FrancophonIA/ELRC3.0 huggingface dataset:
English: Individuals with hypersensitivity after previous administration of Gardasil 9 or Gardasil/Silgard should not receive Gardasil 9.
Maltese: Individwi li żviluppaw sensittività eċċessiva wara li kienu ngħataw Gardasil 9 jew Gardasil/Silgard m'għandhomx jirċievu Gardasil 9.
English: In long-term extensions of clinical studies, no cases of high-grade intraepithelial neoplasia and no cases of genital warts were observed: - through 10.7 years in girls (n=369) and 10.6 years in boys (n = 326), 9-15 years of age at time of vaccination (median follow-up of 10.0 years and 9.9 years, respectively); - through 11.5 years in men (n=917), 16-26 years of age at time of vaccination (median follow-up of 9.5 years); and through 10.1 years in women (n = 685), 24-45 years of age at time of vaccination (median follow-up of 8.7 years).
Maltese: snin u 9.9 snin, rispettivament); sa 11.5 snin fl-irġiel (n=917), li kellhom età ta' 16-26 sena meta tlaqqmu (segwitu medjan ta' 9.5 snin); u sa 10.
English: Acute disseminated encephalomyelitis, Guillain-Barré syndrome, syncope sometimes accompanied by tonic-clonic movements
Maltese: Mhux magħrufa Enċefalomijelite akuta u mifruxa, Sindrome ta' Guillain-Barré, sinkope xi drabi flimkien ma' ċaqliq toniku-kloniku
English: No clinical study of Gardasil 9 was conducted in HIV-infected individuals.
Maltese: Ma twettaq l-ebda studju kliniku b'Gardasil 9 f'individwi infettati bl-HIV.
English: The efficacy of Gardasil 9 against cervical definitive therapy (including loop electrosurgical excision procedure [LEEP] or conisation) related to vaccine HPV types compared to qHPV vaccine was 90.7% (95% CI 76.3, 97.0) with 4/6,016 versus 43/6,018 cases.
Maltese: L-effikaċja ta' Gardasil 9 kontra t-terapija definittiva tal-għonq tal-utru (inkluż il proċedura ta' tessut maqtugħ permezz ta' kirurġija b'wajer irqiq forma ta' ċirku li minnu jgħaddi vultaġġ baxx [LEEP-loop electrosurgical excision procedure] jew jinqata' tessut f'forma konika b'sikkina tal-kirurgu jew laser [conisation]) marbuta mat-tipi tal-HPV tal-vaċċin meta mqabbla malvaċċin qHPV kienet ta' 90.7% (CI ta' 95% 76.3, 97.0) b'4/6,016-il każ kontra 43/6,018-il każ.
English: • demonstration of efficacy against persistent infection and disease related to HPV types 31, 33, 45, 52 and 58 in girls and women aged 16 to 26 years, and
Maltese: • intweriet effikaċja kontra infezzjoni persistenti u mard marbut mat-tipi 31, 33, 45, 52 u 58 ta'
English: Hypersensitivity reactions including anaphylactic/anaphylactoid reactions, bronchospasm and urticaria
Maltese: Mhux magħrufa Reazzjonijiet ta' sensittività eċċessiva li jinkludu reazzjonijiet anafilattiċi/anafilaktojd, bronkospażmu u urtikarja
English: mL
Maltese: GMT
English: HPV Type 16 L1 protein
Maltese: Proteina L1 ta' HPV tat-Tip 16
English: For adjuvant, see section 2.
Maltese: Għas-sustanza awżiljari, ara sezzjoni 2.
English: Gardasil 9 suspension for injection in a pre-filled syringe Human Papillomavirus 9-valent Vaccine (Recombinant, adsorbed)
Maltese: Gardasil 9 suspensjoni għall-injezzjoni f'siringa mimlija għal-lest Vaċċin b'9 tipi ta' Papillomavirus Uman (Rikombinanti, adsorbit)
English: Gardasil 9 is an adjuvanted non-infectious recombinant 9-valent vaccine.
