FrancophonIA/ELRC3.0 huggingface dataset:
English: Efficacy against disease endpoints caused by pre-specified combinations of non-vaccine HPV types was measured.
Icelandic: Mæld var verkun gegn endapunktum sjúkdóms sem var af völdum fyrirfram skilgreindra samsetninga af HPV gerðum sem ekki var bólusett fyrir.
English: Administer the entire dose as per standard protocol.
Icelandic: Sprautið heildarskammtinum samkvæmt hefðbundnum ráðleggingum.
English: In the long-term extension study of Protocol 018, 326 boys 9-15 years old during vaccination with Silgard in the base study, were followed.
Icelandic: Í langtímaframhaldshluta rannsóknaráætlunar 018 var fylgst með 326 drengjum sem bólusettir voru með Silgard á aldrinum 9-15 ára í grunnrannsókninni.
English: Alternatively, Silgard can be administered according to a 3-dose schedule:
Icelandic: Silgard má einnig gefa samkvæmt þriggja skammta bólusetningaráætlun:
English: Silgard, suspension for injection in a pre-filled syringe:
Icelandic: Silgard stungulyf, dreifa í áfylltri sprautu:
English: Among the girls receiving 2 doses of the vaccine, 96%, 100%, 100%, and 84% remained seropositive to anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18, respectively, in the cLIA.
Icelandic: Af stúlkum sem fengu 2 skammta af bóluefninu voru 96% sermisjákvæðar hvað varðar HPV 6-mótefni, 100% hvað varðar HPV 11-mótefni, 100% hvað varðar HPV 16-mótefni og 84% hvað varðar HPV 18-mótefni mælt með cLIA.
English: The Full Analysis Set population included men regardless of baseline HPV status at Day 1, who received at least one vaccination and in whom case counting started at Day 1.
Icelandic: Heildarþýðið samanstóð af körlum án tillits til HPV grunnlínugildis á fyrsta degi, sem fengu a.m.k. eina bólusetningu og þar sem talning tilfella hófst á fyrsta degi.
English: Anti-HPV levels in placebo individuals who had cleared an HPV infection (seropositive and PCR
Icelandic: Það magn mótefna gegn HPV sem bóluefnið kallaði fram var töluvert hærra en það sem fram kom hjá einstaklingum í lyfleysuhópnum sem hlotið höfðu góðan bata af HPV sýkingu (sermisjákvæðar og PCR neikvæðar)
English: • you or your child is allergic (hypersensitive) to any of the active substances or any of the other ingredients of Silgard (listed under “other ingredients”- see section 6).
Icelandic: þú eða barnið þitt er með ofnæmi fyrir virku efnunum eða einhverju öðru innihaldsefni Silgard
English: The efficacy of Silgard in 16- through 26-year-old men was assessed in 1 placebo-controlled, doubleblind, randomised Phase III clinical study (Protocol 020) including a total of 4,055 men who were enrolled and vaccinated without pre-screening for the presence of HPV infection.
Icelandic: Virkni Silgard hjá körlum á aldrinum 16 til 26 ára var metin í í einni tvíblindri, slembiraðaðri III. stigs klínískri samanburðarrannsókn með lyfleysu (rannsóknaráætlun 020) hjá samtals 4.055 körlum sem voru skráðir og bólusettir á þess að áður hafi farið fram skimun að HPV sýkingu.
English: Evidence of an anamnestic response was seen in vaccinated women who were seropositive to relevant HPV type(s) prior to vaccination.
Icelandic: Vísbending um ónæmisminnissvörun kom fram hjá bólusettum konum sem voru sermisjákvæðar gagnvart viðkomandi gerð(um) mannapapillomaveiru fyrir bólusetningu.
English: Silgard, suspension for injection in a pre-filled syringe Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
Icelandic: Silgard, stungulyf, dreifa í áfylltri sprautu Bóluefni gegn mannapapillomaveiru (HPV) [af gerðum 6, 11, 16, 18] (raðbrigða, aðsogað)
English: In the long-term extension study of Protocol 020, 917 men 16-26 years old during vaccination with Silgard in the base study, were followed.
Icelandic: Í langtímaframhaldshluta rannsóknar samkvæmt rannsóknaráætlun 020 var fylgst með 917 karlmönnum sem bólusettir voru með Silgard á aldrinum 16-26 ára í upphaflegu rannsókninni.
