natgillin/translations-raw huggingface dataset:
Oplysningsmaterialet til ordinerende læger om Valdoxan / Thymanax fokuserer på:
The prescriber educational material about Valdoxan / Thymanax will be focused on:
- De potentielle risici ved agomelatin:
- The potential risks of agomelatine
- forhøjede aminotransferaser
- Transaminases Elevations
- interaktion med potente CYP1A2- hæmmere (fx fluvoxamin, ciprofloxacin).
- Interactions with potent CYP 1A2 inhibitors (e. g. fluvoxamine, ciprofloxacin).
- Retningslinjer for leverfunktionsscreening (behov for at kontrollere leverfunktionen hos alle patienter ved
- Guidance for hepatic function screening (Need to perform liver function tests in all patients: at initiation
6 uger (afslutningen af den akutte fase), 12 uger og 24 uger (afslutningen af vedligeholdelsesfasen) og derefter ved klinisk indikation;
of treatment, and then periodically after around six weeks (end of acute phase), twelve weeks and twenty four weeks (end of maintenance phase) and thereafter when clinically indicated;
- Vejledning i tilfælde af kliniske symptomer på nedsat leverfunktion eller abnorme testresultater;
- Guidance in case of clinical symptoms or liver function tests abnormality;
- Advarsel om, at der bør udvises forsigtighed, når behandlingen gives til patienter, der har et stort
- Caution to be exercised when therapy is administered to patients who consume substantial quantities of
alkoholforbrug, eller som er i behandling med lægemidler, der forbindes med risiko for leverskader;
alcohol or who are treated with medicinal products associated with risk of hepatic injury;
- Kontraindiceret til patienter med nedsat leverfunktion (dvs. cirrose eller aktiv leversygdom);
- Contra-indication in patients with hepatic impairment (i. e. cirrhosis or active liver disease);
- Kontraindiceret til patienter i samtidig behandling med potente CYP1A2- hæmmere.
- Contra-indication in patients receiving concomitantly potent CYP1A2 inhibitors.
Det fås som orangegule, aflange tabletter (25 mg).
It is available as orange- yellow, oblong tablets (25 mg).
Den anbefalede dosis Thymanax er én tablet én gang dagligt taget ved sengetid med eller uden mad.
The recommended dose of Thymanax is one tablet once a day, taken at bedtime with or without food.
Leveren skal også kontrolleres, hvis patienten udvikler symptomer, som kan være tegn på leverproblemer.
The patient’ s liver should be checked with blood tests when treatment starts, and then after around six, 12 and 24 weeks of treatment The liver should also be checked if the patient develops symptoms that could indicate liver problems.
Behandlingen skal afbrydes hos patienter med et unormalt indhold af leverenzymer i blodet.
Treatment should be interrupted in patients with abnormal liver enzyme levels in the blood.
Blodprøverne skal i så fald gentages, indtil leverenzymerne er faldet til et normalt niveau.
Blood tests should then be repeated until the liver enzymes have returned to normal levels.
Der bør udvises forsigtighed ved anvendelse til patienter over 65 år, da der ikke klart er påvist nogen gavn af Thymanax i denne aldersgruppe.
Because a benefit of Thymanax has not been shown clearly in patients aged over 65 years, it should be used with caution in this age group.
Thymanax skal også anvendes med forsigtighed til patienter med moderate eller alvorlige nyreproblemer.
It should also be used with caution in patients with moderate or severe kidney problems.
Det må ikke anvendes til patienter, som har leverproblemer.
It must not be used in patients who have liver problems.
Det virker på to måder, både ved at stimulere MT1 - og MT2- receptorerne, som normalt aktiveres af melatonin, og ved at blokere 5- HT 2C - receptorerne, som normalt aktiveres af neurotransmitteren 5- hydroxytryptamin (også kaldet serotonin).
It works in two ways, both by stimulating the MT1 and MT2 receptors, which are normally activated by melatonin, and also by blocking the 5-HT 2C receptors, which are normally activated by the neurotransmitter 5-hydroxytryptamine (also called serotonin).
