FrancophonIA/ELRC3.0 huggingface dataset:
English: HPV 16 and HPV 18 are estimated to be responsible for approximately 70% of cervical cancers and 75-80% of anal cancers; 80% of adenocarcinoma in situ (AIS); 45-70% of high-grade cervical intraepithelial neoplasia (CIN 2/3); 25% of low grade cervical intraepithelial neoplasia (CIN 1); approximately 70% of HPV related high-grade vulvar (VIN 2/3) and vaginal (VaIN 2/3) intraepithelial neoplasia and 80% of HPV related high-grade anal (AIN 2/3) intraepithelial neoplasia.
Maltese: HPV 16 u HPV 18 huma stmati li huma responsabbli għal madwar 70% ta' kansers ċervikali u 7580% ta' kansers anali; 80% ta' adenokarċinoma in situ (AIS); 45-70% ta' neoplasija intraepiteljali ċervikali ta' grad għoli (CIN 2/3); 25% ta' neoplasija intraepiteljali ċervikali ta' grad baxx (CIN 1); madwar 70% ta' neoplasja intraepiteljali ta' grad għoli tal-vulva (VIN 2/3) u vaġinali (VaIN 2/3) u 80% ta' neoplasja intraepiteljali anali ta' grad għoli (AIN 2/3) marbuta ma' HPV.
English: 16- to 26-Year-Old Men
Maltese: Irġiel bejn 16 u 26 sena
English: Individuals 9 to and including 13 years of age Silgard can be administered according to a 2-dose schedule (0.5 ml at 0, 6 months) (see section 5.1).
Maltese: Individwi minn 9 snin sa u inkluż 13-il sena Silgard jista' jingħata skont skeda ta' 2 dożi (0.5 ml fix-xhur 0 u 6) (ara sezzjoni 5.1).
English: In a subset of 598 men (SILGARD = 299; placebo = 299) in Protocol 020 who self-identified as having sex with men (MSM) efficacy against anal intraepithelial neoplasia (AIN grades 1/2/3) and anal cancer, and intra-anal persistent infection was evaluated.
Maltese: F'sottosett ta' 598 raġel (SILGARD = 299; plaċebo = 299) fi Protokoll 020 li kienu ammettew li jkollhom rapporti sesswali mal-irġiel (MSM) kienet evalwata l-effikaċja għal kontra neoplasja talintraepitilju anali (Gradi AIN 1/2/3) u kanċer fl-anus u infezzjoni persistenti intra-anali.
English: The immunogenicity of Silgard was assessed in 20,132 (Silgard n = 10,723; placebo n = 9,409) girls and women 9 to 26 years of age, 5,417 (Silgard n = 3,109; placebo n = 2,308) boys and men 9 to 26 years of age and 3,819 women 24 to 45 years of age (Silgard n = 1,911, placebo n = 1,908).
Maltese: L-immunoġeniċità ta' Silgard kienet evalwata f'20,132 tifla u mara (Silgard n = 10,723; plaċebo n = 9,409) ta' bejn id-9 u s-26 sena, 5,417-il tifel u raġel (Silgard n = 3,109; plaċebo n = 2,308) ta' bejn id9 u s-26 sena u 3,819-il mara ta' bejn l-24 u l-45 sena (Silgard n = 1,911,, plaċebo n = 1,908).
English: Table 2: Analysis of efficacy of Silgard against high grade cervical lesions in the PPE population Silgard Placebo % Efficacy at 2 years
Maltese: Tabella 2: Analiżi ta' l-effikaċja ta' Silgard kontra leżjonijiet ċervikali ta' grad għoli fil-popolazzjoni PPE
English: HIV infection was an exclusion criterion (see also section 4.4).
Maltese: Infezzjoni bl-HIV kienet kriterju ta' esklużjoni (ara wkoll sezzjoni 4.4).
English: HPV 6
Maltese: Tabella 6:
English: An academic study documenting safety and immunogenicity of Silgard has been performed in 126 HIV infected subjects aged from 7 to 12 years (of which 96 received Silgard).
