FrancophonIA/ELRC3.0 huggingface dataset:
English: Neutropenia occurred in 45.3% of relapsed and refractory multiple myeloma patients who received low dose dexamethasone plus pomalidomide (Pom + LD-Dex), and in 19.5% of patients who received high dose dexamethasone (HD-Dex).
Danish: Neutropeni forekom hos 45,3 % af de patienter med recidiverende og refraktært multipelt myelom, som fik en lav dosis af dexamethason + pomalidomid (Pom + LD-Dex), og hos 19,5 % af dem, der fik en høj dosis af dexamethason (HD-Dex).
English: − if you have a viral infection, especially viral hepatitis, herpes, chickenpox or shingles,
Danish: − hvis du har en virusinfektion, navnlig viral hepatitis, herpes, skoldkopper eller helvedesild
English: When Neofordex is given in combination with other medicinal products, refer to their Summaries of Product Characteristics for additional contraindications.
Danish: Når Neofordex gives i kombination med andre lægemidler, henvises til produktresuméerne for de pågældende lægemidler vedrørende yderligere kontraindikationer.
English: Neutropenia was Grade 3 or 4 in 41.7% of patients who received Pom + LD-Dex, compared with 14.8% who received HD-Dex.
Danish: Neutropeni af grad 3 eller 4 forekom hos 41,7 % af de patienter, der fik Pom + LD-Dex, sammenholdt med 14,8 % af dem, der fik HD-Dex.
English: Dexamethasone is metabolized via cytochrome P450 3A4 (CYP3A4).
Danish: Dexamethason metaboliseres via cytokrom P450 3A4 (CYP3A4).
English: − Development of diabetes, loss or increase of appetite, weight gain or weight loss, water retention;
Danish: − udvikling af diabetes, øget eller nedsat appetit, vægtøgning eller vægttab, væskeophobning
English: When Neofordex is used in combination with known teratogens (e.g. thalidomide, lenalidomide, pomalidomide, plerixafor), particular attention to pregnancy testing and prevention requirements is needed (see section 4.6).
Danish: Når Neofordex anvendes i kombination med kendte teratogene stoffer (f.eks. thalidomid, lenalidomid, pomalidomid, plerixafor), skal der udvises særlig omhu med graviditetstestning, og der skal kræves brug af antikonception (se pkt.
English: Not known: Pathological fracture, osteonecrosis, osteoporosis, tendon rupture.
Danish: Ikke kendt: Patologiske frakturer, osteonekrose, osteoporose, seneruptur
English: Concomitant administration of dexamethasone with inducers or inhibitors of CYP3A4 or P-gp may lead to decreased or increased plasma concentrations of dexamethasone, respectively.
Danish: Samtidig anvendelse af induktorer eller inhibitorer af CYP3A4 eller P-gp kan henholdsvis nedsætte eller øge plasmakoncentrationen af dexamethason.
English: Signs of a developing infection may be masked by dexamethasone therapy.
Danish: Tegn på begyndende infektion kan maskeres af behandlingen med dexamethason.
English: Common: Pneumonia, herpes zoster, upper respiratory tract infection, lower respiratory tract infection, oral candidiasis, oral fungal infection, urinary tract infection, herpes simplex, candidal infection;
Danish: Almindelige: Pneumoni, herpes zoster, øvre luftvejsinfektion, nedre luftvejsinfektion, oral candidiasis, orale svampeinfektioner, urinvejsinfektion, herpes simplex, candidainfektion Ikke kendt: Infektion, sepsis
English: In cases of prior tuberculosis with major radiological sequelae or if it is not certain that a full 6-month rifampicin treatment course has been followed, a prophylactic anti-tuberculosis treatment is required.
Danish: Der skal gives profylaktisk antituberkuløs behandling i tilfælde af tidligere tuberkulose med svære radiologiske sequelae, eller ved tvivl om, hvorvidt patienten har gennemført et fuldt seks måneders behandlingsforløb med rifampicin.
English: Uncommon: may affect up to 1 in 100 people
Danish: Ikke almindelige: forekommer hos indtil 1 ud af 100 behandlede
English: • With methotrexate, due to an increased risk of haematological toxicity.
