FrancophonIA/ELRC3.0 huggingface dataset:
English: In one 2-year-old child who took 700 mg, there was an abnormal plantar response in addition to drowsiness and irritability.
Danish: Hos et 2-årigt barn, som fik 700 mg, var der et unormalt plantarrespons i tillæg til døsighed og irritabilitet.
English: Thalidomide does not interact with digoxin.
Danish: Thalidomid interagerer ikke med digoxin.
English: Thalidomide Celgene works by helping the body's immune system and directly attacking the cancer.
Danish: Thalidomide Celgene virker ved at hjælpe kroppens immunsystem og direkte angribe kræften.
English: Educational materials
Danish: Undervisningsmaterialer
English: If possible, take the medicine pack and this leaflet with you.
Danish: Om muligt skal du medbringe medicinpakningen og denne indlægsseddel.
English: All 4 cases involved other possible contributing factors preventing the establishment of a definite direct causal relationship between thalidomide and DRESS, but a link with thalidomide could also not be excluded.
Danish: Alle 4 tilfælde omfattede andre mulige bidragende faktorer, hvilket ikke gør det muligt at fastlægge et afgjort direkte kausalt forhold mellem thalidomid og DRESS, men en forbindelse med thalidomid kan heller ikke udelukkes.
English: If you do not fully understand these instructions, please ask your doctor to explain them again before you take thalidomide.
Danish: Hvis du ikke helt forstår disse instruktioner, skal du bede din læge forklare dem igen, før du tager thalidomid.
English: • A spinning feeling in your head, making it difficult to stand up and move normally.
Danish: • En fornemmelse af, at alting drejer rundt, så det er vanskeligt at stå op og bevæge sig normalt.
English: Careful monitoring of patients for symptoms of neuropathy is recommended.
Danish: Nøje monitorering af patienterne for symptomer på neuropati anbefales.
English: For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Danish: For patienter, der testes positive for HBV-infektion, anbefales konsultation med en læge med ekspertise i behandling af hepatitis B.
English: In plasma, unchanged thalidomide represents 80 % of the circulatory components.
Danish: I plasma udgør uomdannet thalidomid 80 % af de cirkulerende forbindelser.
English: Results of the user testing will have to be provided to the national competent authority and final materials validated at a national level.
Danish: Resultaterne af brugerafprøvningen skal evalueres af den nationale, kompetente myndighed og de endelige materialer godkendes på nationalt niveau.
English: Platelet counts should be monitored on an ongoing basis, in accordance with oncology guidelines.
Danish: Trombocyttallet bør monitoreres løbende i henhold til onkologiske retningslinjer.
English: Additional precautions
Danish: Yderligere forholdsregler
English: If you experience such symptoms, speak to your doctor straight away, who may reduce the dose or discontinue the treatment.
Danish: Hvis du oplever sådanne symptomer, skal du straks tale med din læge, som kan nedsætte dosis eller afbryde behandlingen.
English: Reduce dose or interrupt treatment and continue to monitor the patient with clinical and neurological examination.
Danish: Reducer dosis eller afbryd behandlingen og fortsæt monitorering af patienten med klinisk og neurologisk studie.
English: PVC/PCTFE/aluminium blister containing 14 capsules.
Danish: PVC/PCTFE/aluminium-blisterkort med 14 kapsler.
English: Grade 4 (neuropathy which is disabling)
Danish: Grad 4 (neuropati, der er invaliderende)
English: This is because alcohol can make you sleepy and Thalidomide Celgene can make you even sleepier.
Danish: Det skyldes, at alkohol kan gøre dig døsig, og Thalidomide Celgene kan gøre dig endnu mere døsig.
English: If more than 12 hours has elapsed since missing a dose at the normal time, the patient should not take the dose, but take the next dose at the normal time on the following day.
Danish: Hvis der er gået mere end 12 timer siden en dosis er glemt på det sædvanlige tidspunkt, må patienten ikke tage dosen, men skal tage den næste dosis på det sædvanlige tidspunkt den følgende dag.
English: Peripheral neuropathy generally occurs following chronic use over a period of months.
Danish: Perifer neuropati forekommer almindeligvis efter langvarig anvendelse i et antal måneder.
English: • if you are able to become pregnant, unless you are able to follow or comply with the required contraceptive measures to prevent you from becoming pregnant (see section 2 “Warnings and precautions” and “Pregnancy and breast-feeding”).
Danish: • Hvis du er i stand til at blive gravid, medmindre du er i stand til at overholde eller følge de nødvendige forholdsregler for prævention for at undgå at blive gravid (se punkt 2 ”Advarsler og forsigtighedsregler” og ”Graviditet og amning”).