English: Luxembourg/Luxemburg MSD Belgium BVBA/SPRL Tél/Tel: +32(0)27766211 dpoc_belux@merck.com
Icelandic: +32(0)27766211 dpoc_belux@merck.com
English: Efficacy was evaluated against HPV 6-, 11-, 16-, 18-related external genital warts, penile/perineal/perianal intraepithelial neoplasia (PIN) grades 1/2/3, and persistent infection.
Icelandic: Virkni var metin með tilliti til HPV 6-, 11-, 16- og 18-tengdra kynfæravarta, þekjufrumubreytinga við reður/spöng/umhverfis endaþarm á 1/2/3 stigi og þrálátrar sýkingar.
English: Not known Injection-site cellulitis * Not known Idiopathic thrombocytopenic purpura*, lymphadenopathy* Not known Hypersensitivity reactions including anaphylactic/anaphylactoid reactions* Nervous system disorders Very common Headache Not known Acute disseminated encephalomyelitis*, Dizziness Guillain-Barré syndrome*, syncope sometimes accompanied by tonic-clonic movements*
Icelandic: Bráð, dreifð heila- og mænubólga*, sundl Guillain-Barré heilkenni*, aðsvif sem stundum fylgir vöðvakippa- vöðvaþanshreyfingar*
English: Among men who were naïve to 14 common HPV types, administration of Silgard reduced the incidence of external genital lesions caused by vaccine- or non-vaccine HPV types by 81.5% (95% CI: 58.0, 93.0).
Icelandic: Á meðal karla sem ekki höfðu fengið 14 algengar gerðir HPV, dró lyfjagjöf með Silgard úr tilfellum vefskemmda á kynfærum af völdum HPV gerða sem er bólusett fyrir og ekki bólusett fyrir um 81,5% (95% CI:
English: Allergic reactions that may include difficulty breathing, wheezing (bronchospasm), hives and rash have been reported.
Icelandic: Ofnæmisviðbrögð m.a. andþrengsli, önghljóð (berkjukrampi), ofsakláði og útbrot hafa verið tilkynnt.
English: 1 dose, 0.5 ml pre-filled syringe without needle.
Icelandic: 1 skammtur, 0,5 ml áfyllt sprauta án nálar.
English: The primary analyses of efficacy were conducted in the per-protocol efficacy (PPE) population (i.e. all 3 vaccinations within 1 year of enrolment, no major protocol deviations and naïve to the relevant HPV type(s) prior to dose 1 and through 1 month Postdose 3 (Month 7)).
Icelandic: Fyrstu greiningar á virkni voru gerðar samkvæmt rannsóknaráætlun (þ.e. allar 3 bólusetningarnar innan árs frá skráningu, engin mikilvæg frávik frá rannsóknaráætlun og höfðu ekki áður smitast af viðkomandi HPV gerð fyrir fyrsta skammtinn og í 1 mánuð eftir 3. skammtinn (7. mánuð)).
English: Silgard, suspension for injection:
Icelandic: Silgard stungulyf, dreifa:
English: Among women with an abnormal Pap test at Day 1 who were naïve to the relevant vaccine HPV types at Day 1, efficacy of the vaccine remained high.
Icelandic: 1. degi sem höfðu ekki áður fengið bóluefnisstofna HPV á 1. degi, var virkni bóluefnisins áfram mikil.
English: • Silgard is available in a pre-filled syringe ready to use for intramuscular injection (IM), preferably in the deltoid area of the upper arm.
Icelandic: Silgard fæst í tilbúnum áfylltum sprautum til stungulyfjagjafar í vöðva (IM).
English: The term "premalignant anal lesions" in section 4.1 corresponds to high-grade anal intraepithelial neoplasia (AIN 2/3).
Icelandic: Hugtakið „forstig krabbameins í vefskemmdum á endaþarmi“ í kafla 4.1 vísar til þekjufrumubreytinga í endaþarmi á háu stigi (AIN 2/3).
English: Persistence of Immune Response of Silgard
Icelandic: Ef gleymist að taka einn skammt af Silgard
English: The median duration of follow-up for the combined protocols (005, 007, 013, and 015) was 3.6 years.
