FrancophonIA/ELRC3.0 huggingface dataset:
English: Common side effects (may affect up to 1 in 10 people) - Collection of fluid around the heart (pericardial effusion)
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer) - Væskeansamling omkring hjertet (perikardial effusion)
English: Interaction with other medicinal products and other forms of interaction A need for lower propofol doses has been observed in patients taking valproate.
Danish: Interaktion med andre lægemidler og andre former for interaktion Det er observeret, at patienter, som tager valproat, har brug for lavere doser propofol.
English: Propofol; valproate - Pharmacokinetic drug interaction leading to an increased propofol exposure (EPITT no 18696)
Danish: Propofol; valproat - Farmakokinetisk lægemiddelinteraktion, som medfører øget eksponering for propofol (EPITT nr. 18696)
English: The product information wording in this document is extracted from the document entitled ‘PRAC recommendations on signals' which contains the whole text of the PRAC recommendations for product information update, as well as some general guidance on the handling of signals.
Danish: Ordlyden til opdatering af produktinformationen i dette dokument er et uddrag af dokumentet "PRAC's anbefalinger om signaler", der indeholder den fulde tekst til PRAC's anbefalinger for ajourføring af produktinformationen og visse generelle retningslinjer for håndtering af signaler.
English: Azacitidine - Pericarditis and pericardial effusion (EPITT no 18733)
Danish: Azacitidin - perikarditis og perikardial effusion (EPITT nr. 18733)
English: New product information wording - Extracts from PRAC recommendations on signals
Danish: Ny ordlyd af produktinformation - uddrag af PRAC's anbefalinger vedrørende signaler
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/5725/2017
Danish: Ny ordlyd af produktinformation - uddrag af PRAC's anbefalinger vedrørende signaler EMA/PRAC/38533/2017
English: Undesirable effects Tabulated list of adverse reactions System Organ
Danish: Bivirkninger Tabel over bivirkninger Systemorganklasse Meget
English: Summary of product characteristics (propofol) 4.5.
Danish: Produktresumé (propofol)
English: 1010 Wien Austria
Danish: 1010 Wien
English: 153 43 Aghia Paraskevi, Athens
Danish: 153 43 Aghia Paraskevi, Athen
English: D-55127 Mainz
Danish: D-55127 Mainz Tyskland
English: Flemingweg 18, 2408 AV ALPHEN A/D RIJN The Netherlands
Danish: Flemingweg 18, 2408 AV ALPHEN A/D RIJN
English: Novo Nordisk, Coeur Défense - 100, avenue du Général de Gaulle - 92400 Courbevoie
Danish: Novo Nordisk, Coeur Défense - 100, avenue du Général de Gaulle - 92400 Courbevoie Frankrig
English: List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the Member States
Danish: Fortegnelse over lægemidlernes navne, lægemiddelform(er), styrke(r), indgivelsesvej(e), ansøger(e), indehaver(e) af markedsføringstilladelse(r) i medlemsstaterne
English: Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley, West Sussex RH11 9RT United Kingdom
Danish: Storbritannien Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley, West Sussex RH11
English: Novo Nordisk Hellas Ltd. A. Panagouli 80 & Aghias Triados 65.
Danish: Grækenland Novo Nordisk Hellas Ltd. A. Panagouli 80 & Aghias Triados 65.
English: Boulevard international 55 1070 Brussels
Danish: NOVO NORDISK PHARMA SA Boulevard international 55 1070 Brussels
English: Novo Nordisk - Comércio de Produtos
Danish: Novo Nordisk - Comércio de Produtos Farmacêuticos, Lda.
English: Slovakia Novo Nordisk A/S Novo Allé
Danish: Rumænien Novo Nordisk A/S Novo Allé
English: Novo Nordisk Pharma GmbH
Danish: Novo Nordisk Pharma GmbH Brucknerstr.
