FrancophonIA/ELRC3.0 huggingface dataset:
English: is administered parenterally by intravenous infusion over 1 hour.
Danish: gives parenteralt ved intravenøs infusion gennem en time.
English: The final PL wording was agreed by the CHMP.
Danish: Den endelige ordlyd af indlægssedlen blev godkendt af CHMP.
English: The MAH submitted a proposal for harmonisation of the Quality module.
Danish: Indehaveren af markedsføringstilladelsen fremlagde et forslag om harmonisering af modulet vedrørende kvalitet.
English: The amended therapeutic indication (and posology) for adolescents from 12 years of age is based on noncompany sponsored ganciclovir studies and treatment guidelines2.
Danish: Den ændrede terapeutiske indikation (og dosering) til unge fra 12 år er baseret på undersøgelser af ganciclovir og behandlingsvejledninger, der ikke er virksomhedssponsorerede.2.
English: The CHMP after assessing all the currently available data they concluded that the harmonised therapeutic indication for Cymevene i.v.
Danish: Efter at have vurderet alle de aktuelt tilgængelige data konkluderede CHMP, at den harmoniserede terapeutiske indikation for Cymevene i.v.
English: In allogenic HSCT recipients, the review concluded that CMV disease should be treated with antiviral agents such as ganciclovir or foscarnet with 2-3 weeks of induction therapy followed by 3-4 weeks of maintenance therapy.
Danish: Gennemgangen konkluderede, at for allogene HSCT-patienter bør CMV-sygdommen behandles med antivirale midler, såsom ganciclovir eller foscarnet, med 2-3 ugers induktionsterapi efterfulgt at 3-4 ugers konsolidering.
English: Clinical studies, pharmacodynamics data, and treatment guidelines are provided to support the use of the same dose in adults and adolescents for treatment and prevention of CMV disease.
Danish: Kliniske undersøgelser, farmakodynamiske oplysninger og behandlingsvejledninger stilles til rådighed for at understøtte brugen af samme dosis hos voksne og unge til behandling og forebyggelse af CMV-sygdommen.
English: The safety and efficacy of ganciclovir in children under 12 years of age has not been established.
Danish: Sikkerhed og virkning af ganciclovir hos patienter under 12 år er endnu ikke blevet klarlagt.
English: Section 4.3 - Contraindications
Danish: Punkt 4.3 - Kontraindikationer
English: should be amended as follows: Cymevene is indicated in adults and adolescents from 12 years of age for the: treatment of cytomegalovirus (CMV) disease in immunocompromised patients; prevention of CMV disease in patients with drug-induced immunosuppression (for example following organ transplantation or cancer chemotherapy).
Danish: Cymevene er indikeret til voksne og unge fra 12 år til: - behandling af cytomegalovirus (CMV) sygdom hos immunsvækkede patienter, - forebyggelse af CMV-sygdom hos patienter med medikamentel immunosuppression (som f.eks. efter organtransplantation eller kemoterapi som led i kræftbehandling).
English: The harmonised information on posology was presented by the MAH per indication, i.e. standard dosage for treatment of CMV disease in adults and adolescents from 12 years of age with normal renal function and standard dosage for prevention of CMV disease in adults and adolescents from 12 years of age with normal renal function using prophylaxis or pre-emptive therapy.
Danish: Indehaveren af markedsføringstilladelsen fremlagde de harmoniserede oplysninger om dosering pr. indikation, dvs. standarddosis til behandling af CMV-sygdom hos voksne og unge fra 12 år med normal nyrefunktion, og standarddosis til forebyggelse af CMV-sygdom hos voksne og unge fra 12 år med normal nyrefunktion, med anvendelse af profylakse eller forebyggende terapi.
English: Two contraindications were finally in this section regarding the cross-hypersensitivity and the breast-feeding.
Danish: To kontraindikationer blev angivet i dette afsnit vedrørende krydsallergi og amning.
English: Clinical trials included only patients with haematological malignancy.
