FrancophonIA/ELRC3.0 huggingface dataset:
English: Grade 3-5 reactions have been observed in up to 2.3% of patients treated with Avastin plus chemotherapy as compared with < 1% with chemotherapy alone (NCI-CTCAE v.3).
Danish: Dette skal ses i sammenligning med < 1 % af de patienter, der kun fik kemoterapi (NCICTCAE v. 3).
English: arm compared with RT/T alone (HR = 1.44; 95% CI: 0.90, 2.30).
Danish: HR var 0,93 (95% konfidensinterval: 0,61 ; 1,41; p-værdi = 0,72).
English: ● If you have any further questions, ask your doctor, pharmacist or nurse.
Danish: • Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er mere, du vil vide.
English: p-value (Chi-squared Test) Kaplan-Meier estimates
Danish: 1 Kaplan-Meier-estimater
English: The majority of patients included in the study were White (96%), the median age was 57 years in both treatment arms, 25% of patients in each treatment arm were 65 years of age or over, and approximately 50% of patients had an ECOG PS of 1; 7% of patients in each treatment arm had an
Danish: Ca. 50 % af patienterne havde en ECOG PS på 1, og 7 % af patienterne i de 2 behandlingsarme havde en ECOG PS på 2.
English: Fistulab,d, Muscular weakness, Back pain
Danish: Fistlerb,d Muskel
English: This was a phase III randomised, double-blind (for bevacizumab), clinical trial investigating Avastin 7.5 mg/kg in combination with oral capecitabine and IV oxaliplatin (XELOX), administered on a 3weekly schedule; or Avastin 5 mg/kg in combination with leucovorin with 5-fluorouracil bolus, followed by 5-fluorouracil infusional, with IV oxaliplatin (FOLFOX-4), administered on a 2-weekly schedule.
Danish: Dette var et fase III, randomiseret, dobbeltblindet (med hensyn til bevacizumab), klinisk studie, hvori Avastin 7,5 mg/kg i kombination med oral capecitabin og i.v.
English: Arterial thromboembolism: An increased incidence of arterial thromboembolic reactions was observed in patients treated with Avastin across indications, including cerebrovascular accidents, myocardial infarction, transient ischaemic attacks, and other arterial thromboembolic reactions.
Danish: Arteriel tromboemboli: En forøget forekomst af arterielle tromboemboliske bivirkninger blev observeret hos patienter, som blev behandlet med Avastin, uanset indikation.
English: Avastin should be discontinued in patients with life-threatening (Grade 4) thromboembolic reactions,
Danish: Avastin skal seponeres hos patienter med livstruende (grad 4) tromboemboliske bivirkninger, herunder lungeemboli (NCI-CTCAE v. 3).
English: Median OS (months) Hazard ratio (95% CI) (eCRF)a
Danish: Hazard ratio (95% konfidenstinterval) (eCRF)a p-værdi
English: This condition is usually secondary to wound healing complications, gastrointestinal perforation or fistula formation.
Danish: Der er i sjældne tilfælde rapporteret nekrotiserende fasciitis, inklusive dødelige tilfælde, hos patienter behandlet med Avastin; dette har som regel været sekundært til sårhelingskomplikationer, gastrointestinal perforation eller fisteldannelse.
English: Paclitaxel 175 mg/m2 IV over 3 hours on Day 1 and cisplatin 50 mg/m2 IV on Day 2 plus bevacizumab 15 mg/kg IV on Day 2 (q3w); or
Danish: over 24 timer på dag 1 og cisplatin 50 mg/m2 i.v på dag 2 plus bevacizumab 15 mg/kg i.v.
English: Gastrointestinal perforation a,b
Danish: Gastrointestinal perfora tiona,b
English: 15 mg/kg q 3 weeks
Danish: 15 mg/kg hver 3. uge
English: It is recommended that treatment be continued until disease progression or unacceptable toxicity (see section 5.1, study MO22224).
Danish: Det anbefales, at behandlingen fortsætter indtil sygdomsprogression eller uacceptabel toksicitet (se pkt.
