FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee agreed that Clenil should no longer be used to treat common bronchostenotic conditions (narrowing of the airways in the lungs) because of the lack of rigorous evidence from adequately designed clinical studies.
Danish: I udvalget var der enighed om, at Clenil ikke længere burde anvendes til behandling af forsnævringer af luftvejene i lungerne (almindelig bronkostenose), fordi der savnedes klart bevis fra veltilrettelagte kliniske undersøgelser.
English: In children with recurrent wheezing the response to treatment should be carefully monitored; if no benefit is observed within 2-3 months, Clenil should be discontinued.
Danish: Hvis der ikke ses bedring i løbet af 2-3 måneder, bør behandlingen med Clenil stoppes.
English: Clenil was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Danish: Koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker (CMDh) fandt, at der er behov for harmonisering for Clenil.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Danish: CHMP fandt det nødvendigt at harmonisere produktresuméer, etikettering og indlægssedler i EU på baggrund af de forelagte oplysninger og den videnskabelige drøftelse i udvalget.
English: It is available as a suspension given by inhalation though a nebuliser device, and in asthma it should only be used when the use of other hand-held inhalers is not appropriate.
Danish: Ved astma bør det kun anvendes, når andre håndholdte inhalatorer er uhensigtsmæssige.
English: Median Age (Years)
Danish: Median for alder (år)
English: • are over 65 years of age as you may be more intolerant to the medicine than other patients.
Danish: • er over 65 år, fordi du måske kan være mere intolerant over for medicinen end andre patienter.
English: Recommendations are as stated above for adults.
Danish: Anbefalinger som angivet ovenfor vedrørende voksne.
English: Date of latest renewal: 10/07/2011
Danish: Dato for seneste fornyelse: 10/07/2011
English: Procedures for proper handling and disposal should be observed.
Danish: Procedurer for korrekt håndtering og bortskaffelse bør iagttages.
English: A positive Coombs test has also been observed.
Danish: En positiv Coombs' test er også set.
English: This may predispose patients to opportunistic infections.
Danish: Dette kan prædisponere patienterne for opportunistiske infektioner.
English: 33.1% Not Applicable
Danish: 33,1% Ikke aktuelt
English: Patients with these conditions may be at higher risk of a heart attack.
Danish: Patienter med disse tilstande kan have en højere risiko for hjerteanfald.
English: The frequencies are based on clinical trial data.
Danish: Frekvenserne er baseret på kliniske forsøgsdata.
English: • are pregnant or you think you may be pregnant, you should tell your doctor immediately.
Danish: • er gravid eller tror du kan være gravid, oplyse det til din læge omgående.
English: You may also be given
Danish: Du kan desuden få
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06/07/2001
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første tilladelse: 06/07/2001
English: Patients should be monitored carefully (see
Danish: Patienterne skal overvåges omhyggeligt (se pkt.
English: 53.4% Not Applicable N=82
Danish: 53,4% Ikke aktuelt N=82
English: They are usually only mild or moderate problems and they gradually diminish during the course of
Danish: Det er sædvanligvis kun lette eller moderate problemer, og de mindskes gradvist under behandlingen.
English: The majority of these reactions are mild to moderate in severity.
Danish: Størstedelen af disse reaktioner er milde til moderate.
English: The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and
Danish: Den mest passende MedDRA term er benyttet til at beskrive en vis reaktion og dens synonymer og
English: However, if retreatment is considered, it may be prudent to confirm the presence of CD52 expression.
Danish: Hvis fornyet behandling imidlertid overvejes, vil det være klogt at bekræfte tilstedeværelsen af CD52 udtryk.
English: It is not proposed that regular and systematic monitoring of CD52 expression should be carried out as routine clinical practice.
Danish: Det foreslås ikke, at der skal udføres regelmæssig og systematisk kontrol af CD52-udtrykket som rutinemæssig klinisk procedure.
English: Data available from three uncontrolled B-CLL studies are summarised in the following table:
Danish: Data, som er tilgængelige fra tre ukontrollerede studier af B-CLL, er opsummeret i følgende tabel:
English: There are no known incompatibilities with other medicinal products.
Danish: Der er ingen kendte uforligeligheder med andre lægemidler.
English: In general, older patients (over 65 years of age) tolerate cytotoxic therapy less well than younger individuals.
Danish: I almindelighed tåler ældre patienter (over 65 år) cytotoksisk behandling mindre godt end yngre mennesker.
