FrancophonIA/ELRC3.0 huggingface dataset:
English: Fasting blood lipid determinations (triglycerides and cholesterol) should be performed before bexarotene therapy is initiated and at weekly intervals until the lipid response to bexarotene is established, which usually occurs within two to four weeks, and then at intervals no less than monthly thereafter.
Danish: Fasteniveauet af blodlipider (triglycerider og kolesterol) bør fastslås, før bexaroten-terapi indledes og med ugentlige intervaller, indtil blodlipidernes reaktion over for bexaroten er fastslået.
English: Vomiting Diarrhoea Nausea Anorexia Liver Function Tests Abnormal Cheilitis Dry Mouth Constipation Flatulence
Danish: Opkastning Diarré Kvalme Anoreksi Abnorme leverfunktionsprøver Cheilitis Mundtørhed Obstipation
English: Bexarotene can potentially induce metabolic enzymes and thereby theoretically reduce the efficacy of oestroprogestative contraceptives (see section 4.5).
Danish: Bexaroten kan muligvis inducere metaboliseringsenzymer og derved teoretisk mindske østro-progestative præventionsmidlers virkning (se pkt.
English: ANNEX I
Danish: BILAG 1
English: Back pain, skin infection, fever, parasitic infection, abnormal laboratory test, disorder of mucous membrane, tumour.
Danish: Rygsmerte, hudinfektion, feber, parasitinfektion, abnorme laboratorieprøver, lidelse i slimhinder, svulst.
English: One capsule contains 75 mg of bexarotene.
Danish: En kapsel indeholder 75 mg bexaroten.
English: Changes in hair, herpes simplex, nail disorder, pustular rash, serous drainage, skin discoloration.
Danish: Hårforandringer, herpes simplex, negleforandringer, pustuløst udslæt, serøs dræning, hudmisfarvning.
English: Pancreatitis Hepatic Failure Gastrointestinal Disorder
Danish: Pankreatitis Leversvigt Gastrointestinale gener
English: Nausea, diarrhoea, dry mouth, dry lips, loss of appetite, constipation, excess gas, abnormal liver function tests, vomiting.
Danish: Kvalme, diarré, tør mund, tørre læber, appetittab, forstoppelse, overdreven tarmvind, abnorm leverfunktion, opkastning.
English: Based on the in vitro binding and the retinoid receptor activation profile of the metabolites, and on the relative amounts of individual metabolites in plasma, the metabolites have little impact on the pharmacological profile of retinoid receptor activation by bexarotene.
Danish: Denne vurdering er på baggrund af metabolitternes in vitro-binding og deres retinoid-receptorprofil samt på den relative mængde af de enkelte metabolitter i plasma.
English: Owing to its primarily RXR-binding activity, bexarotene is less likely to cause mucocutaneous, nail, and hair toxicities; arthralgia; and myalgia; which are frequently reported with retinoic acid receptor (RAR) -binding agents.
Danish: På grund af dets hovedsageligt RXR-bindende aktivitet er det mindre sandsynligt, at bexaroten forårsager mukokutan toksicitet, negle- og hårtoksiciteter, artralgi og myalgi.
English: The capsule shell consists of gelatin, sorbitol special-glycerine blend (glycerin, sorbitol, sorbitol anhydrides (1,4-sorbitan), mannitol and water), titanium dioxide (E171) and printing ink (SDA 35A alcohol (ethanol & ethyl acetate), propylene glycol (E1520), iron oxide black (E172), polyvinyl acetate phthalate, purified water, isopropyl alcohol, macrogol 400, ammonium hydroxide 28%).
Danish: Kapslens skal består af gelatine, sorbitol-special-glycerinblanding (glycerin, sorbitol, sorbitolanhydrider, (1,4-sorbitan), mannitol og vand), titandioxid (E171) og trykfarve (SDA 35A alkohol (ethanol og ætylacetat), propylenglykol (E1520), sort jernoxid (E172), polyvinylacetatphthalat, renset vand, isopropylalkohol, macrogol 400, ammoniumhydroxid 28%).
English: Acute pancreatitis associated with elevations of fasting serum triglycerides has been reported in clinical studies.