English: Trial BO17704 was a randomised, double-blind phase III trial of Avastin in addition to cisplatin and gemcitabine versus placebo, cisplatin and gemcitabine in patients with locally advanced (stage IIIb with supraclavicular lymph node metastases or with malignant pleural or pericardial effusion), metastatic or recurrent non-squamous NSCLC, who had not received prior chemotherapy.
Danish: Det blev udført med patienter med lokalt fremskreden (stadie IIIb med supraklaviculære lymfekirtelmetastaser eller med malignt pleural eller perikardial effusion), metastatisk eller recidiverende ikke-planocellulær NSCLC, som ikke tidligere havde fået kemoterapi.
English: At the time of the final primary analysis, the primary endpoint of EFS by independent central review did not show a statistically significant difference between the two treatment arms, with HR of 0.93 (95% CI: 0.61, 1.41; p-value = 0.72).
Danish: Der blev ikke vist en signifikant forbedring af hændelsesfri overlevelse (vurderet af en central Radiology Review Committee), når bevacizumab var føjet til RT/Tbehandlingsarmen, sammenlignet med RT/T-behandlingsarmen alene (Hazard Ratio = 1,44; 95% konfidensinterval: 0,90; 2,30).
English: • a brain condition with symptoms including seizures (fits), headache, confusion, and changes in vision (Posterior Reversible Encephalopathy Syndrome or PRES),
Danish: • tilstand i hjernen (posteriort reversibelt encefalopati syndrom) med symptomer såsom kramper,
English: Avastin is also used for the treatment of adult patients with persistent, recurrent or metastatic cervical cancer.
Danish: Avastin bruges også i behandlingen af voksne patienter med vedvarende livmoderhalskræft, med livmoderhalskræft, som er kommet igen, eller med livmoderhalskræft, der har spredt sig (dannet metastaser).
English: Posology
Danish: Responsrate
English: Gastrointestinal (GI) perforations and Fistulae (see section 4.4) Avastin has been associated with serious cases of gastrointestinal perforation.
Danish: Avastin er blevet forbundet med alvorlige tilfælde af gastrointestinal perforation.
English: Venous thromboembolism (see section 4.8)
Danish: Venøs tromboemboli (se pkt.
English: What Avastin is and what it is used for What you need to know before you use Avastin How to use Avastin
Danish: Det skal du vide, før du begynder at bruge Avastin Sådan skal du bruge Avastin Bivirkninger
English: CP (n = 154)
Danish: (n = 154)
English: PLD
Danish: Vægttab
English: In a trial of patients with persistent, recurrent or metastatic cervical cancer, the incidence of GI-vaginal fistulae was 8.3% in Avastin-treated patients and 0.9% in control patients, all of whom had a history of prior pelvic radiation.
Danish: Gastrointestinale-vaginale fistler i GOG-0240 studiet I et studie hos patienter med persisterende, recidiverende eller metastatisk cervixcancer var forekomsten af gastrointestinale-vaginale fistler 8,3 % hos Avastinbehandlede patienter og 0,9 % i kontrolgruppen.
English: a,b
Danish: Blødninga,b
English: CP (n = 97)
Danish: (n = 97)
English: Overall Survival* (months)
Danish: Endepunkt (måneder)
English: Febrile neutropenia, Leucopenia, Neutropenia a,
Danish: Febril neutropeni Leukopeni Neutropenia Trombocytopeni
English: Gastrointestinal disorder, Stomatitis, Proctalgia
Danish: Gastrointestinale perforationer og fistler (se pkt.
English: {Name and address} <{tel}> <{fax}> <{e-mail}>
Danish: {Navn og adresse} <{Tlf.}> <{Fax}> <{e-mail}>
English: Adults, including the elderly:
Danish: Voksne, inklusive ældre:
English: Concomitant administration should therefore be avoided.
Danish: Samtidig administration bør derfor undgås.
English: Infants and children up to 12 years of age.
Danish: Spædbørn og børn op til 12 år.
English: Most of these patients took medication just prior to going to bed.
Danish: De fleste af disse patienter tog medicinen lige inden, de gik i seng.
English: Take with water.
Danish: Tages sammen med vand.
