FrancophonIA/ELRC3.0 huggingface dataset:
English: No data are available on subcutaneous administration of Cervarix (see section 4.4).
Danish: Der findes ingen tilgængelige data for subkutan administration af Cervarix (se pkt.
English: CIN2+ TVC-naïve(1)
Danish: CIN2+ TVC-naiv kohorte (1)
English: Very common Injection site reactions including pain, redness, swelling, fatigue
Danish: Meget almindelig Reaktioner på injektionsstedet, herunder smerte, rødme og hævelse, træthed
English: CIN3+ TVC-naïve(1)
Danish: CIN3+ TVC-naiv kohorte (1)
English: The efficacy results at the event-triggered analysis were 94.3% (96.1% CI: 91.5;96.3) against 6-month persistent infection and 91.4% (96.1% CI: 89.4;95.4) against 12-month persistent infection.
Danish: Ved den hændelsesudløste analyse var effekten 94,3 % (96,1 % CI: 91,5; 96,3) mod 6-måneders persisterende infektion og 91,4 % (96,1 % CI: 89,4; 95,4) mod 12-måneders persisterende infektion.
English: HPV-31 6M PI HPV-45 6M PI HPV-31 ASC-US+ HPV-45 ASC-US+ N = number of subjects in each group n = number of subjects reporting at least one event in each group 6M PI = 6-month persistent infection CI = Confidence Interval ASC-US= Atypical Cells of Undetermined Significance (abnormal cytology) (1) 3 doses of vaccine, DNA negative and seronegative at month 0 (unless specified) and DNA negative at month 6 for the relevant HPV type (HPV-16 and/or HPV-18) (2) at least one dose of vaccine, irrespective of HPV DNA and serostatus (unless specified) at month 0.
Danish: HPV-31 6-måneders PI HPV-45 6-måneders PI HPV-31 ASC-US+ HPV-45 ASC-US+ N= antal inkluderede personer i hver gruppe n= antal personer som rapporterte mindst et tilfælde i hver gruppe 6-måneders PI = 6-måneders persisterende infektion CI = konfidens interval ASC-US= atypia af pladeepitel af usikker betydning (abnorm cytologi) (1) 3 vaccinedoser, DNA-negative og seronegative ved måned 0 (med mindre det er specificeret) og DNAnegative ved måned 6 for de relevante HPV-typer (HPV-16 og/eller HPV-18) (2) mindst en vaccinedosis, uanset HPV-DNA og serologisk status (med mindre det er specificeret) ved måned 0.
English: Although vaccination may protect you against cervical cancer, it is not a substitute for regular cervical screening.
Danish: Selvom vaccination beskytter dig mod livmoderhalskræft, erstatter det ikke de rutinemæssige screeningsundersøgelser af livmoderhalsen.
English: HPV-16 and HPV-18 are estimated to be responsible for approximately 70% of cervical cancers, 90% of anal cancers, 70% of HPV-related high grade vulvar and vaginal intraepithelial neoplasia and 78% of HPV related high-grade anal (AIN 2/3) intraepithelial neoplasia.
Danish: HPV-16 og HPV-18 antages at være årsag til ca. 70 % af tilfældene af cervixcancer, 90 % af tilfældende af analcancer, 70 % af tilfældene af HPV-relaterede high grade intraepiteliale neoplasier i vulva og i vagina, og 78 % af tilfældene af HPV-relaterede high-grade anal (AIN 2/3) intraepiteliale neoplasier.
English: Clinical efficacy in women aged 26 years and older The efficacy of Cervarix was assessed in a double-blind, randomised Phase III clinical trial (HPV-015) that included a total of 5,778 women aged 26-72 years (median: 37.0 years).
Danish: Klinisk effekt hos kvinder i alderen 26 år og derover Den kliniske effekt af Cervarix er undersøgt i et randomiseret, dobbeltblindet klinisk fase III-studie (HPV-015) med 5.778 kvinder i alderen 26-72 år (median: 37,0 år).
English: • redness or swelling at the injection site
Danish: • rødme eller hævelse ved injektionssted
English: Efficacy against CIN1+ irrespective of the HPV type detected in the lesion was 22.9% (96.2% CI [4.8; 37.7]) (TVC).
Danish: Effekt overfor CIN1+, uanset hvilken HPV-type der blev påvist ved læsionen, var 22,9 % (96,2 % CI [4,8; 37,7]) (TVC).
