natgillin/translations-raw huggingface dataset:
96% af duloxetin er bundet til humane plasmaproteiner.
Duloxetine is approximately 96% bound to human plasma proteins.
Duloxetin bindes til både albumin og alfa- 1- syre- glykoprotein.
Duloxetine binds to both albumin and alpha-l acid glycoprotein.
Både cytochrom P450- 2D6 og - 1A2 katalyserer dannelsen af de to hovedmetabolitter: glukuronidkonjugat af 4- hydroxy- duloxetin og sulfatkonjugat af 5- hydroxy, 6- methoxy- duloxetin.
Both cytochromes P450-2D6 and 1A2 catalyse the formation of the two major metabolites glucuronide conjugate of 4-hydroxy duloxetine and sulphate conjugate of 5hydroxy,6-methoxy duloxetine.
12 timer).
The elimination half-life of duloxetine ranges from 8 to 17 hours (mean of 12 hours).
(gns. på 36 l/ t.).
After an intravenous dose the plasma clearance of duloxetine ranges from 22 l/ hr to 46 l/ hr (mean of 36 l/ hr).
101 l/ t.).
After an oral dose the apparent plasma clearance of duloxetine ranges from 33 to 261 l/ hr (mean 101 l/ hr).
Særlige patientgrupper:
45 Special populations:
25% længere hos ældre) men omfanget af disse forandringer er ikke tilstrækkelige til at retfærdiggøre dosisjusteringer.
Age: pharmacokinetic differences have been identified between younger and elderly females (≥ 65 years) (AUC increases by about 25% and half-life is about 25% longer in the elderly), although the magnitude of these changes is not sufficient to justify adjustments to the dose.
Patienter med terminal nyresygdom i dialysebehandling havde et dobbelt så højt duloxetin- Cmaks. og dobbelt så høje AUC- værdier som raske patienter.
Renal impairment: end stage renal disease (ESRD) patients receiving dialysis had 2-fold higher duloxetine Cmax and AUC values compared with healthy subjects.
Moderat leversygdom (Child- Pugh- gruppe B) påvirkede duloxetins farmako - kinetik.
Hepatic impairment: moderate liver disease (Child Pugh Class B) affected the pharmacokinetics of duloxetine.
Hunmus, som modtog duloxetin i 2 år, havde forøget incidens af hepatocellulære adenomer og karcinomer ved den høje dosis (144 mg/ kg/ dag), men disse blev betragtet som værende sekundære til den mikrosomale enzyminduktion i leveren.
Female mice receiving duloxetine for 2 years had an increased incidence of hepatocellular adenomas and carcinomas at the high dose only (144 mg/ kg/ day), but these were considered to be secondary to hepatic microsomal enzyme induction.
Hunrotter, som fik duloxetin (45 mg/ kg/ dag) før og under parring samt i den tidlige drægtigheds - periode, 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 incidens af kardiovaskulære - og knogle- deformationer, hvor hunkaninerne blev udsat for systemiske påvirkninger under den maksi - male 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 afkom - met 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).
Kapselskal:
46 Capsule shell:
Gelatine, natriumlaurilsulfat, titandioxid (E171), indigotin (E132) og Edible Green Ink.
Gelatin Sodium Lauryl Sulfate Titanium Dioxide (E171) Indigo Carmine (E132) Edible Green Ink
Edible Green Ink indeholder:
Edible Green Ink contains:
Syntetisk sort jernoxid (E172), syntetisk gul jernoxid (E172), propylenglycol og Shellac.
Black Iron Oxide-Synthetic (E172) Yellow Iron Oxide- Synthetic (E172) Propylene glycol Shellac.
Polyvinylchlorid (PVC), polyethylen (PE) og polychlorotrifluoroethylen (PCTFE) - blister forseglet med aluminiumfolie.
Polyvinylchloride (PVC), Polyethylene (PE), and Polychlorotrifluoroethylene (PCTFE) blister sealed with an aluminum foil.
