FrancophonIA/ELRC3.0 huggingface dataset:
English: You should continue to follow your doctor's advice on cervical smear/Pap tests and preventative and protective measures.
Maltese: Inti għandek tkompli ssegwi l-parir tat-tabib tiegħek dwar is-smear ċervikali/testijiet Pap u l-miżuri preventivi u protettivi.
English: Impact on Biopsy and Definitive Therapy Procedures
Maltese: Impatt fuq il-Biopsija u l-Proċeduri Definittivi ta' Terapija
English: Silgard is intended for adolescents and adults from 9 years of age onwards.
Maltese: Silgard huwa maħsub għall-adoloxxenti u l-adulti li għandhom minn 9 snin 'l fuq.
English: Merck Sharp & Dohme Ltd, Hertford Road,
Maltese: Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, Ir-Renju Unit
English: 16- to 26-Year-Old Women (Protocols 013 and 015) GMT (95% CI)
Maltese: Nisa bejn 16 u 26 sena (Protokolli 013 u 015)
English: Clinical Trials
Maltese: TAL-PRODOTT MEDIĊINALI
English: In the FAS population, the corresponding reduction was 45.7% (95% CI: 29.0, 58.7) and 38.1% (95% CI: 19.4,
Maltese: Fil-popolazzjoni FAS, it-tnaqqis li jaqbel ma' dan kien ta' 45.7% (95% CI: 29.0, 58.7) u
English: Table 8: Long-term immunogenicity data (per-protocol population) based on percentage of seropositive subjects as measured by cLIA and IgG LIA (Protocol 018) at 10 years, in girls and boys
Maltese: Tabella 8: Dejta ta' immunoġeniċità fit-tul (popolazzjoni skont il-protokoll) imsejsa fuq il-perċentwal ta' individwi seropożittivi kif imkejjel b'cLIA u IgG LIA (Protokoll 018) fl-10 sena, f'subien u bniet b'età minn 9-15-il sena cLIA
English: • the efficacy of Silgard against HPV 6-, 11-, 16-, 18-related genital warts was 99.0% (95% CI:
Maltese: • l-effikaċja ta' Silgard kontra felul ġenetali relatat ma' HPV 6-, 11-, 16-, 18 kienet 99.0% (95%
English: N Number of cases HPV 6/11/16/18-related external genital lesions
Maltese: N Numru ta' każijiet Leżjonijiet ġenitali esterni marbuta ma' HPV 6/11/16/18
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.
Maltese: Fost nisa li kienu naïve għal 14-il tip komuni ta' HPV u li kellhom test Pap negattiv f'Jum 1, l-amministrazzjoni ta' Silgard naqset l-inċidenza ta' CIN 2/3 jew AIS ikkawżati minn tipi ta' HPV ta' vaċċin jew mhux vaċċin b'42.7% (95% CI : 23.7, 57.3) u ta' felul ġenitali b'82.8% (95% CI: 74.3, 88.8) fl-aħħar tal-istudju.
English: On the basis of this immunogenicity bridging, the efficacy of Silgard in 9- to 15-year-old boys is inferred.
Maltese: Fuq bażi ta' dan it-tnaqqis tad-differenza fl-immunoġeniċità, l-effikaċja ta' Silgard fi bniet ta' bejn 9 u 15-il sena hija inferita.
English: Efficacy was 68.2% (95% CI: 17.9, 89.5; 6 vs. 20 cases [n = 832 from studies in young and adult women combined]) against HPV 16- and 18-related persistent infection in women 16 to 45 years.
Maltese: L-effikaċja kienet 68.2% (95% CI: 17.9, 89.5; 6 vs. 20 każ [n= 832 minn studji b'taħlita ta' nisa żgħar u adulti]) kontra infezzjoni persistenti li għandha x'taqsam ma' HPV 16 u 18 f'nisa bejn l-etajiet ta' 16 u 45 sena.
English: • First injection: at chosen date
Maltese: Tabella 1: Każijiet Avversi
English: These diseases include pre-cancerous lesions of the female genitals (cervix, vulva, and vagina); precancerous lesions of the anus and genital warts in males and females; cervical and anal cancers.
Maltese: Dan il-mard jinkludi feriti pre-kanserużi tal-ġenitali tan-nisa (ċerviċi, vulva, u vaġina); feriti prekanserużi tal-anus u felul ġenitali fl-irġiel u n-nisa; kansers ċervikali u anali.
