FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency's recommendations are based on a review of all available data on the risk of hypersensitivity as well as the benefits of intravenous iron medicines:
Danish: Agenturets anbefalinger er baseret på en gennemgang af alle foreliggende data om risikoen for overfølsomhed såvel som fordelene ved intravenøst administrerede jernholdige lægemidler:
English: • All intravenous iron preparations can cause serious hypersensitivity reactions which can be fatal.
Danish: • Alle intravenøse jernpræparater kan medføre alvorlige overfølsomhedsreaktioner, som kan være fatale.
English: • If you are prescribed intravenous iron, you should immediately tell your doctor if you have previously had an allergic reaction to intravenous iron preparations.
Danish: • Hvis du får ordineret intravenøst jern, skal du straks fortælle lægen, hvis du tidligere har haft en allergisk reaktion over for intravenøse jernpræparater.
English: Intravenous iron-containing products must also not be used in patients with serious hypersensitivity to other parenteral iron products.
Danish: Intravenøst administrerede jernholdige produkter må heller ikke anvendes hos patienter, der er alvorligt overfølsomme over for andre parenterale jernprodukter.
English: You should also tell your doctor if you have certain conditions affecting the immune system and involving inflammation (such as rheumatoid arthritis), a history of asthma, eczema or other allergies, as this may make an allergic reaction to intravenous iron preparations more likely.
Danish: Du bør også informere lægen, hvis du lider af visse sygdomme, der inddrager immunsystemet og medfører inflammation (f.eks. leddegigt) eller hvis du tidligere har haft astma, eksem eller andre former for allergi, da dette medfører større sandsynlighed for en allergisk reaktion over for intravenøse jernpræparater.
English: Treatment should be confined to the second or third trimester, provided the benefits of treatment clearly outweigh the risks to the unborn baby.
Danish: Behandlingen bør begrænses til graviditetens anden eller tredje tremånedersperiode og må kun gives under forudsætning af, at fordelene ved behandlingen klart overstiger risiciene for det ufødte barn.
English: All intravenous iron medicines have a small risk of causing allergic reactions which can be lifethreatening if not treated promptly.
Danish: Alle intravenøst indgivne jernholdige lægemidler medfører en lille risiko for allergiske reaktioner, som kan være livstruende, hvis de ikke straks behandles.
English: Treatment should be confined to the second or third trimester, provided the benefits of treatment clearly outweigh the potential serious risks to the foetus such as anoxia and foetal distress.
Danish: Behandlingen bør begrænses til anden eller tredje tremåneders periode og må kun gives, når fordelene ved behandlingen klart overstiger de potentielle alvorlige risici for fostret såsom anoksi og fosterskade.
English: • The risk of hypersensitivity is increased in patients with known allergies or immune or inflammatory conditions and in patients with a history of severe asthma, eczema or other atopic allergy.
Danish: • Risikoen for overfølsomhed er øget hos patienter med kendte allergier, immunsygdomme eller inflammatoriske sygdomme samt hos patienter, der tidligere har haft svær astma, eksem eller anden atopisk allergi.
English: Intravenous iron preparations are prescribed when iron supplements given by mouth cannot be used or do not work, especially in patients receiving dialysis for kidney failure, before and after operations, or in case of absorption disorders affecting the gut.
Danish: Jernholdige lægemidler til intravenøs indgivelse ordineres, når jerntilskud til indtagelse gennem munden ikke kan anvendes eller ikke virker, navnlig til patienter, der er i dialyse på grund af nyresvigt, før og efter operationer og ved sygdomme, der nedsætter absorptionen fra tarmen.
English: Instead caution is warranted with every dose of intravenous iron that is given, even if previous administrations have been well tolerated.
Danish: I stedet skal der udvises forsigtighed hver gang der gives en dosis intravenøst jern, selv om tidligere administrationer er blevet tålt godt.
English: Iron preparations should only be given in an environment where resuscitation facilities are available, so that patients who develop an allergic reaction can be treated immediately.
