FrancophonIA/ELRC3.0 huggingface dataset:
English: • All educational brochures for patients should contain the following information o That thalidomide is teratogenic o That thalidomide may cause ischaemic heart disease, (including myocardial infarction) o Description of the patient card and its use in the individual Member State o Guidance on handling Thalidomide Celgene for patients, caregivers and family members o National or other applicable specific arrangements for a prescription for thalidomide to be dispensed o That thalidomide must not be given to any other person o That the patient should not donate blood o That the patient should tell their doctor about any adverse events o That any unused capsules should be returned to the pharmacist at the end of the treatment
Danish: • Alle oplysningsbrochurer til patienter skal indeholde følgende oplysninger: o At thalidomid er teratogent o At thalidomid kan forårsage iskæmisk hjertesygdom (herunder myokardieinfarkt) o Beskrivelse af patientkortet og dets anvendelse i den enkelte medlemsstat o Vejledning til patienter, omsorgspersoner og familiemedlemmer i håndtering af
English: Breast-feeding
Danish: Propylenglycol
English: • That he should not donate blood or semen during treatment (including during dose interruptions) and for at least 7 days following discontinuation of thalidomide
Danish: • At han ikke bør donere blod eller sæd under behandlingen (herunder ved pausering af behandlingen) og i mindst 7 dage efter thalidomidbehandlingen afsluttes
English: How to take Thalidomide Celgene
Danish: Sådan skal du tage Thalidomide Celgene
English: Thalidomide causes severe birth defects or death to an unborn baby.
Danish: Thalidomid forårsager alvorlige fødselsdefekter eller fosterdød.
English: • Feeling dizzy.
Danish: • Rysten.
English: What you need to know before you take Thalidomide Celgene 3.
Danish: 2 ”Det skal du vide, før du begynder at tage Thalidomide Celgene”.
English: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Danish: Brug af anden medicin sammen med Thalidomide Celgene Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Do not drive or use any tools or machines if you experience side effects, such as dizziness, tiredness, sleepiness or blurred vision.
Danish: Hvis du oplever bivirkninger såsom svimmelhed, træthed eller sløret syn, må du ikke føre motorkøretøj eller betjene værktøj eller maskiner.
English: • That he should not donate semen during treatment (including during dose interruptions) and for at least 7 days following discontinuation of thalidomide
Danish: • At han ikke må donere sæd under behandlingen (herunder ved pausering af behandingen) og i mindst 7 dage efter thalidomidbehandlingen afsluttes
English: 100 mg daily 0.20 mg/kg daily 2 mg/kg daily
Danish: 0,20 mg/kg dagligt
English: Posterior reversible encephalopathy syndrome (PRES)*
Danish: Posteriort reversibelt encepfalopati-syndrom (PRES)*†, forværring af symptomer på Parkinsons sygdom†
English: 100 mg daily 0.10 mg/kg daily 2 mg/kg daily
Danish: 0,10 mg/kg dagligt
English: • That she should not donate blood during treatment (including during dose interruptions) and for at least 7 days following discontinuation of thalidomide
Danish: • At hun ikke må donere blod under behandlingen (herunder ved pausering af behandlingen) og i mindst 7 dage efter thalidomidbehandlingen afsluttes
English: Prescribing and dispensing restrictions
Danish: Advarsler og forsigtighedsregler
English: Renal failure
Danish: Nyresvigt†
English: Acute myeloid leukaemia*
Danish: Akut myeloid leukæmi*^ Ikke almindelig Myelodysplastisk syndrom*^ Ikke kendt
English: 200 mg daily 0.25 mg/kg daily 2 mg/kg daily
Danish: 0,25 mg/kg dagligt
English: Hepatic and renal impairment
Danish: Nyrer og urinveje
English: Somnolence
Danish: Døsighed
English: Thalidomide Celgene 50 mg hard capsules
Danish: LÆGEMIDLETS NAVN Thalidomide Celgene 50 mg hård kapsel.
English: Thalidomide Celgene 50 mg
Danish: INFORMATION I BRAILLESKRIFT Thalidomide Celgene 50 mg
English: There is minimal cytochrome P450 catalysed hepatic metabolism of thalidomide.
Danish: En meget lille del af thalidomid metaboliseres af CYP i leveren.
