FrancophonIA/ELRC3.0 huggingface dataset:
English: • These defects can include shortened arms or legs, malformed hands or feet, eye or ear defects,
Danish: • Disse defekter kan omfatte kortere arme og ben, misdannede hænder eller fødder, misdannede øjne eller ører samt problemer med de indre organer.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking this medicine in the following situations:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager dette lægemiddel i følgende situationer:
English: Thalidomide Celgene should be taken as a single dose at bedtime, to reduce the impact of somnolence.
Danish: Thalidomide Celgene skal tages som engangsdosis ved sengetid for at reducere den døsige virkning.
English: The majority of the reported cases had recognized risk factors for PRES/RPLS, including hypertension, renal impairment and concomitant use of high dose corticosteroids and/or chemotherapy.
Danish: Hovedparten af de rapporterede tilfælde havde erkendte risikofaktorer for PRES/RPLS, herunder hypertension, nedsat nyrefunktion og samtidig brug af højdosis kortikosteroider og/eller kemoterapi.
English: • Algorithm for Pregnancy Prevention Plan implementation o This shall assist with patient categorisation, and determination of required pregnancy prevention and testing measures.
Danish: • Algoritme til implementering af planen for svangerskabsforebyggelse o Dette skal hjælpe med kategorisering af patienter og bestemmelse af de fornødne forholdsregler vedrørende svangerskabsforebyggelse og graviditetstests.
English: Pups from mothers treated with thalidomide had increased abortions, reduced body weight gain, alterations in learning and memory, decreased fertility, and reduced pregnancy index.
Danish: Unger fra hunner behandlet med thalidomid havde forhøjet abortfrekvens, nedsat forøgelse af kropsvægt, ændringer i indlæring og hukommelse, nedsat fertilitet og reduceret graviditetsindeks.
English: If you are pregnant, you must not take Thalidomide Celgene.
Danish: Hvis du er gravid, må du ikke tage Thalidomide Celgene.
English: For all patients Talk to your doctor before taking Thalidomide Celgene if
Danish: Til alle patienter Kontakt lægen, før du tager Thalidomide Celgene, hvis:
English: Additional adverse reactions from post-marketing experience with thalidomide and not seen in the pivotal study include febrile neutropenia and pancytopenia.
Danish: Yderligere bivirkninger fra erfaring med thalidomid efter markedsføring, som ikke blev set i det pivotale studie, er febril neutropeni og pancytopeni.
English: Modification of dose and regimen
Danish: Ændring af dosering og behandling
English: In documented case reports with hormone evaluation, the event of amenorrhoea was associated with decreased estradiol levels and elevated FSH/LH levels.
Danish: I de dokumenterede sagsrapporter med hormonevaluering var hændelsen amenorré forbundet med nedsatte østrogenniveauer og forhøjede FSH/LH-niveauer.
English: • Pregnancy testing requirements ▪ Advice on suitable tests ▪ Frequency (before commencing, monthly during treatment and after finishing treatment)
Danish: • Krav til graviditetstests Råd om passende tests Frekvens (før påbegyndelse af og månedligt under behandlingen samt efter behandlingsseponering)
English: In a one-year dog study, enlarged and/or blue discoloration of mammary glands and prolonged estrus were observed in females at exposures equal to 1.8 or greater than 3.6-fold the human exposure, respectively.
Danish: I et etårigt hundestudie blev der observeret forstørrelse og/eller blålig misfarvning af mælkekirtlerne og forlænget østrus hos tæver ved eksponering på henholdsvis 1,8 gange og større end 3,6 gange human eksponering.
English: • Numbness, tingling, abnormal coordination or pain in your hands and feet.
Danish: • Følelsesløshed, snurren, abnorm koordinationsevne eller smerter i hænder og fødder.
English: Thromboprophylaxis should be administered for at least the first 5 months of treatment especially in patients with additional thrombotic risk factors.
