natgillin/translations-raw huggingface dataset:
Ved at styrke lukningen af urinrøret forhindrer Ariclaim uønsket tab af urin under fysisk belastning såsom hoste eller latter.
By closing the urethra more powerfully, Ariclaim prevents the unwanted loss of urine during physical stress such as coughing or laughing.
Ariclaim blev til behandling af SUI undersøgt hos i alt 2 850 kvinder.
For the treatment of SUI, Ariclaim has been studied in a total of 2,850 women.
Heri blev Ariclaim (hovedsagelig i en dosis på 40 mg to gange dagligt) sammenlignet med placebo (uvirksom behandling).
The four main studies involved 1,913 women and lasted 12 weeks, comparing Ariclaim (mostly as 40 mg twice a day) with placebo (a dummy treatment).
De vigtigste mål for virkningen var dels hyppigheden af inkontinensepisoder (IEF dvs. det ugentlige antal inkontinensepisoder) angivet i dagskemaer, dels patientens opnåede scoreværdi i et spørgeskema om inkontinensrelateret livskvalitet (I- QOL).
The main measures of effectiveness were incontinence episode frequency (IEF, the number of episodes of incontinence per week) recorded in patient diaries and the patients’ scores on an incontinence-specific quality-of-life questionnaire (I-QOL).
Ariclaim blev til behandling af diabetiske neuropatiske smerter undersøgt i to 12- ugers undersøgelser af 809 voksne med diabetes, som havde haft smerter hver dag i de sidste seks måneder.
For the treatment of diabetic neuropathic pain, Ariclaim has been studied in two 12-week studies in 809 diabetic adults who had had pain every day for at least six months.
Virkningen af tre forskellige doser Ariclaim blev sammenlignet med virkningen af placebo.
The effectiveness of three different doses of Ariclaim was compared with that of placebo.
Det vigtigste mål for virkningen var forandringer i sværhedsgraden af smerterne hver uge, således som patienterne registrerede disse på en 11- points skala i dagskemaer.
The main measure of effectiveness was the change in the severity of pain each week, as recorded by the patients on an 11-point scale in daily diaries.
Hvilken fordel viser undersøgelserne, der er ved Ariclaim?
What benefit has Ariclaim shown during the studies?
4- 5 færre ugentlige inkontinensepisoder end før undersøgelsen).
In all four studies of SUI, the patients treated with Ariclaim had fewer episodes of incontinence after 12 weeks, with about four or five fewer episodes of incontinence per week, in comparison with the number before the study.
Hyppigheden af inkontinensepisoderne faldt med 52% i Ariclaim- gruppen, sammenholdt med et fald på 33% i placebogruppen.
The IEF decreased by 52% in the Ariclaim group, compared with a decrease of 33% in the placebo-treated group.
Også den opnåede score i I- QOL- spørgeskemaerne var bedre i Ariclaim - gruppen end i placebogruppen.
The I-QOL questionnaire scores were also improved in the Ariclaim group compared with the placebo group.
Ariclaim var kun mere effektivt end placebo hos patienter, som havde over 14 inkontinensepisoder om ugen (moderat til svær SUI) ved undersøgelsens start.
Ariclaim was more effective than placebo only in patients who had more than 14 incontinence episodes per week (moderate to severe SUI) at the start of the study.
Til behandling af diabetiske neuropatiske smerter var Ariclaim ved doser på 60 mg en eller to gange dagligt mere effektivt til at reducere smerter end placebo.
For the treatment of diabetic neuropathic pain, Ariclaim at doses of 60 mg once or twice a day was more effective at reducing pain than placebo.
I begge undersøgelserne kunne der iagttages en smertelindring fra den første uge af behandlingen i op til 12 uger hos patienter, som fik Ariclaim, og som havde smertescorer på mellem 1, 17 og 1, 45 point lavere end dem, der fik placebo.
In both studies, pain reduction was seen from the first week of treatment for up to 12 weeks, with patients taking Ariclaim having pain scores between 1.17 and 1.45 points lower than those taking placebo.
De hyppigste bivirkninger ved Ariclaim, når det blev anvendt som behandling mod SUI (som ses hos flere end 1 ud af 10 patienter) er kvalme, mundtørhed, forstoppelse og træthed.
The most common side effects with Ariclaim when used to treat SUI (seen in more than 1 patient in 10) are nausea, dry mouth, constipation and fatigue (tiredness).