English: Haematological disorders
Danish: Hæmatologiske sygdomme
English: 6.6 Special precautions for disposal and other handling
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF
English: How Thalidomide Celgene works
Danish: Sådan virker Thalidomide Celgene:
English: NAME OF THE MEDICINAL PRODUCT
Danish: Oversigt over indlægssedlen
English: • The need to contact their doctor immediately upon suspicion of pregnancy o Male patients
Danish: • Nødvendigheden af øjeblikkelig orientering af den behandlende læge ved mistanke om graviditet
English: 28 hard capsules
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 28 hårde kapsler
English: ANC: Absolute Neutrophil Count a
Danish: Absolut neutrofiltal (/µl)
English: †, Abnormal coordination
Danish: Kramper†, koordinationsforstyrrelser
English: Sexual dysfunction
Danish: Leversygdomme
English: SUMMARY OF PRODUCT CHARACTERISTICS
Danish: Tabel over bivirkninger
English: WALLET CARD
Danish: Mave-tarm-kanalen
English: if you are over 65 years of age.
Danish: - hvis du er over 65 år.
English: 100% of planned dose
Danish: 100 % af den planlagte dosis
English: Do not use Torisel:
Danish: Brug ikke Torisel:
English: Periodical follow-up assessments may be considered.
Danish: Periodisk opfølgning bør overvejes.
English: Interaction studies have only been performed in adults.
Danish: Interaktionsundersøgelser er kun udført hos voksne.
English: Date of the latest renewal: 13 July 2017
Danish: Dato for seneste fornyelse: 13. juli 2017
English: Unopened vial 3 years.
Danish: Uåbnet hætteglas 3 år.
English: Children and adolescents
Danish: Børn og teenagare
English: Gender, weight, race, age
Danish: Køn, vægt, race, alder
English: Post-marketing experience
Danish: Post-marketing erfaring
English: if you drink alcohol or are an alcoholic.
Danish: - hvis du drikker alkohol eller er alkoholiker.
English: These reactions can occur very early in the first infusion, but may also occur with subsequent infusions.
Danish: Disse reaktioner kan optræde meget tidligt ved den første infusion, men kan også optræde ved efterfølgende infusioner.
English: Side effects for which frequency is not known (cannot be estimated from available data):
Danish: Bivirkninger, hvor hyppigheden ikke kendes (kan ikke estimeres ud fra forhåndenværende data):
English: If you are concerned about this, tell your doctor immediately.
Danish: Hvis du er bekymret for dette, skal du straks sige det til lægen.
English: Via Franco Gorgone Zona Industriale 95100 Catania Italy
Danish: Via Franco Gorgone Zona Industriale 95100 Catania Italien
English: Torisel is used to treat the following types of cancer in adults:
Danish: Torisel anvendes til behandling af følgende kræftformer hos voksne:
English: No relevant differences in exposure were apparent when data from the Caucasian population was compared with either the Japanese or Black population.
Danish: Der var tilsyneladende ingen relevante forskelle i eksposition, når data fra den hvide population blev sammenlignet med enten den japanske eller sorte population.
English: Immunosuppressants may affect responses to vaccination.
Danish: Immunosuppressiva kan påvirke reaktionerne på vaccination.
English: Torisel with food and drink
Danish: Brug af Torisel sammen med mad og drikke
English: Sufficient time should be allowed for air bubbles to subside.
Danish: Der skal gå tilstrækkelig tid til, at luftboblerne bliver mindre.
English: None of the 3 cohorts met the criterion for advancing to the second stage of the Simon 2-stage design.
Danish: Ingen af de 3 kohorter opfyldte kriteriet for at gå videre til andet stadie af Simon 2-stadiedesignet.
English: The following information is intended for healthcare professionals only:
Danish: Nedenstående oplysninger er til sundhedspersonale:
English: Discuss alternatives with your doctor.
Danish: Tal med lægen om alternative muligheder.
English: As this medicine is prepared and given by a healthcare professional, it is unlikely you will be given too much or that you will miss a dose.
Danish: Da denne medicin klargøres og indgives af sundhedspersonale, er det usandsynligt, at du vil få for meget, eller at en dosis vil blive glemt.
English: The effect may also be more pronounced at a 25 mg dose.
Danish: Virkningen kan også være mere udtalt ved en dosis på 25 mg.
English: Secondary efficacy endpoints included OS and ORR.
Danish: De sekundære effektendepunkter omfattede OS og ORR.
English: Investigator's choice (inv choice) n = 54
Danish: Investigators valg n = 54
English: For some animals, there were no specific clinical observations or histological changes that suggested inflammation.
Danish: For nogle dyrs vedkommende var der ingen specifikke kliniske observationer eller histologiske forandringer, der tydede på inflammation.
