natgillin/translations-raw huggingface dataset:
• Rul hætteglasset med Ultratard mellem hænderne, indtil væsken er ensartet hvid og uklar
• Roll the vial of Ultratard between your hands until the liquid is uniformly white and cloudy dic
37 lg • Træk en mængde luft ind i sprøjten svarende til dosis af Ultratard.
• Draw as much air into the syringe as the dose of Ultratard you need.
Injicér luften i hætteglasset med den hurtigtvirkende insulin.
Then turn the vial and syringe upside down • Draw the right dose of fast acting insulin into the syringe.
ise • Injicér blandingen straks.
36 is no air left in the syringe, and check the dose • Inject the mixture straight away.
38 lg Hyperglykæmi (højt blodsukker) Ved hyperglykæmi bliver blodsukkeret for højt.
If your blood sugar gets too high Your blood sugar may get too high (this is called hyperglycaemia). i
ret Følgende faktorer kan forårsage hyperglykæmi • Hvis De har glemt at tage Deres insulin • Hvis De gentagne gange tager mindre insulin, end De har brug for
37 Causes of a hyperglycaemia • Having forgotten to take your insulin • Repeatedly taking less insulin than you need • An infection or a fever
39 lg 6 Hvordan De opbevarer Ultratard
6 How to store Ultratard
Kan medbringes og opbevares ved stuetemperatur (ikke over 25°C) i op til 6 uger.
Ultratard vials that are being used or about to be used are not to be kept in the fridge.
London, 16/ 01/ 2007 Dok. ref.
EMEA/ 37021/ 2007 - update
SPØRGSMÅL OG SVAR VEDRØRENDE ANBEFALINGEN AF AFSLAG PÅ ANSØGNINGEN OM MARKEDSFØRINGSTILLADELSE for VALDOXAN/ THYMANAX
QUESTIONS AND ANSWERS ON RECOMMENDATION FOR REFUSAL OF MARKETING AUTHORISATION for VALDOXAN/ THYMANAX
Den 27. juli 2006 vedtog Udvalget for Humanmedicinske Lægemidler (CHMP) en negativ udtalelse, hvori det anbefalede at give afslag på ansøgningen om markedsføringstilladelse for lægemidlet Valdoxan/ Thymanax, 25 mg filmovertrukne tabletter, beregnet til behandling af svære depressive forstyrrelser.
On 27 July 2006 the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a marketing authorisation for the medicinal product Valdoxan/ Thymanax, 25 mg film-coated tablets intended for the treatment of major depressive disorder.
Ansøgeren anmodede om en revurdering af udtalelsen, men trak denne anmodning tilbage, inden CHMP havde gennemført revurderingen.
The applicant requested a re- examination of the opinion, but withdrew this request before the CHMP completed the re-examination.
Hvad er Valdoxan/ Thymanax?
What is Valdoxan/ Thymanax?
Valdoxan/ Thymanax er orange- gule tabletter, der indeholder 25 mg af det aktive stof agomelatin.
Valdoxan/ Thymanax are orange-yellow tablets containing 25 mg of the active substance agomelatine.
Hvad forventedes Valdoxan/ Thymanax anvendt til?
What was Valdoxan/ Thymanax expected to be used for?
Valdoxan/ Thymanax forventedes anvendt til brug hos voksne patienter til behandling af svære depressive forstyrrelser.
Valdoxan/ Thymanax was expected to be used in adult patients to treat major depressive disorder.
Hovedsymptomerne er nedtrykt sindstilstand og tab/ formindsket interesse eller glæde.
The key symptoms are depressed mood and loss/ diminished interest or pleasure.
Hvordan forventes Valdoxan/ Thymanax at virke?
How is Valdoxan/ Thymanax expected to work?
Det aktive stof i Valdoxan/ Thymanax, agomelatin, er en ‘ melatoninagonist ’ og en ‘ 5- HT2C - antagonist ’.
The active substance in Valdoxan/ Thymanax, agomelatine, is a ‘ melatonergic agonist’ and a ‘ 5-HT2C antagonist’.
Dette betyder, at agomelatin stimulerer melatoninreceptorerne MT1 og MT2 (disse receptorer aktiveres normalt af et naturligt hormon, melatonin) og det blokerer 5- HT2C - receptorerne (disse receptorer aktiveres normalt af en kemisk budbringer, serotonin).