English: solution for injection, pre-filled pen
Danish: Danmark injektionsvæske, opløsning, fyldt pen
English: Norditropin NordiFlex 10 mg/1.5 ml, solution for injection, in prefilled pen
Danish: Norditropin NordiFlex 10 mg/1.5 ml, solution for injection, in pre-filled pen
English: Norditropin SimpleXx 10 mg/1.5 ml, solution for injection, in prefilled pen
Danish: Norditropin SimpleXx 10 mg/1.5 ml, solution for injection, in pre-filled pen
English: Norditropin NordiFlex 15 mg/1.5 ml, solution for injection, in prefilled pen
Danish: Norditropin NordiFlex 15 mg/1.5 ml, solution for injection, in pre-filled pen
English: Norditropin SimpleXx 15 mg/1.5 ml, solution for injection, in prefilled pen
Danish: Norditropin SimpleXx 15 mg/1.5 ml, solution for injection, in pre-filled pen
English: solution for injection in pre-filled syringe
Danish: Holland injektionsvæske, opløsning, i fyldt sprøjte (oplossing voor injectie in een voorgevulde) pen
English: • could become pregnant;
Danish: • kan blive gravide
English: Other information about Evista:
Danish: Andre oplysninger om Evista:
English: Evista should not be used in women who:
Danish: Evista bør ikke anvendes af kvinder, som:
English: The marketing authorisation was renewed on 5 August 2003 and on 5 August 2008.
Danish: Markedsføringstilladelsen blev fornyet den 5. august 2003 og den 5. august 2008.
English: The marketing authorisation holder is Daiichi Sankyo Europe GmbH.
Danish: Indehaveren af markedsføringstilladelsen er Daiichi Sankyo Europe GmbH.
English: The recommended dose for adults and the elderly is one tablet taken once a day, with or without food.
Danish: Den anbefalede dosis for voksne og ældre er en tablet en gang daglig med eller uden et måltid.
English: The Committee recommended that Evista be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Evista.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Evista on 5 August 1998.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Evista den 5. august 1998.
English: The full EPAR for Evista is available here.
Danish: Den fuldstændige EPAR for Evista findes her.
English: It is available as white, oval tablets (60 mg).
Danish: Det fås som hvide, ovale tabletter (60 mg).
English: What is the risk associated with Evista?
Danish: Hvilken risiko er der forbundet med Evista?
English: Evista should not be used in people who may be hypersensitive (allergic) to raloxifene or any of the other ingredients.
Danish: Evista bør ikke anvendes hos personer, som kan være overfølsomme (allergiske) over for raloxifen eller et af de øvrige indholdsstoffer.
English: The main measure of effectiveness was how many women had vertebral fractures during the study.
Danish: Den vigtigste målestok for virkningen var, hvor mange kvinder der havde vertebrale frakturer i løbet af undersøgelsen.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) EVISTA EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) EVISTA EPAR - sammendrag for offentligheden
English: Evista is a medicine containing the active substance raloxifene hydrochloride.
Danish: Evista er et lægemiddel, der indeholder det aktive stof raloxifenhydrochlorid.
English: The most common side effects with Evista (seen in more than 1 patient in 10) are vasodilation (hot flushes) and flu-like symptoms.
Danish: De hyppigste bivirkninger ved Evista (som ses hos flere end 1 ud af 10 patienter) er vasodilation (hedestigninger) og influenzalignende symptomer.
English: Patients may also receive calcium and vitamin D supplements if they do not get enough from their diet. Evista is intended for long-term use.
Danish: Patienterne kan også få calcium- og vitamin D-tilskud, hvis de ikke får tilstrækkeligt gennem deres kost.
English: There was no effect of Evista on hip fractures.
Danish: Der var ingen effekt af Evista på hoftefrakturer.
English: The active substance in Evista, raloxifene, is a selective oestrogen receptor modulator (SERM).
Danish: Det aktive stof i Evista, raloxifen, er en selektiv østrogen receptor modulator (SERM).
English: Why has Evista been approved?
Danish: Hvorfor blev Evista godkendt?
English: The fourth study compared the effects of Evista with those of placebo in the treatment of osteoporosis in 7,705 women over four years.
Danish: I den fjerde undersøgelse sammenlignede man effekten af Evista med effekten af placebo til behandling af osteoporose hos 7 705 kvinder over fire år.
English: Raloxifene has the same effect as oestrogen in the bone, but it does not have an effect in the breast or the womb.
Danish: Raloxifen har samme effekt som østrogen i knoglerne, men det har ikke nogen effekt i bryst og livmoder.
English: Evista has been shown to significantly reduce vertebral fractures (breaks in the spine), but not hip fractures.
Danish: Det er påvist, at Evista i væsentlig grad begrænser forekomsten af vertebrale frakturer (brud på rygsøjlen), men ikke hoftefrakturer.
English: For the full list of side effects reported with Evista, see the Package Leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger for Evista fremgår af indlægssedlen.
English: What is Evista?
Danish: Hvad er Evista?
English: Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down.