Danish: • med methotrexat på grund af øget risiko for hæmatotoksisk virkning.
English: When Neofordex is given in combination with other medicinal products, the Summary of Product Characteristics of these other medicinal products must be consulted prior to initiation of treatment with Neofordex.
Danish: Når Neofordex skal gives i kombination med andre lægemidler, skal produktresuméet for disse andre lægemidler gennemgås, før behandlingen med Neofordex iværksættes.
English: Use in combination with other multiple myeloma treatment(s)
Danish: Anvendelse sammen med andre midler mod multipelt myelom
English: − Medicinal products that may increase dexamethasone plasma concentration:
Danish: − Lægemidler, der kan øge plasmakoncentrationen af dexamethason:
English: Potassium supplementation should be given particularly if there is a risk of cardiac arrhythmia or concurrent hypokalaemic medicinal products.
Danish: Der bør gives kaliumtilskud, navnlig ved risiko for kardiale arytmier eller ved samtidig behandling med lægemidler, der forårsager hypokaliæmi.
English: • Lapatinib, due to increased hepatotoxicity of lapatinib likely due to induction of CYP3A4 metabolism.
Danish: • lapatinib, på grund af øget hepatotoksicitet af lapatinib, antagelig som følge af induktion af metaboliseringen via CYP3A4
English: − Medicinal products that may reduce dexamethasone plasma concentration:
Danish: − Lægemidler, der kan nedsætte plasmakoncentrationen af dexamethason:
English: You must tell your doctor immediately if you experience shortness of breath, chest pain or swelling in the arms or legs.
Danish: Du skal straks fortælle det til lægen, hvis du får stakåndethed, brystsmerter eller hævede arme eller ben.
English: In addition, convulsions have been reported with concurrent use of dexamethasone and ciclosporin.
Danish: Der er endvidere beskrevet kramper ved samtidig brug af dexamethason og ciclosporin.
English: In combination with thalidomide or its analogues the most serious adverse reactions were venous thromboembolic events, predominantly deep vein thrombosis and pulmonary embolism, and myelosuppression, particularly neutropenia and thrombocytopenia (see section 4.4).
Danish: Ved kombination med thalidomid eller analoger hertil var de alvorligste bivirkninger venøse tromboemboliske hændelser (hovedsagelig dyb venetrombose og lungeemboli) samt myelosuppression (navnlig neutropeni og trombocytopeni) (se pkt.
English: • Ivermectin, due to a reduction of ivermectin plasma levels.
Danish: • ivermectin, på grund af nedsat plasmakoncentration af ivermectin.
English: How to take Neofordex 4.
Danish: Sådan skal du tage Neofordex 4.
English: Infections and Infestations
Danish: Infektiøse og parasitære sygdomme
English: Neofordex administration should follow instructions for dexamethasone administration when described in the Summary of Product Characteristics of the associated treatment(s).
Danish: Neofordex skal administreres i henhold til anvisningerne før administration af dexamethason, når sådanne anvisninger er givet i produktresuméet for den eller de tilknyttede lægemidler.
English: Hyperglycaemia, insomnia, muscle pain and weakness, asthenia, fatigue, oedema and weight increase occur very commonly.
Danish: Hyperglykæmi, søvnløshed, muskelsmerter og muskelsvaghed, asteni, træthed, ødem og vægtøgning forekommer meget almindeligt.
English: − Cough, breathing difficulties, difficulties speaking, sore throat or mouth, hoarseness, dry mouth,
Danish: − hoste, åndedrætsbesvær, talebesvær, ondt i halsen eller munden, hæshed, mundtørhed, hikke,
English: Therefore, erythropoietic medicinal products, or other medicinal products that may increase the risk of thrombosis, such as hormone replacement therapy, should be used with caution in multiple myeloma patients receiving dexamethasone with thalidomide and its analogues.
Danish: Derfor bør der udvises forsigtighed ved brug af erythropoietiske lægemidler eller andre lægemidler såsom hormonsubstitutionsterapi, der kan øge tromboserisikoen, til patienter med multipelt myelom, der samtidig er i behandling med dexamethason og thalidomid og analoger hertil.
