FrancophonIA/ELRC3.0 huggingface dataset:
English: - You have high blood pressure, - You have ever had blood pressure problems during pregnancy or after giving birth, such as eclampsia, pre-eclampsia, pregnancy-induced high blood pressure, high blood pressure after giving birth.
Danish: - du har højt blodtryk - du har haft problemer med blodtrykket i forbindelse med graviditet eller efter fødslen, for eksempel svangerskabsforgiftning (eklampsi, præ-eklampsi), forhøjet blodtryk forårsaget af graviditet, forhøjet blodtryk efter fødsel.
English: Bromocriptine is contraindicated in patients with uncontrolled hypertension, hypertensive disorders of pregnancy (including eclampsia, pre-eclampsia or pregnancy-induced hypertension), hypertension post-partum and in the puerperium.
Danish: Bromocriptin er kontraindiceret til patienter med ukontrolleret hypertension, hypertensive forstyrrelser i forbindelse med graviditet (inklusive eklampsi, præ-eklampsi eller graviditetsinduceret hypertension), hypertension post-partum samt i puerperiet.
English: In rare cases serious adverse events, including hypertension, myocardial infarction, seizures, stroke, or psychiatric disorders have been reported in post-partum women treated with bromocriptine for the inhibition of lactation.
Danish: I sjældne tilfælde er der rapporteret om alvorlige bivirkninger, inklusive hypertension, myokardieinfarkt, krampeanfald, apopleksi og psykiske forstyrrelser hos kvinder, der post-partum er blevet behandlet med bromocriptin for laktationshæmning.
English: Bromocriptine is contraindicated for use in the suppression of lactation or other non-life threatening indications in patients with a history of coronary artery disease or other severe cardiovascular conditions, or symptoms/history of severe psychiatric disorders.
Danish: Bromocriptin er kontraindiceret til laktationshæmning og andre ikke-livstruende indikationer hos patienter med koronararterielidelse eller andre alvorlige kardiovaskulære tilstande i anamnesen og hos patienter med symptomer på eller anamnese med svære psykiske forstyrrelser.
English: It should also not be used to relieve symptoms of painful breast engorgement after giving birth if these can be adequately treated with non-medical means (such as firm breast support, ice application…) and/ or a painkiller.
Danish: Bromocriptin bør heller ikke anvendes for at lindre symptomer som ømme og spændte bryster efter fødslen, hvis det kan behandles tilstrækkeligt med ikke-medicinske midler (for eksempel bryststøtte, behandling med is…..) og/eller smertestillende lægemidler.
English: Bromocriptine is not recommended for the routine suppression of lactation or for the relief of symptoms of post-partum pain and engorgement which can be adequately treated with nonpharmacological intervention (such as firm breast support, ice application) and/or simple analgesics.
Danish: Bromocriptin kan ikke anbefales til rutinemæssig hæmning af laktation eller for at lindre symptomer som ømme og spændte bryster post-partum, der kan behandles tilstrækkeligt med ikke-farmakologisk behandling (for eksempel bryststøtte, behandling med is) og/eller almindelige analgetika.
English: Bromocriptine may be used for:
Danish: Du kan tage bromocriptin:
English: 4.3 Contraindications [This section should be amended as appropriate to reflect the wording below for all products referred in Annex I]
Danish: 4.3 Kontraindikationer [For alle produkter listet i bilag I skal dette punkt ændres på passende måde for at gengive ordlyden nedenfor]
English: or unremitting headache (with or without visual disturbances), or evidence of central nervous system toxicity develop, the administration of bromocriptine should be discontinued and the patient should be evaluated promptly.
Danish: Hvis der udvikles hypertension, tegn på brystsmerter, alvorlig, progressiv eller vedvarende hovedpine (med eller uden synsforstyrrelser) eller tegn på CNS-toksicitet, skal behandling med bromocriptin afbrydes og patienten straks evalueres.