Danish: De kliniske forsøg omfattede kun patienter med hæmatologisk ondartethed.
English: For treatment in adults, the studies have been conducted by MAH in patients with AIDS.
Danish: For behandling af voksne har indehaveren af markedsføringstilladelsen gennemført undersøgelser hos patienter med AIDS.
English: The use of ganciclovir in paediatric transplant recipients and patients with AIDS/HIV is recommended in current authoritative treatment guidelines.
Danish: Brug af ganciclovir hos pædiatriske patienter, der har fået transplantation, og patienter med AIDS/HIV, anbefales i myndighedernes aktuelle behandlingsvejledninger.
English: • the scope of the referral was the harmonisation of the summary of products characteristics, labelling and package leaflet;
Danish: • indbringelsen vedrørte harmoniseringen af produktresuméet, etiketteringen og indlægssedlen,
English: The treatment of CMV disease in stem cell transplant (SCT) and solid organ transplant (SOT) recipient is recommended by guidelines, the data supporting the proposed indication are obtained from published literature.
Danish: Behandling af CMV-sygdommen hos patienter, der har fået stamcelletransplantation (SCT) eller organtransplantation (SOT) anbefales i retningslinjerne, og data til at understøtte den anbefalede indikation er indhentet fra offentliggjort litteratur.
English: The MAH has not conducted formal studies in the paediatric patient population.
Danish: Indehaveren af markedsføringstilladelsen har ikke gennemført formelle undersøgelser med den pædiatriske patientpopulation.
English: Although data are scarce the benefit-risk conclusion and posology can in the CHMP view, be extrapolated to adolescents of 12 years and older considering the very serious nature of the disease it is indicated for.
Danish: Selv om der kun findes sparsomme tilgængelige data, kan konklusionen på benefit/risk-forholdet og doseringen ifølge CHMP ekstrapoleres til at også omfatte unge på 12 år og derover i betragtning af sygdommens meget alvorlige natur.
English: Section 4.2 - Posology and methods of administration
Danish: Punkt 4.2 - Dosering og administration
English: One non-systematic review of CMV disease diagnosis, prevention, and treatment in hematopoietic stem cell transplant (HSCT) recipients was conducted.
Danish: Der blev udført en ikkesystematisk gennemgang af CMV-sygdomsdiagnose, forebyggelse og behandling hos patienter, der havde fået hæmopoietisk stamcelletransplantation (HSCT).
English: Various clinical treatment guidelines advise on appropriate treatment and prevention of CMV disease in stem cell transplant recipients.
Danish: Flere kliniske behandlingsvejledninger anbefaler en passende behandling og forebyggelse af CMVsygdommen hos patienter, der har fået stamcelletransplantation.
English: Section 4.8 - Adverse events
Danish: Afsnit 4.8 - Bivirkninger
English: For the prevention of CMV disease, ganciclovir is only indicated in transplant recipients and patients receiving cancer chemotherapy.
Danish: Ganciclovir er kun indikeret til at forebygge CMV-sygdommen hos patienter, der har fået transplantation og hos patienter, der får kemoterapi mod cancer.
English: and associated names for which the MAH is F. HoffmanLa Roche Ltd.
Danish: og relaterede navne, hvis indehaver af markedsføringstilladelsen er F. Hoffman - La Roche Ltd. Proceduren for indbringelse af sager blev påbegyndt ved mødet i december 2014.
English: The MAH submitted documentation to support both indications of treatment and prevention of the CMV disease.
Danish: Indehaveren af markedsføringstilladelsen indsendte dokumentation for at understøtte begge beskrivelser af behandling og forebyggelse af cytomegalovirus-sygdommen.
English: Treatment guidelines1 recommend using ganciclovir for CMV prophylaxis in allogenic stem cell transplant recipients and in patients receiving alemtuzumab therapy.
Danish: Behandlingsvejledningerne1 anbefaler at anvende ganciclovir til CMV-profylakse hos patienter, der har fået allogen stamcelletransplantation, og hos patienter der får behandling med alemtuzumab.