English: The latter appears to be related to thalidomide and occurred at exposures greater than 2.4-fold the human exposure.
Danish: Sidstnævnte synes at være relateret til thalidomid og forekom ved eksponering, der var over 2,4 gange større end human eksponering.
English: If less than 12 hours has elapsed since missing a dose, the patient can take the dose.
Danish: Hvis der er gået mindre end 12 timer siden en dosis er glemt, kan patienten tage dosen.
English: The major route of excretion was via the urine (> 90 %) while faecal excretion was minor.
Danish: Den primære udskillelsesvej var via urinen (> 90 %), mens fækal udskillelse var begrænset.
English: These cells collect in the bone marrow and divide out of control.
Danish: Disse celler ophobes i knoglemarven og deler sig ukontrolleret.
English: The risk of intra-uterine death or severe birth defects, primarily phocomelia, is extremely high.
Danish: Risikoen for fosterdød eller alvorlige fødselsdefekter, primært fokomeli, er ekstremt høj.
English: No effects were observed in dogs; however in rats, there was an apparent dose-dependent decrease in total and free T4 that was more consistent in the female.
Danish: Der blev ikke observeret nogen virkning hos hunde; men hos rotter var der en synlig dosisafhægig reduktion af totalt og frit T4, som var mere ensartet hos hunnerne.
English: Thalidomide may also potentially aggravate existing neuropathy and should therefore not be used in patients with clinical signs or symptoms of peripheral neuropathy unless the clinical benefits outweigh the risks.
Danish: Thalidomid kan potentielt også forværre eksisterende neuropati og bør derfor ikke benyttes til patienter med kliniske tegn eller symptomer på neuropati, medmindre de kliniske fordele opvejer risici.
English: • by stimulating part of the immune system to attack the cancer cells.
Danish: • ved at stimulere dele af immunsystemet til at angribe kræftcellerne.
English: If a patient is currently using combined oral contraception, she should switch to one of the effective methods listed above.
Danish: Hvis en patient benytter orale kombinationspræparater, bør hun skifte til en af de effektive metoder, der er angivet herover.
English: • A fall in the number of red and white blood cells and platelets at the same time (pancytopenia).
Danish: • Nedsat antal røde og hvide blodlegemer og blodplader på samme tid (pancytopeni).
English: The results were similar with and without co-administration of thalidomide 200 mg/day to steady-state levels.
Danish: Resultaterne var næsten ens med og uden samtidig indtagelse af thalidomid 200 mg/dag indtil steady-state-niveau.
English: This requirement includes women of childbearing potential who practice absolute and continuous abstinence.
Danish: Dette krav omfatter også kvinder i den fertile alder, der praktiserer fuldstændig og vedvarende seksuel afholdenhed.
English: Therefore, do not have unprotected intercourse, even if you had a vasectomy.
Danish: Derfor må du ikke have ubeskyttet samleje, selv hvis du er vasektomeret.
English: It is not known whether the effect will be different in multiple myeloma patients.
Danish: Det vides ikke, om virkningen vil være en anden hos patienter med myelomatose.
English: • She acknowledges that she understands the hazards and necessary precautions associated with the use of thalidomide.
Danish: • Hun bekræfter, at hun forstår risici og nødvendigheden af de forholdsregler, der er forbundet med anvendelsen af thalidomid.
English: Thalidomide has a chiral centre and is used clinically as a racemate of (+)-(R)- and (-)-(S)-thalidomide.
Danish: Thalidomid har et kiralt center og benyttes klinisk som racemisk blanding af (+)-(R)- og (-)-(S)-thalidomid.
English: Treatment with Thalidomide Celgene may cause a virus to become active again in patients who carry it, resulting in a recurrence of the infection.
Danish: Behandling med Thalidomid Celgene kan få en virus til at blive aktiv igen hos patienter, som bærer denne, hvilket medfører, at infektionen vender tilbage.
English: It can also happen sometime after treatment has stopped.
Danish: Den kan også forekomme nogen tid efter, at behandlingen er ophørt.
English: Pharmacotherapeutic group: immunosuppressants, other immunosuppressants, ATC code: L04AX02.
Danish: Farmakoterapeutisk klassifikation: immunsuppressiva, andre immunsuppressiva, ATC-kode: L04AX02.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: • Brochure for male patients
Danish: • Brochure for mandlige patienter
English: If no improvement or continued worsening of the neuropathy, discontinue treatment.
Danish: Hvis der ikke sker en bedring, eller hvis der sker en forværring af neuropatien, standses behandlingen.