Maltese: Gardasil 9 huwa vaċċin awżiljat, rikombinanti mhux infettiv ta' 9 tipi ta' HPV.
English: Individuals with impaired immune responsiveness, due to either the use of potent immunosuppressive therapy, a genetic defect, Human Immunodeficiency Virus (HIV) infection, or other causes, may not respond to the vaccine.
Maltese: Individwi b'indeboliment fir-rispons immuni, ikkawżat minn użu ta' terapija immunosoppressiva qawwija, difett ġenetiku, infezzjoni bil-Virus tal-Immunodefiċjenza Umana (HIV), jew inkella minħabba kawżi oħra, jistgħu ma jirrispondux għall-vaċċin.
English: In 16- through 26- year-old men (N=4,055) efficacy against HPV 6, 11, 16 or 18-related diseases was 74.9% (95% CI: 8.8, 95.4) for AIN 2/3 (median duration of follow-up of 2.15 years), 100.0% (95% CI: -52.1, 100) for penile/perineal/perianal intraepithelial neoplasia (PIN) 1/2/3, and 89.3% (95% CI: 65.3, 97.9) for genital warts (median duration of follow-up of 4 years).
Maltese: 100.0% (CI ta' 95%: -52.1, 100) għal neoplażja fl-epitelju tal-pene/tal-perinew/perianali (PINpenile/perineal/perianal intraepithelial neoplasia) 1/2/3, u 89.3% (CI ta' 95%: 65.3, 97.9) għal felul ġenitali (tul ta' żmien medjan ta' segwitu ta' 4 snin).
English: Gardasil 9 is intended for adolescents and adults from 9 years of age onwards.
Maltese: Gardasil 9 huwa vaċċin għat-tfal u għall-adolexxenti mill-età ta' 9 snin u għall-adulti.
English: 1 dose (0.5 ml): HPV Type 6 L1 protein
Maltese: Proteina L1 ta' HPV tat-Tip 6
English: In clinical studies 99.2% to 100% who received Gardasil 9 became seropositive for antibodies against all 9 vaccine types by Month 7 across all groups tested.
Maltese: Fi studji kliniċi minn 99.2% sa 100% ta' dawk li rċevew Gardasil 9 saru seropożittivi għal antikorpi kontra d-9 tipi tal vaċċin sa Xahar 7 fil-gruppi kollha ttestjati.
English: Immune response to Gardasil 9 at Month 7
Maltese: Rispons immuni għal Gardasil 9 fix-Xahar 7
English: It is given to protect against diseases caused by Human Papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52 and 58.
Maltese: Huwa jingħata biex jipproteġi kontra mard ikkawżat mit-tipi 6, 11, 16, 18, 31, 33, 45, 52 u 58 tal-Papillomavirus Uman (HPV - Human Papillomavirus).
English: Amorphous aluminium hydroxyphosphate sulfate is included in the vaccine as an adjuvant.
Maltese: Aluminium hydroxyphosphate sulfate amorfu huwa inkluż fil-vaċċin bħala sustanza awżiljari.
English: • for at least 5 years in women who were aged 16 to 26 years at time of vaccination with Gardasil 9, depending on HPV type, 78 to100 % of subjects were seropositive; however, efficacy was maintained in all subjects regardless of seropositivity status for any vaccine HPV type through the end of the study (up to 67 months postdose 3, median follow-up duration of 43 months postdose 3),
Maltese: • għal mill-inqas 5 snin f'nisa li kellhom età minn 16 sa 26 meta tlaqqmu b'Gardasil 9, skont it tip ta' HPV, 78 sa 100 % tal-individwi kienu seropożittivi; madankollu, l-effikaċja nżammet flindividwi kollha irrispettivament mill-istat ta' seropożittività għal kwalunkwe tip ta' HPV talvaċċin sat-tmiem tal-istudju (sa 67 xahar wara d-doża 3, tul ta' żmien medjan ta' segwitu ta'
English: Seropositivity to vaccine HPV types in the per protocol population ranged from 98.3 to 100% by Month 7 in individuals who received Gardasil 9.