English: Speak to your doctor before receiving any vaccinations.
Danish: Tal med din læge inden enhver form for vaccination.
English: These effects will gradually reduce as treatment is continued.
Danish: Disse bivirkninger vil efterhånden mindskes, når behandlingen fortsættes.
English: • The risk of opportunistic infections, in particular CMV viraemia
Danish: ● Risiko for opportunistiske infektioner, specielt CMV-viraemia
English: The ability to generate a primary or anamnestic humoral response to any vaccine has not been studied.
Danish: Evnen til at fremkalde et primært eller anamnestisk humoralt respons på enhver form for vaccine er ikke undersøgt.
English: Gradual escalation from 10 to 30 mg
Danish: Gradvis øgning fra 10 til 30 mg
English: In CLL, too many lymphocytes are produced.
Danish: Ved CLL produceres der for mange lymfocytter.
English: Since CLL occurs commonly in this older age group, these patients should be monitored carefully (see section 4.2).
Danish: Da CLL forekommer almindeligt i denne ældre aldersgruppe, bør disse patienter kontrolleres omhyggeligt (se pkt.
English: 44 (28-NR)
Danish: 44 (28-IN)
English: Median duration of treatment was 11.7 weeks for first-line patients and 9.0 weeks for previously
Danish: Gennemsnitlig behandlingsvarighed var 11,7 uger for 1. linje-patienter, og 9,0 uger for tidligere
English: Usually one or more of these effects happen during the first week after the start of treatment:
Danish: Almindeligvis forekommer en eller flere af disse bivirkninger i løbet af den første uge efter starten på behandlingen:
English: Your doctor will be monitoring the effects of treatment and your progress carefully by examining you and by taking blood samples for analysis on a regular basis.
Danish: Din læge vil omhyggeligt kontrollere virkningerne af behandlingen og dit forløb ved at undersøge dig og ved regelmæssigt at tage blodprøver til analyse.
English: This can only be accepted if preparation of the solution takes place under strictly aseptic conditions and the solution is protected from light.
Danish: Dette kan kun accepteres, hvis tilberedningen af opløsningen finder sted under strengt aseptiske forhold og opløsningen beskyttes mod lys.
English: Therefore, haematological monitoring of patients is indicated.
Danish: Hæmatologisk kontrol af patienterne er derfor indiceret.
English: Each time you are given MabCampath, it will take about 2 hours for all the solution to enter your
Danish: Hver gang du får MabCampath, vil det tage omkring 2 timer for hele opløsningen at komme ind i dit
English: Systemic clearance decreased with repeated administration due to decreased receptor-mediated clearance (i.e. loss of CD52 receptors in the periphery).
Danish: Systemisk clearance faldt ved gentagen indgift på grund af nedsat receptormedieret clearance (dvs. tab af CD 52 receptorer i periferien).
English: The antigen has been found on a small percentage (< 5%) of granulocytes, but not on erythrocytes or platelets.
Danish: Antigenet er fundet på en lille procentdel (< 5%) af granulocytterne, men ikke på erytrocytter eller trombocytter.
English: Read all of this leaflet carefully before you start using this medicine.
Danish: Læs hele denne indlægsseddel grundigt, inden du begynder at bruge medicinen.
English: • steroids, antihistamines or analgesics (treatment for fever) to help reduce some of the side effects.
Danish: • steroider, antihistaminer eller smertestillende stoffer (behandling for feber) for at hjælpe med til at lindre nogle af bivirkningerne.
English: MabCampath treatment may continue for up to 12 weeks depending on your progress.
Danish: Behandlingen med MabCampath kan fortsætte i op til 12 uger afhængig af dit forløb.
English: Therapy should be discontinued if there is evidence of disease progression.
Danish: Behandlingen bør seponeres, hvis der er tegn på sygdomsprogression.
English: The dosage of MabCampath will not be increased until the effects are reduced.
Danish: Doseringen af MabCampath vil ikke blive øget, førend bivirkningerne er mindsket.
English: The frequency of grade 3 or 4 adverse events, such as fever, hypotension and anaemia, may be higher in these patients.
Danish: Frekvensen af grad 3 eller 4 bivirkninger såsom feber, hypotension og anæmi kan være højere hos disse patienter.
English: Because MabCampath is a recombinant humanized protein, a P450 mediated drug-drug interaction would not be expected.
Danish: Eftersom MabCampath er et rekombinant humaniseret protein, vil en P450 formidlet interaktion ikke være forventet.
