FrancophonIA/ELRC3.0 huggingface dataset:
English: - The other ingredients are: maize starch, povidone (E1201), crospovidone (E1202), silica colloidal anhydrous, magnesium stearate (E470b), and lactose monohydrate in the tablet core, as well as talc (E553b), hypromellose (E464), titanium dioxide (E171), and macrogol 8000 in the filmcoating.
Danish: - Øvrige indholdsstoffer: Majsstivelse, povidon (E1201), crospovidon (E1202), kolloid vandfri silica, magnesiumstearat (E470b) og lactosemonohydrat i tabletkernen, såvel som talcum (E553b), hypromellose (E464), titandioxid (E171), macrogol 8000 og gul jernoxid (E172) i filmovertrækket.
English: - The other ingredients are: maize starch, povidone (E1201), crospovidone (E1202), talc (E553b), silica colloidal anhydrous, magnesium stearate (E470b), and lactose monohydrate in the tablet core, as well as talc (E553b), hypromellose (E464), titanium dioxide (E171), and macrogol 8000 in the film-coating.
Danish: Øvrige indholdsstoffer: Majsstivelse, povidon (E1201), crospovidon (E1202), talkum, kolloid vandfri silica, magnesiumstearat (E470b) og lactosemonohydrat i tabletkernen, såvel som talcum (E553b), hypromellose (E464), titandioxid (E171) og macrogol 8000 i filmovertrækket.
English: Arava 20 mg film-coated tablets leflunomide
Danish: Arava 20 mg filmovertrukne tabletter leflunomid
English: 30 film-coated tablets 100 film-coated tablets
Danish: 100 filmovertrukne tabletter
English: Arava 100 mg film-coated tablets leflunomide
Danish: Arava 100 mg filmovertrukne tabletter leflunomid
English: Arava 10 mg film-coated tablets leflunomide
Danish: Arava 10 mg filmovertrukne tabletter leflunomid
English: Each film-coated tablet contains 20 mg leflunomide.
Danish: En filmovertrukken tablet indeholder 20 mg leflunomid.
English: Sanofi-Aventis Deutschland GmbH
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Sanofi-aventis Deutschland GmbH
English: - increased hair loss, - eczema, dry skin, rash, itching, - tendonitis (pain caused by inflammation in the membrane surrounding the tendons usually in the feet or hands), - an increase of certain enzymes in the blood (creatine phosphokinase), - problems in the nerves of the arms or legs (peripheral neuropathy).
Danish: som regel i fødder og hænder), - stigning af visse enzymer i blodet (kreatin fosfokinase) - gener fra nerverne i arme eller ben (perifer neuropati).
English: Arava 100 mg
Danish: INFORMATION I BRAILLESKRIFT Arava 100 mg
English: Musculoskeletal and connective tissue disorders Common:
Danish: Hud og subkutane væv Almindelig:
English: Arava 10 mg
Danish: INFORMATION I BRAILLESKRIFT Arava 10 mg
English: - if you have ever had an allergic reaction to leflunomide (especially a serious skin reaction,
Danish: Tag ikke Arava - hvis du nogensinde har haft en allergisk reaktion over for leflonumid (specielt en alvorlig hudreaktion, ofte ledsaget af feber, ledsmerter, røde pletter på huden eller blærer, f.eks. Stevens
English: Arava 20 mg
Danish: INFORMATION I BRAILLESKRIFT Arava 20 mg
English: Povidone (E1201) Crospovidone (E1202) Talc (E553b)
Danish: Povidon (E 1201) Crospovidon (E 1202) Talcum (E553b) Kolloid vandfri silica Magnesiumstearat (E 470b) Lactosemonohydrat
English: Arava 20 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Arava 20 mg filmovertrukket tablet
English: EU/1/99/118/001 30 tablets EU/1/99/118/002 100 tablets
Danish: EU/1/99/118/002 100 tabletter
English: Tell your doctor immediately if you experience: - pale skin, tiredness, or bruising, as these may indicate blood disorders caused by an imbalance in the different types of blood cells which make up blood, - tiredness, abdominal pain, or jaundice (yellow discolouration of the eyes or skin), as these may indicate serious conditions such as liver failure, which may be fatal, - any symptoms of an infection such as fever, sore throat or cough, as this medicine may increase the chance of a severe infection which may be life-threatening, - cough or breathing problems as these may indicate problems of the lung (interstitial lung disease or pulmonary hypertension), - unusual tingling, weakness or pain in your hands or feet as these may indicate problems with your nerves (peripheral neuropathy).
