FrancophonIA/ELRC3.0 huggingface dataset:
English: The efficacy of GARDASIL against HPV 6-, 11-, 16-, 18-related AIN 2/3 and HPV 16- or 18-related AIN 2/3, in the MSM substudy, was 54.2% (95% CI: 18.0, 75.3; 18/275 versus 39/276) and 57.5% (95% CI: -1.8, 83.9; 8/275 versus 19/276 cases), respectively.
Danish: Gardasils effekt imod HPV 6-, 11-, 16-, 18-relaterede AIN 2/3 og HPV 16- eller 18-relaterede AIN 2/3 i MSM-substudiet var 54,2 % (95 % CI: 18,0; 75,3; 18/275 versus 39/276) og 57,5 % (95 % CI: -1,8; 83,9; 8/275 versus 19/276 tilfælde).
English: Table 6 compares the 1 month Postdose 3 anti-HPV 6, 11, 16, and 18 GMTs in 9- to 15 year-old girls with those in 16- to 26-year old women.
Danish: Tabel 6 sammenligner anti-HPV 6, 11, 16 og 18 GMT'er 1 måned efter 3. dosis hos 9 til 15-årige piger med de tilsvarende værdier for 16 til 26-årige kvinder.
English: Efficacy against HPV 6-, 11-, 16-, 18-related VIN 2/3 was 73.3% (95% CI: 40.3, 89.4), against HPV 6-, 11-, 16-, 18-related VaIN 2/3 was 85.7% (95% CI: 37.6, 98.4), and against HPV 6-, 11-, 16-, 18-related genital warts was 80.3% (95% CI: 73.9, 85.3) in the combined protocols at end of study.
Danish: Effekt imod HPV 6-, 11-, 16-, 18-relateret VIN 2/3 var 73,3 % (95 % CI: 40,3; 89,4), imod HPV 6-, 11-, 16-, 18-relateret VaIN 2/3 var den 85,7 % (95 % CI: 37,6; 98,4) og imod HPV 6-, 11-, 16-, 18relaterede kondylomer 80,3 % (95 % CI: 73,9; 85,3) i de kombinerede protokoller ved studieafslutning.
English: Overall, 67% of individuals were naïve (PCR negative and seronegative) to all 4 HPV types at enrolment.
Danish: På rekrutteringstidspunktet var i alt 67 % af personerne naive (PCR-negative og seronegative) over for alle 4 HPV-typer.
English: Driving and using machines No studies on the effects on the ability to drive and use machines have been performed.
Danish: Trafik- og arbejdssikkerhed Der er ikke undersøgt om Gardasil påvirker evnen til at køre bil og bruge maskiner.
English: In the long-term extension study of Protocol 019, 685 women 24-45 years old during vaccination with Gardasil in the base study were followed.
Danish: I langtidsopfølgningsstudiet af protokol 019 blev 685 kvinder i alderen 24-45 år fulgt gennem Gardasil-vaccinationsprogrammet i basisstudiet.
English: At end of study analysis for anal lesions in the MSM population (median duration of follow-up was 2.15 years), the preventive effect against HPV 6-, 11-, 16-, 18-related AIN 2/3 was 74.9% (95 % CI: 8.8, 95.4; 3/194 versus 13/208) and against HPV 16- or 18-related AIN 2/3 86.6% (95 % CI: 0.0, 99.7; 1/194 versus 8/208).
Danish: Ved studieafslutning viste analysen for anallæsioner i MSM-populationen (median opfølgningstid var 2,15 år) en forebyggende effekt imod HPV 6-, 11-, 16-, 18-relateret AIN 2/3 74,9 % (95 % CI 8,8; 95,4; 3/194 versus 13/208) og imod HPV 16 - eller 18-relateret AIN 2/3 86,6 % (95 % CI 0,0; 99,7; 1/194 versus 8/208).