English: In the HPV naïve population (naïve to 14 common HPV types), Silgard reduced the proportion of men who had a biopsy by 54.2% (95% CI: 28.3, 71.4) and who were treated by 47.7% (95% CI: 18.4, 67.1) at end of study.
Maltese: Fil-popolazzjoni li qatt ma kellha HPV qabel (qatt ma kellha xi wieħed mill-14-il tip komuni ta' HPV), Silgard naqqas il-proporzjon ta' rġiel li kellhom biopsija b'54.2% (95% CI: 28.3, 71.4) u dawk li ġew ikkurati b'47.7% (95% CI: 18.4, 67.1) fi tmiem l-istudju.
English: In the ITT population the corresponding reduction was 23.9% (95% CI: 15.2, 31.7).
Maltese: Fil-popolazzjoni ITT, it-tnaqqis korrespondenti kien 23.9% (95% CI: 15.
English: Men vaccinated with Silgard at 16-26 years of age in Protocol 020 base study were followed up in an extension study.
Maltese: Irġiel imlaqqma b'Silgard fl-età ta' 16-26 sena fl-istudju bażi tal-Protokoll 020 ġew segwiti fi studju ta' estensjoni.
English: A subset of individuals enrolled in the Phase III studies was followed up for a long-term period for safety, immunogenicity and effectiveness.
Maltese: III ġew segwiti għal perjodu fit-tul għas-sigurtà, immunoġeniċità u effikaċja.
English: In the long-term extension study of Protocol 019, 685 women 24-45 years old during vaccination with Silgard in the base study, were followed.
Maltese: Fl-istudju ta' estensjoni fit-tul tal-Protokoll 019, ġew segwiti 685 mara li kellhom minn 24-45 sena meta tlaqqmu b'Silgard fl-istudju bażi.
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.
Maltese: Nisa mlaqqma b'Silgard fl-età ta' 16-23 sena fl-istudju bażi tal-Protokoll 015 se jiġu segwiti sa 14-il sena fi studju ta' estensjoni.
English: In the long-term extension study of Protocol 015, 2,084 women 16-23 years old during vaccination with Silgard in the base study, were followed.
Maltese: Fl-istudju ta' estensjoni fit-tul tal-Protokoll 015, ġew segwiti 2,084 mara li kellhom minn 16-23 sena meta tlaqqmu b'Silgard fl-istudju bażi.
English: Type-specific immunoassays, competitive Luminex-based immunoassay (cLIA), with type-specific standards were used to assess immunogenicity to each vaccine type.
Maltese: Immunoassaġġi speċifiċi għat-tip, immunoassaġġi kompetittivi bbażati fuq Luminex (cLIA), bi standards speċifiċi għat-tip intużaw biex tiġi evalwata l-immunoġeniċità għal kull tip ta' vaċċin.
English: Pharmacotherapeutic group: Viral Vaccine, ATC code: J07BM01
Maltese: Vaċċin virali, kodiċi ATC:
English: The requirement for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines
Maltese: Ir-rekwiżiti għas-sottomissjoni tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq il
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
Maltese: Għaxar snin wara t-tilqim, 79%, 80%, 95% u 40% kienu seropożittivi kontra HPV 6, kontra HPV 11, kontra HPV 16 u kontra HPV 18 f'cLIA, rispettivament, u 92%, 92%, 100% u 92% kienu seropożittivi kontra HPV 6, kontra HPV 11, kontra HPV 16 u kontra HPV 18 f'IgG LIA,
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;
Maltese: Fl-analiżi tat-tmiem tal-istudju għal-leżjonijiet anali fil-popolazzjoni MSM (medja ta' kemm damu jiġu segwiti kienet ta' 2.15 il-sena), l-effett preventiv kontra AIN 2/3 marbut mal-HPV 6, 11, 16, 18 kien 74.9% (95% CI 8.8, 95.4; 3/194 kontra 13/208) u kontra AIN 2/3 marbut mal-HPV 16 jew 18 kien 86.6% (95% CI 0.0, 99.7 ; 1/194 kontra 8/208).
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.