Man mener, at dette medfører et øget niveau af dopamin og noradrenalin mellem 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. nervecellerne i de områder i hjernen, som er involveret i kontrol af stemningslejet.
Reproduction is authorised provided the source is acknowledged. control of mood.
Thymanax kan også hjælpe med at normalisere patientens søvnmønstre.
Thymanax might also help to normalise the patient ’ s sleep patterns.
Virkningerne af Thymanax blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of Thymanax were first tested in experimental models before being studied in humans.
Thymanax er blevet sammenlignet med placebo (en virkningsløs behandling) i fem kortvarige undersøgelser med i alt mere end 1 893 voksne med svær depression.
Thymanax has been compared with placebo (a dummy treatment) in five main short-term studies involving a total of 1,893 adults with major depression.
Tre af disse undersøgelser omfattede patienter, som var behandlet med andre antidepressiva, enten fluoxetin eller paroxetin, som aktivt stof til sammenligning.
Three of these studies included some patients treated with other antidepressants, either fluoxetine or paroxetine, as an ‘ active comparator’.
Behandlingens virkning i disse fem undersøgelser blev hovedsagelig bedømt på ændringen af patienternes symptomer efter seks uger, målt på en standardskala for depression ved navn Hamilton Depression Rating Scale (HAM- D).
The main measure of effectiveness in these five studies was the change in symptoms after six weeks, as measured on a standard scale for depression called the Hamilton Depression Rating Scale (HAM-D).
Virksomheden fremlagde også resultaterne fra endnu en undersøgelse, som sammenlignede Thymanax med sertralin (et andet antidepressivum).
The company also presented the results of a further study comparing Thymanax with sertraline (another antidepressant).
To andre hovedundersøgelser sammenlignede Thymanaxs og placebos evne til at forhindre, at symptomerne kom igen, hos 706 patienter, hvis depression allerede var kontrolleret med Thymanax.
Two other main studies compared the ability of Thymanax and placebo to prevent symptoms returning in 706 patients whose depression had already been controlled with Thymanax.
Det primære effektmål var antallet af patienter, hvis symptomer kom igen i løbet af 24 til 26 ugers behandling.
The main measure of effectiveness was the number of patients whose symptoms returned during 24 to 26 weeks of treatment.
De kortvarige undersøgelser viste, at Thymanax var mere effektivt end placebo i de to undersøgelser, hvor der ikke blev anvendt aktivt sammenligningsstof.
In the short-term studies, Thymanax was seen to be more effective than placebo in the two studies where no active comparator was used.
Den sidste undersøgelse viste, at agomelatin var mere effektivt end sertralin med en forskel i HAM- D- score på 1, 68 efter seks uger.
The additional study showed that agomelatine was more effective than sertraline, with a difference in HAM-D scores of 1.68 after six weeks.
I de første langvarige undersøgelser var der ingen forskel mellem Thymanax og placebo med hensyn til at forhindre, at symptomerne kom igen under 26 ugers behandling.
In the first of the long-term studies, there was no difference between Thymanax and placebo in preventing symptoms returning during 26 weeks of treatment.
Den anden undersøgelse viste imidlertid, at symptomerne kom igen hos 21% af patienterne, som tog Thymanax i 24 uger (34 ud af 165) sammenlignet med 41% af patienterne, som tog placebo (72 ud af 174).
However, the second study showed that symptoms returned in 21% of the patients taking Thymanax over 24 weeks (34 out of 165), compared with 41% of the patients taking placebo (72 out of 174).
De mest almindelige bivirkninger ved Thymanax (som optræder hos mellem 1 og 10 patienter ud af 100) er hovedpine, svimmelhed, søvntrang, søvnløshed, migræne, kvalme, diarré, forstoppelse, mavepine, øget svedafsondring, rygsmerter, træthed, forhøjet leverenzymniveau og angst.
