FrancophonIA/ELRC3.0 huggingface dataset:
English: • The active substance is thalidomide.
Danish: • Aktivt stof: thalidomid.
English: • Prior to launch, all doctors and pharmacists who intend to prescribe or dispense Thalidomide Celgene receive a Dear Healthcare Professional letter as described below.
Danish: • Alle læger og apotekere, der påtænker at ordinere og sælge Thalidomide Celgene, før lanceringen modtager et Kære Sundhedspersonale-brev som beskrevet herunder.
English: • That if she needs to change or stop using her method of contraception she should inform: ▪ The physician prescribing her contraception that she is on thalidomide ▪ The physician prescribing thalidomide that she has stopped or changed her method of contraception
Danish: • At hun, hvis hun har brug for at ændre eller stoppe sin svangerskabsforebyggende metode, skal informere Den læge, der ordinerer det svangerskabsforebyggende middel, om at hun er i behandling med thalidomid Den læge, der ordinerer thalidomid, om at hun har stoppet eller ændret sin svangerskabsforebyggende metode
English: o The printing ink is composed of shellac, black iron oxide (E172) and propylene glycol.
Danish: o Prægeblækket er sammensat af shellac, sort jernoxid (E172) og propylenglykol.
English: • slow the heart rate (induce bradycardia, such as anticholinesterases and beta blockers).
Danish: • Sænker pulsen (inducerer bradykardi, såsom antikolinesteraser og betablokkere).
English: Taking this medicine
Danish: Sådan skal du tage dette lægemiddel
English: The European Medicines Agency has waived the obligation to submit the results of studies with thalidomide in all subsets of the paediatric population in multiple myeloma (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med thalidomid i alle undergrupper af den pædiatriske population med myelomatose (se pkt.
English: Pyrexia, Asthenia, Malaise
Danish: Pyreksi, asteni, utilpashed
English: Grade 2 (interfering with function but not with activities of daily living)
Danish: Grad 2 (funktionsforstyrrelser som ikke påvirker daglige aktiviteter)
English: • Decreased or abnormal sensation (dysaesthesia).
Danish: • Nedsat eller unormal berøringssans (dysæstesi).
English: All unused capsules should be returned to the pharmacist at the end of treatment.
Danish: Ikke anvendte kapsler skal returneres til apoteket ved behandlingens afslutning.
English: • Medroxyprogesterone acetate depot
Danish: • Depotform af medroxyprogesteronacetat
English: Always take Thalidomide Celgene exactly as your doctor or pharmacist has told you to.
Danish: Tag altid Thalidomide Celgene nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: • Low blood cell counts.
Danish: • Nedsat antal hvide blodlegemer.
English: Physicians should carefully evaluate patients before and during treatment using standard cancer screening and institute treatment as indicated.
Danish: Lægerne skal evaluere patienterne omhyggeligt før og under behandlingen ved hjælp af standard-cancerscreening og iværksætte behandling efter gældende retningslinjer.
English: A cumulative search of DRESS cases with thalidomide from spontaneous sources and clinical trials retrieved 8 cases among which 4 cases were assessed as probable or possible drug reaction with eosinophilia and systemic symptoms (DRESS) as per Regiscar criteria.
Danish: En kumulativ søgning efter DRESS-tilfælde med thalidomid fra spontane kilder og kliniske studier afdækkede 8 tilfælde, hvoraf 4 tilfælde blev vurderet som sandsynlig eller mulig lægemiddelreaktion med eosinofili og systemiske symptomer (DRESS) i henhold til Regiscar-kriterierne.
English: If not established on effective contraception, the patient must be referred preferably to an appropriately trained healthcare professional for contraceptive advice in order that contraception can be initiated.
Danish: Hvis der ikke benyttes sikker prævention, skal patienten henvises til relevant uddannet sundhedspersonale med henblik på rådgivning og påbegyndelse af svangerskabsforebyggelse.
English: • He understands the teratogenic risk if engaged in sexual activity with a pregnant woman or a woman of childbearing potential.