English: Very common Headache Not known Acute disseminated encephalomyelitis*, Dizziness
Danish: Ikke kendt Akut dissemineret encefalomyelitis*, Svimmelhed
English: Among women with an abnormal Pap test at Day 1 who were already infected with the relevant vaccine HPV types at Day 1, no vaccine efficacy was observed.
Danish: Der blev ikke set nogen vaccineeffekt hos kvinder, som havde en abnorm Pap-test ved dag 1, og som allerede var inficeret med de relevante vaccine-HPV-typer ved dag 1.
English: This leaflet was last revised in: {MM/YYYY}.
Danish: Denne indlægsseddel blev senest ændret: MM/ÅÅÅÅ.
English: Sodium chloride, L-histidine, polysorbate 80, sodium borate and water for injections.
Danish: Natriumklorid, L-histidin, polysorbat 80, natriumborat og vand til injektionsvæsker.
English: Do not use this vaccine after the expiry date which is stated on the vial label and the outer carton (after EXP).
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på mærkaten på sprøjten og på pakningen (efter Exp) Udløbsdatoen er den sidste dag i den nævnte måned.
English: The efficacy of GARDASIL against HPV 6-, 11-, 16-, 18-related external genital warts was 68.1% (95% CI: 48.8, 79.3).
Danish: Gardasils effekt imod HPV 6-, 11-, 16-, 18-relaterede kondylomer var 68,1 % (95 % CI: 48,8; 79,3).
English: • the efficacy of Gardasil against HPV 6-, 11-, 16-, 18-related CIN (1, 2, 3) or AIS was 96.0%
Danish: • effekten af Gardasil imod HPV 6-, 11-, 16-, 18-relateret CIN (1, 2, 3) eller AIS 96,0 % (95 %
English: Girls and boys vaccinated with Gardasil at 9-15 years of age in Protocol 018 base study were followed up in an extension study.
Danish: Piger og drenge vaccineret med Gardasil i 9-15-års-alderen i protokol 018-basisstudiet blev fulgt i et udvidet studie.
English: In breast-feeding mothers given Gardasil or placebo during the vaccination period of the clinical trials the rates of adverse reactions in the mother and the breast-fed infant were comparable between the vaccination and the placebo groups.
Danish: Andelen af bivirkninger/uønskede hændelser hos moderen og det ammede barn var sammenlignelige for vaccinegruppen og placebogruppen.
English: Gardasil can be administered according to a 2-dose schedule: - First injection: at chosen date - Second injection: 6 months after first injection If the second vaccine dose is administered earlier than 6 months after the first dose, a third dose should always be administered.
Danish: Hvis du er fra 9 år til og med 13 år gammel Gardasil kan gives som et program med 2 doser: Første injektion: på den valgte dato Anden injektion: 6 måneder efter første injektion Hvis den anden vaccinedosis bliver givet tidligere end 6 måneder efter den første dosis, bør der altid gives en tredje dosis.
English: Women vaccinated with Gardasil at 24-45 years of age in Protocol 019 base study were followed up in an extension study.
Danish: Kvinder vaccineret med Gardasil i 24-45-års-alderen i protokol 019-basisstudiet blev fulgt i et udvidet studie.
English: Alternatively, Gardasil can be administered according to a 3-dose schedule: - First injection: at chosen date - Second injection: 2 months after first injection - Third injection: 6 months after first injection The second dose should be administered at least one month after the first dose and the third dose should be administered at least 3 months after the second dose.
Danish: Alternativt kan Gardasil gives efter et program med 3 doser: - Første injektion: på den valgte dato Anden injektion: 2 måneder efter første injektion Tredje injektion: 6 måneder efter første injektion
English: Fourteen years after vaccination, 91%, 91%, 98% and 52% were anti-HPV 6, antiHPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the cLIA, respectively, and 98%, 98%, 100% and 94% were anti-HPV 6, anti-HPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the IgG LIA, respectively.
