FrancophonIA/ELRC3.0 huggingface dataset:
English: • With hypoglycaemic medicinal products, as dexamethasone can raise glycaemic levels and diminish glucose tolerance, with a possibility of ketoacidosis.
Danish: • med lægemidler, der giver hypoglykæmi, da dexamethason kan øge det glykæmiske niveau og nedsætte glukosetolerancen med mulighed for ketoacidose.
English: Neofordex is indicated in adults for the treatment of symptomatic multiple myeloma in combination with other medicinal products.
Danish: Neofordex er indiceret til behandling af symptomgivende multipelt myelom hos voksne, i kombination med andre lægemidler.
English: Paediatric population There is no relevant use of Neofordex in the paediatric population in the indication multiple myeloma.
Danish: Der er ingen relevant anvendelse af Neofordex hos den pædiatriske population til indikationen multipelt myelom.
English: − Aggression, confusion, irritability, nervousness, restlessness, altered mood;
Danish: − aggression, konfusion, irritabilitet, nervøsitet, rastløshed, ændret humør
English: High-dose (40 mg or 20 mg) oral dexamethasone has been studied in the therapy of multiple myeloma in combination with chemotherapy in the VAD regimen (vincristine, adriamycin/doxorubicin and dexamethasone) or in association with novel agents, including thalidomide and its analogues as well as proteasome inhibitors.
Danish: Høje orale doser af dexamethason (40 mg eller 20 mg) er undersøgt til behandling af multipelt myelom kombineret med kemoterapi i VAD-regimet (vincristin, adriamycin/doxorubicin og dexamethason) eller i forbindelse med nye stoffer, herunder thalidomid og analoger dertil samt proteasomhæmmere.
English: Appropriate prophylaxis should be considered for patients with a previous history of, or risk factors for, gastric or duodenal ulceration, haemorrhage or perforation.
Danish: Der bør overvejes passende profylakse til patienter med tidligere gastrisk eller duodenal ulceration, blødning eller perforation, eller med risikofaktorer herfor.
English: In one study, 10.7% of patients treated with thalidomide and dexamethasone experienced grade 3/4 neuropathic reactions, compared to 0.9% of patients treated with dexamethasone alone.
Danish: Én undersøgelse viste således, at 10,7 % af de patienter, der var blevet behandlet med thalidomid og dexamethason, fik neuropatiske reaktioner af grad 3-4, sammenholdt med 0,9 % af dem, der blev behandlet med dexamethason alene.
English: Concomitant administration of erythropoietic medicinal products may also increase thrombotic risk in these patients.
Danish: Ved sideløbende brug af erythropoietiske lægemidler kan der ligeledes være øget tromboserisiko hos sådanne patienter.
English: Neofordex is a medicine that contains the active substance dexamethasone.
Danish: Neofordex er et lægemiddel, der indeholder det aktive stof dexamethason.
English: In post marketing experience tumour lysis syndrome (TLS) has been reported in patients with haematological malignancies following the use of dexamethasone alone or in combination with other chemotherapeutic agents.
Danish: Efter markedsføringen er der rapporteret om tumorlysesyndrom (TLS) hos patienter med hæmatologiske maligniteter efter brug af dexamethason alene eller i kombination med andre kemoterapeutiske midler.
English: Dexamethasone apoptotic activity is enhanced by the combination with thalidomide or its analogues and with proteasome inhibitor (e.g. bortezomib).
Danish: Den apoptotiske aktivitet af dexamethason øges ved kombination med thalidomid eller analoger dertil og med proteasomhæmmere (f.eks. bortezomib).
English: Please inform any doctor, dentist or person who may prescribe a treatment for you that you are currently taking or have recently taken dexamethasone.
Danish: Hvis du får ordineret medicin af lægen, tandlægen eller andre, skal du fortælle vedkommende, at du får eller for nylig har fået dexamethason.
English: Dexamethasone can suppress skin reaction to allergy testing.
Danish: Dexamethason kan undertrykke hudreaktioner over for allergitestning.
