FrancophonIA/ELRC3.0 huggingface dataset:
English: Studies conducted in healthy subjects and patients with multiple myeloma suggest that thalidomide is not influenced to any significant extent by renal or hepatic function (see section 5.2).
Danish: Studier hos raske personer og patienter med myelomatose tyder på, at thalidomid ikke påvirkes i nogen betydelig grad af nedsat nyre- eller leverfunktion (se pkt.
English: Toxic skin eruption, Rash, Dry skin
Danish: Toksisk hududslæt, udslæt, tør hud
English: • That if his partner becomes pregnant he should inform his treating doctor immediately and always use a condom during intercourse
Danish: • At han, hvis hans partner bliver gravid, skal underrette sin behandlende læge med det samme og altid bruge kondom under samleje
English: • All treatment initiation forms and/or equivalent tool should contain the following elements: o Teratogenicity warning o Patients receive appropriate counselling prior to treatment initiation o Date of counselling o Affirmation of patient understanding regarding the risk of thalidomide and the PPP measures o Patient details, signature and date o Prescriber name, signature and date o Aim of this document i.e. as stated in the PPP: “The aim of the treatment initiation form is to protect patients and any possible foetuses by ensuring that patients are fully informed of and understand the risk of teratogenicity and other adverse reactions associated with the use of thalidomide.
Danish: • Alle formularer til påbegyndelse af behandling og/eller tilsvarende værktøjer bør indeholde følgende elementer: o Advarsel om teratogenicitet o Patienterne modtager relevant rådgivning før påbegyndelse af behandling o Dato for rådgivning o Bekræftelse af patientens forståelse af risikoen forbundet med thalidomid og forholdsreglerne i svangerskabsforebyggelsesprogrammet o Patientoplysninger, underskrift og dato o Ordinerende læge, dennes underskrift samt dato o Hensigten med dette dokument, dvs. som formuleret i svangerskabsforebyggelsesprogrammet: ”Hensigten med formularen til påbegyndelse af behandling er at beskytte patienterne og eventuelle fostre ved at sikre, at patienterne er fuldstændigt informeret om og forstår risikoen for teratogenicitet og andre bivirkninger forbundet med brugen af thalidomid.
English: Each capsule contains 50 mg of thalidomide.
Danish: Hver kapsel indeholder 50 mg thalidomid.
English: Patients should be monitored for liver function, particularly in case of pre-existing liver disorder or concomitant use of medicinal product susceptible to induce liver dysfunction (see section 4.8).
Danish: Patienternes leverfunktion skal monitoreres, især i tilfælde af eksisterende leversygdom eller samtidig brug af et lægemiddel, der har tendens til at inducere leverdysfunktion (se pkt.
English: A medically supervised pregnancy test should be performed during the consultation, when thalidomide is prescribed or in the 3 days prior to the visit to the prescriber once the patient had been using effective contraception for at least 4 weeks.
Danish: Der bør foretages en lægeligt overvåget graviditetstest i løbet af den konsultation, hvor thalidomid ordineres, eller tidligst 3 dage før besøget hos den ordinerende læge, og når patienten har anvendt sikker kontraception i mindst 4 uger.
English: In thirteen of these cases, patients took thalidomide alone; amounts ranged from 350 mg to 4000 mg.
Danish: 18 tilfælde af overdosering er beskrevet i litteraturen med doser op til 14,4 gram. I tretten af disse tilfælde tog patienterne udelukkende thalidomid; mængden varierede fra 350 mg til 4.000 mg.
English: • Hearing decreased or deafness.
Danish: • Nedsat hørelse eller døvhed.
English: • He understands the need for the use of a condom if engaged in sexual activity with a pregnant woman or a woman of childbearing potential not using effective contraception (even if the man has had a vasectomy), during treatment, during dose interruption and for at least 7 days following discontinuation of treatment.
Danish: • Han forstår nødvendigheden af brug af kondom ved seksuelt samvær med en gravid kvinde eller en kvinde i den fertile alder, der ikke anvender sikker kontraception (selv hvis manden er vasektomeret) under behandling, ved pausering af behandlingen og i mindst 7 dage efter seponering af behandlingen.
