FrancophonIA/ELRC3.0 huggingface dataset:
English: • Healthcare professionals are reminded that SGLT2 inhibitors are only authorised for treating type 2 diabetes.
Danish: • Sundhedspersoner skal være opmærksomme på, at SGLT2-hæmmere kun er godkendt til behandling af type 2-diabetes.
English: Patients taking these medicines should be aware of the symptoms of diabetic ketoacidosis, including rapid weight loss, nausea or vomiting, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to the breath, a sweet or metallic taste in the mouth, or a different odour to urine or sweat.
Danish: Patienter, der tager disse lægemidler, skal være opmærksomme på symptomerne på diabetisk ketoacidose, herunder hurtigt vægttab, kvalme eller opkastning, mavesmerter, voldsom tørst, hurtig og dyb vejrtrækning, forvirring, usædvanlig søvnighed eller træthed, sødlig ånde, sødlig eller metallisk smag i munden eller forandret lugt af urin eller sved.
English: Symptoms include rapid weight loss, nausea or vomiting, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to the breath, a sweet or metallic taste in the mouth, or a different odour to urine or sweat.
Danish: Symptomerne omfatter hurtigt vægttab, kvalme eller opkastning, mavesmerter, voldsom tørst, hurtig og dyb vejrtrækning, forvirring, usædvanlig søvnighed eller træthed, sødlig ånde, sødlig eller metallisk smag i munden eller forandret lugt af urin eller sved.
English: • Some of the cases of diabetic ketoacidosis in people taking SGLT2 inhibitors did not show the very high sugar levels normally associated with this condition.
Danish: • I nogle af de tilfælde, hvor patienter, der tager SGLT2-hæmmere, har fået diabetisk ketoacidose, er der ikke set de meget høje blodsukkerniveauer, som normalt forbindes med denne tilstand.
English: • Rare cases of diabetic ketoacidosis, including life-threatening ones, have occurred in patients taking SGLT2 inhibitors, used to treat type 2 diabetes.
Danish: • Der er set sjældne tilfælde af diabetisk ketoacidose, herunder livstruende tilfælde, hos patienter, der tager SGLT2-hæmmere til behandling af type 2-diabetes.
English: • Rare cases of diabetic ketoacidosis have occurred in people with type 2 diabetes taking diabetes medicines known as SGLT2 inhibitors.
Danish: • Der er observeret sjældne tilfælde af diabetisk ketoacidose hos patienter med type 2-diabetes, som tager lægemidler, der kaldes SGLT2-hæmmere.
English: Patients should contact a doctor or the nearest hospital straightaway if they have any of these symptoms.
Danish: Hvis patienterne får et eller flere af disse symptomer, skal de straks søge læge eller tage til det nærmeste hospital.
English: Sodium-glucose co-transporter-2 (SGLT2) inhibitors are medicines used to treat type 2 diabetes.
Danish: SGLT2-hæmmere er lægemidler, der anvendes til at behandle type 2-diabetes.
English: These include low insulin-producing capacity in the pancreas, a sudden drop in a patient's insulin dose, increased insulin requirement (due to illness, surgery or alcohol abuse) or conditions that can restrict food intake or lead to severe dehydration.
Danish: Risikofaktorerne omfatter lav insulinproducerende kapacitet i bugspytkirtlen, pludseligt reduceret insulindosis, øget insulinbehov (på
English: • All unused devices or empty containers should be returned systematically according to the local regulation.
Danish: • Alle ubrugte anordninger eller tomme beholdere skal systematisk returneres i henhold til lokale retningslinjer
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Danish: Medlemslandene skal sikre, at alle betingelser og begrænsninger med hensyn til en sikker og effektiv anvendelse af lægemidlet, som beskrevet nedenfor, implementeres:
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Danish: BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET, DER SKAL IMPLEMENTERES AF MEDLEMSLANDENE
English: • Do not use PecFent nasal spray for treatment of more than four breakthrough cancer pain episodes a day
Danish: • Anvend ikke PecFent næsespray til behandling af mere end fire episoder med cancergennembrudssmerter om dagen
English: 1 pre-filled syringe
Danish: 1 Fyldt injektionssprøjte hætteglas (glas)
English: The pharmaceutical form and strength is identical in all countries.
Danish: Lægemiddelform og styrke er identisk i alle lande.
English: This might need to be reviewed for all concerned products.
Danish: Der kan være behov for en gennemgang af dette spørgsmål for alle omfattede produkter.
English: It was therefore suggested to change the content of the paragraph accordingly.
Danish: Det blev derfor foreslået at ændre indholdet af dette afsnit i overensstemmelse hermed.