Maltese: Seropożittività għat-tipi ta' HPV tal-vaċċin fil-popolazzjoni skont il-protokoll varjat minn 98.3 sa 100% sa Xahar 7 f'Individwi li rċevew Gardasil 9.
English: The PPE population consisted of individuals who received all 3 vaccinations with qHPV vaccine in the base study within 1 year of enrolment without major deviations from the study protocol, were seronegative to the relevant HPV type(s) (types 6, 11, 16, and 18) prior to dose 1, and among subjects 16 years and older at enrolment in the base study, PCR negative to the relevant HPV type(s) prior to dose 1 through one month postdose 3 (Month 7).
Maltese: Il-popolazzjoni PPE kienet tikkonsisti f'individwi li rċivew it-3 tilqimiet kollha bil-vaċċin qHPV fl-istudju bażi fi żmien sena minn meta ġew irreġisrati fl-istudju mingħajr devjazzjonijiet kbar mill-protokoll tal-istudju, kienu seronegattivi għat-tip(i) rilevanti ta' HPV (tipi 6, 11, 16, u 18) qabel id-doża 1, u fost individwi li kellhom 16-il sena u aktar meta ġew irreġistrati fl-istudju bażi, kienu negattivi b'PCR għat-tip(i) rilevanti ta' HPV qabel doża 1 sa xahar wara doża 3 (Xahar 7).
English: In a clinical trial that included 640 individuals aged 27 to 45 years and 570 individuals aged 16 to 26 years who received Gardasil 9, the safety profile of Gardasil 9 was comparable between the two age groups.
Maltese: 16 sa 26 sena li rċivew Gardasil 9, il-profil tas-sigurtà ta' Gardasil 9 kien komparabbli bejn iż-żewġ gruppi ta' etajiet differenti.
English: Frequencies are reported as:
Maltese: Il-frekwenzi huma rrappurtati bħala:
English: Not known
Maltese: każijiet*
English: A subset of subjects is being followed up for 10 to 14 years after Gardasil 9 vaccination for safety, immunogenicity, and effectiveness against clinical diseases related to the HPV types in the vaccine.
Maltese: Sottosett ta' individwi qed jiġu segwiti għal 10 snin sa 14-il sena wara tilqim b'Gardasil 9 għassigurtà, l-immunoġeniċità, u l-effikaċja kontra mard kliniku marbut mat-tipi ta' HPV li hemm filvaċċin.
English: IM
Maltese: n
English: The types of anomalies or proportion of pregnancies with an adverse outcome in individuals who received Gardasil 9 or qHPV vaccine were comparable and consistent with the general population.
Maltese: It-tipi ta' anomaliji jew il-proporzjon ta' tqaliet b'riżultati avversi f'individwi li rċevew il-vaċċin Gardasil 9 jew qHPV kienu komparabbli u konsistenti mal-popolazzjoni ġenerali.
English: A total of 92 women were breast-feeding during the vaccination period of the clinical studies of Gardasil 9 in women aged 16 to 26 years.
Maltese: Total ta' 92 mara kienu qed ireddgħu waqt il-perjodu ta' tilqim tal-istudji kliniċi ta' Gardasil 9 f'nisa b'età minn 16 sa 26 sena.
English: These results support the efficacy of Gardasil 9 in women aged 27 to 45 years.
Maltese: Dawn ir-riżultati jsostnu leffikaċja ta' Gardasil 9 f'nisa b'età minn 27 sa 45 sena.
English: Use of hormonal contraceptives did not appear to affect the type-specific immune responses to Gardasil 9.
Maltese: L-użu ta' kontraċettivi tal-ormoni ma deherx li affettwa r-risponsi immuni speċifiċi għat-tip għal Gardasil 9.
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 9 (see section 4.8).
Maltese: Dan huwa bbażat fuq ir-riżultati minn prova klinika li fiha vaċċin dTapIPV ikkombinat ingħata flimkien mal-ewwel doża ta' Gardasil 9 (ara sezzjoni 4.8).