English: During the first week, your doctor will increase the dose of MabCampath slowly to reduce the possibility of you having side effects and to allow your body to tolerate MabCampath better.
Danish: I løbet af den første uge vil din læge langsomt øge mængden af MabCampath for at mindske muligheden for, at du får bivirkninger, og for at give din krop mulighed for bedre at kunne tåle
English: The doctor will carefully monitor you and decide what are the appropriate amounts of MabCampath to give you during your whole treatment period.
Danish: Lægen vil omhyggeligt kontrollere dig og beslutte hvilke mængder af MabCampath, det er passende at give dig i løbet af hele din behandlingsperiode.
English: No information is available for events that occur at lower frequency, due to the size of the population studied; n=147 for first line treated patients and n=149 for previously treated patients.
Danish: Der er ingen tilgængelige informationer for hændelser, der forekommer med lavere hyppighed på grund af størrelsen af den undersøgte population; n=147 for 1. linje-patienter og n=149 for tidligere behandlede
English: In most patients, dose escalation to 30 mg can be accomplished in 3-7 days.
Danish: Hos de fleste patienter kan dosisøgning op til 30 mg gennemføres på 3-7 dage.
English: MabCampath treatment may reduce your natural resistance to infections
Danish: Behandling med MabCampath kan nedsætte din naturlige modstandskraft overfor infektioner.
English: As a result of this binding, the lymphocytes die, and this helps to control the CLL.
Danish: Som resultat af denne binding dør lymfocytterne, og det hjælper med til at holde CLL under kontrol.
English: You should stop breast-feeding when you start your treatment and you should not begin breast-feeding again until at least 4 weeks after you have finished your treatment and you have consulted your doctor
Danish: Du bør ophøre med amning, når du starter din behandling og du bør ikke begynde amning igen før mindst 4 uger efter, du har afsluttet din behandling og du har konsulteret lægen om sagen.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2°C-8°C).
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i køleskab (2°C-8°C).
English: • unusual increased or altered sensitivity to touch
Danish: • usædvanligt forøget eller ændret følsomhed over for berøring
English: Reversible neutropenia was seen following daily intravenous or subcutaneous dosing for 30 days, but not following single doses or daily dosing for 14 days.
Danish: Reversibel neutropeni blev observeret efter daglig intravenøs eller subkutan dosering i 30 dage, men ikke efter enkeltdoser eller daglig dosering i 14 dage.
English: Chromosomal aberrations were categorized according to Döhner's hierarchical model.
Danish: Kromosomale afvigelser blev kategoriseret efter Döhner's hierarkiske model.
English: The 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); very rare (<1/10,000).
Danish: Hyppighederne er defineret som: meget almindelige (≥ 1/10), almindelige (≥ 1/100 til < 1/10), ikkealmindelige (≥ 1/1.000 til < 1/100), sjældne (≥ 1/10.000 til <1/1.000), meget sjældne(<1/10.000).
English: • Summary of Product Characteristics (SPC) and Package Leaflet and Labelling
Danish: ● Produktresumé (SPC) samt indlægsseddel og etikettering
English: Patients have received repeated unit doses of up to 240 mg of MabCampath.
Danish: Der er patienter, som har fået gentagne dosisenheder på op til 240 mg MabCampath.
English: If a patient improves (i.e. achieves a partial response or stable disease) and then reaches a plateau without further improvement for 4 weeks or more, then MabCampath should be discontinued and the patient monitored.
Danish: Hvis en patient bliver bedre (dvs. opnår et delvist respons eller en stabiliseret tilstand) og derefter når et plateau uden yderligere bedring i 4 uger eller mere, bør MabCampath i så fald seponeres og patienten kontrolleres.
English: Like all medicines, MabCampath can cause side effects, although not everybody gets them.
Danish: MabCampath kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: • antibiotics and antivirals may be given to provide you with extra protection.
Danish: • Du vil muligvis få antibiotika og midler mod virus for at give dig en ekstra beskyttelse.
English: Determination of the efficacy of MabCampath is based on overall response and survival rates.
Danish: Bedømmelsen af effekten af MabCampath er baseret på et samlet respons og overlevelsesprocenter.
English: 4.7 Effects on ability to drive and use machines No studies on the effects on the ability to drive and use machines have been performed.
Danish: 4.7 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motorkøretøj eller betjene maskiner.
