natgillin/translations-raw huggingface dataset:
CYMBALTA viste statistisk signifikant fordel i forhold til placebo målt som bedring på Hamilton Anxiety Scale (HAM- A) totalscore og på Sheehan Disability Scale (SDS) som score for total funktionel hæmning.
CYMBALTA demonstrated statistically significant superiority over placebo as measured by improvement in the Hamilton Anxiety Scale (HAM-A) total score and by the Sheehan Disability Scale (SDS) global functional impairment score.
Graden af respons og bedring var også højere med CYMBALTA sammenlignet med placebo.
Response and remission rates were also higher with CYMBALTA compared to placebo.
CYMBALTA viste sammenlignelige resultater med venlafaxin udtrykt i HAM- A totalscore.
CYMBALTA showed comparable efficacy results to venlafaxine in terms of improvements on the HAM-A total score.
I et studie med forebyggelse af tilbagefald blev de patienter, som responderede på 6 måneders akut behandling med open- label CYMBALTA, randomiseret til enten CYMBALTA eller placebo i yderligere 6 måneder.
In a relapse prevention study, patients responding to 6 months of acute treatment with open-label CYMBALTA were randomised to either CYMBALTA or placebo for further 6-months.
CYMBALTA 60 mg til 120 mg en gang daglig viste statistisk signifikant fordel sammenlignet med placebo (p < 0. 0001) ved forebyggelse af tilbagefald målt som tid til tilbagefald.
CYMBALTA 60 mg to 120 mg once daily demonstrated statistically significant superiority compared to placebo (p < 0.001) on the prevention of relapse, as measured by time to relapse.
Incidensen af tilbagefald under den 6- måneders dobbeltblinde follow- up periode var 14% for CYMBALTA og 42% for placebo.
The incidence of relapse during the 6-months double-blind follow-up period was 14% for CYMBALTA and 42% for placebo.
Effekten af CYMBALTA som en behandling af diabetiske neuropatiske smerter blev etableret i 2 randomiserede 12- ugers, dobbeltblinde, placebokontrollerede forsøg med fast dosis hos voksne (22 til 88 år), som havde haft diabetiske neuropatiske smerter i mindst 6 måneder.
The efficacy of CYMBALTA as a treatment for diabetic neuropathic pain was established in 2 randomised, 12-week, double-blind, placebo-controlled, fixed dose studies in adults (22 to 88 years) having diabetic neuropathic pain for at least 6 months.
60 mg én gang daglig og 60 mg to gange daglig.
In both studies, CYMBALTA 60 mg once daily and 60 mg twice daily significantly reduced pain compared with placebo.
Klinisk respons (mindst 50% smertereduktion) blev analyseret i forhold til om, patienten havde oplevet somnolens under behandlingen.
Clinical response rates (50% or greater improvement in pain) were analysed according to 12 whether or not the patient experienced somnolence during treatment.
Duloxetins farmakokinetik viser stor variation mellem patienter (generelt 50- 60%), delvist på grund af køn, alder, ryger ikke - ryger status og CYP2D6 metaboliseringsstatus.
The pharmacokinetics of duloxetine demonstrate large intersubject variability (generally 50-60%), partly due to gender, age, smoking status and CYP2D6 metaboliser status.
12 for opnåelse af den maksimale koncentration fra 6 til 10 timer og mindsker omfanget af absorptionen marginalt (omtrent 11%).
Food delays the time to reach the peak concentration from 6 to 10 hours and it marginally decreases the extent of absorption (approximately 11%).
Der er fundet farmakokinetiske forskelle mellem mænd og kvinder (den tilsyneladende plasma - clearance er omkring 50% lavere hos kvinder).
Gender: pharmacokinetic differences have been identified between males and females (apparent plasma clearance is approximately 50% lower in females).
Det overlap, der er i de kønsbaserede farmakokinetiske forskelle i clearance- området, retfærdiggør ikke en anbefaling om lavere dosis til kvindelige patienter.