English: Therefore, a statement should be added on the use in adolescents and adults.
Danish: Derfor skulle der tilføjes en erklæring om anvendelse hos unge og voksne.
English: Priorix is nationally approved in 20 countries and is approved through the mutual recognition procedure (MRP) in 9 countries.
Danish: Priorix er nationalt godkendt i 20 lande og godkendt ved den gensidige anerkendelsesprocedure (MRP) i 9 lande.
English: Overall summary of the scientific evaluation of Priorix and associated names (see annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Priorix og relaterede navne (se bilag I)
English: The intramuscular route of administration is approved in all Member States except The Netherlands.
Danish: Den intramuskulære indgivelsesvej er godkendt i alle medlemsstater undtagen Nederlandene.
English: There are no data to support the use of PRIORIX with any other vaccines.”
Danish: Der er ingen data til støtte for anvendelse af Priorix sammen med nogen andre vacciner.”
English: In the past decade, several mumps outbreaks have been reported in highly vaccinated populations (two doses).
Danish: I de seneste ti år er der beskrevet flere udbrud af fåresyge i højt vaccinerede befolkningsgrupper (to doser).
English: Vaccine efficacy data should differentiate between one or two doses.
Danish: Effektivitetsdata for vaccinen bør være opdelt for en og to doser.
English: During the CHMP discussion it was questioned whether “pregnancy” should continue to be stated under contraindications.
Danish: Under drøftelserne i CHMP blev der rejst tvivl om, hvorvidt “graviditet” fortsat bør være anført under kontraindikationer.
English: Even if vaccine virus is transmitted, the infection is mild and self-limiting (ACIP 2011).
Danish: Selv hvis der overføres vaccinevirus, er infektionen mild og selvbegrænsende (ACIP 2011).
English: If not given at the same time, an interval of at least one month is recommended between administration of PRIORIX and other live attenuated vaccines.
Danish: Hvis vaccinerne ikke gives samtidig, anbefales et interval på mindst én måned mellem administration af Priorix og andre levende svækkede vacciner.
English: Some vaccines that can be co-administered with Priorix are listed in the SmPC of Belgium, Bulgaria, Cyprus, Denmark, Estonia, France, Luxemburg, Malta, The Netherlands, Poland, Romania and United Kingdom.
Danish: Nogle vacciner, der kan administreres sammen med Priorix, er anført i produktresuméet i Belgien, Bulgarien, Cypern, Danmark, Estland, Frankrig, Luxembourg, Malta, Nederlandene, Polen, Rumænien og Det Forenede Kongerige.
English: A seropositive response by ELISA may not necessarily represent protection, especially for mumps.
Danish: En seropositiv respons, bestemt ved ELISA, er ikke nødvendigvis ensbetydende med beskyttelse, navnlig mod fåresyge.
English: In addition, the product information (PI) was presented using the latest version of the QRD template, version 2, published on 12 October 2011.
Danish: Desuden blev produktinformationen fremlagt med anvendelse af den nyeste QRD-model, version 2, offentliggjort den 12. oktober 2011.
English: The approved lower age limit indicated for the use of Priorix varied from 9 months to 15 months across the individual EU member states reflecting in some cases the national recommendations for routine MMR vaccination.
Danish: Den godkendte nedre aldersgrænse for anvendelse af Priorix varierede fra 9 måneder til 15 måneder mellem de enkelte EU-medlemsstater, hvilket i nogle tilfælde afspejler nationale anbefalinger for rutinemæssig MFRvaccination.
English: As Priorix is contraindicated in pregnant women neither interventional nor active surveillance activities have been set up.
Danish: Da Priorix er kontraindiceret hos gravide, er der hverken iværksat interventionelle aktiviteter eller aktiv overvågning.
English: Approximately 85% of pregnancies will be negatively affected when rubella infection occurs during the first trimester.
Danish: Ca. 85 % af alle graviditeter vil blive negativt påvirket ved infektion med røde hunde i første trimester.
English: The incidence rates among the cases in both these age categories were above 50 and 45 cases per 100,000 respectively.
Danish: I de to aldersgrupper var incidensen henholdsvis over 50 og over 45 tilfælde per 100 000.
English: In addition it was stated that the advice on breastfeeding should be clearer with respect to the different recommendations for vaccinating mothers with children with or without immunodeficiency.
Danish: Desuden blev det nævnt, at anvisningerne om amning skulle være tydeligere hvad angår de forskellige anbefalinger om vaccination af mødre med børn med eller uden immundefekt.
English: The purpose of this Art 30 referral is to harmonise the SmPC across EU member states for Priorix and associated names.
