Tablets/capsules/granules are not suitable for use in children weighing less than 61 kg. Other pharmaceutical forms/strengths may be more appropriate for administration to this population.
Danish: For formuleringer, der ikke kan bruges til at administrere en dosis på 5 mg {Handelsnavn} er ikke egnet til brug til børn, der vejer mindre end 61 kg. Andre lægemiddelformer/styrker kan være mere egnede til behandlingen.
English: Paediatric population {Tradename} is indicated in children (aged 1-18 years) for: - Prevention of delayed chemotherapy induced nausea and vomiting (CINV) as a second line option Rectal route
Danish: Pædiatrisk population {Handelsnavn} er indiceret til børn (i alderen 1-18 år) til: - Forebyggelse af forsinket kemoterapiinduceret kvalme og opkastning (CINV) som andenvalgsbehandling
English: deficiency.
Danish: Depression.
English: Rare (may affect up to 1 in 1,000 people) confusional state convulsion (especially in patients with epilepsy).
Danish: Sjælden (forekommer hos 1 ud af 1.000 patienter)
English: For prolonged release preparations 15mg strength
Danish: For formuleringer med forlænget afgift 15mg
English: The recommended single dose is 15 mg, repeated up to twice daily.
Danish: Den anbefalede enkeltdosis er 15 mg, givet op til to gange dagligt.
English: For formulations which can be used to administer a 5mg dose Tablets/capsules/granules are not suitable for use in children weighing less than 30 kg. Other pharmaceutical forms/strengths may be more appropriate for administration to this population
Danish: For formuleringer, som kan bruges til at administrere en dosis på 5 mg {Handelsnavn} er ikke egnet til brug til børn, der vejer mindre end 30 kg. Andre lægemiddelformer/styrker kan være mere egnede til behandlingen.
English: A minimal interval of 24 hours between two administrations is to be respected, even in case of vomiting or rejection of the dose (see section 4.4).
Danish: Et minimumsinterval på 24 timer mellem to administrationer skal overholdes, selv i tilfælde af opkastning eller afvisning af dosis (se pkt.
English: The maximum recommended daily dose is 30 mg or 0.5mg/kg body weight.
Danish: Den maksimale anbefalede daglige dosis er 30 mg eller 0,5mg/kg legemsvægt.
English: The maximum recommended dose per day is 30 mg or 0.5 mg/kg body weight.
Danish: Den maksimale anbefalede dosis per dag er 30 mg eller 0,5 mg/kg legemsvægt.
English: A minimal interval of 6 hours between two administrations is to be respected, even in case of vomiting or rejection of the dose (see section 4.4).
Danish: Et minimumsinterval på 6 timer mellem to administrationer skal overholdes, selv i tilfælde af opkastning eller afvisning af dosis (se pkt.
English: For immediate release preparations The recommended single dose is 10 mg, repeated up to three times daily.
Danish: For formuleringer med umiddelbar afgift Den anbefalede enkeltdosis er 10 mg, givet op til tre gange dagligt.
English: A minimal interval of 12 hours between two administrations is to be respected, even in case of vomiting or rejection of the dose (see section 4.4).
Danish: Et minimumsinterval på 12 timer mellem to administrationer skal overholdes, selv i tilfælde af opkastning eller afvisning af dosis (se pkt.
English: - you have or may have a rare tumour of the adrenal gland, which sits near the kidney
Danish: - hvis du har eller kan have en sjælden svulst i binyrerne (fæokromocytom).
English: For 30mg prolonged release oral formulations
Danish: For 30 mg formuleringer med forlænget afgift
English: For formulations which cannot be used to administer a 5mg dose {Tradename} is not suitable for use in children weighing less than 61 kg.
Danish: For formuleringer, der ikke kan bruges til administration af en dosis på 5 mg Tabletter/kapsler/granulater er ikke egnede til børn, der vejer mindre end 61 kg.
English: The recommended single dose is 10 mg, repeated up to three times daily.
Danish: Den anbefalede enkeltdosis er 10 mg, givet op til tre gange dagligt.
English: For 15mg prolonged release oral formulations
Danish: For 15 mg formuleringer med forlænget afgift
English: Not known Cardiac arrest, occurring shortly after injectable use, and which can be subsequent to bradycardia (see section 4.4); Atrioventricular block,
Danish: Hjertestop, forekommende kort tid efter injektion og potentielt forudgået af bradykardi (se pkt.