Maltese: Għaxar snin wara t-tilqim, 79%, 85%, 94% u 36% kienu seropożittivi kontra HPV 6, kontra HPV 11, kontra HPV 16 u kontra HPV 18 f'cLIA, rispettivament, u 86%, 79%, 100% u 83% kienu seropożittivi kontra HPV 6, kontra HPV 11, kontra HPV 16 u kontra HPV 18 f'IgG LIA,
English: Immune Responses to Silgard at 1 month post dose 3
Maltese: Risponsi Immuni għal Silgard xahar wara doża 3
English: In the PPE population, no cases of HPV types 6/11 related genital warts, HPV 6/11/16/18 external genital lesions or HPV 6/11/16/18 high grade AIN in MSM were observed through 11.5 years
Maltese: Fil-popolazzjoni PPE, ma kienu osservati l-ebda każijiet ta' felul ġenitali marbut mat-tipi 6/11 ta' HPV, feriti ġenitali esterni b'HPV 6/11/16/18 jew grad għoli ta' AIN b'HPV 6/11/16/18 f'MSM sa 11.5 snin (medjan ta' segwitu ta' 9.5 snin).
English: Silgard is a vaccine for use from the age of 9 years for the prevention of: - premalignant genital lesions (cervical, vulvar and vaginal), premalignant anal lesions, cervical cancers and anal cancers causally related to certain oncogenic Human Papillomavirus (HPV)
Maltese: Silgard hu vaċċin biex jintuża mill-età ta' 9 snin għall-prevenzjoni ta': - leżjonijiet ġenitali (ċervikali, vulvari u vaġinali) qabel isiru malinni, leżjonijiet anali qabel isiru malinni, kansers ċervikali u kansers anali li l-kawża tagħhom hi marbuta ma' ċerti tipi
English: Silgard, suspension for injection in a pre-filled syringe Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
Maltese: Silgard, suspensjoni għall-injezzjoni f'siringa mimlija lesta Vaċċin għall-Papillomavirus Uman [Tipi 6, 11, 16, 18] (Rikombinanti, adsorbit)
English: Efficacy in men with or without prior infection or disease due to HPV 6, 11, 16, or 18
Maltese: Effikaċja f'nisa bi jew mingħajr infezzjoni jew mard preċedenti dovuti għal HPV 6, 11, 16, or 18
English: Suomi/Finland MSD Finland Oy Puh/Tel: +358 (0)9 804 650 info@msd.fi cyprus_info@merck.com
Maltese: +358 (0)9 804 650 info@msd.fi
English: At end of study and in the combined protocols, • the efficacy of Silgard against HPV 6-, 11-, 16-, 18-related CIN 1 was 95.9 % (95% CI: 91.4,
Maltese: Fl-aħħar tal-istudju u fil-protokolli kombinati, • l-effikaċja ta' Silgard kontra CIN 1 relatata ma' HPV 6-, 11-, 16-, 18 kienet ta' 95.9 % (95% CI:
English: The median duration of follow-up was 2.9 years.
Maltese: It-tul medjan ta' żmien li fih ġew segwiti kien ta' 2.9 snin.
English: In a clinical trial of 843 healthy adolescent males and females 11-17 years of age, administration of the first dose of Silgard concomitantly with a combined diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] booster vaccine showed that there was more injection-site swelling and headache reported following concomitant administration.
Maltese: Fi prova klinika ta' 843 raġel u mara adoloxxenti b'saħħithom ta' bejn il-11 u s-17-il sena, l-għoti talewwel doża ta' Silgard fl-istess ħin ma' vaċċin booster kombinat ta' difterja, tetnu, pertussi [aċellulari, komponent] u poljomajelite [inattivat] wera li kien hemm aktar nefħa fis-sit tal-injezzjoni u uġigħ ta' ras irrapportati wara għoti fl-istess ħin.
English: Three clinical studies (Protocols 016, 018 and 020) were used to compare the immunogenicity of Silgard in 9- to 15-year-old boys to 16- to 26-year-old men.
Maltese: Tliet studji kliniċi (Protokolli 016, 018 u 020) intużaw biex iqabblu l-immunoġeniċità ta' Silgard f'subien b'età minn 9 sa 15-il sena ma' dik f'irġiel b'età minn 16 sa 26 sena.
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.