Danish: 14 år efter vaccination var henholdsvis 91%, 91%, 98% og 52% anti-HPV 6-, anti-HPV 11-, anti-HPV 16- og anti-HPV 18-seropositive ved cLIA, og henholdsvis 98%, 98%, 100% og 94% var anti-HPV 6-, anti-HPV 11-, anti-HPV 16- og anti-HPV 18-seropositive ved IgG LIA.
English: Table 6: Immunogenicity bridging between 9- to 15-year-old girls and 16- to 26-year-old women (perprotocol population) based on titres as measured by cLIA 9- to 15-Year-Old Girls (Protocols 016 and 018)
Danish: Tabel 6: Immunogenicitetssammenligning mellem 9- til 15-årige piger og 16- til 26-årige kvinder (per-protokol-population) baseret på titre målt med cLIA
English: In the modified ITT population, the benefit of the vaccine with respect to the overall incidence of CIN 2/3 or AIS (caused by any HPV type) and of genital warts was much lower, with a reduction of 18.4% (95% CI: 7.0, 28.4) and 62.5% (95% CI: 54.0, 69.5), respectively, as Gardasil does not impact the course of infections or disease that are present at vaccination onset.
Danish: Eftersom Gardasil ikke påvirker forløbet af infektioner eller sygdom, som er til stede ved vaccinationens påbegyndelse, var fordelen ved vaccinen for så vidt angår den overordnede forekomst af CIN 2/3 eller AIS (forårsaget af enhver HPV-type) og af kondylomer meget lavere i den modificerede ITT-population med en reduktion på henholdsvis 18,4 % (95 % CI: 7,0; 28,4) og 62,5 % (95 % CI: 54,0; 69,5).
English: Ten years after vaccination, 79%, 85%, 94%, and 36% were anti-HPV 6, antiHPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the cLIA, respectively, and 86%, 79%, 100% and 83% were anti-HPV 6, anti-HPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the IgG LIA, respectively.
Danish: 10 år efter vaccination var henholdsvis 79%, 85%, 94% og 36% anti-HPV 6-, anti-HPV 11-, anti-HPV 16- og anti-HPV 18-seropositive ved cLIA, og henholdsvis 86%, 79%, 100% og 83% var anti-HPV 6-, anti-HPV 11-, anti-HPV 16- og anti-HPV 18-seropositive ved IgG LIA.
English: cases cases
Danish: tilfælde tilfælde
English: In the long-term extension study of Protocol 020, 917 men 16-26 years old during vaccination with Gardasil in the base study were followed.
Danish: I det udvidede langtidsstudie af Protokol 020 blev 917 mænd i alderen 16-26 år fulgt gennem Gardasilvaccinationsprogrammet i basisstudiet.
English: B. PACKAGE LEAFLET (VIAL)
Danish: B. INDLÆGSSEDDEL (HÆTTEGLAS)
English: Gardasil suspension for injection IM use.
Danish: Gardasil injektionsvæske, suspension Intramuskulær brug.
English: Men vaccinated with Gardasil at 16-26 years of age in Protocol 020 base study were followed up in an extension study.
Danish: Mænd vaccineret med Gardasil i 16-26-års-alderen i protokol 020-basisstudiet blev fulgt i et udvidet studie.
English: In the PPE population no cases of HPV diseases (HPV types 6/11/16/18 related high grade CIN) were observed up to approximately 14 years (median followup of 11.9 years).
Danish: I PPE-populationen blev der ikke set tilfælde af HPVsygdom (HPV-typer 6/11/16/18-relateret high-grade CIN) i op til ca. 14 år (median opfølgning på 11,9 år).
English: In the long-term extension study of Protocol 018, 369 girls 9-15 years old during vaccination with Gardasil in the base study were followed.
Danish: I langtidsopfølgningsstudiet af protokol 018 blev 369 piger i alderen 9-15 år fulgt gennem Gardasilvaccinationsprogrammet i basisstudiet.
