natgillin/translations-raw huggingface dataset:
Samtidig brug af antidepressiva Der bør udvises forsigtighed ved samtidig brug af CYMBALTA og antidepressiva.
Use with antidepressants Caution should be exercised when using CYMBALTA in combination with antidepressants.
Perikum Uønskede virkninger kan forekomme hyppigere ved samtidig brug af CYMBALTA og naturlægemidler samt kosttilskud indeholdende perikum (hypericum perforatum).
St John’ s wort Undesirable effects may be more common during concomitant use of CYMBALTA and herbal preparations containing St John’ s wort (Hypericum perforatum).
Selvmordsforestillinger og - adfærd Moderate til svære depressioner og generaliseret angst Depression er forbundet med en øget risiko for selvmordstanker, at forvolde skade på sig selv og selvmord (selvmordsrelaterede handlinger).
Suicide Major Depressive Episodes and Generalised Anxiety Disorder Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide- related events).
Andre psykiske tilstande, som CYMBALTA anvendes til, kan ligeledes være forbundet med en øget risiko for selvmordsrelaterede handlinger.
Other psychiatric conditions for which CYMBALTA is prescribed can also be associated with an increased risk of suicide-related events.
En metaanalyse af placebokontrollerede kliniske forsøg af antidepressive lægemidler til behandling af psykiske lidelser viste en lille forøget risiko for selvmordsadfærd med antidepressiva sammenlignet med placebo hos patienter under 25 år.
A meta-analysis of placebo-controlled clinical trials of antidepressant medicinal products in psychiatric disorders showed
Der var en beskeden nedsættelse af risikoen sammenlignet med placebo hos patienter på 65 og ældre.
4 an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
4 Patienter, og specielt høj- risiko patienter, i medicinsk behandling bør følges nøje, især tidligt i behandlingen og efter dosisændringer.
Close supervision of patients and in particular those at high risk should accompany drug 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.
Perifere diabetiske neuropatiske smerter Som for andre lægemiddelstoffer med lignende farmakologisk virkning (antidepressiva) er der blevet rapporteret isolerede tilfælde af selvmordsforestillinger og - adfærd under duloxetinbehandling eller tidligt efter behandlingens ophør.
Diabetic Peripheral Neuropathic Pain As with other medicinal products with similar pharmacological action (antidepressants), isolated cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation.
CYMBALTA bør ikke bruges til behandling af børn og unge under 18 år.
CYMBALTA should not be used in the treatment of children and adolescents under the age of 18 years.
Blødning Blødningsabnormaliteter såsom ekkymoser, purpura og gastrointestinal blødning er set ved brug af selektive serotoningenoptags- hæmmere – (SSRI- præparater) og serotonin/ noradrenalin - genoptagshæmmere (SNRI- praparater).
Haemorrhage There have been reports of bleeding abnormalities, such as ecchymoses, purpura and gastrointestinal haemorrhage with selective serotonin reuptake inhibitors (SSRIs) and serotonin/ norepinephrine reuptake inhibitors (SNRIs).
Hyponatriæmi Hyponatriæmi er i sjældne tilfælde, hovedsagligt hos ældre, blevet rapporteret ved indgivelse af CYMBALTA.
Hyponatremia Hyponatremia has been reported rarely, predominantly in the elderly, when administering CYMBALTA.
CYMBALTA og placebo.
In clinical trials adverse events seen on abrupt treatment discontinuation occurred in approximately 45% of patients treated with CYMBALTA and 23% of patients taking placebo.
Ældre Moderate til svære depressioner:
Elderly Major Depressive Episodes:
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.
Derfor bør der udvises forsigtighed ved behandling af ældre patienter med maksimaldosis (se pkt.
Therefore, caution should be exercised when treating the elderly with the maximum dosage (see sections 4.2 and 5.2).
Der er begrænsede data vedrørende brugen af CYMBALTA til ældre patienter med generaliseret angst.