English: Thrombocytopenia was also reported very commonly by patients with relapsed/refractory multiple myeloma treated with the combination of dexamethasone with pomalidomide.
Danish: Trombocytopeni blev også meget ofte rapporteret for patienter med recidiverende/refraktært multipelt myelom, der var behandlet med kombinationen af dexamethason og pomalidomid.
English: Common: may affect up to 1 in 10 people
Danish: Almindelige: forekommer hos indtil 1 ud af 10 behandlede
English: • Topical gastro-intestinal medicinal products, antacids and activated carbon, as well as colestyramine, due to reduction of the intestinal absorption of dexamethasone.
Danish: • topikale gastrointestinale lægemidler (antacida og medicinsk kul samt colestyramin), på grund af nedsat optagelse af dexamethason i tarmen.
English: Neofordex 40 mg tablets
Danish: Neofordex, tabletter, 40 mg
English: Concomitant administration of erythropoietic medicinal products or previous history of deep vein thrombosis may also increase thrombotic risk in these patients.
Danish: Sideløbende administration af erythropoietiske lægemidler eller DVT i anamnesen kan ligeledes indebære øget tromboserisiko hos disse patienter.
English: • Praziquantel, due to the reduction of praziquantel plasma concentrations due to an increase of its hepatic metabolism by dexamethasone, with a risk of failure of treatment.
Danish: • praziquantel, på grund af nedsat plasmakoncentration af praziquantel som følge af, at dexamethason øger den hepatiske metabolisering af stoffet med risiko for behandlingssvigt.
English: Common: Rash, erythema, hyperhidrosis, pruritus, dry skin, alopecia;
Danish: Almindelige: Udslæt, erytem, hyperhidrose, pruritus, tør hud, alopeci
English: Thrombocytopenia occurred in 27.0% of relapsed and refractory multiple myeloma patients who received Pom + LD-Dex, and 26.8% of patients who received HD-Dex.
Danish: Trombocytopeni forekom hos 27,0 % af de patienter med recidiverende og refraktært multipelt myelom, som fik Pom + LD-Dex, og hos 26,8 % af dem, som fik HD-Dex.
English: The combination of lenalidomide, thalidomide or pomalidomide with dexamethasone is associated with an increased risk of deep vein thrombosis and pulmonary embolism in patients with multiple myeloma (see section 4.5).
Danish: Kombination af lenalidomid, thalidomid eller pomalidomid med dexamethason øger risikoen for dyb venetrombose og lungeemboli hos patienter med multipelt myelom (se pkt.
English: Treatment with this medicine may cause central serous chorioretinopathy, an eye disease that leads to blurred or distorted vision.
Danish: Behandlingen med dette lægemiddel kan medføre en øjensygdom, der forårsager sløret eller forvrænget syn (central serøs korioretinopati).
English: A similar incidence of high-grade neutropenia was reported in newly diagnosed patients treated with the combination of lenalidomide and dexamethasone.
Danish: En tilsvarende forekomst af neutropeni af høj grad blev beskrevet hos nydiagnosticerede patienter behandlet med kombinationen af lenalidomid og dexamethason.
English: − Heart attack, abnormally slow heartbeat;
Danish: − hjerteanfald, unormalt langsom hjerterytme
English: • With erythropoietic medicinal products or other medicinal products that may increase the risk of thrombosis, such as hormone replacement therapy, in patients receiving thalidomide or its analogues with Neofordex (see sections 4.4 and 4.8).
Danish: • med erythropoietiske lægemidler eller andre lægemidler såsom hormonsubstitutionsterapi, der kan øge tromboserisikoen, hos patienter i behandling med thalidomid eller analoger hertil (se pkt.
English: The dose of the anti-hypertensive treatment may have to be adjusted during the treatment with dexamethasone.
Danish: Dosisjustering af antihypertensiva kan være nødvendig under behandling med dexamethason.
English: Do not take Neofordex
Danish: Tag ikke Neofordex:
English: − Slow wound healing, acne, thinning of the skin, bruising, red or purple discolorations on the skin
Danish: − langsom sårheling, akne, tynd hud, blå mærker, rød eller lilla misfarvning af huden (purpura)
English: − Increased pressure in the eye including glaucoma, choroid and retinal disorders (chorioretinopathy);
Danish: − øget tryk i øjnene, herunder grøn stær, sygdomme i øjets årehinde og nethinde (korioretinopati)
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 kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V*.