Danish: Formålet med denne artikel 30-indbringelse er at harmonisere produktresuméet på tværs af EU's medlemsstater for Priorix og relaterede navne.
English: Section 4.6 - Fertility, pregnancy and lactation Fertility
Danish: Punkt 4.6 - Fertilitet , graviditet og amning
English: The MAH was asked to add some information on this issue.
Danish: Indehaveren af markedsføringstilladelsen blev anmodet om at tilføje nogle oplysninger om dette spørgsmål.
English: The immunogenicity of Priorix was evaluated in several clinical trials in children aged from 12 to 24 months, 11 to 23 months and 9 to 12 months.
Danish: Immunogeniciteten af Priorix blev vurderet i flere kliniske undersøgelser hos børn i alderen 12-24 måneder, 11-23 måneder og 9-12 måneder.
English: Finally, the wording “adverse events” was replaced by “adverse reactions” in all the section as per the QRD comments.
Danish: Endelig blev betegnelsen “bivirkninger” erstattet med “uønskede reaktioner” i hele afsnittet i overensstemmelse med QRD-kommentarerne.
English: As regards HIV, there is no common European guidance on the CD4+ classification for % CD4+ or the cell count number.
Danish: For hiv er der ingen fælleseuropæisk vejledning om klassifikation af CD4+ efter % CD4+ eller celletal.
English: However, it was considered necessary to include age specific %CD4+ as per WHO guidance since vaccination of children from the age of 9 months onwards is indicated.
Danish: Det blev dog anset for nødvendigt at medtage aldersspecifik % CD4+ som foreskrevet i WHO-vejledningen, da vaccination er indiceret til børn fra 9-måneders alderen.
English: However, since new and very complex childhood vaccines are under development it was recommended to list vaccines applicable for co-administration rather than to give a general statement on co-administration with other vaccines.
Danish: Men da nye, meget komplekse børnevacciner er under udvikling, blev det anbefalet at anføre de vacciner, der kan administreres samtidigt, frem for en generel udtalelse om koadministration med andre vacciner.
English: These patients should be vaccinated with caution and preferably using subcutaneous route”.
Danish: Sådanne patienter bør vaccineres med forsigtighed og fortrinsvis ved subkutan administration”.
English: It was decided to delete the statement on pregnancy from 4.4 because according to the guideline on risk assessment of medicinal products on human reproduction and lactation: from data to labeling (EMEA/CHMP/203927/200), reference to pregnancy should only be made in section 4.3 and 4.6.
Danish: Det blev besluttet at slette erklæringen om graviditet fra punkt 4.4, fordi der ifølge ”Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labeling” (EMEA/CHMP/203927/200) kun bør henvises til graviditet i punkt 4.3 og 4.6.
English: For this reason and to reflect the most recent information, the immunogenicity data were differentiated between two groups: “Immune response in children 12 months and older” and “Immune response in children aged 9 to 10 months”.
Danish: Af denne grund, og for at gengive de nyeste oplysninger, blev immunogenicitetsdata opdelt i to grupper: “Immunrespons hos børn over 12 måneder” og “Immunrespons hos børn fra 9 til 10 måneder”.
English: reduce a long paragraph about the use of epinephrine by a general statement about the availability of appropriate medical treatment and supervision following the administration of the vaccine.
Danish: at det lange afsnit om brugen af adrenalin indskrænkes til en generel erklæring om mulighed for passende lægelig behandling og overvågning efter administration af vaccinen,
English: The main divergences between the proposed harmonized SmPC and national product information relates to the description of post marketing reports.
Danish: De vigtigste forskelle mellem de foreslåede harmoniserede produktresuméer og den nationale produktinformation vedrører beskrivelsen af indberetninger efter markedsføring.
English: Subjects with immune deficiencies
Danish: Personer med immundefekter
English: Although women should be asked about the possibility of early pregnancy prior to vaccination, screening tests to exclude pregnancy are not required.
Danish: Kvinder bør inden vaccinationen udspørges om en eventuel tidlig graviditet, men der kræves ikke screeningstest til udelukkelse af graviditet.
English: The theoretical teratogenic risk following rubella vaccination has been estimated to be 0.5% during the first trimester and is up to 1.6%, if the vaccine is given between 1-2 weeks before and 4-6 weeks after conception.
Danish: Den teoretiske teratogene risiko efter vaccination mod røde hunde er beregnet til 0,5 % i første trimester og er op til 1,6 % hvis vaccinen gives i perioden mellem 1-2 uger før og 4-6 uger efter konceptionen.
English: The CHMP noted that recent data from an outbreak in France indicate that the highest incidence of measles infections was observed in infants below 1 year of age, followed by children between one and two years old.
