FrancophonIA/ELRC3.0 huggingface dataset:
English: More recently Priorix has been coadministered with Haemophilus influenzae type b (Hib) and meningococcal C conjugate vaccines as well as with concomitant co-administration with hepatitis A inactivated vaccine and pneumoccocal 7-valent conjugate vaccine.
Danish: I den senere tid er Priorix blevet administreret sammen med Haemophilus influenzae type b- (Hib) og meningokok Ckonjugatvaccine og med inaktiveret hepatitis A-vaccine og 7-valent pneumokok-konjugatvaccine.
English: Vaccination of breastfeeding women with measles, mumps or rubella vaccines has not been related with any safety problem for the women or their infants, although there is limited experience with Priorix during breastfeeding.
Danish: Vaccination af ammende kvinder mod mæslinger, fåresyge eller røde hunde er ikke blevet sat i forbindelse med sikkerhedsproblemer for kvinderne eller deres børn; erfaringerne med anvendelse af Priorix i ammeperioden er imidlertid begrænsede.
English: The CHMP also noted that the contraindication for immune-depressed humans might need a general rewording in all MMR vaccines following the progress of science and the important knowledge of the immunology.
Danish: CHMP bemærkede desuden, at det kan være nødvendigt at omformulere kontraindikationen for immunkompromitterede personer for alle MFR-vacciner i takt med den videnskabelige udvikling og den immunologiske viden.
English: The MAH proposed to use a general sentence and not to list the different vaccines.
Danish: Indehaveren af markedsføringstilladelsen foreslog en generel omtale i stedet for angivelse af de forskellige vacciner.
English: The CHMP agreed that the list of adverse reactions reported from clinical trials and post marketing experience was appropriately reflected in the proposed harmonized SmPC.
Danish: CHMP fandt, at bivirkningerne fra kliniske undersøgelser og eftermarkedserfaringer var fyldestgørende opført i det foreslåede harmoniserede produktresumé.
English: Also for clarity, the CHMP agreed to replace the company's proposal “In such cases, the risk-benefit of immunising with Priorix should be carefully evaluated” by “Patients with existing thrombocytopenia or a history of thrombocytopenia after measles, mumps or rubella vaccination should be immunized with caution”
Danish: Ligeledes af hensyn til klarheden valgte CHMP at erstatte virksomhedens forslag “I sådanne tilfælde bør benefit/risk-forholdet for vaccination med Priorix vurderes nøje” med “Der bør udvises forsigtighed ved vaccination af patienter med eksisterende trombocytopeni eller anamnese med trombocytopeni efter vaccination mod mæslinger, fåresyge eller røde hunde”.
English: In HIV infected children with no evidence of immunosuppression measles vaccine has been safe and the risk of vaccine induced virus disease is very low.
Danish: Sikkerheden af mæslingevaccine er dokumenteret hos hiv-smittede børn uden tegn på immunosuppression, og risikoen for vaccineinduceret virussygdom er meget lav.
English: The MAH stated that there is insufficient experience in the use of Priorix in breastfeeding women and that vaccination of breastfeeding women can be considered if the benefit of vaccination outweighs the risk.
Danish: Indehaveren af markedsføringstilladelsen nævnte, at der ikke er tilstrækkelige erfaringer med brug af Priorix hos ammende kvinder, og at vaccination af ammende kvinder kan overvejes, hvis fordelen ved vaccination overstiger risikoen.
English: The summary of product characteristics (SmPC) adopted in the member states in the MRP and the member states in the national procedures are slightly different.
Danish: Det produktresumé (SmPC), der anvendes i de medlemsstater, der har fulgt den gensidige anerkendelsesprocedure, afviger en smule fra det, der anvendes i de medlemsstater, der har været omfattet af de nationale procedurer.
English: Priorix is a combined freeze-dried measles (M), mumps (M), and rubella (R) vaccine (live) preparation.
Danish: Priorix er en kombineret, frysetørret, levende vaccine mod mæslinger (M), fåresyge (F), og røde hunde (R).
English: Section 4.2 - Posology and method of administration For all countries, the dose of reconstituted Priorix vaccine is 0.5 ml.
Danish: Dosis af den rekonstituerede Priorix vaccine er 0,5 ml i alle lande.