Danish: Osteoporose opstår, når der ikke dannes tilstrækkelig knoglemasse til at erstatte den, som nedbrydes naturligt.
English: • have or have had any blood clot disorders, including deep vein thrombosis and pulmonary embolism (a blood clot in the lungs);
Danish: • har eller har haft blodpropssygdomme, herunder dyb venetrombose og lungeemboli (blodprop i lungen)
English: • have liver disease, severe kidney disease, unexplained bleeding from the womb or endometrial cancer (cancer of the lining of the womb).
Danish: • har en leversygdom, svær nyresygdom, uforklarlige blødninger fra livmoderen eller endometrial cancer (livmoderslimhindekræft).
English: The Committee decided that Evista's benefits are greater than its risks for the treatment and prevention of osteoporosis in postmenopausal women.
Danish: Udvalget besluttede, at fordelene ved Evista er større end risiciene ved behandling og forebyggelse af osteoporose hos postmenopausale kvinder.
English: Over four years, in comparison with placebo, Evista decreased the number of new vertebral fractures by 46% in women who had osteoporosis and by 32% in women who had osteoporosis and an existing fracture.
Danish: Sammenlignet med placebo nedsatte Evista over 4 år hyppigheden af nye vertebrale frakturer med 46 % hos kvinder, som havde osteoporose, og med 32 % hos kvinder, som havde osteoporose og en eksisterende fraktur.
English: Evista is used for the treatment and prevention of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause.
Danish: Evista anvendes til behandling og forebyggelse af osteoporose (en sygdom, der gør knoglerne skøre) hos kvinder, der har været gennem overgangsalderen.
English: Raloxifene acts as an ‘agonist' of the oestrogen receptor (a substance that stimulates the receptor for oestrogen) in some tissues in the body.
Danish: Raloxifen virker som en østrogenreceptor “agonist” (et stof, som stimulerer østrogenreceptoren) i visse former for kropsvæv.
English: Three studies looked at the prevention of osteoporosis in 1,764 women who took either Evista or placebo (a dummy treatment) for two years.
Danish: I tre undersøgelser undersøgte man forebyggelse af osteoporose hos 1 764 kvinder, som fik enten Evista eller placebo (en uvirksomhed behandling) i to år.
English: What is Evista used for?
Danish: Hvad anvendes Evista til?
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that Evista had shown its effectiveness in preventing and treating osteoporosis, and had no effects on the breast or womb.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Evista havde vist sig at være virksomt til forebyggelse og behandling af osteoporose, og at det ikke havde nogen indvirkning på bryst og livmoder.
English: What benefit has Evista shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, der er ved Evista?
English: Evista was more effective than placebo in preventing and treating osteoporosis.
Danish: Evista var mere effektivt end placebo til at forebygge og behandle osteoporose.
English: When used to treat osteoporosis, Evista was more effective than placebo in reducing the number of vertebral fractures.
Danish: Til behandling af osteoporose var Evista mere effektivt end placebo til at reducere antallet af vertebrale frakturer.
English: How has Evista been studied?
Danish: Hvordan blev Evista undersøgt?
English: In the prevention of osteoporosis, women receiving Evista had an increase in bone density in the hip or spine of 1.6% over two years, and those receiving placebo had a decrease of 0.8%.
Danish: Med hensyn til forebyggelse af osteoporose havde kvinder, som fik Evista, en stigning i knogletætheden i hoften eller rygsøjlen på 1,6 % over to år, og dem, der fik placebo, havde et fald på
English: Evista has been studied in the treatment and the prevention of osteoporosis in four main studies.
Danish: Evista blev undersøgt i fire hovedundersøgelser til behandling og forebyggelse af osteoporose.
English: How is Evista used?
Danish: Hvordan anvendes Evista?
English: The studies measured the density of the bones.
Danish: Knogletætheden blev målt i disse undersøgelser.
English: Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall: oestrogen slows down bone breakdown and makes the bones less likely to fracture.
Danish: Osteoporose er mere almindelig hos kvinder efter overgangsalderen, når mængden af det kvindelige hormon østrogen falder.
English: How does Evista work?
Danish: Hvordan virker Evista?
English: Both of these cases were fatal.
Danish: Begge disse tilfælde var dødelige.
English: Treatment Difference [95% Cl]
Danish: Behandlingsforskel [95 % Cl]
English: Date of first authorisation: 18 February 2019
Danish: Dato for første markedsføringstilladelse: 18. februar 2019
English: The apparent volume of distribution is approximately 155 litres.