Icelandic: Miðgildi fyrir eftirfylgnitímabil fyrir sameinaðar rannsóknaráætlanir (005, 007, 013 og 015) var 3,6 ár. Niðurstöður úr einstökum rannsóknum studdu niðurstöðurnar úr sameinuðu greiningunni.
English: (end of study results)
Icelandic: Virkni** í lok rannsókna
English: Vaccination should be postponed
Icelandic: Bólusetningu ætti að fresta þar til eftir meðgöngu.
English: The impact of Silgard against the overall risk for cervical, HPV disease (i.e., disease caused by any HPV type) was evaluated starting 30 days after the first dose in 17,599 individuals enrolled in the two phase III efficacy trials (Protocols 013 and 015).
Icelandic: Áhrif Silgard á heildaráhættu á HPV sjúkdómi í leghálsi (þ.e. sjúkdómi af völdum hvaða gerðar HPV sem er) voru metin hjá 17.599 einstaklingum sem tóku þátt í III.
English: In the FAS population, the corresponding reduction was 45.7% (95% CI: 29.0, 58.7) and 38.1% (95% CI: 19.4,
Icelandic: 29,0; 58,7) og 38,1% (95% CI: 19,4; 52,6).
English: Silgard is available in packs of 1, 10 or 20 pre-filled syringes.
Icelandic: Silgard fæst í pakkningum með 1, 10 eða 20 áfylltum sprautum, með nálarhylki (öryggisbúnaður.
English: The efficacy of Silgard 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%
Icelandic: Virkni Silgard gegn samanlagðri tíðni HPV 16-, eða 18-tengdum þrálátum sýkingum, kynfæravörtum, vefskemmdum á sköpum og leggöngum, CIN af öllum gerðum, AIS og leghálskrabbameini var 84,7%
English: 1 dose, 0.5 ml pre-filled syringe with 2 needles.
Icelandic: 1 skammtur, 0,5 ml áfyllt sprauta með tveimur lausum nálum.
English: In Protocol 012 the efficacy of Silgard against the 6 month definition of persistent infection [samples positive on two or more consecutive visits 6 months apart (±1 month) or longer] related to HPV 16 was 98.7 % (95% CI: 95.1, 99.8) and 100.0% (95% CI: 93.2, 100.0) for HPV 18 respectively, after a follow-up of up to 4 years (mean of 3.6 years).
Icelandic: Í rannsóknaráætlun 012 þar sem virkni Silgard gegn viðvarandi sýkingu var skilgreind var með 6 mánaða tímabili [jákvæð sýni í 2 eða fleiri heimsóknum í röð með 6 mánuðum á milli (±1 mánuð) eða lengur] þá var virkni gegn HPV 16 sýkingu 98,7% (95% CI:
English: No minimum antibody level associated with protection has been identified for HPV vaccines.
Icelandic: Ekki er vitað um lágmarksstyrk mótefna sem veita vörn með tilliti til HPV bóluefna.
English: • the efficacy of Silgard against HPV 6-, 11-, 16-, 18-related genital warts was 99.0% (95% CI:
Icelandic: • virkni Silgard gegn HPV 6-, 11-, 16-, 18-tengdum CIN 1 var 95,9% (95% CI:
English: The active substances are: highly purified non-infectious protein for each of the Human Papillomavirus types (6, 11, 16, and 18).
Icelandic: Hreinsað, smitlaust prótein fyrir hverja mannapapillomaveirugerð (6, 11, 16
English: Protection Against the Overall Burden of HPV disease in 16- Through 26-Year-Old Men
Icelandic: Vernd gegn samanlagðri tíðni HPV sjúkdóma hjá körlum á aldrinum 16 til 26 ára
English: HPV 16/18related CIN 2/3 or AIS HPV 16/18
Icelandic: HPV 16/18tengd CIN
English: 1 Type 18 L1 protein
Icelandic: Mannapapillomaveira 1 af stofni 18 L1 prótein
English: The efficacy of Silgard against HPV 6-, 11-, 16-, 18-related external genital warts was 68.1% (95% CI: 48.8, 79.3).
Icelandic: Virkni Silgard gegn HPV 6-, 11-, 16-, 18-tengdum kynfæravörtum var 68,1% (95% CI:
English: • Inject immediately using the intramuscular (IM) route, preferably in the deltoid area of the upper arm or in the higher anterolateral area of the thigh.