This means that agomelatine stimulates the melatonin receptors MT1 and MT2 (these receptors are normally activated by a natural hormone, melatonin) and it blocks the 5-HT2C receptors (these receptors are normally activated by a chemical messenger, serotonin).
Hovedundersøgelserne omfattede flere end 2. 400 patienter, der tog Valdoxan/ Thymanax.
The main studies involved more than 2,400 patients that took Valdoxan/ Thymanax.
Undersøgelserne så på kort - og langtidseffektiviteten af lægemidlet (korttidsundersøgelserne varede 6 - 8 uger, og langtidsundersøgelserne varede op til et år).
They looked at the short- and long-term effectiveness of the medicine (short-term studies lasting 6-8 weeks and the long- term studies lasting up to a year).
Alle behandlede patienter led af svære depressive forstyrrelser, hvis sværhedsgrad blev vurderet ved brug af en standardiseret vurderingsskala (Hamiltons depressionsskala, HAM- D).
All patients treated suffered from a major depressive disorder, the severity of which was assessed using a standard rating scale (the Hamilton Rating Scale for Depression, HAM-D).
Valdoxan/ Thymanax blev sammenlignet med en placebo (en uvirksom behandling).
Valdoxan/ Thymanax was compared with a placebo (a dummy treatment).
Effektiviteten blev målt ved vurdering af pointtallene i HAM- D vurderingsskalaen før undersøgelsen og efter afslutning af undersøgelsen.
The effectiveness was measured by looking at the score in the HAM-D rating scale before and at the end of the study.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Hvori bestod de vigtigste betænkeligheder, som førte til, at CHMP anbefalede afslag på ansøgning om markedsføringstilladelse?
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What were the major concerns that led to the CHMP to recommend a refusal of the marketing authorisation?
CHMP havde ingen særlige bekymringer vedrørende bivirkninger forbundet med Valdoxan/ Thymanax, da disse kunne være blevet håndteret ved brug af standardredskaber til risikohåndtering.
The major concern of the CHMP was that the effectiveness of Valdoxan/ Thymanax had not been sufficiently shown: • The long-term study did not show that the medicine was effective. • The short-term studies showed that the medicine has an effect, but the extent of this did not allow the Committee to draw a firm conclusion on the medicine ’ s effectiveness The CHMP had no special concerns regarding the side effects associated with Valdoxan/ Thymanax, as these could have been managed using the standard risk management tools.
På dette tidspunkt var CHMP af den opfattelse, at fordelene ved Valdoxan/ Thymanax ikke opvejede risiciene.
At this point in time, the CHMP was of the opinion that the benefits of Valdoxan/ Thymanax did not outweigh its risks.
CHMP anbefalede derfor afslag på markedsføringstilladelse for Valdoxan/ Thymanax.
Hence, the CHMP recommended that Valdoxan/ Thymanax be refused marketing authorisation.
Hvilke konsekvenser har afslaget for patienter, der deltager i kliniske undersøgelser / programmer for specialudlevering af Valdoxan/ Thymanax?
What are the consequences of the refusal for patients undergoing clinical trials/ compassionate use programmes with Valdoxan/ Thymanax?
Firmaet har informeret CHMP om, at der ikke er konsekvenser for patienter, der på nuværende tidspunkt deltager i kliniske undersøgelser eller programmer for specialudlevering af Valdoxan/ Thymanax.
The Company has informed the CHMP that there are no consequences on patients currently included in clinical trials or compassionate use programmes with Valdoxan/ Thymanax.
Indehaveren af markedsføringstilladelsen skal sikre, at alle sundhedsprofessionelle med erfaring i at ordinere/ anvende Valdoxan efter lancering forsynes med oplysningsmateriale, der indeholder følgende:
The Marketing Authorisation Holder (MAH) shall ensure that, at launch, all healthcare professionals who are experienced to prescribe/ use Valdoxan are provided with educational materials containing the following:
Den anbefalede dosis Valdoxan er én tablet én gang dagligt taget ved sengetid med eller uden mad.
The recommended dose of Valdoxan is one tablet once a day, taken at bedtime with or without food.