Data on the use of CYMBALTA in elderly patients with generalised anxiety disorder 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.
5 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.
Lægemidler indeholdende duloxetin Duloxetin benyttes under forskellige varemærker til flere indikationer (behandling af diabetiske neuropatiske smerter, moderate til svære depressioner, generaliseret angst såvel som stressinkontinens).
Medicinal products containing duloxetine Duloxetine is used under different trademarks in several indications (treatment of diabetic neuropathic pain, major depressive episodes, generalised anxiety disorder as well as stress urinary incontinence).
Saccharose CYMBALTA enterokapsler indeholder saccharose.
Sucrose CYMBALTA hard gastro-resistant capsules contain sucrose.
Som konsekvens deraf anbefales det at udvise forsigtighed, når CYMBALTA tages sammen med andre centralt virkende lægemidler eller stoffer, herunder alkohol og sederende lægemidler (benzodiazepiner, morfinlignende præparater, antipsykotika, phenobarbital, sederende antihistaminer).
Consequently, caution is advised when CYMBALTA is taken in combination with other centrally acting medicinal products and substances including alcohol and sedative medicinal products (e. g. benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
På grund af risikoen for serotoninsyndrom må CYMBALTA ikke anvendes sammen med ikke- selektive, irreversible monoaminooxidasehæmmere (MAO- hæmmere) eller i mindst 14 dage efter afbrudt behandling med en MAO- hæmmer.
Monoamine Oxidase Inhibitors (MAOIs): due to the risk of serotonin syndrome, CYMBALTA should not be used in combination with nonselective irreversible monoamine oxidase inhibitors (MAOIs), or within at least 14 days of discontinuing treatment with an MAOI.
På baggrund af duloxetins halveringstid skal der gå mindst 5 dage efter endt behandling med CYMBALTA, før en behandling med en MAO- hæmmer påbegyndes (se afsnit 4. 3).
Based on the half-life of duloxetine, at least 5 days should be allowed after stopping CYMBALTA before starting an MAOI (see section 4.3).
4. 4).
However, the concomitant use of CYMBALTA with selective, reversible MAOIs is not recommended (see section 4.4).
Der er i sjældne tilfælde rapporteret om serotoninsyndrom hos patienter i behandling med SSRI- præparater sammen med serotonerge lægemidler.
Serotonin syndrome: in rare cases, serotonin syndrome has been reported in patients using SSRIs (e. g. paroxetine, fluoxetine) concomitantly with serotonergic medicinal products.
Det anbefales at udvise forsigtighed, hvis CYMBALTA anvendes sammen med serotonerge antidepressiva som SSRI - præparater, tricykliske præparater (f. eks. clomipramin eller amitriptylin), perikum (hypericum perforatum), venlafaxin eller triptaner, tramadol, pethidin og tryptophan.
Caution is advisable if CYMBALTA is used concomitantly with serotonergic antidepressants like SSRIs, tricyclics like clomipramine or amitriptyline, St John’ s wort (Hypericum perforatum), venlafaxine or triptans, tramadol, pethidine and tryptophan.
6 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 6 predominantly metabolised by CYP2D6 (risperidone, tricyclic antidepressants [TCAs] such as nortriptyline, amitriptyline, and imipramine) particularly if they have a narrow therapeutic index (such as flecainide, propafenone and metoprolol).
Samtidig administration af duloxetin med aluminium - og magnesiumholdige antacida eller med famotidin har ingen signifikant virkning på absorbtionshastigheden eller absorptionsfraktionen af duloxetin efter en oral dosis på 40 mg.
Effects of other medicinal products on duloxetine Antacids and H2 antagonists: co-administration of duloxetine with aluminium- and magnesium- containing antacids or duloxetine with famotidine had no significant effect on the rate or extent of duloxetine absorption after administration of a 40 mg oral dose.
Da CYP1A2 er involveret i metaboliseringen af duloxetin, vil samtidig behandling med CYMBALTA og potente CYP1A2- hæmmere sandsynligvis medføre højere koncentrationer af duloxetin.
