FrancophonIA/ELRC3.0 huggingface dataset:
English: It is used in people who have recently been diagnosed and who have not been prescribed another medicine for their multiple myeloma before who are aged 65 years and over, or aged less than 65 years who cannot be treated with high dose chemotherapy, which can be very difficult for the body to handle.
Danish: Det anvendes til personer, som er blevet diagnosticeret for nyligt, og som ikke tidligere har fået ordineret andre lægemidler for myelomatose, som er 65 år og derover, eller under 65 år og som ikke kan behandles med højdosis kemoterapi, en behandling, som kan være meget svær at klare for kroppen.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppering fremstilles bivirkningerne efter aftagende alvorlighed.
English: The effect of thalidomide on thyroid function was assessed in both rats and dogs.
Danish: Thalidomids virkning på skjoldbruskkirtlens funktion blev vurderet hos både rotter og hunde.
English: Myocardial infarction (MI) has been reported in patients receiving thalidomide, particularly in those with known risk factors.
Danish: Myokardieinfarkt (MI) er blevet rapporteret hos patienter, der får thalidomid, især hos patienter med kendte risikofaktorer.
English: These patients either exhibited no symptoms or exhibited symptoms of drowsiness, irritability, “sickness,” and/or headache.
Danish: Disse patienter udviste enten ingen symptomer eller udviste symptomerne døsighed, irritabilitet, en ”utilpashed” og/eller hovedpine.
English: Prophylactic antithrombotic medicinal products, such as low molecular weight heparins or warfarin, should be recommended.
Danish: Forebyggende antitrombotiske lægemidler såsom lavmolekylært heparin eller warfarin anbefales.
English: • Implant
Danish: • Implantat
English: The controlled distribution system includes the use of a patient card and/or equivalent tool for prescribing and/or dispensing controls, and the collecting of detailed data relating to the indication in order to monitor closely the off-label use within the national territory.
Danish: Det kontrollerede distributionssystem omfatter brug af et patientkort og/eller tilsvarende værktøj til kontrol af ordination og/eller udlevering samt indsamling af detaljerede data i forbindelse med indikationen for at monitorere off-label-anvendelse nøje inden for det pågældende land.
English: Patients should be instructed to avoid situations where somnolence may be a problem and to seek medical advice before taking other medicinal products known to cause somnolence.
Danish: Patienterne bør instrueres i at undgå situationer, hvor døsighed kan være et problem, og søge lægens råd før indtagelse af andre lægemidler, der kan forårsage døsighed.
English: • The following information should also be provided in the appropriate educational brochure for patients: o Women of childbearing potential
Danish: • Følgende oplysninger bør også gives i den relevante oplysningsbrochure til patienter: o Kvinder i den fertile alder
English: • That he should not share the treatment with any other person
Danish: • At han ikke må dele behandlingen med nogen anden person
English: The mean elimination half-life of thalidomide in plasma following single oral doses between 50 mg and 400 mg was 5.5 to 7.3 hours.
Danish: Den gennemsnitlige halveringstid for thalidomid i plasma efter oral administration af doser på mellem 50 mg og 400 mg var 5,5 til 7,3 timer.
English: This decrease did not result in clinical signs.
Danish: Det nedsatte trombocyttal medførte ikke kliniske tegn.
English: For patients > 75 years of age, the thalidomide recommended starting dose is 100 mg per day.
Danish: Til patienter > 75 år er den anbefalede startdosis af thalidomid 100 mg dagligt.
English: Patients should be advised as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks (see section 4.7).
Danish: Patienterne bør oplyses om den mulige svækkelse af mentale og/eller fysiske evner, som kræves ved udførelsen af farlige opgaver (se pkt.
English: Amenorrhea during thalidomide therapy should be assumed to result from pregnancy, until it is medically confirmed that the patient is not pregnant.
Danish: Amenorré under behandling med thalidomid skal antages at skyldes graviditet, indtil det er bekræftet, at patienten ikke er gravid.
English: Prior to approval by the National Competent Authority and launch of the medicinal product, the MAH should ensure that the educational materials are provided to and reviewed by the national patients' organisations or if such an organisation does not exist or can not be involved, by a relevant patients group.
Danish: Før godkendelse hos de kompetente, nationale myndigheder og lancering af lægemidlet, skal indehaveren af markedsføringstilladelsen sikre, at undervisningsmaterialet udleveres til og gennemgås af de nationale patientorganisationer eller, hvis en sådan organisation ikke findes eller ikke kan involveres, af en relevant patientgruppe.