English: As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Danish: Som for andre vacciner fremkaldes et beskyttende immunrespons ikke nødvendigvis hos alle de vaccinerede personer.
English: What Cervarix is and what it is used for What you need to know before you receive Cervarix How Cervarix is given
Danish: Virkning og anvendelse Det skal du vide, før du får Cervarix Sådan gives Cervarix
English: Based on the HPV type assignment post-hoc analysis, there was 1 CIN2+ case in the vaccine group versus 92 cases in the control group (Efficacy 98.9% (95% CI: 93.8;100)) and no CIN3+ case in the vaccine group versus 22 cases in the control group (Efficacy 100% (95% CI: 81.8;100)) at the end of study analysis.
Danish: På basis af posthoc HPV-type-bestemmelsen sås der i analysen ved slutningen af studiet ét tilfælde af CIN2+ i vaccinegruppen versus 92 tilfælde i kontrolgruppen (effekt 98,9 % (95 % CI: 93,8; 100)) og ingen tilfælde af CIN3+ i vaccinegruppen versus 22 tilfælde i kontrolgruppen (effekt 100 % (95 % CI: 81,8;
English: Other medicines and Cervarix
Danish: Brug af anden medicin sammen med Cervarix
English: The sequential administration of combined dTpa-IPV followed by Cervarix one month later tended to elicit lower anti-HPV-16 and anti-HPV-18 GMTs as compared to Cervarix alone.
Danish: Sekventiel administration af kombineret dTpa-IPV og efterfølgende administration af Cervarix 1 måned efter plejer at fremkalde lavere geometrisk middeltiter (GMT) for anti-HPV-16 og anti-HPV-18 i forhold til administration af Cervarix alene.
English: Further investigation of the cases with multiple HPV types considered the HPV types detected by Polymerase Chain Reaction (PCR) in at least one of the two preceding cytology samples, in addition to types detected in the lesion to distinguish the HPV type(s) most likely responsible to the lesion (HPV type assignment).
Danish: Yderligere undersøgelse af infektioner med multiple HPV-typer vurderede HPV-typerne bestemt ved polymerasekædereaktion (PCR) i mindst en af de to forudgående cytologiske prøver samt de HPVtyper, som blev set i celleforandringen, for at identificere den eller de HPV-typer, som med størst sandsynlighed var ansvarlige for celleforandringen (HPV-typebestemmelse).
English: Serological data suggest a transfer of anti-HPV-16 and anti-HPV-18 antibodies via the milk during the lactation period in rats.
Danish: Serologiske data fra rotter tyder på, at anti-HPV-16 og anti-HPV-18 antistoffer overføres via modermælk i ammeperioden.
English: If you get any side effects , talk to your doctor or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: In study 024 (a subset of study 001/007), a challenge dose of Cervarix was administered to 65 subjects at a mean interval of 6.8 years after the administration of the first vaccine dose.
Danish: I studie 024 (en undergruppe fra studie 001/007) blev en belastnings-vaccinedosis Cervarix givet til 65 personer gennemsnitligt 6,8 år efter første vaccinedosis.
English: At the end of study analysis, Cervarix reduced definitive cervical therapy procedures (includes loop electrosurgical excision procedure [LEEP], cold-knife Cone, and laser procedures) by 70.2% (95% CI: 57.8;79.3) in TVC-naïve and 33.2% (95% CI: 20.8;43.7) in TVC.
Danish: (3) middel-opfølgningstid på 44 måneder efter første vaccinedosis I analysen ved slutningen af studiet reducerede Cervarix antallet af definitive cervikale behandlingsprocedurer (inkluderende Loop-Electro-Excision Procedure (LEEP), koldknivskonisering og laserbehandling) med 70,2 % (95 % CI: 57,8; 79,3) i kohorten TVC-naive og med 33,2 % (95 % CI: 20,8; 43,7) i TVC-kohorten.
English: The primary efficacy endpoint was CIN2+ associated with HPV-16 and/or HPV-18 (HPV-16/18).
Danish: Det primære endepunkt for effekt var CIN2+ associeret med HPV-16 og/eller HPV-18 (HPV-16/18).
English: There were five cases of 12-month persistent HPV-16/18 infection (4 HPV-16; 1 HPV-18) in the control group and one HPV-16 case in the vaccine group in study 001.