Icelandic: Sprautið lyfinu strax í vöðva (i.m.), helst í axlarvöðva upphandleggs eða hliðlægt ofarlega framan á lærvöðva.
English: Among women who were naïve to 14 common HPV types and had a negative Pap test at Day 1, administration of Silgard reduced the incidence of CIN 2/3 or AIS caused by vaccine- or non-vaccine HPV types by 42.7% (95% CI: 23.7, 57.3) and of genital warts by 82.8% (95% CI: 74.3, 88.8) at end of study.
Icelandic: Á meðal kvenna sem höfðu ekki áður fengið 14 algengar gerðir HPV og fengu neikvætt Pap próf á 1. degi, minnkaði gjöf Silgard tíðni CIN 2/3 eða AIS af völdum HPV gerða í bóluefninu eða gerða sem ekki eru í bóluefninu um 42,7% (95% CI :
English: This population approximates to the general population of women with respect to prevalence of HPV infection or disease at enrolment.
Icelandic: Þetta þýði endurspeglar algengi HPV sýkinga eða sjúkdóma hjá konum almennt við skráningu í rannsóknina.
English: Pharmacotherapeutic group: Viral Vaccine, ATC code: J07BM01
Icelandic: Veirubóluefni, ATC flokkur:
English: 1 dose, 0.5 ml pre-filled syringe with 1 needle.
Icelandic: 1 skammtur, 0,5 ml áfyllt sprauta með einni lausri nál.
English: Nine years after vaccination, 94%, 96%, 99% and 60% were anti-HPV 6, anti-HPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the cLIA, respectively, and 98%, 96%, 100% and 91% were anti-HPV 6, anti-HPV 11, anti-HPV 16 and anti-HPV 18 seropositive
Icelandic: Níu árum eftir bólusetningu voru 94% þeirra sermisjákvæðar hvað varðar HPV 6-mótefni, 96% hvað varðar HPV 11-mótefni, 99% hvað varðar HPV 16-mótefni og 60% hvað varðar HPV 18-mótefni mælt með cLIA.
English: The modified intention to treat (ITT) population included women regardless of baseline HPV status at Day 1, who received at least one vaccination and in whom case counting started at 1 month Postdose 1.
Icelandic: Aðlagað meðferðarákvörðunar (ITT) þýði innihélt konur án tillits til HPV ástands á 1. degi, sem fengu a.m.k.
English: Hypersensitivity to the active substances or to any of the excipients.
Icelandic: Ofnæmi fyrir virku efnunum eða einhverju hjálparefna bóluefnisins.
English: Please speak to your doctor for more information.
Icelandic: Leitið til læknisins eða lyfjafræðings ef þörf er á frekari upplýsingum.
English: What you need to know before you receive Silgard
Icelandic: Áður en byrjað er að nota Silgard
English: Thorough agitation immediately before administration is necessary to maintain
Icelandic: Nauðsynlegt er að hrista bóluefnið vandlega rétt fyrir lyfjagjöf til að viðhalda
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 12 years.
Icelandic: Hjá rannsóknarþýði skv. rannsóknaráætlun komu ekki fram nein tilvik HPV-sjúkdóma (HPV-6/11/16/18 tengdar leghálsfrumubreytingar á háu stigi) í allt að u.þ.b. 12 ár.
English: 20 single doses, 0.5 ml pre-filled syringes without needles.
Icelandic: 20 stakir skammtar, 0,5 ml áfylltar sprautur án nála.
English: Silgard, suspension for injection - pre-filled syringe without needle, pack of 1, 10, 20
Icelandic: Silgard, stungulyf, dreifa - áfyllt sprauta án nálar, pakkning með 1, 10 eða 20 einingum
English: Overall 12% of the combined study population had an abnormal Pap test suggestive of CIN at Day 1.
Icelandic: Pap próf sem gaf til kynna CIN á 1. degi.
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
Icelandic: Hjá rannsóknarþýði skv. rannsóknaráætlun komu ekki fram nein tilvik HPV-sjúkdóma (HPV-6/11/16/18 tengdar leghálsfrumubreytingar af öllum gerðum og kynfæravörtur) í 10,7 ár (við eftirfylgni með miðgildi10,0 ár.