English: The following can be considered to be examples of effective methods of contraception:
Danish: Følgende er eksempler på sikker kontraception:
English: Previous history of thromboembolic events or concomitant administration of erythropoietic agents or other agents such as hormone replacement therapy, may also increase thromboembolic risk in these patients.
Danish: Tidligere tilfælde af tromboemboliske hændelser eller samtidig administration af erytropoietiske midler eller andre midler såsom hormonsubstitution kan også øge risikoen for tromboemboli hos disse patienter.
English: The majority of the reactions occurred within the first 2 months of therapy and resolved spontaneously without treatment after thalidomide discontinuation.
Danish: Størstedelen af reaktionerne fandt sted i løbet af de første 2 måneders behandling og forsvandt spontant uden behandling efter seponering af thalidomid.
English: Extremely intense and serious skin reactions.
Danish: Ekstremt kraftige og alvorlige hudreaktioner.
English: Patients should be evaluated for signs and symptoms of underlying cardiopulmonary disease prior to initiating and during thalidomide therapy.
Danish: Patienterne bør evalueres for tegn og symptomer på underliggende kardiopulmonal sygdom før påbegyndelse af og under behandling med thalidomid.
English: • Age  50 years and naturally amenorrhoeic for  1 year (Amenorrhoea following cancer therapy or during breast-feeding does not rule out childbearing potential).
Danish: • Alder  50 år og naturligt amenorrhoisk i  1 år (Amenorré som følge af cancerbehandling eller under amning udelukker ikke muligheden for at blive gravid).
English: Thalidomide is a powerful human teratogen, inducing a high frequency of severe and lifethreatening birth defects.
Danish: Thalidomid er et kraftigt humant teratogen, der inducerer en høj frekvens af alvorlige og livstruende fødselsdefekter.
English: A peri- and postnatal toxicity study performed in rabbits with thalidomide administered at doses up to 500 mg/kg/day resulted in abortions, increased stillbirths and decreased pup viability during lactation.
Danish: Et peri- og postnatal toksicitetsstudie udført på kaniner med thalidomid indgivet ved doser på op til 500 mg/kg/dag medførte aborter, forøget antal dødfødsler og reduceret levedygtighed af ungerne under amning.
English: • Premature ovarian failure confirmed by a specialist gynaecologist.
Danish: • Tidligt ovariesvigt bekræftet af speciallæge i gynækologi
English: Unchanged thalidomide was a minor component (< 3 % of the dose) in urine.
Danish: Uomdannet thalidomid udgør kun en mindre del af forbindelserne i urinen (< 3 % af dosis).
English: Ideally, pregnancy testing, issuing a prescription and dispensing should occur on the same day.
Danish: Ideelt set bør graviditetstest, ordination samt udlevering foretages samme dag.
English: • That she should not share the treatment with any other person
Danish: • At hun ikke må dele behandlingen med nogen anden person
English: On the basis of the scientific conclusions for thalidomide the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing thalidomide is unchanged subject to the proposed changes to the product information
Danish: På baggrund af de videnskabelige konklusioner for thalidomid er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder thalidomid, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: Multiple myeloma is a type of cancer which affects a certain type of white blood cell, called the plasma cell.
Danish: Myelomatose er en type kræft, der påvirker en gruppe af de hvide blodlegemer, som kaldes plasmaceller.
English: Grade 3 (interfering with activities of daily living)
Danish: Grad 3 (påvirker daglige aktiviteter)
English: Patients must follow the Thalidomide Celgene Pregnancy Prevention Programme.
Danish: Patienter skal følge Thalidomide Celgenes svangerskabsforebyggelsesprogram.
English: Peripheral neuropathy Dose modifications due to peripheral neuropathy are described in Table 2.
Danish: Perifer neuropati Dosisændringer pga. perifer neuropati er beskrevet i tabel 2.
English: Patients should be instructed never to give this medicinal product to another person and to return any unused capsules to their pharmacist at the end of treatment.
Danish: Patienterne skal instrueres i aldrig at videregive dette lægemiddel til andre personer og i at returnere ubenyttede kapsler til apoteket efter endt behandling.
English: Patients should be instructed not to drive cars, use machines or perform hazardous tasks while being treated with thalidomide if they feel tired, dizzy, sleepy or have blurred vison.
Danish: Patienterne bør instrueres i ikke at føre motorkøretøjer, betjene maskiner eller udføre farlige opgaver under behandlingen med thalidomid, hvis de føler sig trætte, svimle, døsige eller har sløret syn.