English: 0.5 ml suspension in a vial (glass) with stopper (halobutyl) and a flip-off plastic cap (aluminium crimp band) in a pack size of 1.
Maltese: 0.5 ml ta' suspensjoni f'kunjett (ħġieġ) b'tapp (halobutyl) u għatu tal-plastik li jinqala' b'daqqa ta' saba' (strixxa tal-aluminju iffurmata bil-pressa) f'daqs ta' pakkett ta' 1.
English: The genotypes for the vaccine comprised of HPV types 6, 11, 16, 18, 31, 33, 45, 52, 58 will be referred to as vaccine HPV types.
Maltese: Il-ġenotipi tal-vaċċin magħmul mit-tipi 6, 11, 16, 18, 31, 33, 45, 52, 58 ta' HPV se jkunu riferuti bħala t-tipi ta' HPV tal-vaċċin.
English: Therefore, the pivotal clinical study (Protocol 001) evaluated the efficacy of Gardasil 9 using qHPV vaccine as a comparator.
Maltese: Għalhekk, l-istudju kliniku l-aktar importanti (Protokoll 001) ivvaluta l-effikaċja ta' Gardasil 9 bl-użu tal-vaċċin qHPV bħala komparatur.
English: Gardasil 9 may slightly and temporarily affect the ability to drive or use machines (see section 4 “Possible side effects”).
Maltese: Gardasil 9 jista' jaffettwa b'mod ħafif u temporanju l-ħila biex inti ssuq u tħaddem magni (ara sezzjoni 4 “Effetti sekondarji possibbli”).
English: Gardasil 9 is available in packs of 1 or 10 pre-filled syringes.
Maltese: Gardasil 9 huwa disponibbli f'pakketti ta' 1 jew 10 siringi mimlija għal-lest.
English: In 7 clinical trials, individuals were administered Gardasil 9 on the day of enrolment and approximately 2 and 6 months thereafter.
Maltese: F'7 provi kliniċi, l-individwi ngħataw Gardasil 9 fil-jum tar-reġistrazzjoni u madwar xahrejn u 6 xhur wara dan.
English: Suspension for injection 10 pre-filled syringes (0.5 ml)
Maltese: U KONTENUT Suspensjoni għall-injezzjoni 10 siringi mimlija għal-lest (0.5 ml)
English: Common (may affect up to 1 in 10 people): side effects found at the injection site (bruising, and itching), fever, tiredness, dizziness and nausea.
Maltese: Komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10): effetti sekondarji li jinstabu fis-sit talinjezzjoni (tbenġil, u ħakk), deni, għeja, sturdament u nawsja.
English: Table 2: Adverse reactions reported from Post-marketing experience with qHPV vaccine System organ class
Maltese: Tabella 2: Reazzjonijiet avversi rrappurtati minn esperjenza ta' wara t-tqegħid fis-suq bit-tilqima qHPV
English: A statistical analysis of non-inferiority was performed at Month 7 comparing cLIA anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18 GMTs between individuals administered Gardasil 9 and individuals administered Gardasil.
Maltese: kontra HPV 11, kontra HPV 16, u kontra HPV 18 bejn individwi li ngħataw Gardasil 9 u individwi li ngħataw Gardasil.
English: In Protocol 003, anti-HPV antibody GMTs at Month 7 among boys and men (HM) aged 16 to 26 years were comparable to anti-HPV antibody GMTs among girls and women aged 16 to 26 years for vaccine HPV types.
Maltese: Fil-Protokoll 003, il-GMTs ta' antikorpi kontra HPV f'Xahar 7 fost subien u rġiel (HM) b'età minn 16 sa 26 sena (HM) kienu komparabbli ma' GMTs ta' antikorpi kontra HPV fost bniet u nisa b'età minn
English: In Protocol 001, GMTs for HPV-6, -11, -16 and -18 were comparable in subjects who received qHPV vaccine or Gardasil 9 for at least 3.5 years.