Maltese: Sar studju akkademiku li ddokumenta s-sigurtà u l-immunoġeniċità ta' Silgard f'126 pazjent infettati bl-HIV li kellhom minn 7 snin sa 12-il sena (li minnhom 96 ħadu Silgard).
English: The median duration of follow-up for these studies was 4.0, 3.0, 3.0, and 3.0 years for Protocol 005, Protocol 007, Protocol 013, and Protocol 015, respectively.
Maltese: It-tul medjan tal-follow-up għal dawn l-istudji kien 4.0, 3.0, 3.0, u 3.0 snin għal Protokoll 005, Protokoll 007, Protokoll 013, u Protokoll 015, rispettivament.
English: The seroprotection rates (proportion of individuals reaching seroprotective level anti-HBs >10 mIU/ml) were unaffected (96.5% for concomitant vaccination and 97.5% for hepatitis B vaccine only).
Maltese: Ir-rati ta' seroprotezzjoni (proporzjon ta' individwi li jilħqu livell seroprotettiv anti-HBs >10 mIU/ml) ma kienux affettwati (96.5 % għal vaċinazzjoni konkomitanti u 97.5 % għal vaċċin ta' l-epatite B waħdu).
English: Rarely (less than 1 in 1000 patients): hives (urticaria).
Maltese: Rari (inqas minn pazjent wieħed minn kull 1000 pazjent): ħorriqija (urtikarja).
English: Depending on HPV type, 60-96% and 78-98% of subjects were seropositive by cLIA and IgG LIA respectively 10 years after vaccination (see Table 8).
Maltese: Skont it-tip ta' HPV, 60-96% u 78-98% tal-individwi kienu seropożittivi b'cLIA u IgG LIA rispettivament 10 snin wara t-tilqim (ara Tabella 8).
English: Silgard, suspension for injection.
Maltese: Silgard, suspensjoni għall-injezzjoni.
English: The individuals who were monitored using VRC-aided surveillance included 10,088 individuals (6,995 females 9 to 45 years of age and 3,093 males 9 to 26 years of age at enrolment) who received Silgard and 7,995 individuals (5,692 females and 2,303 males) who received placebo.
Maltese: 10,088 individwu (6,995 mara, ta' età bejn 9 u 45 sena, u 3,093 raġel ta' età bejn 9 u 26 sena fiż-żmien tar-reġistrazzjoni) li rċivew Silgard u 7,995 individwu (5,692 mara u 2,303 irġiel)li rċevew il-plaċebo.
English: The primary efficacy endpoints included HPV 6-, 11-, 16-, or 18-related vulvar and vaginal lesions (genital warts, VIN, VaIN) and CIN of any grade and cervical cancers (Protocol 013, FUTURE I), HPV 16- or 18-related CIN 2/3 and AIS and cervical cancers (Protocol 015, FUTURE II), HPV 6-, 11-, 16-, or 18-related persistent infection and disease (Protocol 007), and HPV 16-related persistent infection (Protocol 005).
Maltese: Ir-riżultati aħħarin primarji ta' l-effikaċja inkludew feriti tal-vulva u tal-vaġina marbuta ma' HPV 6-, 11-, 16-, jew 18- (felul ġenitali, VIN, VaIN) u CIN ta' kwalunkwe grad u kanċers ċervikali (Protokoll 013, Futur I), CIN 2/3 marbuta ma' HPV 16- jew 18- u AIS u kanċers ċervikali (Protokoll 015, FUTUR II), infezzjoni u marda persistenti marbuta ma' HPV 6-, 11-, 16-, jew 18 (Protokoll 007), u infezzjoni persistenti marbuta ma' HPV 16 (Protokoll 005).
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.
Maltese: Silgard huwa vaċċin mhux infettuż, rikombinanti, kwadrivalenti, adjuvanted ippreparat minn partikuli qishom virus-like particles (VLPs) ippurifikati ħafna tal-proteina maġġuri kapsida L1 tat-tipi ta' HPV 6, 11, 16 u 18.