English: • Treatment initiation forms and/or equivalent tool
Danish: • Formularer til påbegyndelse af behandling og/eller tilsvarende værktøjer
English: Previously infected patients should be closely monitored for signs and symptoms of viral reactivation, including active HBV infection, throughout therapy.
Danish: Patienterne der tidligere er blevet inficeret bør monitoreres nøje for tegn og symptomer på viral reaktivering, herunder aktiv HBV-infektion, under hele behandlingen.
English: • You miss or think you have missed a period, or you have unusual menstrual bleeding, or suspect you are pregnant.
Danish: • Din menstruation udebliver, eller du mener, at en menstruation er udeblevet, eller du har usædvanlig blødning, eller du har mistanke om, at du er gravid
English: Details of the PPP should be agreed wth the National Competent Authorities in each Member State and put in place prior to the launch of the medicinal product.
Danish: Detaljerne i PSF skal aftales med de kompetente, nationale myndigheder i hvert medlemsland og være på plads før lancering af lægemidlet.
English: If you forget to take Thalidomide Celgene at your regular time and
Danish: Hvis du har glemt at tage Thalidomide Celgene til sædvanlig tid, og
English: The risk of venous thromboembolism continues for 4-6 weeks after discontinuing combined oral contraception.
Danish: Risikoen for venøs tromboemboli vedvarer i 4-6 uger efter ophør med orale kombinationspræparater.
English: Thalidomide Celgene contains an active substance called thalidomide.
Danish: Thalidomide Celgene indeholder et aktivt stof, som hedder thalidomid.
English: Patients should be monitored for syncope, bradycardia and atrioventricular block; dose reduction or discontinuation may be required.
Danish: Patienterne skal monitoreres for synkope, bradykardi og atrioventrikulært blok; dosisreduktion eller seponering kan være påkrævet.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER
English: When provided, antiovary antibodies were negative and prolactin level was within the normal range.
Danish: I de tilfælde hvor de forelå, var antiovarieantistoffer negative og prolaktinniveauet inden for normalområdet.
English: • Teratogenicity and the need to avoid foetal exposure
Danish: • Teratogenicitet og nødvendigheden af at undgå føtal eksponering
English: • if you are able to become pregnant, your doctor will record with each prescription that the necessary measures have been taken and will provide you with this confirmation.
Danish: • Hvis du kan blive gravid, vil lægen ved hver ordination registrere, at de nødvendige forholdsregler er taget, og du vil få udleveret denne bekræftelse.
English: Stop taking Thalidomide Celgene and see a doctor straight away if you notice the following serious side effects - you may need urgent medical treatment:
Danish: Hold straks op med at tage Thalidomide Celgene og kontakt omgående lægen, hvis du får nogen af følgende bivirkninger - du kan behøve akut lægebehandling:
English: However, combined hormonal contraceptives are not recommended due to the increased risk of venous thromboembolic disease.
Danish: Kombination med hormonale præventionsmidler frarådes imidlertid pga. den forhøjede risiko for venøs tromboemboli.
English: This may be due to nerve damage (called ‘peripheral neuropathy'), which is a very common side effect.
Danish: Dette kan være på grund af nerveskader (kaldet ”perifer neuropati”), hvilket er en meget almindelig bivirkning.
English: Caution should be used when thalidomide is given in combination with medicinal products that cause drowsiness.
Danish: Forsigtighed bør udvises, når thalidomid gives i kombination med lægemidler, der kan forårsage døsighed.
English: Incidence of neuropathy events leading to discontinuation, dose reduction or interruption increases with cumulative dose and duration of therapy.
Danish: Forekomsten af neuropatiske hændelser, der fører til afbrydelse, dosisreduktion eller seponering af behandlingen øges med den kumulerede dosis og behandlingens varighed.
English: Patients should be advised of the signs and symptoms of these reactions by their prescribers and should be told to seek medical attention immediately if they develop these symptoms.
Danish: Den ordinerende læge skal informere patienterne om tegn og symptomer på disse reaktioner, og patienterne skal informeres om straks at søge lægehjælp, hvis de udvikler disse symptomer.
English: • if you are allergic to thalidomide or any of the other ingredients of this medicine listed in section 6 “Contents of the pack and other information”.
Danish: • Hvis du er allergisk over for thalidomid eller et af de øvrige indholdsstoffer i Thalidomide Celgene (angivet i punkt 6 ”Pakningsstørrelser og yderligere oplysninger”).
English: • by stopping the cancer cells developing
Danish: • ved at stoppe udviklingen af kræftcellerne
English: Patients should be instructed to seek medical care if they develop symptoms such as shortness of breath, chest pain, arm or leg swelling.
