FrancophonIA/ELRC3.0 huggingface dataset:
English: OUTER CARTON TEXT - 1 pre-filled syringe pack with separate needle
Danish: OPLYSNINGER PÅ DEN YDRE PAKNING - pakning med 1 fyldt sprøjte med separat nål
English: Infants aged 2 - 6 months: the primary infant series consists of three doses, each of 0.5 ml, the first dose usually given at 2 months of age and with an interval of at least 1 month between doses.
Danish: Børn i alderen 2 - 6 måneder: Den anbefalede, primære vaccinationsserie er tre doser på hver 0,5 ml, første dosis gives normalt i alderen 2 måneder og med et interval på mindst 1 måned mellem doserne.
English: OUTER CARTON TEXT - 10 pre-filled syringes pack without needle
Danish: OPLYSNINGER PÅ DEN YDRE PAKNING - pakning med 10 fyldte sprøjter uden nåle
English: OUTER CARTON TEXT - 1 vial pack
Danish: OPLYSNINGER PÅ DEN YDRE PAKNING - pakning med 1 hætteglas
English: Administration of unconjugated pneumococcal polysaccharides at 13 months following the primary series with Prevenar elicited an anamnestic antibody response for the 7 serotypes included in the vaccine, indicating
Danish: Der blev fremkaldt en anamnestisk antistofrespons ved alle 7 serotyper i vaccinen efter administration af ukonjugerede pneumokokpolysaccharid-vacciner efter en serie Prevenar-primærvaccinationer, hvilket indikerede, at der havde fundet priming sted.
English: Fever of greater than 39.5 °C per dose was observed in 0.6 to 2.8 % of infants receiving Prevenar and hexavalent vaccines (see section 4.4).
Danish: °C blev observeret hos 0,6% til 2,8% af børnene, som fik Prevenar og
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER
English: EXP:
Danish: Anv.
English: 10 single-dose (0.5 ml) pre-filled syringes without needle.
Danish: 10 enkeltdoser (0,5 ml) fyldte injektionssprøjter uden nål.
English: 1 single-dose (0.5 ml) pre-filled syringe with separate needle.
Danish: 1 enkeltdosis (0,5 ml) fyldt injektionssprøjte med separate nåle.
English: The first dose may be given from the age of 2 months with a second dose at least 2 months later and a third (booster) dose at 11-15 months of age.
Danish: Hvis Prevenar normalt gives som en del af et almindeligt børnevaccinationsprogram, kan det følge en alternativ plan, der består af 2 doser, som gives med mindst 2 måneder mellem doserne, efterfulgt af en tredje dosis (booster), når barnet er 11-15 måneder.
English: What Prevenar looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: The frequency is defined as follows: Very common ( 1/10) Common ( 1/100 to < 1/10)
Danish: Meget sjælden (< 1/10.000).
English: OUTER CARTON TEXT - 1 vial pack with syringe/needles
Danish: OPLYSNINGER PÅ DEN YDRE PAKNING - pakning med 1 hætteglas med sprøjte/nåle
English: Prevenar suspension for injection Pneumococcal saccharide conjugated vaccine, adsorbed
Danish: Prevenar, injektionsvæske, suspension Konjugeret saccharid pneumokokvaccine, adsorberet
English: OUTER CARTON TEXT - 1 pre-filled syringe pack without needle
Danish: OPLYSNINGER PÅ DEN YDRE PAKNING - pakning med 1 fyldt sprøjte uden nål
English: Prevenar suspension for injection in pre-filled syringe Pneumococcal saccharide conjugated vaccine, adsorbed.
Danish: Prevenar, injektionsvæske, suspension i fyldt sprøjte Konjugeret saccharid pneumokokvaccine, adsorberet.
English: Medicinal product subject to medical prescription
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE)
English: Effectiveness
Danish: Indgivelsesmåde
English: 1 or 10 vials without syringe/needles.
Danish: Pakningsstørrelser: 1 eller 10 hætteglas uden sprøjte/nåle.