Danish: - hoste eller åndedrætsproblemer, da disse kan være tegn på lungeproblemer (interstitiel lungesygdom eller pulmonal hypertension), - usædvanlig prikken, svaghed eller smerte i dine hænder eller fødder, da dette kan være tegn på problemer med dine nerver (perifer neuropati).
English: EU/1/99/118/009 3 tablets
Danish: EU/1/99/118/006 100 tabletter
English: EU/1/99/118/003 30 tablets EU/1/99/118/004 100 tablets
Danish: EU/1/99/118/004 100 tabletter
English: Arava 10 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Arava 10 mg filmovertrukket tablet
English: Arava 100 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Arava 100 mg filmovertrukket tablet
English: EU/1/99/118/005-008 EU/1/99/118/010
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/99/118/005-008
English: Package leaflet: Information for the user Arava 20 mg film-coated tablets leflunomide
Danish: LÆGEMIDLETS NAVN Arava 20 mg filmovertrukne tabletter leflunomid
English: Package leaflet: Information for the user Arava 100 mg film-coated tablets leflunomide
Danish: LÆGEMIDLETS NAVN Arava 100 mg filmovertrukne tabletter leflunomid
English: The study is ongoing.
Danish: Studiet er igangværende.
English: You may require medical attention.
Danish: Du kan have behov for lægehjælp.
English: Instructions for administration to the patient
Danish: Instruktioner for administration til patienten
English: # DEATHS / # Land Patient
Danish: # DØDSFALD / # Land - patient
English: Make sure that you read and understand these instructions before using the oral suspension.
Danish: Sørg for, at du læser og forstår disse instruktioner, før du bruger den orale suspension.
English: The dose should be recalculated every 3 months based on changes in body weight, or more often if necessary.
Danish: Dosis bør genberegnes hver tredje måned baseret på ændringer i kropsvægten, eller oftere om nødvendigt.
English: • Wash your hands before and after each use.
Danish: • Vask hænder før og efter hver brug.
English: This case was a Grade 1 osteopenia.
Danish: Dette tilfælde var grad 1 osteopeni.
English: These reactions are presented by system organ class and by frequency.
Danish: Disse reaktioner anføres efter organklasse og hyppighed.
English: Wash your hands before initiating the constitution.
Danish: Vask hænder før påbegyndelse af rekonstituering.
English: • Check to make sure the patient has swallowed all of the dose.
Danish: • Tjek for at være sikker på, at patienten har slugt hele dosis.
English: After constitution: Store in a refrigerator.
Danish: Efter rekonstitution: Opbevares i køleskab.
English: These white cells usually help the body to fight infection.
Danish: De hvide blodlegemer hjælper sædvanligvis kroppen med at bekæmpe infektioner.
English: Take your tablets at the same time every day.
Danish: Tag tabletterne på samme tidspunkt hver dag.
English: Sulphur dioxide (E220)
Danish: Svovldioxid (E220)
English: It cannot be excluded that the effect is larger after multiple doses of dasatinib.
Danish: Det kan ikke udelukkes, at virkningen er større efter flere doser dasatinib.
English: Remove the closure from the bottle.
Danish: Fjern lukningen fra flasken.
English: % with MR4.5
Danish: % med MR4.5
English: Paediatric population Interaction studies have only been performed in adults.
Danish: Pædiatrisk population Interaktionsstudier er kun blevet udført hos voksne.
English: These results are difficult to interpret in the context of chronic diseases such as CML, and require long-term follow-up.