English: Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed).
Maltese: Vaċċin għall-Papillomavirus Uman [Tipi 6, 11, 16, 18] (Rikombinanti, adsorbit).
English: CI)
Maltese: III
English: * Post-Marketing adverse events (frequency cannot be estimated from the available data).
Maltese: * Każijiet avversi ta' wara t-Tqegħid fis-Suq (il-frekwenza ma tistax tiġi stmata mid-dejta disponibbli).
English: Tlf: + 45 4482 4000 dkmail@merck.com
Maltese: MSD Danmark ApS Tlf: + 45 4482 4000 dkmail@merck.com
English: In the HPV naïve population (naïve to 14 common HPV types and had a negative Pap test at Day 1), Silgard reduced the proportion of women who experienced a definitive cervical therapy procedure (Loop Electro-Excision Procedure or Cold-Knife Conization) by 41.9% (95% CI: 27.7, 53.5) at end of study.
Maltese: Fil-popolazzjoni naïve għall-HPV(naïve għal 14-il tip ta' HPV komuni u li kellhom test Pap negattiv f'Jum 1), Silgard naqqas il-proporzjon ta' nisa li esperjenzaw, proċedura ta' terapija ċervikali definittiva (Loop Electro-Excision Procedure jew Cold-Knife Conization) b'41.9% (95% CI: 27.7, 53.5) fl-aħħar tal-istudju.
English: Alternatively, Silgard can be administered according to a 3-dose (0.5 ml at 0, 2, 6 months) schedule.
Maltese: B'mod alternattiv, Silgard jista' jingħata skont skeda ta' 3 dożi (0.5 ml fix-xhur 0, 2 u 6).
English: Nine cases (0.06%) of urticaria were reported in the Silgard group and 20 cases (0.15%) were seen in the adjuvant-containing placebo group.
Maltese: Disa' każijiet (0.06%) ta' urtikarja kienu rrappurtati fil-grupp ta' Silgard u 20 każ (0.15%) kienu osservati fil-grupp li kien qed jingħata s-sustanza li kien fiha l-plaċebo.
English: A clinical study (Protocol 016) compared the immunogenicity of Silgard 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' Silgard fi bniet li kellhom minn 10 sa 15-il sena ma' dik f'nisa ta' età bejn 16 u 23 sena.
English: The term "premalignant anal lesions" in section 4.1 corresponds to high-grade anal intraepithelial neoplasia (AIN 2/3).
Maltese: It-terminu "leżjonijiet anali premalinni" f'sezzjoni 4.1 jikkorrispondi għal neoplasja intraepiteljali anali ta' grad għoli (AIN 2/3).
English: In clinical trials, oral or other contraceptives (e.g. the pill) did not reduce the protection obtained by
Maltese: Fi provi kliniċi, kontraċettivi orali jew kontraċettivi oħrajn (eż. pilloli) ma naqqsux il-protezzjoni
English: Afterwards, the GMTs declined through Month 24 - 48 and then generally stabilized.
Maltese: Wara, ilGMTs naqsu minn Xahar 24 - 48 imbagħad b'mod ġenerali stabilizzaw.
English: Respiratory, thoracic and mediastinal disorders: Very rare: bronchospasm.
Maltese: Rari ħafna: bronkospażmu.
English: HPV types 16 and 18 are responsible for approximately 70% of cervical cancer cases, 75-80% of anal cancer cases; 70% of HPV-related pre-cancerous lesions of the vulva and vagina; 75% of HPV related pre-cancerous lesions of the anus.
Maltese: HPV tipi 16 u 18 huma responsabbli għal madwar 70% tal-każijiet ta' kanċer taċ-ċerviċi, 75-80% tal-każijiet ta' kanċer anali; 70% ta' leżjonijiet pre-kanserużi tal-vulva u tal-vaġina marbuta ma' HPV; 75% tal-feriti pre-kanserużi tal-anus marbuta ma' HPV.