Der bør udvises forsigtighed ved anvendelse til patienter over 65 år, da der ikke klart er påvist nogen gavn af Valdoxan i denne aldersgruppe.
Because a benefit of Valdoxan has not been shown clearly in patients aged over 65 years, it should be used with caution in this age group.
Valdoxan 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.
Man mener, at dette medfører et øget niveau af dopamin og noradrenalin mellem nervecellerne i de 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. områder i hjernen, som er involveret i kontrol af stemningslejet.
Reproduction is authorised provided the source is acknowledged. control of mood.
Valdoxan kan også hjælpe med at normalisere patientens søvnmønstre.
Valdoxan might also help to normalise the patient ’ s sleep patterns.
Virkningerne af Valdoxan blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of Valdoxan were first tested in experimental models before being studied in humans.
Valdoxan er blevet sammenlignet med placebo (en virkningsløs behandling) i fem kortvarige undersøgelser med i alt mere end 1 893 voksne med svær depression.
Valdoxan has been compared with placebo (a dummy treatment) in five main short-term studies involving a total of 1,893 adults with major depression.
Virksomheden fremlagde også resultaterne fra endnu en undersøgelse, som sammenlignede Valdoxan med sertralin (et andet antidepressivum).
The company also presented the results of a further study comparing Valdoxan with sertraline (another antidepressant).
De kortvarige undersøgelser viste, at Valdoxan var mere effektivt end placebo i de to undersøgelser, hvor der ikke blev anvendt aktivt sammenligningsstof.
In the short-term studies, Valdoxan was seen to be more effective than placebo in the two studies where no active comparator was used.
I de første langvarige undersøgelser var der ingen forskel mellem Valdoxan 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 Valdoxan 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 Valdoxan 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 Valdoxan over 24 weeks (34 out of 165), compared with 41% of the patients taking placebo (72 out of 174).
De mest almindelige bivirkninger ved Valdoxan (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 Valdoxan (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.
Nogle af bivirkningerne kan være forbundet med patientens depression snarere end med Valdoxan.
Some of these side effects may be linked to the patient’ s depression rather than Valdoxan itself.
Den fuldstændige liste over alle de indberettede bivirkninger ved Valdoxan fremgår af indlægssedlen.
For the full list of all side effects reported with Valdoxan, see the Package Leaflet.
Valdoxan må ikke anvendes til personer, som kan være overfølsomme (allergiske) over for agomelatin eller andre af indholdsstofferne.
Valdoxan should not be used in people who may be hypersensitive (allergic) to agomelatine or any of the other ingredients.
Det må heller ikke anvendes af patienter, som tager lægemidler, der forsinker nedbrydningen af Valdoxan i kroppen, såsom fluvoxamin (et andet antidepressivum) og ciprofloxacin (et antibiotikum).
It must also not be used in patients who are taking medicines that slow down the breakdown of Valdoxan in the body, such as fluvoxamine (another antidepressant) and ciprofloxacin (an antibiotic).
Valdoxan bør ikke anvendes til ældre patienter med demens.
Valdoxan should not be used in elderly patients with dementia.
Udvalget for Humanmedicinske Lægemidler (CHMP) bemærkede, at fordelene ved Valdoxan 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 Valdoxan’ 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 Valdoxan 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 Valdoxan could be a valuable treatment for some patients as long as their liver function is tested frequently.
CHMP konkluderede derfor, at fordelene ved Valdoxan er større end risiciene ved behandling af voksne med alvorlige episoder af depression.
Therefore, the CHMP decided that Valdoxan’ s benefits are greater than its risks for the treatment of major depressive episodes in adults.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Valdoxan.
The Committee recommended that Valdoxan be given marketing authorisation.
2/ 3 Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Valdoxan?
2/ 3 Which measures are being taken to ensure the safe use of Valdoxan?
Virksomheden, som fremstiller Valdoxan, udleverer informationsmateriale til de læger, som ordinerer Valdoxan, når det bliver markedsført.
The company that makes Valdoxan will supply educational material for prescribers of Valdoxan when it is launched.
Andre oplysninger om Valdoxan:
Other information about Valdoxan:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Valdoxan til Les Laboratoires Servier den 19 februar 2009.
The European Commission granted a marketing authorisation valid throughout the European Union for Valdoxan to Les Laboratoires Servier on 19 February 2009.