English: Lactose monohydrate Microcrystalline cellulose Magnesium stearate Colloidal anhydrous silica
Danish: Lactosemonohydrat Mikrokrystallinsk cellulose Magnesiumstearat
English: Methotrexate is also used to treat rheumatism or psoriasis; - Erythropoietin (EPO, to treat anaemia) - Ciclosporin (for the treatment of psoriasis, atopic dermatitis, rheumatoid arthritis or nephrotic syndrome, and to suppress immune reactions after an organ or bone marrow transplantation) - Ephedrine (to treat asthma attacks or relieve nasal congestion).
Danish: Methotrexat anvendes også til behandling af gigt og psoriasis - erythropoietin (EPO, til behandling af anæmi) - ciclosporin (til behandling af psoriasis, atopisk dermatitis, leddegigt og nefrotisk syndrom samt til undertrykkelse af immunreaktioner efter transplantation af et organ eller knoglemarv) - efedrin (til behandling af astmaanfald eller til lindring af tilstoppet næse)
English: In Pom + LD-Dex treated patients, thrombocytopenia was serious in 1.7% of patients, led to dose reduction in 6.3% of patients, to dose interruption in 8% of patients and to treatment discontinuation in 0.7% of patients.
Danish: Hos de patienter, der blev behandlet med Pom + LD-Dex, var trombocytopeni alvorlig hos 1,7 % af patienterne, medførte dosisreduktion hos 6,3 % af patienterne, afbrydelse af doseringen hos 8 % af patienterne og seponering af behandlingen hos 0,7 % af patienterne.
English: neofordex UNIQUE IDENTIFIER - 2D BARCODE
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE
English: Very common: may affect more than 1 in 10 people
Danish: Meget almindelige: forekommer hos mere end 1 ud af 10 behandlede
English: If the patient experiences any thromboembolic events, treatment must be discontinued and standard anticoagulation therapy started.
Danish: Hvis der opstår tromboemboliske hændelser, skal behandlingen seponeres og sædvanlig antikoagulationsbehandling påbegyndes.
English: The adverse reactions observed in patients treated with dexamethasone are listed below by system organ class and frequency.
Danish: De iagttagne bivirkninger med dexamethason er nedenfor opstillet efter systemorganklasse og hyppighed.
English: If you are elderly, some of the side effects of Neofordex may be more serious, especially thinning of the bones (osteoporosis), high blood pressure, low potassium levels, diabetes, susceptibility to infection and thinning of the skin.
Danish: Hvis du er ældre, kan visse af bivirkningerne af Neofordex være mere alvorlige, navnlig knogleskørhed (osteoporose), forhøjet blodtryk, for lavt kaliumniveau, sukkersyge, modtagelighed for infektion samt tynd hud.
English: Use of corticosteroids requires appropriate monitoring in patients with ulcerative colitis (due to perforation risk), recent intestinal anastomoses, diverticulitis, recent myocardial infarction (risk of left ventricular free wall rupture), diabetes mellitus (or family history), renal insufficiency, hepatic impairment, osteoporosis and myasthenia gravis.
Danish: Anvendelse af kortikosteroider kræver fornøden overvågning hos patienter med ulcerøs kolitis (på grund af risikoen for perforation) nylige tarmanastomoser, divertikulitis, nyligt myokardieinfarkt (risiko for ruptur af den frie væg af venstre ventrikel), diabetes mellitus (eller familiær anamnese hermed), nyreinsufficiens, nedsat leverfunktion, osteoporose og myasthenia gravis.
English: − Epileptic fits;
Danish: − epileptiske anfald
English: Corticosteroids can favour the development of tendonitis and, in exceptional cases, rupture of the affected tendon.
Danish: Kortikosteroider kan fremme udviklingen af tendinitis, som i exceptionelle tilfælde kan medføre seneruptur.
English: Uncommon: Febrile neutropenia, pancytopenia, coagulopathy.
Danish: Ikke almindelige: Febril neutropeni, pancytopeni, koagulopati
English: Consequently, patients with known risk factors for thromboembolism (including prior thrombosis) should be closely monitored.