English: 4.4 Special warnings and precautions for use [For products of 1 mg and 2.5 mg strengths only, this section should be amended as appropriate to reflect the wording below]
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen [Dette punkt skal ændres for præparater med styrkene 1 mg og 2,5 mg, så nedenstående ordlyd gengives på passende måde i teksten]
English: What you need to know before you take bromocriptine [The wording below should be inserted in this section under the following headings for all products referred to in Annex I]
Danish: Det skal du vide, før du begynder at tage bromocriptin [For alle produkter listet i bilag I, skal dette punkt ændres hvor det er passende for at gengive ordlyden nedenfor]
English: 4.1 Therapeutic indications [A. For products of 1 mg and 2.5 mg strengths, the current indication related to lactation inhibition in post-partum, including the examples of mastitis and painful breast engorgement, should be deleted and the below wording should be included in its place]
Danish: 4.1 Terapeutiske indikationer [A. For præparater med styrkerne 1 mg og 2,5 mg skal den aktuelt godkendte indikation relateret til laktationshæmning post-partum, inklusive eksemplerne mastitis og smertefulde brystspændinger, slettes, og nedenstående tekst skal indsættes på dens plads]
English: [For products of 1 mg and 2.5 mg strengths only, this section should be amended as appropriate to reflect the wording below]
Danish: [Dette punkt skal ændres for præparater med styrkene 1 mg og 2,5 mg, så nedenstående ordlyd gengives på passende måde i teksten]
English: Summary of Product Characteristics
Danish: Produktresume
English: [B. For product of higher strengths (5 mg and 10 mg) the indication related to inhibition of lactation in post-partum, including the examples of mastitis and painful breast engorgement, should be removed and the complete PL should be revised to remove wording related to the deleted indication]
Danish: [B. For produkter med højere styrke (5 mg og 10 mg) skal indikationen relateret til laktationshæmning post-partum, inklusiv mastitis og smertefulde brystspændinger, slettes og hele indlægssedlen skal revideres for at slette tekst, der er relateret til den slettede indikation]
English: [B. For product of higher strengths (5 mg and 10 mg) the indication related to inhibition of lactation in post-partum, including the examples of mastitis and painful breast engorgement, should be removed and the complete SmPC should be revised to remove wording related to the deleted indication]
Danish: [B. For produkter med højere styrke (5 mg og 10 mg) skal indikationen relateret til laktationshæmning post-partum, inklusive mastitis og smertefulde brystspændinger, slettes, og hele produktresuméet skal revideres for at slette tekst, der er relateret til den slettede indikation]
English: Note:
Danish: Virkning og anvendelse:
English: [A. For products of 1 mg and 2.5 mg strengths, the current indication related to lactation inhibition in post-partum, including the examples of mastitis and painful breast engorgement, should be deleted and the below wording should be included in its place]
Danish: [A. For præparater med styrke 1 mg og 2,5 mg, skal den aktuelt godkendte indikation relateret til laktationshæmning post-partum, inklusiv eksemplerne mastitis og smertefulde brystspændinger, slettes, og den nedenstående tekst skal indsættes på dens plads] - for at stoppe produktionen af mælk (amning) af medicinske årsager, og når du og lægen har vurderet, at det er nødvendigt.
English: A total of 104 subjects were enrolled.
Danish: I alt 104 forsøgspersoner blev inkluderet.
English: 30 January 2019
Danish: 30. januar 2019
English: (Annex V of the CMDh position).
Danish: (Bilag V af CMDh-indstilling).
English: Hypermagnesaemia was reported in 4 cases, 3 of which were mild and one moderate in severity.
Danish: Hypermagnesæmi blev rapporteret i 4 tilfælde, hvoraf 3 var lette og et moderat i sværhedsgrad.
English: The levels of magnesium in these cases are not considered to represent clinically relevant hypermagnesemia.
Danish: Niveauerne af magnesium i disse tilfælde anses ikke for at udgøre klinisk relevant hypermagnesæmi.
English: Therefore, in view of available data regarding the PASS final study report, the PRAC considered that changes to the conditions of the marketing authorisation were warranted.
Danish: På baggrund af tilgængelige data vedrørende den endelige PASS-studierapport vurderede PRAC derfor, at ændringer i betingelserne for markedsføringstilladelsen var berettigede.
English: Overall, data suggest that neonates can tolerate during a short time a relatively wide range of serum magnesium concentrations without increased risk of adverse outcomes.
Danish: Samlet set tyder data på, at nyfødte i en kort periode kan tolerere en relativt bred vifte af serummagnesiumkoncentrationer uden øget risiko for negative resultater.
English: Transmission to National Competent Authorities of the translations of the annexes to the position:
Danish: Oversættelser af bilagene for indstillingen fremsendes til de relevante nationale myndigheder:
English: The marketing authorisation holder(s) shall remove the following condition(s) (new text underlined and in bold, deleted text strike through)
Danish: Indehaveren/indehaverne af markedsføringstilladelsen skal fjerne følgende betingelse(r) (ny tekst med understregning og fed skrift, slettet tekst med gennemstregning)
English: No potential risk factors for notable increase in serum magnesium were identified.
Danish: Der blev ikke identificeret potentielle risikofaktorer for betydningsfuld stigning i serummagnesium.