Danish: Det tilsyneladende fordelingsvolumen er ca. 155 liter.
English: Not Known (frequency cannot be estimated from the available data)
Danish: Ikke kendt (hyppigheden kan ikke beregnes ud fra tilgængelige data)
English: The following side effects may happen with this medicine:
Danish: De følgende bivirkninger kan forekomme med denne medicin:
English: It may be taken at any time of the day but it is recommended to be taken at the same time every day.
Danish: Det kan tages på et vilkårligt tidspunkt på dagen, men det anbefales at tage det på samme tid hver dag.
English: Do not take this medicine if any of the above applies to you.
Danish: Tag ikke lægemidlet, hvis noget af det ovenstående gælder for dig.
English: AT, BE, BG, CY, CZ, DK, EE, IE, EL, FI, FR, HR, HU, IE, IS, LT, LU, LV, MT, , NO, PL, PT, RO, SE, SI, SK
Danish: AT, BE, BG, CY, CZ, DK, EE, IE, EL, FI, FR, HR, HU, IE, IS, LT, LU, LV, MT, NO, PT, RO, SE, SI, SK
English: Age, gender, body weight and race
Danish: Alder, køn, kropsvægt og race
English: Prior to enrollment, patients had been using their current opioid for an average of 5 years.
Danish: Før patienterne indgik, havde de brugt deres aktuelle opioid i gennemsnitligt 5 år.
English: - if you have had a heart attack within the last 3 months or if you have other severe problems with your heart which cause daily symptoms
Danish: - hvis du har haft et hjerteanfald i løbet af de seneste 3 måneder, eller hvis du har andre alvorlige hjerteproblemer, som giver dig daglige symptomer.
English: Proportion of SBM Responders
Danish: Andel af SBM-respondere
English: This medicine is not for children or adolescents under the age of 18 years because the effects of the medicine in children and adolescents are not known.
Danish: Dette lægemiddel er ikke til børn eller unge under 18 år, da virkningen af lægemidlet hos børn og unge er ukendt.
English: Patients with OIC
Danish: Patienter med OIC
English: However if it is less than 12 hours until your next dose, skip the missed dose, and wait until it is time to take your next tablet.
Danish: Hvis der er mindre end 12 timer til din næste dosis, skal du dog springe den glemte dosis over og vente, til det er tid til at tage din næste tablet.
English: However, once you start taking the medicine, take it at around the same time each day.
Danish: Når du begynder at tage lægemidlet, skal du dog tage det på ca. samme tidspunkt hver dag.
English: The overall benefit risk for each patient should be taken into account.
Danish: Det samlede benefit/risk-forhold for hver patientskal tages i betragtning.
English: There is no clinically significant food effect.
Danish: Der er ingen klinisk signifikant fødevarepåvirkning.
English: The package leaflet is updated accordingly.
Danish: Indlægssedlen er blevet opdateret i overensstemmelse hermed.
English: Treatment difference
Danish: Behandlingsforskel
English: Pharmacokinetics in subpopulations
Danish: Farmakokinetik i subpopulationer
English: If you miss a tablet of Rizmoic, take it as soon as you remember.
Danish: Hvis du glemmer en Rizmoic tablet, skal du tage den, så snart du husker det.
English: (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (frequency cannot be estimated from the available data).
Danish: (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (hyppigheden kan ikke estimeres ud fra forhåndenværende data).
English: • hairs of the skin standing on end
Danish: • hår på huden, der rejser sig
English: Your doctor will advise you about whether you can use Rizmoic if you are pregnant.
Danish: Lægen vil rådgive dig, om hvorvidt du kan bruge Rizmoic, hvis du er gravid.
English: The studies included a 2-week Screening Period, 2-week Treatment Period and 4-week Follow-up Period.
Danish: Studierne omfattede en 2-ugers screeningsperiode, en 2-ugers behandlingsperiode og en 4-ugers opfølgningsperiode.
English: The symptoms resolved.
Danish: Symptomerne gik væk.
English: Kingsfordweg 151 1043GR Amsterdam The Netherlands
Danish: Kingsfordweg 151 1043GR Amsterdam Holland
English: The absolute bioavailability of naldemedine is estimated to be in the range of 20% to 56%.
Danish: Den absolutte biotilgængelighed af naldemedin estimeres til at være inden for intervallet fra 20 % til 56 %.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD-list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: The frequency categories are defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon
Danish: Hyppighedskategorierne er defineret ved hjælp af den følgende konvention: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig
English: Approximately 20% of the naldemedine dose is excreted unchanged in urine.