Based upon the overlap in the range of clearance, gender-based pharmacokinetic differences do not justify the recommendation for using a lower dose for female patients.
Moderat leversygdom (Child- Pugh- gruppe B) påvirkede duloxetins farmakokinetik.
Hepatic impairment: moderate liver disease (Child Pugh Class B) affected the pharmacokinetics of duloxetine.
Ammende mødre:
13 Nursing mothers:
Hunrotter, som fik duloxetin (45 mg/ kg/ dag) før og under parring samt i den tidlige drægtighedsperiode, havde nedsat fødeindtagelse og kropsvægt, afbrydelse af brunstcyklussen, et nedsat indeks for levende fødsler og overlevelse af afkom samt forsinket vækst hos afkommet ved udsættelse for systemisk påvirkning estimeret til at være højst ved den maksimale kliniske eksponering (AUC).
Female rats receiving duloxetine (45 mg/ kg/ day) before and during mating and early pregnancy had a decrease in maternal food consumption and body weight, oestrous cycle disruption, decreased live birth indices and progeny survival, and progeny growth retardation at systemic exposure levels estimated to be at the most at maximum clinical exposure (AUC).
I et embryotoxicitetstudie foretaget på kaniner blev der observeret en højere 13 incidens af kardiovaskulære - og knogle- deformationer, hvor hunkaninerne blev udsat for systemiske påvirkninger under den maksimale kliniske eksponering (AUC).
In an embryotoxicity study in the rabbit, a higher incidence of cardiovascular and skeletal malformations was observed at systemic exposure levels below the maximum clinical exposure (AUC).
Duloxetin fremkaldte adfærdsmæssige bivirkninger hos afkommet i et pre - / postnatal toxicitetstudie med rotter, hvor hunrotter blev udsat for systemiske påvirkninger under den maksimale kliniske eksponering (AUC).
In prenatal/ postnatal toxicity studies in the rat, duloxetine induced adverse behavioural effects in the offspring at exposures below maximum clinical exposure (AUC).
Gelatine Natriumlaurilsulfat Titandioxid (E171) Indigotin (E132) Edible Green Ink
Gelatin Sodium Lauryl Sulfate Titanium Dioxide (E171) Indigo Carmine (E132) Edible Green Ink
Syntetisk sort jernoxid (E172) Syntetisk gul jernoxid (E172) Propylenglycol Shellac.
Black Iron Oxide-Synthetic (E172) Yellow Iron Oxide- Synthetic (E172) Propylene glycol Shellac.
6. 3 Opbevaringstid
14 6.3 Shelf life
Må ikke opbevares over 30°C.
Do not store above 30º C.
CYMBALTA 30 mg findes i pakninger med 7, 28 og 98 kapsler.
CYMBALTA 30 mg is available in packs of 7, 28 and 98 capsules.
14 Ingen særlige forholdsregler.
No special requirements.
CYMBALTA 60 mg hårde enterokapsler.
CYMBALTA 60 mg hard gastro-resistant capsules
Mat grøn kapselbund med påskriften "60 mg" og mat blå kapseltop med påskriften "9542".
The CYMBALTA 60 mg capsule has an opaque green body, imprinted with ‘ 60 mg’ and an opaque blue cap, imprinted with ‘ 9542’.
Doseringer over 60 mg én gang daglig op til maksimaldosis på 120 mg daglig i ligelig fordelte doser er evalueret ud fra et sikkerhedsmæssigt perspektiv i kliniske forsøg.
Dosages above 60 mg once daily, up to a maximum dose of 120 mg per day administered in evenly divided doses, have been evaluated from a safety perspective in clinical trials.
Perifere diabetiske neuropatiske smerter:
16 Diabetic Peripheral Neuropathic Pain:
16 Startdosering samt den anbefalede vedligeholdelsesdosering er 60 mg daglig uden hensyntagen til måltider.
The starting and recommended maintenance dose is 60 mg daily with or without food.