Hjælpestoffer:
Excipients: sucrose 17.2 mg.
Mat grøn kapselbund med påskriften "60 mg" og mat blå kapseltop med påskriften "9542".
Opaque green body, imprinted with ‘ 60 mg’ and an opaque blue cap, imprinted with ‘ 9542’.
Ældre:
Elderly Diabetic Peripheral Neuropathic Pain:
Dosisjustering er ikke nødvendig til patienter med let eller moderat nedsat nyrefunktion (kreatinin - clearance 30- 80 ml/ min).
49 Renal insufficiency No dosage adjustment is necessary for patients with mild or moderate renal dysfunction (creatinine clearance 30 to 80 ml/ min).
Pludselig afbrydelse af behandlingen bør undgås.
Discontinuation of treatment Abrupt discontinuation should be avoided.
4. 4)
Severe renal impairment (creatinine clearance < 30 ml/ min) (see section 4.4).
Nedsat nyrefunktion Forhøjede plasmakoncentrationer af duloxetin forekommer hos patienter med svært nedsat nyrefunktion i hæmodialyse (kreatinin- clearance < 30 ml/ min.).
50 Renal impairment Increased plasma concentrations of duloxetine occur in patients with severe renal impairment on haemodialysis (creatinine clearance < 30 ml/ min).
4. 2.
See section 4.2 for information on patients with mild or moderate renal dysfunction.
47 Samtidig brug af antidepressiva Der bør udvises forsigtighed ved samtidig brug af ARICLAIM og antidepressiva.
Use with antidepressants Caution should be exercised when using ARICLAIM in combination with antidepressants.
Specielt frarådes det at kombinere med selektive reversible MAO- hæmmere.
In particular the combination with selective reversible MAOIs is not recommended.
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.
Hvis patienten, under ARICLAIM- behandling, udvikler agitation eller depressive symptomer, bør en specialist konsulteres, eftersom depression er en alvorlig medicinsk lidelse.
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).
4. 8).
Discontinuation of treatment 51 Withdrawal symptoms when treatment is discontinued are common, particularly if discontinuation is abrupt (see section 4.8).
Saccharose ARICLAIM enterokapsler indeholder saccharose.
Sucrose ARICLAIM gastro-resistant capsules contain sucrose.
49 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 52 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.
Dette er baseret på et forsøg med 6 mælkeproducerende patienter, der ikke ammede deres børn.
53 Breast feeding Duloxetine is very weakly excreted into human milk based on a study of 6 lactating patients, who did not breast feed their children.
50 4. 7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner
4.7 Effects on ability to drive and use machines
Tinnitus 1
Glaucoma
Vertigo Ørepine
Ear and Labyrinth Disorders
sjælden
Tinnitus 1
Mave- tarmkanalen
Gastrointestinal
Kvalme (21, 7%) Mundtørhed (13, 2%)
Nausea (21.7%) Dry mouth (13.2%)
Tilbageholdelse af urin Besværet vandladning Dysuria Natlig vandladning Nedsat urinmængde
Urinary Retention Urinary hesitation Dysuria Nocturia Polyuria Urine flow decreased
Angioneurotisk ødem Stevens - Johnson syndrom
Stevens- Johnson Syndrome Angio-neurotic oedema
Synkope2 Ortostatisk hypotension2 Blodtryksfor - øgelse Perifer kulde - fornæmmelse
Syncope2 Orthostatic
Hypertensive kriser Hypertension
Hypertensive crisis
52
55
Almene symptomer og reaktioner på administration Immunsystemet
General Disorders and Administration Site Conditions
Overfølsomhed
Hyper- sensitivity disorder
Lever og galdeveje Det reproduktive system og mammae
Hepatitis3 Elevated liver enzymes (ALT, AST, alkaline phosphatase)
Psykiske lidelser
Reproductive System and Breast Disorders
Menopausale symptomer
Psychiatric Disorders
1
Suicidal
Søvnforstyrrelser Apati Desorientering Tænderskæren
Sleep disorder Apathy Disorientation
Aggression og angst5 Mani
and anger 5 Mania
4. 4).