English: Thalidomide is contraindicated during pregnancy and in women of childbearing potential unless all the conditions of the Pregnancy Prevention Programme are met (see section 4.3)
Danish: Thalidomid er kontraindiceret under graviditet og til kvinder i den fertile alder, medmindre alle betingelserne i svangerskabsforebyggelsesprogrammet er opfyldt (se pkt.
English: For all other patients, prescriptions of thalidomide should be limited to a maximum of 12 weeks of treatment and continuation of treatment requires a new prescription.
Danish: Ordination af thalidomid bør begrænses til højst 12 ugers behandling for alle andre patienter, og en ny ordination er påkrævet ved fortsat behandling.
English: If powder from thalidomide makes contact with the skin, the skin should be washed immediately and thoroughly with soap and water.
Danish: Hvis pulveret med thalidomid får kontakt med huden, skal huden straks vaskes grundigt med sæbe og vand.
English: Proportion thalidomide, the total mean recovery was 93.6 % of the administered dose by day 8.
Danish: Efter en enkelt oral dosis på 400 mg radioaktivt mærket thalidomid var den totale gennemsnitlige genfinding 93,6 % af den indgivne dosis på Dag 8.
English: Thalidomide Celgene in combination with melphalan and prednisone is indicated as first line treatment of patients with untreated multiple myeloma, aged ≥ 65 years or ineligible for high dose chemotherapy.
Danish: Thalidomide Celgene i kombination med melphalan og prednison er indiceret som førstevalgsbehandling af patienter med ubehandlet myelomatose på >65 år eller som er uegnede til højdosis kemoterapi.
English: Thalidomide is a powerful human teratogen, inducing a high frequency (about 30 %) of severe and live-threatening birth defects such as: ectromelia (amelia, phocomelia, hemimelia) of the upper and/or lower extremities, microtia with abnormality of the external acoustic meatus (blind or absent), middle and internal ear lesions (less frequent), ocular lesions (anophthalmia, microphthalmia), congenital heart disease, renal abnormalities.
Danish: Thalidomid er stærkt teratogent hos mennesker og har en høj frekvens (ca. 30 %) af alvorlige og livstruende fødselsdefekter såsom ektromeli (ameli, fokomeli, hemimeli) af over- og/eller underekstremiteter, mikroti med misdannelse af ydre øregang (blind eller manglende), misdannelser af mellem- og indre øre (mindre hyppigt), okulære misdannelser (anoftalmi, mikroftalmi), medfødte hjertesygdomme, nyremisdannelser.
English: Because of the increased risk of venous thromboembolism in patients with multiple myeloma (MM), combined oral contraceptive pills are not recommended (see section 4.5).
Danish: På grund af den forøgede risiko for venøs tromboemboli hos patienter med myelomatose (MM) frarådes hormonal kontraception med orale kombinationspræparater (se pkt.
English: This may be due to blood clots in the veins of your leg (deep vein thrombosis), which is a common side effect.
Danish: Dette kan være på grund af blodpropper i blodårerne i benene (dyb venøs trombose), og er en almindelig bivirkning.
English: Maximum daily melphalan dose: 24 mg (subjects ≤ 75 years old) or 20 mg (subjects > 75 years old).
Danish: e Maksimal daglig melphalandosis: 24 mg (personer ≤ 75 år) eller 20 mg (personer > 75 år).
English: If thalidomide makes contact with the mucous membranes, they should be thoroughly flushed with water.
Danish: Hvis thalidomid får kontakt med slimhinder, skal de skylles grundigt med vand.
English: Hormonal contraceptives
Danish: Hormonale svangerskabsforebyggende midler
English: Dose delay, reduction or discontinuation, dependent upon the NCI CTC grade, may be necessary.
Danish: Dosisudsættelse, dosisreduktion eller seponering kan være nødvendig afhængigt af toksicitetsgraden (NCI CTC).