De hyppigste bivirkninger, når det blev anvendt til behandling af diabetiske neuropatiske smerter (som ses hos flere end 1 ud af 10 patienter) er hovedpine, søvntrang, kvalme og mundtørhed.
The most common side effects when used to treat diabetic neuropathic pain (seen in more than 1 patient 10) are headache, somnolence (sleepiness), nausea and dry mouth.
Ariclaim bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for duloxetin eller andre af indholdsstofferne.
Ariclaim should not be used in people who may be hypersensitive (allergic) to duloxetine or any of the other ingredients.
Ariclaim bør ikke anvendes til patienter med visse former for leversygdomme eller patienter med svære nyresygdomme.
Ariclaim should not be used in patients with certain types of liver disease or with severe kidney disease.
Ariclaim må ikke anvendes sammen med monoaminoxidasehæmmere (en gruppe af antidepressiva), fluvoxamin (et andet antidepressivum) eller ciprofloxacin eller enoxacin (former for antibiotika).
Ariclaim should not be used with monoamine oxidase inhibitors (a group of antidepressants), fluvoxamine (another antidepressant), or ciprofloxacin or enoxacin (types of antibiotic).
Der må ikke indledes behandling af patienter med ukontrolleret hypertension på grund af risikoen for hypertensive kriser (pludselig farlig blodtryksforhøjelse).
Treatment should not be started in patients with uncontrolled high blood pressure, because of a risk of hypertensive crisis (sudden, dangerously high blood pressure).
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Ariclaim er større end risiciene ved behandling af moderat til svær SUI og diabetiske perifere neuropatiske smerter hos voksne.
The Committee for Medicinal Products for Human Use (CHMP) decided that Ariclaim’ s benefits are greater than its risks for the treatment of moderate to severe SUI and of diabetic peripheral neuropathic pain in adults.
2/ 3 Andre oplysninger om Ariclaim:
2/ 3 Other information about Ariclaim:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Ariclaim den 11. august 2004.
The European Commission granted a marketing authorisation valid throughout the European Union for Ariclaim on 11 August 2004.
Dette sammendrag blev sidst ajourført i 05- 2008.
This summary was last updated in 05-2008.
ARICLAIM 40 mg hårde enterokapsler.
ARICLAIM 40 mg hard gastro-resistant capsules.
Hjælpestoffer:
Excipients: sucrose 11.5 mg.
Mat orange kapselbund med påskriften "40 mg" og mat blå kapseltop med påskriften "9545".
Opaque orange body, imprinted with ’ 40mg’ and an opaque blue cap, imprinted with ‘ 9545’.
5. 1).
ARICLAIM is indicated for women for the treatment of moderate to severe Stress Urinary Incontinence (SUI), (see section 5.1).
Stressinkontinens:
Stress Urinary Incontinence:
Den anbefalede dosering af ARICLAIM er 40 mg to gange daglig uden hensyntagen til måltider.
The recommended dose of ARICLAIM is 40 mg twice daily without regard to meals.
Efter 2- 4 ugers behandling bør patienten evalueres med henblik på vurdering af virkning og bivirkninger af behandlingen.
After 2-4 weeks of treatment, patients should be re-assessed in order to evaluate the benefit and tolerability of the therapy.
Der er dog begrænset data tilgængelig til at understøtte effekten af ARICLAIM 20 mg to gange daglig.
However, limited data are available to support the efficacy of ARICLAIM 20 mg twice daily.
Effekten af ARICLAIM er ikke blevet undersøgt i mere end 3 måneder i placebokontrollerede studier.
The efficacy of ARICLAIM has not been evaluated for longer than 3 months in placebo-controlled studies.
Ved at kombinere ARICLAIM med bækkenbundstræning kan der muligvis opnås en bedre effekt end ved hver af de to behandlinger alene.
Combining ARICLAIM with a pelvic floor muscle training (PFMT) program may be more effective than either treatment alone.
Perifere diabetiske neuropatiske smerter:
Diabetic Peripheral Neuropathic Pain:
5. 2).
The plasma concentration of duloxetine displays large inter-individual variability (see 5.2).
Det medicinske respons bør evalueres efter 2 måneders behandling.
The medicinal product response should be evaluated after 2 months’ of treatment.