English: The MAH should submit the protocol for the above mentioned study.
Danish: Indehaveren af markedsføringstilladelse forelægger protokollen til ovennævnte undersøgelse.
English: No pattern of accumulation or continued increase in serum magnesium levels that would raise any safety concern was observed.
Danish: Der blev ikke observeret noget akkumuleringsmønster eller fortsat stigning i magnesiumniveauer i serum, der kunne give grund til bekymring om sikkerheden.
English: The MAH should conduct a prospective non-interventional post-authorisation safety study to further evaluate magnesium levels observed in term newborn infants and children up to two years of age treated with Numeta G16%E in routine clinical practice.
Danish: Indehaveren af markedsføringstilladelsen udfører en prospektiv, ikke-interventionel sikkerhedsundersøgelse efter markedsføring til yderligere vurdering af de iagttagne magnesiumværdier hos nyfødte og børn op til to år, der behandles med Numeta G16%E i rutinemæssig klinisk praksis.
English: The CMDh reaches the position that the marketing authorisation(s) of the products concerned by this PASS final report should be varied.
Danish: CMDh er nået frem til, at markedsføringstilladelsen/-tilladelserne omfattet af denne endelige PASSrapport bør ændres.
English: October 2018 CMDh meeting
Danish: CMDh-møde i oktober 2018
English: Annex II Conditions to the Marketing Authorisation(s)>
Danish: Bilag II Betingelser for markedsføringstilladelsen/-tilladelserne
English: The descriptive study final report submitted by the MAH complies with their obligation to conduct a prospective non-interventional post-authorisation safety study to further evaluate magnesium levels observed in term newborn infants and children up to two years of age treated in routine clinical practice as imposed during the Article 107i procedure EMEA/H/A-107i/1373 for alanine, arginine, aspartic acid, cysteine, glucose, glutamic acid, glycine, histidine, isoleucine, leucine, lysine monohydrate, methionine, ornithine hydrochloride, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine, calcium chloride, magnesium acetate, potassium acetate, sodium chloride, sodium glycerophosphate, refined soybean oil, refined olive oil containing products.
Danish: Den endelige rapport for det deskriptive studie indsendt af indehaveren af markedsføringstilladelsen, overholder forpligtelsen til at udføre en prospektiv ikke-interventionssikkerhedsundersøgelse efter tilladelse til markedsføring (PASS) for yderligere at evaluere magnesiumniveauer observeret hos fuldbårne nyfødte spædbørn og børn op til to år behandlet efter rutinemæssig klinisk praksis som pålagt i henhold til artikel 107i procedure EMEA/H/A-107i/1373 for produkter der indeholder alanin, arginin, asparaginsyre, cystein, glucose, glutaminsyre, glycin, histidin, isoleucin, leucin, lysinmonohydrat, methionin, ornithinhydrochlorid, phenylalanin, prolin, serin, taurin, threonin, tryptophan, tyrosin, valin, calciumchlorid, magnesiumacetat, kaliumacetat, natriumchlorid, natriumglycerophosphat, raffineret sojabønneolie, raffineret olivenolie.
English: On the basis of the scientific conclusions for the results of the study for the medicinal product(s) containing the active substance Alanine, arginine, aspartic acid, cysteine, glucose, glutamic acid, glycine, histidine, isoleucine, leucine, lysine monohydrate, methionine, ornithine hydrochloride, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine, calcium chloride, magnesium acetate, potassium acetate, sodium chloride, sodium glycerophosphate, refined soybean oil, refined olive oil and concerned by the PASS final report , the CMDh is of the opinion that the benefitrisk balance of the medicinal product(s) mentioned above is unchanged subject to the proposed changes to the product information.