Danish: • Han forstår den teratogene risiko ved seksuelt samvær med en kvinde, som er gravid eller i den fertile alder.
English: Thrombocytopenia, including grade 3 or 4 adverse reactions, has been reported in multiple myeloma patients receiving MPT.
Danish: Trombocytopeni, herunder grad 3 og 4, er blevet rapporteret hos patienter med myelomatose, der fik MPT.
English: In the male dog, after one year of dosing, reversible bile plugs in canaliculi were observed at exposures greater than 1.9-fold the human exposure.
Danish: Efter et års dosering blev der hos hanhunde observeret reversible galdepropper i canaliculi ved eksponering, der var over 1,9 gange større end human eksponering.
English: Immune System Disorders Not Known
Danish: Det endokrine system Ikke kendt
English: • Healthcare professional booklet o History of thalidomide, background on Thalidomide Celgene and its licensed indication o Posology
Danish: • Brochure til sundhedspersonale o Thalidomids historie, baggrundsoplysninger om Thalidomide Celgene og den registrerede indikation o Dosering
English: Among invasive SPMs, cases of MDS/AML were observed in patients receiving lenalidomide in combination with melphalan or immediately following high dose melphalan and autologous stem cell transplantation.
Danish: Bland de invasive SPM'er blev der observeret tilfælde af MDS/AML hos patienter, der fik lenalidomid i kombination med melphalan, eller umiddelbart efter højdosis melphalan og autolog stamcelletransplantation.
English: • Male patients unable to follow or comply with the required contraceptive measures (see section 4.4).
Danish: • Mandlige patienter, der ikke er i stand til at overholde de nødvendige præventionsforholdsregler (se pkt.
English: Teratogenicity
Danish: Teratogenicitet
English: Symptoms include paraesthesia, dysaesthesia, discomfort, abnormal co-ordination or weakness.
Danish: Symptomerne omfatter paræstesi, dysæstesi, ubehag, abnorm koordinationsevne eller svækkelse.
English: These symptoms may be signs of the rare and serious skin reactions Stevens-Johnson syndrome, toxic epidermal necrolysis or DRESS syndrome.
Danish: Disse symptomer kan være tegn på de sjældne og alvorlige hudreaktioner Stevens-Johnsons syndrom, toksisk epidermal nekrolyse eller DRESS-syndrom.
English: Thalidomide is also a non-barbiturate centrally active hypnotic sedative.
Danish: Thalidomid er endvidereet centralt aktivt, non-barbiturat hypnotisk sedativ.
English: Treatment must be initiated and monitored under the supervision of physicians with expertise in managing immunomodulatory or chemotherapeutic agents and a full understanding of the risks of thalidomide therapy and monitoring requirements (see section 4.4).
Danish: Behandling skal initieres og monitoreres af læger med erfaring i brug af immunmodulerende eller kemoterapeutiske midler og med fuld indsigt i risici forbundet med thalidomidbehandling samt kravene om monitorering.
English: • Maximum duration of treatment prescribed o 4 weeks of treatment for women with childbearing potential o 12 weeks of treatment for men and women without childbearing potential
Danish: • Maksimal varighed af ordineret behandling o 4 ugers behandling for kvinder i den fertile alder o 12 ugers behandling for mænd og kvinder, som ikke er i den fertile alder
English: You will be more prone to bleeding and bruising.
Danish: Du kan lettere komme til at bløde og få blå mærker.
English: Thalidomide Celgene is prescribed and dispensed according to the Thalidomide Celgene Pregnancy Prevention Programme (see section 4.4).
Danish: Thalidomide Celgene ordineres og gives i overensstemmelse med Thalidomide Celgenes Svangerskabsforebyggelsesprogram (se pkt.
English: WARNING
Danish: ADVARSEL
English: This could lead to a condition where the tumours break down and cause unusual levels of chemicals in the body which can lead to kidneys failure (this condition is called Tumour Lysis Syndrome) (see also section 4 “Possible side effects”).
