FrancophonIA/ELRC3.0 huggingface dataset:
English: Specific groups of patients
Danish: Særlige patientgrupper
English: In elderly and/or frail patients, the daily dose may be reduced to 20 mg of dexamethasone, according to the appropriate treatment regimen.
Danish: Hos ældre og/eller skrøbelige patienter kan den daglige dosis nedsættes til 20 mg dexamethason i overensstemmelse med det pågældende behandlingsregime.
English: Tablets should be kept in the blister package until administration.
Danish: Tabletterne skal opbevares i blisterpakningen indtil administration.
English: Potassium levels should be monitored and corrected as necessary.
Danish: Kaliumniveauet bør overvåges og om nødvendigt korrigeres.
English: − Lack of body water (dehydration) with thirst or headache;
Danish: − manglende kropsvæske (dehydrering) med tørst eller hovedpine
English: Swallow the prescribed dose of one tablet (40 mg) or half a tablet (20 mg) in the morning with a glass of water.
Danish: Tag den ordinerende dosis på én tablet (40 mg) eller en halv tablet (20 mg) om morgenen med et glas vand.
English: High-dose corticosteroids, including dexamethasone, can cause psychological problems that may sometimes be serious.
Danish: Høje doser af kortikosteroider, herunder dexamethason, kan give psykiske problemer, der undertiden kan være alvorlige.
English: If you forget to take Neofordex If you forget to take Neofordex at the usual time and - if you are less than 12 hours late: take the tablet immediately.
Danish: Hvis du har glemt at tage Neofordex Hvis du har glemt at tage Neofordex på det sædvanlige klokkeslæt og - det er mindre end 12 timer for sent: Tag straks tabletten.
English: If you become ill or are involved in an accident, or if you need surgery (even at the dentist) or require a vaccination (particularly “live virus” vaccines) you should inform the doctor treating you that you are taking or have recently taken high-dose corticosteroids.
Danish: Hvis du bliver syg eller kommer ud for en ulykke, eller hvis du har behov for operation (også hos tandlægen) eller behøver en vaccination (navnlig vaccine, der indeholder levende virus), skal du fortælle den læge, der behandler dig, at du får eller for nylig har fået kortikosteroider i høje doser.
English: If you have difficulties taking the tablet out of the blister or breaking the tablet, ask somebody for help.
Danish: Hvis du har svært ved at få tabletten ud af blisterkortet eller dele tabletten, kan du bede nogen om hjælp.
English: Do not save the spare half tablet to take on another day as this medicine may deteriorate once divided and taken out of its packaging.
Danish: Du skal ikke gemme den tiloversblevne halve tablet for at tage den en anden dag, da dette lægemiddel kan tage skade, når det deles og tages ud af emballagen.
English: Then, keep the spare half tablet in a safe place, out of the sight and reach of children, until you can throw it away properly, as you should not throw away any medicines in wastewater or household waste.
Danish: Opbevar derefter den tiloversblevne halve tablet et sikkert sted, utilgængeligt for børn, indtil du kan bortskaffe den på den rigtige måde - da du ikke må smide lægemidler i spildevand eller husholdningsaffald.
English: Due to possible stability issues affecting half tablets stored after division, half-tablets that are not taken immediately should be discarded in agreement with local precautions for environmental protection (see also 6.4).
Danish: Pga. muligheden for stabilitetsproblemer ved opbevaring af halve tabletter skal halve tabletter, der ikke straks tages, kasseres i henhold til lokale bestemmelser til beskyttelse af miljøet (se også pkt.
English: Prolonged exposure was required to achieve maximum levels of apoptotic markers along with increased caspase-3 activation and DNA fragmentation.
Danish: Det krævede langvarig eksponering at opnå maksimale niveauer af apoptotiske markører sammen med øget caspase-3-aktivering og DNA-fragmentering.