Danish: Ca. 20 % af naldemedindosen udskilles uændret i urinen.
English: The effects of the medicine in pregnant women are not known.
Danish: Virkningen af lægemidlet hos gravide kvinder er ukendt.
English: If you have these conditions and develop opioid withdrawal symptoms (see section 4) or if the opioid medicine no longer controls your pain, contact your doctor immediately.
Danish: Hvis du har disse sygdomme og udvikler opioide abstinenssymptomer (se punkt 4), eller hvis det opioide lægemiddel ikke længere kontrollerer dine smerter, skal du straks kontakte lægen.
English: From baseline to week 1**
Danish: Fra baseline til uge 1**
English: Unknown
Danish: Ikke kendt
English: ANNEX II A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BILAG II A. FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: These patients should be clinically monitored when taking Rizmoic.
Danish: Disse patienter skal overvåges klinisk, mens de tager Rizmoic.
English: You should not drink large amounts of grapefruit juice whilst taking Rizmoic.
Danish: Du må ikke drikke store mængder grapefrugtjuice, mens du tager Rizmoic.
English: Whilst the more limited information provided in these five cases is acknowledged the assessor considers that the potential role of Naldemedine cannot be excluded in all of these.
Danish: Selvom det erkendes, at den tilvejebragte information i disse 5 tilfælde er mere begrænset, mener den vurderingssagkyndige ikke, at naldemedins mulige rolle kan udelukkes i alle disse tilfælde.
English: It is unknown whether naldemedine/metabolites are excreted in human milk.
Danish: Det er ukendt, om naldemedin/metabolitter udskilles i human mælk.
English: Patients responding, n (%) p value* *Statistically significant: p-values based on the Chi-square test.
Danish: Patienter, der respondered e, n (%) p-værdi* *Statistisk signifikant: p-værdier baseret på Chi-square-testen.
English: You will be monitored for opioid withdrawal symptoms (see section 2, under ‘Warnings and Precautions', and section 4).
Danish: Du vil blive overvåget for opioide abstinenssymptomer (se punkt 2 under 'Advarsler og forsigtighedsregler' og punkt 4).
English: The effect on oestrous cycle is not considered clinically relevant at the proposed therapeutic dose.
Danish: Virkningen på østruscyklus anses ikke for at være klinisk relevant ved den foreslåede terapeutiske dosis.
English: The safety and efficacy of naldemedine in children and adolescents aged below 18 years have not yet been established.
Danish: Naldemedins sikkerhed og virkning hos børn og unge i alderen under 18 år er endnu ikke klarlagt.
English: None of the identified cases are without significant confounding factors and the difficulties in definitively determining causality are acknowledged.
Danish: Ingen af de identificerede tilfælde er uden betydelige samtidigt indvirkende faktorer, og det erkendes, at det er svært definitivt at bestemme kausaliteten.
English: The agreed update is aligned with the wording reflected in the product informations for methylnaltrexone and naloxegol.
Danish: Den aftalte opdatering er afstemt med ordlyden i produktinformationerne for methylnaltrexon og naloxegol.
English: Shionogi B.V. Tel/Tel./Teл./Tlf/Tél/Puh/Sími/Τηλ:
Danish: Tel/Tel./Teл./Tlf/Tél/Puh/Sími/Τηλ:
English: • You can take Rizmoic at any time of the day, with food or between meals.
Danish: • Du kan tage Rizmoic på et vilkårligt tidspunkt på dagen, sammen med mad eller mellem måltider.
English: • There is no need to alter the dose of your opioid medicine before starting Rizmoic.
Danish: • Der er ingen grund til at ændre dosis af dit opioide lægemiddel, før du starter med Rizmoic.
English: Opioid withdrawal syndrome typically develops within minutes to several days following administration of an opioid antagonist.
Danish: Opioidabstinenssyndrom udvikler sig typisk i løbet af minutter til flere dage efter administration af en opioidantagonist.
English: - if you suffer from symptoms of opioid withdrawal syndrome (see section 4 Possible side effects) which can develop within minutes to several days after taking a medicine such as Rizmoic.
Danish: - hvis du lider af symptomer på opioidabstinenssyndrom (se punkt 4 Bivirkninger), som kan udvikle sig i løbet af minutter til flere dage, efter der er taget et lægemiddel som Rizmoic.