The most common side effects with Thymanax (seen in between 1 and 10 patients in 100) are headache, dizziness, somnolence (sleepiness), insomnia (difficulty sleeping), migraine, nausea (feeling sick), diarrhoea, constipation, upper abdominal pain (tummy ache), hyperhidrosis (excessive sweating), back pain, fatigue (tiredness), increases in liver enzymes and anxiety.
De fleste bivirkninger var lette eller moderate og forekom i løbet af behandlingens første to uger.
Most side effects were mild or moderate in intensity and happened within the first two weeks of treatment.
Nogle af bivirkningerne kan være forbundet med patientens depression snarere end med Thymanax.
Some of these side effects may be linked to the patient’ s depression rather than Thymanax itself.
Den fuldstændige liste over alle de indberettede bivirkninger ved Thymanax fremgår af indlægssedlen.
For the full list of all side effects reported with Thymanax, see the Package Leaflet.
Thymanax må ikke anvendes til personer, som kan være overfølsomme (allergiske) over for agomelatin eller andre af indholdsstofferne.
Thymanax should not be used in people who may be hypersensitive (allergic) to agomelatine or any of the other ingredients.
Det må ikke anvendes af patienter, der har leverproblemer som cirrose (skrumpelever) eller aktiv leversygdom.
It must not be used in patients who have problems with their liver, such as cirrhosis (scarring of the liver) or active liver disease.
Thymanax bør ikke anvendes til ældre patienter med demens.
Thymanax should not be used in elderly patients with dementia.
Udvalget for Humanmedicinske Lægemidler (CHMP) bemærkede, at fordelene ved Thymanax med hensyn til behandling af depression kan være mindre end dem, der ses med andre antidepressiva.
The Committee for Medicinal Products for Human Use (CHMP) noted that Thymanax’ s benefits in terms of treating depression might be lower than seen with other antidepressants.
Da lægemidlet imidlertid har en ny virkningsmåde, få bivirkninger og en anderledes sikkerhedsprofil end de eksisterende antidepressiva, konkluderede Udvalget, at Thymanax kan være en god behandling for nogle patienter, når blot deres leverfunktion bliver kontrolleret hyppigt.
However, since the medicine has a new mode of action, few side effects and a different safety profile to existing antidepressants, the Committee concluded that Thymanax could be a valuable treatment for some patients as long as their liver function is tested frequently.
CHMP konkluderede derfor, at fordelene ved Thymanax er større end risiciene ved behandling af voksne med alvorlige episoder af depression.
Therefore, the CHMP decided that Thymanax’ s benefits are greater than its risks for the treatment of major depressive episodes in adults.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Thymanax.
The Committee recommended that Thymanax be given marketing authorisation.
2/ 3 Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Thymanax?
2/ 3 Which measures are being taken to ensure the safe use of Thymanax?
Virksomheden, som fremstiller Thymanax, udleverer informationsmateriale til de læger, som ordinerer Thymanax, når det bliver markedsført.
The company that makes Thymanax will supply educational material for prescribers of Thymanax when it is launched.
Dette materiale vil forklare lægemidlets sikkerhed og særligt de eventuelle virkninger på leveren samt dets interaktion med andre lægemidler.
This material will explain the safety of the medicine, particularly its possible effects on the liver and its interactions with other medicines.
Andre oplysninger om Thymanax:
Other information about Thymanax:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Thymanax til Servier (Ireland) Industries Ltd den 19 februar 2009.
The European Commission granted a marketing authorisation valid throughout the European Union for Thymanax to Servier (Ireland) Industries Ltd on 19 February 2009.
Den fuldstændige EPAR for Thymanax findes her.
The full EPAR for Thymanax can be found here.
