FrancophonIA/ELRC3.0 huggingface dataset:
English: Although the results of the depression studies varied, Cymbalta was more effective than placebo in four of the studies.
Danish: Selvom resulaterne af depressionsundersøgelserne varierede, var Cymbalta mere effektivt end placebo i fire af undersøgelserne.
English: For generalised anxiety disorder, Cymbalta was also more effective than placebo at treating the disorder and preventing symptoms returning.
Danish: Til behandling af generaliseret angst var Cymbalta også mere effektivt end placebo til behandling af sygdommen og til forebyggelse af, at symptomerne kom igen.
English: Cymbalta must also not be used in patients with certain types of liver disease or patients with severe kidney disease.
Danish: Cymbalta bør ikke anvendes til patienter med visse leversygdomme eller med svær nyresygdom.
English: By blocking their re-uptake, duloxetine increases the amount of these neurotransmitters in the spaces between these nerve cells, increasing the level of communication between the cells.
Danish: Ved at blokere for genoptagelsen af neurotransmitterne øger duloxetin mængden af neurotransmittere i mellemrummene mellem disse nerveceller og forbedrer dermed kommunikationen mellem dem. Neurotransmittere er med til at holde humøret oppe og mindske smertefornemmelsen.
English: The active substance in Cymbalta, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Danish: Det aktive stof i Cymbalta er duloxetin, der hæmmer genoptagelsen af serotonin og noradrenalin.
English: As with other antidepressants, isolated cases of suicidal thoughts and behaviour have been seen in patients taking Cymbalta, particularly in the first few weeks of treatment for depression.
Danish: Ligesom med andre midler mod depression har patienter i behandling med Cymbalta i enkelte tilfælde haft selvmordstanker og udvist selvmordsadfærd, navnlig i de første uger af behandlingen for depression.
English: For the full list of all side effects reported with Cymbalta, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Cymbalta fremgår af indlægssedlen.
English: For the treatment of diabetic neuropathic pain, Cymbalta was more effective at reducing pain than placebo.
Danish: Til behandling af diabetiske neuropatiske smerter var Cymbalta bedre til at lindre smerterne end placebo.
English: For generalised anxiety disorder, Cymbalta has been compared with placebo in five studies involving a total of 2,337 patients.
Danish: Til behandling af generaliseret angst er Cymbalta blevet sammenlignet med placebo i fem undersøgelser med deltagelse af i alt 2 337 patients.
English: For major depression, Cymbalta has been compared with placebo (a dummy treatment) in eight main studies involving a total of 2,544 patients.
Danish: Ved svær depression blev Cymbalta sammenlignet med placebo (en virkningsløs behandling) i otte hovedundersøgelser af i alt 2 544 patienter.
English: Why has Cymbalta been approved?
Danish: Hvorfor blev Cymbalta godkendt?
English: What is Cymbalta?
Danish: Hvad er Cymbalta?
English: Any patients taking Cymbalta who have distressing thoughts or experiences at any time should tell their doctor immediately.
Danish: Hvis en patient, der er i behandling med Cymbalta, på noget tidspunkt føler sig nedtrykt, bør patienten straks fortælle det til lægen.
English: Since these neurotransmitters are involved in maintaining high mood and reducing the sensation of pain, blocking their re-uptake into nerve cells can improve the symptoms of depression, anxiety and neuropathic pain.
Danish: Når deres genoptagelse i nervecellerne blokeres, kan man derfor opnå en bedring i symptomerne på depression, angst og neuropatiske smerter.
English: Cymbalta duloxetine EPAR summary for the public
Danish: Cymbalta duloxetin
English: The dose of Cymbalta should be reduced gradually when stopping treatment.
Danish: Når behandlingen ophører, bør det ske ved gradvis nedsættelse af dosis af Cymbalta.
English: What is Cymbalta used for?
Danish: Hvad anvendes Cymbalta til?
English: How has Cymbalta been studied?
Danish: Hvordan blev Cymbalta undersøgt?