English: Adverse events were generally similar to those observed in adults (see section 4.8).
Danish: Bivirkningerne lignende generelt dem, der blev konstateret hos voksne (se afsnit 4.8).
English: The fatal events included those due to progression of disease; however a causal relationship cannot be excluded.
Danish: De letale hændelser omfattede hændelser, der skyldtes sygdomsprogression, men en årsagssammenhæng kan ikke udelukkes.
English: if you are allergic to antihistamines or cannot use antihistamines for other medical reasons.
Danish: - hvis du er allergisk over for antihistaminer, eller du ikke kan bruge antihistaminer af andre medicinske grunde.
English: The primary study endpoint was overall survival (OS).
Danish: Det primære forsøgsendemål var den samlede overlevelse (OS).
English: Torisel contains alcohol and can be harmful to those who drink alcohol or to those suffering from alcoholism.
Danish: Torisel indeholder alkohol og kan være skadelig for dem, der drikker alkohol eller er alkoholikere.
English: This may increase the risk of getting fever and infections.
Danish: Dette kan øge risikoen for feber og infektioner.
English: See section 4.4 for additional information concerning serious adverse reactions, including appropriate actions to be taken if specific reactions occur.
Danish: 4.4 for yderligere information om alvorlige bivirkninger, herunder relevante forholdsregler ved specifikke reaktioner.
English: This medicinal product must be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products.
Danish: Dette lægemiddel skal indgives under overvågning af en læge, der har erfaring i brug af antineoplastiske lægemidler.
English: Clinical efficacy and safety
Danish: Klinisk effekt og sikkerhed
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you
Danish: Læs denne indlægsseddel grundigt inden du begynder at få dette lægemiddel, da den indeholder vigtige oplysninger.
English: There are no adequate data from the use of temsirolimus in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data om brugen af temsirolimus hos gravide kvinder.
English: Twenty-four (24, 67%) were Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 1, and 12 (33%) were ECOG PS = 0.
Danish: Fireogtyve (24, 67%) havde Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 1, og 12 (33%) havde ECOG
English: Patients may be immunosuppressed and should be carefully observed for the occurrence of infections, including opportunistic infections.
Danish: Patienterne kan være immunsupprimerede og skal observeres nøje for forekomsten af infektioner, herunder opportunistiske infektioner.
English: This incompatibility has to be considered during the preparation and administration of Torisel.
Danish: Denne uforligelighed skal tages i betragtning ved tilberedningen og indgivelsen af Torisel.
English: Administration in infusion.
Danish: Indgivelse ved infusion.
English: Torisel has not been studied in pregnant women, and it must not be used during pregnancy, unless clearly necessary.
Danish: Torisel er ikke blevet undersøgt hos gravide kvinder, og det må ikke anvendes under graviditet, med mindre det er klart nødvendigt.
English: In particular, you should inform your doctor or pharmacist if you are taking any of the following:
Danish: Specielt skal du informere lægen eller farmaceuten, hvis du tager et af følgende:
English: During treatment with temsirolimus, vaccination may be less effective.
Danish: Under behandlingen med temsirolimus kan vaccinationer være mindre effektive.
English: • Torisel is infused over a 30- to 60-minute period once a week.
Danish: • Torisel infunderes i løbet af en 30- til 60-minutters periode en gang om ugen.
English: The effect on the unbound concentrations of sirolimus has not been determined, but is expected to be larger than the effect on whole-blood concentrations due to the saturable binding to red blood cells.
Danish: Virkningen på de ubundne sirolimusconcentrationer er ikke blevet fastlagt, men forventes at være større end virkningen på fuldblodskoncentrationerne på grund af den saturable binding til røde blodlegemer.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before receiving this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du får dette lægemiddel.
English: Grapefruit and grapefruit juice may increase blood concentrations of Torisel and should be avoided.
Danish: - Grapefrugt og grapefrugtjuice kan øge koncentrationen af Torisel i blodet og bør undgås.
English: Table 1: Adverse reactions from clinical trials in RCC (study 3066K1-304) and in MCL (study 3066K1-305)
Danish: Skema 1: Bivirkninger fra kliniske studier på RCC (studie 3066K1-304) og på MCL (studie 3066K1-305)
English: Swelling of the face, lips, tongue, and throat, possibly causing difficulty breathing.
Danish: Hævelse af ansigtet, læberne, tungen og halsen, som muligvis kan forårsage besvær med at trække vejret.
English: The most important side effects you may experience during the treatment with Torisel are listed below.