Danish: Tæt overvågning er derfor nødvendig ved kendte risikofaktorer for tromboembolisme (herunder tidligere trombose).
English: Not known: Pancreatitis, gastrointestinal perforation, gastrointestinal haemorrhage, gastrointestinal ulcer.
Danish: Ikke kendt: Pankreatitis, gastrointestinal perforation, gastrointestinal blødning, gastrointestinalt ulcus
English: In some cases, the combination of several medicines can increase the side effects of one or the other of these medicines taken separately.
Danish: Når flere lægemidler tages i kombination, kan et eller flere af dem undertiden give flere bivirkninger, end når de tages hver for sig.
English: Neofordex will be given with other medicines for multiple myeloma.
Danish: Neofordex gives sammen med andre lægemidler mod multipelt myelom.
English: You should tell your doctor if you have symptoms of tumour lysis syndrome such as muscle cramping, muscle weakness, confusion, visual loss or disturbances and shortness of breath
Danish: Du bør fortælle det til lægen, hvis du oplever symptomer på tumorlysesyndrom, såsom muskelkramper, muskelsvaghed, forvirring, synstab eller synsforstyrrelser og stakåndethed.
English: - The other ingredients are lactose monohydrate, microcrystalline cellulose, magnesium stearate and colloidal anhydrous silica (see section 2).
Danish: - Øvrige indholdsstoffer: lactosemonohydrat, mikrokrystallinsk cellulose, magnesiumstearat og kolloid vandfri silica (se pkt.
English: No clinical efficacy and safety studies have been conducted using Neofordex in the treatment of multiple myeloma.
Danish: Der er ikke udført kliniske undersøgelser af virkningen og sikkerheden af Neofordex til behandling af multipelt myelom.
English: However, antithrombotic prophylaxis with low-dose acetylsalicylic acid is possible.
Danish: Der kan dog anvendes tromboseprofylakse med lavdosis-acetylsalicylsyre
English: In reproductive toxicity studies in mice, rats, hamsters, rabbits and dogs, dexamethasone has led to embryo-fetal malformations such as increase in cleft palate and skeletal defects; decreases in thymus, spleen and adrenal weight; lung, liver, and kidney abnormalities; and inhibition of growth.
Danish: I reproduktionstoksicitetsundersøgelser hos mus, rotter, hamstre, kaniner og hunde har dexamethason medført embryoføtale misdannelser såsom øget forekomst af ganespalte og skeletdefekter, nedsat thymus-, milt- og binyrevægt, lunge-, lever- og nyreanomalier samt væksthæmning.
English: Active viral disease (especially viral hepatitis, herpes, varicella, shingles).
Danish: Aktiv virussygdom (specielt viral hepatitis, herpes, skoldkopper, herpes zoster).
English: • With medicinal products that carry a risk of Torsades de Pointes, due to increased risk of ventricular arrhythmia.
Danish: • med lægemidler, der medfører risiko for Torsades de Pointes, på grund af øget risiko for ventrikulær arytmi.
English: Other medicines and Neofordex Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Neofordex Fortæl det altid til lægen eller på apoteket, hvis du bruger anden medicin, har gjort det for nylig eller påtænker at gøre det.
English: • Anticonvulsants that are hepatic enzyme inducers: carbamazepine, fosphenytoin, phenobarbital, phenytoin, primidone, due to the reduction of dexamethasone plasma levels and hence its efficacy.
Danish: • antikonvulsiva, som inducerer leverenzymer: carbamazepin, fosphenytoin, phenobarbital, phenytoin og primidon, som følge af reduktion af plasmakoncentrationen af dexamethason og dermed af dets virkning
English: − Sensitivity, numbness, tingling or burning sensation of the skin, or pain in the hands or feet due to nerve damage, dizziness, trembling, headache, loss of or change in the sense of taste;
Danish: − følsomhed, følelsesløshed, snurrende eller brændende hud eller smerter i hænder eller fødder som følge af nervebeskadigelse, svimmelhed, rysten, hovedpine, nedsat eller ændret smagsopfattelse
English: The posology of anti-diabetic medicinal products may have to be adjusted during and after the treatment with dexamethasone.