Danish: Der bør som minimum administreres tromboseprofylakse de første 5 måneder af behandlingen, specielt hos patienter med yderligere risikofaktorer for trombose.
English: Thalidomide Celgene has not formally been studied in patients with impaired renal or hepatic function.
Danish: Thalidomide Celgene er ikke formelt blevet undersøgt hos patienter med nedsat nyre- eller leverfunktion.
English: In order to assist patients in avoiding foetal exposure to thalidomide, the Marketing Authorisation Holder will provide educational material to healthcare professionals to reinforce the warnings about the teratogenicity of thalidomide, to provide advice on contraception before treatment is started and provides guidance on the need for pregnancy testing.
Danish: Med henblik på at hjælpe patienter med at undgå føtal eksponering for thalidomid vil indehaveren af markedsføringstilladelsen udlevere undervisningsmateriale til sundhedspersonalet for at understrege advarslerne om thalidomids teratogene virkninger, for at vejlede omkring prævention før behandlingen påbegyndes og give retningslinjer mht. nødvendigheden af graviditetstests.
English: Cases of viral reactivation have been reported in patients receiving thalidomide, including serious cases of herpes zoster or hepatitis B virus (HBV) reactivation.
Danish: Der er rapporteret tilfælde af viral reaktivering hos patienter, der har fået thalidomid, herunder alvorlige tilfælde af reaktivering af herpes zoster- eller hepatitis B-virus (HBV).
English: • are used for heart problems and complications (such as digoxin), or for thinning the blood (such as warfarin).
Danish: • Anvendes til hjerteproblemer og hjertekomplikationer (såsom digoxin) eller til blodfortynding
English: In addition, single dose administration of 0.5 mg digoxin had no apparent effect on thalidomide pharmacokinetics.
Danish: Desuden havde en enkelt dosis 0,5 mg digoxin ingen tydelig virkning på farmakokinetikken for thalidomid.
English: The distribution of thalidomide is not influenced by age, gender, renal function and blood chemistry variables, to any significant level.
Danish: Fordelingen af thalidomid er ikke signifikant påvirket af alder, køn, nyrefunktion og blodkemivariable.
English: Melphalan and prednisone were dosed at 0.25 mg/kg/day and 2 mg/kg/day respectively on days 1 to 4 of each 6 weeks cycle.
Danish: Melphalan og prednison blev givet i doser på henholdsvis 0,25 mg/kg/dag og 2 mg/kg/dag på dag 1 til 4 af hver 6-ugerscyklus.
English: Thalidomide is a poor substrate for cytochrome P450 isoenzymes and therefore clinically important interactions with medicinal products that are inhibitors and/or inducers of this enzyme system are unlikely.
Danish: Thalidomid er et dårligt substrat for CYP-isoenzymer, og derfor er klinisk vigtige interaktioner med lægemidler, der inhiberer og/eller inducerer dette enzymsystem, usandsynlige.
English: • Sudden pain in your chest or difficulty in breathing.
Danish: • Pludselige smerter i brystet eller åndenød.
English: The adverse reaction profile reported in patients > 75 years of age treated with thalidomide 100 mg once daily was similar to the adverse reaction profile observed in patients ≤ 75 years of age treated with thalidomide 200 mg once daily (see Table 3).
Danish: Den bivirkningsprofil, som blev rapporteret hos patienter > 75 år, der blev behandlet med 100 mg thalidomid en gang dagligt, svarede til den bivirkningsprofil, der blev set hos patienter ≤ 75 år, der blev behandlet med 200 mg thalidomid en gang dagligt (se tabel 3).
English: • you have experienced or have existing neuropathy i.e. nerve damage causing tingling, abnormal co-ordination or pain in your hands or feet (see also section 4 “Possible side effects”).
Danish: • Du har oplevet eller aktuelt har neuropati, dvs. nerveskader, der medfører snurren, unormal koordination eller smerter i hænder og fødder (se også punkt 4 ”Bivirkninger”).
English: No mutagenic or genotoxic effect has been revealed when thalidomide was assayed in a standard battery of genotoxicity tests.