English: Silgard is available in packs of 1, 10 or 20 vials.
Maltese: Silgard hu disponibbli f'pakketti ta' 1, 10 jew 20 kunjett.
English: For composite endpoints, statistically significant efficacy against disease was demonstrated against HPV types phylogenetically related to HPV 16 (primarily HPV 31) whereas no statistically significant efficacy was observed for HPV types phylogenetically related to HPV 18 (including HPV 45).
Maltese: Għal punti ta' tmiem komposti, l-effikaċja b'sinjifikat statistiku kontra l-marda ntweriet kontra tipi ta' HPV relatati filoġenetikament għal HPV 16 (primarjament HPV 31) billi ebda effikaċja li hija statistikament sinjifikanti ma ġiet osservata għal tipi ta' HPV filoġenetikament relatati ma' HPV 18 (inkluż HPV 45).
English: The impact of Silgard on rates of Definitive Cervical Therapy Procedures regardless of causal HPV types was evaluated in 18,150 individuals enrolled in Protocol 007, Protocols 013 and 015.
Maltese: L-impatt ta' Silgard fuq ir-rati ta' Proċeduri ta' Terapija Ċervikali Definittivi irrispettivament mit-tipi ta' HPV kawżali kien evalwat fi 18,150 individwu reġistrati fil-Protokoll 007, Protokolli 013 u 015.
English: Silgard may be administered concomitantly 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) with no significant interference with antibody response to any of the components of either vaccine.
Maltese: Silgard jista' jingħata fl-istess ħin ma' vaċċin booster kombinat li fih difterja (d) u tetnu (T) b'jew pertussi [aċellulari, komponent] (ap) u/jew poljomajelite [inattivat] (IPV) (vaċċini dTap, dT-IPV, TdaPdTap-IPV) mingħajr ebda interferenza sinifikanti b'rispons ta' antikorp għal kwalunkwe komponent ta' vaċċin jew ieħor.
English: Overall, 73% of women were naïve (PCR negative and seronegative) to all 4 HPV types at enrolment.
Maltese: B'mod ġenerali, 67% tal-individwi kienu naïve (negattivi u seronegattivi għal PCR) għall-4 tipi ta' HPV kollha fir-reġistrazzjoni.
English: Anal Intraepithelial Neoplasia (AIN) Grade 2/3 (moderate to high-grade dysplasia) was used in the clinical trials as a surrogate marker for anal cancer.
Maltese: Neoplasja Intraepiteljali Anali (AIN) ta' Grad 2/3 (displasja ta' grad minn moderat sa għoli) intużat fil-provi kliniċi bħala markatur sostitut ta' kanċer anali.
English: HPV 16- or HPV 18related CIN
Maltese: 0) għal HPV 18 rispettivament.
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.
Maltese: L-effikaċja ta' Silgard kontra AIN ta' gradi 2/3 marbuta ma' HPV 6, 11, 16, jew 18, fis-sottostudju MSM, kienet ta' 54.2% (95% CI: 18.0, 75.3; 18/275 kontra 39/276) u 57.5% (95% CI: -1.8, 83.9; 8/275 kontra 19/276 każijiet), rispettivament.
English: 1 dose (0.5 ml) contains approximately:
Maltese: Doża waħda (0.5 ml) fiha madwar:
English: Cervical Intraepithelial Neoplasia (CIN) Grade 2/3 (moderate to high-grade dysplasia) and adenocarcinoma in situ (AIS) were used in the clinical trials as a surrogate marker for cervical cancer.
Maltese: In-Neoplasja Intraepiteljali Ċervikali (CIN) ta' Grad 2/3 (displasja moderata sa grad għoli) u adenokarċinoma in situ (AIS) intużaw fi provi kliniċi bħala indikazzjoni sostituttiva għall-kanċer
English: However, a trend of lower anti-HPV GMTs was observed in the concomitant group.