Danish: Resultaterne er svære at fortolke i konteksten af kroniske sygdomme som CML, og langsigtet opfølgning er påkrævet.
English: Effects on growth and development in paediatric patients
Danish: Effekter på vækst og udvikling hos pædiatriske patienter
English: These results are consistent with those seen at 12, 24 and 36 months.
Danish: Disse resultater stemmer overens med resultaterne, set efter 12, 24 og 36 måneder.
English: Most patients continued treatment without further evidence of myelosuppression.
Danish: De fleste patienter fortsatte behandling uden yderligere tegn på myelosuppression.
English: Patients were treated until disease progression or unacceptable toxicity.
Danish: Patienter blev behandlet indtil sygdomsprogression eller uacceptabel toksicitet.
English: Percent (%) of patients
Danish: Procentdel (%) af patienter
English: Date of first authorisation: 20 November 2006 Date of latest renewal: 15 July 2016
Danish: Dato for første markedsføringstilladelse: 20. november 2006 Dato for seneste fornyelse: 15. juli 2016
English: f In the post-marketing setting, individual cases of Stevens-Johnson syndrome have been reported.
Danish: f Efter markedsføring er der rapporteret om enkelte tilfælde af Stevens-Johnsons syndrom.
English: What you need to know before using this medicine
Danish: Hvad du skal vide før du bruger dette lægemiddel
English: Bone growth and development will be closely monitored in children taking SPRYCEL.
Danish: Knoglevækst og -udvikling vil blive overvåget tæt hos børn, der tager SPRYCEL.
English: The potential for displacement and its clinical relevance are unknown.
Danish: Potentialet for forskydning og dennes kliniske relevans er ukendt.
English: Other side effects that have been reported with frequency not known (cannot be estimated from the available data)
Danish: Andre bivirkninger er blevet rapporteret med ikke kendt frekvens (kan ikke estimeres ud fra forhåndenværende data)
English: This procedure should be performed on a clean surface.
Danish: Proceduren bør udføres på et rent underlag.
English: For higher or lower doses, you may need to take combinations of the different tablet strengths.
Danish: For højere eller lavere dosis kan det være nødvendigt, at du tager en kombination af forskellige tabletstyrker.
English: Find the marking that matches the dose that was prescribed by your doctor.
Danish: Find den markering, der svarer til den dosis, der blev ordineret af lægen.
English: After constitution
Danish: Efter rekonstitution
English: Of note, pleural effusion was reported in 7 (5.6%) patients in this group, and is therefore not included in the table.
Danish: Det skal bemærkes, at pleuraeffusion blev rapporteret hos 7 (5,6%) patienter i denne gruppe, og det er derfor ikke inkluderet i tabellen.
English: *Adjusted for Hasford Score and indicated statistical significance at a pre-defined nominal level of significance.
Danish: * Justereret for Hasford-Score og vist statistisk signifikans ved et præ-defineret normalniveau af signifikans.
English: Refer to the package leaflet for more detailed instructions for use.
Danish: Der henvises til indlægssedlen for mere detaljerede instruktioner for brugen.
English: The random inter-occasion variability in exposure is not expected to affect the cumulative exposure and efficacy or safety.
Danish: Den tilfældige variation i eksponering mellem prøvetagningerne forventes ikke at påvirke den kumulative eksponering og effekten eller sikkerheden.
English: Look at the measurements on the side of the syringe so you can see how much to fill it before you begin.
Danish: Kig på markeringerne på siden af sprøjten, så du kan se hvor meget den skal fyldes, inden du går i gang.
English: No studies have been performed to evaluate dasatinib interaction with other protein-bound medicinal products.
Danish: Der er ikke udført studier til at evaluere dasatinibs interaktion med andre proteinbundne lægemidler.
English: h Frequency reported as common in paediatric studies.
Danish: h Frekvensen er rapporteret som almindelig i pædiatriske studier.
English: Pleural effusion did not impair the ability of patients to obtain a response.
Danish: Pleuraeffusion nedsatte ikke patienternes evne til at opnå respons.