Danish: Der blev ikke påvist mutagene eller genotoksiske virkninger ved analyse af thalidomid med et standardpanel af genotoksiske tests.
English: Pregnancy testing
Danish: Graviditetstestning
English: Teratogenic effects
Danish: Teratogene virkninger
English: Medically supervised pregnancy tests with a minimum sensitivity of 25 mIU/ml must be performed for women of childbearing potential as outlined below.
Danish: Der skal foretages lægeligt overvågede graviditetstests med en følsomhed på mindst 25 mIE/ml på kvinder i den fertile alder som angivet herunder.
English: Pneumonia
Danish: Pneumoni
English: The MAH shall notify the EMA and the appropriate national patients and victims representatives of the proposed launch date before launch in each Member State.
Danish: Indehaveren af markedsføringstilladelsen skal underrette EMA og de relevante repræsentanter for patienter og ofre i det pågældende land om den foreslåede lanceringsdato forud for lanceringen i hver medlemsstat.
English: • Safety advice relevant to all patients o Description and management of ischaemic heart disease (including myocardial infarction) o Disposal of unwanted medicinal product o Not to donate blood during treatment (including during dose interruptions) and for at least 7 days following discontinuation of thalidomide
Danish: • Sikkerhedsrådgivning, der er relevant for alle patienter o Beskrivelse og håndtering af iskæmisk hjertesygdom (herunder myokardieinfarkt) o Bortskaffelse af uønsket lægemiddel o Ikke at donere blod under behandlingen (herunder ved pausering af behandlingen) og i mindst 7 dage efter thalidomidbehandlingen afsluttes
English: The prescriber must inform male and female patients about the expected teratogenic risk and the strict pregnancy prevention measures as specified in the Pregnancy Prevention Programme and provide patients with appropriate educational brochure for patients, patient card and/or equivalent tool in accordance to the national implemented patient card system.
Danish: Den ordinerende læge skal informere mandlige og kvindelige patienter om den forventede teratogene risiko og de strenge svangerskabsforebyggende foranstaltninger, som er specificeret i svangerskabsforebyggelsesprogrammet, og uddele passende patientuddannelsesmateriale, patientkort og/eller tilsvarende værktøj til patienterne i overensstemmelse med det nationalt implementerede patientkortsystem.
English: A female patient or a female partner of a male patient is considered to have childbearing potential unless she meets at least one of the following criteria:
Danish: Kriterier for kvinder, som ikke er i den fertile alder En kvindelig patient eller en kvindelig partner til en mandlig patient anses for at være i den fertile alder, medmindre hun opfylder et af følgende kriterier:
English: Dose delay, reduction or discontinuation, dependent upon the NCI CTC (National Cancer Institute Common Toxicity Criteria) grade, may be necessary.
Danish: Dosisudsættelse, dosisreduktion eller seponering kan være nødvendig afhængigt af toksicitetsgraden (NCI CTC National Cancer Institute Common Toxicity Criteria).
English: Do not use this medicine after the expiry date which is stated on the wallet card and the blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på emballagen og blisterkortet efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: An increased incidence of second primary malignancies (SPM) has also been observed in patients with newly diagnosed MM receiving lenalidomide.
Danish: En hyppigere forekomst af anden primær malignitet (second primary malignancies - SPM) er også blevet observeret hos patienter med nydiagnosticeret MM, der fik lenalidomid.
English: • you have or have had injury to the liver (hepatic disorders) including abnormal liver test results.
Danish: • Du har eller har haft leverskader (hepatiske sygdomme), herunder unormale resultater af leverprøver.
English: • Bleeding or bruising in the absence of injury.
Danish: • Blødning eller blå mærker uden at der har været skader.
English: Patients involved should be preferably naïve to the history of thalidomide.
Danish: Involverede patienter må helst ikke have kendskab til thalidomids historie.