Maltese: Fi Protokoll 001, GMTs għal HPV 6, 11, 16 u 18 kienu komparabbli f'individwi li rċivew vaċċin qHPV jew Gardasil 9 għal mill-inqas 3.5 snin.
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.
Maltese: • Injetta immedjatament bl-użu tar-rotta ġol-muskoli (IM - intramuscular), l-aħjar fiż-żona tal muskolu deltojd tal-parti ta' fuq tad-driegħ jew fiż-żona anterolaterali tal-koxxa.
English: 1 Type 45 L1 protein
Maltese: Papillomavirus Uman1 tat-Tip 45 proteina L12,3
English: Safety was evaluated using vaccination report card (VRC)-aided surveillance for 14 days after each injection of Gardasil 9.
Maltese: (VRC - vaccination report card) għal 14-il jum wara kull injezzjoni ta' Gardasil 9.
English: 1 Type 52 L1 protein
Maltese: Papillomavirus Uman1 tat-Tip 52 proteina L12,3
English: The following side effects have been reported with GARDASIL or SILGARD and may also be seen after getting GARDASIL 9:
Maltese: L-effetti sekondarji li ġejjin kienu rrappurtati b'GARDASIL jew SILGARD u jistgħu jidhru wkoll wara li tieħu GARDASIL 9:
English: The PPE population consisted of individuals who received all 3 vaccinations within one year of enrolment, did not have major deviations from the study protocol, were naïve (PCR negative and seronegative) to the relevant HPV type(s) (types 31, 33, 45, 52, and 58) prior to dose 1, and who remained PCR negative to the relevant HPV type(s) through one month postdose 3 (Month 7).
Maltese: ‡Il-popolazzjoni PPE kienet tikkonsisti f'individwi li rċevew it-tliet tilqimiet kollha fi żmien sena minn meta ġew irreġistrati fl-istudju, ma kellhomx devjazzjonijiet kbar mill-protokoll tal-istudju, kienu inġenwi (negattivi b'PCR u seronegattivi) għat-tip(i) rilevanti ta' HPV (tipi 31, 33, 45, 52, u 58) qabel l-ewwel doża u baqgħu negattivi b'PCR għat-tip(i) rilevanti ta' HPV sa xahar wara it-tielet doża (Xahar 7).
English: Gardasil 9 was efficacious in preventing HPV 31-, 33-, 45-, 52-, and 58-related persistent infection and disease (Table 4).
Maltese: Gardasil 9 kien effikaċi biex jevita infezzjonijiet persistenti u mard marbut ma' HPV 31, 33, 45, 52, u 58 (Tabella 4).
English: N=Number of individuals randomised to the respective vaccination group who received at least one injection.
Maltese: N= Numru ta' individwi li ntgħażlu b'mod każwali għall-grupp rispettiv ta' tilqim u li rċevew mill-inqas injezzjoni waħda.
English: In 24- through 45- year-old women (N=3,817) efficacy against HPV 6, 11, 16 and 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: F'nisa b'età minn 24 sa 45 sena (N=3,817) l-effikaċja kontra infezzjoni persistenti, felul ġenitali, feriti fil-vulva u fil-vaġina, CIN ta' kwalunkwe grad, AIS, u kanċers tal-għonq tal-utru marbuta ma' HPV 6,
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 permezz ta' labra u siringa sterili.
English: • has a weakened immune system, for example due to a genetic defect, HIV infection or medicines that affect the immune system;
Maltese: • għandkom sistema immuni mdgħajfa, per eżempju minħabba difett ġenetiku, infezzjoni b'HIV jew mediċini li jaffettwaw is-sistema immuni;
English: Merck Sharp & Dohme d.o.o.
Maltese: Merck Sharp & Dohme OÜ
English: It is recommended that individuals who receive a first dose of Gardasil 9 complete the vaccination course with Gardasil 9 (see section 4.4).
Maltese: Huwa rakkomandat li individwi li jirċievu l-ewwel doża ta' Gardasil 9 itemmu l-kors ta' tilqim b'Gardasil 9 (ara sezzjoni 4.4).