English: Common: Depression, anxiety, aggression, confusional state, irritability, nervousness, mood alteration, agitation, euphoric mood; Uncommon: Mood swings, hallucinations;
Danish: Meget almindelige: Søvnløshed Almindelige: Depression, angst, aggression, konfusionstilstand, irritabilitet, nervøsitet, humørændringer, agitation, eufori Ikke almindelige: humørsvingninger, hallucinationer Ikke kendt: Mani, psykose, adfærdsforstyrrelser
English: Common: Pollakiuria; Uncommon: Renal failure.
Danish: Almindelige: Pollakisuri Ikke almindelige: Nyresvigt
English: What you need to know before you take Neofordex
Danish: Det skal du vide, før du begynder at tage Neofordex
English: In patients with multiple myeloma, the combination of dexamethasone with thalidomide and its analogues is associated with an increased risk of venous thromboembolism (predominantly deep vein thrombosis and pulmonary embolism) and arterial thromboembolism (predominantly myocardial infarction and cerebrovascular event) (see sections 4.5 and 4.8).
Danish: Hos patienter med multipelt myelom er dexamethason i kombination med thalidomid og analoger hertil forbundet med øget risiko for venøs tromboembolisme (hovedsagelig dyb venetrombose og lungeemboli) og arteriel tromboembolisme (hovedsagelig myokardieinfarkt og cerebrovaskulære hændelser) (se pkt.
English: Studies in animals have shown reductions in female fertility (see Section 5.3).
Danish: Fertilitet Der er påvist nedsat fertilitet hos hundyr (se pkt.
English: Common: Venous thromboembolic reactions, predominantly deep vein thrombosis and pulmonary embolism, hypertension, hypotension, flushing, blood pressure increased, diastolic blood pressure decreased;
Danish: Almindelige: Venøse tromboemboliske reaktioner (hovedsageligt dyb venetrombose og lungeemboli), hypertension, hypotension, rødmen, blodtryksstigning, diastolisk blodtryksfald Ikke kendt: Purpura, blodudtrædning
English: Hepatic impairment or renal insufficiency
Danish: Nedsat leverfunktion eller nyreinsufficiens
English: Thrombocytopenia was Grade 3 or 4 in 20.7% of patients who received Pom + LD-Dex and in 24.2% who received HD-Dex.
Danish: Trombocytopeni af grad 3 eller 4 forekom hos 20,7 % af de patienter, der fik Pom + LD-Dex, og hos 24,2 % af dem, der fik HD-Dex.
English: Prior to the use of Neofordex in combination with any other medicinal product, reference should be made to the Summary of Product Characteristics of that product.
Danish: Før anvendelse af Neofordex i kombination med et andet lægemiddel skal produktresuméet for det pågældende lægemiddel gennemgås.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Neofordex bør ikke anvendes til patienter med de sjældne arvelige lidelser galaktoseintolerans eller Lapp laktasemangel (glukose-/galaktosemalabsorption).
English: Common: Neutropenia, anaemia, thrombocytopenia, lymphopenia, leukopenia, leukocytosis;
Danish: Almindelige: Neutropeni, anæmi, trombocytopeni, lymfopeni, leukopeni, leukocytose
English: Neofordex should not be taken if you are pregnant unless clearly indicated by your doctor.
Danish: Hvis du er gravid, må du ikke tage Neofordex, medmindre lægen udtrykkelig har ordineret det.
English: Tendonitis
Danish: Tendinitis
English: Very common: Muscular weakness, muscle cramps; Common: Myopathy, musculoskeletal pain, arthralgia, pain in extremity;
Danish: Muskler, knogler og bindevæv Meget almindelige: Muskelsvækkelse og -krampe Almindelige: Myopati, smerter i muskler og knogler, artralgi, ekstremitetssmerter
English: − Pain, fever, chills, fainting, vertigo, exhaustion, drowsiness, impaired sense of balance.