Danish: Dette kan føre til en tilstand, hvor tumorerne nedbrydes og danner usædvanligt høje niveauer af nedbrydningsprodukter i kroppen, hvilket kan føre til nyresvigt (denne tilstand kaldes tumorlysesyndrom) (se også punkt 4 ”Bivirkninger”).
English: Medicinal products known to cause peripheral neuropathy Medicinal products known to be associated with peripheral neuropathy (e.g. vincristine and bortezomib) should be used with caution in patients receiving thalidomide.
Danish: Lægemidler, der er kendt for at være forbundet med perifer neuropati (f.eks. vincristin og bortezomib) bør anvendes med forsigtighed til patienter i behandling med thalidomid.
English: Results from IFM 99-06, a Phase 3, randomised, open label, parallel group, multicentre study have demonstrated a survival advantage when thalidomide is used in combination with melphalan and prednisone for 12 cycles of 6 weeks in the treatment of newly diagnosed multiple myeloma patients.
Danish: Resultater fra IFM 99-06, som var et fase 3, randomiseret, ublindet, parallelgruppe, multicenterstudier har påvist en øget overlevelse, når thalidomid benyttes i kombination med melphalan og prednison i 12 cyklusser af 6 ugers varighed til behandling af nydiagnosticerede patienter med myelomatose.
English: Data from in vitro studies and clinical trials suggest that the immunomodulatory, anti-inflammatory and anti-neoplastic effects of thalidomide may be related to suppression of excessive tumour necrosis factor-alpha (TNF-) production, down-modulation of selected cell surface adhesion molecules involved in leukocyte migration and anti-angiogenic activity.
Danish: Data fra in vitro-studier samt kliniske studier synes at pege i retning af, at de immunmodulerende, antiinflammatoriske og antineoplastiske virkninger af thalidomid er forbundet med supprimering af en for kraftig tumornekrosefaktor-alfa(TNF-)-produktion, nedregulering af udvalgte celleoverfladeadhæsionsmolekyler involveret i leukocytmigration samt antiangiogenetisk aktivitet.
English: • Bleeding from the stomach or bowels (gastrointestinal haemorrhage).
Danish: • Blødning fra maven eller tarmen (gastrointestinal blødning).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE TEGNEBOGSKORT
English: For men taking Thalidomide Celgene Thalidomide passes into semen.
Danish: Til mænd, der tager Thalidomide Celgene Thalidomid udskilles i sædvæsken.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Oral anvendelse.
English: However, due to the increased risk of thrombosis in cancer patients, and a potentially accelerated metabolism of warfarin with corticosteroids, close monitoring of INR values is advised during thalidomide-prednisone combination treatment as well as during the first weeks after ending these treatments.
Danish: På grund af den forøgede risiko for trombose hos cancerpatienter og muligheden for accelereret metabolisme af warfarin med kortikosteroider, anbefales der imidlertid omhyggelig monitorering af INR-værdier ved kombinationsbehandling med thalidomid og prednison indtil en uge efter denne behandlingsseponering.
English: The MAH shall agree the details of a controlled distribution system with the National Competent Authorities and must implement such programme nationally to ensure that:
Danish: • Yderligere risikominimeringsforanstaltninger Indehaveren af markedsføringstilladelsen udarbejder detaljerne for et kontrolleret distributionssystem med de kompetente, nationale myndigheder og skal følge et sådant program nationalt for at sikre, at:
English: The MAH should agree the final text of the Dear Healthcare Professional letter and the contents of the Educational Healthcare Professional's Kit with the National Competent Authority in each Member State prior to launch of the medicinal product and ensure that the materials contain the key elements as described below.
Danish: Indehaveren af markedsføringstilladelsen skal aftale den endelige tekst i Kære Sundhedspersonale-brevet og indholdet af undervisningsmaterialet til sundhedspersonalet med de kompetente, nationale myndigheder i hvert medlemsland forud for lancering af lægemidlet samt sikre, at det indeholder de nøgleelementer, der er beskrevet herunder.