English: How is Cymbalta used?
Danish: Hvordan anvendes Cymbalta?
English: What benefit has Cymbalta shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Cymbalta?
English: How does Cymbalta work?
Danish: Hvordan virker Cymbalta?
English: Blister (PVC/PVdC/Alu) 100 x 1 capsules (unit dose)
Danish: Blister (PVC/PVdC /Al) 100 x 1 kapsler (enhedsdosis)
English: Blister (PVC/PVdC/Alu) 50 x 1 tablets
Danish: Blister (PVC/PVdC /Al) 50 x 1 tabletter (enhedsdosis)
English: Immediate Packaging Pack size
Danish: Styrke Lægemiddelform Administration Emballage
English: MA (EU) number (Invented) name Strength Pharmaceutical form Route of administration
Danish: MF (EU)nummer
English: SYSTEM ORGAN CLASS VERY COMMON
Danish: SYSTEMORGANKLASSE MEGET ALMINDELIG
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1310/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/18/1310/001
English: In the event of neutropenia:
Danish: I tilfælde af neutropeni:
English: The amount of Deferiprone Lipomed that you take will depend on your weight.
Danish: Den mængde Deferiprone Lipomed, du tager, afhænger af din vægt.
English: The patient's neutrophil count should be monitored every week.
Danish: Patientens neutrofiltal skal kontrolleres hver uge.
English: There are limited data available on the use of deferiprone in children between 6 and 10 years of age, and no data on deferiprone use in children under 6 years of age.
Danish: Der er begrænsede data til rådighed om brugen af deferipron til børn i alderen fra 6 til 10 år og ingen data om brug af deferipon til børn under 6 år.
English: Deferiprone Lipomed can be taken with or without food; however, you may find it easier to remember to take Deferiprone Lipomed if you take it with your meals.
Danish: Deferiprone Lipomed kan tages med eller uden mad; det kan dog være lettere for dig at huske at tage, hvis du tager det sammen med dine måltider.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 September 2018
Danish: Dato for første godkendelse: 20. september 2018
English: If you are HIV positive or if your liver function is severely impaired, your doctor may recommend additional tests.
Danish: Hvis du er HIV-positiv, eller hvis din leverfunktion er kraftigt nedsat, kan din læge anbefale yderligere undersøgelser.
English: In most cases, the pain disappeared while patients continued taking deferiprone.
Danish: I de fleste tilfælde forsvandt smerten, selv om patienterne fortsatte med at tage deferipron.
English: For women of child bearing age
Danish: Til kvinder i den fødedygtige aldre
English: Plasma Zn2+ concentration Monitoring of plasma Zn2+ concentration, and supplementation in case of a deficiency, is recommended.
Danish: Plasma Zn2+ koncentration Det anbefales at kontrollere plasma Zn2+ koncentrationen og tilføre ekstra i tilfælde af mangel.
English: Limited information is available regarding re-challenge.
Danish: Der er begrænsede informationer tilgængelige vedrørende rechallenge.
English: Therefore, in the event of neutropenia, rechallenge is not recommended.
Danish: I tilfælde af neutropeni kan rechellange derfor ikke anbefales.
English: Deferiprone Lipomed will be most effective if you do not miss any doses.
Danish: Deferiprone Lipomed er mest effektivt, hvis du ikke springer nogen doser over.
English: Not known (frequency cannot be estimated from the available data): - allergic reactions including skin rash or hives
Danish: Ikke kendt (hyppigheden kan ikke skønnes fra de tilgængelige data): - allergiske reaktioner som f.eks. hududslæt eller nældefeber
English: Chronic overdose and neurological disorders
Danish: Kronisk overdosis og neurologiske forstyrrelser
English: • History of recurrent episodes of neutropenia.
Danish: • Tidligere gentagen forekomst af neutropeni.
English: Deferiprone was concluded to produce no significant prolongation of the QT interval.
Danish: Det konkluderedes, at deferipron ikke fremkaldte nogen signifikant forlængelse af QT-intervallet.
