FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 3: Adverse drug reactions (ADRs) reported in pivotal clinical study with thalidomide in combination with melphalan and prednisone and from post marketing use
Danish: Tabel 3: Bivirkninger rapporteret i det pivotale kliniske studie med thalidomid i kombination med melphalan og prednison og fra anvendelse efter markedsføring
English: Even if you do not have a menstrual bleeding following cancer therapy, you may become pregnant.
Danish: Du kan blive gravid, selv hvis du ikke længere får din menstruation efter behandling for kræft.
English: • Pregnancy reporting requirements o Instruction to stop thalidomide immediately upon suspicion of pregnancy, if female patient o Need to refer patient to physician specialised or experienced in dealing with teratology for advice and evaluation o Complete pregnancy reporting form as provided in the “Educational Healthcare Professional's Kit” o Local contact details for reporting of any suspected pregnancy
Danish: • Krav vedrørende indberetning af graviditet o Anvisninger om øjeblikkeligt at seponere thalidomid ved mistanke om graviditet hos kvindelige patienter o Nødvendigt at henvise patienten til vurdering og rådgivning hos en læge, der er specialiseret i eller har erfaring med teratologi o Udfylde formularerne til indberetning af graviditet som udleveret i ”Undervisningsmateriale til sundhedspersonale” o Lokale kontaktoplysninger for indberetning af mistanke om graviditet
English: Common (may affect up to 1 in 10 people)
Danish: Almindelige bivirkninger (kan ramme op til 1 ud af 10 personer):
English: Cases of allergic reactions/angioedema and serious cutaneous reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with the use of Thalidomide.
Danish: Der er rapporteret tilfælde af allergiske reaktioner/angioødem og alvorlige kutane reaktioner, herunder Stevens-Johnsons syndrom (SJS), toksisk epidermal nekrolyse (TEN) og lægemiddelreaktion med eosinofili og systemiske symptomer (DRESS) ved brug af thalidomid.
English: The reported events occurred in young (premenopausal) women (median age 36 years) receiving thalidomide for non-multiple myeloma indications, had an onset within 6 months of initiating treatment and reversed upon discontinuation of thalidomide.
Danish: De rapporterede hændelser forekom hos unge (præmenopausale) kvinder (medianalder 36 år), der fik thalidomid for andre indikationer end myelomatose.
English: • Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses
Danish: Vasektomien skal være bekræftet med to negative sædprøver.
English: What Thalidomide Celgene contains
Danish: Thalidomide Celgene indeholder
English: Particularly, a haemoglobin concentration above 12g/dl should lead to discontinuation of erythropoietic agents.
Danish: Specielt bør behandling med erytropoietiske midler afbrydes ved en hæmoglobinkoncentration på over 12 g/dl.
English: • Hypersensitivity to thalidomide or to any of the excipients listed in section 6.1.
Danish: • Overfølsomhed over for thalidomid eller over for et eller flere af hjælpestofferne anført i pkt.
English: Uncommon (may affect up to 1 in 100 people)
Danish: Ikke almindelige bivirkninger (kan ramme op til 1 ud af 100 personer);
English: Patients with renal or hepatic impairment
Danish: Patienter med nedsat nyre- eller leverfunktion
English: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Danish: Benigne, maligne og uspecificerede tumorer (inkl.
English: 2 D bar code carrying the unique identifier
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Der er anført en 2D-stregkode, som indeholder en entydig identifikator.
English: • That thalidomide is found in semen and the need to use condoms if sexual partner is pregnant or is a woman with childbearing potential not using effective contraception
Danish: • At thalidomid kan findes i sæd og nødvendigheden af at anvende kondom, hvis den seksuelle partner er gravid, eller er en kvinde i den fertile alder og ikke anvender sikker kontraception
English: • The need for pregnancy tests i.e. before treatment, at least every 4 weeks during treatment and after treatment
Danish: • Nødvendigheden af graviditetstest dvs. før behandling, mindst hver 4. uge under behandlingen og efter behandling
English: As thalidomide is found in semen, as a precaution all male patients must use condoms during treatment, during dose interruption and for at least 7 days following discontinuation of treatment if their partner is pregnant or is of childbearing potential not using effective contraception.