English: Pneumococcal polysaccharide serotype 6B*
Danish: Hver 0,5 ml dosis indeholder: Pneumokok polysaccharid serotype 4*
English: OUTER CARTON TEXT- 10 vials pack
Danish: OPLYSNINGER PÅ DEN YDRE PAKNING - pakning med 10 hætteglas
English: 1 single-dose (0.5 ml) pre-filled syringe without needle.
Danish: 1 enkeltdosis (0,5 ml) fyldt injektionssprøjte uden nål.
English: - if your child has any present or past medical problems after any dose of Prevenar.
Danish: Vær ekstra forsigtig med at bruge Prevenar: - hvis Deres barn har eller har haft problemer efter indgivelse af Prevenar.
English: Prevenar suspension for injection in pre-filled syringe Pneumococcal saccharide conjugated vaccine, adsorbed
Danish: Prevenar, injektionsvæske, suspension i fyldt sprøjte Konjugeret saccharid pneumokokvaccine, adsorberet
English: • Seizures (or fits), including those caused by a high temperature
Danish: • Kramper, herunder feberkrampe
English: Pneumococcal polysaccharide serotype 23F*
Danish: Pneumokok polysaccharid serotype 18C* 2 mikrogram Pneumokok polysaccharid serotype 19F* 2 mikrogram Pneumokok polysaccharid serotype 23F* 2 mikrogram
English: urticaria or urticaria-like rash (hives)
Danish: udslæt, nældefeber (urticaria) eller nældefeberlignende udslæt
English: 6.1 List of excipients
Danish: 6.5 Emballagetype og pakningsstørrelser
English: 13 January 2012
Danish: 13. januar 2012
English: Opinion following an Article 35
Danish: Udtalelse efter en artikel 35
English: The Committee adopted a positive opinion on 13 October 2011.
Danish: Udvalget vedtog en positiv udtalelse den 13. oktober 2011.
English: Written explanations were provided by the applicants/marketing authorisation holders on 22 August 2011.
Danish: Ansøgerne/indehaverne af markedsføringstilladelserne afgav skriftlige redegørelser den 22. august 2011.
English: The referral procedure started on 6 April 2011.
Danish: Henvisningsproceduren blev indledt den 6. april 2011.
English: and to address the risk associated with potential misuse in poultry and the need for specific measures, in particular the need for warning sentences in the product information.
Danish: og om at gennemgå risiciene ved eventuel forkert brug hos fjerkræ samt behovet for specifikke foranstaltninger, navnlig advarsler i produktinformationen.
English: The final opinion was converted into a Decision by the European Commission on 13 January 2012.
Danish: Den endelige udtalelse blev omarbejdet til en beslutning af Europa-Kommissionen den 13. januar
English: International non-proprietary names (inn): ceftiofur and cefquinome
Danish: Internationale fællesnavne (INN): ceftiofur og cefquinom
English: The Committee appointed Dr Karolina Törneke as rapporteur and Dr Claire Chauvin as co-rapporteur.
Danish: Som rapportør og medrapportør udpegedes henholdsvis dr. Karolina Törneke og dr. Claire Chauvin.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended summary of product characteristics and package leaflet in the Annex III.
Danish: Listen over de berørte produktnavne fremgår af bilag I. De videnskabelige konklusioner fremgår af bilag II.
English: Article 35 of Directive 2001/82/EC Revised reflection paper on use of 3rd and 4th generation cephalosporins in food producing animals in the EU: development of resistance and impact on human and animal health (EMEA/CVMP/SAGAM/81730/2006-Rev.1)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004307.pdf
Danish: Artikel 35 i direktiv 2001/82/EF Revised reflection paper on use of 3rd and 4th generation cephalosporins in food producing animals in the EU: development of resistance and impact on human and animal health (EMEA/CVMP/SAGAM/81730/2006-Rev.1)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004307.pdf
English: On 17 March 2011, the European Commission presented to the Agency a referral notification under Article 35 of Directive 2001/82/EC, regarding all veterinary medicinal products containing systemically administered (parenteral and oral) 3
Danish: Den 17. marts 2011 underrettede Europa-Kommissionen agenturet om en indbringelse i henhold til artikel 35 i direktiv 2001/82/EF vedrørende alle veterinærmedicinske produkter indeholdende systemiske (parenterale og orale) tredje- og fjerdegenerations cefalosporiner til anvendelse i levnedsmiddelproducerende dyr.