English: Patients with uncontrolled or significant cardiovascular disease were not included in the clinical studies.
Danish: Patienter med ukontrolleret eller betydelig kardiovaskulær sygdom inkluderedes ikke i kliniske studier.
English: There is limited experience with the use of SPRYCEL in this age group.
Danish: Der er begrænset erfaring med brug af SPRYCEL i denne aldersgruppe.
English: Take SPRYCEL daily until your doctor tells you to stop.
Danish: Tag SPRYCEL dagligt, indtil lægen giver dig besked på at stoppe.
English: SPRYCEL oral suspension is taken once daily.
Danish: SPRYCEL oral suspension skal tages 1 gang dagligt.
English: All patients n=167
Danish: Alle patienter n=167
English: This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).
Danish: Dette er fordi store mængder benzylalkohol kan ophobe sig i kroppen og kan forårsage bivirkninger (kaldet "metabolisk acidose").
English: calendar pack: Monday Tuesday Wednesday Thursday Friday
Danish: Kalenderpakning: Mandag
English: You will also have blood tests regularly while you are taking SPRYCEL.
Danish: Du vil også jævnligt få taget blodprøver, mens du tager SPRYCEL.
English: • Do not wash in a dishwasher.
Danish: • Må ikke vaskes i opvaskemaskine.
English: SPRYCEL should be taken at the same time every day.
Danish: SPRYCEL skal tages på samme tid hver dag.
English: All patients were extensively pretreated.
Danish: Alle patienter var ekstensivt forbehandlede.
English: Note that the markings on the syringe are in mL.
Danish: Bemærk, at markeringerne på sprøjten angiver ml.
English: Your doctor will regularly monitor your condition to check whether SPRYCEL is having the desired effect.
Danish: Lægen vil regelmæssigt kontrollere din tilstand for at sikre, at SPRYCEL har den ønskede effekt.
English: CI = confidence interval
Danish: CI = konfidensinterval
English: Slowly push the plunger down until all of the dose has been given.
Danish: Tryk langsom stemplet ned indtil hele dosen er blevet givet.
English: Progression-free survivalb
Danish: Progressionsfri overlevelseb
English: For oral use after constitution.
Danish: Til oral brug efter rekonstitution.
English: There was no significant difference of dasatinib PK between children and adolescents.
Danish: Der var ingen signifikant forskel på dasatinibs PK mellem børn og unge.
English: Common contusion a Includes decreased appetite, early satiety, increased appetite.
Danish: Almindelig kontusion a Inkluderer nedsat appetit, tidlig mæthedsfornemmelse, øget appetit.
English: In these cases, PAH was reported after initiation of dasatinib therapy, including after more than one year of treatment.
Danish: I disse tilfælde blev PAH rapporteret efter initiering af dasatinib behandling, herunder efter mere end et års behandling.
English: This should be taken into account in patients with diabetes mellitus.
Danish: Dette bør tages med i overvejelserne for patienter med diabetes mellitus.
English: Step 4: Write the date of expiry of the constituted oral suspension on the bottle label (the date of expiry of the constituted oral suspension is 60 days from the date of constitution).
Danish: Trin 4: Skriv udløbsdatoen for den rekonstituerede orale suspension på flaskens etiket (udløbsdatoen for den orale suspension er 60 dage fra datoen for rekonstitution).
English: • Put closure back on the bottle and close tightly.
Danish: • Sæt lukningen tilbage på flasken og luk tæt.
English: A change in dose may occur when switching between formulations (i.e., tablets and powder for oral suspension), so you should not switch from one to the other.
Danish: En ændring i dosis kan forekomme når der skiftes mellem formuleringer (dvs. tabletter og pulver til oral suspension), så du bør ikke skifte fra den ene til den anden.
English: The observed food effects do not represent clinically relevant changes in exposure.
Danish: Den observerede effekt af fødeindtag repræsenterer ikke klinisk relevante ændringer i eksponeringen.
English: Patients continuing treatment should be monitored periodically.