English: Email: ctrs@ctrs.fr
Danish: E-mail: ctrs@ctrs.fr
English: Patients/carers should also be alert to possible psychiatric disturbances that may occur either during, or immediately after, dose tapering/withdrawal of systemic steroids, although such reactions have been reported infrequently.
Danish: Patienter/omsorgsgivere bør desuden være opmærksomme på eventuelle psykiske forstyrrelser, der kan optræde enten under eller straks efter dosisnedtrapning/seponering af systemiske steroider, skønt sådanne reaktioner ikke ofte er beskrevet.
English: Multiple myeloma is a progressive rare haematologic disease.
Danish: Multipelt myelom er en sjælden progressiv blodsygdom.
English: • Oral contraceptives, as it cannot be excluded that the efficacy of oral contraceptives may be reduced during treatment.
Danish: • orale antikonceptiva, da det ikke kan udelukkes, at behandlingen forringer effektiviteten af orale antikonceptiva.
English: • With digitalis, as hypokalaemia enhances the toxic effects of digitalis.
Danish: • med digitalis, da hypokaliæmi forstærker de toksiske virkninger af digitalis.
English: Women of childbearing potential and their male partners should take appropriate contraceptive measures.
Danish: Kvinder i den fødedygtige alder og deres mandlige partner bør anvende sikker antikonception.
English: However, both incidence and severity of peripheral neuropathy increase with concomitant bortezomib or thalidomide administration.
Danish: Både hyppigheden og sværhedsgraden af perifer neuropati stiger imidlertid ved samtidig administration af bortezomib eller thalidomid.
English: It the combination is required, monitoring should be reinforced and coagulation parameters controlled after one week and then every other week of treatment as well as after the end of treatment.
Danish: Hvis det er nødvendigt at anvende denne kombination, bør overvågningen skærpes og koagulationsparametre kontrolleres efter en uge og derefter hver anden behandlingsuge samt efter behandlingens afslutning
English: Data on female fertility are contradictory.
Danish: Data om fertiliteten hos hunner er modstridende.
English: Excipient with known effect: Each tablet contains 98.1 mg lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver tablet indeholder 98,1 mg lactose (som monohydrat).
English: If you are using a pill organiser box, use the perforation to separate individual tablets from the blister without opening the packaging.
Danish: Hvis du bruger en tabletæske, skal du bruge perforeringen til at tage de enkelte tabletter ud af blisteren uden at åbne emballagen.
English: The patient populations studied included a wide range of ages, as well as patients considered eligible or ineligible for autologous stem cell transplantation.
Danish: De undersøgte patientpopulationer omfattede et bredt udvalg af aldersgrupper samt patienter, der blev anset for egnede eller uegnede til autolog stamcelletransplantation.
English: Ask your pharmacist how to throw them away.
Danish: Spørg på apoteket, hvordan du bortskaffer dem.
English: Neofordex has moderate influence on the ability to drive and use machines.
Danish: Neofordex påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: White, oblong (11 mm × 5.5 mm) tablet with a score-line on one face.
Danish: Hvid, aflang (11 mm × 5,5 mm) tablet med delekærv på den ene side.
English: Neofordex may cause serious mental health problems.
Danish: Neofordex kan medføre alvorlige psykiske problemer.
English: Bioavailability of dexamethasone is approximately 80%.
Danish: Biotilgængeligheden af dexamethason er ca. 80 %.
English: During treatment, patients should be closely monitored for the appearance of infections.
Danish: Under behandlingen bør patienten nøje overvåges for begyndende infektioner.
English: Patient at high risk of TLS, such as patients with high proliferative rate, high tumour burden, and high sensitivity to cytotoxic agents, should be monitored closely and appropriate precaution taken.
Danish: Patienter med høj risiko for TLS, såsom patienter med høj proliferationsrate, høj tumorbyrde og høj følsomhed over for cytotoksiske midler, bør monitoreres tæt, og der bør tages passende forholdsregler.
English: Patients should be made aware of this risk and self-monitoring of blood and urine should be reinforced, especially during the initiation of treatment.