Inhibitors of CYP 1A2: because CYP1A2 is involved in duloxetine metabolism, concomitant use of duloxetine with potent inhibitors of CYP1A2 is likely to result in higher concentrations of duloxetine.
4. 3)
Therefore CYMBALTA should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section 4.3).
Befolkningsfarmakokinetiske analyser har vist, at rygere har næsten 50% lavere plasmakoncentration af duloxetin sammenlignet med ikke- rygere.
Population pharmacokinetic analyses have shown that smokers have almost 50% lower plasma concentrations of duloxetine compared with non-smokers.
Graviditet Der foreligger ikke tilstrækkelige data om brugen af duloxetin hos gravide kvinder.
Pregnancy There are no adequate data on the use of duloxetine in pregnant women.
CYMBALTA bør kun bruges under graviditeten, hvis de potentielle behandlingsfordele opvejer de potentielle risici for fosteret.
CYMBALTA should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
Eftersom sikkerheden af duloxetin hos spædbørn ikke er kendt, frarådes behandling med CYMBALTA i den periode der ammes.
As the safety of duloxetine in infants is not known, the use of CYMBALTA while breast-feeding is not recommended.
CYMBALTA kan være forbundet med sedation og svimmelhed.
CYMBALTA may be associated with sedation and dizziness.
Patienterne bør informeres om, at hvis de oplever sedation eller svimmelhed, bør de undgå muligt farlige aktiviteter såsom bilkørsel eller betjening af maskiner.
Patients should be instructed that if they experience sedation or dizziness they should avoid potentially hazardous tasks such as driving or operating machinery.
4. 8 Bivirkninger
7 4.8 Undesirable effects
7 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, svimmelhed og obstipation.
The most commonly reported adverse reactions in patients treated with CYMBALTA were nausea, headache, dry mouth, somnolence, fatigue, insomnia, dizziness and constipation.
Bivirkninger Estimeret hyppighed:
Adverse reactions Frequency estimate:
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).
Indenfor hver hyppighedsgruppering er bivirkningerne listet efter faldende grad af alvorlighed.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Ikke almindelig
Very common Investigations
Ukendt
Common
almindelig
Uncommon
hyppighed
Very Rare
Undersøgelser Hjerte
Frequency not known
Vægtstigning Kreatininkinase øget
Weight increase Creatine phosphokinase increased
Hovedpine (15, 3%) Søvnighed (10, 9%) Svimmelhed (10, 3%) Øjne
Nervous System Disorders Headache (15.3%) Somnolence (10.9%) Dizziness (10.3%)
Rysten Paræstesier Smagsforstyr - relser Letargi
Tremor Paraesthesia Dysgeusia Lethargy
Nervøsitet Koncentrations - besvær Dyskinesi Dårlig søvnkvalitet
Nervousness Disturbance in attention Dyskinesia Poor quality sleep
Myoclonus Kramper
Myoclonus Convulsions
Serotoninsyn - drom Ekstrapyrami - dale symptomer Akatisi Psykomotorisk uro
Serotonin syndrome Extra- pyramidal symptoms Akathisia Psychomotor restlessness
Ører og labyrint
Eye Disorders
Diarré Opkastning Dyspepsi Flatulens
Gastrointestinal
Dårlig ånde Frisk blødning per rectum
Disorders
Gastrointestinal blødning
Nausea
Urinretention Dysuri
Diarrhoea
Abnorm urinlugt
Gastroenteritis
Meget
Breath odour
Almindelig
Gastrointesti
Hud og subkutane væv
Frequency not known
Øget perspira - tion Hududslæt Nattesved
(25.2%) Dry mouth (13.8%) Constipation (10.3%)
Angioneurotisk ødem Stevens - Johnson syndrom
Vomiting Dyspepsia Flatulence