Maltese: Fil-popolazzjoni ITT mibdula, il-benefiċċju tal-vaċċin fir-rigward ta' l-inċidenza globali ta' CIN 2/3 jew AIS (ikkawżata minn kwalunkwe tip ta' HPV) u ta' felul ġenitali kien ferm inqas, bi tnaqqis ta' 18.4% (95% CI: 7.0, 28.4) u 62.5% (95% CI: 54.0, 69.5), rispettivament, minħabba li Silgard ma għandux impatt fuq il-kors ta' l-infezzjonijiet jew mard li jfeġġu mal-bidu tat-tilqima.
English: Protection Against the Overall Burden of Cervical HPV disease in 16- Through 26-Year-Old Women
Maltese: Protezzjoni Kontra l-Piż Globali tal-marda HPV Ċervikali f'Nisa ta' Bejn 16 u 26 Sena
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.
Maltese: Fost il-bniet li rċivew 2 dożi tat-tilqima, 96%, 100%, 100%, u 84% baqgħu seropożittivi kontra HPV 6, kontra HPV 11, kontra HPV 16, u kontra HPV 18, rispettivament, f'cLIA.
English: For the 10 individual HPV types, statistical significance was only reached for HPV 31.
Maltese: Għal 10 tipi ta' HPV individwali, is-sinjifikat statistiku intlaħaq biss għal
English: Commonly (more than 1 in 100 patients), side effects found at the injection site include: bruising, itching, pain in extremity.
Maltese: Komuni: (iktar minn pazjent wieħed minn kull 100 pazjent), effetti sekondarji li nstabu fis-sit ta' linjezzjoni jinkludu: tbenġil, ħakk, uġigħ fl-estremitajiet.
English: Silgard can be given with a Hepatitis B vaccine or with a combined booster vaccine containing diphtheria (d) and tetanus (T) with either pertussis [acellular, component] (ap) and/or poliomyelitis [inactivated] (IPV) (dTap, dT-IPV, dTap-IPV vaccines) at a separate injection site (another part of your body, e.g. the other arm or leg) during the same visit.
Maltese: Silgard jista' jingħata ma' vaċċin ta' l-Epatite B jew ma' vaċċin booster ikkombinat li fih difterja (d) u tetnu (T) b'jew pertussi [aċellulari, komponent] (ap) u/jew poljomajelite [inattivat] (IPV) (vaċċini dTap, dT-IPV, TdaPdTap-IPV) f'sit differenti ta' l-injezzjoni (parti oħra minn ġismek, eż. id-driegħ lieħor jew ir-riġel l-ieħor) matul l-istess żjara.
English: In the long-term extension study of Protocol 018, 369 girls 9-15 years old during vaccination with Silgard in the base study, were followed.
Maltese: Fl-istudju ta' estensjoni fit-tul tal-Protokoll 018, ġew segwiti 369 tifla li kellhom minn 9-15-il sena meta tlaqqmu b'Silgard fl-istudju bażi.
English: The most common adverse reactions observed were injection-site adverse reactions (77.1% of vaccinees within 5 days following any vaccination visit) and headache (16.6% of the vaccinees).
Maltese: Ir-reazzjonijiet avversi l-aktar komuni li ġew osservati kienu reazzjonijiet avversi fis-sit tal-injezzjoni (77.1% tal-persuni mlaqqma fi żmien 5 ijiem minn kwalunkwe vista tat-tilqim) u uġigħ ta' ras (16.
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 Silgard does not impact the course of infections or disease that are present at vaccination onset.
Maltese: Fil-popolazzjoni tas-Sett Sħiħ ta' Analiżi (FAS), il-benefiċċju tat-tilqima f'dik li hija inċidenza totali ta' EGL kien aktar baxx, bi tnaqqis ta' 59.3% (95% CI: 40.0, 72.9), minħabba li Silgard ma jaffettwax l-ordni naturali tal-iżvilupp ta' infezzjonijiet jew mard li jkunu preżenti meta
English: Silgard, suspension for injection Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
Maltese: Vaċċin għall-Papillomavirus Uman [Tipi 6, 11, 16, 18] (Rikombinanti, adsorbit)
English: • the efficacy of Silgard against HPV 6-, 11-, 16-, 18-related CIN (1, 2, 3) or AIS was 96.0%
Maltese: • l-effikaċja ta' Silgard kontra CIN (1, 2, 3) jew AIS relatata ma' HPV 6-, 11-, 16-, 18- kienet
English: Women vaccinated with Silgard at 24-45 years of age in Protocol 019 base study were followed up in an extension study.