Danish: Patienten bør gøres opmærksom på denne risiko og selv overvåge blod og urin, navnlig i begyndelsen af behandlingen.
English: If your treatment is to be stopped follow your doctor's advice.
Danish: Hvis du skal stoppe med behandlingen, skal du følge lægens anvisninger.
English: Your doctor will advise on an appropriate diet, and may prescribe potassium, calcium or vitamin D supplements.
Danish: Lægen vil rådgive dig om passende kost og vil muligvis ordinere tilskud af kalium, calcium eller vitamin D.
English: The major part is hydrogenated or hydroxylated in humans, the major metabolites being hydroxy-6-dexamethasone and dihydro-20-dexamethasone.
Danish: Hos mennesker bliver størstedelen hydrogeneret eller hydroxyleret, idet hovedmetabolitterne er hydroxy-6-dexamethason og dihydro-20-dexamethason.
English: − Failure of the thyroid gland to produce normal amounts of hormones (hypothyroidism);
Danish: − manglende evne af skjoldbruskkirtlen til at producere normale mængder hormoner (hypotyroidisme)
English: Neofordex should not be used during pregnancy unless the clinical condition of the woman requires treatment with dexamethasone.
Danish: Neofordex bør ikke anvendes under graviditet, medmindre kvindens kliniske tilstand nødvendiggør behandling med dexamethason.
English: If your dose is half a tablet (20 mg), the tablet should be divided into two equal halves.
Danish: Hvis din dosis er en halv tablet (20 mg), skal tabletterne deles i to lige store dele.
English: If affected, patients should be instructed not to drive, use machines or perform hazardous tasks while being treated with dexamethasone.
Danish: Patienter, der påvirkes på denne måde, skal have besked på ikke at føre motorkøretøj, betjene maskiner eller udføre farlige opgaver under behandlingen med dexamethason.
English: Acute toxicity of dexamethasone is weak and toxic effects have rarely been observed after an acute overdose.
Danish: Den akutte toksicitet af dexamethason er lav, og der er sjældent iagttaget toksiske virkninger efter en akut overdosis.
English: • With acetylsalicylic acid, at doses ≥ 1 g per dose or 3 g per day, due to an increased risk of bleeding.
Danish: • med acetylsalicylsyre i doser ≥ 1 g pr. dosis eller 3 g dagligt, på grund af øget blødningsrisiko.
English: Other cytochrome P450 isoenzymes may also play a role in dexamethasone biotransformation.
Danish: Andre cytokrom P450-isoenzymer kan ligeledes spille en rolle i biotransformationen af dexamethason.
English: Treatment must be initiated and monitored under the supervision of physicians experienced in the management of multiple myeloma.
Danish: Behandlingen skal iværksættes og overvåges under opsyn af læger med erfaring i behandling af multipelt myelom.
English: − if you are allergic to dexamethasone or one of the other ingredients of this medicine (listed in section 6),
Danish: − hvis du er allergisk over for dexamethason eller et af de øvrige indholdsstoffer i Neofordex (angivet i punkt 6)
English: At doses ≥ 500 mg per dose or < 3 g per day, precautions are required due to increased risk of haemorrhage, ulcerations and gastro-intestinal perforation.
Danish: Ved doser ≥ 500 mg pr. dosis eller < 3 g dagligt er sikkerhedsforanstaltninger nødvendige på grund af øget risiko for blødning, ulceration og gastrointestinal perforation.
English: Pack size of 10 tablets.
Danish: Pakningsstørrelse: 10 tabletter.
English: • With anti-hypertensive medicinal products, due to a reduction of their effect (water and sodium retention).
Danish: • med antihypertensiva, på grund af nedsættelse af disses virkning (væske- og natriumretention).
English: Patients should be monitored clinically, including by endoscopy.
Danish: Patienten bør monitoreres klinisk, herunder med endoskopi.