Maltese: Madankollu, ġiet osservata tendenza aktar baxxa ta' GMTs kontra HPV fil-grupp konkomittanti.
English: Posology
Maltese: MANIFATTURI
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*
Maltese: Infezzjonijiet u infestazzjonijiet Mhux magħruf Ċellulite fis-sit tal-injezzjoni* Mhux magħruf Purpura tromboċitopenika idjopatika*, limfadenopatija* Mhux magħruf Reazzjonijiet ta' sensittività eċċessiva li jinkludu reazzjonijiet anafilattiċi/anafilaktojd* Disturbi fis-sistema nervuża Komuni ħafna Uġigħ ta' ras Mhux magħruf Enċefalomijelite akuta u mifruxa*, Sturdament Sindrome ta' Guillain-Barré*, sinkope xi kultant flimkien ma' ċaqliq toniku-kloniku* Nawsja
English: The efficacy of Silgard against CIN (any grade) and CIN 2/3 or AIS caused by 10 non-vaccine HPV types (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59) structurally related to HPV 16 or HPV 18 was evaluated in the combined Phase III efficacy database (N = 17,599) after a median follow-up of 3.7 years (at end of study).
Maltese: L-effikaċja ta' Silgard kontra CIN (kull grad) u CIN 2/3 jew AIS ikkawżati minn 10 tipi ta' HPV mhux vaċċin (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59) strutturalment relatati ma' HPV 16 jew ma' HPV 18, ġiet evalwata fid-database kombinata ta' l-effikaċja ta' Fażi
English: *Number of individuals with at least one follow-up visit after 30 days after Day 1 **Percent efficacy is calculated from the combined protocols.
Maltese: *Numru ta' individwi b'għallinqas żjara ta' follow-up waħda wara 30 jum wara Jum 1 **L-effikaċja perċentwali hija kkalkolata mill-protokolli kkombinati.
English: 1 Type 11 L1 protein
Maltese: Papillomavirus Uman 1 Proteina tip 11 L1
English: As with other vaccines, side effects that have been reported during general use include: swollen glands (neck, armpit, or groin); muscle weakness, abnormal sensations, tingling in the arms, legs and upper body, or confusion (Guillain-Barré Syndrome, acute disseminated encephalomyelitis); dizziness, vomiting, joint pain, aching muscles, unusual tiredness or weakness, chills, generally feeling unwell, bleeding or bruising more easily than normal, and skin infection at the injection site.
Maltese: Bħal b'vaċċini oħra, l-effetti sekondarji li ġew irrapportati matul l-użu ġenerali jinkludu: glandoli minfuħin (għonq, l-abt, jew l-irqiq ta' bejn iż-żaqq u l-koxxa); dgħufija fil-muskoli, sensazzjonijiet mhux normali, tingiż fid-dirgħajn, fir-riġlejn u fil-parti ta' fuq tal-ġisem, jew konfużjoni (Sindrome ta' Guillain-Barré, Enċefalomijelite akuta u mifruxa); sturdament, rimettar, uġigħ fil-ġogi, uġigħ filmuskoli, għeja mhux tas-soltu jew dgħufija, tkexkix ta' bard, tħossok ma tiflaħx b'mod ġenerali, ikollok fsada jew titbenġel b'mod aktar faċli mis-soltu, u infezzjoni fil-ġilda fil-post tal-injezzjoni.
English: Administer the entire dose as per standard protocol.
Maltese: Agħti d-doża kollha skond il-protokoll standard.
English: 0.5 ml suspension in a vial (glass) with stopper (FluroTec-coated or Teflon-coated chlorobutyl elastomer) and flip-off plastic cap (aluminium crimp band) in a pack size of 1, 10 or 20.
Maltese: Suspensjoni ta' 0.5 ml 0.5 ml f'kunjett (ħġieġ) b'tapp (miksi bil-FluroTec jew Teflon miksi bilchlorobutyl elastomer) u għatu tal-plastik flip-off (strixxa crimp ta' l-aluminju) f'pakkett ta' 1, 10 jew
English: CIN 3 and AIS have been accepted as immediate precursors of invasive cervical
Maltese: CIN 3 u AIS ġew aċċettati bħala prekursuri immedjati ta' kanċer ċervikali invażiv.