Danish: Jernpræparater må kun gives på behandlingssteder, hvor der forefindes genoplivningsudstyr, for at sikre øjeblikkelig behandling af patienter, der får en allergisk reaktion.
English: If you are receiving intravenous iron medicines your doctor will closely observe you for any allergic reactions during and for at least 30 minutes after the injection.
Danish: Hvis du får jernholdige lægemidler intravenøst, vil din læge overvåge dig tæt for allergiske reaktioner mens injektionen står på og mindst 30 minutter efterfølgende.
English: Although the data show a clear association of intravenous iron medicines and hypersensitivity reactions, the data cannot be used to detect any differences in the safety profile of the different iron medicines.
Danish: Dataene viser klar sammenhæng mellem intravenøst administrerede jernholdige lægemidler og overfølsomhedsreaktioner, men giver ikke grundlag for at fastslå forskelle i sikkerhedsprofil for forskellige jernholdige lægemidler.
English: • In case of hypersensitivity reactions, healthcare professionals should immediately stop the iron administration and consider appropriate treatment for the hypersensitivity reaction.
Danish: • Ved overfølsomhedsreaktioner skal sundhedspersonalet øjeblikkelig standse administrationen af jern og vælge passende behandling af en sådan reaktion.
English: Intravenous iron medicines should therefore not be used during pregnancy unless clearly necessary.
Danish: Jernholdige lægemidler til intravenøs indgift må derfor ikke anvendes under graviditet, medmindre det er klart nødvendigt.
English: • In view of the limitations of the data the Committee recommended further activities, including yearly reviews of allergic reaction reports and a study to confirm the safety of intravenous iron medicines.
Danish: • I betragtning af de begrænsede foreliggende oplysninger anbefalede udvalget desuden yderligere tiltag, herunder årlig gennemgang af indberetninger om allergiske reaktioner og en undersøgelse, der skal fastlægge sikkerheden ved intravenøst administrerede jernholdige lægemidler.
English: • Intravenous iron products should not be used during pregnancy unless clearly necessary.
Danish: • Intravenøst administrerede jernholdige lægemidler bør ikke anvendes under graviditet, medmindre det er klart nødvendigt.
English: • Intravenous iron-containing products are contraindicated in patients with hypersensitivity to the active substance or excipients.
Danish: • Intravenøst administrerede jernholdige produkter er kontraindiceret hos patienter, der er overfølsomme over for det aktive stof eller hjælpestofferne.
English: The Committee also recommended further activities, including yearly reviews of allergic reaction reports and a study to confirm the safety of intravenous iron medicines.
Danish: Udvalget anbefalede desuden yderligere tiltag bestående i årlig gennemgang af indberetninger om allergiske reaktioner samt en undersøgelse, der skal fastlægge sikkerheden af intravenøst indgivne jernholdige lægemidler.
English: Intravenous iron medicines are used when iron supplements given by mouth cannot be used or do not work.
Danish: Intravenøst indgivne jernholdige lægemidler anvendes, når jerntilskud givet gennem munden ikke kan anvendes eller ikke virker.
English: A test dose is therefore no longer recommended but instead caution is warranted with every dose of intravenous iron that is given, even if previous administrations have been well tolerated.
Danish: Der anbefales derfor ikke længere nogen testdosis; i stedet skal der udvises forsigtighed hver gang der gives en dosis intravenøst jern, selv om patienten ved tidligere lejligheder har tålt det godt.
English: • Intravenous iron medicines should only be administered when staff trained to evaluate and manage anaphylactic and anaphylactoid reactions are immediately available as well as resuscitation facilities.
Danish: • Intravenøst administrerede jernholdige lægemidler bør kun administreres, når der på behandlingsstedet umiddelbart findes personale, som er oplært i at vurdere og behandle anafylaktiske/anafylaktoide reaktioner, samt genoplivningsudstyr.
English: • Intravenous iron medicines are a valuable alternative when iron supplements cannot be given by mouth or have not worked.