Danish: Da thalidomid kan findes i sæd, skal alle mandlige patienter som forholdsregel benytte kondom i behandlingsperioden, ved pausering af behandlingen samt i mindst 7 dage efter seponering af behandling, hvis deres partner er gravid eller er i den fertile alder og ikke anvender sikker kontraception.
English: An increased risk of venous thromboembolism (such as deep vein thrombosis and pulmonary embolism) and arterial thromboembolism (such as myocardial infarction and cerebrovascular event) has been reported in patients treated with thalidomide (see section 4.4).
Danish: Der er observeret en øget risiko for venøs tromboemboli (såsom dyb venetrombose og lungeemboli) og arteriel tromboemboli (såsom myokardieinfarkt og cerebrovaskulær hændelse) ved behandling med thalidomid (se pkt.
English: The extent of thalidomide metabolism by the liver cytochrome P450 system is minimal and intact thalidomide is not excreted by the kidney.
Danish: Thalidomid metaboliseres kun minimalt via leverens CYP-system, og uomdannet thalidomid udskilles ikke gennem nyrerne.
English: Table 4: Comparison of haematological disorders for the melphalan, prednisone (MP) and melphalan, prednisone, thalidomide (MPT) combinations in study IFM 99-06 (see section 5.1) n (% of patients)
Danish: Tabel 4: Sammenligning af hæmatologiske bivirkninger ved kombinationer af melphalan og prednison (MP) overfor melphalan, prednison og thalidomid (MPT) i IFM 99-06-studiet (se pkt.
English: Patients should be monitored for: thromboembolic events, peripheral neuropathy, severe skin reactions, bradycardia, syncope, somnolence, neutropenia and thrombocytopenia (see sections 4.4 and 4.8).
Danish: Patienterne skal monitoreres for tromboemboliske hændelser, perifer neuropati, alvorlige hudreaktioner, bradykardi, synkope, døsighed, neutropeni og trombocytopeni (se pkt.
English: For women of childbearing potential, prescriptions of thalidomide should be limited to a maximum of 4 weeks of treatment and continuation of treatment requires a new prescription.
Danish: Begrænsninger vedrørende ordination og udlevering Ordination af thalidomid bør begrænses til højst 4 ugers behandling for kvinder i den fertile alder, og en ny ordination er påkrævet ved fortsat behandling.
English: As thalidomide is found in semen, as a precaution all male patients must use condoms during treatment, during dose interruption and for at least 7 days following discontinuation of treatment when having sexual intercourse with a pregnant woman or with a woman of childbearing potential who is not using effective contraception.
Danish: Da thalidomid kan findes i sæd, skal alle mandlige patienter som forholdsregel benytte kondom i behandlingsperioden, ved pausering af behandlingen og i mindst 7 dage efter seponering af behandlingen ved samleje med en gravid kvinde eller en kvinde i den fertile alder, der ikke benytter sikker prævention.
English: The most commonly observed adverse reactions associated with the use of thalidomide in combination with melphalan and prednisone are: neutropenia, leukopenia, constipation, somnolence, paraesthesia, peripheral neuropathy, anaemia, lymphopenia, thrombocytopenia, dizziness, dysaesthesia, tremor and peripheral oedema.
Danish: De mest almindeligt observerede bivirkninger forbundet med anvendelse af thalidomid kombineret med melphalan og prednison er: neutropeni, leukopeni, obstipation, døsighed, paræstesi, perifer neuropati, anæmi, lymfopeni, trombocytopeni, svimmelhed, dysæstesi, tremor og perifert ødem.
English: If pregnancy occurs in a woman treated with thalidomide, treatment must be stopped immediately and the patient should be referred to a physician specialised or experienced in teratology for evaluation and advice.
