natgillin/translations-raw huggingface dataset:
Leflunomide Apotex er bioækvivalent med det tilsvarende EU-referencelægemiddel, kan benefit/risk-forholdet for Leflunomide Apotex ikke anses for tilfredsstillende. 
Therefore, and in the absence of a reliable bioequivalence study specifically designed to establish the bioequivalence of Leflunomide Apotex to its EU reference product, the benefit-risk balance of Leflunomide Apotex cannot be considered to be favourable.
Indlægsseddel 1. 
Package Leaflet 1.
Produktinformation kan efterfølgende blive opdateret af myndighededen i den enkelte medlemsstat, i samarbejde med reference medlemsstaten,hvor det er hensigtsmæssigt, i overensstemmelse med den procedurer der er fastlagt i Kapitel 4 artikel III i Direktiv 2001/83/EC. 
The product information may 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.
Derfor vil lægen kontrollere dit blodtryk regelmæssigt de første dage af behandlingen. 
Therefore, your doctor will need to check your blood pressure regularly during the first days of treatment.
Bromocriptin bør ikke anvendes til rutinemæssigt at stoppe mælkeproduktionen. 
Bromocriptine should not routinely be used to stop breast milk production.
Hvis du lige har født, er der større risiko for, at du udvikler visse bivirkninger. 
If you have just given birth you may be more at risk of certain conditions.
Tag ikke bromocriptin hvis: 
Do not take bromocriptine if:
Bemærk: Dette produktresumé, denne mærkning og indlægsseddel er resultatet af en referral procedure. 
This Summary of Product Characteristics, labelling and package leaflet is the outcome of the referral procedure.
- du har eller har haft hjertesygdom eller alvorlig sygdom i blodkarrene - du har eller har haft alvorlige psykiske problemer 
- You have, or have ever had, heart disease, or other severe blood vessel disease - You have, or have ever had, serious mental health problems
Hos nogle patienter var udvikling af krampeanfald og slagtilfælde forudgået af svær hovedpine og/eller forbigående synsforstyrrelser. 
In some patients the development of seizures or stroke was preceded by severe headache and/or transient visual disturbances.
Tal straks med lægen, hvis du oplever højt blodtryk, smerter i brystet eller usædvanlig kraftig eller vedvarende hovedpine (med eller uden synsforstyrrelser). 
Speak immediately to your doctor if you experience high blood pressure, chest pain or unusually severe or persistent headache (with or without vision problems).
Blodtrykket skal monitores omhyggeligt, især i starten af behandlingen. 
Blood pressure should be carefully monitored, especially during the first days of therapy.
[Den aktuelt godkendte produktinformation skal ændres (ved indsættelse, erstatning eller sletning som passende) for at gengive den vedtagede ordlyd, som er givet nedenfor] 
[The existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below]
Forebyggelse eller hæmning af fysiologisk post-partum laktation, hvor der er medicinsk indikation (såsom i tilfælde af tab intrapartum, neonatal død, HIV-infektion hos moderen...). 
Prevention or suppression of post-partum physiological lactation only where medically indicated (such as in case of intrapartum loss, neonatal death, HIV infection of the mother…).
Disse bivirkninger er meget sjældne, men omfatter højt blodtryk, hjertetilfælde, kramper, slagtilfælde eller psykiske forstyrrelser. 
These are very rare, but may include high blood pressure, heart attack, convulsion, stroke or mental problems.
- 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. 
- 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.
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. 
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.
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. 
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.
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. 
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.
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. 
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.
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. 
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.
Du kan tage bromocriptin: 
Bromocriptine may be used for:
4.3 Kontraindikationer [For alle produkter listet i bilag I skal dette punkt ændres på passende måde for at gengive ordlyden nedenfor] 
4.3 Contraindications [This section should be amended as appropriate to reflect the wording below for all products referred in Annex I]
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. 
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.
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] 
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]
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] 
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]
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] 
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]
[Dette punkt skal ændres for præparater med styrkene 1 mg og 2,5 mg, så nedenstående ordlyd gengives på passende måde i teksten] 
[For products of 1 mg and 2.5 mg strengths only, this section should be amended as appropriate to reflect the wording below]
Produktresume 
Summary of Product Characteristics
[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] 
[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]
[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] 
[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]
Virkning og anvendelse: 
Note:
[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. 
[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]
I alt 104 forsøgspersoner blev inkluderet. 
A total of 104 subjects were enrolled.
30. januar 2019 
30 January 2019
(Bilag V af CMDh-indstilling). 
(Annex V of the CMDh position).
Hypermagnesæmi blev rapporteret i 4 tilfælde, hvoraf 3 var lette og et moderat i sværhedsgrad. 
Hypermagnesaemia was reported in 4 cases, 3 of which were mild and one moderate in severity.
Niveauerne af magnesium i disse tilfælde anses ikke for at udgøre klinisk relevant hypermagnesæmi. 