Danish: I studie 001 var der 5 tilfælde af 12måneders persisterende HPV-16/18-infektion (4 HPV-16; 1 HPV-18) i kontrolgruppen og 1 tilfælde af HPV-16 i vaccinegruppen.
English: In study HPV-008, the primary analyses of efficacy were performed on the According to Protocol cohort (ATP cohort: including women who received 3 vaccine doses and were DNA negative and seronegative at month 0 and DNA negative at month 6 for the HPV type considered in the analysis).
Danish: I studiet HPV-008 blev de primære effektanalyser udført på kohorten anført i protokollen (ATPkohorten: kvinder, som fik 3 vaccinedoser, og som var DNA-negative og seronegative ved måned 0 og DNA-negative ved måned 6 over for den HPV-type, der blev vurderet i analysen).
English: Cervarix is available in pre-filled syringes (0,5 ml) with or without needles in packs of 1 and 10.
Danish: Cervarix fås i fyldte injektionssprøjter (0,5 ml) med og uden kanyler i pakningsstørrelser på 1 og 10 stk.
English: The TVC-naïve is a subset of the TVC that includes women with normal cytology, and who were HPV DNA negative for 14 oncogenic HPV types and seronegative for HPV-16 and HPV-18 at baseline.
Danish: Kohorten TVC-naive er en undergruppe af TVC-kohorten og inkluderer kvinder med normal cytologi, som var HPV-DNA-negative over for 14 onkogene HPV-typer og seronegative over for HPV-16 og HPV-18 ved baseline.
English: The content of the syringe should be inspected visually both before and after shaking for any foreign particulate matter and/or abnormal physical appearance prior to administration.
Danish: Indholdet i hætteglasset skal forud for administration inspiceres visuelt for fremmede partikler og/eller ændringer i det fysiske udseende både før og efter omrystning.
English: In clinical trials (HPV-070 and HPV-048) performed in girls aged 9 to 14 years receiving a 2-dose schedule (0, 6 months or 0, 12 months) and young women aged 15-25 years receiving Cervarix according to the standard 0, 1, 6 months schedule, all subjects seroconverted to both HPV types 16 and 18 one month after the second dose.
Danish: I kliniske studier (HPV-070 og HPV-048) med piger i alderen 9-14 år, som følger et 2-dosisprogram (måned 0 og 6 eller måned 0 og 12), og yngre kvinder i alderen 15-25 år, som får Cervarix i overensstemmelse med standardprogrammet (måned 0, 1 og 6), serokonverterede alle personer for både HPV-type 16 og 18 én måned efter anden dosis.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GlaxoSmithKline Biologicals s.a.
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN GlaxoSmithKline Biologicals s.a.
English: Itching/pruritus, rash, urticaria
Danish: Kløe, udslæt, urticaria
English: LIST OF EXCIPIENTS Sodium chloride
Danish: LISTE OVER HJÆLPESTOFFER Natriumchlorid
English: (2) TVC: includes all vaccinated subjects (who received at least one dose of vaccine) irrespective of HPV DNA status, cytology and serostatus at baseline.
Danish: (2) TVC-kohorte: inkluderede alle vaccinerede personer (som havde fået mindst en vaccinedosis) uanset HPV-DNA-status, cytologi og serologisk status ved baseline.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIDOSE VIAL, PACK OF 1, 10, 100
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE FLERDOSISHÆTTEGLAS, PAKNINGSSTØRRELSER PÅ 1, 10, 100
English: 2adsorbed on aluminium hydroxide, hydrated (Al(OH)3)
Danish: 50 mikrogram2adsorberet på aluminiumhydroxidhydrat (Al(OH)3)
English: The Human Papillomavirus (HPV) types contained in the vaccine (HPV types 16 and 18) are responsible for approximately 70% of cervical cancers, 90% of anal cancers, 70% of HPV-related precancerous lesions of the vulva and vagina and 78% of HPV-related pre-cancerous lesions of the anus.
Danish: De typer af humant papillomvirus (HPV), som er i vaccinen (HPV-type 16 og 18), er ansvarlige for ca. 70 % af tilfældene af livmoderhalskræft, 90 % af tilfældene af analkræft, 70 % af HPV-relaterede forstadier til kræft i de ydre kønsorganer hos kvinder og i skeden, og 78 % af HPV-relaterede forstadier til kræft i endetarmsåbningen.
English: Marketing Authorisation Holder and Manufacturer GlaxoSmithKline Biologicals s.a.