Den terapeutiske effekt bør med jævne mellemrum vurderes (mindst hver tredje måned).
The therapeutic benefit should regularly (at least every three months) be reassessed.
2 Leverinsufficiens:
2 Hepatic insufficiency:
4. 3).
ARICLAIM should not be used in patients with liver disease resulting in hepatic impairment (see section 4.3).
Dosisjustering er ikke nødvendig til patienter med let eller moderat nedsat nyrefunktion (kreatinin - clearance 30- 80 ml/ min).
No dosage adjustment is necessary for patients with mild or moderate renal dysfunction (creatinine clearance 30 to 80 ml/ min).
4. 3).
ARICLAIM should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/ min; see section 4.3).
Man bør ikke reducere dosis ved behandling af ældre patienter udelukkende på grund af alder.
Elderly No dosage adjustment is recommended for elderly patients solely on the basis of age.
Forsigtighed bør udvises ved behandling af ældre patienter.
Caution should be exercised when treating the elderly
4. 4).
There is no experience in children (see section 4.4).
Afbrydelse af behandling:
Discontinuation of treatment:
4. 4 og 4. 8).
When stopping treatment with ARICLAIM 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).
5. 2).
Liver disease resulting in hepatic impairment (see section 5.2).
ARICLAIM må ikke anvendes sammen med ikke- selektive, irreversible monoaminooxidasehæmmere
ARICLAIM should not be used in combination with nonselective, irreversible Monoamine Oxidase Inhibitors - MAOIs (see section 4.5).
4. 5).
ARICLAIM should not be used in combination with CYP1A2 inhibitors, like fluvoxamine, ciprofloxacin or enoxacine since the combination results in elevated plasma concentrations of duloxetine (see section 4.5).
4. 4).
Severe renal impairment (creatinine clearance < 30 ml/ min) (see section 4.4).
4. 4 og 4. 8).
The initiation of treatment with ARICLAIM 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).
Mani og krampeanfald ARICLAIM skal anvendes med forsigtighed til patienter med en anamnese med mani eller en diagnose med bipolar forstyrrelse og/ eller krampeanfald.
Mania and Seizures ARICLAIM should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/ or seizures.
4. 5)
Use with antidepressants The use of ARICLAIM in combination with antidepressants (especially with SSRI, SNRI and reversible MAOIs) is not recommended (see below “ Depression, suicidal ideation and behaviour” and Section 4.5).
Perikum Uønskede virkninger kan forekomme hyppigere ved samtidig brug af ARICLAIM og naturlægemidler samt kosttilskud indeholdende perikum (Hypericum perforatum).
3 St John’ s wort Undesirable effects may be more common during concomitant use of ARICLAIM and herbal preparations containing St John’ s wort (Hypericum perforatum).
3 Mydriasis Der er rapporteret om tilfælde af mydriasis i forbindelse med duloxetin, og der skal derfor udvises forsigtighed ved udskrivning af duloxetin til patienter med forhøjet intraokulært tryk eller til patienter med risiko for akut snævervinklet glaukom.
Mydriasis Mydriasis has been reported in association with duloxetine, therefore, caution should be used when prescribing duloxetine in patients with increased intraocular pressure, or those at risk of acute narrow- angle glaucoma.
Blodtryk og hjertefrekvens Duloxetin har været forbundet med en øgning af blodtrykket og klinisk signifikant hypertension hos nogle patienter.
Blood pressure and heart rate Duloxetine has been associated with an increase in blood pressure and clinically significant hypertension in some patients.
Hos patienter med kendt hypertension og/ eller anden hjertelidelse anbefales det derfor, at blodtrykket monitoreres, særligt i løbet af den første måned af behandlingen.
Therefore, in patients with known hypertension and/ or other cardiac disease, blood pressure monitoring is recommended, especially during the first month of treatment.
4. 5).
Caution should also be exercised when duloxetine is used with medicinal products that may impair its metabolism (see section 4.5).
4. 8).
For patients who experience a sustained increase in blood pressure while receiving duloxetine either dose reduction or gradual discontinuation should be considered (see section 4.8).
4. 3.).
In patients with uncontrolled hypertension duloxetine should not be initiated (see section 4.3).
Nedsat nyrefunktion Forhøjede plasmakoncentrationer af duloxetin forekommer hos patienter med svært nedsat nyrefunktion i hæmodialyse (kreatinin- clearance < 30 ml/ min.).