Danish: Hvis en kvinde, der behandles med thalidomid, bliver gravid, skal behandlingen straks seponeres og patienten henvises til vurdering og rådgivning hos en læge, der er specialist i eller har erfaring med teratologi.
English: Prednisone dosed once daily on Days 1 to 4 of each 42-day cycle.
Danish: f Prednison indtaget en gang dagligt på dag 1 til dag 4 i hver cyklus på 42 dage.
English: If you take more Thalidomide Celgene than you should If you take more Thalidomide Celgene than you should, talk to a doctor or go to a hospital straightaway.
Danish: Hvis du har taget for meget Thalidomide Celgene, skal du straks kontakte din læge eller tage på hospitalet.
English: What you need to know before you take Thalidomide Celgene
Danish: Det skal du vide, før du begynder at tage Thalidomide Celgene
English: Hearing impaired or deafness
Danish: Nedsat hørelse eller døvhed†
English: • You must not donate semen: o during treatment o for at least 7 days after stopping treatment
Danish: • Du må ikke være sæddonor: o under behandlingen o i mindst 7 dage efter at behandlingen er ophørt.
English: • Treatment initiation forms and/or equivalent tool for male patients should also include: o Confirmation that the physician has discussed the following:
Danish: • Formularer til påbegyndelse af behandling og/eller tilsvarende værktøjer til mandlige patienter bør også indeholde: o Bekræftelse af, at lægen har talt med patienten om:
English: †, Menstrual disorders including amenorrhea
Danish: Seksuel dysfunktion†, menstruationsforstyrrelser, herunder amenorré†
English: The patients at risk of tumour lysis syndrome are those with high tumour burden prior to treatment.
Danish: Tumorlysesyndrom Det er de patienter, der har stor tumorbyrde inden behandlingen, som har risiko for at få tumorlysesyndrom.
English: What Thalidomide Celgene is used for
Danish: Hvad benyttes Thalidomide Celgene til:
English: • are used for contraception.
Danish: • Anvendes til at forebygge graviditet.
English: Thalidomide must be discontinued for angioedema, Grade 4 rash, exfoliative or bullous rash, or if SJS, TEN or DRESS is suspected, and should not be resumed following discontinuation for these reactions.
Danish: Thalidomid skal seponeres ved angioødem, grad 4 udslæt, eksfoliativt udslæt eller udslæt med blæredannelser, eller hvis der er mistanke om SJS, TEN eller DRESS.
English: The most clinically important adverse reactions associated with the use of thalidomide in combination with melphalan and prednisone or dexamethasone include: deep vein thrombosis and pulmonary embolism, peripheral neuropathy, severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, syncope, bradycardia, and dizziness (see sections 4.2, 4.4 and 4.5).
Danish: De klinisk vigtigste bivirkninger forbundet med anvendelse af thalidomid kombineret med melphalan og prednison eller dexamethason er: dyb venøs trombose og lungeemboli, perifer neuropati, alvorlige hudreaktioner, herunder Stevens-Johnson syndrom og toksisk epidermal nekrolyse, synkope, bradykardi samt svimmelhed (se pkt.
English: • She understands the need for effective contraception, without interruption, at least 4 weeks before starting treatment, throughout the entire duration of treatment, and at least 4 weeks after the end of treatment
Danish: • Hun forstår nødvendigheden af sikker kontraception uden afbrydelse, mindst 4 uger før behandlingen påbegyndes og under hele behandlingsforløbet samt mindst 4 uger efter endt behandling.
English: What Thalidomide Celgene looks like and contents of the pack Thalidomide Celgene are white hard capsules marked “Thalidomide Celgene 50 mg”.
Danish: Thalidomide Celgene er hvide, hårde kapsler mærket ”Thalidomide Celgene 50 mg”.
English: • Blurred vision.
Danish: • Sløret syn.
English: Programme are met (see sections 4.4 and 4.6).
Danish: 4.4 og 4.6).