English: However, ganciclovir readily diffuses across the human placenta.
Danish: Dog vil ganciclovir hurtigt sprede sig til moderkagen.
English: There are no MAH-sponsored studies of CMV treatment in stem cell transplant recipients but various clinical treatment guidelines advise on appropriate treatment and prevention of CMV disease in these patients.
Danish: Der findes undersøgelser af CMV-behandling af patienter, der har fået stamcelletransplantation sponsoreret af indehaveren af markedsføringstilladelsen, men flere kliniske behandlingsvejledninger anbefaler forsvarlig behandling og forebyggelse af CMV-sygdommen for denne type patienter.
English: The dosage recommendations proposed by MAH are in line with the indications.
Danish: Doseringsanbefalingerne, som indehaveren af markedsføringstilladelsen har foreslået, er i overensstemmelse med disse indikationer.
English: and associated names.
Danish: og relaterede navne.
English: MAH state that other oncology patients receiving chemotherapy do not routinely require CMV prophylaxis but certain high-risk patients, such as Asian patients, particularly those receiving rituximab or hyper-CVAD chemotherapy, may benefit.
Danish: Indehaveren af markedsføringstilladelsen bemærker, at andre onkologiske patienter, der får kemoterapi, ikke rutinemæssigt har behov for CMV-profylakse, men at visse højrisikopatienter kan have gavn af behandlingen.
English: There are no MAH-sponsored studies of CMV treatment in oncology patients.
Danish: Der findes ingen undersøgelser af CMV-behandling af onkologiske patienter sponsoreret af indehaveren af markedsføringstilladelsen.
English: The CHMP adopted a positive opinion recommending the variation to the terms of the marketing authorisations for which the summary of products characteristics, labelling and package leaflet as set out in Annex III of the CHMP opinion for Cymevene i.v.
Danish: og relaterede navne, for hvilke produktresumé, etikettering og indlægsseddel fremgår af bilag III til CHMP's udtalelse (se bilag I).
English: Package Leaflet
Danish: Indlægsseddel
English: There are no MAH-sponsored studies of CMV treatment in stem cell transplant recipients.
Danish: Der findes ingen undersøgelser af CMV-behandling på patienter, der har fået stamcelletransplantation, som blev sponsoreret af indehaveren af markedsføringstilladelsen.
English: Following all the changes in the SmPC there were amendments made to the package leaflet (PL).
Danish: Som følge af ændringerne til produktresuméet blev indlægssedlen ændret tilsvarende.
English: The first renewal procedure for the vaccine was finalised in June 2004.
Danish: Den første fornyelsesprocedure for vaccinen blev afsluttet i juni 2004.
English: The CVMP Opinion was adopted on 17 April 2007 and the subsequent Commission Decision on 29 June 2007.
Danish: CVMP's udtalelse blev vedtaget den 17. april 2007, og Kommissionens efterfølgende beslutning blev vedtaget den 29. juni
English: The initial mutual recognition procedure was finalised on 24 June 1999 and eleven other Member States authorised the product at this time.
Danish: Den oprindelige gensidige anerkendelsesprocedure blev afsluttet den 24. juni 1999, og 11 andre medlemsstater godkendte på dette tidspunkt produktet.
English: London, June 2008 EMEA/532090/2007- Rev.1
Danish: London, juni 2008 EMEA/532090/2007- Rev.1
English: In March 2006 an application for a marketing authorisation for this vaccine was submitted, following a repeat use mutual recognition procedure, with Germany acting as Reference Member State.
Danish: I marts 2006 blev der indgivet en ansøgning om markedsføringstilladelse for denne vaccine efter en gentagelse af den gensidige anerkendelsesprocedure med Tyskland som referencemedlemsstat.
English: monographs for inactivated bovine vaccines and have written to the EDQM and asked them to address this.
Danish: monografierne for inaktiverede bovine vacciner og har skrevet til EDQM og bedt dem bringe dette i orden.