English: AntiHBs geometric mean antibody titres were lower on co-administration, but the clinical significance of
Icelandic: Meðaltals mótefnatítrar gegn lifrarbólgu voru lægri við samtímis gjöf, klínískt mikilvægi þess er þó ekki þekkt.
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;
Icelandic: Greining á niðurstöðum í lok rannsóknar á vefskemmdum hjá samkynhneigðum karlmönnum (miðgildi eftirfylgnitímabils var allt að 2,15 ár) voru verndandi áhrif gegn HPV 6, 11, 16, 18 tengdum AIN 2/3, 74,9% (95% CI:
English: 20 single doses, 0.5 ml pre-filled syringes with 2 needles each.
Icelandic: 20 stakir skammtar, 0,5 ml áfylltar sprautur, hver með tveimur lausum nálum.
English: Table 5: Efficacy of Silgard against external genital lesions in the PPE* population of 16-26 year old
Icelandic: Greining á virkni Silgard gegn vefskemmdum á kynfærum hjá körlum á aldrinum 16-26 ára
English: In 7 clinical trials (6 placebo-controlled), individuals were administered Silgard or placebo on the day of enrolment and approximately 2 and 6 months thereafter.
Icelandic: Silgard eða lyfleysu á fyrsta degi rannsóknarinnar og svo u.þ.b. 2 og 6 mánuðum seinna.
English: Any unused vaccine or waste material should be disposed of in accordance with local requirements.
Icelandic: Ónotuðum lyfjum eða úrgangsefnum þarf að farga í samræmi við
English: 20 single doses, 0.5 ml pre-filled syringes with 1 needle each.
Icelandic: 20 stakir skammtar, 0,5 ml áfylltar sprautur, hver með einni lausri nál.
English: Silgard, suspension for injection Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
Icelandic: Silgard, stungulyf, dreifa Bóluefni gegn mannapapillomaveiru (HPV) [af gerðum 6, 11, 16, 18] (raðbrigða, aðsogað)
English: 10 single doses, 0.5 ml pre-filled syringes with 2 needles each.
Icelandic: 10 stakir skammtar, 0,5 ml áfylltar sprautur, hver með tveimur lausum nálum.
English: Overall, 67% of individuals were naïve (PCR negative and seronegative) to all
Icelandic: 67% einstaklingar ekki áður fengið neinar af 4 HPV gerðunum (PCR neikvæðir og mótefnaneikvæðir) við skráningu.
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
Icelandic: 1. degi sem voru þegar með sýkingu af völdum bóluefnisstofna HPV á 1. degi, kom ekki fram nein virkni bóluefnisins.
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 Silgard does not impact the course of infections or disease that are present at vaccination onset.
Icelandic: Í aðlagaða meðferðarákvörðunar ITT þýðinu var ávinningur af bóluefninu með tilliti til heildartíðni CIN 2/3 eða AIS (af völdum allra HPV gerða) og kynfæravartna miklu minni, með lækkun um 18,4% (95% CI:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT
Icelandic: YTRI UMBÚÐUM ORÐSENDING Á YTRI ÖSKJU
English: 10 single doses, 0.5 ml pre-filled syringes without needles.
Icelandic: 10 stakir skammtar, 0,5 ml áfylltar sprautur án nála.
English: 10 single doses, 0.5 ml pre-filled syringes with 1 needle each.
Icelandic: 10 stakir skammtar, 0,5 ml áfylltar sprautur, hver með einni lausri nál.
English: Silgard is an adjuvanted non-infectious recombinant quadrivalent vaccine prepared from the highly purified virus-like particles (VLPs) of the major capsid L1 protein of HPV types 6, 11, 16 and 18.
Icelandic: Silgard er raðbrigða ónæmisglætt bóluefni sem veldur ekki sýkingu, er fjórþætt og er framleitt úr háhreinsuðum veirulíkum ögnum (VLP) úr mikilvægum próteinum veiruskurnar HPV gerða 6, 11, 16 og 18. VLP agnirnar innihalda ekkert veiru DNA, þær geta ekki smitað frumur, fjölgað sér eða valdið sjúkdómi.
English: Ten years after vaccination, 79%, 85%, 94%, and 36% were anti-HPV 6, anti-HPV 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.