English: The MAH performed all the above changes but in order to be consistent with the SmPCs of all GSK vaccines the MAH asked to continue presenting adverse reactions as a list keeping a separation between the adverse reactions reported in clinical trials and the adverse reaction reported in postmarketing.
Danish: Indehaveren af markedsføringstilladelsen foretog alle ovennævnte ændringer, men anmodede om at angive uønskede reaktioner som en liste med opdeling mellem uønskede reaktioner fra kliniske undersøgelser og uønskede reaktioner indberettet efter markedsføring.
English: In order to comply with the SmPC guideline the MAH proposed a list of the adverse reactions in line with the MedDRA system organ classification.
Danish: For at efterkomme vejledningen for produktresuméer fremlagde indehaveren af markedsføringstilladelsen en liste over bivirkninger i overensstemmelse med MedDRA-systemorganklassifikationen.
English: The MAH replaced the seroconversion rates and stated data from children below 12 months of age are yet to come as a study is currently being conducted.
Danish: Indehaveren af markedsføringstilladelsen erstattede oplysningerne om serokonverteringsandele og oplyste, at data for børn under 12 måneder vil foreligge på et senere tidspunkt, idet en undersøgelse er i gang.
English: Though available data in the literature highlight a valuable perspective with regard to the overall risk of vaccine exposure at various stages of pregnancy, the theoretical risk, and because it is impossible to prove that the risk is zero, the MAH proposed that known pregnancy remains a contraindication to administration of rubella-containing vaccine.
Danish: De foreliggende litteraturdata giver en værdifuld tilgang til vurdering af den totale risiko ved eksponering for vaccine i forskellige graviditetsstadier, men på grund af den teoretiske risiko og umuligheden af at bevise, at risikoen er 0, ville indehaveren af markedsføringstilladelsen fortsat lade graviditet være kontraindikation for vaccination mod røde hunde.
English: Studies have shown that breast-feeding postpartum women vaccinated with live attenuated rubella vaccines may secrete the virus in breast milk and transmit it to breast-fed infants without evidence of any symptomatic disease.
Danish: Undersøgelser har vist, at kvinder, der i ammeperioden vaccineres med levende svækket vaccine mod røde hunde, kan udskille virusset i mælken og overføre det til brystbarnet uden tegn på symptomatisk sygdom.
English: Of the notified cases in 2010, almost 30% were hospitalized and a higher severity of the disease was observed in infants under one year of age and adults above 20 years, with respective proportions of hospitalised cases of 38% and 46%.Vaccination of children from 9 months onwards is therefore one tool to contain such outbreaks.
Danish: Af de anmeldte tilfælde i 2010 blev næsten 30 % indlagt, og sygdommens sværhedsgrad var større hos børn under 1 år og voksne over 20 år, hos hvem andelen af indlæggelser var henholdsvis 38 % og 46 %.
English: The CHMP also noted that there are some published data at present that could justify the lifting of the absolute contraindication for pregnant women from MMR vaccines as it is believed that although the vaccination of pregnant women is not recommended, in some individual cases the benefit of vaccination of a pregnant woman might outweigh the risk.
Danish: Desuden bemærkede CHMP, at det ifølge visse publicerede oplysninger kan være berettiget at ophæve den absolutte kontraindikation af MFR-vacciner hos gravide, da fordelen ved vaccination af en gravid kvinde i nogle tilfælde kan tænkes at overstige risikoen, uanset at vaccination af gravide frarådes.
English: The CHMP noted that since vaccination of measles, mumps rubella vaccine is generally contraindicated in pregnant women only limited data of spontaneous abortion, malformations and congenital rubella syndrome in the offspring following vaccination with Priorix are available.
Danish: CHMP konstaterede, at vaccination for mæslinger, fåresyge og røde hunde generelt er kontraindiceret hos gravide, hvorfor der kun findes begrænsede data om spontanaborter og misdannelser og kongenit rubellasyndrom hos afkommet efter vaccination med Priorix.
English: Because of this theoretical teratogenic risk, the WHO recommended in 2011 that rubella vaccination of pregnant women should be avoided in principle, and women who intend to become pregnant should be advised to delay for 1 month following rubella vaccination.
Danish: På grund af denne teoretiske teratogene risiko anbefalede WHO i 2011, at vaccination mod røde hunde i princippet bør undgås hos gravide, og at kvinder, der planlægger graviditet, bør tilrådes at udsætte dette i en måned efter vaccination mod røde hunde.