English: 80339 München, Germany
Danish: 80339 München, Tyskland
English: You should take one capsule ORACEA each day in the morning.
Danish: De skal tage én kapsel ORACEA hver dag om morgenen.
English: This medicinal product is authorised in the Member States of the EEA under the following names:
Danish: Dette lægemiddel er godkendt i EEA-medlemsstaterne under følgende navne:
English: Gastric lavage should be considered.
Danish: Gastrisk lavage bør overvejes.
English: Taking ORACEA with food and drink
Danish: Brug af ORACEA sammen med mad og drikke
English: Post-marketing experience has not identified any new safety concerns.
Danish: Erfaringer efter markedsføringen har ikke rejst nye sikkerhedsspørgsmål.
English: In clinical trials patients were treated for 16 weeks.
Danish: I kliniske forsøg blev patienterne behandlet i 16 uger.
English: ATC code: J01AA02.
Danish: ATC-kode: J01AA02.
English: The National Competent Authorities, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Danish: De nationale kompetente myndigheder skal, koordineret af referencemedlemsstaten, sikre at følgende betingelser opfyldes af indehaveren af markedsføringstilladelsen:
English: Distribution, metabolism and elimination:
Danish: Distribution, metabolisme og elimination:
English: Each pack contains 56 capsules.
Danish: Hver pakke indeholder 56 kapsler.
English: Opacode Black S-1-8114
Danish: Opacode sort S-1-8114
English: • Changes in the number or type of certain blood cells
Danish: • Ændringer i antallet eller typen af visse blodceller
English: The data resulting from this study should be provided to the relevant national competent authorities for assessment.
Danish: Resultaterne fra et sådant studie skal indsendes til de relevante nationale kompetente myndigheder med henblik på vurdering.
English: These effects may be symptoms of a severe allergic (hypersensitivity) reaction.
Danish: Disse bivirkninger kan være symptomer på en svær allergisk reaktion (overfølsomhedsreaktion).
English: Leave 2 to 3 hours after your daily dose of ORACEA before drinking or eating dairy products.
Danish: Vent 2 til 3 timer efter, at De har taget deres daglige dosis ORACEA, inden De drikker eller spiser mælkeprodukter.
English: Other interactions:
Danish: Andre interaktioner:
English: Interactions affecting other medicinal products:
Danish: Interaktioner der påvirker andre lægemidler:
English: Therefore it is recommended that patients should be assessed 4 weeks after stopping treatment.
Danish: Det anbefales derfor, at patienterne vurderes fire uger efter, at de har standset behandlingen.
English: No special requirements
Danish: Ingen særlige forholdsregler
English: ORACEA may make certain antibiotics, including penicillins, less effective.
Danish: ORACEA kan gøre visse antibiotika, herunder penicilliner, mindre effektive.
English: The manufacturer responsible for batch release is:
Danish: Fremstiller ansvarlig for batchfrigivelse:
English: Pharmacokinetics in special populations:
Danish: Farmakokinetikken hos specielle populationer:
English: Since no formal dose-response studies have been conducted, Phase III data were analyzed to investigate the existence of a dose-efficacy relationship.
Danish: Da der ikke er udført formelle dosisrespons-undersøgelser, blev fase III dataene analyseret for at undersøge, om der fandtes et forhold mellem dosis og virkning.
English: Tell your doctor about medications that you are taking or plan to take whilst you are taking ORACEA .
Danish: Fortæl Deres læge om anden medicin, De tager, eller som De planlægger at tage, mens De tager ORACEA.
English: • Allergic (hypersensitivity) reaction throughout the body*
Danish: • Allergiske reaktioner (overfølsomhedsreaktioner) i hele kroppen*
English: • Increased level of urea in the blood
Danish: • Forhøjet niveau af urea i blodet
English: The frequency categories used are:
Danish: Kategorierne for hyppighed er:
English: • High or increased blood pressure
Danish: • Højt eller forhøjet blodtryk
English: Enamel hypoplasia has also been reported.