English: Gardasil 9 has been studied in males 9 to 26 years of age and females 9 to 45 years of age.
Maltese: Gardasil 9 ġie studjat fl-irġiel b'età minn 9 snin sa 26 sena u fin-nisa b'età minn 9 snin sa 45 sena.
English: Subjects previously vaccinated with a 3-dose regimen of quadrivalent HPV types 6, 11, 16, and 18 vaccine (Gardasil), hereafter referred to as qHPV vaccine, may receive 3 doses of Gardasil 9 (see section 5.1).
Maltese: 11, 16, u 18 (Gardasil), li minn hawn 'il quddiem se jissejjaħ vaċċin qHPV (quadrivalent- fih erba' tipi), jistgħu jirċievu 3 dożi ta' Gardasil 9 (ara sezzjoni 5.1).
English: 1 Type 33 L1 protein
Maltese: Papillomavirus Uman1 tat-Tip 33 proteina L12,3
English: Although fainting episodes are uncommon, patients should be observed for 15 minutes after they receive HPV vaccine.
Maltese: Għalhekk, il-persuni li jitlaqqmu għandhom jiġu osservati għal madwar 15-il minuta wara t-tilqim.
English: In the same study, in girls and boys aged 9 to14 years, GMTs at one month after the last vaccine dose were numerically lower for some vaccine types after a 2-dose schedule than after a 3-dose schedule (i.e., HPV types 18, 31, 45, and 52 after 0, 6 months and HPV type 45 after 0, 12 months).
Maltese: Fl-istess studju, fi bniet u subien b'età minn 9 snin sa14-il sena, GMTs xahar wara l-aħħar doża tal vaċċin kienu aktar baxxi b'mod numeriku għal xi tipi tal-vaċċin wara skeda ta' 2 dożi milli wara skeda ta' 3 dożi (i.e., tipi 18, 31, 45, u 52 ta' HPV wara 0, 6 xhur u tip 45 ta' HPV wara 0, 12-il xahar).
English: Human Papillomavirus = HPV
Maltese: Vaċċin qHPV
English: Gardasil 9 is indicated for active immunisation of individuals from the age of 9 years against the following HPV diseases:
Maltese: Gardasil 9 huwa indikat għal tilqim attiv ta' individwi mill-età ta' 9 snin kontra l-mard ta' HPV li ġej:
English: Comparison of Gardasil 9 with qHPV vaccine with respect to HPV types 6, 11, 16, and 18 were conducted in a population of women aged 16 to 26 years from Protocol 001, girls aged 9 to 15 years from GDS01C/Protocol 009 and men aged 16 to 26 years from GDS07C/Protocol 020.
Maltese: It-tqabbil ta' Gardasil 9 mal-vaċċin qHPV rigward it-tipi 6, 11, 16, u 18 ta' HPV sar f'popolazzjoni ta' nisa b'età minn 16 sa 26 sena mill-Protokoll 001, bniet b'età minn 9 snin sa 15-il sena minn
English: As expected for women 27 to 45 years of age (Protocol 004), the observed GMTs were lower than those seen in women aged 16 to 26 years.
Maltese: Kif mistenni għal nisa b'età minn 27 sa 45 sena (Protokoll 004), il-GMTs osservati kienu aktar baxxi minn dawk li dehru f'nisa b'età minn 16 sa 26 sena.
English: 1 Type 18 L1 protein
Maltese: Papillomavirus Uman1 tat-Tip 18 proteina L1 2,3
English: 1 Type 58 L1 protein
Maltese: Papillomavirus Uman1 tat-Tip 58 proteina L12,3
English: In the pivotal study Protocol 001, the efficacy of Gardasil 9 against HPV types 31, 33, 45, 52, and 58 was evaluated compared to qHPV vaccine in women aged 16 to 26 years (N=14,204: 7,099 receiving Gardasil 9; 7,105 receiving qHPV vaccine).