English: Review of pharmacovigiliance and published data does not indicate a risk of CRS in inadvertently vaccinated women, who are pregnant or conceived shortly after vaccination with Priorix.
Danish: En gennemgang af lægemiddelovervågningsdata og publicerede data tyder ikke på risiko for kongenit rubellasyndrom hos accidentelt vaccinerede kvinder, som er gravide ved vaccination med Priorix eller bliver gravide kort derefter.
English: Only if the child is confirmed or suspected to be immunodeficient, risks and benefits of vaccinating its lactating mother should be outweighed.
Danish: Kun i tilfælde af en formodet eller manifest immundefekt hos barnet bør der foretages en afvejning af risici og fordele ved vaccination af dets ammende moder.
English: Although there are only limited data, it was noted that intramuscular administration is standard practice in many Member States.
Danish: Udvalget konstaterede, at intramuskulær indgift er standardpraksis i mange medlemsstater trods de begrænsede data herom.
English: However foetal damage has not been documented when measles, mumps and rubella vaccines have been given to women who were unknowingly in early stages of pregnancy”.
Danish: Der er imidlertid ikke påvist fosterskader ved anvendelse af vaccine mod mæslinger, fåresyge og røde hunde i begyndelsen af en ikke erkendt graviditet”.
English: The CHMP noted that because of this theoretical teratogenic risk, the WHO recommended in 2011 that rubella vaccination of pregnant women should be avoided in principle, and women who intend to become pregnant should be advised to delay for 1 month following rubella vaccination.
Danish: CHMP bemærkede, at denne teoretiske teratogene risiko var årsag til, at WHO i 2011 anbefalede, at vaccination af gravide mod røde hunde i princippet bør undgås, og at kvinder, der planlægger graviditet, bør tilrådes at udsætte dette i en måned efter vaccination mod røde hunde.
English: The MAH also proposed to add a specific sub-section on the paediatric population as per the SmPC guideline.
Danish: Indehaveren af markedsføringstilladelsen ville indsætte et særligt underafsnit om den pædiatriske population i overensstemmelse med vejledningen for produktresuméer.
English: Mumps and rubella vaccine viruses have not been recognized to cause serious complications in HIV-infected persons, but as they are unlikely to benefit and complications could occur severely immunocompromised persons should not be vaccinated.
Danish: Fåresyge- og røde hunde-vaccinevirus er ikke kendt for at forårsage alvorlige komplikationer hos hiv-smittede personer, men svært immunkompromitterede personer bør ikke vaccineres på grund af den tvivlsomme fordel ved vaccinationen og muligheden for komplikationer.
English: Section 4.5 - Interactions with other medicinal products and other forms of interaction Clinical studies demonstrated that Priorix can be administered concomitantly with live attenuated varicella vaccine, DTPa-IPV and combined hepatitis A/B vaccine (Marshall et al., 2006; Stuck et al., 2002; Usonis et al., 2005; Wellington and Goa, 2003).
Danish: Kliniske undersøgelser har vist, at Priorix kan administreres sammen med levende svækket varicellavaccine, DTPa-IPV og kombineret hepatitis A/B-vaccine (Marshall et al., 2006; Stuck et al., 2002; Usonis et al., 2005; Wellington og Goa, 2003).
English: Transmission of the rubella vaccine virus to infants via breast milk as well as transplacental transmission has been documented without any evidence of clinical disease.”
Danish: Der findes dokumenterede eksempler på, at røde hunde-vaccinevirus er blevet overført til spædbørn både transplacentalt og via modermælk uden tegn på klinisk sygdom.”
English: Whereas
Danish: Tal fra
English: The MAH slightly modified the proposed text and the final wording agreed by the CHMP is: “Cases of worsening of thrombocytopenia and cases of recurrence of thrombocytopenia in subjects who suffered thrombocytopenia after the first dose have been reported following vaccination with live measles, mumps and rubella vaccines.
Danish: Indehaveren af markedsføringstilladelsen ændrede en smule i den foreslåede tekst, og den endelige ordlyd, der blev godkendt af CHMP, er: “Der er beskrevet forværring eller recidiv af trombocytopeni hos personer, som fik trombocytopeni efter den primære vaccination med levende vaccine mod mæslinger, fåresyge og røde hunde.
English: delete wording about age of vaccination (covered in section 4.2) The Company also suggested rephrasing the paragraph about the idiopathic thrombocytopenic purpura (ITP).