Renal impairment Increased plasma concentrations of duloxetine occur in patients with severe renal impairment on haemodialysis (creatinine clearance < 30 ml/ min).
4. 3..
For patients with severe renal impairment, see section 4.3.
4. 2 for information om patienter med let til moderat nyreinsufficiens.
See section 4.2 for information on patients with mild or moderate renal dysfunction.
Blødning Blødningsabnormaliteter såsom ekkymoser, purpura og gastrointestinal blødning er set ved brug af selektive serotoningenoptagshæmmere – (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).
Det anbefales at udvise forsigtighed hos patienter i behandling med antikoagulantika og/ eller lægemidler, som påvirker trombocytfunktionen, og hos patienter med kendt blødningstendens.
Caution is advised in patients taking anticoagulants and/ or medicinal products known to affect platelet function, and in patients with known bleeding tendencies.
4. 8).
Discontinuation of treatment Withdrawal symptoms when treatment is discontinued are common, particularly if discontinuation is abrupt (see section 4.8).
ARICLAIM og placebo.
In a clinical trial adverse events seen on abrupt treatment discontinuation occurred in approximately 44% of patients treated with ARICLAIM and 24% of patients taking placebo.
Risikoen for seponeringssymptomer set for SSRI og SNRI kan afhænge af flere faktorer blandt andet behandlingsvarigheden, dosis og hvor hurtigt dosis reduceres.
The risk of withdrawal symptoms seen with SSRI’ s and SNRI’ s may be dependent on several factors including the duration and dose of therapy and the rate of dose reduction.
De mest almindelige bivirkninger er anført under punkt 4. 8.
The most commonly reported reactions are listed in section 4.8.
Disse symptomer er generelt lette til moderate, for nogle patienter kan de dog være svære i intensitet.
Generally the symptoms are mild to moderate, however, in some patients they may be severe in intensity.
Generelt er disse symptomer selvbegrænsende og forsvinder sædvanligvis inden for 2 uger, selvom de i nogle tilfælde kan vare ved i længere tid (2- 3 måneder eller flere).
Generally these symptoms are self-limiting and usually resolve within 2 weeks, though in some individuals they may be prolonged (2-3 months or more).
4. 2.).
It is therefore advised that duloxetine should be gradually tapered when discontinuing treatment over a period of no less than 2 weeks, according to the patient’ s needs (see section 4.2).
Hyponatriæmi Hyponatriæmi er blevet rapporteret, hovedsagligt hos ældre, i sjældne tilfælde ved indgivelse af ARICLAIM.
Hyponatremia Hyponatremia has been reported rarely, predominantly in the elderly, when administering ARICLAIM.
Ældre, cirrose eller dehydrerede patienter samt patienter i behandling med diuretika.
Caution is required in patients at increased risk for hyponatremia; such as elderly, cirrhotic, or dehydrated patients or patients treated with diuretics.
Hyponatriæmi kan skyldes et syndrom med uhensigtsmæssig sekretion af anti- diuretisk hormon (SIADH).
Hyponatremia may be due to a syndrome of inappropriate anti-diuretic hormone secretion (SIADH).
Depression, selvmordsforestillinger og - adfærd Selvom ARICLAIM ikke er godkendt til behandling af depression, findes dets aktive lægemiddelstof (duloxetin) også i et antidepressivt lægemiddel.
4 Depression, suicidal ideation and behaviour Although ARICLAIM is not indicated for the treatment of depression, its active ingredient (duloxetine) also exists as an antidepressant medication.
4 tilstanden i de første få uger eller mere af behandlingen, skal patienterne overvåges nøje, indtil der er sket en forbedring.
As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
Patienter, der tidligere har udført selvmords - relaterede handlinger, eller patienter, der før behandlingsstart har udvist en signifikant grad af selv - mordsforestillinger, har en større risiko for selvmordstanker eller selvmordsadfærd og bør følges nøje under behandlingen.
Patients with a history of suicide-related events or those exhibiting a significant degree of suicidal thoughts prior to commencement of treatment are known to be at a greater risk of suicidal thoughts or suicidal behaviour, and should receive careful monitoring during treatment.
4. 8).
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 Cases of suicidal thoughts and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.8).
Hvis patienten under ARICLAIM- behandling, udvikler agitation eller depressive symptomer bør en specialist konsulteres, eftersom depression er en alvorlig medicinsk tilstand.