Danish: De vigtigste bivirkninger, som du kan få under behandlingen med Torisel, er beskrevet herunder.
English: Store in a refrigerator (2°C - 8°C)
Danish: Opbevares i køleskab (2 °C - 8 °C)
English: Women should not breast-feed during treatment with Torisel, as this medicine may interfere with the growth and development of the baby.
Danish: Kvinder må ikke amme under behandling med Torisel, da denne medicin kan påvirke barnets vækst og udvikling.
English: Others presented with symptoms such as dyspnoea, cough, and fever.
Danish: Andre fremviste symptomer som f.eks. dyspnø, hoste og feber.
English: Therefore, inhibitors of these metabolic pathways are not expected to affect the elimination of temsirolimus.
Danish: Derfor forventes hæmmere af disse metaboliseringsveje ikke at påvirke eliminationen af temsirolimus.
English: Torisel must not be used during pregnancy, unless the risk for the embryo is justified by the expected benefit for the mother.
Danish: Torisel må ikke anvendes under graviditet, medmindre risikoen for fosteret retfærdiggøres af den forventede fordel for moderen.
English: if you are planning to have a vaccination during treatment with Torisel.
Danish: - hvis du planlægger at blive vaccineret under behandlingen med Torisel.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: CI = confidence interval; NA = not applicable.
Danish: CI = sikkerhedsinterval; NA = ikke relevant.
English: Interactions with medicinal products that are P-glycoprotein substrates
Danish: Interaktioner med lægemidler, som er P-glykoprotein-substrater
English: Torisel is for intravenous use only.
Danish: Torisel er kun til intravenøs anvendelse.
English: In addition to regulating cell cycle proteins, mTOR can regulate translation of the hypoxia-inducible factors, HIF-1 and HIF-2 alpha.
Danish: Udover at regulere cellecyklusproteiner, kan mTOR regulere translationen af de hypoxi-inducerende faktorer, HIF-1 og HIF-2 alfa.
English: The admixture should be mixed by inversion of the bag or bottle, avoiding excessive shaking, as this may cause foaming.
Danish: Tilsætningen skal blandes ved at vende posen eller flasken, idet man skal undgå at ryste for kraftigt, da dette kan medføre skumdannelse.
English: Torisel may weaken your immune system.
Danish: Torisel kan svække dit immunforsvar.
English: This leaflet was last revised in <{MM/YYYY}>
Danish: Denne indlægsseddel blev senest ændret <{MM/ÅÅÅÅ}>
English: Exposures in animals were lower than those seen in humans receiving clinically relevant doses of temsirolimus.
Danish: Ekspositionen hos dyr var lavere end den, der er set hos mennesker, der får kliniske relevante temsirolimusdoser.
English: Pharmacokinetic data on temsirolimus and sirolimus are available in patients up to age 79 years.
Danish: Farmakokinetiske data vedrørende temsirolimus og sirolimus findes for patienter op til en alder på 79 år.
English: Empiric treatment with corticosteroids and/or antibiotics may be considered.
Danish: Empirisk behandling med kortikosteroider og/eller antibiotika bør overvejes.
English: Harmful for those suffering from alcoholism.
Danish: Skadeligt for alkoholikere.
English: The combination of temsirolimus and sunitinib resulted in dose-limiting toxicity.
Danish: Kombinationen af temsirolimus og sunitinib resulterede i dosisbegrænsende toksicitet.
English: The results for the MCL clinical trial are summarised in the following table.
Danish: Resultaterne fra MCL-studiet er opsummeret i nedenstående tabel.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 November 2007
Danish: Dato for første tilladelse: 19. november 2007
English: The contribution of the initial 175 mg doses to the efficacy outcome is currently not known.
Danish: Den rolle, som initialdosen på 175 mg spiller for effektudfaldet, er ikke kendt på nuværende tidspunkt.
English: Your doctor will do blood tests to check your liver function and then may decide to lower the dose of Torisel.
Danish: Lægen vil tage blodprøve for at undersøge leverfunktionen, og vil måske beslutte at nedsætte din dosis af Torisel.
English: Interaction with medicinal products metabolised by CYP2D6 or CYP3A4/5
Danish: Interaktion med lægemidler, der metaboliseres af CYP2D6 eller CYP3A4/5
English: Administration of corticosteroids may be considered; however, the efficacy of corticosteroid treatment in this setting has not been established.
Danish: Indgivelse af kortikosteroider kan overvejes: Virkningen af kortikosteroider i denne sammenhæng er dog ikke fastslået.