Danish: • Jernholdige lægemidler til indgivelse i en vene (intravenøst) kan have stor værdi, når jerntilskud gennem munden ikke kan anvendes eller ikke har virket.
English: The review of intravenous iron medicines was triggered by the French medicines agency, the National Agency for the Safety of Medicine and Health Products (ANSM), following a national review in 2010.
Danish: Gennemgangen af intravenøst administrerede jernholdige lægemidler skete på foranledning af den franske lægemiddelstyrelse, Agence nationale de sécurité du médicament et des produits de santé (ANSM), efter at en national gennemgang i 2010 havde fremhævet risikoen for alvorlige allergiske reaktioner, navnlig hos gravide kvinder, som havde fået jernholdige lægemidler intravenøst.
English: Package size l t o r
Danish: Indhold Koncentration) Pakningsstørrelse r l
English: (Invented) name Strength Pharmaceutical form Route of administration
Danish: Styrke Lægemiddelform Administration Emballage Pakningsstørrelse
English: Date of first authorisation: 17 April 2013
Danish: Dato for første markedsføringstilladelse: 17 april 2013
English: These precautions are also applicable to children.
Danish: Disse forholdsregler gælder også for børn.
English: Bilirubin elevation was below 3%.
Danish: Stigning af bilirubin var under 3 %.
English: - Difficulty in sleeping (insomnia).
Danish: - Svært ved at sove (søvnløshed).
English: Tell your doctor if you are using medicines that prevent the formation of blood clots.
Danish: Fortæl din læge hvis du tager medicin, der forebygger dannelsen af blodpropper.
English: - If you forget a dose, take it as soon as you remember.
Danish: - Hvis du glemmer at tage en dosis, så tag den, så snart du kommer i tanke om det.
English: 1 Haematological response criteria (all responses to be confirmed after ≥ 4 weeks):
Danish: 1 1Hæmatologiske responskriterier (hvert respons skal bekræftes ≥ 4 uger):
English: Complete (Confirmed3) [95% CI] Partial
Danish: Fuldstændigt (Bekræftet3) [95 % CI] Delvist
English: Summary of safety profile
Danish: Sammendrag af sikkerhedsprofilen
English: 220 Hafnarfjörður Iceland
Danish: 220 Hafnarfjörður Island
English: - Stir with a spoon until the tablets have completely dissolved.
Danish: - Omrør med en ske indtil tabletterne er opløst fuldstændig.
English: - If you are being treated for Ph-positive ALL:
Danish: - Hvis du behandles for Ph-positiv ALL:
English: Traces of the dissolved tablets may be left behind in the glass.
Danish: Spor af de opløste tabletter kan blive tilbage i glasset.
English: Therefore, caution should be recommended when driving a car or operating machinery.
Danish: Forsigtighed anbefales derfor, når der føres motorkøretøj eller betjenes maskiner.
English: Thyroid stimulating hormone (TSH) levels should be closely monitored in such patients.
Danish: Thyroidstimulerende hormon (TSH)-niveauer bør følges nøje hos sådanne patienter.
English: If it is used during pregnancy, the patient must be informed of the potential risk to the foetus.
Danish: Hvis produktet anvendes under graviditet, skal patienten informeres om den potentielle risiko for fostret.
English: very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Excipients with known effect:
Danish: Hjælpestoffer med kendt effekt:
English: Start 6-MP the 1st day after cranial irradiation completion.)
Danish: Start 6-MP den første dag efter gennemført kraniebestråling.)
English: However if it is nearly time for the next dose, skip the missed dose.
Danish: Men hvis det næsten er tid til at tage den næste dosis, skal du springe den glemte dosis over.
English: Hands should be washed immediately after handling open capsules.
Danish: Der bør vaskes hænder straks efter håndtering af åbne kapsler.
English: These generally occur within the first several months of therapy.
Danish: Disse opstår almindeligvis indenfor de første måneders behandling.
English: Two intermediates of the manufacturing process, which are also present in the final product, are positive for mutagenesis in the Ames assay.