Maltese: Nisa mlaqqma b'Silgard fl-età ta' 24-45 sena fl-istudju bażi tal-Protokoll 019 ġew segwiti fi studju ta' estensjoni.
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
Maltese: Tnaqqis tad-differenza fl-immunoġeniċità bejn subien b'età minn 9 sa 15-il sena u rġiel b'età minn 16 sa 26 sena (popolazzjoni skont il-protokoll) ibbażata fuq titres imkejla b'cLIA
English: Table 7: Immunogenicity bridging between 9- to 15-year-old boys and 16- to 26-year-old men (perprotocol population) based on titres as measured by cLIA
Maltese: Tnaqqis tad-differenza fl-immunoġeniċità bejn bniet ta' bejn 9 u 15-il sena u nisa ta' bejn 16 u 26 sena (popolazzjoni skont il-protokoll) ibbażat fuq titres kif imkejla minn cLIA
English: Silgard must not be injected intravascularly.
Maltese: Silgard m'għandux jiġi injettat intravaskularment.
English: No minimum antibody level associated with protection has been identified for HPV vaccines.
Maltese: L-ebda livell ta' anti-korpi minimu marbut mal-protezzjoni ma kien identifikat għall-vaċċini HPV.
English: Silgard produces type-specific antibodies and has been shown in clinical trials to prevent HPV 6-, 11-, 16-, and 18-related diseases in women 16-45 years of age and in men 16-26 years of age.
Maltese: Silgard jipproduċi anti-korpi speċifiċi għat-tip u fil-provi kliniċi ntwera li jippreveni mard marbut ma' HPV 6, 11, 16, u 18 f'nisa ta' età ta' bejn 16-45 sena u f'irġiel ta' bejn is-16 u s-26 sena.
English: Silgard induced specific antibody responses against HPV types 6, 11, 16, and 18 in pregnant rats, following one or multiple intramuscular injections.
Maltese: Silgard ikkawża risponsi speċifiċi ta' l-anti-korpi kontra t-tipi HPV 6, 11, 16, u 18 f'firien tqal, wara injezzjoni waħda jew aktar fil-muskoli.
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.
Maltese: F'7 provi kliniċi (6 ikkontrollati bil-plaċebo), l-individwi ngħataw Silgard jew il-plaċebo fil-jum tarreġistrazzjoni u madwar xahrejn u 6 xhur wara dan.
English: Name and address of the manufacturers of the biological active substances
Maltese: Isem u indirizz tal-manifatturi tas-sustanzi bijoloġiċi attivi
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.
Maltese: VIN 2/3 relatata ma' HPV 6-, 11-, 16-, 18 kienet ta' 73.3% (95% CI: 40.3, 89.4), kontra VaIN 2/3 relatata ma' HPV 6-, 11-, 16-, 18- li kienet 85.
English: B. Tabulated summary of adverse reactions
Maltese: Sommarju tar-reazzjonijiet avversi miġbura f'tabella
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE
Maltese: TAS-SUSTANZI BIJOLOĠIĊI ATTIVI
English: In the vaccine group, 97.4 to 99.9% became seropositive to all vaccine serotypes by 1 month Postdose 3.
Maltese: Fil-grupp tat-tilqima, 97.4 sa 99.9% saru seropożittivi għas-serotipi kollha tat-tilqima sa xahar Wara d-Doża 3.
English: • Silgard may appear as a clear liquid with a white precipitate prior to agitation.
Maltese: • Silgard jista' jidher bħala likwidu ċar bi preċipitat abjad qabel ma jitħawwad.
English: 0.5 ml suspension in a pre-filled syringe (glass) with plunger stopper (siliconized FluroTec-coated bromobutyl elastomer or non-coated chlorobutyl elastomer) and a tip cap (bromobutyl) without needle or with one or two needle(s) - pack size of 1, 10 or 20.
Maltese: Suspensjoni ta' 0.5 ml f'siringa mimlija għal-lest (ħġieġ) b'tapp li jwaqqaf il-planġer (elastomer talbromobutyl silikonizzat miksi bi FluroTec jew elastomer tal-chlorobutyl mhux miksi) u għatu tat-tarf (bromobutyl), mingħajr labra jew b'labra waħda jew żewġ labriet - daqs tal-pakkett ta' 1, 10 jew 20.