English: Pulmonary embolism*, Interstitial lung disease, Bronchopneumopathy, Dyspnea
Danish: Lungeemboli*, interstitial lungesygdom, bronkopneumopati, dyspnø
English: In addition to thalidomide, hydrolytic products N-(o-carboxybenzoyl) glutarimide and phthaloyl isoglutamine formed via non-enzymatic processes are also present in plasma and in majority in urine.
Danish: Ud over thalidomid findes der hydrolyseprodukter, N-(o-karboxybenzoyl)-glutarimid og ftaloylisoglutamin dannet via nonenzymatiske processer, i plasma og specielthovedsageligt i urinen.
English: The initial dose of melphalan is reduced for elderly > 75 years of age considering baseline bone marrow reserve and renal function.
Danish: Startdosis af melphalan nedsættes til ældre > 75 år under hensyntagen til knoglemarvsreserve og nyrefunktion ved baseline.
English: ANNEX III
Danish: BILAG IV
English: Cardiac failure, Bradycardia
Danish: Hjertesvigt, bradykardi
English: In 10 healthy women, the pharmacokinetic profiles of norethindrone and ethinyl estradiol following administration of a single dose containing 1.0 mg of norethindrone acetate and 0.75 mg of ethinyl estradiol were studied.
Danish: Hos 10 raske kvinder blev de farmakokinetiske profiler for norethindron og ethinylestradiol undersøgt efter indtagelse af en enkelt dosis, der indeholdt 1,0 mg norethinronacetat og 0,75 mg ethinylestradiol.
English: The patient should continue anticoagulation therapy during the course of thalidomide treatment.
Danish: Patienten skal fortsætte med den antikoagulerende behandling under thalidomidbehandlingen.
English: • by stopping blood vessels growing in the cancer
Danish: • ved at stoppe blodkarrenes vækst i kræften
English: • Ovulation inhibitory progesterone-only pills (i.e. desogestrel)
Danish: • Ovulationshæmmende progesteronpiller (dvs. desogesterel)
English: Patients with severe organ impairment should be carefully monitored for adverse reactions.
Danish: Patienter med alvorlig organsvækkelse skal overvåges nøje for bivirkninger.
English: It may not go away, or may go away slowly.
Danish: Det er muligt, det går langsomt væk, men det kan også være vedvarende.
English: • A slow heart rate, heart failure.
Danish: • Langsomme hjerteslag (puls), hjertesvigt.
English: • Depression, confusion, mood changes, anxiety.
Danish: • Depression, forvirring, humørsvingninger, angst.
English: • Pain or swelling in your legs, especially in your lower leg or calves.
Danish: • Smerter eller hævelser i benene, særligt i underbenene eller læggene.
English: • you have high blood pressure in the arteries of the lungs (see also section 4 “Possible side effects”).
Danish: • Du har højt blodtryk i lungernes arterier (se også punkt 4 ”Bivirkninger”).
English: • Pain in the upper abdomen and/or back, which may be severe and which remains for a few days, possibly accompanied by nausea, vomiting, fever and a rapid pulse - these symptoms may be due to the inflammation of the pancreas (pancreatitis).
Danish: • Smerter i den øvre del af maven og/eller ryggen, som kan være svære og kan vare ved i et par dage, muligvis ledsaget af kvalme, opkastning, feber og hurtig puls - disse symptomer kan skyldes betændelse i bugspytkirtlen (pankreatitis).
English: The recommended dose is 200 mg (4 x 50 mg capsules) a day for adults aged 75 years and under or 100 mg (2 x 50 mg capsules) a day for adults aged over 75 years.
Danish: Den anbefalede dosis er 200 mg (4 x 50 mg kapsler) hver dag til voksne på 75 år og derunder og 100 mg (2 x 50 mg kapsler) til voksne over 75 år.
English: Do not breastfeed when taking Thalidomide Celgene as it is not known if thalidomide is passed into human breast milk.
Danish: Du må ikke amme, når du tager Thalidomide Celgene, da det er ukendt, om thalidomid udskilles i mælken hos mennesker.