Sikkerheden og effekten af duloxetin til patienter i disse aldersgrupper er ikke blevet undersøgt.
Children and adolescents The safety and efficacy of duloxetine in these age groups have not been studied.
4. 4 og 4. 8).
When stopping treatment with CYMBALTA the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see sections 4.4 and 4.8).
4. 4 og 4. 8).
The initiation of treatment with CYMBALTA is contraindicated in patients with uncontrolled hypertension that could expose patients to a potential risk of hypertensive crisis (see sections 4.4 and 4.8).
17 4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
17 4.4 Special warnings and precautions for use
Mani og krampeanfald CYMBALTA skal anvendes med forsigtighed til patienter med en anamnese med mani eller en diagnose med bipolar forstyrrelse og/ eller krampeanfald.
Mania and seizures CYMBALTA should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/ or seizures.
Da der muligvis ikke sker nogen forbedring i tilstanden i de første få uger eller mere af behandlingen, skal patienterne overvåges nøje, indtil der er sket en forbedring.
It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
De samme forholdsregler som iagttages ved behandling af patienter med moderate til svære depressioner bør derfor overholdes ved behandling af patienter med andre psykiske sygdomme.
The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.
Der sås ikke forøget risiko hos voksne på 25 år og ældre.
A meta-analysis of placebo-controlled clinical trials of antidepressant medicinal products in psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Der var en beskeden nedsættelse af risikoen sammenlignet med placebo hos patienter på 65 og ældre.
Cases of suicidal thoughts and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.8).
4. 8).
18 Close supervision of patients and in particular those at high risk should accompany medicinal product therapy especially in early treatment and following dose changes.
Det skal gøres klart for patienter og pårørende, at det er nødvendigt at være opmærksom på enhver forværring af tilstanden, selvmordsadfærd eller - tanker, samt usædvanlige ændringer i opførsel, og straks at søge lægehjælp, hvis disse symptomer viser sig.
Patients, (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Der er begrænsede data på brugen af CYMBALTA 120 mg til ældre patienter med moderate til svære depressioner.
Data on the use of CYMBALTA 120mg in elderly patients with major depressive disorders are limited..
Dette kommer til udtryk ved subjektivt ubehag eller pinefuld uro samt et behov for ofte at ændre position i følgeskab med manglende evne til at sidde eller stå stille.
19 Akathisia/ psychomotor restlessness The use of duloxetine has been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still.
Samtidig behandling med duloxetin (40 mg to gange daglig) forøger steady state- AUC for tolterodin (2 mg to gange daglig) med 71%, men
The co-administration of duloxetine (40 mg twice daily) increases steady state AUC of tolterodine (2 mg twice daily) by 71%, but does not affect the pharmacokinetics of its active 5-hydroxyl metabolite and no dosage adjustment is recommended.
Det anbefales at udvise forsigtighed ved administration af CYMBALTA sammen med præparater, som hovedsageligt metaboliseres via CYP2D6 (risperidon, tricycliske antidepressiva [TCA’ er] såsom nortriptylin, amitriptylin og imipramin), specielt hvis disse præparater har et snævert terapeutisk indeks (som f. eks. flecainid, propafenon og metoprolol).
Caution is advised if CYMBALTA is co-administered with medicinal products that are predominantly metabolised by CYP2D6 (risperidone, tricyclic antidepressants [TCAs] such as 20 nortriptyline, amitriptyline, and imipramine) particularly if they have a narrow therapeutic index (such as flecainide, propafenone and metoprolol).
Antikoagulantia og antitrombotiske midler:
Anticoagulants and antiplatelet agents:
Der bør udvises forsigtighed, når duloxetin gives sammen med orale antikoagulantia eller antitrombotiske midler på grund af en potentiel øget risiko for blødning.
Caution should be exercised when duloxetine is combined with oral anticoagulants or antiplatelet agents due to a potential increased risk of bleeding.