Danish: To intermediatorer i fremstillingsprocessen, der også tilstede i det endelige produkt, er positive for mutagenese i Ames testen.
English: Hard capsule (capsule).
Danish: Hård kapsel (kapsel)
English: The mechanism and relevance of these findings in the rat carcinogenicity study for humans are not yet clarified.
Danish: Mekanismen og betydningen for mennesker af disse resultater i carcinogen studiet hos rotter er endnu ikke afklaret.
English: Therefore, the use of imatinib in combination requires special precaution.
Danish: Brug af imatinib i denne kombination kræver derfor særlig forsigtighed.
English: All treatment regimens include administration of steroids for CNS prophylaxis.
Danish: Alle behandlingsregimer inkluderer administration af steroider mod CNS profylakse
English: In the clinical study 38% of patients were ≥ 60 years of age and 12% of patients were ≥ 70 years of age.
Danish: I de kliniske undersøgelser var 38 % af patienterne ≥ 60 år, og 12 % af patienterne var ≥ 70 år.
English: The complete molecular response rate was 48% (49 out of 102 evaluable patients).
Danish: Den samlede molekylære responsrate var 48% (49 ud af 102 evaluerbare patienter).
English: 11 Ion Mihalache Blvd Bucharest
Danish: 11 Ion Mihalache Blvd Bukarest
English: The high rate of CHR is accompanied by the development of a complete cytogenetic response (CCyR) of 65% which is comparable to the results observed in adults.
Danish: Den høje rate af CHR er ledsaget af udvikling af komplet cytogenetisk respons (CCyR) hos 65 %, hvilket er sammenligneligt med resultater observeret hos voksne.
English: Exposure to direct sunlight should be avoided or minimised due to the risk of phototoxicity associated with imatinib treatment.
Danish: Eksponering for direkte sollys bør undgås eller minimeres på grund af risikoen for fototoksicitet, der er forbundet med behandling med imatinib.
English: Caution is therefore recommended.
Danish: Det anbefales derfor at udvise forsigtighed.
English: Use only as directed by a doctor.
Danish: Anvendes som foreskrevet af lægen.
English: 8 to 10 g (single dose): Vomiting and gastrointestinal pain have been reported.
Danish: 8 til 10 g (enkeltdosis): Opkastning og gastrointestinale smerter er blevet rapporteret.
English: Contains lecithin (soya) (E322).
Danish: Indeholder lecithin (soya) (E322).
English: - Slowing of growth in children and adolescents.
Danish: - Langsommere vækst hos børn og unge.
English: - Do not take a double dose to make up a forgotten dose.
Danish: - Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: The primary evidence of efficacy was based on objective response rates.
Danish: Det primære bevis for effekt var baseret på onjektive responsrater.
English: A major response combines both complete and partial responses: complete (0% Ph+ metaphases), partial (1-35%)
Danish: Et hovedrespons kombinerer både fuldstændig og partiel respons: Fuldstændig (0 % Ph+ metafaser), delvis (1-35 %).
English: 2 Cytogenetic response criteria:
Danish: 2 Cytogenetiske responskriterier:
English: Patients will be carefully checked by their doctor for signs of this infection before treatment is started.
Danish: Lægen vil omhyggeligt kontrolleres dig for tegn på denne infektion, før behandlingen påbegyndes.
English: Myeloid blast crisis: 260 patients with myeloid blast crisis were enrolled.
Danish: Myeloid blastkrise: Der inkluderedes 260 patienter med myeloid blastkrise.
English: The estimated 4-year OS in cohort 5-patients was 83.6% compared to 44.8% in the historical controls.
Danish: Den estimerede 4-års OS hos kohorte 5-patienter var 83,6 % sammenlignet med 44,8 % i den historiske kontrolgruppe.
English: - if you are taking the medicine levothyroxine because your thyroid has been removed.
Danish: - hvis du tager medicin indeholdende levothyroxin, fordi din skjoldbruskkirtel er blevet fjernet.