English: Mean half-lives of temsirolimus and sirolimus were 17.7 hours and 73.3 hours, respectively.
Danish: Middelhalveringstider for temsirolimus og sirolimus var henholdsvis 17,7 timer og 73,3 timer.
English: Some patients did not have symptoms or had minimal symptoms.
Danish: Nogle patienter får ikke symptomer eller får meget svage symptomer.
English: Tell your doctor if you have a drinking problem or consume alcohol (see section “Torisel contains ethanol [alcohol]”).
Danish: Fortæl lægen, hvis du har et alkoholproblem eller drikker alkohol (se afsnittet ”Torisel indeholder ethanol [alkohol]”).
English: Antihistamines are given to help prevent an allergic reaction to Torisel, including some lifethreatening and rare fatal allergic reactions.
Danish: Antihistaminer anvendes for at forhindre en allergisk reaktion overfor Torisel, herunder livstruende og sjældne dødelige allergiske reaktioner.
English: There is no specific treatment for temsirolimus overdose.
Danish: Der findes ingen specifik behandling af overdosering med temsirolimus.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om Torisel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: As usual for patients with increased risk for skin cancer, exposure to sunlight and ultraviolet (UV) light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
Danish: Patienter med øget risiko for hudkræft skal begrænse eksponeringen for sollys og ultraviolet lys (UV) ved at bruge beskyttende beklædning og solcreme med en høj solbeskyttelsesfaktor.
English: For instructions on dilution and preparation of the medicinal product before administration, see section
Danish: For yderligere instruktion om fortynding og fremstilling af lægemidlet før administration, se pkt.
English: Studies in animals have shown reproductive toxicity.
Danish: Dyreforsøg har påvist reproduktionstoksicitet.
English: Some patients required discontinuation of temsirolimus or treatment with corticosteroids and/or antibiotics, while some patients continued treatment without additional intervention.
Danish: Hos nogle patienter var seponering af temsirolimus eller behandling med kortikosteroider og/eller antibiotika nødvendig, medens andre patienter fortsatte behandlingen uden yderligere intervention.
English: The use of both an in-line and end-filter is not recommended.
Danish: Brug af både integeret filter og endefilter kan ikke anbefales.
English: The use of live vaccines should be avoided during treatment with temsirolimus.
Danish: Brugen af levende vaccine bør undgås under behandling med temsirolimus.
English: Patients should be monitored early during the infusion and appropriate supportive care should be available.
Danish: Patienterne bør overvåges tidligt under den første infusion, og relevant, understøttende behandling bør være til rådighed.
English: Hyperglycaemia/glucose intolerance/diabetes mellitus
Danish: Hyperglykæmi/glucoseintolerans/diabetes mellitus
English: Serum cholesterol and triglycerides should be tested before and during treatment with temsirolimus.
Danish: Serumcholesterol og triglycerider skal kontrolleres før og under behandlingen med temsirolimus.
English: There is no relevant use of temsirolimus in the paediatric population for the indications of RCC and MCL.
Danish: Det er ikke relevant at anvende temsirolimus i den pædiatriske population til behandling af RCC og MCL.
English: Dose of temsirolimus
Danish: Dosis af temsirolimus
English: The primary endpoint of the study was PFS, as assessed by an independent radiologist and oncology review.
Danish: Studiets primære endepunkt var PFS, som blev vurderet af en uafhængig radiolog og ved onkologisk gennemgang.
English: Read the leaflet for the shelf life of the diluted product.
Danish: Læs indlægssedlen vedrørende opbevaringstid for det fortyndede produkt.
English: A vaccination may be less effective or the use of certain vaccinations should be avoided during treatment with Torisel.
Danish: En vaccination kan være mindre effektiv, og visse vaccinationer bør undgås under behandling med Torisel.
English: If a patient develops a hypersensitivity reaction during the temsirolimus infusion despite the premedication, the infusion must be stopped and the patient observed for at least 30 to 60 minutes (depending on the severity of the reaction).
Danish: Hvis en patient trods præmedicineringen udvikler en overfølsomhedsreaktion under infusionen med temsirolimus, skal infusionen stoppes og patienten observeres i mindst 30 til 60 minutter (afhængig af reaktionens sværhedsgrad).
English: What Torisel contains
Danish: Torisel indeholder
English: In the paediatric population, clearance of temsirolimus was lower and exposure (AUC) was higher than in adults.
Danish: Hos den pædiatriske population var temsirolimus-clearance lavere og ekspositionen (AUC) højere end hos voksne.