English: 1 Type 16 L1 protein
Maltese: Papillomavirus Uman 1 Proteina tip 16 L1
English: The primary time point analysis after 3 years did not reach statistical significance for all pre-specified endpoints.
Maltese: L-analiżi primarja tal-punt ta' tmiem wara 3 snin ma laħqitx sinifikat statistiku għall-punti ta' tmiem pre-speċifikati kollha.
English: Immune Responses to Silgard using a 2-dose schedule in individuals 9-13 years of age
Maltese: Risponsi immuni għal Silgard bl-użu tal-iskeda ta' 2 dożi f'individwi minn 9 snin sa 13-il sena
English: L1 protein in the form of virus-like particles produced in yeast cells (Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895)) by recombinant DNA technology.
Maltese: L1 proteina fis-sura ta' partikuli qishom virus prodotti fiċ-ċelluli tal-ħmira (Saccharomyces cerevisiae CANADE 3C-5 (Speċi 1895)) minn teknoloġija DNA rikombinanti. adsorbit fuq amorphous aluminium hydroxyphosphate sulphate adjuvant (0.225 milligramma Al).
English: 1 Type 18 L1 protein
Maltese: Papillomavirus Uman 1 Proteina tip 18 L1
English: The CD4% or plasma HIV RNA was not affected by vaccination.
Maltese: Is-CD4% jew l-RNA tal-HIV fil-plażma ma kinux
English: Table 4: Results for CIN 2/3 or AIS in Type-Specific HPV-Naïve Individuals
Maltese: Tabella 4: Riżultati għal CIN 2/3 jew AIS f'Individwi naïve għall-HPV Speċifiku għat-Tip † (riżultati
English: • the efficacy of Silgard against HPV 6-, 11-, 16-, 18-related VIN2/3 and VaIN 2/3 was 100%
Maltese: • l-effikaċja ta' Silgard kontra VIN2/3 u VaIN 2/3 relatata ma' HPV 6-, 11-, 16-, 18 kienet 100 %
English: Among 15,706 individuals who received Silgard and 13,617 individuals who received placebo, there were 39 cases of non-specific arthritis/arthropathy reported, 24 in the Silgard group and 15 in the placebo group.
Maltese: Fost it-15,706 individwi li rċivew Silgard u l-13,617-il individwu li rċivew il-plaċebo, kien hemm 39 każ ta' artrite/artropatija mhux speċifika li kienu rrappurtati, 24 fil-grupp ta'
English: Vaccination with Silgard is intended to protect against diseases caused by Human Papillomavirus (HPV) types 6, 11, 16, and 18.
Maltese: Proteina mhux infettiva ippurifikata b'mod qawwi għal kull wieħed mit-tipi ta' Papillomavirus Uman (6, 11, 16, u 18).
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' jkun akkompanjat minn diversi sinjali newroloġiċi bħal disturb temporanju fil-vista, parasteżija u ċaqliq toniku-kloniku tar-riġlejn waqt l-irkupru.
English: The data on Silgard administered during pregnancy did not indicate any safety signal.
Maltese: L-informazzjoni fuq Silgard mogħti waqt it-tqala ma tindikax l-ebda sinjal tas-sigurtà.
English: MSD Polska Sp. z o.o.
Maltese: MSD Italia S.r.l.
English: Overall, 83% of men (87% of heterosexual subjects and 61% of MSM subjects) were naïve (PCR negative and seronegative) to all 4 HPV types at enrolment.
Maltese: Globalment, 83% tal-irġiel (87% tal-individwi eterosesswali u 61% ta' individwi
English: There were no treatment related effects on developmental signs, behaviour, reproductive performance, or fertility of the offspring.