3 See section 4.4
5 Sager med aggression og angst er blevet rapporteret, især tidligt i behandlingen eller efter behandlingsophør.
56 4 Cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.4) 5 Cases of aggression and anger have been reported particularly early in treatment of after treatment discontinuation.
HbA1C var stabilt hos både duloxetin- behandlede og placebo- behandlede 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.
Duloxetin normaliserede smertetærsklen i flere prækliniske modeller af neuropatisk og inflammatorisk smerte og svækkede smerteoplevelsen i en model af vedvarende smerte.
57 Duloxetine normalised pain thresholds in several preclinical models of neuropathic and inflammatory pain and attenuated pain behaviour in a model of persistent pain.
Baseret på overlappet i clearenceintervallerne, berettiger den kønsbaserede forskel i farmakokinetik ikke en anbefaling for brug af lavere dosis til kvinder.
Based upon the overlap in the range of 58 clearance, gender-based pharmacokinetic differences do not justify the recommendation for using a lower dose for female patients.
Gelatine, natriumlaurilsulfat, titandioxid (E171), indigotin (E132), gul jernoxid (E172) og Edible White Ink.
59 Gelatin Sodium Lauryl Sulfate Titanium Dioxide (E171) Indigo Carmine (E132) Yellow Iron Oxide (E172) Edible White Ink
Edible White Ink indeholder:
Edible White Ink contains:
Titandioxid (E171), propylenglycol, Shellac og povidon.
Titanium Dioxide (E171) Propylene glycol Shellac Povidone.
56 6. 2 Uforligeligheder
6.2 Incompatibilities
57 BILAG II
60 ANNEX II
FREMSTILLER( E) ANSVARLIG( E) FOR BATCHFRIGIVELSE
61 A MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Lilly SA Avenida de la Industria No 30 28108 Alcobendas Madrid Spanien
Avda. de la Industria Nº 30, 28108 Alcobendas Madrid Spain
59 BILAG III
62 ANNEX III
61 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
64 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
ARICLAIM 40 mg hårde enterokapsler Duloxetin
ARICLAIM 40 mg, hard gastro-resistant capsules.
Hver kapsel indeholder 40 mg duloxetin (som hydrochlorid).
Each capsule contains 40 mg duloxetine (as hydrochloride)
28 hårde enterokapsler 56 hårde enterokapsler, 98 hårde enterokapsler 140 hårde enterokapsler
28 hard gastro-resistant capsules 56 hard gastro-resistant capsules 98 hard gastro-resistant capsules 140 hard gastro-resistant capsules
EXP {MM/ ÅÅÅÅ}
EXP {MM/ YYYY}.
Eli Lilly Nederland BV, Grootslag 1- 5, NL- 3991 RA Houten, Holland.
Eli Lilly Nederland BV, Grootslag 1-5, NL-3991 RA, Houten, The Netherlands.
63 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
66 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
ARICLAIM 40 mg hårde enterokapsler Duloxetin
ARICLAIM 40 mg hard gastro-resistant capsules Duloxetine
Hver kapsel indeholder 40 mg duloxetin (som hydrochlorid).
Each capsule contains 40 mg duloxetine (as hydrochloride).
98 kapsler Del af en multipakning bestående af 2 pakninger med hver 98 kapsler
98 capsules Component of a multipack comprising 2 packs, each containing 98 capsules.
EU/ 1/ 04/ 283/ 006
EU/ 1/ 04/ 283/ 004
65 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
68 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS (2X98 CAPSULES, 40 MG) WRAPPED IN FOIL (INCLUDING BLUE BOX)
Multipakning bestående af 2 pakninger med hver 98 kapsler
Multipack comprising 2 packs, each containing 98 capsules.