English: • The need for pregnancy tests i.e. before treatment, at least every 4 weeks during treatment and at least 4 weeks after treatment
Danish: • Nødvendigheden af graviditetstests, dvs. før behandlingen, mindst hver 4. uge under behandlingen, og mindst 4 uger efter behandlingen
English: • Do not break, open or chew the capsules.
Danish: • Kapslerne må ikke knækkes, åbnes eller tygges.
English: Acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS) A statistically significant increase of AML and MDS was observed in one clinical study in patients with previously untreated MM receiving the combination of melphalan, prednisone, and thalidomide (MPT).
Danish: Akut myeloid leukæmi (AML) og myelodysplastiske syndromer (MDS) En statistisk signifikant hyppigere forekomst af AML og MDS blev observeret i ét klinisk studie hos patienter med tidligere ubehandlet MM, der fik kombinationen med melphalan, prednison og thalidomid (MPT).
English: Melphalan dosed once daily on Days 1 to 4 of each 42-day cycle.
Danish: c Melphalan indtaget en gang dagligt på dag 1 til dag 4 i hver cyklus på 42 dage.
English: Thalidomide must be discontinued for angioedema, Grade 4 rash, exfoliative or bullous rash, or if Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) or drug reaction with eosinophilia and systemic symptoms (DRESS) is suspected and should not be resumed following discontinuation for these reactions.
Danish: Thalidomid skal seponeres ved angioødem, grad 4 udslæt, eksfoliativt udslæt eller udslæt med blæredannelser, eller hvis der er mistanke om Stevens-Johnsons syndrom (SJS), toksisk epidermal nekrolyse (TEN) eller lægemiddelreaktion med eosinofili og systemiske symptomer (DRESS).
English: A. MANUFACTURER (S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE Navn og adresse på de fremstillere, der er ansvarlige for batchfrigivelse Celgene Distribution B.V.
English: • The need for effective contraception, without interruption, at least 4 weeks before starting treatment, throughout the entire duration of treatment, and at least 4 weeks after the end of treatment
Danish: • Nødvendigheden af sikker kontraception uden afbrydelse mindst 4 uger før behandlingen påbegyndes, under hele behandlingens varighed og mindst 4 uger efter behandlingens afslutning
English: Use only as directed by your doctor.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Må kun anvendes som anvist af lægen.
English: Men
Danish: Mænd
English: * see section 4.8 description of selected adverse reactions identified from post marketing data ^ Acute myeloid leukaemia and Myelodysplastic syndrome were reported in one clinical study in patients with previously untreated MM receiving the combination of melphalan, prednisone and thalidomide (MPT)
Danish: 4.8 Beskrivelse af udvalgte bivirkninger † identificeret i data efter markedsføring ^ Akut myeloid leukæmi og myelodysplastisk syndrom blev rapporteret i ét klinisk studie med patienter med tidligere ubehandlet MM, som fik en kombination af melphalan, prednison og thalidomid (MPT)
English: Acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS) AML and MDS were reported in one clinical study in patients with previously untreated multiple myeloma receiving the combination of melphalan, prednisone, and thalidomide (see section 4.4).
Danish: Akut myeloid leukæmi (AML) og myelodysplastiske syndromer (MDS) AML og MDS blev rapporteret i ét klinisk studie hos patienter med tidligere ubehandlet myelomatose, der fik kombinationen melphalan, prednison og thalidomid (se pkt.
English: • Convulsions.
Danish: • Svimmelhed.