Maltese: Studji li jsostnu l-effikaċja ta' Gardasil 9 kontra t-tipi 31, 33, 45, 52, u 58 ta' HPV L-effikaċja ta' Gardasil 9 f'nisa b'età minn 16 sa 26 sena ġiet stmata fi studju kliniku attiv, ikkontrollat b'komparatur fejn la l-investigatur u lanqas l-individwi li ntgħażlu b'mod każwali ma kienu jafu x'vaċċin qed jingħata, (Protokoll 001) li kien jinkludi total ta' 14,204 nisa
English: It uses the same amorphous aluminium hydroxyphosphate sulfate adjuvant as qHPV vaccine.
Maltese: Huwa juża l-istess sustanza awżiljari, aluminium hydroxyphosphate sulfate amorfu bħall-vaċċin qHPV.
English: Suspension for injection 1 vial (0.5 ml).
Maltese: Suspensjoni għall-injezzjoni Kunjett wieħed (0.5 ml).
English: Animal studies do not indicate reproductive toxicity (see section 5.3).
Maltese: Studji fl-annimali ma jindikawx effetti tossiċi fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: 1 Type 6 L1 protein
Maltese: Papillomavirus Uman1 tat-Tip 6 proteina L12,3
English: On the basis of this immunogenicity bridging, the efficacy of Gardasil 9 in girls and boys aged 9 to 15 years is inferred.
Maltese: Abbażi ta' dan il-bridging ta' immunoġeniċità, tista' tinġibed konklużjoni tal-effikaċja ta' Gardasil 9 fi bniet u subien b'età minn 9 snin sa 15-il sena.
English: Other medicines and Gardasil 9
Maltese: Mediċini oħra u Gardasil 9
English: 1 pre-filled syringe (0.5 ml) with 2 needles 10 pre-filled syringes (0.5 ml) with 2 needles each
Maltese: 10 siringi mimlija għal-lest (0.5 ml) b'2 labriet kull waħda
English: • At the request of the European Medicines Agency; • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: Use with hormonal contraceptives
Maltese: L-użu ma' kontraċettivi tal-ormoni
English: B. Tabulated summary of adverse reactions
Maltese: B. Reazzjonijiet avversi fil-qosor miġbura f'tabella
English: The safety and efficacy of Gardasil 9 in children below 9 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Gardasil 9 fit-tfal taħt l-età ta' 9 snin ma ġewx determinati s'issa.
English: 1 Type 11 L1 protein
Maltese: Papillomavirus Uman1 tat-Tip 11 proteina L12,3
English: 1 Type 31 L1 protein
Maltese: Papillomavirus Uman1 tat-Tip 31 proteina L12,3
English: Because these events were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or to establish, for all events, a causal relationship to vaccine exposure.
Maltese: Provi kliniċi Reazzjonijiet avversi meqjusa li għandhom mill-inqas il-possibbiltà ta' rabta mat-tilqim ġew ikkategorizzati skont il-frekwenza.
English: 1 Type 16 L1 protein
Maltese: Papillomavirus Uman1 tat-Tip 16 proteina L12,3
English: HPV 31-, 33-, 45-, 52-, 58-related cervical definitive therapy procedures
Maltese: marbuta ma' HPV 31, 33, 45, 52, 58 Infezzjoni Persistenti ta' ≥12-il Xahar¶
English: In girls and boys receiving 2 doses at 6- or 12-month interval (+/- 1-month), persistence of antibody response was demonstrated through Month 36; depending on HPV type, 81% to 99% of girls and boys receiving 2 doses at 6-month interval and 88% to 100% of girls and boys receiving 2 doses at 12month interval were seropositive.
Maltese: Fi bniet u subien li rċivew 2 dożi b'intervall ta' 6 xhur jew 12-il xahar bejniethom (+/- xahar 1), il persistenza tar-rispons tal-antikorpi ntweriet sa Xahar 36; skont it-tip ta' HPV, 81% sa 99% ta' bniet u subien li rċivew 2 dożi b'intervall ta' 6 xhur bejniethom u 88% sa 100% ta' bniet u subien li rċivew