English: Thalidomide Celgene is used with two other medicines called ‘melphalan' and ‘prednisone' to treat adults with a type of cancer called multiple myeloma.
Danish: Thalidomide Celgene benyttes sammen med to andre lægemidler, der hedder melphalan og prednison, til behandling af voksne med en kræfttype, som kaldes myelomatose.
English: • Viral infections, including herpes zoster (also known as ‘shingles', a viral disease that causes a painful skin rash with blisters) and recurrence of hepatitis B infection (which can cause yellowing of the skin and eyes, dark brown-coloured urine, right-sided stomach pain, fever and feeling nauseous or being sick).
Danish: • Virusinfektioner, herunder herpes zoster (også kaldet ”helvedesild”, en virussygdom, der forårsager smertefuldt hududslæt med blærer) og fornyet udbrud af hepatitis B-infektion (som kan forårsage gulfarvning af hud og øjne, mørkebrun urin, højresidige mavesmerter, feber og kvalme eller opkastning).
English: • Fever, feeling generally unwell.
Danish: • Feber, alment ubehag.
English: Therefore, these agents should be used with caution in multiple myeloma patients receiving thalidomide with prednisone and melphalan.
Danish: Derfor skal disse midler anvendes med forsigtighed hos patienter med myelomatose, som får thalidomid sammen med prednison og melphalan.
English: There is a linear relationship between body weight and estimated thalidomide clearance; in multiple myeloma patients with body weight from 47-133 kg, thalidomide clearance ranged from approximately 6-12 L/h, representing an increase in thalidomide clearance of 0.621 L/h per 10 kg body weight increase.
Danish: Hos myelomatosepatienter med en legemsvægt mellem 47-133 kg varierede thalidomid-clearance fra ca. 6-12 l/t, hvilket repræsenterer en stigning i thalidomid-clearance på 0,621 l/t pr. 10 kg forøgelse af legemsvægt.
English: • Fall of blood pressure on standing which may lead to fainting.
Danish: • Fald i blodtryk, når du rejser dig, hvilket kan medføre besvimelse.
English: Medicinal products known to be associated with neuropathy should be used with caution in patients receiving thalidomide (see section 4.5).
Danish: Lægemidler, der forbindes med neuropati, bør anvendes med forsigtighed hos patienter, der modtager thalidomid (se pkt.
English: • He understands that if his female partner becomes pregnant whilst he is taking thalidomide or 7 days after he has stopped taking thalidomide, he should inform his treating physician immediately and that it is recommended to refer the female partner to a physician specialised or experienced in teratology for evaluation and advice.
Danish: • Han forstår, at hvis mandens kvindelige partner bliver gravid, mens han tager thalidomid eller 7 dage efter, han er stoppet med at tage thalidomid, skal han straks informere den behandlende læge, og at det anbefales at henvise den kvindelige partner til vurdering og rådgivning hos en læge, der er specialist i eller har erfaring med teratologi.
English: • Severe blood infection (sepsis) accompanied by fever, chills and severe shaking, and possibly complicated by low blood pressure and confusion (septic shock).
Danish: • Alvorlig blodforgiftning (sepsis) ledsaget af feber, kuldegysninger og alvorlig rysten, muligvis kompliceret af lavt blodtryk og forvirring (septisk shock).
English: A medically supervised pregnancy test should be repeated every 4 weeks, including 4 weeks after the end of treatment, except in the case of confirmed tubal sterilisation.
Danish: En lægeligt overvåget graviditetstest bør gentages hver 4. uge samt 4 uger efter, at behandlingen er afsluttet, med undtagelse af tilfælde med bekræftet sterilisation ved lukning af tubae.
English: Very Common Peripheral oedema Common
Danish: Meget almindelig Perifert ødem Almindelig
English: • A brain condition with symptoms including vision changes, headache, seizures, and confusion, with or without high blood pressure (Posterior Reversible Encephalopathy Syndrome or PRES).