English: Based on the rapporteurs' assessment of the currently available data, the CVMP considered that the overall benefit-risk balance for these products remains positive subject to the recommended changes of the product information and that variations are necessary to the terms of the marketing authorisation for all veterinary medicinal products containing systemically administered (parenteral and
Danish: På grundlag af rapportørernes vurdering af de aktuelt tilgængelige data var CVMP af den opfattelse, at det overordnede benefit/risk-forhold for disse produkter fortsat er positivt med det forbehold, at
English: Opinion following an Article 35 referral for all veterinary medicinal products containing systemically administered (parenteral and oral) 3rd and 4th generation cephalosporins intended for use in food producing species
Danish: 1-indbringelse vedrørende alle veterinærmedicinske produkter indeholdende systemiske (parenterale og orale) tredje- og fjerdegenerations cefalosporiner til anvendelse i levnedsmiddelproducerende dyr
English: generation cephalosporins in food producing animals in the European Union: development of resistance and impact on human and animal health (EMEA/CVMP/SAGAM/81730/2006-Rev.1)
Danish: CVMP blev anmodet om en udtalelse om at indføre en anbefaling af forsigtig brug af disse antimikrobielle midler på linje med det reviderede oplæg om anvendelse af tredje- og fjerdegenerations cefalosporiner i levnedsmiddelproducerende dyr i Den Europæiske Union: resistensudvikling og indvirkningen heraf på menneskers og dyrs sundhed (EMEA/CVMP/SAGAM/81730/2006-Rev.1)
English: 200 tablets
Danish: 200 tabletter
English: Film-coated tablet Oral use bottle (HDPE)
Danish: Oral anvendelse Flaske (HDPE)
English: Date of first authorisation: 28 August 2000 Date of latest renewal: 28 August 2010
Danish: Dato for første markedsføringstilladelse: 28. august 2000 Dato for seneste fornyelse: 28. august 2010
English: 21 months.
Danish: 21 måneder.
English: An updated RMP should be submitted:
Danish: • En opdateret RMP skal fremsendes:
English: The rabbit study was performed to specifically examine local tolerance aspects.
Danish: Kaninstudiet blev udført for specifikt at undersøge toleranceaspekter lokalt.
English: It is not known whether Herceptin can affect reproductive capacity.
Danish: Det vides ikke, om Herceptin kan påvirke reproduktionskapaciteten.
English: Other side effects that have been reported with Herceptin use: frequency cannot be estimated from the available data
Danish: Andre bivirkninger som er blevet rapporteret ved brug af Herceptin: hyppighed kan ikke vurderes ud fra tilgængelige data
English: There were also more local reactions at the site of injection and more increases in blood pressure.
Danish: Der var også flere lokale reaktioner ved injektionsstedet og flere blodtryksstigninger.
English: Herceptin subcutaneous formulation was locally and systemically well tolerated.
Danish: Herceptin subkutan formulering var lokalt og systemisk veltolereret.
English: Herceptin can cause breathing difficulties, especially when it is first given.
Danish: Herceptin kan forårsage vejrtrækningsproblemer, specielt når det gives første gang.
English: Unopened vial 4 years
Danish: Uåbnet hætteglas 4 år
English: All doses should be taken at the right time every three weeks.
Danish: Alle doser skal tages på det rigtige tidspunkt hver tredje uge.
English: Herceptin should only be given by a doctor or nurse.
Danish: Herceptin må kun gives af en læge eller sygeplejerske.