Danish: Indehaver af markedsføringstilladelsen og fremstiller GlaxoSmithKline Biologicals s.a.
English: ♦ Uncommon (side effects which may occur in less than 1 per 100 but more than 1 per 1,000 doses of vaccine):
Danish: ♦ Ikke almindelige (bivirkninger, som kan forekomme ved mindre end 1 ud af 100 vaccinationer, men ved mere end 1 ud af 1.000 vaccinationer):
English: The Total Vaccinated Cohort (TVC) included all subjects who received at least one dose of the vaccine, irrespective of their HPV DNA status, cytology and serostatus at baseline.
Danish: Hele den vaccinerede kohorte (TVC - Total Vaccinated Cohort) inkluderede alle, som fik mindst en vaccinedosis uanset deres HPV-DNA-status, cytologi og serologisk status ved baseline.
English: Prophylactic efficacy against HPV-16/18 in women naïve to HPV-16 and/or HPV-18
Danish: Forebyggende effekt mod HPV-16/18 hos kvinder, som var naive over for HPV-16 og/eller HPV-18
English: In study HPV-011, all subjects seroconverted to both HPV-16 and 18 and GMT levels were non inferior to those observed in females aged 15 to 25 years in study HPV-012.
Danish: I studiet HPV-011 serokonverterede alle personer for både HPV-16 og HPV-18, og i studie HPV-012 var GMT non-inferiore til dem, der blev observeret hos unge kvinder i alderen 15 til 25 år.
English: Instructions for administration of the vaccine in pre-filled syringe
Danish: Instruktion for administration af vaccine i fyldt injektionssprøjte
English: In a pooled analysis (HPV-029,-30 & -48), 99.7% and 100% of females aged 9 years seroconverted to HPV types 16 and 18, respectively after the third dose (at month 7) with GMTs at least 1.4-fold and 2.4-fold higher as compared to females aged 10-14 years and 15 to 25 years, respectively.
Danish: I en samlet analyse (HPV-029, -30 og -48) havde henholdsvis 99,7 % og 100 % af pigerne på 9 år serokonverteret for HPV-type 16 og 18 efter tredje dosis (ved måned 7) med GMT på henholdsvis mindst 1,4 og 2,4 gange højere end hos pigerne i alderen 10-14 år og kvinderne i alderen 15-25 år.
English: Includes 15% of subjects with previous history of HPV disease/infection
Danish: Inklusive 15 % af personer med HPV-infektion i anamnesen.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 September 2007.
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: In another clinical trial (study 014) performed in women aged 15 to 55 years, all subjects seroconverted to both HPV types 16 and 18 after the third dose (at month 7).
Danish: I et andet klinisk studie (studie 014) med kvinder i alderen fra 15 til 55 år, serokonverterede alle personer for både HPV-type 16 og 18 efter 3. dosis (ved måned 7).
English: N = number of subjects included in each group n = number of cases (1) ATP: includes women who received 3 doses of vaccine, were DNA negative and seronegative at month 0 and DNA negative at month 6 to the relevant HPV type (HPV-16 or HPV-18) (2) including 4 cases of CIN2+ and 2 cases of CIN3+ in which another oncogenic HPV type was identified in the lesion, concomitantly with HPV-16 or HPV-18.
Danish: N = antal inkluderede personer i hver gruppe n = antal tilfælde (1) ATP-kohorte: inkluderede kvinder, som havde fået 3 vaccinedoser, og som var DNA-negative og seronegative ved måned 0 og DNA-negative ved måned 6 over for den relevante HPV-type (HPV16 eller HPV-18) (2) inklusive 4 tilfælde af CIN2+ og 2 tilfælde af CIN3+, hvor en anden onkogen HPV-type blev identificeret i celleforandringen samtidig med HPV-16 eller HPV-18.
English: ♦ Common (side effects which may occur in less than 1 per 10 but more than 1 per 100 doses of vaccine):
Danish: ♦ Almindelige (bivirkninger, som kan forekomme ved mindre end 1 ud af 10 vaccinationer, men ved mere end 1 ud af 100 vaccinationer):
English: No minimal antibody level associated with protection against CIN of grade 2 or 3 or against persistent infection associated with vaccine HPV types has been identified for HPV vaccines.