English: • Prior to prescribing all healthcare professionals who intend to prescribe (and in agreement with the National Competent Authority, dispense) Thalidomide Celgene are provided with an Educational Healthcare Professional's Kit containing the following: o Educational healthcare professional booklet o Educational brochures for patient o Patient cards o Summary of product characteristics, package leaflet and labelling
Danish: • Alt sundhedspersonale, der påtænker at ordinere (og efter aftale med den kompetente nationale myndighed, sælge) Thalidomide Celgene, før ordinering forsynes med undervisningsmateriale til sundhedspersonale, der indeholder følgende: o Undervisningsbrochure til sundhedspersonale o Oplysningsbrochurer til patienter o Patientkort o Produktresumé, indlægsseddel og etikettering
English: • Even if a woman of childbearing potential has amenorrhea she must follow all the advice on effective contraception
Danish: • Selv hvis en kvinde i den fertile alder har været uden menstruation, skal hun følge råd og vejledning om sikker kontraception.
English: Action should be taken to try to minimize all modifiable risk factors (e.g. smoking, hypertension and hyperlipidaemia).
Danish: Alle risikofaktorer, der kan påvirkes (f.eks. rygning, hypertension og hyperlipidæmi), skal søges minimeret.
English: The decision to take antithrombotic prophylactic measures should be made after careful assessment of an individual patient's underlying risk factors (see sections 4.4, 4.5 and 4.8).
Danish: Beslutningen om at give forebyggende antitrombotisk behandling bør tages efter en grundig vurdering af den enkelte patients underliggende risikofaktorer (se pkt.
English: Very Common Constipation Common
Danish: Meget almindelig Obstipation Almindelig
English: WARNING: Thalidomide causes birth defects and foetal death.
Danish: ADVARSEL: Thalidomid forårsager fødselsdefekter og fosterdød.
English: Your doctor will tell you how to take Thalidomide Celgene and for how long you will need to take it (see section 2, “What you need to know before you take Thalidomide Celgene”).
Danish: Din læge vil fortælle dig, hvordan du skal tage Thalidomide Celgene, og hvor længe du skal tage det (se pkt.
English: Serious cutaneous reactions including Stevens-Johnson syndrome TEN and DRESS have been reported with the use of thalidomide therapy.
Danish: Der er rapporteret om alvorlige kutane reaktioner, herunder Stevens-Johnson syndrom, TEN og DRESS ved anvendelse af thalidomidbehandling.
English: These pregnancy tests should be performed on the day of the prescribing visit or in the 3 days prior to the visit to the prescriber.
Danish: Disse graviditetstests bør udføres samme dag thalidomid ordineres, eller i løbet af de 3 dage, der går forud for besøget hos den ordinerende læge.
English: The incidence of neutropenia grade 3 or 4 reported as adverse reactions was higher in multiple myeloma patients receiving MPT (Melphalan, Prednisone, Thalidomide) than in those receiving MP (Melphalan, Prednisone): 42.7 % versus 29.5 % respectively (study IFM 99-06).
Danish: Neutropeni grad 3 og 4 er rapporteret som bivirkning med højere frekvens hos patienter med myelomatose, der fik MPT (melphalan, prednison, thalidomid) end hos patienter, der fik MP (melphalan, prednison): hhv. 42,7 % versus 29,5 % (studie IFM 99-06).
English: Always use a condom: o during treatment o for at least 7 days after stopping treatment
Danish: Du skal altid bruge kondom: o under behandlingen o i mindst 7 dage efter at behandlingen er ophørt
English: Melphalan dosing: reduce by 50 % for moderate (creatinine clearance: ≥ 30 but < 50 mL/min) or severe (CrCl: < 30mL/min) renal insufficiency e
Danish: d Dosering af melphalan: Nedsæt dosis med 50 % ved moderat nedsat nyrefunktion (kreatininclearance ≥ 30, men < 50 ml/min) eller svært nedsat nyrefunktion (CrCl < 30 ml/min).