Den fuldstændige EPAR for Vidaza findes her.
The full EPAR for Valdoxan can be found here.
EU- nummer EU/ 1/ 08/ 499/ 001 EU/ 1/ 08/ 499/ 002 EU/ 1/ 08/ 499/ 003 EU/ 1/ 08/ 499/ 004 EU/ 1/ 08/ 499/ 005 EU/ 1/ 08/ 499/ 006 EU/ 1/ 08/ 499/ 007 EU/ 1/ 08/ 499/ 008
EU/ 1/ 08/ 499/ 001 EU/ 1/ 08/ 499/ 002 EU/ 1/ 08/ 499/ 003 EU/ 1/ 08/ 499/ 004 EU/ 1/ 08/ 499/ 005 EU/ 1/ 08/ 499/ 006 EU/ 1/ 08/ 499/ 007 EU/ 1/ 08/ 499/ 008
Særnavn Valdoxan Valdoxan Valdoxan Valdoxan Valdoxan Valdoxan Valdoxan Valdoxan
Valdoxan Valdoxan Valdoxan Valdoxan Valdoxan Valdoxan Valdoxan Valdoxan
Styrke 25 mg 25 mg 25 mg 25 mg 25 mg 25 mg 25 mg 25 mg
25 mg 25 mg 25 mg 25 mg 25 mg 25 mg 25 mg 25 mg
Lægemiddelform Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
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)
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 tabletter 14 tabletter 28 tabletter 42 tabletter 56 tabletter 84 tabletter 98 tabletter 100 tabletter
7 tablets 14 tablets 28 tablets 42 tablets 56 tablets 84 tablets 98 tablets 100 tablets
Valdoxan tabletter kan tages alene eller i forbindelse med et måltid.
Valdoxan tablets may be taken with or without food.
4. 4).
Valdoxan 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).
Der foreligger kun begrænsede kliniske data om brug af Valdoxan til ældre patienter over 65 år med moderate til svære depressive enkeltepisoder.
Only limited clinical data is available on the use of Valdoxan in elderly patients ≥ 65 years old with major depressive episodes.
4. 4).
Therefore, caution should be exercised when prescribing Valdoxan to these patients (see section 4.4).
Der foreligger dog kun begrænsede kliniske data om brug af Valdoxan til depressive patienter med alvorligt eller moderat nedsat nyrefunktion.
However, only limited clinical data on the use of Valdoxan in depressed patients with severe or moderate renal impairment with major depressive episodes is available.
4. 3, 4. 4 og 5. 2).
2 Valdoxan is contraindicated in patients with hepatic impairment (see sections 4.3, 4.4 and 5.2).
Valdoxan bør anvendes med forsigtighed til patienter med mani eller hypomani i anamnesen, og lægemidlet skal seponeres hos patienter, der udvikler maniske symptomer.
Valdoxan should be used with caution in patients with a history of mania or hypomania and should be discontinued if a patient develops manic symptoms.
Der bør udvises forsigtighed ved ordination af Valdoxan sammen med moderate CYP1A2- hæmmere (fx propranolol, grepafloxacin, enoxacin), da det kan føre til øget eksponering for agomelatin.
Caution should be exercised when prescribing Valdoxan with moderate CYP1A2 inhibitors (e. g. propranolol, grepafloxacine, enoxacine) which may result in increased exposure of agomelatine.
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 Valdoxan particularly on a 50 mg dose (see section 4.8).
Når Valdoxan blev seponeret hos disse patienter, blev niveauet af aminotransferaser generelt normaliseret.
When Valdoxan was discontinued in these patients, the serum transaminases usually returned to normal levels.
Beslutningen om, hvorvidt patienten skal fortsætte behandlingen med Valdoxan, bør baseres på et klinisk skøn ud fra laboratorieresultater.
The decision whether to continue the patient on therapy with Valdoxan should be guided by clinical judgement pending laboratory evaluations.
Der skal udvises forsigtighed ved administration af Valdoxan 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 Valdoxan is administered to patients who consume substantial quantities of alcohol or who are treated with medicinal products associated with risk of hepatic injury.
Valdoxan 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.
Samtidig administration af Valdoxan og potente CYP1A2- hæmmere (fx fluvoxamin og ciprofloxacin) er derfor kontraindiceret.