English: Electronic mail: lipomed@lipomed.com
Danish: E-mail: lipomed@lipomed.com
English: COMMON (≥1/100 to <1/10)
Danish: ALMINDELIG (≥1/100 TIL
English: The Patient/Carer reminder card shall contain the following key messages (full text is included in Annex IIIA of the marketing authorisation):
Danish: Informationskortet til patienter/omsorgspersoner skal indeholde følgende vigtige sikkerhedsinformationer (den fuldstændige tekst findes i bilag IIIA i markedsføringstilladelsen)
English: This metabolite lacks ironbinding capability due to inactivation of the 3-hydroxy group of deferiprone.
Danish: Denne metabolit mangler jernbindingsevne på grund af inaktivering af 3-hydroxy-gruppen i deferipron.
English: Limited data are available on the combined use of deferiprone and deferasirox, and caution should be applied when considering the use of such combination.
Danish: Der foreligger kun begrænsede data om den kombinerede brug af deferipron og deferasirox, og der skal udvises forsigtighed, når det overvejes at anvende en sådan kombination.
English: To obtain a dose of about 75 mg/kg/day, use the number of tablets suggested in the following tables for the body weight of the patient.
Danish: For at opnå en dosis på ca. 75 mg/kg/dag edet antal tabletter, der foreslås i følgende skemaer til patientens kropsvægt.
English: There is a small chance that you may develop agranulocytosis (very low white blood cell count) while taking Deferiprone Lipomed, which may lead to a serious infection.
Danish: Der er en meget lille risiko for, at du kan udvikle agranulocytose (meget lavt antal hvide blodceller), mens du tager Deferiprone Lipomed, hvilket kan medføre alvorlig infektion.
English: The active substance is deferiprone (3-hydroxy-1,2-dimethylpyridin-4-one), a bidentate ligand which binds to iron in a 3:1 molar ratio.
Danish: Det aktive stof er deferipron (3-hydroxy-1,2-dimetylpyridin-4-et), en bidentat ligand, som binder sig til jern i molarforholdet 3:1.
English: This rate should be considered in the context of the underlying elevated incidence of neutropenia in thalassaemia patients, particularly in those with hypersplenism.
Danish: Denne frekvens bør betragtes i forbindelse med den underliggende forhøjede forekomst af neutropeni hos talassæmi-patienter, specielt hos patienter med hypersplenisme.
English: Deferiprone Lipomed is an iron chelator, a type of medicine that removes excess iron from the body.
Danish: Deferiprone Lipomed er en jernchelator, dvs. en type medicin, der fjerner overskydende jern fra kroppen.
English: To monitor for neutropenia, your doctor will ask you to have a blood test (to check your white blood cell count) performed regularly, as frequently as every week, while you are being treated with Deferiprone Lipomed.
Danish: Din læge vil bede dig om at få taget en blodprøve for at undersøge for neutropeni (kontrollere antallet af hvide blodlegemer) regelmæssigt, så ofte som hver uge, mens du behandles med Deferiprone Lipomed.
English: Systemic exposure to the inactive 3-Oglucuronide increased with decreasing eGFR.
Danish: Den systemiske eksponering for det inaktive 3-O-glucuronid steg med faldende eGFR.
English: Deferiprone Lipomed is packaged in blisters.
Danish: Deferiprone Lipomed er pakket i blisterpakninger.
English: Studies LA16-0102, LA-01 and LA08-9701 compared the efficacy of deferiprone with that of deferoxamine in controlling serum ferritin in transfusion-dependent thalassaemia patients.
Danish: Studierne LA16-0102, LA-01 og LA08-9701 sammenlignede deferiprons' virkning med deferoxamins virkning til styring af serumferritin hos transfusionsafhængige talassæmi-patienter.
English: Deferiprone did not show direct mutagenic properties; however, it did display clastogenic characteristics in in vitro assays and in vivo in animals.