English: • Your doctor will make sure that you have pregnancy tests o before treatment o every 4 weeks during treatment o 4 weeks after stopping treatment
Danish: • Vil din læge sørge for, at du får foretaget graviditetstests o før behandlingen o hver 4. uge under behandlingen o 4 uger efter at behandlingen er ophørt
English: • Pregnancy Prevention Programme information o Definition of women of childbearing potential and actions the prescriber should take if unsure o Information on what is effective contraception o Safety advice for women of childbearing potential
Danish: • Oplysninger om svangerskabsforebyggelsesprogrammet o Definition af kvinder i den fertile alder samt hvilke handlinger, den ordinerende læge skal foretage, hvis der er tvivl o Oplysninger om hvad sikker kontraception er o Sikkerhedsråd til kvinder i den fertile alder
English: Reproductive System and Breast Disorders
Danish: Det reproduktive system og mammae
English: Contraception
Danish: Prævention
English: Frequencies given are based on the observations during a pivotal comparative clinical study investigating the effect of thalidomide in combination with melphalan and prednisone in previously untreated multiple myeloma patients.
Danish: Hyppighederne er baseret på observationer fra det afgørende kliniske pivotale studie af virkningen af thalidomid i kombination med melphalan og prednison hos patienter med tidligere ubehandlet myelomatose.
English: Neutropenia Leukopenia Anaemia
Danish: Neutropeni Leukopeni Anæmi
English: Patients should be monitored and dose delay, reduction or discontinuation may be required (see section 4.2).
Danish: Patienterne bør monitoreres, og dosisudsættelse, dosisreduktion eller seponering kan være nødvendig (se pkt.
English: Some of the cases of HBV reactivation progressed to acute hepatic failure and resulted in discontinuation of thalidomide.
Danish: Nogle af tilfældene af HBV-reaktivering udviklede sig til akut leverinsufficiens og resulterede i afbrydelse af behandlingen med thalidomid.
English: Increase of sedative effects of other medicinal products Thalidomide has sedative properties, thus may enhance the sedation induced by anxiolytics, hypnotics, antipsychotics, H1 antihistamines, opiate derivatives, barbiturates and alcohol.
Danish: Thalidomid har sedative egenskaber og kan derfor forøge den sedative virkning af anxiolytika, hypnotika, antipsykotika, H1-antihistaminer, opiumderivater, barbiturater og alkohol.
English: • Brochure for women of childbearing potential Brochure for women patients who are not of childbearing potential
Danish: • Brochure for kvindelige patienter, som ikke er i den fertile alder
English: Women of childbearing potential must use one effective method of contraception for at least 4 weeks before start of treatment, during treatment, and until at least 4 weeks after thalidomide treatment and even in case of dose interruption unless the patient commits to absolute and continuous abstinence confirmed on a monthly basis.
Danish: Kvinder i den fertile alder skal benytte sikker prævention i mindst 4 uger før påbegyndelse af behandlingen, under behandlingen samt indtil mindst 4 uger efter thalidomidbehandlingen, også ved pausering af behandlingen, medmindre patienten forpligter sig til fuldstændig og vedvarende seksuel afholdenhed, som bekræftes månedligt.
English: Thromboprophylaxis and dosing/anticoagulation therapy recommendations are provided in section 4.2.
Danish: Anbefalinger for tromboseprofylakse og dosering/antikoagulationsbehandling gives i pkt.
English: for 4 days had no effect on the international normalized ratio (INR) in healthy volunteers.
Danish: Flere doser givet som 200 mg thalidomid 1 gang dagligt i 4 dage havde ingen virkning på international normaliseret ratio (INR) hos raske frivillige.
English: Therefore breast-feeding should be discontinued during treatment with thalidomide.
Danish: Amning skal derfor ophøre under behandling med thalidomid.
English: Melphalan c,d,e
Danish: Thalidomida,b Melphalanc,d,e Prednisonf
English: • Core text as agreed by the CHMP
Danish: • Kernetekst som skal godkendes af Udvalget for Humanmedicinske Lægemidler (CHMP)
English: • Allergic reactions such as a localised or generalised pruritic rash and angioedema (types of allergic reaction that may be manifested as hives, rashes, swelling of eyes, mouth or face, difficulty of breathing, or itching).