English: In the clinical study in women 24 to 45 years, 98.4%, 98.1%, 98.8%, and 97.4% of individuals who received Gardasil became anti-HPV 6, anti-HPV 11, antiHPV 16, and anti-HPV 18 seropositive, respectively, by 1 month Postdose 3.
Danish: I det kliniske studie af kvinder mellem 24 og 45 år, blev 98,4 %, 98,1 %, 98,8 % og 97,4 % af de kvinder, der fik Gardasil, henholdsvis anti-HPV 6, anti-HPV 11, antiHPV 16 og anti-HPV 18 seropositive én måned efter 3. dosis.
English: In the PPE population, no cases of HPV diseases (HPV types 6/11/16/18 related External Genital Lesions) were observed through 10.6 years (median followup of 9.9 years).
Danish: I PPE-populationen blev der ikke set tilfælde af HPV-sygdom (HPV-typer 6/11/16/18-relateret eksterne genitale læsioner) gennem 10,6 år (median opfølgning på 9,9 år).
English: Gardasil, suspension for injection :
Danish: Gardasil, injektionsvæske, suspension:
English: HPV 16/18related CIN 2/3 or AIS HPV 16/18related CIN 3
Danish: HPV 16/18-relateret CIN 2/3 eller AIS
English: Gardasil, suspension for injection.
Danish: Gardasil, injektionsvæske, suspension.
English: In the Full Analysis Set (FAS) population, the benefit of the vaccine with respect to the overall incidence of EGL was lower, with a reduction of 59.3% (95% CI: 40.0, 72.9), as Gardasil does not impact the course of infections or disease that are present at vaccination onset.
Danish: Eftersom Gardasil ikke påvirker forløbet af infektioner eller sygdom, som er til stede ved vaccinationens påbegyndelse, var fordelen ved vaccinen for så vidt angår den overordnede forekomst af EGL lavere i fuldt analysesæt (full analysis set FAS)-populationen med en reduktion på 59,3 % (95 % CI: 40,0; 72,9).
English: In the long-term extension study of Protocol 018, 326 boys 9-15 years old during vaccination with Gardasil in the base study were followed.
Danish: I langtidsopfølgningsstudiet af protokol 018 blev 326 drenge i alderen 9-15 år fulgt gennem Gardasilvaccinationsprogrammet i basisstudiet.
English: Women vaccinated with Gardasil at 16-23 years of age in Protocol 015 base were followed up in an extension study.
Danish: Kvinder vaccineret med Gardasil i 16-23-års-alderen i protokol 015-basisstudiet blev fulgt i et udvidet studie.
English: In the clinical studies in women 16 to 26 years of age, 99.8%, 99.8%, 99.8%, and 99.5% of individuals who received Gardasil became anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18-seropositive, respectively, by 1 month Postdose 3.
Danish: I de kliniske studier af kvinder mellem 16 og 26 år blev i alt 99,8 %, 99,8 %, 99,8 % og 99,5 % af de kvinder, der fik Gardasil, henholdsvis anti-HPV 6, anti-HPV 11, anti-HPV 16 og anti-HPV-18 seropositive én måned efter 3. dosis.
English: 1 dose vial, 0.5 ml.
Danish: 1 dosis hætteglas på 0,5 ml.
English: In the clinical study in men 16 to 26 years, 98.9%, 99.2%, 98.8%, and 97.4% of individuals who received Gardasil became anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18 seropositive, respectively, by 1 month Postdose 3.
Danish: I det kliniske studie af mænd mellem 16 til 26 år blev i alt 98,9 %, 99,2 %, 98,8 % og 97,4 % af de personer, der fik Gardasil, anti-HPV 6-, anti-HPV 11-, anti-HPV 16- og anti-HPV 18-seropositive én måned efter 3. dosis.
English: In the PPE population, no cases of HPV diseases (HPV types 6/11/16/18 related CIN any grade and Genital Warts) were observed through 10.7 years (median follow-up of 10.0 years).