Danish: Deferipron udviste ikke nogen direkte mutagene egenskaber; men det udviste klastogene egenskaber ved in vitro-analyser og in vivo hos dyr.
English: Coating: hypromellose, macrogol 6000, titanium dioxide
Danish: Tabletovertræk: Hypromellose, macrogol 6000, titandioxid.
English: Doses of deferiprone in those studies ranged from 50 to 100 mg/kg/day and doses of deferoxamine from 40 to 60 mg/kg/day.
Danish: Doserne af deferipron i disse studier lå mellem 50 og 100 mg/kg/dag og doserne af deferoxamin mellem 40 og 60 mg/kg/dag.
English: If taken during pregnancy, Deferiprone Lipomed may seriously harm the unborn baby.
Danish: Hvis Deferiprone Lipomed tages under graviditet, kan det skade det ufødte barn alvorligt.
English: Have your blood monitored on a weekly basis.
Danish: At få taget en blodprøve hver uge.
English: • To warn women of childbearing age to not become pregnant because deferiprone may seriously harm the unborn baby
Danish: • for at advare kvinder i den fødedygtige om ikke at blive gravide, da deferipron kan skade det udfødte barn alvorligt.
English: If you become pregnant while taking Deferiprone Lipomed, stop taking the medicine immediately and tell your doctor.
Danish: Hvis du bliver gravid, mens du tager Deferiprone Lipomed, skal du omgående ophøre med at tage lægemidlet og underrette din læge.
English: The MAH shall ensure that in each Member State where Deferiprone Lipomed is marketed, all patients/carers who are expected to use Deferiprone Lipomed are provided with the Patient/Carer reminder card as a part of the outer packaging.
Danish: Indehaveren af markedsføringstilladelsen skal i at alle de medlemsstater, hvor Deferiprone Lipomed markedsføres, sikre, at alle patienter/omsorgspersoner, der forventes at anvende Deferiprone Lipomed, modtager et informationskort sammen med den ydre emballage
English: Deferiprone and deferoxamine were equivalent in promoting a net stabilization or reduction of body iron load, despite the continuous transfusional iron administration in those patients (no difference in proportion of patients with a negative trend in serum ferritin between the two treatment groups by regression analysis; p>0.05).
Danish: Deferipron og deferoxamin var ækvivalente med hensyn til at fremme en nettostabilisering eller reduktion af kroppens jernophobning, til trods for den kontinuerlige jernindgivelse via transfusion hos disse patienter (ingen forskel i andelen af patienter med en negativ tendens i serumferritin mellem de to behandlingsgrupper ved regressionsanalyse; p >0,05).
English: If you experience nausea or vomiting, it may help to take your Deferiprone Lipomed with some food.
Danish: Hvis du får kvalme eller kaster op, kan det måske hjælpe at indtage Deferiprone Lipomed sammen med mad.
English: Deferiprone has been shown to cause neutropenia, including agranulocytosis.
Danish: Deferipron har vist sig at forårsage neutropeni, herunder agranulocytose.
English: Following a dose of 25 mg/kg, lower peak serum concentrations have been detected in patients in the fed state (85 µmol/l) than in the fasting state (126 µmol/l), although there was no decrease in the amount of deferiprone absorbed when it was given with food.
Danish: Efter en dosis på 25 mg/kg er der detekteret lavere spidskoncentrationer i serum hos patienter, der havde indtaget føde (85 mikromol/l) end ved fastende tilstand (126 mikromol/l), selv om der ikke var noget fald i mængden af absorberet deferipron, da det blev givet sammen med føde.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per tablet and that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. tablet og er således stort set natriumfrit.
English: If the patient develops an infection while on deferiprone, therapy should be interrupted and the neutrophil count monitored more frequently.
Danish: Hvis patienten udvikler en infektion under behandlingen med deferipron, skal behandlingen seponeres, og neutrofiltallet skal kontrolleres hyppigere.
English: One pack contains 100 film-coated tablets.
Danish: En pakke indeholder 100 filmovertrukne tabletter.
