natgillin/translations-raw huggingface dataset:
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.
Der gik også længere tid, før symptomerne kom igen hos patienter, der fik Cymbalta, end hos dem, der fik placebo.
It also took longer for symptoms to return in patients taking Cymbalta than in those taking placebo.
Ved svær depression er den anbefalede dosis af Cymbalta 60 mg én gang dagligt.
For major depression, the recommended dose of Cymbalta is 60 mg once a day.
I de to undersøgelser, hvor den godkendte dosering af Cymbalta blev sammenlignet med placebo, var Cymbalta mere effektivt.
In the two studies where the approved dose of Cymbalta was compared with placebo, Cymbalta was more effective.
Cymbalta bør ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for duloxetin eller andre af indholdsstofferne.
Cymbalta should not be used in people who may be hypersensitive (allergic) to duloxetine or any of the other ingredients.
Hos patienter, der reagerer på Cymbalta, bør behandlingen fortsættes i flere måneder for at undgå, at sygdommen kommer tilbage.
In patients who respond to Cymbalta, treatment should continue for several months, to prevent the disorder coming back.
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.
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.
Hvilken risiko er der forbundet med Cymbalta?
What is the risk associated with Cymbalta?
Til neuropatiske smerter er Cymbalta blevet sammenlignet med placebo i to 12-ugers undersøgelser hos 809 voksne sukkersygepatienter.
For neuropathic pain, Cymbalta has been compared with placebo in two 12-week studies in 809 diabetic adults.
• perifere diabetiske neuropatiske smerter (smerter forårsaget af sukkersygebetingede nervelidelser i arme og ben).
• pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes);
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.
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.
Selvom resulaterne af depressionsundersøgelserne varierede, var Cymbalta mere effektivt end placebo i fire af undersøgelserne.
Although the results of the depression studies varied, Cymbalta was more effective than placebo in four of the studies.
Til behandling af generaliseret angst var Cymbalta også mere effektivt end placebo til behandling af sygdommen og til forebyggelse af, at symptomerne kom igen.
For generalised anxiety disorder, Cymbalta was also more effective than placebo at treating the disorder and preventing symptoms returning.
Cymbalta bør ikke anvendes til patienter med visse leversygdomme eller med svær nyresygdom.
Cymbalta must also not be used in patients with certain types of liver disease or patients with severe kidney disease.
Ved at blokere for genoptagelsen af neurotransmitterne øger duloxetin mængden af neurotransmittere i mellemrummene mellem disse nerveceller og forbedrer dermed kommunikationen mellem dem. Neurotransmittere er med til at holde humøret oppe og mindske smertefornemmelsen.
By blocking their re-uptake, duloxetine increases the amount of these neurotransmitters in the spaces between these nerve cells, increasing the level of communication between the cells.
Det aktive stof i Cymbalta er duloxetin, der hæmmer genoptagelsen af serotonin og noradrenalin.
The active substance in Cymbalta, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Ligesom med andre midler mod depression har patienter i behandling med Cymbalta i enkelte tilfælde haft selvmordstanker og udvist selvmordsadfærd, navnlig i de første uger af behandlingen for depression.
As with other antidepressants, isolated cases of suicidal thoughts and behaviour have been seen in patients taking Cymbalta, particularly in the first few weeks of treatment for depression.
Den fuldstændige liste over alle de indberettede bivirkninger ved Cymbalta fremgår af indlægssedlen.
For the full list of all side effects reported with Cymbalta, see the Package Leaflet.
Til behandling af diabetiske neuropatiske smerter var Cymbalta bedre til at lindre smerterne end placebo.
For the treatment of diabetic neuropathic pain, Cymbalta was more effective at reducing pain than placebo.
Til behandling af generaliseret angst er Cymbalta blevet sammenlignet med placebo i fem undersøgelser med deltagelse af i alt 2 337 patients.
For generalised anxiety disorder, Cymbalta has been compared with placebo in five studies involving a total of 2,337 patients.
Ved svær depression blev Cymbalta sammenlignet med placebo (en virkningsløs behandling) i otte hovedundersøgelser af i alt 2 544 patienter.
For major depression, Cymbalta has been compared with placebo (a dummy treatment) in eight main studies involving a total of 2,544 patients.
Hvorfor blev Cymbalta godkendt?
Why has Cymbalta been approved?
Hvad er Cymbalta?
What is Cymbalta?
Hvis en patient, der er i behandling med Cymbalta, på noget tidspunkt føler sig nedtrykt, bør patienten straks fortælle det til lægen.
Any patients taking Cymbalta who have distressing thoughts or experiences at any time should tell their doctor immediately.
Når deres genoptagelse i nervecellerne blokeres, kan man derfor opnå en bedring i symptomerne på depression, angst og neuropatiske smerter.
Since these neurotransmitters are involved in maintaining high mood and reducing the sensation of pain, blocking their re-uptake into nerve cells can improve the symptoms of depression, anxiety and neuropathic pain.
Cymbalta duloxetin
Cymbalta duloxetine EPAR summary for the public
Når behandlingen ophører, bør det ske ved gradvis nedsættelse af dosis af Cymbalta.
The dose of Cymbalta should be reduced gradually when stopping treatment.
Hvad anvendes Cymbalta til?
What is Cymbalta used for?
Hvordan blev Cymbalta undersøgt?
How has Cymbalta been studied?
Hvordan anvendes Cymbalta?
How is Cymbalta used?
Hvilken fordel viser undersøgelserne, at der er ved Cymbalta?
What benefit has Cymbalta shown during the studies?
Hvordan virker Cymbalta?
How does Cymbalta work?
Blister (PVC/PVdC /Al) 100 x 1 kapsler (enhedsdosis)
Blister (PVC/PVdC/Alu) 100 x 1 capsules (unit dose)
Blister (PVC/PVdC /Al) 50 x 1 tabletter (enhedsdosis)
Blister (PVC/PVdC/Alu) 50 x 1 tablets
Styrke Lægemiddelform Administration Emballage
Immediate Packaging Pack size
MF (EU)nummer
MA (EU) number (Invented) name Strength Pharmaceutical form Route of administration
SYSTEMORGANKLASSE MEGET ALMINDELIG
SYSTEM ORGAN CLASS VERY COMMON
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/18/1310/001
MARKETING AUTHORISATION NUMBER(S) EU/1/18/1310/001
I tilfælde af neutropeni:
In the event of neutropenia: