FrancophonIA/ELRC3.0 huggingface dataset:
English: In a clinical trial of 843 healthy adolescent males and females 11-17 years of age, administration of the first dose of Gardasil 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' Gardasil 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: Individuals 14 years of age and older Gardasil should be administered according to a 3-dose (0.5 ml at 0, 2, 6 months) schedule.
Maltese: Gardasil għandu jingħata skont skeda ta' 3 dożi (0.5 ml fix-xhur 0, 2 u 6).
English: This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia, and tonic-clonic limb movements during recovery.
Maltese: Dan jista' jiġri flimkien ma' diversi sinjali newroloġiċi bħal disturb temporanju fil-vista, parasteżija u ċaqliq toniku-kloniku tar-riġlejn waqt l-irkupru.
English: Human Papillomavirus = HPV
Maltese: AIS relatata ma' HPV
English: Men vaccinated with Gardasil at 16-26 years of age in Protocol 020 base study were followed up in an extension study.
Maltese: Irġiel imlaqqma b'Gardasil fl-età ta' 16-26 sena fl-istudju bażi tal-Protokoll 020 ġew segwiti fi studju ta' estensjoni.
English: Common Pain in extremity Not known Arthralgia*, Myalgia*
Maltese: Artralġja*, Mijalġja*
English: Composite Endpoint
Maltese: Skop finali
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).
Maltese: L-effikaċja ta' Gardasil kontra l-inċidenza kombinata ta' infezzjoni, felul ġenetali, leżjonijiet vulvari u vaġinali, persistenti relatati ma' HPV 6, 11, 16 jew 18, CIN ta' kwalunkwe grad, AIS u kanċers ċervikali kienet 88.7% (95% CI: 78.1, 94.8).
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.
Maltese: Fl-istudji kliniċi, fin-nisa ta' bejn is-16 u s-26 sena, 99.8 %, 99.8 %, 99.8 %, u 99.5 % ta' l-individwi li rċivew Gardasil saru seropożittivi għal anti-HPV 6, anti-HPV 11, anti-HPV 16, u anti-HPV 18,
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).
Maltese: mard b'HPV (Feriti Ġenitali Esterni marbuta ma' tipi 6/11/16/18 ta' HPV) sa 10.6 snin (medjan ta' segwitu ta' 9.9 snin).
English: 1 Type 11 L1 protein
Maltese: Papillomavirus Uman1 Proteina tip 11 L12,3
English: Clinical Studies
Maltese: KLINIKU
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,
Maltese: • l-effikaċja ta' Gardasil kontra CIN 1 relatata ma' HPV 6-, 11-, 16-, 18 kienet ta' 95.9 % (95% CI: 91.4, 98.4),
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.
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 Gardasil ma jaffettwax l-ordni naturali tal-iżvilupp ta' infezzjonijiet jew mard li jkunu preżenti meta tibda tingħata t-tilqima.
English: • the efficacy of Gardasil against HPV 6-, 11-, 16-, 18-related genital warts was 99.0% (95% CI:
Maltese: • l-effikaċja ta' Gardasil kontra felul ġenetali relatat ma' HPV 6-, 11-, 16-, 18 kienet 99.0% (95% CI: 96.2,99.
English: Gardasil suspension for injection in a pre-filled syringe
Maltese: Gardasil suspensjoni għall-injezzjoni
English: 1 Type 6 L1 protein
Maltese: Papillomavirus Uman1 Proteina tip 6 L12,3
English: Total IgG Luminex Immunoassay (IgG LIA) was used to assess the persistence of immune response in addition to cLIA.
Maltese: Apparti cLIA intuża l-Immunoassaġġ Luminex għal IgG totali (IgG LIA)
English: (see section 4.8).
Maltese: III (Protokoll 020).
English: A clinical study (Protocol 016) compared the immunogenicity of Gardasil in 10- to 15-year-old girls to those in 16- to 23 year old women.
Maltese: Studju kliniku (Protokoll 016) qabbel l-immunoġeniċità ta' Gardasil fi bniet li kellhom minn 10 sa 15
English: Women vaccinated with Gardasil at 16-23 years of age in Protocol 015 base were followed up in an extension study.
Maltese: Nisa mlaqqma b'Gardasil fl-età ta' 16-23 sena fl-istudju bażi tal-Protokoll 015 ġew segwiti fi studju ta' estensjoni.
English: 1 Type 18 L1 protein
Maltese: Papillomavirus Uman1 Proteina tip 18 L12,3
English: 1 Type 16 L1 protein
Maltese: Papillomavirus Uman1 Proteina tip 16 L12,3
English: Gardasil is intended for adolescents and adults from 9 years of age onwards.
Maltese: Gardasil huwa maħsub għall-adoloxxenti u l adulti li għandhom minn 9 snin 'l fuq.
English: Gardasil induced specific antibody responses against HPV types 6, 11, 16, and 18 in pregnant rats, following one or multiple intramuscular injections.
Maltese: Gardasil 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: • Withdraw the 0.5 ml dose of vaccine from the single-dose vial using a sterile needle and syringe.
Maltese: • Iġbed id-doża ta' 0.5 ml tal-vaċċin mill-kunjett ta' doża waħda permezz ta' labra u siringa sterili.
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.
Maltese: Fl-istudju ta' estensjoni fit-tul tal-Protokoll 018, ġew segwiti 369 tifla li kellhom minn 9-15-il sena meta tlaqqmu b'Gardasil fl-istudju bażi.
English: Attach the needle by twisting in a clockwise direction until the needle fits securely on the syringe.
Maltese: Madankollu, ġiet osservata tendenza aktar baxxa ta' GMTs kontra
English: Table 1 presents vaccine-related adverse reactions which were observed among recipients of Gardasil at a frequency of at least 1.0% and also at a greater frequency than observed among placebo recipients.
Maltese: Gardasil fi frekwenza ta' mill-anqas 1.0 % u anke fi frekwenza akbar minn dik li kienet osservata fost ir-reċipjenti tal-plaċebo.
English: Gardasil 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: Gardasil 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: 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.
Maltese: Fl-istudju ta' estensjoni fit-tul tal-Protokoll 018, ġew segwiti 326 tifel li kellhom minn 9-15-il sena meta tlaqqmu b'Gardasil fl-istudju bażi.
English: Since no vaccine is 100% effective and Gardasil will not provide protection against every HPV type, or against existing HPV infections, routine cervical screening remains critically important and should follow local recommendations.
Maltese: Peress li l-ebda vaċċin mhu effettiv 100 % u Gardasil mhux se jipprovdi protezzjoni kontra kull tip ta' HPV jew kontra infezzjonijiet HPV eżistenti, screening ċervikali ta' rutina jibqa' ta' importanza kritika u għandu jsegwi r rakkomandazzjonijiet lokali.
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.
Maltese: estensjoni fit-tul tal-Protokoll 020, ġew segwiti 917-il raġel li kellhom minn 16-26 sena meta tlaqqmu b'Gardasil fl-istudju bażi.
English: AntiHBs geometric mean antibody titres were lower on co-administration, but the clinical significance of this observation is not known.
Maltese: It-titres medji ġeometriċi ta' l-anti-korpi ta' kontra l-HBs kienu inqas fl-għoti flimkien, iżda s-sinifikat kliniku ta' din l-osservazzjoni mhux magħruf.
English: Sodium chloride L-histidine Polysorbate 80
Maltese: Polysorbate 80 Sodium borate
English: Gardasil does not prevent lesions due to a vaccine HPV type in individuals infected with that HPV type at the time of vaccination (see section 5.1).
Maltese: Gardasil ma jimpedixxix leżjonijiet minħabba vaċċin tip HPV f'individwi infettati b'dak it-tip ta' HPV fil-ħin tat-tilqima (ara sezzjoni 5.1).
English: Gardasil, suspension for injection - pre-filled syringe with 2 needles, pack of 1, 10, 20
Maltese: Gardasil, suspensjoni għall-injezzjoni - siringa mimlija lesta b'2 labriet, pakkett ta' 1, 10, 20
English: Gardasil will not protect against other diseases that are not caused by Human Papillomavirus.
Maltese: Gardasil mhux ser jipproteġi kontra mard ieħor li mhux ikkawżat mill-Papillomavirus Uman.
English: Gardasil, suspension for injection in a pre-filled syringe Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
Maltese: Gardasil suspensjoni għall-injezzjoni Vaċċin għall-Papillomavirus Uman [Tipi 6, 11, 16, 18] (Rikombinanti, adsorbit)
English: Gardasil is a vaccine.
Maltese: Immuni ta' Gardasil).
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.
Maltese: Subien u bniet imlaqqma b'Gardasil f'età ta' 9-15-il sena fl-istudju bażi tal-Protokoll 018 ġew segwiti fi studju ta' estensjoni.
English: In post hoc analyses of individuals (who received at least one vaccination) with evidence of a prior infection with a vaccine HPV type (seropositive) no longer detectable (PCR negative) at vaccination onset, the efficacy of Gardasil to prevent conditions due to the recurrence of the same HPV type was 100% (95% CI: 62.8, 100.0; 0 vs. 12 cases [n = 2572 from pooled studies in young women]) against HPV 6-, 11-, 16-, and 18-related CIN 2/3, VIN 2/3, VaIN 2/3, and genital warts in women 16 to 26 years.
Maltese: F'analiżi post hoc ta' individwi (li rċivew mill-anqas tilqima waħda) b'xhiedali kien hemm infezzjoni qabel b'tip ta' HPV (seropożittiv) tat-tilqima li ma nstabx aktar kif beda t-tilqim (negattiv għal PCR), l-effikaċja ta' Gardasil biex tilqa' kontra kondizzjonijiet minħabba rikorrenza tal-istess tip ta' HPV kienet 100% (95% CI: 62.8, 100.
English: Among women who were naïve to 14 common HPV types and had a negative Pap test at Day 1, administration of Gardasil 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: 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: Overall, 73% of women were naïve (PCR negative and seronegative) to all 4 HPV types at enrolment.
Maltese: B'kollox, waqt ir-reġistrazzjoni, 73 % tan-nisa kienu naïve għall-4 tipi kollha ta' HPV (negattivi għal PCR u seronegattivi).
English: The impact of Gardasil against the overall risk for external genital lesions was evaluated after the first dose in 2,545 individuals enrolled in the Phase III efficacy trial (Protocol 020).
Maltese: L-impatt ta' Gardasil kontra r-riskju globali ta' leżjonijiet ġenitali esterni kien stmat wara l-ewwel doża f'2,545 individwu mdaħħla fil-prova tal-effikaċja ta' Fażi
English: It is recommended that individuals who receive a first dose of Gardasil complete the vaccination course with Gardasil (see section 4.4).
Maltese: Huwa rrakkomandat li individwi li jirċievu l-ewwel doża ta' Gardasil itemmu l-kors ta' tilqim b'Gardasil (ara sezzjoni 4.4).
English: In these studies, individuals who were seronegative for anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18 in the cLIA were still protected against clinical disease after a follow-up of 14 years for 16-23 year-old women, 10 years for 24-45 year-old women, and 10 years for 16-26 year-old men.
Maltese: F'dawn l-istudji, individwi li kienu seronegattivi kontra HPV 6, kontra HPV 11, kontra HPV 16, u kontra HPV 18 f'cLIA kienu għadhom protetti kontra mard kliniku wara segwitu ta' 14-il sena għal nisa li kellhom minn 16-23 sena, 10 snin għal nisa li kellhom minn 24-45 sena, u 10 snin għal irġiel li kellhom minn 16-26 sena.
English: The impact of Gardasil 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).
Maltese: L-impatt ta' Gardasil kontra r-riskju globali għal mard HPV (jiġifieri mard ikkawżat minn kwalunkwe tip ta' HPV) ġie evalwat wara 30 jum mill-ewwel doża fi 17,599 individwu reġistrati fiż-żewġ provi ta' l-effikaċja ta' Fażi
English: This is based on the results from a clinical trial in which a combined dTap-IPV vaccine was administered concomitantly with the first dose of Gardasil.
Maltese: Kien hemm rapporti dwar l-għoti ta' doża ogħla mid-dożi rakkomandati ta' Gardasil.
English: The efficacy of Gardasil 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.
Maltese: III, double-blind, randomised, ikkontrollat bil-plaċebo (Protokoll 020) li kien jiġbor fih total ta' 4,055 raġel li ddaħħlu fl-istudju u ġew imlaqqma mingħajr ma sarilhom eżami qabel dwar jekk kellhomx infezzjoni b'HPV.
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: 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 webportal.
Maltese: Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq ilportal elettroniku Ewropew tal-mediċini.
English: In the same study, in girls aged 9-13 years, the immune response after a 2-dose schedule was numerically lower than after a 3-dose schedule (n = 248 at Month 7; n = 82 at Month 36).
Maltese: Fl-istess studju, fi bniet b'età minn 9 snin sa 13-il sena, ir-rispons immuni wara skeda ta' 2 dożi kien aktar baxx b'mod numeriku milli wara skeda ta' 3 dożi (n=248 fix-Xahar 7; n=82 fix-Xahar 36).
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.
Maltese: L-effikaċja ta' Gardasil f'nisa ta' bejn 16 u 26 sena ġiet evalwata f'4 provi kliniċi kkontrollati bilplaċebo, double-blind, randomised ta' Fażi
English: Gardasil, suspension for injection - single dose vial, pack of 1, 10, 20
Maltese: Gardasil, suspensjoni għall-injezzjoni - kunjett għal doża waħda, pakkett ta' 1, 10, 20
English: Gardasil will only protect against diseases that are caused by HPV types 6, 11, 16 and 18 and to a limited extent against diseases caused by certain related HPV types (See section 5.1).
Maltese: Gardasil ser jipproteġi biss kontra l-mard ikkawżat mit-tipi 6, 11, 16 u 18 tal-HPV u sa ċertu punt, kontra l-mard ikkawżat minn ċerti tipi ta' HPV relatati (Ara sezzjoni 5.1).
English: Gardasil must not be injected intravascularly.
Maltese: Gardasil m'għandux jiġi injettat intravaskularment.
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.
Maltese: Fl-istudju kliniku f'nisa ta' bejn l-24 u l-45 sena, 98.4%, 98.1%, 98.8%, u 97.4% tal-individwi li rċevew Gardasil saru seropożittivi għal anti-HPV 6,
English: • the efficacy of Gardasil against HPV 6-, 11-, 16-, 18-related CIN (1, 2, 3) or AIS was 96.0%
Maltese: • l-effikaċja ta' Gardasil kontra CIN (1, 2, 3) jew AIS relatata ma' HPV 6-, 11-, 16-, 18- kienet 96.0 % (95% CI: 92.3, 98.2),
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,
English: At end of study, individuals enrolled in the two Phase-III studies (Protocol-013 and Protocol-015), were followed for up to 4 years (median 3.7 years).
Maltese: III (Protokoll 013 u Protokoll 015), ġew segwiti għal perijodu sa 4 snin (medjan 3.7 snin).
English: *, Guillain-Barré syndrome*, syncope sometimes accompanied by tonic-clonic movements*
Maltese: Enċefalomijelite akuta u mifruxa*, Sturdament1 *, Sindrome ta' Guillain-Barré*,
English: HPV 16- or HPV 18related CIN 2/3 or AIS HPV 16/18related CIN
Maltese: mard b'HPV (kwalunkwe grad ta' CIN marbuta ma' tipi 6/11/16/18 ta' HPV u Felul Ġenitali) sa
English: GARDASIL administered to male rats at the full human dose (120 mcg total protein) had no effects on reproductive performance including fertility, sperm count, and sperm motility, and there were no vaccine-related gross or histomorphologic changes on the testes and no effects on testes weights.
Maltese: GARDASIL li ngħata lil firien maskili f'doża sħiħa tal-bnedmin (proteina totali 120 mcg) ma kellu l ebda effetti fuq ir-riproduzzjoni li tinkludi l-fertilità, l-għadd tal-isperma, u l-motilità tal-isperma u ma kien hemm l-ebda tibdiliet kbar jew istomorfoloġiċi fuq it-testikoli u l-ebda effetti fuq il-piż tat testikoli marbuta mat-tilqima.
English: Vaccination with Gardasil is intended to protect against diseases caused by Human Papillomavirus (HPV) types 6, 11, 16, and 18.
Maltese: Papillomavirus Uman (HPV) tat-tipi 6, 11, 16 u 18.
English: Individuals who develop symptoms indicative of hypersensitivity after receiving a dose of Gardasil should not receive further doses of Gardasil.
Maltese: Individwi li jiżviluppaw sintomi ta' sensittività eċċessiva wara li jirċievu doża ta' Gardasil m'għandhomx jirċievu dożi addizzjonali ta' Gardasil.
English: The impact of Gardasil on rates of biopsy and treatment of EGL regardless of causal HPV types was evaluated in 2,545 individuals enrolled in Protocol 020.
Maltese: Impatt fuq il-Biopsija u l-Proċeduri Definittivi ta' Terapija L-impatt ta' Gardasil fuq ir-rati ta' biopsiji u kura ta' EGL kienu x'kienu t-tipi li kkawżaw HPV ġie stmat f'2,545 individwu li ddaħħlu fil-Protokoll 20.
English: Not known Injection-site cellulitis *
Maltese: Ċellulite fis-sit tal-injezzjoni*
English: Method of administration
Maltese: U MANIFATTUR RESPONSABBLI
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.
Maltese: anti-HPV 11, anti-HPV 16, u anti-HPV 18, rispettivament b'xahar wara d-doża 3. Fl-istudju kliniku fl irġiel minn 16 sa 26 sena, 98.9%, 99.2%, 98.8%, u 97.4% ta' individwi li rċivew Gardasil saru seropożittivi kontra HPV 6, HPV 11, HPV 16, u HPV 18, rispettivament fi żmien xahar Wara d-Doża 3.
English: MSM are at higher risk of anal HPV infection compared to the general population; the absolute benefit of vaccination in terms of prevention of anal cancer in the general population is expected to be very low.
Maltese: MSM għandhom riskju akbar ta' infezzjoni HPV anali meta mqabbla mal-popolazzjoni ġenerali; ilbenefiċċju assolut tat-tilqim mil-lat li jiġi evitat il-kanċer anali fil-popolazzjoni ġenerali hu mistenni li jkun baxx ħafna.
English: What Gardasil looks like and contents of the pack 1 dose of Gardasil suspension for injection contains 0.5 ml.
Maltese: Doża waħda ta' Gardasil suspensjoni għall-injezzjoni fiha 0.5 ml.
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)
Maltese: Bniet bejn 9 u 15-il sena (Protokolli 016 u 018)
English: The indication is based on the demonstration of efficacy of Gardasil in females 16 to 45 years of age and in males 16 to 26 years of age and on the demonstration of immunogenicity of Gardasil in 9- to 15-year old children and adolescents.
Maltese: L-indikazzjoni hija bbażata fuq il-fatt li Gardasil wera effikaċja f'nisa bejn l-etajiet ta' 16 u 45 sena u f'irġiel bejn l-etajiet ta' 16 u 26 sena u għall-fatt li Gardasil wera immunoġeniċità fi tfal u adoloxxenti bejn l-etajiet ta' 9 snin u 15-il sena.
English: Gardasil, suspension for injection - pre-filled syringe with 1 needle, pack of 1, 10, 20
Maltese: Gardasil, suspensjoni għall-injezzjoni - siringa mimlija lesta b'labra waħda, pakkett ta' 1, 10, 20
English: Intramuscular (IM) use.
Maltese: Effikaċja fl-aħħar talistudju
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%
Maltese: 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, rispettivament.
English: The efficacy of Gardasil in 24- through 45 year-old women was assessed in 1 placebo-controlled, double-blind, randomised Phase III clinical study (Protocol 019, FUTURE III) including a total of 3,817 women, who were enrolled and vaccinated without pre-screening for the presence of HPV infection.
Maltese: II u III, li kienu jinkludu total ta' 20,541 mara, li kienu rreġistrati u vaċċinati mingħajr screening minn qabel, għall-preżenza ta' infezzjoni tal-HPV.
English: In a supplemental analysis, the efficacy of Gardasil was evaluated against HPV 16/18-related CIN 3 and AIS.
Maltese: F'analiżi supplimentali, l-effikaċja ta' Gardasil ġiet evalwata kontra CIN 3 u AIS relatati ma' HPV
English: 1 dose, 0.5 ml pre-filled syringe with 2 needles.
Maltese: Doża waħda, siringa mimlija lesta ta' 0.5 ml b'2 labriet.
English: Gardasil cannot cause the diseases it protects against.
Maltese: Bħalissa, it-tul ta' żmien ta' protezzjoni kontra kanser anali mhuwiex magħruf.
English: In addition, a subset of vaccinated women who received a challenge dose of Gardasil 5 years after the onset of vaccination, exhibited a rapid and strong anamnestic response that exceeded the anti-HPV GMTs observed 1 month Postdose 3.
Maltese: sfida ta' Gardasil 5 snin wara l-bidu tal-tilqima, urew reazzjoni anamnestika mgħaġġla u b'saħħitha li qabżet l-anti-HPV GMTs osservati xahar Wara d-Doża 3.
English: Immunogenicity was related to age and Month 7 anti-HPV levels were significantly higher in younger individuals.
Maltese: L-immunoġeniċità kienet marbuta mal-età u l-livelli ta' kontra l-HPV fix-Xahar 7 kienu ogħla b'mod sinifikanti fl-individwi ż-żgħar.