Danish: CHMP konstaterede, at data fra et nyligt udbrud i Frankrig viser, at den højeste forekomst af mæslingeinfektioner fandtes hos børn under et år, efterfulgt af børn mellem et og to år.
English: In conclusion, based on the clinical data the lower age limit of the indication is endorsed, however since the immune response following a single dose of Priorix is lower in children under 12 months of age a reference to sections 4.2, 4.4 and 5.1 has been included.
Danish: Som konklusion kan den nedre aldersgrænse for indikationen godkendes på grundlag af de kliniske data, men da immunresponsen efter en enkelt dosis af Priorix er svagere hos børn under 12 måneder, er der indsat en henvisning til punkt 4.2, 4.4 og 5.1.
English: The final agreed wording is: “Women who intend to become pregnant should be advised to delay for 1 month following PRIORIX vaccination.
Danish: Den endeligt vedtagne ordlyd er: “Kvinder, der påtænker at blive gravide, bør tilrådes at vente til en måned efter vaccinationen med Priorix”.
English: As regards the intramuscular route of administration no information was provided in the updated clinical dossier, but was provided in the initial application for marketing authorisation.
Danish: For den intramuskulære indgivelsesvej var der ingen oplysninger i den opdaterede kliniske dokumentation, men derimod i den oprindelige ansøgning om markedsføringstilladelse.
English: The WHO classification of HIV-related disease in adults and children published in 2006 states the following: “Immunological criteria for diagnosing advanced HIV in a child younger than five years of age with severe HIV infection: %CD4+ <25 among those younger than 12 months %CD4+ <20 among those aged 12-35 months %CD4+ <15 among those aged 36-59 months”
Danish: WHO-klassificeringen af hiv-relateret sygdom hos voksne og børn, der blev offentliggjort i 2006, indeholder følgende ordlyd: “Immunologiske kriterier for diagnose af fremskreden hiv-infektion hos børn under fem år: %CD4+ <25 hos børn under 12 måneder %CD4+ <20 hos børn i alderen 12-35 måneder %CD4+ <15 hos børn i alderen 36-59 måneder”
English: The CHMP agreed that the sentence regarding fructose intolerance should change from “Patients with rare hereditary problems of fructose intolerance should not take this medicine.” to “Patients with rare hereditary problems of fructose intolerance should not be vaccinated with PRIORIX since it contains sorbitol”.
Danish: CHMP afgjorde, at sætningen vedrørende fruktoseintolerans bør ændres fra “Patienter med sjældne arvelige problemer med fruktoseintolerans bør ikke anvende dette lægemiddel.” til “Patienter med sjældne arvelige problemer med fruktoseintolerans bør ikke vaccineres med Priorix, da det indeholder sorbitol”.
English: The method of administration of Priorix is subcutaneous injection, although it can also be given by intramuscular injection.
Danish: Priorix indgives ved subkutan injektion, men kan dog også indgives intramuskulært.
English: The CHMP noted that there are no theoretical risks of vaccination during breastfeeding.
Danish: CHMP konstaterede, at der ikke er nogen teoretisk risiko ved vaccination i ammeperioden.
English: This was endorsed by the CHMP following review and assessment of the clinical study report that was submitted to support the coadministration of Priorix with this vaccine.
Danish: Dette blev godkendt af CHMP efter vurdering af den kliniske undersøgelsesrapport, der blev forelagt til støtte for koadministration af Priorix og denne vaccine.
English: Inadvertent vaccination of unknowingly pregnant women with PRIORIX should not be a reason for termination of pregnancy”.
Danish: Accidentel vaccination med Priorix af kvinder med ikke erkendt graviditet bør ikke være grund til afbrydelse af graviditeten”.
English: The CHMP therefore suggested adding the information from a recent systematic review that “MMR-associated thrombocytopenia is rare and generally self-limited”.
Danish: CHMP foreslog derfor at tilføje følgende information fra en nylig systematisk gennemgang: “Trombocytopeni i forbindelse med MFR er sjælden og sædvanligvis selvbegrænsende”.
English: In general, the MAH proposed a harmonised text drafted mainly using as basis the one approved in the MRP procedure with some amendments.
Danish: Generelt foreslog indehaveren af markedsføringstilladelsen en harmoniseret tekst, der hovedsagelig var baseret på den, der var godkendt ved den gensidige anerkendelsesprocedure, med visse ændringer.
English: There is currently no information to conclude that there is a teratogenic risk following vaccination with MMR vaccines however the theoretical concern remains.