English: In the event of severe neutropenia or agranulocytosis:
Danish: I tilfælde af alvorlig neutropeni eller agranulocytose:
English: In clinical trials, weekly monitoring of the neutrophil count has been effective in identifying cases of neutropenia and agranulocytosis and those episodes resolved once therapy was withdrawn.
Danish: Ved kliniske studier har ugentlig monitorering af neutrofiltallet vist sig effektivt til identifikation af tilfælde af neutropeni og agranulocytose, og disse episoder forsvandt, når behandlingen blev seponeret.
English: Lipomed GmbH Hegenheimer Strasse 2 79576 Weil am Rhein GERMANY
Danish: Lipomed GmbH Hegenheimer Strasse 2 79576 Weil am Rhein Tyskland
English: Prescribers are reminded that the use of doses above 100 mg/kg/day is not recommended.
Danish: Ordinerende læger mindes om, at brugen af doser over 100 mg/kg/dag frarådes.
English: Regardless of the degree of renal impairment, the majority of the dose of deferiprone was excreted in the urine over the first 24 hours as deferiprone 3-O-glucuronide.
Danish: Uanset graden af nyreinsufficiens blev størstedelen af deferipron-dosen udskilt i urinen som deferipron 3-O-glucuronid over de første 24 timer.
English: In the event of agranulocytosis, re-challenge is contraindicated.
Danish: I tilfælde af agranulocytose er rechallenge kontraindiceret.
English: Dose adjustments when used with other iron chelators In patients for whom monotherapy is inadequate, Deferiprone Lipomed may be used with deferoxamine at the standard dose (75 mg/kg/day) but should not exceed 100 mg/kg/day.
Danish: Dosisjusteringer ved anvendelse sammen med andre jernkelerende stoffer Hos patienter, hvor monoterapi er utilstrækkelig, kan Deferiprone Lipomed anvendes sammen med deferoxamin med en standarddosis (75 mg/kg/dag), men bør ikke overstige 100 mg/kg/dag.
English: • To increase patient awareness of the importance of regular monitoring of the neutrophil count during treatment with Deferiprone Lipomed
Danish: • for at øge patientens bevidshed om vigtigheden af regelmæssig monitorering af neutrofiltallet under behandling med Deferiprone Lipomed
English: White to off-white, glossy surface, oval film-coated tablet.
Danish: Hvid til off-white, blank, oval, filmovertrukket tablet.
English: Deferiprone Lipomed contains sodium
Danish: Deferiprone Lipomed indeholder natrium
English: Talk to your doctor or pharmacist before taking Deferiprone Lipomed.
Danish: Tal med din læge eller apotektet, inden du begynder at tage Deferiprone Lipomed.
English: After starting Deferiprone Lipomed therapy, it is recommended that serum ferritin concentrations, or other indicators of body iron load, be monitored every two to three months to assess the long-term effectiveness of the chelation regimen in controlling the body iron load.
Danish: Efter påbegyndelse af Deferiprone Lipomed -behandling anbefales det, at koncentrationerne af serumferritin eller andre indikatorer for jernophobning i kroppen overvåges hver anden til tredje måned for at vurdere den langsigtede effektivitet af et kelationsregimen til styring af jernophobning i kroppen.
English: Abdominal pain Vomiting
Danish: Abdominalsmerter Opkastning
English: The observed incidence of the less severe form of neutropenia (neutrophils <1.5 x 109/l) is 4.9% (2.5 cases per 100 patient-years).
Danish: Den observerede forekomst af den mindre alvorlige form for neutropeni (neutrofiltal < 1, 5 x 109//l) er 4,9% (2,5 tilfælde pr. 100 patient-år).
English: • To increase patient awareness of the significance of any symptoms of infection while taking Deferiprone Lipomed
Danish: • for at øge patientens bevidsthed om betydningen af ethvert symtom på infektion, under behandling med Deferiprone Lipomed
English: Data from the pooled safety database from clinical trials (1343 patient-years exposure to deferiprone monotherapy and 244 patient-years exposure to deferiprone and deferoxamine) showed statistically significant (p<0.05) differences in the incidence of adverse reactions based on System Organ Class for “Cardiac disorders”, “Musculoskeletal and connective tissue disorders” and “Renal and urinary disorders”.