Danish: Emaljehypoplasi er ligeledes indberettet.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF ORACEA
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF ORACEA
English: • Increased pressure in the brain
Danish: • Øget tryk i hjernen
English: The procedure was referred to the CHMP, who raised a number of issues through a List of Questions and a subsequent List of Outstanding Issues, which were addressed by the Applicant.
Danish: Sagen vedrørende proceduren blev indbragt for CHMP, der rejste en række spørgsmål på en liste over spørgsmål og en efterfølgende liste over uafklarede spørgsmål, der blev besvaret af ansøgeren.
English: B. LABELLING
Danish: B. ETIKETTERING
English: Overall it is estimated that, since authorization, more than 400,000 prescriptions for Oracea were filled at pharmacies in the USA up to November 2007 and the post-marketing experience identified no new safety concerns.
Danish: Generelt vurderes det, at der efter tilladelsen og indtil november 2007 er udskrevet mere end 400.000 recepter på Oracea til apoteker i USA, og der er efter markedsføringen ikke fundet nye sikkerhedsproblemer.
English: Patients should be evaluated after 6 weeks and, if no effect is seen, consideration should be given to stopping treatment.
Danish: Patienterne bør evalueres efter seks uger, og hvis der ikke ses nogen virkning, bør det overvejes at standse behandlingen.
English: • Changes in some blood tests (amount of glucose in blood or tests of liver function).
Danish: • Ændringer i nogle blodprøver (mængden af sukker i blodet eller ændring i prøver af leverfunktion).
English: Mean change from baseline to Week 16 in total inflammatory lesion count:
Danish: Middel ændring fra baseline til uge 16 i det totale antal inflammatoriske læsioner:
English: In humans, the use of tetracyclines during a limited number of pregnancies has not revealed any specific malformation to date.
Danish: Hos mennesker har brugen af tetracykiner under et begrænset antal graviditeter ikke afsløret nogen specifik misdannelse til dato.
English: • Worsening of the immune system disease known as systemic lupus erythematosus (SLE)
Danish: • Forværring af den immunsystemsygdom, der kaldes systemisk lupus erythematosus (SLE)
English: • Allergic reaction causing swelling of the eyes, lips or tongue*
Danish: • Allergisk reaktion, der medfører hævelse af øjne, læber eller tunge*
English: Upon discontinuation, lesions tended to reappear at 4 weeks follow-up.
Danish: Efter afbrydelse af behandlingen havde læsionerne tendens til at vende tilbage ved 4-ugers opfølgningsbesøget.
English: Between 40% and 60% of an administered dose can be accounted for in the urine by 92 hours, and approximately 30% in the faeces.
Danish: Mellem 40 % og 60 % af en administreret dosis kan genfindes i urinen efter 92 timer, og cirka 30 % kan genfindes i fæces.
English: The Applicant was also requested to reflect information on this issue in sections 4.4 and 5.1 of the SPC.
Danish: Ansøgeren blev også bedt om at angive oplysninger om dette spørgsmål i afsnit 4.4 og 5.2 i produktresuméet.
English: Studies in animals have not demonstrated a teratogenic effect.
Danish: Dyreforsøg har ikke påvist teratogene virkninger.
English: Mean (SD) change from baseline
Danish: Middel (SD) ændring fra baseline
English: • Abnormal reaction of the skin to sunlight
Danish: • Unormal reaktion i huden over for sollys
English: Symptoms:
Danish: Symptomer:
English: If you take more ORACEA capsules than you should, ask your doctor immediately for advice.
Danish: Hvis De har taget flere ORACEA kapsler, end De skulle, skal De omgående spørge Deres læge til råds.
English: Provided that the proposed indication mirrors the primary endpoint in the pivotal studies, as currently suggested, the CHMP considered that efficacy could be regarded as sufficiently demonstrated in the presently studied populations in the submitted phase 3 studies.
Danish: Under forudsætning af at den foreslåede indikation afspejler det primære slutpunkt i pilotundersøgelserne, således som det synes på nuværende tidspunkt, fandt CHMP, at virkningen kan betragtes som værende tilstrækkeligt påvist i de aktuelt undersøgte populationer i de indsendte resultater af fase 3-undersøgelser.