English: D-82377 Penzberg Germany
Danish: D-82377 Penzberg Tyskland
English: Herceptin is not genotoxic.
Danish: Herceptin er ikke genotoksisk.
English: If not used immediately, preparation should take place in controlled and validated aseptic conditions.
Danish: Hvis lægemidlet ikke anvendes med det samme skal tilberedningen finde sted under kontrollerede og validerede aseptiske betingelser.
English: Do not dilute with glucose solutions since these cause aggregation of the protein.
Danish: Må ikke fortyndes med glukoseopløsninger da disse kan forårsage aggregation af proteinet.
English: Only patients with a large amount of HER2 will be treated with Herceptin.
Danish: Kun patienter med store mængder HER2 vil blive behandlet med Herceptin.
English: SISH technology is however, recommended to allow for the parallel evaluation of tumor histology and morphology.
Danish: SISH-teknologi anbefales dog for at tillade den parallelle vurdering af tumorhistologien og -morfologien.
English: Other side effects were similar.
Danish: Andre bivirkninger var sammenlignelige.
English: (<1/10,000), not known (cannot be estimated from the available data).
Danish: < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: • Infusion solutions should be used immediately after dilution.
Danish: • Infusionsopløsninger skal anvendes umiddelbart efter fortynding.
English: Greater than 70 % of patients enrolled exhibited 3+ overexpression.
Danish: Mere end 70 % af de inkluderede patienter udviste en 3+ overekspression.
English: New injections should be given at least 2.5 cm away from an old site.
Danish: Nye injektioner skal gives mindst 2,5 cm fra et gammelt injektionssted.
English: The median Tmax following subcutaneous administration was approximately 3 days, with high interindividual variability (range 1-14 days).
Danish: Den mediane Tmax efter subkutan administration var omkring 3 dage med stor interindividuel variabilitet (interval: 1-14 dage).
English: If you stop using Herceptin
Danish: Hvis du holder op med at få Herceptin
English: The interval between consecutive Herceptin subcutaneous formulation administrations should not be less than three weeks.
Danish: Intervallet mellem på hinanden følgende administrationer af Herceptin subkutan formulering skal ikke være mindre end tre uger.
English: Some of the severe events occurred on the day of the injection.
Danish: Nogle af de alvorlige bivirkninger opstod på samme dag som injektionen.
English: Malta (See United Kingdom)
Danish: Malta (See Ireland)
English: *Cmin,ss - Cmin at steady state **Cmax,ss = Cmax at steady state *** time to 90% of steady-state
Danish: ved steady state **Cmax,ss = Cmax ved steady state ***Tid til 90 % af steady state
English: Children and adolescents Herceptin is not recommended for anyone under the age of 18 years.
Danish: Herceptin anbefales ikke til børn og unge under 18 år.
English: Paediatric population There is no relevant use of Herceptin in the paediatric population.
Danish: Pædiatrisk population Det er ikke relevant at bruge Herceptin i den pædiatriske population.
English: Fertility There is no fertility data available.
Danish: Fertilitet Der foreligger ingen data vedrørerende fertilitet.
English: The clinical relevance of these antibodies is not known.
Danish: Den kliniske relevans af disse antistoffer kendes ikke.
English: The effects may be moderate to severe and could cause death.
Danish: Påvirkningerne kan være moderate til svære og kan forårsage død.
English: Non-clinical data for recombinant human hyaluronidase reveal no special hazard for humans based on conventional studies of repeated dose toxicity including safety pharmacology endpoints.
Danish: Non-kliniske data for rekombinant human hyalorunidase viser ingen særlige risici for mennesker baseret på konventionelle studier af toksicitet efter gentagne doser herunder farmakologiske sikkerhedsendepunkter.
English: It has been associated with a fatal outcome.
Danish: Dette er blevet forbundet med dødelig udgang.
English: The median duration of follow-up in the Herceptin arm was 3.8 years.