Danish: På nuværende tidspunkt findes der ingen oplysninger, hvoraf det kan sluttes, at der er teratogen risiko efter vaccination med MFR-vacciner, men den teoretiske betænkelighed er fortsat tilstede.
English: The final agreed wording is: “Transmission of measles and mumps virus from vaccinees to susceptible contacts has never been documented.
Danish: Den endeligt vedtagne ordlyd er: “Overførsel af mæslinge- og fåresygevirus fra den vaccinerede til modtagelige kontakter er aldrig dokumenteret.
English: Priorix is contraindicated in pregnant women.
Danish: Priorix er kontraindiceret ved graviditet.
English: The CHMP noted that the current clinical experience with Priorix is limited to children and no trials were performed in adolescents and adults.
Danish: CHMP konstaterede, at de nuværende kliniske erfaringer med Priorix begrænser sig til børn, og at der ikke er udført undersøgelser hos unge og voksne.
English: Section 4.4 - Special warnings and precautions for use To be in line with the SmPC guideline the company proposed to:
Danish: Punkt 4.4 - Særlige advarsler og forsigtighedsregler vedrørende brugen Af hensyn til overensstemmelsen med vejledningen for produktresuméer var det virksomhedens hensigt:
English: More specifically: “For use in children between 9 to 12 months of age see sections 4.2, 4.4 and 5.1.” The MAH had also included in this section the sentence “The use of PRIORIX should be based on official recommendations.” but the CHMP agreed to move it at the beginning of section 4.2 Posology and method of administration because as per the guideline on SmPC dated September 2009 the reference to official recommendations should be made under section 4.2.
Danish: Mere specifikt: “Vedrørende anvendelse hos børn fra ni til tolv måneder: Se punkt 4.2, 4.4 og 5.1.” Indehaveren af markedsføringstilladelsen havde under samme punkt desuden indsat sætningen “Anvendelsen af Priorix bør baseres på officielle anbefalinger”, men CHMP valgte at flytte denne bemærkning til begyndelsen af punkt 4.2, Dosering og indgivelsesmåde, fordi henvisninger til officielle anbefalinger skal placeres under punkt 4.2 i henhold til vejledningen for udarbejdelse af produktresuméer dateret september 2009.
English: Because of the much higher likelihood of thrombocytopenia after natural infection, the benefits of vaccination most often exceed the risks of severe symptomatic thrombocytopenia caused by immunization.
Danish: Da sandsynligheden for trombocytopeni er langt større ved naturlig infektion, overstiger fordelene ved vaccination oftest risikoen for svær symptomatisk trombocytopeni som følge af vaccinationen.
English: The theoretical maximum risk for CRS after administration of the vaccine at 1.6%, is much lower than the risk of major non-CRS induced congenital defects during pregnancy (Bozzo et al., 2011).
Danish: Den teoretiske maksimale risiko for kongenit rubellasyndrom (CRS) efter administration af vaccinen er 1,6 % og dermed langt lavere end risikoen for alvorlige, ikke-CRS-forårsagede medfødte defekter under graviditeten (Bozzo et al., 2011).
English: Mumps vaccine efficacy has also been suggested to be lower in high-transmission settings (Brockhoff 2004).
Danish: Vaccine mod fåresyge er desuden blevet antaget at være mindre effektiv under omstændigheder med høj sygdomsoverførsel (Brockhoff 2004).
English: The risk for measles vaccination (enhancement of spontaneous abortion of stillbirth) is indicated to be unknown.
Danish: Risikoen ved mæslingevaccination (øget forekomst af spontanabort og dødfødsel) angives at være ukendt.
English: Women of Childbearing Potential
Danish: Fødedygtige kvinder
English: The CHMP recommended reordering of some of the statements and adding subtitles to clearly distinguish each precaution (i.e. thrombocytopenia, immunocompromised patients, and transmission).
Danish: The CHMP anbefalede omordning af visse af erklæringerne og tilføjelse af underoverskrifter for at få en klar opdeling mellem de enkelte forsigtighedsregler (dvs. trombocytopeni, immunkompromitterede patienter og overførsel af sygdom).
English: Finally, the CHMP asked the seroconversion rates given to be replaced by more recent data reported for the Human Serum Albumin-free (HSA-free) formulation of Priorix and also asked the MAH if there are any immunogenicity data available from the Human Serum Albumin-free (HSAfree) formulation in children below 12 months of age.
Danish: Endelig anmodede CHMP om, at de forelagte serokonverteringsprocenter blev erstattet af nyere data for den HSA-fri (humant serumalbumin) formulering af Priorix, og udvalget ønskede oplyst, om der fandtes immunogenicitetsdata for den HSA-fri formulering hos børn under 12 måneder.