Knogler, led, muskler og bindevæv
Eructation Gastritis Stomatitis
Musculoskele - tale smerter Muskelstivhed Muskelkramper
Haematochezi a
Muskelsitren
nal haemorrhage
Trismus
Renals and Urinary Disorders
Det endokrine system Hypotyroidisme Metabolisme og ernæring
Urinary Retention Dysuria Urinary hesitation Nocturia Polyuria Urine flow decreased
Nedsat appetit
Urine odour abnormal
Hyperglykæmi
Skin and Subcutaneous Tissue Disorders
Infektioner og parasitære sygdomme Vaskulære sygdomme
Sweating increased Rash Night sweats
(især rapporteret hos diabetikere) Laryngitis
Urticaria Dermatitis contact Cold sweat Photo- sensitivity reactions Increased tendency to bruise
Blodtryksfor - øgelse Perifer kulde - fornemmelse Ortostatisk hypotension2 Synkope2
Angio- neurotic oedema Stevens- Johnson Syndrome
Hypertension Hypertensive kriser
Muscoskeletal and connective tissue disorders
Almene symptomer og reaktioner på administrationsstedet Træthed
Musculo- skeletal pain Muscle tightness Muscle spasm
Mavesmerter
Muscle twitching
Generel unormal
Trismus
Brystsmerter
Endocrine disorders Hypo- thyroidism Metabolism and Nutrition Disorders
(10, 8%) Immunsystemet
Decreased Appetite
Kuldegysninger følelse Føler sig kold Tørst Generel utilpashed Varmefølelse Gangforstyrrelse
Hyperglycemi a (reported especially in diabetic patients)
Overfølsomhed
Dehydration SIADH Hyponatremia
Anafylaktisk reaktion
Infections and infestations Laryngitis Vascular Disorders
Lever og galdeveje
Flushing
Forhøjede lever - enzymer (ALAT, ASAT, alkalisk fosfatase) Hepatitis3
Blood pressure increase Peripheral coldness Orthostatic hypotension2 Syncope2
Ikterus Leversvigt
Hypertension Hypertensive crisis
Almindelig
Very Rare
Meget Almindelig Ikke almindelig Sjælden Meget
General Disorders and Administration Site Conditions Fatigue (10.8%)
Ukendt
Abdominal pain Chills
almindelig
Chest pain
Akut leverskade
Hyper- sensitivity disorder
sjælden
Anaphylactic reaction
hyppighed
Jaundice Hepatic failure
Ejakulationspro - blemer Forsinket ejakulation Seksuel dysfunktion Gynækologisk blødning
Ejaculation disorder Ejaculation delayed Sexual dysfunction Gynaecologica l haemorrhage
Psykiske forstyrrelser Søvnløshed (10, 4%) 1
Psychiatric Disorders Insomnia
Uro Nedsat libido Angst Abnorm orgasme Abnorme drømme Søvnforstyr - relser
(10.4%) 1
Tænderskæren Desorientering Apati
Libido decreased Anxiety Orgasm abnormal Abnormal dreams Sleep disorder
Mani Hallucinationer Aggression og vrede4
Disorientation Hallucinations Apathy Aggression and anger4
Selvmords - forestilling5 Selvmords - adfærd 5
ideation 5 Suicidal5 behaviour
2 Sager med ortostatisk hypotension og synkope er blevet rapporteret - særligt i behandlingsopstarten 3 Se pkt 4. 4.
2 Cases of orthostatic hypotension and syncope have been reported especially at the initiation of treatment.
4 Sager med aggression og vrede er blevet rapporteret, især tidligt i behandlingen eller efter behandlingsophør.
3 See section 4.4 4 Cases of aggression and anger have been reported particularly early in treatment of after treatment discontinuation.
4. 4).
5 Cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.4)
Seponering af duloxetin (særlig ved pludseligt ophør) fører normal til seponeringssymptomer.
Discontinuation of duloxetine (particularly when abrupt) commonly leads to withdrawal symptoms.
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.
10 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.