Danish: Den mediane opfølgningstid i Herceptin-armen var 3,8 år.
English: When Herceptin binds to HER2 it stops the growth of such cells and causes them to die.
Danish: Når Herceptin bindes til HER2 stopper det væksten af sådanne celler, hvilket resulterer i, at de dør.
English: Administration-related reactions
Danish: Administrationsrelaterede reaktioner
English: The efficacy results from the interim efficacy analysis crossed the protocol pre-specified statistical boundary for the comparison of 1-year of Herceptin versus observation.
Danish: Effektresultaterne fra den interime effektanalyse krydsede protokollens præspecificerede statistiske grænse for sammenligningen af 1-år med Herceptin versus observation.
English: • performed under aseptic conditions by trained personnel in accordance with good practice rules especially with respect to the aseptic preparation of parenteral products.
Danish: • Udføres under aseptiske betingelser af trænet personale i henhold til god klinisk praksis, især i forhold til aseptisk klargørelse af parenterale produkter.
English: A careful risk-benefit assessment should be made before deciding to treat with Herceptin.
Danish: Der skal foretages en grundig risk-benefit vurdering før det besluttes, om der skal behandles med Herceptin.
English: A volume overage of 4 % ensures that the labelled dose of 150 mg can be withdrawn from each vial.
Danish: Et volumenoverskud på 4 % sikrer, at den angivne dosis på 150 mg kan trækkes op af hvert hætteglas.
English: Therefore, these patients should not be treated with Herceptin (see section 4.3).
Danish: Disse patienter bør derfor ikke behandles med Herceptin (se pkt.
English: Upon opening of the vial, the solution should be used immediately.
Danish: Efter åbning af hætteglasset bør opløsningen bruges med det samme.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benifit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelvoervågning eller risikominimering) er nået.
English: No grade 4 or grade 5 adverse events were reported.
Danish: Der blev ikke rapporteret nogen grad 4 og grad 5 bivirkninger.
English: Two different types (formulations) of Herceptin exist:
Danish: Herceptin findes i to typer (formuleringer):
English: • one is given as an infusion into a vein over 30 to 90 minutes
Danish: • én, der gives som en infusion i en vene over en periode på 30 til 90 minutter
English: The difference was not statistically significant, however more than half of the patients in the anastrozole alone arm crossed over to a Herceptin containing regimen after progression of disease.
Danish: Forskellen var ikke statistisk signifikant, men mere end halvdelen af patienterne i armen med anastrozol alene skiftede til et regime indeholdende Herceptin efter sygdomsprogression.
English: As Herceptin does not contain any antimicrobial-preservative, from a microbiological point of view, the medicine should be used immediately.
Danish: Da Herceptin ikke indeholder et antimikrobielt konserveringsmiddel bør lægemidlet fra et mikrobiologisk synspunkt anvendes med det samme.
English: The dose of Herceptin depends on your body weight.
Danish: Herceptindosis afhænger af din legemsvægt.
English: No. patients with event p=0.0555 * defined as absence of any invasive cancer both in the breast and axillary nodes
Danish: Antal patienter med en hændelse p=0,0555 * defineret som fravær af hvilken som helst invasiv kræft både i bryst og aksilknuder
English: These medicines (or any other anthracyclines) can damage heart muscle and increase the risk of heart problems with Herceptin.
Danish: Disse lægemidler (og ethvert andet antracyklin) kan skade hjertet og øge risikoen for hjerteproblemer sammen med Herceptin.
English: Herceptin may also be given once a week for metastatic breast cancer.
Danish: Herceptin kan også gives én gang om ugen ved metastatisk brystkræft.
English: However, capecitabine itself showed higher concentrations and a longer half-life when combined with Herceptin.
Danish: Capecitabin viste dog højere koncentrationer og længere halveringstid, når det blev kombineret med Herceptin.