English: You must take this medicine on the appropriate days, exactly as your doctor prescribed.
Danish: Du skal tage dette lægemiddel nøjagtigt på de dage, som din læge har ordineret.
English: This includes any possible side effects not listed in this leaflet.
Danish: Dette gælder også bivirkninger, der ikke fremgår af denne indlægsseddel.
English: Prescribing physicians should carefully evaluate which dose of dexamethasone to use, taking into account the condition and disease status of the patient.
Danish: Den ordinerende læge bør nøje vurdere, hvilken dosis af dexamethason der skal anvendes på grundlag af patientens tilstand og sygdomsstatus.
English: In patients not already prescribed bisphosphonates for multiple myeloma related bone disease, bisphosphonates should be considered, particularly if risk factors for osteoporosis are present.
Danish: Hos patienter, der ikke allerede har fået ordineret bisfosfonater til behandling af knoglesygdom relateret til multipelt myelom, bør bisfosfonater overvejes, navnlig ved risikofaktorer for osteoporose.
English: You should also tell your doctor if you have had tuberculosis or if you have stayed in regions where roundworm infections are common.
Danish: Du skal fortælle det til lægen, hvis du har haft tuberkulose eller har opholdt dig i et område, hvor angreb af rundorm er almindeligt forekommende.
English: Neofordex should not be used with live attenuated vaccines (see section 4.5).
Danish: Neofordex bør ikke anvendes sammen med levende svækkede vacciner (se pkt.
English: The treatments with the two medicinal products should be separated by at least one week.
Danish: Der bør gå mindst én uge mellem administration af de to lægemidler.
English: Glucocorticoids have only weak acute toxicity.
Danish: Glukokortikoider har kun ringe akut toksicitet.
English: Dexamethasone is bound by plasma proteins, principally albumin, up to about 80%, depending on the administered dose.
Danish: Dexamethason er op til 80 % bundet til plasmaproteiner, hovedsagelig albumin, alt efter den administrerede dosis.
English: • With live attenuated vaccines, due to risk of vaccine-related illness with risk of death.
Danish: • med levende svækkede vacciner, på grund af risiko for vaccinerelateret sygdom med mulig fatal udgang.
English: Laboratoires CTRS 63, rue de l'Est 92100 Boulogne-Billancourt France
Danish: Laboratoires CTRS 63, rue de l'Est 92100 Boulogne-Billancourt Frankrig
English: • With non-steroidal anti-inflammatory drugs (NSAIDs), due to an increased risk of gastrointestinal ulceration.
Danish: • med non-steroide antiinflammatoriske lægemidler (NSAID), på grund af øget risiko for gastrointestinal ulceration
English: Elimination The plasma half-life of dexamethasone is approximately 250 minutes.
Danish: Elimination Plasmahalveringstiden af dexamethason er ca. 250 minutter.
English: If you get an infection of any kind during treatment with this medicine, contact your doctor immediately.
Danish: Hvis du får en infektion af nogen art under behandlingen med dette lægemiddel, skal du straks kontakte lægen.
English: Dexamethasone crosses the blood-brain barrier and the placental barrier and passes into breast milk.
Danish: Dexamethason passerer blod-hjernebarrieren og placentabarrieren og går over i brystmælk.
English: Your doctor may change the dose and frequency of administration based on certain parameters including your blood analyses, your general condition, other medicines prescribed to you and your response to the treatment.
Danish: Lægen vil muligvis ændre dosis og hyppighed af indtagelsen af lægemidlet alt efter dine blodprøver, din almentilstand, hvilke andre lægemidler, du har fået ordineret, og hvordan du reagerer på behandlingen.
English: The usual posology of dexamethasone is 40 mg once per day of administration.
Danish: Den sædvanlige dosis af dexamethason er 40 mg én gang pr. administrationsdag.
English: Treatment with high-dose dexamethasone increases the risk of developing serious infections, in particular due to bacteria, yeasts and/or parasites.