(40 MG HÅRDE ENTEROKAPSLER)
70 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS (40 mg hard gastro- resistant capsules)
EXP {MM/ ÅÅÅÅ}
< EXP {MM/ YYYY}.
68 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
71 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
ARICLAIM 20 mg hårde enterokapsler Duloxetin
ARICLAIM 20 mg, hard gastro-resistant capsules.
Hver kapsel indeholder 20 mg duloxetin (som hydrochlorid).
Each capsule contains 20 mg duloxetine (as hydrochloride).
28 hårde enterokapsler 56 hårde enterokapsler
28 hard gastro-resistant capsules 56 hard gastro-resistant capsules.
(20 MG HÅRDE ENTEROKAPSLER)
73 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS (20 mg hard gastro- resistant capsules)
ARICLAIM 20 mg hårde enterokapsler Duloxetin
ARICLAIM 20 mg hard gastro-resistant capsules Duloxetine
71 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
74 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
ARICLAIM 30 mg hårde enterokapsler Duloxetin
ARICLAIM 30 mg, hard gastro-resistant capsules.
Se indlægssedlen for yderligere oplysninger.
Contains sucrose See leaflet for further information
7 hårde enterokapsler 28 hårde enterokapsler 98 hårde enterokapsler
7 hard gastro-resistant capsules, 28 hard gastro-resistant capsules 98 hard gastro-resistant capsules
EXP {MM/ ÅÅÅÅ}
EXP
30 MG HÅRDE ENTEROKAPSLER
76 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 30 mg hard gastro-resistant capsules
74 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
77 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
ARICLAIM 60 mg hårde enterokapsler Duloxetin
Duloxetine
28 hårde enterokapsler 98 hårde enterokapsler.
28, hard gastro-resistant capsules 98, hard gastro-resistant capsules.
76 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
79 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 60 mg hard gastro-resistant capsules
78 INDLÆGSSEDDEL:
81 PACKAGE LEAFLET:
ARICLAIM 40 mg hårde enterokapsler ARICLAIM 20 mg hårde enterokapsler Duloxetin (som hydrochlorid)
ARICLAIM 40 mg hard gastro-resistant capsules ARICLAIM 20 mg hard gastro-resistant capsules Duloxetine (as hydrochloride)
- Spørg lægen eller på apoteket, hvis der er mere, du vil vide..
- If you have any further questions, ask your doctor or pharmacist.
- Lægen har ordineret ARICLAIM til dig personligt.
- This medicine has been prescribed for you.
Lad derfor være med at give det til andre.
Do not pass it on to
Det kan være skadeligt for andre, selvom de har de samme symptomer, som du har
It may harm them, even if their symptoms are the same as yours.
ARICLAIMs virkning og hvad du skal bruge det til 2.
What ARICLAIM is and what it is used for 2.
Det skal du vide, før du begynder at tage ARICLAIM 3.
Before you take ARICLAIM 3.
Sådan skal du tage ARICLAIM 4.
How to take ARICLAIM 4.
Bivirkninger 5 Sådan opbevarer du ARICLAIM 6.
How to store ARICLAIM 6.
ARICLAIMS VIRKNING OG HVAD DU SKAL BRUGE DET TIL
WHAT ARICLAIM IS AND WHAT IT IS USED FOR
ARICLAIM øger niveauet af serotonin og noradrenalin i nervesystemet.
ARICLAIM increases the levels of serotonin and norepinephrine in the nervous system.
ARICLAIM er et lægemiddel til oral indtagelse til behandling af stressinkontinens (SUI) hos kvinder, eller til behandling af diabetiske neuropatiske smerter hos voksne.
ARICLAIM is a medicine to be taken by mouth to treat Stress Urinary Incontinence (SUI) in women or to treat a condition called diabetic neuropathic pain in adults.