21 Tabel 1 viser observerede bivirkninger fra spontane rapporter samt fra placebo- kontrollerede kliniske forsøg med depression, generaliseret angst, diabetisk neuropatisk smerte og fibromyalgi (omfattende en total på 8239 patienter – heraf fik 5075 patienter duloxetin og 3164 patienter fik placebo).
Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled clinical trials (comprising a total of 8239 patients, 5075 on duloxetine and 3164 on placebo) in depression, generalized anxiety disorder and diabetic neuropathic pain and fibromyalgia.
De mest almindelige rapporterede bivirkninger hos patienter i behandling med CYMBALTA var kvalme, hovedpine, mundtørhed, søvnighed, træthed, søvnløshed, svimmelhed og forstoppelse.
21 The most commonly reported adverse reactions in patients treated with CYMBALTA were nausea, headache, dry mouth, somnolence, fatigue, insomnia, dizziness and constipation.
Meget almindelig (≥1/ 10), almindelig (≥1/ 100 til, < 1/ 10), ikke almindelig (≥1/ 1. 000 til, < 1/ 100), sjælden (≥1/ 10. 000 til, < 1/ 1. 000), meget sjælden (< 1/ 10. 000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100), rare (≥ 1/ 10,000 and < 1/ 1,000), very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
Gastroenteritis Opstød Gastritis Stomatitis
Disorders
Dårlig ånde Frisk blødning per rectum
Nausea (25.2%) Dry mouth (13.8%) Constipation (10.3%)
Gastrointestinal blødning
Diarrhoea Vomiting Dyspepsia Flatulence
Urinretention Dysuri
Gastroenteritis Eructation Gastritis Stomatitis
Ukendt
Very Rare
almindelig
Frequency not known
Besværet vandladning Natlig vandladning Polyuri Nedsat urinmængde
Renals and Urinary
hyppighed
Urine odour abnormal
Øget perspira - tion Hududslæt Nattesved
Sweating increased Rash Night sweats
Nældefeber Kontaktdermatitis Koldsved Lysfølsomheds - reaktioner Øget tendens til at få blå mærker
Urticaria Dermatitis contact Cold sweat Photo- sensitivity reactions Increased tendency to bruise
Angioneurotisk ødem Stevens - Johnson syndrom
Angio- neurotic oedema Stevens- Johnson Syndrome
Musculoskele - tale smerter Muskelstivhed Muskelkramper
Musculo- skeletal pain Muscle tightness Muscle spasm
Hyperglykæmi
Decreased Appetite
Infektioner og parasitære sygdomme Vaskulære sygdomme
Hyperglycemi a (reported especially in diabetic patients)
(især rapporteret hos diabetikere) Laryngitis
Dehydration SIADH Hyponatremia
SIADH Hyponatriæmi
Infections and infestations Laryngitis Vascular Disorders
Blodtryksfor - øgelse Perifer kulde - fornemmelse Ortostatisk hypotension2 Synkope2
Blood pressure increase Peripheral coldness Orthostatic hypotension2 Syncope2
(10, 8%) Immunsystemet
General Disorders and Administration Site Conditions Fatigue (10.8%)
Overfølsomhed
Abdominal pain Chills
Anafylaktisk reaktion
Feeling abnormal Feeling cold Thirst
Lever og galdeveje
Chest pain
Mani Hallucinationer Aggression og vrede 4
Disorientation Hallucinations Apathy Aggression and anger4
Selvmords - forestilling 5 Selvmords - adfærd 5
ideation 5 Suicidal5 behaviour
De mest almindelige bivirkninger er svimmelhed, sensoriske forstyrrelser (inklusiv paraesthesia), søvnforstyrrelser (inklusiv søvnløshed og intense drømme), træthed, opstemthed eller angst, kvalme og/ eller opkastning, rysten, hovedpine, irritabilitet, diaré, hyperhidrosis og vertigo.
Dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), fatigue, agitation or anxiety, nausea and/ or vomiting, tremor, headache, irritability, diarrhoea, hyperhydrosis and vertigo are the most commonly reported reactions.
Generelt for SSRI - og SNRI- hæmmere er disse symptomer lette til moderate og selvbegrænsende, selvom de hos nogle patienter kan være svære og/ eller vedvare i længere tid.
It is therefore advised that when duloxetine
4. 2 og 4. 4).
24 treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see sections 4.2 and 4.4).
I de kliniske 12- ugers akut fase duloxetin forsøg med patienter med diabetisk neuropatisk smerte blev der observeret en lille men statistisk signifikant stigning i faste blodglucose hos duloxetinbehandlede patienter.
In the 12 week acute phase of three clinical trials of duloxetine in patients with diabetic neuropathic pain, small but statistically significant increases in fasting blood glucose were observed in duloxetine- treated patients HbA1c was stable in both duloxetine-treated and placebo-treated patients.
Effekten af CYMBALTA er vist med den anbefalede faste dosis på 60 mg én gang daglig i tre ud af tre randomiserede dobbeltblinde, placebokontrollerede forsøg på voksne akutte ambulante patienter med moderate til svære depressioner.
The efficacy of CYMBALTA at the recommended dose of 60 mg once a day was demonstrated in three out of three randomized, double- blind, placebo-controlled, fixed dose acute studies in adult outpatients with major depressive disorder.
Som helhed er der vist effekt af CYMBALTA ved en daglig fast dosering mellem 60 og 120 mg i ialt fem ud af syv randomiserede dobbeltblinde, placebokontrollerede forsøg på voksne akutte ambulante patienter med moderate til svære depressioner.
Overall, CYMBALTA’ s efficacy has been demonstrated at daily doses between 60 and 120 mg in a total of five out of seven randomized, double-blind, placebo-controlled, fixed dose acute studies in adult outpatients with major depressive disorder.
CYMBALTA viste sig signifikant bedre end placebo målt som forbedring i total score på Hamilton 17- punkts skalaen (HAM- D) (inklusiv både følelses og somatiske symptomer ved depression).
25 CYMBALTA demonstrated statistical superiority over placebo as measured by improvement in the 17-item Hamilton Depression Rating Scale (HAM-D) total score (including both the emotional and somatic symptoms of depression).
25 patienter, som kunne tåle behandlingen med CYMBALTA 60 mg en gang daglig var sammenlignelig med den, der blev set hos yngre voksne.
Tolerability of CYMBALTA 60 mg once day in elderly patients was comparable to that seen in the younger adults.
Selvom data fra et etårigt open- label forsøg viser nogen evidens på langtidseffekt, er der ikke nogen afgørende effektdata tilgængelige fra placebokontrollerede forsøg for behandling i længere end 12 uger.
26 Although data from a one-year open label study offer some evidence for longer-term efficacy, no conclusive efficacy data for treatments longer than 12 weeks duration are available from placebo- controlled studies.
Duloxetins farmakokinetik viser stor variation mellem patienter (generelt 50- 60%), delvist på grund af køn, alder, ryger ikke- ryger status og CYP2D6 metaboliseringsstatus.
The pharmacokinetics of duloxetine demonstrate large intersubject variability (generally 50-60%), partly due to gender, age, smoking status and CYP2D6 metaboliser status.
26 for opnåelse af den maksimale koncentration fra 6 til 10 timer og mindsker omfanget af absorptionen marginalt (omtrent 11%).
Food delays the time to reach the peak concentration from 6 to 10 hours and it marginally decreases the extent of absorption (approximately 11%).
5. 3 Prækliniske sikkerhedsdata
27 5.3 Preclinical safety data
I et embryotoxicitetstudie foretaget på kaniner blev der observeret en højere 27 incidens af kardiovaskulære - og knogle- deformationer, hvor hunkaninerne blev udsat for systemiske påvirkninger under den maksimale kliniske eksponering (AUC).