Danish: Behandling med højdosis-dexamethason øger risikoen for alvorlige infektioner, navnlig med bakterier, gærsvampe og/eller parasitter.
English: − Fever due to a lack of certain white blood cells, lack of all types of blood cells, diminished blood clotting, decreased magnesium or calcium levels in the blood;
Danish: − feber på grund af mangel på visse hvide blodlegemer, mangel på alle typer blodlegemer, nedsat størkning af blodet, nedsat magnesium- eller calciumindhold i blodet
English: Potassium levels should be monitored during treatment.
Danish: Kaliumindholdet bør overvåges under behandlingen.
English: Reference should be made to all the relevant Summary of Product Characteristics prior to the commencement of any combination treatment for additional information.
Danish: Alle relevante produktresuméer bør gennemgås inden påbegyndelse af enhver kombinationsbehandling.
English: Adverse reactions to Neofordex correspond to the predictable safety profile of glucocorticoids.
Danish: Bivirkningerne med Neofordex svarer til den forventelige sikkerhedsprofil for glukokortikoider.
English: A minor part of administered dexamethasone is excreted unchanged by the kidney.
Danish: En mindre del af det administrerede dexamethason udskilles uændret via nyrerne.
English: If such patients have been in contact with people with chickenpox or measles, a preventive treatment with intravenous normal immunoglobulin or passive immunisation with varicella zoster immunoglobulin (VZIG) must be started as appropriate.
Danish: Hvis sådanne patienter har været i kontakt med personer med skoldkopper eller mæslinger, skal der efter behov iværksættes forebyggende behandling med intravenøst normalt immunglobulin eller passiv immunisering med varicella-zoster immunglobulin (VZIG).
English: A haemoglobin concentration above 12 g/dl should lead to discontinuation of erythropoietic medicinal products.
Danish: Er hæmoglobinkoncentrationen over 12 g/dl, bør erythropoietiskelægemidler seponeres.
English: Talk to your doctor before taking Neofordex if you or a member of your immediate family have suffered, or currently suffer from severe depression or manic attacks.
Danish: Tal med lægen, før du får Neofordex, hvis du selv eller nogen i din nære familie har eller har haft svær depression eller maniske anfald.
English: If you take more Neofordex than you should If you take too much Neofordex contact your doctor or hospital immediately.
Danish: Hvis du har taget for meget Neofordex Hvis du har taget for meget Neofordex, skal du straks kontakte lægen eller hospitalet.
English: You must not breast-feed during treatment.
Danish: Du må ikke amme under behandlingen.
English: Post-natal development assessment of animals treated prenatally presented decreased glucose tolerance and insulin sensitivity, behavioural alterations and decrease in brain and body weight.
Danish: Ved vurdering af den postnatale udvikling af dyr, der var behandlet prænatalt, sås nedsat glukosetolerance og insulinfølsomhed, adfærdsændringer og nedsat hjerne- og kropsvægt.
English: Dexamethasone has been shown to induce multiple myeloma cell death (apoptosis) via a down-regulation of Nuclear Factor-κB activity and an activation of caspase-9 through second mitochondria-derived activator of caspase (Smac; an apoptosis promoting factor) release.
Danish: Dexamethason er påvist at inducere celledød (apoptose) af celler fra multipelt myelom gennem nedregulering af aktiviteten af nuklear faktor κB og aktivering af caspase-9 gennem frigivelse af den anden mitokondrielt deriverede aktivator af caspase (Smac, en apoptose-fremmende faktor).
English: The efficacy and safety of dexamethasone combination treatment in multiple myeloma has been confirmed in numerous clinical studies in newly diagnosed patients and in patients with relapsed or refractory disease.
Danish: Virkningen og sikkerheden af kombinationsbehandling med dexamethason ved multipelt myelom er påvist i talrige kliniske undersøgelser hos nydiagnosticerede patienter og hos patienter med recidiverende eller refraktær sygdom.