English: Table 5: Efficacy of Silgard against external genital lesions in the PPE* population of 16-26 year old
Maltese: L-effikaċja ta' Silgard kontra leżjonijiet ġenitali esterni fil-popolazzjoni PPE* ta' rġiel
English: Individuals 14 years of age and older Silgard should be administered according to a 3-dose (0.5 ml at 0, 2, 6 months) schedule.
Maltese: Individwi ta' 14-il sena u akbar Silgard għandu jingħata skont skeda ta' 3 dożi (0.5 ml fix-xhur 0, 2 u 6).
English: The efficacy for HPV 16/18 related CIN 2/3 or AIS is based on data from protocols 005 (16-related endpoints only), 007, 013, and 015.
Maltese: Leffikaċja għal CIN 2/3 jew AIS relatati ma' HPV 16/18 hija bbażata fuq tagħrif minn protokolli 005 (16-il-punt ta' tmiem relatat biss), 007, 013, u 015.
English: In the vaccine group, 99.1 to 100% became seropositive to all vaccine serotypes by 1 month Postdose 3.
Maltese: Fil-grupp bil-vaċċin, 99.1 sa 100 % saru seropożittivi għas-serotipi kollha tal-vaċċin sa xahar Wara d-Doża 3.
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).
Maltese: Fi Protokoll 012, l-effikaċja ta' Silgard kontra d-definizzjoni ta' 6 xhur ta' infezzjoni persistenti [kampjuni pożittivi fuq żewġ żjarat konsekuttivi jew aktar b'6 xhur bejniethom (±1 xahar) jew aktar] relatati ma' HPV 16 kienet 98.7 % (95% CI: 95.1, 99.8) u 100.
English: 10 single doses, 0.5 ml pre-filled syringes with 1 needle each.
Maltese: 10 dożi singoli, siringi mimlijin lesti ta' 0.5 ml mingħajr labar. 20 doża singola, siringi mimlijin lesti ta' 0.5 ml mingħajr labar.
English: Safety and immunogenicity of the vaccine have been assessed in individuals aged from 7 to 12 years who are known to be infected with human immunodeficiency virus (HIV) (see section 5.1).
Maltese: Is-sigurtà u l-immunoġeniċità tat-tilqima ġew stmati f'individwi b'età minn 7 snin sa 12-il sena magħrufa li kienu infettati bil-vajrus tal-immunodefiċjenza umana (HIV) (ara sezzjoni 5.1).
English: The clinical significance of this observation is not known.
Maltese: Is-sinifikat kliniku ta' din l-osservazzjoni mhuwiex magħruf.
English: Silgard, suspension for injection - pre-filled syringe with 2 needles, pack of 1, 10, 20
Maltese: Silgard, suspensjoni għall-injezzjoni - siringa mimlija lesta b'2 labriet, pakkett ta' 1, 10, 20
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Maltese: Studji fl-annimali ma jindikawx effetti ta' ħsara diretti jew indiretti fis-sistema riproduttiva (ara sezzjoni 5.3). Ma kinux osservati effetti fuq il-fertilità maskili fil-firien (ara sezzjoni 5.3).
English: The efficacy of Silgard 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
Maltese: L-effikaċja ta' Silgard kontra l-inċidenza kombinata ta' infezzjoni persistenti relatata ma' HPV 6-, 11-, 16 jew 18, felul ġenitali, leżjonijiet vulvari u vaġinali, CIN ta' kwalunkwe grad, AIS u kanċers ċervikali kienet ta' 47.
English: The vaccine also produces type-specific antibodies in 9- to 15-year-old children and adolescents.
Maltese: Il-vaċċin jipproduċi wkoll anti-korpi speċifiċi għat-tipi ta' HPV fit-tfal u fl-adolexxenti ta' bejn 9 u 15-il sena.
English: Anti-HPV responses at Month 7 among 9- to 15-year-old boys were non-inferior to anti-HPV responses in 16- to 26-year-old men for whom efficacy was established in the Phase III studies.
Maltese: Risponsi kontra HPV fix-Xahar 7 fost subien b'età minn 9 sa 15-il sena ma kinux inferjuri għal risponsi kontra l-HPV f'irġiel b'età minn 16 sa 26 sena li l-effikaċja fihom kienet stabbilita fi studji ta' Fażi