EU/ 1/ 08/ 498/ 001 EU/ 1/ 08/ 498/ 002 EU/ 1/ 08/ 498/ 003 EU/ 1/ 08/ 498/ 004 EU/ 1/ 08/ 498/ 005 EU/ 1/ 08/ 498/ 006 EU/ 1/ 08/ 498/ 007 EU/ 1/ 08/ 498/ 008
EU Procedure number EU/ 1/ 08/ 498/ 001 EU/ 1/ 08/ 498/ 002 EU/ 1/ 08/ 498/ 003 EU/ 1/ 08/ 498/ 004 EU/ 1/ 08/ 498/ 005 EU/ 1/ 08/ 498/ 006 EU/ 1/ 08/ 498/ 007 EU/ 1/ 08/ 498/ 008
Særnavn Thymanax Thymanax Thymanax Thymanax Thymanax Thymanax Thymanax Thymanax
Invented name Thymanax Thymanax Thymanax Thymanax Thymanax Thymanax Thymanax Thymanax
Styrke 25 mg 25 mg 25 mg 25 mg 25 mg 25 mg 25 mg 25 mg
Strength 25 mg 25 mg 25 mg 25 mg 25 mg 25 mg 25 mg 25 mg
Emballage Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC)
Packaging Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC)
Paknings- størrelse 7 14 28 42 56 84 98 100
Package size 7 14 28 42 56 84 98 100
LÆGEMIDLETS NAVN
1 1 NAME OF THE MEDICINAL PRODUCT
Lactosemonohydrat 61, 84 mg.
Excipient: lactose monohydrate 61.84 mg
Orange til gul, aflang, filmovertrukket tablet med blåt firmalogo påtrykt den ene side.
Orange-yellow, oblong, film-coated tablet with blue imprint of company logo on one side.
Major depression (moderat til svær depression) hos voksne.
Treatment of major depressive episodes in adults
Den anbefalede dosis er 25 mg en gang dagligt ved sengetid.
The recommended dose is 25 mg once daily taken orally at bedtime.
Såfremt der ikke er opnået bedring af symptomerne efter to ugers behandling, kan dosis øges til 50 mg en gang dagligt, dvs. to tabletter a 25 mg indtaget samtidig ved sengetid.
After two weeks of treatment, if there is no improvement of symptoms, the dose may be increased to 50 mg once daily, i. e. two 25 mg tablets, taken together at bedtime.
4. 4).
Liver function tests should be performed in all patients: at initiation of treatment, and then periodically after around six weeks (end of acute phase), twelve weeks and twenty four weeks (end of maintenance phase) and thereafter when clinically indicated (see also section 4.4).
Patienter med depression bør behandles i en tilstrækkelig periode på mindst seks måneder for at sikre, at de er symptomfri.
Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free of symptoms.
Thymanax tabletter kan tages alene eller i forbindelse med et måltid.
Thymanax tablets may be taken with or without food.
4. 4).
Thymanax is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy (see section 4.4).
Virkningen er ikke klart påvist hos ældre (≥ 65 år).
Efficacy has not been clearly demonstrated in the elderly (≥ 65 years).
Der foreligger kun begrænsede kliniske data om brug af Thymanax til ældre patienter over 65 år med moderate til svære depressive enkeltepisoder.
Only limited clinical data is available on the use of Thymanax in elderly patients ≥ 65 years old with major depressive episodes.
4. 4).
Therefore, caution should be exercised when prescribing Thymanax to these patients (see section 4.4).
Der foreligger dog kun begrænsede kliniske data om brug af Thymanax til depressive patienter med alvorligt eller moderat nedsat nyrefunktion.
However, only limited clinical data on the use of Thymanax in depressed patients with severe or moderate renal impairment with major depressive episodes is available.
4. 3, 4. 4 og 5. 2).
2 Thymanax is contraindicated in patients with hepatic impairment (see sections 4.3, 4.4 and 5.2).
Seponering af behandlingen:
Treatment discontinuation:
Nedsat leverfunktion (dvs. levercirrose eller aktiv leversygdom) (se pkt.
Hepatic impairment (i. e. cirrhosis or active liver disease) (see sections 4.2 and 4.4).
4. 5).