Danish: Der er ikke for HPV-vacciner fastsat en minimumgrænse for antistofniveauet associeret med beskyttelse mod CIN grad 2 eller 3 eller mod persisterende infektion med vaccinerelaterede HPVtyper.
English: Efficacy against HPV-16/18 in women with evidence of HPV-16 or HPV-18 infection at study entry.
Danish: Effekt mod HPV-16/18 hos kvinder med evidens for HPV-16- eller HPV-18-infektion ved inkludering i studiet.
English: Multidose vial EU/1/07/419/010 EU/1/07/419/011 EU/1/07/419/012
Danish: Flerdosisbeholder EU/1/07/419/010 EU/1/07/419/011 EU/1/07/419/012
English: From 15 years and above Three doses each of 0.5 ml at 0, 1, 6 months** *If the second vaccine dose is administered before the 5th month after the first dose, a third dose should always be administered.
Danish: og 6** *Hvis den anden dosis administreres før den 5. måned efter første dosis, skal der altid gives en tredje dosis.
English: Table 6: Vaccine efficacy for non-vaccine oncogenic HPV types
Danish: Tabel 6: Effekt af vaccinen mod onkogene ikke-vaccine-HPV-typer ATP-kohorte(1)
English: • other injection site reactions such as hard lump, tingling or numbness.
Danish: • andre reaktioner på injektionsstedet, som en hård knude, prikkende eller sovende fornemmelse i huden.
English: In clinical trials a similar safety profile has been observed in subjects with prior or current HPV infection as compared to subjects negative for oncogenic HPV DNA or seronegative for HPV-16 and HPV-18 antibodies.
Danish: I kliniske studier er en sammenlignelig sikkerhedsprofil set for personer, der tidligere har haft eller har en HPV-infektion, sammenlignet med personer, der var negative for onkogen HPV-DNA eller seronegative for HPV-16 og HPV-18 antistof.
English: In study HPV-008, the incidence of high grade cervical lesions was compared between the placebo and vaccine group irrespective of the HPV DNA type in the lesion.
Danish: Forekomsten af high-grade cervikale celleforandringer blev i studiet HPV-008 sammenlignet for placebo- og vaccinegruppen uafhængig af HPV-DNA-typen i celleforandringerne.
English: End of study analysis(3)
Danish: End-of-study analyse(3)
English: Cervarix may also be administered concomitantly with meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine (MenACWY-TT); with combined hepatitis A (inactivated) and hepatitis B (rDNA) vaccine (Twinrix) or with hepatitis B (rDNA) vaccine (Engerix B).
Danish: Cervarix kan også administreres samtidigt med meningokokserogrupperne A, C, W-135, Y tetanustoksoid konjugeret vaccine (MenACWY-TT); med kombineret hepatitis A- (inaktiveret) og hepatitis B (rDNA)vaccine (Twinrix) eller samtidigt med hepatitis B (rDNA)-vaccine (Engerix-B).
English: N = number of subjects included in each group (1) TVC naïve: includes all vaccinated subjects (who received at least one dose of vaccine) who had normal cytology, were HPV DNA negative for 14 oncogenic HPV types and seronegative for HPV-16 and HPV-18 at baseline.
Danish: N = antal inkluderede personer i hver gruppe (1) kohorte TVC-naive: inkluderede alle vaccinerede personer (som havde fået mindst en vaccinedosis), som havde normal cytologi, var HPV-DNA-negative over for 14 onkogene HPV-typer og seronegative over for HPV-16 og HPV-18 ved baseline.
English: Cervarix may be administered concomitantly with a combined booster vaccine containing diphtheria (d), tetanus (T) and pertussis [acellular] (pa) with or without inactivated poliomyelitis (IPV), (dTpa, dTpa-IPV vaccines), with no clinically relevant interference with antibody response to any of the components of either vaccine.
Danish: Cervarix kan administreres samtidig med en booster-kombinationsvaccine indeholdende difteri (d), tetanus (T) og acellulær pertussis (pa) samt med eller uden inaktiveret poliovaccine (IPV), (dTpa, dTpa-IPV-vaccine) uden interferens af klinisk relevans med antistofresponset mod nogen af nævnte vaccinekomponenter.
English: No efficacy study against anal premalignant lesions has been conducted with Cervarix.
Danish: Der er ikke udført effektstudier med Cervarix overfor præmaligne anale celleforandringer.
English: The primary efficacy endpoint was incident infection with HPV-16 and/or HPV-18.