English: Doxycycline is almost completely absorbed after oral administration.
Danish: Doxycyclin absorberes næsten fuldstændig efter oral administration.
English: Treatment should cease at the first sign of photosensitivity.
Danish: Behandlingen bør afbrydes ved det første tegn på lysoverfølsomhed.
English: ANNEX I LIST OF THE NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT(S) IN THE MEMBER STATES
Danish: BILAG I LISTE OVER LÆGEMIDLETS NAVNE, LÆGEMIDDELFORM, STYRKE, INDGIVELSESVEJ, ANSØGER(E) I MEDLEMSSTATERNE
English: Therefore such medicinal products or foodstuffs should be taken after a period of 2 to 3 hours following ingestion of doxycycline.
Danish: Derfor bør sådanne lægemidler eller madvarer ikke tages før 2 til 3 timer efter indtagelse af doxycyclin.
English: If you suspect or learn that you are pregnant whilst taking ORACEA, contact your doctor immediately.
Danish: Hvis De har mistanke om, eller hvis De finder ud af, at De er gravid, mens De tager ORACEA, skal De omgående kontakte Deres læge.
English: if you are pregnant ORACEA should not be used from the 4th month of because it may harm the unborn child.
Danish: hvis De er gravid, bør De ikke anvende ORACEA fra den 4. måned, da det kan skade det ufødte barn.
English: The conditions of the Marketing Authorisation are set out in Annex IV.
Danish: Betingelserne for markedsføringstilladelsen fremgår af bilag IV.
English: The possibility of an increased risk of bleeding events should be borne in mind.
Danish: Man bør være opmærksom på muligheden for en øget risiko for blødningshændelser.
English: Important information about some of the ingredients of ORACEA ORACEA contains sugar (sucrose).
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i ORACEA ORACEA indeholder sukker (sukrose).
English: Do not take milk or dairy products at the same time as ORACEA since these products contain calcium which may reduce the effectiveness of ORACEA.
Danish: Indtag ikke mælk eller mælkeprodukter på samme tidspunkt som ORACEA, da disse produkter indeholder kalk, som kan nedsætte virkningen af ORACEA.
English: However, the clinician should always be aware of the possibility of adverse events occurring and should monitor patients accordingly.
Danish: Lægen bør dog altid være opmærksom på, at der kan opstå bivirkninger og overvåge patienterne i overensstemmelse hermed.
English: The clinical studies showed no treatment-related serious AEs and tolerability seems to be unaffected by gender, age or disease severity.
Danish: Kliniske undersøgelser viste ingen behandlingsrelaterede, alvorlige bivirkninger, og toleransen synes upåvirket af køn, alder og sygdomsgrad.
English: Cardinal Health UK 417 Ltd, Great Oakley, Corby, Northamptonshire NN18 8HS, UK.
Danish: Cardinal Health UK 417 Ltd, Great Oakley, Corby, Northamptonshire NN18 8HS, Storbritannien.
English: Mechanism of Action: The pathophysiology of the inflammatory lesions of rosacea is, in part, a manifestation of a neutrophil-mediated process.
Danish: Virkningsmekanisme: Patofysiologien af de inflammatoriske læsioner af rosacea er, delvis, en manifestation af en neutrofil-medieret proces.
English: The indication rosacea as defined by the study inclusion criteria was regarded to fulfil these criteria.
Danish: Indikationen rosacea blev anset for at opfylde inklusionskriterierne, således som de blev defineret i undersøgelsen.
English: The clinical relevance of these findings remains unknown.
Danish: Den kliniske relevans af disse fund er stadig ikke kendt.
English: These conditions disappeared rapidly when the drug was discontinued.
Danish: Disse tilstande forsvandt hurtigt, når behandlingen med lægemidlet blev afbrudt.
English: Quinapril may reduce the absorption of doxycycline due to the high magnesium content in quinapril tablets.
Danish: Quinapril kan reducere absorptionen af doxycyclin på grund af det høje magnesiumindhold i quinapril-tabletter.
English: Peak plasma levels were generally achieved at 2 to 3 hours after administration.
Danish: Peak-plasmaniveauer blev normalt opnået 2 til 3 timer efter administrationen.