ARICLAIM menes at virke ved at øge styrken i lukkemusklen i blæren, som holder urinen tilbage, når du ler, nyser eller udøver fysisk aktivitet.
ARICLAIM is believed to work by increasing the strength of the muscle that holds back urine when you laugh, sneeze, or perform physical activities.
Virkningen af ARICLAIM forstærkes, når behandlingen kombineres med bækkenbundstræning.
The efficacy of ARICLAIM is reinforced when combined with a training program called Pelvic Floor Muscle Training (PFMT).
Neuropatiske smerter er en medicinsk tilstand, hvor smerterne ofte beskrives som brændende, stikkende, sviende, jagende, skærende eller som et elektrisk stød.
Neuropathic pain is a medical condition in which the pain is commonly described as burning, stabbing, stinging, shooting or aching or like an electric shock.
Der kan forekomme følelsesløshed i det påvirkede område, eller påvirkninger såsom berøring, varme, kulde eller tryk kan fremkalde smerte.
There may be loss of feeling in the affected area, or sensations such as touch, heat, cold or pressure may cause pain.
ARICLAIMs virkning indsætter hos de fleste patien ter med diabetiske neuropatiske smerter indenfor 1 uge efter behandlingens start.
The effect of ARICLAIM may be noticeable in many patients with diabetic neuropathic pain within 1 week of treatment.
DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE ARICLAIM
BEFORE YOU TAKE ARICLAIM
Tage ikke ARICLAIM:
Do not take ARICLAIM
- Hvis du er overfølsom (allergisk) over for duloxetin eller et af de øvrige indholdsstoffer.
- If you are allergic (hypersensitive) to duloxetine or any of the inactive ingredients of
- Hvis du tager, eller inden for de sidste 14 dage har været i behandling med en MAO- hæmmer
- If you are taking or have taken within the last 14 days, another medicine known as a monoamine
"Anvendelse af anden medicin").
oxidase inhibitor - MAOI (see section below ‘ Taking other medicines’).
- Hvis du har en leversygdom.
- If you have liver disease.
- Hvis du tager fluvoxamin (til behandling af bl. a. depression), ciprofloxacin eller enoxacin (til
- If you are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or
behandling af infektioner).
82
- Hvis du har svært nedsat nyrefunktion.
- If you have severe kidney disease.
- Hvis du lider af ukontrolleret forhøjet blodtryk.
- If you suffer from uncontrolled high blood pressure.
I følgende situationer kan du muligvis ikke bruge ARICLAIM.
Take special care with ARICLAIM The following are reasons why ARICLAIM may not be suitable for you.
Kontakt din læge før du tager medicinen, hvis de situationer passer på dig:
If any of them apply to you, talk to your doctor before you take the medicine:
- Hvis du tager anden medicin mod depression.
- You are taking other medicines to treat depression.
- Hvis du tager et naturlægemiddel eller kosttilskud, der indeholder perikum (Hypericum
- You are taking a herbal treatment containing St.
perforatum).
John’ s Wort (Hypericum perforatum).
- Hvis du har en nyresygdom.
- You have kidney disease.
- Hvis du tidligere har haft krampeanfald.
- You have had seizures (fits).
- Hvis du lider af eller tidligere har lidt af mani eller bipolar lidelse.
- You suffer from or have suffered from mania or bipolar disorder.
- Hvis du har øjenproblemer, såsom visse typer af grøn stær (glaukom - forøget tryk i øjet).
- You have eye problems, such as certain kinds of glaucoma (increased pressure in the eye).
- Hvis du tidligere har lidt af blødningsforstyrrelser (tendens til blå mærker).
- You have a history of bleeding disorders (tendency to develop bruises).
- Hvis du har risiko for lavt natriumniveau
- You are at risk of low sodium levels.
- Hvis du har højt blodtryk.
- You have high blood pressure.