English: In addition, the addition of interruption or discontinuation recommendations regarding the risk of severe skin reactions in general, in line with the one already approved for the structural analogues lenalidomide and pomalidomide, is supported.
Danish: Desuden støttes det, at der tilføjes anbefalinger for afbrydelse eller seponering hvad angår risikoen for svære hudreaktioner generelt, i overensstemmelse med de allerede godkendte anbefalinger for de strukturelle analoger, lenalidomid og pomalidomid.
English: A diagnosis of PRES/RPLS requires confirmation by brain imaging.
Danish: En diagnose på PRES/RPLS kræver bekræftelse via hjernescanning.
English: • The patient complies with the conditions of the Pregnancy Prevention Programme including confirmation that she has an adequate level of understanding
Danish: • Patienten overholder betingelserne i svangerskabsforebyggelsesprogrammet, herunder bekræftelse af, at hun har forstået dette i tilstrækkelig grad.
English: • The other excipients are: o The capsule content contains pregelatinised starch and magnesium stearate.
Danish: • Øvrige indholdsstoffer: o Kapslens indhold indeholder prægelatiniseret stivelse og magnesiumstearat.
English: No time dependency of the pharmacokinetics has been observed.
Danish: Der er ikke observeret nogen tidsafhængighed for farmakokinetikken.
English: Symptoms may occur some time after thalidomide treatment has been stopped and may resolve slowly or not at all.
Danish: Der kan forekomme symptomer nogen tid efter, at behandlingen med thalidomid er seponeret, og disse kan forsvinde langsomt eller slet ikke.
English: In the event of an overdose, the patient's vital signs should be monitored and appropriate supportive care given to maintain blood pressure and respiratory status.
Danish: I tilfælde af overdosering monitoreres patientens vitale tegn, og relevant understøttende behandling gives til opretholdelse af blodtryk og respiration.
English: > 75 < 1,500 but
Danish: > 75 < 1.500, men
English: Do not take Thalidomide Celgene if any of the above applies to you.
Danish: Tag ikke Thalidomide Celgene, hvis noget af ovenstående gælder for dig.
English: • National specific requirements agreed with the National Competent Authority regarding: o Distribution of the product o Procedures to ensure that all appropriate measures have been performed prior to thalidomide being dispensed
Danish: • Specifikke, nationale krav som skal godkendes af de kompetente, nationale instanser med hensyn til: o Produktdistribution o Procedurer til at sikre at alle relevante forholdsregler er blevet taget, inden thalidomid ordineres
English: Tell your doctor straight away if you notice any of the following serious side effects:
Danish: Kontakt straks din læge, hvis du bemærker en eller flere af følgende alvorlige bivirkninger:
English: Continue to monitor the patient with clinical examination.
Danish: Fortsæt monitorering af patienten med klinisk studie.
English: • cause sleepiness as thalidomide may increase their effects.
Danish: • Forårsager døsighed, da thalidomid kan øge denne virkning.
English: (For description of symptoms see section 4 “Possible side effects”).
Danish: (For beskrivelse af symptomerne, se punkt 4 ”Bivirkninger”).
English: Infections Patients should be monitored for severe infections including sepsis and septic shock.
Danish: Infektioner Patienterne skal monitoreres for svære infektioner, herunder sepsis og septisk shock.
English: • you have or have ever had previous viral infection, particularly varicella zoster, hepatitis B infection, or HIV.
Danish: • Du har eller nogensinde har haft en virusinfektion, især varicella zoster, hepatitis B-infektion eller hiv.
English: There are in vitro data indicating that prednisone may give rise to enzyme induction which could reduce the systemic exposure of concomitantly used medicinal products.
Danish: Der findes in vitro-data, der angiver, at prednison kan fremkalde enzyminduktion, hvilket muligvis kan reducere den systemiske eksponering af samtidigt anvendte lægemidler.
English: Thalidomide Celgene with food, drink and alcohol Do not drink alcohol while you are taking Thalidomide Celgene.
Danish: Brug af Thalidomide Celgene sammen med mad, drikke og alkohol Du må ikke drikke alkohol, når du tager Thalidomide Celgene.
English: • you experienced or have existing slow heart rate (this may be a symptom of bradycardia).
Danish: • Du har oplevet eller aktuelt har en langsom puls (dette kan være et symptom på bradykardi).
English: White blood cell count and differential should be monitored on an ongoing basis, in accordance with oncology guidelines, especially in patients who may be more prone to neutropenia.
Danish: Tælling af hvide blodlegemer og differentialtælling bør udføres løbende i henhold til onkologiske retningslinjer, især hos patienter, som kan have en større tendens til neutropeni.