English: Black iron oxide (E172) Propylene glycol
Danish: Sort jernoxid (E172)
English: Cardiovascular disorders
Danish: Kardiovaskulære sygdomme
English: 200 mg daily 0.125 mg/kg daily 2 mg/kg daily
Danish: 0,125 mg/kg dagligt
English: • Treatment initiation forms and/or equivalent tool for women with no childbearing potential should also include: o Confirmation that the physician has discussed the following:
Danish: • Formularer til påbegyndelse af behandling og/eller tilsvarende værktøjer til kvinder, som ikke er i den fertile alder, bør også indeholde: o Bekræftelse af, at lægen har talt med patienten om:
English: Thalidomide Celgene 50 mg hard capsules thalidomide
Danish: Thalidomide Celgene 50 mg hårde kapsler thalidomid
English: Viral infections, including herpes zoster and hepatitis B virus reactivation
Danish: Alvorlige infektioner (f.eks. fatal sepsis, herunder septisk shock)†, virusinfektioner, herunder reaktivering af herpes zoster og hepatitis B-virus†
English: ANNEX I
Danish: BILAG I PRODUKTRESUMÉ
English: Thromboembolic events
Danish: Tromboemboliske hændelser
English: Thalidomide Celgene is taken daily in treatment cycles, each cycle lasting 6 weeks, in combination with melphalan and prednisone which are taken on days 1 to 4 of each 6 week cycle.
Danish: Lægemidlet tages i kombination med melphalan og prednison, som tages på dag 1-4 i hver 6-ugers periode.
English: If you do become pregnant during the treatment with thalidomide, you must stop the treatment and inform your doctor immediately.
Danish: • Du har heteroseksuelt samleje uden anvendelse af effektiv prævention Hvis du bliver gravid under behandling med thalidomid, skal du straks stoppe behandlingen og underrette din læge.
English: • Inflammation of the cells lining your stomach wall.
Danish: • Betændelse af cellerne på indersiden af mavesækken (mavekatar).
English: • Injury to the liver (hepatic disorder) including abnormal liver test results.
Danish: • Leverskade, herunder unormale prøver for leverfunktionen.
English: • Constipation.
Danish: • Forstoppelse.
English: This includes sedatives (such as anxiolytics, hypnotics, antipsychotics, H1 antihistamines, opiate derivatives and barbiturates).
Danish: (såsom ”nervemedicin”, sovemedicin, antipsykotika, allergimedicin, morfinlignende præparater og barbiturater).
English: Capsules should not be opened or crushed.
Danish: • Kapslerne må ikke knuses eller tygges.
English: For men taking Thalidomide Celgene who have a female partner who is able to become pregnant, please see section 2 “What you need to know before you take Thalidomide Celgene”.
Danish: Mænd, der tager Thalidomide Celgene, og som har en kvindelig partner, der kan blive gravid, skal læse pkt.
English: • Women of childbearing potential unless all the conditions of the Pregnancy Prevention
Danish: • Kvinder i den fertile alder, medmindre alle betingelserne i svangerskabsforebyggelsesprogrammet er opfyldt (se pkt.
English: If you are in doubt, talk to your doctor.
Danish: Spørg lægen, hvis du er i tvivl.
English: Measures of renal function (CrCl) and liver function (blood chemistry) indicate minimal effect of kidney and liver function on the pharmacokinetics of thalidomide.
Danish: Måling af nyrefunktion (kreatininclearance) og leverfunktion (leverfunktionsprøver) indikerer, at nyre- og leverfunktion kun har en minimal indflydelse på thalidomids farmakokinetik, så det forventes ikke, at thalidomids metabolisme påvirkes af nedsat lever- eller nyrefunktion.
English: Patients should not donate blood during treatment (including during dose interruptions) and for at least 7 days following discontinuation of thalidomide.
Danish: Patienter må ikke donere blod under behandlingen (herunder ved pausering af behandlingen) samt i mindst 7 dage efter, at de er ophørt med at tage thalidomid.
English: Discontinue treatment
Danish: Stands behandlingen.
English: • Indigestion, feeling sick (nausea), being sick (vomiting), dry mouth.
Danish: • Fordøjelsesbesvær, kvalme, opkastning, tør mund.