Danish: Patienterne skal instrueres i at søge lægehjælp, hvis de udvikler symptomer såsom åndenød, smerter i brystet, hævelse af arme eller ben.
English: The spectrum of activity of thalidomide is not fully characterised.
Danish: Thalidomids aktivitetsspektrum er ikke fuldt ud beskrevet.
English: Non-enzymatic hydrolysis of thalidomide, being the primary clearance mechanism, suggests that the potential for drug-drug interactions with thalidomide is low.
Danish: Non-enzymatisk hydrolyse af thalidomid, som er den primære clearance-mekanisme, tyder på, at potentialet for lægemiddel-lægemiddelinteraktioner med thalidomid er lille.
English: Thalidomide shows immunomodulatory, anti-inflammatory and potential anti-neoplastic activities.
Danish: Thalidomid udviser immunmodulerende, antiinflammatorisk og potentielt antineoplastisk aktivitet.
English: There is no relevant use of Thalidomide Celgene in the paediatric population in the indication of multiple myeloma.
Danish: Det er ikke relevant at anvende Thalidomide Celgene hos den pædiatriske population til indikationen myelomatose.
English: Thalidomide is present in the semen of male patients at levels similar to plasma concentrations (see section 4.4).
Danish: Thalidomid er til stede i sæd hos mandlige patienter i mængder, der svarer til plasmakoncentrationen (se pkt.
English: Patients and physicians are advised to be observant for the signs and symptoms of thromboembolism.
Danish: Patienter og læger opfordres til at være opmærksomme på tegn og symptomer på tromboemboli.
English: If the patient experiences any thromboembolic events, treatment must be discontinued and standard anticoagulation therapy started.
Danish: Hvis patienten oplever tromboemboliske hændelser, skal behandlingen standses, og standard antikoagulerende behandling påbegyndes.
English: Cases of pulmonary hypertension, some fatal, have been reported in patients treated with thalidomide.
Danish: Der er rapporteret tilfælde af pulmonal hypertension, nogle dødelige, hos patienter behandlet med thalidomid.
English: Bradycardic effect
Danish: Bradykardiel virkning
English: The capsules are supplied in a wallet card containing 28 capsules (2 blisters of 14 capsules each).
Danish: Kapslerne leveres i en yderkarton, der indeholder 28 kapsler (2 blisterkort med 14 kapsler).
English: The MAH should agree on the implementation of the patient card system in each Member State.
Danish: Indehaveren af markedsføringstilladelsen skal indvillige i at implementere et patientkortsystem i hvert medlemsland.
English: You will have been given an educational brochure for patient by your doctor.
Danish: Din læge har givet dig en oplysningsbrochure til patienter.
English: Despite the small number of cases of DRESS, considering that this adverse reaction is a known risk listed in the EU SmPC of the structural analogues lenalidomide and pomalidomide and taking into consideration that other severe cutaneous adverse reactions (SCARs) are already listed in the thalidomide EU SmPC (SJS and TEN), the PRAC concluded that a causal relationship between thalidomide and DRESS cannot be excluded.
Danish: Trods det lille antal tilfælde af DRESS men i betragtning af, at denne bivirkning er en kendt risiko anført i det europæiske produktresumé for de strukturelle analoger lenalidomid og pomalidomid, samt under hensyntagen til, at andre svære kutane bivirkninger (SJS og TEN) allerede er anført i det europæiske produktresumé for thalidomid, konkluderede PRAC, at et kausalt forhold mellem thalidomid og DRESS ikke kan udelukkes.
English: • The collection of detailed data to understand demographics of target population, indication and number of women of child bearing potential in order to monitor closely the off-label use within national territory.
Danish: • Indsamling af detaljerede oplysninger for at forstå målpopulationens demografi, indikation og antal kvinder i den fertile alder til nøje overvågning af off-label-brug inden for de nationale grænser
English: What is multiple myeloma
Danish: Hvad er myelomatose:
English: Pack sizes: 28 capsules (two blisters) in a wallet card.
Danish: Pakningsstørrelse: 28 kapsler (2 blisterkort) i en yderkarton.
English: These may be symptoms of a heart attack/myocardial infarction (which may be due to blood clots in the arteries of your heart).
Danish: Dette kan være symptomer på hjerteanfald/myokardieinfarkt (hvilket kan skyldes blodpropper i arterierne i dit hjerte).
English: • Feeling weak, faint or unsteady, lack of energy or strength, low blood pressure.