Consequently, co-administration of Valdoxan with potent CYP1A2 inhibitors (e. g. fluvoxamine, ciprofloxacin) is contraindicated.
Benzodiazepiner, lithium, paroxetin, fluconazol og theophyllin.
No evidence of pharmacokinetic or pharmacodynamic interaction with medicinal products which could be prescribed concomitantly with Valdoxan in the target population was found in phase I clinical trials: benzodiazepines, lithium, paroxetine, fluconazole and theophylline.
Hvis behandling med Valdoxan anses for nødvendig, bør amningen indstilles.
If treatment with Valdoxan is considered necessary, breastfeeding should be discontinued.
Over 3. 900 depressive patienter har fået Valdoxan i kliniske forsøg.
In clinical trials, over 3,900 depressed patients have received Valdoxan.
Det kan derfor være vanskeligt at fastslå, hvilke symptomerne der skyldes selve sygdommen, og hvilke der skyldes behandlingen med Valdoxan.
It is therefore sometimes difficult to ascertain which symptoms are a result of the illness itself and which are a result of treatment with Valdoxan.
Valdoxans virkning og sikkerhed ved moderat til svær depression er undersøgt i et klinisk program med 5. 800 patienter, hvoraf 3. 900 blev behandlet med Valdoxan.
The efficacy and safety of Valdoxan in major depressive episodes have been studied in a clinical programme including 5,800 patients of whom 3,900 were treated with Valdoxan.
To forsøg med justerbar dosis og fire med fast dosis.
Six placebo controlled trials have been performed to investigate the short term efficacy of Valdoxan in major depressive disorder: two flexible dose studies and four fixed dose studies.
Patienter, der responderede på 8/ 10 ugers akut behandling med Valdoxan 25- 50 mg en gang dagligt i et åbent forsøg blev randomiseret til enten Valdoxan 25- 50 mg en gang dagligt eller placebo i yderligere 6 måneder.
Patients responding to 8/ 10-weeks of acute treatment with open-label Valdoxan 25-50 mg once daily were randomised to either Valdoxan 25-50 mg once daily or placebo for further 6-months.
Valdoxan 25- 50 mg en gang dagligt viste et statistisk signifikant bedre resultat sammenlignet med placebo (p=0, 0001) for det primære effektmål, dvs. forebyggelse af recidiverende depression målt som tid til recidiv.
Valdoxan 25- 50 mg once daily demonstrated a statistically significant superiority compared to placebo (p=0.0001) on the primary outcome measure, the prevention of depressive relapse, as measured by time to relapse.
Valdoxan og placebo.
The incidence of relapse during the 6-months double-blind follow up period was 22% and 47% for Valdoxan and placebo, respectively.
Hos depressive patienter forlængede Valdoxan 25 mg den dybe søvn (Slow Wave Sleep) uden at ændre mængden af REM- søvn (Rapid Eye Movement) eller REM- latenstiden.
In depressed patients, treatment with Valdoxan 25 mg increased slow wave sleep without modification of REM (Rapid Eye Movement) sleep amount or REM latency.
Hos patienter med depression i remission har en specifik komparativ undersøgelse af seksuel dysfunktion vist en numerisk tendens (ikke statistisk signifikant) til mindre seksuel dysfunktion under behandlingen med Valdoxan end med venlafaxin ved måling af seksualdrift, ophidselse og orgasme ud fra scoringen på Sex Effects Scale (SEXFX).
6 In a specific sexual dysfunction comparative study with remitted depressed patients, there was a numerical trend (not statistically significant) towards less sexual emergent dysfunction than venlafaxine for Sex Effects Scale (SEXFX) drive arousal or orgasm scores on Valdoxan.
Analysen af de samlede resultater fra undersøgelser baseret på Arizona Sexual Experience Scale (ASEX) viste, at Valdoxan ikke var forbundet med seksuel dysfunktion.
The pooled analysis of studies using the Arizona Sexual Experience Scale (ASEX) showed that Valdoxan was not associated with sexual dysfunction.
Valdoxan havde en neutral virkning på legemsvægt, hjertefrekvens og blodtryk i kliniske forsøg.
Valdoxan had neutral effect on body weight, heart rate and blood pressure in clinical studies.