English: Overall Survival, Median months Progression-Free Survival, Median months
Danish: Samlet overlevelse, Median måneder Progressionsfri overlevelse Median måneder Tid til sygdomsprogression, Median måneder Samlet responsrate, %
English: Not known +Acute respiratory distress syndrome Not known +Bronchospasm
Danish: Ikke kendt +Akut respiratorisk distress syndrom Ikke kendt +Bronkospasmer
English: Neoplasm progression
Danish: Neoplasma progression
English: No long-term animal studies have been performed to establish the carcinogenic potential of Herceptin, or to determine its effects on fertility in males.
Danish: Der er ikke foretaget langtidsstudier på dyr for at fastslå Herceptins carcinogene potentiale eller bestemme dets virkning på fertilitet hos hanner.
English: Infusion reactions, allergic-like reactions and hypersensitivity It is estimated that approximately 40 % of patients who are treated with Herceptin will experience some form of infusion-related reaction.
Danish: Infusionsreaktioner, allergilignende reaktioner og overfølsomhed Det estimeres, at ca. 40 % af patienterne, som bliver behandlet med Herceptin, vil opleve infusionsrelaterede reaktioner i en eller anden form.
English: • prepared in a laminar flow hood or biological safety cabinet using standard precautions for the safe handling of intravenous agents.
Danish: • Udføres i et laminært flow eller biologisk sikkerhedsskab ved brug af standard forholdsregler til sikker håndtering af intravenøse midler.
English: For monotherapy, the rate was 6 % - 9 %.
Danish: Ved monoterapi var frekvensen 6-9 %.
English: Reversibility of mild symptomatic and asymptomatic left ventricular dysfunction was demonstrated for 79.5 % of patients.
Danish: Reversibilitet af let symptomatisk og asymptomatisk dysfunktion af venstre ventrikel blev påvist hos 79,5 % af patienterne.
English: No injection should be given into areas where the skin is red, bruised, tender or hard.
Danish: Injektioner må aldrig gives på områder, hvor huden er rød, har blå mærker, er følsom eller hård.
English: In this trial, 87 % of patients entered had disease that was IHC3+, and 95 % of patients entered had disease that was IHC3+ and/or FISH-positive.
Danish: I dette studie havde 87 % af de inkluderede patienter sygdom, som var IHC3+ og 95 % af de inkluderede patienter havde sygdom, der var IHC3+ og/eller FISH-positiv.
English: If you experience any of the above symptoms when your treatment with Herceptin has finished, you should see your doctor and tell them that you have previously been treated with Herceptin.
Danish: Hvis du får nogle af ovenstående symptomer, når behandlingen med Herceptin er stoppet, skal du kontakte din læge og fortælle, at du tidligere er blevet behandlet med Herceptin.
English: Hyaluronidase is found in most tissues of the human body.
Danish: I den humane krop findes hyalorunidase i de fleste væv.
English: • Your doctor will advise you of the risks and benefits of taking Herceptin during pregnancy.
Danish: • Lægen vil rådgive dig om risiko og fordele ved at tage Herceptin under graviditet.
English: • pain in the arms and/or legs
Danish: • smerter i armene og/eller benene
English: Herceptin loading dose should be administered as a 90-minute intravenous infusion.
Danish: En støddosis af Herceptin bør administreres som en 90 minutters intravenøs infusion.
English: The incidence of symptomatic cardiac dysfunction was 1.7% in the Herceptin arm .
Danish: Hyppigheden af symptomatisk kardiel dysfunktion var 1,7 % i Herceptin-armen.
English: Death (OS event):
Danish: Død (OS- hændelse):
English: HER2 overexpression assessment
Danish: Vurdering af HER2-overekspression
English: p-value versus
Danish: p-værdi versus
English: How to store Herceptin Herceptin will be stored by the health professionals at the hospital or clinic.
Danish: Herceptin vil blive opbevaret af sundhedspersonale på hospitalet eller i klinikken.
English: Some of these side effects may be serious and may lead to hospitalisation.
Danish: Nogle af disse bivirkninger kan være alvorlige og kan medføre hospitalsindlæggelse.