English: The Marketing Authorisation Holder was requested to provide all supporting data to justify a positive benefit-risk ratio for the treated animal.
Danish: Indehaveren af markedsføringstilladelsen blev anmodet om at fremlægge alle oplysninger, der kunne understøtte et positivt benefit/risk-forhold for det behandlede dyr.
English: EMEA/532090/2007-Rev.1
Danish: EMEA/532090/2007-Rev.1-DA
English: CVMP have noted the inconsistencies (with regard to extraneous agents testing) in the Ph.Eur.
Danish: CVMP har noteret sig uoverensstemmelserne (med hensyn til testning for fremmede agenser) i Ph.Eur.
English: Denmark could not agree with the granting of the marketing authorisation and the matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures, CMD(v) and subsequently the Committee for Medicinal Products for Veterinary Use (CVMP).
Danish: Danmark kunne ikke tilslutte sig udstedelse af en markedsføringstilladelse, og sagen blev henvist til koordinationsgruppen for gensidig anerkendelse og decentraliserede godkendelsesprocedurerveterinære anliggender, CMD(v), og efterfølgende Udvalget for Veterinærlægemidler (CVMP).
English: Bovilis BVD was first authorised in Germany as Bovilis BVD-MD.
Danish: Bovilis BVD blev første gang godkendt i Tyskland som Bovilis BVD-MD.
English: The production and testing of Bovilis BVD vaccine are in accordance with the relevant requirements of Directive 2001/82/EC, the relevant EU guidelines and the relevant monographs of the Ph.Eur.
Danish: Fremstilling og testning af Bovilis BVD-vaccine er i overensstemmelse med de relevante krav i direktiv 2001/82/EC, de pågældende EU-retningslinjer og de pågældende monografier i Ph.Eur.
English: Therefore the requested additional specified extraneous testing requirement was not scientifically justified for Bovilis BVD.
Danish: Det anmodede ekstra krav om specificeret testning for fremmede agenser var således ikke videnskabeligt berettiget for Bovilis BVD.
English: The product is indicated for the active immunisation of cows and heifers from eight months of age onwards to protect the foetus against transplacental infection with BVDV.
Danish: Produktet er indiceret til aktiv immunisering af køer og kvier fra ottemåneders-alderen til beskyttelse af fosteret mod transplacental infektion med BVDV.
English: During its meeting of November 2006, the CVMP started a referral procedure under Article 33(4) of Directive 2001/82/EC as amended for Bovilis BVD/Bovilis BVD-MD.
Danish: CVMP indledte ved sit møde i november 2006 en indbringelsesprocedure i overensstemmelse med artikel 33, stk. 4, i direktiv 2001/82/EF, med senere ændringer, for Bovilis BVD/Bovilis BVD-MD.
English: Bovilis BVD/Bovilis BVD-MD is an inactivated virus vaccine containing the inactivated antigen of cytopathic BVD virus strain C-86.
Danish: Bovilis BVD/Bovilis BVD-MD er en inaktiveret virus-vaccine, som indeholder inaktiveret antigen af cytopatisk BVD-virusstamme C-86.
English: The CVMP concluded that the benefit - risk assessment for Bovilis BVD was favourable.
Danish: CVMP konkluderede, at benefit/risk-forholdet for Bovilis BVD var positivt.
English: Denmark considered that the proposed testing regime to demonstrate freedom from extraneous agents was insufficient to ensure that Bovilis BVD/Bovilis BVD-MD would not interfere with their national eradication campaigns for certain animal diseases and that, therefore, the benefit/risk assessment for Bovilis BVD/Bovilis BVD-MD was unfavourable, authorisation of the product representing a potential serious risk to animal health.
Danish: Danmark fandt, at det foreslåede testprogram til påvisning af fravær af fremmede agenser ikke var tilstrækkeligt til at sikre, at Bovilis BVD/Bovilis BVD-MD ikke ville gribe ind i landets nationale program til udryddelse af visse sygdomme hos dyr, og at benefit/risk-forholdet for Bovilis BVD/Bovilis BVD-MD følgelig var negativt, således at en godkendelse af produktet ville udgøre en potentiel alvorlig risiko for dyrs sundhed.