- Hvis du er i behandling med anden medicin, der kan give leverskader.
- You are currently being treated with another medicine which may cause liver damage.
- Hvis du tager anden medicin, der indeholder duloxetin.
- You are taking other medicines containing duloxetine.
- Hvis du ikke kan tåle visse sukkertyper (se nedenfor).
- You have intolerance to some sugars (see below).
3).
- You are considering stopping ARICLAIM (see section 3).
Hvis du har en depression eller lider af en angstsygdom, kan du af og til få tanker om at skade dig selv eller begå selvmord.
Thoughts of suicide and worsening of your depression or anxiety disorderIf you are depressed and/ or have anxiety disorders you can sometimes have thoughts of harming or killing yourself.
Du vil mere sandsynligt tænke på dette:
You may be more likely to think like this:
- Hvis du tidligere har haft tanker om at begå selvmord eller om at skade dig selv.
- If you have previously had thoughts about killing or harming yourself.
- Hvis du er en yngre person, eftersom erfaringer fra undersøgelser har vist, at der er øget risiko for
Information from clinical trials has shown an increased risk of suicidal
selvmordsadfærd hos unge under 25 år med psykiske forstyrrelser, som bliver behandlet med antidepressiv medicin.
behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.
Brug hos børn og unge under 18 år ARICLAIM bør ikke bruges til behandling af børn og unge under 18 år.
Use in children and adolescents under 18 years of age ARICLAIM should not be used for children and adolescents under the age of 18 years.
Du skal også være klar over at selvmordsrelateret adfærd (selvmordsforsøg og selvmordstanker) og fjendtlighed (overvejende aggression, modsættende adfærd og vrede) hyppigere er blevet observeret hos børn og unge behandlet med medicin af denne gruppe.
Also, you should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines.
Der foreligger endnu ikke data på langtidssikkerhed hos børn og unge hvad angår vækst, modning, kognitiv - og adfærdsudvikling ved brug af ARICLAIM.
Also, the long-term safety effects concerning growth, maturation, and cognitive and behavioural development of ARICLAIM in this age group have not yet been demonstrated.
Det aktive stof (duloxetin) i ARICLAIM bruges i andre lægemidler mod andre tilstande (depression og stressinkontinens).
The main ingredient of ARICLAIM, duloxetine, is used in other medicines for other conditions (depression and urinary incontinence).
Du må ikke tage ARICLAIM sammen med en MAO - hæmmer eller inden for 14 dage efter afsluttet behandling med en MAO- hæmmer.
83 Monoamine Oxidase Inhibitors (MAOI): you should not take ARICLAIM with an MAOI or within 14 days of stopping an MAOI.
Hvis du tager en MAO- hæmmer sammen med en række forskellige receptpligtige lægemidler, heriblandt ARICLAIM, kan det medføre alvorlige og endda livstruende bivirkninger.
Taking an MAOI together with many prescription medicines, including ARICLAIM, can cause serious or even life-threatening side effects.
Du skal vente mindst 14 dage, efter at du er holdt op med at tage en MAO- hæmmer, før du må begynde at tage ARICLAIM.
You must wait at least 14 days after you have stopped taking an MAOI before you can take ARICLAIM.
Du skal ligeledes vente mindst 5 dage, efter at du er holdt op med at tage ARICLAIM, før du må begynde at tage en MAO- hæmmer.
Also, you need to wait at least 5 days after you stop taking ARICLAIM before you take an MAOI.
Dette omfatter alkohol og sløvende lægemidler (benzodiazepiner, morfinlignende præparater, antipsykotika, phenobarbital og sløvende antihistaminer).
CNS medicines: caution is advised when ARICLAIM is taken in combination with other centrally acting medicines or substances, including alcohol and sedative medicines(benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
Fortæl det til din læge, hvis du tager nogle af disse lægemidler.
Inform your doctor if you are taking any of these medicines.