In an embryotoxicity study in the rabbit, a higher incidence of cardiovascular and skeletal malformations was observed at systemic exposure levels below the maximum clinical exposure (AUC).
Duloxetin fremkaldte adfærdsmæssige bivirkninger hos afkommet i et præ - / postnatal toxicitetstudie med rotter, hvor hunrotter blev udsat for systemiske påvirkninger under den maksimale kliniske eksponering (AUC).
In prenatal/ postnatal toxicity studies in the rat, duloxetine induced adverse behavioural effects in the offspring at exposures below maximum clinical exposure (AUC).
Gelatine Natriumlaurilsulfat Titandioxid (E171) Indigotin (E132) Gul jernoxid (E172) Edible White Ink.
Gelatin Sodium Lauryl Sulfate Titanium Dioxide (E171) Indigo Carmine (E132) Yellow Iron Oxide (E172) Edible White Ink
Titandioxid (E171) Propylenglycol Shellac Povidon
Titanium Dioxide (E171) Propylene glycol Shellac Povidone.
6. 4 Særlige opbevaringsforhold
28 6.4 Special precautions for storage
CYMBALTA 60 mg findes i pakninger med 28, 56, 84, 98, 100 (hver pakning indeholder 5 kartoner med hver 20 kapsler) og 500 kapsler (hver pakning indeholder 25 kartoner med hver 20 kapsler).
CYMBALTA 60 mg is available in packs of 28, 56, 84, 98, 100 (Each pack contains 5 cartons of 20 capsules) and 500 capsules (Each pack contains 25 cartons of 20 capsules).
28 6. 6 Regler for destruktion og anden håndtering
6.6 Special precautions for disposal
FREMSTILLER( E) ANSVARLIG( E) FOR BATCHFRIGIVELSE
30 A MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Disse er specificeret i den plan for pharmacovigilance, som er godkendt i version 03 af den risk management- plan (RMP), som er præsenteret i Modul 1. 8. 2 af markedsføringstilladelsen og enhver efterfølgende opdatering af RMP, som er godkendt af CHMP.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 03 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
I henhold til CHMP Guideline for Risk Management Systemer for lægemidler til humant brug, skal den opdaterede RMP indsendes samtidig med den næste periodiske sikkerhedsopdateringsrapport (PSUR).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any updated RMP should be submitted at the same time as the following Periodic Safety Update Report (PSUR).
Yderligere skal en opdateret RMP indsendes • Når der modtages ny information, som kan påvirke den gældende sikkerhedsspecifikation, pharmacovigilanceplan eller risikominimerende aktiviteter. • Inden for 60 dage efter at en vigtig milepæl er nået i forbindelse med (pharmacovigilance eller risikominimering). • Efter anmodning fra EMEA.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
CYMBALTA 30 mg hårde enterokapsler Duloxetin
CYMBALTA 30 mg, hard gastro-resistant capsules.
Hver kapsel indeholder 30 mg duloxetin (som hydrochlorid).
Each capsule contains 30 mg of duloxetine as hydrochloride
7 hårde enterokapsler 28 hårde enterokapsler 98 hårde enterokapsler
7 hard gastro-resistant capsules 28 hard gastro-resistant capsules 98 hard gastro-resistant capsules
SÆRLIGE OPBEVARINGSBETINGELSER
Store in the original package.
34 Opbevares i den originale yderpakning.
34 10.
35 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
35 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 30 mg hard gastro-resistant capsules
CYMBALTA 30 mg hårde enterokapsler Duloxetin
CYMBALTA 30 mg hard gastro-resistant capsules Duloxetine
36 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
36 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CYMBALTA 60 mg hårde enterokapsler Duloxetin
CYMBALTA 60 mg hard gastro-resistant capsules.
Hver kapsel indeholder 60 mg duloxetin (som hydrochlorid).
Each capsule contains 60 mg of duloxetine as hydrochloride