English: OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR BOVILIS BVD/BOVILIS BVD-MD
Danish: UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 33, STK. 4 VEDRØRENDE BOVILIS BVD/BOVILIS BVD-MD
English: The CVMP concluded that the production of Bovilis BVD vaccine is in compliance with GMP requirements, that extraneous agent testing of raw materials are carried out according to the relevant requirements and that extraneous agent testing of finished batches of Bovilis BVD for FMDV, BLV, BTV and IBRV is not required in the relevant monographs.
Danish: overensstemmelse med de relevante krav, og at testning for fremmede agenser i færdige batcher af Bovilis BVD for FMDV, BLV, BTV og IBRV ikke er påkrævet i de relevante monografier.
English: The CVMP considered that in general, the absence of extraneous agents in vaccines can be ensured by: GMP compliance of the production system
Danish: CVMP anså, at fravær af fremmede agenser i vacciner generelt kan sikres ved: Overholdelse af god fremstillingspraksis (GMP) i produktionssystemet Testning af råmaterialerne for fremmede agenser Testning af batcher af det færdige præparat for fremmede agenser, hvis det er nødvendigt.
English: It is therefore not authorised to be used in this way.
Danish: Det er derfor ikke godkendt til anvendelse på denne måde.
English: • or through an evaluation of individual case reports.
Danish: ● eller ved evaluering af individuelle rapporter.
English: The median age was 64 years.
Danish: Den mediane alder var 64 år.
English: The results of these prespecified analyses are as follows:
Danish: Resultaterne fra disse præspecificerede analyser er følgende:
English: ● you are pregnant.
Danish: • hvis du er gravid.
English: You must not use this medicine if you are pregnant.
Danish: Du må ikke anvende denne medicin, hvis du er gravid.
English: It is important that a well-validated and robust methodology is chosen to avoid false negative or false positive determinations.
Danish: Det er vigtigt, at grundigt validerede og robuste metoder anvendes for at hindre falsk negative eller falsk positive resultater.
English: • epidemiological studies\non-interventional or observational studies,
Danish: ● epidemiologiske studier/non-interventionsstudier eller observationsstudier,
English: These results have been confirmed through an independent radiological review.
Danish: Disse resultater er blevet bekræftet ved en uafhængig radiologisk vurdering.
English: FIGO staging version dated 1988 was used in this trial.
Danish: FIGO stadieinddeling version 1988 var brugt i dette studie.
English: which may be severe.
Danish: kønsdele og urinveje,
English: • problems with the eyes (including increased production of tears),
Danish: • problemer med øjnene (inklusive øget tåreproduktion),
English: Seven patients in each arm had an objective response.
Danish: Syv patienter i hver arm viste objektiv respons.
English: It has not been developed or made for injection into the eye.
Danish: Det er ikke blevet udviklet eller fremstillet til injektion i øjet.
English: You will be treated with Avastin once every 2 or 3 weeks.
Danish: Du vil blive behandlet med Avastin én gang hver 2. eller 3. uge.
English: Discuss with your doctor to make sure that you do not combine these medicine.
Danish: Tal med din læge for at sikre, at du ikke kombinerer disse 2 lægemidler.
English: Invasive dental procedures are also an identified risk factor.
Danish: Invasive tandprocedurer er også en kendt risikofaktor.
English: From a microbiological point of view, the product should be used immediately.
Danish: Fra et mikrobiologisk synspunkt skal præparatet anvendes øjeblikkelig.
English: The incidence varied between 10% (4/40) and 20% (3/15).
Danish: Hyppigheden varierede mellem 10 % (4/40) og 20 % (3/15).