Concomitant use of potent CYP1A2 inhibitors (e. g. fluvoxamine, ciprofloxacin) (see section 4.5).
I kliniske forsøg sås selvmordsadfærd (selvmordsforsøg og selvmordstanker) og fjendtlighed (overvejende aggressivitet, oppositionel adfærd og vrede) hyppigere hos børn og unge, der fik andre antidepressiva, end hos dem, der fik placebo.
In clinical trials among children and adolescents treated with other antidepressants, suicide-related behaviour (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed compared to those treated with placebo.
Anvendelse til ældre patienter med demens:
Use in elderly patients with dementia:
Mani / Hypomani:
Mania / Hypomania:
Thymanax bør anvendes med forsigtighed til patienter med mani eller hypomani i anamnesen, og lægemidlet skal seponeres hos patienter, der udvikler maniske symptomer.
Thymanax should be used with caution in patients with a history of mania or hypomania and should be discontinued if a patient develops manic symptoms.
Selvmord/ selvmordstanker:
Suicide/ suicidal thoughts:
En metaanalyse af placebokontrollerede kliniske forsøg med antidepressiva hos voksne patienter med psykiske forstyrrelser viste en øget risiko for selvmordsadfærd hos patienter under 25 år, der fik antidepressiva, sammenlignet med patienter, der fik placebo.
A meta-analysis of placebo- controlled clinical trials of antidepressants in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo, in patients less than 25 years old.
Kombination med potente CYP1A2- hæmmere er kontraindiceret.
Combination with CYP1A2 inhibitors (see sections 4.3 and 4.5) Combination with potent CYP1A2 inhibitors is contraindicated.
Der bør udvises forsigtighed ved ordination af Thymanax sammen med moderate CYP1A2- hæmmere (fx propranolol, grepafloxacin, enoxacin), da det kan føre til øget eksponering for agomelatin.
Caution should be exercised when prescribing Thymanax with moderate CYP1A2 inhibitors (e. g. propranolol, grepafloxacine, enoxacine) which may result in increased exposure of agomelatine.
Forhøjede aminotransferaser:
Increased serum transaminases:
4. 8).
In clinical studies, elevations of serum transaminases (> 3 times the upper limit of the normal range) have been observed in patients treated with Thymanax particularly on a 50 mg dose (see section 4.8).
Når Thymanax blev seponeret hos disse patienter, blev niveauet af aminotransferaser generelt normaliseret.
When Thymanax was discontinued in these patients, the serum transaminases usually returned to normal levels.
6 uger (afslutningen af den akutte fase), efter ca.
Liver function tests should be performed in all patients: at initiation of treatment and then periodically after around six weeks (end of acute phase), after around twelve and twenty four weeks (end of maintenance phase) and thereafter when clinically indicated.
12 uger og 24 uger (afslutningen af
Any patient who develops
Patienter, som får forhøjede aminotransferaser, skal have leverfunktionen kontrolleret igen efter 48 timer.
3 increased serum transaminases should have his/ her liver function tests repeated within 48 hours.
Behandlingen skal seponeres, hvis stigningen i aminotransferaser overstiger 3 x den øvre grænse for normalområdet, og leverfunktionen skal kontrolleres regelmæssigt, indtil niveauet for aminotransferaser er normaliseret.
Therapy should be discontinued if the increase in serum transaminases exceeds 3X upper limit of normal and liver function tests should be performed regularly until serum transaminases return to normal.
Hvis en patient udvikler symptomer på leverdysfunktion, skal leverfunktionen kontrolleres.
If any patient develops symptoms suggesting hepatic dysfunction liver function tests should be performed.
Beslutningen om, hvorvidt patienten skal fortsætte behandlingen med Thymanax, bør baseres på et klinisk skøn ud fra laboratorieresultater.
The decision whether to continue the patient on therapy with Thymanax should be guided by clinical judgement pending laboratory evaluations.
Hvis der observeres icterus, skal behandlingen seponeres.
If jaundice is observed therapy should be discontinued.