Danish: Det primære endepunkt for effekt var forbigående infektion med HPV-16 og/eller HPV-18.
English: In all age groups, GMTs remained at least 5- to 32-fold for HPV-16 and 3- to 14-fold for HPV-18 above those elicited in women who cleared a natural infection for both antigens.
Danish: For alle grupperne forblev GMT for HPV-16 og HPV-18 på henholdvis mindst 5 til 32 gange og 3 til 14 gange over dem, der blev observeret hos kvinder, som selv havde bekæmpet en naturlig infektion for begge antigener.
English: 0.5 milligrams Al3+ in total 4L1 protein in the form of non-infectious virus-like particles (VLPs) produced by recombinant DNA technology using a Baculovirus expression system which uses Hi-5 Rix4446 cells derived from Trichoplusia ni. For the full list of excipients, see section 6.1.
Danish: 4L1 protein i form af ikke-smitsom viruslignende partikel (VLP) produceret ved hjælp af rekombinant DNA-teknologi med brug af et Baculovirus-system, som anvender Hi-5-Rix4446-celler fra Trichoplusia ni.
English: End of study vaccine efficacy against 6-month persistent infection and CIN2+ associated with individual non-vaccine oncogenic HPV types is presented in Table 6 (ATP cohort).
Danish: Effekten af vaccinen mod 6-måneders persisterende infektion og CIN2+ associeret med de enkelte onkogene ikke-vaccine-HPV-typer ved slutningen af studiet er anført i tabel 6 (ATP-kohorte).
English: BATCH NUMBER LOT:
Danish: FREMSTILLERENS BATCHNUMMER Lot
English: Pack sizes of 1 and 10 pre-filled syringes with or without needles.
Danish: Pakningsstørelser på 1 og 10 fyldte injektionssprøjter med eller uden kanyler.
English: Shake before use
Danish: Omrystes før brug.
English: Deutschland GlaxoSmithKline GmbH & Co. KG
Danish: GlaxoSmithKline GmbH & Co.
English: Other HPV types can also cause ano-genital cancers.
Danish: Også andre HPV-typer kan forårsage kræft i endetarmsåbningen/analkanalen og kønsorganerne.
English: (3) mean follow-up of 40 months post dose 3
Danish: (3) middel-opfølgningstid på 40 måneder efter tredje vaccinedosis
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 dose (0.5 ml)
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 1 dosis (0,5 ml)
English: At the event-triggered analysis the efficacy was 92.9% (96.1% CI: 79.9;98.3) against CIN2+ and 80%
Danish: Ved den hændelsesudløste analyse var effekten 92,9 % (96,1 % CI:79,9; 98,3) mod CIN2+ og 80 % (96,1 % CI: 0,3; 98,1) mod CIN3+.
English: Suspension for injection 1 multidose vial 2 doses (1 ml)
Danish: Injektionsvæske, suspension 1 flerdosis hætteglas 2 doser (1 ml)
English: (2) mean follow-up of 44 months post dose 1
Danish: (2) middel-opfølgningstid på 44 måneder efter første vaccinedosis
English: N = number of subjects included in each group n = number of cases (1) ATP: includes women who received 3 doses of vaccine, were DNA negative and seronegative at month 0 and DNA negative at month 6 to the relevant HPV type (HPV
Danish: N = antal inkluderede personer i hver gruppe n = antal tilfælde (1) ATP-kohorte: inkluderede kvinder, som havde fået 3 vaccinedoser, og som var DNA-negative og seronegative ved måned 0 og DNA-negative ved måned 6 over for den relevante HPV-type (HPV
English: 6M PI and/or CIN1+ 6M PI
Danish: 6-måneders PI og/eller CIN1+ 6-månders PI CIN2+ 1/1.852 6/1.818
English: 0.5 ml of suspension in a pre-filled syringe (type I glass) with a plunger stopper (rubber butyl) with or without needles.
Danish: 0,5 ml suspension i fyldt injektionssprøjte (type I-glas) med en stempelprop (butylgummi) med eller uden kanyler.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2 doses (1 ml)
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 2 doser (1 ml)
English: Tel: + 49 (0)89 360448701 produkt.info@gsk.com
Danish: KG Tel: + 49 (0)89 360448701 produkt.info@gsk.com
English: For storage after first opening, see section 6.3.
Danish: Opbevaringsforhold efter anbrud, se pkt.