Danish: Dosisjustering af antidiabetiske lægemidler kan være nødvendig under og efter behandling med dexamethason
English: Patients must avoid contact with subjects with chickenpox or measles.
Danish: Patienten skal undgå kontakt med personer med skoldkopper eller mæslinger.
English: Risks may be higher with high doses (see also section 4.5 for pharmacokinetic interactions that can increase the risk of adverse reactions), although dose levels do not allow prediction of the onset, type severity or duration of reactions.
Danish: 4.5 vedrørende farmakokinetiske interaktioner, der kan øge bivirkningsrisikoen), men dosisniveauet gør det ikke muligt at forudsige sådanne reaktioners indsætten, sværhedsgrad eller varighed.
English: In case of neutropenia, the physician should consider the use of growth factors in patient management.
Danish: Ved neutropeni bør behandling med vækstfaktorer overvejes.
English: What Neofordex contains - The active substance is dexamethasone.
Danish: Neofordex indeholder: - Det aktive stof er dexamethason.
English: Talk to your doctor before taking Neofordex - if you have liver or kidney disease, - if you have heart disease or you have recently had a heart attack, - if you have high blood pressure, high cholesterol or you are a smoker, - if you have diabetes or if there is a history of diabetes in your family, - if you have osteoporosis, especially if you are a woman who has been through the menopause, - if you have glaucoma (increased eye pressure) or if there is a history of glaucoma in your family, - if you have myasthenia gravis (a disease affecting the muscles), - if you have a peptic ulcer (ulcer in your stomach or duodenum), or a history of peptic ulcers, stomach bleeding or perforation, - if you have inflammation of the colon, diverticulitis, or have recently had surgery on the intestine, - if you have inflammation of a tendon.
Danish: Sig det til lægen, inden du får Neofordex: - hvis du har lever- eller nyreproblemer - hvis du har hjertesygdom eller for nylig har haft et hjerteanfald - hvis du har forhøjet blodtryk eller forhøjet kolesterol eller er ryger - hvis du har sukkersyge, eller der er sukkersyge i familien - hvis du har knogleskørhed, navnlig hvis du er kvinde efter overgangsalderen - hvis du har grøn stær (øget tryk i øjet) eller nogen i familien har haft grøn stær - hvis du har myasthenia gravis (en nervesygdom, påvirker musklerne) - hvis du har mavesår (sår i mavesækken eller tolvfingertarmen) eller tidligere har haft mavesår,
English: The common adverse reactions to systemic corticosteroids may be associated with more serious consequences in old age, especially osteoporosis, hypertension, hypokalaemia, diabetes, susceptibility to infection and thinning of the skin.
Danish: De almindelige bivirkninger af systemiske kortikosteroider kan have mere alvorlige konsekvenser hos ældre, navnlig osteoporose, hypertension, hypokaliæmi, diabetes, modtagelighed for infektion samt tynd hud.
English: • With hypokalaemic medicinal products: hypokalemic diuretics, single or in combination, laxatives, tetracosactide, intravenous amphotericin B, due to increased risk of hypokalaemia.
Danish: • med lægemidler, der bevirker hypokaliæmi: monoterapi eller kombinationsbehandling med diuretika, der bevirker hypokaliæmi, samt laksantia, tetracosactid og intravenøst amphotericin B på grund af øget risiko for hypokaliæmi.
English: Based on human experience, dexamethasone is suggested to cause congenital malformations, particularly intra-uterine growth retardation and rarely neonatal adrenal insufficiency, when administered during pregnancy.
Danish: Erfaringer fra mennesker tyder på, at brug af dexamethason under graviditeten medfører kongenitte misdannelser, navnlig nedsat intrauterin vækst og i sjældne tilfælde neonatal binyrebarkinsufficiens.
English: Any hypokalaemia should be corrected and patients should be monitored clinically, for electrolytes and by electrocardiograpy.
Danish: Eventuel hypokaliæmi bør korrigeres, og patientens kliniske tilstand skal monitoreres, for elektrolytter og ved hjælp af EKG
English: FN was associated with dose interruption in 3.7% of patients, and with dose reduction in 1.3% of patients, and with no treatment discontinuations.