English: Figure 1: Progression free survival in first line study (by treatment group)
Danish: Figur 1: Undersøgelse af progressionsfri overlevelse hos 1. linje-patienter (efter behandlingsgruppe)
English: The following table outlines the recommended procedure for dose modification following the occurrence of haematological toxicity while on therapy:
Danish: Den følgende tabel skitserer den anbefalede procedure for dosisændring efter forekomst af hæmatologisk toksicitet under behandlingen:
English: Any spillage or waste material should be disposed of by incineration.
Danish: Alt spild eller affaldsstof skal bortskaffes ved forbrænding.
English: The potential for an increased risk of infection-related complications may exist following treatment with multiple chemotherapeutic or biological agents.
Danish: Der kan være mulighed for en øget risko for infektionsrelaterede komplikationer efter behandling med multiple kemoterapeutika eller biologiske præparater.
English: If these events are moderate to severe, then dosing should continue at the same level prior to each dose escalation, with appropriate premedication, until each dose is well tolerated.
Danish: Hvis disse hændelser er moderate til alvorlige, bør doseringen fortsætte på det samme niveau forud for hver dosisøgning, og med passende præmedicinering, indtil hver dosis tåles godt.
English: 36 (19-NR)
Danish: 36 (19-IN)
English: Your doctor will treat you, as appropriate, if you have any side effects.
Danish: Din læge vil behandle dig på passende måde, hvis du får bivirkninger.
English: Gradual escalation from 10 to 30 mg 30 mg iv 3 x weekly 30 mg iv 3 x weekly 30 mg iv 3 x weekly
Danish: Gradvis øgning fra 10 til 30 mg Afsluttende doseringsregime 30 mg iv 3 x ugentlig 30 mg iv 3 x ugentlig 30 mg iv 3 x ugentlig
English: • have heart disease or chest pains and/or you are receiving treatment to reduce high blood pressure, as MabCampath may make these conditions worse.
Danish: • har hjertesygdom eller brystsmerter, og/eller du får behandling for at nedsætte forhøjet blodtryk, da MabCampath eventuelt kan forværre disse tilstande.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Danish: Hvis du vil have yderligere oplysninger om denne medicin, skal du henvendedig til den lokale repræsentant for indehaveren af markedsføringstilladelsen.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in
Danish: Dette lægemiddel bør ikke blandes med andre lægemidler end dem, der er nævnt i pkt.
English: Rai Stage III/IV Disease
Danish: Rai-stadium III/IV sygdom
English: Significant Fab binding was also observed in the male reproductive tract (epididymis, sperm, seminal
Danish: Betydende Fab-binding blev også observeret i de mandlige forplantningsorganer (epididymis, sperma,
English: Previously treated B-CLL patients:
Danish: Tidligere behandlede B-CLL-patienter:
English: However you should be cautious as confusion and sleepiness have been seen.
Danish: Du skal dog udvise forsigtighed, da der er set forvirring og søvnighed.
English: Once a patient meets all laboratory and clinical criteria for a complete response, MabCampath should be discontinued and the patient monitored.
Danish: Så snart en patient opfylder alle laboratoriemæssige og kliniske kriterier på en fuldstændigt respons, bør MabCampath seponeres og patienten kontrolleres.
English: United Kingdom/Ireland Genzyme Therapeutics Ltd. (United
Danish: United Kingdom/Ireland Genzyme Therapeutics Ltd. (United Kingdom),
English: Complete blood counts and platelet counts should be obtained at regular intervals during MabCampath therapy and more frequently in patients who develop cytopenias.
Danish: Der bør foretages fuldstændig blodtælling og trombocyttælling med regelmæssige intervaller under behandling med MabCampath og oftere hos patienter, som udvikler cytopenier.
English: However, caution should be exercised as confusion and somnolence have been reported.
Danish: Der bør dog udvises forsigtighed, da der er rapporteret om konfusion og somnolens.
English: Alemtuzumab does not appear to damage haematopoietic stem cells or progenitor cells.
Danish: Alemtuzumab synes ikke at ødelægge hæmatopoietiske stamceller eller progenitorceller.
English: With repeated administration and consequent plasma concentration accumulation, the rate of elimination approached zero-order kinetics.
Danish: Ved gentagen indgift og deraf følgende plasmakoncentrationsakkumulation nærmede eliminationshastigheden sig nul-ordenskinetik.