Danish: Patienter, der fortsætter behandlingen, bør monitoreres regelmæssigt.
English: 140 mg once daily n = 304
Danish: 140 mg 1 gang dagligt n = 304
English: at least 45
Danish: mindst 45
English: Common tinnitus
Danish: Almindelig tinnitus
English: The primary endpoint was MCyR at 12 weeks.
Danish: Det primære endepunkt var MCyR ved 12 uger.
English: • Review total prescribed dose and determine number of milliliters (mL) you will need.
Danish: • Gennemgå den totale ordinerede dosis og fastlæg antal milliliter (ml), du skal bruge.
English: % with MMR
Danish: % med MMR
English: Table 16: How to split a dose of oral suspension that is greater than 11 mL
Danish: Tabel 16: Sådan deles en dosis af oral suspension, som er større end 11 ml
English: If no explanation is found, or if there is no improvement with dose reduction or interruption, the diagnosis of PAH should be considered.
Danish: Hvis der ikke findes nogen forklaring eller hvis der ikke ses nogen bedring ved dosisreduktion eller -afbrydelse, bør diagnosen PAH overvejes.
English: You cannot be sure you will receive the correct dose if you crush, cut, chew or disperse the tablets.
Danish: Du kan ikke være sikker på du får den korrekte dosis, hvis du knuser, deler, tygger eller opløser tabletterne.
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); not known (cannot be estimated from available post-marketing data).
Danish: Hyppigheden defineres som: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: MONTHS
Danish: MÅNEDER
English: • Hold plunger to prevent it from moving.
Danish: • Hold fast i stemplet for at undgå det bevæger sig.
English: For details on preparation and administration of this medicinal product and instructions for use, see section 6.6.
Danish: For detaljer vedrørende forberedelse og administration af dette lægemiddel og instruktioner for brugen, se pkt.
English: See section 4.2 for the recommended starting dose.
Danish: 4.2 for den anbefalede startdosis.
English: QT interval was corrected for heart rate by Fridericia's method.
Danish: QTintervallet korrigeredes for hjertefrekvens ved Fridericias metode.
English: After constitution The oral suspension is stable for 60 days.
Danish: Den orale suspension er stabil i 60 dage.
English: Monitor patients less than 3 years of age for respiratory symptoms.
Danish: Patienter under 3 år skal monitoreres for respiratoriske symptomer.
English: Your doctor will check for some of these effects during your treatment.
Danish: Lægen vil undersøge dig for nogle af disse bivirkninger under behandlingen.
English: It was usually managed with dose reduction or interruption.
Danish: Dette blev sædvanligvis håndteret med dosisreduktion eller afbrydelse.
English: 24 months 36 months 48 months 60 months p=0.0021
Danish: 24 måneder 36 måneder 48 måneder 60 måneder p=0,0021
English: You should stop breast-feeding while you are taking SPRYCEL.
Danish: Du bør stoppe med at amme, mens du tager SPRYCEL.
English: Wash the outside and the inside of the syringe with water and allow to air dry after each use to reuse for the next day.
Danish: Vask sprøjten udvendigt og indvendigt med vand og lad den lufttørre efter hver brug, så den er klar til brug den næste dag.
English: If you forget to take SPRYCEL
Danish: Hvis du har glemt at tage SPRYCEL
English: If SPRYCEL is used during pregnancy, the patient must be informed of the potential risk to the foetus.
Danish: Hvis SPRYCEL anvendes under graviditet, skal patienten informeres om den potentielle risiko for fostret.
English: See the "Instructions for administration to the patient" at the end of the package leaflet for how to give a dose of SPRYCEL oral suspension.
Danish: Se ”Instruktioner for administration til patienten” sidst i indlægssedlen for, hvordan en dosis SPRYCEL oral suspension skal gives.
English: In patients that receive a subsequent stem cell transplantation, SPRYCEL can be administered for an additional year post-transplantation.
Danish: Hos patienter, der får en efterfølgende stamcelletransplantation, kan SPRYCEL administreres i yderligere et år efter transplantationen.