English: • Treatment initiation forms and/or equivalent tool for women of childbearing potential should also include: o Confirmation that the physician has discussed the following:
Danish: • Formularer til påbegyndelse af behandling og/eller tilsvarende værktøjer til kvinder i den fertile alder bør også omfatte: o Bekræftelse af, at lægen har talt med patienten om:
English: • The need to stop thalidomide immediately upon suspicion of pregnancy
Danish: • Nødvendigheden af øjeblikkeligt seponering af anvendelse af thalidomid ved mistanke om graviditet
English: †, Pancreatitis Gastrointestinal haemorrhage
Danish: Gastrointestinal perforation†, pankreatitis†, gastrointestinal blødning†
English: You must not donate blood during Thalidomide Celgene treatment and for at least 7 days after stopping treatment.
Danish: Du må ikke være bloddonor under behandlingen og i mindst 7 dage efter, at behandlingen med Thalidomide Celgene er ophørt.
English: Skin irritation, sores or swelling in the mouth, throat, eyes, nose and around the genitals, oedema and fever and flulike symptoms may occur.
Danish: næsen og rundt om kønsdelene, ødem og feber og influenzalignende symptomer.
English: If you are not sure, talk to your doctor or pharmacist before taking Thalidomide Celgene.
Danish: Spørg din læge eller apotekspersonalet, før du tager Thalidomide Celgene, hvis du er i tvivl.
English: Adverse reactions for haematological disorders are provided compared to the comparator arm, as the comparator has a significant effect on these disorders (Table 4).
Danish: Hæmatologiske bivirkninger er sammenlignet med behandlingen i kontrolgruppen, hvor behandlingen i sig selv havde betydelige virkninger på blod- og lymfesystem (tabel 4).
English: LABELLING AND PACKAGE LEAFLET
Danish: BILAG III ETIKETTERING OG INDLÆGSSEDDEL
English: • A hole in part of your large bowel (colon) which can cause infection.
Danish: • Hul på tyktarmen, hvilket kan medføre betændelse.
English: You must use one effective method of contraception if you are a woman who is able to become pregnant (see section 2, “What you need to know before you take Thalidomide Celgene”).
Danish: Du skal benytte sikker prævention, hvis du er kvinde og kan blive gravid (se pkt.
English: Thalidomide dosed once daily at bedtime on Days 1 to 42 of each 42-day cycle.
Danish: 2 mg/kg dagligt a Thalidomid indtaget en gang dagligt ved sengetid på dag 1 til dag 42 i hver cyklus på 42 dage.
English: • The need to contact their doctor immediately upon suspicion of pregnancy
Danish: • Nødvendigheden af øjeblikkeligt at orientere den behandlende læge ved mistanke om graviditet
English: Male patients should not donate semen or sperm during treatment (including during dose interruptions) and for at least 7 days following discontinuation of thalidomide.
Danish: Mandlige patienter må ikke donere sæd under behandling (herunder ved pausering af behandlingen) samt i mindst 7 dage efter, at de er ophørt med at tage thalidomid.
English: • Patient cards and/or equivalent tools: o verification that appropriate counselling has taken place o documentation of childbearing potential status o check box (or similar) which physician ticks to confirm that patient is using effective contraception (if woman of childbearing potential) o verification of initial negative pregnancy test prior to start of treatment (if woman of childbearing potential) o pregnancy test dates and results
Danish: som lægen krydser af for at bekræfte, at patienten anvender sikker kontraception (hvis kvinde i den fertile alder) o bekræftelse af første negativ graviditetstest inden påbegyndelse af behandling (hvis kvinde i den fertile alder) o datoerne for graviditetstest og resultat
English: Hypothyroidism
Danish: Hypotyroidisme†
English: Thalidomide Celgene 50 mg thalidomide
Danish: LÆGEMIDLETS NAVN Thalidomide Celgene 50 mg thalidomid
English: What Thalidomide Celgene is
Danish: Hvad er Thalidomide Celgene:
English: Unused medicinal product should be returned to your pharmacist.
Danish: IKKE ANVENDT LÆGEMIDDEL SAMT AFFALD HERAF Ikke anvendt lægemiddel skal afleveres på apoteket.