Generally, for SSRIs and SNRIs, these events are mild to moderate and self-limiting, however, in some patients they may be severe and/ or prolonged.
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 var stabilt hos både duloxetinbehandlede og placebo- behandlede patienter.
HbA1c was stable in both duloxetine-treated and placebo-treated patients.
De hjertefrekvenskorrigerede QT- intervaller hos duloxetinbehandlede patienter adskilte sig ikke fra dem, der blev observeret i placebogruppen.
The heart rate-corrected QT interval in duloxetine-treated patients did not differ from that seen in placebo-treated patients.
Der er rapporteret tilfælde af overdosering af duloxetin, alene eller i kombination med andre lægemidler, i doser på 4800 mg.
Cases of overdoses, alone or in combination with other medicinal products, with duloxetine doses of 4800mg were reported.
Søvnighed, coma, serotoninsyndrom, kramper, opkastning og takykardi.
Signs and symptoms of overdose (duloxetine alone or with mixed medicinal products) included somnolence, coma, serotonin syndrome, seizures,, vomiting and tachycardia.
Moderate til svære depressioner:
Major Depressive Episodes:
I et klinisk forsøgsprogram med 3158 patienter (svarende til 1285 patientår) blev CYMBALTA undersøgt mod DSM- IV kriterierne for moderate til svære depressioner.
CYMBALTA was studied in a clinical programme involving 3,158 patients (1,285 patient-years of exposure) meeting DSM-IV criteria for major depression.
Effekten af CYMBALTA er vist med den anbefalede faste dosis på 60 mg én gang daglig i tre ud af tre randomiserede dobbeltblinde, placebo- kontrollerede forsøg på voksne akutte ambulante patienter med moderate til svære depressioner.
The efficacy of CYMBALTA at the 11 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, placebo- kontrollerede 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).
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).
Data for virkning og bedring viste sig også statistisk signifikant bedre for CYMBALTA sammenlignet med placebo.
Response and remission rates were also statistically significantly higher with CYMBALTA compared with placebo.
Kun en lille del af de inkluderede patienter i de vigtigste kliniske forsøg led af svære depressioner (basislinie HAM- D > 25).
Only a small proportion of patients included in pivotal clinical trials had severe depression (baseline HAM-D > 25).
I et forsøg med forebyggelse af tilbagefald, hvor patienterne blev randomiserede til enten CYMBALTA 60 mg eller placebo, efter 12- ugers akut behandling med open- label CYMBALTA 60 mg én gang daglig viste CYMBALTA 60 mg én gang daglig sig statistisk signifikant bedre end placebo (p=0, 004) på den primære parameter, som var forebyggelsen af depressive tilbagefald målt som tid til tilbagefald.
CYMBALTA 60 mg once daily demonstrated a statistically significant superiority compared to placebo (p=0.004) on the primary outcome measure, the prevention of depressive relapse, as measured by time to relapse.
Hyppigheden af tilbagefald i den 6- måneders dobbeltblinde follow- up periode var henholdsvis 17% for duloxetin og 29% for placebo.
The incidence of relapse during the 6-months double-blind follow-up period was 17% and 29% for duloxetine and placebo, respectively.
Den procentvise del af de ældre
The effect of CYMBALTA 60 mg once a day in elderly depressed patients (≥ 65 years) was specifically examined in a study that showed a statistically significative difference in the reduction of the HAMD17 score for duloxetine-treated patients compared to placebo.
11 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.
Generaliseret angst CYMBALTA viste statistisk signifikant fordel i forhold til placebo i fem ud af fem studier inklusive fire randomiserede, dobbeltblinde, placebokontrollerede akutstudier og et studie af forebyggelse af tilbagefald hos voksne patienter med generaliseret angst.
Generalised Anxiety Disorder CYMBALTA demonstrated statistically significant superiority over placebo in five out of five studies including four randomized, double-blind, placebo-controlled acute studies and a relapse prevention study in adult patients with generalised anxiety disorder.