Danish: Kliniske undersøgelser har meldt om akut pankreatitis i forbindelse med forhøjede serumtriglycerider.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines, such as
Danish: Brug af anden medicin sammen med Targretin Fortæl altid lægen, hvis du tager anden medicin eller har gjort det for nylig eller planlægger at tage lægemidler som
English: EXPIRY DATE
Danish: udløbsdato
English: Nervous system disorders
Danish: Nervesystem et
English: adverse reactions noted with increased frequency when bexarotene was administered at a dose of >300 mg/m2/day (compared to administration to CTCL patients at 300 mg/m2/day) in non-CTCL cancer patients.
Danish: Bivirkninger konstateret med øget hyppighed, når bexaroten blev indgivet i en dosis på >300 mg/m2/dag til non-CTCL-cancerpatienter (sammenlignet med indgivelse til CTCLpatienter i en dosis på 300 mg/m2/dag)
English: Each capsule contains 75 mg of bexarotene.
Danish: Hver kapsel indeholder 75 mg bexaroten.
English: Abnormal vision, blurred vision, inflammation of the eye lids, cataract, inflammation of the white part of the eye, lesion of the cornea of the eye, ear disorder, defect in field of vision.
Danish: Abnormt syn, uskarpt syn, betændelse af øjenlågene, stær, betændelsestilstand af øjets hvide del, hornhindelæsion, ørelidelse, defekt synsfelt.
English: Blood tests to evaluate the function of your liver and thyroid gland and to monitor your red blood cell and white blood cell counts will be obtained before therapy is started and will be monitored during therapy.
Danish: Før behandlingen påbegyndes, vil der blive taget blodprøver for at vurdere din lever- og skjoldbruskkirtelfunktion samt for at måle antallet af røde og hvide blodceller.
English: Irreversible cataracts involving the posterior area of the lens occurred in rats and dogs treated with bexarotene at systemic exposures that are achievable clinically in humans.
Danish: Ved systemisk eksponering, som er klinisk opnåelig for mennesker, optrådte der hos rotter og hunde behandlet med bexaroten irreversibel cataract i hindens bagerste område.
English: General disorders and administration site conditions
Danish: Almene symptomer og reaktioner på administratio nsstedet
English: If fasting triglycerides are elevated or become elevated during treatment, institution of antilipaemic therapy is recommended, and if necessary, dose reductions (from 300 mg/m2/day of bexarotene to 200 mg/m2/day, and if necessary to 100 mg/m2/day) or treatment discontinuation.
Danish: Hvis påkrævet kan doseringen nedsættes (fra bexaroten 300 mg/m2 /dag til 200 mg/m2 /dag, og til 100 mg/m2 /dag, i fald det er nødvendigt), eller terapien kan afbrydes.
English: Blood disorders, eosinophilia, leukocytosis, lymphocytosis, purpura, elevated and decreased numbers of blood platelets.
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 behandlede): Blodforstyrrelser, eosinofili, leukocytose, lymfocytose, purpura (spontan blødning i hud og slimhinder), forhøjet eller nedsat antal blodplader.
English: Leucopenia
Danish: Leukopeni
English: Skin Ulcer Alopecia Skin Hypertrophy Skin Nodule Acne Sweating Dry Skin Skin Disorder
Danish: Hudsår Alopeci Hudhypertrofi Hudknude Akne Perspiration Tør hud Hudlidelse
English: Uncontrolled hypertriglyceridaemia.
Danish: Ukontrolleret hypertriglyceridæmi
English: Of these, liver failure, subsequently determined to be not related to bexarotene, was the only one to occur in a CTCL patient.
Danish: Blandt disse blev det senere fastslået, at leversvigt ikke var forbundet med bexaroten.
English: Each Targretin capsule contains 75 mg of the active substance bexarotene.
Danish: - Aktivt stof: Hver Targretin-kapsel indeholder 75 mg af det virksomme stof, bexaroten.
English: Women of child-bearing potential without effective birth-control measures.
Danish: Fødedygtige kvinder uden effektiv prævention Tidligere tilfælde af pankreatitis
English: Exfoliative Dermatitis Pruritus Rash
Danish: Eksfoliativ dermatitis Pruritus Udslæt
English: Muscle weakness.
Danish: Muskelsvaghed.
English: Serous Drainage Herpes Simplex Pustular Rash Skin Discoloration Hair Disorder Nail Disorder
Danish: Serøs drænage Herpes simplex Pustuløst udslæt Hudmisfarvning Hårlidelse Neglelidelse
English: How to take Targretin
Danish: Sådan skal du tage Targretin
English: TARGRETIN 75 mg soft capsules Bexarotene
Danish: TARGRETIN 75 mg kapsler, bløde Bexaroten
English: Determination of haemoglobin should be obtained at baseline, weekly during the first month and then monthly thereafter.
Danish: Hæmoglobinniveauets udgangsværdi bør fastslås og måles ugentligt i den første måned og derefter månedligt.
English: Dry skin, skin disorder, loss of hair, skin ulcer, acne, skin thickening, skin nodule, increased sweating.
Danish: Hududtørring, hudlidelse, hårtab, sårdannelse på huden, filipenser, fortykkelse af huden, hudknude, øget svedning.
English: Doses up to 1000 mg/m 2/day of bexarotene have been administered in clinical studies with no acute toxic effects.
Danish: Der er i kliniske undersøgelser indtaget bexaroten i doser på op til 1000 mg/m 2/dag uden akut,
English: What Targretin is and what it is used for What you need to know before you take Targretin How to take Targretin
Danish: Det skal du vide, før du begynder at tage Targretin Sådan skal du tage Targretin Bivirkninger
English: LFT elevations associated with the use of bexarotene have been reported.
Danish: Abnormaliteter ved leverfunktionstestning (LFT) Der foreligger meldinger om LFT-forhøjelse i forbindelse med anvendelsen af bexaroten.
English: Joint aches, bone pain, muscle aches.
Danish: Ledsmerter, knoglesmerter, muskelømhed.
English: Targretin 75 mg soft capsules
Danish: Targretin 75 mg bløde kapsler.
English: Gout Bilirubinemia BUN Increased High Density Lipoprotein Decreased
Danish: Arthritis urica Bilirubinæmi Forhøjet blod urea nitrogen Reduceret HDLkolesterol
English: Anaemia associated with bexarotene therapy has been reported in clinical studies.
Danish: Kliniske undersøgelser har meldt om anæmi i forbindelse med bexaroten-terapi.
English: Butylated hydroxyanisole may cause irritation to the mucous membranes, therefore the capsules must be swallowed intact and not chewed.
Danish: Butyleret hydroxyanisol kan forårsage irritation af slimhinderne.
English: Hyperlipidaemia has been identified as an effect associated with the use of bexarotene in clinical studies.
Danish: Kliniske undersøgelser har fastslået, at hyperlipidæmi er en virkning forbundet med bexaroten.
English: On the basis of the oxidative metabolism of bexarotene by cytochrome P450 3A4 (CYP3A4), coadministration with other CYP3A4 substrates such as ketoconazole, itraconazole, protease inhibitors, clarithromycin and erythromycin may theoretically lead to an increase in plasma bexarotene concentrations.
Danish: På baggrund af bexarotens oxidative metabolisme gennem cytokrom P450 3A4 (CYP3A4), kan samtidig indgivelse af andre CYP3A4-substrater så som ketoconazol,
English: Leucopenia associated with bexarotene therapy has been reported in clinical studies.
Danish: Kliniske undersøgelser har meldt om leukopeni i forbindelse med bexaroten-terapi.
English: Gastrointestinal disorder, liver failure, inflammation of the pancreas.
Danish: Mave-tarmforstyrrelse, leversvigt, betændelsestilstand af bugspytkirtlen.
English: However, concomitant administration of gemfibrozil resulted in substantial increases in plasma concentrations of bexarotene and therefore, concomitant administration of gemfibrozil with bexarotene is not recommended (see section 4.5).
Danish: Samtidig indtagelse af gemfibrozil medførte dog en væsentlig forøgelse i plasmakoncentrationen af bexaroten.
English: Ear disorder
Danish: Perifert ødem
English: Thyroid function test alterations
Danish: Ændringer ved thyroideafunktionstestning
English: Myalgia
Danish: Myastaeni
English: Hypothyroidism
Danish: Hypotyroidisme
English: Overactive thyroid.
Danish: Overaktiv skjoldbruskkirtel.
English: Musculoskeletal and connective tissue disorders
Danish: Knoglesmerter Artralgi Myalgi
English: If you take more Targretin than you should If you have taken more than the prescribed dose of Targretin, you must contact your doctor.
Danish: Kontakt lægen, skadestuen eller apoteket, hvis du har taget flere Tagretin-kapsler, end der står her, eller flere end lægen har foreskrevet.
English: If you have an intolerance to some sugars, speak to your doctor before taking this medicinal product.
Danish: Kontakt lægen, inden du tager dette lægemiddel, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
English: Haemorrhage Hypertension Oedema Vasodilatation Varicose Vein
Danish: Blødning Hypertension Ødem Vasodilatation Åreknuder
English: Thyroid disorder.
Danish: Skjoldbruskkirtelforstyrrelse.
English: 200 (2 x 100) tablets (multipack)
Danish: 200 (2 x 100) tabletter (multipakke)
English: The potential risk for humans is unknown.
Danish: Den potentielle risiko hos mennesker er ukendt.
English: Elimination half-life is 8-12 hours.
Danish: Halveringstiden er 8-12 timer.
English: Less than 1% of the dose is excreted unchanged in urine.
Danish: Mindre end 1% af dosis udskilles uændret i urinen.
English: TABLE 2
Danish: TABEL 2
English: Therefore, the combination should be administered with caution, especially in the elderly.
Danish: Kombinationen bør derfor gives med forsigtighed, især til ældre.
English: There are also links to other websites about rare diseases and treatments.
Danish: Der er også links til websites om sjældne sygdomme og hvordan de behandles.
English: Steady state plasma concentrations are reached within 5 days of treatment.
Danish: Steady state plasmakoncentrationer nås inden for 5 dages behandling.
English: Dosing with food (high fat meal) delays absorption by about 1 hour with an increase in total
Danish: Indtagelse sammen med føde (fedtrigt måltid) forsinker absorptionen omkring 1 time og øger den totale
English: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
Danish: • når der modtages ny information, der kan have indflydelse på den gældende sikkerhedsspecifikation, pharmacovigilance-plan eller på risikominimeringsaktiviteter
English: The progress report will include full documentation of efforts to achieve the target for yearly recruitment: an increased number of 30 patients/year is expected.
Danish: Statusrapporten vil omfatte komplet dokumentation for tiltag til at opnå målet for årlig rekrutering: forventet øgning i antal er 30 patienter pr. år.
English: Ask your doctor for advice before taking both of these medicines together.
Danish: Spørg lægen til råds, før du tager disse to typer medicin samtidig.
English: Effects of celecoxib on other medicinal products
Danish: Virkningen af celecoxib på andre lægemidler
English: If you feel dizzy or tired after taking Onsenal, do not drive or use machinery until you are feeling normal again.
Danish: Hvis du bliver svimmel eller træt efter at have taget Onsenal, bør du ikke køre bil eller betjene maskiner, før du føler dig normal igen.
English: Clinical aspects
Danish: Kliniske aspekter:
English: The study population included 58 patients with a prior subtotal or total colectomy and 25 patients with an intact colon.
Danish: Forsøgspopulationen omfattede 58 patienter med en tidligere subtotal eller total kolektomi og 25 patienter med en intakt colon.
English: • Known hypersensitivity to sulphonamides.
Danish: • Kendt overfølsomhed over for sulfonamider.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu/.
Danish: Du kan finde yderligere information om Onsenal på Det europæiske Lægemiddelagenturs (EMAs) hjemmeside http://www.ema.europa.eu/.
English: Taking ONSENAL with food and drink You can take Onsenal with or without food.
Danish: Brug af Onsenal sammen med mad og drikke Du kan tage Onsenal sammen med mad eller uden for måltider.
English: No studies on the effect on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motorkøretøj eller betjene maskiner.
English: Elderly: The dose for elderly FAP patients has not been established.
Danish: Ældre: Dosis til ældre FAP-patienter er ikke fastlagt.
English: What ONSENAL contains
Danish: Onsenal indeholder:
English: However, adequate monitoring for methotrexate-related toxicity should be considered when combining these two
Danish: Imidlertid bør passende monitorering af methotrexatrelateret toksicitet overvejes, når disse to lægemidler kombineres.
English: Severe renal impairment is a contraindication to use.
Danish: Svært nedsat nyrefunktion er en kontraindikation for anvendelse.
English: • Patients with renal insufficiency with estimated creatinine clearance <30 ml/ min.
Danish: • Patienter med nyreinsufficiens med estimeret kreatinclearance <30 ml/min.
English: Always take Onsenal exactly as your doctor has told you.
Danish: Tag altid Onsenal nøjagtigt efter lægens anvisning.
English: The maximum recommended daily dose is 800 mg.
Danish: Den maksimale anbefalede daglige dosis er 800 mg.
English: • Active peptic ulceration or gastrointestinal (GI) bleeding.
Danish: • Aktivt peptisk ulcus eller gastrointestinal (GI) blødning.
English: This medicine has been authorised under “exceptional circumstances”.
Danish: Onsenal er godkendt under ”særlige omstændigheder”.
English: There is no clinical experience of overdose in clinical trials.
Danish: Der er ingen klinisk erfaring med overdosering i kliniske forsøg.
English: The frequencies of these reactions are difficult to determine but are generally considered to be very rare (affecting less than 1 person in every 10,000)
Danish: Hyppigheden af disse bivirkninger er svær at bestemme, men anses generelt for at være meget sjældne (forekommer hos mindre end 1 person ud af 10.000):
English: The plasma concentration of celecoxib is approximately 100% increased in elderly women (>65 years).
Danish: Celecoxibs plasmakoncentration er øget ca. 100% hos ældre kvinder (65 år).
English: You must not take Onsenal if you are pregnant or if it is possible that you become pregnant.
Danish: Du må ikke tage Onsenal, hvis du er gravid, eller hvis der er mulighed, at du bliver gravid.
English: The clinical significance of this in vitro finding is unknown.
Danish: Den kliniske betydning af disse in vitro-fund er ikke kendt.
English: Cyclooxygenase is responsible for generation of prostaglandins.
Danish: Cyclooxygenase er ansvarlig for dannelsen af prostaglandiner.
English: Because not all adverse drug reactions are reported to the MAH and included in the safety database, the frequencies of these reactions cannot be reliably determined.
Danish: Da ikke alle bivirkninger bliver rapporteret til indehaveren af markedsføringstilladelsen og dermed ikke er inkluderet i sikkerhedsdatabasen, kan hyppigheden af disse bivirkninger ikke bestemmes på pålidelig måde.
English: Like all medicines, ONSENAL can cause side effects, although not everybody gets them.
Danish: Onsenal kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: • Pfizer Manufacturing Deutschland GmbH, Heinrich-Mack-Strasse 35, 89257 Illertissen, Germany
Danish: • Pfizer Manufacturing Deutschland GmbH, Heinrich-Mack-Strasse 35, 89257 Illertissen, Tyskland
English: A randomized double-blind placebo controlled study was conducted in 83 patients with FAP.
Danish: En randomiseret dobbelt-blind placebokontrolleret undersøgelse blev udført med 83 FAP-patienter.
English: The MAH will submit a progress report for the CHIP trial, including an update on safety data, in the 8th annual reassessment and will submit a full study report for the completed study when available.
Danish: Indehaveren af markedsføringstilladelsen vil indsende en statusrapport til CHIP-forsøget, herunder en opdatering af sikkerhedsdata, i forbindelse med den 8. årlige revurdering og vil indsende den endelige forsøgsrapport for det afsluttede forsøg, så snart denne er tilgængelig.
English: Caution should be used as there is no experience in such patients at doses higher than 200 mg.
Danish: Der bør udvises forsigtighed, da der savnes erfaring med doser højere end 200 mg hos disse patienter.
English: Familial Adenomatous Polyposis (FAP) is a genetic disease resulting from an autosomal dominant genetic alteration of a tumor suppressor gene, the adenomatous polyposis coli (APC) gene.
Danish: Familiær adenomatøs polypose (FAP) er en genetisk sygdom, som skyldes en autosomal dominant genetisk forandring af et tumorsuppressorgen, adenomatosis polyposis coli-gen (APC-gen).
English: Celecoxib is well absorbed reaching peak plasma concentrations after approximately 2-3 hours.
Danish: Celecoxib absorberes godt og når maksimal plasmakoncentration efter ca. 2-3 timer.
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being
Danish: • senest 60 dage efter en vigtig milepæl er nået (pharmacovigilance eller risikominimering)
English: Onsenal 200 mg capsules contain lactose (49.8 mg).
Danish: Onsenal 200 mg kapsler indeholder lactose (49,8 mg).
English: Treatment with celecoxib in FAP has been studied for up to 6 months and has not been shown to reduce the risk of gastrointestinal or other form of cancer or the need for surgery.
Danish: Behandling med celecoxib hos FAP-patienter er blevet fulgt i op til 6 måneder og har ikke vist, at risikoen for gastrointestinal cancer, andre former for cancer eller behovet for kirurgi nedsættes.
English: Celecoxib has been shown to reduce the number and size of adenomatous colorectal polyps.
Danish: Celecoxib har vist sig at reducere antallet og størrelsen af adenomatøse colorektale polypper.
English: Three metabolites, inactive as COX-1 or COX-2 inhibitors, have been identified in human plasma i.e., a primary alcohol, the corresponding carboxylic acid and its glucuronide conjugate.
Danish: 3 metabolitter, inaktive som COX-1- eller COX-2-hæmmere, er identificeret i humant plasma, dvs. en primær alkohol, den tilsvarende carboxylsyre og dets glucuronidkonjugat.
English: Onsenal is packed in blisters and supplied in boxes of 10 or 60 capsules.
Danish: Onsenal er pakket i blisterkort og findes i pakninger med 10 eller 60 kapsler.
English: Celecoxib is mainly eliminated by metabolism.
Danish: Celecoxib elimineres hovedsagligt via metabolisme.
English: The metabolic capacity in patients with mild to moderate impairment was best correlated to their albumin values.
Danish: Den metaboliske kapacitet hos patienter med let til moderat nedsat leverfunktion kunne bedst korreleres til deres albuminværdier.
English: In particular, the frequency of routine endoscopic surveillance should not be decreased and FAP-related
Danish: Især bør hyppigheden af rutinemæssig endoskopisk kontrol ikke reduceres, og FAP-relateret kirurgi bør ikke udsættes.
English: The increases for both celecoxib dose groups versus placebo were mainly due to an increased incidence of myocardial infarction.
Danish: Stigningen i begge celecoxibdosisgrupper versus placebo kan primært tilskrives en stigning i hyppigheden af myokardieinfarkt.
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any updated RMP should be submitted at the same time as the following Periodic Safety Update Report
Danish: I overensstemmelse med CHMP-retningslinjerne for risikostyringsprogrammer for lægemidler til human brug skal en opdateret RMP fremsendes samtidig med den efterfølgende periodiske
English: Therefore, patients receiving oral anticoagulants should be closely monitored for their prothrombin time INR.
Danish: Patienter, som får orale antikoagulantia bør derfor kontrolleres nøje med hensyn til protrombintid INR.
English: NSAIDs may reduce the effect of diuretics and antihypertensive medicinal products.
Danish: NSAID kan nedsætte effekten af diuretika og antihypertensiva.
English: • Established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease
Danish: • Konstateret iskæmisk hjertesygdom, perifer arteriel sygdom og/eller cerebrovaskulær sygdom.
English: Pharmacotherapeutic group: Antineoplastic, ATC code: L01XX33
Danish: Farmakoterapeutisk klassifikation: Antineoplastisk middel, ATC kode: L01XX33.
English: • Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score >10) (Class C).
Danish: • Svær leverdysfunktion (serumalbumin <25 g/l eller Child-Pugh score >10) (klasse C).