Danish: − smerter, feber, kulderystelser, besvimelsesanfald, svimmelhed, udmattelse, døsighed, nedsat balanceevne.
English: • Obligation to conduct post-authorisation measures N/A
Danish: • Forpligtelse til foranstaltninger efter udstedelse af markedsføringstilladelse Ikke relevant
English: Neofordex 40 mg tablets dexamethasone
Danish: Neofordex, tabletter, 40 mg Dexamethason
English: Particular care is needed when treating patients with glaucoma (or family history of glaucoma) as well as when treating patients with ocular herpes simplex, because of possible corneal perforation.
Danish: Ved glaukom (eller familiær anamnese med glaukom) og ved okulær herpes simplex er særlig forsigtighed nødvendig på grund af muligheden for corneaperforation.
English: • Midazolam, due a reduction in midazolam plasma levels by CYP3A4 induction.
Danish: • midazolam, på grund af nedsat plasmakoncentration af midazolam som følge af induktion af CYP3A4.
English: Immunocompromised patients who have not previously had chickenpox or measles are particularly at risk.
Danish: der ikke tidligere har haft skoldkopper eller mæslinger.
English: No data on male fertility are available.
Danish: Der foreligger ingen data om fertilitet hos handyr.
English: Neofordex contains lactose
Danish: Neofordex indeholder lactose
English: Common: Vomiting, diarrhoea, nausea, dyspepsia, stomatitis, gastritis, abdominal pain, dry mouth, abdominal distension, flatulence;
Danish: Meget almindelige: Konstipation Almindelige: Opkastning, diarré, kvalme, dyspepsi, stomatitis, gastritis, abdominalsmerter, mundtørhed, abdominal distension, flatulens
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: − Bacterial, viral or fungal infections, including pneumonia, shingles, infections of the nose, mouth, tonsils or throat, bronchitis, herpes, bladder infection;
Danish: − bakterie-, virus- eller svampeinfektioner, herunder lungebetændelse, helvedesild, infektioner i næse,
English: • Aprepitant and fosaprepitant, due to an increase of dexamethasone plasma concentrations by a reduction of its hepatic metabolism.
Danish: • aprepitant og fosaprepitant, på grund af øget plasmakoncentration af dexamethason gennem nedsættelse af dets metabolisering i leveren.
English: A similar incidence of high-grade thrombocytopenia was reported in newly diagnosed patients treated with the combination of lenalidomide and dexamethasone.
Danish: En tilsvarende forekomst af trombocytopeni af høj grad blev indberettet for nydiagnosticerede patienter, der blev behandlet med lenalidomid kombineret med dexamethason.
English: Neofordex contains lactose.
Danish: Neofordex indeholder lactose.
English: − Having trouble sleeping;
Danish: − søvnbesvær
English: − Vomiting, nausea, diarrhoea, indigestion, bloating, swollen and/or painful stomach;
Danish: − opkastning, kvalme, diarré, fordøjelsesbesvær, oppustethed, oppustet mave og/eller mavesmerter
English: Not known: Purpura, bruising.
Danish: Ikke kendt: Hudatrofi, akne
English: Common: Bronchitis, cough, dyspnoea, pharyngolaryngeal pain, hoarseness, hiccough.
Danish: Almindelige: Bronkitis, hoste, dyspnø, faryngolaryngeale smerter, hæshed, hikke
English: Grade 4 febrile neutropenia episodes were observed infrequently (0.6% in lenalidomide/dexamethasone-treated patients compared to 0.0% in placebo/dexamethasone treated patients).
Danish: Der blev iagttaget ikke-hyppige episoder af febril neutropeni af grad 4 (0,6 % hos patienter behandlet med lenalidomid/dexamethason, sammenholdt med 0,0 % hos patienter behandlet med placebo/dexamethason).
English: • Ephedrine, due to a reduction in dexamethasone plasma levels by increased metabolic clearance.