If while on ARICLAIM therapy, the patient develops agitation or depressive symptoms, specialised medical advice should be sought, as depression is a serious medical condition.
4. 2).
If a decision to initiate antidepressant pharmacological therapy is taken, the gradual discontinuation of ARICLAIM is recommended (see Section 4.2).
Brug hos børn og unge under 18 år Der er ikke foretaget nogen kliniske forsøg med duloxetin på børn.
Use in children and adolescents under 18 years of age No clinical trials have been conducted with duloxetine in paediatric populations.
I kliniske forsøg blev selvmordsrelateret adfærd (selvmords - forsøg og selvmordstanker) og fjendtlighed (overvejende aggression, modsættende adfærd og vrede) hyppigere observeret hos børn og unge behandlet med antidepressiva sammenlignet med placebo - behandlede.
Suicide-related behaviours (suicide attempts and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger), were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo.
Der mangler data på langtidssikkerhed hos børn og unge hvad angår vækst, modning, kognitiv - og adfærdsudvikling.
Long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.
Lægemidler indeholdende duloxetin Duloxetin benyttes under forskellige varemærker til flere indikationer (behandling af diabetiske neuropatiske smerter, moderate til svære depressioner så vel som stressinkontinens).
Medicinal products containing duloxetine Duloxetine is used under different trademarks in several indications (treatment of diabetic neuropathic pain, major depressive episodes as well as stress urinary incontinence).
4. 8).
Hepatitis/ increased liver enzymes Cases of liver injury, including severe elevations of liver enzymes (> 10 times upper limit of normal), hepatitis and jaundice have been reported with duloxetine (see section 4.8).
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.
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.
Saccharose ARICLAIM- enterokapsler indeholder saccharose.
Sucrose ARICLAIM gastro-resistant capsules contain sucrose.
Patienter med sjældne arvelige lidelser som fructoseintolerans, glucose- galactose- malabsorption eller invertase- isomaltase- insufficiens bør ikke tage denne medicin.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
4. 5 Interaktion med andre lægemidler og andre former for interaktion
5 4.5 Interaction with other medicinal products and other forms of interaction
På grund af risikoen for serotoninsyndrom må ARICLAIM ikke anvendes sammen med ikke- selektive, irreversible monoaminooxidasehæmmere (MAO- hæmmere) samt i mindst 14 dage efter afbrudt behandling med en MAO- hæmmer.
Monoamine oxidase inhibitors (MAOIs): due to the risk of serotonin syndrome, ARICLAIM 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 ARICLAIM, 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 ARICLAIM before starting an MAOI (see section 4.3).
Der er i sjældne tilfælde rapporteret om serotoninsyndrom hos patienter i behandling med SSRI- præparater (f. eks. paroxetin eller fluoxetin) sammen med serotonerge læge - midler.
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 ARICLAIM anvendes sammen med serotonerge antidepressiva som SSRI- præparater, tricykliske præparater (f. eks. clomipramin eller amitriptylin), perikum (Hypericum perforatum), venlafaxin eller triptaner, tramadol, petidin og tryptophan.
Caution is advisable if ARICLAIM 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.
Det anbefales at udvise forsigtighed, når ARICLAIM tages sammen med andre centralt virkende lægemidler eller stoffer, herunder alkohol og sederende lægemidler (benzo - diazepiner, morfinlignende præparater, antipsykotika, phenobarbital, sederende antihistaminer).
CNS medicinal products: caution is advised when ARICLAIM is taken in combination with other centrally acting medicinal products or substances, including alcohol and sedative medicinal products (benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
Duloxetins virkning på andre lægemidler Lægemidler, der metaboliseres via CYP1A2:
Effect of duloxetine on other medicinal products Medicinal products metabolised by CYP1A2:
Theophyllins (et CYP1A2- substrat) farmakokinetik blev ikke påvirket signifikant ved samtidig behandling med duloxetin (60 mg to gange daglig).
The pharmacokinetics of theophylline, a CYP1A2 substrate, were not significantly affected by co-administration with duloxetine (60 mg twice daily).
Lægemidler, der metaboliseres via CYP2D6:
Medicinal products metabolised by CYP2D6:
Duloxetin er en moderat CYP2D6- hæmmer.
Duloxetine is a moderate inhibitor of CYP2D6.