Danish: Febril neutropeni var forbundet med afbrydelse af doseringen hos 3,7 % af patienterne og med dosisreduktion hos 1,3 % af patienterne, men uden seponering af behandlingen.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof eller for et eller flere af hjælpestofferne anført i pkt.
English: Neofordex is a high-dose glucocorticoid.
Danish: Neofordex er et højdosis-glukokortikoid.
English: • Docetaxel and cyclophosphamide, due to reduction of their plasma levels by induction of CYP3A and P-gp.
Danish: • docetaxel og cyclophosphamid, på grund af reduktion af plasmakoncentrationen af disse lægemidler gennem induktion af CYP3A og P-gp
English: Low-grade peripheral neuropathic reactions, predominantly grade 1 paraesthesia, may be observed with dexamethasone alone in up to 34% of newly diagnosed multiple myeloma patients.
Danish: Ved monoterapi med dexamethason ses perifere neuropatiske reaktioner af lav grad, hovedsagelig paræstesi af grad 1, hos op til 34 % af patienter med nydiagnosticeret multipelt myelom.
English: No data are available on the biotransformation of dexamethasone in hepatically impaired patients.
Danish: Der foreligger ingen data om biotransformationen af dexamethason ved nedsat leverfunktion.
English: • Erythromycin, due to increased metabolism of erythromycin in non-carriers of the CYP3A5*1 allele after dexamethasone treatment.
Danish: • erythromycin, på grund af øget metabolisering af erythromycin efter behandling med dexamethason af personer, der ikke bærer CYP3A5*1-allelet
English: These are common (may affect up to 1 in 10 people) and may include: - feeling depressed (including thinking about suicide) - feeling high (mania), very happy (euphoria) or moods that go up and down, - feeling anxious, having difficulty in concentrating and memory loss, - feeling, seeing or hearing things that do not exist or believing in things that are not real, having gloomy thoughts, changing how you act.
Danish: Det kan dreje sig om følgende: - nedtrykthed (herunder selvmordstanker) - følelse af at være høj (mani) eller meget opstemt (eufori) eller humørsvingninger - angst, koncentrationsbesvær og hukommelsessvækkelse - at mærke, se eller høre ting, der ikke findes, eller tro på ting, der ikke er virkelige, dystre tanker, ændret handlemåde Hvis du oplever nogen af disse symptomer, skal du straks tale med en læge.
English: − Increased need for diabetes medicine, salt imbalance, potassium loss due to low carbon dioxide levels (a condition called metabolic alkalosis);
Danish: − øget behov for sukkersygemedicin, saltubalance, tab af kalium på grund af lavt indhold af kuldioxid
English: − Stroke, difficulties in coordination or movement, fainting;
Danish: − slagtilfælde, nedsat koordinations- eller bevægelsesevne, besvimelse
English: Common: Atrial fibrillation, supraventricular extrasystoles, tachycardia, palpitations;
Danish: Almindelige: Atrieflimren, supraventrikulære ekstrasystoler, takykardi, palpitationer
English: This may include headache, problems with your vision (including pain or swelling in the eye), feeling or being sick, fever, pain in your muscles and joints, swelling in the inside of your nose, weight loss, itchy skin and conjunctivitis.
Danish: De kan bestå i hovedpine, problemer med synet (med smerter eller hævelse af øjnene), kvalme eller opkastning, feber, muskel- og ledsmerter, opsvulmning i næsen, vægttab, hudkløe og betændelse i øjets bindehinde (konjunktivitis).
English: The efficacy of oral contraceptives may be reduced during dexamethasone treatment (see section 4.5).
Danish: Virkningen af orale kontraceptiva kan være nedsat under behandling med dexamethason (se pkt.
English: This medicine does not require any special storage conditions.
Danish: Der er ingen særlige krav vedrørende opbevaring for dette lægemiddel.
English: Prolonged use of corticosteroids may produce subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.