English: Film-coated tablet (tablet).
Danish: Filmovertrukken tablet (tablet)
English: 20 out of the 50 (40%) patients in cohort 5 received haematopoietic stem cell transplant.
Danish: 20 ud af 50 (40 %) patienter i kohorte 5 fik hæmatopoietisk stamcelletransplantation.
English: - if you have ever had or might now have a hepatitis B infection.
Danish: - hvis du nogensinde har været eller måske er smittet med hepatitis B-virus.
English: Cranial irradiation (Block 5 only)
Danish: Kraniebestråling (kun blok 5)
English: One blister contains 10 tablets.
Danish: En blister indeholder 10 tabletter.
English: Mean absolute bioavailability for imatinib is 98%.
Danish: Den gennemsnitlige absolutte biotilgængelighed for imatinib er 98 %.
English: It is important to cover sunexposed areas of skin and use sunscreen with high sun protection factor (SPF).
Danish: Det er vigtigt at dække de områder af huden, som udsættes for solen, og at bruge solcreme med høj solbeskyttelsesfaktor (SPF).
English: Ileus/intestinal obstruction*, gastrointestinal perforation*, diverticulitis*, gastric antral vascular ectasia (GAVE)*
Danish: Ileus/intestinal obstruktion*, gastrointestinal perforation*, diverticulitis*, gastric antral vascular ectasia (GAVE)*
English: ANC = absolute neutrophil count a occurring after at least 1 month of treatment
Danish: ANC = fuldstændigt antal neutrofilocytter a opstået efter mindst 1 måneds behandling
English: The rate of haematological response was 70% with a duration of 2-3 months.
Danish: Incidensen af hæmatologisk respons var 70 % med en varighed på 2-3 måneder.
English: Ki values in human liver microsomes were 27, 7.5 and 7.9 μmol/L, respectively.
Danish: Ki værdier i humane levermikrosomer var henholdsvis 27; 7,5 og 7,9 μmol/l.
English: Elderly patients: Imatinib pharmacokinetics have not been specifically studied in older people.
Danish: Ældre patienter: Imatinibs farmakokinetik er ikke specifikt undersøgt hos ældre.
English: Lymphoid blast crisis: a limited number of patients were enrolled in phase I studies (n=10).
Danish: Lymfoid blastkrise: der inkluderedes et begrænset antal patienter i fase I undersøgelser (n=10).
English: Non-neoplastic lesions not identified in earlier preclinical studies were the cardiovascular system, pancreas, endocrine organs and teeth.
Danish: Non-neoplastisk skade, som ikke er identificeret ved tidligere prækliniske studier, er i det kardiovaskulære system, pankreas, endokrine organer og tænder.
English: 3 Complete cytogenetic response confirmed by a second bone marrow cytogenetic evaluation performed at least one month after the initial bone marrow study.
Danish: 3 Fuldstændigt cytogenetisk respons bekræftet ved endnu en cytogenetisk knoglemarvsundersøgelse udført mindst 1 måned efter den initiale knoglemarvsundersøgelse.
English: While you are taking Imatinib Actavis, your doctor will regularly check whether the medicine is working.
Danish: Mens du tager Imatinib Actavis, vil din læge regelmæssigt kontrollere, om lægemidlet virker.
English: The rate of response was also higher in the patients treated at 600 mg (33%) as compared to the patients treated at 400 mg (16%, p=0.0220).
Danish: Hovedresponsniveauet var også større hos patienter behandlet med 600 mg (33 %) sammenlignet med patienter behandlet med 400 mg (16 %, p=0,0220).
English: It is important that you do this as long as your doctor or pharmacist tells you to.
Danish: Det er vigtigt, at du tager det så længe, lægen eller apotekspersonalet fortæller dig, at du skal.
English: Some children and adolescents taking Imatinib Actavis may have slower than normal growth.
Danish: Nogle børn og unge, der får Imatinib Actavis, kan vokse langsommere end normalt.