Danish: På baggrund af de videnskabelige konklusioner for resultaterne af studiet for lægemiddel/lægemidler indeholdende det aktive stof alanin, arginin, asparaginsyre, cystein, glucose, glutaminsyre, glycin, histidin, isoleucin, leucin, lysinmonohydrat, methionin, ornithinhydrochlorid, phenylalanin, prolin, serin, taurin, threonin, tryptophan, tyrosin, valin, calciumchlorid, magnesiumacetat, kaliumacetat, natriumchlorid, natriumglycerophosphat, raffineret sojabønneolie, raffineret olivenolie og omfattet af den endelige PASS-rapport, er CMDh af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, nævnt ovenfor, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: Changes to be made to the conditions of the marketing authorisation(s) of medicinal product(s) containing the active substance Alanine, arginine, aspartic acid, cysteine, glucose, glutamic acid, glycine, histidine, isoleucine, leucine, lysine monohydrate, methionine, ornithine hydrochloride, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine, calcium chloride, magnesium acetate, potassium acetate, sodium chloride, sodium glycerophosphate, refined soybean oil, refined olive oil concerned by the non-interventional imposed PASS final report
Danish: Ændringer af betingelserne for markedsføringstilladelsen for lægemidler med indhold af det aktive stof alanin, arginin, asparaginsyre, cystein, glucose, glutaminsyre, glycin, histidin, isoleucin, leucin, lysinmonohydrat, methionin, ornithinhydrochlorid, phenylalanin, prolin, serin, taurin, threonin, tryptophan, tyrosin, valin, calciumchlorid, magnesiumacetat, kaliumacetat, natriumchlorid, natriumglycerophosphat, raffineret sojabønneolie, raffineret olivenolie berørt af den pålagte ikke-interventionelle endelige PASS-rapport
English: Taking into account the PRAC Assessment Report for the non-interventional imposed PASS final report for the medicinal product(s) containing the active substance Alanine, arginine, aspartic acid, cysteine, glucose, glutamic acid, glycine, histidine, isoleucine, leucine, lysine monohydrate, methionine, ornithine hydrochloride, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine, calcium chloride, magnesium acetate, potassium acetate, sodium chloride, sodium glycerophosphate, refined soybean oil, refined olive oil and concerned by the PASS final report , the scientific conclusions are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om ikke-interventionssikkerhedsundersøgelser efter tilladelse til markedsføring (PASS) for lægemidler indeholdende det aktive stof Alanin, arginin, asparaginsyre, cystein, glucose, glutaminsyre, glycin, histidin, isoleucin, leucin, lysinmonohydrat, methionin, ornithinhydrochlorid, phenylalanin, prolin, serin, taurin, threonin, tryptophan, tyrosin, valin, calciumchlorid, magnesiumacetat, kaliumacetat, natriumchlorid, natriumglycerophosphat, raffineret sojabønneolie, raffineret olivenolie og berørt af PASS-slutrapporten , er de videnskabelige konklusioner som følger:
English: Glass vial
Danish: Farveløse hætteglas
English: Withdrawal period
Danish: Tilbageholdelsestid intravenøs injection
English: EU Number
Danish: Ikke relevant
English: Ref.: EMA/751799/2009 EMA/H/C/572
Danish: ref.: EMEA/751799/2009 EMEA/H/C/572
English: The European Commission granted a marketing authorisation valid throughout the European Union for Cymbalta to Eli Lilly Nederland BV on 17 December 2004.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Cymbalta til Eli Lilly Nederland BV den 17. december 2004.
English: It is available as gastroresistant capsules (white and blue: 30 mg; green and blue: 60 mg).
Danish: Det leveres som enterokapsler (hvide og blå: 30 mg; grønne og blå: 60 mg).
English: Cymbalta is used to treat adults with the following diseases:
Danish: Cymbalta anvendes til behandling af voksne med følgende sygdomme:
English: Most of these were mild or moderate, starting early in treatment and getting milder as treatment continued.
Danish: De fleste af bivirkningerne var lette eller moderate og satte ind tidligt under behandlingen, men aftog efterhånden.
English: • generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).
Danish: • generaliseret angst (langvarig angst eller ængstelighed over for hverdagens begivenheder).
English: Most patients will need to take 60 mg per day.
Danish: De fleste patienter skal tage 60 mg om dagen.
English: Other information about Cymbalta:
Danish: Andre oplysninger om Cymbalta:
English: Cymbalta is a medicine that contains the active substance duloxetine.
Danish: Cymbalta er et lægemiddel, der indeholder det aktive stof duloxetin.
English: A response is usually seen in two to four weeks.
Danish: Behandlingen begynder sædvanligvis at virke efter to til fire uger.
English: The most common side effects with Cymbalta (seen in more than 1 patient in 10) are nausea (feeling sick), headache, dry mouth, somnolence (sleepiness) and dizziness.
Danish: De mest almindelige bivirkninger ved Cymbalta (som ses hos flere end 1 ud af 10 patienter) er kvalme, hovedpine, mundtørhed, søvntrang og svimmelhed.
English: Patients who also have major depression should start with 60 mg once a day.
Danish: Patienter, som også har svær depression, bør starte med 60 mg en gang dagligt.
English: The full EPAR for Cymbalta can be found here.
Danish: Den fuldstændige EPAR for Cymbalta findes her.
English: The main measure of effectiveness was the change in the severity of pain each week.