English: Thalidomide may cause fatigue (very common), dizziness (very common), somnolence (very common) and blurred vision (common) (see section 4.8).
Danish: Thalidomid kan imidlertid medføre træthed (meget almindelig), svimmelhed (meget almindelig), døsighed (meget almindelig) og sløret syn (almindelig) (se pkt.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: • you have experienced fever, chills and severe shaking, and possibly complicated by low blood pressure and confusion (these may be symptoms of severe infections).
Danish: • Du har oplevet feber, kulderystelser og svære rystelser, muligvis kompliceret af lavt blodtryk og forvirring (dette kan være symptomer på svære infektioner).
English: Dispensing of thalidomide should occur within a maximum of 7 days of the prescription.
Danish: Udlevering af thalidomid bør ske højst 7 dage efter ordination.
English: These complications are caused by the break-down products of dying cancer cells and may include the following: changes to blood chemistry; high potassium, phosphorus, uric acid, and low calcium consequently leading to changes in kidney function, heart beat, seizures, and sometimes death.
Danish: Disse komplikationer skyldes nedbrydningsprodukter fra døende kræftceller og kan omfatte følgende: ændringer i blodkemi, højt niveau af kalium, fosfor og urinsyre og lavt niveau af calcium og som følge heraf ændringer i nyrefunktion, hjerteslag, krampeanfald og til tider død.
English: Animal studies have shown excretion of thalidomide in breast milk.
Danish: Dyrestudier har påvist udskillelse af thalidomid i mælk.
English: Your doctor should evaluate if you develop additional types of haematological malignancies (called acute myeloid leukaemia and myelodysplastic syndromes) during your treatment with Thalidomide Celgene (see also section 4 “Possible side effects”).
Danish: Lægen skal vurdere, om du udvikler yderligere typer ondartede blodsygdomme (kaldet akut myeloid leukæmi og myelodysplastiske syndromer) under din behandling med Thalidomid Celgene (se også punkt 4 ”Bivirkninger”).
English: Venous and arterial thromboembolic events
Danish: Venøse og arterielle tromboemboliske hændelser
English: • Sleepiness, feeling tired.
Danish: • Døsighed, træthed.
English: Once the patient has been stabilised on the anticoagulation treatment and any complications of the thromboembolic event have been managed, the thalidomide treatment may be restarted at the original dose dependent upon a benefit-risk assessment.
Danish: Så snart patienten er stabiliseret med den antikoagulerende behandling, og passende foranstaltninger er truffet vedrørende eventuelle komplikationer af den tromboemboliske hændelse, kan thalidomidbehandlingen genoptages med den oprindelige dosis, såfremt dette understøttes af en vurdering af fordele og risici.
English: Table 2: Recommended dose modifications for thalidomide -related neuropathy in first line treatment of multiple myeloma
Danish: Tabel 2: Anbefalede dosisændringer for thalidomid-relateret neuropati under førstevalgsbehandling af myelomatose
English: • You must use one effective method of contraception: o for at least 4 weeks before starting treatment o during treatment o until at least 4 weeks after stopping treatment Your doctor will tell you what method of contraception to use.
Danish: • Du skal benytte mindst én effektiv præventionsmetode: o i mindst 4 uger før behandlingen påbegyndes o under behandlingen o indtil mindst 4 uger efter at behandlingen er ophørt Din læge vil fortælle dig, hvilke præventionsmetoder du kan benytte.
English: The maximum daily melphalan dose is 20 mg in patients > 75 years of age (see Table 1).
Danish: Den maksimale daglige melphalandosis er 20 mg til patienter > 75 år (se tabel 1).
English: • Tubal sterilisation
Danish: • Sterilisation ved lukning af tubae
English: Patients with known risk factors for MI, including prior thrombosis, should be closely monitored and action should be taken to try to minimise all modifiable risk factors (e.g. smoking, hypertension, and hyperlipidaemia).