English: - Imatinib Actavis is not recommended during pregnancy unless clearly necessary as it may harm your baby.
Danish: - Imatinib Actavis anbefales ikke under graviditeten, medmindre det er strengt nødvendigt, da det kan skade din baby.
English: Hypersensitivity to soya or peanut.
Danish: Overfølsomhed over for soya eller jordnødder.
English: The duration of imatinib therapy can vary with the treatment programme selected, but generally longer exposures to imatinib have yielded better results.
Danish: Varigheden af behandling med imatinib kan variere med det valgte behandlingsprogram, men generelt har længere eksponering for imatinib givet de bedste resultater.
English: Your doctor has prescribed Imatinib Actavis because you suffer from a serious condition.
Danish: Din læge har udskrevet Imatinib Actavis, fordi du lider af en alvorlig sygdom.
English: The capsule contains light yellow powder.
Danish: Kapslen indeholder lysegult pulver.
English: AST: >ULN (can be normal or <ULN if total bilirubin is >ULN)
Danish: ASAT: >ULN (kan være normal eller <ULN hvis total bilirubin er >ULN)
English: Blast crisis is defined as blasts ≥ 30% in blood or bone marrow or extramedullary disease other than hepatosplenomegaly.
Danish: Blastkrise defineres som ≥ 30 % blaster i blod eller knoglemarv eller ekstramedullær sygdom ud over hepatosplenomegali.
English: The plasma AUC for this metabolite was found to be only 16% of the AUC for imatinib.
Danish: Plasma AUC for denne metabolit blev kun fundet at være 16 % af AUC for imatinib.
English: Talk to your doctor before taking Imatinib Actavis: - if you have or have ever had a liver, kidney or heart problem.
Danish: Kontakt lægen, før du tager Imatinib Actavis: - hvis du har eller har haft lever-, nyre- eller hjerteproblemer.
English: Safety data from this study seem to be in line with the safety profile of imatinib in Ph+ ALL patients.
Danish: Sikkerhedsdata fra dette studie synes at være i overensstemmelse med sikkersprofilen for imatinib hos Ph+ ALL-patienter.
English: - Pain in your hips or difficulty walking.
Danish: - Smerte i hoften eller svært ved at gå.
English: Reykjavíkurvegur 76-78, Hafnarfjörður Iceland
Danish: Reykjavíkurvegur 76-78, Hafnarfjörður Island
English: - Once the tablet has dissolved, drink everything in the glass straight away.
Danish: - Når tabletten er opløst, så drik hele glassets indhold med det samme.
English: The suspension should be administered immediately after complete disintegration of the tablet(s).
Danish: Suspensionen skal administreres straks efter fuldstændig opløsning af tabletten/tabletterne.
English: - Take Imatinib Actavis with a meal.
Danish: - Tag Imatinib Actavis sammen med et måltid.
English: They may increase or decrease the effect of Imatinib Actavis, either leading to increased side effects or making Imatinib Actavis less effective.
Danish: De kan enten øge eller nedsætte virkningen af Imatinib Actavis, hvilket kan resultere i enten flere bivirkninger, eller de kan gøre Imatinib Actavis mindre virksomt.
English: In a recent publication updated information from 6 of these 11 patients revealed that all these patients remained in cytogenetic remission (range 32-38 months).
Danish: Opdaterede oplysninger om 6 af disse 11 patienter, som er publiceret for nylig, viste, at alle disse patienter forblev i cytogenetisk remission ( 32-38 måneder).
English: This medicinal product contains lecithin (soya).
Danish: Dette lægemiddel indeholder lecithin (soya).
English: Considering the combined concentration of imatinib and the metabolite and the maximum daily milk intake by infants, the total exposure would be expected to be low (~10% of a therapeutic dose).
Danish: Den totale koncentration af imatinib og metabolitten og spædbørns maksimale daglige indtagelse af mælk taget i betragtning, er det forventet, at den totale eksponering er lav (~10% af den terapeutiske dosis).