Danish: I PPE-populationen, blev der ikke set tilfælde af HPV-sygdom (HPV-typer 6/11/16/18-relateret CIN alle grader og kondylomer) gennem 10,7 år (median opfølgning på 10,0 år).
English: In the PPE population, no cases of HPV diseases (HPV types 6/11/16/18 related CIN any grade and Genital Warts) were observed through 10.1 years (median follow-up of 8.7 years).
Danish: I PPE-populationen blev der ikke set tilfælde af HPVsygdom (HPV-typer 6/11/16/18-relateret CIN alle grader og kondylomer) gennem 10,1 år (median opfølgning på 8,7 år).
English: In clinical trials, oral or other contraceptives (e.g. the pill) did not reduce the protection obtained by Gardasil.
Danish: I kliniske studier blev den beskyttelse, som opnåedes med Gardasil, ikke nedsat af præventionsmidler i tabletform (f.eks. p-piller) eller andre svangerskabsforebyggende midler.
English: 20 single dose vials, 0.5 ml each.
Danish: 20 enkeltdoser hætteglas på 0,5 ml.
English: Gardasil, suspension for injection in a pre-filled syringe.
Danish: Gardasil, injektionsvæske, suspension i fyldt injektionssprøjte.
English: The efficacy of Gardasil against the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection, genital warts, vulvar and vaginal lesions, CIN of any grade, AIS, and cervical cancers was 88.7% (95% CI: 78.1, 94.8).
Danish: Effekten af Gardasil imod den kombinerede forekomst af HPV 6-, 11-, 16- og 18-relateret persisterende infektion, kondylomer, vulva- og vaginallæsioner, alle grader af CIN, AIS og cervixcancer var 88,7 % (95 % CI: 78,1; 94,8).
English: • the efficacy of Gardasil against HPV 6-, 11-, 16-, 18-related genital warts was 99.0% (95% CI:
Danish: • effekten af Gardasil imod HPV 6-, 11-, 16-, 18-relaterede kondylomer 99,0 % (95 % CI: 96,2;
English: The efficacy of Gardasil against the combined incidence of HPV 16- or 18-related persistent infection, genital warts, vulvar and vaginal lesions, CIN of any grade, AIS, and cervical cancers was 41.6% (95% CI: 24.3, 55.2).
Danish: Effekten af Gardasil imod den kombinerede forekomst af HPV 16- eller 18-relateret persisterende infektion, kondylomer, vulva- og vaginallæsioner, alle grader af CIN, AIS og cervixcancere var 41,6 % (95 % CI: 24,3; 55,2).
English: In a subset of 598 men (GARDASIL = 299; placebo = 299) in Protocol 020 who self-identified as having sex with men (MSM) efficacy against anal intraepithelial neoplasia (AIN grades 1/2/3) and anal cancer, and intra-anal persistent infection was evaluated.
Danish: Effekten imod anal intraepitelial neoplasi (AIN grad 1/2/3) og analcancer samt intraanal persisterende infektion blev vurderet i en undergruppe på 598 mænd (GARDASIL = 299; placebo = 299) i Protokol
English: Ten years after vaccination, 79%, 80%, 95% and 40% were anti-HPV 6, antiHPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the cLIA, respectively, and 92%, 92%, 100%
Danish: 10 år efter vaccination var henholdsvis 79%, 80%, 95%, og 40% anti-HPV 6-, anti-HPV 11-, anti-HPV 16- og anti-HPV 18-seropositive ved cLIA, og henholdsvis 92%, 92%, 100% og 92% var anti-HPV 6-, anti-HPV 11-, anti-HPV 16- og anti-HPV 18-seropositive ved IgG LIA.