Danish: Patienter med kendte risikofaktorer for MI, herunder trombose i anamnesen, skal overvåges nøje, og alle risikofaktorer, der kan påvirkes (f.eks. rygning, hypertension og hyperlipidæmi), skal søges minimeret.
English: Follow-up and end of treatment
Danish: Follow-up og afslutning af behandling
English: • She understands the need and accepts to undergo pregnancy testing every 4 weeks except in case of confirmed tubal sterilisation
Danish: • Hun forstår dette behov og accepterer, at der skal foretages graviditetstest hver 4. uge med undtagelse af tilfælde med bekræftet sterilisation ved lukning af tubae.
English: • you have had an allergic reaction whilst taking Thalidomide Celgene such as rash, itching, swelling, dizziness or trouble breathing.
Danish: • Du har haft en allergisk reaktion, mens du har taget Thalidomid Celgene, såsom udslæt, kløe, hævelser, svimmelhed eller vejrtrækningsbesvær.
English: The benefit achieved with thalidomide and the risk of AML and MDS must be taken into account before initiating treatment with thalidomide in combination with melphalan and prednisone.
Danish: Fordelen, der kan opnås med thalidomid, og risikoen for AML og MDS skal overvejes, før behandling med thalidomid i kombination med melphalan og prednison indledes.
English: Hepatic disorders, mainly abnormal liver test results, were reported.
Danish: Leversygdomme, overvejende unormale leverfunktionstests, er blevet rapporteret.
English: Deep vein thrombosis*
Danish: Dyb venetrombose*
English: During the treatment with Thalidomide Celgene you have an increased risk of developing blood clots in the veins and arteries (see also section 4 “Possible side effects”).
Danish: Under behandlingen med Thalidomide Celgene har du en øget risiko for at udvikle blodpropper i blodkarrene (se også punkt 4 ”Bivirkninger”).
English: Educational Healthcare Professional's Kit The Educational Healthcare Professional's Kit shall contain the following elements:
Danish: Undervisningsmateriale til sundhedspersonale Undervisningsmaterialet til sundhedspersonale skal indeholde følgende elementer:
English: In 18 healthy male volunteers, multiple dose administration of 200 mg thalidomide had no apparent effect on the single dose pharmacokinetics of digoxin.
Danish: Hos 18 raske mandlige personer havde flere doser 200 mg thalidomid ingen tydelig virkning på farmakokinetikken for en enkelt dosis digoxin.
English: Table 1: Starting doses for thalidomide in combination with melphalan and prednisone Age (years)
Danish: Tabel 1: Startdoser for thalidomid i kombination med melphalan og prednison Alder (år)
English: Dispensing of thalidomide to women of childbearing potential should occur within 7 days of the prescription and following a medically supervised negative pregnancy test result.
Danish: Udlevering af thalidomid til kvinder i den fertile alder skal ske inden for 7 dage efter ordinationen og efter en medicinsk monitoreret graviditetstest med negativt udfald.
English: Allergic reactions (hypersensitivity, angioedema, urticaria)
Danish: Allergiske reaktioner (overfølsomhed, angioødem, urticaria) †
English: It is unknown whether thalidomide is excreted in human breast milk.
Danish: Det er ukendt, om thalidomid udskilles i human mælk.
English: Peripheral neuropathy is a very common, potentially severe, adverse reaction of treatment with thalidomide that may result in irreversible damage (see section 4.4).
Danish: Perifer neuropati er en meget almindelig, potentielt alvorlig bivirkning ved behandling med thalidomid, som kan medføre irreversible skader (se pkt.
English: • Pregnancy initial and outcome reporting forms
Danish: • Formularer til første indberetning og udfald af graviditet
English: The MAH should also agree with each Member State prior to the launch of the product:
Danish: Indehaveren af markedsføringstilladelsen skal også før lancering af produktet aftale følgende med medlemsstaterne:
English: • The need to avoid foetal exposure
Danish: • Nødvendigheden af at undgå føtal eksponering