Danish: Behandlingens virkning blev hovedsagelig bedømt på ændringen i smerteintensiteten hver uge.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Cymbalta's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Cymbalta opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Cymbalta.
English: ‘Gastroresistant' means that the capsules' contents pass through the stomach without being broken down until they reach the intestine.
Danish: Enterokapsler er kapsler, hvis indhold passerer gennem mavesækken uden at nedbrydes, før det når tarmene.
English: For generalised anxiety disorder, the recommended starting dose is 30 mg once a day, but the dose can be increased to 60, 90 or 120 mg depending on the patient's response.
Danish: Ved behandling af generaliseret angst er den anbefalede startdosis 30 mg én gang dagligt, men den kan øges til 60, 90 eller 120 mg afhængigt af patientens reaktion.
English: Treatment must not be started in patients with uncontrolled hypertension (high blood pressure), because of a risk of hypertensive crisis (sudden, dangerously high blood pressure).
Danish: Behandlingen bør ikke indledes hos patienter med ukontrolleret forhøjet blodtryk, da dette kan medføre risiko for pludselige, foruroligende store blodtryksstigninger.
English: Cymbalta must not be used together with monoamine oxidase inhibitors (another group of antidepressants), fluvoxamine (another antidepressant), or ciprofloxacin or enoxacin (types of antibiotic).
Danish: Cymbalta bør ikke anvendes sammen med MAO-hæmmere (monoaminoxidasehæmmere, en anden type lægemidler mod depression), fluvoxamin (et andet middel mod depression) eller ciprofloxacin eller enoxacin (to typer antibiotika).
English: The fifth study looked at how long it took for symptoms to return in 429 patients who had initially responded to Cymbalta.
Danish: I den femte undersøgelse så man på, hvor lang tid det tog, inden symptomerne vendte til bage hos 429 patienter, hos hvem Cymbalta oprindeligt havde virket.
English: For diabetic neuropathic pain, the recommended dose is 60 mg per day but some patients may need a higher dose of 120 mg per day.
Danish: Til diabetiske neuropatiske smerter er den anbefalede dosis 60 mg om dagen, men nogle patienter kan have brug for en højere dosis på 120 mg dagligt.
English: It also took longer for symptoms to return in patients taking Cymbalta than in those taking placebo.
Danish: Der gik også længere tid, før symptomerne kom igen hos patienter, der fik Cymbalta, end hos dem, der fik placebo.
English: For major depression, the recommended dose of Cymbalta is 60 mg once a day.
Danish: Ved svær depression er den anbefalede dosis af Cymbalta 60 mg én gang dagligt.
English: In the two studies where the approved dose of Cymbalta was compared with placebo, Cymbalta was more effective.
Danish: I de to undersøgelser, hvor den godkendte dosering af Cymbalta blev sammenlignet med placebo, var Cymbalta mere effektivt.
English: Cymbalta should not be used in people who may be hypersensitive (allergic) to duloxetine or any of the other ingredients.
Danish: Cymbalta bør ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for duloxetin eller andre af indholdsstofferne.
English: In patients who respond to Cymbalta, treatment should continue for several months, to prevent the disorder coming back.
Danish: Hos patienter, der reagerer på Cymbalta, bør behandlingen fortsættes i flere måneder for at undgå, at sygdommen kommer tilbage.
English: The other two studies looked at how long it took for symptoms to return in patients who had initially responded to Cymbalta, including 288 patients with a history of repeated episodes of depression for up to five years.
Danish: De andre to undersøgelser så på, hvor lang tid der gik, inden symptomerne vendte tilbage hos patienter, der oprindeligt havde reageret på Cymbalta, heraf 288 patienter, som tidligere havde haft gentagne episoder med depression i op til fem år.
English: What is the risk associated with Cymbalta?
Danish: Hvilken risiko er der forbundet med Cymbalta?
English: For neuropathic pain, Cymbalta has been compared with placebo in two 12-week studies in 809 diabetic adults.
Danish: Til neuropatiske smerter er Cymbalta blevet sammenlignet med placebo i to 12-ugers undersøgelser hos 809 voksne sukkersygepatienter.
English: • pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes);
Danish: • perifere diabetiske neuropatiske smerter (smerter forårsaget af sukkersygebetingede nervelidelser i arme og ben).
English: In patients who respond to Cymbalta, treatment should continue for several months to prevent the disease coming back, or for longer in patients who have had repeated periods of depression in the past.
Danish: Hos patienter, der reagerer på Cymbalta, bør behandlingen fortsættes i flere måneder for at forhindre tilbagefald eller længere hos patienter, som tidligere har haft gentagne perioder med depression.