Danish: • Svækkelse, mathed eller vaklen, manglende energi eller styrke, lavt blodtryk.
English: For women of childbearing potential, thalidomide is contraindicated unless all of the following conditions are met:
Danish: For kvinder i den fertile alder er thalidomid kontraindiceret, medmindre alle efterfølgende betingelser er opfyldt:
English: Some of the cases of herpes zoster reactivation resulted in disseminated herpes zoster, requiring a temporary hold of the treatment with thalidomide and adequate antiviral treatment.
Danish: Nogle af tilfældene af reaktivering af herpes zoster resulterede i dissemineret herpes zoster, som krævede et midlertidigt stop af behandlingen med thalidomid og passende antiviral behandling.
English: o The capsule shell contains gelatin and titanium dioxide (E171).
Danish: o Kapselovertrækket indeholder gelatine og titandioxid (E171).
English: The median overall survival (OS) was 51.6 ± 4.5 and 33.2 ± 3.2 months in the MPT and MP groups, respectively (97.5 % CI 0.42 to 0.84).
Danish: Den mediane samlede overlevelse (OS) var 51,5 ± 4,5 og 33,2 ± 3,2 måneder i henholdsvis MPT- og MP- gruppenrne (97,5 % KI 0,42 - 0,84).
English: As thalidomide is found in semen, as a precaution all male patients taking thalidomide must meet the following conditions:
Danish: Da thalidomid kan findes i sæd, skal alle mandlige patienter, der tager thalidomid, som forholdsregel opfylde følgende betingelser:
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA PC:
English: Allergic reactions and severe skin reactions
Danish: Allergiske reaktioner og svære hudreaktioner
English: However, this has not formally been studied in patients with impaired renal or hepatic function; therefore patients with severe renal or hepatic impairment should be carefully monitored for any adverse events.
Danish: Dette er dog ikke blevet formelt undersøgt hos patienter med nedsat nyre- eller leverfunktion, og derfor bør patienter med svært nedsat nyre- eller leverfunktion monitoreres omhyggeligt for alle bivirkninger.
English: Thalidomide Celgene as per the recommended posology has minor or moderate influence on the ability to drive and use machines.
Danish: Thalidomid Celgene i den anbefalede dosering påvirker i mindre eller moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: Thalidomide interruption or discontinuation should be considered for Grade 2-3 skin rash.
Danish: Det bør overvejes at afbryde eller seponere thalidomid ved grad 2-3 hududslæt.
English: Syncope, bradycardia and atrioventricular block
Danish: Synkope, bradykardi og atrioventrikulært blok
English: Animal studies have demonstrated differences in species susceptibility to the teratogenic effects of thalidomide.
Danish: Dyrestudier har vist forskelle i arternes følsomhed overfor thalidomids teratogene virkninger.
English: To remove the capsule from the blister, press only one end of the capsule out to push it through the foil.
Danish: Tag kapslen ud af blisteren ved kun at trykke på den ene ende af kapslen, når den presses gennem folien.
English: Most patients taking thalidomide can be expected to experience adverse reactions.
Danish: De fleste patienter, der tager thalidomid, kan forvente at opleve bivirkninger.
English: There is no specific antidote for a thalidomide overdose.
Danish: Der er ingen specifik antidot ved thalidomidoverdosering.
English: Pulmonary hypertension
Danish: Pulmonal hypertension
English: The MAH shall implement a Pregnancy Prevention Programme (PPP) in each Member State.
Danish: Indehaveren af markedsføringstilladelsen skal implementere et program til svangerskabsforebyggelse (PSF) i hvert medlemsland.
English: Thalidomide does not interact with hormonal contraceptives.
Danish: Thalidomid interagerer ikke med hormonale svangerskabsforebyggende midler.
English: • She understands the need to commence the treatment as soon as thalidomide is dispensed following a negative pregnancy test
Danish: • Hun forstår nødvendigheden af påbegyndelse af behandling, så snart som thalidomid ordineres efter en negativ graviditetstest.
English: If your partner becomes pregnant whilst you are taking thalidomide, you should inform your doctor immediately.
Danish: Hvis din partner bliver gravid, mens du tager thalidomid, skal du straks underrette din læge.
English: Signs and symptoms included visual disturbance, headache, seizures and altered mental status, with or without associated hypertension.
Danish: Tegn og symptomer inkluderede visuelle forstyrrelser, hovedpine, krampeanfald og ændret mentalstatus, med eller uden associeret hypertension.
English: Very common (may affect more than 1 in 10 people)
Danish: Meget almindelige (kan ramme flere end 1 ud af 10 personer)