English: Gardasil suspension for injection Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
Danish: Gardasil suspension til injektion Human papillomavirusvaccine [type 6, 11, 16, 18] (rekombinant, adsorberet)
English: Gardasil, suspension for injection in a pre-filled syringe :
Danish: Gardasil, injektionsvæske, suspension i fyldt injektionssprøjte:
English: The efficacy of Gardasil against the combined incidence of HPV 16- or 18-related persistent infection, genital warts, vulvar and vaginal lesions, CIN of any grade, AIS, and cervical cancers was 84.7% (95% CI: 67.5, 93.7).
Danish: Effekten af Gardasil imod den kombinerede forekomst af HPV 16- eller 18-relateret persisterende infektion, kondylomer, vulva- og vaginallæsioner, alle grader af CIN, AIS og cervixcancer var 84,7 % (95 % CI: 67,5, 93,7).
English: Gardasil, suspension for injection - pre-filled syringe without needle, pack of 1, 10, 20
Danish: Gardasil, injektionsvæske, suspension- fyldt sprøjte uden kanyle, pakning med 1, 10, 20
English: The efficacy of Gardasil against the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection, genital warts, vulvar and vaginal lesions, CIN of any grade, AIS, and cervical cancers was 47.2% (95% CI: 33.5, 58.2).
Danish: Effekten af Gardasil imod den kombinerede forekomst af HPV 6-, 11-, 16- og 18-relateret persisterende infektion, kondylomer, vulva- og vaginallæsioner og alle grader af CIN, AIS og cervixcancere var 47,2 % (95 % CI: 33,5; 58,2).
English: Gardasil, suspension for injection - pre-filled syringe with 2 needles, pack of 1, 10, 20
Danish: Gardasil, injetionsvæske, suspension- fyldt sprøjte med to kanyler, pakning med 1, 10, 20
English: Not known Injection-site cellulitis *
Danish: Ikke kendt Cellulitis på injektionsstedet
English: 10 single dose vials, 0.5 ml each.
Danish: 10 enkeltdoser hætteglas på 0,5 ml.
English: At end of study and in the combined protocols, • the efficacy of Gardasil against HPV 6-, 11-, 16-, 18-related CIN 1 was 95.9 % (95% CI: 91.4,
Danish: • effekten af Gardasil imod HPV 6-, 11-, 16-, 18-relateret CIN 1 95,9 % (95 % CI: 91,4; 98,4),
English: Composite Endpoint
Danish: Mave-tarm-kanalen
English: Merck Sharp & Dohme BV Waarderweg 39
Danish: Merck Sharp & Dohme B.V.
English: EU/1/06/357/007 - pack of 1 EU/1/06/357/008 - pack of 10 EU/1/06/357/021 - pack of 20
Danish: EU/1/06/357/007 - pakning med 1 stk. EU/1/06/357/008 - pakning med 10 stk. EU/1/06/357/021 - pakning med 20 stk.
English: Musculoskeletal and Connective Tissue Disorders
Danish: Knogler, led, muskler og bindevæv
English: Gardasil, suspension for injection - pre-filled syringe with 1 needle, pack of 1, 10, 20
Danish: Gardasil, injektionsvæske, suspension- fyldt sprøjte med én kanyle, pakning med 1, 10, 20
English: EU/1/06/357/003 - pack of 1 EU/1/06/357/004 - pack of 10 EU/1/06/357/019 - pack of 20
Danish: EU/1/06/357/003 - pakning med 1 stk. EU/1/06/357/004 - pakning med 10 stk. EU/1/06/357/019 - pakning med 20 stk.
English: Gardasil, suspension for injection Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
Danish: Gardasil, injektionsvæske, suspension Human papillomavirusvaccine [type 6, 11, 16, 18] (rekombinant, adsorberet)
English: EU/1/06/357/005 - pack of 1 EU/1/06/357/006 - pack of 10 EU/1/06/357/020 - pack of 20
Danish: EU/1/06/357/005 - pakning med 1 stk. EU/1/06/357/006 - pakning med 10 stk. EU/1/06/357/020 - pakning med 20 stk.