English: Figure 1: Kaplan-Meier estimate of time to major molecular response (MMR)
Danish: Figur 1: Kaplan-Meier estimat over tid til major molekylært respons (MMR)
English: ANC: absolute neutrophil count *lower tablet dose not available
Danish: ANC: absolut neutrofiltal *lavere tabletdosis ikke tilgængelig
English: How to take SPRYCEL 4.
Danish: Sådan skal du tage SPRYCEL 4.
English: • If a second dose is needed to complete the total prescribed dose, repeat steps 3 through 10.
Danish: • Hvis en anden dosis er nødvendig for at give hele den ordinerede dosis, gentag da trin 3 til 10.
English: SPRYCEL must be administered orally.
Danish: SPRYCEL skal administreres oralt.
English: Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose, or even stopping treatment briefly.
Danish: Afhængigt af hvordan behandlingen virker på dig, kan lægen foreslå en højere eller lavere dosis eller foreslå, at behandlingen afbrydes kortvarigt.
English: The mean apparent oral clearance is 363.8 L/hr (CV% 81.3%).
Danish: Den gennemsnitlige tilsyneladende orale clearance er 363,8 l/t (CV% 81,3%).
English: Dasatinib should be administered with caution to patients who have or may develop prolongation of QTc.
Danish: Dasatinib bør administreres med forsigtighed til patienter som har, eller kan udvikle, forlængelse af QTc.
English: A total of 2,712 patients were evaluated in clinical studies; of these 23% were ≥ 65 years of age and 5% were ≥ 75 years of age.
Danish: Der er i alt evalueret 2.712 patienter i kliniske studier; af disse var 23% ≥ 65 år og 5% ≥ 75 år.
English: This may be a sign of damage to blood vessels known as thrombotic microangiopathy (TMA).
Danish: Dette kan være et tegn på skade på blodkarrene kendt som trombotisk mikroangiopati (TMA).
English: Powder for oral suspension 5 to less than 10
Danish: Pulver til oral suspension 5 til under 10
English: If PAH is confirmed, dasatinib should be permanently discontinued.
Danish: Hvis PAH bekræftes, bør dasatinib seponeres permanent.
English: These instructions show you how to give a dose of SPRYCEL oral suspension to the patient.
Danish: Disse instruktioner viser dig hvordan du skal give en dosis SPRYCEL oral suspension til patienten.
English: Benzoic acid/Benzoate salt may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).
Danish: Benzoesyre/benzoesalte kan øge gulsot (gulning af huden og øjnene) hos nyfødte (op til 4 uger gamle).
English: There were 45 different BCR-ABL mutations in 38% of patients enrolled in this study.
Danish: Der sås 45 forskellige BCR-ABL-mutationer hos 38% af patienterne inkluderet i studiet.
English: SPRYCEL inhibits the growth of these leukaemic cells.
Danish: SPRYCEL hæmmer væksten af disse leukæmiske celler.
English: Experience with overdose of SPRYCEL in clinical studies is limited to isolated cases.
Danish: Erfaring fra kliniske studier med overdosis af SPRYCEL er begrænset til isolerede tilfælde.
English: Paediatric patients with CML
Danish: Pædiatriske patienter med CML
English: If marrow cellularity is >10%, resumption of treatment with SPRYCEL may be considered.
Danish: Hvis marvcellulariteten er >10%, kan en genoptagelse af behandlingen med SPRYCEL overvejes.
English: Major molecular response All patients
Danish: Major molekulært respons Alle patienter
English: PFS was analysed on an intent-to-treat principle and patients were followed to events including subsequent therapy.
Danish: PFS blev analyseret ud fra princippet intent-to-treat, og patienterne blev fulgt til hændelser inkluderende efterfølgende behandling.
English: Shake bottle repeatedly for 30 seconds.
Danish: Omryst flasken gentagende gange i 30 sekunder.
English: If there are still visible clumps, continue shaking until no clumps are visible.
Danish: Hvis der stadig er synlige klumper, fortsæt da med at ryste, indtil alle synlige klumper er væk.