Danish: Data fra den poolede sikkerhedsdatabase fra kliniske studier (1343 patientårs eksponering for deferipron monoterapi og 244 patientårs eksponering for deferipron og deferoxamin) viste statistisk signifikante (p<0,05) forskelle i forekomsten af bivirkninger baseret på systemorganklassen "Hjerte", "Knogler, led, muskler og bindevæv" samt "Nyrer og urinveje".
English: HIV positive or other immunocompromised patients No data are available on the use of deferiprone in HIV positive or other immunocompromised patients.
Danish: HIV-positive eller på anden vis immunudsatte patienter Der findes ingen tilgængelige data om anvendelse af deferipron på patienter, som er HIV-positive eller på anden vis har et defekt immunforsvar.
English: Episodes of hypotonia, instability, inability to walk, and hypertonia with inability of limb movement have been reported in children in the post-marketing setting with standard doses of deferiprone.
Danish: Episoder med hypotoni, ustabilitet, manglende evne til at gå og hypertoni med manglende evne til at bevæge lemmerne er rapporteret hos børn efter markedsføringen ved standarddoser af deferipron.
English: Subjects were categorized into 3 groups based on the Child-Pugh classification score: healthy volunteers, mild hepatic impairment (Class A: 5- 6 points), and moderate hepatic impairment (Class B: 7- 9 points).
Danish: Forsøgsdeltagerne blev inddelt i 3 grupper ud fra Child-Pughklassifikationsscoren: raske frivillige, let leverinsufficiens (klasse A: 5-6 point) og moderat leverinsufficiens (klasse B: 7-9 point).
English: Data from the published literature on iron balance studies in patients with thalassaemia major show that the use of deferiprone concurrently with deferoxamine (co-administration of both chelators during the same day, either simultaneously or sequentially, e.g., deferiprone during the day and deferoxamine during the night), promotes greater iron excretion than either drug alone.
Danish: Publicerede data om jernbalancestudier hos talassæmi-patienter viser, at brugen af deferipron samtidig med deferoxamin (samtidig administration af begge kelerende stoffer på samme dag enten samtidigt eller sekventielt, f.eks. deferipron om dagen og deferoxamin om aftenen), fremmer større jernudskillelse end med kun ét af disse lægemidler.
English: Clinical studies have demonstrated that deferiprone is effective in promoting iron excretion and that a dose of 25 mg/kg three times per day can prevent the progression of iron accumulation as assessed by serum ferritin, in patients with transfusion-dependent thalassaemia.
Danish: Kliniske studier har vist, at deferipron er effektivt til fremme af jernudskillelse, og at en dosis på 25 mg/kg tre gange daglig kan forebygge progression af jernakkumulation vurderet ved serumferritin hos patienter med transfusions-afhængig talassæmi.
English: Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og blisterpakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: This condition, known as severe neutropenia or agranulocytosis, has occurred in 1 to 2 out of 100 people who have taken deferiprone in clinical studies.
Danish: Denne tilstand, som kaldes svær neutropeni eller agranulocytose, optrådte hos 1 til 2 ud af 100 personer, som tog deferiproni kliniske studier.
English: The higher rate of “Cardiac disorders” reported during combination therapy than monotherapy was possibly due to the higher incidence of pre-existing cardiac disorders in patients who received combination therapy.
Danish: Den højere forekomst af bivirkninger i systemorganklassen "Hjerte", rapporteret under kombinationsterapi end monoterapi, skyldtes muligvis den højere forekomst af allerede eksisterende hjertesygdomme hos patienter, som fik kombinationsterapi.
English: PATIENT/CARER REMINDER CARD ((Front Cover))
Danish: INFORMATIONSKORT TIL PATIENT/OMSORGSPERSON ((Forside))