Icelandic: Tíu árum eftir bólusetningu voru 79% þeirra sermisjákvæðar hvað varðar HPV 6-mótefni, 85% hvað varðar HPV 11-mótefni, 94% hvað varðar HPV 16-mótefni og 36% hvað varðar HPV 18 mótefni mælt með cLIA.
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.
Icelandic: Tafla 6 ber saman HPV 6, HPV 11, HPV 16 og HPV 18 1 mánuði eftir 3. skammt hjá 15- 19 ára
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pre-filled syringe label text
Icelandic: Lýsing á útliti Silgard og pakkningastærðir
English: Silgard, suspension for injection - pre-filled syringe with 2 needles, pack of 1, 10, 20
Icelandic: Silgard, stungulyf, dreifa - áfyllt sprauta með tveimur lausum nálum, pakkning með 1, 10 eða 20 einingum
English: Ten years after vaccination, 79%, 80%, 95% and 40% were anti-HPV 6, anti-HPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the cLIA, respectively, and 92%, 92%, 100% and 92% were anti-HPV 6, anti-HPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the IgG
Icelandic: Tíu árum eftir bólusetningu voru 79% þeirra sermisjákvæðir hvað varðar HPV 6-mótefni, 80% hvað varðar HPV 11-mótefni, 95% hvað varðar HPV 16-mótefni og 40% sermisjákvæðir hvað varðar HPV 18-mótefni mælt með cLIA.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL TEXT
Icelandic: INNRI UMBÚÐUM LÍTILLA EININGA
English: The Full Analysis Set population (also known as the ITT population) included women regardless of baseline HPV status at Day 1, who received at least one vaccination and in whom case counting started at Day 1.
Icelandic: Heildar þýðið (einnig þekkt sem Intent To Treat (ITT) hópur) samanstóð af konum án tillits til HPVgrunnlínugildis á fyrsta degi, sem fengu a.m.k.
English: Silgard, suspension for injection - pre-filled syringe with 1 needle, pack of 1, 10, 20
Icelandic: Silgard, stungulyf, dreifa - áfyllt sprauta með einni lausri nál, pakkning með 1, 10 eða 20 einingum
English: Women vaccinated with Silgard at 16-23 years of age in Protocol 015 base study will be followed up to 14 years in an extension study.
Icelandic: rannsóknaráætlun 015 í grunnrannsókninni verður fylgt eftir í framhaldsrannsókn í allt að 14 ár.
English: Table 3: Efficacy of Silgard in high grade cervical lesions in the modified ITT-population including women regardless of baseline HPV status
Icelandic: Virkni Silgard gegn vefskemmdum í leghálsi á háu stigi hjá aðlöguðu ITT þýði án tillits til HPV ástands í byrjun
English: Medicinal product subject to medical prescription.
Icelandic: Það er notað ásamt ónæmisbælandi lyfjum.
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.
Icelandic: 88; 95,4; 3/194 miðað við 13/208) og gegn HPV 16 eða 18 tengdum AIN 2/3, 86,6% (95% CI 0,0, 99,7; 1/194 miðað við 8/208).
English: Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration.
Icelandic: Lyf sem ætluð eru til notkunar í stungulyfsformi skal athuga vel með tilliti til agna eða litabreytinga fyrir lyfjagjöf.
English: The efficacy of Silgard 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.
Icelandic: Virkni Silgard gegn HPV 6-, 11-, 16- ,18-tengdum AIN 2/3 og HPV 16- eða 18 tengdum AIN 2/3, í undirrannsókninni hjá samkynhneigðum var 54,2% (95% CI:
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 follow-up of
Icelandic: Hjá rannsóknarþýði skv. rannsóknaráætlun komu ekki fram nein tilvik HPV-sjúkdóma (HPV- 6/11/16/18 tengd sár á ytri kynfærum) í 10,6 ár (við
English: The indication is based on the demonstration of efficacy of Silgard in females 16 to 45 years of age and in males 16 to 26 years of age and on the demonstration of immunogenicity of Silgard in 9- to 15-year old children and adolescents.
Icelandic: Ábendingin byggir á virkni sem sýnt hefur verið fram á hjá konum 16 til 45 ára og hjá körlum 16 til 26
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY
Icelandic: D. FORSENDUR EÐA TAKMARKANIR ER VARÐA ÖRYGGI