Danish: Virksomheden ville desuden omformulere afsnittet om idiopatisk trombocytopenisk purpura (ITP).
English: The final agreed wording is: “Immunocompromised patients who have no contraindication for this vaccination (see section 4.3) may not respond as well as immunocompetent patients, therefore some of these patients may acquire measles, mumps or rubella in case of contact, despite appropriate vaccine administration.
Danish: Den endeligt vedtagne ordlyd er: “Immunkompromitterede patienter, for hvem denne vaccination ikke er kontraindiceret (se punkt 4.3) vil ikke nødvendigvis udvise lige så god respons som immunkompetente patienter.
English: • the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holder(s) have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Priorix and associated names (see Annex I).
Danish: • det produktresumé og den etikettering og indlægsseddel, der er foreslået af indehaveren (indehaverne) af markedsføringstilladelserne, blev vurderet på grundlag af den forelagte dokumentation og de videnskabelige drøftelser i udvalget,
English: The geometric mean titers (GMTs) for seroconverters were 2431.9 mIU/ml, 1010.0 U/ml and 67.1 IU/ml for the anti-measles, anti-mumps and anti-rubella antibodies, respectively which were slightly lower than the values reported following subcutaneous administration (2958 mIU/ml, 1400 U/ml and 73 IU/ml, respectively).
Danish: Den geometriske middeltiter (GMT) hos de serokonverterede personer var henholdsvis 2 431,9 mIE/ml, 1 010,0 E/ml og 67,1 IE/ml for antistoffer mod mæslinger, fåresyge og røde hunde.
English: Organisation (WHO) to routinely vaccinate potentially susceptible, asymptomatic HIV positive children and adults.
Danish: På grund af det alvorlige forløb af infektion med naturligt forekommende mæslinger hos patienter med fremskreden hiv-infektion anbefaler WHO rutinemæssig vaccination af potentielt modtagelige, asymptomatiske hiv-positive børn og unge.
English: However, none of the field (outbreak) studies provided by the MAH
Danish: Der fandtes imidlertid ikke specifikke data for Priorix i de feltundersøgelser (vedrørende udbrud), der var fremlagt af indehaveren af markedsføringstilladelsen.
English: Nervous System (CNS) disorders be reworded as follows “Due caution should be employed in administration of PRIORIX to individuals with Central Nervous System (CNS) disorder, susceptibility to febrile convulsions or family history of convulsions.
Danish: Da der ikke foreligger immunogenicitetsdata om indvirkningen af profylaktisk anvendelse af antipyretika, anbefaledes det, at afsnittet om anvendelse af Priorix til personer med CNS-lidelser omformuleres til: “Der bør udvises forsigtighed ved anvendelse af Priorix til personer med lidelser i centralnervesystemet, disposition for febrile kramper eller familiær anamnese med kramper.
English: Priorix is contraindicated in pregnancy but since there is currently no information to conclude that there is a teratogenic risk following vaccination with MMR vaccines the following wording was agreed: “PRIORIX is contraindicated during pregnancy (see section 4.3).
Danish: Derfor fastlagdes følgende ordlyd: “Priorix er kontraindiceret under graviditet (se punkt 4.3).
English: A number of studies documented increased risk of developing mumps with increasing time after vaccination (Vandermeulen et al., 2004; Cortese et al., 2008; Castilla et al., 2009), and data from the United Kingdom indicate vaccine effectiveness may decrease with age, which probably also reflects increasing time from vaccination (Cohen et al., 2007).
Danish: En række af undersøgelserne viste, at risikoen for fåresyge øgedes med den forløbne tid siden vaccinationen (Vandermeulen et al., 2004; Cortese et al., 2008; Castilla et al., 2009).
English: Priorix is indicated for the active immunisation against measles, mumps and rubella.
Danish: Priorix er indiceret til vaccination mod mæslinger, fåresyge og røde hunde.
English: These patients should be monitored carefully for signs of measles, parotitis and rubella.” Regarding the paragraph on transmission the proposal of the MAH was considered in principle acceptable by the CHMP with the addition that not only rubella but also measles pharyngeal excretion is known to appear.
Danish: Vedrørende afsnittet om sygdomsoverførsel anså CHMP i princippet forslaget fra indehaveren af markedsføringstilladelsen for at være acceptabelt med den tilføjelse, at ekskretion af virus fra svælget ikke kun forekommer ved røde hunde, men også ved mæslinger.