English: ≤ 75 < 1,500 but
Danish: ≤ 75 < 1.500, men
English: Hepatitis B virus status should be established before initiating treatment with thalidomide.
Danish: Hepatitis B-virusstatus bør fastlægges før påbegyndelse af behandling med thalidomid.
English: • She should be capable of complying with effective contraceptive measures
Danish: • Hun skal være i stand til at følge effektive forholdsregler for prævention.
English: • Women who are pregnant (see section 4.6).
Danish: • Kvinder, som er gravide (se pkt.
English: • Worsening of Parkinson's disease symptoms (such as tremor, depression or confusion).
Danish: • Forværring af symptomer fra Parkinsons sygdom (såsom rysten, depression eller forvirring).
English: • Tumour Lysis Syndrome - metabolic complications that can occur during the treatment of cancer and sometimes even without treatment.
Danish: • Tumorlysesyndrom - stofskiftekomplikationer, der kan forekomme i løbet af kræft-behandling og nogle gange endda uden behandling.
English: Thalidomide is metabolised almost exclusively by non-enzymatic hydrolysis.
Danish: Thalidomid metaboliseres næsten udelukkende ved non-enzymatisk hydrolyse.
English: Grade 1 (paraesthesia, weakness and/or loss of reflexes) with no loss of function
Danish: Grad 1 (paræstesi, svækkelse og/eller reflekstab) uden funktionstab
English: • Pregnancy prevention requirement, definition and need for adequate contraceptive methods
Danish: • Krav til svangerskabsforebyggelse, definition og nødvendighed af hensigtsmæssige svangerskabsforebyggende metoder
English: • She is informed and understands the potential consequences of pregnancy and the need to rapidly consult her doctor if there is a risk of pregnancy
Danish: • Hun er blevet oplyst om og forstår de potentielle konsekvenser ved graviditet samt nødvendigheden af øjeblikkeligt at kontakte lægen, hvis der er risiko for graviditet.
English: These can happen during treatment, or after treatment has stopped.
Danish: Det kan forekomme under behandlingen, eller efter at behandlingen er ophørt.
English: If you are able to become pregnant, your doctor will record with each prescription that the necessary measures, as outlined above, have been taken
Danish: Hvis du kan blive gravid, vil din læge ved hver ordination registrere, at der er taget de nødvendige forholdsregler som beskrevet ovenfor.
English: Oxidative metabolism does not contribute significantly to the overall metabolism of thalidomide.
Danish: Oxidativ metabolisme bidrager ikke signifikant til den overordnede thalidomid-metabolisme.
English: • Educational brochures for patients: o The educational brochures for patients should be of 3 types:
Danish: • Oplysningsbrochurer til patienter o Der skal være 3 typer oplysningsbrochurer til patienter:
English: Taking into account the PRAC Assessment Report on the PSUR(s) for thalidomide, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for thalidomid er CHMP nået frem til følgende videnskabelige konklusioner:
English: Do not take thalidomide if you are pregnant or could become pregnant.
Danish: Tag ikke thalidomid, hvis du er gravid eller muligvis kan blive gravid.
English: For women taking Thalidomide Celgene Before starting the treatment, you should ask your doctor if you are able to become pregnant, even if you think this is unlikely.
Danish: Til kvinder, der tager Thalidomide Celgene Før du begynder på behandlingen, skal du spørge din læge, om du kan blive gravid, selv hvis du mener, det er usandsynligt.
English: The test should ensure the patient is not pregnant when she starts treatment with thalidomide.
Danish: Testen skal sikre, at patienten ikke er gravid, når hun starter behandlingen med thalidomid.
English: • The need for effective contraception
Danish: • Nødvendigheden af sikker kontraception
English: A clear mechanism by which thalidomide can induce amenorrhea is not elucidated.
Danish: En præcis mekanisme, hvorved thalidomid kan inducere amenorré, er ikke klarlagt.
English: Patients should be monitored and dose reduction may be required.
Danish: Patienterne bør monitoreres, og reduceret dosis kan være påkrævet.
English: The use of thalidomide could be associated with menstrual disorders including amenorrhea.
Danish: Brugen af thalidomid kan være forbundet med menstruationsforstyrrelser, herunder amenorré.
English: Thalidomide must never be used by women who are pregnant or by women who could become pregnant unless all the conditions of the Pregnancy Prevention Programme are met.
Danish: Thalidomid må aldrig benyttes af kvinder, der er gravide, eller af kvinder, der kan blive gravide, medmindre alle betingelserne i svangerskabsforebyggelsesprogrammet er opfyldt.