The levels of magnesium in these cases are not considered to represent clinically relevant hypermagnesemia.
På baggrund af tilgængelige data vedrørende den endelige PASS-studierapport vurderede PRAC derfor, at ændringer i betingelserne for markedsføringstilladelsen var berettigede. 
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.
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. 
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.
Oversættelser af bilagene for indstillingen fremsendes til de relevante nationale myndigheder: 
Transmission to National Competent Authorities of the translations of the annexes to the position:
Indehaveren/indehaverne af markedsføringstilladelsen skal fjerne følgende betingelse(r) (ny tekst med understregning og fed skrift, slettet tekst med gennemstregning) 
The marketing authorisation holder(s) shall remove the following condition(s) (new text underlined and in bold, deleted text strike through)
Der blev ikke identificeret potentielle risikofaktorer for betydningsfuld stigning i serummagnesium. 
No potential risk factors for notable increase in serum magnesium were identified.
Indehaveren af markedsføringstilladelse forelægger protokollen til ovennævnte undersøgelse. 
The MAH should submit the protocol for the above mentioned study.
Der blev ikke observeret noget akkumuleringsmønster eller fortsat stigning i magnesiumniveauer i serum, der kunne give grund til bekymring om sikkerheden. 
No pattern of accumulation or continued increase in serum magnesium levels that would raise any safety concern was observed.
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. 
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.
CMDh er nået frem til, at markedsføringstilladelsen/-tilladelserne omfattet af denne endelige PASSrapport bør ændres. 
The CMDh reaches the position that the marketing authorisation(s) of the products concerned by this PASS final report should be varied.
CMDh-møde i oktober 2018 
October 2018 CMDh meeting
Bilag II Betingelser for markedsføringstilladelsen/-tilladelserne 
Annex II Conditions to the Marketing Authorisation(s)>
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. 
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.
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. 
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.
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 
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
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: 
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:
Farveløse hætteglas 
Glass vial
Tilbageholdelsestid intravenøs injection 
Withdrawal period
Ikke relevant 
EU Number
ref.: EMEA/751799/2009 EMEA/H/C/572 
Ref.: EMA/751799/2009 EMA/H/C/572
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Cymbalta til Eli Lilly Nederland BV den 17. december 2004. 
The European Commission granted a marketing authorisation valid throughout the European Union for Cymbalta to Eli Lilly Nederland BV on 17 December 2004.
Det leveres som enterokapsler (hvide og blå: 30 mg; grønne og blå: 60 mg). 
It is available as gastroresistant capsules (white and blue: 30 mg; green and blue: 60 mg).
Cymbalta anvendes til behandling af voksne med følgende sygdomme: 
Cymbalta is used to treat adults with the following diseases:
De fleste af bivirkningerne var lette eller moderate og satte ind tidligt under behandlingen, men aftog efterhånden. 
Most of these were mild or moderate, starting early in treatment and getting milder as treatment continued.
• generaliseret angst (langvarig angst eller ængstelighed over for hverdagens begivenheder). 
• generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).
De fleste patienter skal tage 60 mg om dagen. 
Most patients will need to take 60 mg per day.
Andre oplysninger om Cymbalta: 
Other information about Cymbalta:
Cymbalta er et lægemiddel, der indeholder det aktive stof duloxetin. 
Cymbalta is a medicine that contains the active substance duloxetine.
Behandlingen begynder sædvanligvis at virke efter to til fire uger. 
A response is usually seen in two to four weeks.
De mest almindelige bivirkninger ved Cymbalta (som ses hos flere end 1 ud af 10 patienter) er kvalme, hovedpine, mundtørhed, søvntrang og svimmelhed. 
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.
Patienter, som også har svær depression, bør starte med 60 mg en gang dagligt. 
Patients who also have major depression should start with 60 mg once a day.
Den fuldstændige EPAR for Cymbalta findes her. 
The full EPAR for Cymbalta can be found here.
Behandlingens virkning blev hovedsagelig bedømt på ændringen i smerteintensiteten hver uge. 
The main measure of effectiveness was the change in the severity of pain each week.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Cymbalta opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Cymbalta. 
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.
Enterokapsler er kapsler, hvis indhold passerer gennem mavesækken uden at nedbrydes, før det når tarmene. 
‘Gastroresistant' means that the capsules' contents pass through the stomach without being broken down until they reach the intestine.
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. 
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.
Behandlingen bør ikke indledes hos patienter med ukontrolleret forhøjet blodtryk, da dette kan medføre risiko for pludselige, foruroligende store blodtryksstigninger. 
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).
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). 
Cymbalta must not be used together with monoamine oxidase inhibitors (another group of antidepressants), fluvoxamine (another antidepressant), or ciprofloxacin or enoxacin (types of antibiotic).
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. 
The fifth study looked at how long it took for symptoms to return in 429 patients who had initially responded to Cymbalta.
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. 
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.