Danish: • Allergiske reaktioner, såsom kløende udslæt lokalt eller over hele kroppen samt angioødem (allergisk reaktion, der kan vise sig som nældefeber, udslæt, hævelse af øjne, mund eller ansigt, vejrtrækningsbesvær eller kløe).
English: Patients and physicians are advised to be observant for signs and symptoms of bleeding including petechiae, epistaxis and gastrointestinal haemorrhage, especially in case of concomitant medicinal product prone to inducing bleeding (see sections 4.5 and 4.8).
Danish: Patienter og læger rådes til at være opmærksomme på tegn og symptomer på blødning, herunder petekkier, næseblod og gastrointestinal blødning, især ved samtidig brug af et lægemiddel, der har tendens til at inducere blødning (se pkt.
English: • That he should return the capsules to the pharmacist at the end of treatment
Danish: • At han skal levere kapslerne tilbage til apoteket ved behandlingens seponering
English: • Levonorgestrel-releasing intrauterine system (IUS)
Danish: • Levonorgestrel-afgivende intrauterint indlæg (IUD)
English: Adverse reactions from post-marketing experience such as febrile neutropenia and pancytopenia were reported with thalidomide.
Danish: Efter markedsføring er der rapporteret bivirkninger såsom febril neutropeni og pancytopeni med thalidomid.
English: • A fall in the number of white blood cells (neutropenia) accompanied by fever and infection.
Danish: • Nedsat antal hvide blodlegemer (neutropeni) ledsaget af feber og infektion.
English: (see sections 4.2 and 4.8).
Danish: 4.2 og 4.8).
English: Lymphopenia Thrombocytopenia
Danish: Lymfopeni Trombocytopeni
English: White opaque capsules marked “Thalidomide Celgene 50 mg”.
Danish: Hvide, uigennemsigtige kapsler med markeringen ”Thalidomide Celgene 50 mg”.
English: If pregnancy occurs in a partner of a male patient taking thalidomide, the female partner should be referred to a physician specialised or experienced in teratology for evaluation and advice.
Danish: Hvis graviditet forekommer hos en partner til en mand, der tager thalidomid, skal den kvindelige partner henvises til vurdering og rådgivning hos en læge, der er specialist i eller har erfaring med teratologi.
English: Severe skin reactions
Danish: Alvorlige hudreaktioner
English: Thalidomide must not be used at any time during pregnancy (see sections 4.4 and 4.6).
Danish: Thalidomid må ikke indtages på noget tidspunkt under graviditet (se pkt.
English: Women of childbearing potential/Contraception in males and females Women of childbearing potential must use one effective method of contraception for at least 4 weeks before start of treatment, during treatment including during dose interruptions, and until at least 4 weeks after thalidomide treatment (see section 4.4).
Danish: Kvinder i den fertile alder/prævention hos mænd og kvinder Kvinder i den fertile alder skal benytte en sikker prævention i mindst 4 uger før påbegyndelse af behandling, under behandlingen, herunder ved pausering af behandlingen, og indtil mindst 4 uger efter behandlingen med thalidomid (se pkt.
English: It is recommended to press only on one end of the capsule to remove it from the blister, thereby reducing the risk of capsule deformation or breakage.
Danish: Det anbefales kun at trykke på den ene ende af kapslen for at få den ud af blisteren.
English: Capsules should not be opened or crushed (see section 6.6).
Danish: Kapslerne må ikke åbnes eller knuses (se pkt.
English: • Previous bilateral salpingo-oophorectomy, or hysterectomy.
Danish: • Tidligere bilateral salpingo-ooforektomi eller hysterektomi • XY-genotype, Turners syndrom, uterin agenesi.
English: • Adverse reaction reporting forms
Danish: • Formularer til indberetning af bivirkninger
English: • you experience or have experienced in the past severe skin reactions called Stevens-Johnson syndrome, toxic epidermal necrolysis or drug reaction with eosinophilia and systemic symptoms(which is also known as DRESS or drug hypersensitivity syndrome).