Maltese: Ma kien hemm l-ebda effetti marbuta malkura fuq sinjali ta' l-iżvilupp, imġiba, prestazzjoni riproduttiva, jew il-fertilità tal-frieħ.
English: In all populations (women 9 - 45 years, men 9 - 26 years), peak anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18 GMTs cLIA were observed at Month 7.
Maltese: Fil-popolazzjonijiet kollha (nisa minn 9 - 45 sena, irġiel minn 9 - 26 sena), l-ogħla GMTs cLIA kontra HPV 6, kontra HPV 11, kontra HPV 16, u kontra HPV 18 kienu osservati f'Xahar 7.
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) biex jistma l-persistenza tar-rispons immuni.
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
Maltese: Disa' snin wara t-tilqim, 94%, 96%, 99% u 60% kienu seropożittivi kontra HPV 6, kontra HPV 11, kontra HPV 16 u kontra HPV 18 f'cLIA, rispettivament, u 98%, 96%, 100% u 91% kienu seropożittivi kontra HPV 6, kontra HPV 11, kontra HPV 16 u kontra HPV 18
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.
Maltese: Tabella 6 tqabbel l-anti-HPV 6, 11, 16 u 18 GMTs xahar Wara d-Doża 3 fi bniet ta' bejn 9 u 15-il sena ma' dawk f'nisa ta' età bejn 16 u 26 sena.
English: In addition, in clinical trials adverse reactions that were judged to be vaccine- or placebo-related by the study investigator were observed at frequencies lower than 1%:
Maltese: Flimkien ma' dan, fi provi kliniċi, kienu osservati reazzjonijiet avversi li kienu meqjusa millinvestigatur ta' l-istudju bħala li huma marbuta mal-vaċċin jew mal-plaċebo fi frekwenzi ta' inqas minn 1%:
English: The primary efficacy endpoints included the combined incidence of HPV 6-, 11-, 16- or 18-related and the combined incidence of HPV 16- or HPV 18-related persistent infection (6 month definition), genital warts, vulvar and vaginal lesions, CIN of any grade, AIS, and cervical cancers.
Maltese: Il-punti ta' tmiem primarji tal-effikaċja nkludew l-inċidenza kombinata ta' infezzjoni persistenti relatata ma' HPV 6, 11, 16 jew 18 u l-inċidenza kombinata ta' infezzjoni persistenti relatata ma' HPV 16 jew HPV 18 (definizzjoni ta' 6 xhur), felul ġenitali, leżjonijiet vulvari u vaġinali, CIN ta' kwalunkwe grad, AIS, u kanċers ċervikali.
English: Silgard is available in packs of 1, 10 or 20 pre-filled syringes.
Maltese: Silgard hu disponibbli f'pakketti ta' 1, 10 jew 20 siringa mimlija għal-lest.
English: Table 1 presents vaccine-related adverse reactions which were observed among recipients of Silgard at a frequency of at least 1.0% and also at a greater frequency than observed among placebo recipients.
Maltese: Tabella 1 tippreżenta r-reazzjonijiet avversi marbuta mat-tilqima li kienu osservati fost ir-reċipjenti ta' Silgard fi frekwenza ta' mill-anqas 1.0 % u anke fi frekwenza akbar minn dik li kienet osservata fost ir-reċipjenti tal-plaċebo.
English: In the second CIN 3 case observed in a patient infected with HPV 51 at Day 1 (in 2 of 9 specimens); HPV 16 was detected at a Month 51 biopsy (in 1 of 9 specimens) and HPV 56 was detected in 3 of 9 specimens at Month 52 in tissue excised during LEEP. ***Patients were followed for up to 4 years (median 3.6 years) Note: Point estimates and confidence intervals are adjusted for person-time of follow-up.
Maltese: Xahar 51 (f'1 minn 9 kampjuni) u HPV 56 ġie rilevat fi 3 minn 9 kampjuni wara Xahar 52 f'tessut imneħħi waqt LEEP. ***Il-pazjenti ġew segwiti sa perijodu ta' 4 snin (medjan 3.6 snin)