English: Patients and physicians are advised to be observant for signs and symptoms of bleeding, including petechiae and epistaxes, especially in case of concomitant treatment susceptible to induce bleeding.
Danish: Patienter og læger rådes til at være opmærksomme på tegn og symptomer på blødning, herunder petekkier og epistaxis, navnlig ved samtidig behandling med midler, der kan fremkalde blødning.
English: At the end of dexamethasone treatment, the dose should be tapered in a stepwise fashion until a complete stop.
Danish: Ved afslutningen af behandling med dexamethason bør dosis nedtrappes trinvis til fuldstændigt ophør.
English: Particular care is required when considering the use of systemic corticosteroids in patients with existing or previous history of severe affective disorders in themselves or in their first degree relatives.
Danish: Særlig forsigtighed bør udvises, når det overvejes at anvende systemiske kortikosteroider ved eksisterende eller tidligere svær affektiv sygdom enten hos patienten selv eller dennes nærmeste slægtninge.
English: Such infections can also be caused by microorganisms that rarely cause disease under normal circumstances (opportunistic infections).
Danish: Sådanne infektioner kan desuden forårsages af mikroorganismer, der under normale omstændigheder sjældent er patogene (opportunistiske infektioner).
English: This risk is increased by concomitant use of fluoroquinolones and in patients undergoing dialysis with secondary hyperparathyroidism or after renal transplantation.
Danish: Denne risiko er øget ved samtidig anvendelse af fluorquinoloner og hos dialysepatienter med sekundær hyperparatyroidisme samt efter nyretransplantation.
English: − Frequent urination;
Danish: − hyppig vandladning
English: Advise patients to not dispose of unused tablets through household waste or wastewater.
Danish: Patienterne skal gøres opmærksomme på, at de ikke bør bortskaffe ubrugte tabletter som husholdningsaffald eller i spildevand.
English: The tablet can be divided into two equal halves.
Danish: Tabletten kan deles i to lige store dele.
English: Patients and physicians are advised to be observant for the signs and symptoms of thromboembolism.
Danish: Patienter og læger rådes til at være på vagt over for tegn og symptomer på tromboembolisme.
English: If you have had blood clots in the past you should inform your doctor before taking Neofordex.
Danish: Hvis du har haft en blodprop, skal du fortælle det til lægen, før du tager Neofordex.
English: Exposed patients should be advised to seek medical attention without delay.
Danish: Eksponerede patienter skal have besked på straks at søge læge.
English: Take one half tablet straightaway.
Danish: Tag en halv tablet med det samme.
English: Halved tablets that are not taken immediately should be disposed of (see section 6.6).
Danish: Halverede tabletter, der ikke tages straks, skal kasseres (se pkt.
English: Other MDR transporters may also have a role in dexamethasone transport.
Danish: Andre MDR-transportproteiner kan ligeledes spille en rolle ved transport af dexamethason.
English: Note: It is important that while you are taking Neofordex you avoid contact with anyone who is suffering from chickenpox, measles or shingles.
Danish: Bemærk: Mens du får Neofordex, at det vigtigt, at du undgår kontakt med enhver, der har skoldkopper, mæslinger eller helvedesild.
English: Certain viral diseases (varicella, measles) can be aggravated in patients receiving glucocorticoid treatment or who have received glucocorticoid treatment within the previous 3 months.
Danish: Visse virussygdomme (skoldkopper, mæslinger) kan forværres hos patienter, som er i behandling med glukokortikoider eller har været det inden for de sidste 3 måneder.
English: Glucocorticoid therapy may reduce the effect of anti-diabetic and antihypertensive treatment.
Danish: Glukokortikoider kan nedsætte virkningen af antidiabetisk og antihypertensiv behandling.
English: Treatment with a high-dose corticosteroid may reduce your body's ability to fight infection.
Danish: Et højdosiskortikosteroid kan nedsætte kroppens evne til at bekæmpe infektioner.