Danish: Langvarig brug af kortikosteroider kan medføre posterior subkapsulær katarakt, glaukom, eventuelt med beskadigelse af nervus opticus, og øget modtagelighed for sekundære svampe- eller virusinfektioner i øjnene.
English: 10 x 1 tablets in OPA/Aluminium /PVC-Aluminium perforated unit dose blister.
Danish: 10 x 1 tabletter i perforeret enkeltdosisblister af OPA/aluminium/PVC-aluminium.
English: Uncommon: Myocardial ischaemia, bradycardia; Not known: Congestive heart failure.
Danish: Ikke almindelige: Myokardieiskæmi, bradykardi Ikke kendt: Venstresidig hjerteinsufficiens
English: − Thinning of the bones with increased risk of fracture, bone disease, ruptured tendon.
Danish: − knogleskørhed med øget risiko for brud, knoglesygdomme, brist af sener.
English: Each tablet contains dexamethasone acetate equivalent to 40 mg dexamethasone.
Danish: Hver tablet indeholder dexamethasonacetat svarende til 40 mg dexamethason.
English: Particular care is needed when treating patients with renal impairment, hypertension or congestive heart failure.
Danish: Særlig forsigtighed må udvises ved behandling af patienter med nedsat nyrefunktion, hypertension eller venstresidigt hjertesvigt.
English: Patients with hepatic impairment or renal insufficiency require appropriate monitoring; patients with hepatic impairment should be dosed with caution as there are no data for this patient population (see sections 4.4 and
Danish: Til patienter med nedsat leverfunktion bør doseringen sættes forsigtigt, da der ikke findes data for denne patientpopulation (se pkt.
English: What you need to know before you take Neofordex 3.
Danish: Det skal du vide, før du begynder at tage Neofordex 3.
English: Women should avoid pregnancy during Neofordex treatment.
Danish: Kvinder bør undgå at blive gravide under behandling med Neofordex.
English: − Muscle wasting, pain of the muscles, joints, bones or limbs;
Danish: − muskelsvind, smerter i muskler, led, knogler eller lemmer
English: Contact your doctor if you notice painful, stiff or swollen joints or tendons.
Danish: Kontakt lægen, hvis du får ømme, stive eller hævede led eller sener.
English: Patients should be instructed to seek medical care if they develop symptoms such as shortness of breath, chest pain, arm or leg swelling.
Danish: Patienten bør instrueres i at søge læge ved symptomer såsom stakåndethed, brystsmerter eller hævede arme eller ben.
English: Effects of other medicinal products on dexamethasone Dexamethasone is metabolized via cytochrome P450 3A4 (CYP3A4), and transported by the P-glycoprotein (P-gp, also known as MDR1).
Danish: Dexamethason metaboliseres via cytokrom P450 3A4 (CYP3A4) og transporteres af P-glykoprotein (P-gp, også kaldet MDR1).
English: Febrile neutropenia (FN) was experienced in 6.7% of patients who received Pom + LD-Dex, and in no patients who received HD-Dex.
Danish: Febril neutropeni (FN) forekom hos 6,7 % af de patienter, der fik Pom + LD-Dex, og hos ingen af dem, der fik HD-Dex.
English: Neutropenia was the most frequently reported Grade 3 or 4 haematological adverse reaction in patients with relapsed/refractory multiple myeloma treated with the combination of dexamethasone with pomalidomide.
Danish: Neutropeni var den hyppigst rapporterede hæmatologiske bivirkning af grad 3 eller 4 hos patienter med recidiverende/refraktært multipelt myelom, der var blevet behandlet med kombinationen af dexamethason og pomalidomid.
English: • Ciclosporin, due to a reduction of ciclosporin bioavailability and plasma levels.
Danish: • ciclosporin, på grund af nedsat biotilgængelighed og plasmakoncentration af ciclosporin.
English: Dexamethasone may cause confusional state, hallucinations, dizziness, somnolence, fatigue, syncope and blurred vision (see section 4.8).
Danish: Dexamethason kan forårsage konfusion, hallucinationer, svimmelhed, somnolens, træthed, synkope og sløret syn (se pkt.