English: In cases of abnormal levels (methaemoglobinemia), the treatment should be immediately and permanently stopped.
Danish: I tilfælde af methæmoglobinæmi skal behandlingen stoppes øjeblikkeligt, og du må ikke <tage/få> {Handelsnavn} på et senere tidspunkt.
English: For formulations which can be used to administer a 5mg dose {Tradename} is not suitable for use in children weighing less than 30 kg.
Danish: For formuleringer, som kan bruges til administration af en dosis på 5 mg Tabletter/kapsler/granulater er ikke egnede til børn, der vejer mindre end 30 kg.
English: Uncommon (may affect up to 1 in 100 people) raised levels of a hormone called prolactin in the blood which may cause: milk production in men, and women who are not breast-feeding irregular periods hallucination decreased level of consciousness slow heartbeat (particularly with intravenous route) allergy
Danish: • Forhøjede niveauer af hormonet prolaktin i blodet, hvilket kan medføre mælkeproduktion hos mænd og hos kvinder, der ikke ammer
English: Children and adolescents For all formulations
Danish: Brug til børn og unge
English: Dose
Danish: Asteni.
English: All indications (paediatric patients aged 1-18 years)
Danish: Almindelig (forekommer hos mellem 1 og 10 patienter)
English: The recommended dose is 0.1 to 0.15 mg/kg body weight, repeated up to 3 times daily, given by slow injection into a vein.
Danish: Alle indikationer (pædiatriske patienter i alderen 1-18 år) Den anbefalede enkeltdosis er 0,1 til 0,15 mg/kg legemsvægt, givet op til tre gange dagligt ved langsom injektion i en vene.
English: The time interval of at least 24 hours specified in the section 4.2 should be respected between each metoclopramide administration, even in case of vomiting and rejection of the dose, in order to avoid overdose.
Danish: 4.2, overholdes mellem hver administration af metoclopramid, selv i tilfælde af opkastning og afvisning af dosis.
English: - to prevent nausea and vomiting that may occur after surgery - to treat nausea and vomiting including nausea and vomiting which may occur with a migraine - to prevent nausea and vomiting caused by radiotherapy
Danish: Voksne {Handelsnavn} anvendes til voksne til at: - forebygge kvalme og opkastning efter en operation - behandle kvalme og opkastning, herunder kvalme og opkastning i forbindelse med migræne - forebygge kvalme og opkastning forårsaget af strålebehandling
English: 30 mg strength prolonged release preparations
Danish: 30 mg formuleringer med forlænget afgift
English: Confusional state
Danish: • Konfusion
English: You must wait at least 24 hours between each metoclopramide dose, even in case of vomiting and rejection of the dose, in order to avoid overdose.
Danish: For at undgå overdosering skal der være mindst 24 timer mellem hver metoclopramiddosis, også hvis dukaster op eller afviser en dosis.
English: - to prevent delayed nausea and vomiting that may occur after chemotherapy - to prevent nausea and vomiting caused by radiotherapy
Danish: Voksne {Handelsnavn} anvendes til voksne til at: - forebygge forsinket kvalme og opkastning efter kemoterapi - forebygge kvalme og opkastning forårsaget af strålebehandling
English: Uncommon Hypersensitivity Not known Anaphylactic reaction (including anaphylactic shock particularly with intravenous formulation
Danish: • Allergisk reaktion, som kan blive alvorlig (især ved intravenøs injektion
English: 4.4 Special warnings and precautions for use
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen For alle administrationsveje med undtagelse af formuleringer med forlænget afgift Neurologiske sygdomme
English: You must wait at least 6 hours between each metoclopramide dose, even in case of vomiting and rejection of the dose, in order to avoid overdose.
Danish: For at undgå overdosering skal der være mindst 6 timer mellem hver metoclopramiddosis, også hvis du kaster op eller afviser en dosis.
English: The recommended dose is 0.1 to 0.15 mg/kg body weight, repeated up to 3 times daily, taken by mouth (oral route).
Danish: Forebyggelse af kvalme og opkastning efter kemoterapi (børn i alderen 1-18 år) Den anbefalede enkeltdosis er 0,1 til 0,15 mg/kg legemsvægt, givet op til tre gange dagligt gennem munden (oral administration).
English: Renal and Hepatic Impairment
Danish: Blod og lymfesystem
English: Vascular disorder
Danish: Nedsat nyrefunktion