English: • if you are pregnant or think you may be pregnant or are planning to become pregnant, as Thalidomide Celgene causes birth defects and foetal death.
Danish: • Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, eftersom Thalidomide Celgene forårsager fødselsdefekter og fosterdød.
English: No specific dose recommendations for these patient populations are available.
Danish: Der findes ingen specifik doseringsanbefaling for disse patientgrupper.
English: You will have been given specific instructions by your doctor, particularly on the effects of thalidomide on unborn babies (outlined in the Thalidomide Celgene Pregnancy Prevention Programme).
Danish: Din læge har givet dig specifikke instruktioner, især om virkningerne af thalidomid på ufødte børn (beskrevet i Thalidomide Celgenes Svangerskabsforebyggelsesprogram).
English: Confusional state, Depression
Danish: Forvirring, depression
English: If the neuropathy resolves to Grade 1 or better, the treatment may be restarted, if the benefit/risk is favourable.
Danish: Hvis neuropatien remitterer til grad 1 eller bedre, kan behandlingen genstartes, hvis dette understøttes af en vurdering af fordele og risici.
English: Therefore, considering the seriousness of this risk, the PRAC considers that the risk should be reflected in the PI of thalidomide.
Danish: I betragtning af hvor alvorlig denne risiko er, vurderer PRAC derfor, at denne risiko skal afspejles i produktinformationen for thalidomid.
English: • you have had a heart attack, have ever had a blood clot in the past, or if you smoke, have high blood pressure or high cholesterol levels.
Danish: • Du har haft et hjerteanfald, nogensinde har haft en blodprop, eller hvis du ryger, har højt blodtryk eller højt kolesterolindhold i blodet.
English: This 18 month difference was statistically significant with a hazard ratio of reduction of risk of death in the MPT arm of 0.59, 97.5 % confidence interval of 0.42-0.84 and p-value of < 0.001 (see Figure 1).
Danish: Denne 18 måneders forskel var statistisk signifikant med en hazard ratio på 0,59 for reduktion af risikoen for dødsfald i MPT-armen, et 97,5 % konfidensinterval på 0,42-0,84 og en p-værdi på < 0,001 (se figur 1).
English: It is very common that thalidomide causes somnolence.
Danish: Det er meget almindeligt, at thalidomid forårsager døsighed.
English: No specific pattern was identified between hepatocellular and cholestatic abnormalities, with some cases having a mixed presentation.
Danish: Intet særligt mønster blev identificeret mellem hepatocellulære og kolestatiske anomalier, og nogle tilfælde havde en blandet forekomst.
English: • Sexual dysfunction, for example impotence.
Danish: • Seksuel dysfunktion, f.eks. rejsningsproblemer (impotens).
English: You must stop treatment and inform your doctor straight away if:
Danish: Du skal straks ophøre med behandlingen og kontakte din læge med det samme, hvis:
English: The recommended dose of thalidomide is 200 mg orally per day.
Danish: Den anbefalede thalidomiddosis er 200 mg oralt dagligt.
English: It is recommended that clinical and neurological examinations are performed in patients prior to starting thalidomide therapy, and that routine monitoring is carried out regularly during treatment.
Danish: Det anbefales, at kliniske og neurologiske studier udføres på patienter før påbegyndelse af behandling med thalidomid samt at rutinemæssig monitorering udføres jævnligt under behandlingen.
English: • That if she is pregnant or plans to be, she must not take thalidomide
Danish: • At hun, hvis hun er gravid eller planlægger at blive gravid, ikke må tage thalidomid
English: Your doctor may monitor your blood cell counts during treatment with Thalidomide Celgene.
Danish: Din læge kan holde øje med dit blodcelletal under behandlingen med Thalidomide Celgene.
English: • you have a fall in the number of platelets.
Danish: • Du oplever et fald i antallet af blodplader.
English: Do not apply pressure on the centre of the capsule as this can cause it to break.
Danish: Tryk ikke midt på kapslen, da det kan forårsage, at den knækker.
English: You must follow the contraception advice given to you by your doctor.
Danish: Du skal følge den vejledning om svangerskabsforebyggelse, din læge har givet dig.
English: Your doctor may check if you have a high total amount of tumour throughout the body, including your bone marrow.
Danish: Lægen vil måske undersøge, om du har mange eller store tumorer (svulster) i kroppen, herunder i din knoglemarv.
English: In humans, thalidomide is a proven teratogen.
Danish: Hos mennesker er thalidomid et bevist teratogen.
English: OR < 100,000 but
Danish: ELLER < 100.000, men