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report
Danish: I overensstemmelse med CHMP-retningslinjerne for risikostyringsprogrammer for lægemidler til human brug skal en opdateret RMP fremsendes samtidig med den efterfølgende periodiske
English: CD4 and CD8 T-cell counts begin to rise from weeks 8-12 during treatment and continue to recover for several months following the discontinuation of treatment.
Danish: CD4 og CD8 T-celletallet begynder at stige fra uge 8-12 under behandlingen og fortsætter med at stige i flere måneder efter seponering af behandlingen.
English: Your doctor will inform you accordingly
Danish: Din læge vil derfor informere dig.
English: No apparent difference in pharmacokinetics between males and females was observed nor was any apparent age effect observed.
Danish: Der blev ikke observeret nogen tydelig forskel i farmakokinetik mellem mænd og kvinder, ej heller blev der observeret nogen tydelig alderseffekt.
English: The bag should be inverted gently to mix the solution.
Danish: Posen bør vendes forsigtigt for at blande opløsningen.
English: Histopathology results from bone marrow samples revealed no remarkable changes attributable to treatment.
Danish: Histopatologiske undersøgelsesresultater af knoglemarvsprøver viste ingen bemærkelsesværdige ændringer, som kunne tilskrives behandlingen.
English: There are no dose modifications recommended for severe lymphopenia given the mechanism of action
Danish: Der anbefales ingen dosismodifikationer for alvorlig lymfopeni på grund af virkemekanismerne for
English: The active substance in MabCampath, alemtuzumab, is a monoclonal antibody.
Danish: Det aktive stof i MabCampath, alemtuzamab, er et monoklonalt antistof.
English: MabCampath should be used within 8 hours after dilution.
Danish: MabCampath bør anvendes inden 8 timer efter fortynding.
English: Asymptomatic laboratory positive Cytomegalovirus (CMV) viraemia should not necessarily be considered a serious infection requiring interruption of therapy.
Danish: Asymptomatisk laboratorie-positiv Cytomegalovirus (CMV) viræmi bør ikke nødvendigvis betragtes som en alvorlig infektion, der kræver seponering af behandlingen.
English: • are a woman of childbearing potential or a fertile man, then you should use effective contraceptive methods before you start treatment, during treatment and for 6 months after treatment.
Danish: • er en kvinde i den fertile alder eller en fertil mand, anvende effektive svangerskabsforebyggende metoder, før du starter behandlingen, under behandlingen og 6
English: No other findings, in the above toxicity studies, provide information of significant relevance to clinical
Danish: Der er ikke andre fund i ovennævnte toksicitetsstudier, der giver oplysninger af betydning for den
English: Preclinical evaluation of alemtuzumab in animals has been limited to the cynomolgus monkey because of the lack of expression of the CD52 antigen on non-primate species.
Danish: Præklinisk vurdering af alemtuzumab hos dyr har været begrænset til cynomolgus-aben på grund af det manglende udtryk af CD52 antigenet hos ikke-primater.
English: Medicinal products for the treatment of hypersensitivity reactions, as well as preparedness to institute emergency measures in the event of reaction during administration is necessary (see section 4.2).
Danish: Lægemidler til behandling af hypersensitivitetsreaktioner såvel som beredskab til at indlede akut behandling i tilfælde af en reaktion under indgivelse er nødvendig (se pkt.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3.3 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP
Danish: Indehaveren af markedsføringstilladelsen er forpligtet til at foretage de undersøgelser og supplerende pharmacovigilance-aktiviteter, som er beskrevet i pharmacovigilance-planen (ifølge aftalen i risikostyringsprogrammets (RMP) version i henhold til version 3.3, Modul 1.8.2 i markedsføringsansøgningen), og enhver efterfølgende opdatering af RMP, som er godkendt af CHMP.
English: *Pearson chi-square test or Exact test *** log-rank test stratified by Rai group (Stage I-II vs III-IV)
Danish: *** log-rank test stratificeret efter Rai gruppe (Stadium I-II vs III-IV)
English: Store in a refrigerator (2C-8C).
Danish: Opbevares i køleskab (2°C-8°C).
English: After the last 30 mg dose, the median volume of distribution at steady-state was 0.15 l/kg (range: 0.1-0.4 l/kg), indicating that distribution was primarily to the extracellular fluid and plasma compartments.
Danish: Efter den sidste dosis på 30 mg var det mediane fordelingsvolumen ved steady state 0,15 l/kg (område: 0,1-0,4 l/kg) tydende på, at fordelingen primært var til de ekstracellulære væske- og plasmakompartments.