English: In patients with existing thrombocytopenia or a history of thrombocytopenia after measles, mumps or rubella vaccination the risk-benefit of administering PRIORIX should be carefully evaluated.
Danish: Benefit/riskforholdet for Priorix bør efter en vaccination mod mæslinger, fåresyge eller røde hunde vurderes nøje for patienter med eksisterende trombocytopeni eller med anamnese med trombocytopeni.
English: Treatment should start with a low dose that is gradually increased over the first 14 days of treatment.
Danish: Behandlingen bør indledes med en lav dosis, der gradvist øges i løbet af de første 14 dage af behandlingen.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Norvir on 26 August 1996.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Norvir den 26. august 1996.
English: This is a summary of the European public assessment report (EPAR) for Norvir.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Norvir.
English: The full EPAR for Norvir can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Norvir findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: For younger patients, the recommended dose depends on the body surface area (calculated using the patient's height and weight).
Danish: Til yngre patienter afhænger den anbefalede dosis af legemsoverfladen (beregnet ud fra patientens højde og vægt).
English: Other information about Norvir
Danish: Andre oplysninger om Norvir
English: The main measure of effectiveness was based on the number of patients whose disease got worse or who died.
Danish: Behandlingens virkning blev hovedsagelig bedømt på antallet af patienter, hvis sygdom blev værre, eller som døde.
English: A risk management plan has been developed to ensure that Norvir is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Norvir anvendes så sikkert som muligt.
English: The standard dose for adults is 100 or 200 mg, once or twice a day.
Danish: Den normale dosis til voksne er 100 eller 200 mg én eller to gange dagligt.
English: This means that it blocks a viral enzyme called protease, which is involved in the reproduction of HIV.
Danish: Det betyder, at det blokerer et viralt enzym kaldet protease, som medvirker ved formeringen af hiv.
English: CD4 T cells are white blood cells that are important in helping to fight infections, but which are killed by HIV.
Danish: CD4 T-celler er hvide blodlegemer, der er vigtige i bekæmpelsen af infektioner, men som dræbes af HIV.
English: It is available as an oral solution (80 mg/ml), as a powder for oral solution (100 mg sachets), as capsules (100 mg) and as tablets (100 mg).
Danish: Det fås som en oral opløsning (80 mg/ml), pulver til oral opløsning (100-mg-breve), kapsler (100 mg) og tabletter (100 mg).
English: The recommended dose for adults (aged 18 years or over) is 600 mg twice a day.
Danish: Den anbefalede dosis til voksne (18 år og derover) er 600 mg to gange dagligt.
English: For more information about treatment with Norvir, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Norvir, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Norvir.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Norvir skal anvendes.
English: Norvir is a medicine that contains the active substance ritonavir.
Danish: Norvir er et lægemiddel, der indeholder det aktive stof ritonavir.
English: What measures are being taken to ensure the safe and effective use of Norvir?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Norvir?
English: Norvir does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: Norvir helbreder ikke hivinfektion eller aids, men kan sinke den skade på immunsystemet og de infektioner og sygdomme, der er forbundet med aids.
English: In the first study of Norvir as an antiviral medicine, 16% of the Norvir-treated patients (86 out of 543) experienced a worsening of disease or died, compared with 33% of the patients taking placebo (181 out of 547).
Danish: I den første undersøgelse af Norvir som antiviralt lægemiddel oplevede 16 % af de patienter, der blev behandlet med Norvir (86 af 543), en forværring eller døde af sygdommen, sammenlignet med 33 % af de patienter, der fik placebo (181 ud af 547).
English: This causes an increase of antiviral levels in the blood of such medicines and thus it boosts their antiviral activity.
Danish: Dette medfører højere antivirale niveauer af denne type lægemidler i blodet, hvorved deres antivirale aktivitet forstærkes.
English: Norvir has been studied as an antiviral medicine in two main studies involving 1,446 patients.
Danish: Norvir er blevet undersøgt som antiviralt lægemiddel i to hovedundersøgelser, der omfattede 1 446 patienter.
English: Treatment with Norvir should be given by a doctor who has experience in the treatment of HIV infection.
Danish: Behandling med Norvir bør foretages af en læge med erfaring i behandling af hivinfektion.