English: EU/1/06/357/001 - pack of 1 EU/1/06/357/002- pack of 10 EU/1/06/357/018- pack of 20
Danish: EU/1/06/357/001 - pakning med 1 stk. EU/1/06/357/002 - pakning med 10 stk. EU/1/06/357/018 - pakning med 20 stk.
English: - If you have any further questions, please ask your doctor or pharmacist.
Danish: Spørg lægen eller apotekspersonalet, hvis der er mere du vil vide.
English: Gardasil, suspension for injection - single dose vial, pack of 1, 10, 20
Danish: Gardasil, injektionsvæske, suspension - hætteglas med én dosis, pakning med 1, 10, 20 stk.
English: Gardasil, suspension for injection in a pre-filled syringe Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
Danish: Gardasil, injektionsvæske, suspension i fyldt sprøjte Human papillomavirusvaccine [type 6, 11, 16, 18] (rekombinant, adsorberet)
English: The efficacy of Gardasil in 16- through 26 year-old women was assessed in 4 placebo-controlled, double-blind, randomised Phase II and III clinical studies including a total of 20,541 women, who were enrolled and vaccinated without pre-screening for the presence of HPV infection.
Danish: Gardasils effekt hos kvinder i alderen fra 16 til 26 år blev vurderet i 4 placebo-kontrollerede, dobbeltblindede, randomiserede kliniske fase II og III studier.
English: Gardasil suspension for injection in a pre-filled syringe Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
Danish: Gardasil injektionsvæske, suspension i fyldt sprøjte Human papillomavirusvaccine [type 6, 11, 16, 18] (rekombinant, adsorberet)
English: Posology
Danish: Hyppighed
English: Gardasil suspension for injection in a pre-filled syringe
Danish: Gardasil injektionsvæske, suspension i fyldt sprøjte i.m.
English: - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Danish: Kontakt lægen eller apotekspersonalet, hvis en bivirkning bliver værre, eller du eller dit barn får bivirkninger, som ikke er nævnt her.
English: Qualitative and quantitative composition
Danish: Kvalitativ og kvantitativ sammensætning
English: The reasoning being that:
Danish: Rationalet er som følger:
English: Meat and offal: 107 days.
Danish: Kød og indmad: 107 dage.
English: Finally, consideration has been given to the analytical methods that were used.
Danish: Endelig er der taget hensyn til de anvendte analysemetoder.
English: Information was received regarding the composition of the affected products (n = 5).
Danish: Der blev fremlagt oplysninger om sammensætningen af de omhandlede produkter (n = 5).
English: The last product is formulated with a large percentage of glycerol formal.
Danish: Det sidste produkt er formuleret med en stor andel glycerolformal.
English: The differences between the two residues studies have been considered.
Danish: Der er taget hensyn til forskellene mellem de to restkoncentrationsstudier.
English: The two products used in the studies include almost the same excipients, but in different quantities.
Danish: De to produkter, der er anvendt i studierne, indeholder næsten de samme hjælpestoffer, men i forskellige mængder.
English: However, there are some significant differences between this and the other product formulations that are in the scope of this referral procedure.
Danish: Der er dog nogle signifikante forskelle mellem dette produkt og de andre produktformuleringer, der er omfattet af denne indbringelsesprocedure.
English: A 41-day withdrawal period was determined, following statistical evaluation of the residues depletion data using the WT1.4 software.
Danish: Der blev fastsat en tilbageholdelsestid på 41 dage efter statistisk evaluering af data om nedbrydning af restkoncentrationer ved brug af WT1.4-software.
English: The main non-aqueous vehicle, propylene glycol, is present in both products in different quantities.
Danish: Det centrale ikke-vandige vehikel, propylenglykol, er indeholdt i begge produkter i forskellige mængder.
English: One of these products (‘Flukiver 5%') was used in the pivotal residues study, Study 1.
Danish: Et af disse produkter (Flukiver 5%) blev anvendt i det centrale restkoncentrationsstudie, studie 1.