Danish: • ephedrin, på grund af nedsættelse af dexamethasons plasmakoncentration gennem øget metabolisk clearance
English: − Ulcers, perforations and/or bleeding in the oesophagus (gullet), stomach or intestine, inflamed pancreas
Danish: − sår, perforation og/eller blødning i spiserør (esophagus), mave eller tarm, inflammeret bugspytkirtel (der kan vise sig som smerter i ryggen eller maven)
English: Common: Peripheral neuropathy, dizziness, psychomotor hyperactivity, disturbance in attention, memory impairment, tremor, paraesthesia, headache, ageusia, dysgeusia, somnolence, lethargy, balance impaired, dysphonia;
Danish: Almindelige: Perifer neuropati, svimmelhed, psykomotorisk hyperaktivitet, opmærksomhedsforstyrrelser, hukommelsessvækkelse, tremor, paræstesi, hovedpine, ageusi, dysgeusi, somnolens, letargi, nedsat balanceevne, dysfoni Ikke almindelige: Cerebrovaskulær hændelse, transitorisk cerebral iskæmi, amnesi, koordinationsforstyrrelse, ataksi, synkope Ikke kendt: Kramper
English: Not known: Adrenal atrophy, steroid withdrawal syndrome, adrenal insufficiency, hirsutism, menstrual irregularity.
Danish: Almindelige: Cushings syndrom Ikke almindelige: Hypotyroidisme Ikke kendt: Adrenal atrofi, steroid-abstinenssyndrom, binyreinsufficiens, hirsutisme, uregelmæssig menstruation
English: • With rifampicin, due to reduction of dexamethasone plasma concentrations and efficacy by an increase of its hepatic metabolism.
Danish: • rifampicin, på grund af reduktion af dexamethasons plasmakoncentration og virkning gennem øget metabolisering i leveren
English: You must read the package leaflets of all medicinal products to be taken in combination with Neofordex for information related to these medicines before starting treatment with Neofordex.
Danish: Før du begynder behandlingen med Neofordex, skal du læse indlægssedlerne for alle de lægemidler, Neofordex skal gives sammen med, for at få information om de pågældende lægemidler.
English: Method of administration Oral use.
Danish: Oral anvendelse.
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Danish: Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide om brugen af lægemidlet.
English: • Rifabutin, due to reduced rifabutin plasma levels by induction of intestinal and hepatic CYP3A4.
Danish: • rifabutin, på grund af reduktion af plasmakoncentration af rifabutin gennem induktion af CYP3A4 i tarmen og leveren
English: Uncommon: Conjunctivitis, increased lacrimation; Not known: Chorioretinopathy, glaucoma.
Danish: Almindelige: Sløret syn, katarakt Ikke almindelige: Konjunktivitis, øget tåreflåd Ikke kendt: Korioretinopati, glaukom
English: • Aminogluthetimide, due to a reduction of the efficacy of dexamethasone through an increase of its hepatic metabolism.
Danish: • aminoglutethimid, på grund af reduktion af dexamethasons virkning gennem øget metabolisering i leveren
English: • Indinavir, due to a strong reduction of indinavir plasma levels by intestinal CYP3A4 induction.
Danish: • indinavir, på grund af kraftig reduktion af plasmakoncentrationen af indinavir i dyreforsøg gennem induktion af CYP3A4 i tarmen
English: Neofordex contains lactose, a sugar.
Danish: Neofordex indeholder sukkerarten lactose.
English: Respiratory, thoracic, or mediastinal disorders
Danish: Luftveje, thorax og mediastinum
English: Grade 4 febrile neutropenia episodes were observed infrequently (0.6% in lenalidomide/dexamethasone-treated patients compared to 0.0% in placebo/dexamethasone treated patients; see section 4.8).
Danish: Der blev iagttaget få episoder af febril neutropeni af grad 4 (0,6 % hos patienter behandlet med lenalidomid/dexamethason, sammenholdt med 0,0 % hos patienter behandlet med placebo/dexamethason; se pkt.
English: Uncommon: Hypothyroidism;
Danish: Ikke almindelige: Urticaria
English: Tablets may be broken in two equal halves using the score line to provide the 20 mg dose.
Danish: For at administrere 20 mg kan tabletten deles i to lige store dele ved hjælp af delekærven.
English: − Muscle cramps, muscle weakness;
Danish: − muskelkrampe, muskelsvækkelse
English: How to take Neofordex
Danish: Sådan skal du tage Neofordex