Danish: • En hjernelidelse med symptomer, der omfatter synsforandringer, hovedpine, krampeanfald og forvirring med eller uden højt blodtryk (posteriort reversibelt encefalopati-syndrom eller PRES).
English: If the patient experiences peripheral neuropathy, follow the dose and schedule modification instruction provided in section 4.2.
Danish: Hvis patienten oplever perifer neuropati, følges doserings- og modificeringsanvisningerne i pkt.
English: Peripheral neuropathy*, Tremor, Dizziness, Paraesthesia, Dysaesthesia, Somnolence
Danish: Meget almindelig Perifer neuropati*, tremor, svimmelhed, paræstesi, dysæstesi, somnolens
English: • you have kidney or liver problems (see also section 4 “Possible side effects”).
Danish: • Du har lever- eller nyreproblemer (se også punkt 4 ”Bivirkninger”).
English: • That she should return the capsules to the pharmacist at the end of treatment
Danish: • At hun skal levere kapslerne tilbage til apoteket ved behandlingens afslutning
English: A study in rabbits demonstrated no effect on fertility indices in males or females although testicular degeneration was observed in males.
Danish: Et studie på kaniner viste ingen påvirkning af fertilitetsindeks hos hverken hanner eller hunner, skønt testikeldegeneration blev observeret hos hannerne.
English: Marketing Authorisation Holder Celgene Europe B.V.
Danish: Indehaver af markedsføringstilladelsen Celgene Europe B.V.
English: Platelet Count (/µL)
Danish: Trombocyttal (/µl)
English: • Chest infection (pneumonia), lung disease.
Danish: • Lungebetændelse (pneumoni), lungesygdom.
English: • Irregularities of the heartbeat (heart block or atrial fibrillation), feeling faint or fainting.
Danish: • Uregelmæssige hjerteslag (hjerteblok eller atrieflimren), besvimelse eller følelse af at skulle besvime.
English: Due to the sedative effect associated with thalidomide, administration at bedtime is known to generally improve tolerability.
Danish: b På grund af thalidomids sedative virkning har indtagelse ved sengetid generelt en positiv indvirkning på tolerabiliteten.
English: Data from patients with end-stage renal disease suggest no impact of kidney function on thalidomide pharmacokinetics.
Danish: Data for patienter med nyresygdom i slutstadiet tyder ikke på, at nyrefunktionen påvirker thalidomids farmakokinetik.
English: • you have a fall in the number of white blood cells (neutropenia) accompanied by fever and infection.
Danish: • Du oplever et fald i antallet af hvide blodlegemer (neutropeni) ledsaget af feber og infektion.
English: Decreased platelet counts were noted in the mouse and rat studies.
Danish: Nedsat trombocyttal fandtes i studier med mus og rotter.
English: If Stevens-Johnson syndrome, TEN or DRESS is suspected, use of thalidomide should not be resumed (see section 4.2 and 4.4).
Danish: Hvis der er mistanke om Stevens-Johnson syndrom, TEN eller DRESS, må anvendelse af thalidomid ikke genoptages (se pkt.
English: MP (n=193)
Danish: n (% af patienterne) MP (n=193)
English: It is important to note that a small number of patients with multiple myeloma may develop additional types of cancer, especially haematological malignancies, and it is possible that this risk may be increased with Thalidomide Celgene treatment; therefore your doctor should carefully evaluate the benefit and risk when you are prescribed Thalidomide Celgene.
Danish: Det er vigtigt at bemærke, at et lille antal patienter med myelomatose kan udvikle andre former for kræft, især ondartede blodsygdomme, og det er muligt, at behandling med Thalidomide Celgene kan øge denne risiko.
English: Do not take Thalidomide Celgene
Danish: Tag ikke Thalidomide Celgene
English: • A condition affecting the skin caused by inflammation of small blood vessels, along with pain in the joints and fever (leukocytoclastic vasculitis).
Danish: • En tilstand, der angriber huden, og som skyldes betændelse i små blodkar, med smerter i leddene og feber (leukocytoklastisk vaskulitis).