English: Mean between-group difference (95% confidence limits) p-Valuea a p-Value for treatment difference in change from baseline (ANOVA)
Danish: Middel forskel mellem grupperne (95 % konfidensgrænser) p-værdia a p-værdi for behandlingsforskel i ændring fra baseline (ANOVA)
English: • Damage to red blood cells (haemolytic anaemia)
Danish: • Beskadigelse af de røde blodlegemer (hæmolytisk anæmi)
English: ORACEA should not be used in patients with ocular manifestations of rosacea (such as ocular rosacea and/or blepharitis/meibomianitis) as there are limited efficacy and safety data in this population.
Danish: ORACEA bør ikke anvendes hos patienter med okulære manifestationer af rosacea (såsom okulær rosacea og/eller blefaritis/meibomitis), da der er begrænsede data vedrørende virkning og sikkerhed i denne population.
English: ORACEA should not be used at the same time as the medicine isotretinoin because of the risk of increased pressure in the brain.
Danish: ORACEA bør ikke anvendes samtidig med medicinen isotretinoin på grund af risikoen for øget tryk i hjernen.
English: The CHMP was also satisfied with the explanation on the exclusion criteria of nodule numbers, as no effect on nodules is claimed in the proposed indication.
Danish: CHMP var også tilfreds med forklaringen om eksklusionskriteriet for antallet af noduli, da stoffet ikke påstås at have en effekt på noduli i den foreslåede indikation.
English: Caution should be observed in the treatment of patients with myasthenia gravis who may be at risk of worsening of the condition.
Danish: Der skal udvises forsigtighed i behandlingen af patienter med myasthenia gravis, hvor der kan være risiko for, at deres tilstand forværres.
English: Pack size: 56 capsules in 4 strips of 14 each
Danish: Pakningsstørrelse: 56 kapsler i 4 strips hver af 14 stk.
English: Regarding erythema, the CHMP considered that despite the absence of evidence of a positive effect on erythema, there are no indications of any risk of worsening of erythema during Oracea therapy.
Danish: Med hensyn til erytem fandt CHMP at der, på trods af manglende bevis for en positiv virkning på erytem, ikke er findes indikationer for risiko for en forværring af erytemet under behandling med Oracea..
English: The clinical significance of these findings is not known.
Danish: Den kliniske betydning af disse fund er ukendt.
English: A peri/postnatal toxicity study in rats revealed no significant effects at therapeutically relevant doses.
Danish: Et peri-/postnatalt toksicitetsstudie med rotter afslørede ingen signifikante virkninger ved de terapeutisk relevante doser.
English: These medicines may reduce the effectiveness of ORACEA if taken at the same time.
Danish: Disse typer medicin kan nedsætte virkningen af ORACEA, hvis de tages samtidig.
English: • Inflammation of the membrane surrounding the heart
Danish: • Betændelse i den membran, der omgiver hjertet
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Hvis Deres læge har fortalt Dem, at der er visse sukkerstoffer, De ikke kan tåle, skal De kontakte Deres læge, inden De tager denne medicin.
English: The CHMP also considered that the survey referred to by the Applicant, showing that papulopustular lesions are readily recognized and rated by dermatologists providing a qualitative as well as quantitative measurement, was relevant; therefore the currently proposed indication was considered clinically applicable and practical.
Danish: CHMP fandt også, at undersøgelsen, som ansøgeren henviste til, og som viste at papulopustuløse læsioner er let genkendelige og bedømmes af dermatologer og giver en kvantitativ såvel som en kvalitativ måling, var relevant, og det fandtes derfor, at den aktuelt foreslåede indikation var klinisk anvendelig og praktisk.
English: In these cases observation is recommended.
Danish: I disse tilfælde anbefales det at overvåge patienten.
English: ORACEA must not be used to treat infections caused by organisms susceptible (or suspected to be susceptible) to doxycycline.
Danish: ORACEA må ikke anvendes til behandling af infektioner, der er forårsaget af organismer, der kan påvirkes af (eller som mistænkes at kunne påvirkes af) doxycyclin.