English: Both co-primary objectives were met:
Danish: Begge primære formål blev opfyldt:
English: Precautions to be taken before handling or administering the medicinal product
Danish: Sikkerhedsforanstaltninger som skal tages før håndtering og administration af lægemidlet
English: • localised pus collection,
Danish: • lokaliseret ansamling af pus,
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at bruge dette lægemiddel, da det indeholder vigtige oplysninger.
English: Elderly patients: No dose adjustment is required in the elderly.
Danish: Ældre patienter: Dosisjustering er ikke nødvendig hos ældre.
English: every 3 weeks.
Danish: hver anden uge.
English: The most serious adverse reactions were:
Danish: De alvorligste bivirkninger var:
English: Patients older than 65 years have an increased risk of experiencing the following side effects :
Danish: Patienter over 65 år har øget risiko for at få følgende bivirkninger:
English: • lack of energy,
Danish: • mangel på energi,
English: There were no objective (partial or complete) radiological responses (MacDonald criteria).
Danish: Der var ingen objektive (delvise eller komplette) radiologiske respons (Macdonald kriterier).
English: When Avastin is injected directly into the eye (unapproved use), the following side effects may occur:
Danish: Hvis Avastin injiceres direkte i øjet (ikke-godkendt brug), kan følgende bivirkninger forekomme:
English: These results were consistent with those from various sensitivity analyses and in clinically relevant subgroups.
Danish: Disse resultater var konsistente med resultater fra forskellige sensitivitetsanalyser og i klinisk relevante undergrupper.
English: Intravitreal use Avastin is not formulated for intravitreal use.
Danish: Intravitreal anvendelse Avastin er ikke formuleret til intravitreal anvendelse.
English: There were no complete responses and 2 partial responses (MacDonald criteria).
Danish: Der var ingen komplette respons og 2 delvise respons (Macdonald kriterier).
English: Avastin may also cause changes in laboratory tests carried out by your doctor.
Danish: Avastin kan også forårsage ændringer i de laboratorieundersøgelser, som din læge foretager.
English: Objective response rate was low in both treatment arms and the difference was not significant.
Danish: Objektiv responsrate var lav i begge behandlingsarme, og forskellen var ikke signifikant.
English: * if specified, the frequency has been derived from clinical trial data
Danish: *Hvis frekvens angives, er den udledt af data fra kliniske studier
English: A total of 16 patients (4.4%) were > 75 years old.
Danish: I alt 16 patienter (4,4 %) var > 75 år.
English: Post-marketing adverse reactions are included in both Tables 1 and 2, where applicable.
Danish: Postmarketing-bivirkninger er inkluderet i både tabel 1 og 2, hvis relevant.
English: No specific studies in animals have been conducted to evaluate the effect on fertility.
Danish: Der er ikke foretaget specifikke dyreforsøg for at undersøge virkningen på fertilitet.
English: In addition, the primary endpoint was also assessed by an independent review committee (IRC).
Danish: Desuden blev det primære endepunkt også vurderet af en uafhængig evalueringskomité (IRC).
English: • loss of appetite,
Danish: • tab af appetit,
English: • spontaneous reporting,
Danish: ● spontane indberetninger,
English: Please discuss with your doctor if you noticed this previously.
Danish: Tal med din læge, hvis du tidligere har bemærket dette.
English: A systematic premedication is not warranted.
Danish: En systematisk præmedicinering anbefales ikke.
English: This does not necessarily mean that these side effects were strictly caused by Avastin.
Danish: Det betyder ikke at disse bivirkninger nødvendigvis kun skyldes Avastin.
English: Further details of each study and the results are provided below.
Danish: Nærmere detaljer om de to studier og resultaterne heraf er beskrevet nedenfor.
English: Please consult your doctor for more information.
Danish: Kontakt din læge for at få yderligere information.
English: Before you are given Avastin or while you are being treated with Avastin:
Danish: Før du får Avastin, eller imens du bliver behandlet med Avastin:
English: Avastin is for single-use only, as the product contains no preservatives.
Danish: Avastin er udelukkende til engangsbrug, da produktet ikke indeholder konserveringsmidler.