English: Posterior reversible encephalopathy syndrome (PRES)/ Reversible posterior leukoencephalopathy syndrome (RPLS)
Danish: Posteriort reversibelt encefalopati-syndrom (PRES) / reversibelt leukoencefalopati-syndrom (RPLS) Tilfælde af PRES/RPLS er blevet rapporteret.
English: • Kidney disease (renal failure).
Danish: • Nyresygdom (nyresvigt).
English: At the end of your treatment you should return all unused capsules to the pharmacist or doctor.
Danish: Ved behandlingsophør skal du aflevere alle ubrugte kapsler til apoteket eller din læge.
English: Due to thalidomide's potential to induce bradycardia, caution should be exercised with medicinal products having the same pharmacodynamic effect such as active substances known to induce torsade de pointes, beta blockers or anticholinesterase agents.
Danish: På grund af thalidomids potentiale for at fremkalde bradykardi bør forsigtighed udvises ved samtidig brug af lægemidler, der har samme farmakodynamiske virkning, såsom betablokkere, kolinesterasehæmmere og aktive stoffer, der vides at kunne inducere torsade de pointes.
English: • Chest pain spreading to the arms, neck, jaw, back or stomach, feeling sweaty and breathless, feeling sick or vomiting.
Danish: • Brystsmerter, som spreder sig til arme, hals, kæbe, ryg eller mave, følelse af at være svedig og stakåndet, kvalme eller opkastning.
English: • Inflammation and swelling of the tubes in your lungs (bronchitis).
Danish: • Betændelse eller hævelse af forgreningerne i lungerne (bronkitis).
English: • Increase in blood pressure within blood vessels that supply the lungs which can lead to shortness of breath, tiredness, dizziness, pain in the chest, a faster heartbeat, or swelling in the legs or ankles (pulmonary hypertension).
Danish: • Forhøjet blodtryk i blodkar, der fører blod til lungerne, hvilket kan medføre stakåndethed, træthed, svimmelhed, brystsmerter, hurtigere hjerteslag eller hævede ben eller ankler (pulmonal hypertention).
English: In addition, you must not become pregnant while taking Thalidomide Celgene.
Danish: Hertil kommer, at du ikke må blive gravid, mens du tager Thalidomide Celgene.
English: No evidence of carcinogenicity was observed at exposures approximately 15, 13 and 39 times the estimated clinical AUC at the recommended starting dose in mice, male rats and female rats respectively.
Danish: Der blev ikke observeret tegn på karcinogenicitet i mus, han- eller hunrotter ved eksponering på henholdsvis ca. 15, 13 og 39 gange den anslåede kliniske AUC ved anbefalet startdosis.
English: Table 3 contains only the adverse reactions for which a causal relationship with medicinal product treatment could reasonably be established observed in the pivotal study and from post-marketing experience.
Danish: Tabel 3 indeholder kun bivirkninger, der har en beviselig sammenhæng med thalidomidbehandling observeret i det pivotale studie og efter markedsføring.
English: • That if his partner becomes pregnant he should inform his treating doctor immediately and always use a condom
Danish: • At han, hvis hans partner bliver gravid, skal underrette den behandlende læge med det samme, og altid anvende kondom
English: The melphalan recommended starting dose is 0.1 to 0.2 mg/kg daily according to bone marrow reserve along with a further 50 % dose reduction for moderate (creatinine clearance: ≥ 30 but < 50 mL/minute) or severe (CrCl: < 30 mL/minute) renal insufficiency.
Danish: Den anbefalede startdosis af melphalan er 0,1-0,2 mg/kg dagligt i henhold til knoglemarvsreserve sammen med yderligere dosisnedsættelse på 50 % ved moderat nedsat nyrefunktion (kreatininclearance ≥ 30, men < 50 ml/minut) eller svært nedsat nyrefunktion (CrCl < 30 ml/minut).
English: The adverse reaction of the skin may appear as rashes with or without blisters.
Danish: Hudrelaterede bivirkninger kan vise sig som udslæt med eller uden blæredannelse.