Der skal udvises forsigtighed ved administration af Thymanax til patienter med et stort alkoholforbrug, eller som er i behandling med lægemidler, der er forbundet med risiko for leverskader.
Caution should be exercised when Thymanax is administered to patients who consume substantial quantities of alcohol or who are treated with medicinal products associated with risk of hepatic injury.
Thymanax indeholder lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, en sjælden form af arvelig lactasemangel (Lapp Lactase deficiency) eller glucose/ galactosemalabsorption.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Mulige interaktioner, der påvirker agomelatin:
Potential interactions affecting agomelatine:
Agomelatin omdannes hovedsageligt via cytokrom P450 1A2 (CYP1A2) (90%) og via CYP2C9/ 19 (10%).
Agomelatine is metabolised mainly by cytochrome P450 1A2 (CYP1A2) (90%) and by CYP2C9/ 19 (10%).
Fluvoxamin, som er en potent CYP1A2 - og en moderat CYP2C9- hæmmer, hæmmer omsætningen af agomelatin markant, hvilket fører til en stigning med faktor 60 (interval 12- 412) i eksponeringen for agomelatin.
Fluvoxamine, a potent CYP1A2 and moderate CYP2C9 inhibitor markedly inhibits the metabolism of agomelatine resulting in a 60-fold (range 12-412) increase of agomelatine exposure.
Samtidig administration af Thymanax og potente CYP1A2- hæmmere (fx fluvoxamin og ciprofloxacin) er derfor kontraindiceret.
Consequently, co-administration of Thymanax with potent CYP1A2 inhibitors (e. g. fluvoxamine, ciprofloxacin) is contraindicated.
Kombination af agomelatin med østrogener (moderate CYP1A2- hæmmere) fører til en flere gange større eksponering for agomelatin.
Combination of agomelatine with oestrogens (moderate CYP1A2 inhibitors) results in a several fold increased exposure of agomelatine.
Agomelatins mulige påvirkning af andre lægemidler:
Potential for agomelatine to affect other medicinal products:
Agomelatin inducerer ikke CYP450- isoenzymer in vivo.
In vivo, agomelatine does not induce CYP450 isoenzymes.
Agomelatin hæmmer ikke CYP1A2 in vivo eller de øvrige CYP450 in vitro.
Agomelatine inhibits neither CYP1A2 in vivo nor the other CYP450 in vitro.
Agomelatin påvirker derfor ikke eksponeringen for lægemidler, der metaboliseres af CYP450.
Therefore, agomelatine will not modify exposure to medicinal products metabolised by CYP 450.
Lægemidler, der binder med høj affinitet til plasmaprotein:
Medicinal products highly bound to plasma protein:
Benzodiazepiner, lithium, paroxetin, fluconazol og theophyllin.
No evidence of pharmacokinetic or pharmacodynamic interaction with medicinal products which could be prescribed concomitantly with Thymanax in the target population was found in phase I clinical trials: benzodiazepines, lithium, paroxetine, fluconazole and theophylline.
Elektrokonvulsiv terapi (ECT):
Electroconvulsive therapy (ECT):
5. 3).
Animal studies have not shown proconvulsant properties (see section 5.3).
4 4. 6 Graviditet og amning
4 or postnatal development (see section 5.3).
Det vides ikke, om agomelatin udskilles i modermælk.
It is not known whether agomelatine is excreted into human milk.
Agomelatin eller dets metabolitter udskilles i mælken hos diegivende rotter.
Agomelatine or its metabolites are excreted in the milk of lactating rats.
Det er ikke fastlagt, om agomelatin kan påvirke brystbarnet.
Potential effects of agomelatine on the breast-feeding infant have not been established.
Hvis behandling med Thymanax anses for nødvendig, bør amningen indstilles.
If treatment with Thymanax is considered necessary, breastfeeding should be discontinued.
Over 3. 900 depressive patienter har fået Thymanax i kliniske forsøg.
In clinical trials, over 3,900 depressed patients have received Thymanax.