Danish: • Du får eller tidligere har haft svære hudreaktioner kaldet Stevens-Johnsons syndrom, toksisk epidermal nekrolyse eller lægemidelreaktion med eosinofili og systemiske symptomer (også kaldet DRESS eller lægemiddeloverfølsomhedssyndrom).
English: Counselling
Danish: Rådgivning
English: • Fever, chills, sore throat, cough, mouth ulcers or any other symptoms of infection.
Danish: • Feber, kulderystelser, ondt i halsen, hoste, sår i munden eller andre symptomer på infektion.
English: Thalidomide causes birth defects and foetal death.
Danish: Thalidomid forårsager fødselsdefekter og fosterdød.
English: This may be due to blood clots in the arteries leading to your lungs (called ‘pulmonary embolism'), which is a common side effect.
Danish: Dette kan være udløst af blodpropper i de arterier, der fører blod til lungerne (det kaldes ”lungeemboli”).
English: Patients treated with thalidomide have an increased risk of venous thromboembolism (such as deep vein thrombosis and pulmonary embolism) and arterial thromboembolism (such as myocardial infarction and cerebrovascular event) (see section 4.8).
Danish: Patienter behandlet med thalidomid har en øget risiko for venøs tromboemboli (såsom dyb venetrombose og lungeemboli) og arteriel tromboemboli (såsom myokardieinfarkt og cerebrovaskulær hændelse), se pkt.
English: • Obligations of healthcare professionals who intend to prescribe or dispense Thalidomide Celgene including o The need to provide comprehensive advice and counselling to patients o That patients should be capable of complying with the requirements for the safe use of thalidomide o Need to provide patients with the appropriate patient educational material o Report any pregnancy, or adverse events to Celgene and the local health authority (if applicable to a Member State) using the forms provided in the “Educational Healthcare Professional's Kit”
Danish: • Sundhedspersonalets pligter ved ordination eller salg af Thalidomide Celgene, herunder o Nødvendigheden af at yde omfattende vejledning og rådgivning til patienterne o At patienterne skal være i stand til at efterkomme kravene om sikker anvendelse af thalidomid o Nødvendigheden af at udlevere relevant undervisningsmateriale til patienterne o Indberetning af alle tilfælde af graviditet eller utilsigtede hændelser til Celgene og den lokale sundhedsmyndighed (hvis relevant i en medlemsstat) ved brug af formularerne i ”undervisningsmateriale til sundhedspersonale”
English: This includes medicines obtained without a prescription, including herbal medicines.
Danish: Dette gælder også medicin, som ikke er købt på recept, f. eks. naturlægemidler og vitaminer og mineraler.
English: In addition to the adverse reactions outlined above, thalidomide in combination with dexamethasone in other clinical studies led to the very common adverse reaction of fatigue; common adverse reactions of transient ischaemic event, syncope, vertigo, hypotension, mood altered, anxiety, blurred vision, nausea and dyspepsia; and uncommon adverse reactions of cerebrovascular accident, diverticular perforation, peritonitis, orthostatic hypotension and bronchitis.
Danish: Ud over de ovennævnte bivirkninger medførte Thalidomid i kombination med dexamethason i andre kliniske studier træthed som en meget almindelig bivirkning samt almindelige bivirkninger i form af forbigående iskæmisk hændelse, synkope, vertigo, hypotension, stemningsforandringer, ængstelse, sløret syn, kvalme og dyspepsi og ikke almindelige bivirkninger i form af cerebrovaskulær hændelse, divertikelperforation, peritonitis, ortostatisk hypotension og bronkitis.
English: Neutropenia, Leukopenia, Anaemia, Lymphopenia, Thrombocytopenia
Danish: Meget almindelig Neutropeni, leukopeni, anæmi, lymfopeni, trombocytopeni
English: If you forget to take Thalidomide Celgene
Danish: Hvis du har glemt at tage Thalidomide Celgene: