FrancophonIA/ELRC3.0 huggingface dataset:
English: In particular, the requirements of the pregnancy prevention programme for combination treatment with thalidomide or its analogues must be followed.
Danish: Navnlig skal kravene overholdes i svangerskabsforebyggelsesprogrammet for kombinationsbehandling med thalidomid eller analoger hertil.
English: Dexamethasone is transported by the P-glycoprotein (also known as MDR1).
Danish: Dexamethason transporteres af P-glykoprotein (også betegnet MDR1).
English: Dexamethasone is a synthetic glucocorticoid; it combines high anti-inflammatory effects with low mineralocorticoid activity.
Danish: Dexamethason er et syntetisk glukokortikoid, der forener høj antiinflammatorisk virkning med lav mineralokortikoid virkning.
English: Pharmacotherapeutic group: Corticosteroids for systemic use, glucocorticoids, ATC code: H02AB02
Danish: Farmakoterapeutisk klassifikation: Kortikosteroider til systemisk brug, usammensatte, glukokortikoider, ATC-kode: H02AB02
English: Do not use this medicine if you notice any defects, or any signs of deterioration of the tablets or packaging.
Danish: Brug ikke Neofordex, hvis du bemærker defekter eller tegn på ældning af tabletterne eller emballagen.
English: Patients receiving Neofordex in combination with products containing thalidomide, lenalidomide or pomalidomide should adhere to the pregnancy prevention programmes of those products.
Danish: Patienter, der får Neofordex i kombination med produkter indeholdende thalidomid, lenalidomid eller pomalidomid, bør følge de graviditetsforebyggende programmer for produkterne.
English: Ciclosporin may also increase the intracellular uptake of dexamethasone.
Danish: Ciclosporin kan desuden øge den intracellulære optagelse af dexamethason.
English: The following combinations require precautions due to changes in dexamethasone pharmacokinetics:
Danish: Følgende kombinationer kræver særlige forholdsregler på grund af ændringerne i farmakokinetikken af dexamethason:
English: Treatment for active gastric or duodenal ulceration should be commenced prior to initiation of corticosteroids.
Danish: Ved aktivt gastrisk eller duodenalt ulcus bør behandling heraf iværksættes inden initiering af kortikosteroidbehandling.
English: Patients/carers should be encouraged to seek medical advice if worrying psychological symptoms develop, especially if depressed mood or suicidal ideation is suspected.
Danish: Patienter/omsorgsgivere bør tilskyndes til at søge læge ved foruroligende psykiske symptomer, navnlig ved mistanke om nedtrykthed eller suicidaltanker.
English: Concomitant use of dexamethasone and ciclosporine should be avoided.
Danish: Samtidig brug af dexamethason og ciclosporin bør undgås
English: It is characterized by excessive numbers of abnormal plasma cells in the bone marrow and overproduction of intact monoclonal immunoglobulin (IgG, IgA, IgD, or IgE) or Bence-Jones protein only (free immunoglobulin monoclonal κ and λ light chains).
Danish: Den er karakteriseret ved et for højt antal abnorme plasmaceller i knoglemarven og overproduktion af intakt monoklonalt immunglobulin (IgG, IgA, IgD eller IgE) eller af Bence-Jones protein alene (frie monoklonale lette κ- og λ-kæder fra immunglobulin).
English: The patient should continue anticoagulation therapy during the course of treatment with dexamethasone and thalidomide or its analogues.
Danish: Patienten bør fortsætte på antikoagulationsbehandling under behandlingen med dexamethason og thalidomid eller analoger hertil.
English: Dexamethasone is similar to glucocorticoids which are naturally produced in the body.
Danish: Dexamethason ligner de glukokortikoider, som kroppen danner naturligt.
English: FN was reported to be serious in 4.0% of patients.
Danish: Febril neutropeni blev rapporteret som alvorlig hos 4,0 % af patienterne.
English: − Tiredness, weakness, swelling of the body and face.
Danish: − træthed, svaghed, hævelse af kroppen og ansigtet.
English: In case of active infectious disease, appropriate antiinfective treatment must be added to the treatment with Neofordex.
Danish: Ved aktiv infektionssygdom skal behandlingen med Neofordex suppleres med passende antiinfektiøs behandling.
English: During treatment, a diet low in simple sugars and high in protein should be followed due to the hyperglycaemic effect of corticosteroids and their stimulation of protein catabolism with a negative nitrogen balance.
Danish: Under behandlingen bør patienten følge en diæt med lavt indhold af simple sukkerarter og højt proteinindhold på grund af kortikosteroiders hyperglykæmiske virkning og stimulation af proteinkatabolismen med negativ kvælstofbalance.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på kartonen og blisterkortet efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Endocrine disorders
Danish: Endokrine sygdomme
English: This can sometimes lead to infections caused by germs that rarely cause infection under normal circumstances (called opportunistic infections).
Danish: Dette kan undertiden medføre infektioner forårsaget af mikroorganismer, der under normale omstændigheder sjældent giver infektion (opportunistiske infektioner).
English: The dose of insulin, oral anti-diabetics and anti-hypertensive medicinal products may have to be increased.
Danish: Det kan være nødvendigt at øge dosis af insulin, orale antidiabetika og antihypertensiva.
English: Smoking has no influence on dexamethasone pharmacokinetics.
Danish: Rygning har ingen indflydelse på farmakokinetikken af dexamethason.
English: − Inability of the body to respond normally to severe stress such as accidents, surgery or illness due to insufficient function of the adrenal glands, severe unusual headache with visual disturbances linked to the withdrawal of treatment, irregularity of menstrual cycles in women;
Danish: − manglende evne af kroppen til at reagere normalt på stærke belastninger såsom uheld, operationer eller sygdomme som følge af utilstrækkelig binyrefunktion, svær usædvanlig hovedpine med synsforstyrrelser ved ophør af behandlingen, uregelmæssig menstruation hos kvinder
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Neofordex therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Danish: Der skal tages stilling til, om der skal ophøres med amning eller om behandlingen med Neofordex skal ophøre eller slet ikke iværksættes, under hensyntagen til fordelene ved amning for barnet og den terapeutiske fordel for moderen.
English: Once the patient has been stabilised on the anticoagulation treatment and any complications of the thromboembolic event have been managed, the treatment with dexamethasone and thalidomide or its analogues may be restarted at the original dose dependent upon a benefit risk assessment.
Danish: Når patienten er stabiliseret på antikoagulationsbehandling, og eventuelle komplikationer som følge af tromboemboliske hændelser er behandlet, kan behandlingen med dexamethason og thalidomid eller analoger dertil genoptages i den oprindelige dosering, afhængigt af forudgående benefit/risk-vurdering.
English: Less common but serious adverse reactions include: pneumonia and other infections and psychiatric disorders (see section 4.4).
Danish: Følgende mindre almindelige, men alvorlige bivirkninger forekommer: pneumoni og andre infektioner samt psykiske lidelser (se pkt.
English: In extremely rare cases, a tendon may rupture.
Danish: I meget sjældne tilfælde kan det medføre brud på en sene.
English: This is particularly important if you notice signs of pneumonia: cough, fever, shortness of breath and chest pain.
Danish: Dette er særlig vigtigt, hvis du bemærker tegn på lungebetændelse: hoste, feber, stakåndethed og brystsmerter.
English: Patients should be monitored for haematological adverse reactions, especially neutropenia.
Danish: Patienten bør overvåges for hæmatologiske bivirkninger, navnlig neutropeni.
English: After oral administration of Neofordex, dexamethasone peak plasma levels are reached at a median of three hours.
Danish: Efter oral administration af Neofordex nås maksimal plasmakoncentration efter et mediant tidsrum på 3 timer.
English: The administration of such medicinal products and Neofordex should be separated by at least two hours.
Danish: Der bør gå mindst to timer mellem administration af sådanne lægemidler og Neofordex
English: When thalidomide, lenalidomide or pomalidomide is used, particular attention to pregnancy testing and prevention requirements is needed.
Danish: Hvis der anvendes thalidomid, lenalidomid eller pomalidomid, skal man være særligt omhyggelig med graviditetstest og prævention.
English: The combination of dexamethasone with lenalidomide or pomalidomide may cause a decrease in normal white blood cells (blood cells that help fight infection) and/or blood platelets (which help prevent bleeding).
Danish: Kombination af dexamethason med lenalidomid eller pomalidomid kan medføre for lavt antal normale hvide blodlegemer (dvs. de blodlegemer, der er med til at bekæmpe infektioner) og/eller blodplader (som er med til at forebygge blødning).
English: Glucocorticoids are excreted in human milk and effects have been shown in breastfed newborns/infants of treated women.
Danish: Glukokortikoider udskilles i human mælk, og virkninger heraf er set hos nyfødte/spædbørn, der ammes af kvinder, som er i behandling med glukokortikoider.
English: Individual tablets in intact packaging should be separated from the blister using the perforation, e.g. for use in multi-compartment compliance aids.
Danish: De enkelte tabletter i en intakt pakning skal udtages af blisteren ved hjælp af perforationen, f.eks. til anvendelse i medicinæsker.
English: The decision to take antithrombotic prophylactic measures should be made after careful assessment of an individual patient's underlying risk factors.
Danish: Inden der træffes tiltag til tromboseprofylakse, bør den enkelte patients underliggende risikofaktorer nøje vurderes.
English: The incidence rate of certain adverse reactions varies depending on the combination treatment used.
Danish: For visse bivirkninger afhænger forekomsten af den anvendte kombinationsbehandling
English: This leaflet was last revised in
Danish: Denne indlægsseddel blev senest ændret i .
English: − Inflammation of the eye and/or eyelids, increased tearing;
Danish: − inflammation af øjne og/eller øjenlåg, øget tåreflåd
English: Data are derived from historical experience and clinical studies in multiple myeloma patients in which dexamethasone was used as monotherapy or in combination with placebo.
Danish: Dataene er udledt af historiske erfaringer og kliniske undersøgelser hos patienter med multipelt myelom, hvor dexamethason blev anvendt som monoterapi eller i kombination med placebo.
English: • With fluoroquinolones, due to possibly increased risk of tendonitis and, in exceptional cases, rupture of the affected tendon, particularly after long-term treatment.
Danish: • med fluorquinoloner på grund af øget risiko for tendinitis og i exceptionelle tilfælde seneruptur, navnlig efter langvarig behandling
English: • Clarithromycin, erythromycin, telithromycin, itraconazole, ketoconazole, posaconazole, voriconazole, nelfinavir, ritonavir: Increased dexamethasone plasma concentration due to reduction of its hepatic metabolism by these enzyme inhibitors.
Danish: • clarithromycin, erythromycin, telithromycin, itraconazol, ketoconazol, posaconazol, voriconazol, nelfinavir og ritonavir: disse enzymhæmmere øger plasmakoncentrationen af dexamethason ved at nedsætte dets metabolisering i leveren.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE SIKKER OG EFFEKTIV BRUG AF LÆGEMIDLET
English: Patients should be informed of the signs and symptoms of pneumonia and be advised to seek medical attention in case of their appearance.
Danish: Patienten bør informeres om tegn og symptomer på pneumoni og have besked på at søge læge, hvis de viser sig.
English: You must avoid getting pregnant during treatment with Neofordex.
Danish: Du skal undgå at blive gravid under behandlingen med Neofordex.
English: Dexamethasone is a type of hormone called a glucocorticoid, sometimes called a corticoid or corticosteroid, with various actions including effects on white blood cells, which form part of the immune system (the body's natural defences).
Danish: Dexamethason er et hormon af typen glukokortikoider, der også kaldes kortikoider eller kortikosteroider og har en række virkninger på de hvide blodlegemer, som er en del af kroppens naturlige forsvar, immunsystemet.
English: It can also affect the nitro blue tetrazolium (NBT) test for bacterial infections and cause false-negative results.
Danish: (nitro blue tetrazolium) for bakterielle infektioner og give falske negative resultater.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Neofordex 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 resultater af undersøgelser med Neofordex i alle undergrupper af den pædiatriske population ved multipelt myelom (se pkt.
English: In Pom + LD-Dex treated patients neutropenia was infrequently serious (2.0% of patients), did not lead to treatment discontinuation, and was associated with treatment interruption in 21.0% of patients, and with dose reduction in 7.7% of patients.
Danish: Hos patienter behandlet med Pom + LD-Dex forekom alvorlig neutropeni ikke hyppigt (2,0 % af patienterne) og medførte ikke seponering af behandlingen, men var forbundet med afbrydelse af behandlingen hos 21,0 % af patienterne og med dosisreduktion hos 7,7 % af patienterne.
English: − Reduction in the number of red or white blood cells and/or platelets, or increased number of white blood cells, decreased levels of potassium or of albumin (a protein) in the blood, increased levels of uric acid in the blood, changes in liver function tests;
Danish: − nedsat antal røde eller hvide blodlegemer og/eller blodplader, eller øget antal hvide blodlegemer, nedsat koncentration i blodet af kalium eller albumin (et protein), forhøjet indhold i blodet af urinsyre, ændrede leverfunktionsprøver
English: Prophylactic antithrombotic treatment should be recommended, especially in patients with additional thrombotic risk factors.
Danish: Patienten bør anbefales forebyggende antitrombotisk behandling, navnlig ved ekstra risikofaktorer for trombose.
English: Systemic treatment with glucocorticoids can induce chorioretinopathy which may result in impaired vision including loss of vision.
Danish: Systemisk behandling med glukokortikoider kan fremkalde korioretinopati, som kan medføre synsnedsættelse, herunder tab af synet.
English: Common: Liver function tests abnormal, alanine aminotransferase increased.
Danish: Almindelige: Abnorme leverfunktionsprøver, forhøjet alaninaminotransferase
English: Patients from endemic areas (tropical and sub-tropical regions, southern Europe) should have a stool examination and if required an eradication of the parasite before initiating dexamethasone treatment.
Danish: Der tages fæcesprøve fra patienter fra områder, hvor sygdommen er endemisk (tropiske og subtropiske egne, Sydeuropa), og i givet fald skal parasitten udryddes før initiering af behandlingen med dexamethason.
English: − Cushing's syndrome, i.e. weight gain of the trunk and face, excessive sweating, stretch marks, visible swollen capillaries (small blood vessels) and dryness of the skin, growth of extra facial hair (especially in women) and thinning of the hair;
Danish: − Cushings syndrom, dvs. vægtøgning af kroppen og ansigtet, svedtendens, strækmærker, synlige opsvulmede små blodkar (kapillærer), hudtørhed, ekstra behåring i ansigtet (særlig hos kvinder) og tyndere hår
English: Dexamethasone may cause congenital malformations (see section 5.3).
Danish: Dexamethason kan forårsage kongenitte misdannelser (se pkt.
English: The side effects listed below were seen when dexamethasone was taken for the treatment of multiple myeloma and for the treatment of other diseases.
Danish: Nedenstående bivirkninger blev iagttaget, når dexamethason blev anvendt til behandling af multipelt myelom og andre sygdomme.
English: The dose and administration frequency varies with the therapeutic protocol and the associated treatment(s).
Danish: Dosis og administrationshyppighed afhænger af behandlingsprotokollen og den eller de tilknyttede lægemidler.
English: Dexamethasone also down-regulated anti apoptotic genes and increased IκB-α protein levels.
Danish: Dexamethason nedregulerede desuden anti-apoptotiske gener og øgede koncentrationen af IκB-α-protein.
English: If you think you may have had contact with anyone with these conditions, you should inform your doctor immediately.
Danish: Hvis du tror, at du har haft kontakt med nogen med en af disse sygdomme, skal du straks fortælle det til lægen.
English: You may also feel a ‘withdrawal symptom'.
Danish: Du vil muligvis også få “abstinenssymptomer”.
English: In males, fertility may be decreased through germ cell apoptosis and spermatogenic defects.
Danish: Hos hannerne kan fertiliteten være nedsat som følge af apoptose af kimceller og defekter i spermatogenesen.
English: Treatment with this medicine may cause tendon inflammation.
Danish: Behandlingen med dette lægemiddel kan fremme senebetændelse.
English: Neutropenia and thrombocytopenia
Danish: Neutropeni og trombocytopeni
English: Neofordex is used to treat adult patients with multiple myeloma, a cancer of the blood affecting the white blood cells that produce antibodies.
Danish: Neofordex anvendes til behandling af voksne med multipelt myelom, en type blodkræft, der udgår fra de hvide antistofproducerende blodlegemer.
English: − Increased blood sugar levels, constipation;
Danish: − øget blodsukker, forstoppelse
English: Children do not develop multiple myeloma.
Danish: Børn og unge Børn får ikke multipelt myelom.
English: A complete blood cell count, including white blood cell count with differential count, platelet count, haemoglobin, and haematocrit should be performed at baseline, every week for the first 8 weeks of dexamethasone/lenalidomide treatment and monthly thereafter to monitor for cytopenias.
Danish: For at overvåge for cytopeni bør der foretages en komplet blodtælling, herunder leukocyttal med differentialtælling, trombocyttal, hæmoglobin og hæmatokrit, ved baseline, hver uge i de første otte uger af behandlingen med dexamethason/lenalidomid, og derefter én gang månedligt.
English: − Fast or irregular heart rhythm, too high or too low blood pressure, formation of blood clots that may clog blood vessels (for example in legs or lungs), swelling of arms or legs, reddening of the skin of the face or body;
Danish: − hurtig eller uregelmæssig hjerterytme, for højt eller for lavt blodtryk, dannelse af blodpropper, der kan tilstoppe blodkarrene i f.eks. benene eller lungerne, hævede arme eller ben, rødme af huden i ansigtet eller på kroppen
English: Very common: Fatigue, asthenia, oedema (including peripheral and facial oedema);
Danish: Meget almindelige: Træthed, asteni, ødem (herunder perifert og facialt ødem)
English: Dexamethasone has no clinically significant pharmacokinetic interaction with thalidomide, lenalidomide, pomalidomide, bortezomib, vincristine or doxorubicin.
Danish: Dexamethason har ingen klinisk signifikant interaktion med thalidomid, lenalidomid, pomalidomid, bortezomib, vincristin eller doxorubicin.
English: Each carton contains 10 x 1 tablets in OPA/Aluminium /PVC-Aluminium perforated unit dose blister.
Danish: Hver karton indeholder 10 x 1 tabletter i perforeret enkeltdosisblister af OPA/aluminium/PVC-aluminium.
English: In controlled studies, combination treatment with dexamethasone consistently showed better outcomes in terms of survival and response than single-agent dexamethasone.
Danish: Kontrollerede undersøgelser har samstemmende vist bedre udfald af kombinationsbehandling med dexamethason hvad angår overlevelse og respons end af dexamethason som monoterapi.
English: No dose adjustment is needed in the treatment of multiple myeloma.
Danish: Dosisjustering er ikke nødvendig ved behandling af multipelt myelom.
English: In addition, amphotericin B carries a risk of cardiac enlargement and cardiac failure with concurrent use.
Danish: Samtidig anvendelse af amphotericin B medfører desuden risiko for kardiomegali og kardialt svigt
English: Dexamethasone may be used with known teratogens (e.g. thalidomide, lenalidomide, pomalidomide, plerixafor), or with cytotoxic substances which are contraindicated in pregnancy.
Danish: Dexamethason kan anvendes sammen med kendte teratogener (f.eks. thalidomid, lenalidomid, pomalidomid, plerixafor) og med cytotoksiske stoffer, der er kontraindiceret ved graviditet.
English: The tablet can be divided for administration of a 20 mg dose (see section 4.2).
Danish: Tabletten kan deles for at administrere en dosis på 20 mg (se pkt.
English: The incidence of predictable adverse reactions, including adrenal atrophy, correlates with dose, timing of administration and the duration of treatment (see section 4.4).
Danish: Forekomsten af forudsigelige bivirkninger, herunder adrenal atrofi, afhænger af dosering, administrationstidspunkt og behandlingsvarighed (se pkt.
English: Patients and/or carers should be warned that potentially severe psychiatric adverse reactions may occur with systemic steroids (see section 4.8).
Danish: Patienterne og/eller dennes omsorgsgiver bør advares om, at systemiske steroider kan give potentielt svære psykiatriske bivirkninger (se pkt.
English: Repeated, daily administration of dexamethasone also leads to reduced dexamethasone plasma levels due to the induction of CYP3A4 and P-gp.
Danish: Gentagen daglig administration af dexamethason fører ligeledes til nedsat plasmakoncentration af dexamethason som følge af induktion af CYP3A4 og P-gp.
English: Concomitant administration of dexamethasone with substances that are metabolised via CYP3A4 or transported by P-gp could lead to increased clearance and decreased plasma concentrations of these substances:
Danish: Administration af dexamethason sammen med stoffer, der metaboliseres via CYP3A4 eller transporteres af P-gp, kan medføre øget clearance og lavere plasmakoncentration af sådanne stoffer:
English: If you stop taking Neofordex
Danish: Hvis du holder op med at tage Neofordex
English: Parasite eradication must be successfully terminated before dexamethasone use (see section 4.4).
Danish: Parasitangreb skal være udryddet før anvendelse af dexamethason (se pkt.
English: • Isoniazid, as glucocorticoids may decrease isoniazid plasma concentrations, probably due to a stimulation of hepatic metabolism of isoniazid and a reduction of glucocorticoid metabolism.
Danish: • isoniazid, da glukokortikoider kan sænke plasmakoncentrationen af isoniazid, antagelig som følge af stimulation af den hepatiske metabolisering af isoniazid og nedsat glukokortikoid-metabolisme
English: • Oral anticoagulants, due to a possible impact of corticosteroids on the metabolism of the oral anticoagulant and on coagulation factors, as well as the haemorrhagic risk (mucosa of the digestive tract, vascular fragility) of dexamethasone therapy itself at high doses or treatment periods above 10 days.
Danish: • orale antikoagulantia, på grund af kortikosteroiders mulige indvirkning på orale antikoagulantia og koagulationsfaktorerne og på grund af den øgede blødningsrisiko (mave-tarmslimhinden, skrøbelige kar), som dexamethason i sig selv medfører ved anvendelse i høje doser eller i mere end 10 dage.
English: Do not drive, use any tools or machines or carry out any hazardous tasks if you experience side effects, such as confusion, hallucinations, dizziness, tiredness, sleepiness, fainting or blurred vision.
Danish: Undlad at føre motorkøretøj, betjene maskiner eller udføre farligt arbejde, hvis du får bivirkninger såsom omtågethed, hallucinationer, svimmelhed, træthed, søvnighed, besvimelsesanfald eller sløret syn.